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Operating instructions
Datascope
AS
™
A n e s t h e s i A D e l i v e ry s ys t e m
0070-01-0684-02_revB_AS3000 ops color.indd 1 3/10/10 5:14:09 PM
Operating instructions
Datascope
AS
™
A n e s t h e s i A D e l i v e ry s ys t e m
AS3000
™
is a U.S. trademark of Mindray DS USA, Inc.
Passport 2
®
is a U.S. registered trademark of Mindray DS USA, Inc.
Selectatec
®
is a registered trademark of Ohmeda.
Spectrum
®
is a U.S. registered trademark of Mindray DS USA, Inc.
Spectrum OR
™
is a U.S. trademark of Mindray DS USA, Inc.
Copyright
© Mindray DS USA, Inc., 2008. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Mindray DS USA, Inc.
AS3000™ Operating Instructions 0070-10-0684-01
Table of Contents
AS3000™ Operating Instructions 0070-10-0684-01 i
Table of Contents ii
(FiO
2
)...................................................................................................................................2 - 25
2
Absorbers ..............................................................................................................................................4 - 2
2
Absorber Resistance.........................................................................................................................5 - 2
2
Absorber Capacity...........................................................................................................................5 - 2
0070-10-0684-01 AS3000™ Operating Instructions
Table of Contents
Sensor ......................................................................................................................................5 - 8
Flush ........................................................................................................................................5 - 10
AS3000™ Operating Instructions 0070-10-0684-01 iii
Table of Contents
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iv 0070-10-0684-01 AS3000™ Operating Instructions
Foreword Introduction
Foreword
The AS3000 Anesthesia Delivery System Operating Instructions are intended to provide information for proper operation.
General knowledge and understanding of the features and functions of the AS3000
Anesthesia Delivery System are prerequisites for its proper use.
NOTE: Do not operate this system before reading these instructions.
Information for servicing this instrument is contained in the AS3000 Anesthesia Delivery
System Service Manual, part number 0070-00-0683. For additional information or assistance, please contact an authorized representative in your area.
CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician or other practitioner licensed by state law to use or order the use of this device.
NOTE: Figures in this manual are provided for reference purposes only. Screens will likely differ based on the system configuration and selected parameters.
Warnings, Cautions, and Notes
Please adhere to all warnings, cautions, and notes that are listed throughout this manual.
A WARNING is provided to alert the user to potential serious outcomes (death, injury, or serious adverse events) to the patient or the user.
A CAUTION is provided to alert the user to use special care necessary for the safe and effective use of the device. They may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware. Cautions are also provided to alert the user to the adverse effects on this device due to misuse and the care necessary to avoid such effects.
A NOTE is provided when additional general information is applicable.
AS3000™ Operating Instructions 0070-10-0684-01 v
vi
Introduction Warnings
Warnings
WARNING: In order to prevent an electric shock, the machine
(protection class I) may only be connected to a correctly grounded mains connection (socket outlet with grounding contact).
WARNING: Possible explosion hazard. Do not operate machine near flammable anesthetic agents or other flammable substances. Do not use flammable anesthetic agents (i.e., ether or cyclopropane.)
WARNING: The use of anti-static or electrically conductive breathing tubes, when utilizing high frequency electric surgery equipment, may cause burns, and is therefore not recommended in any application of this machine.
WARNING: Possible fire hazard. Fuses (i.e., additional sockets) must only be replaced by fuses of the same type and with the same rating.
WARNING: Possible electric shock hazard. The machine may only be opened by authorized service personnel.
WARNING: Do not use a broken unit or accessory. Periodically check all cables (e.g., AC line cord and patient connection cables) for damage that may occur through normal use. Replace cable if damaged in any way.
WARNING: Compressed gasses are considered Dangerous Goods/
Hazardous Materials per I.A.T.A. and D.O.T. regulations. It is a violation of federal and international law to offer any package or over pack of dangerous goods for transportation without the package being appropriately identified, packed, marked, classified, labeled, and documented according to D.O.T. and I.A.T.A. regulations.
Please refer to the applicable I.A.T.A. Dangerous Goods
Regulations and/or the Code of Federal Regulations 49
(Transportation, Parts 171-180) for further information.
WARNING: The patient should be visually monitored by qualified personnel. In certain situations, life-threatening circumstances may occur which may not necessarily trigger an alarm.
WARNING: Always set the alarm limits so that the alarm is triggered before a hazardous situation occurs. Incorrectly set alarm limits may result in operating personnel not being aware of drastic changes in the patient’s condition.
WARNING: This machine must only be operated by trained, skilled medical staff.
WARNING: Connection of equipment to the auxiliary mains socket outlet(s) may increase the leakage currents to values exceeding the allowable limits.
WARNING: Electric shock and fire hazard: Do not clean the machine while it is on and/or plugged in.
WARNING: Disconnect the power plug from the mains supply before removing the rear panels or servicing the AS3000 unit.
0070-10-0684-01 AS3000™ Operating Instructions
Warnings
WARNING: Independent means of ventilation (e.g. a self-inflating manually powered resuscitator with mask) must be available whenever the AS3000 is in use.
WARNING: Malfunction of the central gas supply system may cause more than one or even all devices connected to it to stop their operation simultaneously.
WARNING: The anesthesia system will cease to deliver gas at pressures below the minimum specified gas pipeline supply pressure.
WARNING: Use a cleaning and disinfection schedule that conforms to your institution's disinfection and risk-management policies.
• Refer to the material safety data as applicable.
• Refer to the operation and maintenance manuals of all disinfection equipment.
• Do not inhale fumes that may result from any disinfection process.
WARNING: Use extreme care while handling the absorbent as it is a caustic irritant.
WARNING: Use care in lifting and manipulating vaporizers during the mounting process as their weight may be greater than expected, based on their size and shape.
WARNING: Use care in lifting and manipulating the breathing system block during removal from its mounting arm as handling may be awkward due to its weight and shape.
WARNING: Do not use talc, zinc stearate, calcium carbonate, corn starch or similar material to prevent sticking of the bellows, as these materials may enter the patient's lungs or airway, causing irritation or injury.
WARNING: All gas supplies should be of medical grade.
WARNING: Single use respiratory hoses and face masks should not be reused.
WARNING: To avoid endangering a patient, do not perform testing or maintenance when the machine is in use.
WARNING: Review the performance specifications of the disposal system with which the transfer and receiving systems are intended to be used, to ensure compatibility.
WARNING: The AS3000 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the
AS3000 should be observed to verify normal operation in the configuration in which it will be used.
WARNING: Ensure that the current alarm presets are appropriate prior to use on each patient.
WARNING: Ensure that both O
2
and N
2
O flow controllers are turned
OFF fully at the start and at the end of each case.
WARNING: Due to the size and weight of the A3000, it should only be moved by qualified personnel.
AS3000™ Operating Instructions 0070-10-0684-01
Introduction vii
Introduction
WARNING: To avoid tip hazards, use care when moving the AS3000 up or down inclines, around corners and across thresholds.
Remove all monitoring equipment mounted to the side of the AS3000 prior to transport. Do not attempt to roll the
AS3000 over hoses, cords or other obstacles.
WARNING: Remove all equipment from the top shelf of the AS3000 before moving.
WARNING: Do not remove the absorber canister while the ventilator is running in an automatic ventilation mode. This should only be done in STANDBY mode with no patient connected.
Warnings viii 0070-10-0684-01 AS3000™ Operating Instructions
Cautions
Cautions
CAUTION: Perform the daily checks specified on the checklist and, in case of a fault, do not operate the system until the fault has been corrected.
CAUTION: Before starting the machine, users must be familiar with the information contained in these Operating Instructions and must have been trained by an authorized representative.
CAUTION: If the machine does not function as described, it must be examined and repaired as necessary by qualified service personnel before being returned to use.
CAUTION: Handle the machine with care to prevent damage or functional faults.
CAUTION: Ensure that the gas supply of the machine always complies with the technical specifications.
CAUTION: Before clinical use, the machine must be correctly calibrated and/or the respective tests must be performed, as described in these Operating Instructions.
CAUTION: If faults occur during the initial calibration or testing, the machine should not be operated until those faults have been corrected by a qualified service person.
CAUTION: After servicing, functional, sensor, and system tests must be performed before clinical use.
CAUTION: Only bacterial filters with a low flow resistance should be connected to the Breathing System and/or the patient connection.
CAUTION: After changing the CO
2 system leak test.
pre-paks, perform a fresh-gas
CAUTION: After changing the loose fill absorbent, perform a fresh-gas system leak test.
CAUTION: Only vaporizers with Interlock-System may be used with the AS3000 unit.
CAUTION: After each exchange of a vaporizer, perform a fresh-gas system leak test.
CAUTION: Use cleaning agent sparingly. Excess fluid could enter the machine, causing damage.
CAUTION: Do not autoclave any parts of the AS3000 unless specifically identified as autoclaveable in this manual. Clean the
AS3000 only as specified in this manual.
CAUTION: Do not autoclave the airway pressure limiting (APL) valve.
CAUTION: This Anesthesia System is NOT suitable for use in a magnetic resonance imaging (MRI) environment.
CAUTION: To prevent system damage:
AS3000™ Operating Instructions 0070-10-0684-01
Introduction ix
Introduction x
Cautions
• Refer to the literature supplied by the manufacturer of the cleaning agent.
• Never use organic, halogenated or petroleum-based solvents, anesthetics, glass cleaning agents, acetone or other irritant agents.
• Never use abrasive agents (i.e. steel wool or silver polish) to clean components.
• Keep all liquids away from electronic components.
• Prevent liquid from entering the equipment.
• All cleaning solutions used must have a pH between 7.0 and 10.5.
CAUTION: Never immerse the oxygen sensor or its connector in any type of liquid.
• Dispose of the oxygen sensor per the manufacturer’s specification.
CAUTION: Do not use acetic hydroperoxide or formaldehyde steaming.
CAUTION: The valve disc is fragile and must, therefore, be handled with care while removing the valve cage from the valve assembly.
CAUTION: The valve disc is fragile and must, therefore, be handled with care while removing it from the valve cage.
CAUTION: If moisture remains in the bellows after cleaning, it may become tacky.
CAUTION: Communications connectors are for Service Technician use only. Any computer connected to this equipment must comply with IEC 60950.
CAUTION: Do not wash the inner surface of the oxygen sensor.
CAUTION: Do not autoclave the oxygen sensor.
CAUTION: Prior to use after cleaning or disinfecting, power up the
system as described in section 2.6 and follow the on-screen
prompts to perform the Leak Test and the Compliance Test.
CAUTION: The PAW gauge and oxygen sensor cannot withstand immersion or the heat and pressure of autoclaving.
CAUTION: When installing absorber Pre-Paks assure the bottom of the
Pre-Pak rests on the top of the gasket inside the absorber canister.
CAUTION: Users should monitor oxygen percentage (O2%) when using the Auxiliary O2/AIR Flow Meters. Unknown oxygen concentrations may be delivered to the patient unless oxygen monitoring is used.
CAUTION: Verify that the bellows is fully inflated before starting an automatic ventilation mode on the patient. If the bellows is deflated and at the bottom of its travel at the start of an automatic ventilation mode, the bellows may become deformed.
0070-10-0684-01 AS3000™ Operating Instructions
Notes Introduction
Notes
NOTE:
NOTE:
NOTE:
NOTE:
NOTE:
NOTE:
NOTE:
NOTE:
NOTE:
The AS3000 is intended to be operated with its integral
Breathing Pressure monitoring in use.
The AS3000 is intended to be operated with its integral
Breathing Pressure limitation devices in use.
The AS3000 is intended to be operated with its integral
Exhaled Volume monitoring in use.
The AS3000 is intended to be operated with its integral
Breathing System integrity Alarm System in use.
The AS3000 is intended to be operated with its integral
Continuing Pressure Alarm in use.
The AS3000 is intended to be operated with its integral O
2 monitoring in use.
The AS3000 is intended to be operated with an external
CO
2
CO
2
monitor complying with ISO 21647. Connection to the
monitor should be via a sample line from the Patient
Circuit.
Any Anesthesia Vapor Delivery Device is to be used with an
Anesthetic Agent Monitor complying with ISO 21647.
Connection to the Agent monitor should be via a sample line from the Patient Circuit.
The AS3000 batteries are not user serviceable components.
Only an authorized service representative can replace the batteries. If the system is not used for an extended period, contact a service representative to have the batteries disconnected. The batteries may be subject to local regulations regarding disposal. At the end of the battery life, dispose of the batteries in accordance with any local regulations.
Intended Use
The AS3000 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient's ventilation.
The AS3000 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.
Unpacking
Remove the machine from the shipping carton and examine it for signs of shipping damage.
Save all packing materials, invoice, and bill of lading. These may be required to process a claim with the carrier. Check all materials against the packing list. Contact the Customer
Service Department at (800) 288-2121 or (201) 995-8237 for prompt assistance in resolving shipping problems.
AS3000™ Operating Instructions 0070-10-0684-01 xi
Introduction
Symbols
The following table provides descriptions of symbols that are used on the device and/or within this manual.
SYMBOL DESCRIPTION
Attention, Consult
Accompanying Documents /
Refer to Manual
Low priority message
SYMBOL DESCRIPTION
Type BF Equipment
Alarm Icon
Medium priority message Alarm Mute Icon
High priority message
Equipotentiality
Alternating Current (AC)
Full Battery Indicator
Low Battery Indicator
Internal Battery
Protective Earth (Ground)
Fuse
Catalog Number
Latex-free product
Interference may occur in the vicinity of equipment marked with this symbol
Plug Icon
Serial Number
Lock
Unlock
Date Code
Recycle
Separate treatment from general waste at end of life
Symbols xii 0070-10-0684-01 AS3000™ Operating Instructions
1.0
Product Description
FIGURE 1-1 The AS3000 Anesthesia Delivery System
AS3000™ Operating Instructions 0070-10-0684-01 1 - 1
General System Overview
1.1
1 - 2
1.1.1
1.1.2
Product Description
General System Overview
The AS3000 is a continuous flow anesthesia system which offers manual or automatic ventilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems.
Anesthesia Ventilator
The AS3000 ventilator offers multiple ventilation modes: Controlled Mandatory Ventilation with volume control (CMV), Pressure Control Ventilation (PCV), Synchronized Intermittent
Mandatory Ventilation (SIMV), and Pressure Support (PS) ventilation. Electronic PEEP is available in all ventilation modes. User control over inspiratory flow (SLOPE) is possible in
PCV, SIMV, and PS modes. Automatic fresh gas compensation limits the effect on the patient of user changes in fresh gas flow rate. The traditional bellows system is driven by oxygen and makes patient disconnections clearly visible.
Fresh Gas Dosing
The AS3000 fresh gas dosing subsystem offers the following features:
• Dual-flow tubes (backlit for dark room viewing) to display the O
2 at all times
, N
2
O, and Air flows
• A knob guard to prevent inadvertent movement of the flow control knobs
• Gas supply gauges to indicate the gas pipeline supply pressures and gas cylinder pressures
• An auxiliary O
2
flow meter
• An auxiliary Air flow meter
• An O
2
flush button
Safety systems within the AS3000 work to prevent hypoxic mixtures from being delivered to the patient. Nitrous oxide will not be delivered unless oxygen pressure is present. A mechanical safety system assures that at least 21% O
2
is present when setting mixtures of O
2 and N
2
O.
OFF fully at the start and at the end of each case.
All AS3000 units noted with Model No. 0998-00-3024-02 are designed to maintain a safe
O
2
:N
2
O ratio by allowing nitrous oxide to be set to a flow rate that is proportional to a previously adjusted flow of oxygen. The N
2
O flow is limited by the flow of O
2
so that a safe ratio of no less than 21% oxygen can be maintained. This version is designed to maintain oxygen flow at its previously set level when N
2
O is decreased.
When the user is adjusting N
2
O and O
2
flow rates, always adjust the oxygen flow first to enable the nitrous oxide flow. To add N
2
O to the fresh gas flow, the user must fully open the
N
2
O flowmeter valve, but only after opening the O
2
flowmeter valve.
All AS3000 units noted with Model No. 0998-00-3024-01 maintain a safe O
2
:N
2
O ratio by adding O
2
flow as the user increases the N
2
O flow. This version is not designed to maintain oxygen flow at the highest flow level achieved when nitrous oxide is decreased.
0070-10-0684-01 AS3000™ Operating Instructions
Product Description
1.1.3
1.1.4
1.1.5
1.1.6
General System Overview
For AS3000 models noted with Model No. 0998-00-3024-01, the user can avoid redundant steps when adjusting N
2
O and O
2
by always adjusting the O
2
flow after adjusting N
2
O flow. This will assure that the desired oxygen flow is achieved.
Vaporizer Mounting
The AS3000 contains a 2-position Selectatec type vaporizer mounting system. Lighting incorporated above the vaporizers enables them to be seen in a darkened environment.
Breathing System
The AS3000 breathing system is heated to minimize condensation inside the block and to return the patient's moisture. The breathing system provides access to the APL valve and breathing bag along with a view of the mechanical breathing pressure gauge. The APL valve has a single turn knob that provides a clear view of the manual breathing pressure setting.
The absorber assembly incorporates a cam lock device that opens and closes to provide access to the absorber canisters. CO
2
absorbent pre-paks or loose fill can be used (see
Chapter 4, Accessories). A water trap that can be drained is also provided on the absorber
assembly.
Two (2) flow sensors in the breathing system measure inspired and exhaled gases for control and monitoring. Spirometry is standard. Inspired oxygen concentration is monitored via a fuel-cell type sensor and breathing pressure is also monitored. The breathing system can be swiveled for ease of positioning. A test plug is provided between the two main hose connections to allow for automated leak testing during startup. Connection to the Anesthesia
Gas Scavenging System (AGSS) is made from the bottom rear of the breathing system.
Power Management
The advanced power management system of the AS3000 provides AC power for its main system functions while also charging its internal batteries. In the case of an AC power failure, the AS3000 will operate for a minimum of 45 minutes on battery power. A recessed main switch is provided to power the system ON and OFF.
The four (4) auxiliary AC outlets provided on the rear of the machine operate independent of the main switch position.
Workplace Ergonomics
The AS3000 is a full-featured anesthesia delivery work station. The raised perimeter of its stainless steel work surface controls items that might otherwise roll or slide off its edge. The work surface light has high and low brightness settings. Its wrap-around handle enables fine positioning of the machine. Three (3) large drawers are available for storage. The top drawer is lockable with a key. Rail mounts are provided on both sides of the machine to enable positioning of system elements and mounting of patient monitors and most standard attachment arms for other devices. A non-slip footrest and brakes for the front wheels are provided. The top shelf can be used for additional equipment.
AS3000™ Operating Instructions 0070-10-0684-01 1 - 3
Responsibilities of Operators
1.2
Product Description
Responsibilities of Operators
The proper function of the AS3000 system can only be guaranteed if it is operated and serviced in accordance with the information provided in this manual and the AS3000
Service Manual. Non-compliance with this information voids all guarantee claims.
NOTE: This manual only describes the operation of the machine.
Information about service and repair is contained in the
AS3000 Service Manual.
The machine must be operated by qualified and trained personnel only. All operators must fully observe these operating instructions and relevant additional documentation. They must also comply with the WARNINGS and CAUTIONS detailed in this manual.
1 - 4 0070-10-0684-01 AS3000™ Operating Instructions
Product Description
1.3
Key Features
FEATURE
Display
Navigation
Ventilation
Fresh Gas Delivery
Breathing System
Work Surface
Electronic PEEP
Clear Data Display
DESCRIPTION
10.4 inch color liquid crystal display
Hard keys and Navigator
™
Knob for easy navigation
Multiple advanced modes of ventilation: CMV, PCV,
SIMV, PS
Dual Flow Tubes for ease of use
3 cylinder mount locations on rear
Heated, adjustable swivel, front hose ports, single turn APL valve
Large stainless steel
Additional Rail mount extended work surface
Positive End Expiratory Pressure (PEEP) is set and controlled electronically.
2 large waveforms for pressure and volume or
Spirometry Loops - standard
Key Features
AS3000™ Operating Instructions 0070-10-0684-01 1 - 5
User Interface
1.4
Product Description
User Interface
The Display of the User Interface (described in section 1.4.1) provides waveforms, numeric
data and menu tabs. The keys and Navigator
™
Knob of the Keypad Area (described in
section 1.4.2) enable the user to power up the system, silence alarms, access menu tabs, and
switch between manual and mechanical ventilation. The following figure is an example of the
User Interface with the display during system power-up.
Keypad Area
Display Navigator
™
Knob
FIGURE 1-2 Example of the User Interface with the display during system power-up
1 - 6 0070-10-0684-01 AS3000™ Operating Instructions
Product Description User Interface
1.4.1
Alarm
Icon Area
1
Display
FIGURE 1-3 and the descriptions that follow provide an overview of the Display.
Alarm Message
Area
Date and
Time
Power
Source
4
Patient
Type Tile
5
Ventilation
MODE Tile
6
7
Waveform
Area
8
Parameter
Area
9
User
Message
Area
Parameter
Setup Tiles
FIGURE 1-3 Display
1. Alarm Icon Area
When any parameter enters an alarm state, an Alarm Icon
Pressing the MUTE key displays an Alarm Mute Icon
is displayed in this area.
in this area with a 120 second
countdown timer. (See item 4 in section 1.4.2 for a complete description of the MUTE key.)
2. Alarm Message Area
Technical messages and functional alarm messages are displayed in this area. See sections
2.12.3.1 and 2.12.3.2 for table listings of the individual messages and their associated
priority levels. High priority messages are red. Medium and low priority messages are yellow. Up to 2 messages can be displayed in this area.
AS3000™ Operating Instructions 0070-10-0684-01 1 - 7
User Interface
1 - 8
Product Description
3. Date and Time
From the Date sub-menu of the System menu tab, the date can be configured to display in one of the following formats: MM/DD/YY, DD/MM/YY or YY/MM/DD. The default format is MM/DD/YY. From the Time sub-menu of the System menu tab, the time can be adjusted and configured to display in 12-hour or 24-hour format. The default format is 12-hour.
4. Power Source
A Plug Icon and Battery Indicator are always present and will illuminate as follows:
Plug Icon
While the system is functioning on AC power, the plug icon is constantly illuminated.
During battery operation, the plug icon flashes.
Battery Indicator
Full Battery Low Battery
When batteries are installed and the system is functioning on battery power, the battery indicator provides a visual reference for the approximate charge level of the batteries.
5. Patient Type Tile
NOTE: The ventilation mode must be set to STANDBY in order to change the patient type. The default patient type on powerup is Adult.
Rotating the Navigator
™
Knob to this tile highlights the current setting. Pressing the
Navigator
™
Knob while this tile is highlighted will toggle the patient type between Adult and Child.
6. Ventilation MODE Tile
NOTE: STANDBY is the default ventilation mode at startup.
During normal operation, this tile displays the current ventilation mode. It is also used to choose a different ventilation mode. Press the Navigator
™
Knob while this tile is highlighted and rotate the knob in either direction to scroll through the following ventilation modes:
STANDBY, MANUAL, CMV, PCV, SIMV, and PS.
When the desired mode is displayed, press the Navigator
™
Knob to select it. The tile will flash to indicate that a new mode is pending. The parameter setup tiles associated with the selected ventilation mode will be displayed. Before activating the new mode (i.e. while the new mode is pending), the Navigator
™
Knob can be used to adjust each associated
parameter. (See item 10 in this section for descriptions of the parameter setup tiles and how
to adjust settings.)
NOTE: A message will be displayed in the user message area to indicate that the displayed parameter values are for the pending ventilation mode.
0070-10-0684-01 AS3000™ Operating Instructions
Product Description User Interface
With all parameters set, rotate the Navigator
™
Knob back to the ventilation MODE tile and press the knob to activate the new ventilation mode.
NOTE: If the new ventilation mode has not yet been activated and the Navigator
™
Knob is not pressed or rotated for 15 seconds, a time-out will occur, causing the display to revert back to the previous mode and its associated parameters.
7. Waveform Area
One of the following three waveform configurations will be displayed in this area:
• Pressure vs. Time and Flow vs. Time waveforms (see the example in FIGURE 2-14)
• Pressure-Volume Spirometry Loop (see the example in FIGURE 2-15)
• Flow-Volume Spirometry Loop (see the example in FIGURE 2-16)
The default waveform configuration is Pressure vs. Time and Flow vs. Time.
NOTE: When in STANDBY ventilation mode, the X and Y-axes for
Pressure vs. Time and Flow vs. Time are displayed, but the waveforms are inactive.
8. Parameter Area
Patient parameters are displayed in this area in the following 3 parameter groups:
• Pressure (see section 2.11.1)
• FiO
2
(Inspired O
2
9. User Message Area
The following user messages are displayed in this area:
MESSAGE
Displayed parameter values are for the pending mode!
Ventilator setting is not possible!
Pressure, Volume and Apnea Alarms are
OFF.
Automatic Ventilation not available!
Current ventilation mode is xxx.
REASON
The ventilation MODE tile is flashing.
The attempted parameter setting is not possible.
Alarms have been turned off in MANUAL mode.
During the initial power-up System Self Test, failures have been encountered with the PEEP valve, Inspiratory sensor or Inspiratory valve.
Indicates the current ventilation mode when the ventilation mode tile is flashing.
10. Parameter Setup Tiles
The eight (8) parameter setup tiles are used to display and adjust the parameter settings.
Pressing the Navigator
™
Knob when a parameter setup tile is highlighted selects the tile for setting adjustment. Rotating the Navigator
™
Knob clockwise will increase the setting and rotating it counterclockwise will decrease the setting. The range of settings for each parameter has a maximum and minimum value.
AS3000™ Operating Instructions 0070-10-0684-01 1 - 9
User Interface Product Description
NOTE: If setting adjustments have not yet been accepted, and the
Navigator
™
Knob is not pressed or rotated for 15 seconds, a time-out will occur, causing the display to revert back to the previous settings.
The layout of the parameter setup tiles varies with the chosen ventilation mode as indicated in the following table:
Tile #1
Tile #2
Tile #3
Tile #4
Tile #5
Tile #6
Tile #7
Tile #8
STANDBY
Blank
Blank
Blank
Blank
Blank
Blank
Blank
Blank
CMV
V
T
Freq
I:E
T
P
PEEP
Blank
Blank
Blank
VENTILATION MODE
PCV
P
TARGET
Freq
I:E
Blank
PEEP
Blank
Blank
T
SLOPE
SIMV
V
T
Freq
T
INSP
T
P
PEEP
ΔP
Trigger
T
SLOPE
PS
Blank
Freq
MIN
Blank
Blank
PEEP
ΔP
Trigger
T
SLOPE
MANUAL
Blank
Blank
Blank
Blank
Blank
Blank
Blank
ALARM
a. V
T
(Tidal Volume) – The V
T
unit of measure is ml and it has separate default settings for the Adult and Child patient types.
• The range of settings for the Adult patient type is 40 to 1400 ml, in increments of 10 ml and its default is 600 ml.
• The range of settings for the Child patient type is 40 to 1400 ml, in increments of 10 ml and its default is 120 ml.
NOTE: This parameter is available in the CMV and SIMV with
PS ventilation modes.
b. Freq (Frequency) – The Freq unit of measure is bpm. It has separate default settings for the Adult and Child patient types that vary depending on the chosen ventilation mode as follows:
CMV and PCV
• The range of settings for the Adult patient type is 4 to 60 bpm, in increments of
1 bpm and its default is 8 bpm.
• The range of settings for the Child patient type is 4 to 60 bpm, in increments of
1 bpm and its default is 20 bpm.
SIMV with PS
• The range of settings for the Adult patient type is 2 to 60 bpm, in increments of
1 bpm and its default is 4 bpm.
• The range of settings for the Child patient type is 2 to 60 bpm, in increments of
1 bpm and its default is 4 bpm.
1 - 10 0070-10-0684-01 AS3000™ Operating Instructions
Product Description User Interface
c. I:E (Ratio of Inspiratory Time to Expiratory Time) – The I:E ratio does not have a unit of measure. The range of settings for both the Adult and Child patient types is 4:1 to 1:5, in increments of 0.5 and its default is 1:2.
NOTE: This parameter is available in the CMV and PCV ventilation modes.
d. T
INSP
(Inspiratory Time) – The T
INSP
unit of measure is sec and it has separate settings for the Adult and Child patient types.
• The range of settings for the Adult patient type is 0.2 to 5.0 seconds, in increments of 0.1 seconds and its default is 2 seconds.
• The range of settings for the Child patient type is 0.2 to 5.0 seconds, in increments of 0.1 seconds and its default is 1 second.
NOTE: This parameter is available in the SIMV with PS ventilation mode only.
e. PEEP (Positive End-Expiratory Pressure) – The PEEP unit of measure is
cmH
2
O. The range of settings for both the Adult and Child patient types is Off and
3 to 30 cmH
2
O, in increments of 1 cmH
2
O. Its default is Off.
NOTE: This parameter is available in the CMV, PCV, SIMV with PS, and PS ventilation modes.
f. Freq
MIN
(Frequency Min) – The Freq
MIN
unit of measure is bpm and it has separate settings for the Adult and Child patient types.
• The range of settings for the Adult patient type is 2 to 60 bpm, in increments of
1 bpm and its default is 2 bpm.
• The range of settings for the Child patient type is 2 to 60 bpm, in increments of
1 bpm and its default is 4 bpm.
NOTE: This parameter is available in the PS ventilation mode only.
g. T
P
(Inspiratory Pause) – The T
P
unit of measure is %. The range of settings for both the Adult and Child patient types is Off and 5 to 60%, in increments of 5%. Its default is 10%.
NOTE: This parameter is available in the CMV and SIMV with
PS ventilation modes.
h. Trigger (Flow Trigger) – The Trigger unit of measure is L/min and it has separate settings for the Adult and Child patient types.
• The range of settings for the Adult patient type is 1 to 15 L/min, in increments of
1 L/min and its default is 3 L/min.
• The range of settings for the Child patient type is 1 to 15 L/min, in increments of
1 L/min and its default is 2 L/min.
NOTE: This parameter is available in the SIMV with PS and
PS ventilation modes.
AS3000™ Operating Instructions 0070-10-0684-01 1 - 11
User Interface Product Description
i. P
TARGET
(Target Pressure) – The P
TARGET
unit of measure is cmH of settings for both the Adult and Child patient types is 5 to 70 cmH
2 increments of 1 cmH
2
2
O. The range
O, in
O. The default for the Adult patient type is 20 cmH default for the Child patient type is 10 cmH
2
O.
2
O. The
NOTE: This parameter is available in the PCV ventilation mode only.
j. ΔP (Differential Target Pressure) – The ΔP unit of measure is cmH
2
O. The range of settings for both the Adult and Child patient types is 3 to 50 cmH
2 increments of 1 cmH
2
O. The default for the Adult patient type is 5 cmH
2 default for the Child patient type is 5 cmH
2
O.
O, in
O. The
NOTE: This parameter is available in the SIMV with PS and
PS ventilation modes.
k. T
SLOPE
(Inspiratory Slope) – The T
SLOPE
unit of measure is sec. The range of settings for both the Adult and Child patient types is 0 to 2 seconds, in increments of
0.1 seconds. Its default is 0.5 seconds.
NOTE: This parameter is available in the PCV, SIMV with PS, and PS ventilation modes.
1 - 12 0070-10-0684-01 AS3000™ Operating Instructions
Product Description
1.4.2
User Interface
Keypad Area
The following provides a brief explanation of the components of the Keypad Area (shown
1. AC Power LED
A green LED that is used to indicate that the unit is connected to the AC Power within the facility.
2. MANUAL/AUTO key
Press this key to change the current ventilation mode to manual mode. Each successive key press will toggle between manual mode and the previously selected ventilation mode.
3
2
4
3. ALARM LIMITS key
Press this key to open the Alarm menu tab. If the
Alarm menu tab is already open when the ALARM
LIMITS key is pressed again, the Alarm menu tab will close.
5
4. MUTE key
Press this key to mute (silence) audio alarm tones for all currently alarming parameters for 120 seconds or until the alarm conditions are no longer present. Any new alarms that occur while the alarm tone is muted will disable the mute and sound the new alarm tone.
While the alarms are muted, an Alarm Mute icon with a 120 second countdown timer is presented in the upper left corner of the display.
7
8
FIGURE 1-4 Keypad Area
5. SPIROMETRY key
This key toggles the waveform area between the Pressure vs. Time and Flow vs. Time waveforms and the two (2) loop display configurations of the Spirometry Loop Window
The first key press displays the “Pressure-Volume” loop display configuration. The second key press displays the “Flow-Volume” loop display configuration. After both configurations have been cycled through the display, a third key press returns the display to the Pressure vs. Time and Flow vs. Time waveforms.
AS3000™ Operating Instructions 0070-10-0684-01 1 - 13
User Interface Product Description
6. MENU key
This key toggles the waveform area between the currently displayed waveform(s) and the menu tabs.
The first key press after initial power-up opens the Calibrate menu tab with the Start
Calibration button highlighted. From the currently displayed waveform(s), subsequent pressing of the MENU key opens the last viewed menu tab. If a menu tab is already open when the MENU key is pressed, that menu tab will close, returning the waveform area to the currently displayed waveform(s).
7. NORMAL SCREEN key
Press this key at any time to return the display to the normal operating mode. All menu tabs are closed.
8. Navigator
™
Knob
Rotate this knob to highlight the various tiles or menu tabs on the display. Press the center of the knob to select a highlighted item.
NOTE: If a change of setting (Ventilation Mode, Patient Type,
Ventilation Parameter, Alarm Limit or System Setting) is in process, and any key except MUTE is pressed prior to confirming that change, the system will revert back to the previously confirmed setting.
1 - 14 0070-10-0684-01 AS3000™ Operating Instructions
Product Description
1.5
Front View
Front View
2
3
5
6
8
FIGURE 1-5 Front View
PART(S)
1. User Interface
2. Auxiliary Outputs/
Fresh Gas Dosing
Components
3. Vaporizer Mounting
Manifold
4. Power Switch
5. Breathing System
6. Pressure Gauges
7. O
2
Flush Button
8. AGSS
DESCRIPTION
An interface for 2 Selectatec-type Vaporizers to mount
in this location. See section 1.7.
This switch is used to turn the system ON and OFF.
Absorber circuit with integrated bag-in-bottle, active and passive valves (such as the APL valve). See section
1.8 for an in depth description.
Indicate the pressure at pipeline inlets and at cylinder inlets for O
2
, Air, and N
2
O.
Provides high flow O
2
to the inspiratory limb of the breathing system. This button is functional regardless of whether or not the system is powered ON.
Anesthetic Gas Scavenging System
AS3000™ Operating Instructions 0070-10-0684-01 1 - 15
Auxiliary Outputs/Fresh Gas Dosing Components
1.6
Product Description
Auxiliary Outputs/Fresh Gas Dosing Components
1
1 - 16
FIGURE 1-6 Auxiliary Outputs/Fresh Gas Dosing Components
PART(S)
1. Auxiliary O
2
Flowmeters
/AIR
DESCRIPTION
0 - 15 L/min O
2
flowmeter and 0 - 15 L/min AIR flowmeter for auxiliary O
2
/AIR output.
4. Auxiliary O
2
5. Oxygen Outlet
1
2
2. Flowmeter Tubes
1
• N
2
O Low
• N
2
O High
• AIR Low
• AIR High
• O
2
Low
• O
2
High
3. Flow Control Knobs
2
• N
2
• AIR
• O
2
O
Output
/AIR
Low range for settings between 0.1 to 1 L/min
High range for settings between 1 to 12 L/min
Low range for settings between 0.1 to 1 L/min
High range for settings between 1 to 15 L/min
Low range for settings between 0.1 to 1 L/min
High range for settings between 1 to 10 L/min
Gas dosing
Gas dosing
Gas dosing
Nozzle for auxiliary O
2
/AIR output. Combines the auxiliary O
2
/AIR flowmeters into a single output.
High pressure O
2
outlet for connecting external devices such as a jet ventilator.
Use the tops of the floats when reading the flowmeter tubes.
Turn knob counterclockwise to increase flow.
0070-10-0684-01 AS3000™ Operating Instructions
Product Description
1.7
Vaporizer Mounting Manifold
1
2
Vaporizer Mounting Manifold
3
FIGURE 1-7 Vaporizer Mounting Manifold
PART(S)
1. Locking Device
2. Valve Cartridge of
Vaporizer Mount
3. Mounting Bar
DESCRIPTION
Vaporizer locking mechanism to secure against accidental disconnection.
Vaporizer index and outlet parts.
Bar holds two vaporizers. An interlock within the vaporizers provides for use of one vaporizer to deliver one agent at a time.
AS3000™ Operating Instructions 0070-10-0684-01 1 - 17
Breathing System
1.8
1.8.1
Breathing System
Top View
3
4
Product Description
1
2
5
6
7
1 - 18
8 9
10
FIGURE 1-8 AS3000 Breathing System, Top View
11
12
13
PART(S)
1. Breathing System
Pneumatic Hoses
2. Oxygen Sensor
External Cable
3. Bellows (including bellows dome)
1
4. PAW Gauge
2
5. Oxygen Sensor
6. O
2
Cell Plug
7. Bag Arm
1
2
DESCRIPTION
Six pneumatic hoses that control the manual/vent switch and exhaust valves in the breathing system and provide the ventilator with flow sensor information.
Connection to galvanic fuel cell
Durable bellows that separates the breathing system gases from the oxygen drive gas.
Indicates the patient airway pressure
Galvanic fuel cell
Used to seal the oxygen sensor port when it is not in use.
Provides the interface to the manual ventilation bag.
The bellows dome is a transparent cover with graduation marks from 300 to 1500. These marks are for qualitative purposes only. Tidal volume (V
T
) should be read exclusively from the display of the user interface.
The APL valve and PAW gauge numerics are for reference only. Calibrated patient airway pressure is displayed on the user interface.
0070-10-0684-01 AS3000™ Operating Instructions
Product Description Breathing System
1.8.2
8. Expiration Valve
9. Expiratory Limb
10. Y-Piece Seal
11. APL (Airway Pressure
Limiting) Valve
2
12. Inspiratory Limb
13. Inspiration Valve
1
2
Allows flow of expiratory gas from the patient to the rebreathing system.
Exhaled breathing circuit connection
Provides a parking position to seal the breathing circuit ypiece during the compliance test.
Rotary regulator for setting the pressure control during manual ventilation. Set to OPEN during Spontaneous breathing.
Inhaled breathing circuit connection
Valve allows flow of inspiratory gas to the patient.
The bellows dome is a transparent cover with graduation marks from 300 to 1500. These marks are for qualitative purposes only. Tidal volume (V
T
) should be read exclusively from the display of the user interface.
The APL valve and PAW gauge numerics are for reference only. Calibrated patient airway pressure is displayed on the user interface.
Bottom View
2
1
4
3
5
FIGURE 1-9 AS3000 Breathing System, Bottom View
PART(S)
1. Drive Gas Hose
2. CO
2
Absorber
Canisters
3. Waste Gas Hose
4. Heater Wire
5. Fresh Gas Hose
DESCRIPTION
Provides drive gas to the bellows.
The two chambers hold CO
2
absorbent material (either loose fill or pre-paks).
Hose that routes exhaust gases from the breathing system to the AGSS (Anesthetic Gas Scavenging System).
Provides power to the breathing system heater.
Provides fresh gas to the breathing system.
AS3000™ Operating Instructions 0070-10-0684-01 1 - 19
Rear View
1.9
Rear View
1
2
Product Description
1 - 20
FIGURE 1-10 Rear View
PART(S)
1. AC Outlets
3
2. Gas Pipeline
Supply Connections
3. Cylinders
DESCRIPTION
Additional devices up to a total maximum power consumption of 8 amps can be connected to four outlets.
Connections for O
2
, Air, and N
2
O from the central gas supply.
Supply tanks containing high pressure O
2
, Air, and
N
2
O to act as a backup supply if the pipeline pressure is removed.
0070-10-0684-01 AS3000™ Operating Instructions
2.0
Operations
2.1
2.2
Getting Started
The factory default settings for waveforms, parameters, alarms, and functions enable the system to begin operation immediately upon powering up. However, all of these settings can be changed for specific patient or departmental needs.
The AS3000 offers controlled ventilation for Adult and Child patient sizes, with default ventilation parameters and alarm related settings for each.
Select the patient size from the Patient Type Tile (item 5 in section 1.4.1) based on the
ventilation requirements of the patient. Tube and filter systems should also be fitted to the patient.
NOTE: Patient size should be set to match the actual patient before operating the system since certain operating characteristics are based on the selected patient size.
The following sections outline installation, configuration, check-out, and pre-operation testing procedures. Startup procedures and other periodically performed tests and calibration steps are also provided.
Installation
After removing the machine from its shipping crate, connect the following accessories, if available, prior to preparing the machine for initial setup:
• Waste gas scavenger assembly
• Patient suction regulator
AS3000™ Operating Instructions 0070-10-0684-01 2 - 1
Initial Setup
2.3
Operations
Initial Setup
The following steps must be carried out upon initial assembly or in any instance which requires disassembly of any gas machine part(s):
1. Position the machine in a location that enables the operating controls, ventilator display, and flowmeter tubes to be within easy reach.
2. Set the brakes on the casters.
3. Connect the gas supply by plugging the hose connectors into the gas supply sockets.
Verify that the pressure of the gas supply is within the specifications of the machine.
4. Mount the user interface to its mounting arm and connect the cable.
5. If the breathing system has not yet been connected to the machine:
a. Remove the transportation cover, if attached.
b. Install the side bracket.
c. Install the breathing system onto the side bracket.
6. Install the CO
2
absorber canisters.
7. Connect the manual ventilation bag to the bag arm on the breathing system.
8. Connect a patient breathing circuit to the inspiratory and expiratory connections.
9. Connect the waste gas hose between the bottom of the breathing system and the top of the gas scavenging system.
10. Connect the hose from the gas scavenger to the operating room’s EVAC connector.
11. Connect the fresh gas hose between the bottom of the breathing system and the CGO
(Common Gas Outlet) on the side of the machine.
12. Connect the heater wire between the bottom of the breathing system and the side of the machine.
13. Connect the drive gas hose between the bottom of the breathing system and the side of the machine.
14. Connect the pneumatic hoses between the side of the breathing system and the side of the machine.
15. Insert the oxygen sensor into the oxygen sensor port.
16. Connect the oxygen sensor external cable between the oxygen sensor and the side of the machine.
17. Plug the mains cable into a grounded socket and switch on the power supply using the mains switch (located on the front of the machine). Wait until the ventilator display provides information about the leak test.
2 - 2 0070-10-0684-01 AS3000™ Operating Instructions
Operations Preoperative Checkout
2.4
Preoperative Checkout
This checkout should be conducted before administering anesthesia. Refer to special procedures or precautions in this manual.
NOTE: This is a guideline which can be modified to accommodate variations in local clinical practice. Such local modifications should have appropriate peer review.
If an anesthetist uses the same machine in successive cases, this checkout need not be repeated or may be abbreviated after the initial checkout.
1. Inspect the system for:
a. Identification number
b. Valid inspection sticker
c. Damage to flowmeters, vaporizers, gauges, supply hoses
d. Complete breathing system with adequate CO
2
absorbent pre-paks or loose fill
e. Correct mounting of cylinders in yokes
f. Presence of cylinder wrench
g. Auxiliary O
2
supply, available and functioning
2. Per manufacturers’ specifications, turn ON the patient monitors to allow time for their warm-up (ECG, Blood Pressure, SpO
2
, Gas Monitoring, etc.).
3. Verify that self-inflating manual ventilation device is available and functioning.
4. Prepare the Anesthetic Gas Scavenging System (AGSS). Refer to section 3.1.11 for
removal instructions:
a. Remove the AGSS from the AS3000. While viewing the float, turn the AGSS upside down to verify whether the float moves freely along its shaft. Replace the float as necessary. Reconnect the AGSS to the AS3000.
b. Connect the vacuum hose to the vacuum port. Adjust the position of the float to be between the Min and Max lines by turning its flow adjustment knob
(counterclockwise increases flow, clockwise decreases flow).
c. Drain any moisture from the waste gas hose.Connect the waste gas hose to the
AGSS waste gas port.
5. Check that:
a. Flow-control valves are off
b. Vaporizers are off
c. Vaporizers are filled (not overfilled)
d. Filler caps are sealed tightly
e. Two vaporizers cannot be turned on at the same time
6. Check oxygen (O
2
) cylinder supply:
a. Disconnect pipeline supply (if connected) and return cylinder and pipeline pressure gauges to zero with O
2
flush valve.
b. Open O
2
cylinder; check pressure. A typical full cylinder pressure is 1900 psig.
Replace the cylinder if its pressure is less than 1000 psig.
c. Close O
2
cylinder and observe gauge for evidence of high-pressure leak.
d. With the O
2
flush valve, flush to empty the piping.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 3
Preoperative Checkout
2 - 4
Operations
7. Check nitrous oxide (N
2
O) cylinder supply:
a. Disconnect pipeline supply (if connected) and return cylinder and pipeline pressure gauges to zero with the flow control knob.
b. Open N
2
O cylinder; check pressure. A typical full cylinder pressure is 745 psig.
Replace the cylinder if its pressure is less than 600 psig.
c. Close N
2
O cylinder and observe gauge for evidence of high-pressure leak.
8. Check Air cylinder supply:
a. Disconnect pipeline supply (if connected) and return cylinder and pipeline pressure gauges to zero with the flow control knob.
b. Open Air cylinder; check pressure. A typical full cylinder pressure is 1900 psig.
Replace the cylinder if its pressure is less than 1000 psig.
c. Close Air cylinder and observe gauge for evidence of high-pressure leak
9. Test Central Pipeline Gas Supplies:
a. Inspect supply hoses (should not be cracked or worn).
b. Connect supply hoses, verifying correct color coding.
c. Adjust both O
2
and N
2
O flows to at least mid-range.
d. Verify that the O
2
and N
2
O supply pressures hold (>50 psig).
e. Shut off flow-control valves.
f. Adjust the AIR flow to at least mid-range.
g. Verify that the AIR supply pressure hold (>50 psig).
h. Shut off flow-control valves.
10. Connect Accessories:
a. Connect the breathing circuit to the corresponding ports on the breathing system.
b. Connect the manual ventilation bag to the bag arm.
11. Verify that unidirectional valves are present in each limb.
12. Power up the system as described in section 2.6 and follow the on-screen prompts to
perform the Leak Test and the Compliance Test.
13. Test flowmeters:
a. Check that all floats are at bottom of tube with flow-control valves closed.
b. Adjust flow of all gases through their full range and check for erratic movements of floats.
14. Test Hypoxic-Guard System:
a. Attempt to create hypoxic O
2 completely.
/ N
2
O mixture by opening the N
2
O flow control valve
b. Increase the O
2
flow and observe O
2 minimum concentration of 21% O
2
and N
2
O rise in proportion to maintain a
in fresh gas.
15. Test O
2 supply gas pressure failure system:
a. Set O
2
, N
2
O, and Air gas flows to mid-range.
b. Ensure that the O
2
gas cylinder is closed.
c. Disconnect the O
2
supply from the AS3000.
d. Verify that all flows, except Air, fall to zero.
0070-10-0684-01 AS3000™ Operating Instructions
Operations Preoperative Checkout
e. Verify that:
• an alarm tone sounds
• the alarm message
• an alarm tone sounds
• the alarm message
O2 Supply Failure is displayed in red text
f. Open the O
2
gas cylinder. Verify that the alarm tone stops and the alarm message is removed from the display.
g. Close all gas cylinders and bleed piping pressures.
h. Verify that:
O2 Supply Failure is displayed in red text
i. Shut off all flow-control valves.
j. Re-connect the O
2
supply to the AS3000.
16. Perform High Pressure Leak Test:
a. Connect a breathing circuit and ventilation bag.
b. Set APL Valve to 70 cm H
2
O.
c. Occlude Y-piece.
d. Turn O
2 flow to 50 ml/min.
e. Inflate bag with O
2
flush to 40 cm H
2
O on the PAW gauge.
f. Verify that circuit holds pressure for greater than 10 seconds.
g. If vaporizers are installed, repeat steps e and f for each vaporizer while it is
enabled.
h. Set the APL valve to SP.
17. Test Ventilator in MANUAL ventilation mode:
a. Remove the O
2
sensor and install the plug into the breathing system.
b. Set the ventilation mode to MANUAL.
c. Set the APL valve to 20.
d. Set Air flow to 5 liter/minute.
e. Squeeze the manual ventilation bag once every 10 seconds.
f. Verify that the test lung inflates and deflates to approximately 20 cm H
2
O pressure.
g. Verify that peak pressure, plat pressure, PEEP, tidal volume, minute volume, and frequency values appear on screen.
h. Verify that the FiO
2
reading is approximately 21%.
i. Verify a pressure waveform appears on screen along with the bag compressions.
j. Set the APL valve to the SP position and stop squeezing the manual ventilation bag.
k. Re-install the O
2
sensor into the breathing system.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 5
Preoperative Checkout Operations
18. Test the CMV ventilation mode:
a. Activate the CMV ventilation mode.
b. Set attributes as follows:
ATTRIBUTE
Patient Size
V
T
Freq
I:E
PEEP
T
P
O
2
Flow
SETTING
Adult
600
8
1:2
Off
10
2 Liters/minute
c. Verify that the displayed Tidal Volume is within 15% of the set value within 5 breaths.
d. Verify that the O
2
display reads greater than 94 within 5 minutes.
19. Test the PCV ventilation mode:
a. Activate the PCV ventilation mode.
b. Set attributes as follows:
ATTRIBUTE
Patient Size
P
TARGET
Freq
I:E
PEEP
T
SLOPE
O
2
Flow
SETTING
Adult
20
8
1:2
Off
0.5
2 Liters/minute
c. Verify that the PEAK pressure settles within 20% of the set value within 5 breaths.
d. Re-activate the CMV ventilation mode.
20. Low FiO
2
Alarm Test
a. Press the ALARM LIMITS key.
b. Set the Low FiO
2
alarm limit to be higher than the current FiO
2
reading.
c. Verify that:
• an alarm tone sounds
• the alarm message Low FiO2 is displayed in red text
d. Set the Low FiO
2
alarm limit back to 18.
2 - 6 0070-10-0684-01 AS3000™ Operating Instructions
Operations Preoperative Checkout
21. High and Low PAW Alarm Test
a. Set the High PAW alarm limit to be below the current PEAK pressure reading.
b. Verify that:
• an alarm tone sounds
• the alarm message after several breaths
High Airway Pressure is displayed in red text
• expiration begins when the pressure limit is reached
c. Set the High PAW alarm limit to 50.
d. Set the Low PAW alarm limit to be above the current PEAK pressure reading.
e. Verify that:
• an alarm tone sounds
• the alarm message after several breaths
Low Airway Pressure is displayed in yellow text
f. Set the Low PAW alarm limit to 10.
22. Low MV and APNEA Alarm Test
a. Set the Low MV alarm limit to the highest value.
b. Verify that:
• an alarm tone sounds
• the alarm message after several breaths
Low Minute Volume is displayed in yellow text
c. Set the Low MV alarm limit to 1.
d. Press the MANUAL/AUTO key.
NOTE: Prior to the APNEA alarm message referenced in the following step, Low Airway Pressure and Low Minute
Volume alarm messages may also be displayed.
e. After 60 seconds, verify that:
• an alarm tone sounds
• the alarm message APNEA is displayed in red text
23. Place the system in STANDBY ventilation mode.
24. Check for appropriate level of patient suction.
25. Check, connect, and calibrate other electronic monitors.
26. Turn on and set other appropriate alarms for equipment to be used.
NOTE: The following step should be performed every 3 days or when prompted by the machine.
27. Perform the Oxygen Sensor Calibration as detailed in section 2.9.
NOTE: The following step should be performed weekly or whenever a new vaporizer is installed or when CO
2 absorbent is replaced.
28. Test for leaks in the machine and vaporizers by performing the High Pressure Leak Test as described in step 16 of this section.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 7
Before Every Patient
2.5
Operations
Before Every Patient
• Verify that the O
2
tank is full prior to each new patient being attached to the device or when a different operator uses the gas machine.
• Check for appropriate level of patient suction.
• Verify ability of required monitors and check alarms.
• Verify CO
2
absorbent is not exhausted.
• Verify that the bellows is fully inflated before starting an automatic ventilation mode.
CAUTION:
Inflating the Bellows
On initial power-up, the bellows is automatically inflated if the Leak Test is performed.
However, in between patients, if the bellows is at the bottom of its travel:
1. Install a breathing circuit and connect the Y-piece to the Test port.
2. Select CMV mode and confirm the selection.
3. Immediately push the O
2
button until the bellows is completely filled.
4. Return to STANDBY mode and remove Y-piece from Test port.
Maintaining Inflated Bellows
To prevent the bellows from deflating completely to the bottom of its travel:
• Do not disconnect the breathing circuit from the AS3000 or the patient while the ventilator is running in an automatic ventilation mode. Return to MANUAL or STANDBY modes first.
• Do not run the ventilator in an automatic ventilation mode without any fresh gas flow.
• Do not remove the absorber canister while the ventilator is running in an automatic ventilation mode. This should only be done in STANDBY mode with no patient connected.
• Do not remove the O
2
sensor or sensor adapter from the breathing system block while the ventilator is running in an automatic ventilation mode. This should only be done in
STANDBY mode with no patient connected.
NOTE: If the O
2
sensor is removed when performing calibration, immediately install the plug in its place.
• Do not remove the Inspiratory/Expiratory check valve dome rings while the ventilator is running in an automatic ventilation mode. This should only be done in STANDBY mode with no patient connected.
2 - 8 0070-10-0684-01 AS3000™ Operating Instructions
Operations
2.6
Initial Power-Up
Initial Power-Up
Turn the power switch (item 4, page 1-15) to the ON position. A System Self Test will be
automatically initiated and will be indicated on the Display. When the self test is complete, the following message will be displayed: Select Continue to Start Leak Test
(recommended), or select Bypass to proceed to Normal screen.
• If Continue is selected, follow the onscreen prompts to perform the Leak test. When the
Leak test is complete, select Continue to proceed to the Compliance test.
NOTE: The Leak test will automatically proceed to the Compliance test if the leak rate is less than 500 mL/min
• Follow the onscreen prompts to perform the Compliance test. When the Compliance test is complete, select Continue and the system will proceed to displaying the
Pressure vs. Time and Flow vs. Time waveforms in STANDBY ventilation mode.
• If Bypass is selected, the system will skip the Leak test and the Compliance test and proceed directly to displaying the Pressure vs. Time and Flow vs. Time waveforms in
STANDBY ventilation mode.
NOTE: If the Leak test result is greater than 1000 ml and the user selects MANUAL, Automatic Ventilation will be disabled.
NOTE: Bypassing the Compliance test is not recommended.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 9
Adjusting the Date and Time
2.7
Operations
Adjusting the Date and Time
Press the MENU key and rotate the Navigator
™
Knob until the System menu tab is displayed. Press the Navigator
™
Knob to access the choices on the System menu tab.
Adjusting the Date
1. Rotate the Navigator
™
Knob until Edit Date is highlighted and press the knob to access the Edit Date sub-menu.
2. Rotate and press the Navigator
™
Knob as necessary to adjust the date and set the format to one of the following three (3) configurations: MM/DD/YY, DD/MM/YY or
YY/MM/DD.
NOTE: The default format is MM/DD/YY.
3. Select Done to save the date adjustments and return to the System menu tab.
Adjusting the Time
1. Rotate the Navigator
™
Knob until Edit Time is highlighted and press the knob to access the Edit Time sub-menu.
2. Rotate and press the Navigator
™
Knob as necessary to adjust the time and set the format to either 12 Hour or 24 Hour.
NOTE: The default format is 12 Hour and the adjustable parameters are hours and minutes.
3. Select Done to save the time adjustments and return to the System menu tab.
2 - 10 0070-10-0684-01 AS3000™ Operating Instructions
Operations
2.8
Vaporizer Installation
Vaporizer Installation
1. Align the vaporizer over the valve cartridges of the mounting bar. Hang the vaporizer
on the mounting bar as shown in FIGURE 2-1. Note that the locking mechanism handle
is in the unlocked position.
Locking Mechanism
Handle in the
Unlocked Position
FIGURE 2-1 Vaporizer, Unlocked
2. Rotate the locking mechanism handle clockwise into the locked position as shown in
Locking Mechanism
Handle in the
Locked Position
FIGURE 2-2 Vaporizer, Locked
AS3000™ Operating Instructions 0070-10-0684-01 2 - 11
Oxygen Sensor Calibration
2.9
Operations
Oxygen Sensor Calibration
NOTE: Oxygen Sensor Calibration can be performed in all ventilation modes.
1. Allow the breathing system to warm up and reach thermal equilibrium (approximately
30-60 minutes).
2. Press the MENU key and then use the Navigator
™
Knob to scroll to the Calibrate menu tab (shown in FIGURE 2-3). Select the Start Calibration button.
2 - 12
FIGURE 2-3 Calibrate Menu Tab
3. After the Start Calibration button has been selected, the screen shown in FIGURE 2-4
or FIGURE 2-6 will be displayed, instructing the user to remove the oxygen sensor (item
5, FIGURE 1-8) from the breathing system and expose it to room air for at least three
minutes before proceeding. The O
2
This is the amplified O
2
sensor voltage is displayed during the calibration.
cell voltage at the A/D converter for the oxygen sensor.
NOTE: The O
2
sensor voltage is not displayed for UI versions 2.24 and lower.
4. Flush the O
2
O
2
sensor with air from the auxiliary output for 5-10 seconds to ensure that no
bubbles are trapped in the sensor.
NOTE: Do not shake the O
2
sensor during calibration.
NOTE: Keep the O
2
sensor in a vertical position, connector side up, during calibration.
NOTE:
NOTE:
Place the O
2 sensor on top of the heated block during calibration to minimize the temperature difference from within the heated block.
If the system is going to be used during the calibration, insert the O
2
cell plug (item 6, FIGURE 1-8) into the port from
which the oxygen sensor was removed using a push and turn motion.
0070-10-0684-01 AS3000™ Operating Instructions
Operations Oxygen Sensor Calibration
5. After at least three minutes have passed, select the Next button to initiate the calibration
process. The progress bar shown in FIGURE 2-5 or FIGURE 2-7 will be displayed.
FIGURE 2-4 Oxygen Sensor
Calibration Instructions
FIGURE 2-5 Oxygen Sensor
Calibration Progress Bar
FIGURE 2-6 Oxygen Sensor
Calibration Instructions (UI versions 2.24 and lower)
FIGURE 2-7 Oxygen Sensor
Calibration Progress Bar
(UI versions 2.24 and lower)
AS3000™ Operating Instructions 0070-10-0684-01 2 - 13
Oxygen Sensor Calibration Operations
6. Proceed based on one of the following two conditions:
• If the calibration is successful, the screen shown in FIGURE 2-8 will be
displayed, instructing the user to reinstall the oxygen sensor into the breathing system.
Select the Done button to complete the process.
• If the calibration fails, the screen shown in FIGURE 2-9 will be displayed,
instructing the user to either repeat the calibration (by selecting the Repeat Cal button) or to replace the oxygen sensor. If the oxygen sensor must be replaced, select the Exit button, replace the oxygen sensor, and then repeat the calibration.
FIGURE 2-8 Oxygen Sensor
Calibration Successful
FIGURE 2-9 Oxygen Sensor
Calibration Failed
2 - 14 0070-10-0684-01 AS3000™ Operating Instructions
Operations Ventilation Modes
2.10
2.10.1
2.10.2
2.10.2.1
Ventilation Modes
STANDBY
This is the operating mode in which all system functionality is idle. It is the default system startup operating mode and is used between ventilation operations.
MANUAL
MANUAL mode is the operating mode used for manually ventilating a patient or to let a patient breathe spontaneously. To use the manual/spontaneous ventilation mode, the user must first set the APL valve to the appropriate pressure value and then select the mode using the MANUAL/AUTO key on the User Interface or selecting MANUAL Mode via the
Navigator Knob. Note that pressing the MANUAL/AUTO key again will put the Ventilator back into the previously selected ventilation mode.
The message “Pressure, Volume and Apnea Alarms are OFF.” is displayed in the lower left corner of the main screen when operating in MANUAL Mode with the ALARM control set to OFF.
Set the ALARM control to ON to remove this message and enable Pressure, Volume and
Apnea alarms in MANUAL Mode.
See section 2.12.3.2 “Functional Alarm Messages” for a list of Alarm Messages
Setting the APL Valve
For Manual Ventilation
Rotate the APL valve adjustment knob to the desired pressure.
NOTE: Clockwise rotation increases the pressure, and counterclockwise rotation decreases the pressure.
The patient can be ventilated by hand using the breathing bag. The pressure will be limited to the value set on the APL valve.
For Spontaneous Breathing
Rotate the APL valve adjustment knob fully counterclockwise, until the SP marking on the
knob lines up with the index mark on the bottom section of the valve (see item 11 in
FIGURE 1-8). The valve will then be open for spontaneous patient breathing.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 15
Ventilation Modes Operations
2.10.3
Continuous Mandatory Ventilation (CMV)
CMV mode is used to provide Continuous Mandatory Ventilation (CMV) to a patient. This is a volume mode where the user sets the desired tidal volume to be delivered to the patient’s lungs and the desired frequency.
The breathing cycle is specified by the user’s selection of frequency, I:E ratio, inspiratory pause time, PEEP, and tidal volume.
Compliance compensation is applied in CMV mode so that the tidal volume delivered to the patient more closely corresponds to the tidal volume setting. System compliance is determined during startup testing. To achieve the best performance, the patient hoses used during startup testing of compliance should match the hoses to be used during the procedure.
Note that in certain cases, when the ventilator is operating near its performance limits, compliance compensation will not be possible. When the AS3000’s performance limit is reached, it will not be possible to increment the frequency setting or the tidal volume setting and the message Ventilator setting is not possible. will be displayed in the user message area.
See section 1.4, User Interface for detailed selection procedures and for the ranges and
default values for the parameters of CMV mode ventilation. To change any parameter during
CMV mode ventilation, rotate the Navigator
™
Knob to the correct tile, press the knob to select that parameter, rotate the knob to change the parameter as desired, and then press the knob to confirm the new selected value.
Note that if the measured breathing pressure exceeds the Paw high alarm limit value, the ventilator will cycle to expiration to relieve that pressure.
Pressure
(cmH2O)
Peak pressure
Plateau pressure
T
P
Inspiration time
FIGURE 2-10 Typical CMV Waveform
Expiration time
PEEP
Time (s)
2 - 16 0070-10-0684-01 AS3000™ Operating Instructions
Operations Ventilation Modes
2.10.3.1
CMV Parameter Settings
User Adjustable Parameters for CMV
• V
T
(Tidal Volume)
• I:E (Ratio of Inspiratory Time to Expiratory Time)
• Freq (Frequency)
• T
P
(Inspiratory Pause)
• PEEP (Positive End Expiratory Pressure)
Ranges and Delivery Accuracy for CMV
V
T
(ml)
I:E
Freq (bpm)
T
P
(%)
PEEP (cmH
2
O)
ADULT*
40 - 1400 (600)
4:1 - 1:5 (1:2)
4 - 60 (8)
Off, 5 - 60 (10)
Off, 3 - 30 (Off)
CHILD*
40 - 1400
(120)
DELIVERY ACCURACY
Adult: ± 15% or at least 50 ml
Child: ± 15% or at least 16 ml
4:1 - 1:5 (1:2)
4 - 60 (20)
Times of phases is ± 35%
± 1
Off, 5 - 60 (10) ± 30%
Off, 3 - 30 (Off) 3 - 12 cmH
2
13 - 17 cmH
2
18 - 24 cmH
O (± 2 cmH
2
2
O)
O (± 3 cmH
2
O (± 6 cmH
2
O)
O)
25 - 30 cmH
2
O (± 12 cmH
2
O)
* Defaults appear in parenthesis in bold text.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 17
Ventilation Modes Operations
2.10.4
Pressure Controlled Ventilation (PCV)
PCV mode is used to provide Pressure Controlled Ventilation (PCV) to the patient. In PCV, the patient receives breaths with a fixed pressure limit and frequency. A continuous pressure is presented to the patient’s airway during the inspiratory time (T
INSP
). The rise time of the pressure waveform is controlled by the setting of T
SLOPE
.
T
SLOPE
Inspiration
Expiration
Pressure
Decelerating
Flow
Flow
Volume
FIGURE 2-11 Typical PCV Waveform
Definitions
TRIGGER METHOD
PEEP setting
Inspiratory flow setting
Inspiratory time
FLOW TRIGGERED
PEEP is at least 5 cmH
2
O below target pressure.
The user sets the time T
SLOPE
required to reach the set ΔP. The ventilator regulates the inspiratory flow to match the T
SLOPE set by the user.
time
The set T
SLOPE
time will not be greater than the time resulting from the set I:E ratio and frequency. In case of conflict, the set
I:E ratio and frequency will override the set T
SLOPE
time.
2 - 18 0070-10-0684-01 AS3000™ Operating Instructions
Operations Ventilation Modes
2.10.4.1
PCV Parameter Settings
User Adjustable Parameters for PCV
• P
TARGET
(Target Pressure)
• I:E (Ratio of Inspiratory Time to Expiratory Time)
• Freq (Frequency)
• T
SLOPE
(Inspiratory Slope)
• PEEP (Positive End Expiratory Pressure)
Ranges and Delivery Accuracy for PCV
P
TARGET
(cmH
2
O)
I:E
Freq (bpm)
T
SLOPE
(sec)
PEEP (cmH
2
O)
ADULT*
5 - 70 (20)
4:1 - 1:5 (1:2)
4 - 60 (8)
0 - 2 (0.5)
Off, 3 - 30 (Off)
CHILD*
5 - 70 (10)
DELIVERY ACCURACY
5 - 29 (± 3 cmH
2
30 - 70 (± 7 cmH
O),
2
O)
Times of phases is ± 35% 4:1 - 1:5 (1:2)
4 - 60 (20)
0 - 2 (0.5)
± 1
± 1.0 sec
Off, 3 - 30 (Off) 3 - 12 cmH
2
13 - 17 cmH
2
18 - 24 cmH
O (± 2 cmH
2
2
O)
O (± 3 cmH
2
O (± 6 cmH
2
O)
O)
25 - 30 cmH
2
O (± 12 cmH
2
O)
* Defaults appear in parenthesis in bold text.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 19
Ventilation Modes Operations
2.10.5
Synchronized Intermittent Mandatory Ventilation (SIMV)
SIMV mode provides Synchronized Intermittent Mandatory Ventilation (SIMV) to the patient as well as the capability for Pressure Supported (PS) spontaneous breathing between needed mandatory breaths. SIMV in the AS3000 is a volume mode where the user can set the tidal volume, frequency, inspiratory pause, PEEP, and inspiratory time. Mandatory breaths are synchronized with the patient’s inspiratory effort.
NOTE: The PS (Pressure Support) function within SIMV operates as described in the next section.
SIMV mode enables the patient to breath spontaneously with or without pressure support between mandatory breaths. If no inspiratory effort is detected, the AS3000 delivers a mandatory breath per the set rate.
2 - 20
FIGURE 2-12 Typical SIMV Waveform
Definitions
TRIGGER METHOD
Ventilation end (start of breath detection phase)
“SIMV breath” trigger window
Pressure support end
FLOW TRIGGERED
Expiratory flow reaches a threshold value near 0.
Set pressure support target pressure
Inspiratory flow setting
Frequency stability
25% of expiration time
Inspiratory flow reaches 25% of the maximum value. Timeout after 3 seconds.
The set target pressure for the pressure support is a differential pressure value (ΔP).
The user sets the time T
SLOPE
required to reach the set ΔP. The ventilator regulates the inspiratory flow to match the T
SLOPE set by the user.
time
If the SIMV breath is triggered, the time difference between the trigger and scheduled mandatory breath is added to the expiratory time of the next cycle.
0070-10-0684-01 AS3000™ Operating Instructions
Operations Ventilation Modes
2.10.5.1
SIMV Parameter Settings
User Adjustable Parameters for SIMV
• V
T
(Tidal Volume)
• T
INSP
(Inspiratory Time)
• Freq (Frequency)
• T
P
(Inspiratory Pause)
• Trigger (Flow Trigger)
• ΔP (Differential Target Pressure)
• T
SLOPE
(Inspiratory Slope)
• PEEP (Positive End Expiratory Pressure)
Ranges and Delivery Accuracy for SIMV
V
T
(ml)
T
INSP
(sec)
Freq (bpm)
T
P
(%)
Trigger (l/min)
ΔP (cmH
2
O)
T
SLOPE
(sec)
PEEP (cmH
2
O)
ADULT*
40 - 1400 (600)
0.2 - 5.0 (2)
2 - 60 (4)
Off, 5 - 60 (10)
1 - 15 (3)
3 - 50 (5)
0 - 2 (0.5)
Off, 3 - 30 (Off)
CHILD*
40 - 1400
(120)
0.2 - 5.0 (1)
DELIVERY ACCURACY
Adult:
Child:
± 15% for T
INSP
± 30% for T
INSP
from1 - 5
< 1
± 15%, at least 16 ml
± 10% or 0.1, whichever is greater
2 - 60 (4)
Off, 5 - 60 (10)
± 1
± 30%
1 - 15 (2)
3 - 50 (5)
± 1.3
Adult:
Child:
3 - 35 (± 3 cmH
2
O),
36 - 50 (± 12 cmH
2
3 - 50 (± 3 cmH
2
O)
O)
± 1.0 sec 0 - 2 (0.5)
Off, 3 - 30 (Off) 3 - 12 cmH
2
13 - 17 cmH
2
18 - 24 cmH
O (± 2 cmH
2
2
O)
O (± 3 cmH
2
O (± 6 cmH
2
O)
O)
25 - 30 cmH
2
O (± 12 cmH
2
O)
* Defaults appear in parenthesis in bold text.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 21
Ventilation Modes Operations
2.10.6
Pressure Support (PS)
In Pressure Support (PS) mode, the patient’s effort is supported by the AS3000 at a preset level of inspiratory pressure. Inspiration is triggered and cycled by patient effort.
The user can set the Trigger flow, Pressure Support level, PEEP, minimum allowed breathing frequency, and Slope Time. If the Freq (min) is violated, the AS3000 will give an Apnea
Ventilation breath to assure ventilation is occurring.
Pressure
Trigger indicator Trigger indicator
Apnea ventilation
P
Time [s]
T slope
1/Freq.
MIN
1/Freq.
MIN
Flow
100%
25%
Time [s]
Flow trigger Flow trigger
FIGURE 2-13 Typical PS Waveforms
Definitions
TRIGGER METHOD
Pressure support end
Ventilation end (start of breath detection phase)
Set pressure support target pressure
What kind of Apnea backup should be used
Inspiratory flow setting
No trigger
FLOW TRIGGERED
Inspiratory flow reaches 25% of the maximum value. Timeout after 3 seconds.
Expiratory flow reaches a threshold value near 0.
The set target pressure for the pressure support is a differential pressure value (ΔP).
The Freq
MIN
parameter in PS mode can be set by the user to avoid Apnea.
The user sets the time T
SLOPE
required to reach the set ΔP. The ventilator regulates the inspiratory flow to match the T
SLOPE set by the user.
time
2 - 22 0070-10-0684-01 AS3000™ Operating Instructions
Operations Ventilation Modes
2.10.6.1
PS Parameter Settings
User Adjustable Parameters for PS
• Freq
MIN
(Frequency MIN)
• Trigger (Flow Trigger)
• ΔP (Differential Target Pressure)
• T
SLOPE
(Inspiratory Slope)
• PEEP (Positive End Expiratory Pressure)
Ranges and Delivery Accuracy for PS
Freq
MIN
(bpm)
Trigger (l/min)
ΔP (cmH
2
O)
ADULT*
2 - 60 (2)
1 - 15 (3)
3 - 50 (5)
T
SLOPE
(sec)
PEEP (cmH
2
O)
0 - 2 (0.5)
Off, 3 - 30 (Off)
CHILD*
2 - 60 (4)
DELIVERY ACCURACY
± 1
1 - 15 (2)
3 - 50 (5)
± 1.3
Adult:
Child:
3 - 35 (± 3 cmH
2
O)
36 - 50 (± 12 cmH
2
3 - 50 (± 3 cmH
2
O)
O)
± 1.0 sec 0 - 2 (0.5)
Off, 3 - 30 (Off) 3 - 12 cmH
2
13 - 17 cmH
2
18 - 24 cmH
O (± 2 cmH
2
2
O)
O (± 3 cmH
2
O (± 6 cmH
2
O)
O)
25 - 30 cmH
2
O (± 12 cmH
2
O)
* Defaults appear in parenthesis in bold text.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 23
Parameter Monitoring Operations
2.11
2.11.1
Parameter Monitoring
The system displays waveforms and Spirometry loops in the Waveform Area (item 7 in
FIGURE 1-3) and digital data in the Parameter Area (item 8 in FIGURE 1-3). The digital
data is separated into three parameter groups: Pressure, Volume, and Inspired O
2
(FiO
2
).
Pressure
The Pressure parameter group consists of 3 parameters:
• Airway Peak Pressure (PEAK)
• Plateau Pressure (PLAT) or Mean Pressure (MEAN)
• Positive End Expiratory Pressure (PEEP)
The unit of measure for these parameters is cmH
2
O. If data is over range, an up-arrow ( ) is displayed. If data is under range, a down-arrow ( ) is displayed.
NOTE:
NOTE:
The high alarm limit for Airway Peak Pressure (PEAK) is displayed to the top right of the reading. The low alarm limit for Airway Peak Pressure (PEAK) is displayed to the bottom right of the reading.
The display of either Plateau Pressure (PLAT) or Mean
Pressure (MEAN) is configured from the System menu tab.
The associated Pressure vs. Time and Flow vs. Time waveforms are displayed together
2 - 24
FIGURE 2-14 Example Pressure vs. Time and Flow vs. Time Waveforms
0070-10-0684-01 AS3000™ Operating Instructions
Operations Parameter Monitoring
2.11.2
2.11.3
Pressure vs. Time
The Y-axis of the Pressure vs. Time waveform is labeled Paw (which represents Airway
Pressure). The unit of measure is cmH
2
O and, depending on the size of the pressure signal, the Y-axis will automatically adjust to one of the following 3 scales:
• 0 to 10, in increments of 5
• 0 to 30, in increments of 10
• 0 to 80, in increments of 20
Though the X-axis is not labeled, it represents a time scale of 0 to 15 seconds.
NOTE: Peak pressure readings that are greater than 80 cmH
2 be clipped at 80 cmH
2
O.
O will
Flow vs. Time
The Y-axis of the Flow vs. Time waveform represents Flow. The unit of measure is L/min and its scale is -90 to +90, in increments of 45, but only absolute numbers are displayed. Though the X-axis is not labeled, it represents a time scale of 0 to 15 seconds.
Volume
The Volume parameter group consists of 3 parameters:
• Tidal Volume (V
T
) - The unit of measure is ml.
• Minute Volume (MV) - The unit of measure is Liter.
• Respiration Frequency (Freq) - The unit of measure is bpm.
If data is over range for these parameters, an up-arrow ( ) is displayed.
NOTE:
Inspired O
2
(FiO
2
)
• The unit of measure is %.
• If data is over range, an up-arrow ( ) is displayed. If data is under range, a downarrow ( ) is displayed.
NOTE:
The high alarm limit for Minute Volume (MV) is displayed to the top right of the reading. The low alarm limit for Minute
Volume (MV) is displayed to the bottom right of the reading.
The high alarm limit is displayed to the top right of the reading. The low alarm limit is displayed to the bottom right of the reading.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 25
Parameter Monitoring Operations
2.11.4
Spirometry
Spirometry is a respiratory monitoring technology that provides continuous (breath-by-breath) measurement of patient lung mechanics. The resultant pressure, volume, flow, compliance, and resistance data enables quick assessment of the patient’s pulmonary status.
Open the Spirometry Loop Window by pressing the SPIROMETRY key.
NOTE: Pressing the NORMAL SCREEN key at any time while the
Spirometry Loop Window is open will close the Spirometry
Loop Window.
There are two (2) Spirometry loop display configurations that can be accessed: Pressure-
Volume and Flow-Volume. By default, the Pressure-Volume loop is displayed with the first press of the SPIROMETRY key. The second key press displays the Flow-Volume loop. After both configurations have been cycled through the display, a third key press returns the display to the Normal Screen.
When the Spirometry Loop Window opens, the user may elect to store a reference loop by navigating to the Save Reference button, which will be highlighted. Pressing the
Navigator
™
Knob will then save the currently plotting loop as a reference loop (in a different color).
NOTE: Only one reference loop can be saved.
Pressure-Volume Spirometry Loop
FIGURE 2-15 is an example of the Pressure-Volume loop.
2 - 26
FIGURE 2-15 Example Pressure-Volume Loop
0070-10-0684-01 AS3000™ Operating Instructions
Operations Parameter Monitoring
The Y-axis of the Pressure-Volume Spirometry loop represents Volume. The unit of measure is
ml and its scale is 0 to 1500, in increments of 250. The X-axis is labeled Paw (which represents Airway Pressure). The unit of measure is cmH
2
O and its scale is -20 to 80, in increments of 20.
Flow-Volume Spirometry Loop
FIGURE 2-16 is an example of the Flow-Volume loop.
FIGURE 2-16 Example Flow-Volume Loop
The Y-axis of the Flow-Volume Spirometry loop represents Flow. The unit of measure is
L/min and its scale is -90 to +90, in increments of 45, but only absolute numbers are displayed. The X-axis represents Volume. The unit of measure is ml and its scale is 0 to
1400, in increments of 750.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 27
Alarms Operations
2.12
Alarms
Unless otherwise stated, all alarms occur immediately after the onset of an alarm event. The
Alarm menu tab enables adjustments to alarm limits and alarm volume. To access the
Alarm menu tab (see the example in FIGURE 2-17), press the ALARMS LIMITS key.
NOTE: There are separate Alarm menu tabs for the two patient types (Adult and Child) which will be indicated at the top left of each tab.
2 - 28
2.12.1
FIGURE 2-17 Example Adult Alarm menu tab
Setting Parameter Alarm Limits
1. From the Alarm menu tab, use the Navigator
™
Knob to set alarm limits as desired for the parameters shown in the following table. The LOW and HIGH alarm limits for each parameter have separate defaults for the Adult and Child patient sizes.
LOW HIGH
RANGE
1
0 – 20
RANGE
1
1 – 25
10 – 80
21 – 100
DEFAULT
Adult: 12
Child: 6
Adult: 50
Child: 40
Adult: 100
Child: 100
2. To save alarm limit settings, press the Navigator
™
Knob.
0070-10-0684-01 AS3000™ Operating Instructions
Operations
2.12.2
2.12.3
Alarm Volume
The Alarm Volume sub menu is used to adjust the volume level of the audio portion of the alarms. A 10 segment bar display adjusts from 1 segment for the lowest volume to 10 segments for the highest volume. As each segment is highlighted, a sample tone for that volume level is sounded. The default volume level is 2 segments.
Technical Messages and Functional Alarm Messages
Based on the priority levels listed in the tables in sections 2.12.3.1 and 2.12.3.2, each
message will display in the Alarm Message Area (item 2, FIGURE 1-3) with an associated
symbol as follows:
• Low priority
• Medium priority
• High priority
Alarms
AS3000™ Operating Instructions 0070-10-0684-01 2 - 29
Alarms Operations
2.12.3.1
Technical Messages
The following table lists the individual technical messages, their associated priority levels, reasons for the messages, and possible solutions.
MESSAGE
BDU EEPROM Data Failure
PRIORITY
N/A
EEPROM IC Failure
WDT Failure
AD/DA failure
PEEP failure
Inspiration Valve Failure
Vent/Manual Valve Failure
Expiration Sensor Failure
N/A
N/A
N/A
N/A
N/A
N/A
N/A
REASON(S)
Incorrect checksum during EEPROM check
EEPROM cannot read/write
Incorrect Watchdog state
Incorrect D/A A/D data
PEEP valve data is incorrect
The valve test yielded abnormal feedback voltage.
Valve state incorrect
The expiration sensor data is incorrect.
SOLUTION(S)
This alarm occurs during startup only and renders the system nonoperational. Contact technical support.
This alarm occurs during startup only and renders the system nonoperational. Contact technical support.
This alarm occurs during startup only and renders the system nonoperational. Contact technical support.
This alarm occurs during startup only and renders the system nonoperational. Contact technical support.
This alarm occurs during startup only. The leak test is bypassed and the system is placed in
STANDBY ventilation mode. Contact technical support.
This alarm occurs during startup only. The leak test is bypassed and the system is placed in
STANDBY ventilation mode. Contact technical support.
This alarm occurs during startup only and renders the system nonoperational. Contact technical support.
This alarm occurs during startup only and renders the system nonoperational. Contact technical support.
2 - 30 0070-10-0684-01 AS3000™ Operating Instructions
Operations Alarms
MESSAGE
O
2
Supply Failure
Power Fail
Low Battery
O
2
Sensor Failure
(This alarm can occur during startup or normal operation.)
BDU Communication Failure
(This alarm can occur during startup or normal operation.)
Alarm Speaker Failure
PRIORITY
High
Low
Medium
High
High
N/A
REASON(S)
O
2
gas pressure is lower than 29.1 psi
± 15% for more than
0.5 seconds.
The main AC power has failed.
NOTE: The system automatically switches to battery power to provide approximately 45 minutes of run time.
During battery operation, the battery voltage decreases below 22 Volts.
NOTE: When this alarm occurs, there are only 10 minutes remaining until the system shuts down.
The O
2
sensor cable is disconnected or the
O
2
sensor has failed.
SOLUTION(S)
If this alarm occurs during startup, the leak test is bypassed and the system is placed in
STANDBY ventilation mode. Contact technical support. Check the O
2 supply line and the O
2 cylinder. Replace the O
2 cylinder if necessary.
Ensure that the AC power cord is connected to the receptacle. Check the main power supply and fuses. Replace fuses as necessary. Contact technical support if the problem is not resolved.
Resume AC power operation immediately.
Manually ventilate the patient. Ensure that the battery remains fully charged at all times.
If this alarm occurs during normal operation, the GUI cannot send or receive data from the
BDU unit for more than 0.5 seconds.
During startup testing, no response was received from the alarm speaker.
Ensure that the O
2
sensor is properly connected at both ends. Replace the
O
2
sensor if it has failed.
If this alarm occurs during startup, the system is rendered nonoperational. Repeat the startup tests as necessary. Contact technical support.
If this alarm occurs during startup, the system is rendered nonoperational. Contact technical support. If this alarm occurs during normal operation, manually ventilate the patient.
This alarm occurs during startup only and places the system in STANDBY ventilation mode. All system functions except audible alarms are available. Contact technical support.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 31
Alarms
2 - 32
Operations
MESSAGE
O
2
Cal Due
Software Version Error
Keyboard Communication
Failure
(This alarm can occur during startup or normal operation.)
Pressure Sensor Failure
Inspiration Sensor Fail
Software Mismatch or Failure to Shut Down Completely
PRIORITY
Low
N/A
Low
N/A
N/A
N/A
REASON(S)
72 hours have elapsed since the last
O
2
Calibration.
When the internal
BDU, user interface, and keyboard software components were checked for proper configuration, the software versions did not match with the released set.
Internal electrical failure of subsystems communication
SOLUTION(S)
This alarm occurs during startup only and renders the system nonoperational.
Contact technical support.
The startup test of the
PAW sensor yielded an abnormal voltage at ambient pressure.
The inspiration sensor data is incorrect.
Fresh gas is flowing during startup.
Power is recycled to the unit too quickly.
If this alarm occurs during startup, the system is rendered nonoperational. If this alarm occurs during normal operation, the ventilator will continue to operate in the current mode with the current settings and the user interface display will be shut down after one (1) minute. The system should be considered nonfunctional at the time of this alarm. Contact technical support.
This alarm occurs during startup only and renders the system nonoperational. Contact technical support.
This alarm occurs during startup only and places the system in STANDBY ventilation mode.Try restarting the system with all gas flows OFF. If message reappears, switch to MANUAL ventilation mode and manually ventilate patient. Contact technical support.
Applicable to UI versions
2.25 and higher. This alarm occurs during startup only. Shut down the unit and wait until the backlight is fully extinguished before restoring power.
0070-10-0684-01 AS3000™ Operating Instructions
Operations Alarms
2.12.3.2
Functional Alarm Messages
The following table lists the individual functional alarm messages, their associated priority levels, reasons for the messages, and possible solutions.
MESSAGE
Continuous Pressure
High Airway Pressure*
Low Airway Pressure*
PRIORITY
High
High
Medium
REASON(S)
Pressure sensor failure, sampling channel blockage, excessive exhalation resistance
(possibly due to channel blockage)
V
T
is set too high, patient airway blockage, exhalation valve blockage
For Freq setting >= 4:
Airway pressure below pressure alarm low limit for > 15 seconds
Negative Pressure
Low FiO
2
High
High
For Freq setting < 4:
Airway pressure below pressure alarm low limit for > 30 seconds
Airway Pressure of -2 cmH
2
O or less for more than 4 seconds.
The FiO
2
reading is less than the low alarm limit setting, compensation of air or N
2
O is too high, un-calibrated O
2
O
2
sensor failure
sensor,
Check patient or increase supply of fresh gas.
Reset the Low FIO
2 alarm limit.
Reduce compensation.
Perform the calibration.
Replace O
2 sensor.
Reset the High
FIO
2
alarm limit.
High FiO
*
2
High Minute Volume*
Low Minute Volume*
Medium
Medium
Medium
The FiO
2
reading is greater than the high alarm limit setting.
The MV reading is greater than the high alarm limit setting.
The MV reading is less than the low alarm limit setting, leakage of the patient breathing circuit occurs
Reset the High MV alarm limit.
Reset the Low MV alarm limit. Check for leakage at patient connections.
These functional alarm messages are disabled when Manual Mode Alarm control on the Main
Screen is set to “OFF” and the ventilation mode is set to MANUAL.
SOLUTION(S)
Switch to bag mode and manually ventilate patient, check tubes and sampling lines, fix any blockages. If the alarm still exists, contact technical support.
Reset the High
PAW alarm limit, check expiratory cycle, fix any blockages. Check
V
T
settings. Check patient airway, fix any blockages.
Reset the Low PAW alarm limit. Check the parallel sampling lines.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 33
Alarms
2.12.4
MESSAGE
APNEA*
APNEA Backup
High PEEP
*
PRIORITY
High
Medium
Medium
REASON(S)
Breathing/ventilation has stopped (detected by pressure and volume monitoring) for a period greater than 30 seconds in mechanical ventilation modes or for greater than
60 seconds in manual ventilation mode.
Freq
MIN
in PS mode triggers the ventilator.
Expiratory pressure 5 cmH
2
O above PEEP for 2 breaths, or
SOLUTION(S)
Check patient
Check patient
Check waste gas hose for moisture
Expiratory pressure 5 cmH
2
O above PEEP in PS mode for more than 30 seconds
These functional alarm messages are disabled when Manual Mode Alarm control on the Main
Screen is set to “OFF” and the ventilation mode is set to MANUAL.
Alarm Functions Test
1. Activate the CMV ventilation mode.
2. Set attributes as follows:
ATTRIBUTE
Patient Size
V
T
Breath Rate
I:E
PEEP
T
P
O
2
Flow
SETTING
Adult
600
8
1:2
Off
10
2 Liters/minute
3. Perform steps 20 to 23 of the Preoperative Checkout in section 2.4.
Operations
2 - 34 0070-10-0684-01 AS3000™ Operating Instructions
Operations
2.13
System
The System menu tab contains configuration settings for Pressure Display, Language,
Display mode, Date and Time, and System Defaults. This menu also includes the result of the last leak test performed.
System
FIGURE 2-18 Example System menu tab
1. Pressure Display
Provides selections of Pplat (Plateau Pressure) or Pmean pressure display. The default is
Pplat.
2. Language
Allows the user to choose from available display languages.
NOTE: The AS3000 is only available in English.
3. Display
Accesses the AS3000’s demo mode.
NOTE: This Feature is password protected and is intended for use by Mindray personnel only.
4. Date
Provides for adjustment of the current date and selections for date format.
5. Time
Provides for adjustment of the current time and selections for time format.
6. Restore Defaults
Allows the user to restore alarm limits, pressure display and ventilation settings to default values.
AS3000™ Operating Instructions 0070-10-0684-01 2 - 35
System Operations
7. Leak Test
Allows the user to show the result of the latest Leak Test. To show the Leak Test result, select
Show Result from the Leak Test menu. The Leak Test Result will be displayed on the right
portion of the System menu tab (see figure 2-19).
FIGURE 2-19 Example Leak Test Results
The Leak Test Result screen displays Leak Value, displayed in mL/min, The Test Date, the date the test was performed and Test Time the time the test was performed. If the Leak Test
was bypassed, a value of Bypassed will be displayed for Leak Value (see figure 2-20).
2 - 36
FIGURE 2-20 Example of a Bypassed Leak Test
0070-10-0684-01 AS3000™ Operating Instructions
3.0
User Maintenance
•
Refer to the material safety data as applicable.
•
Refer to the operation and maintenance manuals of all disinfection equipment.
•
Do not inhale fumes that may result from any disinfection process.
CAUTION:
•
Refer to the literature supplied by the manufacturer of the cleaning agent.
•
•
Never use abrasive agents (i.e. steel wool or silver polish) to clean components.
•
Keep all liquids away from electronic components.
•
Prevent liquid from entering the equipment.
•
All cleaning solutions used must have a pH between 7.0 and 10.5.
CAUTION:
Never immerse the oxygen sensor or its connector in any type of liquid.
•
Dispose of the oxygen sensor per the manufacturer’s specification.
CAUTION:
Do not wash the inner surface of the oxygen sensor.
AS3000™ Operating Instructions 0070-10-0684-01 3 - 1
CAUTION:
CAUTION:
The PAW gauge and oxygen sensor cannot withstand immersion or the heat and pressure of autoclaving.
CAUTION:
Do not autoclave the airway pressure limiting (APL) valve.
User Maintenance
3 - 2 0070-10-0684-01 AS3000™ Operating Instructions
User Maintenance
3.1
3.1.1
3.1.2
3.1.3
Cleaning and Disinfection
Cleaning and Disinfection
CAUTION:
General Guidelines
Heed all WARNINGS and CAUTIONS listed at the beginning of this chapter. Prior to use, refer to the facility’s infection control policy to determine the frequency and level at which cleaning and disinfection should be performed. If disinfection is required, all components must first be cleaned and dried as described in the following sub-sections. For additional information about infection control practices, refer to the APIC Guidelines for Selection and
Use of Disinfectants, published in the American Journal of Infection Control, Vol. 24, No. 4,
August 1996.
For additional information about infection control, refer to the ASA’s Recommendations for
Infection Control for the Practice of Anesthesiology, second edition. For additional information on reprocessing medical devices, refer to AAMI TIR 30:2003, A compendium of process, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
External Surfaces
• Using a soft cloth with a water-soluble detergent or disinfectant wipes, clean all outer surfaces, hoses, and cables. If using disinfectant wipes, follow the manufacturer’s instructions for use.
Bellows Assembly
FIGURE 3-1 Bellows Assembly
Read all content in this section before disassembling, cleaning, disinfecting, and reassembling the bellows to avoid equipment malfunction and patient injury.
AS3000™ Operating Instructions 0070-10-0684-01 3 - 3
Cleaning and Disinfection User Maintenance
1. The bellows dome is a transparent cover with graduation marks from 300 to 1500.
Remove the bellows dome by turning it counterclockwise and lifting it away from the breathing system. See FIGURE 3-2.
FIGURE 3-2 Removing the Bellows Dome
2. Detach the bellows from the base plate as shown in FIGURE 3-3.
3 - 4
FIGURE 3-3 Detaching the Bellows
0070-10-0684-01 AS3000™ Operating Instructions
User Maintenance
3. Detach the top plate from the bellows as shown in FIGURE 3-4.
Cleaning and Disinfection
FIGURE 3-4 Detaching the Top Plate
NOTE: While performing the following step, note the orientation of the bellows adapter ring as it is being removed to ensure that it is properly inserted during reassembly.
4. Remove the bellows adapter ring from inside the bellows as shown in FIGURE 3-5.
FIGURE 3-5 Removing the Bellows Adapter Ring
AS3000™ Operating Instructions 0070-10-0684-01 3 - 5
Cleaning and Disinfection
5. Remove the bellows dome O-ring as shown in FIGURE 3-6.
User Maintenance
3 - 6
FIGURE 3-6 Removing the Bellows Dome O-ring
6. Cleaning
a. To prevent damage, wash each component gently with hot water, using a mild, nonenzyme detergent that is recommended for rubber and plastic. Ensure that all bellows surfaces are cleaned.
b. Rinse with clean, hot water, and allow to dry.
NOTE: Dry the bellows by allowing it to hang so that it is fully expanded. This will facilitate thorough drying and prevent it from sticking to itself.
CAUTION:
If moisture remains in the bellows after cleaning, it may become tacky.
c. After all bellows components are completely dry, inspect them for damage before disinfection or re-assembly and functional testing.
d. If disinfecting the bellows components, continue with step 7, otherwise skip to
0070-10-0684-01 AS3000™ Operating Instructions
User Maintenance
3.1.4
Cleaning and Disinfection
7. Disinfection
NOTE: Ensure that all bellows components have been cleaned as
described in step 6 before disinfecting.
Using an FDA cleared Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high level disinfection and rinsing of all bellows components while adhering to facility policies and procedures.
8. Connect the bellows to the breathing system by reassembling all components in the reverse order. Prior to use after cleaning or disinfecting, power up the system as
described in section 2.6 and follow the on-screen prompts to perform the Leak Test and
the Compliance Test.
Inspiration and Expiration Valves
The following procedure is written generically for a single, unspecified valve. It should be performed on both the inspiration and expiration valves.
Control
Hose
Tall Bag
Arm
Expiration
Valve
Inspiration
Valve
FIGURE 3-7 Location of Expiration and Inspiration Valves
AS3000™ Operating Instructions 0070-10-0684-01 3 - 7
Cleaning and Disinfection User Maintenance
1. Turning it counterclockwise, loosen and remove the valve retaining ring as shown in
FIGURE 3-8.
Valve
Retaining
Ring
3 - 8
FIGURE 3-8 Valve Retaining Ring Removal
2. Remove the valve dome as shown in FIGURE 3-9, ensuring that the valve o-ring (also shown) remains seated.
Valve
Dome
Valve
O-ring
FIGURE 3-9 Valve Dome Removal
CAUTION:
0070-10-0684-01 AS3000™ Operating Instructions
User Maintenance Cleaning and Disinfection
3. The valve cage will be removed in this step (refer to FIGURE 3-10). The six prongs of the valve cage have tabs that secure it in the valve assembly. While noting the previous
CAUTION, use two hands to remove the valve cage by gently manipulating the prongs to release the tabs. As the valve cage is lifted away from the assembly, ensure that the valve disc does not fall out.
Valve
Cage
Prong with securing tab
Valve
Disc
Ridge that secures the
Valve Cage
FIGURE 3-10 Valve Cage Removal
CAUTION:
4. Remove the valve disc from the valve cage as shown in FIGURE 3-11.
Valve
Disc
FIGURE 3-11 Valve Disc Removal
AS3000™ Operating Instructions 0070-10-0684-01 3 - 9
Cleaning and Disinfection User Maintenance
5. Cleaning
a. Wash each component using a mild detergent and water solution.
b. Rinse with clean, hot water, and allow to dry.
c. After all components are completely dry, verify that the valve disc and the prongs of the valve cage are undamaged before disinfection or re-assembly and functional testing.
d. If disinfecting the valve components, continue with step 6, otherwise skip to step 7.
6. Disinfection
NOTE: Ensure that all valve components have been cleaned as described in step 5 before disinfecting.
Using an FDA cleared Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high level disinfection and rinsing of all valve components while adhering to facility policies and procedures.
7. Reassemble the valve components in the reverse order, noting any previously stated
CAUTION. Prior to use after cleaning or disinfecting, power up the system as described
in section 2.6 and follow the on-screen prompts to perform the Leak Test and the
Compliance Test.
3 - 10 0070-10-0684-01 AS3000™ Operating Instructions
User Maintenance
3.1.5
Cleaning and Disinfection
Oxygen Sensor
1. The oxygen sensor is a component that is pressed into position for use. It is not necessary to remove this component to clean it. However, if removal is desired, first
FIGURE 3-12 Oxygen Sensor External
Cable Removal
FIGURE 3-13 Oxygen Sensor Removal
CAUTION:
Never immerse the oxygen sensor or its connector in any type of liquid.
•
Dispose of the oxygen sensor per the manufacturer’s specification.
CAUTION:
Do not wash the inner surface of the oxygen sensor.
CAUTION:
Do not autoclave the oxygen sensor.
2. Clean the oxygen sensor exterior with a soft, lint-free cloth, and a mild detergent and water solution. Allow to dry thoroughly.
3. Inspect the oxygen sensor for damage and replace as necessary.
4. Re-insert the oxygen sensor if it had been removed.
AS3000™ Operating Instructions 0070-10-0684-01 3 - 11
Cleaning and Disinfection
3.1.6
User Maintenance
APL Valve
1. Loosen the APL valve at its base by turning it counterclockwise, and then remove the APL
valve as shown in FIGURE 3-14.
APL Valve
3 - 12
Base
FIGURE 3-14 APL Valve Removal
2. Cleaning
a. Clean the APL valve with a soft, lint-free cloth, and a solution of mild detergent and water. Allow it to dry thoroughly.
b. If disinfecting the APL valve, continue with step 3, otherwise skip to step 4.
3. Disinfection
NOTE: Ensure that the APL valve has been cleaned as described in step 2 before disinfecting.
Using an FDA cleared Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high level disinfection and rinsing of the APL valve while adhering to facility policies and procedures.
4. Replace the APL valve by turning its base clockwise until it is securely tightened. Prior to
use after cleaning or disinfecting, power up the system as described in section 2.6 and
follow the on-screen prompts to perform the Leak Test and the Compliance Test.
0070-10-0684-01 AS3000™ Operating Instructions
User Maintenance
3.1.7
Cleaning and Disinfection
PAW Gauge
1. The PAW gauge is a component that is pressed into position for use. It is not necessary to remove this component to clean it. However, if removal is desired, simply grasp it and
lift it away from the absorber block as shown in FIGURE 3-15.
PAW
Gauge
FIGURE 3-15 PAW Gauge Removal
CAUTION:
The PAW gauge and oxygen sensor cannot withstand immersion or the heat and pressure of autoclaving.
2. Clean the PAW gauge with a soft, lint-free cloth, and a mild detergent and water solution. Allow it to dry thoroughly.
3. Re-insert the PAW gauge if it was removed. Prior to use after cleaning or disinfecting,
power up the system as described in section 2.6 and follow the on-screen prompts to
perform the Leak Test and the Compliance Test.
AS3000™ Operating Instructions 0070-10-0684-01 3 - 13
Cleaning and Disinfection
3.1.8
User Maintenance
Bag Arm
1. Turning it counterclockwise, loosen the bag arm retaining ring and then remove the bag
arm from the breathing system block (see FIGURE 3-16).
3 - 14
Bag Arm
FIGURE 3-16 Bag Arm Removal
Retaining
Ring
2. Cleaning
a. Clean the bag arm with a soft, lint-free cloth, and a solution of mild detergent and water. Allow it to dry thoroughly.
b. If disinfecting the bag arm, continue with step 3, otherwise skip to step 4.
3. Disinfection
NOTE: Ensure that the bag arm has been cleaned as described in step 2 before disinfecting.
Using an FDA cleared Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high level disinfection and rinsing of the bag arm while adhering to facility policies and procedures.
4. Reassemble the bag arm to the breathing system. Prior to use after cleaning or
disinfecting, power up the system as described in section 2.6 and follow the on-screen
prompts to perform the Leak Test and the Compliance Test.
0070-10-0684-01 AS3000™ Operating Instructions
User Maintenance
3.1.9
Cleaning and Disinfection
Absorber Canisters
1. Locate the absorber drain as shown in FIGURE 3-17.
Drain Valve
Absorber
Drain
(underneath)
FIGURE 3-17 Absorber Drain Valve Location
2. Refer to FIGURE 3-18. While holding a small cup below the drain, turn the valve to the
Open position and collect any water that may have gathered. Turn the valve to the
Close position and discard the water.
Drain Valve
FIGURE 3-18 Absorber Drain Valve (Close Up View)
AS3000™ Operating Instructions 0070-10-0684-01
Absorber Drain
3 - 15
Cleaning and Disinfection User Maintenance
WARNING: Use extreme care while handling the absorbent as it is a caustic irritant.
3. Rotate the locking mechanism handle counterclockwise into the unlocked position as
shown in FIGURE 3-19. This separates the absorber canisters from the top of the
assembly. While noting the previous WARNING, remove the absorber canisters. Then remove the pre-pak or loose fill absorbent from the canisters. Dispose of the absorbent per the manufacturer’s specification.
3 - 16
Absorber
Canisters
Locking Mechanism
Handle in the
Unlocked Position
FIGURE 3-19 Absorber Canisters, Unlocked
4. Cleaning
a. Clean the absorber canisters with a soft, lint-free cloth, and a solution of mild detergent and water. Allow them to dry thoroughly.
b. If disinfecting the Absorber Canisters, continue with step 5, otherwise skip to step 6.
5. Disinfection
NOTE: Ensure that the Absorber Canisters have been cleaned as
described in step 4 before disinfecting.
Using an FDA cleared Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high level disinfection and rinsing of the Absorber Canisters while adhering to facility policies and procedures.
WARNING: Use extreme care while handling the absorbent as it is a caustic irritant.
NOTE: Ensure that the absorber canisters are completely dry before adding absorbent.
0070-10-0684-01 AS3000™ Operating Instructions
User Maintenance Cleaning and Disinfection
6. While noting the previous WARNING, add new pre-pak or loose fill absorbent to the absorber canisters. Re-install the absorber canisters into the assembly. Rotate the locking mechanism handle clockwise into the locked position as shown in FIGURE 3-20.
Locking Mechanism
Handle in the
Locked Position
3.1.10
FIGURE 3-20 Absorber Canisters, Locked
Breathing System Block
1. Remove all of the following components from the breathing system block:
• Bellows Assembly
• Oxygen Sensor
• Inspiratory and Expiratory Valves (all components)
• APL Valve
• PAW Gauge
• Bag Arm
• Absorber Canisters
2. Disconnect the fresh gas hose from the CGO (Common Gas Outlet) on the left side of the system. The opposite end of this hose is integrated into the breathing system block and therefore, does not get removed.
3. Disconnect the waste gas hose, drive gas hose, and heater cable from the bottom of the breathing system block.
4. Disconnect the breathing system pneumatic hoses from the side of the breathing system block.
NOTE: At this point, the breathing system block is ready to be removed from its mounting arm.
AS3000™ Operating Instructions 0070-10-0684-01 3 - 17
Cleaning and Disinfection User Maintenance
5. While grasping the sides of the breathing system block as shown in FIGURE 3-21, lift it
away from its mounting arm.
3 - 18
Absorber
Block
FIGURE 3-21 Breathing System Block Removal
Mounting
Arm
6. Cleaning
a. Clean the breathing system block exterior with a soft, lint-free cloth, and a mild detergent and water solution. Allow to dry thoroughly.
b. If disinfecting the breathing system block, continue with step 7, otherwise skip to step 8.
7. Disinfection
NOTE: Ensure that the breathing system block has been cleaned as described in step 6 before disinfecting. High level disinfection of the breathing system block can be performed through steam autoclaving up to a maximum temperature of 134 ºC (273 ºF).
Using an autoclave, follow the manufacturer’s instructions for high level disinfection of the breathing system block while adhering to facility policies and procedures.
8. Reassemble the breathing system components in reverse order. Prior to use after
cleaning or disinfecting, power up the system as described in section 2.6 and follow the
on-screen prompts to perform the Leak Test and the Compliance Test.
0070-10-0684-01 AS3000™ Operating Instructions
User Maintenance Cleaning and Disinfection
3.1.11
AGSS (Anesthetic Gas Scavenging System) and AGSS Transfer Hose
1. Disconnect the EVAC hose from the AGSS.
2. Remove the AGSS and Transfer Hose from the AS3000 as shown in FIGURE 3-22.
FIGURE 3-22 AGSS and Transfer Hose Removal
AS3000™ Operating Instructions 0070-10-0684-01 3 - 19
Cleaning and Disinfection User Maintenance
3. Clean the outer surface of the AGSS and Transfer Hose with a soft, lint-free cloth, and a mild detergent and water solution. Allow to dry thoroughly.
4. Remove the top of the AGSS as shown in FIGURE 3-23. Inspect the AGSS filter as shown in FIGURE 3-24 and shake it over a waste container to clean it as necessary. If the filter must be replaced, dispose of the old filter per local government policy.
FIGURE 3-23 Removal of AGSS Top FIGURE 3-24 AGSS Filter Inspection
5. Reassemble the AGSS and Transfer Hose and reconnect them to the AS3000 in the reverse order.
3 - 20 0070-10-0684-01 AS3000™ Operating Instructions
User Maintenance
3.2
Regular Maintenance
Regular Maintenance
Visual inspection should be performed every 30 days to ensure timely replacement of worn or damaged parts.
1. Power off the system.
2. Perform an overall visual inspection of the system.
3. Power up the system as described in section 2.6 and follow the on-screen prompts to
perform the Leak Test and the Compliance Test.
AS3000™ Operating Instructions 0070-10-0684-01 3 - 21
Regular Maintenance User Maintenance
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3 - 22 0070-10-0684-01 AS3000™ Operating Instructions
4.0
Accessories
4.1
4.2
The following accessories are designed for the AS3000 Anesthesia Delivery System. The use of other accessories is not recommended. To place an order for these or other accessories, contact Customer Service at 1.800.288.2121 or order accessories online at www.mindray.com.
Vaporizers
• Vaporizer, Sevoflurane (P/N 0992-00-0148)
• Quickfill Bottle Adapter, Sevoflurane (P/N 0004-00-0100)
• Vaporizer, Isoflurane (P/N 0992-00-0149)
• Quickfill Bottle Adapter, Isoflurane (P/N 0004-00-0101)
Gas Supply Hoses
10 Foot Length
1
2
3
GAS
O
2
N
2
O
Air
VAC
EVAC
EVAC
1
P/N
2
0004-00-0077-XX
0004-00-0078-XX
0004-00-0079-XX
0004-00-0080-XX
0004-00-0081-XX
0004-00-0081-XX
OHMEDA
-01
-01
-01
-03
-01
-21
3
CHEMETRON
-02
-02
-02
-04
-02
-22
3
PURITAN
BENNETT
-03
-03
-03
-05
-03
-23
3
VAC wall connector
The “-XX” in each P/N (Part Number) represents a “Tail Code” that completes the P/N. See footnote 3.
-XX Tail Codes (substitute these numbers for the -XX in the P/N column to complete the Part Number)
DISS
FEMALE
3
-04
-04
-04
-06
-04
-24
AS3000™ Operating Instructions 0070-10-0684-01 4 - 1
CO
2
Absorbers
4.3
4.4
CO
2
Absorbers
• CO
2
Absorber Pre-Pack (P/N 0683-00-0326-01)
• Loose Fill CO
2
Absorber (P/N 0683-00-0325-01)
Miscellaneous
• DPM 6/7 to AS3000 Installation Kit (P/N 0040-00-0452)
• DPM 6/7 Module Rack Mounting Kit (P/N 0040-00-0451)
• Monitor Mounting Arm, Pivoting, 16” (P/N 0436-00-0198)
• Suction Regulator (P/N 0992-00-0256)
• Suction Regulator Mount (P/N 0436-00-0207)
• Suction Canister Bracket (P/N 0436-00-0212)
• Bag, Reservoir, Reusable (P/N 0138-00-0022)
• Adult Test Lung (P/N 0138-00-0012)
• Utility Tray (P/N 0436-00-0204)
• Writing Surface Insert (P/N 045-000250-00) for Utility Tray (P/N 0436-00-0258)
• AS3000 User Maintenance Kit (P/N 0040-00-0457)
Accessories
4 - 2 0070-10-0684-01 AS3000™ Operating Instructions
5.0
Product Specifications
5.1
Safety Designations
Safety designations per IEC 60601-1 Standard:
Type of protection against electric shock:
Class 1 and Internal Electric Power Source. Where the integrity of the external protective earth conductor arrangement is in doubt, equipment shall be operated from its internal electric power source.
Degree of protection against electric shock:
Supply Connection:
Type BF Applied Part
Internal Battery Operation:
Mode of Operation:
Protection Against Hazards of
Explosion:
Protection Against Ingress of
Liquids:
Degree of Electrical Connection
Between Equipment and Patient:
Degree of Mobility:
AC Operation:
120 VAC (nominal) 60Hz; 10A
24 VDC Internal Battery
Continuous
Not protected. (Ordinary)
Not protected. (Ordinary)
Equipment designed for non-electrical connection to the patient.
Mobile
AS3000™ Operating Instructions 0070-10-0684-01 5 - 1
5.2.3
5.2.4
5.2.5
5.2.6
ASTM F 1208 – 89 (2005) Disclosures
5.2
5.2.1
5.2.2
Product Specifications
ASTM F 1208 – 89 (2005) Disclosures
Based on the following disclosures, the AS3000 meets ASTM Standard Specification F1208 for Anesthesia Breathing Systems.
Leakage of Breathing System
The AS3000 complies with ASTM F 1208 – 89 (2005) section 7.1.1 — The maximum leakage of the breathing system does not exceed 300 mL/min when pressurized to 3.0 kPa
(30 cmH
2
O).
Resistance of Breathing Systems
The typical pressure drops due to inspiratory and expiratory gas flow in the breathing system at reference flows of 0.5 and 1.0 liter/sec are:
• With Expiratory flow = 0.5 liter/sec then Resistance = 1.5 cmH
2
O
• With Expiratory flow = 1.0 liter/sec then Resistance = 5.4 cmH
2
O
• With Inspiratory flow = 0.5 liter/sec then Resistance = 1.1 cmH
2
O
• With Inspiratory flow = 1.0 liter/sec then Resistance = 3.5 cmH
2
O
Volume of Gas not delivered to patient due to Internal Compliance
• 95 ml at 2 kPa
• 200 ml at 4 kPa
CO
2
Absorber Resistance
For a filled CO
2
absorber, resistance at 1 Liter/sec flow = 6.9 cmH
2
O.
CO
2
Absorber Capacity
CO
2
absorber capacity is 2 pre-paks or 1500 ml in each canister.
Unidirectional Valve Opening Pressure
The pressure to open moist inspiratory and expiratory valves does not exceed 0.15 kPa (1.5 cmH
2
O).
5 - 2 0070-10-0684-01 AS3000™ Operating Instructions
Product Specifications
5.3
5.3.1
5.3.2
5.3.3
5.4
General
General
Dimensions
Height: 54.3 in ± 0.2 in (1380 mm ± 5 mm)
Width: 25.6 in ± 0.2 in (650 mm ± 5 mm)
Depth: 27.2 in ± 0.2 in (690 mm ± 5 mm)
Weight (without vaporizers or gas cylinders)
326 lbs or less (148 kg or less)
Stability Configurations and Conditions
Tilted through an angle of 10º, front, both sides, and back, with all drawers loaded to 10 lbs each and left open. Back tilt performed with three gas cylinders attached.
WARNING: Due to the size and weight of the A3000, it should only be moved by qualified personnel.
AS3000 over hoses, cords or other obstacles.
WARNING: Remove all equipment from the top shelf of the AS3000 before moving.
Environmental
Operating temperature:
Storage temperature:
Humidity (operating and storage):
Atmospheric pressure
(operating and storage):
+50 to 104°F (+10 to +40°C)
+14 to 140°F (-10 to +60°C)
15-90% RH, non-condensing
700 to 1060 hPa
AS3000™ Operating Instructions 0070-10-0684-01 5 - 3
Electrical
5.5
5.5.1
5.6
5.6.1
5.6.2
5.7
5.7.1
5.5.2
5.5.3
Product Specifications
Electrical
Electrical Power Requirements
Mains power supply:
Current input:
Power consumption:
Main Fuse:
100 to 240 VAC, 50/60 Hz, 10 A
120 VAC - 10 A
(2 A for AS3000, 8 A for auxiliary outlets)
Less than 200 VA (not including auxiliary outlets)
2 x 10A
Battery Power Requirements
Battery:
Battery run time:
Battery charge time:
2 x 12 V Sealed Lead Acid
45 minutes minimum
8 hours maximum
Auxiliary Outlets
Number of outlets: 4
Output voltage per Outlet:
Fuses:
NOTE:
120 VAC, 60 Hz, 2A maximum
4
×
2 A
IEC 60601-1-1 applies when medical electrical equipment, non-medical electrical equipment, or combinations thereof are connected to the auxiliary mains socket outlet(s).
Pneumatic
Central Gas Supply Requirements
40.6 psi to 87.0 psi (280 kPa to 600 kPa) for all three gases (O
2
, N
2
O, Air)
Cylinder Gas Supply Requirements
E Cylinder / pin indexed per CGA V-1 for all three gases (O
2
, N
2
O, Air)
Gas Management
Ratio System
Integrated with automatic N
2
O cutoff when O
2
fails (minimum of 21% Vol% O
2
in fresh gas).
5 - 4 0070-10-0684-01 AS3000™ Operating Instructions
Product Specifications
5.8
5.9
Breathing System
Breathing System
Absorber capacity:
Absorber system:
Condensation block:
Block heater warm-up time:
System compliance:
Loose Fill 2 x 1500 ml or 2 Pre-paks
Loose fill or Pre-pak canisters
Heated Breathing System (35 +5/- 2°C)
Less than 100 minutes at 10°C ambient temperature and less than 45 minutes at 20°C ambient temperature
Approx. 5 ml/Pa x 100 with standard hoses
Ventilator
Electronically controlled, gas driven bellows ventilator with fresh gas compensation complies with ISO 8835-5.
Ventilation modes: CMV (Volume), PCV (Pressure Control),
SIMV (Synchronized Volume), Pressure Support,
Manual, and Spontaneous
Patient types:
Tidal volume:
Pressure delivery range:
Ventilation frequency:
Adult and Child
40 - 1400 ml
Child: 40 - 400 ml (± 17% or at least 20 ml)
Adult: 300 - 1400 ml (± 15% or at least 50 ml)
5 - 70 cmH
2
O Manual and PCV modes
3 - 80 cmH
2
O PS and SIMV modes
2 - 60 bpm
CMV+PCV
Child: 4 - 60 bpm
Adult: 4 - 60 bpm
SIMV+PS
Child: 2 - 60 bpm
Adult: 2 - 60 bpm
I: E ratio:
Inverse I:E ratio:
Plateau (End Insp.):
1:1; 1:1.5; 1:2, 1:2.5, 1:3, 1:3.5, 1:4, 1:4.5, 1:5
(not available in SIMV or PS modes)
1.5:1, 2:1, 2.5:1, 3:1, 3.5:1, 4:1
(not available in SIMV or PS modes)
Off, 5% - 60% of inspiratory period
(CMV and SIMV modes only)
AS3000™ Operating Instructions 0070-10-0684-01 5 - 5
Ventilator
5 - 6
Product Specifications
PEEP:
Pressure limitation:
P
TARGET
T insp
:
Trigger:
:
ΔP Pressure support:
T
SLOPE
/Insp Flow:
Freq min/Apnea:
Max. Insp. pressure:
(pneumatic safety valve)
Manual pressure control:
(APL Valve)
Fresh Gas Compensation:
Compliance test:
Leak tests:
Oxygen monitor:
(per ISO 21647:2004)
Pressure monitor:
Off, 3 - 30 cmH
2
O
3 - 12 cmH
2
O (± 2 cmH
2
O)
13 - 17 cmH
2
O (± 3 cmH
2
O)
18 - 24 cmH
2
O (± 6 cmH
2
O)
25 - 30 cmH
2
O (± 12 cmH
2
O)
PMAX in CMV and SIMV modes is equal to High
Airway Pressure alarm setting.
(PEEP + 5 cmH
2
O) - 70 cmH
2
O (PCV mode only)
5 - 29 cmH
2
O (± 3 cmH
2
O)
30 - 70 cmH
2
O (± 7 cmH
2
O)
0.2 - 5.0 sec (± 10% or 0.1, whichever is greater)
(SIMV mode only)
1 - 15 l/min (± 1.3 l/min)
(SIMV and PS modes only)
3 - 50 cmH
2
O (PS and SIMV modes only)
Child: 3 - 50 (± 3 cmH
2
O)
Adult: 3 - 35 (± 3 cmH
2
O); 36 - 50 (± 12 cmH
2
O)
0 - 2 sec (± 1.0 sec) (PCV, SIMV, and PS modes only)
2 - 60 bpm (± 1 bpm) (PS mode only)
80 cmH
2
O (± 10 cmH
2
O)
0 - 70 cmH
2
O
Automatic
Automatic after confirmation
Automatic after confirmation
Type: Galvanic Fuel cell
FiO
2
display 0 - 100 vol% O
2
, resolution 1%, response time (80%) less than 10 sec.
Real-time graphics (waveform)
Numerical pressure values for PEEP,
Pmean, Ppeak, Pplateau
Pressure range: –20 to 99 cmH
2
O
0070-10-0684-01 AS3000™ Operating Instructions
Product Specifications Anesthetic Gas Scavenging System (Low Flow)
5.9.1
5.10
Volume monitor:
Resolution: 1 cmH
2
O
Real-time graphics (waveform)
Numerical values for Tidal volumes, breathing frequency, minute volumes
Tidal Volume Range: 0 to 2900 ml
Minute Volume Range: 0.1 to 28 liters
Rate: 0 to 256 bpm
Resolution Tidal Volume: 1 ml
Resolution Minute Volume: 0.1 liters
Accuracy of the measurements after 5 breaths
Pressure:
O
2
:
Volume:
± 20% of the measured value, at least 2 cmH
2
O
± 3 Vol %*
Adult mode: ± 15% of the measured value*
Child mode: 25 ml or ± 15% of the measured value
(whichever is greater)*
Flow tubes: ± 10% of full scale* (per ASTM F1101-90 2003)
Rate:
*
± 1 bpm*
ATPS (Ambient Temperature Pressure Saturated)
Anesthetic Gas Scavenging System (Low Flow)
Flow Range:
Maximum constant flow before spillage occurs:
Particle Filter:
25 to 50 l/min
50 l/min
Replaceable
AS3000™ Operating Instructions 0070-10-0684-01 5 - 7
Inputs / Outputs Product Specifications
5 - 8
5.11
5.11.1
5.11.1.1
5.11.1.2
5.11.1.3
5.11.1.4
5.11.1.5
5.11.2
5.11.2.1
5.11.2.2
5.11.2.3
5.11.2.4
5.11.2.5
5.11.2.6
Inputs / Outputs
Electrical
Input Power
Input power is provided via a captive line cord with a 120 volt/14 A hospital grade plug.
Auxiliary Outlets
Four 120-volt outlets
O
2
Sensor
Two-pin connector for O
2
cell cable.
Breathing System Heater
Four-pin connector for Breathing System Heater cable.
External Communication Port
Port B is available for RS-232 digital communication per Communication Protocol Document
(P/N 0070-00-0706). Contact Mindray for more information.
Pneumatic
Pipeline connections
DISS threaded body as per CGA V-5 for all three gases (O
2
, N
2
O, Air)
Cylinder connection(s)
Three E-cylinder gas tank yokes, pin indexed (PISS) by gas type (O
2
, N
2
O, Air), per
CGA V-1.
Vaporizer connection(s)
Two vaporizers (max) using the Selectatec mounting system.
Breathing System Connections
Pneumatic connectors are provided on the Breathing System. One connection each for the inspiration and expiratory hoses of the pneumatic circuit. A connection for the breathing bag and a port for the O
2
fuel cell. A Plug connection for leak testing. A Drive Gas hose connection, a breathing system pneumatics connection, an AGSS connector to provide the exhaust to the scavenger, and a CGO hose.
CGO (Common Gas Outlet)
Connector on side of machine provides fresh gas to the Breathing System.
Oxygen Output Connectors
Tapered fitting supplies output of Aux. O
2
Flowmeter. DISS O
2
connector is available on side of machine to provide wall O
2
to a jet ventilation device or other device.
0070-10-0684-01 AS3000™ Operating Instructions
Product Specifications Displays / Controls
5.11.2.7
5.12
5.12.1
5.12.1.1
5.12.1.2
5.12.1.3
5.12.1.4
5.12.2
5.12.2.1
Oxygen Gas Power Outlet
DISS Male O
2
fitting on the left side of the machine which provides a maximum flow of
90 l/min at a pressure range of 40.5 to 87 psi.
Displays / Controls
Electronic
User Interface
Display - Color LCD
Keypad Area - incorporates an AC power LED, hard keys, and a Navigator
™
Knob.
• AC Power LED - a green LED that indicates when AC power is applied
• Hard Keys - as follows:
a. MANUAL/AUTO
b. ALARM LIMITS c. MUTE d. SPIROMETRY e. MENU f. NORMAL SCREEN
• Navigator
™
Knob - located in the Keypad Area for control of the user interface
Main Switch
ON/OFF switch for power to the AS3000 system.
Vaporizer/Work Light
A three-position switch (OFF, LOW, and HIGH) that controls the lighting over the work surface and vaporizers.
Audio Indicators
An audio speaker is provided to annunciate alarms and key presses. Audio alarms are in accordance with IEC60601-1-8. The measured sound pressure range for the audio alarm is
76.6 dB(A) to 81.5 dB(A).
Pneumatic
Line Pressure Gauges
Three line pressure gauges monitor the pipeline pressure supply of O
2
, N
2
O, and Air. The range of each gauge is 0 to 145 psi (0 to 1000 kPa).
AS3000™ Operating Instructions 0070-10-0684-01 5 - 9
Displays / Controls Product Specifications
5.12.2.2
5.12.2.3
5.12.2.4
5.12.2.5
Cylinder Pressure Gauges
Cylinder pressure gauges are provided to monitor the cylinder tank pressure for O
2
, N
2
O, and Air. The range of each gauge is 0 to 3500 psi for O
2
and Air, and 0 to 1400 psi for
N
2
O.
Flowmeter and Control Valve
Three control knobs, one each for N
2
O, Air, and O
2 are used to set the fresh gas dosing flow. Flow set by the control knobs is monitored by six flowmeter tubes. Two each for N
2
O,
Air, and O
2
. The scale of the flowmeters is,
N
2
O High Range: 1 to 12 L/min
0.1 to 1 L/min N
2
O Low Range:
Air High Range: 1 to 15 L/min
Air Low Range:
O
2
High Range:
O
2
Low Range:
0.1 to 1 L/min
1 to 10 L/min
0.1 to 1 L/min
O
2
Flush
A push button O
2
flush valve supplies O
2
flow directly to the fresh gas outlet when depressed. The button returns to its original closed position when released.
APL Valve
The APL valve for limiting maximum breathing pressure in manual mode is located on the
Breathing System block.
5 - 10 0070-10-0684-01 AS3000™ Operating Instructions
Product Specifications Electromagnetic Capability
5.13
Electromagnetic Capability
The AS3000 meets the requirements of IEC 60601-1-2/EN 60601-1-2.
NOTE:
NOTE:
The AS3000 needs special precautions regarding EMC and needs to be installed and put into service according to the
EMC information provided below.
Portable and mobile RF communications equipment can affect the AS3000. See tables 5-1 through 5-4 that follow.
TABLE 5-1
GUIDANCE AND DECLARATION - ELECTROMAGNETIC EMISSION
The AS3000 is intended for use in the electromagnetic environment specified below. The customer or the user of the AS3000 should assure that it is used in such an environment.
EMISSIONS
TEST
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions IEC
61000-3-2
Voltage fluctuations/
Flicker emissions IEC
61000-3-3
COMPLIANCE
Group 1
Class A
Class A
Complies
ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
The AS3000 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The AS3000 is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
TABLE 5-2
GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY
The AS3000 is intended for use in the electromagnetic environment specified below. The customer or the user of the AS3000 should assure that it is used in such an environment.
IMMUNITY
TEST
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
IEC 60601 TEST
LEVEL
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/ output lines
±1 kV differential mode
±2 kV common mode
COMPLIANCE
LEVEL
±6 kV contact
±8 kV air
±2 kV for power supply lines
N/A
±1 kV differential mode
±2 kV common mode
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment.
Mains power quality should be that of a typical commercial or hospital environment.
AS3000™ Operating Instructions 0070-10-0684-01 5 - 11
Electromagnetic Capability Product Specifications
TABLE 5-2 (Continued)
GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY
The AS3000 is intended for use in the electromagnetic environment specified below. The customer or the user of the AS3000 should assure that it is used in such an environment.
IMMUNITY
TEST
Voltage dips, short interruptions and voltage variations on power supply input lines IEC
61000-4-11
IEC 60601 TEST
LEVEL
<5% U
T in U in U
T
) for 0.5 cycle
40% U in U
T
T
70% U
T
T
(>95% dip
(60% dip
) for
5 cycles
(30% dip
) for
25 cycles
COMPLIANCE
LEVEL
<5% U
T in U in U
T
40% U
T
T
(>95% dip
) for 0.5 cycle
(60% dip
) for
5 cycles
70% U in U
T
T
(30% dip
) for
25 cycles
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Mains power quality should be that of a typical commercial or hospital environment. The AS3000 requires continued operation during power mains interruptions and is therefore provided with batteries that supply uninterruptible power.
<5% U
T in U
T
(>95% dip
) for 5 sec
3 A/m
<5% U
T in U
T
(>95% dip
) for 5 sec
3 A/m Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
U
T
is the A.C. mains voltage prior to application of the test level.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
TABLE 5-3
GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY
The AS3000 is intended for use in the electromagnetic environment specified below. The customer or the user of the AS3000 should assure that it is used in such an environment.
IMMUNITY
TEST
IEC 60601 TEST
LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Portable and mobile RF communications equipment should be used no closer to any part of the AS3000 than the separation distance derived from the following calculations:
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
Recommended separation distance
d = 1.2 x
P
5 - 12 0070-10-0684-01 AS3000™ Operating Instructions
Product Specifications Electromagnetic Capability
TABLE 5-3 (Continued)
GUIDANCE AND DECLARATION - ELECTROMAGNETIC IMMUNITY
The AS3000 is intended for use in the electromagnetic environment specified below. The customer or the user of the AS3000 should assure that it is used in such an environment.
IMMUNITY
TEST
IEC 60601 TEST
LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3 V/m d = 1.2 x
P
80 MHz to 800 MHz
d = 2.3 x
P
800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
NOTE:
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a
should be less than the compliance level in each frequency range.
b
Interference may occur in the vicinity of equipment marked with the following symbol:
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE:
a b
These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
AS3000 is used exceeds the applicable RF compliance level above, the AS3000 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AS3000.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
AS3000™ Operating Instructions 0070-10-0684-01 5 - 13
Electromagnetic Capability Product Specifications
TABLE 5-4
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE AS3000
The AS3000 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AS3000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AS3000 as recommended below, according to the maximum output power of the communications equipment.
RATED MAXIMUM
OUTPUT POWER (P)
OF TRANSMITTER
IN WATTS (W)
SEPARATION DISTANCE (d) IN METERS (m) ACCORDING
TO FREQUENCY OF TRANSMITTER
150 kHz to
80 MHz
80 MHz to
800 MHz
800 MHz to
2.5 GHz
0.01
0.1
1
10
100
d = 1.2 x
0.12
0.38
1.2
3.8
12
P
d = 1.2 x
0.12
0.38
1.2
3.8
12
P
d = 2.3 x
0.23
0.73
2.3
7.3
23
P
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
5 - 14 0070-10-0684-01 AS3000™ Operating Instructions
Product Specifications Warranty Statements
5.14
Warranty Statements
Mindray DS USA, Inc. warrants that components within the anesthesia system will be free from defects in workmanship and materials for the number of years shown on the invoice.
Under this extended warranty, Mindray DS USA, Inc. will repair or replace any defective component at no charge for labor and/or materials. This extended warranty does not cover consumable items such as (but not limited to) batteries and external cables.
Recommended preventative maintenance, as prescribed in the Service Manual, is the responsibility of the user, and is not covered by this warranty.
Except as otherwise provided herein, the terms, conditions, and limitations of Mindray DS
USA, Inc.’s standard warranty will remain in effect.
Mindray DS USA, Inc. warrants that its products will be free from defects in workmanship and materials for a period of one (1) year from the date of purchase except that disposable or one-time use products are warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use, whichever is sooner.
This warranty does not cover consumable items such as, but not limited to, batteries, external cables, sensors, cuffs, hoses, or mounts.
Mindray DS USA, Inc. will not be liable for any incidental, special, or consequential loss, damage, or expense directly or indirectly arising from the use of its products, liability under this warranty and the buyer’s exclusive remedy under this warranty is limited to servicing or replacing at Mindray DS USA, Inc.’s option at the factory or at an authorized distributor, any product which shall under normal use and service appear to the Company to have been defective in material or workmanship.
No agent, employee, or representative of Mindray DS USA, Inc. has any authority to bind
Mindray DS USA, Inc. to any affirmation, representation, or warranty concerning its products, and any affirmation, representation or warranty made by any agent, employee, or representative shall not be enforceable by buyer.
This warranty is expressly in lieu of any other express or implied warranties, including any implied warranty or merchantability or fitness, and of any other obligation on the part of the seller.
Damage to any product or parts through misuse, neglect, accident, or by affixing any nonstandard accessory attachments or by any customer modification voids this warranty.
Mindray DS USA, Inc. makes no warranty whatever in regard to trade accessories, such being subject to the warranty of their respective manufacturers.
A condition of this warranty is that this equipment or any accessories which are claimed to be defective be returned when authorized, freight prepaid to Mindray DS USA, Inc.,
Mahwah, New Jersey 07430. Mindray DS USA, Inc. shall not have any responsibility in the event of loss or damage in transit.
AS3000™ Operating Instructions 0070-10-0684-01 5 - 15
Disclaimers Product Specifications
5.15
5.15.1
5.16
5.17
Calibration may be performed without the need to disassemble the instrument. It is the responsibility of the purchaser to perform calibration as necessary, in accordance with the instructions provided in this manual.
Disclaimers
Product Improvements
Mindray DS USA, Inc. retains the right to modify the machine and/or operating instructions without prior notification. These operating instructions explain all features of the AS3000 system and are correct at time of manufacture. Instructions and models produced at a later stage, may contain improvements or modifications that were not included in previous models.
Phone Numbers and How To Get Assistance
A network of service representatives and factory-trained distributors is available. Prior to requesting service, perform a complete operational check of the instrument to verify proper control settings. If operational problems continue to exist, contact the Service Department at
(800) 288-2121, ext: 8116 for Technical Support or (201) 995-7875 for assistance in determining the nearest field service location.
Please include the instrument model number, the serial number, and a description of the problem with all requests for service.
Warranty questions should be directed to a local representative. A list of offices, along with their phone numbers, is provided at the end of this manual.
NOTE: Upon request, calibration instructions or other information will be provided to assist the user’s appropriately qualified technical personnel in repairing those parts of the AS3000 which are designated as repairable.
Manufacturer’s Responsibility
The effects on safety, reliability, and performance of the equipment are the manufacturer’s responsibility only if:
a. assembly operations, extensions, readjustments, modifications or repairs are carried out by authorized personnel; and
b. the electrical installation of the relevant room complies with the appropriate requirements; and
c. the equipment is used in accordance with the instructions for use
5 - 16 0070-10-0684-01 AS3000™ Operating Instructions
6.0
Glossary
6.1
Glossary of Terms
AD/DA
AGSS
APL
BDU cmH
2
O
CMV
EEPROM
FiO
2
Freq
Freq
MIN
IC
I:E
L
L/min ml
MV
N/A
Paw or PAW
PCV
PEEP
PIP
PS
P
TARGET
ΔP
Analog to Digital/Digital to Analog
Anesthetic Gas Scavenging System
Airway Pressure Limiting
Basic Digital processing Unit
Centimeters of Water
Volume Controlled Continuous Mandatory Ventilation
Electrically Erasable Programmable Read Only Memory
Fraction of inspired oxygen
Frequency
Minimum Frequency (PS mode only)
Integrated Circuit
Ratio of Inspiratory Time to Expiratory Time liter liters per minute milliliter
Minute Volume
Not Applicable
Airway Pressure
Pressure Controlled Ventilation
Positive End-Expiratory Pressure
Peak Inspiratory Pressure
Pressure Support Ventilation
Target Pressure
Differential Pressure
AS3000™ Operating Instructions 0070-10-0684-01 6 - 1
Glossary of Terms
SIMV
T
INSP
T
P
T
SLOPE
Trigger
VO
2
I
V
T
WDT
Synchronized Intermittent Mandatory Ventilation
Inspiratory Time
Inspiratory Pause Time
Inspiratory Slope Time
Flow Trigger
Oxygen Consumption Index
Tidal Volume
Watch Dog Timer
Glossary
6 - 2 0070-10-0684-01 AS3000™ Operating Instructions
Glossary Glossary of Terms
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AS3000™ Operating Instructions 0070-10-0684-01 6 - 3
0070-10-0684-01 Rev H October 07, 2010
Mindray DS USA, Inc. • 800 MacArthur Boulevard • Mahwah, NJ 07430 • USA •
Dom. Customer Service: 1.800.288.2121 • Intl. Customer Service: +1.201.995.8000 •
Dom. Fax: 1.800.926.4275 • Intl. Fax: +1.201.995.8680 • www.mindray.com
Mindray Medical Netherlands B.V.• P.O. Box 26 • 3870 CA Hoevelaken • The Netherlands •
Tel: +31 33 25 44 911 • Fax: +31 33 25 37 621
Mindray (UK) Limited • 3 Percy Road • St. John’s Park • Huntingdon • Cambridgeshire PE29 6SZ •
United Kingdom • Tel: 01480 416840 • Fax: 01480 436588
Mindray Medical France SARL • Europarc Créteil •123, Chemin des Bassins •
94035 Créteil Cedex • France • Tel: (0)1.45.13.91.50 • Fax: (0)1.45.13.91.51
Mindray Medical German GmbH • Zwischen den Bächen 4 • 64625 Bensheim • Germany •
Tel: +49.6251.17524-0 • Fax: +49.6251.17524-20
Mindray Medical International Ltd. • 2813 Office Tower, Convention Plaza • No 1 Harbour Road •
Wanchai • Hong Kong • Tel: +852 2793 5596 • Fax: +852 2344 8824
0002-08-8918
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