Indications For Use ...........................................................................................................................................................................................................ix
Responsibilities of Operators........................................................................................................................................................................................ix
Warnings, Cautions, and Notes....................................................................................................................................................................................ix
Notes.................................................................................................................................................................................................................................. xvii
Intellectual Property Statement................................................................................................................................................................................ xix
Warranty Statements .................................................................................................................................................................................................... xix
Phone Numbers and How To Get Assistance.........................................................................................................................................................xx
Manufacturer and Address ..........................................................................................................................................................................................xx
Symbols.............................................................................................................................................................................................................................. xxi
General System Overview .........................................................................................................................................................................................1 - 2
General Description..........................................................................................................................................................................................1 - 2
Key Features ........................................................................................................................................................................................................1 - 3
Fresh Gas Dosing ...............................................................................................................................................................................................1 - 3
Breathing System ..............................................................................................................................................................................................1 - 5
Active Anesthetic Gas Scavenging System..............................................................................................................................................1 - 6
Passive Anesthetic Gas Scavenging System (Optional).......................................................................................................................1 - 6
Power Management / Battery Supply........................................................................................................................................................1 - 6
Main Unit (Front View).....................................................................................................................................................................................1 - 9
Main Unit (Rear View)....................................................................................................................................................................................1 - 11
Main Unit (Left View)..................................................................................................................................................................................... 1 - 13
Main Unit (Right View)..................................................................................................................................................................................1 - 14
Main Unit (Top View)..................................................................................................................................................................................... 1 - 15
Breathing System (Top View).....................................................................................................................................................................1 - 16
Breathing System (Left View)..................................................................................................................................................................... 1 - 17
Active Anesthetic Gas Scavenging System........................................................................................................................................... 1 - 19
Passive Anesthetic Gas Scavenging System (AGSS) (Right View).................................................................................................1 - 22
Install the Vaporizer.....................................................................................................................................................................................................2 - 5
Filling and Draining the Vaporizer ..............................................................................................................................................................2 - 7
Install the DGSS.............................................................................................................................................................................................................2 - 8
System Interface .................................................................................................................................................3 - 1
Main Screen Components.........................................................................................................................................................................................3 - 2
System Information Header .....................................................................................................................................................................................3 - 6
Date and Time ....................................................................................................................................................................................................3 - 9
Show Reference .............................................................................................................................................................................................. 3 - 17
Save Loop.......................................................................................................................................................................................................... 3 - 17
Measured Values Area ............................................................................................................................................................................................. 3 - 24
System Softkeys......................................................................................................................................................................................................... 3 - 25
Capture Event (software bundle version 02.02.00 and later) .........................................................................................................3 - 25
History (software bundle version 02.02.00 and later) .......................................................................................................................3 - 25
System Tab................................................................................................................................................................................................................... 3 - 38
Service Tab................................................................................................................................................................................................................... 3 - 44
Preoperative Test Schedules....................................................................................................................................................................................4 - 2
Test Intervals .......................................................................................................................................................................................................4 - 2
Inspect the System.......................................................................................................................................................................................................4 - 3
System Self-Test............................................................................................................................................................................................................4 - 6
Leak and Compliance Tests ......................................................................................................................................................................................4 - 9
Automatic Circuit Leak and Compliance Test.........................................................................................................................................4 - 9
Preoperative Check List (software bundle version 02.09.00 and later).................................................................................................. 4 - 17
Power Failure Alarm Test........................................................................................................................................................................................4 - 18
Check the Cylinder Pressure.......................................................................................................................................................................4 - 20
O2 Cylinder High Pressure Leak Test ....................................................................................................................................................... 4 - 20
N2O Cylinder High Pressure Leak Test.................................................................................................................................................... 4 - 20
Air Cylinder High Pressure Leak Test.......................................................................................................................................................4 - 20
ii046-003777-00A5/A3™ Operating Instructions
Table of Contents
Flow Control System Test....................................................................................................................................................................................... 4 - 21
Breathing System Leak Test in Manual Ventilation Status .............................................................................................................. 4 - 24
Prepare for Alarm Tests................................................................................................................................................................................4 - 26
Test the O2 Concentration Monitoring and Alarms...........................................................................................................................4 - 26
Test the Low Minute Volume (MV) Alarm.............................................................................................................................................. 4 - 27
Test the Apnea Alarm....................................................................................................................................................................................4 - 27
Test the Continuous Airway Pressure Alarm ........................................................................................................................................4 - 27
Test the High Paw Alarm..............................................................................................................................................................................4 - 28
Test the Low Paw Alarm............................................................................................................................................................................... 4 - 28
Inspect the Active/Passive Anesthetic Gas Scavenging System.............................................................................................................. 4 - 29
Inspect the AGSS.............................................................................................................................................................................................4 - 29
Inspect the DGSS ............................................................................................................................................................................................ 4 - 29
Inspect the Passive AGSS.............................................................................................................................................................................4 - 29
Powering On the A5/A3 Anesthesia System ......................................................................................................................................................5 - 2
Powering Off the A5/A3 Anesthesia System......................................................................................................................................................5 - 2
End Case / Standby Mode ..............................................................................................................................................................................5 - 3
Select the Patient Size (Adult, Pediatric, Infant).....................................................................................................................................5 - 5
Input Fresh Gas .............................................................................................................................................................................................................5 - 6
Set N2O, Air, and O2 Inputs ............................................................................................................................................................................5 - 6
Set Anesthetic Agent .......................................................................................................................................................................................5 - 7
Set Manual Ventilation Mode........................................................................................................................................................................5 - 9
Setting Monitor Mode (A5 with AG Module connected)................................................................................................................. 5 - 11
Make Settings before Starting Mechanical Ventilation Mode .......................................................................................................5 - 14
Volume Control Ventilation (VCV)............................................................................................................................................................5 - 14
Pressure Control Ventilation (PCV)........................................................................................................................................................... 5 - 15
Gas (available with the AG module) ........................................................................................................................................................ 5 - 21
Inspired O2 (available without the AG module)..................................................................................................................................5 - 21
Gas Waveform (available with the AG module) ..................................................................................................................................5 - 23
Alarm System Self-Test....................................................................................................................................................................................6 - 2
Types of Alarms and Messages.....................................................................................................................................................................6 - 3
Displayed Order of Alarm Messages...........................................................................................................................................................6 - 6
Auto Alarm Limits...........................................................................................................................................................................................6 - 14
Setting CO2 Apnea Delay Time (software bundle version 02.09.00 and later) ........................................................................6 - 14
Alarm and Prompt Messages................................................................................................................................................................................6 - 15
Theory of Operation....................................................................................................................................................................................................7 - 3
Breathing System Maintenance..............................................................................................................................................................................7 - 4
Calibrate the O2 Sensor...................................................................................................................................................................................7 - 7
Water Build-up in the Flow Sensor.........................................................................................................................................................................7 - 9
Prevent Water Build-up...................................................................................................................................................................................7 - 9
Clear Water Build-up ........................................................................................................................................................................................7 - 9
Waste Gas Transfer Tube Maintenance................................................................................................................................................................7 - 9
Cleaning and Disinfection...................................................................................................................................................................................... 7 - 11
General Guidelines.........................................................................................................................................................................................7 - 11
Cleaning and Disinfecting Agents / Autoclaving................................................................................................................................ 7 - 11
Bag Arm.............................................................................................................................................................................................................. 7 - 21
Breathing System Block................................................................................................................................................................................7 - 25
Active Anesthetic Gas Scavenging System........................................................................................................................................... 7 - 28
Understand MAC Values............................................................................................................................................................................................8 - 3
Identify External AG Modules ..................................................................................................................................................................................8 - 4
Prepare to Measure AG ..............................................................................................................................................................................................8 - 5
Make AG Settings .........................................................................................................................................................................................................8 - 6
Set CO2 Unit ........................................................................................................................................................................................................8 - 6
Set CO2 Placement ...........................................................................................................................................................................................8 - 6
Set CO2 Scale ......................................................................................................................................................................................................8 - 6
Gas Bench Flow Rate ........................................................................................................................................................................................8 - 6
Set Alarm Limits .................................................................................................................................................................................................8 - 7
Scavenge the Sample Gas.........................................................................................................................................................................................8 - 9
Calibrate the AG Module ........................................................................................................................................................................................8 - 10
Wiring and PC Board Materials.....................................................................................................................................................................9 - 4
Main Electrical Power Specifications..........................................................................................................................................................9 - 7
Battery Power Specifications.........................................................................................................................................................................9 - 7
Communication Ports......................................................................................................................................................................................9 - 8
Oxygen Ratio Controller...............................................................................................................................................................................9 - 10
Breathing System Specifications .........................................................................................................................................................................9 - 10
Breathing System Volume........................................................................................................................................................................... 9 - 10
CO2 Absorber Assembly............................................................................................................................................................................... 9 - 10
Water Trap.........................................................................................................................................................................................................9 - 10
Breathing System Connections.................................................................................................................................................................9 - 10
Breathing System Temperature Controller........................................................................................................................................... 9 - 13
Anesthetic Gas Scavenging System (AGSS)..................................................................................................................................................... 9 - 14
Effect of Interfering Gas on AG Measured Value................................................................................................................................. 9 - 18
ASTM F 1208 – 89 (2005) Disclosures.................................................................................................................................................................9 - 25
Leakage of Breathing System..................................................................................................................................................................... 9 - 25
Resistance of Breathing Systems .............................................................................................................................................................. 9 - 25
CO2 Absorber Resistance............................................................................................................................................................................. 9 - 25
CO2 Absorber Capacity................................................................................................................................................................................. 9 - 25
Data Storage (Non-Volatile) and Recording .................................................................................................................................................... 9 - 26
AG Accessories .............................................................................................................................................................................................................A - 2
CO2 Absorbent Canister............................................................................................................................................................................................A - 2
Gas Cylinder Accessories .......................................................................................................................................................................................... A - 2
Gas Supply Hoses ........................................................................................................................................................................................................A - 3
Manuals and Reference Cards ................................................................................................................................................................................A - 3
Mounting Accessories ............................................................................................................................................................................................... A - 3
Networking and USB Storage .................................................................................................................................................................................A - 4
User Accessible Spare Parts ...............................................................................................................................B - 1
Active AGSS ................................................................................................................................................................................................................... B - 2
Breathing System ........................................................................................................................................................................................................ B - 2
CO2 Absorbent Canister............................................................................................................................................................................................ B - 2
Flow Sensor ................................................................................................................................................................................................................... B - 2
Gas Cylinder Accessories .......................................................................................................................................................................................... B - 3
O2 Sensor........................................................................................................................................................................................................................ B - 3
Battery ............................................................................................................................................................................................................................. B - 3
Parameters and Factory Defaults......................................................................................................................C - 1
Waveform/Spirometry Tabs (A5 Only)................................................................................................................................................................. C - 2
Alarm Limits................................................................................................................................................................................................................... C - 3
Setup Menu ...................................................................................................................................................................................................................C - 5
Alarm Volume and History....................................................................................................................................................................................... C - 8
Date and Time .............................................................................................................................................................................................................. C - 8
Demographics.............................................................................................................................................................................................................. C - 9
Ventilation Modes....................................................................................................................................................................................................... C - 9
Pneumatic Diagram........................................................................................................................................... D - 1
Pneumatic Diagram of the A5/A3 System..........................................................................................................................................................D - 2
Abbreviations, Symbols, and Units of Measure ...............................................................................................E - 1
Units of Measure...........................................................................................................................................................................................................E - 4
WAR NIN G:Do not operate the A5/A3 Anesthesia System before reading these
instructions.
The operating instructions for the A5/A3 Anesthesia Delivery System (hereinafter referred to as A5/A3
Anesthesia System, A5/A3 System, A5/A3, or individual A5 and A3) are intended to provide
information for proper installation, operation, and general maintenance of the A5/A3 System to the
user.
General knowledge and understanding of the features and functions of the A5/A3 System are
prerequisites for its proper use.
For servicing information or assistance, please contact an authorized representative in your area.
Rx only:U.S. Federal Law restricts this device to sale by or on the order of a
NOTE:Figures in this manual are provided for reference purposes only.
physician or other practitioner licensed by state law to use or order the
use of this device.
Screens may differ based on the system configuration and selected
parameters.
Indications For Use
The A5/A3 Anesthesia 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 A5/A3 is intended for use by licensed clinicians, for patients requiring anesthesia within a health
care facility, and can be used for adult and pediatric populations.
WARNING:The A5/A3 is intended to be operated only by licensed clinicians and
qualified anesthesia personnel who have received adequate training in
its use. Anyone unauthorized or untrained must not perform any
operation on the A5/A3.
WARNING:The A5/A3 is not suitable for use in an MRI environment.
Responsibilities of Operators
The proper function of the A5/A3 System can only be guaranteed if it is operated and serviced in
accordance with the information provided in this manual and by an authorized Mindray service
representative. Non-compliance with this information voids all guarantee claims.
The A5/A3 System 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 WAR NIN GS , CAUTIONS, and NOTES detailed in this manual.
Warnings, Cautions, and Notes
Please adhere to all warnings, cautions, and notes that are listed throughout this manual. They are
summarized here for your reference.
WAR NIN G — Indicates a potential hazard or unsafe practice that, if not avoided, could result in death
or serious injury to the patient or user.
CAUTION — Indicates a potential hazard or unsafe practice that, if not avoided, could result in
product/property damage or minor personal injury to the patient or user.
NOTE — Provides application tips or other useful information.
A5/A3™ Operating Instructions046-003777-00ix
IntroductionWarnings
Warnings
WARNING:Do not operate the A5/A3 Anesthesia System before reading these
WARNING:All analog or digital products connected to this system must be
WARNING:This machine must only be operated by trained, skilled medical staff.
WARNING:Before putting the system into operation, the operator must verify that
WARNING:The equipment must be connected to a properly installed power outlet
WARNING:Multiple AC power outlets are provided on the rear of the A5/A3. These
instructions.
certified passing the specified IEC standards (such as IEC 60950 for data
processing equipment and IEC 60601-1 for medical electrical
equipment). All configurations shall comply with the valid version of
IEC 60601-1. The personnel who are responsible for connecting the
optional equipment to the I/O signal port shall be responsible for
medical system configuration and system compliance with IEC 60601-1.
the equipment, connecting cables, and accessories are in correct
working order and operating condition.
with protective earth contacts only. If the installation does not provide
for a protective earth conductor, disconnect it from the power line or
operate from the equipment’s internal battery supply.
outlets are intended to supply power to additional equipment that
form a part of the anesthesia system (i.e. vaporizers, gas analyzers,
etc.). Do not connect other equipment to these outlets, as patient
leakage current may be affected. Each outlet is rated 3 A; the total
current that may be drawn through all outlets is 10 A on the A5 System
and 9 A on the A3 System; do not attempt to exceed these load ratings.
Do not connect additional Multiple Portable Socket Outlets (i.e.
Multiple outlet extension cords) (MPSOs) or extension cords to these
outlets.
WARNING:Do not put MPSOs on the floor.
WARNING:Connect the A5/A3 Anesthesia System to an AC power source before the
internal battery power source is depleted.
WARNING:Do not open the equipment housings. All servicing and future
upgrades must be carried out only by trained and authorized Mindray
personnel.
WARNING:Do not rely exclusively on the audible alarm system for patient
monitoring.
WARNING:Adjustment of alarm volume to a low level may result in a hazard to the
patient.
WARNING:Alarm settings should be customized according to different patient
situations. Constantly keeping the patient under close surveillance is
the most reliable way for safe patient monitoring.
WARNING:The physiological parameters and alarm messages displayed on the
WARNING:Dispose of the packaging material, observing the applicable waste
screen of the equipment are for the caregiver’s reference only and
cannot be directly used as the basis for clinical treatment.
control regulations and keeping it out of children’s reach.
x046-003777-00A5/A3™ Operating Instructions
WarningsIntroduction
WARNING:To avoid the possibility of explosion, do not use the equipment in the
WARNING:Fresh gas flow must never be switched off before the vaporizer is
WARNING:To avoid the risk of electric shock, this equipment must only be
WARNING:The use of anti-static or electrically conductive breathing tubes, when
WARNING:Possible electric shock hazard. The machine may only be opened by
WARNING:The patient should be visually monitored by qualified personnel. In
WARNING:Always set the alarm limits so that the alarm is triggered before a
presence of flammable anesthetic agents, vapors or liquids. Do not use
flammable anesthetic agents such as ether and cyclopropane for this
equipment. Use only non-flammable anesthetic agents that meet the
requirements specified in ISO 80601-2-13. The A5/A3 Anesthesia
System can be used with halothane, enflurane, isoflurane, sevoflurane,
and desflurane. Only one anesthetic agent can be used at a time.
switched off. The vaporizer must never be left switched on without a
fresh-gas flow. Anesthetic agent vapor at a high concentration can get
into the machine lines and ambient air, causing harm to people and
materials.
connected to a supply mains with protective earth.
utilizing high frequency electric surgery equipment, may cause burns,
and is therefore not recommended in any application of this machine.
authorized service personnel.
certain situations, life-threatening circumstances may occur that may
not necessarily trigger an alarm.
hazardous situation occurs. Incorrectly set alarm limits may result in
operating personnel not being aware of drastic changes in the patient’s
condition.
WARNING:Connection of both medical and non-medical 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
WARNING:Disconnect the power plug from the mains supply before removing the
WARNING:Malfunction of the central gas supply system may cause more than one
WARNING:The anesthesia system will cease to deliver gas at pressures below the
WARNING:Use a cleaning and disinfection schedule that conforms to your
WARNING:Use extreme care while handling the absorbent as it contains a caustic
powered on and/or plugged into an outlet.
rear panels or servicing the A5/A3 unit.
or even all devices connected to it to stop their operation
simultaneously.
minimum specified gas pipeline supply pressure.
institution's disinfection and risk-management policies.
•Refer to the material safety data sheet as applicable.
•Refer to the operation and maintenance manuals of all
disinfection equipment.
•Do not inhale fumes that may result from any disinfection process.
irritant.
A5/A3™ Operating Instructions046-003777-00xi
IntroductionWarnings
WARNING:Use care in lifting and manipulating vaporizers during the mounting
WARNING:Do not use talc, zinc stearate, calcium carbonate, corn starch, or similar
WARNING:All gas supplies should be of medical grade.
WARNING:Single use respiratory hoses, face masks, sensors, sodalime, water
WARNING:To avoid endangering a patient, do not perform testing or maintenance
WARNING:Review the performance specifications of the disposal system that the
WARNING:The A5/A3 should not be used adjacent to or stacked with other
WARNING:Ensure that the current alarm presets are appropriate before use on
process as their weight may be greater than expected, based on their
size and shape.
material to prevent sticking of the bellows, as these materials may
enter the patient's lungs or airway, causing irritation or injury.
traps, sampling lines, airway adapters, and other single use items may
be considered potential biologically hazardous items and should not
be reused. Dispose of these items in accordance with hospital policy
and local regulations for contaminated and biologically hazardous
items.
when the machine is in use.
transfer and receiving systems are intended to be used with, to ensure
compatibility.
equipment. If adjacent or stacked use is necessary, the A5/A3 should be
observed to veri fy norm al operation in the configuration in which it will
be used.
each patient.
WARNING:A hazard can exist if different alarm presets are used for the same or
similar equipment in any single area.
WARNING:Due to the size and weight of the A5/A3, it should only be moved by
qualified personnel.
WARNING:Overloading machine may cause tipping. Equipment attached to the
side of the machine should fall within the rated weights to prevent
tipping of the machine.
WARNING:Excess load may cause a tip hazard while moving the A5/A3. Before
moving, remove all equipment from the top shelf and all monitoring
equipment mounted to the side of the A5/A3. Use care when moving
the A5/A3 up or down inclines, around corners, and across thresholds.
Do not attempt to roll the A5/A3 over hoses, cords, or other obstacles.
WARNING:Leaks or internal venting of sampled gas may affect accuracy. Perform
the proper preoperative tests to ensure that the device is performing
properly. Leaky circuits can not be used.
WARNING:Connection of the A5/A3 exhaust port to the hospital’s waste gas
WARNING:Operation of the A5/A3 below the minimum flow values may cause
WARNING:Ensure that an independent means of ventilation (e.g. a self-inflating
scavenging system is strongly recommended to prevent exposure of
hospital personnel to the A5/A3 exhaust gases.
inaccurate results.
manually powered resuscitator with mask) is available whenever the
A5/A3 is in use.
xii046-003777-00A5/A3™ Operating Instructions
WarningsIntroduction
WARNING:Usage of accessories found with damaged packaging may cause
WARNING:Before using the A5/A3 System (after cleaning or disinfecting), power
WARNING:Improperly cleaned materials may result in biocontamination. Use a
WARNING:If the A5/A3 is damaged in any way that compromises the safety of the
WARNING:Oxygen, when present in high concentrations, can significantly
WARNING:Use of lubricants not recommended by Mindray may increase the
biocontamination or failure. The operator should check accessory
packaging integrity before use.
up the system and follow the on-screen prompts to perform the leak
test and the compliance test. (see
Complia nce Test s".)
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.
The user should follow the recommended disinfection routine for this
machine and any reusable accessories.
patient or user, discontinue use and attach a visible tag that marks the
A5/A3 as unusable. Call Mindray Technical Support.
increase the chance of fire or an explosion. Oil and grease may
spontaneously ignite and should not be used where oxygen
enrichment may occur.
danger of fire or explosion. Use lubricants approved by Mindray.
section4.5 (page 4-9) "Leak and
WARNING:Low-pressure regulators and flow-meters are susceptible to high
pressure, and may burst if improperly maintained or disassembled
while under pressure. Changing connectors or disassembling should be
performed only by qualified personnel.
WARNING:Do not disassemble the low-pressure regulator, flow-metering device,
or connector while under pressure. The release of sudden pressure may
cause injury.
WARNING:Review the specifications of the AGSS transfer and receiving systems
and the specifications of the A5/A3 System to ensure compatibility and
to prevent a mismatched receiving system.
WARNING:Avoid connecting two or more hose assemblies in series as this may
WARNING:A hazard may exist due to the use of improper connectors. Ensure all
WARNING:Avoid replacing a high-pressure flexible connection with one of lower
WARNING:Reusing breathing circuits or reusable accessories that are not
WARNING:Inspect all breathing system components carefully before each use.
cause a loss of pressure and flow.
assemblies use the proper connectors.
nominal inlet pressure.
disinfected may cause cross-contamination. Disinfect the breathing
circuits and reusable accessories before use.
Ensure all components do not contain any obstructions or debris that
can cause a potential hazard to the patient.
WARNING:Use breathing circuits and manual bags in accordance with ASTM F1208
and compatible with standard 22mm male conical fittings per ASTM
specifications F 1054.
A5/A3™ Operating Instructions046-003777-00xiii
IntroductionCautions
WARNING:The mains plug is used to isolate the Anesthesia System circuits
WARNING:Do not touch the patient when connecting the peripheral equipment
WARNING:If the Drive Gas Pressure Low alarm occurs when the gas supply
WARNING:The anesthesia system shall not be serviced or maintained while being
WARNING:Additional MULTIPLE SOCKET- OUTLET or extension cord shall not be
electrically from the SUPPLY MAINS. Do not position the Anesthesia
System so that it is difficult to operate the plug.
via the I/O signal ports or replacing the oxygen cell to prevent patient
leakage current from exceeding the requirements specified by the
standard.
pressure is greater than 200 kPa, contact your service personnel or us.
connected on a patient.
connected to the ME SYSTEM.
Cautions
CAUTION:To ensure patient safety, use only parts and accessories specified in this
CAUTION:At the end of its service life, the equipment, as well as its accessories,
CAUTION:Magnetic and electrical fields are capable of interfering with the proper
manual.
must be disposed of in compliance with the guidelines regulating the
disposal of such products, and in accordance with local regulations for
contaminated and biologically hazardous items.
performance of the equipment. Ensure that all external devices
operating in the vicinity of the equipment comply with the relevant
EMC requirements. Mobile phones, x-ray equipment, and MRI devices
are possible sources of interference as they may emit higher levels of
electromagnetic radiation.
CAUTION:This system operates correctly at the electrical interference levels
identified in this manual. Higher levels can cause nuisance alarms that
may stop mechanical ventilation. Be aware of false alarms caused by
high-intensity electrical fields.
CAUTION:The A5/A3 Anesthesia System may become unstable if the unit is tilted
beyond 10 degrees. Use extreme caution when moving or resting the
unit on surfaces exceeding a 10 degree slope. Do not hang articles on
the sides of the unit that would cause an excessive imbalance.
CAUTION:Perform the daily checks specified on the checklist. In case of a system
CAUTION:Before starting the machine, users must be familiar with the
CAUTION:If the machine does not function as described, it must be examined and
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
fault, do not operate the system until the fault has been corrected.
information contained in these Operating Instructions and must have
been trained by an authorized representative.
repaired as necessary by qualified service personnel before being
returned to use.
technical specifications.
xiv046-003777-00A5/A3™ Operating Instructions
CautionsIntroduction
CAUTION:Before clinical use, the machine must be correctly calibrated and/or the
CAUTION:If system faults occur during the initial calibration or testing, the
CAUTION:After servicing, functional, sensor, and system tests must be performed
CAUTION:Only vaporizers with Selectatec Interlock-Systems may be used with
CAUTION:After each exchange of a vaporizer, perform a vaporizer leak test.
CAUTION:Use cleaning agent sparingly. Excess fluid could enter the machine,
CAUTION:Do not autoclave any parts of the A5/A3 unless specifically identified as
CAUTION:To prevent system damage:
respective tests must be performed, as described in these Operating
Instructions.
machine should not be operated until those faults have been corrected
by a qualified service person.
before clinical use.
the A5/A3 unit.
causing damage.
autoclavable in this manual. Clean the A5/A3 only as specified in this
manual.
•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 as per the local regulations.
CAUTION:Do not use acetic hydroperoxide or formaldehyde steaming.
CAUTION:The valve disc in each of the inhalation and exhalation valve assemblies
on the breathing system is fragile and must be handled with care while
removing the valve cage from the valve assembly.
CAUTION:If moisture remains in the bellows after cleaning, the bellows surface
folds may become tacky and prevent the bellows from properly
expanding. Ensure all moisture is removed from the bellows after
cleaning.
CAUTION:Only connect Mindray approved equipment to the A5/A3
communication ports. Equipment connected to the A5/A3 ethernet
ports must comply with IEC 60950.
CAUTION:Do not connect any non-isolated devices to the DB9/RS232C interface
of the A5/A3.
CAUTION:Do not connect any devices to the SB ports other than Mindray
approved USB storage devices and a supported USB mouse (see
‘‘Networking and USB Storage’’ on page A-4).
A5/A3™ Operating Instructions046-003777-00xv
IntroductionCautions
CAUTION:Do not wash the inner surface of the oxygen sensor.
CAUTION:Do not autoclave the following components: Paw gauge, oxygen
sensor, flow sensor, and bellows. These components cannot withstand
immersion or the heat and pressure of autoclaving.
CAUTION:Users should monitor oxygen percentage (FiO2%) when using the
Auxiliary O
delivered to the patient unless oxygen monitoring is used.
/Air Flow Meters. Unknown oxygen concentrations may be
2
CAUTION:The A5/A3 is NOT suitable for use in a magnetic resonance imaging
(MRI) environment.
CAUTION:To ensure measurement accuracy and to avoid possible damage to the
A5/A3, use only Mindray-approved cables and accessories.
CAUTION:Use the power cord provided with the product. If a substitute is
necessary, use only hospital grade power cords.
CAUTION:Do not use a damaged or 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 cables if damaged in any
way.
CAUTION:Use of other oxygen sensors may cause improper oximeter
performance.
CAUTION:Unintended movement may occur if the casters are not locked. The
operator should lock casters during use of the machine.
CAUTION:Unsecured devices may slide off the top shelf. Devices should be
securely attached to the top shelf.
CAUTION:The voltage on the auxiliary outlets is the same voltage as the outlet
into which the A5/A3 machine is plugged. Ensure that devices plugged
into the auxiliary outlets are rated for the same supply voltage as the
A5/A3.
CAUTION:During the transport and storage of the vaporizer, block the gas inlet
and outlet of the vaporizer with plugs to prevent foreign substances
from entering the vaporizer.
CAUTION:Do not use any flow outlets as handles for moving the A5/A3. The flow
outlets may become damaged. Use the metal side bars on the main
body when moving the A5/A3.
CAUTION:Do not push down on the bag arm forcefully or hang heavy objects
onto it. Excessive weight may bend and damage the bag arm.
CAUTION:Use caution when disconnecting “quick connectors”, as the sudden
release of pressure may cause injury.
CAUTION:Avoid factors that can contribute to deterioration of the hose
assemblies. Factors include excessive bending, crushing, abrasion,
system pressures and temperatures that exceed hose ratings, and
improper installation.
CAUTION: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.
xvi046-003777-00A5/A3™ Operating Instructions
NotesIntroduction
CAUTION:Turn the flow controls slowly. To avoid damaging the control valves, do
not turn further when the flowmeter reading is outside the range.
When turning a flow control knob clockwise to decrease flow, the
flowmeter should reach zero before the knob reaches its most
clockwise mechanical stop (Off) position. Do not turn any further when
the knob has reached the Off position.
Similarly, when turning a flow control knob counterclockwise to
increase flow from zero, the flowmeter reading should not indicate a
change from zero until the flow control knob is turned approximately
one (1) rotation counterclockwise from the Off position, and only if
permitted according to the gas ratio control system.
Notes
NOTE:Figures in this manual are provided for reference purposes only.
Screens may differ based on the system configuration and selected
parameters.
NOTE:Put the equipment in a location where you can easily see the screen and
access the operating controls.
NOTE:Keep this manual close to the equipment so that it can be obtained
conveniently when needed.
NOTE:The software was developed in compliance with IEC 60601-1. The
possibility of hazards arising from software errors is minimized.
NOTE:This manual describes all features and options. Your equipment may
not have all of them.
NOTE:The A5/A3 is intended to be operated with its integral Breathing
Pressure monitoring in use.
NOTE:The A5/A3 is intended to be operated with its integral Breathing
Pressure limitation devices in use.
NOTE:The A5/A3 is intended to be operated with its integral Exhaled Volume
monitoring in use.
NOTE:The A5/A3 is intended to be operated with its integral Breathing System
integrity Alarm System in use.
NOTE:The A5/A3 is intended to be operated with its integral Continuing
Pressure Alarm in use.
NOTE:The A5/A3 is intended to be operated with its integral O2 monitoring in
use.
NOTE:The A5/A3 is intended to be operated with an external CO2 monitor
complying with ISO 80601-2-55. Connection to the CO
be via a sample line from the patient circuit.
NOTE:The Anesthesia Vapor Delivery Device is to be used with an Anesthetic
Agent Monitor complying with ISO 80601-2-55. Connection to the
Agent monitor should be via a sample line from the Patient Circuit.
NOTE:Continuously monitor the anesthetic agent concentration when using
the Anesthesia System to ensure accurate output of the anesthetic
agent.
monitor should
2
A5/A3™ Operating Instructions046-003777-00xvii
IntroductionNotes
NOTE:Check the liquid level of the anesthetic agent before and during all
NOTE:The A5/A3 System is designed to be equipped with an anesthetic vapor
NOTE:The A5/A3 battery supply is not a user serviceable component. Only an
NOTE:Areas designated for the servicing of oxygen equipment shall be clean,
NOTE:Opening the cylinder valve quickly may cause unexpected pressure
NOTE:Accuracy of the flowrate may be affected by varying inlet pressure,
NOTE:The power device, terminal units and pipeline system can be supplied
NOTE:Regional or national regulations that apply to manufacturers of
operations. When the liquid level is below the warning line, more
anesthetic agent needs to be added. Refer to the vaporizer Instructions
For Use for filling the vaporizer and other information.
delivery device that complies with ISO 80601-2-13.
authorized service representative can replace the battery supply. If the
system is not used for an extended period, contact a service
representative to have the battery supply disconnected. The batteries
may be subject to local regulations regarding disposal. At the end of
the battery life, dispose of the battery supply in accordance with local
regulations.
free of oil and grease, and not used for the repair of other equipment.
differentials and create a potential for fire or explosion arising from
oxygen pressure shocks. Open and shut the cylinder valve slowly.
varying outlet resistance, or varying ambient temperature.
by one or several different manufacturers.
medical devices can exist.
NOTE:For the method of connecting A5 to external monitor or other devices,
please see Anesthesia Machine Bracket Installation Instructions.
NOTE:The A5 can be equipped with one scavenger system to provide the best
match with the hospital’s waste-gas disposal system. The scavenger
system shall comply with ISO 80601-2-13.
NOTE:The Anesthesia System is compatible with gases (O2, N2O, an d Air) and
anaesthetic agents (Halothane, Enflurane, Isoflurane, Sevoflurane, and
Desflurane).
NOTE:The leakage of AGSS is measured by the method recommended in ISO
NOTE:The Anesthesia System is compatible with gases (O2, N2O, and Air) and
NOTE:The leakage of AGSS is measured by the method recommended in ISO
80601-2-13.
anaesthetic agents (Halothane, Enflurane, Isoflurane, Sevoflurane, and
Desflurane).
80601-2-13.
xviii046-003777-00A5/A3™ Operating Instructions
Intellectual Property StatementIntroduction
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the
intellectual property rights to this Mindray product and this manual. This manual may refer to
information protected by copyright or patents and does not convey any license under the patent
rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information. Disclosure of
the information in this manual in any manner whatsoever without the written permission of Mindray
is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative
work of this manual in any manner whatsoever without the written permission of Mindray is strictly
forbidden.
, and are the trademarks, registered or otherwise, of Mindray in
China and other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.
This posting serves as notice under 35 U.S.C.§287(a) for Mindray patents: http://
www.mindrayna.com/patents.
Warranty Statements
Mindray DS USA, Inc. warrants that its products will be free from defects in workmanship and
materials for a period of three (3) years 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, O
absorbents, breathing circuits, hoses, or mounts.
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.
Recommended preventative maintenance, as prescribed in the Maintenance section of this 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. 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.
sensors, CO2
2
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 non-standard
accessory attachments or by any customer modification voids this warranty. Mindray DS USA, Inc.
makes no warranty whatsoever in regard to trade accessories, such being subject to the warranty of
their respective manufacturers.
A5/A3™ Operating Instructions046-003777-00xix
IntroductionDisclaimers
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.
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 A5/A3 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 877.913.9663 (toll free) for
Technical Support or 650.316.3199 (outside North America) for assistance in determining the nearest
field service location.
Please include the instrument model number, the serial number (located on the back of the A5/A3),
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 A5/A3 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
Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan,
Shenzhen 518057, P.R. China
xx046-003777-00A5/A3™ Operating Instructions
SymbolsIntroduction
Symbols
The following table provides descriptions of symbols that are used on the device and/or within this
manual.
SYMBOLDESCRIPTIONSYMBOLDESCRIPTION
Caution
Defibrillator proof
type BF equipment
Electrical:
Alternating Current
(AC)
Electrical:
Equipotentiality
Electrical:
Fuse or circuit breaker
Electrical:
Input Output
Electrical:
Internal Battery
Electrical:
Light
Environment:
Tem per atu re R an ge
Environment:
Humidity Range
Environment:
Pressure Range
Gas Cylinder
Gas Inlet
Gas Outlet
Gas Flow:
Flow Control
Gas Flow: Maximum
Electrical:
Power On
Electrical:
Power Standby
Electrical:
Protective Earth
(Ground)
Electrical:
E
A5/A3™ Operating Instructions046-003777-00xxi
WEEE (Waste of
Electrical and
Electronic
Equipment) Marking.
Separate treatment
from general waste at
end of life.
Gas Flow: Minimum
Gas Flow Total
Gas:
O2 Flush
O2 Sensor Connector
IntroductionSymbols
134°C
134°C
Identifier:
Manufacturer
Gas Pipeline Connection
Identifier:
Manufacturer’s
Reference/Catalog
Material:
Polyphenyl-sulfone
Number
Identifier:
Serial Number
Indicator
Lock/Unlock:
Direction
Lock/Unlock:
Lock
Lock/Unlock:
Unlock
No Heavy Objects
Do Not Crush
Material:
Polysulfone
Tou ch pa d
Manual ventilation via Breathing Bag
Automatic Ventilation
Wate r Trap
Autoclavable
Not Autoclavable
Caution: Hot
Water Drain
Do Not Oil
Filter Access
Direction of flow
Drawer weight limit
Conforms to AAMI Std. ES 60601-1,
MR Unsafe - do not
subject to magnetic
resonance imaging
(MRI)
IEC Std.60601- 1-8, ISO Std. 80601-2-
13, ISO Std. 80601-2-55.
Certified to CSA Std. C22.2 No. 60601-
1, CSA Std. C22.2 No.60601-1-8, ISO
Std. 80601-2-13, ISO Std. 80601-2-55.
Canister opened
Canister closed
xxii046-003777-00A5/A3™ Operating Instructions
SymbolsIntroduction
WarningRefer to instruction manual/booklet
Protection against
IPX1
vertically falling water
drops
Battery supply fully charged.
AC power connected and
Alarm Icon
powering system.
Battery supply partially
charged. AC power connected,
charging battery supply, and
Alarm Silence Icon
power system.
Battery supply fully charged
and powering system. AC
Low priority message
power not connected.
Battery supply partially
charged and powering system.
AC power not connected.
Battery supply low charged
and powering system.
Recharging recommended. AC
power not connected.
Battery supply not installed.
Medium priority message
High priority message
Breathing System Warmer Off
A5/A3™ Operating Instructions046-003777-00xxiii
IntroductionSymbols
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xxiv046-003777-00A5/A3™ Operating Instructions
1.0
Product Description
General System Overview ................................................................................................................................................................... 1-2
The A5/A3 Anesthesia System is a device intended to administer, continuously or intermittently, a
general inhalation anesthetic to a patient, and to maintain a patient's ventilation. The A5/A3 also
provides for ventilatory monitoring of the patient. The anesthesia system is intended to be used in
the patient environment.
The A5/A3 Anesthesia System consists of a main unit (includes an anesthetic ventilator and
flowmeter monitor assembly) and a detachable breathing system. The applied part of the anesthesia
system are breathing tubes and masks. Connect the patient to the anesthesia system via breathing
tubes and masks.
The A5 Anesthesia System provides the following ventilation modes:
• Volume Control Ventilation (VCV), which includes the Pressure Limit Ventilation (PLV) function
• Spontaneous ventilation in Manual mode with APL fully open
• Manual Ventilation through the use of a breathing bag
Electronic PEEP is available in all automatic ventilation modes. User control of the inspiratory flow rise
(Tslope) is possible in PCV, SIMV, and PS modes. Automatic fresh gas compensation limits the effect
on the patient ventilation from changes in fresh gas flow rate by the operator. The traditional bellows
system is driven by oxygen and makes patient disconnections clearly visible.
The A5/A3 Anesthesia System provides the following common functions:
• Automatic leak detection
• Circuit gas leakage compensation and automatic compliance compensation
• Cylinder and central pipeline gas supply connections available for gas input
• Electronically displayed flowmeter and electronically adjustable PEEP
• Electronic timer to display the duration between the start and end of an operation
• Work table light
• Mounting rails to connect an external patient monitor
1 - 2046-003777-00A5/A3™ Operating Instructions
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