Operating Instructions
336 Pages
Preview
Page 1
Foreword
Introduction
Foreword WARNING:
Do not operate the A5/A4 Anesthesia System before reading these instructions.
The operating instructions for the A5/A4 Anesthesia Delivery System (hereinafter referred to as A5/A4 Anesthesia System, A5/A4 System, A5/A4, or individual A5 and A4) are intended to provide information for proper installation, operation, and general maintenance of the A5/A4 System to the user. General knowledge and understanding of the features and functions of the A5/A4 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 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 may differ based on the system configuration and selected parameters.
NOTE:
This operating instructions is suitable for the Anesthesia System with software bundle version 03.00.00 and greater.
Indications For Use The A5/A4 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/A4 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric (including neonate, infant, child and adolescent) populations. WARNING:
The A5/A4 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/A4.
WARNING:
The A5/A4 is not suitable for use in an MRI environment.
Responsibilities of Operators The proper function of the A5/A4 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/A4 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 WARNINGS, 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. WARNING - 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.
A5/A4 Operating Instructions
ix
Introduction
Warnings
NOTE - Provides application tips or other useful information.
Warnings
x
WARNING:
Do not operate the A5/A4 Anesthesia System before reading these instructions.
WARNING:
All analog or digital products connected to this system must be 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.
WARNING:
This machine must only be operated by trained, skilled medical staff.
WARNING:
Before putting the system into operation, the operator must verify that the equipment, connecting cables, and accessories are in correct working order and operating condition.
WARNING:
The equipment must be connected to a properly installed power outlet 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.
WARNING:
Multiple AC power outlets are provided on the rear of the A5/A4. These 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 A4 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/A4 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 screen of the equipment are for the caregiver’s reference only and cannot be directly used as the basis for clinical treatment.
WARNING:
Dispose of the packaging material, observing the applicable waste control regulations and keeping it out of children’s reach.
A5/A4 Operating Instructions
Disclaimers
Introduction
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/A4 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/A4), 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/A4 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
Manufacturer and Address Manufacturer:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address:
Mindray Building, Keji 12th Road South, High-tech industrial park, Nanshan, Shenzhen 518057, P.R. China
A5/A4 Operating Instructions
xxi
System Tab
System Interface
SYSTEM TAB BUTTON
CHOICES
DESCRIPTION
Time Settings
Time Zone (Default = UTC-05:00)
Select to set the UTC time zone offset.
Daylight Savings (Default =Manual, Auto)
Select to set the Daylight Savings Time (DST) to be adjusted automatically by the A5/A4 system, or manually by the authorized administrator. If the region or country of installation does not observe DST, change this setting to Manual. If Daylight Savings is set to Auto, the Daylight Savings Time On/Off button in the Date/Menu dialog becomes inactive and cannot be selected (see FIGURE 312).
DST Start (Default =First Sunday in April at 2:00 AM)
Select to set the START of Daylight Savings Time. This setting is not available if DST is set to Manual.
DST End (Default =Last Sunday in October at 3:00 AM)
Select to set the END of Daylight Savings Time. This setting is not available if DST is set to Manual.
Network
See section 3.13.1 (page 3-46) "Network Configuration".
Change Password
-
Select to change the System tab password. The authorized administrator should change the default password immediately after the system is installed to prevent unauthorized access to the System tab. The password can be up to 6 digits in length containing numerals 0 to 9.
Units
Pressure (default=cmH2O, hPa, mbar)
Select to set the Pressure Unit of measure.
CO2 (default=mmHg, kPa, %)
Select to set the CO2 unit.
NOTE:
The Set CO2 Unit button only displays if an external AG module is connected to the A5/A4.
TABLE 3-11 System Tab Settings
3 - 44
A5/A4 Operating Instructions
System Interface
System Tab
SYSTEM TAB BUTTON
CHOICES
DESCRIPTION
Configuration Information
-
Select to display the machine ID and the status of system functions.
Export Data
-
Select to export patient data via mass storage device.
Clear History
On (default) Off
Configures the Clear History setting at the end of the case. When turned on, event logs and all trends will be deleted at the start of the case. When turned off, event logs and all trends will not be deleted at the start of the case.
Optimizer (optional)
Optimizer (default=Off, On)
Select to turn on or off the fresh gas flow optimizer.
Agent Usage (default=Off, On
Select to turn on or off the agent usage calculation function.
Cost/ml of Liquid Agent
Select to set the cost of the agent per ml.
NOTE: If cost is set to zero then the cost of the agent per ml will not be displayed. Recruitment (A5 only, optional)
On(default) Off
Select to turn on or off the lung recruitment tool.
TABLE 3-11 System Tab Settings
A5/A4 Operating Instructions
3 - 45
Ventilation Modes
5.6
5.6.1
Operations
Ventilation Modes NOTE:
In all ventilation modes, when inspiration pressure reaches the high alarm limit of Paw, the system switches to expiration immediately and airway pressure is released.
NOTE:
When the drive gas supply fails, mechanical ventilation cannot work normally.
Monitored Parameters NOTE:
The monitored parameters are measured in the condition of BTPS (body temperature and pressure saturated).
The A5/A4 monitors the following ventilation parameters:
PARAMETER
RANGE*
PEAK
-20 –120 cmH2O
MEAN
-20 – 120 cmH2O
Vt
0 – 3000 ml
MV
0 – 100 L
PLAT
-20 – 120 cmH2O
Rate
0 – 120 bpm
PEEP
0 – 70 cmH2O
FiO2
18 – 100%**
I:E
-
COMMENTS
Displayed only in SIMV-VC, SIMV-PC, SIMV-VG, and CPAP/ PS modes
* If the monitored parameter is out of range, it will be displayed as “- - -”. **FiO2 measurements between 100% and 110% inclusive will be displayed as 100%. Above this range, the system will display “- - -”.
5.6.2
Ventilation Modes The A5/A4 provides the following ventilation modes:
5.6.3 5-8
VENTILATION MODE
PARAMETERS
VCV
Vt, Rate, I:E, Tpause, PEEP, Plimit
SIMV-VC
Vt, Rate, Tinsp, Tpause, PEEP, Plimit, ΔP, Trigger, Tslope,
PCV
Pinsp, Rate, I:E, PEEP, Tslope
PCV-VG
Vt, Plimit, Rate, I:E, PEEP, Tslope
SIMV-PC
Pinsp, Rate, Tinsp, ΔP, Trigger, PEEP, Tslope
SIMV-VG
Vt, Rate, Tinsp, PEEP, Plimit, ΔP, Trigger, Tslope
CPAP/PS
Min Rate, ΔP, Trigger, PEEP, Tslope, Apnea Ti, ΔP apnea
APRV
Phigh, Plow, Thigh, Tlow, Tslope
Manual
Bypass (A5 only), Alarms, Monitor (available with AG module), CO2 Alarms
Change Ventilation Mode A5/A4 Operating Instructions
Alarm and Prompt Messages
Alarms and Messages
ALARM PRIORITY
MACHINE MODE WHEN CHECKED
STARTUP RESULT IF FAIL
MESSAGE
CAUSE
Ventilator Initialization: Time out
Self-test result cannot be obtained due to an internal communication error.
High
Startup
NonFunctional
REMARK CPU Board
Drive Gas Pressure Low
Drive Gas Pressure is low.
High
Startup
All
Ventilator Control Board
O2 Supply Failure / O2 Supply: Fail
O2 Supply Failure.
High
Startup
All
Ventilator Control Board
Power Supply Voltage Error / Power Supply Voltage: Fail
3.3 V, 5 V, 12 V voltage error.
High
Startup
Only Manual
Power Board
RT Clock Needs Battery
There is no button battery cell available in the system, or the button battery cell power is depleted.
High
Startup only
All
CPU Board
RT Clock Failure / RT Clock: Fail
RT chip malfunction.
High
Startup only
All
CPU Board
External AG Self Test Error
If the module sends the ErrorMsg, except for data limit error and unspecified accuracy, "External AG Self Test Error" will be triggered.
Low
Startup only
All
AG Module
External AG: Time out
External AG selftest result cannot be obtained due to communication error.
Low
Startup only
All
AG Module
TABLE 6-4 Startup Alarm Messages
6.6.1.2
CPU Board Runtime Alarm ALARM PRIORITY
MACHINE MODE WHEN CHECKED
DISABLE IN STANDBY MODE
MESSAGE
CAUSE
IP Address Conflict
The IP address of the machine is the same as the IP address of another device in the local network.
Medium
Runtime
No
Fan Failure
Speed of the fan ≤ 20% of normal speed
Medium
Runtime
No
Fan Failure 02
Speed of Module Rack fan < 3640
Medium
Runtime
No
TABLE 6-5 CPU Board Runtime Alarm Messages
6 - 20
A5/A4 Operating Instructions
Alarms and Messages
6.6.1.3
Alarm and Prompt Messages
Power Board Runtime Alarm ALARM PRIORITY
MACHINE MODE WHEN CHECKED
DISABLE IN STANDBY MODE
MESSAGE
CAUSE
Power System Comm Stop
Lost communication with CPU board for 10 seconds.
High
Runtime
No
Power Supply Voltage Error
3.3 V, 5 V, 12 V voltage error
High
Runtime
No
Low Battery Voltage!
Battery voltage is less than 10.6 V for 5 seconds.
High
Runtime
No
System going DOWN, Battery depleted!
Battery voltage is less than 10.2 V.
High
Runtime
No
Battery Undetected
Battery undetected
Medium
Runtime
No
Battery in Use
AC power fail
Low
Runtime
No
Power Board High Temp
Power board temperature is greater than 95° C
High
Runtime
No
Heating Module Failure
1. Both resistance temperatures are greater than 106° C for 20 seconds. 2. One of the resistance temperatures is greater than 110° C for 15 seconds.
Low
Runtime
No
Breathing Circuit Not Mounted
Breathing Circuit is not mounted.
High
Runtime
No
TABLE 6-6 Power Board Runtime Alarm Messages
6.6.1.4
NOTE:
If the power board loses communication with the CPU board for 10 seconds, the alarm buzzer will be turned on.
NOTE:
If the system restarts accidentally, the alarm buzzer will sound for 10 seconds to show notification.
Electronic Flowmeter Board Runtime Alarm ALARM PRIORITY
MACHINE MODE WHEN CHECKED
DISABLE IN STANDBY MODE
MESSAGE
CAUSE
Flowmeter Voltage Error
DVCC, AVDD, or VC voltage error
High
Runtime
No
N2O Flow Too High
N2O flow is greater than 15 L/min for 1 second.
Low
Runtime
No
O2 Flow Too High
O2 flow is greater than 25 L/ min for 1 second.
Low
Runtime
No
Air Flow Too High
Air flow is greater than 20 L/ min for 1 second.
Low
Runtime
No
TABLE 6-7 Electronic Flowmeter Board Runtime Alarm Messages
A5/A4 Operating Instructions
6 - 21
Alarm and Prompt Messages
Alarms and Messages
ALARM PRIORITY
MACHINE MODE WHEN CHECKED
DISABLE IN STANDBY MODE
MESSAGE
CAUSE
O2-N2O Ratio Error
N2O flow is greater than 0.5 L/ min and greater than 4 times O2 flow for 1.6 seconds.
High
Runtime
No
Flowmeter Comm Stop
Lost communication with CPU board for 10 seconds. When this alarm is triggered, the fresh gas flow value will be displayed as '---'.
High
Runtime
No
NO Fresh Gas
Fresh gas flow is less than 50 mL/min for 5 seconds when the machine is not in Standby mode or Monitor mode..
Medium
Runtime
Yes
Internal N2O Flow Failure
The I2C communication between the CPU and N2O flow sensor has failed.
Low
Runtime
No
Internal O2 Flow Failure
The I2C communication between the CPU and O2 flow sensor has failed.
Low
Runtime
No
Internal Air Flow Failure
The I2C communication between the CPU and Air flow sensor has failed.
Low
Runtime
No
TABLE 6-7 Electronic Flowmeter Board Runtime Alarm Messages
6.6.1.5
Ventilator Control Board Runtime Alarm
*
ALARM PRIORITY
MACHINE MODE WHEN CHECKED
DISABLE IN STANDBY MODE
MESSAGE
CAUSE
Aux Control Module Comm Stop
Lost communication with CPU board for 10 seconds.
High
Runtime
No
Ventilator Voltage Error
1. DA 1.2V voltage error. 2. VCM voltages error. 3. 3-way valve 12V voltage error.
High
Runtime
No
PEEP Valve Failure
1. PEEP valve voltage error 2. PEEP valve pressure error
Medium
Runtime
No
Insp Valve Failure
1. Inspiratory valve voltage error 2. Inspiratory valve flow error
Medium
Runtime
No
Safety Valve Failure
PEEP safety valve voltage error
Medium
Runtime
No
N/A - Not Applicable. This alarm message does not exist within this mode and therefore cannot be disabled or enabled.
TABLE 6-8 Ventilator Control Board Runtime Alarm Messages
6 - 22
A5/A4 Operating Instructions
Alarms and Messages
Alarm and Prompt Messages
ALARM PRIORITY
MACHINE MODE WHEN CHECKED
DISABLE IN STANDBY MODE
MESSAGE
CAUSE
Flow Sensor Failure
1. Inspiratory flow is out of range. 2. Expiratory flow is out of range.
Low
Runtime
No
Check Flow Sensors
1. Inspiratory reverse flow 2. Expiratory reverse flow
High
Runtime
N/A *
Pinsp Not Achieved
Pinsp does not reach the Pinsp setting in pressure mode.
Low
Runtime
N/A *
Vt Not Achieved
Vt does not reach the Vt setting in volume mode.
Low
Runtime
N/A *
Auto Ventilation Disabled
When system is in the Auto Ventilation, Non functional state
High
Runtime
N/A*
Automatic Ventilation Disabled
The machine is in the automatic ventilation disabled state.
Low
Runtime
No
Auto Ventilation Disabled-Leak Test Failed
Automatic Circuit Leak Test failed, and the result is "Manual Only".
Low
Runtime
No
Patient Circuit Leak
Patient is not connected or circuit leak.
Medium
Runtime
N/A*
CO2 Absorber Canister Not Locked
CO2 Canister is not mounted.
High
Runtime
No
O2 Sensor Disconnected
Both AG module and O2 sensor are not connected.
Low
Runtime
No
Replace O2 sensor
O2 sensor depletion.
Medium
Runtime
No
Perform 100% O2 Sensor Calibration
O2 value is greater than 110 % or between 5 % and 15 % for 3 seconds.
Low
Runtime
No
Ventilator Comm Stop
Lost communication with the CPU board for 10 seconds.
High
Runtime
No
Drive Gas Pressure Low
Drive Gas Pressure is low.
High
Runtime
No
O2 Supply Failure
O2 Supply Failure
High
Runtime
No
Fresh Gas Flow Too High
In VCV and SIMV-VC modes, the fresh gas flow is greater than or equal to the desired flow.
Low
Runtime
N/A*
*
N/A - Not Applicable. This alarm message does not exist within this mode and therefore cannot be disabled or enabled.
TABLE 6-8 Ventilator Control Board Runtime Alarm Messages
A5/A4 Operating Instructions
6 - 23
Alarm and Prompt Messages
*
Alarms and Messages
ALARM PRIORITY
MACHINE MODE WHEN CHECKED
DISABLE IN STANDBY MODE
MESSAGE
CAUSE
Pressure Monitoring Channel Failure
For VPM: Monitoring value of PEEP sensor or Paw Sensor is out of range. For VCM: 1.Monitoring value of PEEP sensor or Paw Sensor is out of range. 2.Zeroing of PEEP sensor or Paw Sensor is abnormal 3. PEEP sensor is reversely connected.
Medium
Runtime
No
Aux Control Module Voltage Error
VPM 1.3V voltage error.
Low
Runtime
No
N/A - Not Applicable. This alarm message does not exist within this mode and therefore cannot be disabled or enabled.
TABLE 6-8 Ventilator Control Board Runtime Alarm Messages
6.6.1.6
Anesthetic Gas (AG) Module Alarm Messages
ALARM PRIORITY
MACHINE MODE WHEN CHECKED
DISABLE WHEN EXTERNAL AG IS IN STANDBY MODE
MESSAGE
CAUSE
AG Hardware Error
AG module Hardware Error.
Medium
Runtime
Yes
O2 Sensor Error
Paramagnetic O2 sensor error.
Medium
Runtime
Yes
External AG Self Test Error
Module fault or communication failure between the module and anesthesia system.
Low
Runtime
Yes
AG Hardware Malfunction
AG module hardware malfunction. The AG module enters Standby and measurement stops.
High
Runtime
Yes
AG Init Error
The AG module was installed improperly or malfunctioned.
High
Runtime
Yes
AG No Watertrap
The AG module watertrap was installed improperly or not installed.
Low
Runtime
Yes
AG Watertrap Type Wrong
When the patient type is infant, but the watertrap type is adult/pediatric, this alarm will be triggered.
Low
Runtime
Yes
TABLE 6-9 AG Module Alarm Messages
6 - 24
A5/A4 Operating Instructions
Alarms and Messages
Alarm and Prompt Messages
ALARM PRIORITY
MACHINE MODE WHEN CHECKED
DISABLE WHEN EXTERNAL AG IS IN STANDBY MODE
MESSAGE
CAUSE
AG Change Watertrap
When the actual flow is less than 75 % of the set flow, the alarm indicates that the watertrap is gradually occluded and it is necessary to replace the water trap.
Medium
Runtime
Yes
AG Comm Stop
AG module malfunction or communication failure.
High
Runtime
No
AG Airway Occluded
Pump rate is lower than 20 ml/min for 1 second.
High
Runtime
Yes
AG Zero Failed
Gas measurements may have bad accuracy during zeroing.
Low
Runtime
Yes
Mixed Agent and MAC < 3
More than one anesthetic gas and MAC <3
Low
Runtime
Yes
Mixed anesthetic gas and MAC >= 3
More than one anesthetic gas and MAC >= 3
Medium
Runtime
Yes
Incompatible AG Software Version
The AG Version Limit is On, and the AG module is loaded while the AG software version is lower than 1.7.3.0
High
Runtime
No
CO2 Over Range
The monitoring value exceeds the measurable range.
Low
Runtime
Yes
The monitoring value of Rate exceeds the measurable range. when this type of alarm is triggered, “--” will be displayed.
Low
Runtime
Yes
N2O Over Range Hal Over Range Enf Over Range Iso Over Range Sev Over Range Des Over Range O2 Over Range Rate Over Range
TABLE 6-9 AG Module Alarm Messages
A5/A4 Operating Instructions
6 - 25
Alarm and Prompt Messages
Alarms and Messages
6.6.2
Prompt Messages
6.6.2.1
Prompt Messages Displayed in Alarm Area MESSAGE
TIMEOUT
REMARK
Pressure, Volume and Apnea Alarms are OFF
Correspond status does not exist.
This Alarms Off icon and message appear on a white background when the Alarms button in the Manual mode tab is set to Off.
CO2 and CO2 Apnea Alarms are OFF
Correspond status does not exist.
This message appears when the CO2 Alarms button in the Manual mode tab is set to OFF.
Load Configuration Failure
10 sec
This message appears when the download or latest configuration update failed.
DEMO Mode - Not for Clinical Use
Never
This message appears when the system is set to demo mode from the Service tab.
Service Mode - Not for Clinical Use
Never
This message appears when the machine is worked in Service mode.
Apnea Ventilation
Correspond status does not exist.
This message appears when the Min Rate triggers a breath in CPAP/PS ventilation mode.
Calibrate O2 sensor for 21 %
• When the machine is powered on, if more than 72 hours have elapsed since the last successful calibration, the prompt message Calibrate O2 sensor for 21% is displayed. The message disappears after successful calibration. • If the machine is kept powered on, the prompt message Calibrate O2 sensor for 21% is displayed at the next Standby mode after 5am after 72 hours have elapsed since the last successful calibration. • If the alarm message RT Clock Needs Battery or RT Clock Failure is displayed, the prompt message Calibrate O2 sensor for 21% is disabled. • If the calibrate time is empty, the prompt message Calibrate O2 sensor for 21% is displayed.
Auto-zero in process
Correspond status does not exist.
This message appears when auto-zeroing of the pressure sensors is in process.
Fresh Gas Is On
Correspond status does not exist.
This message is displayed if the fresh gas flow value is flashing in Standby mode.
New functions activated, please restart!
After the machine restart
This message appears when activation successfully completed.
Calibrate O2 sensor for 100%
It will not disappear until O2 sensor calibration successfully performed
This message displays when the 100 % calibration data could not be revised correctly after 21% O2 sensor calibrate successfully.
Could not locate time server
It will not disappear until the Interval of SNTP Protocol is set to Off or the time server is available again.
This message displays when the Interval SNTP Protocol is not Off and the time server is unavailable for five (5) intervals.
External AG Loaded Successfully
5s
External AG Unloaded Successfully
5s
External AG Loaded Successfully. and External AG Unloaded. will not display at the same time. Only the latest one will be shown when both of them exist.
External AG Startup
/
External AG module is starting up. This prompt message is triggered by External AG.
TABLE 6-10 Prompt Messages Displayed in Alarm Area
6 - 26
A5/A4 Operating Instructions
Alarms and Messages
Alarm and Prompt Messages
MESSAGE
TIMEOUT
REMARK
External AG Warmup
/
External AG module is warming up. This prompt message is triggered by External AG.
External AG Zeroing
/
Gas concentrations cannot be measured during zero, instead the last measured concentrations are reported to the application.
Leak Test Not Performed
Only appears in standby mode. It will disappear when both the automatic and manual leak test has been performed.
This message displays when either the automatic leak test or manual leak test was skipped from startup, or when the last time that the leak test was performed was more than 24 hours ago.
TABLE 6-10 Prompt Messages Displayed in Alarm Area
6.6.2.2
Prompt Messages Displayed in Pop-up Area MESSAGE
TIMEOUT
REMARK
Can only End Case in Manual Mode!
5 sec
This message appears if the End Case button is selected when the Manual switch is set to Auto and the machine is in non-standby.
Invalid Age! Please check DOB or current system time.
5 sec
This message appears after entering the patient’s date of birth if the calculated age of the patient is outside the accepted range (0-150).
Patient Size can only be changed in Manual Mode or in Standby
5 sec
This message appears when the Patient Size selection is pressed while the system is in Automatic Ventilation mode.
Vent modes can only be changed using "Set Mode" button below
5 sec
This message appears when the Current Mode area is pressed.
Out of Range
5 sec
This message appears when the entered value is outside the allowable range.
Invalid Password
5 sec
This message appears when the entered password is wrong.
Saving User Configuration has failed.
5 sec
This message appears when the Saving User Configuration process has failed.
New password input is inconsistent.
5 sec
This message appears when the new password and the confirmed new password do not match.
Automatic ventilation disabled. Check lever on breathing system.
15 sec
This message appears when exiting Standby mode while the Auto/Manual switch is in Auto position and system is in the Automatic Ventilation disabled state.
Fresh gas flow detected! Adjust all flowmeters to zero
After fresh gas flow is turned off or after exiting Manual Circuit Leak Test or Automatic Circuit Leak Test & Compliance Test screen.
This message appears in the first Manual Circuit Leak Test or Automatic Circuit Leak Test & Compliance Test screen when fresh gas flow is detected.
TABLE 6-11 Prompt Messages Displayed in Pop-up Area
A5/A4 Operating Instructions
6 - 27
Alarm and Prompt Messages
Alarms and Messages
MESSAGE
TIMEOUT
REMARK
Access to System settings only available in Standby
5 sec
This message appears when the current mode is in non-standby and the user tries to enter the Setup > System menu.
Can not end case while fresh gas flow is detected!
5 sec
This message appears when user tries to end the case by pressing the disabled End Case button while fresh gas is on, Auto/ Manual switch is set to Manual, and the system is in non-standby.
Set Auto/Manual switch to Manual position before starting case
1. When triggered by turning on fresh gas, it will disappear after fresh gas flow is turned off or Auto/Manual switch is set to Manual; 2. When triggered by touching the Waveforms/ Spirometry screen, it will disappear after 5 seconds or Auto/Manual switch is set Manual.
When Auto/Manual switch is in Auto position and system is in Standby mode, this message will appear in the following cases: 1. Turning on fresh gas 2. Touching the Waveforms/Spirometry screen
Set Auto/Manual switch to Manual position and adjust all flowmeters to zero.
5 sec
This message appears in the first Automatic Circuit Leak Test & Compliance Test screen when pressing the disabled Continue button.
Set Auto/Manual switch to Auto position and adjust all flowmeters to zero.
5 sec
This message appears in the first Manual Circuit Leak Test screen when pressing the disabled Continue button.
Can only End Case in Manual Mode!
5 sec
This message displays when the Auto/ Manual switch is in Auto position and the system is in non-Standby, then if the user presses the disabled End Case button.
TABLE 6-11 Prompt Messages Displayed in Pop-up Area
6 - 28
A5/A4 Operating Instructions
7.0
Maintenance
Theory of Operation...7-3 Block Diagram...7-3 Maintenance Schedule ...7-4 Breathing System Maintenance...7-4 Flow Sensor Calibration ...7-5 O2 Sensor Calibration...7-7 Water Build-up in the Flow Sensor ... 7-10 Waste Gas Transfer Tube Maintenance... 7-10 Electrical Safety Inspection... 7-10 Cleaning and Disinfection... 7-12 DGSS and Waste Gas Transfer Hose... 7-30
A5/A4 Operating Instructions
7-1
Maintenance
7-2
WARNING:
Do not use a malfunctioning A5/A4 Anesthesia System. Have all repairs and service done by an authorized service representative.
WARNING:
Use a cleaning and disinfection schedule that conforms to your 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.
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:
Only use lubricants approved for anesthesia or O2 equipment.
WARNING:
Do not use lubricants that contain oil or grease. They can burn or explode in the presence of high O2 concentrations.
WARNING:
Obey infection control and safety procedures. Utilized equipment may contain blood and body fluids.
WARNING:
Movable parts and removable components may present a pinch or a crush hazard. Use care when moving or replacing system parts and components.
WARNING:
Before using the A5/A4 System (after cleaning or disinfecting), power up the system and follow the on-screen prompts to perform the leak test and the compliance test. (see section 4.5 (page 4-9) "Leak and Compliance Tests".)
CAUTION:
To prevent system damage: •
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 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.
NOTE:
No repair should ever be attempted by anyone not having experience in the repair of devices of this nature. Replace damaged parts with components manufactured or sold by Mindray. Then test the unit to ensure that it complies with the manufacturer’s published specifications.
A5/A4 Operating Instructions
Maintenance
7.1
Theory of Operation
Theory of Operation The A5/A4 System is a pneumatically-driven and electronically-controlled anesthesia machine. Three types of supply gases are available: N2O, O2, and Air. The user adjusts supply gas flows through the flowmeters. The mixed gas outputted from the flowmeters is further mixed with the anesthetic agent inside the anesthetic vaporizer to form the fresh gas. During the inspiratory phase, the microprocessor-controlled inspiratory valve produces the preset drive gas inspiratory flow and the expiratory valve closes. The drive gas enters the bellows dome in the patient circuit and depresses the bellows inside the dome to move downward. This forces the gas inside the bellows to enter the patient's lungs until the end of the inspiratory phase. During the expiratory phase, the inspiratory valve closes and the expiratory valve opens. The patient can expire freely. The patient's expired gas, mixed with the fresh gas, enters and lifts the bellows inside the dome. The drive gas outside the bellows is scavenged to the Anesthetic Gas Scavenging System (AGSS) until the end of the expiratory phase. During ventilation, the ventilator performs real-time monitoring over airway pressure and flow. If the airway pressure or minute volume is outside the user-preset alarm limits, an audible and visible alarm occurs. When the airway pressure is higher than the limit value determined by the PEAK high alarm limit, the ventilator enters the expiratory phase automatically to avoid causing injury to the patient. Additionally, the ventilator has a built-in pressure safety valve that opens at an approximate pressure of 110 cmH2O (11 kPa).
7.2
Block Diagram Anesthetic Ventilator
Anesthetic Gas Delivery Device (Vaporizer)
Anesthetic Gas Delivery System
Anesthetic Gas Scavenging System (AGSS)
Hospital’s Disposal System
Breathing System
Patient
FIGURE 7-1 Block Diagram of A5/A4 System
A5/A4 Operating Instructions
7-3
Maintenance Schedule
7.3
Maintenance
Maintenance Schedule The schedules listed in TABLE 7-1 are the minimum frequency based on 2000 hours of usage per year. The equipment should be serviced more frequently if used more than this yearly usage. Maintenance should be performed by a trained technician. NOTE:
During cleaning and setup, inspect the parts and seals for damage. Replace or repair as necessary.
MINIMUM FREQUENCY
MAINTENANCE
Daily
Clean the external surfaces.
Every 72 hours
Perform 21% O2 calibration (O2 sensor in breathing system). The A5/A4 will prompt the user for 21% O2 calibration (only for units with an galvanic O2 cell).
Monthly
Water trap on AG module.
Annually
Periodic maintenance due, to be performed by a trained technician. Gas Bench calibration. Contact Mindray Technical Support for details.
Every three years
Periodic maintenance due, to be performed by a trained technician. Contact Mindray Technical Support for details.
As necessary
• Perform 100% O2 calibration after replacing the O2 sensor. • Replace the O2 sensor if it cannot be calibrated. • Before installing the cylinder, use a new cylinder gasket on the cylinder yoke. • Empty the water trap if there is water buildup. • Replace the soda lime in the canister if soda lime color change is detected. Follow the manufacturer’s instructions. • Replace the flow sensor if the seal for the flow sensor is damaged, the membrane inside the flow sensor is cracked or distorted, or the flow sensor is cracked or distorted. • Calibrate the flow sensor after re-installing the cleaned or disinfected flow sensor, after replacing with a new flow sensor, or when tidal volume measurement is inaccurate. • Replace the waste gas transfer tube if it is damaged. • Inspect the O2 flush button for normal movement. If not ,refer to the service manual for the disassembling and cleaning.
TABLE 7-1 Maintenance Schedule
7.4
Breathing System Maintenance When cleaning the breathing system, replace any parts that are visibly cracked, chipped, distorted or worn. For details, refer to ‘‘Inspect the System’’ on page 4-3 and ‘‘Cleaning and Disinfection’’ on page 7-12.
7-4
A5/A4 Operating Instructions
Maintenance
7.5
Flow Sensor Calibration
Flow Sensor Calibration WARNING:
Do not perform calibration while the unit is connected to a patient.
NOTE:
During calibration, do not operate the pneumatic parts. Do not move or press the breathing tubes.
NOTE:
Calibrate the flow sensor after re-installing the cleaned or disinfected flow sensor, after replacing with a new flow sensor, or when tidal volume measurement is inaccurate.
NOTE:
This calibration is only intended for the user. A trained technician should always perform the flow calibration in the service mode when a calibration is required.
The flow sensor must be calibrated whenever the flow volume is out of specification or after changing the flow sensor. To calibrate the flow sensor: 1. Ensure that the supply gas pressure is normal. 2. Turn off all fresh gas inputs. 3. Set the ventilation switch to the automatic ventilation position. 4. Remove the bellows and reinstall the bellows housing. 5. Plug the Y-piece of the breathing circuit into the leak test port to close the breathing system. 6. Remove the water trap. 7. Ensure that the system is in Standby mode. If not, select the End Case button in the Manual tab and follow the screen prompts to end the case and enter Standby mode. 8. Select the Setup softkey, then the Calibrate Flow Sensor button. 9. Follow the on-screen prompts and select the Begin button to start to calibrate the flow sensor (see FIGURE 7-2). The calibration process takes several minutes. The system will display the results of the calibration status when the process is completed. 10. Reinstall the bellows and water trap. 11. Select Done to close the Calibration window (see FIGURE 7-3). 12. Select the Accept or Cancel softkey to close the Setup window. NOTE:
A5/A4 Operating Instructions
In case of repeated calibration failure, contact Mindray Technical Support.
7-5