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AS3000 Operators Manual

1. Ordinary Not protected Ordinary Equipment designed for non electrical connection to the patient Mobile WARNING Possible explosion hazard Do not operate machine near flammable anesthetic agents or other flammable substances Do not use flammable anesthetic agents i e ether or cyclopropane AS3000 Operating Instructions 0070 10 0684 01 ASTM F 1208 89 2005 Disclosures Product Specifications 5 2 5 2 1 5 2 2 5 2 3 5 2 4 5 2 5 5 2 6 ASTM F 1208 89 2005 Disclosures Based on the following disclosures the AS3000 meets ASTM Standard Specification F1208 for Anesthesia Breathing Systems Leakage of Breathing System The AS3000 complies with ASTM F 1208 89 2005 section 7 1 1 The maximum leakage of the breathing system does not exceed 300 mL min when pressurized to 3 0 kPa 30 cmH30 Resistance of Breathing Systems The typical pressure drops due to inspiratory and expiratory gas flow in the breathing system at reference flows of 0 5 and 1 0 liter sec are e With Expiratory flow 0 5 liter sec then Resistance 1 5 cmH20 e With Expiratory flow 1 0 liter sec then Resistance 5 4 cmH2O e With Inspiratory flow 0 5 liter sec then Resistance 1 1 cmH20 e With Inspiratory flow 1 0 liter sec then Resistance 3 5 cmH20 Volume of Gas not delivered to patient due to Internal Compliance e 95 ml at 2 kPa e 200 ml at 4 kPa CO Absorber Resistance For a filled CO absorber resist
2. Pneumatic Pipeline connections DISS threaded body as per CGA V 5 for all three gases O2 N2O Air Cylinder connection s Three E cylinder gas tank yokes pin indexed PISS by gas type O2 N20 Air per CGA V 1 Vaporizer connection s Two vaporizers max using the Selectatec mounting system Breathing System Connections Pneumatic connectors are provided on the Breathing System One connection each for the inspiration and expiratory hoses of the pneumatic circuit A connection for the breathing bag and a port for the O fuel cell A Plug connection for leak testing A Drive Gas hose connection a breathing system pneumatics connection an AGSS connector to provide the exhaust to the scavenger and a CGO hose CGO Common Gas Outlet Connector on side of machine provides fresh gas to the Breathing System Oxygen Output Connectors Tapered fitting supplies output of Aux O2 Flowmeter DISS O connector is available on side of machine to provide wall O to a jet ventilation device or other device 0070 10 0684 01 AS3000 Operating Instructions Product Specifications 5 11 2 7 5 12 5 12 1 5 12 1 1 5 12 1 2 5 12 1 3 5 12 1 4 5 12 2 5 12 2 1 Displays Controls Oxygen Gas Power Outlet DISS Male O fitting on the left side of the machine which provides a maximum flow of 90 l min at a pressure range of 40 5 to 87 psi Displays Controls Electronic User Interface Display Color LCD Key
3. 7 Leak Test Allows the user to show the result of the latest Leak Test To show the Leak Test result select Show Result from the Leak Test menu The Leak Test Result will be displayed on the right portion of the System menu tab see figure 2 19 Calibrate Service canalla Leak Test Result Leak Value 45 ml min Language ae Test Date 02 10 2009 oat Volume Test Time 11 23 am VT Date i MV Time Restore Defaults Press Menu Key to Exit FIGURE 2 19 Example Leak Test Results The Leak Test Result screen displays Leak Value displayed in mL min The Test Date the date the test was performed and Test Time the time the test was performed If the Leak Test was bypassed a value of Bypassed will be displayed for Leak Value see figure 2 20 Calibrate Service ls Leak Test Result Emma Leak Value Bypassed Desk Test Date 02 09 2009 Test Time 03 38 pm Date Time Restore Defaults Press Menu Key to Exit FIGURE 2 20 Example of a Bypassed Leak Test 2 36 0070 10 0684 01 AS3000 Operating Instructions z0 User Maintenance WARNING WARNING CAUTION CAUTION CAUTION AS3000 Operating Instructions Use a cleaning and disinfection schedule that conforms to your institution s disinfection and risk management policies Refer to the material safety data as applicable e Refer to the operation and maintenance manuals of all disinfection equipment Do not inhale fumes that may result from any disinfection process Do not use
4. Introduction Cautions CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION e 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 e 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 Never immerse the oxygen sensor or its connector in any type of liquid e Dispose of the oxygen sensor per the manufacturer s specification Do not use acetic hydroperoxide or formaldehyde steaming The valve disc is fragile and must therefore be handled with care while removing the valve cage from the valve assembly The valve disc is fragile and must therefore be handled with care while removing it from the valve cage If moisture remains in the bellows after cleaning it may become tacky Communications connectors are for Service Technician use only Any computer connected to this equipment must comply with IEC 60950 Do not wash the inner surface of the oxygen sensor Do not autoclave the oxygen sensor Prior to use after cleaning or disinfecting power up the system as descr
5. P N 0683 00 0326 01 e Loose Fill CO Absorber P N 0683 00 0325 01 Miscellaneous e DPM 6 7 to AS3000 Installation Kit P N 0040 00 0452 e DPM 6 7 Module Rack Mounting Kit P N 0040 00 0451 e Monitor Mounting Arm Pivoting 16 P N 0436 00 0198 e Suction Regulator P N 0992 00 0256 e Suction Regulator Mount P N 0436 00 0207 e Suction Canister Bracket P N 0436 00 02 12 e Bag Reservoir Reusable P N 0138 00 0022 e Adult Test Lung P N 0138 00 001 2 e Utility Tray P N 0436 00 0204 e Writing Surface Insert P N 045 000250 00 for Utility Tray P N 0436 00 0258 e AS3000 User Maintenance Kit P N 0040 00 0457 0070 10 0684 01 AS3000 Operating Instructions so Product Specifications 5 1 Safety Designations Safety designations per IEC 60601 1 Standard Type of protection against electric shock Degree of protection against electric shock Supply Connection Internal Battery Operation Mode of Operation Protection Against Hazards of Explosion Protection Against Ingress of Liquids Degree of Electrical Connection Between Equipment and Patient Degree of Mobility Class 1 and Internal Electric Power Source Where the integrity of the external protective earth conductor arrangement is in doubt equipment shall be operated from its internal electric power source Type BF Applied Part AC Operation 120 VAC nominal 60Hz 10A 24 VDC Internal Battery Continuous Not protected
6. Correct mounting of cylinders in yokes f Presence of cylinder wrench g Auxiliary O supply available and functioning Per manufacturers specifications turn ON the patient monitors to allow time for their warm up ECG Blood Pressure SoO2 Gas Monitoring etc Verify that self inflating manual ventilation device is available and functioning Prepare the Anesthetic Gas Scavenging System AGSS Refer to section 3 1 11 for removal instructions a Remove the AGSS from the AS3000 While viewing the float turn the AGSS upside down to verify whether the float moves freely along its shaft Replace the float as necessary Reconnect the AGSS to the AS3000 b Connect the vacuum hose to the vacuum port Adjust the position of the float to be between the Min and Max lines by turning its flow adjustment knob counterclockwise increases flow clockwise decreases flow c Drain any moisture from the waste gas hose Connect the waste gas hose to the AGSS waste gas port Check that a Flow control valves are off b Vaporizers are off c Vaporizers are filled not overfilled d Filler caps are sealed tightly e Two vaporizers cannot be turned on at the same time Check oxygen Oz cylinder supply a Disconnect pipeline supply if connected and return cylinder and pipeline pressure gauges to zero with O flush valve b Open Op cylinder check pressure A typical full cylinder pressure is 1900 psig Replace the cylinder if its pr
7. High Minute Volume Medium The MV reading is greater Reset the High MV than the high alarm limit alarm limit setting Low Minute Volume Medium The MV reading is less Reset the Low MV than the low alarm limit setting leakage of the patient breathing circuit occurs arm limit Check for leakage at patient connections Q These functional alarm messages are disabled when Manual Mode Alarm control on the Main Screen is set to OFF and the ventilation mode is set to MANUAL AS3000 Operating Instructions 0070 10 0684 01 Alarms Operations 2 12 4 2 34 MESSAGE APNEA PRIORITY REASON S SOLUTION S High Breathing ventilation has Check patient stopped detected by pressure and volume monitoring for a period greater than 30 seconds in mechanical ventilation modes or for greater than 60 seconds in manual ventilation mode APNEA Backup High PEEP Medium Fregmin in PS mode Check patient triggers the ventilator Medium Expiratory pressure 5 Check waste gas cmH20 above PEEP for 2 hose for moisture breaths or Expiratory pressure 5 cmH20 above PEEP in PS mode for more than 30 seconds These functional alarm messages are disabled when Manual Mode Alarm control on the Main Screen is set to OFF and the ventilation mode is set to MANUAL Alarm Functions Test 1 Activate the CMV ventilation mode 2 Set attributes as follows ATTRIBUTE SETTING Pa
8. High PAW alarm limit to 50 d Set the Low PAW alarm limit to be above the current PEAK pressure reading e Verify that e an alarm tone sounds e the alarm message VAN I Low Airway Pressure is displayed in yellow text after several breaths f Set the Low PAW alarm limit to 10 22 Low MV and APNEA Alarm Test a Set the Low MV alarm limit to the highest value b Verify that e an alarm tone sounds e the alarm message NN Il Low Minute Volume is displayed in yellow text after several breaths c Set the Low MV alarm limit to 1 d Press the MANUAL AUTO key NOTE Prior to the APNEA alarm message referenced in the following step Low Airway Pressure and Low Minute Volume alarm messages may also be displayed e After 60 seconds verify that e an alarm tone sounds e the alarm message VAN Hl APNEA is displayed in red text 23 Place the system in STANDBY ventilation mode 24 Check for appropriate level of patient suction 25 Check connect and calibrate other electronic monitors 26 Turn on and set other appropriate alarms for equipment to be used NOTE The following step should be performed every 3 days or when prompted by the machine 27 Perform the Oxygen Sensor Calibration as detailed in section 2 9 NOTE The following step should be performed weekly or whenever a new vaporizer is installed or when CO absorbent is replaced 28 Test for leaks in the machine and vaporizers by performing the High Pressure Leak
9. Leak Test and the Compliance Test AS3000 Operating Instructions 0070 10 0684 01 3 21 Regular Maintenance User Maintenance This page intentionally left blank 3 22 0070 10 0684 01 AS3000 Operating Instructions zo Accessories The following accessories are designed for the AS3000 Anesthesia Delivery System The use of other accessories is not recommended To place an order for these or other accessories contact Customer Service at 1 800 288 2121 or order accessories online at www mindray com 4 1 Vaporizers e Vaporizer Sevoflurane P N 0992 00 01 48 e Quickfill Bottle Adapter Sevoflurane P N 0004 00 0100 e Vaporizer Isoflurane P N 0992 00 01 49 e Quickfill Bottle Adapter Isoflurane P N 0004 00 0101 4 2 Gas Supply Hoses 10 Foot Length PURITAN DISS GAS P N OHMEDA CHEMETRON BENNETT FEMALE O 0004 00 0077 XX 01 02 03 OA N20 0004 00 0078 XX 01 02 03 04 Air 0004 00 0079 XX 01 02 03 04 VAC 0004 00 0080 XX 03 04 05 06 EVAC 0004 00 0081 XX 01 02 03 04 EVAC 0004 00 0081 XX 21 22 23 24 1 VAC wall connector 2 The XX in each P N Part Number represents a Tail Code that completes the P N See footnote 3 3 XX Tail Codes substitute these numbers for the XX in the P N column to complete the Part Number AS3000 Operating Instructions 0070 10 0684 01 CO Absorbers 4 3 4 4 Accessories CO Absorbers e CO Absorber Pre Pack
10. MESSAGE BDU EEPROM Data Failure EEPROM IC Failure PRIORITY N A N A REASON S Incorrect checksum during EEPROM check EEPROM cannot read write SOLUTION S This alarm occurs during startup only and renders the system non operational Contact technical support This alarm occurs during startup only and renders the system non operational Contact technical support WDT Failure N A Incorrect Watchdog state This alarm occurs during startup only and renders the system non operational Contact technical support AD DA failure PEEP failure N A N A Incorrect D A A D data PEEP valve data is incorrect This alarm occurs during startup only and renders the system non operational Contact technical support This alarm occurs during startup only The leak test is bypassed and the system is placed in STANDBY ventilation mode Contact technical support Inspiration Valve Failure N A The valve test yielded abnormal feedback voltage This alarm occurs during startup only The leak test is bypassed and the system is placed in STANDBY ventilation mode Contact technical support Vent Manual Valve Failure N A Valve state incorrect This alarm occurs during startup only and renders the system non operational Contact technical support Expiration Sensor Failure N A The expiration sensor data is incorrect This alarm occurs during startup on
11. The Leak test will automatically proceed to the Compliance test if the leak rate is less than 500 mL min e Follow the onscreen prompts to perform the Compliance test When the Compliance test is complete select Continue and the system will proceed to displaying the Pressure vs Time and Flow vs Time waveforms in STANDBY ventilation mode e f Bypass is selected the system will skip the Leak test and the Compliance test and proceed directly to displaying the Pressure vs Time and Flow vs Time waveforms in STANDBY ventilation mode NOTE If the Leak test result is greater than 1000 ml and the user selects MANUAL Automatic Ventilation will be disabled NOTE Bypassing the Compliance test is not recommended AS3000 Operating Instructions 0070 10 0684 01 2 9 Adjusting the Date and Time Operations 2 7 Adjusting the Date and Time Press the MENU key and rotate the Navigator Knob until the System menu tab is displayed Press the Navigator Knob to access the choices on the System menu tab Adjusting the Date 1 Rotate the Navigator Knob until Edit Date is highlighted and press the knob to access the Edit Date sub menu 2 Rotate and press the Navigator Knob as necessary to adjust the date and set the format to one of the following three 3 configurations MM DD YY DD MM YY or YY MM DD NOTE The default format is MM DD YY 3 Select Done to save the date adjustments and return to the System menu tab Adjustin
12. adhering to facility policies and procedures WARNING Use extreme care while handling the absorbent as it is a caustic irritant NOTE Ensure that the absorber canisters are completely dry before adding absorbent 3 16 0070 10 0684 01 AS3000 Operating Instructions User Maintenance Cleaning and Disinfection 6 While noting the previous WARNING add new pre pak or loose fill absorbent to the absorber canisters Re install the absorber canisters into the assembly Rotate the locking mechanism handle clockwise into the locked position as shown in FIGURE 3 20 Locking Mechanism Handle in the Locked Position FIGURE 3 20 Absorber Canisters Locked 3 1 10 Breathing System Block 1 Remove all of the following components from the breathing system block e Bellows Assembly e Oxygen Sensor e Inspiratory and Expiratory Valves all components e APL Valve e PAW Gauge e Bag Arm e Absorber Canisters 2 Disconnect the fresh gas hose from the CGO Common Gas Outlet on the left side of the system The opposite end of this hose is integrated into the breathing system block and therefore does not get removed 3 Disconnect the waste gas hose drive gas hose and heater cable from the bottom of the breathing system block 4 Disconnect the breathing system pneumatic hoses from the side of the breathing system block NOTE At this point the breathing system block is ready to be removed from its mounting arm WARNING U
13. and 2 12 3 2 for table listings of the individual messages and their associated priority levels High priority messages are red Medium and low priority messages are yellow Up to 2 messages can be displayed in this area AS3000 Operating Instructions 0070 10 0684 01 User Interface Product Description 3 Date and Time From the Date sub menu of the System menu tab the date can be configured to display in one of the following formats MM DD YY DD MM YY or YY MM DD The default format is MM DD YY From the Time sub menu of the System menu tab the time can be adjusted and configured to display in 12 hour or 24 hour format The default format is 12 hour 4 Power Source A Plug Icon and Battery Indicator are always present and will illuminate as follows Plug Icon GE While the system is functioning on AC power the plug icon is constantly illuminated During battery operation the plug icon flashes Battery Indicator q Full Battery q Low Battery When batteries are installed and the system is functioning on battery power the battery indicator provides a visual reference for the approximate charge level of the batteries 5 Patient Type Tile NOTE The ventilation mode must be set to STANDBY in order to change the patient type The default patient type on power up is Adult Rotating the Navigator Knob to this tile highlights the current setting Pressing the Navigator Knob while this
14. associated priority levels reasons for the messages and possible solutions MESSAGE PRIORITY REASON S SOLUTION S Continuous Pressure High Pressure sensor failure Switch to bag sampling channel mode and blockage excessive manually ventilate exhalation resistance patient check possibly due to channel tubes and blockage sampling lines fix any blockages If the alarm still exists contact technical support High Airway Pressure High Vz is set too high patient Reset the High airway blockage PAW alarm limit exhalation valve blockage check expiratory cycle fix any blockages Check Vr settings Check patient airway fix any blockages Low Airway Pressure Medium For Freq setting gt 4 Reset the Low PAW Airway pressure below alarm limit Check pressure alarm low limit the parallel for gt 15 seconds sampling lines For Freq setting lt 4 Airway pressure below pressure alarm low limit for gt 30 seconds Negative Pressure High Airway Pressure of 2 Check patient or cmH 0 or less for more increase supply of than 4 seconds fresh gas Low FiO High The FiO reading is less Reset the Low FIO than the low alarm limit alarm limit setting compensation of Reduce air or N20 is too high compensation un calibrated O sensor Perform the O sensor failure calibration Replace O sensor High FiO Medium The FiO reading is Reset the High greater than the high FIO alarm limit alarm limit setting
15. at Mindray DS USA Inc s option at the factory or at an authorized distributor any product which shall under normal use and service appear to the Company to have been defective in material or workmanship No agent employee or representative of Mindray DS USA Inc has any authority to bind Mindray DS USA Inc to any affirmation representation or warranty concerning its products and any affirmation representation or warranty made by any agent employee or representative shall not be enforceable by buyer This warranty is expressly in lieu of any other express or implied warranties including any implied warranty or merchantability or fitness and of any other obligation on the part of the seller Damage to any product or parts through misuse neglect accident or by affixing any non standard accessory attachments or by any customer modification voids this warranty Mindray DS USA Inc makes no warranty whatever in regard to trade accessories such being subject to the warranty of their respective manufacturers A condition of this warranty is that this equipment or any accessories which are claimed to be defective be returned when authorized freight prepaid to Mindray DS USA Inc Mahwah New Jersey 07430 Mindray DS USA Inc shall not have any responsibility in the event of loss or damage in transit AS3000 Operating Instructions 0070 10 0684 01 5 15 Disclaimers 5 15 5 15 1 5 16 5 17 Product Specificat
16. cleaning or disinfecting power up the system as described in section 2 6 and follow the on screen prompts to perform the Leak Test and the Compliance Test 3 1 1 General Guidelines Heed all WARNINGS and CAUTIONS listed at the beginning of this chapter Prior to use refer to the facility s infection control policy to determine the frequency and level at which cleaning and disinfection should be performed If disinfection is required all components must first be cleaned and dried as described in the following sub sections For additional information about infection control practices refer to the APIC Guidelines for Selection and Use of Disinfectants published in the American Journal of Infection Control Vol 24 No 4 August 1996 For additional information about infection control refer to the ASA s Recommendations for Infection Control for the Practice of Anesthesiology second edition For additional information on reprocessing medical devices refer to AAMI TIR 30 2003 A compendium of process materials test methods and acceptance criteria for cleaning reusable medical devices 3 1 2 External Surfaces e Using a soft cloth with a water soluble detergent or disinfectant wipes clean all outer surfaces hoses and cables If using disinfectant wipes follow the manufacturer s instructions for use 3 1 3 Bellows Assembly FIGURE 3 1 Bellows Assembly Read all content in this section before disassembling cleaning disinfecting an
17. damage or functional faults Ensure that the gas supply of the machine always complies with the technical specifications Before clinical use the machine must be correctly calibrated and or the respective tests must be performed as described in these Operating Instructions If faults occur during the initial calibration or testing the machine should not be operated until those faults have been corrected by a qualified service person After servicing functional sensor and system tests must be performed before clinical use Only bacterial filters with a low flow resistance should be connected to the Breathing System and or the patient connection After changing the CO pre paks perform a fresh gas system leak test After changing the loose fill absorbent perform a fresh gas system leak test Only vaporizers with Interlock System may be used with the AS3000 unit After each exchange of a vaporizer perform a fresh gas system leak test Use cleaning agent sparingly Excess fluid could enter the machine causing damage Do not autoclave any parts of the AS3000 unless specifically identified as autoclaveable in this manual Clean the AS3000 only as specified in this manual Do not autoclave the airway pressure limiting APL valve This Anesthesia System is NOT suitable for use in a magnetic resonance imaging MRI environment To prevent system damage AS3000 Operating Instructions 0070 10 0684 01 ix
18. delivered to patient due to Internal Compliance c ceceeceeceeeeeseeseeseeseeeeseeteestenseetentens 5 2 COs Absorber Resistance A sant aip i css suasle es REE EA dncdegeancdegdurspdeesnsdlecesdeedeasancoenes 5 2 CO Absorber Capacity ceca vent cucties e dd dd tt fantasies 5 2 Unidirectional Valve Opening Pressure ooonnnicnnnnnnnnnoncnocononcn conan nono nono nono no nono c anni can cananea nani 5 2 A RIE a a 5 3 Dimension A A nia 5 3 Weight without vaporizers or gas cylinders onnonnnnnnncnnicnnnnononnoca nana noncnancon aran no nono n conc cononona nina nn caracas 5 3 Stability Configurations and Conditions ccecceecceeecsseeseeeseeeceeeecseeeseceaeceesseeeseeeseeeeeeneceseesseeeseeeteeeeenseens 5 3 Environmental arr An E r a E N E E E E A T A A stebomheeuin tes 5 3 E A E T A E a a i 5 4 Electrical Power Requirements rta io O 5 4 Battery Power Requirements eddie it Dido ic E dy dc EAEE 5 4 Auxiliar OU ia tii caste das 5 4 Pneumatics 5 4 Central Gas Supply Requirements 5 4 Cylinder Gas Supply Requirements ccscceesceeeeseeeeneeesseeeeneeceaeecnaeeesseeceaeestaeesneeeseaeestaeesnreeenteessieeeseeesas 5 4 Gas Managementiec ce cree o aaron IRE ee hate A EAE 5 4 ii 0070 10 0684 01 AS3000 Operating Instructions Table of Contents RO aa dada 5 4 O NN 5 5 Ventilato a A a ee co Ped dG 5 5 Accuracy of the measurements after 5 breaths ccccesccesseesseeseeeseenseeeeeseeneeceeeeeeeenae
19. for Oz Air and N20 from the central gas Supply Connections supply 3 Cylinders Supply tanks containing high pressure Oz Air and N20 to act as a backup supply if the pipeline pressure is removed 20 0070 10 0684 01 AS3000 Operating Instructions 20 Operations 2 Getting Started The factory default settings for waveforms parameters alarms and functions enable the system to begin operation immediately upon powering up However all of these settings can be changed for specific patient or departmental needs The AS3000 offers controlled ventilation for Adult and Child patient sizes with default ventilation parameters and alarm related settings for each Select the patient size from the Patient Type Tile item 5 in section 1 4 1 based on the ventilation requirements of the patient Tube and filter systems should also be fitted to the patient NOTE Patient size should be set to match the actual patient before operating the system since certain operating characteristics are based on the selected patient size The following sections outline installation configuration check out and pre operation testing procedures Startup procedures and other periodically performed tests and calibration steps are also provided 2 2 Installation After removing the machine from its shipping crate connect the following accessories if available prior to preparing the machine for initial setup e Waste gas scavenger assemb
20. in an automatic ventilation mode Return to MANUAL or STANDBY modes first e Do not run the ventilator in an automatic ventilation mode without any fresh gas flow e Do not remove the absorber canister while the ventilator is running in an automatic ventilation mode This should only be done in STANDBY mode with no patient connected e Do not remove the O sensor or sensor adapter from the breathing system block while the ventilator is running in an automatic ventilation mode This should only be done in STANDBY mode with no patient connected NOTE If the O sensor is removed when performing calibration immediately install the plug in its place e Do not remove the Inspiratory Expiratory check valve dome rings while the ventilator is running in an automatic ventilation mode This should only be done in STANDBY mode with no patient connected 0070 10 0684 01 AS3000 Operating Instructions Operations Initial Power Up 2 6 Initial Power Up Turn the power switch item 4 page 1 15 to the ON position A System Self Test will be automatically initiated and will be indicated on the Display When the self test is complete the following message will be displayed Select Continue to Start Leak Test recommended or select Bypass to proceed to Normal screen e If Continue is selected follow the onscreen prompts to perform the Leak test When the Leak test is complete select Continue to proceed to the Compliance test NOTE
21. of measure is emHO and its scale is 20 to 80 in increments of 20 Flow Volume Spirometry Loop FIGURE 2 16 is an example of the Flow Volume loop Flow Volume Flow L min Press NORMAL SCREEN to Exit Save Reference FIGURE 2 16 Example Flow Volume Loop 4 The Y axis of the Flow Volume Spirometry loop represents Flow The unit of measure is L min and its scale is 20 to 90 in increments of 45 but only absolute numbers are displayed The X axis represents Volume The unit of measure is ml and its scale is O to 1400 in increments of 750 AS3000 Operating Instructions 0070 10 0684 01 2 27 Alarms Operations 2 12 Alarms Unless otherwise stated all alarms occur immediately after the onset of an alarm event The Alarm menu tab enables adjustments to alarm limits and alarm volume To access the Alarm menu tab see the example in FIGURE 2 17 press the ALARMS LIMITS key NOTE There are separate Alarm menu tabs for the two patient types Adult and Child which will be indicated at the top left of each tab Pressure PEAK FIO Saume _UQUOOO00 Press Menu Key to Exit FIGURE 2 17 Example Adult Alarm menu tab 2 12 1 Setting Parameter Alarm Limits 1 From the Alarm menu tab use the Navigator Knob to set alarm limits as desired for the parameters shown in the following table The LOW and HIGH alarm limits for each parameter have separate defaults for the Adult and Child pati
22. retaining ring and then remove the bag arm from the breathing system block see FIGURE 3 16 Bag Arm Ring FIGURE 3 16 Bag Arm Removal 2 Cleaning a Clean the bag arm with a soft lintfree cloth and a solution of mild detergent and water Allow it to dry thoroughly b If disinfecting the bag arm continue with step 3 otherwise skip to step 4 3 Disinfection NOTE Ensure that the bag arm has been cleaned as described in step 2 before disinfecting Using an FDA cleared Gluteraldehyde disinfection solution follow the manufacturer s instructions for high level disinfection and rinsing of the bag arm while adhering to facility policies and procedures 4 Reassemble the bag arm to the breathing system Prior to use after cleaning or disinfecting power up the system as described in section 2 6 and follow the on screen prompts to perform the Leak Test and the Compliance Test 3 14 0070 10 0684 01 AS3000 Operating Instructions User Maintenance Cleaning and Disinfection 3 1 9 Absorber Canisters WARNING Do not remove the absorber canister while the ventilator is running in an automatic ventilation mode This should only be done in STANDBY mode with no patient connected 1 Locate the absorber drain as shown in FIGURE 3 17 Drain Valve Absorber Drain underneath FIGURE 3 17 Absorber Drain Valve Location 2 Refer to FIGURE 3 18 While holding a small cup below the drain turn the valve to the Open positio
23. selected parameters Warnings Cautions and Notes Please adhere to all warnings cautions and notes that are listed throughout this manual A WARNING is provided to alert the user to potential serious outcomes death injury or serious adverse events to the patient or the user A CAUTION is provided to alert the user to use special care necessary for the safe and effective use of the device They may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury but about which the user should be aware Cautions are also provided to alert the user to the adverse effects on this device due to misuse and the care necessary to avoid such effects A NOTE is provided when additional general information is applicable AS3000 Operating Instructions 0070 10 0684 01 v Introduction Warnings Warnings WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING In order to prevent an electric shock the machine protection class I may only be connected to a correctly grounded mains connection socket outlet with grounding contact Possible explosion hazard Do not operate machine near flammable anesthetic agents or other flammable substances Do not use flammable anesthetic agents i e ether or cyclopropane The use of anti static or electrically co
24. the start and at the end of each case All AS3000 units noted with Model No 0998 00 3024 02 are designed to maintain a safe O Nb0 ratio by allowing nitrous oxide to be set to a flow rate that is proportional to a previously adjusted flow of oxygen The N20 flow is limited by the flow of O so that a safe ratio of no less than 21 oxygen can be maintained This version is designed to maintain oxygen flow at its previously set level when N20 is decreased When the user is adjusting N20 and O flow rates always adjust the oxygen flow first to enable the nitrous oxide flow To add N20 to the fresh gas flow the user must fully open the N20 flowmeter valve but only after opening the O flowmeter valve All AS3000 units noted with Model No 0998 00 3024 01 maintain a safe O2 N20 ratio by adding O flow as the user increases the N20 flow This version is not designed to maintain oxygen flow at the highest flow level achieved when nitrous oxide is decreased 0070 10 0684 01 AS3000 Operating Instructions Product Description 1 1 3 1 1 4 1 1 5 1 1 6 General System Overview For AS3000 models noted with Model No 0998 00 3024 01 the user can avoid redundant steps when adjusting N20 and Op by always adjusting the O flow after adjusting N20 flow This will assure that the desired oxygen flow is achieved Vaporizer Mounting The AS3000 contains a 2 position Selectatec type vaporizer mounting system Lighting incorporated above the
25. vaporizers enables them to be seen in a darkened environment Breathing System The AS3000 breathing system is heated to minimize condensation inside the block and to return the patient s moisture The breathing system provides access to the APL valve and breathing bag along with a view of the mechanical breathing pressure gauge The APL valve has a single turn knob that provides a clear view of the manual breathing pressure setting The absorber assembly incorporates a cam lock device that opens and closes to provide access to the absorber canisters CO2 absorbent pre paks or loose fill can be used see Chapter 4 Accessories A water trap that can be drained is also provided on the absorber assembly Two 2 flow sensors in the breathing system measure inspired and exhaled gases for control and monitoring Spirometry is standard Inspired oxygen concentration is monitored via a fuel cell type sensor and breathing pressure is also monitored The breathing system can be swiveled for ease of positioning A test plug is provided between the two main hose connections to allow for automated leak testing during startup Connection to the Anesthesia Gas Scavenging System AGSS is made from the bottom rear of the breathing system Power Management The advanced power management system of the AS3000 provides AC power for its main system functions while also charging its internal batteries In the case of an AC power failure the AS3000 will operate for
26. volumes Tidal Volume Range O to 2900 ml Minute Volume Range 0 1 to 28 liters Rate O to 256 bpm Resolution Tidal Volume 1 ml Resolution Minute Volume 0 1 liters 5 9 1 Accuracy of the measurements after 5 breaths Pressure 20 of the measured value at least 2 cmH20 O 3 Vol Volume Adult mode 15 of the measured value Child mode 25 ml or 15 of the measured value whichever is greater Flow tubes 10 of full scale per ASTM F1101 90 2003 Rate 1 bpm ATPS Ambient Temperature Pressure Saturated 5 10 Anesthetic Gas Scavenging System Low Flow Flow Range 25 to 50 l min Maximum constant flow before 50 l min spillage occurs Particle Filter Replaceable AS3000 Operating Instructions 0070 10 0684 01 5 7 Inputs Outputs 5 11 5 11 1 5 11 1 1 5 11 1 2 5 11 1 3 5 11 1 4 5 11 1 5 5 11 2 5 11 2 1 5 11 2 2 5 11 2 3 5 11 2 4 5 11 2 5 5 11 2 6 Product Specifications Inputs Outputs Electrical Input Power Input power is provided via a captive line cord with a 120 volt 14 A hospital grade plug Auxiliary Outlets Four 120 volt outlets 0 Sensor Two pin connector for O cell cable Breathing System Heater Four pin connector for Breathing System Heater cable External Communication Port Port B is available for RS 232 digital communication per Communication Protocol Document P N 0070 00 0706 Contact Mindray for more information
27. 00 Operating Instructions 0070 10 0684 01 5 11 Electromagnetic Capability TABLE 5 2 Continued Product Specifications GUIDANCE AND DECLARATION ELECTROMAGNETIC IMMUNITY The AS3000 is intended for use in the electromagnetic environment specified below The customer or the user of the AS3000 should assure that it is used in such an environment IMMUNITY TEST Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 1 1 IEC 60601 TEST LEVEL lt 5 Ur gt 95 dip in Uy for 0 5 cycle 40 Ur 60 dip in Uy for 5 cycles 70 Ur 30 dip in Up for 25 cycles lt 5 Uy gt 95 dip in Uy for 5 sec COMPLIANCE LEVEL lt 5 Uy gt 95 dip in Uy for 0 5 cycle 40 Ur 60 dip in Uy for 5 cycles 70 Ur 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in Uy for 5 sec ELECTROMAGNETIC ENVIRONMENT GUIDANCE Mains power quality should be that of a typical commercial or hospital environment The AS3000 requires continued operation during power mains interruptions and is therefore provided with batteries that supply uninterruptible power Power frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz should be at levels characteristic of magnetic field a typical location in a typical IEC 61000 4 8 commercial or hospital environment Uy is the A C mains voltage prior to application of the test level TABLE 5 3 G
28. 00 is intended to be operated with an external CO monitor complying with ISO 21647 Connection to the CO monitor should be via a sample line from the Patient Circuit NOTE Any Anesthesia Vapor Delivery Device is to be used with an Anesthetic Agent Monitor complying with ISO 21647 Connection to the Agent monitor should be via a sample line from the Patient Circuit NOTE The AS3000 batteries are not user serviceable components Only an authorized service representative can replace the batteries If the system is not used for an extended period contact a service representative to have the batteries disconnected The batteries may be subject to local regulations regarding disposal At the end of the battery life dispose of the batteries in accordance with any local regulations Intended Use The AS3000 Anesthesia Delivery System is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient s ventilation The AS3000 is intended for use by licensed clinicians for patients requiring anesthesia within a health care facility and can be used in both adult and pediatric populations Unpacking Remove the machine from the shipping carton and examine it for signs of shipping damage Save all packing materials invoice and bill of lading These may be required to process a claim with the carrier Check all materials against the packing list Contact the Customer Servic
29. 3 Workplace Ergonomics nisser neika taia ii ea iia oaie ia te iera ia dect ibi 1 3 Responsibilities of Operators eian a a e aa e 1 4 Key Features 1 5 User Interface 1 6 BI le AAR E EA E A E N E A 1 7 Nole e WNE o EE A A A AE E A A AE A loli d ica 1 13 Front NiS Wal dida a Ea aea DEA E E AES dia 1 15 Auxiliary Outputs Fresh Gas Dosing Components s ccssceeesseeenseeeeeeeeeeeseeeeseeeneecseeseaeesseeseeessaeesnteenaeennees 1 16 Vaporizer Mounting Manifold 1 17 Breathing System 1 18 TOP tE da el EE TEE tes Riad 1 18 Bottom View omenana en A le E A AI 1 19 O O ies 1 20 Operations ccoomccococcooccnonccnnoccnocccnnccnonccnncccnacicncccnnoccnccccnoccnncccnncconoconnccconoconacicnococacecacaconese l 2 Getting Started Installation Initial Setup Preoperative Checkout Betore Every Poli lacio Initial Powers dais Adjusting the Date and Time Vaporizer Installation Oxygen Sensor Calibration Ventilation Modes STANDBY MANUAL i eiea dada did Setting the APL Valve till ii ed da iS Continuous Mandatory Ventilation CMY NA NO Pressure Controlled Ventilation PCV PCV Parameter Settings Synchronized Intermittent Mandatory Ventilation SIMV SIMV Parameter Settings Pressure Support PS PS Parameter Settings Parameter Monitoring Pressure AS3000 Operating Instructions 0070 10 0684 01 i Table of Contents Mol a AA a aid Inspired Oo FO ii eesigi ane eaea EEE E a RETE EE
30. 3000 Operating Instructions Operations Oxygen Sensor Calibration 5 After at least three minutes have passed select the Next button to initiate the calibration process The progress bar shown in FIGURE 2 5 or FIGURE 2 7 will be displayed r Remove the oxygen sensor from the Calibrating breathing system Expose the sensor to room air for at least three minutes Ei before proceeding O2 Sensor 0 235 V O Sensor 0 235 V EZB FIGURE 2 4 Oxygen Sensor FIGURE 2 5 Oxygen Sensor Calibration Instructions Calibration Progress Bar N r Remove the oxygen sensor from the Calibrating breathing system Expose the sensor to room air for at least three minutes Ei before proceeding d FIGURE 2 6 Oxygen Sensor FIGURE 2 7 Oxygen Sensor Calibration Instructions UI Calibration Progress Bar versions 2 24 and lower UI versions 2 24 and lower AS3000 Operating Instructions 0070 10 0684 01 2 13 Oxygen Sensor Calibration Operations 6 Proceed based on one of the following two conditions e If the calibration is successful the screen shown in FIGURE 2 8 will be displayed instructing the user to reinstall the oxygen sensor into the breathing system Select the Done button to complete the process e If the calibration fails the screen shown in FIGURE 2 9 will be displayed instructing the user to either repeat the calibration by selecting the Repeat Cal button or to replace the
31. 3000 Service Manual The machine must be operated by qualified and trained personnel only All operators must fully observe these operating instructions and relevant additional documentation They must also comply with the WARNINGS and CAUTIONS detailed in this manual 0070 10 0684 01 AS3000 Operating Instructions Product Description Key Features 1 3 Key Features FEATURE DESCRIPTION Display 10 4 inch color liquid crystal display Navigation Hard keys and Navigator Knob for easy navigation Ventilation Multiple advanced modes of ventilation CMV PCV SIMV PS Fresh Gas Delivery Dual Flow Tubes for ease of use 3 cylinder mount locations on rear Breathing System Heated adjustable swivel front hose ports single turn APL valve Work Surface Large stainless steel Additional Rail mount extended work surface Electronic PEEP Positive End Expiratory Pressure PEEP is set and controlled electronically Clear Data Display 2 large waveforms for pressure and volume or Spirometry Loops standard AS3000 Operating Instructions 0070 10 0684 01 1 5 User Interface Product Description 1 4 User Interface The Display of the User Interface described in section 1 4 1 provides waveforms numeric data and menu tabs The keys and Navigator Knob of the Keypad Area described in section 1 4 2 enable the user to power up the system silence alarms acc
32. Cleaning and Disinfection 3 1 11 AGSS Anesthetic Gas Scavenging System and AGSS Transfer Hose 1 Disconnect the EVAC hose from the AGSS 2 Remove the AGSS and Transfer Hose from the AS3000 as shown in FIGURE 3 22 FIGURE 3 22 AGSS and Transfer Hose Removal AS3000 Operating Instructions 0070 10 0684 01 3 19 Cleaning and Disinfection User Maintenance 3 Clean the outer surface of the AGSS and Transfer Hose with a soft lint free cloth and a mild detergent and water solution Allow to dry thoroughly 4 Remove the top of the AGSS as shown in FIGURE 3 23 Inspect the AGSS filter as shown in FIGURE 3 24 and shake it over a waste container to clean it as necessary If the filter must be replaced dispose of the old filter per local government policy FIGURE 3 23 Removal of AGSS Top FIGURE 3 24 AGSS Filter Inspection 5 Reassemble the AGSS and Transfer Hose and reconnect them to the AS3000 in the reverse order 20 0070 10 0684 01 AS3000 Operating Instructions User Maintenance Regular Maintenance 3 2 Regular Maintenance WARNING To avoid endangering a patient do not perform testing or maintenance when the machine is in use Visual inspection should be performed every 30 days to ensure timely replacement of worn or damaged parts 1 Power off the system 2 Perform an overall visual inspection of the system 3 Power up the system as described in section 2 6 and follow the on screen prompts to perform the
33. Ea EA EEEE SEEE E E EEE Va S dos SpIrOMe Viriato O EE A ET EE E AE NE AR E EA AAAA VaN lo Tn EE EE E E E E NON Setting Parameter Alarm mitico E EA ARa aeia Alarm Volume Technical Messages and Functional Alarm Messages Technical E AAA E TN Functional Alarm Messages ci A di a AAA ds Alarm Functions Testne in iaoea ie iria Paid bie User Maintenance scccoccccccccccnncccnnncnncannananarannccnccccccoccccnccccnncccnnaconacanaaranaconacacacacccccacccnones Y 1 Cleaning and Disintection ai aaa General Guidelines iaa lis casada ExtemnaliSurfaces a ta ee a a ea e o Hae Siew do e a Me ad te Bellows Assembly ndanani eenaa aak e eia dida Inspiration and Expiration Valves Oxygen Sensor 3 TN dba oN verre o tenner etree perce Peet re ope re o ree pee de es Breathing System Blocks i242 n e ca caci n cee ohne be ied oot oleh AGSS Anesthetic Gas Scavenging System and AGSS Transfer Hose Regular Maintenance NGPONIZSPS is iia A A faa ahs SNe wart AS Gas Supply Hoses cirio ai COs Absorbers iia o a ad e dl Miscellaneous Product Specifications oommmscscrronoscicccnnsonoccccnonanccconccnoneniccccccnnnonnancccccnanacacaciconanacacacoceso Y I Satety Designs ti a tia 5 1 ASTM F 1208 89 2005 Disclosures 5 2 Leakage of Breathing Mid dad caren tented 5 2 Resistance of Breathing Systems c ccscceseesseeseeseeeeeeseceseeeeeseceseeeseeeeeseeeaeenseeeeseeeseeseesseseaeeeeeeneeeneenaes 5 2 Volume of Gas not
34. L Airway Pressure Rotary regulator for setting the pressure control during Limiting Valve manual ventilation Set to OPEN during Spontaneous breathing 12 Inspiratory Limb Inhaled breathing circuit connection 13 Inspiration Valve Valve allows flow of inspiratory gas to the patient 1 The bellows dome is a transparent cover with graduation marks from 300 to 1500 These marks are for qualitative purposes only Tidal volume Vr should be read exclusively from the display of the user interface 2 The APL valve and PAW gauge numerics are for reference only Calibrated patient airway pressure is displayed on the user interface 1 8 2 Bottom View FIGURE 1 9 AS3000 Breathing System Bottom View PART S DESCRIPTION 1 Drive Gas Hose Provides drive gas to the bellows 2 CO Absorber The two chambers hold CO absorbent material either Canisters loose fill or pre paks 3 Waste Gas Hose Hose that routes exhaust gases from the breathing system to the AGSS Anesthetic Gas Scavenging System 4 Heater Wire Provides power to the breathing system heater 5 Fresh Gas Hose Provides fresh gas to the breathing system AS3000 Operating Instructions 0070 10 0684 01 1 19 Rear View Product Description 1 9 Rear View FIGURE 1 10 Rear View PART S DESCRIPTION 1 AC Outlets Additional devices up to a total maximum power consumption of 8 amps can be connected to four outlets 2 Gas Pipeline Connections
35. Operating Instructions Datascope AS 3000 ANESTHESIA DELIVERY SYSTEM mindray NORTH AMERICA 0070 01 0684 02_revB_AS3000 ops color indd 1 3 10 10 5 14 09 PM Operating Instructions Datascope AS 3000 ANESTHESIA DELIVERY SYSTEM mindray TH AMERICA AS3000 is a U S trademark of Mindray DS USA Inc Passport 2 is a US registered trademark of Mindray DS USA Inc Selectatec is a registered trademark of Ohmeda Spectrum is a U S registered trademark of Mindray DS USA Inc Spectrum OR is a US trademark of Mindray DS USA Inc Copyright Mindray DS USA Inc 2008 All rights reserved Contents of this publication may not be reproduced in any form without permission of Mindray DS USA Inc AS3000 Operating Instructions 0070 10 0684 01 Table of Contents O ONE v Warnings Ca tions and NotesSession iiaii ene as EEN EEEE KE EEKi ES EAEE ESEESE EE EE EEEN Saat v Waring Saee NN vi ESTEE E E T och cates neni E A E S ix E RE NR Intended Use Unpaid e eds dll e do Mol iii A A a E EEEE EEA Aa xii Product Description ccccccccccccccccccccccccccccccccccscccccccccccccccccccsccccccsccccccsccccccccccccccccccccccsees T General System Oven Wii di iii iris 1 2 Anesthesia Ventilator secre tees ee A th ouster EE Cave dees AA ENE ONOR 1 2 Fresh Gas Dosing taba eee riadas 1 2 Vaporizer Mounting visitas ti dida E E AE E ES 1 3 Breathing A O RN 1 3 Power Mangas aa aid aie 1
36. RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The AS3000 is suitable for use in all establishments CISPR 11 other than domestic establishments and those directly Harmonic Class A connected to the public low voltage power supply emissions IEC network that supplies buildings used for domestic 61000 3 2 purposes Voltage Complies fluctuations Flicker emissions IEC 61000 3 3 TABLE 5 2 GUIDANCE AND DECLARATION ELECTROMAGNETIC IMMUNITY The AS3000 is intended for use in the electromagnetic environment specified below The customer or the user of the AS3000 should assure that it is used in such an environment IMMUNITY IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC TEST LEVEL LEVEL ENVIRONMENT GUIDANCE Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or discharge ESD ceramic tile If floors are covered IEC 61000 4 2 8 KV air 8 kV air with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power 2 kV for power Mains power quality should be that transient burst supply lines supply lines of a typical commercial or hospital IEC 61000 4 4 environment 1 kV for input N A output lines Surge 1 kV differential 1 kV differential Mains power quality should be that IEC 61000 4 5 mode mode of a typical commercial or hospital environment 2 kV common 2 kV common mode mode AS30
37. System 1 8 1 Top View FIGURE 1 8 AS3000 Breathing System Top View PART S DESCRIPTION Breathing System Six pneumatic hoses that control the manual vent switch Pneumatic Hoses and exhaust valves in the breathing system and provide the ventilator with flow sensor information 2 Oxygen Sensor Connection to galvanic fuel cell External Cable 3 Bellows including Durable bellows that separates the breathing system gases bellows dome from the oxygen drive gas 4 PAW Gauge Indicates the patient airway pressure 5 Oxygen Sensor Galvanic fuel cell 6 Op Cell Plug Used to seal the oxygen sensor port when it is not in use 7 Bag Arm Provides the interface to the manual ventilation bag 1 The bellows dome is a transparent cover with graduation marks from 300 to 1500 These marks are for qualitative purposes only Tidal volume Vz should be read exclusively from the display of the user interface 2 The APL valve and PAW gauge numerics are for reference only Calibrated patient airway pressure is displayed on the user interface 0070 10 0684 01 AS3000 Operating Instructions Product Description Breathing System 8 Expiration Valve Allows flow of expiratory gas from the patient to the re breathing system 9 Expiratory Limb Exhaled breathing circuit connection 10 Y Piece Seal Provides a parking position to seal the breathing circuit y piece during the compliance test 11 AP
38. Test as described in step 16 of this section AS3000 Operating Instructions 0070 10 0684 01 2 7 Before Every Patient 2 5 Operations Before Every Patient e Verify that the O2 tank is full prior to each new patient being attached to the device or when a different operator uses the gas machine e Check for appropriate level of patient suction e Verify ability of required monitors and check alarms e Verify CO absorbent is not exhausted e Verify that the bellows is fully inflated before starting an automatic ventilation mode CAUTION Verify that the bellows is fully inflated before starting an automatic ventilation mode on the patient If the bellows is deflated and at the bottom of its travel at the start of an automatic ventilation mode the bellows may become deformed Inflating the Bellows On initial power up the bellows is automatically inflated if the Leak Test is performed However in between patients if the bellows is at the bottom of its travel 1 Install a breathing circuit and connect the Y piece to the Test port 2 Select CMV mode and confirm the selection 3 Immediately push the O button until the bellows is completely filled 4 Return to STANDBY mode and remove Y piece from Test port Maintaining Inflated Bellows To prevent the bellows from deflating completely to the bottom of its travel e Do not disconnect the breathing circuit from the AS3000 or the patient while the ventilator is running
39. Tingp unit of measure is sec and it has separate settings for the Adult and Child patient types e The range of settings for the Adult patient type is 0 2 to 5 0 seconds in increments of 0 1 seconds and its default is 2 seconds e The range of settings for the Child patient type is 0 2 to 5 0 seconds in increments of 0 1 seconds and its default is 1 second NOTE This parameter is available in the SIMV with PS ventilation mode only e PEEP Positive End Expiratory Pressure The PEEP unit of measure is cmH20 The range of settings for both the Adult and Child patient types is Off and 3 to 30 cmH20 in increments of 1 cmH2O Its default is Off NOTE This parameter is available in the CMV PCV SIMV with PS and PS ventilation modes f Freqmin Frequency Min The Freqayy unit of measure is bpm and it has separate settings for the Adult and Child patient types e The range of settings for the Adult patient type is 2 to 60 bpm in increments of 1 bpm and its default is 2 bpm e The range of settings for the Child patient type is 2 to 60 bpm in increments of 1 bpm and its default is 4 bpm NOTE This parameter is available in the PS ventilation mode only g Tp Inspiratory Pause The Tp unit of measure is The range of settings for both the Adult and Child patient types is Off and 5 to 60 in increments of 5 Its default is 10 NOTE This parameter is available in the CMV and SIMV with PS ventilation modes h
40. Trigger Flow Trigger The Trigger unit of measure is L min and it has separate settings for the Adult and Child patient types e The range of settings for the Adult patient type is 1 to 15 L min in increments of 1 L min and its default is 3 L min e The range of settings for the Child patient type is 1 to 15 L min in increments of 1 L min and its default is 2 L min NOTE This parameter is available in the SIMV with PS and PS ventilation modes AS3000 Operating Instructions 0070 10 0684 01 1 11 User Interface Product Description i Prarcet Target Pressure The PrarGer unit of measure is emHO The range of settings for both the Adult and Child patient types is 5 to 70 cmH 0 in increments of 1 cmH20 The default for the Adult patient type is 20 cmH O The default for the Child patient type is 10 cmH 0 NOTE This parameter is available in the PCV ventilation mode only j AP Differential Target Pressure The AP unit of measure is emH gO The range of settings for both the Adult and Child patient types is 3 to 50 cmH20O in increments of 1 cmH 2O The default for the Adult patient type is 5 cmH2O The default for the Child patient type is 5 cmH20 NOTE This parameter is available in the SIMV with PS and PS ventilation modes k TsLope Inspiratory Slope The TsLope unit of measure is sec The range of settings for both the Adult and Child patient types is O to 2 seconds in increments of 0 1 seconds Its
41. UIDANCE AND DECLARATION ELECTROMAGNETIC IMMUNITY The AS3000 is intended for use in the electromagnetic environment specified below The customer or the user of the AS3000 should assure that it is used in such an environment IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the AS3000 than the separation distance derived from the following calculations Recommended separation distance Conducted RF d 1 2x JP IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms 0070 10 0684 01 AS3000 Operating Instructions Product Specifications TABLE 5 3 Continued Electromagnetic Capability GUIDANCE AND DECLARATION ELECTROMAGNETIC IMMUNITY The AS3000 is intended for use in the electromagnetic environment specified below The customer or the user of the AS3000 should assure that it is used in such an environment IMMUNITY TEST Radiated RF IEC 61000 4 3 IEC 60601 TEST COMPLIANCE LEVEL LEVEL 3 V m 3 V m 80 MHz to 2 5 GHz ELECTROMAGNETIC ENVIRONMENT GUIDANCE d 1 2x JP 80 MHz to 800 MHz d 2 3x JP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an e
42. a minimum of 45 minutes on battery power A recessed main switch is provided to power the system ON and OFF The four 4 auxiliary AC outlets provided on the rear of the machine operate independent of the main switch position Workplace Ergonomics The AS3000 is a full featured anesthesia delivery work station The raised perimeter of its stainless steel work surface controls items that might otherwise roll or slide off its edge The work surface light has high and low brightness settings lts wrap around handle enables fine positioning of the machine Three 3 large drawers are available for storage The top drawer is lockable with a key Rail mounts are provided on both sides of the machine to enable positioning of system elements and mounting of patient monitors and most standard attachment arms for other devices A non slip footrest and brakes for the front wheels are provided The top shelf can be used for additional equipment AS3000 Operating Instructions 0070 10 0684 01 1 3 Responsibilities of Operators Product Description 1 2 Responsibilities of Operators The proper function of the AS3000 system can only be guaranteed if it is operated and serviced in accordance with the information provided in this manual and the AS3000 Service Manual Non compliance with this information voids all guarantee claims NOTE This manual only describes the operation of the machine Information about service and repair is contained in the AS
43. ance at 1 Liter sec flow 6 9 cmH 0 CO Absorber Capacity CO absorber capacity is 2 pre paks or 1500 ml in each canister Unidirectional Valve Opening Pressure The pressure to open moist inspiratory and expiratory valves does not exceed 0 15 kPa 1 5 cmH gt 0 0070 10 0684 01 AS3000 Operating Instructions Product Specifications 3 5 3 1 5 3 2 5 3 3 5 4 General General Dimensions Height 54 3 in 0 2 in 1380 mm 5 mm Width 25 6 in 0 2 in 650 mm 5 mm Depth 27 2 in 0 2 in 690 mm 5 mm Weight without vaporizers or gas cylinders 326 lbs or less 148 kg or less Stability Configurations and Conditions Tilted through an angle of 10 front both sides and back with all drawers loaded to 10 lbs each and left open Back tilt performed with three gas cylinders attached WARNING Due to the size and weight of the A3000 it should only be moved by qualified personnel WARNING To avoid tip hazards use care when moving the AS3000 up or down inclines around corners and across thresholds Remove all monitoring equipment mounted to the side of the AS3000 prior to transport Do not attempt to roll the AS3000 over hoses cords or other obstacles WARNING Remove all equipment from the top shelf of the AS3000 before moving Environmental Operating temperature 50 to 104 F 10 to 40 C Storage temperature 14 to 140 F 10 to 60 C Humidity operating and storage 15 90 RH non
44. arget pressure for the pressure support is a differential pressure pressure value AP Inspiratory flow setting The user sets the time TsLopg required to reach the set AP The ventilator regulates the inspiratory flow to match the Ts opg time set by the user Frequency stability If the SIMV breath is triggered the time difference between the trigger and scheduled mandatory breath is added to the expiratory time of the next cycle 2 20 0070 10 0684 01 AS3000 Operating Instructions Operations 2 10 5 1 SIMV Parameter Settings User Adjustable Parameters for SIMV e Vz Tidal Volume Tisp Inspiratory Time e Freq Frequency e Tp Inspiratory Pause e Trigger Flow Trigger e AP Differential Target Pressure Tsope Inspiratory Slope e PEEP Positive End Expiratory Pressure Ranges and Delivery Accuracy for SIMV Ventilation Modes ADULT CHILD DELIVERY ACCURACY Vr ml AO 1400 600 40 1400 Adult 15 for Tinsp from 5 1 20 30 for TiNsp lt 1 Child 15 at least 16 ml Tinsp sec 0 2 5 0 2 0 2 5 0 1 10 or 0 1 whichever is greater Freq bpm 2 60 4 2 60 4 1 Tp Off 5 60 10 Off 5 60 10 30 Trigger l min 1 15 3 1 15 2 1 3 AP cmH 0 3 50 5 3 50 5 Adult 3 35 3 cmH20 36 50 12 cmH20 Child 3 50 3 cmH20 TsLopE sec O 2 0 5 O 2 0 5 1 0 sec PEEP cmH Off 3 30 Off Off 3 30 Off 3 12 c
45. condensing Atmospheric pressure 700 to 1060 hPa operating and storage AS3000 Operating Instructions 0070 10 0684 01 5 3 Electrical 5 5 5 5 1 5 5 2 5 5 3 5 6 5 6 1 5 6 2 5 7 5 7 1 Product Specifications Electrical Electrical Power Requirements Mains power supply 100 to 240 VAC 50 60 Hz 10 A Current input 120 VAC 10 A 2 A for AS3000 8 A for auxiliary outlets Power consumption Less than 200 VA not including auxiliary outlets Main Fuse 2x 10A Battery Power Requirements Battery 2 x 12 V Sealed Lead Acid Battery run time A5 minutes minimum Battery charge time 8 hours maximum Auxiliary Outlets Number of outlets 4 Output voltage per Outlet 120 VAC 60 Hz 2A maximum Fuses 4x2A NOTE IEC 60601 1 1 applies when medical electrical equipment non medical electrical equipment or combinations thereof are connected to the auxiliary mains socket outlet s Pneumatic Central Gas Supply Requirements 40 6 psi to 87 0 psi 280 kPa to 600 kPa for all three gases Oz N20 Air Cylinder Gas Supply Requirements E Cylinder pin indexed per CGA V 1 for all three gases O2 N20 Air Gas Management Ratio System Integrated with automatic N20 cutoff when O fails minimum of 21 Vol O in fresh gas 0070 10 0684 01 AS3000 Operating Instructions Product Specifications 5 8 Breathing System Absorber capacity Absorber system Condensation block Block heater warm u
46. d avoid Apnea Inspiratory flow setting The user sets the time Ts opg required to reach the set AP The ventilator regulates the inspiratory flow to match the Ts opg time set by the user 2 22 0070 10 0684 01 AS3000 Operating Instructions Operations 2 10 6 1 PS Parameter Settings User Adjustable Parameters for PS e Frequin Frequency MIN e Trigger Flow Trigger e AP Differential Target Pressure Tsiope Inspiratory Slope e PEEP Positive End Expiratory Pressure Ranges and Delivery Accuracy for PS Ventilation Modes ADULT CHILD DELIVERY ACCURACY Freqmin bpm 2 60 2 2 60 4 Trigger l min 1 15 3 1 15 2 21 3 AP cmH20 3 50 5 3 50 5 Adult 3 35 3 cmH20 36 50 12 cmH20 Child 3 50 3 cmH20 TsLopE sec O 2 0 5 0 2 0 5 1 0 sec PEEP cmH20 Off 3 30 Off Off 3 30 Off 3 12 cmH2O 2 cmH20 13 17 cmH9O 3 cmH20 18 24 cmH20O 6 cmH 0 25 30 cmH9O 12 cmH 0 Defaults appear in parenthesis in bold text AS3000 Operating Instructions 0070 10 0684 01 2 23 Parameter Monitoring 2 11 2 11 1 2 24 Operations Parameter Monitoring The system displays waveforms and Spirometry loops in the Waveform Area item 7 in FIGURE 1 3 and digital data in the Parameter Area item 8 in FIGURE 1 3 The digital data is separated into three parameter groups Pressure Volume and Inspired Op FiO Pr
47. d enable Pressure Volume and Apnea alarms in MANUAL Mode See section 2 12 3 2 Functional Alarm Messages for a list of Alarm Messages 2 10 2 1 Setting the APL Valve For Manual Ventilation Rotate the APL valve adjustment knob to the desired pressure NOTE Clockwise rotation increases the pressure and counterclockwise rotation decreases the pressure The patient can be ventilated by hand using the breathing bag The pressure will be limited to the value set on the APL valve For Spontaneous Breathing Rotate the APL valve adjustment knob fully counterclockwise until the SP marking on the knob lines up with the index mark on the bottom section of the valve see item 11 in FIGURE 1 8 The valve will then be open for spontaneous patient breathing AS3000 Operating Instructions 0070 10 0684 01 2 15 Ventilation Modes Operations 2 10 3 Continuous Mandatory Ventilation CMV CMV mode is used to provide Continuous Mandatory Ventilation CMY to a patient This is a volume mode where the user sets the desired tidal volume to be delivered to the patient s lungs and the desired frequency The breathing cycle is specified by the user s selection of frequency E ratio inspiratory pause time PEEP and tidal volume Compliance compensation is applied in CMV mode so that the tidal volume delivered to the patient more closely corresponds to the tidal volume setting System compliance is determined during startup testing To ac
48. d re assembling the bellows to avoid equipment malfunction and patient injury AS3000 Operating Instructions 0070 10 0684 01 3 3 Cleaning and Disinfection User Maintenance 1 The bellows dome is a transparent cover with graduation marks from 300 to 1500 Remove the bellows dome by turning it counterclockwise and lifting it away from the breathing system See FIGURE 3 2 FIGURE 3 2 Removing the Bellows Dome 2 Detach the bellows from the base plate as shown in FIGURE 3 3 FIGURE 3 3 Detaching the Bellows 3 4 0070 10 0684 01 AS3000 Operating Instructions User Maintenance Cleaning and Disinfection 3 Detach the top plate from the bellows as shown in FIGURE 3 4 e A FIGURE 3 4 Detaching the Top Plate NOTE While performing the following step note the orientation of the bellows adapter ring as it is being removed to ensure that it is properly inserted during reassembly 4 Remove the bellows adapter ring from inside the bellows as shown in FIGURE 3 5 AAA T FIGURE 3 5 Removing the Bellows Adapter Ring AS3000 Operating Instructions 0070 10 0684 01 3 5 Cleaning and Disinfection User Maintenance 5 Remove the bellows dome O ring as shown in FIGURE 3 6 Bids de ll liza FIGURE 3 6 Removing the Bellows Dome O ring 6 Cleaning a To prevent damage wash each component gently with hot water using a mild non enzyme detergent that is recommended for rubber and plastic Ensure that all bellow
49. default is 0 5 seconds NOTE This parameter is available in the PCV SIMV with PS and PS ventilation modes 0070 10 0684 01 AS3000 Operating Instructions Product Description User Interface 1 4 2 Keypad Area The following provides a brief explanation of the components of the Keypad Area shown in FIGURE 1 4 1 AC Power LED A green LED that is used to indicate that the unit is connected to the AC Power within the facility E 2 MANUAL AUTO key em Press this key to change the current ventilation mode to AUTO manual mode Each successive key press will toggle ALARM between manual mode and the previously selected LIMITS ventilation mode fe 3 ALARM LIMITS key MUTE Press this key to open the Alarm menu tab If the Alarm menu tab is already open when the ALARM SPIROMETRY LIMITS key is pressed again the Alarm menu tab Oy will close oar MENU 4 MUTE key Press this key to mute silence audio alarm tones for all currently alarming parameters for 120 seconds or until the alarm conditions are no longer present Any new alarms that occur while the alarm tone is muted will disable the mute and sound the new alarm tone While the alarms are muted an Alarm Mute icon EX with a 120 second countdown timer is presented in the upper left corner of the display UR JA 4 Keypad Area 5 SPIROMETRY key This key toggles the waveform area between the Pressure vs Time and Flow vs Time wavefo
50. e Department at 800 288 2121 or 201 995 8237 for prompt assistance in resolving shipping problems AS3000 Operating Instructions 0070 10 0684 01 xi Introduction Symbols Symbols The following table provides descriptions of symbols that are used on the device and or within this manual SYMBOL A A A 2 molle lt DESCRIPTION Attention Consult Accompanying Documents Refer to Manual Low priority message Medium priority message High priority message Equipotentiality Alternating Current AC Protective Earth Ground Fuse Catalog Number Serial Number Lock Unlock SYMBOL Li DESCRIPTION Type BF Equipment Alarm Icon Alarm Mute Icon Full Battery Indicator Low Battery Indicator Internal Battery Latex free product Interference may occur in the vicinity of equipment marked with this symbol Plug Icon Date Code Recycle Separate treatment from general waste at end of life xii 0070 10 0684 01 AS3000 Operating Instructions wo Product Description FIGURE 1 1 The AS3000 Anesthesia Delivery System AS3000 Operating Instructions 0070 10 0684 01 General System Overview Product Description 1 1 General System Overview The AS3000 is a continuous flow anesthesia system which offers manual or automatic ventilation easily adjustable fresh gas delivery anesthetic agent delivery ventilation monitoring con
51. e Numbers and How To Get Assistance cecccceceeesseeeeseesereeeneeeeneeceneeeseeeneecssesseeeseteesneeennteenireseneeennteesas 5 16 Manufacturer s Responsibility cs ic cosececcaesctegesesascasncste cab sacs cossubcabeodhenbon dada a a Ea EEEE e 5 16 AAN Glossary Ter condi decida dnd odio do RINDA caste cstvuvd scuncoudea souk iiaa a ERG tad 6 1 AS3000 Operating Instructions 0070 10 0684 01 iii Table of Contents This page intentionally left blank iv 0070 10 0684 01 AS3000 Operating Instructions Foreword Introduction Foreword The AS3000 Anesthesia Delivery System Operating Instructions are intended to provide information for proper operation General knowledge and understanding of the features and functions of the AS3000 Anesthesia Delivery System are prerequisites for its proper use NOTE Do not operate this system before reading these instructions Information for servicing this instrument is contained in the AS3000 Anesthesia Delivery System Service Manual part number 0070 00 0683 For additional information or assistance please contact an authorized representative in your area CAUTION U S Federal Law restricts this device to sale by or on the order of a physician or other practitioner licensed by state law to use or order the use of this device NOTE Figures in this manual are provided for reference purposes only Screens will likely differ based on the system configuration and
52. e in lifting and manipulating vaporizers during the mounting process as their weight may be greater than expected based on their size and shape WARNING Use care in lifting and manipulating the breathing system block during removal from its mounting arm as handling may be awkward due to its weight and shape WARNING Do not use talc zinc stearate calcium carbonate corn starch or similar material to prevent sticking of the bellows as these materials may enter the patient s lungs or airway causing irritation or injury WARNING All gas supplies should be of medical grade WARNING Single use respiratory hoses and face masks should not be reused WARNING To avoid endangering a patient do not perform testing or maintenance when the machine is in use WARNING Review the performance specifications of the disposal system with which the transfer and receiving systems are intended to be used to ensure compatibility WARNING The AS3000 should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the AS3000 should be observed to verify normal operation in the configuration in which it will be used WARNING Ensure that the current alarm presets are appropriate prior to use on each patient WARNING Ensure that both O and N20 flow controllers are turned OFF fully at the start and at the end of each case WARNING Due to the size and weight of the A3000 it should only be moved by quali
53. eneeenseceeeeeneenteneees 5 7 Anesthetic Gas Scavenging System Low Flow oooonooninnnncnnocinocnoccnoconoconanonncnno nono no co nn conan nono no nono ncan cnn rana nana 5 7 AS RN 5 8 Electrical e ee ne td dd a O 5 8 INPUEPO Wer a a 5 8 Auxiliary Outlets ia diz 5 8 OE E NN 5 8 Br athing System H dter tact nsec tas on a aa a ar aE e daban AE 5 8 External Communication Port 5 8 O a EN feu ety EEE A 5 8 Pipeline connections oes eani a seu snla sel cauucsdaviteasedcesesousncosddes sh lousncdeedeuceiteavercvsncoduhdavancdead 5 8 Cylinder connection s ii ta dit ice beaded ies 5 8 Vaporizer connections micas A Aa 5 8 Breathing System COMEN ici ti nit ca as 5 8 CGO Common Gas Qui ui da di di 5 8 Oxygen Output Connectors i tesis erari reie aE e aE addon ios coal 5 8 Oxygen Gas Power Outlet aogesi ieii La A RE E E A E A a NE ENA Eaa 5 9 Displays Cool ia EE 5 9 Electra plastilina dida oie nde 5 9 Us e eo di ida 5 9 Main Switch ii a da e adn 5 9 Vaporizer Work Light 5 9 Audio MGIC CONS siipii erena NN 5 9 PAEUMGTIC RE 5 9 Line Pressur Gauges mit ld diia lat dee nade doudusd e A A ltda 5 9 Cylinder Pressure GALEANA PaaITNSS xs 5 10 Flowmeter and Control Valve 5 10 OssFlUSh caer ee eet aaa a e tase Meat eds det do a O 5 10 APL VAVE a IA 5 10 Electromagnetic Gapability caco a aaa 5 11 Warranty atentar id A E A A A ad nl 5 15 Dil Mt Letonie CUNA E SS 5 16 Product Improvement iia riada do dd a a e id 5 16 Phon
54. ent sizes LOW HIGH PARAMETER RANGE DEFAULT RANGE DEFAULT MV L min 0 20 Adult 1 1 25 Adult 12 Child 1 Child 6 PAW cmH 0 0 70 Adult 4 10 80 Adult 50 Child 4 Child 40 FIO 9 18 99 Adult 18 21 100 Adult 100 Child 18 Child 100 1 The increment for all ranges and all units of measure is 1 2 Available in all ventilation modes except STANDBY 2 To save alarm limit settings press the Navigator Knob 28 0070 10 0684 01 AS3000 Operating Instructions Operations Alarms 2 12 2 Alarm Volume The Alarm Volume sub menu is used to adjust the volume level of the audio portion of the alarms A 10 segment bar display adjusts from 1 segment for the lowest volume to 10 segments for the highest volume As each segment is highlighted a sample tone for that volume level is sounded The default volume level is 2 segments 2 12 3 Technical Messages and Functional Alarm Messages Based on the priority levels listed in the tables in sections 2 12 3 1 and 2 12 3 2 each message will display in the Alarm Message Area item 2 FIGURE 1 3 with an associated symbol as follows e Low priority IN e Medium priority IN II e High priority IN 111 AS3000 Operating Instructions 0070 10 0684 01 2 29 Alarms 2 12 3 1 Technical Messages Operations The following table lists the individual technical messages their associated priority levels reasons for the messages and possible solutions
55. ent ventilation mode when the ventilation mode tile is flashing 10 Parameter Setup Tiles The eight 8 parameter setup tiles are used to display and adjust the parameter settings Pressing the Navigator Knob when a parameter setup tile is highlighted selects the tile for TM ATA setting adjustment Rotating the Navigator Knob clockwise will increase the setting and rotating it counterclockwise will decrease the setting The range of settings for each parameter has a maximum and minimum value AS3000 Operating Instructions 0070 10 0684 01 1 9 User Interface Product Description NOTE If setting adjustments have not yet been accepted and the Navigator Knob is not pressed or rotated for 15 seconds a time out will occur causing the display to revert back to the previous settings The layout of the parameter setup tiles varies with the chosen ventilation mode as indicated in the following table VENTILATION MODE STANDBY CMV PCV SIMV PS MANUAL Tile 1 Blank Vi TARGET Vi Blank Blank Tile 2 Blank Freq Freq Freq Freqmin Blank Tile 3 Blank I E 1 E Tinsp Blank Blank Tile 44 Blank Tp Blank Tp Blank Blank Tile 5 Blank PEEP PEEP PEEP PEEP Blank Tile 6 Blank Blank Blank AP AP Blank Tile 7 Blank Blank Blank Trigger Trigger Blank Tile 8 Blank Blank TsLope TsLopE TsLoPE ALARM a Vr Tidal Volume The Vy unit of measure is ml and it has separate default settings for the Adult and Chi
56. entilation SIMV SIMV mode provides Synchronized Intermittent Mandatory Ventilation SIMV to the patient as well as the capability for Pressure Supported PS spontaneous breathing between needed mandatory breaths SIMV in the AS3000 is a volume mode where the user can set the tidal volume frequency inspiratory pause PEEP and inspiratory time Mandatory breaths are synchronized with the patient s inspiratory effort NOTE The PS Pressure Support function within SIMV operates as described in the next section SIMV mode enables the patient to breath spontaneously with or without pressure support between mandatory breaths If no inspiratory effort is detected the AS3000 delivers a mandatory breath per the set rate H SIMV Rate _______________ setting Tinsp mn Texp setting calculated Inspiration Start Expiration Start MV Inspiration Watch Trigger e me Expiration Watch Watch Breath detection phase PS active trigger simycycle bmp Monitor exhalation of manditory breath Settling time idle FIGURE 2 12 Typical SIMV Waveform Definitions TRIGGER METHOD FLOW TRIGGERED Ventilation end start of breath Expiratory flow reaches a threshold value near O detection phase SIMV breath trigger window 25 of expiration time Pressure support end Inspiratory flow reaches 25 of the maximum value Timeout after 3 seconds Set pressure support target The set t
57. erating personnel not being aware of drastic changes in the patients condition This machine must only be operated by trained skilled medical staff Connection of equipment to the auxiliary mains socket outlet s may increase the leakage currents to values exceeding the allowable limits Electric shock and fire hazard Do not clean the machine while it is on and or plugged in Disconnect the power plug from the mains supply before removing the rear panels or servicing the AS3000 unit vi 0070 10 0684 01 AS3000 Operating Instructions Warnings Introduction WARNING Independent means of ventilation e g a self inflating manually powered resuscitator with mask must be available whenever the AS3000 is in use WARNING Malfunction of the central gas supply system may cause more than one or even all devices connected to it to stop their operation simultaneously WARNING The anesthesia system will cease to deliver gas at pressures below the minimum specified gas pipeline supply pressure WARNING Use a cleaning and disinfection schedule that conforms to your institution s disinfection and risk management policies Refer to the material safety data as applicable e Refer to the operation and maintenance manuals of all disinfection equipment Do not inhale fumes that may result from any disinfection process WARNING Use extreme care while handling the absorbent as it is a caustic irritant WARNING Use car
58. esired first disconnect the oxygen sensor external cable as shown in FIGURE 3 12 Then grasp the oxygen sensor and lift it away from the absorber block as shown in FIGURE 3 13 FIGURE 3 12 Oxygen Sensor External FIGURE 3 13 Oxygen Sensor Removal Cable Removal CAUTION Never immerse the oxygen sensor or its connector in any type of liquid e Dispose of the oxygen sensor per the manufacturer s specification CAUTION Do not wash the inner surface of the oxygen sensor CAUTION Do not autoclave the oxygen sensor 2 Clean the oxygen sensor exterior with a soft lintfree cloth and a mild detergent and water solution Allow to dry thoroughly o Inspect the oxygen sensor for damage and replace as necessary gt Re insert the oxygen sensor if it had been removed AS3000 Operating Instructions 0070 10 0684 01 3 11 Cleaning and Disinfection User Maintenance 3 1 6 APL Valve 1 Loosen the APL valve at its base by turning it counterclockwise and then remove the APL valve as shown in FIGURE 3 14 APL Valve Base FIGURE 3 14 APL Valve Removal 2 Cleaning a Clean the APL valve with a soft lint free cloth and a solution of mild detergent and water Allow it to dry thoroughly b If disinfecting the APL valve continue with step 3 otherwise skip to step 4 3 Disinfection NOTE Ensure that the APL valve has been cleaned as described in step 2 before disinfecting Using an FDA cleared Gluteraldehyde disi
59. ess menu tabs and switch between manual and mechanical ventilation The following figure is an example of the User Interface with the display during system power up Keypad Area ALARM UMTS AS 3000 MENU Display Navigator Knob FIGURE 1 2 Example of the User Interface with the display during system power up 0070 10 0684 01 AS3000 Operating Instructions Product Description User Interface 1 4 1 Display FIGURE 1 3 and the descriptions that follow provide an overview of the Display Alarm Message Date and Power Patient Area Time Source Type Tile Ventilation Mie 3 4 5 MODE Tile Icon Area Alarm Message 1 120 sec DN Alarm Message 2 Paw cmH 0 Pressure Ma MA R w L min Volume oe ee omi 7 y e T Waveform FiO2 i Parameter Area Area Message prompts appear here line 1 wala prompts appear here line 2 Freq Tinsp PEEP Trigger TSLOPE cmH70 L min User Message Area 10 Parameter Setup Tiles FIGURE 1 3 Display 1 Alarm Icon Area When any parameter enters an alarm state an Alarm Icon 1 is displayed in this area Pressing the MUTE key displays an Alarm Mute Icon EX in this area with a 120 second countdown timer See item 4 in section 1 4 2 for a complete description of the MUTE key 2 Alarm Message Area Technical messages and functional alarm messages are displayed in this area See sections 2 12 3 1
60. essure pneumatic safety valve Manual pressure control APL Valve Fresh Gas Compensation Compliance test Leak tests Oxygen monitor per ISO 21647 2004 Pressure monitor 0070 10 0684 01 Product Specifications Off 3 30 cmH20 3 12 cmH2O 2 cmH20 13 17 cmH2O 3 cmH20 18 24 cmH 0O 6 cmH20 25 30 cmH2O 12 cmH20 PMAX in CMV and SIMV modes is equal to High Airway Pressure alarm setting PEEP 5 cmH20 70 cmH20 PCV mode only 5 29 cmH2O 3 cmH20 30 70 cmH 20 7 cmH20 0 2 5 0 sec 10 or 0 1 whichever is greater SIMV mode only 1 15 l min 1 3 l min SIMV and PS modes only 3 50 cmH20 PS and SIMV modes only Child 3 50 3 cmH20 Adult 3 35 3 cmH20 36 50 12 cmH20 O 2 sec 1 0 sec PCV SIMV and PS modes only 2 60 bpm 1 bpm PS mode only 80 cmH2O 10 cmH20 0 70 cmH20 Automatic Automatic after confirmation Automatic after confirmation Type Galvanic Fuel cell FiO display O 100 vol O resolution 1 response time 80 less than 10 sec Real time graphics waveform Numerical pressure values for PEEP Pmean Ppeak Pplateau Pressure range 20 to 99 cmH0 AS3000 Operating Instructions Product Specifications Anesthetic Gas Scavenging System Low Flow Resolution 1 cmH O Volume monitor Real time graphics waveform Numerical values for Tidal volumes breathing frequency minute
61. essure Differential Pressure 0070 10 0684 01 Glossary of Terms Glossary SIMV TinsP Tp TsLoPE Trigger VOI Vr WDT Synchronized Intermittent Mandatory Ventilation Inspiratory Time Inspiratory Pause Time Inspiratory Slope Time Flow Trigger Oxygen Consumption Index Tidal Volume Watch Dog Timer 0070 10 0684 01 AS3000 Operating Instructions Glossary Glossary of Terms This page intentionally left blank AS3000 Operating Instructions 0070 10 0684 01 6 3 0070 10 0684 01 Rev H October 07 2010 Mindray DS USA Inc 800 MacArthur Boulevard e Mahwah NJ 07430 e USA e Dom Customer Service 1 800 288 2121 e Intl Customer Service 1 201 995 8000 e Dom Fax 1 800 926 4275 e Intl Fax 1 201 995 8680 e www mindray com Mindray Medical Netherlands B V e PO Box 26 e 3870 CA Hoevelaken e The Netherlands e Tel 31 33 25 44 911 e Fax 31 33 25 37 621 Mindray UK Limited e 3 Percy Road St John s Park e Huntingdon e Cambridgeshire PE29 6SZ e United Kingdom Tel 01480 416840 Fax 01480 436588 Mindray Medical France SARL e Europarc Cr teil 123 Chemin des Bassins 94035 Cr teil Cedex e France Tel 0 1 45 13 91 50 e Fax 0 1 45 13 91 51 Mindray Medical German GmbH Zwischen den Bdchen 4 e 64625 Bensheim Germany Tel 49 6251 17524 0 e Fax 49 6251 17524 20 Mindray Medical International Ltd 2813 Office Tower Convention Plaza No 1 Harbour Road e Wanchai e Hong Kon
62. essure The Pressure parameter group consists of 3 parameters e Airway Peak Pressure PEAK e Plateau Pressure PLAT or Mean Pressure MEAN e Positive End Expiratory Pressure PEEP The unit of measure for these parameters is emH20 If data is over range an up arrow f is displayed If data is under range a down arrow y is displayed NOTE The high alarm limit for Airway Peak Pressure PEAK is displayed to the top right of the reading The low alarm limit for Airway Peak Pressure PEAK is displayed to the bottom right of the reading NOTE The display of either Plateau Pressure PLAT or Mean Pressure MEAN is configured from the System menu tab The associated Pressure vs Time and Flow vs Time waveforms are displayed together in the Waveform Area Paw cmH 0 FIGURE 2 14 Example Pressure vs Time and Flow vs Time Waveforms 0070 10 0684 01 AS3000 Operating Instructions Operations Parameter Monitoring Pressure vs Time The Y axis of the Pressure vs Time waveform is labeled Paw which represents Airway Pressure The unit of measure is emH O and depending on the size of the pressure signal the Y axis will automatically adjust to one of the following 3 scales e Oto 10 in increments of 5 e Oto 30 in increments of 10 e 0 to 80 in increments of 20 Though the X axis is not labeled it represents a time scale of O to 15 seconds NOTE Peak pressure readings that are greater than 80 cmH 0 will be cli
63. essure hold gt 50 psig Shut off flow control valves a Connect the breathing circuit to the corresponding ports on the breathing system b Connect the manual ventilation bag to the bag arm 11 Verify that unidirectional valves are present in each limb 12 Power up the system as described in section 2 6 and follow the on screen prompts to perform the Leak Test and the Compliance Test 13 Test flowmeters a Check that all floats are at bottom of tube with flow control valves closed b Adjust flow of all gases through their full range and check for erratic movements of floats 14 Test Hypoxic Guard System a Attempt to create hypoxic O2 N2O mixture by opening the N20 flow control valve completely b Increase the O flow and observe O and N20 rise in proportion to maintain a minimum concentration of 21 Og in fresh gas 15 Test O supply gas pressure failure system a Set O2 N20 and Air gas flows to mid range b Ensure that the O gas cylinder is closed c Disconnect the O supply from the AS3000 d Verify that all flows except Air fall to zero 2 4 0070 10 0684 01 AS3000 Operating Instructions Operations P e Preoperative Checkout Verify that e an alarm tone sounds e the alarm message AN III o2 Supply Failure is displayed in red text Open the O gas cylinder Verify that the alarm tone stops and the alarm message is removed from the display Close all gas cylinders and bleed piping p
64. essure is less than 1000 psig c Close O cylinder and observe gauge for evidence of high pressure leak d With the O flush valve flush to empty the piping AS3000 Operating Instructions 0070 10 0684 01 2 3 Preoperative Checkout Operations 7 Check nitrous oxide N20 cylinder supply a Disconnect pipeline supply if connected and return cylinder and pipeline pressure gauges to zero with the flow control knob b Open N20 cylinder check pressure A typical full cylinder pressure is 745 psig Replace the cylinder if its pressure is less than 600 psig c Close N20 cylinder and observe gauge for evidence of high pressure leak 8 Check Air cylinder supply a Disconnect pipeline supply if connected and return cylinder and pipeline pressure gauges to zero with the flow control knob b Open Air cylinder check pressure A typical full cylinder pressure is 1900 psig Replace the cylinder if its pressure is less than 1000 psig c Close Air cylinder and observe gauge for evidence of high pressure leak 9 Test Central Pipeline Gas Supplies a Inspect supply hoses should not be cracked or worn b c Adjust both Oz and N20 flows to at least mid range d e f Adjust the AIR flow to at least mid range El h 10 Connect Accessories Connect supply hoses verifying correct color coding Verify that the O2 and N20 supply pressures hold gt 50 psig Shut off flow control valves Verify that the AIR supply pr
65. est the CMV ventilation mode a Activate the CMV ventilation mode b Set attributes as follows ATTRIBUTE SETTING Patient Size Adult Vr 600 Freq 8 I E 1 2 PEEP Off Tp 10 Op Flow 2 Liters minute c Verify that the displayed Tidal Volume is within 15 of the set value within 5 breaths d Verify that the O display reads greater than 94 within 5 minutes 19 Test the PCV ventilation mode a Activate the PCV ventilation mode b Set attributes as follows ATTRIBUTE SETTING Patient Size Adult PTARGET 20 Freq 8 I E 1 2 PEEP Off TsLopE 0 5 O Flow 2 Liters minute c Verify that the PEAK pressure settles within 20 of the set value within 5 breaths d Re activate the CMV ventilation mode 20 Low FiO Alarm Test a Press the ALARM LIMITS key b Set the Low FiO alarm limit to be higher than the current FiO reading c Verify that e an alarm tone sounds e the alarm message AN IIl Low FiO2 is displayed in red text d Set the Low FiO alarm limit back to 18 2 6 0070 10 0684 01 AS3000 Operating Instructions Operations Preoperative Checkout 21 High and Low PAW Alarm Test a Set the High PAW alarm limit to be below the current PEAK pressure reading b Verify that e an alarm tone sounds e the alarm message N 111 High Airway Pressure is displayed in red text after several breaths e expiration begins when the pressure limit is reached c Set the
66. f the patient s pulmonary status Open the Spirometry Loop Window by pressing the SPIROMETRY key NOTE Pressing the NORMAL SCREEN key at any time while the Spirometry Loop Window is open will close the Spirometry Loop Window There are two 2 Spirometry loop display configurations that can be accessed Pressure Volume and Flow Volume By default the Pressure Volume loop is displayed with the first press of the SPIROMETRY key The second key press displays the Flow Volume loop After both configurations have been cycled through the display a third key press returns the display to the Normal Screen When the Spirometry Loop Window opens the user may elect to store a reference loop by navigating to the Save Reference button which will be highlighted Pressing the Navigator Knob will then save the currently plotting loop as a reference loop in a different color NOTE Only one reference loop can be saved Pressure Volume Spirometry Loop FIGURE 2 15 is an example of the Pressure Volume loop r 7 Pressure Volume 80 PAW cmH20 Press NORMAL SCREEN to Exit Save Reference FIGURE 2 15 Example Pressure Volume Loop 0070 10 0684 01 AS3000 Operating Instructions Operations Parameter Monitoring The Y axis of the Pressure Volume Spirometry loop represents Volume The unit of measure is ml and its scale is O to 1500 in increments of 250 The X axis is labeled Paw which represents Airway Pressure The unit
67. fied personnel AS3000 Operating Instructions 0070 10 0684 01 vii Introduction Warnings WARNING To avoid tip hazards use care when moving the AS3000 up or down inclines around corners and across thresholds Remove all monitoring equipment mounted to the side of the AS3000 prior to transport Do not attempt to roll the AS3000 over hoses cords or other obstacles WARNING Remove all equipment from the top shelf of the AS3000 before moving WARNING Do not remove the absorber canister while the ventilator is running in an automatic ventilation mode This should only be done in STANDBY mode with no patient connected viii 0070 10 0684 01 AS3000 Operating Instructions Cautions Introduction Cautions CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION Perform the daily checks specified on the checklist and in case of a fault do not operate the system until the fault has been corrected Before starting the machine users must be familiar with the information contained in these Operating Instructions and must have been trained by an authorized representative If the machine does not function as described it must be examined and repaired as necessary by qualified service personnel before being returned to use Handle the machine with care to prevent
68. g Tel 852 2793 5596 e Fax 852 2344 8824 0002 08 8918
69. g the Time 1 Rotate the Navigator Knob until Edit Time is highlighted and press the knob to access the Edit Time sub menu 2 Rotate and press the Navigator Knob as necessary to adjust the time and set the format to either 12 Hour or 24 Hour NOTE The default format is 12 Hour and the adjustable parameters are hours and minutes 3 Select Done to save the time adjustments and return to the System menu tab 0070 10 0684 01 AS3000 Operating Instructions Operations 2 8 Vaporizer Installation Vaporizer Installation WARNING Use care in lifting and manipulating vaporizers during the mounting process as their weight may be greater than expected based on their size and shape 1 Align the vaporizer over the valve cartridges of the mounting bar Hang the vaporizer on the mounting bar as shown in FIGURE 2 1 Note that the locking mechanism handle is in the unlocked position Locking Mechanism Handle in the Unlocked Position Sevoflurane Orinar vas E Wa y FIGURE 2 1 Vaporizer Unlocked 2 Rotate the locking mechanism handle clockwise into the locked position as shown in FIGURE 2 2 Locking Mechanism Handle in the Locked Position FIGURE 2 2 Vaporizer Locked AS3000 Operating Instructions 0070 10 0684 01 2 11 Oxygen Sensor Calibration Operations 2 9 Oxygen Sensor Calibration NOTE Oxygen Sensor Calibration can be performed in all ventilation modes 1 Allow the breathing syste
70. ge as shown in FIGURE 3 11 we i FIGURE 3 11 Valve Disc Removal AS3000 Operating Instructions 0070 10 0684 01 3 9 Cleaning and Disinfection User Maintenance 5 Cleaning a Wash each component using a mild detergent and water solution b Rinse with clean hot water and allow to dry c After all components are completely dry verify that the valve disc and the prongs of the valve cage are undamaged before disinfection or re assembly and functional testing d If disinfecting the valve components continue with step 6 otherwise skip to step 7 6 Disinfection NOTE Ensure that all valve components have been cleaned as described in step 5 before disinfecting Using an FDA cleared Gluteraldehyde disinfection solution follow the manufacturer s instructions for high level disinfection and rinsing of all valve components while adhering to facility policies and procedures 7 Reassemble the valve components in the reverse order noting any previously stated CAUTION Prior to use after cleaning or disinfecting power up the system as described in section 2 6 and follow the on screen prompts to perform the Leak Test and the Compliance Test 0070 10 0684 01 AS3000 Operating Instructions User Maintenance Cleaning and Disinfection 3 1 5 Oxygen Sensor 1 The oxygen sensor is a component that is pressed into position for use It is not necessary to remove this component to clean it However if removal is d
71. hieve the best performance the patient hoses used during startup testing of compliance should match the hoses to be used during the procedure Note that in certain cases when the ventilator is operating near its performance limits compliance compensation will not be possible When the AS3000 s performance limit is reached it will not be possible to increment the frequency setting or the tidal volume setting and the message Ventilator setting is not possible will be displayed in the user message area See section 1 4 User Interface for detailed selection procedures and for the ranges and default values for the parameters of CMV mode ventilation To change any parameter during CMV mode ventilation rotate the Navigator Knob to the correct tile press the knob to select that parameter rotate the knob to change the parameter as desired and then press the knob to confirm the new selected value Note that if the measured breathing pressure exceeds the Paw high alarm limit value the ventilator will cycle to expiration to relieve that pressure Pressure cmH20 Peak pressure Plateau pressure PEEP Inspiration time Expiration time Time s FIGURE 2 10 Typical CMV Waveform 2 16 0070 10 0684 01 AS3000 Operating Instructions Operations Ventilation Modes 2 10 3 1 CMV Parameter Settings User Adjustable Parameters for CMV Vr Tidal Volume LE Ratio of Inspiratory Time to Expiratory Time Freq Frequency Tp I
72. hin the anesthesia system will be free from defects in workmanship and materials for the number of years shown on the invoice Under this extended warranty Mindray DS USA Inc will repair or replace any defective component at no charge for labor and or materials This extended warranty does not cover consumable items such as but not limited to batteries and external cables Recommended preventative maintenance as prescribed in the Service Manual is the responsibility of the user and is not covered by this warranty Except as otherwise provided herein the terms conditions and limitations of Mindray DS USA Inc s standard warranty will remain in effect Mindray DS USA Inc warrants that its products will be free from defects in workmanship and materials for a period of one 1 year from the date of purchase except that disposable or one time use products are warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use whichever is sooner This warranty does not cover consumable items such as but not limited to batteries external cables sensors cuffs hoses or mounts Mindray DS USA Inc will not be liable for any incidental special or consequential loss damage or expense directly or indirectly arising from the use of its products liability under this warranty and the buyer s exclusive remedy under this warranty is limited to servicing or replacing
73. ibed in section 2 6 and follow the on screen prompts to perform the Leak Test and the Compliance Test The PAW gauge and oxygen sensor cannot withstand immersion or the heat and pressure of autoclaving When installing absorber Pre Paks assure the bottom of the Pre Pak rests on the top of the gasket inside the absorber canister Users should monitor oxygen percentage O2 when using the Auxiliary O2 AIR Flow Meters Unknown oxygen concentrations may be delivered to the patient unless oxygen monitoring is used Verify that the bellows is fully inflated before starting an automatic ventilation mode on the patient If the bellows is deflated and at the bottom of its travel at the start of an automatic ventilation mode the bellows may become deformed 0070 10 0684 01 AS3000 Operating Instructions Notes Introduction Notes NOTE The AS3000 is intended to be operated with its integral Breathing Pressure monitoring in use NOTE The AS3000 is intended to be operated with its integral Breathing Pressure limitation devices in use NOTE The AS3000 is intended to be operated with its integral Exhaled Volume monitoring in use NOTE The AS3000 is intended to be operated with its integral Breathing System integrity Alarm System in use NOTE The AS3000 is intended to be operated with its integral Continuing Pressure Alarm in use NOTE The AS3000 is intended to be operated with its integral O monitoring in use NOTE The AS30
74. ions Calibration may be performed without the need to disassemble the instrument It is the responsibility of the purchaser to perform calibration as necessary in accordance with the instructions provided in this manual Disclaimers Product Improvements Mindray DS USA Inc retains the right to modify the machine and or operating instructions without prior notification These operating instructions explain all features of the AS3000 system and are correct at time of manufacture Instructions and models produced at a later stage may contain improvements or modifications that were not included in previous models Phone Numbers and How To Get Assistance A network of service representatives and factory trained distributors is available Prior to requesting service perform a complete operational check of the instrument to verify proper control settings If operational problems continue to exist contact the Service Department at 800 288 2121 ext 8116 for Technical Support or 201 995 7875 for assistance in determining the nearest field service location Please include the instrument model number the serial number and a description of the problem with all requests for service Warranty questions should be directed to a local representative A list of offices along with their phone numbers is provided at the end of this manual NOTE Upon request calibration instructions or other information will be provided to assist the u
75. itions TRIGGER METHOD FLOW TRIGGERED PEEP setting PEEP is at least 5 cmH2O below target pressure Inspiratory flow setting The user sets the time Ts opg required to reach the set AP The ventilator regulates the inspiratory flow to match the Ts opg time set by the user Inspiratory time The set Tsiope time will not be greater than the time resulting from the set I E ratio and frequency In case of conflict the set LE ratio and frequency will override the set Ts opg time 2 18 0070 10 0684 01 AS3000 Operating Instructions Operations Ventilation Modes 2 10 4 1 PCV Parameter Settings User Adjustable Parameters for PCV Prarcet Target Pressure LE Ratio of Inspiratory Time to Expiratory Time Freq Frequency Tstope Inspiratory Slope PEEP Positive End Expiratory Pressure Ranges and Delivery Accuracy for PCV ADULT CHILD DELIVERY ACCURACY Prarcer emH20 5 70 20 5 70 10 5 29 3 cmH 20 30 70 7 cmH20 LE 4 1 1 5 1 2 4 1 1 5 1 2 Times of phases is 35 Freq bpm 4 60 8 4 60 20 1 TsLopE sec O 2 0 5 O 2 0 5 1 0 sec PEEP cmH20 Off 3 30 Off Off 3 30 Off 3 12 cmH2O 2 cmH20 13 17 cmH20 3 cmH 0 18 24 cmH20O 6 cmH20 25 30 cmH9O 12 cmH 0 Defaults appear in parenthesis in bold text AS3000 Operating Instructions 0070 10 0684 01 2 19 Ventilation Modes Operations 2 10 5 Synchronized Intermittent Mandatory V
76. l Hose Tall Bag Expiration Inspiration Arm Valve Valve FIGURE 3 7 Location of Expiration and Inspiration Valves AS3000 Operating Instructions 0070 10 0684 01 3 7 Cleaning and Disinfection User Maintenance 1 Turning it counterclockwise loosen and remove the valve retaining ring as shown in FIGURE 3 8 Valve Retaining Ring FIGURE 3 8 Valve Retaining Ring Removal 2 Remove the valve dome as shown in FIGURE 3 9 ensuring that the valve o ring also shown remains seated Valve O ring FIGURE 3 9 Valve Dome Removal CAUTION The valve disc is fragile and must therefore be handled with care while removing the valve cage from the valve assembly 3 8 0070 10 0684 01 AS3000 Operating Instructions User Maintenance Cleaning and Disinfection 3 The valve cage will be removed in this step refer to FIGURE 3 10 The six prongs of the valve cage have tabs that secure it in the valve assembly While noting the previous CAUTION use two hands to remove the valve cage by gently manipulating the prongs to release the tabs As the valve cage is lifted away from the assembly ensure that the valve disc does not fall out Valve Cage Prong with securing tab Valve Disc Ridge that secures the Valve Cage FIGURE 3 10 Valve Cage Removal CAUTION The valve disc is fragile and must therefore be handled with care while removing it from the valve cage 4 Remove the valve disc from the valve ca
77. ld patient types e The range of settings for the Adult patient type is 40 to 1400 ml in increments of 10 ml and its default is 600 ml e The range of settings for the Child patient type is 40 to 1400 ml in increments of 10 ml and its default is 120 ml NOTE This parameter is available in the CMV and SIMV with PS ventilation modes b Freq Frequency The Freq unit of measure is bpm It has separate default settings for the Adult and Child patient types that vary depending on the chosen ventilation mode as follows CMV and PCV e The range of settings for the Adult patient type is 4 to 60 bpm in increments of 1 bpm and its default is 8 bpm e The range of settings for the Child patient type is 4 to 60 bpm in increments of 1 bpm and its default is 20 bpm SIMV with PS e The range of settings for the Adult patient type is 2 to 60 bpm in increments of 1 bpm and its default is 4 bpm e The range of settings for the Child patient type is 2 to 60 bpm in increments of 1 bpm and its default is 4 bpm 1 10 0070 10 0684 01 AS3000 Operating Instructions Product Description User Interface c kE Ratio of Inspiratory Time to Expiratory Time The IE ratio does not have a unit of measure The range of settings for both the Adult and Child patient types is 4 1 to 1 5 in increments of 0 5 and its default is 1 2 NOTE This parameter is available in the CMV and PCV ventilation modes d Tinsp Inspiratory Time The
78. lectromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the AS3000 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the AS3000 as recommended below according to the maximum output power of the communications equipment RATED MAXIMUM OUTPUT POWER P OF TRANSMITTER SEPARATION DISTANCE d IN METERS m ACCORDING IN WATTS W TO FREQUENCY OF TRANSMITTER 150 kHz to 80 MHz to 800 MHz to 80 MHz 800 MHz 2 5 GHz d 1 2x JP d 1 2x JP d 2 3x JP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 0070 10 0684 01 AS3000 Operating Instructions Product Specifications Warranty Statements 5 14 Warranty Statements Mindray DS USA Inc warrants that components wit
79. lectromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the gt vicinity of equipment marked with the following symbol NOTE NOTE At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted the oretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an elec tromagnetic site survey should be considered If the measured field strength in the location in which the AS3000 is used exceeds the applicable RF compliance level above the AS3000 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the AS3000 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m AS3000 Operating Instructions 0070 10 0684 01 Electromagnetic Capability Product Specifications TABLE 5 4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE AS3000 The AS3000 is intended for use in an e
80. ly e Patient suction regulator AS3000 Operating Instructions 0070 10 0684 01 Initial Setup Operations 2 3 Initial Setup The following steps must be carried out upon initial assembly or in any instance which requires disassembly of any gas machine part s 1 Position the machine in a location that enables the operating controls ventilator display and flowmeter tubes to be within easy reach 2 Set the brakes on the casters 3 Connect the gas supply by plugging the hose connectors into the gas supply sockets Verify that the pressure of the gas supply is within the specifications of the machine 4 Mount the user interface to its mounting arm and connect the cable 5 If the breathing system has not yet been connected to the machine a Remove the transportation cover if attached b Install the side bracket c Install the breathing system onto the side bracket 6 Install the CO absorber canisters 7 Connect the manual ventilation bag to the bag arm on the breathing system 8 Connect a patient breathing circuit to the inspiratory and expiratory connections 9 Connect the waste gas hose between the bottom of the breathing system and the top of the gas scavenging system 10 Connect the hose from the gas scavenger to the operating room s EVAC connector 11 Connect the fresh gas hose between the bottom of the breathing system and the CGO Common Gas Outlet on the side of the machine 12 Connect the heate
81. ly and renders the system non operational Contact technical support 0070 10 0684 01 AS3000 Operating Instructions Alarms MESSAGE PRIORITY REASON S SOLUTION S O Supply Failure High O gas pressure is If this alarm occurs lower than 29 1 psi during startup the leak 15 for more than test is bypassed and the 0 5 seconds system is placed in STANDBY ventilation mode Contact technical support Check the O supply line and the O cylinder Replace the O2 cylinder if necessary Power Fail Low The main AC power Ensure that the AC has failed power cord is connected to the receptacle Check NOTE The system the main power supply automatically and fuses Replace fuses switches to battery as necessary Contact power to provide technical support if the approximately 45 problem is not resolved minutes of run time Low Battery Medium During battery Resume AC power operation the battery operation immediately voltage decreases Manually ventilate the below 22 Volts patient Ensure that the battery remains fully NOTE When this charged at all times alarm occurs there are only 10 minutes remaining until the system shuts down Op Sensor Failure High The O sensor cable Ensure that the O sensor This alarm can occur during is disconnected or the is properly connected at startup or normal operation O sensor has failed both ends Replace the O sensor if it has failed If this alarm occurs d
82. m to warm up and reach thermal equilibrium approximately 30 60 minutes 2 Press the MENU key and then use the Navigator Knob to scroll to the Calibrate menu tab shown in FIGURE 2 3 Select the Start Calibration button Oxygen Sensor Start Calibration Press MENU Key to Exit FIGURE 2 3 Calibrate Menu Tab 3 After the Start Calibration button has been selected the screen shown in FIGURE 2 4 or FIGURE 2 6 will be displayed instructing the user to remove the oxygen sensor item 5 FIGURE 1 8 from the breathing system and expose it to room air for at least three minutes before proceeding The O sensor voltage is displayed during the calibration This is the amplified O cell voltage at the A D converter for the oxygen sensor NOTE The O sensor voltage is not displayed for UI versions 2 24 and lower 4 Flush the O sensor with air from the auxiliary output for 5 10 seconds to ensure that no O bubbles are trapped in the sensor NOTE Do not shake the O sensor during calibration NOTE Keep the O sensor in a vertical position connector side up during calibration NOTE Place the O sensor on top of the heated block during calibration to minimize the temperature difference from within the heated block NOTE If the system is going to be used during the calibration insert the O cell plug item 6 FIGURE 1 8 into the port from which the oxygen sensor was removed using a push and turn motion 0070 10 0684 01 AS
83. mH 0 2 cmH 0 13 17 cmH20 3 cmH20 18 24 cmH20O 6 cmH 0 25 30 cmH9O 12 cmH 0 Defaults appear in parenthesis in bold text AS3000 Operating Instructions 0070 10 0684 01 2 21 Ventilation Modes Operations 2 10 6 Pressure Support PS In Pressure Support PS mode the patient s effort is supported by the AS3000 at a preset level of inspiratory pressure Inspiration is triggered and cycled by patient effort The user can set the Trigger flow Pressure Support level PEEP minimum allowed breathing frequency and Slope Time If the Freq min is violated he AS3000 will give an Apnea Ventilation breath to assure ventilation is occurring Trigger indicator Trigger indicator Pressure Apnea ventilation i Time s 1 Tslope 1 Freq min l l I l 1 1 Freq mN _ l I I I i I Time s a Flow trigger Flow trigger No trigger FIGURE 2 13 Typical PS Waveforms Definitions TRIGGER METHOD FLOW TRIGGERED Pressure support end Inspiratory flow reaches 25 of the maximum value Timeout after 3 seconds Ventilation end start of breath Expiratory flow reaches a threshold value near O detection phase Set pressure support target The set target pressure for the pressure support is a differential pressure pressure value AP What kind of Apnea backup The Freqmin parameter in PS mode can be set by the user to should be use
84. n and collect any water that may have gathered Turn the valve to the Close position and discard the water Drain Valve After draining Close the valve E Absorber Drain FIGURE 3 18 Absorber Drain Valve Close Up View AS3000 Operating Instructions 0070 10 0684 01 3 15 Cleaning and Disinfection User Maintenance WARNING Use extreme care while handling the absorbent as it is a caustic irritant 3 Rotate the locking mechanism handle counterclockwise into the unlocked position as shown in FIGURE 3 19 This separates the absorber canisters from the top of the assembly While noting the previous WARNING remove the absorber canisters Then remove the pre pak or loose fill absorbent from the canisters Dispose of the absorbent per the manufacturer s specification i Absorber Canisters EE Locking Mechanism Handle in the Unlocked Position FIGURE 3 19 Absorber Canisters Unlocked 4 Cleaning a Clean the absorber canisters with a soft lint free cloth and a solution of mild detergent and water Allow them to dry thoroughly b If disinfecting the Absorber Canisters continue with step 5 otherwise skip to step 6 5 Disinfection NOTE Ensure that the Absorber Canisters have been cleaned as described in step 4 before disinfecting Using an FDA cleared Gluteraldehyde disinfection solution follow the manufacturer s instructions for high level disinfection and rinsing of the Absorber Canisters while
85. nds a time out will occur causing the display to revert back to the previous mode and its associated parameters 7 Waveform Area One of the following three waveform configurations will be displayed in this area e Pressure vs Time and Flow vs Time waveforms see the example in FIGURE 2 14 e Pressure Volume Spirometry Loop see the example in FIGURE 2 15 e Flow Volume Spirometry Loop see the example in FIGURE 2 16 The default waveform configuration is Pressure vs Time and Flow vs Time NOTE When in STANDBY ventilation mode the X and Y axes for Pressure vs Time and Flow vs Time are displayed but the waveforms are inactive 8 Parameter Area Patient parameters are displayed in this area in the following 3 parameter groups e Pressure see section 2 11 1 e Volume see section 2 11 2 e FiO Inspired O3 see section 2 11 3 9 User Message Area The following user messages are displayed in this area MESSAGE REASON Displayed parameter values are for the The ventilation MODE tile is flashing pending mode Ventilator setting is not possible The attempted parameter setting is not possible Pressure Volume and Apnea Alarms are Alarms have been turned off in MANUAL mode OFF Automatic Ventilation not available During the initial power up System Self Test failures have been encountered with the PEEP valve Inspiratory sensor or Inspiratory valve Current ventilation mode is xxx Indicates the curr
86. nductive breathing tubes when utilizing high frequency electric surgery equipment may cause burns and is therefore not recommended in any application of this machine Possible fire hazard Fuses i e additional sockets must only be replaced by fuses of the same type and with the same rating Possible electric shock hazard The machine may only be opened by authorized service personnel Do not use a broken unit or accessory Periodically check all cables e g AC line cord and patient connection cables for damage that may occur through normal use Replace cable if damaged in any way Compressed gasses are considered Dangerous Goods Hazardous Materials per 1 A T A and D O T regulations It is a violation of federal and international law to offer any package or over pack of dangerous goods for transportation without the package being appropriately identified packed marked classified labeled and documented according to D O T and I A T A regulations Please refer to the applicable 1 A T A Dangerous Goods Regulations and or the Code of Federal Regulations 49 Transportation Parts 171 180 for further information The patient should be visually monitored by qualified personnel In certain situations life threatening circumstances may occur which may not necessarily trigger an alarm Always set the alarm limits so that the alarm is triggered before a hazardous situation occurs Incorrectly set alarm limits may result in op
87. nfection solution follow the manufacturer s instructions for high level disinfection and rinsing of the APL valve while adhering to facility policies and procedures 4 Replace the APL valve by turning its base clockwise until it is securely tightened Prior to use after cleaning or disinfecting power up the system as described in section 2 6 and follow the on screen prompts to perform the Leak Test and the Compliance Test 3 12 0070 10 0684 01 AS3000 Operating Instructions User Maintenance Cleaning and Disinfection 3 1 7 PAW Gauge 1 The PAW gauge is a component that is pressed into position for use It is not necessary to remove this component to clean it However if removal is desired simply grasp it and lift it away from the absorber block as shown in FIGURE 3 15 PAW Gauge FIGURE 3 15 PAW Gauge Removal CAUTION The PAW gauge and oxygen sensor cannot withstand immersion or the heat and pressure of autoclaving 2 Clean the PAW gauge with a soft lint free cloth and a mild detergent and water solution Allow it to dry thoroughly 3 Re insert the PAW gauge if it was removed Prior to use after cleaning or disinfecting power up the system as described in section 2 6 and follow the on screen prompts to perform the Leak Test and the Compliance Test AS3000 Operating Instructions 0070 10 0684 01 3 13 Cleaning and Disinfection User Maintenance 3 1 8 Bag Arm 1 Turning it counterclockwise loosen the bag arm
88. nspiratory Pause PEEP Positive End Expiratory Pressure Ranges and Delivery Accuracy for CMV ADULT CHILD DELIVERY ACCURACY Vr mh 40 1400 600 40 1400 Adult 15 or at least 50 ml 120 Child 15 or at least 16 ml LE 4 1 1 5 1 2 4 1 1 5 1 2 Times of phases is 35 Freq bpm 4 60 8 4 60 20 Tp Off 5 60 10 Off 5 60 10 30 PEEP cmH20 Off 3 30 Off Off 3 30 Off 3 12 cmH2O 2 cmH20 13 17 cmH20O 3 cmH 0 18 24 cmH 0 6 cmH20 25 30 cmH9O 12 cmH 0 Defaults appear in parenthesis in bold text AS3000 Operating Instructions 0070 10 0684 01 2 17 Ventilation Modes Operations 2 10 4 Pressure Controlled Ventilation PCV PCV mode is used to provide Pressure Controlled Ventilation PCV to the patient In PCV the patient receives breaths with a fixed pressure limit and frequency A continuous pressure is presented to the patient s airway during the inspiratory time Tinsp The rise time of the pressure waveform is controlled by the setting of TsLope TsLopE i Inspiration f e a NSS l Expiration e y Pressure 1 i i i i i i i i i i i 1 i 4 i 1 i i i 1 1 1 1 1 1 i i 1 i 1 i i 1 i i i 1 i i i i i 1 i i So i wt was oo AA n i 1 T 1 1 1 1 1 1 Decelerating Flow Flow Volume FIGURE 2 11 Typical PCV Waveform Defin
89. ommunication system is rendered non startup or normal operation operational If this alarm occurs during normal operation the ventilator will continue to operate in the current mode with the current settings and the user interface display will be shut down after one 1 minute The system should be considered non functional at the time of this alarm Contact technical support Pressure Sensor Failure N A The startup test of the This alarm occurs during PAW sensor yielded startup only and renders an abnormal voltage the system non at ambient pressure operational Contact technical support Inspiration Sensor Fail N A The inspiration sensor This alarm occurs during data is incorrect startup only and places Fresh gas is flowing the system in STANDBY during startup ventilation mode Try re starting the system with all gas flows OFF If message reappears switch to MANUAL ventilation mode and manually ventilate patient Contact technical support Software Mismatch or Failure N A Power is recycled to Applicable to Ul versions to Shut Down Completely the unit too quickly 2 25 and higher This alarm occurs during startup only Shut down the unit and wait until the backlight is fully extinguished before restoring power 0070 10 0684 01 AS3000 Operating Instructions Operations Alarms 2 12 3 2 Functional Alarm Messages The following table lists the individual functional alarm messages their
90. output 2 Flowmeter Tubes e N20 Low Low range for settings between 0 1 to 1 L min e N20 High High range for settings between 1 to 12 L min e AIR Low Low range for settings between 0 1 to 1 L min e AIR High High range for settings between 1 to 15 L min e O low Low range for settings between 0 1 to 1 L min e O High High range for settings between 1 to 10 L min 3 Flow Control Knobs e N20 Gas dosing e AIR Gas dosing O Gas dosing 4 Auxiliary O2 AIR Nozzle for auxiliary O2 AIR output Combines the Output auxiliary O2 AIR flowmeters into a single output 5 Oxygen Outlet High pressure O outlet for connecting external devices such as a jet ventilator 1 Usethe tops of the floats when reading the flowmeter tubes 2 Turn knob counterclockwise to increase flow 1 16 0070 10 0684 01 AS3000 Operating Instructions Product Description Vaporizer Mounting Manifold 1 7 Vaporizer Mounting Manifold i S Eaj ka A FIGURE 1 7 Vaporizer Mounting Manifold PART S DESCRIPTION 1 Locking Device Vaporizer locking mechanism to secure against accidental disconnection 2 Valve Cartridge of Vaporizer index and outlet parts Vaporizer Mount 3 Mounting Bar Bar holds two vaporizers An interlock within the vaporizers provides for use of one vaporizer to deliver one agent at a time AS3000 Operating Instructions 0070 10 0684 01 Breathing System Product Description 1 8 Breathing
91. oxygen sensor If the oxygen sensor must be replaced select the Exit button replace the oxygen sensor and then repeat the calibration Calibration successful A Reinstall the sensor into breathing system after calibration FIGURE 2 8 Oxygen Sensor Calibration Successful 2 14 0070 10 0684 01 r Calibration failed Repeat Calibration one more time or Replace Sensor FIGURE 2 9 Oxygen Sensor Calibration Failed AS3000 Operating Instructions Operations Ventilation Modes 2 10 Ventilation Modes 2 10 1 STANDBY This is the operating mode in which all system functionality is idle It is the default system startup operating mode and is used between ventilation operations 2 10 2 MANUAL MANUAL mode is the operating mode used for manually ventilating a patient or to let a patient breathe spontaneously To use the manual spontaneous ventilation mode the user must first set the APL valve to the appropriate pressure value and then select the mode using the MANUAL AUTO key on the User Interface or selecting MANUAL Mode via the Navigator Knob Note that pressing the MANUAL AUTO key again will put the Ventilator back into the previously selected ventilation mode The message Pressure Volume and Apnea Alarms are OFF is displayed in the lower left corner of the main screen when operating in MANUAL Mode with the ALARM control set to OFF Set the ALARM control to ON to remove this message an
92. p time System compliance 5 9 Ventilator Breathing System Loose Fill 2 x 1500 ml or 2 Pre paks Loose fill or Pre pak canisters Heated Breathing System 35 5 2 C Less than 100 minutes at 10 C ambient temperature and less than 45 minutes at 20 C ambient temperature Approx 5 ml Pa x 100 with standard hoses Electronically controlled gas driven bellows ventilator with fresh gas compensation complies with ISO 8835 5 Ventilation modes Patient types Tidal volume Pressure delivery range Ventilation frequency E ratio Inverse l E ratio Plateau End Insp AS3000 Operating Instructions CMV Volume PCV Pressure Control SIMV Synchronized Volume Pressure Support Manual and Spontaneous Adult and Child AO 1400 ml Child 40 400 ml 17 or at least 20 ml Adult 300 1400 ml 15 or at least 50 ml 5 70 cmH20 Manual and PCV modes 3 80 cmH20 PS and SIMV modes 2 60 bpm CMV PCV SIMV PS Child 4 60 bpm Child 2 60 bpm Adult 4 60 bpm Adult 2 60 bpm 1 1 1 1 5 1 2 1 2 5 1 3 1 3 5 1 4 1 4 5 1 5 not available in SIMV or PS modes 1 5 1 2 1 2 5 1 3 1 3 5 1 4 1 not available in SIMV or PS modes Off 5 60 of inspiratory period CMV and SIMV modes only 0070 10 0684 01 5 5 Ventilator PEEP Pressure limitation PTARGET 7 insp Trigger AP Pressure support Tstope Insp Flow Freq min Apnea Max Insp pr
93. pad Area incorporates an AC power LED hard keys and a Navigator Knob AC Power LED a green LED that indicates when AC power is applied e Hard Keys as follows a MANUAL AUTO b ALARM LIMITS c MUTE d SPIROMETRY e MENU f NORMAL SCREEN Navigator Knob located in the Keypad Area for control of the user interface Main Switch ON OFF switch for power to the AS3000 system Vaporizer Work Light A three position switch OFF LOW and HIGH that controls the lighting over the work surface and vaporizers Audio Indicators An audio speaker is provided to annunciate alarms and key presses Audio alarms are in accordance with IEC60601 1 8 The measured sound pressure range for the audio alarm is 76 6 dB A to 81 5 dB A Pneumatic Line Pressure Gauges Three line pressure gauges monitor the pipeline pressure supply of Oz N20 and Air The range of each gauge is O to 145 psi O to 1000 kPa AS3000 Operating Instructions 0070 10 0684 01 5 9 Displays Controls 5 12 2 2 5 12 2 3 5 12 2 4 5 12 2 5 Product Specifications Cylinder Pressure Gauges Cylinder pressure gauges are provided to monitor the cylinder tank pressure for Oo N20 and Air The range of each gauge is O to 3500 psi for O and Air and O to 1400 psi for N20 Flowmeter and Control Valve Three control knobs one each for N20 Air and O are used to set the fresh gas dosing flow Flow set by the control knobs is monitored by si
94. pped at 80 cmH 0O Flow vs Time The Y axis of the Flow vs Time waveform represents Flow The unit of measure is L min and its scale is 20 to 90 in increments of 45 but only absolute numbers are displayed Though the X axis is not labeled it represents a time scale of O to 15 seconds 2 11 2 Volume The Volume parameter group consists of 3 parameters e Tidal Volume V7 The unit of measure is ml e Minute Volume MV The unit of measure is Liter e Respiration Frequency Freq The unit of measure is bpm If data is over range for these parameters an up arrow is displayed NOTE The high alarm limit for Minute Volume MV is displayed to the top right of the reading The low alarm limit for Minute Volume MV is displayed to the bottom right of the reading 2 11 3 Inspired O Fi0 e The unit of measure is e If data is over range an up arrow f is displayed If data is under range a down arrow y is displayed NOTE The high alarm limit is displayed to the top right of the reading The low alarm limit is displayed to the bottom right of the reading AS3000 Operating Instructions 0070 10 0684 01 2 25 Parameter Monitoring 2 11 4 2 26 Operations Spirometry Spirometry is a respiratory monitoring technology that provides continuous breath by breath measurement of patient lung mechanics The resultant pressure volume flow compliance and resistance data enables quick assessment o
95. pressed prior to confirming that change the system will revert back to the previously confirmed setting 1 14 0070 10 0684 01 AS3000 Operating Instructions Product Description 1 5 Front View FIGURE 1 5 Front View PART S User Interface Front View DESCRIPTION See section 1 4 2 Auxiliary Outputs Fresh Gas Dosing Components See section 1 6 Vaporizer Mounting Manifold An interface for 2 Selectatec type Vaporizers to mount in this location See section 1 7 Power Switch Breathing System This switch is used to turn the system ON and OFF Absorber circuit with integrated bag in bottle active and passive valves such as the APL valve See section 1 8 for an in depth description Pressure Gauges Indicate the pressure at pipeline inlets and at cylinder inlets for Og Air and N20 Op Flush Button Provides high flow Og to the inspiratory limb of the breathing system This button is functional regardless of whether or not the system is powered ON AGSS Anesthetic Gas Scavenging System AS3000 Operating Instructions 0070 10 0684 01 1 15 Auxiliary Outputs Fresh Gas Dosing Components Product Description 1 6 Auxiliary Outputs Fresh Gas Dosing Components FIGURE 1 6 Auxiliary Outputs Fresh Gas Dosing Components PART S DESCRIPTION 1 Auxiliary O2 AIR O 15 L min O flowmeter and O 15 L min AIR Flowmeters flowmeter for auxiliary O2 AIR
96. r wire between the bottom of the breathing system and the side of the machine 13 Connect the drive gas hose between the bottom of the breathing system and the side of the machine 14 Connect the pneumatic hoses between the side of the breathing system and the side of the machine 15 Insert the oxygen sensor into the oxygen sensor port 16 Connect the oxygen sensor external cable between the oxygen sensor and the side of the machine 17 Plug the mains cable into a grounded socket and switch on the power supply using the mains switch located on the front of the machine Wait until the ventilator display provides information about the leak test 2 2 0070 10 0684 01 AS3000 Operating Instructions Operations 2 4 Preoperative Checkout Preoperative Checkout This checkout should be conducted before administering anesthesia Refer to special procedures or precautions in this manual NOTE This is a guideline which can be modified to accommodate variations in local clinical practice Such local modifications should have appropriate peer review If an anesthetist uses the same machine in successive cases this checkout need not be repeated or may be abbreviated after the initial checkout 1 Inspect the system for a Identification number b Valid inspection sticker c Damage to flowmeters vaporizers gauges supply hoses d Complete breathing system with adequate CO absorbent pre paks or loose fill e
97. ressures Verify that e an alarm tone sounds e the alarm message NN II o2 Supply Failure is displayed in red text Shut off all flow control valves Re connect the O2 supply to the AS3000 16 Perform High Pressure Leak Test a b h Connect a breathing circuit and ventilation bag Set APL Valve to 70 cm H20 Occlude Y piece Turn O flow to 50 ml min Inflate bag with O flush to 40 cm H20 on the PAW gauge Verify that circuit holds pressure for greater than 10 seconds If vaporizers are installed repeat steps e and f for each vaporizer while it is enabled Set the APL valve to SP 17 Test Ventilator in MANUAL ventilation mode p AS3000 Operating Instructions Remove the O sensor and install the plug into the breathing system Set the ventilation mode to MANUAL Set the APL valve to 20 Set Air flow to 5 liter minute Squeeze the manual ventilation bag once every 10 seconds Verify that the test lung inflates and deflates to approximately 20 cm H2O pressure Verify that peak pressure plat pressure PEEP tidal volume minute volume and frequency values appear on screen Verify that the FiO reading is approximately 21 Verify a pressure waveform appears on screen along with the bag compressions Set the APL valve to the SP position and stop squeezing the manual ventilation bag Re install the O sensor into the breathing system 0070 10 0684 01 2 5 Preoperative Checkout Operations 18 T
98. rms and the two 2 loop display configurations of the Spirometry Loop Window described in section 2 11 The first key press displays the Pressure Volume loop display configuration The second key press displays the Flow Volume loop display configuration After both configurations have been cycled through the display a third key press returns the display to the Pressure vs Time and Flow vs Time waveforms AS3000 Operating Instructions 0070 10 0684 01 1 13 User Interface Product Description 6 MENU key This key toggles the waveform area between the currently displayed waveform s and the menu tabs The first key press after initial power up opens the Calibrate menu tab with the Start Calibration button highlighted From the currently displayed waveform s subsequent pressing of the MENU key opens the last viewed menu tab If a menu tab is already open when the MENU key is pressed that menu tab will close returning the waveform area to the currently displayed waveform s 7 NORMAL SCREEN key Press this key at any time to return the display to the normal operating mode All menu tabs are closed 8 Navigator Knob Rotate this knob to highlight the various tiles or menu tabs on the display Press the center of the knob to select a highlighted item NOTE If a change of setting Ventilation Mode Patient Type Ventilation Parameter Alarm Limit or System Setting is in process and any key except MUTE is
99. s surfaces are cleaned b Rinse with clean hot water and allow to dry NOTE Dry the bellows by allowing it to hang so that it is fully expanded This will facilitate thorough drying and prevent it from sticking to itself CAUTION If moisture remains in the bellows after cleaning it may become tacky c After all bellows components are completely dry inspect them for damage before disinfection or re assembly and functional testing d If disinfecting the bellows components continue with step 7 otherwise skip to step 8 3 6 0070 10 0684 01 AS3000 Operating Instructions User Maintenance Cleaning and Disinfection 7 Disinfection NOTE Ensure that all bellows components have been cleaned as described in step 6 before disinfecting Using an FDA cleared Gluteraldehyde disinfection solution follow the manufacturer s instructions for high level disinfection and rinsing of all bellows components while adhering to facility policies and procedures 8 Connect the bellows to the breathing system by reassembling all components in the reverse order Prior to use after cleaning or disinfecting power up the system as described in section 2 6 and follow the on screen prompts to perform the Leak Test and the Compliance Test 3 1 4 Inspiration and Expiration Valves The following procedure is written generically for a single unspecified valve It should be performed on both the inspiration and expiration valves Contro
100. se 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 AS3000 Operating Instructions 0070 10 0684 01 3 17 Cleaning and Disinfection User Maintenance 5 While grasping the sides of the breathing system block as shown in FIGURE 3 21 lift it away from its mounting arm Absorber Mounting Block Arm FIGURE 3 21 Breathing System Block Removal 6 Cleaning a Clean the breathing system block exterior with a soft lint free cloth and a mild detergent and water solution Allow to dry thoroughly b If disinfecting the breathing system block continue with step 7 otherwise skip to step 8 7 Disinfection NOTE Ensure that the breathing system block has been cleaned as described in step 6 before disinfecting High level disinfection of the breathing system block can be performed through steam autoclaving up to a maximum temperature of 134 C 273 F Using an autoclave follow the manufacturer s instructions for high level disinfection of the breathing system block while adhering to facility policies and procedures 8 Reassemble the breathing system components in reverse order Prior to use after cleaning or disinfecting power up the system as described in section 2 6 and follow the on screen prompts to perform the Leak Test and the Compliance Test 3 18 0070 10 0684 01 AS3000 Operating Instructions User Maintenance
101. ser s appropriately qualified technical personnel in repairing those parts of the AS3000 which are designated as repairable Manufacturer s Responsibility The effects on safety reliability and performance of the equipment are the manufacturer s responsibility only if a assembly operations extensions readjustments modifications or repairs are carried out by authorized personnel and b the electrical installation of the relevant room complies with the appropriate requirements and c the equipment is used in accordance with the instructions for use 0070 10 0684 01 AS3000 Operating Instructions 6 0 6 1 Glossary Glossary of Terms AD DA AGSS APL BDU cmH20 CMV EEPROM FiO2 Freq Freqmin IC LE L L min ml MV N A Paw or PAW PCV PEEP PIP PS PTARGET AP AS3000 Operating Instructions Analog to Digital Digital to Analog Anesthetic Gas Scavenging System Airway Pressure Limiting Basic Digital processing Unit Centimeters of Water Volume Controlled Continuous Mandatory Ventilation Electrically Erasable Programmable Read Only Memory Fraction of inspired oxygen Frequency Minimum Frequency PS mode only Integrated Circuit Ratio of Inspiratory Time to Expiratory Time liter liters per minute milliliter Minute Volume Not Applicable Airway Pressure Pressure Controlled Ventilation Positive End Expiratory Pressure Peak Inspiratory Pressure Pressure Support Ventilation Target Pr
102. 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 To prevent system damage e 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 e Keep all liquids away from electronic components e Prevent liquid from entering the equipment e All cleaning solutions used must have a pH between 7 0 and 10 5 Never immerse the oxygen sensor or its connector in any type of liquid e Dispose of the oxygen sensor per the manufacturer s specification Do not wash the inner surface of the oxygen sensor 0070 10 0684 01 User Maintenance CAUTION Prior to use after cleaning or disinfecting power up the system as described in section 2 6 and follow the on screen prompts to perform the Leak Test and the Compliance Test CAUTION The PAW gauge and oxygen sensor cannot withstand immersion or the heat and pressure of autoclaving CAUTION Do not autoclave the airway pressure limiting APL valve 3 2 0070 10 0684 01 AS3000 Operating Instructions User Maintenance Cleaning and Disinfection 3 1 Cleaning and Disinfection CAUTION Prior to use after
103. tient Size Adult Vr 600 Breath Rate 8 IE 1 2 PEEP Off Tp 10 O Flow 2 Liters minute 3 Perform steps 20 to 23 of the Preoperative Checkout in section 2 4 0070 10 0684 01 AS3000 Operating Instructions Operations System 2 13 System The System menu tab contains configuration settings for Pressure Display Language Display mode Date and Time and System Defaults This menu also includes the result of the last leak test performed Pressure Display Language ais PEEP Displa EVER Locas Volume vT Date Time Restore Defaults Press Menu Key to Exit FIGURE 2 18 Example System menu tab 1 Pressure Display Provides selections of Pplat Plateau Pressure or Pmean pressure display The default is Pplat 2 Language Allows the user to choose from available display languages NOTE The AS3000 is only available in English 3 Display Accesses the AS3000 s demo mode NOTE This Feature is password protected and is intended for use by Mindray personnel only 4 Date Provides for adjustment of the current date and selections for date format 5 Time Provides for adjustment of the current time and selections for time format 6 Restore Defaults Allows the user to restore alarm limits pressure display and ventilation settings to default values AS3000 Operating Instructions 0070 10 0684 01 2 35 System Operations
104. tile is highlighted will toggle the patient type between Adult and Child 6 Ventilation MODE Tile NOTE STANDBY is the default ventilation mode at startup During normal operation this tile displays the current ventilation mode It is also used to choose a different ventilation mode Press the Navigator Knob while this tile is highlighted and rotate the knob in either direction to scroll through the following ventilation modes STANDBY MANUAL CMV PCV SIMV and PS When the desired mode is displayed press the Navigator Knob to select it The tile will flash to indicate that a new mode is pending The parameter setup tiles associated with the selected ventilation mode will be displayed Before activating the new mode i e while the new mode is pending the Navigator Knob can be used to adjust each associated parameter See item 10 in this section for descriptions of the parameter setup tiles and how to adjust settings NOTE A message will be displayed in the user message area to indicate that the displayed parameter values are for the pending ventilation mode 0070 10 0684 01 AS3000 Operating Instructions Product Description User Interface With all parameters set rotate the Navigator Knob back to the ventilation MODE tile and press the knob to activate the new ventilation mode NOTE If the new ventilation mode has not yet been activated and TM the Navigator Knob is not pressed or rotated for 15 seco
105. uring startup the system is rendered non operational Repeat the startup tests as necessary Contact technical support BDU Communication Failure High If this alarm occurs If this alarm occurs This alarm can occur during during normal during startup the startup or normal operation operation the GUI system is rendered non cannot send or operational Contact receive data from the technical support If this BDU unit for more alarm occurs during than 0 5 seconds normal operation manually ventilate the patient Alarm Speaker Failure N A During startup This alarm occurs during AS3000 Operating Instructions 0070 10 0684 01 testing no response was received from the alarm speaker startup only and places the system in STANDBY ventilation mode All system functions except audible alarms are available Contact technical support Operations MESSAGE PRIORITY REASON S SOLUTION S O Cal Due Low 72 hours have elapsed since the last O Calibration Software Version Error N A When the internal This alarm occurs during BDU user interface startup only and renders and keyboard the system non software components operational Contact were checked for technical support proper configuration the software versions did not match with the released set Keyboard Communication Low Internal electrical If this alarm occurs Failure failure of subsystems during startup the This alarm can occur during c
106. venient ergonomics and state of the art safety systems Anesthesia Ventilator The AS3000 ventilator offers multiple ventilation modes Controlled Mandatory Ventilation with volume control CMV Pressure Control Ventilation PCV Synchronized Intermittent Mandatory Ventilation SIMV and Pressure Support PS ventilation Electronic PEEP is available in all ventilation modes User control over inspiratory flow SLOPE is possible in PCV SIMV and PS modes Automatic fresh gas compensation limits the effect on the patient of user changes in fresh gas flow rate The traditional bellows system is driven by oxygen and makes patient disconnections clearly visible Fresh Gas Dosing The AS3000 fresh gas dosing subsystem offers the following features e Dualflow tubes backlit for dark room viewing to display the O2 N20 and Air flows at all times e A knob guard to prevent inadvertent movement of the flow control knobs Gas supply gauges to indicate the gas pipeline supply pressures and gas cylinder pressures e An auxiliary O flow meter e An auxiliary Air flow meter e An O flush button Safety systems within the AS3000 work to prevent hypoxic mixtures from being delivered to the patient Nitrous oxide will not be delivered unless oxygen pressure is present A mechanical safety system assures that at least 21 Op is present when setting mixtures of O and N20 WARNING Ensure that both O and N20 flow controllers are turned OFF fully at
107. x flowmeter tubes Two each for N20 Air and O The scale of the flowmeters is N20 High Range 1 to 12 L min N20 Low Range 0 1 to 1 L min Air High Range 1 to 15 L min Air Low Range 0 1 to 1 L min O High Range 1 to 10 L min O Low Range 0 1 to 1 L min 0 Flush A push button Oo flush valve supplies Oz flow directly to the fresh gas outlet when depressed The button returns to its original closed position when released APL Valve The APL valve for limiting maximum breathing pressure in manual mode is located on the Breathing System block 0070 10 0684 01 AS3000 Operating Instructions Product Specifications Electromagnetic Capability 5 13 Electromagnetic Capability The AS3000 meets the requirements of IEC 60601 1 2 EN 60601 1 2 NOTE The AS3000 needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below NOTE Portable and mobile RF communications equipment can affect the AS3000 See tables 5 1 through 5 4 that follow TABLE 5 1 GUIDANCE AND DECLARATION ELECTROMAGNETIC EMISSION The AS3000 is intended for use in the electromagnetic environment specified below The customer or the user of the AS3000 should assure that it is used in such an environment EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions Group 1 The AS3000 uses RF energy only for its internal CISPR 11 function Therefore its

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