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1. NS J le 08 p 07 l cir cr gt A SAM FIGURE D 3 Main Unit Left View ATTENTION NUMBER DESCRIPTION 06 Auxiliary O5 Air Gas Outlet Nozzle barbed connector for auxiliary O Air output Combines the auxiliary O Air flowmeters into a single output 07 Maximum supporting weight 25 kg at a maximum distance of 0 31 m 08 Warning Hot D 8 046 003777 00 A5 A3 Operating Instructions Abbreviations Symbols and Units of Measure Attention Symbols FIGURE D 4 Main Unit Right View ATTENTION NUMBER DESCRIPTION 09 Maximum supporting weight 25 kg at a maximum distance of 0 31 m 10 Maximum supporting weight 25 kg at a maximum distance of 0 31 m 11 Maximum supporting weight 25 kg at a maximum distance of 0 31 m A5 A3 Operating Instructions 046 003777 00 D 9 Attention Symbols Abbreviations Symbols and Units of Measure e ne Front FIGURE D 5 Main Unit Top View ATTENTION NUMBER DESCRIPTION 12 Top Shelf 40 kg MAX 88 Ibs MAX D 10 046 003777 00 A5 A3 Operating Instructions Abbreviations Symbols and Units of Measure Attention Symbols FIGURE D 6 Breathing System Top View ATTENTION NUMBER DESCRIPTION 13 Do not push down on the bag arm forcefully or hang heavy objects onto it Excessive weight may bend and damage the bag arm 14 Autoclavable up
2. 5 6 8 2 5 6 8 3 5 6 8 4 Synchronized Intermittent Mandatory Ventilation Volume Control SIMV VC 709 2 2o ml bpm sec Setup Alarms cmH20 FIGURE 5 11 Synchronized Intermittent Mandatory Ventilation Volume Control SIMV VC Tab SIMV VC means to deliver synchronized intermittent mandatory volume controlled ventilation to the patient In the SIMV VC mode the ventilator waits for patient s next inspiration based on the specified time interval The sensitivity depends on Trigger If Trigger is reached within the trigger waiting time called synchronous trigger window the ventilator delivers volume controlled ventilation synchronously with the preset tidal volume and inspiratory time If the patient does not inspire within the trigger window the ventilator delivers volume controlled ventilation to the patient at the end of trigger window Spontaneous breathing outside trigger window can acquire pressure support In VCV and SIMV VC modes when inspiration pressure reaches Plimit the inspiration pressure is held Synchronized Intermittent Mandatory Ventilation Pressure Control SIMV PC A5 Only 30 Of 109 On cmH20 bpm sec L min cmH20 cmH20 FIGURE 5 12 Synchronized Intermittent Mandatory Ventilation Pressure Control SIMV PC Tab SIMV PC is available on the A5 only SIMV PC means to deliver synchronized intermittent mandatory pressure controlled ventilation to the patient In the SIMV PC mode the ventilat
3. Manual Only error condition Example System Self Test Complete Bundle PEEP Valve 01 00 01 Select Retry to repeat the System Self Test or Select Manual Only to proceed Automatic Ventilation will be disabled The Manual Only error condition indicates that the A5 A3 can be used in manual mode only Select Retry to repeat the System Self Test or Select Manual Only to place the device in manual ventilation mode only The following low priority alarm will be displayed on the main screen Automatic Ventilation Disabled NV Automatic Ventilation Disabled WARNING Selecting the Manual Only button will disable automatic ventilation Machine Non Functional error condition Example System Self Test Complete PEEP Valve Power Supply Voltage Select Retry to repeat System Self Test or Contact service The Machine Non Functional error condition indicates that the A5 A3 cannot be used Select Retry to repeat the System Self Test or Contact service if this error condition persists NOTE Service Access button The Service Access button is only available to Mindray authorized service personnel and requires a service password TABLE 4 2 Types of System Self Test Results Bundle Version The Bundle Version is displayed in all System Self Test results This is the version number of the package of software that is installed in the A5 A3 If the Bundle Version displ
4. 12 Ventilations Mode and Setting Parameters Area Displays tabs for all ventilation modes VCV SIMV VC PCV SIMV PC PS and Manual Bypass Each tab displays the ventilation mode and its parameters Select a tab and the Set Mode softkey to change the ventilation mode Select a parameter button to change the parameter setting See Ventilation Modes on page 5 7 13 System Softkeys Setup Select to open the Setup menu The Setup menu contains the General tab Display tab System tab and Service tab Alarms Select to open the Alarms menu to set alarm limits set alarm volume view alarm log and view all active alarms Silence Select to silence all currently sounding alarm tones for 120 seconds The alarm silence icon and 120 second countdown time appear at the top of the screen Select again to clear the alarm silence Note however that a new alarm will sound if that alarm occurs while the system is in a silenced state If this occurs you can select the Silence softkey again to silence the new alarm and reset the silence countdown timer to 120 seconds SIMV PC and Bypass are only available on A5 046 003777 00 A5 A3 Operating Instructions System Interface System Information Header 3 2 System Information Header 3 2 1 Elapsed Timer Displays the elapsed time Located at the top left ofthe Main Screen Select to start stop or reset the timer FIGURE 3 3 Elapsed Timer E
5. Point of Care Facility Enter up to 20 characters per field These fields are NOT cleared when the patient is discharged These fields can be changed only by editing them directly TABLE 3 2 Demographic Tab Fields for Patient and Hospital Data 046 003777 00 A5 A3 Operating Instructions System Interface Demographics Tab Demographics Tab Demographics Patient ID 1234 5678 First Name Last Name Point of Care DOB Weight Ibs 121671985 O Age 2 FIGURE 3 17 Demographics Tab A5 A3 Operating Instructions 046 003777 00 Ventilation Mode Tabs System Interface 3 7 Ventilation Mode Tabs Displays tabs for all ventilation modes Each tab displays the ventilation mode and its parameters FIGURE 3 18 to FIGURE 3 25 A5 ventilation modes VCV SIMV VC PCV SIMV PC PS and Manual A3 ventilation modes VCV SIMV VC PCV PS and Manual z a TT Ventilation Mode Tabs Setup Alarms FIGURE 3 18 Ventilation Mode Tabs To change the ventilation mode 1 Select a desired ventilation mode tab The Set Mode softkey begins to blink green 2 Optionally select one or more parameter buttons to change the parameter settings of the desired ventilation mode Select the Accept button to accept each parameter change 3 Select the Set Mode softkey to finalize and change the ventilation mode NOTE If the Set Mode softkey is not selected after several seconds an audible
6. 1 1 10 Workplace Ergonomics The A5 A3 is a full featured anesthesia delivery work station The raised perimeter of its stainless steel work surface retains items that might otherwise roll or slide off its edge The work surface light has high and low brightness settings The wrap around handle enables fine positioning of the machine Three 3 large drawers are available for storage All drawers can be locked with a key Rail mounts on both sides of the machine enable mounting of patient monitors and most standard attachment arms for other devices For the A5 a non slip footrest and central brake are provided For the A3 a non slip footrest and individual caster brakes are provided The top shelf can be used to mount additional equipment The operator of the A5 A3 should be positioned in front of the monitor at a comfortable distance to view all displayed waveforms text and controls A5 A3 Operating Instructions 046 003777 00 l Physical Views Product Description 1 2 Physical Views 1 2 1 Main Unit Front View FIGURE 1 2 Main Unit Front View PART S DESCRIPTION A1 Alarm Light Illuminates red yellow or cyan during an alarm condition to indicate the alarm priority Red high pri
7. Drawer weight limit Conforms to UL std 60601 1 IEC 60601 2 13 Certified to CAN CSA std C22 2 No 601 1 No 60601 2 13 Alarm Icon Alarm Silence Icon Low priority message Medium priority message High priority message Breathing System Warmer Off Xx 046 003777 00 A5 A3 Operating Instructions 1 Product Description General System Overview Physical Views A5 A3 Operating Instructions 046 003777 00 General System Overview Product Description 1 1 1 1 1 General System Overview General Description The A5 Anesthesia System p Volume Control Venti Pressure Control Venti Synchronized Intermi with without PS opti Synchronized Intermi with without PS op he A5 A3 Anesthesia System is a device intended to administer continuously or intermittently a general inhalation anesthetic to a patient and to maintain a patient s ventilation The A5 A3 also provides for ventilatory monitoring of the patient The A5 A3 Anesthesia System consists of a main unit includes an anesthetic ventilator and flowmeter monitor assembly and a detachable breathing system ovides the following ventilation modes ation VCV which includes the Pressure Limit Ventilation PLV function lation PCV with without Volume Guarantee VG ventilation mode tent Mandatory Ventilation SIMV with VC mode on tent Mandatory Ventilation SIMV with PC mode ion Pressure Sup
8. MACHINE MODE STARTUP ALARM WHEN RESULT IF MESSAGE CAUSE PRIORITY CHECKED FAIL REMARK Ventilator Self test result cannot High Startup Non CPU Board Initialization be obtained due to an Functional Time out internal communication error Drive Gas Drive Gas Pressureislow High Startup All Ventilator Pressure Low Control Board O Supply O Supply Failure High Startup All Ventilator Failure O Control Supply Fail Board Power Supply 3 3V 5V 12V voltage High Startup Only Power Voltage Error error Manual Board Power Supply Voltage Fail RT Clock Needs There is no button High Startup only All CPU Board Battery battery cell available in the system or the button battery cell power is depleted RT Clock Failure RT chip malfunction High Startup only All CPU Board RT Clock Fail TABLE 6 4 Startup Alarm Messages 6 6 2 2 CPU Board Runtime Alarm MACHINE DISABLE IN ALARM MODE WHEN STANDBY MESSAGE CAUSE PRIORITY CHECKED MODE IP Address Conflict The IP address of the Medium Runtime No machine is the same as the IP address of another device in the local network Fan Failure Speedofthefan lt 20 of Medium Runtime No normal speed TABLE 6 5 CPU Board Runtime Alarm Messages 6 6 2 3 Power Board Runtime Alarm MACHINE DISABLE IN ALARM MODE WHEN STANDBY MESSAGE CAUSE PRIORITY CHECKED MODE Power System Lost communication with High Runtime No Comm Stop CPU board for 10 seconds Power Supply 3 3V 5V 12V voltage error High Runtime No Voltage Er
9. A5 A3 Operating Instructions 046 003777 00 7 19 Cleaning and Disinfection Maintenance 7 9 10 Absorber Canister 1 Locate the condensate drain valve at the bottom of the absorber canister assembly Absorber Canister Condensate Drain Turn the condensate drain valve to open and close pen FIGURE 7 18 Condensate Drain Valve Close Up View 2 While holding a small cup below the drain turn the condensate drain valve clockwise to open the drain and collect any water that may have gathered Turn the drain valve counter clockwise to close the drain Discard any water collected WARNING Use extreme care while handling the absorbent as it is a caustic irritant 3 Rotate the locking mechanism handle clockwise into the unlocked position as shown in FIGURE 7 19 This separates the absorber canister from the top of the assembly While noting the previous WARNING remove the absorber canister Then remove the Pre Pak or loose fill absorbent from the canisters Dispose of the absorbent per the manufacturer s specification 7 20 046 003777 00 A5 A3 Operating Instructions Maintenance Cleaning and Disinfection 7 9 11 Unlocked Position Locked Position FIGURE 7 19 Absorber Canister Unlocked FIGURE 7 20 Absorber Canister Locked 4 Cleaning a Clean the absorber canister with a soft lint free cloth and a recommended cleaning agent See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoc
10. Displays and Controls Specifications Product Specifications Individual Flow Meter Control Needle Valve and Knob Configuration NO Air O Displayed Range N50 Air O 0 to 15 L min Control Range N50 0 to 10 L min Control Range Air 0 to 15 L min Control Range O5 0 to 15 L min Accuracy 10 or 0 12 L min whichever is greater Resolution 50 mL min Q 0 to 1 L min 100 mL min Q 1 to 15 L min Rotations 5 from 0 flow to maximum flow Total Flow Meter Range Oto 10 L min 10 of the indicated value for flows between 1096 and 10096 of full scale with oxygen Auxiliary O and Air Flow Meter Flow range for each meter 0 to 15 L min Auxiliary O Gas Power Outlet A5 Only O Flush Pushbutton green Pressure range 280 to 600 kPa Maximum flow 290 L min Flow rate 35 to 50 L min Inspiratory Airway Pressure Gauge 20 to 100 cmH5O 4 of full scale reading 4 of actual reading TABLE 8 26 Pneumatic Controls 8 16 046 003777 00 A5 A3 Operating Instructions Product Specifications Alarms 8 12 Alarms Self test Self testing of alarm system functions alarm light speaker and buzzer is performed when A5 A3 System is powered on Alarm Indicators Audible speaker buzzer Visual alarm light and on screen alarm messages Audible and visual alarms comply with the requirements of IEC 60601 1 8 Alarm Categories Physiological alarms three
11. Plimit Line FIGURE 3 31 Plimit Line NOTE The Plimit line does not affect the auto scaling algorithm If the Plimit line is turned on but not visible it may be because the line is positioned off the waveform scale To set the Plimit line to ON or OFF 1 Select Setup softkey gt Display tab 2 Select the Plimit Line button to ON or OFF 046 003777 00 A5 A3 Operating Instructions System Interface System Tab 3 12 System Tab The System tab is accessible only by authorized administrative service personnel with password access The system tab can only be accessed in Standby mode NOTE The default System tab password is 1234 The authorized administrator should change the default password immediately after the system is installed to prevent unauthorized access to the System tab The password can be up to 6 digits in length containing numerals 0 to 9 S FIGURE 3 32 A5 A3 Setup menu gt System tab SYSTEM TAB BUTTON CHOICES DESCRIPTION Calibration 02 Sensor Select to calibrate the O2 sensor Follow the screen instructions The date and time of the last calibration is displayed next to the O2 Sensor button Language English default Select to set the language of the user interface text French Spanish Portuguese Russian Turkish Dutch Default Patient Size Adult Select to set the default patient size Pediatric Infant default TABLE 3 3 System tab settings A5 A3 Operating Inst
12. Relationships of Ventilation Parameters scccsssssssccsssescecsssesseesssseceessssescessusesescsnsessssssscesssuseccessussecesssusseesssnseccessueeesssnssseessnsecescenseccecsunseceesnaeeeesenueees 5 1 Parameter Monitoring Waveforms Pressure 1 Auto zeroing the Press re Sensors dale 5 1 MATE 5 1 SE ai 1 Spirometry A5 Only 1 O Oo 00000 4 4 OO 0 HP 3 0 Y uN N N gt O O Spirometry Loops Wavetorm A toscaling A A fpes leitete cete 5 20 Alarms and Messages eere eere eene eene tentes etna en seen sense enses senses senses A O Alarm System anos Types of Alarms and Messages Alarm Indicators A5 A3 Operating Instructions 046 003777 00 iii Table of Contents Displaying Alarms Displayed Order of Alarm Messages Setting Alarm Volume SO AMO ec Alam Limits E AA EN EAE E E T rad Setting Alarm Limits Loading Alarm Defaults Aut Ala EMIS A a ettet E E ete tuor aA aE E S Eea EES E a Naia Alarm and Prompt KEET C LAEE EEE E AASE AEAEE AE E E EA Physiological Alarm Messages Technical Alarm Messages Startup Alarm Messages EPU BoardiR ntime Alacan AN a A N AD NA cia Power Board R ntimie Alarm saute tteeteperetespretbeguietes enotristtten ii ii oeei esai Er o aai tas Saa E AS En EE ee cete aS Electronic Flowmeter Board Runtime Alarm Ventilator Control Board Runtime Alarm Prompt Mes
13. 1 hour 2 hour 6 hour 12 hour 24 hour Primary Server IP Enter Primary Server IP default 132 163 4 103 Secondary Server IP Enter Secondary Server IP default 210 72 145 44 TABLE 3 4 Network Configuration Settings and Parameters A5 A3 Operating Instructions 046 003777 00 3 31 Service Tab System Interface 3 13 Service Tab Accessible only by Mindray authorized service personnel Please contact Mindray Technical Support for assistance 3 32 046 003777 00 A5 A3 Operating Instructions 10 Preoperative Tests Vaporizer Tests mn Breathing System Tests Alarm Tests Preoperative Preparations nspect the AGSS A5 A3 Operating Instructions 046 003777 00 Preoperative E sse RR RR GE RARE A SR E D OONN 4 2 O col tige due 4 3 Pre operative Checkout Ist sette ei at 4 4 SysternSelfz Tess cose resedit A open et ce us d eS uns 4 7 Feak cand Compliance Tests a dea Eo MCA Id R LET UE 4 9 PowerFall te Aldbtri esto oot tr epa qom diet ne edd ente 4 17 Pipeline TestSiz iih te comet dace at he cet ie el cate ob tee te te uei Lectio Mp aho ide Alaa ud 4 18 Basic Ventilation Tesi dette tte matta ett ak does cel uke el 4 20 A DO IM LL M M E A 4 21 Flow Control System Test 1 23 25 27 1 30 31 Preoperative Test Schedules Preoperative Tests 4 1 Preoperative Test Schedules Preoperative tests on the A5 A3 should be performed ac
14. A B 3 SU Me rra dl B 4 AlarrmVol rme aid B 6 Date anacTittess sues emn tb o a e o ea B 6 O B 7 Linked Ventilation Parameter Relationships ttt tette B 12 Non Linked Ventilation Parameter Relationships ttt B 14 A5 A3 Operating Instructions 046 003777 00 Waveform Spirometry Tabs A5 Only Parameters and Factory Defaults B 1 Waveform Spirometry Tabs A5 Only Current selection saved when OBJECT RANGE DEFAULT powered off Waveform Spirometry Waveform tab Spirometry Waveform tab No Tab tab Spirometry Tab Loop Pressure Flow Pressure No Type Spirometry Tab Save Reference Baseline Reference No Loop Spirometry Tab Show Off Baseline time Off No Reference Spirometry Tab Pressure Flow Pressure No Review Loops Loop Type 2 046 003777 00 A5 A3 Operating Instructions Parameters and Factory Defaults B 2 Alarm Limits Alarm Limits Current selection saved when PARAMETER RANGE DEFAULT UNIT powered off Peak High The greater of 10 and Adult 50 cmH O Yes Paw Low 1 to 100 Pediatric 40 Step 1 Infant 40 Peak Low Otothelesserof70 and Adult 10 cmH5O Yes Paw High 1 Pediatric 8 Step 1 Infant 8 MV High The greater of 0 2 and Adult 12 L min Yes MV Low 0 1 to 25 Pediatric 6 Step 0 1 Infant 6 MV Low Otothelesserof20and Adult 1 L min Yes MV High 1 Pediatric 1 Step 0 1 Infant 0 2 FiO High The greater of 21 and Off Yes FiO Lo
15. 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 Drs W van Royenstraat 8 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 Cambridgeshire PE29 6SZ e United Kingdom Tel 01480 416840 Fax 01480 436588 Mindray Medical France SARL e Europarc Cr teil e 123 Chemin des Bassins e 94035 Cr teil Cedex e France Tel 0 1 45 13 91 50 e Fax 0 1 45 13 91 51 Mindray Medical Germany GmbH Zwischen den B chen 4 64625 Bensheim e Deutschland e Tel 49 6251 17524 0 e Fax 49 6251 17524 20 Mindray Medical International Ltd e 2813 Office Tower Convention Plaza No 1 Harbour Road e Wanchai e Hong Kong Tel 852 2793 5596 e Fax 852 2344 8824 Medstar Importa o e Exporta o Ltda e Av Vereador Jos Diniz 3300 e S o Paulo SP e CEP 04804 000 e Brazil e Tel 55 11 2872 3385 e Fax 55 11 2872 3385 0002 08 8918
16. Do not block 046 003777 00 A5 A3 Operating Instructions Product Description Physical Views PART S DESCRIPTION B4 Communication Ports SP1 DP1 CS1 SB1 SB2 See section 8 6 4 pg 8 7 Communication Ports CAUTION Do not connect any devices to the SB ports other than Mindray approved USB storage devices and a supported USB mouse see Networking and USB Storage on page A 5 B5 Auxiliary AC Outlets A5 Additional devices up to a total maximum power of 10 amps can be connected to four 4 outlets A3 Additional devices up to a total maximum power of 9 amps can be connected to three 3 outlets The A5 outlets are covered with two 2 metal plates the A3 outlets are covered with one 1 metal plate and require a tool to access Only authorized personnel can access these outlets B6 Equipotential stud lug Provides a ground point B7 Hooks Allows user to hang or wrap cords B8 Cylinder Supply Connections Interface connectors to high pressure supply tanks Op Air and N50 B9 Gas Pipeline Supply Connections for O5 Air and N50 from a pipeline gas supply Connections B10 Sample Line Exhaust Gas Inlet Inlet for waste gas from an optionally attached gas module Merges with the AGSS connector that connects to the AGSS B11 AGSS Connector Connects the AGSS or waste gas disposal system B12 AGSS Anesthetic Gas Scavenging System B13 Cylinders Supply tanks E
17. Fresh Gas Flow N20 Ai E 120 sec FIGURE 3 6 Alarm Silence Icon 3 6 046 003777 00 A5 A3 Operating Instructions System Interface System Information Header 3 2 5 Date and Time Displays the current system date and time FIGURE 3 7 Date and Time 700 12 1 18 T0 Off 550 FIGURE 3 7 Date and Time Icon To adjust the date and time l Select the Date and Time icon The Date Time dialog is displayed FIGURE 3 8 2 Usethe dialog keypad and softkeys to adjust the date time 12 24 hour format date format and daylight savings time NOTE If applicable select Daylight Savings Time first before all other settings NOTE If the Daylight Savings Time On Off button in the Date Time dialog see Figure 3 8 is inactive and cannot be selected it is because the Daylight Savings setting has been set to Auto in the System settings see Table 3 3 System tab settings on page 27 3 Select the Accept to finalize your changes Date Time 4 FIGURE 3 8 Date and Time Menu A5 A3 Operating Instructions 046 003777 00 3 7 System Information Header System Interface 3 2 6 Battery Status Displays the main power supply and battery state FIGURE 3 9 For more information on the advanced power management system of the A5 A3 see Power Management Battery Supply on page 1 5 Battery Status Icon 700 12 11 FIGURE 3 9 Battery Status Icon PART S DESCRIPTION Batt
18. Inspiratory Minute Volume MVinsp Expiratory Tidal Volume VTexp Inspiratory Tidal Volume VTinsp Ratio of Inspiratory time to Expiratory time I E Positive End Expiratory Pressure PEEP Rate Peak Inspiratory Pressure PEAK Plateau Pressure PLAT Mean Pressure MEAN Dynamic Airway Compliance Compl and Airway Resistance Raw A5 A3 Operating Instructions 046 003777 00 3 Demographics Tab System Interface 3 6 Demographics Tab The Demographics tab is located on the main screen next to the Waveforms tab on the A3 system and next to the Spirometry tab on the A5 system FIGURE 3 17 The Demographics tab contains editable fields to enter patient and hospital data TABLE 3 2 NOTE Facility data should be entered when first setting up the machine After entering facility data the user should go to the System tab gt Manage Defaults gt Save as O R Defaults so that the data is not erased on power cycle or discharge EDITABLE FIELD COMMENT Patient ID Enter up to 20 characters per field These fields are cleared when the patient is First Name discharged or ifthe A5 A3 is power cycled Last Name DOB Date Of Birth Enter the information from the virtual keypad If the calculated age of the Weight Ibs kg patient is outside the accepted range 0 150 a prompt message is displayed These fields are cleared when the patient is discharged or if the A5 A3 is power cycled Bed Room
19. Networking and USB Storage A 10 Networking and USB Storage PART NUMBER DESCRIPTION 0012 00 1274 01 CAT 5 Ethernet Cable Patch STP 6 1 83m 0012 00 1274 02 CAT 5 Ethernet Cable Patch STP 25 7 62m 0012 00 1274 03 CAT 5 Ethernet Cable Patch STP 50 15 24m 0012 00 1392 05 CAT 5 Ethernet Cable Crossover STP 3 0 91 m 0012 00 1392 06 CAT 5 Ethernet Cable Crossover STP 6 1 83 m 0012 00 1392 07 CAT 5 Ethernet Cable Crossover STP 10 3 05 m 0012 00 1392 08 CAT 5 Ethernet Cable Crossover STP 20 6 10 m 0992 00 0297 01 USB Storage Device 2GB 0000 10 10751 USB Wired Mouse A 11 O Sensor PART NUMBER DESCRIPTION 040 001270 00 O Sensor A Series 801 0631 00102 00 O Sensor Cable and Housing A Series 801 0631 00091 00 O Sensor Cable A Series A 12 Vaporizers PART NUMBER DESCRIPTION 0992 00 0148 Sevoflurane Vaporizer with Quick Fill Adapter 0004 00 0100 Sevoflurane Quick Fill Bottle Adapter 0992 00 0149 Isoflurane Vaporizer with Fill Adapter 0004 00 0101 Isoflurane Fill Bottle Adapter A5 A3 Operating Instructions 046 003777 00 A 5 Vaporizers Accessories This page intentionally left blank A 6 046 003777 00 A5 A3 Operating Instructions so XX Parameters and Factory Defaults Wavetorm Spirometny Tabs A5Only cs erts i e ttd Re due B 2
20. remove and reinstall the vaporizer 2 If a vaporizer lifts off the manifold repeat steps 1 through 3 to reinstall the vaporizer If the vaporizer lifts off a second time do not use the system WARNING For the A5 A3 Anesthesia System using or turning on more than one vaporizer simultaneously is prohibited and prevented by a mechanical interlock Do not attempt to override this safety mechanism 2 6 046 003777 00 A5 A3 Operating Instructions Installation Install the Vaporizer 2 3 1 Filling and Draining the Vaporizer Install only Mindray approved vaporizers compliant to ISO 8835 4 on the A5 A3 unit See section A 12 pg A 5 Vaporizers Refer to the manufacturer s vaporizer Instructions For Use for filling or draining the vaporizer and other information WARNING Ensure that the correct anesthetic agent is used The vaporizer is designed with the specific anesthetic agent named on it and further indicated by color coded labelling The concentration of the anesthetic agent actually output will vary if the vaporizer is filled with the wrong agent WARNING Do not reuse the agent drained from the vaporizer Treat as a hazardous chemical and follow local regulations for proper disposal A5 A3 Operating Instructions 046 003777 00 2 7 Install the Vaporizer Installation This page intentionally left blank 2 8 046 003777 00 A5 A3 Operating Instructions 3 0 System Interface Main ads 3 2 SA tt aloe
21. 0081 32 EVAC DISS to VAC Chemetron Gas Supply Hose 15 ft 0004 00 0081 33 EVAC DISS to VAC Puritan Bennett Gas Supply Hose 15 ft 0004 00 0081 34 EVAC DISS to VAC DISS Female Gas Supply Hose 15 ft Manuals and Reference Cards PART NUMBER 046 003777 02 DESCRIPTION A5 A3 Operations Manual Hardcopy English 046 003777 01 A5 A3 Operations Manual CD 046 001764 05 A5 A3 Anomalies List 801 0631 00081 00 A5 A3 Pre Operation Checklist English A5 A3 Auxiliary O2 Air Reference Card 801 0631 00082 00 A 9 Mounting Accessories PART NUMBER 0436 00 0169 DESCRIPTION Monitor Mounting Arm Pivot 12 0386 00 0344 Mounting Kit GM3 to GCX mount adapter plate 0040 00 0452 Mounting Kit DPM6 7 T5 amp T8 to GCX Mount Adapter Plate 115 009637 00 Kit for SMR to A5 A3 without Hooks 0436 00 0198 Monitor Mounting Arm Pivot 16 0436 00 0258 Utility Tray Two Pivot 24 045 000250 00 Writing Surface Insert for Utility Tray 0436 00 0259 Mount Suction Canister 0992 00 0256 Regulator Patient Suction 0436 00 0207 Mounting Arm Suction Regulator 050 000702 00 Mounting Adapter Plate with Cable Hooks 115 011304 00 Cable Management Kit 115 004003 00 Mounting Kit for DPM7 Monitor 115 004004 00 Mounting Kit for DPM6 Monitor 046 003777 00 A5 A3 Operating Instructions Accessories
22. 4 Adjust the vaporizer concentration from 0 to 196 Ensure that the O flow must not decrease more than 1 L min through the full range Otherwise install a different vaporizer and repeat this step If the problem persists the malfunction is in the anesthesia system Do not use this system 5 Test each vaporizer as per the steps above NOTE Do not perform this test on the vaporizer when the concentration control is between OFF and the first graduation above 0 zero as the amount of anesthetic drug outputted is very small within this range 4 11 2 Manual Leak Test 1 Setthe Auto Manual ventilation switch to Manual 2 Connecta breathing circuit to the inspiratory and expiratory ports Connect a ventilation bag to the bag arm 3 Set APL Valve to 75 cmH 0 4 Close the breathing system at the patient connection by connecting the Y piece on the breathing circuit to the leak test port 5 Inflate the ventilation bag with O flush to 40 cmH 0 6 Verify that circuit holds pressure for greater than 10 seconds 7 Setthe APL valve to SP 4 11 3 Vaporizer Leak Test 1 Setthe ventilation Auto Manual ventilation switch to Manual 2 Setthe APL valve to the SP position A5 A3 Operating Instructions 046 003777 00 4 23 Vaporizer Tests Preoperative Tests 3 Connect one end of the breathing circuit to the bag arm one end to the inspiratory port and the Y piece to the test port 4 Mountand lock the vaporizer
23. 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 The valve will then be open for spontaneous patient breathing NOTE In the manual ventilation mode you can use the APL valve to adjust the breathing system pressure limit and gas volume in the manual bag When the pressure in the breathing system reaches the pressure limit set for the APL valve the valve opens to release excess gas NOTE The APL valve adjusts the breathing system pressure limit during manual ventilation Its scale shows approximate pressure Cardiac Bypass Mode A5 Only Cardiac Bypass mode is only available in Manual ventilation mode This mode turns off pressure volume and apnea alarms when they are not appropriate e g during heart lung bypass NOTE When Bypass mode is On the Alarms button is disabled and set to Off A confirmation dialogue appears when turning Bypass mode On Enter Cardiac Bypass mode by setting the Bypass softkey in Manual mode to On When the Bypass softkey is set to On the Alarm softkey is disabled and set to Off automatically When Bypass is set to Off the Alarm button returns to its setting before entering Bypass When exiting Manual mode or discharging a patient Bypass will be set to Off Discharge FIGURE 5 7 Bypass Mode Softkey Setting Alarms In Manual ventilation mode when Bypass is set to Off the pressure
24. Brightness Area 3 24 046 003777 00 A5 A3 Operating Instructions System Interface Display Tab Key Click Volume To adjust the key click volume 1 Select Setup softkey gt Display tab 2 In the Key Click Volume area select the buttons to adjust the key click volume 3 Select the Accept button to confirm the change Display Select the buttons to T adjust the key click volume FIGURE 3 30 A5 A3 Display Tab gt Key Click Volume Area Clean Screen To clean the LCD touch screen 1 Select Setup softkey gt Display tab 2 Select the Clean Screen button The screen will lock for 10 seconds for cleaning Calibrate Touch To calibrate the LCD touch screen 1 Select Setup softkey gt Display tab 2 Select the Calibrate Touch button 3 Follow the on screen directions Pressure Display To change the pressure display Select Setup softkey gt Display tab e Select the Pressure Display button Choose between Mean and Plat A OND Select the Accept button to confirm the change A5 A3 Operating Instructions 046 003777 00 3 25 Display Tab System Interface Plimit Line The Plimit line function displays a dashed line in the Pressure waveform area to indicate the Plimit position The Plimit line can be displayed in VCV SIMV VC and PCV with VG on mode The Plimit line function can be switched On or Off by the user The default value for Plimit Line is On
25. High priority IN 111 Medium priority IN Il Low priority N To display a list of all active alarms 1 Onthe Main Screen select the Alarms softkey or touch the Alarm Message area at the top of the screen The Alarms windows is displayed 2 Selectthe Active tab A list of all active alarm messages is displayed FIGURE 6 2 Up to 15 current alarms can be displayed on screen after which a scroll bar is used to display the remaining alarms Alarms are displayed in order of priority and time See section 6 2 1 pg 6 7 Displayed Order of Alarm Messages for more information Limit AN Power System Comm Stop Calibrate 02 sensor for 21 Load Alarm Defaults FIGURE 6 2 Active Alarms list in the Alarms window A5 A3 Operating Instructions 046 003777 00 6 5 Displaying Alarms Alarms and Messages To display filter or clear the Alarm Log 1 Onthe Main Screen select the Alarms softkey The Alarms windows is displayed 2 Select the Log tab Alist of all previous alarm messages is displayed 3 Select the arrow keys on the right side to move through the list of alarms 4 Optionally select the Filter button to display All alarms or only High Medium or Low priority alarms 5 Optionally select the Clear Log button to remove all alarms from the log f System Comm Stop Infant Fan Failure 02 i 23 300 mi 4 5 L min 0 cmH20 15 cmH20 18 cmH20 15 bpm 6 cmH20 FIGURE 6 3 Alar
26. Hose for Gas module to Quick Release Fitting A 3 Breathing System PART NUMBER DESCRIPTION 801 0631 00054 00 Bellows Dome A Series 801 0631 00055 00 Bellows Assembly A Series 801 0631 00057 00 Insp Exp Connector A Series 801 0631 00059 00 Insp Exp Connector Rotary Cap A Series 801 0631 00058 00 Water Trap A Series 801 0631 00061 00 Check valve dome A Series 801 0631 00104 00 Check valve A Series 801 0631 00063 00 Bag Arm Fixed Height A Series 801 0631 00064 00 Airway pressure gauge A Series A 2 046 003777 00 A5 A3 Operating Instructions Accessories CO Absorbent Canister e A 4 CO Absorbent Canister PART NUMBER DESCRIPTION 801 063 1 00066 00 CO Absorbent Canister A Series 801 0631 00099 00 CO Bypass Assembly A Series 801 0631 00092 00 CO Absorber Hose A Series 801 0631 00100 00 CO Absorber Base with Drain Valve A Series 0683 00 0325 01 CO Absorbent Loose Fill 1 0683 00 0325 12 CO Absorbent Loose Fill 12 0683 00 0326 01 CO Absorbent Pre Pak 1 0683 00 0326 12 CO Absorbent Pre Pak 12 A 5 Flow Sensor PART NUMBER DESCRIPTION 801 0631 00056 00 Expiratory Flow Sensor Assembly A Series 801 0631 00060 00 Inspiratory Flow Sensor Assembly A Series e e A 6 Gas Cylinder Accessories PART NUMBER DESCRIPTION 0348 00 0185 Washer Seal for Cylinder 801 063 1 00079 00 Gas C
27. Level 1 to 15 L min Plateau End Insp Plateau pressure in VCV and SIMV VC mode Adjustable from Off 5 to 60 of inspiratory period TABLE 8 20 General Ventilator Specifications Ventilator Parameter Settings Range Apnea Ti 0 2 to 5 0 sec PS Step 0 1 sec Tidal Volume 20 to 1500 mL VCV SIMV VC PCV Step 1 mL Respiration Rate 4 to 100 bpm VCV SIMV VC PCV SIMV PC Step 1 bpm Minimum Rate 2 to 60 bpm PS Step 1 bpm LE 4 1 to 1 8 VCV PCV Step 0 5 Tinsp 0 2 to 5 sec SIMV PC SIMV VC Step 0 1 sec Pinsp 5 to 70 cmH50 PCV SIMV PC Step 1 cmH5O Tpause OFF 5 to 6096 VCV SIMV VC Step 196 Plimit 10 to 100 cmH5O VCV SIMV VC Step 1 cmH O PEEP OFF 3 to 30 cmH 0O VCV SIMV VC PCV SIMV PC PS Step 1 cmH50 AP 3 to 50 cmH50 SIMV VC SIMV PC PS Step 1 cmH O Trigger 1to 15 L min SIMV VC SIMV PC PS Step 1 L min Tslope 0 0 to 2 0 sec SIMV VC SIMV PC PCV PS Step 0 1 sec NOTE The Tslope setting is an approximation The exact waveform shape may not be realized under certain clinical scenarios TABLE 8 21 Ventilator Parameter Settings Range 046 003777 00 A5 A3 Operating Instructions Product Specifications Ventilator Specifications VtG Off 20 to 1500 mL PCV Step 1 PlimVG 5 to 100 cmH50 PCV Step 1 cmH 5O SIMV PC VtG and PlimVG available on A5 only TA
28. Low Runtime No min for 1 second O N O Ratio Error N Oflowis greater than 0 5 L High Runtime No min and greater than 4 times O flow for 1 6 seconds Flowmeter Comm Lost communication with High Runtime o Stop CPU board for 10 seconds When this alarm is triggered the fresh gas flow value will be displayed as NO Fresh Gas Fresh gas flow is less than 50 Medium Runtime Yes mL min for 5 seconds when the machine is not in Standby mode 046 003777 00 A5 A3 Operating Instructions Alarms and Messages Alarm and Prompt Messages disabled or enabled A5 A3 Operating Instructions 046 003777 00 MACHINE DISABLE IN ALARM MODE WHEN STANDBY MESSAGE CAUSE PRIORITY CHECKED MODE Internal NO Flow Thel2C communication Low Runtime No Failure between the CPU and N20 flow sensor has failed Internal O Flow The I2C communication Low Runtime No Failure between the CPU and O flow sensor has failed Internal Air Flow The I2C communication Low Runtime No Failure between the CPU and Air flow sensor has failed TABLE 6 7 Electronic Flowmeter Board Runtime Alarm Messages 6 6 2 5 Ventilator Control Board Runtime Alarm MACHINE DISABLE IN ALARM MODE WHEN STANDBY MESSAGE CAUSE PRIORITY CHECKED MODE Aux Control Lost communication with High Runtime No Module Comm CPU board for 10 seconds Stop Ventilator Voltage 5V or 12V voltage error High Runtime No Error PEE
29. NOTE Apnea Ti permits the user to vary the inspiratory time of the apnea backup breaths Apnea backup breaths are only triggered when the patient does not achieve the Min Rate that is set by the user If the patient s spontaneous breaths meet or exceed the Min Rate the apnea backup is not used NOTE Before activating a new mechanical ventilation mode ensure that all related parameters are set appropriately A5 A3 Operating Instructions 046 003777 00 5 15 Start Mechanical Ventilation Operations 5 7 5 8 5 9 Start Mechanical Ventilation NOTE Before starting a new mechanical ventilation mode ensure that all related ventilation parameters are set appropriately To start mechanical ventilation from Standby mode 1 Setthe Auto Manual ventilation switch to Manual 2 Exit Standby by touching the main screen or by turning on the fresh gas flow to more than 0 2 L min 3 Setthe Auto Manual ventilation switch to Auto The A5 A3 system will begin mechanical ventilation Stop Mechanical Ventilation To stop mechanical ventilation l Ensure that the breathing system is set up and the APL valve is set properly before stopping mechanical ventilation 2 Setthe Auto Manual Bag switch to the Manual Bag position This selects manual ventilation and stops mechanical ventilation Relationships of Ventilation Parameters Ventilation modes may share the same ventilation parameters and values For example SIMV VC a
30. Never immerse the oxygen sensor or its connector in any type of liquid Dispose of the oxygen sensor per the manufacturer s specification Do not wash the inner surface of the oxygen sensor Do not autoclave the following components Paw gauge oxygen sensor flow sensor and bellows These components cannot withstand immersion or the heat and pressure of autoclaving No repair should ever be attempted by anyone not having experience in the repair of devices of this nature Replace damaged parts with components manufactured or sold by Mindray Then test the unit to ensure that it complies with the manufacturer s published specifications 046 003777 00 A5 A3 Operating Instructions Maintenance Theory of Operation 7 1 Theory of Operation The A5 A3 System is a pneumatically driven and electronically controlled anesthesia machine Three types of supply gases are available N5O O and Air The user adjusts supply gas flows through the flowmeters The mixed gas outputted from the flowmeters is further mixed with the anesthetic agent inside the anesthetic vaporizer to form fresh gas During the inspiratory phase the microprocessor controlled inspiratory valve produces the preset drive gas inspiratory flow and the expiratory valve closes The drive gas enters the bellows dome in the patient circuit and depresses the bellows inside the dome to move downward This forces the gas inside the bellows to enter the patient s lungs until the
31. Operating Instructions Preoperative Tests Pre operative Checkout List 8 Perform a 40 cmH 0 manual leak test If present set the left vaporizer to ON and perform a 40 cmH50 manual leak test Set the vaporizer to OFF Repeat for the right vaporizer if installed See Manual Leak Test on page 4 23 Perform a vaporizer leak test for each vaporizer installed on the A5 A3 system See Manual Leak Test on page 4 23 Check that AGSS float moves freely Set the vacuum flow so that the float position is between the Min and Max lines Inspect the AGSS on page 4 31 Drain any moisture from the breathing system water trap Prior to each patient before administering anesthesia the following should be done 9 Inspect the A5 A3 for damage or hazardous conditions ensure all necessary equipment and supplies are present e g drugs CO absorbent not exhausted breathing circuits and tank wrench Check that central supply O N20 and Air pressures are each within the pipeline input range specifications i e 40 to 87 psi Check that O5 N5O and Air flowmeters operate properly Check that all flow levels on the monitor screen are at zero flow with flow control valves closed Adjust flow of all gases through their full ranges and check for erratic movements of the gas levels Check that a hypoxic mixture of less than 21 O may not be administered Attempt to create an hypoxic O5 N50 mixture by slowly opening the N20 flow
32. Operating Instructions 046 003777 00 Cleaning and Disinfection Maintenance FIGURE 7 6 Detaching the Bellows 3 Detach the top plate from the bellows as shown in FIGURE 7 7 DT FIGURE 7 7 Detaching the Bellows Top Plate 4 Remove the bellows adapter ring from inside the bellows as shown in FIGURE 7 8 Note the orientation of the bellows adapter ring as it is being removed to ensure that it is properly inserted during reassembly If the ring contains grooves the ring should be oriented so that the grooves are facing downward in the final reassembly Grooves on adapter ring face downward FIGURE 7 8 Removing the Bellows Adapter Ring 7 12 046 003777 00 A5 A3 Operating Instructions Maintenance Cleaning and Disinfection 5 Remove the bellows dome O ring as shown in FIGURE 7 9 FIGURE 7 9 Removing the Bellows Dome O ring 6 Cleaning a To prevent damage wash each component gently using a recommended cleaning agent See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving Ensure that all bellows surfaces are cleaned Do not autoclave the bellows 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 Do not autoclave the following components Paw gauge oxygen sensor flow sensor and bellows These components cannot wit
33. Pinsp Rate Tinsp PS On Off AP Trigger PEEP Tslope PS Min Rate AP Trigger PEEP Tslope Apnea Ti Manual Bypass A5 only Alarms 5 6 3 Change Ventilation Mode To change ventilation mode to Manual 1 Use the Auto Manual Bag switch on the breathing system block to enter and exit Manual ventilation mode To change ventilation mode to VCV SIMV VC PCV SIMV PC A5 only or PS 1 Select the tab of the desired ventilation mode The Set Mode button or Preset Mode button in manual will flash FIGURE 5 5 A5 A3 Operating Instructions 046 003777 00 5 7 Ventilation Modes Operations 2 Select the Set Mode button or Preset Mode button in manual to confirm If the Set Mode button is not selected after several seconds an audio reminder will sound for several seconds and then the system will return to the previous ventilation mode 3 Optionally select each available ventilation parameter to edit the parameter setting 4 Move the Auto Manual Bag switch to the Auto position NOTE When the Auto Manual switch is in Auto position all the buttons in Manual tab Alarms Bypass and Discharge are disabled Alarms are set to On and Bypass is set to Off oO So DD 150 12 1201 3 1 On 1020 Orr I cmH20 bpm sec L min cmH20 sec cmH20 FIGURE 5 5 Ventilation Mode Tabs 5 6 4 Set Manual Ventilation Mode Manual ventilation mode is used for manually ventilating a patient or to let a patient breathe sp
34. Tpause 10 PEEP OFF Plimit 30 cmH 0 7 Turn the O flow control to set the O flow to 0 5 to 1 L min 8 Push the O flush button to expand the bellows to the top of the bellow enclosure 9 Touch the screen to exit Standby mode and begin ventilation 10 Ensure that The main screen displays the correctly set data The measured values should be within the tolerances specified in the specifications see Table 8 24 Control and Monitoring Accuracy on page 8 13 The bellows inflates and deflates normally during mechanical ventilation 4 13 2 Test the O Concentration Monitoring and Alarms 1 Setthe Auto Manual switch to Manual 2 Remove the O sensor After three minutes ensure that the sensor measures approximately 21 O in room air by verifying the FiO value on the main screen 3 Select the Alarms softkey and then the Limits tab Set the FiO low alarm limit to 50 4 Ensure that a low O alarm Paw Too Low occurs 5 Set the FiO low alarm limit back to a value less than the measured O value and ensure that the alarm cancels 6 Put the O sensor back in the breathing system 7 Select the Alarms softkey and then the Limits tab Set the FiO high alarm limit to 50 8 Connect the manual bag to the manual bag port Push the O flush button to fill the manual bag Ensure that the sensor measures at least 90 O 9 Ensure that a high O alarm occurs 10 Set the FiO high alarm limit to 10096 and en
35. USB mouse can serve as a backup to both the touchscreen and touchpad 1 1 3 Fresh Gas Dosing The A5 A3 fresh gas dosing subsystem offers the following features Virtual On Screen dual flow tube and numerical readouts to display the O5 N50 and Air flows Aknob guard to prevent inadvertent movement of the flow control knobs e Gas supply gauges to indicate the gas pipeline supply pressures and gas cylinder pressures Mechanical total flowmeter to display the combined flow of O Air and NO An O flush button A single combined output of auxiliary O and Air with flowmeters Safety systems within the A5 A3 work to prevent hypoxic mixtures from being delivered to the patient Nitrous oxide will not be delivered unless oxygen flow is present A pneumatic safety system assures that at least 2196 O is present when setting mixtures of O and N5O Additionally if the A5 A3 is placed in Power Standby mode O fresh gas flow is not available WARNING Ensure that both O and N50 flow controllers are turned OFF fully at the start and at the end of each case All A5 A3 units are designed to maintain a safe O5 N5O 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 2196 oxygen can be maintained The A5 A3 is designed to maintain oxygen flow at its previously set level when N5O is decreased When adjusti
36. Workplace Ergo mommies m E Physical Views Main Unit Front View Main Unit Rear View 1 10 MINUTES MES dida 1 12 EIA AR A teens eter re eerta A A est bene A ON esee secre Er AEREE 1 13 Main Unit Top View 14 Breathing System Top View 15 Breathing System Left Views ia p nin te i aan aaia eE E eee id 1 17 Anesthetic Gas Scavenging System AGSS Top Front and Right Views sssssssssssssssccssssececcssseccecsnssececesuseecessnssecesensssecessneseesseneseesee 1 18 AAA sedereke aoaea oessa oo aeeai a EN ETE N EAEE AREA AE AEE Lm EAEE EEE EE A Initial Setup Install the Vaporizer Filling and Draining the Vaporizer ssssesscccsssesccccsssescccesssseccesssescccesusescccsusessecsssseseecsusecescsnssecesessneececcsuseccecsusesescssuseecsssussesssnsseesesneeseessnneeeeeenee 2 7 SA N Main CCA COM OA aii 3 2 System Information Header eerte tette ee EOE ttes eater deett ette etd b eite Naa 3 5 Elapsed Timer Patient Size Alarm and Prompt Messages Missisipi n En K AEAEE E SE aa AI A E EEK E 3 5 A AS 3 6 Date and Time Battery Status Fresh Gas Flow Display Waveforms Tab tects s EEE E E E EE EE TE Waveform Colorear cnica LI Waveforms Autoscalltig 4 oerte EE AEE A ET AAE AEAEE E E AE A A A 3 11 A5 A3 Operating Instructions 046 003777 00 i Table of Contents Spirometry Tab A5 Only Loop T
37. a cam lock device that opens and closes to provide access to the absorber canister Either a CO absorbent Pre Pak or loose fill can be used Two water traps that can be drained are located on the CO absorber assembly and on the breathing system block NOTE Operating the A5 A3 with a full water trap in the breathing system block does not allow the water to condense appropriately The trap should be removed and emptied when filled with water 046 003777 00 A5 A3 Operating Instructions Product Description General System Overview Two 2 flow sensors in the breathing system measure inspired and expired gases for control and monitoring Inspired oxygen concentration is monitored via a fuel cell type sensor Breathing pressure is monitored with both a PAW gauge mechanical and electronic gauge The breathing system can be swiveled for ease of positioning A leak test port is provided to allow for leak testing during startup The main pneumatic components of the Breathing System are as follows Inspiratory Valve passive e Expiratory Valve passive Airway Pressure Limiting Valve APL Connection for O Sensor CO Absorber Assembly Bellows Assembly Auto Manual bag switch Bagarm PAW Gauge The Breathing system connects to the A5 A3 main unit through the following ports Drive gas port designed for use with oxygen as the drive gas Fresh gas port Exhaust gas port Flow sensor pressure transmiss
38. be seen in a darkened environment A maximum of two vaporizers can be attached for use at any one time Halothane Enflurane Isoflurane Desflurane and Sevoflurane vaporizers can be used For the A5 model a third non functional vaporizer parking spot on the side of the unit is provided as part of the standard configuration Anesthesia Ventilator The A5 A3 ventilator offers multiple ventilation modes Volume Control Ventilation VCV Synchronized Intermittent Mandatory Ventilation Volume Control SIMV VC Pressure Control Ventilation PCV Pressure Support PS ventilation and Manual ventilation The A5 offers additional ventilation modes which include Pressure Control Ventilation PCV with and without Volume Guarantee VG and Synchronized Intermittent Mandatory Ventilation Pressure Control SIMV PC Breathing System A portion of the patient circuit is integrated into an assembly block called the Breathing System The system contains a temperature controller which warms the block to a temperature of 359C typical at 20 C ambient temperature to limit the formation of water condensate The Breathing System can be swiveled horizontally up to 50 degrees for user convenience The breathing system provides access to the APL valve and breathing bag along with a view of the airway 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
39. breath rate SIMV PC synchronized intermittent mandatory ventilation pressure control SIMV VC synchronized intermittent mandatory ventilation volume control SP Spontaneous breathing T insp time of inspiration Tpause percentage of inspiratory plateau time in inspiratory time Tstope time for the pressure to rise to target pressure Trigger trigger sensitivity V tidal volume V G tidal volume guarantee VCV volume control ventilation VG volume guarantee control 046 003777 00 A5 A3 Operating Instructions Abbreviations Symbols and Units of Measure Symbols D 2 Symbols SYMBOL DESCRIPTION SYMBOL DESCRIPTION minus gt greater than percent lt less than or equal to per divide or gt greater than or equal to approximately plus or minus A power x multiply plus copyright equal to m trademark less than e registered trademark A5 A3 Operating Instructions 046 003777 00 D 3 Units of Measure Abbreviations Symbols and Units of Measure D 3 Units of Measure UNIT OF UNIT OF MEASURE DESCRIPTION MEASURE DESCRIPTION A Ampere Amp m meter Ah Amp hour mAh microAmp hour bpm breath per minute mbar mbar C degree Celsius mg milligram cc cubic centimeter min minute cm centimeter ml mL milliliter cmH O0 centimeter of water
40. control valve fully with the O flow valve fully closed no N5O gas should be flowing Then slowly open the O flow valve and observe O and N O rise in proportion to maintain a minimum concentration of 21 O in fresh gas Perform a vaporizer leak test for each vaporizer installed on the A5 A3 system See Manual Leak Test on page 4 23 Verify that Auxiliary O5 and Air are available and functioning Verify that a Self inflating Manual Ventilation device is available and functioning Check that the O5 NO and Air cylinders if present are mounted on the A5 A3 have adequate pressure and no high pressure leaks are present See Cylinder Tests on page 4 21 Check that valves on the O5 N30 and Air cylinders if present are closed until needed to prevent unintentional use of gas 10 With a breathing circuit and reservoir bag attached check that the unidirectional valves operate by visual inspection 11 Check ventilation capability in Standby Manual VCV and PCV ventilator modes 12 Check that patient suction is adequate to clear the airway 13 verify ability of required monitors and check alarms The following step is recommended to be performed when prompted by the machine Complete the 2196 O Calibration See O Sensor Calibration on page 7 6 The following step is recommended when replacing an O sensor A5 A3 Operating Instructions 046 003777 00 4 5 Pre operative Checkout List Preoperative Te
41. deett eiut A atest 3 5 Fresh Gas FIOWDIS Pla cita atte d deed amps 3 9 HUGE ED 3 10 Spirometry TADA a ma a due iato C te eal Bote d 3 12 VentilatioriMode TaD5 soe tameii tas usui tud entes Md ce 3 18 Measured Values ATea ac et et M t i A delhi LU el ak teu Lira adis 3 20 System SOFTKEY Sr cta ute e a utet el e eel cea LL 3 21 A O 3 24 A5 A3 Operating Instructions 046 003777 00 Main Screen Components System Interface 3 1 Main Screen Components The components of the Main screen are shown in FIGURE 3 1 Current Mode AMI O2 Sensor Failure E ADULT VCV A No breath detected in last 120 secs 120 sec Waveforms 129 NE Du prese ae cmH20 cmH20 Setup Alarms 12 13 FIGURE 3 1 A5 Main Screen Components 3 2 046 003777 00 A5 A3 Operating Instructions System Interface Main Screen Components AMI High Priority Message Waveforms Alarms 12 13 FIGURE 3 2 A3 Main Screen Components MAIN SCREEN NUMBER COMPONENT DESCRIPTION 1 Elapsed Timer Displays elapsed time Select to start stop or reset the timer 2 Fresh Gas Flow Area Displays real time flowmeter levels for N50 Air and O5 3 Patient Size Displays the currently selected patient size Adult Pediatric or Infant Select to change the patient size when the A5 A3 is in Standby mode or Manual mode 4 Current Ventilation Mode Displays the current ventilation mode VCV SIMV VC PCV SIMV PC PS Manual or Bypas
42. dialog box will appear with the choices of Baseline and Reference Select Baseline A confirmation dialog will be displayed with the text Selecting Yes will replace the currently saved Baseline loop Do you want to proceed If Yes is selected the currently saved baseline loop will be replaced If No is chosen the save will be aborted To save a reference loop 1 From the main screen select Spirometry tab gt Save Loop softkey If a baseline loop is already saved in memory a dialog box will appear with the choices of Baseline and Reference Select Reference A maximum of four 4 sets of Reference loops plus one 1 Baseline loop and corresponding numeric data can be saved When the maximum of four 4 loops is reached and the user attempts another save a confirmation dialog will be displayed with the following text Selecting Yes will replace the oldest reference loop Do you want to proceed If Yes is chosen the oldest data will be removed as the new data is added If No is chosen the save will be aborted 3 5 4 Review Loops Button Selecting the Review Loops softkey FIGURE 3 15 displays the Review Loops screen FIGURE 3 16 The following areas and selections are displayed Small Loop Windows These small graphic windows show the baseline and reference loops The baseline loop only one is always located on the left and has a white border around its graph The reference loops up to four are located t
43. due to inspiratory and expiratory gas flow in the breathing system at reference flows of 0 5 and 1 0 L sec are Manual Inspiratory flow flow rate 0 5 L s 0 59 kPa resistance Manual Inspiratory flow flow rate 1 0 L s 0 24 kPa resistance Manual Expiratory flow flow rate 0 5 L s 0 21 kPa resistance Manual Expiratory flow flow rate 1 0 L s 0 43 kPa resistance Auto Inspiratory flow flow rate 0 5 L s 0 23 kPa resistance Auto Inspiratory flow flow rate 1 0 L s 0 58 kPa resistance Auto Expiratory flow flow rate 0 5 L s 0 44 kPa resistance Auto Expiratory flow flow rate 1 0 L s 0 20 kPa resistance CO Absorber Resistance For a filled CO absorber resistance at 1 L sec flow 0 14 kPa CO Absorber Capacity CO absorber capacity is 1 Pre Pak or 1500 mL Unidirectional Valve Opening Pressure Dry 0 03 kPa opening pressure Wet 0 05 kPa opening pressure 046 003777 00 A5 A3 Operating Instructions Product Specifications Data Storage Non Volatile and Recording 8 15 Data Storage Non Volatile and Recording Configuration Storage A5 A3 anesthesia system supports one factory configuration group and one user configuration group Each configuration has three patient size types Adult Pediatric and Infant Log Storage 500 entries of alarm log 500 entries of activity log 500 entries of error log 500 entries of service log TABLE 8 30 Data Storage Non Vo
44. following priority high medium or low Technical Alarm This is an alarm caused by a machine related variable It requires a response from the user It can have the following priority high medium or low Prompt Message This is a message to the user It does not require a response from the user It always has the lowest priority below Physiological and Technical alarms It is displayed in black A5 A3 Operating Instructions 046 003777 00 6 3 Introduction Alarms and Messages 6 1 3 Alarm Indicators The A5 A3 provides the following alarm indicators Analarm LED located on top of the LCD monitor The LED can illuminate red yellow cyan or OFF depending on the alarm condition Table 6 1 describes the alarm behavior of different alarm types and different alarm priority labels If multiple alarms occur simultaneously the audio and LED behavior will follow the highest priority active alarm Colored alarm messages displayed on the Main Screen High priority messages are red Medium priority messages are yellow Low priority messages are cyan Prompt messages are black Messages are displayed according to priority and time See Displayed Order of Alarm Messages on page 6 7 Alarm audio through the system alarm speaker Table 6 1 lists the audio behavior for each type of alarm ALARM ALARM LED ALARM TYPE PRIORITY AUDIO BEHAVIOR MESSAGE BEHAVIOR COLOR Physiological High Play hig
45. for 2196 is displayed at the next Standby mode after 5am after 72 hours have elapsed since the last successful calibration NOTE If the alarm message RT Clock Needs Battery or RT Clock Failure is displayed the prompt message Calibrate O2 sensor for 21 is disabled The O sensor must be removed from the breathing system before calibrating it at 21 The O sensor can be reinstalled after verifying that there is no water build up in the O sensor and its installation part 7 6 046 003777 00 A5 A3 Operating Instructions Maintenance O Sensor Calibration 7 6 1 Calibrate the O5 Sensor 21 O sensor calibration can be performed in all ventilation modes when calibrating from the Setup General tab When calibrating from the Setup System tab the A5 A3 must be placed in Standby mode and a system password is required See System Tab on page 3 27 for password information NOTE The breathing system automatically seals off the O sensor port when the O sensor is removed 1 Set the A5 A3 to Standby mode a Set the Auto Manual ventilation switch to Manual b Turn off all fresh gas flows by turning their knobs clockwise Wait until all fresh gas flow levels are effectively at 0 0 L min i e flow 0 05 L min C Select the Discharge button in the Manual tab NOTE The A5 A3 system will not allow the Discharge button to be selected until the Auto Manual ventilation switch is set to Manual and system detects
46. mm millimeter dB decibel mmHg millimeter of mercury F Fahrenheit ms millisecond g gram mV milliVolt hr hour mW milliWatt Hz Hertz ppm part per million hPa hectoPascal S Sec second inch inch V Volt k kilo VA Volt Amp kg kilogram VAC Volts alternating current kPa kiloPascal Q Ohm psi pound force per square inch uA microAmp L I liter uV microVolt lb pound Ww Watt nm nanometer 046 003777 00 A5 A3 Operating Instructions Abbreviations Symbols and Units of Measure Attention Symbols D 4 Attention Symbols The following figures provide descriptions of symbols of Attention that are used on the device and or within this manual C 3 O hal BL ooo joco A 4 FIGURE D 1 Main Unit Front View A5 A3 Operating Instructions 046 003777 00 D 5 Attention Symbols Abbreviations Symbols and Units of Measure ATTENTION NUMBER DESCRIPTION 01 Total Flowmeter The total flowmeter is calibrated based on 100 O The accuracy of the flowmeter may degrade with other gas or mixed gas When viewing the readings on the total flowmeter keep your visual angle at the same level of the float The reading of the scale may vary when viewed at a different angle If the readings shown on the electronic flowmeters di
47. onto the vaporizer mount Certain vaporizers need to be set to at least 196 for correct testing See the vaporizer manufacturer s manual for details 5 Set the fresh gas flow to 200 mL min 6 Set the APL valve to 75 and verify that the pressure on the airway pressure gauge increases above 30 cmH20 within 2 minutes 7 Turn off the vaporizer 8 Repeat Steps 4 5 6 and 7 for the other vaporizer 4 24 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Breathing System Tests 4 12 Breathing System Tests WARNING Objects in the breathing system can stop gas flow to the patient This can cause injury or death Ensure that there are no test plugs or other objects in the breathing system WARNING Do not use a test plug that is small enough to fall into the breathing system 1 Ensure that the breathing system is correctly connected and not damaged 2 Ensure that the check valves in the breathing system work correctly 1 The inspiratory check valve opens during inspiration and closes at the start of expiration 2 The expiratory check valve opens during expiration and closes at the start of inspiration 4 12 1 Bellows Test l Select the Discharge button in the Manual tab 2 Follow the screen prompts to discharge the patient and enter Standby mode 3 Set the ventilation switch to the automatic ventilation position 4 Setallflow controls to Off 5 Close the breathing system at the patient connectio
48. problems If the problem persists contact your service personnel NOTE The Disable in Manual and Cardiac Bypass mode column indicates how this alarm is controlled by the alarm on off button and the cardiac bypass mode button in manual mode NOTE The Disable in Standby mode column indicates which physiological alarms will be disabled automatically in Standby mode A5 A3 Operating Instructions 046 003777 00 6 13 Alarm and Prompt Messages 6 6 1 Physiological Alarm Messages Alarms and Messages DISABLED DISABLED WHEN IN ALARM ALARM STANDBY MESSAGE CAUSE PRIORITY IS OFF MODE Apnea Two triggering conditions occur Medium Yes N A simultaneously 1 Paw lt PEEP 3 cmH5O for more than 30 seconds 2 Vt lt 10 mL for more than 30 seconds Apnea 2 min No breath has been detected within High Yes N A the last 120 seconds Paw Too High Ppeak gt Paw high alarm limit setting High Yes N A Paw Too Low Ppeak x Paw low alarm limit setting High Yes N A for 20 seconds Pressure Limiting Paw gt Plimit Low N A N A FiO Too High FiO gt high alarm limit setting Medium No N A FiO Too Low FiO lt low alarm limit setting High No N A MV Too High MV gt high alarm limit setting Medium Yes N A MV Too Low MV low alarm limit setting Medium Yes N A Continuous Paw in the breathing circuit High No N A Airway Pressure sustained airway pressure alarm limit for 15 se
49. the individual fresh gas flows are effectively turned off i e flow 0 05 L min d Follow the screen prompts to discharge the patient and enter Standby mode 2 Select Setup General Calibrate O Sensor Only 21 O sensor calibration is available in the General tab or Select Setup gt System system password needed gt Calibration gt O Sensor Both 21 and 100 O sensor calibrations are available in the System tab The 21 button is highlighted by default NOTE In the System tab 21 oxygen sensor calibration must be completed before performing 100 calibration The 100 button is disabled if a 21 oxygen sensor calibration has not been successfully completed within 72 hours 3 Remove the O sensor from the O sensor port on the breathing system Allow three 3 minutes for the sensor to acclimate to the environment 4 Carefully follow the on screen prompts to prepare for calibration 5 Select the Begin button to start 21 O sensor calibration The system will indicate the calibration status when the process is completed 6 When 21 O sensor calibration is successfully completed reinstall the O5sensor into the O5 sensor port on the breathing system If an error code in red e g 00 00 00 10 is displayed see Table 7 2 O Sensor Calibration Error Codes on page 7 8 for troubleshooting information 7 Ifyou are in the Setup gt General select Done when 21 O2 sensor calibration is completed Skip the
50. the measured value whichever is greater gt 1500 mL not defined TABLE 8 24 Control and Monitoring Accuracy A5 A3 Operating Instructions 046 003777 00 8 13 Ventilator Specifications Product Specifications Airway Pressure Monitoring 2 0cmH 0 or 5 of the set value whichever is greater PEEP Monitoring Accuracy 0 to 30 cmH5O 2 0 cmH5O or 10 of the displayed value whichever is greater gt 30 cmH 0 not defined Respiration Monitoring Accuracy 1 bpm or 10 of the set value whichever is smaller Minute Volume Monitoring Accuracy 0 to 30 L min 15 of the displayed value repeatable to 5 over a 1 hour period Specifications are applicable after warm up time of the Breathing System Section 8 8 7 TABLE 8 24 Control and Monitoring Accuracy 8 14 046 003777 00 A5 A3 Operating Instructions Product Specifications Displays and Controls Specifications 8 11 Displays and Controls Specifications 8 11 1 Electronic Controls Display Size Color LCD 15 inch diagonal 4 3 ratio 1024 X 768 resolution TFT technology with touch screen Graphic Waveforms Airway Pressure and Flow Graphic Virtual Flow Meters Displayed range N O Air O 0 to 15 L min Control range Air O5 0 to 15 L min Control range N50 0 to 10 L min Accuracy 10 or 0 12 L min whichever is greater Resolution 50 mL min Q 0 to 1 L min 100 mL min 1 to 15 L min Numeric Data Tidal Volume Minute
51. the patient requires continuous automatic ventilation Select the Patient Size Adult Pediatric Infant Patient size can only be changed when the current ventilation mode is Manual mode or Standby mode 1 Select Manual mode or the Discharge button in the Manual tab to enter Standby mode 2 Select the Patient Size softkey at the top left of the main screen The softkey displays Adult Pediatric or Infant 3 Select the Patient Size Adult Pediatric or Infant 4 Select the Accept softkey to finalize your selection NOTE The A5 A3 saves the latest patient parameter settings VCV PCV PCV VG A5 only PS SIMV VC SIMV PC A5 only and Alarms for each patient type Adult Pediatric and Infant Changing to another patient type does not erase the parameter settings from the previous patient type For example changing from Adult to Pediatric and back to Adult will result in the Adult patient parameter settings still saved Patient Size k 4 FIGURE 5 4 Patient Size Setup Menu Oxygen Sensor Calibration If oxygen sensor calibration is needed please see O Sensor Calibration on page 7 6 046 003777 00 A5 A3 Operating Instructions Operations Input Fresh Gas 5 5 Input Fresh Gas 5 5 1 Set N5O Air and O Inputs 1 You can control the N5O Air and O flows in the fresh gas through the N50 Air and O flow controls Readings of the gas flow can be seen on the respective elec
52. this location Bar holds two vaporizers An interlock within the vaporizers provides for use of one vaporizer to deliver one agent at a time D2 Key Lock Key and lock for securing the drawers D3 Storage Drawers Drawers 3 for storage lockable D4 Rail Mount Enables mounting of patient monitors and most standard attachment arms for other devices Rail mounts are on both left and right sides of the A5 A3 A5 A3 Operating Instructions 046 003777 00 1 13 Physical Views Product Description 1 2 5 Main Unit Top View Front FIGURE 1 6 Main Unit Top View PART S DESCRIPTION E1 Top Shelf Top level surface E2 Work Level Shelf Work Level surface stainless steel E3 Handle Wrap around metal bar used to assist moving the A5 A3 device E4 Mounting Holes Allows mounting of optional equipment to the top shelf e g DPM6 and DPM7 mounting plates and kits See section A 9 pg A 4 Mounting Accessories 14 046 003777 00 A5 A3 Operating Instructions Product Description Physical Views 1 2 6 Breathing System Top View FIGURE 1 7 Breathing System Top View PART S F1 Bellows including bellows dome DESCRIPTION Bellows that separates the breathing system gases from the oxygen drive gas F2 PAW Gauge Indicates the patient airway pressure F3 Expiratory Limb Exhaled breathing circuit connection
53. to 134 C Polyphenylsulfone PPSU 15 APL Valve The APL valve and PAW gauge numerics are for reference only Calibrated patient airway pressure is displayed on the user interface A5 A3 Operating Instructions 046 003777 00 D 11 Attention Symbols Abbreviations Symbols and Units of Measure FIGURE D 7 Breathing System Left View ATTENTION NUMBER DESCRIPTION 16 134 C gt PPSU lt Autoclavable up to 134 C Operating the A5 A3 with a full water trap in the breathing system block does not allow the water to condense appropriately The trap should be removed and emptied when filled with water Operating without a water trap will cause the Leak Test to fail 17 Bellows Dome The bellows dome is a transparent cover with graduation marks from 300 to 1500 These marks are for qualitative purposes only Tidal volume VT should be read exclusively from the display of the user interface Delivered tidal volume VT is a combination of bellows displacement and fresh gas flow D 12 046 003777 00 A5 A3 Operating Instructions Abbreviations Symbols and Units of Measure Attention Symbols This page intentionally left blank A5 A3 Operating Instructions 046 003777 00 D 13 046 003777 00 Rev B October 4 2012 Mindray DS USA Inc 800 MacArthur Boulevard e Mahwah NJ 07430 e USA e Dom
54. use or order the use of this device To ensure patient safety use only parts and accessories specified in this manual At the end of its service life the equipment as well as its accessories must be disposed of in compliance with the guidelines regulating the disposal of such products and in accordance with local regulations for contaminated and biologically hazardous items Magnetic and electrical fields are capable of interfering with the proper performance of the equipment Ensure that all external devices operating in the vicinity of the equipment comply with the relevant EMC requirements Mobile phones x ray equipment and MRI devices are possible sources of interference as they may emit higher levels of electromagnetic radiation This system operates correctly at the electrical interference levels identified in this manual Higher levels can cause nuisance alarms that may stop mechanical ventilation Be aware of false alarms caused by high intensity electrical fields The A5 A3 Anesthesia System may become unstable if the unit is tilted beyond 10 degrees Use extreme caution when moving or resting the unit on surfaces exceeding a 10 degree slope Do not hang articles on the sides of the unit that would cause an excessive imbalance Perform the daily checks specified on the checklist In case of a system fault do not operate the system until the fault has been corrected Before starting the machine users must be familiar wit
55. volume and apnea alarms can be turned off by setting the Alarms softkey to Off The related alarm limits are then displayed as Off Pressure volume and apnea alarms can be turned on by setting the Alarms softkey to On which returns the related alarm limits to their original settings A5 A3 Operating Instructions 046 003777 00 5 9 Ventilation Modes Operations Waveforms Discharge FIGURE 5 8 Set Alarms to Off 5 6 5 Make Settings before Starting Mechanical Ventilation Mode 1 Set the Auto Manual ventilation switch to Manual If discharging a patient select the Discharge button in the Manual tab to enter Standby mode 2 Select the desired ventilation mode tab 3 Set the desired ventilation parameters 4 Select the Preset button flashing green on the right of the ventilation tabs to confirm the ventilation mode 5 If necessary push the O flush button to inflate the bellows 6 Ifin Standby exit Standby by touching the main screen or by turning on the fresh gas flow to more than 0 2 L min 7 Tobegin mechanical ventilation set the Auto Manual ventilation switch to Auto 5 6 6 Set Volume Control Ventilation VCV Volume Control Ventilation VCV mode is a fully mechanical ventilation mode In the VCV mode each time mechanical ventilation starts gas is delivered to the patient at a constant flow which reaches the preset Vt within the gas delivery time To ensure a certain amount of Vt the resulted air
56. wrench is attached 8 Thenecessary emergency equipment is available and in good condition 9 Equipment for airway maintenance and tracheal intubation is available and in good condition 10 Inspect the color of the sodalime in the canister Replace the sodalime immediately if obvious color change is detected The sodalime is white when new If it is purple it must be changed 11 Applicable anesthetic and emergency drugs are available 12 13 Ensure the breathing system is in proper position The casters are not damaged or loose and the brake s is set and prevents movement 14 The AC mains indicator and the battery indicator are displayed when the power cord is connected to the AC power source If the indicators are not displayed the system does not have electrical power 15 The A5 A3 anesthesia machine is switched on or off normally A5 A3 Operating Instructions 046 003777 00 4 3 Pre operative Checkout List Preoperative Tests 4 3 4 3 1 4 3 2 Pre operative Checkout List Introduction The purpose of the pre operative checkout is to detect potential system problems before use An effective method for detecting pneumatic circuit occlusions leaks and other system problems can be found in the A5 A3 pre operative checkout procedures In addition it is recommended that the breathing circuit be tested for the ability to effectively deliver positive pressure ventilation before beginning each case Tes
57. 0 cmH5O Infant 20 cmH O Infant 20 cmH O PlimVG A5 Range 5 100 only cmH O Step 1 cmH5O Default Pinsp PEEP Range Range Range Range Range Off 3 to 30 cmH O Step 1 cmH O Default Off Off 3 to 30 cmH O Step 1 cmH O0 Default Off Off 3 to 30 cmH O Step 1 cmH O0 Default Off Off 3 to 30 cmH O Step 1 cmH O Default Off Off 3 to 30 cmH 0 Step 1 cmH5O Default Off s nojag K10J2p pub s1ejeuruog sepoyy UOHD YU3SA 01 8 00ZZZ 009rO suoyonusu BuyosadO we V SV A D PARAMETER VCV SIMV VC PCV SIMV PC PS MANUAL gt AP Range Range Range 3 3 to 50 cmH O 3 to 50 cmH 0 3 to 50 cmH 0 m 1 Step 1 Step 1 Step 1 o gt n Defaults Defaults Defaults Adult 8 cmH 0 Adult 8 cmH 0 Adult 8 cmH 0 Pediatric 5 cmH 0 Pediatric 5 cmH 0 Pediatric 5 cmH 0 Infant 5 cmH5O Infant 5 cmH5O Infant 5 cmH5O Trigger Range Range Range 1to 15 L min 1to 15 L min 1 to 15 L min Step 1 Step 1 Step 1 Defaults Defaults Defaults Adult 3 L min Adult 3 L min Adult 3 L min Pediatric 2 L min Pediatric 2 L min Pediatric 2 L min Infant 2 L min Infant 2 L min Infant 2 L min Tslope Range 0 0 to 2 0 sec Range 0 0 to 2 0 sec Range 0 0 to 2 0 sec Range 0 0 to 2 0 sec Step 0 1 sec Step 0 1 sec Step 0 1 sec Step 0 1 sec Default 0 2 sec Default 0 2 sec Default 0 2 sec Default 0 2 sec PS Range On O
58. 03777 00 4 25 Breathing System Tests Preoperative Tests 4 Connect the manual bag to the manual bag port 5 Connect the Y piece on the breathing circuit to the leak test port 6 Turn the APL valve control to 30 cmH 0O 7 Push the O flush button to inflate the manual bag 8 Ensure that the reading on the airway pressure gauge is with the range of 25 to 35 cmH 0 9 Turn the APL valve control to the fully open position 10 Set the O flow to 3 L min Turn any other gases off 11 Ensure that the reading on the airway pressure gauge is less than 5 cmH5O 12 Push the O flush button continuously Ensure that the reading on the airway pressure gauge does not exceed 10 cmH 0O 13 Turn the O flow control to Off Ensure that the reading on the airway pressure gauge does not decrease below 0 cmH5O 4 26 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Alarm Tests 4 13 Alarm Tests Alarms also can be verified by creating an alarm condition on the A5 A3 and verifying the corresponding alarm indicators are present on the monitor 4 13 1 Prepare for Alarm Tests 1 Connect a test lung or manual bag to the Y piece of the breathing circuit 2 Set the Auto Manual switch to Auto 3 Setthe system switch to the On position 4 Set the system to Standby mode 5 Set the Patient Size to Adult 6 Set the ventilator controls as follows e Ventilation mode select VCV e Vt 500 mL Rate 12 bpm e E 12
59. 2 2 Adjust the Concentration of Anesthetic Agent Push and turn the concentration control on the vaporizer to set the appropriate concentration of anesthetic agent For details about how to use the anesthetic agent refer to the Vaporizer Instructions for Use 5 6 046 003777 00 A5 A3 Operating Instructions Operations Ventilation Modes 5 6 Ventilation Modes NOTE In all ventilation modes when inspiration pressure reaches the high alarm limit of Paw the system switches to expiration immediately and airway pressure is released 5 6 1 Monitored Parameters The A5 A3 monitors the following ventilation parameters PARAMETER RANGE COMMENTS PEAK 20 120 cmH O MEAN 20 120 cmH O Vt 0 3000 mL MV 0 100L PLAT 20 120 cmH 0 Rate 0 120 bpm PEEP 0 70 cmH O FiO 18 100 LE Displayed only in SIMV VC SIMV PC and PS modes If the monitored parameter is out of range it will be displayed as FjO measurements between 100 and 110 inclusive will be displayed as 100 Above this range the system will display 5 6 2 Ventilation Modes The A5 A3 provides the following ventilation modes VENTILATION MODE PARAMETERS VCV Vt Rate E Tpause PEEP Plimit SIMV VC Vt Rate Tinsp Tpause PEEP Plimit PS On Off AP Trigger Tslope PCV A5 VtG PlimVG Pinsp Rate I E PEEP Tslope A3 Pinsp Rate I E PEEP Tslope SIMV PC A5 only
60. 3 Setthe system switch to the On position 4 Set the flow controls approximately to mid range approximately 6 L min 5 Check that all pipeline pressure gauges show 280 to 600 kPa 6 Disconnect the N5O pipeline supply 7 Ensure that the N5O gauge goes to zero 4 18 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Pipeline Tests 4 7 3 Air Pipeline Test NOTE Different from the O pipeline supply when the Air pipeline supply is disconnected no alarms related to Air pressure occur as Air pressure decreases 1 Connect the Air pipeline supply 2 Close all cylinder valves ifthe A5 A3 anesthesia machine is equipped with cylinders 3 Setthe system switch to the On position 4 Set the flow controls approximately to mid range approximately 6 L min 5 Check that all pipeline pressure gauges show 280 to 600 kPa 6 Disconnect the Air pipeline supply 7 Ensure that the Air gauge goes to zero A5 A3 Operating Instructions 046 003777 00 4 19 Basic Ventilation Testing Preoperative Tests 4 8 Basic Ventilation Testing a Attach a breathing circuit and breathing bag b Attach an adult test lung or breathing bag to the patient end of the Y fitting of the breathing circuit Set the O flow to 3 L min and set the N5O and AIR flow rates to zero flow d Set the ventilator controls to VENTILATOR CONTROLS VENTILATOR SETTINGS Patient Type Adult Ventilation Mode
61. 61000 4 5 mode mode a typical commercial or hospital environment 2 kV common 2 kV common mode mode Voltage dips lt 5 U gt 95 dip lt 5 U gt 95 dip Mains power quality should be that of short a typical commercial or hospital interruptions and voltage variations on power supply in Ur for 0 5 cycle 40 Ur 60 dip in Ux for 5 cycles in Ur for 0 5 cycle 4096 Ur 6096 dip in Ux for 5 cycles environment The A5 A3 requires continued operation during power mains interruptions and is therefore input lines IEC provided with batteries that supply 61000 4 11 uninterruptible power 70 Ur 30 dip in 70 Ur 30 dip in Uy for 25 cycles Uy for 25 cycles 596 Uz 29596 dip 596 Uz 29596 dip in UT for 5 sec in Uy for 5 sec Power frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz should be at levels characteristic of a magnetic field typical location in a typical IEC 61000 4 8 commercial or hospital environment Ur is the A C mains voltage prior to application of the test level TABLE 8 32 Continued Guidance and Declaration Electromagnetic Immunity GUIDANCE AND DECLARATION ELECTROMAGNETIC IMMUNITY The A5 A3 is intended for use in the electromagnetic environment specified below The customer or the user of the A5 A3 should assure that it is used in such an environment IMMUNITY IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT TEST LEVEL LEVEL GUIDANCE Portable and m
62. 7 00 A5 A3 Operating Instructions po Abbreviations Symbols and Units of Measure Abbreviations Symbols and Units of Measure Abbreviations inset UASO MCA SUITE aset teet hood tds bet indebite Aan iiaia D 4 Attention Symbols A5 A3 Operating Instructions 046 003777 00 D Abbreviations Abbreviations Symbols and Units of Measure D 1 Abbreviations ABBREVIATION DESCRIPTION AA anesthetic agent AG anesthetic gas AGSS anesthetic gas scavenging system APL airway pressure limit Apnea Ti inspiratory time for apnea backup breaths BTPS body temperature and pressure saturated C compliance C yn CO carbon dioxide FIO fractional concentration of oxygen in inspired gas Flow flow LE ratio of inspiration time to expiration time MEAN mean pressure Min Rate minimum breath rate MV minute volume NO nitrous oxide O oxygen P insp pressure control level of inspiration Plimit pressure limit level Plim VG pressure limit level of volume guarantee PAW airway pressure PCV pressure control ventilation PEAK peak pressure PEEP positive end expiratory pressure PLAT plateau pressure PS pressure support AP pressure support level added to PEEP R resistance Rate
63. A23 AC Status LED Illuminated when the system is connected to an AC power source A24 Battery Charging LED Illuminated when the battery supply is charging A25 Main Power Switch Switch to turn the system ON or switch to Power Standby If the system is plugged into an external power source the internal battery supply will continue charging in both ON and Power Standby switch positions If the A5 A3 is in Power Standby mode O fresh gas flow is not available A26 Handle Metal bar used to assist moving the A5 A3 A27 Key lock Key and lock for securing the drawers A28 Storage Drawers Drawers 3 for storage lockable A5 A3 Operating Instructions 046 003777 00 Physical Views Product Description 1 2 2 Main Unit Rear View a cm mcam E Ne eure ld F M B8 F gt pa I NU 1 A B10 B a S B11 N ye N d N d N A EI pel B12 FIGURE 1 3 Main Unit Rear View PART S DESCRIPTION B1 Circuit Breakers Breakers for each auxiliary outlet A5 3 A each quantity 4 10 A total quantity 1 A3 3 A each quantity 3 B2 Mains Inlet Connects the mains power cord B3 Exhaust Fan Forces air to cool electronics and prevent buildup of O3 concentration
64. Auto Manual ventilation switch to Manual 2 Turn off all fresh gas flows by turning their knobs clockwise Wait until all fresh gas flow levels are effectively at 0 0 L min i e flow 0 05 L min NOTE The A5 A3 system will not allow the Discharge button to be selected until the Auto Manual ventilation switch is set to Manual and system detects the individual fresh gas flows are effectively turned off i e flow 0 05 L min 3 Select the Discharge button in the Manual tab see Figure 5 2 4 Follow the screen prompts to discharge the patient and enter Standby mode A5 A3 Operating Instructions 046 003777 00 5 3 Oxygen Sensor Calibration Operations 5 3 2 5 4 5 To exit Standby set the Auto Manual ventilation switch to Manual then touch the screen or turn on the fresh gas flow to more than 0 2 L min of individual gas NOTE To exit Standby by turning on the fresh gas flow the flow must be increased to more than 0 2 L min NOTE The Discharge button can be selected only when the system is not in Standby all fresh gas flows are off and the Auto Manual switch is in the Manual position NOTE When the system is in Standby mode the Bypass and Discharge buttons in the Manual tab are disabled However the Alarms button remains enabled and can be toggled to On or Off WARNING Selecting Discharge to enter Standby mode will stop automatic ventilation and parameter monitoring Do not select Standby mode if
65. BLE 8 21 Ventilator Parameter Settings Range Ventilator Performance Drive Pressure 280 to 600 kPa Inspiratory flow range 2 4 to 110 L min Flow Valve Range 1 to 110 L min TABLE 8 22 Ventilator Performance Ventilator Monitored Parameters Oxygen Monitor Type Galvanic fuel cell FiO displayed 18 to 100 vol O Accuracy of measurements volume fraction of 2 5 2 5 gas level Response Time of O Sensor lt 20 seconds Pressure Monitor PEEP range 0 to 70 cmH O Pmean range 20 to 120 cmH O Ppeak range 20 to 120 cmH5O Pplateau range 20 to 120 cmH5O Ventilator Monitor Tidal Volume Range 0 to 3000 mL Minute Volume Range 0 to 100 L Respiration Monitor Rate range 0 to 120 bpm TABLE 8 23 Ventilator Monitored Parameters Control and Monitoring Accuracy Volume Control O driving 60 mL 10 mL 260 mL and x210 mL 15 mL gt 210 mL 7 of the set value Volume Control 75 mL 15 mL 275 mL 20 mL or 10 of the set value whichever is greater Pressure Control Pinsp 2 5 cmH5O or 7 of the set value whichever is greater Plimit 10 of the set value PEEP Control 3 to 30 cmH 0 2 0 cmH50 or 10 of the displayed value whichever is greater OFF not defined Volume Monitoring O driving 60 mL 10 mL 260 mL and lt 210 mL 18 mL gt 210 mL 9 of the set value Volume Monitoring lt 75mL 15 mL gt 75 mL and lt 1500 mL 20mL or 10 of
66. Compliance button Follow the on screen directions and prompts See Leak and Compliance Tests on page 4 9 for more information Note that information for the last Leak Test Compliance is displayed next to the button Breathing System Warmer Select to set the breathing system Warmer On default or Warmer Off If the Breathing System is selected Warmer Off or if AC power is not connected the system displays an icon to indicate that the warmer is not active amp After cycling power the breathing system warmer will return to the default state NOTE The breathing system warmer is inactive when the A5 A3 is powered by the battery supply Zero Flow Meters To zero the flow meters select the Zero Flow Meters button Follow the on screen directions and prompts Note that information for the last zeroing of the flow meters is displayed next to the button NOTE Before zeroing the flow meters make sure to disconnect the gas supply N50 Air O A5 A3 Operating Instructions 046 003777 00 3 23 Display Tab System Interface 3 11 Display Tab Screen Brightness To adjust the screen brightness 1 Select Setup softkey gt Display tab FIGURE 3 29 2 In the Screen Brightness area select buttons to adjust the screen brightness 3 Select the Accept button to confirm the change or select Cancel to ignore the change Select the buttons to adjust screen brightness FIGURE 3 29 A5 A3 Display Tab Screen
67. Conditions 046 003777 00 A5 A3 Operating Instructions Table of Contents Environmental Specifications Electrical Specifications Main Electrical Power Specifications Battery Power A Auxiliary Electrical Outlets nd dientes dd deese eaae dede ane une beider iiie Communication Ports Pneumatic Specifications SN Pipeline Supply N Q Air iOS mmm Cylinder S pply NJO T1073 E Drive Gas N50 Automatic Cutoff O Controls Oxygen Ratio Cot ion Breathing System Specifications scscsssaccsssscscssseccosssceacpesscossoavosacenvanscossnategeoecontescdstauiesoncovesstedvanesstscoadadebenasbedecnstatecabcdbessinsabecschabecn bonded cdeequtivebeaicpeaccbanell Breathing System Volume CO Absorber Assembly Water Trap Vaporizer Connections cese coepi etes teptpee pute EE AEN EEA dos ENANOS EE NSSE EESIN EEEE TEENE Breath EM COMEN eniinn nae a a a E quete tire aae lai eTEN APL Valve Breathing System Temperature Controller Breathing Circuit O odie A IO Anesthetic Gas Scavenging System AGSS Ventilator Specifications Displays and Controls Specifications A AA A A IS ANA Safety Specifications ASTM F 1208 89 2005 Disclosures Leakage of Breathing S Eu C RR Resistance of Breathing SYSteMns scicc scsesccscscastesssnnacoscctesscagescnasatecoasasa oceans cabdeueseacdunstasonsanbscebsontsgosenassas elenvasesgans
68. F4 Inspiratory Limb Inhaled breathing circuit connection F5 Expiration Valve Allows flow of expiratory gas from the patient to the re breathing system and prevents reverse flow F6 F7 Inspiration Valve Bag Arm Allows flow of inspiratory gas to the patient and prevents reverse flow Provides the interface to the manual ventilation bag F8 O Sensor Cable Assembly An electro galvanic fuel cell device to measure the concentration of O5 The assembly is composed of the O cable O cell cover and O sensor F9 APL Airway Pressure Limiting Valve Rotary regulator for setting the breathing system pressure limit during manual ventilation Its scale shows approximate pressure Set to SP during Spontaneous breathing A5 A3 Operating Instructions 046 003777 00 1 15 Physical Views Product Description PART S DESCRIPTION F10 Auto Manual Bag Switch Enables switching between Automatic and Manual ventilation modes T The bellows dome is a transparent cover with graduation marks from 300 to 1500 mL These marks are for reference only Tidal volume Vt should be read exclusively from the display of the user interface Delivered Vt is a combination of bellows displacement and fresh gas flow 2 The APL valve and Paw gauge numerics are for reference only Calibrated patient airway pressure is dis played on the user interface 1 16 046 003777 00 A5 A3 Operating Instruction
69. From power up If the A5 A3 System is being powered on the system automatically initiates a self test followed by Automatic Circuit Leak and Compliance Test and the Manual Circuit Leak Test If the Skip button is selected the system bypasses these tests and enters the Standby screen or From the main screen Select the Setup softkey gt General tab gt Test Leak Compliance button 2 Follow the directions on the screen 1 Adjust the APL to the 50 cmH20 position 2 Adjust all flowmeters to zero 3 Set the Auto Manual switch to Manual 4 Press the O2 flush button until the PAW gauge value is between 25 and 35 cmH20 5 Select Continue to proceed with the Manual Circuit Leak Test or Select Skip to go directly to operational mode NOTE The Continue button can be selected only when the Auto Manual Switch is set to the Manual position and when no fresh gas is detected 4 14 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Leak and Compliance Tests 3 Compare the test results with the information in Table 4 4 Manual Circuit Leak Test Results on page 4 15 and proceed accordingly RESULTS COMMENTS OPTIONS Pass Manual Circuit Leak Test passed Example Adjust the APL valve to SP position Select Continue to proceed to the main screen Manual Circuit Leak Test Complete Adjust APL valve to SP position as shown and select Continue to proceed Fail Fresh gas flow detected Manual Circuit Lea
70. GURE 7 10 Location of Expiration and Inspiration Valves 1 Remove the valve dome as shown in FIGURE 7 11 turning it counterclockwise FIGURE 7 11 Valve Dome Removal CAUTION The valve disc in each of the inhalation and exhalation valve assemblies on the breathing system is fragile and must be handled with care while removing the valve cage from the valve assembly 2 Thevalve cage will be removed in this step refer to FIGURE 7 12 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 7 14 046 003777 00 A5 A3 Operating Instructions Maintenance Cleaning and Disinfection 3 Remove the valve disc from the valve cage as shown in FIGURE 7 12 4 Remove the O ring from the bottom of the valve assembly as shown in FIGURE 7 12 Valve Cage Valve Disc O ring FIGURE 7 12 Valve Cage Removal CAUTION The valve disc in each of the inhalation and exhalation valve assemblies on the breathing system is fragile and must be handled with care while removing the valve cage from the valve assembly 5 Cleaning a Wash each component using a recommended cleaning agent See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving b Rinse with clean hot water
71. IGURE 3 12 Waveforms Tab Waveforms FIGURE 3 12 Main Screen Waveforms Tab 3 4 1 Waveform Color WAVEFORM COLOR DESCRIPTION Orange Indicates the color of the Paw waveform Cyan Indicates the color of the Flow waveform Purple During the inspiratory phase Paw and Flow waveforms change to purple when spontaneous breath is detected in ventilation modes that contain pressure support TABLE 3 1 Waveform color 3 10 046 003777 00 A5 A3 Operating Instructions System Interface Waveforms Tab 3 4 2 Waveforms Autoscaling If the measured value of Paw or Flow is larger than the boundary at the end of breath cycle the system will auto scale the Paw or Flow at the beginning of the next breath cycle If the measured value of Paw or Flow is less than the boundary minus a margin at the end of two continuous breath cycles the A5 A3 System will auto scale the Paw or Flow at the beginning of next breath cycle Paw scale The margin will be 10 cmH O Flow scale The margin will be 10 L min if Flow lt 30 L min The margin will be 15 L min if Flow 30 L min A5 A3 Operating Instructions 046 003777 00 3 11 Spirometry Tab A5 Only System Interface 3 5 Spirometry Tab A5 Only Displays separate looped graphs of Pressure Volume FIGURE 3 13 and Flow Volume FIGURE 3 14 Spirometry Tab ADULT vev 00 io gp ua pito NO FSC Spirometry Pressure Volume PEAK PLAT PEEP Show Refer
72. M DD Yes e Demographics Current selection saved when PARAMETER RANGE DEFAULT powered off Day DOB 1 31 Yes Month DOB 1 12 Yes Year DOB 1900 2099 Yes Weight Units lbs kg lbs Yes Weight Range 0 660 Ibs Yes 0 300 kg 046 003777 00 A5 A3 Operating Instructions Parameters and Factory Defaults Ventilation Modes B 7 Ventilation Modes Current selection saved OBJECT RANGE DEFAULT when powered off Ventilation VCV SIMV VC PCV VCV Yes Mode Tab SIMV PC PS SIMV PC available only on A5 VENTILATION MODE PARAMETERS Manual Bypass Alarms VCV Vt Rate E Tpause PEEP Plimit SIMV VC Vt Rate Tinsp Tpause PEEP Plimit PS On Off AP Trigger Tslope PCV VtG PlimVG Pinsp Rate I E PEEP Tslope SIMV PC Pinsp Rate Tinsp PS On Off AP Trigger PEEP Tslope PS Min Rate AP Trigger PEEP Tslope Apnea Ti SIMV PC VtG PlimVG and Bypass are available only on A5 A5 A3 Operating Instructions 046 003777 00 B 7 00ZZZ 009rO suoyonusu Buyo1ed we v ov PARAMETER VCV SIMV VC PCV SIMV PC PS MANUAL Vt Range Range 20 to 1500 mL 20 to 1500 mL Step 1 Step 1 Defaults Defaults Adult 600 mL Adult 600 mL Pediatric 120 mL Pediatric 120 mL Infant 20 mL Infant 20 mL VtG A5 only Range 20 to 1500 mL Step 1 Default off VG A5 only Default off Rate Range 4 to 100 bpm Ra
73. Manual Flowmeter Flowmeter Board Voltage Fail Flowmeter Self 1 CPU Flash or WTD High Startup Non Electronic Test Error error Functional Flowmeter Flowmeter Self 2 Table blank or error Board Test Fail Flowmeter Self Self test result cannot High Startup Non Electronic Test Time out be obtained due to an Functional Flowmeter internal communication Board error Aux Control 1 CPU Flash or WTD High Startup Non Aux Vent ModuleSelfTest error Functional Control Error Aux 2 After power on CPU Board Control Module board can t Self Test Fail communicate with the Aux Control board Aux Control Self test result cannot High Startup Non Aux Vent Module Self be obtained due to an Functional Control Test Time out internal communication Board error A5 A3 Operating Instructions 046 003777 00 6 15 Alarm and Prompt Messages Alarms and Messages MACHINE MODE STARTUP ALARM WHEN RESULT IF MESSAGE CAUSE PRIORITY CHECKED FAIL REMARK Ventilator Self 1 CPU TIMER RAM High Startup Non Ventilator Test Error WTD EEPROM or AD Functional Control Ventilator Self error Board Test Fail 2 After power on CPU board cannot communicate with the ventilator board Ventilator Self Self test result cannot High Startup Non Ventilator Test Time out be obtained due to an Functional Control internal communication Board error Ventilator 5V or 12V voltage error High Startup Only Ventilator Voltag
74. ONS MACHINE NON FUNCTIONAL Automatic Circuit Leakage Pass Compliance Test XX X mL cmH 0 Safety Valve Control Fail Example Automatic Circuit Leak amp Compliance Test Complete Automatic Circuit Leakage Compliance Test Saftey Valve Control Select Retry to repeat the test or Contact service Safety valve control test or pressure verification test failed Select Retry to repeat the Automatic Circuit Leak Test amp Compliance test or Contact service if this error condition persists NOTE Service Access button The Service Access button is only available to Mindray authorized service personnel and requires a service password Time out Example Test result cannot be shown due to an internal communication error Select Retry to repeat the Automatic Circuit Leak Test amp Compliance test or Select Override to skip the test TABLE 4 3 Automatic Circuit Leak and Compliance Test Results A5 A3 Operating Instructions 046 003777 00 4 13 Leak and Compliance Tests Preoperative Tests 4 5 2 Manual Circuit Leak Test The Manual Circuit Leak Test screen is displayed in FIGURE 4 2 Manual Circuit Leak Test Continue FIGURE 4 2 Manual Circuit Leak Test screen To Perform a Manual Circuit Leak Test NOTE If fresh gas is detected by the system before proceeding with the Manual Circuit Leak Test a message is displayed on the screen to adjust all flowmeters to zero l
75. Only the four most recently saved reference loops are listed chronologically When a Reference loop or Baseline loop is selected to display in the Spirometry Loop Window the time stamp will also be displayed 3 9 3 Save Loop Select the Save Loop softkey FIGURE 3 15 to save the currently plotting loop including its numeric data as either a baseline loop or reference loop Only one baseline loop and up to four reference loops can be saved Additional plotting loops can be saved to replace the baseline loop or reference loops Only the four most recent reference loops are saved The saved baseline or reference loop can be reviewed with its numeric data via Review Loops softkey or displayed with the currently plotting loop on the same graph for comparison via Show Reference softkey NOTE A reference loop cannot be saved without first saving a baseline loop The A5 system will always make the first saved loop as the baseline loop if no previous loops have been saved Afterward additional loops can be saved either as a baseline replacement or as a new reference loop A5 A3 Operating Instructions 046 003777 00 3 13 Spirometry Tab A5 Only System Interface To save a baseline loop 1 From the main screen select Spirometry tab gt Save Loop softkey If there is no baseline loop saved in memory the currently plotting loop will be saved automatically as the baseline loop 2 Ifa baseline loop is already saved in memory a
76. P Valve Failure 1 PEEP valve voltage error Medium Runtime No 2 PEEP valve pressure error Insp Valve Failure 1 Inspiratory valve voltage Medium Runtime No error 2 Inspiratory valve flow error Safety Valve PEEP safety valve voltage Medium Runtime No Failure error Flow Sensor 1 Inspiratory flow is out of Low Runtime No Failure range 2 Expiratory flow is out of range Check Flow 1 Inspiratory reverse flow High Runtime N A Sensors 2 Expiratory reverse flow Pinsp Not Pinsp does not reach the Low Runtime N A Achieved Pinsp setting in pressure mode Vt Not Achieved Vt does not reach the Vt Low Runtime N A setting in volume mode Automatic The machine is in the Low Runtime No Ventilation automatic ventilation Disabled disabled state Auto Ventilation Automatic Circuit Leak Low Runtime No Disabled LeakTest Test failed and the result is Failed Manual Only N A Not Applicable This alarm message does not exist within this mode and therefore cannot be Alarm and Prompt Messages Alarms and Messages TABLE 6 8 Ventilator Control Board Runtime Alarm Messages MACHINE DISABLE IN ALARM MODE WHEN STANDBY MESSAGE CAUSE PRIORITY CHECKED MODE Patient Circuit 1 Vte is less than Vti to the Medium Runtime N A Leak maximum of 200 mL and 50 for 30 seconds 2 Vti is less than Vt delivery in volume mode 3 Patient is not connected CO Absorber CO Canister is not High Runtime No Caniste
77. PCV Tidal Volume Guarantee VtG Off Target Pressure Piysp 20 Breath Rate freq 8 IE Ratio E 1 2 PEEP PEEP Off Inspiratory Slope Tslope 0 5 e Select PCV and begin ventilation f Verify that the breathing bag at the patient end of the Y fitting of the breathing circuit inflates and deflates and that the PLAT on the display and the PAW gauge are consistent with the Ptarget setting 4 20 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Cylinder Tests 4 9 Cylinder Tests NOTE You do not need to perform cylinder tests if the A5 A3 anesthesia machine is not equipped with cylinders 4 9 1 Check the Cylinder Pressure 4 Set the system switch to the Off position and connect the cylinders to be checked Open each cylinder valve using the supplied wrench Ensure that each cylinder has sufficient pressure If not close the applicable cylinder valve and install a full cylinder O cylinder input range 6 9 to15 5 MPa 1000 2250 psi N50 cylinder input range 4 2 to 6 MPa 600 870 psi Air cylinder input range 6 9 to15 5 MPa 1000 2250 psi Close all cylinder valves 4 9 2 O Cylinder High Pressure Leak Test PON Set the system switch to the Off position and disconnect the O pipeline supply Turn off the O flowmeter Open the O cylinder valve Record the current cylinder pressure Close the O cylinder valve Record the cylinder pressure after one minute Ifthe c
78. PLAT i or 8096 PEAK or last value LE NE PEEP PlimVG If VtG OFF If VtG OFF If VtG OFF If VtG OFF then Pinsp then Pinsp then Pinsp thenPinsp If VtG isa If VtG isa If VtG isa If VtG is a value then value then value then value then last value of last value of last value last value of PlimVG PlimVG of PlimVG PlimVG Tslope E T A s The parameter value is shared between the previous and current ventilation modes Available on A5 only A5 A3 Operating Instructions 046 003777 00 B 11 Linked Ventilation Parameter Relationships Parameters and Factory Defaults CURRENT PREVIOUS VENTILATION MODE VENTILATION MODE amp PARAMETERS AFFECTED VCV SIMV VC PCV SIMV PC PS SIMV Pinsp PLAT bs PC or 80 PEAK or last value Rate si x Tinsp i PS PS On AP _ Trigger it led PEEP i Tslope 5 ll PS Min Rate kd B hi AP ET Trigger d s ki Peep M Tslope x Apnea Ti hi The parameter value is shared between the previous and current ventilation modes Available on A5 only B 12 046 003777 00 A5 A3 Operating Instructions Parameters and Factory Defaults Non Linked Ventilation Parameter Relationships B 9 Non Linked Ventilation Parameter Relationships VENTILATION Parameter MODE Parameter Relationship Equation s VCV Rate
79. Size 430mm x 132mm x 114mm Tolerance 5mm Extract Flow 25 to 50 L min Resistance lt 0 35 kPa 75 L min TABLE 8 19 Anesthetic Gas Scavenging System AGSS A5 A3 Operating Instructions 046 003777 00 8 11 Ventilator Specifications Product Specifications 8 10 Ventilator Specifications General Ventilator Specifications Ventilation Modes e Manual ventilation mode with breathing bag Spontaneous ventilation in manual mode with APL fully open Volume Control Ventilation VCV mode with PLV function A3 Pressure Control Ventilation PCV mode A5 Pressure Control Ventilation PCV mode with without VG ventilation mode e Pressure Support PS ventilation mode e Synchronous Intermittent Mandatory Ventilation SIMV mode with VCV ventilation mode A5 Synchronous Intermittent Mandatory Ventilation SIMV mode with PCV ventilation mode Patient Size Adult Pediatric Infant Fresh Gas Flow Compensation Volume compensated ventilation Inspiratory Flow Min Max The A5 A3 does not allow combinations of ventilation parameters e g E Vt and Freq to be set if the resultant inspiratory flow is greater than 110 L m maximum or less than 2 4 L min minimum Inspiratory Flow Range 2 4 to 110 L min Low Flow Anesthesia Tidal volume delivery at 1 L min total fresh gas flow Trigger Window PS and SIMV are adjustable flow triggers Inspiratory Trigger
80. Specifications 046 003777 00 A5 A3 Operating Instructions Product Specifications Safety Specifications Grounding Complies with the requirements of clause 18 in IEC 60601 1 Impedance The impedance between the protective earth terminal and any accessible metal part e g screw and equipotential stud that is protectively earthed does not exceed 0 1 ohm Protective Grounding Complies with the requirements of clause 58 in IEC 60601 1 The protective earth terminal is not used for the mechanical connection between different parts of the equipment or the fixing of any component not related to protective earthing or functional earthing TABLE 8 28 Safety Specifications A5 A3 Operating Instructions 046 003777 00 8 19 ASTM F 1208 89 2005 Disclosures Product Specifications 8 14 8 14 1 8 14 2 8 14 3 8 14 4 8 14 5 ASTM F 1208 89 2005 Disclosures Based on the following disclosures the A5 A3 meets ASTM Standard Specification F1208 for Anesthesia Breathing Systems Leakage of Breathing System Mode Resistance Pressure Leakage 10 19 mL min 3kPa Manual mode Bypass Off Leakage 15 10 mL min 3kPa Manual mode Bypass On Leakage 8 15 mL min 3kPa Mechanical Ventilation mode Bypass Off Leakage 14 77 mL min 3kPa Mechanical Ventilation mode Bypass On TABLE 8 29 Leakage of Breathing System Resistance of Breathing Systems The typical pressure drops
81. Storage teet tte epe due dte beides dte A 5 M Io EE A 5 Meoglrc C E A 5 A5 A3 Operating Instructions 046 003777 00 Accessory Kits Accessories WARNING Use only accessories specified in this chapter Using other accessories may cause incorrect measured values or equipment damage WARNING Disposable accessories can not be reused Reuse may degrade performance or cause cross contamination WARNING Check the accessories and their packages for damage Do not use them if any sign of damage is detected WARNING At the end of its service life the equipment as well as its accessories must be disposed of in compliance with the guidelines regulating the disposal of such products and in accordance with local regulations for contaminated and biologically hazardous items The following accessories are designed for the A5 A3 Anesthesia 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 A 1 Accessory Kits PART NUMBER DESCRIPTION 0060 00 1912 A5 Anesthesia System Sales BOM 0060 00 1936 A3 Anesthesia System Sales BOM 115 009546 00 Kit User Resource Kit A 2 AGSS PART NUMBER DESCRIPTION 801 0631 00098 00 Waste Gas Scavenger Assembly 801 0631 00074 00 AGSS Transfer Tube 801 0631 00078 00 Waste Gas
82. System Test Vaporizer TS it cada Vaporizer Back Press Ur Td aida DENEIBEC IA e M M Vaporizer Leak Test Breathing System Tests Bellows TOS eer RED c ia Breathing System Leak Test in Manual Ventilation Status eeessssssesccccsssesseccsssessecssseccecesnssesecssnssecsessussescenusesesssusesesssneseceesnsecescanneceessnee 4 25 APL Valve Test Alarm Tests Prepare for Alarm Tests d Test the O Concentration Monitoring and AlarMs csscssssssssssssssssssssssssssssssssssssssssssssssssssssesssssssssssssssssssssssssssssssssssssssssssssssssssssscesssssesssssses 4 27 ii 046 003777 00 A5 A3 Operating Instructions Table of Contents Test the Low Minute Volume MV Alarm Test the Apnea Alarm Test the Continuous Airway Pressure Alarm TesttheHigh Ad a eee ere te ed A E te A E a e aa aR Test thel ow Paw Alain ys sranna iaar eeu cette aa R a aS Preoperative Preparations Inspect the AGSS Operations NN Powering On the A5 A3 Anesthesia System sssesssssssssssssesssssssssssssesesessssssssssesssesssesssssnsesseseseessnsessossessessssnsessosegseessnsessssessessssnsesssessseessssessssesseseesnees 5 2 Powering Off the A5 A3 Anesthesia System ccoo reee 5 2 Patiert Setupi i s ett A AR A E IN Discharge Standby Mode Select the Patient Size Adult Pediatric Infant Oxygen Sensor Calibration a AE ARS teet tse O e LE EE LS eto NOES Set N50 Air and MA iia Set Anesth
83. TE NOTE NOTE NOTE NOTE NOTE 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 Turn the flow controls slowly To avoid damaging the control valves do not turn further when the flowmeter reading is outside the range When turning a flow control knob clockwise to decrease flow the flowmeter should reach zero before the knob reaches its most clockwise mechanical stop Off position Do not turn any further when the knob has reached the Off position Similarly when turning a flow control knob counterclockwise to increase flow from zero the flowmeter reading should not indicate a change from zero until the flow control knob is turned approximately one 1 rotation counterclockwise from the Off position and only if permitted according to the gas ratio control system Figures in this manual are provided for reference purposes only Screens may differ based on the system configuration and selected parameters Put the equipment in a location where you can easily see the screen and access the operating controls Keep this manual close to the equipment so that it can be obtained conveniently when needed The software was developed in compliance with IEC 60601 1 4 The possibility of hazards arising from software errors is minimized This manual describes all features and options Your equipment may not have all of th
84. VAULT COPY Operating Instructions A5 A3 Anesthesia System mindray Operating Instructions A5 A3 Anesthesia System mindray A5 and A3 are U S trademarks of Mindray DS USA Inc Selectatec is a registered trademark of Ohmeda Copyright O Mindray DS USA Inc 2010 All rights reserved Contents of this publication may not be reproduced in any form without permission of Mindray DS USA Inc Table of Contents Foreword Indications For Use Responsibilities of Operators Warnings Cautions and Notes MEMINI HG viii Cautions ORO xvii DEA A AE EE AE EA A xvii Phone Numbers and How To Get Assistance Manufacturer s Responsibility Symbols Product DescriptioN sicomimsiccioncaracssiornioncicnconcaincecincrrncorinconncococirnciononcoriacoriconia ion o 1 1 CT TACITI EACH OVerviE W EET doseroudebedascunacodeeustesecbayaduebe taser touanvasuasetbasteayensstsaahimedeaeacneas 1 2 General DESCriptiO estatales derrotan ios 1 2 SS NN Fresh Gas Dosing Flow Control Flow Pressure Sensing ionien aeaaeae ti Defence Vaporizer MOUNTING e A A N A A E S Anesthesia Ventilator Breathing System Anesthetic Gas Scavenging System AGSS Power Management 7 Battery SUpply cete tecto bitbn tinte bortis bottone tutto aebu ek dde hedaderonsasibsodabers
85. Volume Peak airway pressure PEEP Mean or Plateau pressure Breath Rate FiO2 AC Power Indicator LED Green illuminated plugged active AC power line Not illuminated unplugged or inactive AC power line Battery State Indicator LED Solid green illuminated battery supply is charging or fully charged Not illuminated battery supply is discharging or not charging Work Light Settings Off Low High Main Power Switch ON position power applied to unit O fresh gas flow available Power Standby position power applied only to charge battery supply O fresh gas flow not available Note Flow of Air is independent of the main power switch position and is regulated by the flow control knobs Touchpad A5 only Allows alternate control of the touch screen Mouse SB port on rear of A5 A3 allows connection of a mouse for alternate control of the touch screen TABLE 8 25 Electronic Controls 8 11 2 Pneumatic Controls Line Pressure Gauges Gauges N50 Air O Range 0 to 145 psi 0 to 1000 kPa Accuracy 4 of full scale reading 896 of actual reading Units of measure kPa psi Cylinder Pressure Gauges Gauges N50 Air O N20 0 to 1400 psi 0 to 10 MPa Air 0 to 3500 psi 0 to 25 MPa O5 0 to 3500 psi 0 to 25 MPa Accuracy 4 of full scale reading 896 of actual reading Units of measure kPa psi TABLE 8 26 Pneumatic Controls A5 A3 Operating Instructions 046 003777 00 8 15
86. Volume Spirometry loop represents Flow The unit of measure is L min and its scale is 90 to 90 in increments of 45 but only absolute numbers are displayed The X axis represents Volume The unit of measure is mL and its scale is O to 1400 in increments of 750 5 10 4 2 Waveform Autoscaling If the measured values of Paw Flow or Volume are larger than the boundary at the end of breath cycle the system will autoscale the Paw Flow or Volume at the beginning of next breath cycle If the measured values of Paw Flow or Volume are less than the boundary minus a margin see Table 5 1 at the end of two continuous breath cycles the system will autoscale the Paw Flow or Volume at the beginning of the next breath cycle SCALE MARGIN Paw 10 cmH20 Flow 10 L min if Flow lt 30 L min 15 L min if Flow gt 30 L min Volume 25 mL if volume 100 mL 100 mL if volume 100 mL TABLE 5 1 Autoscaling Margins of Paw Flow and Volume 5 20 046 003777 00 A5 A3 Operating Instructions Operations so Alarms and Messages o sl E eivys atudecc eae ead a Chee eee alle BVA ares 6 2 A ol 6 5 Setting nate tantae d data ped tenni 6 8 SIIe GIGIHOP ANETA AE ton oen ttt b ert ies db ien edt Usato debat 6 9 Setting Alarm a peer RE ARR bed Re d e t edi 6 10 Alarm amd Prompt Messages ed ed 6 13 A5 A3 Operating Instructions 046 003777 00 Introduction Alarms and Messages 6 1 Introduction The A5 A3 System provides alarm
87. Vt Tidal volume mL Rate Breath rate bpm E Ratio of inspiratory time to expiratory time Tpause Percentage of inspiratory plateau time in inspiratory time PEEP Positive end expiratory pressure cmH5O Plimit Pressure limit level cmH 0 NOTE Before activating a new mechanical ventilation mode ensure that all related parameters are set appropriately 5 6 7 Set Pressure Control Ventilation PCV Pressure control ventilation PCV mode is a basic fully mechanical ventilation mode In the PCV mode each time mechanical ventilation starts PAW rises rapidly to the preset Pinsp Then gas flow slows down through the feedback system to keep PAW constant until expiration starts at the end of inspiration The tidal volume delivered in the PCV mode changes based on patient pulmonary compliance and airway resistance In the PCV mode you can set PEEP to improve expiration of end tidal carbon dioxide and to increase oxygenation of breathing process A5 A3 Operating Instructions 046 003777 00 5 11 Ventilation Modes Operations For the A5 in PCV mode Tidal Volume Guarantee VtG can be enabled with the VtG setting When VtG is a value then Pinsp is disabled The ventilator attempts to deliver the set VtG while maintaining the PAW at or below PlimVG When VtG is Off PlimVG is disabled and Pinsp is enabled Changing the value of Pinsp will automatically set PlimVG to the same value but PlimVG can be adjusted with
88. ace of the A5 A3 A5 A3 Operating Instructions 046 003777 00 xiii Introduction Cautions CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION Do not connect any devices to the SB ports other than Mindray approved USB storage devices and a supported USB mouse see Networking and USB Storage on page A 5 Do not wash the inner surface of the oxygen sensor Do not autoclave the following components Paw gauge oxygen sensor flow sensor and bellows These components cannot withstand immersion or the heat and pressure of autoclaving Users should monitor oxygen percentage FiO596 when using the Auxiliary O2 Air Flow Meters Unknown oxygen concentrations may be delivered to the patient unless oxygen monitoring is used The A5 A3 is NOT suitable for use in a magnetic resonance imaging MRI environment To ensure measurement accuracy and to avoid possible damage to the A5 A3 use only Mindray approved cables and accessories Use the power cord provided with the product If a substitute is necessary use only hospital grade power cords Do not use a damaged or broken unit or accessory Periodically check all cables e g AC line cord and patient connection cables for damage that may occur through normal use Replace cables if damaged in any way Use of other oxygen
89. ak and Compliance Tests Preoperative Tests RESULTS Automatic Circuit Leakage Fail Fresh gas flow detected Compliance Test Fail Example Automatic Circuit Leak amp Compliance Test Complete Automatic Circuit Leakage Compliance Test COMMENTS OPTIONS Fresh gas is detected Approximate threshold for fresh gas detection is 0 05 L min of flow from any individual gas flow Adjust all flowmeters to zero Select Retry to repeat the test Automatic Circuit Leakage Fail Compliance Test Fail Example Automatic Circuit Leak amp Compliance Test Complete Automatic Circuit Leakage Compliance Test Check the following and select Retry to repeat the test recommended 1 Is the condensate drai 2 or Select Manual Only to proceed Automatic Ventilation will be disabled Leak rate 21000 mL min Fresh gas is not detected Follow on screen directions to troubleshoot the problem or Select Manual Only to place the device in manual ventilation mode only The following low priority alarm will be displayed on the main screen Auto Ventilation Disabled Leak Test Failed Auto Ventilation Disabled Leak Test Failed WARNING Selecting the Manual Only button will disable automatic ventilation TABLE 4 3 Automatic Circuit Leak and Compliance Test Results 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Leak and Compliance Tests RESULTS COMMENTS OPTI
90. al loss damage or expense directly or indirectly arising from the use of its products liability under this warranty and the buyer s exclusive remedy under this warranty is limited to servicing or replacing at Mindray DS USA nc 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 o 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 epresentation 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 sh
91. all not have any responsibility in the event of loss or damage in transit Disclaimers Product Improvements Mindray DS USA Inc retains the right to modify the machine and or operating instructions without prior notification These operating instructions explain all features of the A5 A3 System and are correct at time of manufacture Instructions and models produced at a later stage may contain improvements or modifications that were not included in previous models A5 A3 Operating Instructions 046 003777 00 xvii Introduction Phone Numbers and How To Get Assistance 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 located on the back of the A5 A3 and a description of the problem with all requests for service Warranty questions should be directed to a local representative A list of offices along with their phone numbers is provided at the end of this manual NOTE Upon request calibration instructions or other information will be provided to assist the user s app
92. an Mindray approved USB storage devices and a supported USB mouse see Networking and USB Storage on page A 5 Data Port DP1 One test port for connection of calibration equipment by a Mindray authorized service representative TABLE 8 8 Communication Ports A5 A3 Operating Instructions 046 003777 00 8 7 Pneumatic Specifications Product Specifications 8 7 Pneumatic Specifications 8 7 1 Pipeline Supply N50 Air O gt Pipeline Input Range N50 280 to 600 kPa 40 to 87 psi Air 280 to 600 kPa 40 to 87 psi O 280 to 600 kPa 40 to 87 psi Pipeline Connections DISS threaded body as per CGA V 5 Gas Configuration N50 Air O TABLE 8 9 Pipeline Supply 8 7 2 Cylinder Supply N5O Air O2 Cylinder Supply E cylinder American style and pin indexed per CGA V 1 O Cylinder Input Range 6 9 to 15 5 MPa 1000 to 2250 psi N50 Cylinder Input Range 4 2 to 6 MPa 600 to 870 psi Air Cylinder Input Range 6 9 to 15 5 MP 1000 to 2250 psi Cylinder Connections Pin Index Safety System PISS Yoke Configuration N50 Air O TABLE 8 10 Cylinder Supply 8 7 3 Drive Gas 0 8 7 4 NO Automatic Cutoff An NO automatic cutoff stops the flow of NO when O flow is less than 200 mL min 8 7 5 O Controls O supply failure alarm lt 220 kPa 32 psi 8 7 6 Oxygen Ratio Controller Provides 25 4 O when N5O valve is fully open and O flow range is 0 8L min t
93. and allow to dry Afterall 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 6 Disinfection NOTE Ensure that all valve components have been cleaned as described in step 5 before disinfecting See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving and use an approved disinfecting agent for all valve components while adhering to facility policies and procedures 7 Reassembly Reassemble the valve components in the reverse order noting any previously stated CAU TION Prior to use after cleaning or disinfecting power up the system and follow the on screen prompts to perform the Leak Test and the Compliance Test See section 4 5 pg 4 9 Leak and Compliance Tests A5 A3 Operating Instructions 046 003777 00 7 15 Cleaning and Disinfection Maintenance 7 9 6 Oxygen Sensor 1 The oxygen sensor is a component that is pressed into position for use It is not necessary to remove this component to clean it However if removal is desired first disconnect the oxygen sensor cable from the main unit as shown in FIGURE 7 13 Then hold the oxygen sensor and pull straight out firmly from the breathing system block TW Wr a Oxygen Sensor Cable Connection to Main Unit Oxygen Sensor FIGURE 7 13 Oxygen Sen
94. and power is switched from battery to AC automatically to ensure continuous system use The on screen battery symbol indicates the battery status See FIGURE 1 1 PART S DESCRIPTION Battery supply is fully charged AC power is connected The A5 A3 is being powered by AC power The solid portion represents the current charge level of the batteries in proportion to its maximum charge level Battery supply is partially charged AC power is connected and charging battery supply The A5 A3 is being powered by AC power Battery supply is fully charged AC power is not connected The A5 A3 is being powered by internal battery supply Battery supply is partially charged AC power is not connected The A5 A3 is being powered by internal battery supply 1 6 046 003777 00 A5 A3 Operating Instructions Product Description General System Overview PART S DESCRIPTION Battery supply is low charged Batteries need to be charged immediately to operate as a safe power backup AC power is not connected The A5 A3 is being powered by internal battery supply Battery supply is not installed FIGURE 1 1 Battery Status Ifthe battery capacity is too low power supply failure will result A high level alarm will be triggered and the message Low Battery Voltage will be displayed in the technical alarm area In this case apply AC power to the A5 A3 Anesthesia System to resume operation and charge the battery supply
95. anship 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 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 his manual Recommended preventative maintenance as prescribed in the Maintenance section of this manual is the responsibility of the user and is not covered by this warranty Except as otherwise provided herein the terms conditions and limitations of Mindray DS USA Inc s standard warranty will remain in effect indray 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 O sensors CO absorbents breathing circuits hoses or mounts indray DS USA Inc will not be liable for any incidental special or consequenti
96. arm is sounded Alarm self test 5 The System Self Test progress bar is displayed 6 The System Self Test is automatically started Hardware self test 7 Theresults of the System Self Test are displayed TABLE 4 1 A5 A3 System Self Test Sequence RESULT COMMENTS OPTIONS Pass condition The Pass condition indicates that the A5 A3 has passed Example the System Self Test No errors have been detected Alarms System Self Test Complete and hardware are functioning properly Select Continue to enter the Automatic Circuit Leak and Compliance Test screen or Select Skip to enter the Standby with automatic ventilation enabled Select Continue to perform leak test recommended Or Select Skip to go directly to operational mode TABLE 4 2 Types of System Self Test Results A5 A3 Operating Instructions 046 003777 00 4 7 System Self Test RESULT All Functional error condition Example System Self Test Complete ive Gas Pressure Low I Select Accept to perform leak test recommended or Select Skip to go directly to operational mode Preoperative Tests COMMENTS OPTIONS The All Functional error condition indicates that errors have been detected However all automatic ventilation manual and bypass modes are still enabled Select Accept to enter the Automatic Circuit Leak and Compliance Test screen or Select Skip to enter the main screen with automatic ventilation enabled
97. at the AC mains indicator and battery charge indicator are extinguished An audible alarm should sound and the prompt message Battery in Use should be displayed on the main screen 4 Reconnect the AC mains 5 Ensurethat the AC mains indicator and battery charge indicator are illuminated The prompt message Battery in Use should not be displayed on the main screen 6 Setthe system switch to the Off position A5 A3 Operating Instructions 046 003777 00 4 17 Pipeline Tests Preoperative Tests 4 7 Pipeline Tests 4 7 1 O Pipeline Test 1 Connect the O pipeline supply 2 Close all cylinder valves ifthe A5 A3 anesthesia machine is equipped with cylinders 3 Setthe system switch to the On position 4 Set the flow controls approximately to mid range approximately 6 L min 5 Ensure that all pipeline pressure gauges show 280 to 600 kPa 6 Disconnect the O pipeline supply 7 As O pressure decreases alarms for O Supply Failure and Drive Gas Pressure Low should occur 8 Ensure that the O gauge goes to zero 4 7 2 N O Pipeline Test NOTE When doing the N50 pipeline test connect the O supply first to enable N50 flow control NOTE Different from O pipeline supply when N50 supply is disconnected no alarms related to N2O pressure occur as N50 pressure decreases 1 Connect the O and N50 pipeline supplies 2 Close all cylinder valves if the A5 A3 anesthesia machine is equipped with cylinders
98. ays a fail status contact Mindray Technical Support 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Leak and Compliance Tests 4 5 Leak and Compliance Tests 4 5 1 Automatic Circuit Leak and Compliance Test The Automatic Circuit Leak Test screen is displayed in FIGURE 4 1 Fresh Gas Flow Automatic Circuit Leak amp Compliance Test Air 02 Continue FIGURE 4 1 Automatic Circuit Leak Test To Perform an Automatic Circuit Leak Test NOTE The A5 A3 system records the result of the last Automatic Circuit Leak Test in the General tab including if the test had passed failed or was skipped To access this information from the main screen select the Setup softkey gt General tab NOTE If fresh gas is detected by the system before proceeding with the Automatic Circuit Leak amp Compliance Test a message is displayed on the screen to adjust all flowmeters to zero 1 From power up If the A5 A3 System is being powered on the system automatically initiates a self test and enters the Automatic Circuit Leak Test screen followed by the Manual Circuit Leak Test screen If the Skip button is selected the system bypasses the Automatic Circuit Leak Test and the Manual Circuit Leak Test and enters the Standby screen or From the main screen Select the Setup softkey gt General tab gt Test Leak Compliance button A5 A3 Operating Instructions 046 003777 00 4 9 Leak and Complia
99. be reused Dispose of these items in accordance with hospital policy and local regulations for contaminated and biologically hazardous items To avoid endangering a patient do not perform testing or maintenance when the machine is in use Review the performance specifications of the disposal system that the transfer and receiving systems are intended to be used with to ensure compatibility The A5 A3 should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the A5 A3 should be observed to verify normal operation in the configuration in which it will be used Ensure that the current alarm presets are appropriate before use on each patient A hazard can exist if different alarm presets are used for the same or similar equipment in any single area Due to the size and weight of the A5 A3 it should only be moved by qualified personnel Overloading machine may cause tipping Equipment attached to the side of the machine should fall within the rated weights to prevent tipping of the machine Excess load may cause a tip hazard while moving the A5 A3 Before moving remove all equipment from the top shelf and all monitoring equipment mounted to the side of the A5 A3 Use care when moving the A5 A3 up or down inclines around corners and across thresholds Do not attempt to roll the A5 A3 over hoses cords or other obstacles Leaks or internal venting of sampled gas may affect accuracy Per
100. bility with External Connectors Enclosure Rigidity and Strength Impairment of Cooling Leakage Current Complies with the requirements of clause 24 1 in IEC 60601 1 Complies with the requirements of clause 56 3 in IEC 60601 1 Complies with the requirements of clauses 16a 21a and 21b in IEC 60601 1 Complies with the requirements of clause 55 in UL 60601 1 Complies with the requirements of clause 52 5 5 in IEC 60601 1 EN 60601 1 UL 60601 1 Complies with the requirements of clause 19 in IEC 60601 1 UL 60601 1 Earth leakage current Normal condition lt 300 uA Single fault condition x 1000 uA Enclosure leakage current Normal condition lt 100 uA Single fault condition lt 300 uA Patient leakage current Normal condition lt 100 uA Single fault condition lt 500 uA Patient auxiliary current d c Normal condition lt 10 uA e Single fault condition lt 50 uA Patient auxiliary current a c Normal condition lt 100 uA e Single fault condition lt 500 uA Patient leakage current applied part plus mains voltage Single fault condition lt 5000 uA Dielectric Strength Complies with the requirements of clause 20 in IEC 60601 1 EN 60601 1 Mains supply to earth A a1 1500 VRMS 1 min Mains supply to applied part B a 4000 VRMS 1 min Applied part to earth B d 1500 VRMS 1 min Isolation at network port 1500 VRMS 1 min TABLE 8 28 Safety
101. ble the AGSS and Transfer Hose and reconnect them to the A5 A3 in the reverse order A5 A3 Operating Instructions 046 003777 00 7 25 Regular Maintenance Maintenance 7 10 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 and follow the on screen prompts to perform the Leak Test and the Compliance Test See section 4 5 pg 4 9 Leak and Compliance Tests 7 26 046 003777 00 A5 A3 Operating Instructions so Product Specifications Standards ormpllalmee so RE RE RR RR ERE RR RE eile RR 8 2 A deig omui pide tabe UEM 8 3 Physical Specific atout Meroe dide emerat ie luta Mta t Ope dd Mtn OON 8 4 Stability Configurations and Conditions eres 8 4 Environmental Specification c aU A t PC MM E LE AE 8 5 aio aia AAA edu t d dat edens 8 6 Pneumatic Specificationssi tee M ad a Mb dr ML Li eR ee Lue Lal e Lair el dl Lees 8 8 Breathing System Specifications o ote beo t e ab el e do bed 8 9 Anesthetic Gas Scavenging System AGSS mic css 8 11 Ventilator Specifications 2 Display NA Controls Specificati n aaa 8 15 Alan OCRE UE O 8 17 a E E MI m Ms 8 18 ASTM F 1208 89 2005 Disclosures cocccnnnaaca
102. bled when the current mode is PS SIMV VC or SIMV PC ALARM LIMIT ADJUST FORMULA Paw High PEAK 5 or PLAT 10 whichever is greater minimum 35 cmH20 Paw Low PLAT PEEP x 0 6 PEEP 1 minimum 3 cmH20 maximum Paw High 1 MV High MV x 1 4 minimum 2 0 L min MV Low MV x 0 6 minimum 0 3 L min maximum MV High 0 1 TABLE 6 2 Auto Alarm Limits The parameters in the formula are all measured parameters The new alarm limits for Paw are calculated on the basis of average values for PEAK PLAT and PEEP The value used for average uses he value of the last four ventilation cycles or the value in one minute whichever is smaller Spontaneous breaths by the patient are not taken into account f there is not a valid measured MV the corresponding MV alarm limits will not be adjusted f the average value for PEAK PLAT and PEEP cannot be calculated the corresponding alarm limits will not be adjusted f the calculated alarm limit is more than the high threshold of setting range or less than the low hreshold the corresponding threshold is used as the auto alarm limit 046 003777 00 A5 A3 Operating Instructions Alarms and Messages Alarm and Prompt Messages 6 6 Alarm and Prompt Messages This section lists the following alarms and messages Physiological Alarm Messages e Technical Alarm Messages Prompt Messages For each alarm message corresponding actions are given instructing you to troubleshoot
103. ckwise flow OFF Then turn the N5O flow control fully counterclockwise open position There should be no N5O flow since there is no O flow yet Turn the O control to the values shown in the table below The N5O value should meet the criteria shown in the table STEP O5 FLOW SETTING L MIN N20 FLOW L MIN 1 0 0 2 0 5 lt 1 88 3 0 8 gt 1 96 and lt 3 01 4 1 0 gt 2 45 and lt 3 76 5 2 0 gt 4 90 and lt 7 52 6 3 0 gt 7 34and lt 11 29 7 0 0 6 Disconnect the O pipeline supply or close the O cylinder valve NOTE When 0 supply is disconnected alarms for O Supply Failure and Drive Gas Pressure Low occur as O5 pressure decreases 7 Setthe system switch to the Off position 4 22 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Vaporizer Tests 4 11 Vaporizer Tests WARNING During the vaporizer tests the anesthetic agent exits from the fresh gas outlet Use a safe and approved procedure to remove and collect the agent WARNING To prevent damage turn the flow controls fully clockwise flow OFF before using the system Before the test ensure that the vaporizers are correctly installed For details about vaporizer installation see Install the Vaporizer on page 2 5 4 11 1 Vaporizer Back Pressure Test 1 Connect the O pipeline supply or open the O cylinder valve 2 Set the O flow to 6 L min 3 Ensure that the O flow stays constant
104. conds Negative Paw lt 10 cmH5O for 1 second High No N A Pressure A N A Not Applicable This alarm message does not exist within this mode and therefore cannot be disabled or enabled TABLE 6 3 Physiological Alarm Messages 046 003777 00 A5 A3 Operating Instructions Alarms and Messages Alarm and Prompt Messages 6 6 2 Technical Alarm Messages 6 6 2 1 Startup Alarm Messages NOTE Startup alarms will not trigger the alarm sound and alarm light NOTE Startup alarms priority is only used to display in the alarm logbook NOTE Startup Result if Fail column indicates the result when this startup phase alarm is triggered which may be ALL only manual and Non Functional NOTE All indicates that all Automatic Ventilation Manual Ventilation and Cardiac Bypass modes are enabled Only Manual indicates that only Manual Ventilation and Cardiac Bypass modes are enabled Non Functional indicates that the A5 A3 Anesthesia System cannot be used MACHINE MODE STARTUP ALARM WHEN RESULT IF MESSAGE CAUSE PRIORITY CHECKED FAIL REMARK Bundle Version Incompatible firmware N A Startup Non CPU Board Error version is installed Functional Incompatible version found Bundle Version Self test result cannot N A Startup Non CPU Board Time out be obtained due to an Functional internal communication error Flowmeter DVCC AVDD or VC High Startup Only Electronic Voltage Error voltage error
105. cording to the test intervals listed below 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 NOTE It is recommended that the user check that N5O cutoff and O N 0 ratio are normal before use Use an O concentration tester to monitor the O concentration in the gas output 4 1 1 Test Intervals Perform the preoperative tests listed below at these events When required after a maintenance or service procedure Every day before the first patient System Self Test Section 4 4 Leak and Compliance Tests Section 4 5 e Pipeline Tests Section 4 7 Cylinder Tests Section 4 9 Flow Control System Test Section 4 10 e Vaporizer Tests Section 4 11 Before each patient Inspect the System Section 4 2 Pre operative Checkout List Section 4 3 Perform the Leak Compliance Test Section 4 5 Power Failure Alarm Test Section 4 6 Breathing System Tests Section 4 12 Alarm Tests Section 4 13 Inspect the AGSS Section 4 15 NOTE Read and understand the operation and maintenance of each component before using the A5 A3 anesthesia machine NOTE Do not use the A5 A3 anesthesia machine if a test failure occurs Contact Mindray Technical Support for assistance NOTE A checklist of the anesthetic system should be provided including anesthet
106. d for silencing alarms See Figure 3 27 Setup Alarms FIGURE 3 27 System Softkeys Setup Softkey Select the Setup softkey on the main screen to display the Setup menu See Figure 3 27 System Softkeys on page 21 The Setup menu contains the General tab Display tab System tab and Service tab See section 3 11 pg 3 24 Display Tab Alarms Softkey Select the Alarms softkey on the main screen to open the Alarms menu to set alarm limits set alarm volume view alarm log and view all active alarms See Alarms and Messages on page 6 1 Silence Softkey Select the Silence softkey on the main screen to silence all currently sounding alarm tones for 120 seconds The alarm silence icon and 120 second countdown time appear at the top of the screen Select again to clear the alarm silence Note however that a new alarm will sound if that alarm occurs while the system is in a silenced state If this occurs you can select the Silence softkey again to silence the new alarm and reset the silence countdown timer to 120 seconds A5 A3 Operating Instructions 046 003777 00 3 21 Setup System Interface 3 10 3 10 1 Setup Select the Setup softkey FIGURE 3 27 to open the Setup menu FIGURE 3 28 The Setup menu contains the General tab Display tab System tab and Service tab See section 3 11 pg 3 24 Display Tab NOTE The System tab is only available in Standby mode NOTE The Service tab is for use on
107. delivered to the patient The auto zeroing intervals are startup 5 mins 15 mins 30 mins 60 mins and every 60 mins thereafter NOTE The A5 A3 will display the message Auto zeroing in process during the auto zeroing intervals Volume The Volume parameter group consists of 3 parameters Tidal Volume V7 The unit of measure is mL milliliter Minute Volume MV The unit of measure is L min liters per minute Respiratory Rate Rate The unit of measure is bpm breaths per minute If the parameter data is out of range it is displayed as 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 Inspired O FiO The unit of measure is 96 volume 96 If the parameter data is out of range it is displayed as FIO2 measurements between 100 and 110 inclusive will be displayed as 100 Above this range the system will display NOTE FiO values above 100 although not realistic are possible due to errors in calibration 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 046 003777 00 A5 A3 Operating Instructions Operations Parameter Monitoring Waveforms 5 10 4 Spirometry A5 Only Spirometry is a respiratory monitoring technology tha
108. e Error Manual Control Ventilator Board Voltage Fail PEEP Valve 1 PEEP valve voltage Medium Startup Only Ventilator Failure PEEP error Manual Control Valve Fail 2 PEEP valve pressure Board error Insp Valve 1 Inspiratory valve Medium Startup Only Ventilator Failure Insp voltage error Manual Control Valve Fail 2 Inspiratory valve flow Board error Safety Valve PEEP safety valve Medium Startup Only Ventilator Failure Safety voltage error Manual Control Valve Fail Board Flow Sensor Ventilator flow is out of Low Startup Only Ventilator Failure Flow range Manual Control Sensor Fail Board Calibrate Flow 1 Calibration table isn t Low Startup Only Ventilator Sensor and Insp found in EEPROM Manual Control Valve 2 Checksum of Board Calibration table does not match Calibrate 1 Calibration table isn t Low Startup Only Ventilator Pressure Sensor found in EEPROM Manual Control and PEEP Valve 2 Checksum of Board Calibration table does not match Calibrate O 1 Calibration table isn t Low Startup All Ventilator Sensor found in EEPROM Control 2 Checksum of Board Calibration table does not match Ventilator After power on CPU High Startup Non CPU Board Initialization board cannot send the Functional Error parameter settings to Ventilator the ventilator board Initialization Fail 046 003777 00 A5 A3 Operating Instructions Alarms and Messages Alarm and Prompt Messages
109. e to close the Calibration window 12 Select Accept to close the Setup window NOTE In case of repeated calibration failure contact Mindray Technical Support Calibrate Flow Sensor Calibrate Flow Sensor Prepare 1 Set the Auto Manual switch to Auto Calibration Successful postion 2 Make sure that the supply gas pressure is sufficient Reinstall the bellows water trap and open fresh gas flows before operating 3 Remove bellows from bellows machine mount and reinstall bellows cover 4 Remove the water trap us FIGURE 7 2 Flow Sensor Calibration FIGURE 7 3 Flow Sensor Calibration Begin Successful A5 A3 Operating Instructions 046 003777 00 7 5 O Sensor Calibration Maintenance 7 6 O Sensor Calibration Perform O calibration when the measured value of O concentration has a large deviation from other reference sources or when the O sensor is replaced If the O5 sensor is replaced 10096 O sensor calibration is required For continued O sensor accuracy the A5 A3 checks for 21 O calibration approximately every 72 hours The A5 A3 prompts the user for 21 O calibration as follows When the machine is powered on if more than 72 hours have elapsed since the last successful calibration the prompt message Calibrate O2 sensor for 2196 is displayed The message disappears after successful calibration If the machine is kept powered on the prompt message Calibrate O2 sensor
110. eathing system and CO absorbent canister to produce condensed water Check the inspiratory and expiratory flow sensors when abnormal flow waveform or unstable tidal volume fluctuation is detected Check the sensor for water If there is water build up clear it immediately before use To prevent water build up Use a filter between the flow sensor and the patient to limit water condensation in the flow sensor Check the water trap for water before using the A5 A3 Anesthesia System If there is water build up clear it immediately 7 7 2 Clear Water Build up The water build up inside the flow sensor will result in inaccurate measured value of tidal volume If there is water built up inside the flow sensor remove the sensor and clear the water Then reinstall the sensor for use WARNING Check water build up inside the flow sensor before every system use Pooled water in the flow sensor causes erroneous readings WARNING Ensure that all breathing system parts are completely dried after the breathing system is cleaned and disinfected 7 8 AGSS Transfer Tube Maintenance Check the tube of the AGSS transfer system Replace it if it is damaged A5 A3 Operating Instructions 046 003777 00 7 9 Cleaning and Disinfection Maintenance 7 9 Cleaning and Disinfection CAUTION Before using the A5 A3 System after cleaning or disinfecting power up the system and follow the on screen prompts to perform the Leak Test and the Com
111. ecsssssseeccssusesesssusseesssussseessnseceecsnseceeesnssesessnnseeeesnseees B 14 Pneumatic Diagram cresce eese eene eene senses aetas etos seen sets setas etos se sos senos esos esos se soos sense sons en ssesossesossesssessssenssessssesssesss C 1 Pneumatic Diagram of the A5 A3 SysteM ssssssssssssssssssssseesssesssssssssessssssssessssessssssssssssssesssesssssssusssssssesssssssnsssesessasssssnsessessesssssssessessassssssueeeessesssssnees Abbreviations Symbols and Units of Measure e eeee eese esten eene eene enses sense neta sens tn sess tas etas ta stesse Abbreviations Symbols Units of Measure Attention Symbols 046 003777 00 A5 A3 Operating Instructions Foreword Introduction Foreword WARNING Do not operate the A5 A3 Anesthesia System before reading these instructions The operating instructions forthe A5 A3 Anesthesia Delivery System hereinafter referred to as A5 A3 Anesthesia System A5 A3 System A5 A3 or individual A5 and A3 are intended to provide information for proper installation operation and general maintenance of the A5 A3 System to the user General knowledge and understanding of the features and functions of the A5 A3 System are prerequisites for its proper use For servicing information or assistance please contact an authorized representative in your area CAUTION U S Federal Law restricts this device to sale by or on the order of a physician or ot
112. ected to it to stop their operation simultaneously The anesthesia system will cease to deliver gas at pressures below the minimum specified gas pipeline supply pressure Use a cleaning and disinfection schedule that conforms to your institution s disinfection and risk management policies Refer to the material safety data as applicable Refer to the operation and maintenance manuals of all disinfection equipment Do not inhale fumes that may result from any disinfection process Use extreme care while handling the absorbent as it is a caustic irritant A5 A3 Operating Instructions 046 003777 00 ix Introduction Warnings WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING 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 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 All gas supplies should be of medical grade Single use respiratory hoses face masks sensors sodalime water traps sampling lines airway adapters and other single use items may be considered potential biologically hazardous items and should not
113. ed distorted or worn For details refer to Inspect the System on page 4 3 and Cleaning and Disinfection on page 7 10 046 003777 00 A5 A3 Operating Instructions Maintenance Flow Sensor Calibration 7 5 Flow Sensor Calibration WARNING Do not perform calibration while the unit is connected to a patient NOTE During calibration do not operate the pneumatic parts Do not move or press the breathing tubes The flow sensor must be calibrated whenever the flow volume is out of specification or after changing the flow sensor To calibrate the flow sensor Ensure that the supply gas pressure is normal Turn off all fresh gas inputs Set the ventilation switch to the automatic ventilation position PON Remove the bellows and reinstall the bellows housing 5 Plug the Y piece of the breathing circuit into the leak test port to close the breathing system 6 Remove the water trap 7 Ensure that the system is Standby mode If not select the Discharge button in the Manual tab and follow the screen prompts to discharge the patient and enter Standby mode 8 Select the Setup softkey then the Calibrate Flow Sensor button 9 Follow the on screen prompts and select the Begin button to start to calibrate the flow sensor The calibration process takes several minutes The system will display the results of the calibration status when the process is completed 10 Reinstall the bellows and water trap 11 Select Don
114. em The A5 A3 is intended to be operated with its integral Breathing Pressure monitoring in use The A5 A3 is intended to be operated with its integral Breathing Pressure limitation devices in use The A5 A3 is intended to be operated with its integral Exhaled Volume monitoring in use The A5 A3 is intended to be operated with its integral Breathing System integrity Alarm System in use The A5 A3 is intended to be operated with its integral Continuing Pressure Alarm in use The A5 A3 is intended to be operated with its integral O monitoring in use The A5 A3 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 The 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 A5 A3 Operating Instructions 046 003777 00 xv Introduction Notes NOTE Continuously monitor the anesthetic agent concentration when using the Anesthesia System to ensure accurate output of the anesthetic agent NOTE Check the liquid level of the anesthetic agent before and during all operations When the liquid level is below the warning line more anesthetic agent needs to be added Refer to the vaporizer Instructions For Use for filling the vaporizer and other information NOTE The A5 A3 System i
115. ence FIGURE 3 13 Spirometry Pressure Volume Loop Current Mo VCV Spirometry Flow Volume PEAK PLAT Show Reference FIGURE 3 14 Spirometry Flow Volume Loop 25 18 6 25 18 6 3 12 046 003777 00 A5 A3 Operating Instructions System Interface Spirometry Tab A5 Only Spirometry loops reflect patient lung function and ventilation They also indicate other related parameters such as compliance over inflation breathing system leak and airway blockage The system provides two spirometry loops P V Paw volume loop and F V flow volume loop Data of P V and F V loops come from pressure and flow data Only one loop is displayed at a time The spirometry tab displays four softkeys Loop Type Show Reference Save Loop and Review Loops 3 5 1 Loop Type The Loop Type selection is used to select Pressure Volume loop or Flow Volume loop to display on the spirometry screen Default Loop Type is Pressure Volume loop Show Reference Review Loops Loop Type Save Loop FIGURE 3 15 Spirometry Softkeys Loop Type Show Reference Save Loop and Review Loops 3 5 2 Show Reference The Show Reference softkey can be selected only after a baseline has been saved via the Save Loop softkey The Show Reference softkey FIGURE 3 15 is used to select and display a saved Baseline loop Reference loop or no loop Off in the Spirometry Loop Window overlapped with the currently plotting loop
116. end of the inspiratory phase During the expiratory phase the inspiratory valve closes and the expiratory valve opens The patient can expire freely The patient s expired gas mixed with the fresh gas enters and lifts the bellows inside the dome The drive gas outside the bellows is scavenged to the Anesthetic Gas Scavenging System AGSS until the end of the expiratory phase During ventilation the ventilator performs real time monitoring over airway pressure and flow If the airway pressure or minute volume is outside the user preset alarm limits an audible and visible alarm occurs When the airway pressure is higher than the limit value determined by the PEAK high alarm imit the ventilator enters the expiratory phase automatically to avoid causing injury to the patient Additionally the ventilator has a built in pressure safety valve that opens at an approximate pressure of 110 cmH50 11kPa 7 2 Block Diagram Anesthetic Ventilator Anesthetic Gas Scavenging System AGSS Anesthetic Gas Hospital s Delivery Device Vaporizer Disposal System Breathing Patient Anesthetic Gas Delivery System System FIGURE 7 1 Block Diagram of A5 A3 System A5 A3 Operating Instructions 046 003777 00 7 3 Maintenance Schedule Maintenance 7 3 7 4 Maintenance Schedule The schedules listed below are the minimum frequency based on 2000 hours of usage per year The equipment shou
117. ery supply is fully charged AC power is connected The A5 A3 is being powered by AC power The solid portion represents the current charge level of the batteries in proportion to its maximum charge level Battery supply is partially charged AC power is connected and charging batteries The A5 A3 is being powered by AC power Battery supply is fully charged AC power is not connected The A5 A3 is being powered by internal batteries Battery supply is partially charged AC power is not connected The A5 A3 is being powered by internal batteries Battery supply is low charged Batteries need to be charged immediately to operate as a safe power backup AC power is not connected The A5 A3 is being powered by internal batteries Battery supply is not installed FIGURE 3 10 Battery Status 3 8 046 003777 00 A5 A3 Operating Instructions System Interface Fresh Gas Flow Display 3 3 Fresh Gas Flow Display Displays real time flowmeter levels for N50 Air and O5 FIGURE 3 11 The flowmeter numerics display a precision to two decimal digits for flows 1 L min and one decimal digit for flows 2 1 L min Fresh Gas Flow Display Fresh Gas FI res as Flow N20 Air 02 vev 700 G25 ur TON MOTE FIGURE 3 11 Fresh Gas Flow Display A5 A3 Operating Instructions 046 003777 00 3 Waveforms Tab System Interface 3 4 Waveforms Tab Displays PAW cmH5O and Flow L min waveforms F
118. etic Agent Select the Desired Anesthetic Agent Adjust the Concentration of Anesthetic Agent csssssccssssssssccsssesssecssseccecssssssccssssssscssssecesssnssesssnsssessnssecesssussecessnnseceecnuseesesaneeeesseneeeeses 5 6 MSIE ci 5 7 Monitored Parameters 7 Ventilation Modes 7 Change Ventilation Mode 7 Set Manhual Ventilatiori Mode issiria ii la been puta score petente caca EE 5 8 Make Settings before Starting Mechanical Ventilation Mode sssssssscssssessecsssesseccsssescecssseececssssecessnssececsnsececeesneesescsnseceecsnnsecessnsseeessnaeses 5 1 Set Volume Control Ventilation VCV 1 To Set VCV Mode 1 Set Pressure Control Ventilation PCV 5 1 MO SEE PREV ip H 5 1 Synchronized Intermittent Mandatory Ventilation SIMV ssssssscssssssssccsssesceccssseseccssseccscssseeescssssesessnssecesssnesesessnsesescsnssceecennseceesnssesessnseses 5 1 Pressure Support in Synchronized Intermittent Mandatory Ventilation SIMV Synchronized Intermittent Mandatory Ventilation Volume Control SIMV VC Synchronized Intermittent Mandatory Ventilation Pressure Control SIMV PC A5 Only seen 5 To Set SIMV VG OF SIMV PC Mode ttp oia 5 1 Set Pressure Support Ventilation PS To Set PS Mode Start Mechanical Ventilation Stop Mechanical V ntilatiOn ettet rece eorr idee eee i ettet eR Reti Ree el ace ee pe etes bt ecu iet oreet AR eee CRT 5
119. etwork button see Figure 3 33 Select Main screen gt Setup button gt System tab gt Network button m FIGURE 3 33 Network Configuration Screen Table 3 4 on page 30 lists the network settings and parameters A5 A3 Operating Instructions 046 003777 00 3 29 System Tab System Interface SETTINGS PARAMETERS This Machine Configure Ethernet Enter IP Address default 192 168 23 250 e Subnet default 255 255 255 0 e Default Gateway default blank Configure Serial 1 Hour 2 Hour 6 Hour 12 Hour 24 Hour Select Protocol None default MR Link MR WATO e Baud Rate 57600 11520 default Data Bits 8 default Stop Bits 1 default 2 Parity Odd Even None default Interval 10 Sec 30 Sec 1 Min default 5 Min 30 Min Network Protocol HL7 Select On Off default Interval enabled when HL7 On Select 10 sec 30 sec 1 min default 5 min 30 min 1 hour 2 hour 6 hour 12 hour 24 hour Destination IP enabled when HL7 On Enter Destination IP default 192 168 23 200 Port enabled when HL7 On Enter Port default 1550 TABLE 3 4 Network Configuration Settings and Parameters 3 30 046 003777 00 A5 A3 Operating Instructions System Interface System Tab SETTINGS PARAMETERS SNTP Protocol Interval Select Off default 10 sec 30 sec 1 min 5 min 30 min
120. f delay sound can be adjusted in the System Alerts setting in the Alarm Volume menu When the user turns on the machine during the power off delay period the countdown timer will disappear and the ventilator will resume its previous state NOTE The powering off function is not implemented during Standby only when actively ventilating Seconds until machine powers off Actuate power switch to recover Countdown timer screen 046 003777 00 A5 A3 Operating Instructions Operations Patient Setup 5 3 5 3 1 Patient Setup Discharge Standby Mode The Discharge button is located in the Manual tab FIGURE 5 2 The Discharge button can be selected only when the Auto Manual ventilation switch is set to Manual and when all gas flows are turned off Discharge Button Discharging the patient changes the current patient size to the default patient size and loads the user defaults for the system clears the patient demographics clears the User Alarm Log and Spirometry Loops including the currently plotting loop reference loop and baseline loop and places the system into Standby mode see Figure 5 3 In Standby all system functions are idle It is the default system startup mode and is used after discharging a patient Adult Standby Fresh Gas Flow Waveforms N20 AIR 02 turn on fres r touch here to start case FIGURE 5 3 Standby Mode To discharge the patient and enter Standby 1 Set the
121. ff Range On Off Step Step Default Off Default Off Bypass A5 Range On Off only Step Default Off Alarm Range On Off Step Default On Apnea Ti Range 0 2 to 5 0 sec Step 0 1 sec Default 5 0 sec adult 3 0 sec Pediatric 2 0 sec Infant The Tslope setting is an approximation The exact waveform shape may not be realized under certain clinical scenarios s nojag K1ojop pup ssajawiosog Parameters and Factory Defaults Linked Ventilation Parameter Relationships B 8 Linked Ventilation Parameter Relationships The table below lists how parameter values are affected when changing ventilation modes For example ventilation modes that share the same parameters may also share the same parameter values when changing from one ventilation mode to the other Other parameters may have their values set differently when changing ventilation modes CURRENT PREVIOUS VENTILATION MODE VENTILATION MODE amp PARAMETERS AFFECTED VCV SIMV VC PCV SIMV PC PS VCV Vt MeasuredVt or last value LE S Tpause T PEEP 7 Plimit x P SIMV VC Vt MeasuredVt or last value Tinsp Tpause Ed PEEP Plimit id Ex PS d id PS On AP Trigger i td id Tslope jf t be PCV VtG zn Pinsp
122. ffer from that on the total flowmeter the electronic flowmeter will prevail and the total flowmeter is an approximate value 02 Only vaporizers with Selectatec Interlock Systems may be used with the A5 A3 unit Use vaporizers compliant to ISO 8835 4 See section A 12 pg A 5 Vaporizers Refer to the manufacturer s vaporizer Instructions For Use for filling or draining the vaporizer and other information 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 D 6 046 003777 00 A5 A3 Operating Instructions Abbreviations Symbols and Units of Measure Attention Symbols igm FIGURE D 2 Main Unit Rear View ATTENTION NUMBER DESCRIPTION 03 Each auxiliary outlet is rated at 100 to 120 VAC 60 Hz 04 Individual outlet current is limited to 3 A Total mains output current is limited to 10 A 05 Sample Line Exhaust Gas Inlet Inlet for waste gas from an optionally attached gas module Merges with the AGSS connector that connects to the AGSS A5 A3 Operating Instructions 046 003777 00 D 7 Attention Symbols Abbreviations Symbols and Units of Measure 06
123. for airway maintenance manual ventilation and tracheal intubation and applicable anesthetic and emergency drugs are available 4 Setthe Auto Manual ventilation switch to Manual 5 Connectthe manual bag to the manual bag port 6 Turn off all vaporizers 7 Turn the APL valve control to the SP position to fully open the APL valve 8 Turnallflow controls to set all gas flows to Off 9 Ensure that the breathing system is correctly connected and not damaged WARNING Before connecting a patient flush the A5 A3 anesthesia machine with 8 L min of O for at least two minutes This removes unwanted mixtures and by products from the system 4 30 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Inspect the AGSS 4 15 Inspect the AGSS 1 Connect the vacuum hose to the EVAC port or vacuum port of the healthcare facility and turn on the waste gas disposal system 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 2 Check if the float can rise and exceed the MIN mark If any blockage tackiness or damage occurs to the float disassemble clean the filter and assemble the float again or replace the float 3 Drain any moisture from the waste gas hose Reconnect the waste gas hose to the AGSS waste gas port NOTE Do not block the AGSS pressure compensation openings during the inspection If the floa
124. form the proper preoperative tests to ensure that the device is performing properly Leaky circuits can not be used Connection of the A5 A3 exhaust port to the hospital s waste gas scavenging system is strongly recommended to prevent exposure of hospital personnel to the A5 A3 exhaust gases Pins of connectors identified with the ESD warning symbol should not be touched Connections should not be made to these connectors unless ESD precautionary procedures are used Operation of the A5 A3 below the minimum flow values may cause inaccurate results 046 003777 00 A5 A3 Operating Instructions Warnings Introduction WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING This equipment system is intended for use by healthcare professionals only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as reorienting or relocating the device or shielding the location Ensure that an independent means of ventilation e g a self inflating manually powered resuscitator with mask is available whenever the A5 A3 is in use Usage of accessories with package damage may cause biocontamination or failure The operator should check accessory packaging for storage integrity before use Before using the A5 A3 System after cleaning
125. g the disabled Continue button Set Auto Manual switch to 5 sec This message appears in the first Manual Auto position and adjust all flowmeters to zero Circuit Leak Test screen when pressing the disabled Continue button TABLE 6 11 Prompt Messages Displayed in Pop up Area 046 003777 00 A5 A3 Operating Instructions zo Maintenance A t ee a E sU e D AR Ud d 7 3 BlockiDIagrarti cte tpa a eee tpa etium 7 3 Maintenance Schedule rettet ated bets at o da ied db p dd bertus 7 4 Breathing System Maintenance ttt ttt ttt ttt ttt ttt ttt ttti 7 4 Flow Sensor Calibration soe a a ette te o a Ci ad 7 5 O Sensor Calibtatiokis sca a iter ttem Dept Diaria edenda tana EAE 7 6 Water Buildzup irithe FOW SENSOR uos ebbe e a a 7 9 A6SS Transfer Tube Maintenance a oo let Decio dell ada Ll eo cedo de ed 7 9 ars dedueti onte a a ub tte LM etr tent 7 10 Regular Maintenance A5 A3 Operating Instructions 046 003777 00 7 Maintenance WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING CAUTION CAUTION CAUTION CAUTION NOTE Do not use a malfunctioning A5 A3 Anesthesia System Have all repairs and service done by an authorized service representative Use a cleaning and disinfection schedule that conforms to your institution s disinfection and risk management policies Refer to the material safety data as applicable Refer to the operation and main
126. h priority alarm sound white text red Red Alarm file the interval between each background high play is 5 1 sec priority icon Qiu Medium Play medium priority alarm black text yellow Yellow sound file the interval background medium between each play is 5 1 priority icon Low Play low priority alarm sound white text cyan Cyan file the interval between each background low play is 17 1 sec priority icon ZA Technical High Play high priority alarm sound white text red Red Alarm file the interval between each background high play is 5 1 sec priority icon QA Medium Play medium priority alarm black text yellow Yellow sound file the interval background medium between each play is 5 1 priority icon Low Play low priority alarm sound white text cyan Cyan file the interval between each background low play is 17 1 sec priority icon A Prompt None None white text black off Message background TABLE 6 1 Alarm indicators audio and on screen messages 046 003777 00 A5 A3 Operating Instructions Alarms and Messages Displaying Alarms 6 2 Displaying Alarms On the LCD monitor screen alarm messages are automatically displayed at the top area of the Main Screen when alarm conditions occur see FIGURE 6 4 Additionally a list of all active alarms and an alarm log can be found in the Alarms window See FIGURE 6 2 and FIGURE 6 3 Each message is displayed with an associated priority symbol as follows
127. h 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 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 Xii 046 003777 00 A5 A3 Operating Instructions Cautions Introduction CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION If system 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 After changing the CO Pre Pak or loose fill absorbent perform a fresh gas system leak test Only vaporizers with Selectatec Interlock Systems may be used with the A5 A3 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 n
128. he test ES Select Accept to proceed using previous compliance values 3 1mL cmH20 on 11 17 2011 Leak rate 200 mL min Compliance test failed The results screen displays the compliance values and time of the last compliance test that passed If the compliance test has never been performed successfully the compliance values and test time are displayed as Select Accept to proceed to the Manual Circuit Leak Test screen and use the previous compliance values or Select Retry to repeat the Automatic Circuit Leak Test amp Compliance test Automatic Circuit Leakage XXX mL min Compliance Test Fail Example Automatic Circuit Leak amp Compliance Test Complete Automatic Circuit Leakage Compliance Test Check the following and select Retry to repeat the test recommended Select Accept to proceed using previous compliance values 3 1 mL cmH20 on 11 17 2011 Leak rate gt 200 mL min and lt 1000 mL min The results screen displays the compliance values and time of the last compliance test that passed If the compliance test has never been performed successfully the compliance values and test time are displayed as Select Accept to proceed to the Manual Circuit Leak Test screen and use the previous compliance values or Select Retry to repeat the Automatic Circuit Leak Test amp Compliance test TABLE 4 3 Automatic Circuit Leak and Compliance Test Results 046 003777 00 Le
129. hen selected 4 Usethe on screen keypad to enter the desired parameter value For each parameter the range of values is displayed above the keypad The section Alarm Limits on page B 3 also lists the range of values for Paw MV and FiO 5 Select Accept to save the change or select Cancel to not save 6 Repeat Steps 3 to 6 for each parameter value Limits FIGURE 6 7 Limits tab in the Alarms window 6 10 046 003777 00 A5 A3 Operating Instructions Alarms and Messages Alarm Limits 6 5 2 Loading Alarm Defaults Users can load the user alarm limit defaults of all modules from the Alarms window To load alarm limit defaults 1 On the Main Screen select the Alarms softkey The Alarms windows is displayed 2 Select the Load Alarm Defaults button at the bottom of the Alarms window The alarm limits defaults are loaded for FiO2 MV and PEAK 3 Select the Accept button to save these settings and close the Alarms window Limits Load Alarm Defaults button FIGURE 6 8 Load Alarm Defaults button in the Alarms window A5 A3 Operating Instructions 046 003777 00 6 11 Alarm Limits Alarms and Messages 6 5 3 Auto Alarm Limits The Auto Alarm Limits function uses an algorithm based on measured values The relationship is shown in the table below The Auto Alarm Limits button is disabled when the A5 A3 is in Standby mode or Manual mode The Auto Alarm Limits button is also disa
130. her practitioner licensed by state law to use or order the use of this device NOTE Figures in this manual are provided for reference purposes only Screens may differ based on the system configuration and selected parameters Indications For Use The A5 A3 Anesthesia System is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient s ventilation The A5 A3 is intended for use by licensed clinicians for patients requiring anesthesia within a health care facility and can be used for adult and pediatric populations WARNING The A5 A3 is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use Anyone unauthorized or untrained must not perform any operation on the A5 A3 WARNING The A5 A3 is not suitable for use in an MRI environment Responsibilities of Operators The proper function of the A5 A3 System can only be guaranteed if it is operated and serviced in accordance with the information provided in this manual and by an authorized Mindray service representative Non compliance with this information voids all guarantee claims The A5 A3 System must be operated by qualified and trained personnel only All operators must fully Observe these operating instructions and relevant additional documentation They must also comply with the WARNINGS CAUTIONS and NOTES detailed in this man
131. hstand immersion or the heat and pressure of autoclaving CAUTION If moisture remains in the bellows after cleaning the bellows surface folds may become tacky and prevent the bellows from properly expanding Ensure all moisture is removed from the bellows after cleaning Afterall 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 7 Disinfection NOTE Ensure that all bellows components have been cleaned as described in step 6 before disinfecting See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving and use an approved disinfecting agent for all bellows components while adhering to facility policies and procedures 8 Connectthe bellows to the breathing system by reassembling all components in the reverse order Prior to use after cleaning or disinfecting power up the system and follow the on screen prompts to perform the Leak Test and the Compliance Test See section 4 5 pg 4 9 Leak and Compliance Tests A5 A3 Operating Instructions 046 003777 00 7 13 Cleaning and Disinfection Maintenance 7 9 5 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 Expiration Valve Inspiration Valve FI
132. ic gas delivery system monitoring device alarm system and protective device which are intended to be used for the anesthetic system whether they are used alone or assembled together 4 2 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Inspect the System 4 2 Inspect the System NOTE Ensure that the breathing system is correctly connected and not damaged Perform the following inspection checklist before operating the A5 A3 unit 1 The A5 A3 anesthesia machine is correctly connected and undamaged 2 Inspectthe system for a Damage to flowmeters vaporizers gauges supply hoses b Complete breathing system with adequate CO absorbent Pre Pak or loose fill Correct mounting of cylinders in yokes d Presence of cylinder wrench e Auxiliary O5 supply available and functioning 3 Checkthat a Gas cylinders are turned off until needed to prevent the unintended use of gases b Flow control valves are off Vaporizers are off d Vaporizers are filled not overfilled e Filler caps are sealed tightly f Two vaporizers cannot be turned on at the same time 4 All components are correctly attached 5 The breathing system is correctly connected the breathing tubes are undamaged and the self inflating manual ventilation device is available and functioning 6 The gas supplies are connected and the pressures are correct 7 Cylinder valves are closed on models with cylinder supplies Verify that the cylinder
133. idance and Declaration Electromagnetic Emission GUIDANCE AND DECLARATION ELECTROMAGNETIC IMMUNITY The A5 A3 is intended for use in the electromagnetic environment specified below The customer or the user of the A5 A3 should assure that it is used in such an environment IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC IMMUNITY 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 with IEC 61000 4 2 X8 kV air 8 kV air synthetic material the relative humidity should be at least 3096 Electrical fast 2 kV for power 2 kV for power Mains power quality should be that of transient burst supply lines supply lines a typical commercial or hospital IEC 61000 4 4 environment 1 kV for input 1 kV for input output lines output lines TABLE 8 32 Guidance and Declaration Electromagnetic Immunity 046 003777 00 A5 A3 Operating Instructions Product Specifications Electromagnetic Capability GUIDANCE AND DECLARATION ELECTROMAGNETIC IMMUNITY The A5 A3 is intended for use in the electromagnetic environment specified below The customer or the user of the A5 A3 should assure that it is used in such an environment IMMUNITY TEST IEC 60601 TEST LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDANCE Surge 1 kV differential 1 kV differential Mains power quality should be that of IEC
134. ilence softkey is selected all active alarms are silenced and the icon on the left side of the alarm message changes to indicate that the alarm is silenced When the 120 second silence icon appears the audio alarms are silenced for 120 seconds after which the audio alarms resume If you select the Silence softkey while all alarms are silenced then the audio alarms will resume immediately NOTE A new alarm will sound if that alarm occurs while the system is in a silenced state If this occurs you can select the Silence softkey again to silence the new alarm and reset the silence countdown timer to 120 seconds Alarm Silenced Icon ZX BDU Communication Error A 120 sec FIGURE 6 6 Alarm silenced icon A5 A3 Operating Instructions 046 003777 00 6 9 Alarm Limits Alarms and Messages 6 5 Alarm Limits 6 5 1 Setting Alarm Limits Users can set the high and low alarm limits of Paw MV and FiO to create alarm conditions consistent with patient needs The alarm is then triggered when the parameter value is greater than the High Limit or lesser than the Low Limit NOTE When using the A5 A3 Anesthesia System ensure that the alarm limits of each parameter are set to the appropriate values for the patient To set the Alarm Limits 1 Onthe Main Screen select the Alarms softkey The Alarms windows is displayed 2 Select the Limits tab See FIGURE 6 7 3 Select a parameter softkey The softkey is highlighted w
135. in a hazard to the patient Alarm settings should be customized according to different patient situations Constantly keeping the patient under close surveillance is the most reliable way for safe patient monitoring The physiological parameters and alarm messages displayed on the screen of the equipment are for the caregiver s reference only and cannot be directly used as the basis for clinical treatment Dispose of the packaging material observing the applicable waste control regulations and keeping it out of children s reach viii 046 003777 00 A5 A3 Operating Instructions Warnings Introduction WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING To avoid the possibility of explosion do not use the equipment in the presence of flammable anesthetic agents vapors or liquids Do not use flammable anesthetic agents such as ether and cyclopropane for this equipment Use only non flammable anesthetic agents that meet the requirements specified in IEC 60601 2 13 or ISO 8835 The A5 A3 Anesthesia System can be used with halothane enflurane isoflurane sevoflurane and desflurane Only one anesthetic agent can be used ata time Fresh gas flow must never be switched off before the vaporizer is switched off The vaporizer must never be left switched on without a fresh gas flow Anesthetic agent vapor at a high conce
136. ing Separate treatment from general waste at end of life Identifier Manufacturer Identifier Manufacturer s Reference Catalog Number Identifier Serial Number Indicator c N Lock Unlock Direction ED Es 134 C Lock Unlock Lock Lock Unlock Unlock No Heavy Objects Do Not Crush Autoclavable MAX MIN O 0 gt PPSU lt gt PSU lt Kio Os Gas Flow Flow Control Gas Flow Maximum Gas Flow Minimum Gas Flow Total Gas O Flush O Sensor Connector Gas Pipeline Connection Material Polyphenyl sulfone Material Polysulfone Touchpad Manual ventilation via Breathing Bag Automatic Ventilation Water Trap Do Not Oil A5 A3 Operating Instructions 046 003777 00 xix Introduction Symbols be Not Autoclavable Caution Hot Water Drain Battery supply fully charged AC power connected and powering system Battery supply partially charged AC power connected charging battery supply and power system Battery supply fully charged and powering system AC power not connected Battery supply partially charged and powering system AC power not connected Battery supply low charged and powering system Recharging recommended AC power not connected Battery supply not installed gt A 5 kg MAX 11 lbs MAX ETL CLASSIFIED Intertek 3191955 LN L N hj Y gt 2 Filter Access Direction of flow
137. ing of the scale may vary when viewed at a different angle NOTE If the readings shown on the electronic flowmeters differ from that on the total flowmeter the electronic flowmeter will prevail and the total flowmeter is an approximate value 5 5 2 Set Anesthetic Agent NOTE You do not need to perform this operation if inspiratory anesthetic agent is not used NOTE The A5 A3 anesthesia system can be mounted with vaporizers A5 A3 Operating Instructions corresponding with halothane enflurane isoflurane sevoflurane and desflurane Only one of the vaporizers can be opened at a time because the vaporizers are featured with an interlock system 046 003777 00 Input Fresh Gas Operations 5 5 2 1 Select the Desired Anesthetic Agent 1 Determine the anesthetic agent to be used and then fill the vaporizer NOTE The A5 A3 should use Mindray approved vaporizers compliant to ISO 8835 4 Refer to the manufacturer s vaporizer Instructions For Use for filling or draining the vaporizer and other information WARNING Ensure that the correct anesthetic agent is used The vaporizer is designed with the specific anesthetic agent named on it and further indicated by color coded labelling The concentration of the anesthetic agent actually output will vary if the vaporizer is filled with the wrong agent 2 Mount the vaporizer filled with anesthetic agent onto the A5 A3 Anesthesia System See Install the Vaporizer on page 2 5 5 5
138. ing to Manual If Daylight Savings is set to Auto the Daylight Savings Time On Off button in the Date Menu dialog becomes inactive and cannot be selected see FIGURE 3 8 Select to set the START of Daylight Savings Time This setting is not available if DST is set to Manual Select to set the END of Daylight Savings Time This setting is not available if DST is set to Manual 3 00 AM Network See section 3 12 1 pg 3 29 Network Configuration Change Password 1234 default Select to change the System tab password The authorized administrator should change the default password immediately after the system is installed to prevent unauthorized access to the System tab The password can be up to 6 digits in length containing numerals 0 to 9 Set Pressure Unit cmH20 default Select to set the Pressure Unit of measure hPa mbar TABLE 3 3 System tab settings 046 003777 00 A5 A3 Operating Instructions System Interface System Tab SYSTEM TAB BUTTON CHOICES DESCRIPTION Configuration Select to display the machine ID and the status of Information system functions E g gt Configuration Status Activated Activated Inactivated Activated Activated Inactivated Inactivated Export Data Select to export patient data via mass storage device TABLE 3 3 System tab settings 3 12 1 Network Configuration Network configuration settings can be set via the N
139. inuous Airway Pressure alarm occurs 6 Disconnect the breathing circuit and ensure that the alarm cancels 7 Reconnect the breathing circuit 4 13 6 Test the High Paw Alarm 1 Set the ventilation switch to the automatic ventilation position 2 Select the Alarms softkey and then the Limits tab 3 Set the PEAK low alarm limit to 0 cmH 0 and PEAK high alarm limit to 10 cmH 0 4 Ensure that a high Paw alarm Paw Too High occurs 5 Set the PEAK high alarm limit to 40 cmH35O 6 Ensure the high Paw alarm cancels 4 13 7 Test the Low Paw Alarm 1 Set the ventilation switch to the automatic ventilation position 2 Select the Alarms softkey and then Limits tab 3 Set the Peak low alarm limit to 2 cmH30 4 Disconnect the test lung or manual bag from the Y piece of the breathing circuit 4 28 Wait for 20 seconds View the alarm area and ensure that a low Paw alarm occurs 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Alarm Tests 6 Connect the test lung or manual bag to the Y piece of the breathing circuit If using a manual bag squeeze the bag to cancel the alarm 7 Ensure the low Paw alarm cancels A5 A3 Operating Instructions 046 003777 00 4 29 Preoperative Preparations Preoperative Tests 4 14 Preoperative Preparations 1 Ensure that the ventilator parameters and alarm limits are set to applicable clinical levels 2 Ensure that the system is in Standby 3 Ensure that the equipment
140. ion pipeline port The Breathing System contains the following ports for end user connections Inspiratory port for Inspiratory hose of patient breathing circuit Expiratory port for Expiratory hose of patient breathing circuit Manual Breathing Bag Arm Connection for the O cell Water trap Leak test port for sealing the breathing circuit during leak testing 1 1 8 Anesthetic Gas Scavenging System AGSS The A5 A3 includes a waste gas scavenger that attaches to the side rail mount on the system The A5 A3 provides a port for the connection of the waste line from an anesthetic gas monitor 1 1 9 Power Management Battery Supply The advanced power management system of the A5 A3 provides AC power for main system functions while charging the system s internal battery supply During AC power failure the A5 A3 will operate on battery power for a minimum of 75 minutes with one 1 new battery installed A3 or 150 minutes with two 2 new batteries installed A5 See Battery Power Specifications on page 8 6 A recessed main switch is provided to power the system ON and to put the system on power standby where the battery supply continues to charge as necessary when the A5 A3 is plugged into an external power source The main switch also stops the O fresh gas supply when the A5 A3 is placed in Power Standby mode A5 A3 Operating Instructions 046 003777 00 1 5 General System Overview Product Description Auxilia
141. ise or counter clockwise to adjust the flow in the AGSS until the float is between Min and Max marks H3 Exhaust Port Exhaust port to the hospital s waste gas scavenging system H4 Inlet Port Intake for exhaust gases from the breathing system An AGSS transfer hose connects the Inlet and AGSS ports see FIGURE 1 3 to transfer the exhaust gases H5 Float Indicates exhaust flow Adjusted by turning the Flow Adjust Knob H2 until the float is between the Min and Max marks 1 18 046 003777 00 A5 A3 Operating Instructions 20 Installation Unpacking Initial Setup instalite Vaporizelsss ce ettet t th re ettet ita Blatt ub tadedan itt A5 A3 Operating Instructions 046 003777 00 Installation WARNING WARNING WARNING WARNING WARNING CAUTION This equipment must be installed by a factory authorized representative Continuous use of desiccated sodalime may endanger patient safety Adequate precautions should be taken to ensure that the sodalime in the CO absorbent canister does not become desiccated Turn off all gases when finished using the system When electrosurgical equipment is used keep the electrosurgical leads away from the breathing system the O sensor and other parts of the A5 A3 Anesthesia System Keep available backup manual ventilation and a respirator with mask in case the electrosurgical equipment prevents safe use of the ventilator Ensure the correct operations of a
142. isplayed 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 FIGURE 5 14 Example Simulated Pressure vs Time and Flow vs Time Waveforms A5 A3 Operating Instructions 046 003777 00 5 17 Parameter Monitoring Waveforms Operations 5 10 1 1 5 10 2 5 10 3 Pressure vs Time The Y axis of the Pressure vs Time waveform is labeled Paw which represents Airway Pressure The unit of measure is cmH 0 and depending on the size of the pressure signal the Y axis will automatically adjust to one of the following 3 scales Oto 10 in increments of 5 Oto 30 in increments of 10 Oto 80 in increments of 20 Though the X axis is not labeled it represents a time scale of O to 15 seconds Flow vs Time The Y axis of the Flow vs Time waveform represents Flow The unit of measure is L min and its scale is 90 to 90 in increments of 45 Though the X axis is not labeled it represents a time scale of 0 to 15 seconds Auto zeroing the Pressure Sensors The A5 A3 auto zeros the pressure sensors at regular intervals to compensate for changes in temperature and or barometric pressure that could affect both pressure and flow measurements This may affect the waveforms on the screen but does not affect the volume pressure
143. k Test failed Example Fresh gas is detected Manual Circuit Leak Test Complete Adjust all flowmeters to zero Select Retry to repeat the test TABLE 4 4 Manual Circuit Leak Test Results A5 A3 Operating Instructions 046 003777 00 4 15 Leak and Compliance Tests Preoperative Tests RESULTS COMMENTS OPTIONS Fail Manual Circuit Leak Test failed Example Fresh gas is not detected Manual Circuit Leak Test Complete Check the following and select Retry to repeat the test recommended E Adjust APL valve to SP position as shown and select Accept to proceed Follow on screen directions to troubleshoot the problem or Adjust APL valve to SP position and select Accept to proceed to the main screen Time out Example Manual Circuit Leak Test Complete Check the following and select Retry to repeat the test recommended Or Adjust APL valve to SP position as shown and select Accept to proceed Test result cannot be shown due to an internal communication error Select Retry to repeat the Automatic Circuit Leak Test amp Compliance test or Select Override to skip the test TABLE 4 4 Manual Circuit Leak Test Results 4 4 16 046 003777 00 A5 A3 Operating Instructions Preoperative Tests Power Failure Alarm Test 4 6 Power Failure Alarm Test l Setthe system switch to the On position 2 Disconnect the AC mains 3 Ensure th
144. l patient monitor Network ready Flow trigger mode available for PS and SIMV Auxiliary O and air supply Active AGSS N50 cutoff Vaporizer Total flow rotameter 046 003777 00 A5 A3 Operating Instructions Product Description General System Overview 1 1 2 Key Features FEATURE DESCRIPTION Display 15 inch color LCD with touchscreen Navigation Graphical user interface for easy navigation Ventilation Manual and automatic ventilation modes and monitoring VCV SIMV VC PCV SIMV PC A5 only PS and Manual Fresh Gas Delivery Continuous and intermittent anesthesia flow total flow rotameter virtual dual flow tubes electronically displayed on screen for ease of use 3 cylinder mount locations on rear Breathing System Heated adjustable swivel side hose ports single turn APL valve Ergonomics Large stainless steel work surface Adjustable Breathing System block via swivel up to 50 degrees Electronic PEEP Positive End Expiratory Pressure PEEP is set and controlled electronically Clear Data Display Two large waveforms for pressure and flow or Spirometry Loops A5 only USB Mouse Support The A5 A3 system supports a wired USB mouse which can be plugged into one of the two SB ports at the rear of the unit A cursor appears when the mouse is plugged The cursor disappears if the user touches the screen or after 15 seconds of mouse inactivity A3 The USB mouse can serve as a backup to the touchscreen A5 The
145. l setup ofthe A5 A3 Anesthesia System must be performed by an authorized Mindray service representative Please contact Mindray Technical Support for any additional assistance NOTE The A5 A3 is intended to be operated with an external CO2 monitor complying with ISO 21647 Connection to the CO2 monitor should be via a sample line from the patient circuit 2 4 046 003777 00 A5 A3 Operating Instructions Installation Install the Vaporizer 2 3 Install the Vaporizer CAUTION Only vaporizers with Selectatec Interlock Systems may be used with the A5 A3 unit WARNING Use vaporizers compliant to ISO 8835 4 See section A 12 pg A 5 Vaporizers Refer to the vaporizer manufacturer s Instructions For Use for mounting filling or draining the vaporizer and other information 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 NOTE The barometric pressure may differ from the calibration pressure of the anesthetic vaporizer This may cause an inaccurate output of the anesthetic agent The operator should continuously monitor the concentration of anesthetic agent during system use to determine if the outputted concentration is accurate FIGURE 2 1 shows the location of the vaporizer mounting system on the A5 A3 unit pur M gt E T Vaporizer mounts for two I I inline vaporizers poa a
146. lapsed Timer FIGURE 3 3 Elapsed Timer 3 2 2 Patient Size Displays the currently selected patient size Adult Pediatric or Infant Select to change the patient size when the A5 A3 is in Standby mode or Manual mode FIGURE 3 4 Patient Size Patient Size NS 7 FIGURE 3 4 Patient Size Menu 3 2 3 Alarm and Prompt Messages Displays physiological alarms technical alarms and prompt messages The most recent highest priority alarm is displayed at the top The remaining alarms are displayed in the lower area and grouped by priority The most recent of these alarms is displayed first Select this area to display a list of all active alarms See Alarms and Messages on page 6 1 for tables that list the individual messages and their associated priority levels High priority messages are red Medium priority messages are yellow Low priority messages are cyan Prompt messages are black FIGURE 3 5 A5 A3 Operating Instructions 046 003777 00 3 5 System Information Header System Interface AUN Power System Comm Stop Fresh Gas Flow N20 AIR 02 f ANI Power System Comm Stop Calibrate 02 sensor for 21 E FIGURE 3 5 Alarm and Prompt Messages 3 2 4 Alarm Silence Icon The Alarm Silence icon and Alarm Silence countdown timer are displayed when the Silence softkey is selected which indicates that all currently sounding alarms are silenced for 120 seconds FIGURE 3 6 Alarm Silence Icon ADULT
147. latile and Recording A5 A3 Operating Instructions 046 003777 00 8 21 Electromagnetic Capability Product Specifications 8 16 Electromagnetic Capability The A5 A3 meets the requirements of IEC 60601 1 2 EN 60601 1 2 The A5 A3 needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below Portable and mobile RF communications equipment can affect the A5 A3 See Table 8 31 on page 22 through Table 8 33 on page 23 that follow GUIDANCE AND DECLARATION ELECTROMAGNETIC EMISSION The A5 A3 is intended for use in the electromagnetic environment specified below The customer or the user of the A5 A3 should assure that it is used in such an environment EMISSIONS TEST RF emissions CISPR 11 COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE Group 1 The A5 A3 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Conducted emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations Flicker emissions IEC 61000 3 3 Class B The A5 A3 is suitable for use in all establishments other than domestic establishments and those directly Class B connected to the public low voltage power supply network that supplies buildings used for domestic purposes Class A Complies TABLE8 31 Gu
148. laving Allow them to dry thoroughly b If disinfecting the Absorber Canister continue with step 5 otherwise skip to step 6 5 Disinfection NOTE Ensure that the Absorber Canister has been cleaned as described in step 4 before disinfecting See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving and use an approved disinfecting agent for the Absorber Canister while adhering to facility policies and procedures WARNING Use extreme care while handling the absorbent as it is a caustic irritant NOTE Ensure that the absorber canister is completely dry before adding absorbent 6 While noting the previous WARNING add new Pre Pak or loose fill absorbent to the absorber canister Re install the absorber canister into the assembly Rotate the locking mechanism handle clockwise into the locked position as shown in FIGURE 7 20 Breathing System Block 1 Remove all of the following components from the breathing system block Bellows Assembly Oxygen Sensor Inspiratory and Expiratory Valves all components APL Valve PAW Gauge Bag Arm Absorber Canister A5 A3 Operating Instructions 046 003777 00 7 21 Cleaning and Disinfection Maintenance Inspiratory and Expiratory Flow Sensors 2 Remove the absorber canister and canister mount mandatory CAUTION Use care in lifting and manipulating the breathing system block during removal from its mounting arm as handling may be awkward due
149. ld be serviced more frequently if used more than this yearly usage Maintenance should be performed by a trained technician NOTE During cleaning and setup inspect the parts and seals for damage Replace or repair as necessary MINIMUM FREQUENCY MAINTENANCE Daily Clean the external surfaces Every 72 hours Perform 21 O calibration O5 sensor in breathing system The A5 A3 will prompt the user for 21 O calibration Annually Periodic maintenance due to be performed by a trained technician Contact Mindray Technical Support for details Every three years Periodic maintenance due to be performed by a trained technician Contact Mindray Technical Support for details As necessary Perform 100 O calibration after replacing the O sensor Replace the O sensor if it cannot be calibrated e Before installing the cylinder use a new cylinder gasket on the cylinder yoke Empty the water trap if there is water buildup Replace the sodalime in the canister if sodalime color change is detected Follow the manufacturer s instructions Replace the flow sensor if the seal for the flow sensor is damaged the membrane inside the flow sensor is cracked or distorted or the flow sensor is cracked or distorted e Replace the transfer tube if it is damaged TABLE 7 1 Maintenance Schedule Breathing System Maintenance When cleaning the breathing system replace any parts that are visibly cracked chipp
150. levels high medium low Technical alarms three levels high medium low Sound Levels 10 alarm sound levels adjustable levels 1 to 10 Alarm Status Normal Status all alarms are functioning properly Silence Status silenced alarms do not produce alarm audio only new alarms produce alarm audio Sound Pressure levels normal operation without alarm lt 60 dBA Measured from the patient s head location at 1 meter height 1 meter from the front of the unit and 1 meter to the left of the unit TABLE 8 27 Alarms A5 A3 Operating Instructions 046 003777 00 8 17 Safety Specifications Product Specifications Safety Specifications Vibration Test Frequency range 10 to 2000 Hz ASD10 to 100Hz 1 0 m s2 Hz ASD 100 to 200Hz 3 dB Octave ASD200 to 2000Hz 0 5 m s Hz Duration 10 min axis per each perpendicular axis 3 total Shock Test Peak acceleration 150 m s 15 3 g Duration 11 ms Pulse shape half sine Number of shocks 3 shocks per direction per axis 18 total Drop Complies with the requirements of clause 21 6 rough handling in IEC 60601 1 Spillage and Ingress of Liquids Complies with the requirements of clause 44 3 in IEC 60601 1 and also the requirements in IEC 60529 for non protective equipment IPXO Surface Temperature Complies with the requirements of clauses 42 1 42 2 and 42 3 in IEC 60601 1 Mechanical Stability Incompati
151. ll life support and monitoring equipment Do not use masks or breathing tubes that are antistatic or conductive They can cause burns if they are used near high frequency electrosurgical equipment This A5 A3 Anesthesia System has waste gas exhaust ports The operator of the machine should pay attention to the disposal of the residual breathing gas scavenged The operational environment and the power source of the equipment must comply with the requirements as specified in the A5 A3 Product Specifications on page 8 1 046 003777 00 A5 A3 Operating Instructions Installation Unpacking 2 1 Unpacking When the A5 A3 Anesthesia System is delivered IMMEDIATELY inspect the box for any damage b Ifthere is NO damage and ALL tip indicators on the box exterior are intact then sign and date the bill of lading or airway bill to indicate safe receipt of the A5 A3 Ifthere is DAMAGE or ANY of the tip indicators on the box exterior have activated then conditionally accept the delivery and clearly describe the damages on the bill of lading or airway bill BOTH the carrier and recipient must sign and date the bill of lading or airway bill Save all damaged factory packaging until further instructed by Mindray The receiver should immediately contact Mindray Customer Service at 800 288 2121 or 201 995 8000 A5 A3 Operating Instructions 046 003777 00 2 3 Initial Setup Installation 2 2 Initial Setup The initia
152. lo A5 only Additional vaporizer mount for one inactive vaporizer FIGURE 2 1 Location of Vaporizer Mounting System l If replacing and removing the vaporizer lift each vaporizer straight up off the manifold Do not pull the vaporizer forward Do not rotate the vaporizer on the manifold 2 Align the new vaporizer over the valve cartridges of the mounting bar slightly tilting back the vaporizer Hang the vaporizer on the mounting bar as shown in FIGURE 2 2 Ensure that the locking mechanism handle is in the unlocked position Ensure that the dial is in the T Transport position or equivalent depending upon the vaporizer manufacturer s Instructions For Use A5 A3 Operating Instructions 046 003777 00 2 5 Install the Vaporizer Installation Locking Mechanism Handle in the Unlocked Position Vaporizer dial in the T position Sevoflurane Urges a a 9 FIGURE 2 2 Vaporizer Unlocked 3 Rotate the locking mechanism handle clockwise into the locked position as shown in FIGURE 2 3 NOTE If installing a Desflurane vaporizer refer to the manufacturer s Instructions For Use on installation and use of the vaporizer Locking Mechanism Handle in the Locked Sevoflurane Dr ger Vaj 100 gt FIGURE 2 3 Vaporizer Locked 4 Final check 1 Ensure that the top of the vaporizer is horizontal If not
153. ly by Mindray Technical Service Please contact Mindray Technical Support for details Many of these functions are only available ifthe A5 A3 is in Standby mode General Tab The General tab provides access to calibrate the O5 sensor and flow sensor perform system leak and compliance tests activate the breathing system warmer and zero flow meters The General tab also displays information for the most recent calibrations and leak test results whether they were passed failed or skipped See Figure 3 28 Setup General FIGURE 3 28 General Tab Calibrate O Sensor To calibrate the O sensor select the Calibrate O Sensor button Follow the on screen directions and prompts See O Sensor Calibration on page 7 6 for more information Note that information for the last O sensor calibration is displayed next to the button Calibrate Flow Sensor To calibrate the flow sensor select the Calibrate Flow Sensor button Follow the on screen directions and prompts See Flow Sensor Calibration on page 7 5 for more information Note that information for the last flow sensor calibration is displayed next to the button 046 003777 00 A5 A3 Operating Instructions System Interface Setup Leak Test Compliance The Test Leak Compliance button enables the A5 A3 system to perform a manual leak test and automatic leak test and calculates the compliance for the A5 A3 To perform a leak test select the Test Leak
154. ms Window Log tab is displayed 6 6 046 003777 00 A5 A3 Operating Instructions Alarms and Messages Displaying Alarms 6 2 1 Displayed Order of Alarm Messages Alarm messages are displayed in order of priority and time of occurrence FIGURE 6 4 shows the alarm messages list divided into two areas Area A and Area B Area A Highest priority AND most recent alarm Area B Less priority or less recent alarms ZN BDU Communication Error ADULT VCV FIGURE 6 4 Displayed order of alarm messages Alarm messages are displayed in Area A and Area B according to the following rules To bein Area A an alarm must be both the highest priority AND the most recent Area A does not cycle The remaining active alarms and prompt messages cycle in Area B New Alarms with less priority than alarms in Area A are displayed immediately in Area B and the cycle proceeds from that position in the list Alarms cycling in Area B are grouped and displayed in the following order highest priority medium priority low priority and prompt messages In each group the most recent alarm is displayed first e If the alarm in Area A is removed then the most recent and highest priority alarm from Area B is moved to Area A A5 A3 Operating Instructions 046 003777 00 6 7 Setting Alarm Volume Alarms and Messages 6 3 Setting Alarm Volume Users can set the audio level of alarms and system alerts by selecting the Alarms softkey o
155. n by connecting the Y piece on the breathing circuit to the leak test port 6 Push the O flush button to expand the bellows to the top of the bellows enclosure 7 Ensure that the pressure does not increase to more than 15 cmH5O on the airway pressure gauge 8 Thebellows should not fall faster than a rate of approximately 300 mL min If the leak rate is greater troubleshoot the source of the leak If the source of the leak is the bellows then the bellows must be replaced 4 12 2 Breathing System Leak Test in Manual Ventilation Status l Select the Discharge button in the Manual tab 2 Follow the screen prompts to discharge the patient and enter Standby mode 3 Setthe Auto Manual ventilation switch to Manual 4 Connectthe manual bag to the manual bag port 5 Turn the APL valve control to fully close the APL valve 75 cmH 0 6 Turn the O flow control to set the O flow to 0 15 L min 7 Connect the Y piece on the breathing circuit to the leak test port 8 Push the O flush button to let the pressure increase to approximately 30 cmH5O on the airway pressure gauge 9 Release the flush button A pressure decrease on the airway pressure gauge indicates a leak Contact your service personnel 4 12 3 APL Valve Test l Select the Discharge button in the Manual tab 2 Follow the screen prompts to discharge the patient and enter Standby mode 3 Setthe Auto Manual switch to Manual A5 A3 Operating Instructions 046 0
156. n the Main Screen to display the Alarms window FIGURE 6 5 The Alarms volume settings adjust the audio level of all High Medium and Low Priority sounding alarms The System Alerts volume settings adjust the audio level of all sounding pop up prompts and non confirmed ventilation mode alerts To set the Alarm Volume 1 Onthe Main Screen select the Alarms softkey The Alarms window is displayed 2 Select the Audio tab Volume controls for Alarms and System Alerts are displayed 3 Adjust the volume by selecting the increase or decrease buttons The Alarms volume has 10 levels of adjustment Default level is 5 The System Alerts volume has 10 levels of adjustment Default level is 2 4 Select Accept to activate your changes and exit the Alarms window Selecting Cancel will discard your changes and exit the Alarms window WARNING Do not rely exclusively on the audible alarm system when using the A5 A3 Anesthesia System Adjustment of alarm volume to a low level may result in a hazard to the patient Always keep the patient under close surveillance 6 8 046 003777 00 A5 A3 Operating Instructions Alarms and Messages Silencing Alarms 6 4 Silencing Alarms When an alarm condition occurs and the alarm audio is sounded the user can select the Silence softkey at the bottom of screen to silence the alarm audio In silenced status all the alarm indicators work normally except audible alarm tones When the S
157. nce Tests Preoperative Tests 2 Follow the directions on the screen 1 Seal the Y piece A 2 Ensure that the sample line port of the breathing circuit is occluded 3 Install the manual bag 4 Adjust all flowmeters to zero 5 Set the Auto Manual switch to the Auto position 6 Press the O flush button to completely fill the bellows 7 Select Continue to proceed with the Automatic Circuit Leak Test NOTE The Continue button can be selected only when the Auto Manual switch is set to the Auto position and when no fresh gas is detected 3 Compare the test results with the information in Table 4 3 Automatic Circuit Leak and Compliance Test Results on page 4 11 and proceed accordingly 4 10 046 003777 00 A5 A3 Operating Instructions Preoperative Tests A5 A3 Operating Instructions RESULTS Leak and Compliance Tests COMMENTS OPTIONS Automatic Circuit Leakage Pass Compliance Test XX X mL cmH 0 Example Automatic Circuit Leak amp Compliance Test Complete Automatic Circuit Leakage Compliance Test Select Continue to proceed Leak rate lt 200 mL min Compliance test results are displayed in green Select Continue to proceed to the Manual Circuit Leak Test screen Automatic Circuit Leakage Pass Compliance Test Fail Example Automatic Circuit Leak Compliance Test Complete Automatic Circuit Leakage Compliance Test Select Retry to repeat t
158. ncorrect gas mixtures can cause patient injury If the O5 N5O ratio system does not supply O and N20 in the correct proportions do not use the system CAUTION Slowly open the cylinder valves to avoid damage Do not use excessive force on the flow controls After performing the cylinder tests close all cylinder valves if cylinder supplies are not used CAUTION Turn the flow controls slowly To avoid damaging the control valves do not turn further when the flowmeter reading is outside the range When turning a flow control knob clockwise to decrease flow the flowmeter should reach zero before the knob reaches its most clockwise mechanical stop Off position Do not turn any further when the knob has reached the Off position Similarly when turning a flow control knob counterclockwise to increase flow from zero the flowmeter reading should not indicate a change from zero until the flow control knob is turned approximately one 1 rotation counterclockwise from the Off position and only if permitted according to the gas ratio control system To perform the flow control system tests 1 Connect the pipeline supplies or slowly open the cylinder valves 2 Turn all flow controls fully clockwise flow OFF 3 Setthe system switch to the On position 4 Donotuse the system if the low battery alarm or other ventilator failure alarms occur 5 Test the O N5O ratio system with change of O flow Turn the O5 and N5O flow controls fully clo
159. nd VCV both include Vt Plimit Rate Tpause and PEEP Therefore these parameter values that are linked may be passed from the previous ventilation mode to the current mode Section B 8 Linked Ventilation Parameter Relationships on page B 12 includes a table that lists how the linked parameter values are set when changing ventilation modes Ventilation parameter values that are non linked are set according to relationship equations Section B 9 Non Linked Ventilation Parameter Relationships on page B 14 includes a table of equations to show how non linked parameter values are set when changing ventilation modes 046 003777 00 A5 A3 Operating Instructions Operations Parameter Monitoring Waveforms 5 10 Parameter Monitoring Waveforms The system displays waveforms and Spirometry loops in the Waveform Area and digital data in the Parameter Area The digital data is separated into three parameter groups Pressure Volume and Fraction of Inspired O FiO 5 10 1 Pressure The Pressure parameter group consists of 3 parameters Airway Peak Pressure PEAK Plateau Pressure PLAT or Mean Pressure MEAN Positive End Expiratory Pressure PEEP The unit of measure for these parameters is cmH3O If the parameter data is out of range it is displayed as 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 d
160. ng N5O and O flow rates always adjust the oxygen flow first to enable the nitrous oxide flow To add NO to the fresh gas flow open the NO flowmeter valve but only after opening the O5 flowmeter valve A5 A3 Operating Instructions 046 003777 00 1 3 General System Overview Product Description 1 1 4 1 1 4 1 1 1 5 1 1 6 Flow Control Flow Control needle Valve and Knob Three independent flow control knobs allow setting the input flow rates of N5O Air and O into the fresh gas flow N50 Automatic Cutoff An N5O automatic cutoff valve stops the flow of N5O if O flow is less than 200 mL min O Pressure Loss Alarm An O pressure loss alarm annunciates when oxygen pressure is less than 220 kPa 32 psi Oxygen Ratio Controller An O ratio controller ensures that there is always at least 2196 oxygen concentration in the fresh flow when N5O is fully open Flow Pressure Sensing The Breathing System block contains patient flow and pressure sensors to measure inspiratory flow expiratory flow and inspiratory pressure These sensors enable spirometry as well as standard pressure and flow monitoring Vaporizer Mounting The A5 A3 contains a 2 position Selectatec type vaporizer mounting system to enable anesthetic agents to be introduced into the fresh gas flow The mounting system adapts vaporizers with interlock which permits only one agent at a time to be administered Lighting above the vaporizers enables them to
161. nge 4 to 100 bpm Range 4to 100bpm Range 4 to 100 bpm Step 1 bpm Step 1 bpm Step 1 bpm Step 1 bpm Defaults Defaults Defaults Defaults Adult 8 bpm Adult 8 bpm Adult 8 bpm Adult 8 bpm Pediatric 15 bpm Pediatric 15 bpm Pediatric 15 bpm Pediatric 15 bpm Infant 20 bpm Infant 20 bpm Infant 20 bpm Infant 20 bpm Min Rate Range 2 to 60 bpm Step 1 bpm Defaults Adult 4 bpm Pediatric 6 bpm Infant 12 bpm Range 1 8 to 4 1 Step 0 5 Default 1 2 Range 1 8 to 4 1 Step 0 5 Default 1 2 sepoyy uoup iuoA sinpjeq K10jop pub ssajawiosog suoyonusu Buyoledo m EV GV 00ZZZ 009rO PARAMETER VCV SIMV VC PCV SIMV PC PS MANUAL Tinsp Range 0 2 to 5 sec Range 0 2 to 5 sec Step 0 1 sec Step 0 1 sec Defaults Defaults Adult 2 0 sec Adult 2 0 sec Pediatric 1 0 sec Pediatric 1 0 sec Infant 1 0 sec Infant 1 0 sec Pinsp Range Range PEEP 5 to 70 cmH O PEEP 5to 70 cmH O Step 1 cmH O0 Step 1 cmH O Defaults Defaults Adult 15 cmH O Adult 15 cmH O Pediatric 10 cmH5O Pediatric 10 cmH5O Infant 10 cmH 5O Infant 10 cmH 5O Tpause Range Range Off 596 to 6096 Off 596 to 6096 Step 196 Step 196 Default 1096 Default 1096 Plimit Range Range 10 to 100 cmH O 10 to 100 cmH O Step 1 cmH5O Step 1 cmH5O Defaults Defaults Adult 50 cmH O Adult 50 cmH 0 Pediatric 40 cmH5O Pediatric 4
162. noonomemeess 8 20 Data Storage Non Volatile and Recording 8 21 Electromagnetic Ca Pabbil ad e ad 8 22 A5 A3 Operating Instructions 046 003777 00 Standards Compliance Standards Compliance Product Specifications The A5 A3 Anesthesia System is in compliance with the following industry standards AAMI ISO 10993 1 2003 ISO 10993 1 2009 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing AAMI ISO 15223 1 2012 Medical Devices Symbols to be used with Medical Device labels labelling and information to be supplied ASTM F1101 90 2003 Standard Specification for Ventilators Intended for Use During Anesthesia CGA V 1 2005 Standard for Compressed Gas Cylinder Valves Outlet and Inlet Connections CGA V 5 2008 Diameter Index Safety System Non interchangeable Low Pressure Connections for Medical Gas Applications IEC 60068 2 27 2008 EN 60068 2 27 2009 Basic Environmental Testing Procedures Part 2 Tests Tes Ea and Guidance Shock IEC 60068 2 64 2008 EN 60068 2 64 2008 Environmental Testing Part 2 Test Methods Test Fh Vibration Broad band Random Digital Control and Guidance IEC 60601 1 1988 A1 1991 A2 1995 Medical Electrical Equipment Part 1 General Requirements for Safety IEC 60601 1 2 2007 Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requiremen
163. nsert the PAW gauge if it was removed Prior to use after cleaning or disinfecting power up the system and follow the on screen prompts to perform the Leak Test and the Compliance Test See section 4 5 pg 4 9 Leak and Compliance Tests 7 18 046 003777 00 A5 A3 Operating Instructions Maintenance Cleaning and Disinfection 7 9 9 Bag Arm 1 At the base of the bag arm locate the retaining ring Turn the ring counterclockwise until it is no longer threaded Lift the bag arm from the breathing system block see FIGURE 7 16 Bag Arm Retaining Ring aS FIGURE 7 16 Bag Arm Removal MES UN 2 Cleaning a Clean the bag arm with a soft lint free cloth and a recommended cleaning agent See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving 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 See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving and use an approved disinfecting agent for 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 and follow the on screen prompts to perform the Leak Test and the Compliance Test See section 4 5 pg 4 9 Leak and Compliance Tests
164. nted to the side of the A5 A3 before moving Do not attempt to roll the A5 A3 over hoses cords or other obstacles 8 4 046 003777 00 A5 A3 Operating Instructions Product Specifications Environmental Specifications e e e e 8 5 Environmental Specifications Operating Temperature 10 to 40 C 50 to 104 F Storage Temperature 20 to 60 C 4 to 140 F oxygen sensor 20 to 50 C Humidity Operating and Storage 15 to 90 RH non condensing Atmospheric Pressure Operating 70 kPa to 106 7 kPa Atmospheric Pressure Storage 50 kPa to 106 7 kPa Resistance to Ingress of Fluids Complies with the requirements of clause 44 3 in IEC 60601 1 and also the requirements in IEC 60529 for non protective equipment IPXO TABLE 8 4 Environmental Specifications A5 A3 Operating Instructions 046 003777 00 8 5 Electrical Specifications Product Specifications 8 6 Electrical Specifications 8 6 1 Main Electrical Power Specifications The A5 A3 complies with UL 60601 1 for its main power supply Power Supply Input Voltage 100 to 120 VAC 60 Hz Power Supply Input Current 12 A maximum for A5 unit 10 A maximum for A5 auxiliary outlets 12 A maximum for A3 unit 9 A maximum for A3 auxiliary outlets Power Cord 5 0 05 m length hospital grade TABLE 8 5 Main Electrical Power Specifications 8 6 2 Battery Power Specifications Battery Type Sealed Lithium ion 11 1 V 4 5 Ah A5 t
165. ntration can get into the machine lines and ambient air causing harm to people and materials In order to prevent electric shock the machine protection class I may only be connected to a correctly grounded mains connection i e socket outlet with grounding contact The use of anti static or electrically conductive breathing tubes when utilizing high frequency electric surgery equipment may cause burns and is therefore not recommended in any application of this machine Possible electric shock hazard The machine may only be opened by authorized service personnel The patient should be visually monitored by qualified personnel In certain situations life threatening circumstances may occur that 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 operating personnel not being aware of drastic changes in the patient s condition Connection of both medical and non medical equipment to the auxiliary mains socket outlet s may increase the leakage currents to values exceeding the allowable limits Electric shock and fire hazard Do not clean the machine while it is powered on and or plugged into an outlet Disconnect the power plug from the mains supply before removing the rear panels or servicing the A5 A3 unit Malfunction of the central gas supply system may cause more than one or even all devices conn
166. o 3L min 8 8 046 003777 00 A5 A3 Operating Instructions Product Specifications Breathing System Specifications 8 8 Breathing System Specifications 8 8 1 Breathing System Volume Automatic Ventilation Total volume 4350 mL 100 mL including bellows Bellows 1500 mL 100 mL Manual Ventilation 3300 mL 100 mL not including breathing bag TABLE 8 11 Breathing System Volume 8 8 2 CO Absorber Assembly Absorber Capacity 1 Pre Pak 1500 100 mL Absorber Canister Contents 1 Pre Pak canister or Loose Fill absorbent TABLE 8 12 CO Absorber Assembly 8 8 3 Water Trap Mode detachable separately Capacity 6 1 mL TABLE 8 13 Water Trap 8 8 4 Vaporizer Connections Vaporizer Positions A5 3 2 active 1 inactive A3 2 active Mounting Mode Selectatec with interlocking function TABLE 8 14 Vaporizer Connections 8 8 5 Breathing System Connections Exhalation Connection 22 mm OD ISO 15 mm ID ISO Taper Inhalation Connection 22 mm OD ISO 15 mm ID ISO Taper Connections from Breathing System to 30 mm OD ISO a Gas Scavenger TABLE 8 15 Breathing System Connections 8 8 6 APL Valve Range SP Approximately 0 to 75 cmH O Adjustable Range of Motion 330 10 degrees Tactile Knob Indication 30 cmH50 and above TABLE 8 16 APL Valve A5 A3 Operating Instructions 046 003777 00 8 9 Breathing System Specifications Product Specifications Minimum press
167. o the right of the baseline loop The reference loops are displayed from oldest left to newest right The baseline loop information is displayed below the small baseline loop window The reference loop information is displayed in cyan highlight for the reference loop that is selected Large Loop Window This graphic window shows an enlarged view of the selected reference loop overlapped with the baseline loop Loop Type The Loop Type selection is used to choose the type of loop to review The choices are Pressure Volume and Flow Volume Default Loop Type is Pressure Volume loop Delete Loop The Delete Loop selection is used to delete a selected Reference loop When a reference loop is deleted the newer reference loops will shift to the left The Delete Loop button will be disabled grayed out if no reference loops have been saved The baseline loop cannot be deleted It can only be replaced by another baseline loop 3 14 046 003777 00 A5 A3 Operating Instructions System Interface Spirometry Tab A5 Only Non selected Selected Reference Non selected Reference Loop Non selected Baseline Loop Reference Loop Loop small Numeric Data Selected Area Reference oop large emm h d FIGURE 3 16 Review Loops window Numeric Data Area Displays the numerical data associated with a saved Baseline loop and saved Reference loops The parameters listed in column form include Time Expiratory Minute Volume MVexp
168. obile RF communications equipment should be used no closer to any part of the A5 A3 than the separation distance derived from the following calculations Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 12x JP IEC 61000 4 6 150 kHz to 80 MHz outside ISM bands 10 Vrms 10 Vrms 150 kHz to 80 MHz in ISM bands TABLE8 33 Guidance and Declaration Electromagnetic Immunity A5 A3 Operating Instructions 046 003777 00 Electromagnetic Capability Product Specifications GUIDANCE AND DECLARATION ELECTROMAGNETIC IMMUNITY The A5 A3 is intended for use in the electromagnetic environment specified below The customer or the user of the A5 A3 should assure that it is used in such an environment IMMUNITY IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT TEST LEVEL LEVEL GUIDANCE Radiated RF IEC 10 V m 10 V m 61000 4 3 80 MHz to 2 5 GHz 2 Hz sine wave JP 8096 AM modulation d 23x 800 MHz to 2 5 GHz d 1 2x JP 80MHzto800 MHz 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 electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked lt e with the following symbol NOTE At 80 MHz and 800 MHz the higher f
169. of the A5 A3 System JezijodeA C 1 qo d 4 eme 9 i is x b R u d e ze u a eee T ST AM o 8 M te n om 11 E a n d a j m Ep 07 PA a be 61 6t 2r Noa Dd Tog Li lt lt LT 3 EH PES S T ssov lt 5 n emm E E z E zi A a s Lp 9p ag mold le PEO M Y ry E d zi u o 6 06 T NI n ae __ on gt E L 1 Tr LUN Ts vr gt o c Q FIGURE C 1 Pneumatic Diagram of the A5 A3 System A5 A3 Operating Instructions 046 003777 00 Pneumatic Diagram Pneumatic Diagram of the A5 A3 System NO DESCRIPTION NO DESCRIPTION 1 O Gas Pipeline Connection 30 Auxiliary Air Flowmeter 2 O Gas Cylinder Connection 31 Inspiratory Check Valve 3 N50 Gas Pipeline Connection 32 Sodalime Absorber Canister 4 N50 Gas Cylinder Connection 33 Bypass Valve 5 Air Ga
170. ontaneously To use the manual mode the user must first set the APL valve to the desired pressure value and then use the Auto Manual switch on the breathing module to enter and exit Manual mode Push the O flush button to inflate the bag if necessary When the Auto Manual switch is set to Manual and the Alarms button in the Manual mode tab is set to Off the alarm limit indicators on the main screen to the right of the measured values related to Pressure and Volume such as PEAK and MV will change to Off see Figure 5 6 The Alarms button setting On Off in the Manual mode tab is saved and restored when toggling from Manual to Auto and back to Manual mode For example ifthe Alarms button is set to Off this setting will be saved and restored to Off after switching to Auto and back to Manual mode FIGURE 5 6 Alarm Limit Indicators 5 8 046 003777 00 A5 A3 Operating Instructions Operations Ventilation Modes Setting the APL Valve for Manual Ventilation Rotate the APL valve adjustment knob to the desired pressure The number on the rotating portion that lines up with the index mark on the bottom section of the valve indicates the approximate pressure setting 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 Setting the APL Valve for Spontaneous
171. or waits for patient s next inspiration based on the specified time interval The sensitivity depends on Trigger If Trigger is reached within the trigger waiting time called synchronous trigger window the ventilator delivers pressure controlled ventilation synchronously with the preset tidal volume and inspiratory time If the patient does not inspire within the trigger window the ventilator delivers pressure controlled ventilation to the patient at the end of trigger window Spontaneous breathing outside trigger window can acquire pressure support To Set SIMV VC or SIMV PC Mode 1 Select the SIMV VC tab or SIMV PC tab on the Main Screen 2 Check that all SIMV VC or SIMV PC parameters are set appropriately If necessary select the parameter softkey to edit the parameters settings FIGURE 5 12 A5 A3 Operating Instructions 046 003777 00 5 13 Ventilation Modes Operations 3 Select the Set Mode softkey to confirm SIMV VC parameters Vt Tidal volume mL Rate Breath rate bpm Tinsp Time of inspiration sec Tpause Inspiratory pause 96 PEEP Positive end expiratory pressure cmH 0 Plimit Pressure limit level Trigger Flow trigger level L min PS Pressure support On Off AP Change in pressure cmH5O Tslope Rise time sec SIMV PC A5 only parameters Pinsp Peak inspiratory airway pressure cmH 0 Rate Breath rate bpm Tinsp Time of inspiration sec Trigge
172. or disinfecting power up the system and follow the on screen prompts to perform the Leak Test and the Compliance Test See section 4 5 pg 4 9 Leak and Compliance Tests Improperly cleaned materials may result in biocontamination Use a cleaning and disinfection schedule that conforms to your institution s disinfection and risk management policies Refer to the material safety data as applicable Refer to the operation and maintenance manuals of all disinfection equipment The user should follow the recommended disinfection routine for this machine and any reusable accessories If the A5 A3 is damaged in any way that compromises the safety of the patient or user discontinue use and attach a visible tag that marks the A5 A3 as unusable Call Mindray Technical Support Oxygen when present in high concentrations can significantly increase the chance of fire or an explosion Oil and grease may spontaneously ignite and should not be used where oxygen enrichment may occur Use of lubricants not recommended by Mindray may increase the danger of fire or explosion Use lubricants approved by Mindray Low pressure regulators and flow meters are susceptible to high pressure and may burst if improperly maintained or disassembled while under pressure Changing connectors or disassembling should be performed only by qualified personnel Do not disassemble the low pressure regulator flow metering device or connector while under pres
173. or is connected to the cable Sampled data is greater correctly than 2900 AD value Check that the O sensor output voltage in the calibration menu is steady Replace the O sensor 00 00 00 08 2196 calibration value is Check that the O sensor is connected to the cable outside of the expected correctly range 150 500 Check that the O sensor is in 21 O AD value Check that the O sensor output voltage in the calibration menu is steady Replace the O sensor 00 00 00 10 10096 calibration value is Check that the O sensor is connected to the cable outside of the expected correctly range 800 2028 AD Check that the O sensor is in 100 O value Check that the O sensor output voltage in the calibration menu is steady Replace the O sensor 00 00 00 20 Error writing to EEPROM Repeat the calibration Replace the O sensor Replace the CPU board TABLE 7 2 0 Sensor Calibration Error Codes 046 003777 00 A5 A3 Operating Instructions Maintenance Water Build up in the Flow Sensor 7 7 Water Build up in the Flow Sensor 7 7 1 Prevent Water Build up Water comes from the condensation of exhaled gas and a chemical reaction between CO and the sodalime in the CO absorbent canister At lower fresh gas flows more water builds up because of the following More CO stays in the CO absorbent canister to react and produce water More moist exhaled gas stays in the br
174. ority Yellow 2 medium priority cyan low priority off no alarm condition A2 LCD Touchscreen Display See section System Interface on page 3 1 System Interface A3 Auxiliary O gt Air Flowmeters Auxiliary O7 Air Flowmeters for auxiliary O gt Air output A4 Auxiliary O gt Air Gas Outlet Nozzle barbed connector for auxiliary O7 Air output Combines the auxiliary O Air flowmeters into a single output of O only Air only or O Air blend depending upon the O and Air flow adjustments 1 8 046 003777 00 A5 A3 Operating Instructions Product Description Physical Views PART S DESCRIPTION A5 Auxiliary O Gas Power Outlet High pressure O outlet DISS connector for connecting A5 only external devices such as a jet ventilator A6 Flow Control Knobs N50 Air and O gas dosing Turn each knob counterclockwise to increase flow A7 Pressure Gauges pipeline Indicate the pressure at pipeline inlets for O5 Air and N5O A8 Pressure Gauges cylinder Indicate the pressure at cylinder inlets for O Air and N20 A9 Total Flow Meter Displays the combined flow rate of O Air and N5O A10 O Sensor Electrical Port Connects the O sensor cable on the breathing system to the main A5 A3 unit A11 O Flush Button Provides high flow O to the inspiratory limb of the breathing system A12 Touchpad Allows alternate control of the touch screen Pull
175. ot autoclave any parts of the A5 A3 unless specifically identified as autoclaveable in this manual Clean the A5 A3 only as specified in this manual To prevent system damage Refer to the literature supplied by the manufacturer of the cleaning agent Never use organic halogenated or petroleum based solvents anesthetics glass cleaning agents acetone or other irritant agents Never use abrasive agents i e steel wool or silver polish to clean components Keep all liquids away from electronic components Prevent liquid from entering the equipment All cleaning solutions used must have a pH between 7 0 and 10 5 Never immerse the oxygen sensor or its connector in any type of liquid Dispose of the oxygen sensor per the manufacturer s specification Do not use acetic hydroperoxide or formaldehyde steaming The valve disc in each of the inhalation and exhalation valve assemblies on the breathing system is fragile and must be handled with care while removing the valve cage from the valve assembly If moisture remains in the bellows after cleaning the bellows surface folds may become tacky and prevent the bellows from properly expanding Ensure all moisture is removed from the bellows after cleaning Only connect Mindray approved equipment to the A5 A3 communication ports Equipment connected to the A5 A3 ethernet ports must comply with IEC 60950 Do not connect any non isolated devices to the DB9 RS232C interf
176. out affecting the value of Pinsp 15 IMPA FIGURE 5 10 Pressure Control Ventilation Tab 5 6 7 1 To Set PCV Mode 1 Select the PCV tab on the Main Screen 2 Check that all PCV parameters are set appropriately If necessary select the parameter softkey to edit the parameters settings FIGURE 5 10 3 Select the Set Mode softkey to confirm PCV parameters VtG A5 only Tidal volume guarantee mL PlimVG A5 only pressure limit level of volume guarantee cmH O Pinsp Peak inspiratory airway pressure cmH5O Rate Breath rate bpm kE Ratio of inspiratory time to expiratory time PEEP Positive end expiratory pressure cmH 0 Tslope Rise time sec NOTE Before activating a new mechanical ventilation mode ensure that all related parameters are set appropriately 5 6 8 Synchronized Intermittent Mandatory Ventilation SIMV The A5 supports two modes of SIMV SIMV volume control SIMV VC and SIMV pressure control SIMV PC The A3 supports SIMV VC only 5 6 8 1 Pressure Support in Synchronized Intermittent Mandatory Ventilation SIMV In SIMV VC and SIMV PC A5 only Ventilation modes PS Ventilation can be turned on and off by changing the PS setting to On and Off respectively When PS Ventilation is Off the AP and Tslope settings are disabled in SIMV VC mode and the AP setting is disabled in SIMV PC mode 5 12 046 003777 00 A5 A3 Operating Instructions Operations Ventilation Modes
177. out to use A5 only A13 AGSS Anesthetic Gas Scavenging System A14 Wheel Lock Locks or releases the brakes for all wheels when depressed A5 only A wheel lock indicator displays red to indicate that the wheels are locked Green indicates unlocked A15 Wheel Lock Indicator Displays a lock symbol in red background to indicate the A5 only wheels are locked or an unlock symbol in green background to indicate the wheels are unlocked A16 Wheels Casters to enable the A5 A3 System to be moved Casters on the A5 lock via a central brake Casters on the A3 lock via individual locking levers on each caster A17 Work Light Located under the top shelf to illuminate the work level shelf and allow the user to read the vaporizer dial setting in a darkened room A18 Work Light Switch Turns on off the work light Three settings Off Low and High The user can turn on the work light only when the main power switch is turned on A19 Vaporizer Mounting Manifold An interface for two Selectatec type vaporizers to mount in Mounting Bar this location Bar holds two vaporizers An interlock within the vaporizers provides for use of one vaporizer to deliver one agent at a time A20 Vaporizer Mount Valve Vaporizer index and outlet ports Cartridge A21 Vaporizer Parking Spot Holds a non functional vaporizer for user convenience A5 standard A3 optional A22 Vaporizer Locking Device Vaporizer locking mechanism to secure against accidental disconnection
178. pliance Test See section 4 5 pg 4 9 Leak and Compliance Tests 7 9 1 General Guidelines Follow 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 7 9 2 Cleaning and Disinfecting Agents Autoclaving The A5 A3 should be cleaned and disinfected before its first use then daily and as often as needed Table 7 1 Maintenance Schedule on page 7 4 Table 7 3 lists the cleaning and disinfecting agents and autoclaving process that may be used on the A5 A3 Anesthesia System AGENT CLASSIFICATION Water detergent Soapy water pH value of detergent at 7 0 to 10 5 de
179. pment shall be operated from its internal electric power supply i e battery supply Degree of Protection against Electric Shock BF defibrillation proof Power Supply Connection External electric power supply 100 to 120 VAC 60 Hz 12 A Internal battery supply Lithium ion 11 1V 4 5 Ah 1 or 2 batteries installed Mode of Operation Continuous Degree of Protection against Hazards of Explosion Ordinary equipment without protection against explosion not for use with flammable anesthetics Degree of Protection against Ingress of Liquids Ordinary equipment without protection against ingress of liquids IPXO IEC 60529 Electrical Connection between Equipment and Patient Equipment designed for non electrical connection to the patient Degree of Mobility Mobile including the base and casters of the anesthesia machine Disinfection Steam autoclavable or disinfectable breathing system only TABLE 8 2 Safety Designations 8 2 1 Oxygen Enriched Environments The A5 A3 complies with the standards for oxygen enriched environments by staying below the required power threshold or by providing forced ventilation and ventilation failure monitoring and alarm 8 2 2 Wiring and PC Board Materials The A5 A3 complies with NRTL standards for wiring and PC board materials Primary wiring is double insulated jacketed All wires are UL recognized A5 A3 Operating Inst
180. port PS ventilation mode Spontaneous ventilation in Manual mode with APL fully open Manual Ventilation through the use of a breathing bag Cardiac Bypass mode The A3 Anesthesia System provides the following ventilation modes Volume Control Ventilation VCV which includes the Pressure Limit Ventilation PLV function Pressure Control Venti lation PCV Synchronized Intermittent Mandatory Ventilation SIMV with VC mode with without PS option Pressure Support PS ventilation mode Spontaneous ventilation in Manual mode with APL fully open anual Ventilation through the use of a breathing bag Electronic PEEP is available in all automatic ventilation modes User control over inspiratory flow Tslope is possible in PCV SIMV and PS modes Automatic fresh gas compensation limits the effect on the patient ventilation from changes in fresh gas flow rate by the operator The traditional bellows system is driven by oxygen and makes patient disconnections clearly visible The A5 A3 Anesthesia System provides the following common functions Automatic leak detection Circuit gas leakage compensation and automatic compliance compensation Cylinder and central pipeline gas supply connections available for gas input Electronically displayed flowmeter and electronically adjustable PEEP Electronic timer to display the duration between the start and end of an operation Work table light Mounting rails to connect an externa
181. r Flow trigger level L min PEEP Positive end expiratory pressure cmH5O Tslope Rise time sec PS Pressure support On Off AP Change in pressure cmH5O NOTE Before activating a new mechanical ventilation mode ensure that all related parameters are set appropriately 5 6 9 Set Pressure Support Ventilation PS In Pressure Support PS mode the patient s effort is supported by the A5 A3 at a preset level of inspiratory pressure Inspiration is triggered and cycled by patient effort The user can set the Trigger flow AP PEEP minimum allowed breathing frequency and Slope Time If the Min Rate bpm is violated the A5 A3 will give an Apnea Ventilation breath to assure ventilation is occurring 5 6 9 1 To Set PS Mode MSN PTS FM ELM vr a 4 C82 132 Of 10 23 55 0 cmH20 L min cmH20 sec sec FIGURE 5 13 Pressure Support Tab 1 Select the PS tab on the Main Screen 2 Check that all PS parameters are set appropriately If necessary select the parameter softkey to edit the parameters settings FIGURE 5 13 5 14 046 003777 00 A5 A3 Operating Instructions Operations Ventilation Modes 3 Select the Set Mode softkey to confirm PS parameters Min Rate Minimum rate bpm applies to apnea backup breaths only AP Change in pressure cmH 0 Trigger Flow trigger level L min PEEP Positive end expiratory pressure cmH5O Tslope Rise time sec Apnea Ti Apnea Inspiratory Time
182. r Not mounted Locked O Sensor O Sensor is not Low Runtime No Disconnected connected Replace O sensor The O value is less than Medium Runtime No 506 Calibrate O O value is greater than Low Runtime No Sensor 11096 or between 596 and 15 for 3 seconds Ventilator Comm Lost communication with High Runtime No Stop the CPU board for 10 seconds Drive Gas Pressure Drive Gas Pressure is low High Runtime No Low O Supply Failure O Supply Failure High Runtime No Fresh Gas Flow In VCV and SIMV VC Low Runtime N A Too High modes the fresh gas flow is greater than or equal to the desired flow TABLE 6 9 Ventilator Control Board Runtime Alarm Messages cont d 046 003777 00 A5 A3 Operating Instructions Alarms and Messages Alarm and Prompt Messages 6 6 3 Prompt Messages 6 6 3 1 Prompt Messages Displayed in Alarm Area MESSAGE TIMEOUT REMARK ya Pressure Volume and Correspond status This Alarms Off icon and message appear on a O Apnea Alarms are OFF does not exist white background when the Alarms button in the Manual mode tab is set to OFF Load Configuration Failure 10 sec This message appears when load user or latest configuration failed DEMO Mode Not for Never This message appears when the system is set to Clinical Use Demo mode from the Service tab Service Mode Not for Never This message appears when the machine is Clinical Use worked in Service mode Apnea Ventilation Correspond statu
183. remaining steps below or If you are in the Setup gt System and wish to skip 100 O sensor calibration select Done to close the calibration window Skip the remaining steps below 8 Select the 100 button to perform 100 O sensor calibration 9 Carefully follow the on screen prompts to prepare for calibration A5 A3 Operating Instructions 046 003777 00 7 7 O Sensor Calibration Maintenance 10 Select the Begin button to start 100 O sensor calibration The system will indicate the calibration status when the process is completed If an error code in red e g 00 00 00 10 is displayed see Table 7 2 O Sensor Calibration Error Codes on page 7 8 for troubleshooting information 11 After calibration select Done to close the calibration window NOTE In case of repeated calibration failures replace the O sensor and repeat the calibration If calibration still fails contact Mindray Technical Support ERROR CODE DESCRIPTION RECOMMENDED ACTION 00 00 00 01 O sensor calibration is Perform O sensor calibration again canceled 00 00 00 02 O supply pressure is low Check that the O sensor is connected to the cable During 10096 calibration correctly process O supply pressure Check the O supply pressure was not sufficient Check that the O sensor output voltage in the calibration menu is steady Replace the O sensor 00 00 00 04 O sensor is disconnected Check that the O sens
184. reminder is sounded and then the desired ventilation mode is cancelled 11 10 Off cmH20 ml bpm cmH20 8 0 2 Sep cmH20 sec FIGURE 3 20 ventilation Mode SIMV VC 3 18 046 003777 00 A5 A3 Operating Instructions System Interface Ventilation Mode Tabs PCV WR M S ee Cee plo lool o Mots ml cmH20 emH20 bpm cmH20 sec FIGURE 3 21 ventilation Mode PCV A5 unit 15 12 cmH20 L min cmH20 sec a Off 02 50 emH20 Discharge FIGURE 3 25 ventilation Mode Manual Note Bypass function is available only on the A5 A5 A3 Operating Instructions 046 003777 00 3 19 Measured Values Area System Interface 3 8 Measured Values Area The Measured Values area is used to display the numerical data The parameters include Peak Inspiratory Pressure PEAK Plateau Pressure PLAT user can configure this to display Mean Pressure MEAN or PLAT see Pressure Display on page 3 25 Positive End Expiratory Pressure PEEP IE Ratio Expiratory Tidal Volume Vt Expiratory Minute Volume MV Breath Rate Rate and Inspiratory 0 FiO FIGURE 3 26 Measured Values Area FIGURE 3 26 Measured Values Area 20 046 003777 00 A5 A3 Operating Instructions System Interface System Softkeys 3 9 3 9 1 3 9 2 3 9 3 System Softkeys The A5 A3 System provides system softkeys at the bottom right of the main screen for direct access to the system setup alarms menu an
185. requency range applies NOTE 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 Vt 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 A5 A3 is used exceeds the applicable RF compliance level above the A5 A3 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorient ing or relocating the A5 A3 b Overthe frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m TABLE 8 33 Continued Guidance and Declaration Electromagnetic Immunity 046 003777 00 A5 A3 Operating Instructions Ao Accessories TA KILS snc nc e AR E M Al I Ae ME A MEE A 2 O b NR Rina eumdem e ES A 2 O dent dte M beni A 2 Breathing O ten Dort added eta A 2 CO Absorbent Canisters oed o Ro teo tede ake cet A 3 EIOWSSEIISDE PA eme c M ELO M LR aM M tuna ota Ed A 3 ES a ba fatus A 3 GaSSUPPIVHOSES mE A 3 Manuals and Reference Card s idad A 4 Mounting Accessories Networkirig and USB
186. ropriately qualified technical personnel in repairing those parts of the A5 A3 which are designated as repairable Manufacturer s Responsibility The effects on safety reliability and performance of the equipment are the manufacturer s responsibility only if a assembly operations extensions readjustments modifications or repairs are carried out by authorized personnel and b the electrical installation of the relevant room complies with the appropriate requirements and the equipment is used in accordance with the instructions for use Symbols The following table provides descriptions of symbols that are used on the device and or within this manual SYMBOL DESCRIPTION SYMBOL DESCRIPTION Attention Consult Accompanying Documents Refer to Manual Defibrillator proof type BF Environment equipment CA Humidity Range lt Environment Temperature Range Environment Pressure Range Electrical Alternating Current AC Electrical Equipotentiality Gas Cyli der Electrical Gas Inlet Fuse or circuit breaker lt Electrical Gas Outlet Input Output ap xviii 046 003777 00 A5 A3 Operating Instructions Symbols Introduction E3 Q D D E mal LSN Electrical Internal Battery Electrical Light Electrical Power On Electrical Power Standby Electrical Protective Earth Ground Electrical WEEE Waste of Electrical and Electronic Equipment Mark
187. ror A5 A3 Operating Instructions 046 003777 00 6 17 Alarm and Prompt Messages Alarms and Messages MACHINE DISABLE IN ALARM MODE WHEN STANDBY MESSAGE CAUSE PRIORITY CHECKED MODE Low Battery Battery voltage is less High Runtime No Voltage than 10 6V for 5 seconds System going Battery voltage is less High Runtime No DOWN Battery than 10 2V depleted Battery Battery undetected Medium Runtime No Undetected Battery in Use AC power fail Low Runtime No Power Board High Power board temperature High Runtime No Temp is greater than 95 C Heating Module 1 Both resistance Low Runtime No Failure temperatures are greater than 105 C or less than 0 C for 20 seconds 2 One of the resistance temperatures is greater than 110 C for 15 seconds Breathing Circuit Breathing Circuit is not High Runtime No Not Mounted mounted TABLE 6 6 Power Board Runtime Alarm Messages NOTE If the power board loses communication with the CPU board for 10 seconds the alarm buzzer will be turned on 6 6 2 4 Electronic Flowmeter Board Runtime Alarm MACHINE DISABLE IN ALARM MODE WHEN STANDBY MESSAGE CAUSE PRIORITY CHECKED MODE Flowmeter DVCC AVDD or VC voltage High Runtime No Voltage Error error N20 Flow Too High NO flow is greater than 15 Low Runtime o L min for 1 second O Flow Too High O flow is greater than 25 L Low Runtime No min for 1 second Air Flow Too High Air flow is greater than 20 L
188. ructions 046 003777 00 8 3 Physical Specifications Product Specifications 8 3 Physical Specifications Dimensions Height 1400 mm 25 mm Width 1050 mm 25 mm including breathing system Depth 805 mm 25 mm Weight A3 150 kg 331 lbs 5 kg no vaporizers or gas cylinders A5 160 kg 353 lbs 5 kg Work Surface Width 616 mm 24 3 in 25 mm stainless steel Depth 380 mm 15 0 in 25 mm Height 850 mm 33 5 in 25 mm Top Shelf Weight Capacity 40 kg 88 2 lbs Width 616 mm 24 3 in 25 mm Depth 362 mm 14 3 in 25 mm Side Mounting Rails Supporting weight 25 kg at a maximum distance of 0 41 m Bag Arm Length 312 mm 10 mm Height 1150 mm 10 mm Swiveling angle 150 10 degrees Drawers Drawers are of equal size internal dimensions Height 135 mm 10 mm e Width 440 mm 10 mm Depth 385 mm 10 mm Casters Diameter 15 cm 6 in Brake A5 model central brake with lock unlock indicator A3 model individual caster brakes TABLE 8 3 Physical Specifications 8 4 Stability Configurations and Conditions Maintains stability when tilted 10 degrees as required by IEC60601 1 clause 24 WARNING Due to the size and weight of the A5 A3 it should only be moved by qualified personnel WARNING To avoid tip hazards use care when moving the A5 A3 up or down inclines around corners and across thresholds Remove all equipment from the top shelf and mou
189. ructions 046 003777 00 3 27 SYSTEM TAB BUTTON CHOICES Save Defaults Save as O R Defaults Manage Defaults Load User Defaults Load O R Defaults Restore Partial Defaults Import Defaults Export Defaults System Interface DESCRIPTION Select Save Defaults or Save as O R Defaults to save the current configuration as the user default configuration Select Load User Defaults or Load O R Defaults to load the user default configuration Select Restore Partial Defaults to overwrite the user defaults and system settings with the factory default settings Note that network settings will not be restored Select Import Defaults to import a copy ofthe defaults from the USB mass storage device if one has been inserted into an SB port at the rear ofthe A5 A3 unit Select Export Defaults to export a copy of the defaults to the USB mass storage device if one has been inserted into an SB port at the rear of the A5 A3 unit Time Zone Default UTC 05 00 Time Settings Daylight Savings Default Manual Auto DST Start Default First Sunday in April at 2 00 AM DST End Default Last Sunday in October at Select to set the UTC time zone offset Select to set the Daylight Savings Time DST to be adjusted automatically by the A5 system or manually by the authorized administrator If the region or country of installation does not observe DST change this sett
190. ry AC outlets on the rear of the machine operate independently of the main switch position The A5 provides four 4 auxiliary AC outlets the A3 provides three 3 auxiliary AC outlets The auxiliary AC outlets are not powered when operating the A5 A3 on the internal battery supply NOTE Use the battery supply in the A5 A3 at least once every month to extend battery life Charge the battery supply before its power capacity is depleted NOTE Inspect and replace the battery supply at regular service intervals Long term battery life depends on how frequent and how long the battery supply is used For a properly maintained and stored lithium ion battery its long term life expectancy is approximately three 3 years In more aggressive usage life expectancy can be shortened Replacing lithium ion batteries every three 3 years is recommended NOTE The operating time of a battery depends on equipment configuration and operation NOTE In case of battery failure contact Mindray service personnel for battery supply replacement The A5 A3 Anesthesia System is designed to operate on battery power whenever AC power is interrupted When the A5 A3 is connected to an AC power source the battery supply is charged whether or not the A5 A3 is turned on In case of power failure the A5 A3 will automatically switch to run from the internal battery supply When AC power source is restored within the specified time the battery supply begins recharging
191. s 5 Waveforms Tab See Waveforms Tab on page 3 10 6 Spirometry Tab A5 only See Spirometry Tab A5 Only on page 3 12 7 Demographics Tab See Demographics Tab on page 3 16 SIMV PC and Bypass are only available on A5 A5 A3 Operating Instructions 046 003777 00 3 3 Main Screen Components NUMBER MAIN SCREEN COMPONENT System Interface DESCRIPTION 8 Alarm Prompt Message Area Displays physiological alarms technical alarms and prompt messages The most recent highest priority alarm is displayed at the top The remaining alarms are displayed in the lower area and grouped by priority The most recent of these alarms is displayed first Select this area to display a list of all active alarms See Alarms and Messages on page 6 1 for tables that list the individual messages and their associated priority levels High priority messages are red Medium priority messages are yellow Low priority messages are cyan Prompt messages are black Alarm Silence Icon Displays the alarm silence icon and Alarm Silence countdown timer for 120 seconds when the Silence softkey is selected 10 System Date and Time Displays the current system date and time Select to adjust the date and time See Date and Time on page 3 7 11 Main Power Supply and Battery Status Icon Displays the main power supply and battery state See Power Management Battery Supply on page 1 5
192. s Product Description Physical Views 1 2 7 Breathing System Left View FIGURE 1 8 Breathing System Left View PART S DESCRIPTION G1 CO Absorber Canister Container for CO absorbent material loose fill or Pre Paks G2 Condensate Drain Valve Turn counter clockwise looking from bottom to drain water collected in the absorber canister G3 Absorber Canister Lock Lever type locking mechanism to lock horizontal position or unlock vertical position the absorber canister from the canister assembly G4 Water Trap Accumulates condensate from the breathing system Must be removed and emptied periodically To remove turn clockwise looking from top G5 Absorber Bypass Assembly Maintains pressure in the breathing circuit when changing the sodalime contents in the CO absorber canister A5 A3 Operating Instructions 046 003777 00 1 17 Physical Views Product Description 1 2 8 Anesthetic Gas Scavenging System AGSS Top Front and Right Views Top View AY in Uu Right View Rear a TT I Max Max iin Min T dle FIGURE 1 9 AGSS Top Front and Right Views PART S DESCRIPTION H1 Mounting Rail Attachment Allows the AGSS to be mounted on the side rail Contains a thumbscrew that must be tightened against the mounting rail H2 Flow Adjust Knob Turn clockw
193. s Pipeline Connection 34 O Sensor 6 Air Gas Cylinder Connection 35 Airway Pressure Gauge 7 Gas Cylinder Pressure Regulator 36 Inspiratory Flow Sensor 400kPa 8 Pressure Relief Valve 758kPa 37 Patient Connector 9 Drive Gas Inlet Filter 38 Expiratory Flow Sensor 10 Pressure Regulator 200kPa 39 Water Trap 11 Inspiratory Flow Control Valve 40 Expiratory Check Valve 12 Inspiratory Flow Sensor 41 Auto Manual Bag Switch 13 Safety Valve 110 cmH5O 42 Breathing Bag 14 Pop off Valve 43 APL Valve 15 PEEP Safety Valve 44 Auxiliary O5 Gas Power Outlet A5 only 16 Drive Gas Pressure Switch 140kPa 45 Bellows 17 PEEP Proportional Valve 46 Pressure Relief Valve 1kPa 10 cmH 0 18 Exhaust Valve 47 Negative Pressure Check Valve 1 cmH5O 19 Flow Restrictor 48 Gas Container 20 O Flush Valve 49 Pressure Sensor 21 Flow Restrictor 50 Total Flowmeter 22 O Pressure Switch 220kPa 51 Auxiliary Oxygen Flowmeter 23 Pressure Regulating Valve 220kPa 52 Free Breathing Check Valve 24 System Switch 53 Pressure Sensor 25 Oxygen Ratio Controller ORC 54 AGSS 26 Flow Control and Electronic Display 55 Check Valve Module 27 Dual Vaporizer Block 56 Back pressure valve 28 Check Valve 57 Flow compensation valve 29 Pressure Relief Valve 37 9kPa A5 A3 Operating Instructions 046 003777 00 C 3 Pneumatic Diagram of the A5 A3 System Pneumatic Diagram This page intentionally left blank C 4 046 00377
194. s This message appears when the Min Rate does not exist triggers a breath in PS ventilation mode Calibrate O sensor for 21 When the machine is powered on if more than 72 hours have elapsed since the last successful calibration the prompt message Calibrate O2 sensor for 21 is displayed The message disappears after successful calibration If the machine is kept powered on the prompt message Calibrate O2 sensor for 21 is displayed at the next Standby mode after 5am after 72 hours have elapsed since the last successful calibration If the alarm message RT Clock Needs Battery or RT Clock Failure is displayed the prompt message Calibrate O2 sensor for 21 is disabled If the calibrate time is empty the prompt message Calibrate O2 sensor for 21 is displayed Auto zero in process Correspond status This message appears when auto zeroing of the does not exist pressure sensors is in process Fresh Gas Is On Correspond status This message is displayed if the fresh gas flow does not exist value is flashing in Standby mode New functions activated After the machine This message appears when activation please restart restart complete successfully TABLE 6 10 Prompt Messages Displayed in Alarm Area 6 6 3 2 Prompt Messages Displayed in Pop up Area MESSAGE TIMEOUT REMARK Can only Discharge in 5 sec This message appears if the Discharge Manual Mode button is selected when the Manual swi
195. s and messages that are indicated to the user by visual and audible alerts Alarms and messages appear at the top of the Main Screen and in the Alarms window See Figure 6 1 Users can adjust alarm properties which include setting alarm limits to trigger alarm conditions adjusting alarm volume and silencing alarms Alarm Messages i Alarms Window A Power System Comm Stop Manual Fresh Gas Flow Alarms Limit N20 AIR AN Power System Comm Stop Calibrate 02 sensor for 21 Load Alarm i ME s E Alarms Window Softkey Silence Alarms Softkey FIGURE 6 1 Alarms and messages on the main screen and in the Alarms window 6 1 1 Alarm System Self Test The A5 A3 System performs a self test of its alarm system when powered on The self test includes the alarm LED and speaker as follows During the self test the alarm LED will illuminate in sequence the colors red yellow and cyan for approximately 1 second each color The system speaker will produce one tone after the alarm light is in self test 6 2 046 003777 00 A5 A3 Operating Instructions Alarms and Messages Introduction 6 1 2 Types of Alarms and Messages The A5 A3 provides the following types of alarms and messages below See section 6 6 pg 6 13 Alarm and Prompt Messages for the list of alarms and messages see Physiological Alarm This is an alarm caused by a patient related variable It requires a response from the user It can have the
196. s designed to be equipped with an anesthetic vapor delivery device that complies with ISO 11196 NOTE The A5 A3 battery supply is not a user serviceable component Only an authorized service representative can replace the battery supply If the system is not used for an extended period contact a service representative to have the battery supply disconnected The batteries may be subject to local regulations regarding disposal At the end of the battery life dispose of the battery supply in accordance with local regulations NOTE Areas designated for the servicing of oxygen equipment shall be clean free of oil and grease and not used for the repair of other equipment NOTE Opening the cylinder valve quickly may cause unexpected pressure differentials and create a potential for fire or explosion arising from oxygen pressure shocks Open and shut the cylinder valve slowly NOTE Accuracy of the flowrate may be affected by varying inlet pressure varying outlet resistance or varying ambient temperature NOTE The power device terminal units and pipeline system can be supplied by one or several different manufacturers NOTE Regional or national regulations that apply to manufacturers of medical devices can exist xvi 046 003777 00 A5 A3 Operating Instructions Warranty Statements Introduction Warranty Statements Mindray DS USA Inc warrants that components within the anesthesia system will be free from defects in workm
197. sages Prompt Messages Displayed in Alarm Area Prompt Messages Displayed in Pop up Area o ssssssssssssesscccsssescecssssececsnsssccecssssccecsnssecessuuseseecssuseseessuesecesssuseccesuueseessaneseesennsecesesnsecsectuee A O Theory of Operation Block Diagram Maintenance Schedule Breathing System Md O a ia Flow Sensor Calibrati ERR ICE ERO iris O Sensor Calibration Calibrate the O2 Sensor Water Build up in the Flow Sensor Prevent Water B ild Up oerte trit tetendit ledere dde AAA M E AGSS Transfer Tube Maintenance m Cleaning and Disinfection 10 General CIUS ATI RE E H 10 Cleaning and Disinfecting Agents AUtOCIaVING ssssssssssscssscsssssssesssssssesssssessssssssssssseesssssssessssssssssessessssnsessesssessssssssessesssssssnesesesssessnsnees 7 10 External Surfaces 7 10 Bellows Assembly 7 11 Inspiration and Expiration Valves 7 14 OXY GEN SENSO Ton e NN 7 16 A o s tent ANTEN NEEE SEEE E AE RAN 7 17 PAW Gauge 7 18 9 Breathing System Block ir AGSS Anesthetic Gas Scavenging System and AGSS Transfer HOSC ssssssssccsssssccsssssseccsssecccessseccecsnssececcnuseesessnssececcsussesesnneseceseneseesee Regular Maintenance Product Specifications Standards Compliance Safety Designations D Oxygen Enfiched Environments cria das 8 3 MUA naen ARAA AE A EA RAA AAAA A RA OARE 8 3 Physical Specifications Stability Configurations and
198. sh gas flow is turned off or after exiting Manual Circuit Leak Test or Automatic Circuit Leak Test amp Compliance Test screen This message appears in the first Manual Circuit Leak Test or Automatic Circuit Leak Test amp Compliance Test screen when fresh gas flow is detected Access to System settings 5 sec This message appears when the current only available in Standby mode is in non standby and the user tries to enter the Setup gt System menu Can not discharge while 5 sec This message appears when user tries to fresh gas flow is detected discharge by pressing the disabled Discharge button while fresh gas is on Auto Manual switch is setto Manual and the system is in non standby Set Auto Manual switch to Manual position before starting case 1 When triggered by turning on fresh gas it will disappear after fresh gas flow is turned off or Auto Manual switch is set to Manual 2 When triggered by touching the Waveforms Spirometry screen it will disappear after 5 seconds or Auto Manual switch When Auto Manual switch is in Auto position and system is in Standby mode this message will appear in the following cases 1 Turning on fresh gas 2 Touching the Waveforms Spirometry screen is set Manual Set Auto Manual switch to 5 sec This message appears in the first Manual position and adjust Automatic Circuit Leak Test amp Compliance all flowmeters to zero Test screen when pressin
199. sinfecting 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 See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving and use an approved disinfecting agent for the APL valve while adhering to facility policies and procedures 4 Reassemble the APL valve by turning its base collar clockwise until it is securely tightened Prior to use after cleaning or disinfecting power up the system and follow the on screen prompts to perform the Leak Test and the Compliance Test See section 4 5 pg 4 9 Leak and Compliance Tests A5 A3 Operating Instructions 046 003777 00 7 17 Cleaning and Disinfection Maintenance 7 9 8 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 hold it and lift it straight up from the absorber block as shown in FIGURE 7 15 FIGURE 7 15 PAW Gauge Removal CAUTION Do not autoclave the following components Paw gauge oxygen sensor flow sensor and bellows These components cannot withstand immersion or the heat and pressure of autoclaving 2 Clean the PAW gauge with a soft lint free cloth and a recommended cleaning agent See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving Allow it to dry thoroughly 3 Re i
200. size containing high pressure O Air and N50 to act as backup supply if the pipeline pressure is removed Note Tanks not supplied by Mindray B14 AGSS Transfer Hose Routes exhaust gases from main unit to scavenger A5 A3 Operating Instructions 046 003777 00 1 11 Physical Views 1 2 3 Product Description Main Unit Left View 2 LF oo i LH l at i4 I CED dd E q i ore 2 T d h a FIGURE 1 4 Main Unit Left View PART S DESCRIPTION c1 Auxiliary O Air Auxiliary O 5 Air Flowmeters for auxiliary O5 Air output Flowmeters C2 Auxiliary O Air Gas Nozzle barbed connector for auxiliary O Air output Combines the Outlet auxiliary O gt Air flowmeters into a single output c3 Auxiliary O Gas High pressure O outlet DISS connector for connecting external Power Outlet devices such as a jet ventilator A5 only C4 Rail Mount Enables mounting of patient monitors and most standard attachment arms for other devices Rail mounts are on both left and right sides of the A5 A3 046 003777 00 A5 A3 Operating Instructions Product Description Physical Views 1 2 4 Main Unit Right View FIGURE 1 5 Main Unit Right View PART S DESCRIPTION D1 Vaporizer Mounting An interface for two Selectatec type vaporizers to mount in Manifold Mounting Bar
201. sor and Cable CAUTION Never immerse the oxygen sensor or its connector in any type of liquid Dispose of the oxygen sensor per the manufacturer s specification CAUTION Do not wash the inner surface of the oxygen sensor CAUTION Do not autoclave the following components Paw gauge oxygen sensor flow sensor and bellows These components cannot withstand immersion or the heat and pressure of autoclaving 2 Clean the oxygen sensor exterior with a soft lint free cloth and a recommended cleaning agent See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving Allow to dry thoroughly 3 Inspect the oxygen sensor for damage and replace as necessary 4 Re insert the oxygen sensor if it had been removed 7 16 046 003777 00 A5 A3 Operating Instructions Maintenance Cleaning and Disinfection 7 9 7 APL Valve 1 The APL valve is a component that is plugged into position and secured by a threaded base collar Loosen the base collar of the APL valve by turning the collar not the valve knob counterclockwise until it is no longer threaded as shown in FIGURE 7 14 Then firmly pull the APL valve upward to remove APL Valve Knob APL Valve Base Collar threaded FIGURE 7 14 APL Valve Removal 2 Cleaning a Clean the APL valve with a soft lint free cloth and a recommended cleaning agent See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving Allow it to dry thoroughly b if di
202. stem components in reverse order Prior to use after cleaning or disinfecting power up the system and follow the on screen prompts to perform the Leak Test and the Compliance Test See section 4 5 pg 4 9 Leak and Compliance Tests CAUTION To ensure patient safety use only parts and accessories specified in this manual CAUTION To ensure measurement accuracy and to avoid possible damage to the A5 A3 use only Mindray approved cables and accessories A5 A3 Operating Instructions 046 003777 00 7 23 Cleaning and Disinfection 7 9 12 Maintenance AGSS Anesthetic Gas Scavenging System and AGSS Transfer Hose 1 Disconnect the EVAC hose from the AGSS See FIGURE 7 23 2 Remove the AGSS and Transfer Hose from the A5 A3 Transfer Hose EVAC Hose Port FIGURE 7 23 AGSS and Transfer Hose Removal 3 Clean the outer surface of the AGSS and Transfer Hose with a soft lint free cloth and a recommended cleaning agent See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving Allow to dry thoroughly 4 Referto FIGURE 7 24 Remove the top of the AGSS Inspect the AGSS filter 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 disposal regulations 046 003777 00 A5 A3 Operating Instructions Maintenance Cleaning and Disinfection AGSS Filter FIGURE 7 24 Removal of AGSS Top AGSS Filter Inspection 5 Reassem
203. stem into operation the operator must verify that the equipment connecting cables and accessories are in correct working order and operating condition The equipment must be connected to a properly installed power outlet with protective earth contacts only If the installation does not provide for a protective earth conductor disconnect it from the power line or operate from the equipment s internal battery supply Multiple AC power outlets are provided on the rear of the A5 A3 These outlets are intended to supply power to additional equipment that form a part of the anesthesia system i e vaporizers gas analyzers etc Do not connect other equipment to these outlets as patient leakage current may be affected Each outlet is rated 3 A the total current that may be drawn through all outlets is 10 A on the A5 System and 9 A on the A3 System do not attempt to exceed these load ratings Do not connect additional MPSOs or extension cords to these outlets Do not put MPSO Multiple Portable Socket Outlet i e multiple outlet extension cords on the floor Connect the A5 A3 Anesthesia System to an AC power source before the internal battery power source is depleted Do not open the equipment housings All servicing and future upgrades must be carried out only by trained and authorized Mindray personnel Do not rely exclusively on the audible alarm system for patient monitoring Adjustment of alarm volume to a low level may result
204. sts Complete the 21 and 100 O Calibration See O Sensor Calibration on page 7 6 The following step is recommended to be performed weekly whenever a new vaporizer is installed or when CO absorbent is replaced Perform a vaporizer leak test See Manual Leak Test on page 4 23 4 6 046 003777 00 A5 A3 Operating Instructions Preoperative Tests System Self Test 4 4 System Self Test When the A5 A3 is powered on it performs a self test to ensure its alarm system alarm LED speaker and buzzer and hardware flowmeter board ventilator board assistant ventilator board power board and CPU board are properly functioning To perform a system self test 1 Turn the power switch on the front panel to the ON position The A5 A3 powers up and begins its system self test See Table 4 1 for the system self test sequence After the system self test is completed the test results are displayed on the screen Startup alarm messages also may be displayed See Table 4 2 for a list of possible test result conditions See Table 6 6 2 1 for a list of Startup Alarm Messages 2 Proceed to operate or troubleshoot the A5 A3 based on the self test results SYSTEM SELF TEST SEQUENCE COMMENTS 1 A high pitched beep is sounded Alarm self test 2 The A5 A3 startup screen is displayed 3 TheLED above the touchscreen illuminates in sequence Alarm self test red yellow and blue 4 Atest low priority al
205. sure The release of sudden pressure may cause injury Review the specifications of the AGSS transfer and receiving systems and the specifications of the A5 A3 System to ensure compatibility and to prevent a mismatched receiving system Avoid connecting two or more hose assemblies in series as this may cause a loss of pressure and flow A hazard may exist due to the use of improper connectors Ensure all assemblies use the proper connectors Avoid replacing a high pressure flexible connection with one of lower nominal inlet pressure A5 A3 Operating Instructions 046 003777 00 xi Introduction Cautions WARNING WARNING WARNING Cautions CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION Reusing breathing circuits or reusable accessories that are not disinfected may cause cross contamination Disinfect the breathing circuits and reusable accessories before use Inspect all breathing system components carefully before each use Ensure all components do not contain any obstructions or debris that can cause a potential hazard to the patient Use breathing circuits and manual bags in accordance with ASTM F1208 and compatible with standard 22mm male conical fittings per ASTM specifications F 1054 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
206. sure that the alarm cancels A5 A3 Operating Instructions 046 003777 00 4 27 Alarm Tests Preoperative Tests 4 13 3 Test the Low Minute Volume MV Alarm 1 Set the ventilation switch to the automatic ventilation position Set the ventilation mode to VCV Select the Alarms softkey and then the Limits tab Set the MV low alarm limit to 8 0 L min Ensure that a low MV alarm occurs after approximately 60 seconds Select the Alarms softkey and then the Limits tab Set the MV low alarm limit back to a value less than the measured MV value and ensure that the alarm cancels 4 13 4 Test the Apnea Alarm Peps 6 Connect the manual bag to the manual bag port Set the Auto Manual ventilation switch to Manual Turn the APL valve control to set the APL valve to 10 cmH 0 Inflate using the O pushbutton and squeeze the manual bag to ensure that a complete breathing cycle occurs on screen Stop inflating the manual bag and wait for more than 30 seconds to ensure that the apnea alarm occurs Inflate and squeeze the manual bag to ensure that the apnea alarm cancels 4 13 5 Test the Continuous Airway Pressure Alarm Pon Connect the manual bag to the manual bag port Turn the O flow control clockwise to set the O flow to Off Turn the APL valve control to set the APL valve to 30 cmH5O position Set the Auto Manual ventilation switch to Manual Push the O flush button for approximately 15 seconds Ensure that the Cont
207. t cannot rise the possible reasons are 1 The float surface is tacky Turn over the AGSS and check if the float moves up and down freely 2 The float is rising slowly The filter may be blocked Check if the filter is blocked 3 The waste gas disposal system is not working or the pump rate is less than 50 L min at which the AGSS works normally Check the waste gas disposal system A5 A3 Operating Instructions 046 003777 00 4 31 Inspect the AGSS Preoperative Tests This page intentionally left blank 4 32 046 003777 00 A5 A3 Operating Instructions so Operations Powering Onthe A5 A3 Anesthesia O dde dads 5 2 PU etc chat Desert i ll 5 3 Oxygen Sensor Calibration tette eb ue vg Abe enda a tt Ote dta 5 4 Input EreshGids A NN 5 5 Ventilation Modes Start Mechanical VentilatiOris thee epitheto steep gus 5 16 Stop Mechanical Ventilators tot lt tede da ted e tees 5 16 Relationships of Ventilation Parameters ettet ettet ttis 5 16 Parameter Monitoring Waveforms cinc 5 17 A5 A3 Operating Instructions 046 003777 00 Powering On the A5 A3 Anesthesia System Operations 5 1 5 2 WARNING Before using the A5 A3 Anesthesia System on the patient ensure that the system is correctly assembled and in good condition and that all the tests described in the Preoperative Test are already completed In case of test failure do not use the system Have a qualified Mindray service representative repair the sys
208. t provides continuous breath by breath measurement of patient lung mechanics The resultant pressure volume flow compliance and resistance data enables quick assessment of the patient s pulmonary status Open the Spirometry Loop Window by selecting the SPIROMETRY tab 5 10 4 1 Spirometry Loops Currently plotting loop reference loop and baseline loop can be displayed in Manual and Mechanical Ventilation modes Discharge Patient will clear Spirometry Loops baseline and reference loops Restart the machine will clear Spirometry Loops baseline and reference loops Spirometry is disabled in Bypass mode If Bypass mode is entered when the Spirometry tab is open then the system will switch to the Waveforms tab Pressure Volume Spirometry Loop FIGURE 5 15 is an example of the Pressure Volume loop Pressure Volume Show Review Reference Loops FIGURE 5 15 Pressure Volume Loop 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 of measure is cmH 30 and its scale is 20 to 80 in increments of 20 A5 A3 Operating Instructions 046 003777 00 5 19 Parameter Monitoring Waveforms Flow Volume Spirometry Loop FIGURE 5 16 is an example of the Flow Volume loop Flow Volume Show Reference FIGURE 5 16 Flow Volume Loop The Y axis of the Flow
209. tch is set to Auto and the machine is in non standby Invalid Age Please check 5 sec This message appears after entering the DOB or current system patient s date of birth if the calculated age time of the patient is outside the accepted range 0 150 Patient Size can only be 5 sec This message appears when the Patient changed in Manual Mode Size selection is pressed while the system or in Standby is in Automatic Ventilation mode A5 A3 Operating Instructions 046 003777 00 6 21 Alarm and Prompt Messages Alarms and Messages MESSAGE TIMEOUT REMARK Vent modes can only be 5 sec This message appears when the Current changed using Set Mode Mode area is pressed button below Out of Range 5 sec This message appears when the entered value is outside the allowable range Invalid Password 5 sec This message appears when the entered password is wrong Saving User Configuration 5 sec This message appears when the Saving has failed User Configuration process has failed New password input is 5 sec This message appears when the new inconsistent password and the confirmed new password do not match Automatic ventilation 15 sec This message appears when exiting disabled Check lever on breathing system Standby mode while the Auto Manual switch is in Auto position and system is in the Automatic Ventilation disabled state Fresh gas flow detected Adjust all flowmeters to zero After fre
210. tem Powering On the A5 A3 Anesthesia System Connect the gas supplies and gas cylinders to the A5 A3 Connect the power cord to the AC power source Ensure that the AC power LED is illuminated Set the system switch to ON Ensure that both the operating state LED and battery LED are illuminated the battery is being charged or fully charged The display shows the start up screen The alarm LED flashes red yellow and cyan once in turn and then a beep is given This verifies that audible and visual alarms are operational After several seconds the system self test screen is displayed and the A5 A3 runs its system self test Powering Off the A5 A3 Anesthesia System The A5 A3 system provides a powering off function with the following features A prompt sound is given when user turns off the A5 A3 If the power switch is turned off in Standby mode the A5 A3 will immediately power off If the power switch is turned off in Manual mode or in any of the Automatic ventilation modes the A5 A3 will wait 12 seconds to power off completely In the 12 second power off delay period the screen will display a 10 second countdown timer If the A5 A3 is performing Automatic ventilation the ventilator will continue ventilating the patient in the current ventilation mode A beep is sounded for each second of the countdown from 10 to 1 second after which a two second shutdown sound is given when the timer reaches zero The volume of power of
211. tenance manuals of all disinfection equipment Do not inhale fumes that may result from any disinfection process 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 Only use lubricants approved for anesthesia or O equipment Do not use lubricants that contain oil or grease They can burn or explode in the presence of high O concentrations Obey infection control and safety procedures Used equipment may contain blood and body fluids Movable parts and removable components may present a pinch ora crush hazard Use care when moving or replacing system parts and components Before using the A5 A3 System after cleaning or disinfecting power up the system and follow the on screen prompts to perform the Leak Test and the Compliance Test See section 4 5 pg 4 9 Leak and Compliance Tests To prevent system damage Refer to the literature supplied by the manufacturer of the cleaning agent Never use organic halogenated or petroleum based solvents anesthetics glass cleaning agents acetone or other irritant agents Never use abrasive agents i e steel wool or silver polish to clean components Keep all liquids away from electronic components Prevent liquid from entering the equipment All cleaning solutions used must have a pH between 7 0 and 10 5
212. tergent Sodium hypochloride bleach solution in water 1096 intermediate level disinfectant Isopropyl alcohol 7096 intermediate level disinfectant Super Sani Cloth 0 5 Quaternary ammonium chloride intermediate level disinfectant and 5596 Isopropyl alcohol Virkon intermediate level disinfectant Autoclaving process high level disinfectant All breathing system components are autoclavable except the Paw gauge flow sensor O sensor and bellows The components can be autoclaved up to a maximum temperature of 134 C 273 F TABLE 7 3 Cleaning and Disinfecting Agents 7 9 3 External Surfaces Use a soft cloth with an approved cleaning agent See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving to clean all outer surfaces hoses and cables 7 10 046 003777 00 A5 A3 Operating Instructions Maintenance Cleaning and Disinfection 7 9 4 Bellows Assembly 1200 1500 Vr mt A a a FIGURE 7 4 Bellows Assembly Read all content in this section before disassembling cleaning disinfecting and re assembling the bellows to avoid equipment malfunction and patient injury 1 The bellows dome is a transparent cover with graduation marks from 300 to 1500 mL Remove the bellows dome by turning it counterclockwise and lifting it away from the breathing system See FIGURE 7 5 FIGURE 7 5 Removing the Bellows Dome 2 Detach the bellows from the base plate as shown in FIGURE 7 6 A5 A3
213. ting nstructions for special procedures precautions and step by step instructions WARNING To ensure proper machine operation user safety and patient safety follow all checkout procedures established by the facility before administering anesthesia to the patient Each day before administering anesthesia the following should be done 1 With the anesthesia machine connected to AC Power turn the Mains switch to ON and verify that the unit is operating on AC Follow the on screen prompts to perform and complete the automatic machine start up tests 2 a Check the O Supply fail safe message and alarm See O Pipeline Test on page 4 18 b Test low O concentration alarm See Test the O Concentration Monitoring and Alarms on page 4 27 c Test high and low airway pressure alarms See Test the High Paw Alarm on page 4 28 See Test the Low Paw Alarm on page 4 28 d Test low minute volume and apnea alarms See Test the Low Minute Volume MV Alarm on page 4 28 See Test the Apnea Alarm on page 4 28 3 Verify that the O sensor displays approximately 21 in room air and above 94 after exposure to 100 O See Test the O Concentration Monitoring and Alarms on page 4 27 4 Check that the vaporizers are properly installed and sufficiently filled and that filler ports are tightly closed Verify that only one vaporizer turns ON at a time Install the Vaporizer on page 2 5 046 003777 00 A5 A3
214. ting the ability to properly ventilate a test lung can quickly identify an occluded circuit limb and other breathing circuit problems Before starting each case test the machine s ability to ventilate the patient by removing the breathing bag from the bag arm and connecting it to the patient connection elbow or Y piece on he disposable circuit Set the ventilator to deliver a specific tidal volume to the test lung and verify he exhaled tidal volume monitor Observe that the test lung breathing bag inflates as the bellows descends and that the test lung deflates during the exhalation phase Observe that the measured exhaled volume matches the tidal volume set on the ventilator With the ventilator running lower the fresh gas flow to zero and observe if the bellows rapidly falls with each exhalation If this occurs then a leak should be suspected identified and repaired This test should be performed before starting each case By verifying that a test lung breathing bag can be manually and mechanically ventilated this indicates that the A5 A3 is capable of ventilating a patient with the attached breathing circuit Suggested Pre operative Checkout List Below is a suggested checkout list that should be conducted before administering anesthesia This is a guideline which users are encouraged to modify according to their local clinical practice Such local modifications should have appropriate peer review Users should refer to the A5 A3 Opera
215. to its weight and shape CAUTION The breathing system block is calibrated and matched with the anesthesia machine at the factory A label in the back of the machine indicates the serial number of the matching breathing system block When reassembling ensure that the breathing system block and anesthesia machine are properly matched Otherwise the breathing system must be recalibrated 3 While holding the sides of the breathing system block firmly separate and slide it away from its mounting arm FIGURE 7 22 Breathing System Block Removal Bottom View 7 22 046 003777 00 A5 A3 Operating Instructions Maintenance Cleaning and Disinfection 4 Cleaning a Clean the breathing system block exterior with a soft lint free cloth and a recommended cleaning agent See section 7 9 2 pg 7 10 Cleaning and Disinfecting Agents Autoclaving Allow to dry thoroughly b If disinfecting the breathing system block continue with step 5 otherwise skip to step 6 5 Disinfection NOTE Ensure that the breathing system block has been cleaned as described in step 4 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 6 Reassemble the breathing sy
216. transducers may cause improper oximeter performance Unintended movement may occur if the casters are not locked The operator should lock casters during use of the machine Unsecured devices may slide off the top shelf Devices should be securely attached to the top shelf The voltage on the auxiliary outlets is the same voltage as the outlet into which the A5 A3 machine is plugged Ensure that devices plugged into the auxiliary outlets are rated for the same supply voltage as the A5 A3 During the transport and storage of the vaporizer block the gas inlet and outlet of the vaporizer with plugs to prevent foreign substances from entering the vaporizer Do not use any flow outlets as handles for moving the A5 A3 The flow outlets may become damaged Use the metal side bars on the main body when moving the A5 A3 Do not push down on the bag arm forcefully or hang heavy objects onto it Excessive weight may bend and damage the bag arm Use caution when disconnecting quick connectors as the sudden release of pressure may cause injury Avoid factors that can contribute to deterioration of the hose assemblies Factors include excessive bending crushing abrasion system pressures and temperatures that exceed hose ratings and improper installation xiv 046 003777 00 A5 A3 Operating Instructions Notes Introduction CAUTION CAUTION Notes NOTE NOTE NOTE NOTE NOTE NOTE NOTE NO
217. tronic flowmeter on the screen Below the electronic flowmeters and between the pressure gauges is the total flowmeter showing the total flow of the mixed gas Safety systems within the A5 A3 work to prevent hypoxic mixtures from being delivered to the patient Nitrous oxide will not be delivered unless oxygen flow is present A mechanical safety system assures that at least 21 O is present when setting mixtures of O and N5O Ensure that both O and N5O flow controllers are turned OFF fully clockwise at the start and at the end of each case All A5 A3 units are designed to maintain a safe O5 N5O ratio by allowing nitrous oxide to be set to a flow rate that is proportional to a previously adjusted flow of oxygen The N50 flow is limited by the flow of O so that a safe ratio of no less than 21 oxygen can be maintained When adjusting NO and O flow rates always adjust the oxygen flow first to enable the nitrous oxide flow To add N50 to the fresh gas flow the user must open the NO flowmeter valve but only after opening the O flowmeter valve NOTE The A5 A3 anesthesia system can be used alone as a ventilator You can adjust O5 concentration in the breathing system through the O flow control NOTE The total flowmeter is calibrated based on 100 O5 The accuracy of the flowmeter may degrade with other gas or mixed gas NOTE When viewing the readings on the total flowmeter keep your visual angle at the same level of the float The read
218. ts and Tests IEC 60601 1 4 2000 Collateral Standard Programmable Electrical Medical Systems IEC 60601 1 8 2006 Collateral Standard General Requirements Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems IEC 60601 2 13 2003 Medical Electrical Equipment Part 2 13 Particular Requirements for the Safety and Essential Performance of Anaesthetic Systems IEC 62304 2006 Medical Device Software Software Life Cycle Processes IEC 62366 2007 Medical Devices Application of Usability Engineering to Medical Devices ISO 13485 2003 Medical Devices Quality Management Systems Requirements for Regulatory Purposes ISO 14971 2007 Medical Devices Application of Risk Management to Medical Devices ISO 21647 2004 Medical Electrical Equipment Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors ISO 5356 1 2004 Anaesthetic and Respiratory Equipment Conical Connectors Part 1 Cones and Sockets TABLE8 1 Standards Compliance 046 003777 00 A5 A3 Operating Instructions Product Specifications Safety Designations 8 2 Safety Designations Type of Protection against Electric Shock Class equipment with internal electric power supply Where the integrity of the external protective earth ground in the installation or its conductors is in doubt the equi
219. twork On Off Off Yes Network Protocol HL7 046 003777 00 A5 A3 Operating Instructions Parameters and Factory Defaults Setup Menu Current selection saved when powered PARAMETER RANGE DEFAULT off System Tab Network 10 sec 30 sec 1 min 5 1 min Yes Network Protocol min 30 min 1 hr 2 hr 6 Interval hr 12 hr 24 hr System Tab Network 192 168 23 200 Yes Network Protocol Destination IP System Tab Network 0 65535 1550 Yes Network Protocol Port Configuration System Tab Network 10 sec 30 sec 1 min 5 Off Yes SNTP Protocol Interval min 30 min 1 hr 2 hr 6 hr 12 hr 24 hr System Tab Network 0 255 132 163 4 103 Yes SNTP Protocol Primary Server IP System Tab Network 0 255 210 72 145 44 Yes SNTP Protocol Secondary Server IP 046 003777 00 A5 A3 Operating Instructions Alarm Volume and Log B 4 B 5 B 6 Parameters and Factory Defaults Alarm Volume and Log Current selection saved when PARAMETER RANGE DEFAULT powered off Alarm Volume level 1 10 5 Yes System Alerts level 1 10 2 Yes Volume Alarm Log High Medium Low All All Yes Filter Date and Time Current selection saved when PARAMETER RANGE DEFAULT powered off Day 1 31 1 Yes Month 1 12 1 Yes Year 2009 2099 2009 Yes Hour 00 24 hr Yes 12 am 12 hr Minute 00 60 00 Yes AM PM AM PM AM Yes 12 24 hour 12 24 12 Yes Date format YYYY M
220. ual Warnings Cautions and Notes Please adhere to all warnings cautions and notes that are listed throughout this manual They are summarized here for your reference WARNING Indicates a potential hazard or unsafe practice that if not avoided could result in death or serious injury to the patient or user CAUTION Indicates a potential hazard or unsafe practice that if not avoided could result in product property damage or minor personal injury to the patient or user NOTE Provides application tips or other useful information A5 A3 Operating Instructions 046 003777 00 vii Introduction Warnings Warnings WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING Do not operate the A5 A3 Anesthesia System before reading these instructions All analog or digital products connected to this system must be certified passing the specified IEC standards such as IEC 60950 for data processing equipment and IEC 60601 1 for medical electrical equipment All configurations shall comply with the valid version of IEC 60601 1 1 The personnel who are responsible for connecting the optional equipment to the 1 O signal port shall be responsible for medical system configuration and system compliance with IEC 60601 1 1 This machine must only be operated by trained skilled medical staff Before putting the sy
221. ure to open the APL Dry 0 1 kPa valve Wet 0 1 kPa Expiratory resistance TABLE 8 16 APL Valve 8 8 7 Breathing System Temperature Controller Breathing System Temperature 35 C typical at 20 C ambient temperature Maintained to Note The block heater does not operate while the system is being powered by the internal battery supply TABLE 8 17 Breathing System Temperature Controller 8 8 8 Breathing Circuit Parameters System Compliance Volume of gas lost due to internal compliance manual ventilation mode only lt 2mL cm H2O Impedance in Manual Mode lt 6 cmH20O the gas under test is a bi directional sine wave at a frequency of 20 with tidal volume of 1 L Impedance in Automatic lt 6 cmH5O the gas under test is a semi sine wave at a Ventilation Mode frequency of 20 with tidal volume of 1 L Leakage lt 150 mL 3kPa System Safety Pressure on 110 10 cmH50 10 110 L min Patient Circuit TABLE 8 18 Breathing Circuit Parameters 8 8 9 Materials All materials in contact with the patient s exhaled gas are autoclavable except the flow sensors pressure gauge bellows and O cell All materials in contact with the patient s gas are latex free 8 10 046 003777 00 A5 A3 Operating Instructions Product Specifications Anesthetic Gas Scavenging System AGSS 8 9 Anesthetic Gas Scavenging System AGSS Type of the Applicable Low flow Disposable System
222. vtsdgnasshdcabagedinbobatatesennddstcroaneaiegterd CO Absorber Resistance CO Absorber Capacity Unidirectional Valve Opening Pressure cscsssssscccsssesseccssssccccsssescecssseeccccsuseceessssseesesnsseeesssseccesssnusssesssnsseecessuseesssusseesesneescessnseceeesnseeeeesnnseeeestaee Data Storage Non Volatile and Recording ssssscsssssesssscssseccecssseccesssseccccssssececsnssceessnseceessusecesssnssccessuuseessssusssesssuescesssussesessnsecescsnsecceceunseceesnuseeesenneees Electromagnetic Capability rrt cia SN tieu eee ERE Nee eee rete Ne ERREUR rer RENE ER e eto eee perse dietus CO AbsorbentCahnister tetris phe tetdoretiab testes aia dL Gas Cylinder Accessories Gas Supply Hoses Manuals and Reference Cards ni e ci MA A O Networking and USB Storage O Sensor Vaporizers A5 A3 Operating Instructions 046 003777 00 v Table of Contents Parameters and Factory Defaults eere ee eee eese esee eee enses sens enses sens sens ense ense sss ensenssessesseessessesssesseeseessesssc D 1 Waveforrt Spirometry Tabs AS Only e seais B 2 Alarm Limits Setup Menu Alarm Volume and Log Date and Time Demographiess osse A E o MA etr Ventilation Modes Linked Ventilation Parameter Relationships Non Linked Ventilation Parameter Relationships sssssscssssssescccsssessecssseececssssescccssseceecssssececcsuse
223. w 1 to 100 Off Step 1 FiO Low 18 to the lesser of 98 18 Yes and FiO High 1 Step 1 A5 A3 Operating Instructions 046 003777 00 Setup Menu B 4 B 3 Setup Menu Parameters and Factory Defaults Current selection saved when powered PARAMETER RANGE DEFAULT off General Tab Breathing Warmer On Warmer Warmer On No System Off Display Tab Pressure Mean PLAT PLAT Yes Display Display Tab Plimit Line On Off On Yes Display Tab Screen level 1 10 5 Yes Brightness Display Tab Key Click level 1 10 2 Yes Volume System Tab Language English French English Yes Spanish Portuguese Russian Turkish Dutch System Tab Default Adult Pediatric Infant Infant Yes Patient Size System Tab Network 0 255 192 168 23 250 Yes This Machine Configure Ethernet IP Address System Tab Network 0 255 255 255 255 0 Yes This Machine Configure Ethernet Subnet System Tab Network 0 255 Yes This Machine Configure Ethernet Default Gateway System Tab Network 4800 9600 57600 9600 Yes This Machine Configure 115200 Serial Baud Rate System Tab Network Off On Off Yes This Machine Configure Serial Flow Control System Tab Network Odd Even None None Yes This Machine Configure Serial Parity System Tab Network 8 7 6 5 8 Yes This Machine Configure Serial Data Bits System Tab Network 2 1 5 1 1 Yes This Machine Configure Serial Stop Bits System Tab Ne
224. way pressure Paw changes based on patient pulmonary compliance and airway resistance In VCV mode you need to set Plimit to prevent high airway pressure from injuring the patient In this mode you can select to set Tpause to improve patient pulmonary gas distribution and PEEP to improve expiration of end tidal carbon dioxide and to increase oxygenation of breathing process 5 10 046 003777 00 A5 A3 Operating Instructions Operations Ventilation Modes To ensure the set tidal volume gas delivery the ventilator adjusts gas flow based on the measured inspiratory volume dynamically compensates for the loss of tidal volume arising from breathing system compliance and system leakage and eliminates the effect of fresh gas as well This is called tidal volume compensation In the VCV mode if tidal volume compensation has failed the A5 A3 Anesthesia System can continue delivering gas stably but cannot compensate for the effects of fresh gas flow and breathing system compliance losses In VCV and SIMV VC modes when inspiration pressure reaches Plimit respectively the inspiration pressure is held 12 sd FIGURE 5 9 volume Control Ventilation VCV Tab 5 6 6 1 To Set VCV Mode 1 Select the VCV tab on the Main Screen 2 Checkthat all VCV parameters are set appropriately If necessary select the parameter softkey to edit the parameters settings FIGURE 5 9 3 Select the Set Mode softkey to confirm VCV parameters
225. wo 2 batteries A3 one 1 battery Battery Run time One 1 new battery installed gt 75 minutes Two 2 new batteries installed gt 150 minutes Run time criteria VCV mode Tv 500 mL Rate 10 bpm LE 1 2 Plimit 30 cmH5O PEEP OFF Time to Shutdown from gt 5 minutes new fully charged battery supply Lower Battery Alarm Battery Charge Time New Battery lt 8 hours from an initial charge of 10 Charging occurs whenever AC is applied to the A5 A3 System TABLE 8 6 Battery Power Specifications 8 6 3 Auxiliary Electrical Outlets Number of Outlets A5 4 A3 3 Output Voltage 100 to 120 VAC 60 Hz corresponds to power supply input voltage Output Current of Each Auxiliary Outlet 3A Output Current Total A5 10A A3 9A Breaker Rating per Auxiliary Outlet 3A Breaker Rating Total A5 10A A3 No total current breaker TABLE 8 7 Auxiliary Electrical Outlets 8 6 046 003777 00 A5 A3 Operating Instructions Product Specifications Electrical Specifications 8 6 4 Communication Ports Communication Port SP1 One DB9 male connector on the rear of the A5 A3 Provides a non isolated output serial RS232C interface CAUTION Do not connect any non isolated devices to the DB9 RS232C interface of the A5 A3 Network Port CS1 One RJ 45 network port SB Ports SP1 SP2 Two SB ports CAUTION Do not connect any devices to the SB ports other th
226. ylinder Wrench 6700 0020 300 A 7 Gas Supply Hoses PART NUMBER DESCRIPTION 15 FOOT LENGTH 0004 00 0077 11 O Gas Supply Hose 15 ft Ohmeda 0004 00 0077 12 O Gas Supply Hose 15 ft Chemetron 0004 00 0077 13 O Gas Supply Hose 15 ft Puritan Bennett 0004 00 0077 14 O Gas Supply Hose 15 ft DISS Female 0004 00 0078 11 N50 Gas Supply Hose 15 ft Ohmeda 0004 00 0078 12 N50 Gas Supply Hose 15 ft Chemetron 0004 00 0078 13 N50 Gas Supply Hose 15 ft Puritan Bennett 0004 00 0078 14 N50 Gas Supply Hose 15 ft DISS Female 0004 00 0079 11 Air Gas Supply Hose 15 ft Ohmeda 0004 00 0079 12 Air Gas Supply Hose 15 ft Chemetron 0004 00 0079 13 Air Gas Supply Hose 15 ft Puritan Bennett 0004 00 0079 14 Air Gas Supply Hose 15 ft DISS Female 0004 00 0080 13 VAC Gas Supply Hose 15 ft Ohmeda 0004 00 0080 14 VAC Gas Supply Hose 15 ft Chemetron A5 A3 Operating Instructions 046 003777 00 A 3 Manuals and Reference Cards PART NUMBER 0004 00 0080 15 Accessories DESCRIPTION 15 FOOT LENGTH VAC Gas Supply Hose 15 ft Puritan Bennett 0004 00 0080 16 VAC Gas Supply Hose 15 ft DISS Female 0004 00 0081 11 EVAC Gas Supply Hose 15 ft Ohmeda 0004 00 0081 12 EVAC Gas Supply Hose 15 ft Chemetron 0004 00 0081 13 EVAC Gas Supply Hose 15 ft Puritan Bennett 0004 00 0081 14 EVAC Gas Supply Hose 15 ft DISS Female 0004 00 0081 31 EVAC DISS to VAC Ohmeda Gas Supply Hose 15 ft 0004 00
227. ylinder pressure decreases more than 5000 kPa 725 psi install a new cylinder gasket Repeat steps 1 through 6 If the leak continues do not use the cylinder supply system 4 9 3 N50 Cylinder High Pressure Leak Test 1 Set the system switch to the Off position and disconnect the N50 pipeline supply 2 Turn off the N20 flowmeter 3 Open the N5O cylinder valve 4 Record the current cylinder pressure Close the N5O cylinder valve Record the cylinder pressure after one minute If the cylinder pressure decreases more than 700 kPa 100 psi install a new cylinder gasket Repeat steps 1 through 6 If the leak continues do not use the cylinder supply system 4 9 4 Air Cylinder High Pressure Leak Test 1 Set the system switch to the Off position and disconnect the Air pipeline supply 2 Turn off the Air flowmeter 3 Open the Air cylinder valve 4 Record the current cylinder pressure 5 6 Close the Air cylinder valve Record the cylinder pressure after one minute If the cylinder pressure decreases more than 5000 kPa 725 psi install a new cylinder gasket Repeat steps 1 through 6 If the leak continues do not use the cylinder supply system A5 A3 Operating Instructions 046 003777 00 4 21 Flow Control System Test Preoperative Tests 4 10 Flow Control System Test WARNING If N20 is available and flows through the system during this test use a safe and approved procedure to collect and remove N20 gas WARNING I
228. ype Show Reference Save LI a Review Loops Button Demographics Tab Ventilation Mode Tabs Measured Values Area O Setup Softkey Alarms Softkey Silence Softkey Display Tab System Tab Network Configuration A Preoperative T sts eei Deae Na RL Preoperative Test Sched les 2 e eet tyr ttes e e vete ete m ee ep ute Ee reve eret test 4 2 Test Intervals Inspect the System Pre operative Checkout List VEG CRIM peer Em Suggested Pre operative Checkout List sscscssssesssccssssscccssssescccssseseecssseceessnssececsssseceessnssecsessssecescssssecsessuscecsssueseeessnsesesesnseceecsnnseseesnsseeeeenseses 4 4 System Self Test Leak and Compliance Tests Automatic Circuit Leak and Compliance Test m Manual Cir it Leak KNEE B dise Power Failire Ad Td A e ads Pipeline Tests O Pipeline Test N50 Pipeline Test AAA br tite aset e EAR RE EN Ee e tene e bi ere ete pese NNAS Basic Ventilation Testing Cylinder Tests Check the Cylinder Pressure O5 Gylinder High Pressure keak Ti tie etes ep E R tees eboe EEA SS N50 Cylinder High Pressure Leak Test s csceisoossscsescsecenscntnsondscosssbisedesbinsdevodvedssadectcoscecesendcceconisoednshcepsnisindasnadotsinebisedecdia eqododgencdeceeeeeconthesdes Air Cylinder High Pressure Leak Test Flow Control
229. z Rate lt 300 x EA 1 7 E Rate lt 150x M XN 1 1 E 4 lt Rate lt 100 Vt IE o J a mm Vt 1833x LEES Rate sof 22 TP Vt gt 20x E Rate 20 lt Vt lt 1500 Plimit Plimit gt PEEP 5 10 lt Plimit lt 100 SIMV VC Rate Rate Tinsp 0 4 4 Rate lt 100 Vt 20x Tinsp 1 TP lt V1 lt 1833x Tinsp 1 TP 20 lt Vt lt 1500 AP AP lt Plimit PEEP 3 lt AP lt 50 Plimit Plimit gt PEEP 5 Plimit gt AP PEEP 10 lt Plimit lt 100 A5 A3 Operating Instructions 046 003777 00 B 13 Non Linked Ventilation Parameter Relationships Parameters and Factory Defaults VENTILATION Parameter MODE Parameter Relationship Equation s PCV Rate HE Rate 300x I I E 1 Rate lt 150 x 1 1 E 4 lt Rate lt 100 VtG If VtG is not Off 60x s E e NG gt 0 EE HE Rate 60x T A OIL Rate 20 lt Vt lt 1500 Pinsp Pinsp gt PEEP 5 A5 only 5 lt Pinsp lt 70 PlimVG PlimVG gt PEEP 5 A5 only 5 PlimVG lt 100 SIMV PC Rate 0 A5 ONLY Rate lt Tinsp 0 4 4 lt Rate lt 100 Pinsp Pinsp gt PEEP 5 5 lt Pinsp lt 70 B 14 046 003777 00 A5 A3 Operating Instructions G0 Pneumatic Diagram Pneumatic Diagram of the A5 A3 System catt dieti cete did A5 A3 Operating Instructions 046 003777 00 Pneumatic Diagram Pneumatic Diagram

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