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1. ccccccsccssscseecsnecsescseecsencseueseuesusseneseussusseusssesses 4 9 ES TESTINGALA Muros o ee esac a o cl e la E cs o 4 10 4 6 TESTING THE BREATHING SYSTEM dia s 4 12 4 6 1 Checking Oxygen flush SWITCH ooocccocnccocnocccnncocnononnononononnnnonnonornonannnnnnnnnnnnnannnns 4 12 4 6 2 Testing Breathing SySteM ococoonccconcoccnnooconenonoconnonannonannononnnnnnonannonannonnnnnnrnnnnanenanos 4 12 4 6 3 TOSO ARE V UVO arado dales dates 4 12 AT UES TING VENTILATOR a ea decos 4 13 01 2008 i ANASTAZJA 7500 User Manual 5 INSTALLING AND GONNECT N Gioasrcinssinstaai ces trite eatete tte ee trieteeatete teenies 5 1 5 1 INSTALLING PRODUCT dla cien io 5 2 5 1 1 A A E ne 5 2 5 1 2 BreatiNg CrCON UMY A diia 5 2 5 1 3 ADSODOF CV CIC ia dia an Gilat 5 2 5 1 4 The bellows Assembly base eisai ices suomi A A A A 5 2 5 2 INSTALEN ABSORBE cas ea tee tna id ee dem ns eee tenn dio de see 5 3 5 2 1 When to replace absorbent occooccoccnoconoconoconoconoconcconconnnonononanonanonanonanonanenaninanonos 5 3 5 2 2 LPISAS SCIMIOIIIG ADSOIDOE a ti ati 5 4 9 2 3 FING ADS ODO Di A yess Aad anaes AS 5 4 D0 CONNECTING TUBES ANDENES a EE 5 5 D4 CONNECTING GAS AND ELECTRICITY moring risina eo 5 6 5 4 1 A A N 5 6 5 4 2 AUXINALY NAINS SOCKEL QUID a eens 5 7 5 4 3 A a hotest a lca a neta eae a ie vateen wales intone cadence eiec 5 7 5 4 4 UU AE SAN 5 8 9 4 5 ENINASF GAS SUDDIV IM ol a 5 8 5 5 HOW TO INSTALL GAS CYLINDER TESTING
2. Patient parameter is fixedly displayed in the left side of the monitoring area It includes seven parameters V Tidal volume MV Minute volume f Respiratory frequency Poeax Peak value of airway pressure Pola Pressure at the end of FiO Oxygen concentration inspiratory pause time C compliance Waveform is displayed in the right side of the monitoring area It has four types Flow t waveform V t waveform Paw V loop and V FLOW loop More details refer to section 3 5 2 4 5 3 Parameter setup area Parameter setup area lies on the bottom part of the screen It includes V Tidal volume f Breaths per minute I E Inspiration to expiration time Tp Inspiratory pause time Piimit Maximum airway pressure limit Vsens Triggering flow sensitivity setting 2 14 01 2008 2 4 6 Rear Panel 2 Anesthetic System Control 1 amp 7 Item Display interface Power and Signal interface Battery O2 Interface Sensor Figure 2 11 Rear Panel 1 2 3 4 5 6 T 8 Display Power interface Battery O Sensor interface Exhaust Port Driven Gas Outlet Fuse Signal interface P amp V interface of sampling parallel line Description Use display power cable and signal cable to connect relevant interface of rear panel with interfaces on rear of display screen respectively Display power interface and signal interface provide power supply and signal to the display Refer to section 7 6 RJ 11 standard in
3. 10 Flow Control Ts Read top of float when the flowmeter is being read a ea Pa S alm A DA Fl Il Hele I i Mt pin Figure 2 2 ANASTAZJA 7500 side view Figure 2 2 each control function on the side view of Anastazja7500 Item Diagram Description J _ Push down to lock and Castor with break gt A by a pull up to unlock 01 2008 2 3 ANASTAZJA 7500 User Manual 2 4 Im SE D NOOO Figure 2 3 Anastazja7500 back view Auxiliary mains socket outlet Anesthetic ventilator unit O cylinder Air pipeline O pipeline 01 2008 2 4 6 Power socket N20 cylinder Nameplate N20 pipeline 2 Anesthetic System Control 2 2 The Breathing system module A CAUTION Any adult anesthetic ventilator system used together with the anesthetic gas supply system must be in accordance with ISO 8835 2 7 Po tf fe l Figure 2 4 Breathing system module 1 2 3 4 5 6 f 8 9 0 1 _D _ Absorber mount release handle Absorber Carbon dioxide absorbent Exhalation Port patient circuit connector Exhalation valve Airway pressure gauge Bellows assembly auto ventilation APL adjustable pressure limit valve Inhalation valve Manual reservoir bag auto ventilation switch Inhalation Port Patient circuit port Manual reservoir bag port 01 2008 2 5 ANASTAZJA 7500 User Manual Figure 2 4 the breathing system
4. All connectors of gas supply have different dimensions and structures It can avoid wrong operation occurs 5 4 1 AC inlet AC Power 230VAC 50Hz 5 5A Max Fuse 250V6A 25X20 F Clasp can stop power cord breaking off ZN WARNING 5 6 250V6A d 5X20 F Mains Supply __ 230VAC 50Hz 5 5A Max Switch the anesthesia machine to backup battery in case of AC failure alarm and prompt alarm message displaying on the screen 01 2008 5 Installing and Connecting 5 4 2 Auxiliary mains socket outlet A CAUTION Auxiliary mains socket outlets operator accessible should be not more than four when in use ANASTAZJA 7500 This label displays the voltage of the power supply and the rated ampere value of the circuit breaker Fuse 250V 2A 5X20 F Maximum current outlet 1 5A each 4 5A total FUSE FUSE FUSE FUSE Fuse LC C al ha ad wt Na Sa 250V2A d 5X20 F 250V2A d 5X20 F 250V2A d 5X20 F 1 54 Max 1 5A Max 1 5A Max IN Mains Output Total Load 4 5A Max 5 43 Serial Port RS 232 port on the rear of display can permit serial inlet and outlet of command and data Signal Standard RS232C ElA 574 Signal Definition DTE configuration Interface DB9 M DB 9 Connector Pin Out ignal Name Signal Description Carrier Detect Receive Data Transmit Data Data Terminal Ready mo 4 2 B a 5 e CN RI Ring Indicator 01 2008 5 7 ANASTAZJA 7500 Use
5. Check the patient Check the sampling hose Reconnect the hose Replace the gas supply Plug in the flow sensor Reassemble the bellows assembly sampling Remove the occlusion Repair waste gas scavenging system Reconnect breathing resorption interface Check and replace a bellows base Check and replace a bellows Check and replace an exhalation diaphragm Check and replace O rings 8 5 ANASTAZJA 7500 User Manual 8 4 Default setting Range CCC TS 1 Upper limit FiO OFF 21 to 100 1 00 V is See section 10 8 4 10 cmH20 8 6 01 2008 9 Accessories 9 1 The breathing System Description Bellows housing Bellows Base plate Pop off valve Locking spring Seal Bellows base 9 2 The Absorber Assembly Description Absorber cycle APL valve assembly Oxygen flush Exhalation valve Gas pressure gauge Handle Water scavenging valve module Reusable absorber O ring Manual reservoir bag ventilator switch assembly Stock Number BA100 6 BA100 5 BA100 10 BA100 4 BA100 11 BA100 2 BA100 1 Stock Number AC100 AC100 3 235 895 AC100 1 6 AC100 7 AC100 6 AC100 11 AC100 9 AC100 8 3 AC100 4 01 2008 9 1 ANASTAZJA 7500 User Manual 9 3 Others Description Oz pipeline N20 pipeline Air pipeline Power cord Probe Pipe tee Sampling parallel lines Anesthetic cycle for adult Power cable Signal cable O sensor sampling line Lead acid battery assembly Reus
6. menu Turn the knob to select Return and then press it Step 8 Exit Menu 1 Turn the knob to select Exit menu and then press it or 2 Press MENU key directly 2 Anesthetic System Control 01 2008 2 19 ANASTAZJA 7500 User Manual 2 5 2 Menu diagram See Figure 2 12 Some functions are optional Press MENU key displaying on the screen the Menu window Turn the knob to select a submenu Menu Cal Into Exit Low High L Press nikal 3 30 l f ba 5 z2 s 10 Menu acoiMmedif WY S00 Software ala Hardware Version 1 00 ID 2020183826542720 Service Telephone 8610 88799987 Fax 8610 88791201 Copyright beijing Aeonmed Co Ltd Meru Display DEMO Language ENGLISH Wave P_Unit D lkPa Menu Please select the sensor of calibration 2 Oxygen Sensor a Flow Valve Meru Figure 2 12 Menu diagram 2 20 01 2008 3 Operating Guide 3 1 Starting System Step 1 Connect power supply Plug the power cord into AC power outlet The power indicator light will be bright when power is connected Step 2 Power on self test Press power ON OFF key and last 2 seconds Display start RUN indicator light brightly and enter LOGO interface See Figure 3 1 Later self testing interface appears See Figure 3 2 If self testing succeeds the display works normally and the system is situated stan
7. Turn the knob to LA n select Exit menu and then press it or 2 Press MENU key directly 3 8 01 2008 Language 10 reo th F_u ALE Fat IFT KLE LULIL 3 Operating Guide 3 1 3 Ventilation Mode Set Current ventilation mode shown at top right corner of the display with arrow pointed up See figure 3 4 Standby mode VCV mode 20 Pressure mode 0 SIMV mode 0 5 10 15s Manual mode Figure 3 4 Step 1 Turn the knob make cursor point to the current ventilation mode A CAUTION Exit the menu before carrying out this step Step 2 Press the knob to make sure the grounding changed Step 3 Turn the knob to select ventilation mode required Step 4 Press the knob to save the setup 01 2008 3 9 ANASTAZJA 7500 User Manual 3 1 4 Ventilator Control Set 1 Standby mode all parameters can be adjusted 2 SIMV mode fiw replace f Tp and Plimit displays it means unadjusted Adjustable range o Vr 0 50 1500 mL O fwv 1 40 times eo T 0 5 4 0s o Vsens 1 30L min 3 VCV mode Plimit and Vsens displays it means unadjusted According to Vr f LE Tp the flow of inspiratory phase can be calculated by the following formula Flow Vz x I E x f 1000 1 L min Gas flow limit lower 5L min upper 75L min 4 Pressure mode Tp and Vsens displays it means unadjusted 5 Manual mode all parameters displays it means unad
8. e Bellow assembly up and down during auto ventilation Adjust O flow to 5L min Make sure e Pressure at the end of expiration is OcmH2O approximately e Right data displayed on the screen e Bellow assembly up and down during auto ventilation Test O monitoring and alarm e Remove O sensor from the absorber cycle and confirm that O concentration measured in the room air is about 21 e Adjust lower limit of O2 concentration to 50 and confirm that FiO low alarm occurs e Adjust lower limit of Oz concentration to 21 again and confirm that the alarm eliminates e Put O sensor back to the absorber cycle e Adjust upper limit of O2 concentration to 50 again e Press O flush to charge the breathing system and confirm that FiO high alarm occurs e Adjust upper limit of O2 concentration to 100 and conform that the alarm eliminates e Let O sensor pass pure O for 2 minutes and conform that O concentration measured is about 100 01 2008 10 11 12 13 4 Preoperative Checkout Test low minute volume alarm Turn to Alarm_set menu Adjust lower limit of MV to 6L min and conform that Minute Volume Low alarm occurs Turn to Alarm_set menu again Adjust lower limit of MV to 10L min and conform that the alarm eliminates Test high airway pressure alarm View Poeak on the screen Adjust lower limit of Paw to below Ppeak and conform that Paw high a
9. flush 35 to 75 L min 01 2008 10 3 ANASTAZJA 7500 User Manual O failure alarm and the associate cut off device O pressure O failure alarm 20 to 200kPa N20 cut off 50 to 220kPa A CAUTION O failure alarm takes precedence of N20 cut off 10 2 3 Classification According to IEC60601 1 ANASTAZJA 7500 belongs to the following classifications Class equipment Type B equipment General equipment Mobile equipment Flammable anesthetic cannot be used Operate continuously 10 3 Power supply Voltage 230VAC 50Hz Input power Not more than 50VA Maximum input current 5 5A Fuse at mains supply inlet 250V 6A 5X20 F Fuse above auxiliary mains 250V 2A 5X20 F socket outlets outlet Maximum output current of 1 5A each 4 5A total auxiliary mains socket outlets Fuse in rear of ventilator 250V 1A 5X20 T Earth resistance lt 0 20 AN WARNING Then connection of equipment to the auxiliary mains socket outlets can increase the patient leakage currents to values exceeding the allowable limits in the event of a defective protective earth conductor 10 4 01 2008 10 Specification and Operation Theory 10 3 1 Power cord Length 9 meters Rating voltage 90 to 264VAC Capacity of current 220 to 240VAC 10A Type Three core cable Medical level 10 4 Electromagnetic Compatibility Changing or reassembling this equipment without FARUM S A authorization may cause electromagnetic com
10. sensor Useful life Operational principle Not more than 15 seconds Chemical fuel cell 12 months normal operating Oz monitoring modules can monitor and display oxygen concentration of the patient circuit and contain one oxygen sensor The O sensor can detect the proportionable voltage on its surface generated with partial pressure of Oo The O sensor is chemical fuel cell and its metal electrode can be oxidated when oxygen diffuses into it The current generated from oxidation proportion O partial pressure on the surface of electrode The electrode will be used up gradually in oxidation process The voltage of sensor would be affected by the temperature of gas mixture monitored Thermistor on the shell of sensor will auto compensate temperature difference inside the sensor Signal processing and circuit analyzing can be used in the O monitoring modules So the signal of Oz sensor could be transformed to Os concentration Besides the concentration displays on the screen and compares with alarm limit value saved if the concentration exceeds the limits alarm should be occurred 01 2008 10 17
11. ventilate patient Monitoring still available Switch to bag mode manually bag ventilate patient Monitoring still available Switch to bag mode manually bag ventilate patient Monitoring is non effective Switch to bag mode manually bag ventilate patient Monitoring is non effective Check pipeline gas supply or Replace O cylinder Check connection Check mains supply Check fuses Resume to use mains supply immediately Charging Switch to bag mode Set lower O limit to OFF Ventilator failure monitoring is non effective Ventilator using failure stop Repair Please contact eligible service representative Please contact eligible service representative Please contact eligible service representative Please contact eligible service representative Please contact eligible service representative Replace fuses when melted Maintain battery periodically and ensure it full charged Please contact eligible service representative Please contact eligible service representative 8 2 2 Message Paw continuous High Paw High Paw Low Vt Low FiO Low FiO High Minute Volume High Minute Volume Low Priority High High Medium Medium Medium Medium Medium Medium Functional alarm Condition Pressure failure Channel of sampling blocked sensor Resistance of exhalation is too high or
12. 2 4 5 Display Screen The display of the ventilator is a color TFT which can display the monitoring and setting parameters waveforms alarm information as well as displayed on the screen See Figure 2 9 The screen has three areas information area 1 monitoring area 2 and parameter setup area 3 Figure 2 9 Display Screen 2 4 5 1 Information area Information area lies on the top part of the screen which is used to display the current status of the ventilator and the patient The information area contains following components 1 2 3 4 Figure 2 10 Information area 1 Alarm bell When alarm appears the color of alarm bell accords with the background color of the upper prior alarm message press alarm silence key X dashed line appears on the alarm bell and 110 seconds counts down More details refer to section 8 1 2 Alarm messages Technical alarm and functional alarm supplied by the system and not more than two alarm messages displayed on the top of the screen More details refer to section 8 2 3 Power supply Two kinds of power supply AC power external and internal battery 4 Ventilation mode Five ventilation modes VCV mode Pressure mode SIMV mode Manual mode and Standby mode Turn and press the knob to setup ventilation mode required and press again to save it 01 2008 2 13 ANASTAZJA 7500 User Manual 2 4 5 2 Monitoring area Monitoring area has two parts Patient parameter and waveform
13. 3 15 4 Preoperative Checkout 4 1 Anastazja7500 Preoperative Checkout procedures Test interval Preoperative Checkout should be done in the following situation Before use of the first patient each day Before use of each patient After repair or maintenance Test schedule is given in the table below Before use of the first patient each day Before use of each patient system check Breathing system test Power failure alarm test Ventilator test Gas pipeline and gas cylinder test Flow control test Vaporizer installation and test Alarm test Breathing system test Ventilator test A WARNING Do not use this system before the operation and maintenance manual are read and understood e Whole system connection e All warnings and cautions e Using guide of each system module e Testing method of each system module Before using this system e Complete all tests of this section e Test all the rest of system modules If test failure do not use this system Please contact service representative 01 2008 4 1 ANASTAZJA 7500 User Manual 4 1 1 System Checkout A WARNING make sure the breathing circuit is connected correctly and in good condition Make sure 1 2 3 Equipment is in good condition All the components are correctly connected Breathing circuit is correctly connected and in good condition there is sufficient absorbent in the breathing system Vaporizer is in lock position and is fill
14. A WARNING ANASTAZJA 7500 is not to be used with infant 01 2008 1 1 ANASTAZJA 7500 User Manual Figure 1 1 ANASTAZJA 7500 1 2 01 2008 1 Introduction 1 2 Symbols Used in the Manual and in the Equipment A Warnings and A Cautions indicate all the possible dangers in case of violation of the stipulations in this manual Refer to and follow them A WARNING indicates potential hazards to operators or patients A CAUTION indicates potential damage to equipment Instead of illustrations other symbols may also be utilized Not all of them may necessarily appear in the equipment and manual The symbols include ZA CAUTION OO C O z ON Power OFF Power Stand by Stand by or preparatory state for a part of the equipment ON only for part of the equipment OFF only for part of the equipment Direct Current Alternating Current Protectively earth Earth Frame or chassis ground Date of manufacture This manual complies with EN 1041 R A e A AA i REP SN ul 01 2008 Type B equipment Type BF equipment Type CF equipment Warning or Caution ISO 7000 0434 NOTE refer to the manual IEC601 1 This way up Dangerous Voltage Input Output CE Representative Serial Number Address of manufacture 1 3 ANASTAZJA 7500 User Manual Y Equipotential Alarm Silence Movement in one direction Lock gt pe Close drain valve ii Inspira
15. Breathing components system Absorber cycle Bellows assembly Cleaning and sterilization of pre use first Clean the machine s panel and all surfaces with soft cloth soaked with the water soluble sterilizing agent Sterilize main unit with ultraviolet radiation Do not use acetic hyctro peroxide or formaldehyde steaming Refer to section 6 2 Washing refer to section 6 4 Washing refer to section 6 5 4 6 2 Cleanable Breathing System Components Threaded tubes contacted with patient mask Y piece connector elbow bend reservior bag Threaded tubes and bag repetitious Pipe T Sampling probe parallel lines of flow and Components marked 134 Designed for using only once not need to sterilize The waste should be recovered When to replace these expendable products with medical level and equal specification should be selected to use Washing to sterilize Washing to sterilize Clean with soap before use of each patient and then washing in disinfecting solution after airing are pressure resistant and heat resistant and can be cleaned by hand or by machine by using the mild agent with PH lt 10 5 Scrub them thoroughly then air out to dry Clean the bellows assembly by disassembling them or they will take longer to dry To dry hang the bellows by from its top disk while spread fully Moisture remaining in the folds of the bellows may make the bellows tacky Reassemble the bel
16. SETTING nadie 8 6 Y AE US EERE EET REET EERE ER EET EERE TREE CECE a 9 1 9 1 THE BREATHING SYS TE Mircea cti 9 1 O2 THEABSORBER ASSEMB escritas 9 1 A A A ae eeeadcatedes ac 9 2 10 SPECIFICATIONS AND OPERATION THEORY cccccsseeceseeeeneeceneseeneseeneneees 10 1 10 1 GAS CIRCUIT OF ANASTAZJA 7 500 isis asi 10 1 10 2 SYSTEM TECHNICAL SPECIFICATION ii sake teint gets ads Sheeaincegvodssauehoiateteate dae hieencaake 10 3 A A A A A r 10 3 OZ A aaah te ata te hate tl Mera de ae Sew ewe seers ane te aks haere N aedion 10 3 10 23 EIASSIIGAUON e EEE esheets EE near waco steele E A A E i 10 4 103 POWER SUP lo a E a de rta tee ee Paced 10 4 IN A A 10 5 10 4 ELECTROMAGNETIC COMPATIBILITY saz suid sediciecdwe scat oetesendagitned ldi deeds ldi 10 5 105 RAYSICAL SPECIFICATION 2 caco odio lde tido 10 10 10 6 ENVIRONMENT REQUIREMENTS ssscucisto desora cede ete seer sleek St acc ttdaa dutatsntocecnddalecenstanddendtos 10 10 10 7 BREATHING SYSTEM TECHNICAL SPECIFICATIONS ccccsecccceeceeceeceeseecesseeeesaeeeeseueeeseeesenes 10 11 10 9 GANESTHESIAWENTILAT OR tss cecstet cocteg ltecat as See a deena tenseocceneeindeettncdaneias 10 12 10 8 1 Operation TROON zpra ita 10 12 10 82 Pernormance OF VENINAIOF a dai 10 13 10 68 93 Set NngV nilaon ModE 00d aa 10 14 10 8 4 Setting ventilating parameters ccccsccccseeccsseccuscnsuscnsusensusccsensusensusensuseasassnaess 10 14 10 86 95 Gas dynamics pendrman Os sasi
17. a ee eS a ee 1 3 1 3 2 ANTEC A Bit etc a a a eet a 4 1 3 3 Calibrate flow SCNSOF oisc 8 23 ee uesossae ic ite A Se 11 1 3 4 Calibrate flow Valve 1ccccccccssccsescnsusensunccseesausensusensusensuscausessusessusensusessasecuassausenaass 7 14 7 4 MAINTAINING OXYGEN SENSOR inicia 7 15 1 4 1 Technical FreQUIFEMentS ccoccooncocncooonoconocononononononononanonononanonanonnnnnnnnnnnnnnnnnnnnennnonnnen 7 15 7 4 2 Recommended Da SENSO 0 A A A a i 7 15 TO REPLACING FUSES 200 dat abia 7 16 1 5 1 Replacing fuse Of mains SUPPLY 1cccccccssccccesescuscnsusensueccusessusensusensuscasessusensusensuseaes 16 1 5 2 Replacing fuse of auxiliary mains socket Qutlets cooocooccoconoconoconoconoconononononos 1 17 ESE Replacing fuse Of ventilator coconcoccnnoccnnoocnneconocannonannoncnnonononannonannoncnnonaninnnnons 7 17 7 6 MAINTAINING BATES dt ont doo 7 18 8 ALARM AND TROUBLESHOOTING ooooccconccconccnonncnonacononononanonononnnnrnnnnrnnnnrenanrrnanrrnnnnenan 8 1 8 1 ABOUTALARMesoancotaa leads 8 1 O2 ALARM MESSAGE US ade Aa IERA 8 2 8 2 1 TECNICA MAI E EAE r E E E 8 2 ii 01 2008 8 2 2 e are are AA eee a aa Ore ER ht ae a En ES Tw ee eee ee a 8 3 9 93 TROUBLEESADO TIN e e eines 8 4 8 3 1 Anesthesia machine troubleshooting and ANALYZING cccocccconnoconnononncnonnconnnnnanonons 8 4 8 3 2 MV300 Troubleshooting and ANALYZING coooccconncconccocnncccnonocnononocnannconnnnnnnnnonnonanoss 8 5 SA DERE
18. affected by absorption and reflection from structures objects and people The ISM industrial scientific and medical bands between 150kHz and 80MHz are 6 765 MHz to 6 795 MHz 13 553MHz to 13 567MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 The compliance levels in the ISM frequency bands between 150 kHz and 80MHz and in the frequency range 80MHz to 2 5GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ANASTAZJA 7500 Anaesthetic Workstation is used exceeds the applicable RF compliance level above the ANASTAZJA 7500 Anaesthetic Workstation should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the ANASTAZJA 7500 Anaesthetic Workstation Over the frequency range 150 kHz to 80
19. and leave all the used bellows assembly components during the operation process in the operating room Immerse the bellows assembly components in the 1 1000 benzalkonium bromide or 1 5 cresol for 30 minutes after finishing the operation 2 Final disposal perform the final sterilizing disposal after the bellows assembly components are processed by the above mentioned preliminary disposal e Scrub the bellows assembly in a soap and water solution Thoroughly rinse in cold water and dry e f conditions permit suffocating the components directly contacted with patients with formald or oxirane is preferred or perform immersing sterilization respectively For example the components used by open pulmonary TB patients must be immersed in 3 cresol for 30 minutes the components used by tetanus aeruginosa infection patients must be immersed in 0 2 potassium permanganate for 30 minutes the components used by gas gangrene patients must be immersed in 0 1 chlorhexidine for 30 minutes the components used by pulmonary abscess patients must be immersed in 0 1 benzalkonium bromide for 60 minutes the components used by pseudomonas patients must be immersed in 0 1 benzalkonium bromide for 120 minutes e the components being immersed need to be rinsed by water and dried for next use e scrub and rinse the components indirectly contacted with patients with 1 3 phenol solution or soap and water solution and water Irradiate them by using the ultraviol
20. cause injury to patients or operators ANASTAZJA 7500 is equipped with all purpose alternating current outlet for connecting other medical equipments Do not connect non medical equipment to these outlets Otherwise the surface leaking current may exceed the range permitted by EN60601 1 under normal conditions and misoperation may be dangerous to patients or operators A complete system current leaking test according to EN60601 1 must be performed after any equipment is connected to these outlets A WARNING medical electrical equipment operators contact non medical electrical equipment and patients at same time It is dangerous of patients or operators 01 2008 10 5 ANASTAZJA 7500 User Manual Guidance and manufacture s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The ANASTAZJA 7500 Anaesthetic Workstation is intended for use in the electromagnetic environment specified below The customer of the user of the ANASTAZJA 7500 Anaesthetic Workstation should assure that A Emission test is used in such and environment Compliance Electromagnetic environment guidance mission test emissions The ANASTAZJA 7500 Anaesthetic Workstation CISPR 11 uses RF energy only for its internal function Group 1 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The ANASTAZJA 7500 Anae
21. channel of exhalation blocked Paw greater than upper limit Settings of Vr higher Patient alrway blocked Exhalation valve blocked No driven gas Sampling lines fall off or blocked Respiratory frequency lower Measuring value is under half of settings Seeper in the sampling line occurs Calibrating value excursion of flow valve occurs FiO less than lower limit Compensation of air or N20 overmuch O sensor non calibrated O sensor failure FiO greater than upper limit MV greater than upper limit MV less than lower limit Leakage occurs 8 Alarm and Troubleshooting Operator Action Switch to bag mode manually bag ventilate patient Check tubes and sampling lines and dispose block existed Reset upper limit of Paw Check expiratory cycle and dispose block existed Check V settings Check airway of patient and dispose block existed Reset lower limit of Paw Operation can be continuous Swing the sampling lines automatically Reset lower limit of FiO Reduce compensation Perform the calibration Replace O sensor Reset upper limit of FIO Reset upper limit of MV Reset lower limit of MV Check patient end 01 2008 Repair If the alarm still exists please contact eligible service representative Check the parallel sampling lines If excursion occurs please contact eligible service representative 8 3 ANASTAZJA 7500 Use
22. components function control Item N 7 9 2 6 Absorber release APL valve Manual bag auto switch mount reservoir ventilation Diagram Two soda lime canisters are applied with a volume of 1500 ml for each so that it can be continuously used for 6 8 hours at full load The water from the is drained via the reaction water collector underneath Auto ventilation off gas into reservoir bag Auto ventilation on gas into bellows 01 2008 Description Adjust the pressure limit of the breathing system during the manual ventilation process The readings are approximate The colors represent different pressure zones Green represents safety zone yellow represents transition Zone red represents high pressure zone Adjusting ranges between 0 19 6 kPa Select manual ventilation reservoir bag or auto ventilation ventilator 2 Anesthetic System Control 2 2 1 Absorber cycle 2 2 1 1 Structure The functions of absorber cycle absorb carbon dioxide vent exhaust gas assistant respiration monitor airway pressure drain water generated by chemistry etc 12 a o E m ise sessen TUU Fo 27 K QQ A US On Figure 2 5 Absorber cycle 1 APL valve 7 Lower absorber 2 Inhalation valve 8 Upper absorber 3 Inspiratory port 9 Expiratory port 4 Bag Ventilator Switch 10 Exhalation valve 5 Reservoir Bag 11 Fixat
23. delivery the components and assemblies of this product is warranted to be free from defects manufacturing techniques and materials provided that the same is properly operated under the conditions of normal use and regular maintenance The warranty period for other parts is three years Expendable parts are not included FARUM S A obligation under the above warranties is limited to repairing free of charge Free Obligations e FARUM S A obligation under the above warranties does not include the freight and other fees e FARUM S A is not responsible for any direct indirect or final product broken and delay which result from improper use alteration by using the assemblies unratified and maintenance by anyone other than FARUM S A This warranty does not apply to the followings Improper use Machines without maintenance or machines broken The label of FARUM S A original serial number or mark is removed or replaced Other manufacturers product Security reliability and operating condition FARUM S A is not responsible for the security reliability and operating condition of this product in case that e The assemblies are disassembled extended and readjusted This product is not operated correctly in accordance with the manual instruction The power supply used or operating environment does not follow the requirements in this manual 2 01 2008 Return Follow the steps in case that the product needs to be returned to FARU
24. f I E Tp Cinspiratory pause Pressure mode Vis f l E Plimit maximum airway pressure limit setting SIMV mode Vis fimvs Tis Vsens trigger sensitivity of volume Manual mode 10 8 4 Setting ventilating parameters Range Resolution Vr 0 50 to 1500 mL 10 mL Maximum V output limited by 75L min see 10 8 5 flow valve f 4 to 100 bpm 1 bpm l E 1 0 5 to 1 8 0 5 Tp 5 to 50 OFF only available in VCV mode 5 Piimit 0 5 to 7 kPa only available in Pressure mode 0 1 kPa Vaie 1 to 30 L min only available in SIMV mode 1 L min 10 8 5 Gas dynamics performance Gas source Anesthetic system Gas component O Rating pressure 250 kPa Input pressure range 280 to 600 kPa Flow valve range 5 to 75 L min Output Pressure range 0 to 6 kPa flow range 0 to 75 L min 10 14 01 2008 10 Specification and Operation Theory 10 8 6 Setting alarm parameters Item Limit Range Resolution MV Lower O to 20 L min 1 L min minute volume Upper 1 to 25 L min 1 L min Paw Lower O to 2 kPa 0 1 kPa amway pressure Upper 2 to 8 kPa 0 1 kPa f Lower O to 100 bpm 1 bpm respiratory frequency Upper 4 to 110 bpm 1 bpm FiO Lower OFF 21 100 1 Oxygen concentration Upper 21 100 OFF 19 A CAUTION If the alarm limits of FiO are OFF and O sensor not connected the No O sensor alarm will cancel A CAUTION All lower limits of parameters in above table may not be set up the upper limits nor may the uppe
25. first xxxx the year of manufacturing the second xx the month the third xxx equipment number 2 01 2008 Statement FARUM S A holds the copyrights to this manual which is non public published and reserves the rights to keep it as a secure document Refer to this manual when operating maintaining and repairing FARUM S A products only Anyone other than FARUM S A may not make it known to others Proprietary materials protected by the copyright law are included in this manual Any section of it cannot be reproduced copied or translated into other languages without any prior written approval from FARUM S A who reserves the copyright Everything written in this manual is considered to be correct FARUM S A is not legally responsible for any mistakes printed within and any damages caused by incorrect installation and operation FARUM S A does not supply privileges endowed by the patent law to any other parties FARUM S A is not legally responsible for the results caused by patent law breaking and any rights of the third party violating Refer to this manual before any FARUM S A product is used The manual includes operating procedures which must be performed with cautiously operations that may result in non normal working conditions and the dangers which may damage equipment or cause bodily harm FARUM S A is not responsible for the security reliability and function of the equipments in case that the dangers damages and non norm
26. functions of the subsystems above are set and adjusted by the keys on the panel 10 12 01 2008 10 Specification and Operation Theory Gxygen Suppl y Filter Pressure Resi st ance Adj ust Regul at or D spl ay Gas cut off Nai n Board Boar d Val ve Secondar y Expi ratory py nospher e Regul at or Val ve N Beep Fl ow Oont rol Val ve Power Pressure Rel i ef Ar ygen Absor ber Val ve M xer _ l ovs A r cui t Fl ow Bases Oxygen Concertrati on Sensor Input Ar Filter Y A ece Pressure Sanpl i ng A pe Pat i ent Figure 10 2 Operation principle sketch diagram of ventilator 10 8 2 Performance of ventilator Maximum pressure of airway system security Not more than 6 kPa Compliance Electrical safety Noise of whole unit Not more than 40 mL kPa Meet requirements for Class I type B equipment specified in EN60601 1 Medical Electrical equipment Part one General requirement for safety Not more than 65dB A 01 2008 10 13 ANASTAZJA 7500 User Manual 10 8 3 Setting ventilation mode Ventilation mode Adjustable respiratory parameters VCV mode Vr
27. pass through the system during the test which should be securely collected and removed according to safe and eligible methods Patients may be injured by improper gas mixture The link system should not be used if a proper ratio of O and N20 is not possible Before continuous testing perform test of the O monitoring device according to step 8 in section 4 6 Follow the steps to test the flow control pee Ne occur 5 Make sure Connect the pipeline gas supplies or slowly open the cylinder valve Turn all of the flow control valve knobs completely clockwise to the minimum flow Turn on mains switch Do not use this system if the battery is not fully charged or other ventilator failure alarms e The oxygen flow is between 25mL min and 75mL min e No gas flowing in any other flow tube e Step 6 and step 7 are only applicable for the N2O system test ZN WARNING During Step 6 to Step 7 keep link systems working state Only adjust testing of control N20 in step 6 and O in step 7 Adjust flow according to order N20 firstly O2 secondly The oxygen sensor being used must be calibrated correctly 6 To test the flow increase of the link system e Turn clockwise the N2O and O flow control till the end minimum flow e Turn counterclockwise the N20 flow control slowly e Make sure that the oxygen flow is increasing The concentration of the oxygen tested must 2 21 during the complete process 01 2008 4 7
28. the top plate of the breathing circuit with both hands connect the position fixing hole to the limb post sit it on the limb post then tighten the knob 1 knob 2 fixing hole 3 bolt hole 5 1 4 The bellows Assembly base Connect the bellows assembly base to the bolt hole 3 of the absorber cycle then tighten the Screws 5 2 01 2008 5 Installing and Connecting 5 2 Installing Absorber AX CAUTION The ANASTAZJA 7500 shall comply with configurations and conditions under which clause 24 of the General Standard IEC 601 1 A WARNING Follow the proper security measures Do not use the absorber if the anesthetic is chloroform or trichloroethylene Avoid to let the skin or eyes touch the materials in the absorber Clean the affected part immediately and seek medical attention if materials come in contact with skin or eyes Do not replace absorber during the period of ventilating Replace the absorbent often to prevent the deposition of non metabolism gas as the system is not on Check the color of the absorbent after finishing each case The original color of the absorbent may be restored when not in use Refer to the labels of the absorbent for the details Carbon monoxide is released if completely dried absorbent contact with the anesthetic Replace the absorbent for security Perform leakage testing of breathing system in bag control mode after disassembling the absorber The absor
29. top prior alarms is red but the grounding of middle prior and the lowest prior ones are yellow 3 4 1 Alarm tone Judging prior level from the tone of alarms Top prior 5 tones 2 hurry 9 seconds interval repeat Middle prior 3 tones 6 seconds interval repeat Low prior 2 tones 3 4 2 Alarm Silence When alarming press alarm silence key eliminate sound for 110 seconds During the silence spare time displayed on the screen Details about alarm messages refer to chapter 8 01 2008 3 13 ANASTAZJA 7500 User Manual 3 5 Waveform 1 Paw t waveform Y Axis airway pressure X Axis time More details refer to section 10 8 8 Figure 3 5 Paw t waveform 2 Flow t waveform Flow scale 90 to 90L min Time scale O to 15s Time Axis Positive inspiratory direction above OL min level minus expiratory direction below OL min level no gas flow on OL min level Figure 3 6 Flow t waveform 3 V t waveform Y Axis Tidal volume range 0 to 1 2L Waveform of respiratory phase presents saw shaped See Figure 3 7 1 inspiratory phase 2 expiratory phase Figure 3 7 V t waveform 3 14 01 2008 3 Operating Guide 4 Paw V Loop Optional Y Axis pressure X Axis tidal volume See Figure 3 8 Figure 3 8 Paw V loop 5 V FLOW Loop Optional Y Axis flow inspiratory flow above OL min level expiratory flow below OL min level X Axis tidal volume See Figure 3 9 Figure 3 9 V FLOW loop 01 2008
30. 3 minutes to perform 21 O sensor calibration Before performing 100 O sensor calibration 21 O sensor calibration must be finished 7 4 01 2008 7 User Maintenance Step 1 Press MENU key a menu window appears on the screen Step 2 Turn the knob to select Cal submenu Into Eeturn Press the knob the cursor appears on the Return 01 2008 7 5 ANASTAZJA 7500 User Manual Step 3 Turn the knob to select Oxygen Sensor Press the knob a new menu named Oxygen Sensor Calibration cover the original Please attention to the message on the menu Step 4 Press the knob a new gt window named 21 gt a O Masses Oxygen Sensor Calibration cover the original Perform the operation in accordance with the prompt on the screen Disassemble O sensor from absorber cycle and put it in the air not less than 3 minutes 7 6 01 2008 Step 5 Press the knob to perform the calibration In the process of calibration the word Calibrating displays on the screen CAL finish will be displayed on the window after the calibration succeed Then put O sensor back to the patient circuit according to the prompt on the window and perform 100 calibration If 21 calibration failure the word CAL fault displays on the window If the calibration failure occurs e Repeat these steps to calibrate it again e f still failure p
31. ANASTAZJA 7500 User Manual 11 12 13 4 8 To test the flow increase of the link system Set the nitrous oxide flow to 9 0L min Set the oxygen flow to 3 min or higher Turn the flow control valve knob of the oxygen clockwise slowly Be sure that the oxygen flow is getting reduced The concentration of the oxygen tested must gt 21 during the complete process Adjust all of the gas full flow to ensure that the flowmeter floats must move smoothly Shut off the oxygen supply either by closing the oxygen cylinder valve or by disconnecting the oxygen pipeline supply Make sure As pressure decreases the oxygen supply failure alarm must continuously sound Disconnect the flow of nitrous oxide and oxygen to be sure that the oxygen flow will be the last to stop Air flow remains If oxygen is the driving gas of the ventilator the oxygen supply failure alarm must continuously sound Turn all of the flow control valve knobs completely clockwise to the minimum flow Reconnect oxygen pipeline supplies or open the oxygen cylinder valve slowly Turn off mains supply 01 2008 4 Preoperative Checkout 4 4 Installing and testing of vaporizer 4 4 1 Installation A WARNING Do not take the vaporizer away from the bypass valve with its locking lever locked Do not use more than one vaporizer at the same time in this system Install vaporizers in accordance with the following steps The vaporizer must be disassembled
32. Anesthetic Apparatus typ Anastazja 7500 0297 User s Manual 01 2008 14 01 2008 i E FARUM S A Adres 74 Jagiello ska street 03 301 Warszawa Poland 2 lt 1 Fe Us NA S A Heandquarter 0 22 811 14 11 Sales Department 0 22 811 06 79 Fax 0 22 811 4059 Tel Fax 0 22 811 19 22 www farum com pl ANASTAZJA 7500 User Manual User Responsibility This product will perform in conformity with the description contained in the operating manual and accompanying labels and or inserts when assembled operated maintained and repaired in accordance with the instructions provided This product must be checked periodically Do not use product if defective Replace all broken missing worn distorted or contaminated parts If repair or replacement becomes necessary a telephone call or written request for service advice should be made to the nearest Aeonmed customer service center This product or any of its parts must be repaired in accordance with the written instructions provided by Aeonmed and by Aeonmed trained personnel The product must not be altered without the prior written approval of Aeonmed The user of this product shall assume the full responsibility for any malfunction resulting from improper use faulty maintenance improper repair damage or alteration by anyone other than Aeonmed personnel NOTE Each FARUM S A product has a serial number such as Anastazja7500 xxxx xxxxx ANASTAZJA 7500 machine model the
33. Cal menu ReTUrr Step 6 Exit Select Return and press knob then turn to Exit menu and press it again or press the MENU key directly 01 2008 7 13 ANASTAZJA 7500 User Manual 7 3 4 Calibrate flow valve Make sure e Pressure range of driven gas oxygen 280 to 600kPa e All connections of tubes and lines should be correct e Leakage of breathing system should comply with the requirements in section 4 6 e Operating 5min at least in VCV mode Vt 500 f 20 Il E 1 2 Tp 0FF Calibrating Press MENU key and perform flow sensor calibration according to the steps of section7 3 3 Input 2020 on the following figure and Menu press OK then the calibrating starts until window And the ventilation mode becomes standby Flow valve calibration Note Make sure that ventilator does not leal Adjust pressure to 0 4 MPa Connect with 3L bag Do CAL after bellows is full of air Once again push During the calibrating process press the MENU key to exit and the calibrating will cease MENO to quit If the calibration failure it may be because the increase of tidal volume monitored is Password 2000 non linear just contact eligible service i Ok Return representative OK If password is wrong see the following Menu figure Flow valve calibration Note Make sure that ventilator does not leak To calibrate flow valve when there be a Adjust pressure to 0 4 MPa Connect wit
34. HIGH PRESSURE LEAK coocccocccccccccoccncncnconcncnncnnnnos 5 9 5 6 CONNECT GAS SCAVENGING TRANSFER amp RECEIVING SYSTEM 0cccceccceeeeeeeeeeeeeeseeeeaeeeeaes 5 10 6 CLEANING AND STERILIZING our 6 1 6 1 CLEANING AND STERILIZATION OF PRE USE FIRST c sccccssecceeeceeseceueeceeccuceseuseceuseseeeseeeeaas 6 2 6 2 CLEANABLE BREATHING SYSTEM COMPONENTS 0ccceccceceeeceseeeeeeeeaeeeseeeeseueeseesseeesaeeees 6 2 O ABSORBER ac o saco 6 3 6 3 1 Auto cleaning with agent Or dISINTeCtOF ooocoonccconncconnoconoconnnnoonononnonannonononononnnonnns 6 3 6 3 2 Manuale AIG pea 6 3 6 3 3 Advanced SUCTIIZING rerien E sean a E E A E E E 6 3 0 ABSORBER AS SEMBICY garrian E N E AN 6 4 0O THE BELLOWS ASSEMBLY miea E a E E E acuueassteneescy 6 4 6 5 1 DIS ASS CIN saiae a a e aa 6 5 6 5 2 TESTO FURCHON ciel essen asst ty ei 6 8 6 5 3 ASSEM ES sra a a aa o ean 6 10 6 5 4 Cleaning and Sterilizing ucraniana dile cdtas 6 11 6 5 5 Regular IVIQINICNANG Orionis traes stds ui ii A dd oben AAN atada 6 12 1 USER MAINTENANCE suicida 7 1 7 1 REPAIR POLICY airnn Me esha caterer ed 7 1 7 2 MAINTAINING OUTLINE AND SCHEDULE 0ccccecceceeeeeeeeeeeceeeeeeseeeeseeeeseeeseeeeseueeseeesseeeeeeeees 7 2 1 2 1 JSernmanlenaC O essre ua a oi deba 7 2 1 2 2 FGI TANS SIV Oe REPUTO tisdale 1 2 1 2 3 SUIS UN Ai 1 3 7 3 MAINTAINING THE BREATHING SYSTEM ccocccccccccncnccncnnnncnnnnnnnnnnnnnnnonncnonnnnonnnnrnnnnnnrnnnannnnannnnnnes 7 3 1 3 1 ROPIaCO Os NU
35. M S A 1 Obtain the rights of return Contact with the customer service of FARUM S A by informing them the number and type of the product The number is marked on the surface of the product Return is unacceptable if the number cannot be identified Enclose a statement of the number type and the reason of return as well 2 Transportation charges Transportation and insurance charges must be prepaid by the user for transporting the product to FARUM S A for repairing Customers charges is added with regard to the products sold to non Chinese mainland users 01 2008 3 Contents STATEMENT aaa 1 E INTRODUCTION do 1 1 1 1 WHAT SANASTAZJA OOO eee lle ad 1 1 VA Range Tor US e ao 1 1 1 2 SYMBOLS USED IN THE MANUAL AND IN THE EQUIPMENT occcoocccccnccncnncnnnoncncnnncnnnnnnnnonannnnnnnnos 1 3 2 ANESTHETIC SYSTEM CONTROL onccooccconccconncconncnnnncononnnnnnnnnoncnnnnrnnnnnrnnnrrnnnnrnnanennnnes 2 1 2 1 ANESTHETIC SS TEM een oes alana ce al ial ia 2 1 2 2 HE BREATHING SYSTEM MODULE i 2 5 2 2 1 ADSODOr CV Gl Ocarina seta celine lios 2 2 2 2 DENOWS ASSCIMDIY cn areas breeders matey ies mamas 2 10 29 VAPORIZER CONTROL ii alias 2 11 2de VENTILATOR CONTROL ES 2 11 2 4 1 FON e A A ue A douearn eles ee 2 11 2 4 2 TROY S A ii cieids 2 12 2 4 3 HIQIG GIONS A A A e ate 2 12 2 4 4 A A A 2 12 2 4 5 MESA E ceed heel oznes deh EE EAS 2 13 2 4 6 A 2 15 2 E N ae ce ne A ee a ee eee ee 2 17 2 5 1 OPEN Gude rendie a hls sate auecceeas
36. MHz field strengths should be less than 3 V m 10 8 01 2008 10 Specification and Operation Theory Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for LIFE SUPPORTING EQUIPMENT and SYSTEMS Recommended separation distances between portable and mobile RF communications equipment and the ANASTAZJA 7500 Anaesthetic Workstation The ANASTAZJA 7500 Anaesthetic Workstation is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ANASTAZJA 7500 Anaesthetic Workstation can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ANASTAZJA 7500 Anaesthetic Workstation as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum m output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter E W d For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance f
37. Manual 4 Detach the top plate from the bellows 5 Remove the bellows assembly s adapter ring En ta a AN f 6 Push the locking spring to the center and then remove the plate 6 6 01 2008 6 Cleaning and sterilizing 7 Remove the pop off valve diaphragm and the pop off valve seat A WARNING Do not remove bellows assembly seat from diaphragm of the pressure relief valve This can distort the seat or diaphragm and cause injury to the patient 8 Push to the center then remove the locking spring 9 Remove the seal 01 2008 6 7 ANASTAZJA 7500 User Manual 6 5 2 Testing Function A WARNING Do not use any object small enough to slip completely into the system when occluding the breathing system for test purposes A WARNING Always check the breathing system components for foreign objects before using on a patient This test is to ensure all the components are installed correctly lt cannot replace the system test The bellows assembling can be installed in case they requirement testing Otherwise they need to be disassembled to check and replace broken components then reassembled and tested Hold the bellows assembly in hands vertically upwards to occlude the driving gas port before installing Invert the bellows assembly If the descending velocity of the bellows top is no more than 100 ml min this could be because the driving gas port is not properly sealed bellows or seal is not i
38. able thread tube Reusable thread tube Reusable thread tube Reservoir bag O cylinder N20 cylinder Castor Castor with break 9 2 Specification om om om 5m 3m One off 1 5m 1 5m 3m expanded 22x600 mm 15x600 mm p 22x450 mm 3L 4L 4L p 125 mm 6125 mm 01 2008 Stock Number CA034 CA035 CA056 WD0128 WJ156 WJ088 CA040 WJ194 MV300 E JL 1 MV300 E JL 2 MV300 E JL 3 CA058 WJ196 WJ198 WJ195 WJ023 WJ048 WJ049 WJ035 WJ036 10 Specifications and Operation Theory 10 1 Gas circuit of ANASTAZJA 7500 A ret et fF SF 4 Figure 10 1 Gas circuit diagram 01 2008 10 1 ANASTAZJA 7500 User Manual see Figure 10 1 1 N20 cylinder 22 APL valve 0 19 to 0 6kPa 2 N20 Pipeline 23 Airway gauge 3 O cylinder 24 Absorber 4 O pipeline 25 O flush 5 Air pipeline 26 N gt 20 0 gt linkage 6 Gauge 27 O flowmeter 7 Checkvalve 28 Air flowmeter 8 Reducer 400kPa 29 N20 flowmeter 9 Obs reservoir 30 Vaporizer 1 10 Reversal valve 31 Vaporizer 2 100 to 220kPa 11 Whistle 32 Micro checkvalve 12 N20 cut off 20 to 200kPa 33 To air 13 Reducer 250kPa 34 Exhalation valve 14 Magnetic valve 35 Inhalation valve 15 Flow valve 36 O sensor 16 Safety valve 6kPa 37 Probe 17 Exhaust valve 38 Patient 18 Spill over valve 39 Flow sensor 0 1 to 0 3kPa 19 Bellows 40 Pressure sensor 20 Manual reversal valve 41 Ventilator 21 Manual rese
39. al phenomenon mentioned in this manual happen Free repairs for these malfunctions will not be provided by FARUM S A FARUM S A have the rights to replace any content in this manual without notice Manufacturer Responsibility FARUM S A is responsible for the security reliability and function of the equipments when to following conditions are adhered to o Installation adjustments mending and repairs must be performed by individuals authorized by FARUM S A Necessary electrical equipment and the working environment must be in accordance with the national standards professional standards and the requirements listed in this manual e Equipment must be used as instructed in the operating instructions CAUTION This equipment is not for family use CAUTION Malfunctioning equipment may become invalid and cause bodily injury if a set of effective and approving repairing proposals cannot be submitted by the institution which is responsible for using this equipment The paid theoretical framework diagram will be supplied according to customer requirements by FARUM S A plus calibrating method and other information to help the customer under the assistance of qualified technicians repair the equipment parts where can be done by customer himself based on the stipulation by FARUM S A 01 2008 1 ANASTAZJA 7500 User Manual Warranty Manufacturing techniques and materials For a period of three months from the date of original
40. ale 10 6 Environment requirements Temperature Operation 10 to 40 C Storage 10 to 40 C Relative Humidity Operation Not more than 80 non condensing Storage Not more than 90 non condensing Atmospheric pressure Operation 86 to 106 kPa Storage 86 to 106 kPa Height Operation 500 to 800 mmHg 3565 to 440m Storage 375 to 800 mmHg 5860 to 440m 10 10 01 2008 10 Specification and Operation Theory 10 7 Breathing system technical specifications Compensation of fresh gas Absorbent Connection Leakage of breathing system Resistance of breathing system Resistance of APL valve Leakage of connector Resistance of checkvalve Flow compensation range 0 to 10 L min Gas components O2 N20 air anesthetic agent Capacity 1500 ml each Common Gas Outlet ISO 5356 connector At pressure of 3 kPa Leakage of flow lt 150 ml min At flow of 60L min Resistance of exhalation lt 0 6 kPa Resistance of inhalation lt 0 6 kPa At flow of 30L min Resistance of exhalation 2 2 kPa Resistance of inhalation 2 2 kPa Patient cycle of small resistance should be used in accordance with the relevant standard At flow of 60L min resistance of flow 0 05 to 3 kPa At flow of 30L min resistance of flow 0 1 to 0 5 kPa Resistance of flow lt 50 ml min APL valve close fully Dryness 0 15 kPa The pressure generated by a wet unidirectional valve lt 0 14 kPa The pressure to open a wet unidirectio
41. and reinstalled if its top is not horizontal 2 Set the locking lever of the vaporizer so that it is locked Try to lift the vaporizer directly upwards so as to separate itself from the bypass valve but do not pull the vaporizer forwards Be careful not to rotate it on the bypass valve 4 As the vaporizer is taken away from the bypass valve reinstall the vaporizer and then follow step 1 to step 3 Do not use this system if you cannot put return the vaporizer to a horizontal position on the bypass valve 5 Try on opening two vaporizers at the same time e Testing any possible instance of each combination e f more than one vaporizer can be opened at the same time disassemble and reinstall them then perform step 1 to step 5 4 4 2 Testing Vaporizer Back Pressure A CAUTION About performance testing of vaporizer refer to relevant instruction for use 01 2008 4 9 ANASTAZJA 7500 User Manual 4 5 Testing alarm 1 2 3 4 4 10 Connect reservoir bag to patient end Set bag ventilator switch to ventilator control Turn on mains switch Set control options Ventilation mode VCV mode Ventilator V 700ml f 20bpm IE 1 2 Plimit 40cmH20 Anesthetic machine O flow minimum flow 25 75mL min All other gas close Press O flush button to inflate bellows Set bag ventilator switch to bag control and then set to ventilator control again Make sure e Auto ventilation start e Display right data on the screen
42. assembly if the standard pipeline is used in the waste gas scavenging system 2 2 2 2 ventilating circulation e w a A TL al at PEA a a Inhalation primary phase Exhalation primary phase Exhalation end phase 1 Exhalation valve 6 Driving gas 8 Excess gas of patient 2 Driving gas 7 From patient circuit ereun 3 Gas of patient circuit 4 Spill over valve 5 To patient circuit 2 10 01 2008 2 Anesthetic System Control 2 3 Vaporizer Control Refer to operating and maintenance manual of vaporizer for more details A WARNING Anesthetic vapour delivery device used with anesthetic system must be in accordance with ISO 8835 4 2 4 Ventilator Control A CAUTION Anesthetic ventilator accords with ISO 8835 5 A CAUTION Monitoring conditions of this system Ambient temperature 29 C Air temperature 30 C Air humidity 30 Gas component Oxygen A CAUTION If the temperature of sensor is lower than dew point of breathing gas vapour may coagulate on the surface of sensor and oxygen concentration monitored may be lower than practice value Optional function SIMV mode P V loop and V Flow loop can be added by code 2 4 1 Front Panel Front panel consists of display screen keys indicators and a knob Menu Display Language ENGLISH vw Figure 2 8 Front Panel 01 2008 2 11 ANASTAZJA 7500 User Manual Press the key and hold on for 2 second you Mains switch key can start or shut o
43. ber in this system can be used repetitious The capacity of each absorber is 1500mL It is recommended to use Medisorb absorbent Only air oxygen carbon monoxide halothane enflurane isoflurane sevoflurane and can desflurane be used for the absorber 5 2 1 When to replace absorbent Changed color of the soda lime in the absorbent indicates that it has absorbed the carbon dioxide however this color is not 100 accurate To decide whether to replace the absorbent use CO monitoring machine Remove the changed color absorbent immediately The soda lime will restore its original color several hours later and that may mislead the operator 01 2008 9 3 ANASTAZJA 7500 User Manual 9 2 2 Disassembling Absorber The absorber is reusable Follow the disassembling procedures 1 Turn on drain valve to get rid of water generated by chemical reaction 2 Rotate the handle clockwise to disassemble the absorber 9 2 3 Filling Absorbent 1 Remove the absorbent of absorber Cleaning and sterilization refer to section 6 3 Fill the absorber with fresh absorbent after dryness Wipe soda lime fell on the edge of absorber and then install it back Make sure the airtightness is well and that no leakage and spillage 9 4 01 2008 5 Installing and Connecting 5 3 Connecting tubes and lines A CAUTION CO monitor in accordance with ISO 9918 should be connected at elbow bend of patient end A CAUTION Anesthetic agent mon
44. conds Displaying all the time until alarm disappears A CAUTION There are two alarm display areas and the array of alarms is according to priority from high to low A CAUTION When alarm silencing the alarm bell has A dashed X on itself and the color of bell d accords with of which the higher priority 66 alarm 01 2008 8 1 ANASTAZJA 7500 User Manual 8 2 Alarm message list ZA CAUTION 8 2 1 Message AD DA Failure Exhaust Valve Failure Flow Valve Failure Flow Sensor Failure Calibration Valve Failure No Driver Gas Supply Mains Failure Battery Low No O Sensor Communication Failure DC Failure Power 8 2 Operation instruction is not included in the alarm message list Priority High High High High Low High Low Low Low Low High Technical alarm Condition Picking card failure Zero wander Chip failure Cables fall off Flow valve failure Cables fall off The 25 pin cable falls off 2 Sampling circuit break off self tuning blocked valve Gas exhausted Central gas supply ceasing or lack Connection failure Power failure Used out Battery failure Connection failure Cables fall off Defective circuit Power board failure 01 2008 Operator Action Ventilator failure Switch to bag mode manually bag ventilate patient Monitoring is non effective Switch to bag mode manually bag
45. d by mode If failure alarm message is displayed on the screen Please carry out operation in accordance with the prompt information O RUN O Nn Figure 3 1 LOGO interface 01 2008 3 1 ANASTAZJA 7500 User Manual acomnedifs MV300 SoftHare UER 03 26 01 HardHare VER 1 00 SelftTest Y Figure 3 2 Self testing Ea Paw t Warnning 10 l s Poeak A Pplat O aa IN Ventilator system failure Oj __ Please shut dow 3 and contact service Ero e tha C mL emH20 0 T ie Ad 45 30 j A 10 l s aa fiz oro fs Figure 3 3 Self test failure A WARNING if any unwonted malfunction appears change bag ventilator switch to manual mode stop mechanical ventilating 3 2 01 2008 3 1 1 Alarm Limit Set Step 1 Press MENU key then display a menu window on the screen Step 2 Turn the knob to select Alarm_set submenu Step 3 Press the knob to select Return 01 2008 3 Operating Guide T 1 a STE A RET UE 3 3 ANASTAZJA 7500 User Manual Step 4 Turn the knob to select option required Step 5 Press the knob the grounding of option displays different color and high brightness Step 6 Turn the knob to adjust the value 3 4 01 2008 3 Operating Guide Step 7 Press the knob to save the new adjustment Go to next setup or exit Alarm_set menu al aos RET 11 TL Step 8 Exit Alarm_set menu T
46. d exhalation valve Dismount the cover of the inspiration and expiratory valves by rotating it counter clockwise then clean all parts of them with the gauze soaked with water soluble sterilizing agent after all parts cleaned and dried recover it in original integration Then one must check the leakage and the movement of the inspiration and expiration valves in accordance with the required regulation and checking procedure Please handle all parts with care preventing any damage 2 Absorber module Either vapouring not more than 50 C or immersion sterilization can be used in practice in case of immersion all sterilized parts must be dried with the high pressure air or oxygen before reuse 6 5 The Bellows Assembly This section is about disassembling assembling cleaning and sterilizing the bellows assembly Read all content of this section before disassembling assembling cleaning and sterilizing the bellows assembly to avoid equipment malfunction and patient injury A CAUTION The material of the bellows is made of latex 6 4 01 2008 6 Cleaning and sterilizing 6 5 1 Disassembling To disassembling the bellows assembly To assemble the bellows assembly perform the steps in Disassembling the bellows assembly in reverse order 1 Loosen the screws from the bellows assembly base then remove the bellows assembly 2 Turn counterclockwise and remove the bellows housing 3 01 2008 6 5 ANASTAZJA 7500 User
47. d maintaining manual of all the sterilizing equipments Wear safety gloves and safety goggles The O2 sensor may leak and burn by Chlorine Potassium Oxide if damaged Do not inhale fumes Do not inhale fume To prevent damage Refer to the data supplied by the manufacturer if there are any questions about the agent Never use any organic halogenate or oil base solvent anesthetic glass agent acestone or other irritant agents Never use any abrasive agent to clean any of the components i e Steel wool silver polish or agent Keep liquids far from the electrical components Prevent liquid from entering the equipment Do not immerse the synthetic rubber components more than 15 minutes any longer will cause inflation or accelerating aging Only the components marked 134 are pressure resistant and heat resistant The PH value of the cleaning solution must be from 7 0 to 10 5 Talc zinc stearate calcium carbonate or corn starch that has been used to prevent tackiness could contaminate a patient s lung or esophagus causing injury Never immerse the circuit O sensor or flow sensor connector in the liquid Never dispose the circuit O sensor connector by using hot press Do not clean the inner surface of the flow sensor Clean the outer surface by using a damp cloth Check if there is damage in the components Replace if necessary 01 2008 6 1 ANASTAZJA 7500 User Manual 6 1 Main unit
48. e air pressure exceeds the set value of the safety valve 6kPa the safety valve can open automatically and the gas will be discharged from the safety valve The electromagnetic valve will be closed in expiration the pressure exerted on the diaphragm of the expiration valve will disappear and the diaphragm will loose Thus the gas room connects with the atmosphere directly The gas compressed in the bellows by the ventilator will discharge to the atmosphere through the expiration valve The process above will be repeated along with the breath rhythm During the above procedures it is the electromagnetic valve that controls the gas flowing direction and is controlled by the mainframe board In inspiration the electromagnetic valve will be opened while in expiration it will be closed In the Figure 10 2 the display plate is used for the digital display for the respiration rate breath frequency the tidal volume and the oxygen concentration the display of the corresponding display lamps and the display of the luminous line of the pressure The mainframe board is the central processing unit of the ventilator circuit part It not only controls the opening and closing of the electromagnetic valve but also receives and processes the pressure signal the flow signal It receives the inputs from the panel and sends the signal that will be outputted to display to the display plate The voltage stabilizing power supply provides the circuit needed voltages The
49. e exists all the same do not use this system Step 5 7 should be repeated for all the cylinders N20 pressure drop in one minute should not exceed 00kPa 10 Close all the cylinder valves 01 2008 4 3 4 4 ANASTAZJA 7500 User Manual A CAUTION Do not leave the cylinder valves open during pipeline gas supply period otherwise cylinder gas supply will be used up and lead to insufficient supply in case of pipeline malfunction 11 Connect pipeline gas supply 12 Check pipeline pressure according to the table below ANSI U S and International Australia Canada 345kPa 50psig France and Japan ISO Italy Scandinavia South Africa Spain and Switzerland 414kPa 60psig Austria and Germany 500kPa 75psig 01 2008 4 Preoperative Checkout 4 3 Monitoring Flow Control ZN WARNING 4 3 1 ZN WARNING A CAUTION Refer to Step 1 to 13 of monitoring without oxygen for monitoring without oxygen Refer to Step 1 to 13 of monitoring with oxygen for monitoring with oxygen Monitoring without oxygen The monitoring system cannot be replaced by link system The fresh gas containing enough oxygen may not avoid the existence of low oxygen mixture in the breathing circuit If NO exists it will pass through the system during the test which should be securely collected and removed Patients may be injured by improper gas mixture The link system should not be used if a proper ratio of O and N20 is not possib
50. ed with sufficient anesthetic The connection and pressure of pipeline gas supply system are correct The connected cylinder valve should be closed if there are backup cylinders AN WARNING Do not leave the cylinder valves open during pipeline gas supply 10 11 4 2 period otherwise cylinder gas supply will be used up and lead to insufficient supply in case of pipeline malfunction The required emergency device is ready and in good condition The device for airway maintenance organ cannula are ready and in good condition The applicable anesthetic and emergency medicine are ready Make sure the truckles are tight and locked and free of motion Connect the power cord to the AC power outlet The power indicator light will light up when power is connected If failure that means no electric power supplying Exchange other sockets close breaker or replace power cord Mains failure alarm test Press power ON OFF key lasting 2 seconds stand by interface appears after self test After operating 5 minutes pull out power cord Make sure that power off failure alarm occurs it has the following characteristics e Alarm sound e Mains Failure message displays on the screen e Mains icon flickering Connect power cord again Make sure the alarm eliminate 01 2008 4 2 4 Preoperative Checkout Testing the gas supply pipeline and the gas cylinder AN CAUTION A user must confirm that gas supply is connected c
51. erform 100 oxygen sensor calibration step 7 And then calibrate 21 O sensor again when the 100 calibration succeeded If not replace O sensor and then recalibrate it 01 2008 7 User Maintenance CAL finish 1 1 ANASTAZJA 7500 User Manual Step 6 Exit to 21 Oxygen Sensor Calibration menu please turn the knob to select Return Press the knob back to Oxygen Sensor Calibration menu 01 2008 7 User Maintenance 7 3 2 2 Calibrate 100 O sensor It will cost more than 3 minutes to perform 21 O sensor calibration Before performing 100 O sensor calibration 21 O sensor calibration must be finished A WARNING Never to perform the calibration when the system connected with patient Step 7 Turn the knob to Menu select 100 option Oxygen Sensor Calibration Note Only past the 21 oxygen sensor calibration successfully then the 100 oxygen sensor calibration is possible Press the knob a new Menu window named 100 Oxygen Sensor Calibration cover the 100 Oxygen Sensor Calibration original gt Note Before calibration oxygen sensor Perform the operation in in the breath system must be passed through accordance with the pure oxygen for three minutes at least prompt on the screen 01 2008 7 9 ANASTAZJA 7500 User Manual Step 8 Press the knob to y perform the Es de ie i ovet em MER eet l Info calibration E In the proce
52. et ray for 30 minutes if necessary 6 5 5 Regular Maintenance A WARNING Do not perform any tests and repairs when the equipment is being used to avoid patient injury Perform the following check every 30 days to be sure that component worn by use and daily cleaning are replaced in time Test by eyes Separate the bellows assembly and anesthesia machine Disassemble the bellows assembly A WARNING Never separate the diaphragm and the valve seat in a pop off valve Check each component carefully to check for cracks distortion dissolution inflation and other physical changes Replace them if necessary Assemble the bellows assembly and then perform the leak test 6 12 01 2008 User Maintenance WARNING To avoid fire o Use the lubricant approved for anesthesia or O equipments use eo Never oil or grease any anesthesia or O equipment In general oils and greases oxidize readily and the presence of O are highly flammable eo All the covers or housings for the system use must be made of static proof material as static material may cause fire A WARNING Follow sterilizing control and security stipulations because used equipment may contain blood and body fluids A WARNING Movable components and detachable parts can cause injury Use caution when system components and parts are being moved or replaced A WARNING No shock and strong vibration should happen during transportation because the glass cove
53. event the staff working in the operating rooms from injury This requirement must be followed in the testing and clinical application 01 2008 9 Installing and Connecting CAUTION CAUTION ZA CAUTION ZN WARNING ZN WARNING Z WARNING ZA CAUTION ZA CAUTION ZA CAUTION O monitoring must be used on this equipment For the related stipulations refer to local standards According to the European standard EN 740 and International Standard IEC 60601 2 13 ISO 8835 1 this equipment must use expiratory volume monitoring Oz monitoring in accordance with EN 12342 or ISO 7767 and CO monitoring in accordance with EN 864 or ISO 9918 Anesthetic monitoring in accordance with ISO 21647 2004 must be made as the anesthetic vaporizer is being used according to the European standard EN 740 and International Standard IEC 60601 2 13 ISO 8835 1 Operating room environment can be influenced by the expiratory gas Some unexpected dangers may occur if the anesthetic has been not tested for a long time The operator must dispose of expiratory gas in a timely fashion according as required and examine other items to minimize the chances of danger and malfunction Be sure the gas pipeline supply hoses and the breathing circuit components are non poisonous do not cause patient allergy and do not create dangerous by product through reaction with the anesthesia gas or the anesthetic To prevent generating wron
54. ff ventilator Alarm silence key Press the key alarm mutes for 110 seconds Press the key change original ventilation Manual mode key mode to manual mode Press again back to the original ventilation mode Press the key a Menu window appeared on Menu key the display screen more details refer to section 2 5 2 4 3 Indicators O RUN Running Indicator The indicator brightly as ventilator operating O vu AC Indicator The indicator brightly as AC power effectively The indicator dark as AC power failure 2 4 4 Knob The user may use the rotary knob to select the menu item and modify the setup It can be rotated clockwise or counter clockwise and pressed like other buttons The user may use the knob to realize the operations on the screen and in the system menu and parameter menu The rectangular mark on the screen that moves with the rotation of the knob is called cursor Operation can be performed at any position at which the cursor can stay Operating method Move the cursor to the item where the operation is wanted m Press the knob m One of the following four situations may appear The background color of cursor may become into the contrast color which implies that the content in the frame can change with the rotation of the knob e Pull down menu or dialogue box may appear on the screen or the original menu is replaced by the new menu Oo Save setup 2 12 01 2008 2 Anesthetic System Control
55. fuses AN WARNING Disconnect from power supply before replacing fuses otherwise that can injure operator even death A WARNING Replace fuses with only those of the specified type and current rating otherwise that can damage the equipment A CAUTION The fuse is fragile so replacement should be carefully Do not use excessive force 7 5 1 Replacing fuse of mains supply The location of fuse as shown in the following figure with arrow pointed up 250V6A gt 5X20 F Mains Supply __ 230VAC 50Hz 5 5A Max Replacing steps 1 Insert the screwdriver into the groove on the top of fuse box Prize up gently The cover of fuse box springs lightly Take off the cover Take out fuses Enclose the new ones Push the cover to original place Connect mains supply CON OO BW N 7 16 01 2008 7 User Maintenance 7 5 2 Replacing fuse of auxiliary mains socket outlets The location of fuse is in the rear panel of the machine see Figure 2 3 The specification is shown in the following figure FUSE FUSE Fuse Fuse Fuse ES El E E o wt Li o 250V2A 5X20 F 250V2A 5X20 F 250V2A gt 5X20 F Total Load 4 5A Max Replacing steps 1 Plug the screwdriver to groove on the end of fuse box Turn counterclockwise 3 to 5 circles then pull out fuse tubes lightly Take off fuse tubes Enclose the new ones Push fuse tubes to original place gently Turn clockwise 3 to 5 circles with screwdriver to tighten Co
56. g Breathing System Turn the switch of the anesthesia machine to Manual Bag Pressure gauge is zeroed APL Valve knob should be fully clockwise to the maximum Connect the wye connector to the test lung Occlude the manual reservoir bag on the port below the switch Press the oxygen flush button or open the flowmeter to make the indication of the pressure gauge achieve 3KPa then release the button and close the flowmeter After 20 seconds observation the pressure indicated by the pressure gauge must not exceed 0 3KPa 4 6 3 Testing APL Valve Adjust the positions of every switch and knob according to the method of testing Breathing system Leak Open the oxygen flow to 5 liters per minute Adjust the APL valve to position the pressure of the pressure gauge in different places respectively The common gas outlet must overflow some gas as the pressure is stable A WARNING Be sure that there is no any testing plug or foreign objects in the Breathing System 4 12 01 2008 4 Preoperative Checkout 4 Testing Ventilator 1 Connect the test lung to the patient circuit port 2 Setthe Reservoir bag Ventilator switch to the Reservoir bag position 3 Turn on mains switch 4 Set control options Ventilation mode VCV mode Ventilator V 700ml f 20bpm I E 1 2 Plimit 40cmH2O Anesthetic machine O flow less than 200mL All other gas close Press O flush to charge bellows Set the bag Ventilator switch to ventilator contro
57. g data and malfunction please use the cables hoses and tubes from FARUM S A It is dangerous if there is anesthetic in the absorber Measures must be made to prevent the soda lime in the absorber from drying Turn off all the gas supplies after finishing using the system This system can be operated correctly under IEC 60601 1 2 interference Higher level interference may cause alarm and result in auto ventilation suspension To avoid equipment false alarm caused by high strength electric field e Put the electricity surgical conducting wire far from the place where the breathing system and the O sensor are put on e Do not put the electricity surgical conducting wire on any parts of the anesthetic system 01 2008 9 1 ANASTAZJA 7500 User Manual CAUTION To protect the patient as the electricity surgical equipment is being used e Monitor and ensure that all the life supporting and monitoring equipment are operated correctly e Ensure that the backup manual ventilator can be used immediately in case that electricity surgical equipment cannot secure the use of ventilator e Never use electrical conduction masks or hoses 5 1 Installing Product 5 1 1 Shelf Unpack the bottom package take out the shelf and lock its truckles so it cannot move freely 5 1 2 Breathing circuit limb Connect the breathing circuit limb to its mounting tracks then tighten the screws 5 1 3 Absorber cycle When installing hold
58. g schedule is a recommended minimum standard based upon normal usage and environmental conditions Frequency of maintenance for the equipment should be higher if your actual schedule is more than the minimum standard 7 2 1 User maintenance Minimum maintaining Planned maintaining Standard Standard Daily Clean the outer surface weekly Perform 21 O sensor calibration Ventilate the system open flowmeter and make sure that the float move up and down smoothly It can prevent blocking and clinging monthly Perform 100 O sensor calibration Test leakage of bellows assembly refer to section 6 5 2 When cleaning and installing Check if any components are broken and replace or repair them if necessary As required Replace new gasket of cylinder gas supply Perform flow sensor calibration when flow waveform is unusual Replace O sensor one year generally Open the drain valve and replace absorbent in the absorber 7 2 2 Permissive Repairing Minimum maintaining Planned maintaining Standard Standard 6 months Test electric current leakage 6 months Test mechanical safety valve 12 months Perform the maintenance checking testing calibrating and replacing of the components stipulated in this manual by qualified individuals Notes This is the recommended minimum maintaining level Perform the local policies if they are equal to or higher than those in this manual 7 2 01 2008 7 User Maintenance 7 2 3 Useful
59. h 3L bag Do difference of 30 between the value of CAL after bellows is full of air Once again push tidal volume monitored and the settings EU Gia Gene Valve Calibrtion IN Invalid Password 7 14 01 2008 7 User Maintenance 7 4 Maintaining oxygen sensor Perform the calibration periodically interval refer to section 7 2 1 7 4 1 Technical requirements O sensor belongs to expendable so the user should pay attention to period of validity and use it in accordance with performance and requirements The technical requirements of O2 sensor used in the ANASTAZJA 7500 are the following Maximum input of interface O to 500mV DC Form and definition of interface FCC 68 4 cores telephone plug RJ11 4 see the following figure MOLEX 4P4C MODULAR JACK _ Typical input at 21 concentration 5 to 20mV Accuracy in measurement and full scale error lt 1 0 to 100 Operating temperature O to 40 Response time not more than 15 seconds Useful life not less than 12 months Accordable standard EN12598 1507767 7 4 2 Recommended O sensor Type V 03A OOM 105 M 07 MOX 4 Manufacturer Ventrex AnviteC International City Technology Technologies Response time T 5 8 15 second Useful life 12 16 12 month Current Yes Yes No No applied A CAUTION More detailed parameters refer to technical data up to date publicized by the manufacturer 01 2008 7 15 ANASTAZJA 7500 User Manual 7 5 Replacing
60. ion module 6 Handle 12 Airway Pressure Gauge 2 2 1 2 Principle Gas flow schematic diagram see Figure 2 6 01 2008 2 7 ANASTAZJA 7500 User Manual Bag operating 1 Expiratory gas of patient 2 Sampling airway pressure 3 via exhalation valve unidirectional 4 bypass switch normal close o enter into absorber 6 leave absorber fresh gas compensation 8 Bag Ventilator Bag ON 9 APL valve sampling path 10 via exhalation valve unidirectional 11 Inspiratory gas 2 8 01 2008 LH Ce LAS Ad gt LEVEE da AE ay pom Ph Te AAA 1 K te i Figure 2 6 Gas flow schematic diagram 01 2008 2 Anesthetic System Control Ventilator operating 1 Expiratory gas of patient 2 Sampling airway pressure 3 via exhalation valve unidirectional 4 bypass switch normal close 5 enter into absorber 6 leave absorber fresh gas compensation 8 gas of patient 9 Bag Ventilator Bag OFF 10 via exhalation valve unidirectional 11 Inspiratory gas 2 9 ANASTAZJA 7500 User Manual 2 2 2 Bellows Assembly 2 2 2 1 Ports Figure 2 7 Ports of bellows assembly 1 Breathing system connector 2 Exhaust gas port 3 Driven gas connector 4 Adapter A WARNING Never connect exhaust gas port with sub atmospheric system directly Or else leakage of breathing system generates The adapter can be used to connect the waste gas scavenging system to the bellows
61. itor in accordance with ISO 21647 2004 should be connected at pipe T installed inspiratory port ZA CAUTION O sensor should be connected at pipe T installed inspiratory port 1 O sensor connector 2 pipe T 01 2008 5 5 ANASTAZJA 7500 User Manual 5 4 Connecting Gas and Electricity ZN WARNING WARNING ZN WARNING ZA CAUTION ZA CAUTION WARNING IEC 60601 1 1 applies both for combination of items of medical electrical equipment and for combinations of at least one item of medical electrical equipment with one or more items of non medical electrical equipment Even if there is no functional connection between the individual pieces of equipment when they are connected to an auxiliary mains socket outlet they constitute a medical electrical system It is essential that operators are aware of the risks of increased leakage currents when equipment is connected to an auxiliary mains socket outlet The equipment connected to the power outlet will increase electric current leakage Test electric current leakage regularly A malfunction of the central gas supply system may cause more than one or even all devices connected to it to stop their operation simultaneously Disconnect the anesthetic workstation from the gas supply after use to prevent contamination or pollution of the pipeline system Only the medical gas supply should be used Other types of gas supply may contain water oil or other pollutants
62. justed Steps of setting refer to section 3 1 3 3 10 01 2008 3 Operating Guide 3 2 Starting Auto Ventilation A WARNING Before getting started make sure to set the patient circuit installing and controlling correctly The following procedures assume that the system is in on position and manual reservoir gas ventilating mode Step 1 Make sure the control settings coincide with the clinical settings Step 2 Set the reservoir bag ventilator switch to auto ventilation position Auto ventilation ON gas goes to the bellow Step 3 Select auto ventilation Refer to section 3 1 3 Step 4 Fill the bellows with O flush if necessary 01 2008 3 11 ANASTAZJA 7500 User Manual 3 3 Shutting Off Auto Ventilation Step 1 Before stopping the auto ventilation make sure the setting of manual circuit is complete and the setting of APL valve is correct This valve is used to adjust the pressure limit of the breathing system during the manual ventilation period Step 2 Set the reservoir bag ventilation switch to reservoir bag position Select Manual ventilation auto ventilation ventilator stop CAUTION Auto ventilation OFF gas goes to the reservoir bag Take the monitoring reading of the anesthetic ventilator rather than the observed reading of the bellows 3 12 01 2008 3 Operating Guide 3 4 Alarm Alarm message displays on the top of screen The grounding of
63. l Press the Oxygen flush button to inflate the bellows Ensure e Auto ventilation start e No low pressure alarm e Ventilator displays the correct data e The bellows ascend and descend during the period of auto ventilation Set the O flow control to 5L min Ensure e Ending expiratory pressure is about 0 cmH20 e Ventilator displays the correct data e The bellows inflate and scavenge during the period of auto ventilation 10 Set the ventilator control and alarm limits to the proper clinical level 11 Turn off mains supply and close all valves of gas cylinders if not to use the system 12 Ensure that the things in the following table should be prepared completely Apparatus Airway maintenance Manual ventilation Organ cannula anesthesia and emergent drugs applicably 01 2008 4 13 ANASTAZJA 7500 User Manual 13 System preparation Close all vaporizers Open the APL valve Set the bag ventilator switch to bag control Set all the flow controls to the minimum Be sure that the breathing system connects correctly A WARNING Be sure that the breathing system connects correctly A WARNING Flush the anesthesia machine for at least one minute by using O with 5L min flow speed to remove unnecessary mixed gas and objects in the system before connecting the equipment to the patient end A WARNING Anesthesia equipment must be connected to the waste gas 4 14 scavenging system to outlet the waste gas to pr
64. larm occurs Adjust lower limit of Paw to above Ppeax and conform that Paw high alarm eliminates Test low airway pressure alarm Remove reservoir bag form the absorber cycle Other alarm occurs such as Minute volume low Make sure that Paw low alarm occurs Test continuous high airway pressure alarm Set control options APL valve Set to the maximum value Bag Ventilator switch Bag Set bag ventilator switch to bag control auto ventilation should stop Block up patient end and press O flush button Make sure that Paw continuous high alarm occurs after 15 seconds approximately Turn off mains supply 01 2008 4 11 ANASTAZJA 7500 User Manual 4 6 Testing the Breathing System Refer to the operating manual and Verify the non return valve in the Breathing circuit module works normally The non return exhalation valve will ascend during the exhalation period while it will descend during the inhalation period A WARNING Objects in the breathing system can interrupt or disrupt the delivery of breathing system gas resulting in possible patient death or injury Do not use any testing plug small enough to slip completely into the breathing system 4 6 1 Checking Oxygen flush Switch Press the oxygen flush button the sound of gas should be heard from the fresh gas outlet then release The button must immediately drop back to its position and stop delivering the gas 4 6 2 Testin
65. le The following procedures can test whether the link system has serious malfunction however it cannot determine whether the calibration is correct The gas flow switch should be adjusted slowly Do not turn it hard when the reading of the flowmeter goes beyond the maximum or minimum flow rate otherwise the control valve can be damaged and the control will not work Follow the steps to test the flow control ee Oe I ee Connect the pipeline gas supply or open the cylinder valves slowly Turn clockwise all the flow control till the end minimum flow Turn on mains switch Do not use this system if the battery is not fully charged or other ventilator failure alarm occurs Make sure e The oxygen flow is between 25mL min and 75mL min e No gas flowing in any other flow tube e Step 6 and step 7 are only applicable for the N2O system test 01 2008 4 5 ANASTAZJA 7500 User Manual A WARNING During Step 6 to Step 7 keep link systems working state Only adjust testing of control N20 in step 6 and O in step 7 Adjust flow according to order N20 firstly O2 secondly If adjustable range exceeds please adjust flow control to the nearest place and perform this step again 6 To test the flow increase of the link system e Turn clockwise the N2O and O flow control till the end minimum flow e Turn counterclockwise the N20 flow control slowly e Set N20 flow control to the rate described in the following tab
66. le The O flow must be higher than the minimum flow limit Set N2O flow to O flow must be higher than the minimum flow liters per minute liters per minute 0 6 0 2 1 5 0 5 3 1 0 70 2 5 7 This step tests the function of the Link System when flow is reduced you should Set N2O flow to O flow must be higher than the minimum flow liters per minute liters per minute 6 0 2 0 3 0 1 0 0 6 0 2 8 Adjust full flow of all the gas to ensure that the flowmeter float must move smoothly 9 Shut off the oxygen supply either by closing the oxygen cylinder valve or by disconnecting the oxygen pipeline supply 10 Make sure e As pressure decreases the oxygen supply failure alarm must continuously sound e Disconnect the flow of nitrous oxide and oxygen to be sure that the oxygen flow will be the last to stop e Air flow remains e fthe oxygen is the driving gas of the ventilator the oxygen supply failure alarm must continuously sound 11 Turn all of the flow control valve knobs completely clockwise to the minimum flow 12 Reconnect oxygen pipeline supplies or slowly open the oxygen cylinder valve 13 Turn off mains supply 4 6 01 2008 4 Preoperative Checkout 4 3 2 Monitoring with Oxygen ZN WARNING A CAUTION The monitoring system cannot be replaced by link system The fresh gas containing enough oxygen may not avoid the existence of low oxygen mixture in the breathing circuit If NO exists it will
67. life estimation A CAUTION The useful life of the following parts should be considered in normal environment and operating requirements Sampling probe and parallel lines 1500 times Threaded tubes used repetitiously Not less than 1 year Power cord cables 8 years sampling line of O sensor Bellows assembly except bellows 1500 times Drain valve 5000 times Battery 1 year Lamp tubes of display 50 000 hours Pipelines pipe T 8 years Main unit 8 years 7 3 Maintaining the Breathing System Parts that are broken crushed worn or distorted must be replaced immediately when cleaning the breathing system Refer to the sections corresponding to reassembly and testing 7 3 1 Replace O sensor A WARNING Comply with the relevant rules about biohazard when to dispose sensor No burning Replacement steps 1 Pull out the connector of sampling line from O sensor 2 Pull out the O sensor from the pipe T 3 Replace it with a new one and connect the sampling line to O sensor 01 2008 7 3 ANASTAZJA 7500 User Manual 7 3 2 Calibrate O sensor A WARNING Do not perform the calibration steps when the system connected with patient When to calibrate O sensor ambient pressure must be equal with monitoring pressure of delivering O in the patient circuit If operating pressure is not equal with calibrating pressure the accuracy of reading may exceed range stated 7 3 2 1 Calibrate 21 O sensor It will cost more than
68. ling line and probe connect right avoid liquid entering and leakage ES Probe of sampling and sampling parallel line Flow of breathing cycle is measured by means of pressure difference Avoid water entering into the probe and sampling parallel line in the process of operating otherwise parameter monitored will be affected Ensure airtightness of sampling system if sampling device is aging please replace it Sterilization cleaning it with sterilizing agent then swing it mechanically The formation and preparation of the agent must be done in accordance with the direction given by the manufacturer O Sensor Operation condition 0 5 to 2 0 Bar More details refer to section 7 4 01 2008 2 Anesthetic System Control 2 5 Menu 2 5 1 Operating Guide Calibrate or carry out other process explanation will be displayed on the screen A demonstration like the following steps Step 1 Press MENU key then display a menu window on the screen nt i 1 J Jefault Return Step 2 Press knob to select Return Info 01 2008 2 17 ANASTAZJA 7500 User Manual Step 3 Turn the knob to select option required such as Wave Step 4 Press the knob then a pull down menu appears Step 5 Turn the knob to select option required 2 18 01 2008 Step 6 Press the knob to save new setup Go to next setup or exit System menu Step 7 Exit System
69. lows assembly prior to the hot press disposal Put the bellows assembly up side down when the hot press disposal is being processed 6 2 01 2008 6 Cleaning and sterilizing 6 3 Absorber Refer to Disassembling the Absorber in the section 5 2 2 A WARNING The dry absorber may be very dangerous with the presence of any anesthetic Take proper measures to avoid dry soda lime in the absorbent Switch off all gas supplies after use 6 3 1 Auto cleaning with agent or disinfector Clean the absorber in the agent or disinfector according to the cleaning procedure Put the absorber in the heat up room with the maximum temperature as 80 C or with the room temperature Higher level sterilization is recommended if the agent and disinfector cannot sterilize equipment 6 3 2 Manual cleaning Rinse the absorber Immerse the absorber completely in the sink with water and agent about three minutes at a temperature of 40 C 104 Rinse the absorber Higher level sterilization must be performed after cleaning by hand 6 3 3 Advanced Sterilizing The absorber must be cleaned before advanced sterilizing The absorber can be placed in high temperature and high pressure conditions The maximum temperature recommended is 134 C 273 Put the soda lime into the absorber after being dried and then tighten the knob Clear all soda lime debris 01 2008 6 3 ANASTAZJA 7500 User Manual 6 4 Absorber assembly 1 Inhalation valve an
70. nal valve lt 0 1 kPa Compliance of absorber lt 50 ml kPa 01 2008 10 11 ANASTAZJA 7500 User Manual 10 8 Anesthesia Ventilator 10 8 1 Operation Theory The high pressure oxygen enters the pressure reduction valve and the output pressure from the pressure reduction valve is stabilized at 0 25MPa already adjusted before ex factory The output gas from the pressure reduction valve enters the electromagnetic valve In inspiring the electromagnetic valve is open the two way outputs enter the flow valve and the pressure reduction valve ll respectively The one entering the pressure reduction valve Il presses on the diaphragm in the expiration valve by means of the gas pressure to control the opening and closing of the expiration valve and the output pressure is stabilized at 0O 05MPa already adjusted before ex factory The other one enters the flow valve the tidal volume value could be changed through adjusting the flow valve The pure oxygen entering the gas line is mixed in accordance with a certain proportion in the gas room The air enters from the venturi type valve and a unidirectional valve is installed in the venturi type valve to prevent the gas overflowing The sponge gas entrance is adopted for the unidirectional valve to reduce noise and filtrate the gas to be breathed in A safety valve is installed on the side face of the gas room to prevent that the air pressure is too high and will make hurt to a patient When th
71. ninn E A E E A a 10 14 10 68 60 Setling alarm parameters iii td 10 15 LOOT VOUM O anr n a A a O inde 10 15 10 86 67 Monitoring PORO Manco di 10 16 10 8 9 Os monitoring specification zsrsr erian eE aa aaa E Eia EEE 10 17 01 2008 lil 1 Introduction 1 1 Whats ANASTAZJA 7500 ANASTAZJA 7500 is a compact and integrated anesthesia transmitting system The breathing machine not only provides patients in operation with auto ventilation but also monitors and displays the patient s various parameters The ventilator used in the system is controlled by a microprocessor The anesthetic ventilator controlled by microprocessor of ANASTAZJA 7500 includes monitor internally volume mode and other functions optional lt can be used for communication with cardiac blood vessel and monitor of breathing gas by serial interface Not all the optional functions available may be included in the manual It is also possible to add other equipment to the top or middle of this system for added functions For more information with respect to the existing product please feel free to contact the local representatives A WARNING The user of ANASTAZJA 7500 must be professional and trained A WARNING ANASTAZJA 7500 is unsuitable for use in a magnetic resonance imaging MRI environment 1 1 1 Range for used ANASTAZJA 7500 is applicable for patients of over 25 Kg with standard set and for child of over 12 Kg with cycles and CO monitoring device of child
72. nnect mains supply NOOO BW N 7 5 3 Replacing fuse of ventilator The location of fuse is in the rear panel of the ventilator See Figure 2 11 6 The specification is shown in the following figure 250V1A 5X20 T Replacing steps 1 Plug the screwdriver to groove on the end of fuse box Turn counterclockwise 3 to 5 circle then pull out fuse tubes lightly Take off fuse tubes Enclose the new ones Push fuse tubes to original place gently Turn clockwise 3 to 5 circles with screwdriver to tighten Connect mains supply NOOO h 0 N 01 2008 7 17 ANASTAZJA 7500 User Manual 7 6 Maintaining battery 1 Specification DC 24V 2 3 AH 12V lead acid battery two in serial Charge 8 hours typically 2 Cautions Charge Connect mains supply the system will maintain auto charging battery It is recommended that charging time is better than 8 hours Discharge It will last 90 minutes generally to use the battery supply The alarm Battery Low should be displayed on the screen when the capacity of battery is not enough until the system shut off The user operator should connect mains supply to charge battery in time and avoid the system shut off abnormally Do not disassemble battery device without valid authorization Do not short circuit between positive plate and negative plate of battery 3 Storage The maintenance of charging should be carried out with interval of 3 months at least if storage of battery exceed
73. nstalled correctly or other component are broken and that the descending velocity exceeds the limit 6 8 01 2008 6 Cleaning and sterilizing Open the driving gas port to make the bellows fully spread and then occludes the breathing system connector Turn the bellows assembly so it faces vertically upwards If the descending velocity of the bellows top is no more than 100 ml min this could be because the bellows or pop off valve is not installed correctly or other component are broken and the descending velocity exceeds the limit 01 2008 6 9 ANASTAZJA 7500 User Manual 6 5 3 Assembly lists 1 housing 5 locking spring 2 bellows 6 seal 3 rim 7 bellows base 4 spill over valve 8 holder 6 10 01 2008 6 Cleaning and sterilizing 6 5 4 Cleaning and Sterilizing Follow the machine and sterilizer manufacturer s cleaning recommendations 1 Cleaning 1 Disassembling AN WARNING Never separate the diaphragm and the valve seat in a pop off valve 2 To prevent component damage clean them lightly Put the recommended nonenzyme mild agent used for latex and plastic in hot water A CAUTION Do not immerse them more than 15 minutes to prevent inflation or aging 3 Rinse using clean hot water and then dry A CAUTION Dry by hanging while fully spread If moisture is left in the bellows they may become tacky 4 Check the components if they are broken or damp then perform the assembling and function te
74. or the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66MHz to 40 70MHz NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150kHz and 80MHz and in the frequency range 80MHz to 2 5GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 01 2008 10 9 ANASTAZJA 7500 User Manual 10 5 Physical specification All specifications are approximately maybe changed at any moment without notice A CAUTION Do not put ANASTAZJA 7500 into the shock environment A CAUTION Do not lay the heavy on the top or into the draws System Height 1350mm Width 656mm Depth 622mm Weight 148kg Castor 125mm 5 in with breakers on the front castors Drawer 130mm H x465mm W x360mm D Display 10 4 TFT LCD Cylinder gauge scale 0 to 25MPa Resolution 50kPa Accuracy 2 5 of full scale Pipeline gauge scale 0 to 1MPa Resolution 1MPa Accuracy 2 5 of full scale Airway gauge Scale 2 to 10kPa Resolution 200Pa Accuracy 2 5 of full sc
75. orrectly there is no any disconnection leakage faulty connection in gas circuits and pressure indicates correctly Stop using and check gas connections if abnormal A CAUTION To prevent from damage CON O o A OQ Open cylinder valve slowly Never control the flow with excessive force Skip step 2 if the system is not using cylinder gas supply Disconnect all pipeline gas supply and close all the cylinder valves e lf the readings of the pipeline pressure gauge and cylinder pressure gauge are not zero e switch on O supply e Adjust flow control to middle range e Make sure all the pressure gauges are reset to zero except the O pressure gauge e Switch off O supply e Make sure the O pressure gauge is reset to zero The low O supply alarm should be on when pressure drops Make sure cylinders are fully filled e Open each cylinder valve e Make sure the pressure of each cylinder is high enough In case the pressure is insufficient close the corresponding cylinder valve and install a fully filled cylinder Test cylinder high pressure leak one by one Close flowmeters Open the cylinders Record the cylinder pressures Close the cylinder valves Begin to record the pressures after one minute If O pressure drops to 5000kPa it means there is a leakage e f leakage exists according to direction of section 5 5 replace a new sheet gasket and then tighten T handle e Perform this step again If leakag
76. patibility problems Contact with FARUM S A for assistance Designing and testing this equipment is in accordance with the following stipulations A WARNING using cell phone or other radio radiant equipment near this product may cause malfunction Closely monitor the working condition of this equipment if there is any radio radiant supply nearby Using other electrical equipment in this system or nearby may cause interference Check if the equipment works normally in these conditions before using on a patient Be careful of the following when ANASTAZJA 7500 is connected Do not put any object which is not in accordance with EN60601 1 in the 1 5M range of patients An isolated transformer must be used for alternating current supply in accordance with IEC60989 or additional protective ground wires are equipped if all the devices for medical or non medical use are connected to ANASTAZJA 7500 by using signal input signal output cable If a portable all purpose outlet is used as the alternating current supply it must be in accordance with EN60601 1 1 and cannot be put on the floor Using another portable all purpose outlet is not recommended Do not connect the non medical equipment directly to the alternating current outlet on the wall Only the alternating current supply of the isolated transformer can be used Otherwise the surface leaking current may exceed the range permitted by EN60601 1 under the normal conditions and misoperation may
77. pecified in this manual Halothane desflurane sevoflurane enflurane and isoflurane have been found to be non flammable agents Independent means of ventilation e g a self inflating manually powered resuscitator with mask should be available whenever the anesthetic system is in use Do not use antistatic or electrically conductive breathing tubes and mask Leakage and douse of liquid such as anesthetic agent bring on dangerous states or malfunctions inside device 01 2008 2 1 ANASTAZJA 7500 User Manual a a AZ a Tea Tea Figure 2 1 Drawer Oxygen Flush Common Gas Outlet O N oO wo 11 ventilator 13 Isoflurane Vaporizer 7 5 Foa A 3 ANASTAZJA 7500 front view N20 pipeline pressure gauge Autoclavable Bellows Assembly Display Screen of anesthetic 15 N20 cylinder pressure gauge 12 13 14 15 MTI E x Reservoir Bag Absorber cycle Air pipeline pressure gauge Oz pipeline pressure gauge Flowmeters Enflurane Vaporizer O cylinder pressure gauge Figure 2 1 each control function on the front view of Anastazja7500 3 2 2 Item Oxygen Flush Common gas outlet Diagram 01 2008 Description Press Oxygen Flush button to supply O to the breathing system with high flow rate connects the anesthesia machine to the breathing system 2 Anesthetic System Control Turn the knob counterclockwise to increase the flow turn clockwise to decrease the flow
78. r 2kV for power supply lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Uy 60 dip in Ur for 5 cycles 70 UT 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the ANASTAZJA 7500 Anaesthetic Workstation requires continued operation during power mains interruptions it is recommended that the ANASTAZJA 7500 Anaesthetic Workstation be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 01 2008 Ur is the a c mains voltage prior to application of the test level 10 7 ANASTAZJA 7500 User Manual Guidance and manufacture s declaration electromagnetic immunity for LIFE SUPPORTING EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The ANASTAZJA 7500 Anaesthetic Workstation is in
79. r Manual 5 4 4 Pipeline gas supply inlet AIR N2O O 280kPa 600kPa 280kPa 600kPa 280kPa 600kPa 2 8bar 6bar 2 8bar 6bar 2 8bar 6bar Pressure inlet 280 to 600 kPa Pipeline connector DISS Diameter indexed safety system and NIST non interchangeable screw threaded It can prevent wrong connection generating 5 4 5 Cylinder gas supply inlet Cylinder connector PISS Pin indexed safety system It can prevent wrong connection generating A WARNING The connecting procedures of O and NO to the rear of the anesthesia system have been provided Each has a different dimension to avoid user s misoperation A continuous pressure monitoring device is installed in the front of the anesthesia system to monitor each gas that connects with hospital supply pipelines 5 8 01 2008 5 Installing and Connecting 5 5 How to install gas cylinder Testing high pressure leak AN CAUTION Do not turn the cylinder valve on when the pipeline gas supply is being used The gas supply of the cylinder may be used out in case of pipeline failure so that the backup supply may be insufficient 1 Turn the handle T of the cylinder valve clockwise until it is tight Close the valve of the cylinder to be changed Remove the valve cap from the new cylinder 4 Keep the cylinder inlet away from all the objects which could be damaged by the release of high pressure gas 5 To clear the cylinder valve of any debris use the cylinde
80. r Manual Frequency Medium f greater than upper Reset upper limit of f High limit Examine the patient and The patient has confirm independent independent respiration exists or respiration otherwise Frequency Medium Monitoring value not Check the connection and Low more than settings leakage of patient end Wye pipe falls off 8 3 Troubleshooting 8 3 1 Anesthesia machine troubleshooting and analyzing Symptom Possible Cause Recommended Action Patient breathing circuit APL valve is on Turn APL valve to off gasigax soda lime in the cylinder port Reinstall or remove the is not sealed very well natrium calcareousness grains at the joint Screw tubes are broken or Replace or reinstall the connector loosens valves loosen Tighten them Bag ventilator switch failure Please contact eligible service representative Excessive pressure APL valve is adjusted Adjust it properly caused by manual incorrectly ventilation Switch to bag control Leakage occurs at bag Please contact eligible service bellows charging switch ventilator switch representative to ventilator control bag charging APL valve doesn t work APL valve failure Please contact eligible service normally representative 8 4 01 2008 8 3 2 Symptom The digital tube has no power and ventilator does not work Ventilator stops operating suddenly indicator light turns off and sounds alarm Maximum pressure alarm sounds continuously Minimum pre
81. r limits be set below the lower limits 10 8 7 Volume Type of volume sensor Pressure difference Physiological dead space 9 5 mL of sampling probe 01 2008 10 15 ANASTAZJA 7500 User Manual 10 8 8 Monitoring performance Item Range Resolution Accuracy Vr O to 2000 mL 1 mL 30 mL below 200 mL 15 other MV O to 30 L min 1 L min 15 f O to 100 bpm 1 bpm 5 above 20 bpm 1 bpm other Poeak O to 8 kPa 0 1 kPa 200 Pa below 2 kPa 10 other Polat 0 to 8 kPa 0 1 kPa 200 Pa below 2 kPa 10 other FIO gt 14 to 105 1 3 C O to 99 mL cmH20 1mL cmH20 2 mL cmH20 below 10 mL cmH20 20 other Electric quantity 100 75 50 25 0 If 0 displays and mains supply not connected the system will shut down Paw t waveform Pressure monitoring range 20 to 80 cmH20 Paw t waveform display pressure axis varies with the upper alarm limit of Paw O to 30 cmH2O 10 to 40 cmH2O 31 to 50 cmH2O 15 to 60 cmH2O 51 to 80 cmH2O 20 to 80 cmH2O Paw t waveform display time axis varies with the f setting O to 20 bpm O to 15 sec 21 to 40 bpm O to 10 sec 41 to 100 bpm O to 5 sec Flow t waveform Flow scale 90 to 90L min Time scale O to 15s V t waveform Y Axis Tidal volume range O to 1 2L Paw V loop Y Axis pressure X Axis tidal volume V FLOW loop Y Axis flow X Axis tidal volume 10 16 01 2008 10 Specification and Operation Theory 10 8 9 O monitoring specification Response time Type of O
82. r of flowmeter is fragile A WARNING Disposal of waste or invalidated apparatus must be in accordance with the relevant policies in local government 7 1 Repair Policy Do not use malfunctioning equipment Make all necessary repairs or have the equipment serviced by an authorized FARUM S A Service Representative After repair test the equipment to ensure that it is functioning properly in accordance with the manufacturer s published specifications To ensure full reliability have all repairs and service done by an authorized FARUM S A Representative If this is not possible replacement and maintenance of parts in this manual should be performed by a competent trained individual with experience in Anesthesia Systems repair and appropriate testing and calibration equipment A CAUTION No repair should ever be undertaken or attempted by anyone without proper qualifications and equipment It is recommended that you replace damaged parts with components manufactured or sold by FARUM S A After any repair work test the unit to ensure it complies with the manufacturer s published specifications Contact the nearest FARUM S A Service Center for service assistance In all cases other than where FARUM S A warranty is applicable repairs will be made at FARUM S A current list price for the replacement part s plus a reasonable labor charge 01 2008 7 1 ANASTAZJA 7500 User Manual 7 2 Maintaining Outline and Schedule The followin
83. r wrench to briefly open then close the cylinder 6 Install the cylinder e Align index pin with the basic hole of the gas cylinder e Close yoke piece and screw handle T 7 Perform the high pressure leak test e Disconnect the pipeline gas supply e Close flowmeter e Open the cylinder e Close the cylinder e Record the pressure of the cylinder e If the pressure of the O cylinder drops more than 5000 KPa 725PSi after one minute the high pressure circuit has an unacceptable leak e lf the pressure of the N2O cylinder drops more than 690 KPa after one minute the high pressure circuit has an unacceptable leak Repairing gas leak Install a fresh cylinder gasket and tighten the connector Repeat this step Do not use this system in case of continuous gas leak 01 2008 9 9 ANASTAZJA 7500 User Manual 5 6 Connect gas scavenging transfer amp receiving system There are two ports releasing exhaust gas in this system Connect the two ports to gas scavenging transfer and receiving system with tubes 1 APL valve 2 Exhausting port of bellows assembly see the following figure number 2 is the exhausting port 5 10 01 2008 6 Cleaning and sterilizing ZN WARNING ZA CAUTION ZN WARNING ZA CAUTION Use a cleaning and sterilizing schedule that conforms to your institution s sterilization and risk management policies Refer to the material safety data policy of each agent Refer to the operating an
84. rvoir bag 42 Display screen A CAUTION Follow all instructions on how to operate all equipment in the anesthesia system including monitoring equipment alarm systems and protecting equipment 10 2 01 2008 10 Specification and Operation Theory 10 2 System technical specification 10 2 1 Drive Gas supply Pipeline Oo Air N2O Cylinder O NoO Connect to cylinder PISS pin indexed safety system Reducer 400kPa Connect to pipeline DISS male DISS female NIST ISO 5359 All fittings used to connect Oz Air and N20 pipeline gas supply are all ready Display pressure Gauges with color coded Input pressure at pipeline 280 to 600kPa inlets AN WARNING All gas supplies must be in accordance with medical level AN CAUTION Pressure at pipeline inlets must be according to 280 to 600kPa when delivering ceases in the anesthetic gas delivering system 10 2 2 Flow Gas component Scale thin tube Scale thick tube O 0 05 to 1 L min 1 1 to 10 L min N20 0 05 to 1 L min 1 1 to 10 L min Air 0 1 to 10 L min Accuracy With regard to the flow between 10 of full scale or 300 ml min higher is preferred and full scale under the condition of 20C 101 3 kPa flow meter precision is within the 10 of indicated values The precision is 4 degree when the flow is lower than 10 of full scale or 300 ml min higher is preferred Adjust O and Nitrous oxide proportionally to ensure the O concentration is no less than 25 O
85. s 3 months Stored environment should avoid dampness high temperature If improper maintenance makes battery damage replace it in time to avoid liquid of battery corrading the apparatus Replace the battery please contact FARUM S A service representatives FARUM S A is not legally responsible for the damage caused by improper maintenance or operation AN CAUTION An authorized FARUM S A services representative can replace battery If not to use the battery for long time please contact FARUM S A service representatives to disconnect battery The waste battery should be disposed in accordance with the local policies 7 18 01 2008 8 Alarm and Troubleshooting A WARNING No repair should ever be undertaken or attempted by anyone without proper qualifications and equipment 8 1 About alarm A CAUTION If alarm occurs protect patient safe firstly and then go to diagnose fault or service it necessarily Alarm messages displays on the top area of display screen See Figure 8 1 1 Figure 8 1 Alarm message area The high priority alarms must be disposed immediately Priority Volume Silence Prompt Alarm bell High 5 tones 2 hurry 110 seconds Red background 3 Red flickering Periods 9 seconds Displaying frequency 2HZ Medium 3 tones 110 seconds Yellow background 2 1 Yellow flickering Periods 6 seconds Displaying frequency 0 5Hz Low 2 tones 110 seconds Yellow background 1 Yellow Periods 27 se
86. ss of calibration the word Calibrating displays on the screen CAL finish will be displayed on the window after the calibration succeed If 100 calibration failure the word CAL fault displays on the window If the calibration failure occurs e Recalibrate it e Reduce airway pressure and try it again e f failure still exists replace O sensor and perform 21 calibration Step 9 Press MENU key to exit directly 7 10 01 2008 7 User Maintenance 7 3 3 Calibrate flow sensor Step 1 Press MENU key a menu window appears on the screen Step 2 Turn the knob to select Cal submenu RETU Press the knob the sett Cu rsor appears on the F si y e i 53 ET Llarm set Info Return E 01 2008 7 11 ANASTAZJA 7500 User Manual Step 3 Turn the knob to select Flow sensor syst em Milan set l Please elert lease EE lc Press the knob a new window named Flow Sensor Calibration covers the original Pay attention to the prompt on the screen Step 4 Press the knob to j perform the calibration gt ystem sel Info In the process of calibration the word Calibrating displays on the screen 7 12 01 2008 7 User Maintenance CAL finish will be displayed on the window after the calibration succeeds Step 5 Turn the knob to select Return option Press the knob back to
87. ssure alarm sounds continuously No indication from the airway pressure gauge Tidal volume readings does not display normally The bellows is inflated excessively The bellows does not expand during ventilation or tends to collapse Possible Cause Power supply unplugged Power switch is off Fuse is burned Power supply is interrupted cable IS Patient circuit is occluded Patients respiratory tract is occluded Maximum pressure setting is too low Ventilator parameters changed Patient s pipeline leaks Alarm settings is too high Patient s co operation changes Sampling hose is disconnected or broken Sampling hose is disconnected Gas supply drains Flow sensor is unplugged The inner and outer O rings of bellows base are broken Bellows is broken Pop off valve is broken Gas scavenging port is occluded Malfunctioning waste gas scavenging system creates excessive resistance or vacuum Breathing resorption interface is unplugged Bellows base is broken Tear or leak in the bellows Exhalation diaphragm is broken O rings are broken 01 2008 8 Alarm and Troubleshooting MV300 Troubleshooting and Analyzing Recommended Action Plug in power supply cable Turn on power switch Replace with a new one Use manual ventilation Check and adjust patient circuit Check the patient Readjust the alarm setting Recalculate the ventilator parameter Check the pipeline leak part Reset the alarm settings
88. st 5 Connect the bellow assembly ventilator and breathing system 6 Perform the preoperative check 2 Sterilizing Cleaning and sterilizing must be performed at the same time Follow instructions for the common bellows assembly sterilization methods Sterilizing after general patient use Clean the inner and outer parts of the bellows assembly in a soap and water solution Rinse thoroughly in cold water and dry with soft cloth Immerse plastic and latex instruments in 70 80 ethyl alcohol for half an hour Take them out using the aseptically transmits pliers then store in clean containers Repeat this step before next use Components made of metal and glass can be sterilized with high pressure steam When the steam pressure is increased by the autoclave the rising temperature can concrete the bacterium protein rapidly to kill bacteria In 1 05 KG CM2 steam pressure the temperature rises to 121C All bacteria and most sorus can be killed if this temperature is maintained for 15 25 minutes Sterilizing after special infection or infectious patient use Open pulmonary TB pulmonary abscess pseudomonas tetanus aeruginosa infection gas gangrene or infectious hepatitis is included Used bellows assembly components must be completely sterilized according to preliminary and final disposal procedures 01 2008 6 11 ANASTAZJA 7500 User Manual 1 Preliminary disposal Perform in accordance with the isolated disposal stipulation Collect
89. sthetic Workstation is CISPR 11 suitable for use in all establishments including Harmonic emissions domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fications flicker emissions Complies IEC 61000 3 3 10 6 01 2008 10 Specification and Operation Theory Guidance and manufacture s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The ANASTAZJA 7500 Anaesthetic Workstation is intended for use in the electromagnetic environment specified below The customer or the user of ANASTAZJA 7500 Anaesthetic Workstation should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50Hz magnetic field IEC 61000 4 8 NOTE IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 UT 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Compliance level 6 kV contact 8 kV ai
90. tanage me easace aie nel N 2 17 2 5 2 MENTA Ma area 2 20 3 OPERATING GUIDE oca aooscas 3 1 3 1 STARTING VS TEM al iia 3 1 3 1 1 ANAIS E A sees aa et ann e E e O 3 3 3 1 2 Restore Delat SOl oriai a i cea E A 3 6 3 1 3 ventillan Modo le decades 3 9 3 1 4 venator CONUO OO raii ir r A A a ra 3 10 3 2 STARTINGAUTO VENTILATION 0 tee lote a e a 3 11 329 SHUTTING OFFAUTO VENTILATION ii iodo a ea ae N 3 12 Oe O A N 3 13 3 4 1 AAA TOTS ech tah Sel li do 3 13 3 4 2 PATI SUCIIC Oe asec ah ts sate ong sheers a aap ute babii dugat bei tede deh vndaapenteie satan Gabe ete 3 13 OO WNEFORM onrein a title 3 14 4 PREOPERATIVE CHECKOU Tania aa 4 1 4 1 ANASTAZJA 500 PREOPERATIVE CHECKOUT PROCEDURES c cccoccccccnconcncnncnnnnnnnncnconcnonncnnnnnnnos 4 1 4 1 1 SV SION CAC CKOUE aryen Terena a E E A a 4 2 4 1 2 Mains failure A EDTO Sita ii A A dit ie 4 2 4 2 TESTING THE GAS SUPPLY PIPELINE AND THE GAS CYLINDER 0cccceeeeseeeeeeeeeaeeseeeeseeeesaees 4 3 4 3 MONITORING FLOW CONTRO Esad ia 4 5 4 3 1 Monitoring without OXYYQEN ooccocccocccocncoconoconoconocncnononononononanonanonanonnnnnannnannnaronannnnrnnnos 4 5 4 3 2 Monitoring With OXY GON 1 ccccccceccnsescnsesccneccsessusensusensusccusessusensusensuseausessusessanenauseaes 4 7 4 4 INSTALLING AND TESTING OF VAPORIZER sccccsccceeeeceseecaseccseeceueesaueesaueeeaeesegeesaueeseeeeseeeeees 4 9 4 4 1 MSTA UON erea E E Sad smianbaaaetcseadenicy E 4 9 4 4 2 Testing Vaporizer Back Pressure
91. tended for use in the electromagnetic environment specified below The customer or the user of ANASTAZJA 7500 Anaesthetic Workstation should assure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic environment guidance test test level level Portable and mobile RF communications equipment should be used no closer to any part of the ANASTAZJA 7500 Anaesthetic Workstation including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted 3 Vims d BSP RF 150 kHz to Y IEC 80 MHz 12 61000 4 6 outside ISM d E bands Y NP 150 kHz to 8O0MHz in ISM band J 27 800 MHz to 2 5 GHz 1 10 Vern ar 80 MHz to 800 MHz E 1 Radiated RF IEC Where P is the maximum output power rating of the 61000 4 3 10 V m 80 MHz to 2 5 GHz transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres 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 with the following symbol Co NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is
92. terface Use oxygen sampling line to connect O sensor with O sensor interface Oxygen concentration value measured by O sensor is transmitted to the ventilator through O sensor interface If no O sensor in the breathing system the alarm message No O sensor will be shown in the display screen 01 2008 2 15 ANASTAZJA 7500 User Manual 4 Exhaust Port 5 Driven Gas Outlet 6 Fuse 8 P amp V interface Accessory relatively 2 16 Don t block exhaust port It is only a outlet of driven gas Safety valve inside exhaust port may be used to limit maximum of airway pressure When airway pressure exceeding the maximum the safety valve will open and exhaust for protecting airway of patient The maximum airway pressure is 6 kPa Size male 16 mm taper Use thread tube to connect driven gas outlet with driven gas inlet of bellows Inspiratory phase gas from ventilator drives bellows to make fresh gas enter into the airway Expiratory phase return gas from the airway drives bellows to make gas from ventilator exhaust through exhaust port 250V 1A 5X20 T more details refer to section 7 5 3 Connect sampling parallel line to P8V interface the other end to probe It provides basis for monitoring and troubleshooting that the real time airway pressure is transmitted to the ventilator Parameter monitored such as Vr and MV are calculated by ventilator basing on the flow via the probe A CAUTION Ensure samp
93. tion flow insp 134 C Autoclavable Auto ventilation Gas cylinder 1 4 ci Exp XXXX View the reading on the top of float Reservoir bag location manual ventilation Movement in two directions Unlock Open drain valve release liquid Expiration flow Oxygen flush CE Representative The system with this label under the stipulations in the operating manual complies with the requirements related from 93 42 EEC xxxx is the certificate number used by FARUM S A quality system to certify authorizations 2 Anesthetic System Control 2 1 Anesthetic system ZA CAUTION WARNING ZN WARNING ZN WARNING ZN WARNING The anesthetic system is intended to be used with the following monitoring devices alarm systems and protection devices pressure measuring in accordance with 8 1 of ISO 8835 2 pressure limitation device in accordance with 51 101 1 of 1EC60601 2 13 exhaled volume monitor in accordance with 51 101 4 of 1EC60601 2 13 breathing system integrity alarm system in accordance with 51 101 5 of IEC60601 2 13 continuing pressure alarm in accordance with 51 101 6 of IEC60601 2 13 O monitor in accordance with ISO 9918 To avoid explosion hazards flammable anesthetic agents such as ether and cyclopropane shall not be used in this anesthetic workstation Only anesthetic agents which comply with the requirements for non flammable anesthetic agents as s
94. urn the knob to select Return and then press it Step 9 Exit Menu 1 Turn the knob to select Exit menu and then press it or 2 Press MENU key directly T pe int oa 01 2008 3 5 ANASTAZJA 7500 User Manual 3 1 2 Restore Default Set Restore default setting includes eo Wave and P_unit items in the system submenu e All items in the alarm_set submenu In a state of default waveform display and pressure unit is Flow t and 0 1kPa respectively about details of alarm setting refer to section 8 4 Step 1 Press MENU key 0 Menu then display a menu ME window on the screen Display Language ENGLISH Mes mine kPa Step 2 Press the knob the Menu cursor point to Return automatically Display Language ENGLISH Wave Eras D 1kPa MET 3 6 01 2008 Step 3 Turn the knob to select Default Step 4 Press the knob and then display a dialogue box on the menu Step 5 Turn the knob to select Yes and then the state of Wave and P_ Unit restore default setup See section 8 4 3 Operating Guide 01 2008 mj ab aae Jefa MES rt re E Nm al ira ta arar are od Sure 1 obren AeTturr T ol into Feturn ReTuUrr 3 7 ANASTAZJA 7500 User Manual Step 6 Exit System menu Turn the knob to select Return and then press it Step 7 Exit Menu 1

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