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Mindray Wato EX-65 Anaesthesia Machine

1. 9 1 3 1 Parameter amp graph Area This area may display E CO2 parameters m AG parameters E BIS parameters WN Electronic flowmeters For details refer to the respective sections of this chapter 5 1 3 2 Big Numerics Measured Values Sharing Area This area displays either big numerics or measured values EH When screen layout is set to big numerics this area is displayed as shown below E When screen layout is set to measured values screen this area displays Paw waveform and ventilation parameters as shown below cmH20 a cmH201 Lts c 1 J mLicmH20 5 2 Screen Setup To set the desired screen style 1 Select the Screens shortcut key and select Screens 2 You can toggle between Normal Screen Big Numerics and Measured Values 5 3 Parameter Monitoring 5 3 1 O2 Concentration Monitoring If your anesthesia machine is configured with an O2 sensor select Maintenance User Maintenance gt gt Set 02 Sensor Monitoring gt gt Then select ON from the pop up menu to monitor the patient s F102 Select OFF if you do not need to use the O2 sensor monitoring function which the anesthesia machine has You can make the following settings when O2 Sensor Monitoring is set to ON 5 3 1 1 Switch on O Sensor or O Module l Select the User Setup shortcut key and select O2 Monitoring Source gt gt 2 Select O2 Sensor or 02 Module as desired Select OFF if you do not need to use t
2. Low Limit 0 to Chigh limit 5 mL than the low limit The specified high limit shall always be greater High Limit 0 2 to 30L Low Limit ES lt 0 to 1OL than the low limit High Limit 4 to 100 BPM The specified high limit Rate shall always be greater 2 to Chigh limit 2 BPM than the low limit High Limit 6 to 97 cmH 0 Paw B 9 Anesthetic vaporizer Anesthetic vaporizer for details refer to the vaporizer Instructions for Use Penlon Sigma Delta or Sigma Alpha anesthetic vaporizers Five Type types of vaporizers with anesthetic agents halothane enflurane isoflurane sevoflurane desflurane are available Single or double vaporizer positions optional l Selectatec with interlocking function Selectatec is registered Mounting mode trademark of Datex Ohmeda Inc B 10 AGSS Transfer and Receiving System Specifications Stainless screen with hole diameter of 140 150 u m State indication of the disposal The float falls below the MIN mark on the sight glass when the system disposal system does not work or the pump rate is lower than 50 L min Connector of the disposal BS6834 1987 standard connector system B 10 B 11 O2 Sensor Specifications Output 9 13 mV at 210 hPa O2 Range 0 to 1500 hPa O2 100 O2 signal deviation 10041 o Expected working life 1 5 x 106 for measurement 20 C PE 0 8 x 106 for measurement 40 C Response time 21 air to 100 02 Linearity Linear
3. 3 Return address Please send the part s or equipment to the address offered by the Customer Service Department Contact Information Manufacturer Shenzhen Mindray Bio Medical Electronics Co Ltd Address Mindray Building Kej1 12th Road South Hi tech Industrial Park Nanshan Shenzhen 518057 P R China Tel 86 755 26582479 86 755 26582888 Fax 86 755 26582934 86 755 26582500 Website www imindray com EC Representative Shanghai International Holding Corp GmbH Europe Address Eiffestrabe 80 Hamburg 20537 Germany Tel Fax 0049 40 2513175 0049 40 255726 IV Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety This manual is based on the maximum configuration and therefore some contents may not apply to your product If you have any question please contact us This manual is an integral part of the product It should always be kept close to the equipment so that it can be obtained conveniently when needed Intended Audience This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures practices and terminology as required for monitoring of critically ill patients Illustrations All illustrations
4. 4 Select Scale to change the select CO waveform scale Options include 40 60 and 80 if the unit is mmHg 5 0 7 5 and 10 0 if the unit is or kPa 5 Select X to exit the current menu For details about displaying the CO waveform refer to 5 3 3 2Display CO2 Waveform 9 6 Change Anesthetic Agent If the anesthetic agent used changes the AG module is capable of detecting the gas mixture during the transition period The time required for anesthetic agent exchange depends upon the type of anesthesia low flow or high flow and the features of the anesthetic agents used pharmacokinetics During the exchange the anesthesia machine gives no prompt message and the MAC values displayed may be inaccurate The M type AG module cannot identify anesthetic agent automatically Therefore you need to change the setting of Agent to let the agent set consistent with the agent applied The A type AG module can identify anesthetic agent automatically When one anesthetic agent decreases below the threshold value and another anesthetic agent plays the dominant role the anesthesia machine can identify such exchange automatically and displays the name and data of the dominant anesthetic agent 9 7 Measurement Limitations Measurement accuracy may degrade due to Leakage or internal leakage of the sample gas Mechanical shock Cyclic pressure which is greater than 10 kPa 100 cmH20 Other interference source if av
5. 4 Select X to exit the current menu 5 3 5 5 Review TVe and MV Trends For details about reviewing TVe and MV trends refer to 12 Trend and Logbook 5 3 6 Tidal Volume Compensation Tidal volume compensation compensates for lack of tidal volume due to the effects of Fresh gas flow or Loss of gas compression or Breathing system compliance or Small amount of leakage or Combination of the factors above to achieve the consistency between actually delivered tidal volume and the set tidal volume By default the system automatically performs tidal volume compensation If the measured tidal volume is quite different from the tidal volume indicated by the bellows you can turn off tidal volume compensation By changing the set tidal volume or switching over to pressure ventilation mode you can achieve the consistency between the tidal volume indicated by the bellows and the tidal volume required To turn off tidal volume compensation do as follows 1 Select the User Setup shortcut key 2 Select TV Comp and select OFF 3 Select to exit the current menu If the current ventilation mode is VCV or SIMV VC the system prompts TV Comp Off when tidal volume compensation is turned off In the volume ventilation mode tidal volume compensation is turned off automatically if the fresh gas pressure is too high or the flow sensor has a great measurement deviation or there is significant leakage in the breathing system
6. Other options selects an appropriate value according to the amount of O2 in the ventilation gas mixture 8 14 m AG Comp enters the concentration of anesthetic gas if there is in the ventilation gas mixture to compensate for the effect of anesthetic gas upon the readings The total of the concentrations of O2 compensation and AG compensation cannot be greater than 100 8 5 2 4 Set Maximum Hold In the CO2 parameter area EtCO2 and FiCO2 values are refreshed in real time To set EtCO2 and FiCO2 1 Access the Gas Module Setup gt gt menu 2 Select Max Hold and select Single Breath EtCO and FiCO are calculated based on each breath 10 sland 20 s EtCO and FiCO2 refer to the highest and the lowest CO2 values measured respectively within the configured time period 10 s or 20 s 8 5 2 5 Restore Defaults Select Defaults from the Gas Module Setup gt gt menu Then all the menu options except Working Mode are restored to the factory default configurations 8 5 2 6 Set CO2 Waveform 1 Select the waveform area to access the waveform setup menu 2 Select Waveform and select CO2 3 Select Sweep and set waveform sweep speed to an appropriate value The greater the value is the faster the waveform sweeps the wider the waveform is 4 Select Scale and toggle between 9 40 60 and 80 if the unit is mmHg 5 0 7 5 and 10 0 if the unit is or kPa 5 Select LX to exit
7. easily switch between the other three types of screen by using the Screens shortcut key NOTE This manual describes all functions and modules Some of the operations may be inapplicable to your equipment All illustrations in this manual serve as examples only They may not necessarily reflect the setup or data displayed on your anesthesia machine 5 1 5 1 1 Standby Screen When the anesthesia machine is not in use for a short period of time entering standby status can help save power and extend service life of the machine The anesthesia machine enters standby status automatically after start up To enter standby status you can also push the D key in operating mode and then select Ok from the pop up menu The following figure shows the standby screen 2008 07 11 10 10 24 JD fal Vent Mode Al Alarm Setup User Setup Press to exit standby Maintenance Rate BPM TIP TI Plimit cmH20 PEEP omH20 300 15 25 30 OFF In standby status the following changes occur to the system NW Displaying monitored parameters and waveforms is disabled The system is in standby Status m The ventilator stops supplying gases m The parameters can be set When the standby status exits the system will operate based on the final settings in standby status m Physiological alarms are cleared automatically Technical alarms function normally NW The gas module enters standby status To exit standby push
8. Key Error M The key was pressed and held for more than five seconds E ee Keyboard malfunction Stop using the keyboard Contact help the patient breathe and restart the anesthesia machine Ventilator Device Fault H Equipment malfunction Mechanical ventilation and Ventilate Manually monitoring did not work Use manual ventilation mode to If the alarm cancels restart mechanical ventilation Ventilator H CPU error Unreliable monitoring Use Hardware Error 01 manual ventilation mode to help Ventilator H RAM error the patient breathe Contact your Hardware Error 02 service personnel Ventilator H ROM error Hardware Error 03 Ventilator H Watchdog error Hardware Error 04 a Ventilator H EEPROM error Hardware Error 05 Ventilator H Internal AD error Hardware Error 06 Ventilator H External AD error Hardware Error 07 Ventilator H 5 V power error Hardware Error 08 Ventilator H 12 V power error Hardware Error 09 Ventilator H Safety valve control Hardware Error 11 failure by the auxiliary control board Ventilator H Safety valve control Hardware Error 12 failure by the main control board Auxi Ctrl Module H No message of test completion is received after 10 second Error wait during the auxiliary control board pressure effectiveness and safety valve control effectiveness test No message of zeroing completion is received after 10 second wait when the auxiliar
9. Push the control knob and turn it to set Backup Mode Active to the appropriate value 3 Push the control knob to confirm the setting 4 Select Ok to activate the current setting 5 To cancel the current setting and exit the current menu select Cancel or push the Normal Screen key 4 20 4 4 6 6 Parameter Range and Default Value in PSV Mode Pinsp 5 to 60 cmH20 lcmH20 15cmH20 PCV backup 4 to 60 BPM ventilation mode me armor IBPM 12 BPM Plimit 10 to 100 cmH20 1 cmH20 30 cmH20O 5 to 60 cmH20 l cmH20 15 cmH20 OFF 4 to 30 PEEP lemH20 OFF cmH20 Trigger Pressure 20 to 1 cmH2O 2 cmH20 Level sota Osim PSV Insp a 5 to 60 5 25 Termination Level 4 5 Start Mechanical Ventilation After settings of the related parameters are already made you can enter mechanical ventilation mode by pushing the Standby key D on the panel and then selecting Ok from the pop up menu to exit the standby status The system will then work in the selected mechanical ventilation mode NOTE o Before starting a new mechanical ventilation mode make sure that all related parameters are set appropriately 4 21 4 6 Set the Timer 4 6 1 Start the Timer To start the timer select the timer setup shortcut key and select Start NOTE eo During timing if you select Start from the Timer Setup menu again timing continues normally instead of restart 4 6 2 Stop the Timer To stop
10. and Low Limit respectively for each parameter 3 Select X to exit the current menu 11 4 4 Set BIS Alarm Limits 1 Select the Alarm Setup shortcut key and then Gas Module gt gt 2 Set High Limit and Low Limit respectively for each parameter 3 Select X to exit the current menu 11 5 Set Alarm Level To set the alarm level for CO2 or AG select the Alarm Setup shortcut key Gas Module gt gt Alarm Level The CO2 or AG alarm level toggles between High and Med To set the alarm level for BIS select the Alarm Setup shortcut key BIS Module gt gt gt Alarm Level The BIS alarm level toggles between High Med and Low NOTE eo For this anesthesia machine only alarm levels for the parameters related to CQ AG or BIS module can be set Alarm level for other parameters is factory configured 11 6 Set Cardiopulmonary Bypass CPB Alarm In non mechanical ventilation mode l Select the Alarm Setup shortcut key and select Ventilator gt gt 2 Select CPB and toggle between ON and OFF The systems prompts CPB when CPB is set to ON 3 In mechanical ventilation mode the system automatically sets CPB to OFF Such setting is not user adjustable N WARNING Take care to set CPB to ON because some physiological alarms are not triggered under this setting These disabled physiological alarms include apnea alarm Volume Apnea gt 2 min Paw too low TVe t
11. 0 100 O2 Packaging Sealed package Service life Not more than 13 months after unpacked in compliance with the service conditions specified by the manufacturer Effect of interfering gas 50 He 50 02 80 N2 0 20 02 47 Halothane 28 8 02 67 2 N20 5 Sevoflurane 28 57 02 66 5 N20 5 Enflurane 28 5 02 66 5 N20 1 8 5 Isoflaranc 28 59 02 166 5 N20 5 CO2 28 5 02 166 5 N20 Theory of Operation O2 sensor can monitor the patient s F102 O2 sensor is of the self powered diffusion limited metal air battery type comprising an anode electrolyte diffusion barrier and air cathode as shown below Air supply Solid membrane Diffusion barrier Load resistor ___Electrolyte At the cathode oxygen is reduced to hydroxyl ions according to the equation O2 2H20 4e gt 40H The hydroxyl ions in turn oxidise the metal anode as follows 2Pb 40H gt 2PbO 2H20 4e Overall the cell reaction may be represented as 2Pb 02 gt 2PbO 02 sensor 1s current generator and the current is proportional to the rate of oxygen consumption Faraday s Law This current can be measured by connecting a resistor across the output terminals to produce a voltage signal If the passage of oxygen into the sensor is purely diffusion limited by the solid membrane diffusion barrier then this signal is a measure of the oxygen partial pressure Signal Stability O2 sensor has highly stable outputs over their ope
12. 1 min 2 min and 4 min to view the trend graph 12 1 12 2 Trend Table A trend table is used to recall the patient s physiological parameter data at a specific time point The parameter data are reflected through a table You can recall TVe MV Ppeak FiO EtCO Plat PEEP Pmean Rate and BIS data at the selected resolution within a maximum of 24 hour operating time When the anesthesia machine 1s restarted the trend table is recorded anew Select the Maintenance shortcut key Trend and Logbook gt gt Trend Table gt gt to access the window as shown below Trend Table E Time 10 11 01 10 10 30 10 10 00 10 09 30 10 05 00 10 08 30 10 08 00 10 07 30 View the previous page E Select Resolution and toggle between 30 s 1 min 5 min and 30 min to view the trend table E To browse the trend table Select Left or Right to scroll left or right to view more measured values Select Prev Page or Next Page to scroll up or down to view more measured values 12 2 12 3 Alarm Logbook For alarm logbook the system provides up to 100 events which are stored in chronological order When a new event occurs after 100 events are already stored the new event overwrites the earliest one To access the Alarm Logbook window select the Maintenance shortcut key Trend and Logbook gt gt Alarm Logbook gt gt Phys Alarm Logbook rt 12 12 08 55 R
13. 6 Set Cardiopulmonary Bypass CPB AlarM onnnnnnnnnnnnininococonocininininnnnnnnnnnnnnnnnanananannnnns 11 5 PLASCENMIVS TVE ADI e a hace tahoe alan teal 11 6 TTS Det Aiea O olen eee nen eee a ees 11 6 EI Alarm SUENA TA sa 11 7 MI o o EMMA O AE AO A ste 11 7 TES Cancel l20 Ss Alar S eC E sa add 11 7 S OY a Ne Mane E Reais ates Se NE Fare Pe E Sees PERSO 11 7 P Trend ANG TOS DOOK wiceciss da 12 1 Ia hs 2X6 D deere Rea nee eee mc ERIC nee RCE EEE EIR TRICE REPRE ICR TE SMNCE ERE ann Een on eee ae tericner ep ae ten 12 1 DCM ACen N E E S EEE aca E EEE N ERN 12 2 WARS LOr DOO AAA E ATE 12 3 13 Installations and Connections wisscccceccccdedecectcacccacccedadecusecedececsecdesdsaccdedeacdesessssededdesssecess 13 1 lista llibe Breathino Sye earner ono 13 1 13 1 Breathing System Diastams di 13 2 AZC rur Adap er DIAT anea E E E eh tae 13 3 13 1 3 Install the Breathing system ccccccccccccccoconononononinininininaninnnnnnnnnnnnnnnnnnnnnnnnnannns 13 4 1314 Install he ae A E E EA 13 6 tansal the Belo WS R 13 7 ILO Mal ther low Sens ad 13 9 Sic r Instale OZ EOS Fundido 13 10 13 08 Instale Soda CAMUS AA 13 12 13 2 Install the Breathing TUS E E 13 19 13 3 distal he Midna Ban ada ian na de aer O ad wens 13 20 3 Ae iaSta lhe VADO o ist 13 21 A ASS EME the O mentee eee eat ie ene N Cert Eats oe ren Ceres Eaters ee oe 13 21 13 42 Fill the Va porze er a A A E T TENA 13 25 Ds A A ANON 13 27 13 35 InstallReplace Me Gas Cid eS area 13 29 1526 Mas C
14. Automatic sensor zeroing failed Zero the sensor manually or restart the machine 3 way Valve 3 way valve connection or control failure The machine L TV Not Achieved The tidal volume was less than the set value for Failure was operational but with unreliable monitoring Use manual ventilation mode to help the patient breathe when necessary Heating Module Thermistor or heating rod failure Check the sensor for Failure vapor condensation IP Address Conflict M Set IP address again Mechanical H Software reset abnormal Restart the anesthesia machine Ventilation Failure If the problem persists contact your service personnel D 7 TVe gt TVI1 TVe is greater than TVi for consecutive six cycles Check the flow sensor TV Delivery Too TVi is greater than the set value by 20 for consecutive High i Insp Reverse Flow There is gas flowing through the inspiratory flow sensor six times Check the fresh gas flow during expiration for consecutive six cycles Check the inspiratory check valve There is gas flowing the expiratory flow sensor during Exp Reverse Flow inhalation for consecutive six cycles Check the expiratory check valve Auxiliary control Channel Failure Auxi Ctrl Module H Selftest CPU error Auxiliary control module Hardware Error 01 hardware selftest error The Auxi Ctrl Module H Selftest RAM error safety protection mechanism Hardware F roro may be ineffective It is ded
15. BIS Module Setup menu and then select ON Press the key on the BIS module Select Start Sensor Check in the BIS sensor check window NW The cyclic impedance check stops automatically if the impedances of all electrodes are within the valid range To manually stop a cyclic impedance check you can either Select Cyc Imped Check in the BIS Module Setup menu and then select OFF Press the LF key on the BIS module Select Stop Sensor Check in the BIS sensor check window 10 8 BIS Sensor Check Window To open the sensor check window select Sensor Check gt gt in the BIS Module Setup menu The graphic in the BIS sensor check window automatically adapts to show the type of sensor you are using show three or four electrodes as required Each symbol in the graphic represents an electrode and illustrates the most recently measured impedance status of the electrodes is the reference electrode the ground electrode 3 and are signal electrodes Pass Pass Pass 10 6 1 Measure electrode impedance 2 Time of the most recent impedance check 3 Start stop cyclic impedance checks 4 Show sensor information The measured electrode to skin impedance and electrode status are displayed above each electrode Lead off Electrode falls off and has no skin Reconnect electrode or check the contact sensor to skin contact If necessary clean and dry skin Noise The EEG signal 1s too noisy
16. CO alarm limits Range mmHg Accuracy mmHg Step mmHg EtCO High Limit low limit 2 to 150 1 EtCO Low Limit 0 to high limit 2 FiCO2 High Limit 0 to 150 Microstream CO2 Module Specifications Microstream CO module Measurement mode Microstream Measurement range Accuracy Measurement range 0 to 38 mmHg 2 mmHg and accuracy 39 to 99 mmHg 5 0 08 for every ImmHg above 38mmHg Measurement Meets accuracy requirements within 6 hours accuracy drift B 14 Microstream CO module Flow 50 mL min accuracy 7 5 mL min 15 mL min eat El 30 s typical reaching 5 of the accuracy in stable state within 3 Initialization time minutes Rise time lt 190 ms 10 to 90 Delay time 2 7 s typical System total eee 2 9 s typical including rise time and delay time response time Calibrate the module for the first time after it has worked for 1200 hours Calibration cycle and thencalibrate once per year afterwards Or calibrate the module after it has worked for 4000 hours whichever is longer Microstream CO module alarm specifications CO alarm limits Range mmHg Accuracy mmHg Step mmHg EtCO High Limit low limit 2 to 99 1 l EtCO Low Limit 0 to high limit 2 Sidestream CO2 Module Specifications Sidestream CO module Measurement range Accuracy Measurement range and 0 to 40 mmHg 2 mmHg accuracy 41 to 76 mmHg 5 of the reading 77 to 99 mmHg 10 of the reading a
17. Check the sensor to skin contact If ee necessary clean and dry skin Although BIS may still be measured when the electrode status is Noise or High all electrodes should be in Pass status for the best performance 10 9 Set BIS Smoothing Rate Select Smoothing Rate from the BIS Module Setup gt gt menu and toggle between 10 s 15 s and 30 s The smoothing rate defines how the anesthesia machine averages the BIS value A smaller smoothing rate indicates increased responsiveness to changes in the patient s state A bigger smoothing rate indicates a smoother BIS trend with decreased sensitivity to artifacts 10 10 Restore Defaults Select Defaults from the BIS Module Setup menu Then all the options in this menu except Cont Imped Check and Cyc Imped Check are restored to the factory default configurations 10 7 10 11 Set BIS Related Waveforms To set BIS EEG waveform l 2 gt Select the waveform area open the corresponding menu Select BIS EEG for Waveform Select Sweep and set waveform sweep speed to an appropriate value The greater the value is set to the faster the waveform sweeps the wider the waveform 1s Select Scale and set waveform scale to an appropriate value Select Filter and toggle between ON and OFF Select LX to exit the current menu To set BIS Trend waveform l 2 3 4 Select the waveform area open the corresponding menu Selec
18. Cylinder supplies could be depleted leaving an insufficient reserve supply in case of pipeline failure eo Use a new gasket when installing or replacing the cylinder 13 30 13 6 Install Modules Push the module into the slot with force until you hear a click indicating the module is installed in place To remove the module lift the wrench at the bottom of the module and then drag the module outward After inserting the module make sure that the indicator on the module is lit up If not re plug the module 13 6 1 Install the CO2 Module 13 6 2 Install the AG Module 13 31 13 6 3 Install the BIS Module 13 7 Pneumatic Connectors This anesthesia machine provides two types of connectors pipeline connectors for Oo N20 and AIR and cylinder connectors for O and N20 For the pipeline connectors four types of configuration are available Or O and N O O and AIR O N20 and AIR For the cylinder connectors three types of configurations are available O2 O and NO O and O For details refer to 2 2 Equipment Appearance WARNING Use medical grade gas supplies only Other types of gas supplies may contain water oil or other contaminants When the central piping system fails one or more equipment connected may stop work Make sure that cylinders are available When gas supplies are cut off there is still pressure inside the pipeline Remember to release the gas inside the pipe
19. Gas Exhaust tube Metal chip To scavenge the sample gas to the waste gas disposal system depress the metal chip and then plug the exhaust tube to the ports marked A sample gas return to the AGSS on the anesthesia machine as shown in the above picture WARNING When using microstream CO2 module to perform CO2 measurements on the patient who is receiving or has recently received anesthetic agents connect the gas outlet to the waste gas disposal system to prevent the medical staff from breathing in the anesthetic agent 8 11 8 4 5 Zero the Sensor Zeroing the sensor aims to eliminate the effect of baseline drift on the readings during the measurement so as to ensure measurement accuracy For microstream CO2 module a zero calibration is carried out automatically when necessary You can also start a manual zero calibration when deemed necessary To manually start a zero calibration enter the Gas Module Setup gt gt menu and then select Zero You do not need to disconnect the sensor from the breathing system when performing the zeroing 8 4 6 Calibrate the Sensor For microstream CO2 module a calibration should be performed once a year or when the measured value has a great deviation 8 4 7 Oridion Information Microstream This trademark is registered in Israel Japan German and America already Oridion Patents This device and the CO2 sampling consumables designed for use herewith are covered by o
20. In this case the system prompts TV Comp Off and the menu item of TV Comp turns grey indicating that this option 1s disabled You need to troubleshoot the problem After the fault is troubleshot the system prompts TV Comp Available You can set TV Comp to ON to restore the TV compensation function 5 12 5 3 Volume Monitoring 5 3 1 Display Volume Waveform Volume ml 3000 5 3 7 2 Set Volume Waveform 1 Select the waveform area to access the waveform setup menu 2 Select Waveform and select Volume 3 Select Sweep and toggle between 6 25 mm s and 12 5 mm s The greater the value is the faster the waveform sweeps 4 Select Scale and toggle between 500 1000 and 1500 The volume ranges corresponding to the waveform scales are 500 0to500 ml 1000 0 to 1000 ml 1500 0 to 1500 ml 5 Select to exit the current menu 5 3 8 Breath Rate Monitoring 5 3 8 1 Display Breath Rate Refer to 5 3 5 1Display Tidal Volume and Breath Rate Parameters 5 3 8 2 Set Breath Rate Alarm Limits 1 Select the Alarm Setup shortcut key and select Ventilator gt gt 2 Set Rate high and low alarm limits in the Ventilator Alarm Limits menu 3 Select to exit the current menu 5 3 9 BIS Monitoring 5 3 9 1 Display BIS Parameters If your anesthesia machine 1s configured with BIS module on the normal screen BIS related parameters are displayed as shown below W BIS Bi
21. Make sure that the ventilator parameters and alarm limits are set to applicable clinical levels For details refer to 4 Operations and Ventilation Setup Make sure that the system is Standby Make sure that the equipment for airway maintenance manual ventilation and tracheal intubation and applicable anesthetic and emergency drugs are available Set the bag mechanical ventilation switch to the bag position Connect the manual bag to the manual bag port Turn off all vaporizers Turn the APL valve control to fully open the APL valve MIN position Turn all flow controls to set all gas flows to minimum Make sure that the breathing system is correctly connected and not damaged 6 15 NWARNING o Before connecting a patient flush the anesthesia machine with 5 L min of O for at least one minute This removes unwanted mixtures and by products from the system 6 11 Inspect the AGSS Assemble the AGSS as described in 13 10 2Assemble the AGSS and then turn on the waste gas disposal system Check 1f the float can rise and exceed the MIN mark If any blockage tackiness or damage occurs to the float disassemble and assemble the float again or replace the float NOTE e Do not block the AGSS pressure compensation openings during the inspection If the float cannot rise the possible reasons are 1 The float is tacky Turn over the AGSS and check if the float moves up and down freely 2 The float is rising slowly The
22. The anesthesia machine must only be operated by qualified anesthesia personnel who have received adequate training in its use NWARNING eo This anesthesia machine is intended for use by qualified anesthesia personnel only or under their guidance Anyone unauthorized or untrained must not perform any operation on it o This anesthesia machine is not suitable for use in an MRI environment 2 1 2 Contraindications The anesthesia machine is contraindicated for use on patients who suffer pneumothorax or severe pulmonary incompetence 2 1 3 Components The anesthesia machine consists of a main unit vaporizer five optional anesthetic agents enflurane isoflurane sevoflurane desflurane and halothane anesthetic ventilator electronic flowmeter assembly breathing system etc The anesthesia machine provides monitoring and displaying of respiratory mechanics RM parameters airway resistance and compliance and spirometry loops as well It is configured with the following ventilation modes volume control ventilation VCV pressure control ventilation PCV pressure support ventilation PSV synchronized intermittent mandatory ventilation volume control SIMV VC and synchronized intermittent mandatory ventilation pressure control SIMV PC The anesthesia machine can be externally connected to a patient monitor which is in compliance with the requirements of relevant international standard and can be configured with an
23. Ventilator performance Integrated electronic PEEP OFF 4 to 30 cmH gt O increment 1 cmH O Drive pressure Peak flow Range of flow valve 280 to 600 kPa 100 L min 1 to 100 L min Ventilator monitored parameters z lt O2 concentration J o Pmean Pplat by 0 to 100 L min 0 to 2500 mL 18 to 100 20 to 120 cmH 0 20 to 120 cmH 0 20 to 120 cmH 0 4 1 to 1 10 PEEP monitored parameter Range 0 to 70 cmH O B 8 B 8 Ventilator Accuracy lt 75 ml 15 ml gt 75 ml 20 ml or 10 of the set value whichever is greater Control and monitoring accuracy Volume control Pinsp 3 0 cmH2O or 8 of the set value whichever is greater Pressure control o Plimit 4 0 cmH O or 10 of the set value whichever is greater 4 to 30 cmH20 2 0 cmH20 or 10 of the displayed value PEEP control whichever is greater OFF not defined lt 75 ml 15 ml gt 75 ml and lt 1500 ml 20 ml or 10 of the set value whichever is greater gt 1500 ml not defined 0 to 30 cmH O 2 0 cmH20 or 10 of the displayed value whichever is greater gt 30 cmH20 not defined 20 to 100 The specified high limit shall always be greater Low Limit 18 to Chigh limit 2 than the low limit Volume monitoring PEEP monitoring accuracy Alarm settings Parameter High Limit FiO2 The specified high limit shall always be greater High Limit 5 to 1600 mL TVe
24. When zeroing the sensor during the measurement disconnect the sensor from the breathing system first 8 5 5 Calibrate the Sensor For the mainstream CO module calibration is not required Contact us if calibration is necessary 8 16 9 AG and 02 Concentration Monitoring 9 1 Introduction The anaesthetic gas AG module measures the patient s anesthetic and respiratory gases and incorporates the features of the O module and BIS module as well The AG anesthesia gas module determines the concentrations of certain gases using the infrared IR light absorption measurement The gases that can be measured by the AG module absorb IR light Each gas has its own absorption characteristic The gas is transported into a sample cell and an optical IR filter selects a specific band of IR light to pass through the gas For multiple gas measurement there are multiple IR filters This means that higher concentration of IR absorbing gas causes a lower transmission of IR light The amount of IR light transmitted after it has been passed though an IR absorbing gas is measured From the amount of IR light measured the concentration of gas present can be calculated Oxygen does not absorb IR light as other breathing gases and is therefore measured relying on its paramagnetic properties Inside the O sensor are two nitrogen filled glass spheres mounted on a strong rare metal taut band suspension This assembly is suspended in a symmetrica
25. Y piece When the breathing tubes and Y piece are fully dry install them onto the breathing system with reference to 13 2 Install the Breathing Tubes 14 3 9 Flow Sensor It is recommended to clean the flow sensor as determined by your hospital s policy Or you can refer to the methods recommended in the table of 14 3 Clean amp Disinfect and Re install the Breathing System to clean and disinfect the flow sensor CAUTION a oe Do not autoclave the flow sensor Do not use high pressure gas or brushes to clean the flow sensor Do not use cleaning solvents that are not approved for use with polycarbonates Do not clean the interior surface of the flow sensor Use a damp cloth on the external surface only Submerge the flow sensor in the disinfectant solution for the disinfection period Rinse the flow sensor with clean water Completely dry the flow sensor before use Refer to 13 1 6 Install the Flow sensor to install the flow sensor in the reverse order NWARNING Tighten the locking nuts when installing the flow sensor Failure to do so may result in invalid measurement 14 20 NWARNING eo The end of inspiration expiration connectors which connects the breathing tube shall be kept downward to prevent condensed water from entering the breathing system 14 3 10 O2 Sensor NWARNING e Do not put both of the breathing system and the O sensor in liquid or autoclave them o Water vapor may condense on th
26. drive gas comes from O or AIR gas supply Filter 8 filters the drive gas again Regulator 9 helps keep the drive gas pressure to stay within a fixed pressure range Pressure switch monitors the drive gas pressure If the drive gas pressure 1s lower than the preset pressure limit an alarm appears on the ventilator display Inspiratory flow control valve 10 controls the inspiratory flow The proportional PEEP valve 16 monitors the opening and closing of expiratory valve 17 and produces PEEP as well During inspiration A 3 the microprocessor controlled valve 10 creates the preset inspiratory flow and expiratory valve 17 closes The drive gas goes into the bellows 45 and depresses the bag inside the bellows to move downward This forces the gas inside the bag to go through the sodalime canister 34 to enter the patient lung until the end of inspiration During expiration valve 10 closes and expiratory valve 17 opens The patient expires freely The exhaled gas mixed with the fresh gas goes into the bag to lift up the bag inside the bellows The drive gas outside of the bag is scavenged to the AGSS until the end of expiration During the ventilation the ventilator performs real time monitoring of airway pressure paw and tidal volume TV If the paw or TV is outside of the user preset alarm limits an audible and visual alarm occurs When paw is higher than the limit value the ventilator enters expiratory state automatically to avoid causing inj
27. eo The data shown in this table are from ISO 21647 which are published by the U S Food and Drug Administration for a healthy 40 year old male patient o In actual applications the effects of age weight and other factors on the inhaled anesthetic agent should be considered When one or more than one anesthetic agents are used the formula for calculating MAC 1s EtAgent o AgentVol i Where N stands for the number of all anesthetic agents including MAC N20 which the AG module can measure EtAgenti for the concentration of end tidal anesthetic agent and AgentVoli for the IMAC value corresponding to the anesthetic agent For example if the AG module detects 4 Des 0 5 Hal and 50 N20 in the patient end tidal mixed gas the MAC value is calculated as follows 0 0 0 mac 48 0 5 50 167 7 3 0 77 105 NOTE o The MAC value calculation formula is applicable to adults only 9 3 Identify AG Modules There are two types of AG modules available 1 M type which cannot identify anesthesia gas automatically 2 A type which can identify anesthesia gas automatically AG setup key 0 gt Measure standby key O o Indicator Gas outlet O 3 gt lt Ai BIS sensor connector O Az IN AN w AG watertrap fixer For details about BIS refer to 10 BIS Monitoring NOTE The AG module is configured with the function of compensating barometric pre
28. in this manual serve as examples only They may not necessarily reflect the setup or data displayed on your anesthesia machine Conventions E Italic text is used in this manual to quote the referenced chapters or sections E 1s used to enclose screen texts NW isused to indicate operational procedures FOR YOUR NOTES VI Contents II Sale EA E E E E E twa lewatiawasiee E O E 1 1 1 ll SAIC By MALO PMMA IO ia a E E 1 1 AAA PPP basa A E E A E iawn ees 1 2 UL 2 VALIOSA a 1 2 EESE Lo a PA E FE mR mn ree a PNT eee me Pane erate mon 1 3 ELA NOU A earthen aan aaeactet E E 1 4 LALA SOS Seder ite cane aren nes ote omnes orep mers rom nT G Sta Tear et ont Sta Ttar Tre eoTnn aa Tarra 1 5 2 MWC BASICS va secessesiesscaehiasasdestesacacsiesucgenselacachiesncaensesacacsessaendasacaesceescaendadacdencecncaendacscaencasenges 2 1 DNS y SEC aN IVE SC Hf CLO Ns ae aa tt ea ce o e teens 2 1 A rer rn erent etc See eee 2 1 2 42 COMMAINCICATIONS sereia Anann EEn eee in ean 2 1 ANS COMPO CMS eat lcd ola aer labor 2 2 2 28 GU piMmenl Appeabane Gv E E a 2 3 P ETOD oh Aer RR MOT SOD PTET OTE SO SY RIT EERE SOT SY RSE EPR CREE EE 2 3 LL AU VIEW a 2 7 E ES E 2 12 3 System Controls and Basic Settigs oommmmssr rr ss 3 1 3 1 Display COM lA AAA AAA A A a TI 3 1 AD A A agate ase asta eats 3 3 Sn suet ache nts cule tat E E A EE T 3 5 Bde LAdjus CEA A A os 3 5 3 3 2 Adj st Sound VOLUING e 3 5 933 Cl Oy o A eaten eae oie aes aber tebe Mat Nabe S
29. lt 330 ms 100 mL min Rise time lt 400 ms 70 mL min lt 3 s 100 mL min lt 3 5 s 7 OmL min Measured by using neonatal watertrap and 2 5 m neonatal Delay time sampling line lt 5 s 100 mL min lt 6 5 s 70 mL min Measured by using adult watertrap and 2 5 m adult sampling line System total response time lt 3 5 s 100 mL min Sidestream CO module lt 4 s 70 mL min Measured by using neonatal watertrap and 2 5 m neonatal sampling line lt 5 5 s 100 mL min lt 7 s 70 mL min Measured by using adult watertrap and 2 5 m adult sampling line Pump rate accuracy 15 of the set value or 15 mL min whichever is greater l 30 s The module enters the warming up status after the startup Start time l l 1 minute later it enters the Full accuracy status Stability 0 8 mmHg within 24 hours EtCO2 Low Limit 0 to high limit 2 mmHg EtCO2 High Limit low limit 2 to 99 mmHg 1 mmHg FiCO2 High Limit 0 to 99 mmHg Effect of interfering gas on CO2 measured value Gas N20 Hal Sev Iso Enf Des as pg Additional error caused by gas interference when measured at 0 to 40 mmHg lt S lt 15 Typical accuracy measurement conditions are l 2 3 4 Measurement starts when the module warm up state ends Ambient pressure 750 to 760 mmHg room temperature 22 to 28 C The gas under test is dry gas and the balance gas is N2 Pump rate 100 mL min breath rate not greater than 50 rpm fluctuation of breat
30. malfunction a Ie AG Accuracy Error M The measured value is outside of the measurement een ha Fi02 ALM LMT The Fi02 alarm limit settings are outside of the range ERR EtCO2 ALM LMT M The EtCO alarm limit settings are outside of the range ERR FiCO2 ALM LMT M The FiCO2 alarm limit settings are outside of the range E EtN20 ALM LMT M The EtN O alarm limit settings are outside of the range E ne FIN20 ALM LMT M The FIN2O alarm limit settings are outside of the range A EtAA ALM LMT M The EtAA alarm limit settings are outside of the range E FIAA ALM LMT M The FiAA alarm limit settings are outside of the range E a wa AG No Watertrap AG Zero Failed AG Change The AG watertrap fell off from the anesthesia machine The AG module zeroing failed The AG watertrap was changed Watertrap The measured value is outside of the measurement range Contact your service personnel CO2 Accuracy L The measured value is outside of the declared accuracy amaie m O2 Accuracy L ome N20 Accuracy L me AA Accuracy L nea D 10 CO EtCO2 ALM LMT H The EtCO alarm limit settings are outside of the range module ERR FiCO2 ALM LMT The FiCO2 alarm limit settings are outside of the range ERR CO2 Cal Error An error occurred to CO calibration CO2 Init Error H The CO module was installed improperly or malfunctioned CO2 Selftest Error Module fault or communication failure between the MAC l
31. o Before comnecting the equipment to the power line check that the voltage and frequency ratings of the power line are the same as tube indicated on the equipment s label or in this manual o Always install or carry the equipment properly to avoid damage caused by drop impact strong vibration or other mechanical force o The anesthesia machine keeps stable with a 10 tilt in typical configuration Do not hang articles on both sides of the anesthesia machine for fear of getting tilted 1 3 1 1 4 Notes NOTE Put the equipment in a location where you can easily see the screen and access the operating controls Keep this manual close to the equipment so that it can be obtained conveniently when needed The software was developed in compliance with IEC 60601 1 4 The possibility of hazards arising from software errors is minimized This manual describes all features and options Your equipment may not have all of them 1 2 Equipment Symbols A Attention Consult Dangerous voltage accompanying documents this manual gt P PS U lt Material description Alarm silence key MV amp TVe RX MV amp TVe alarm key Normal screen key O flush button ACGO On ACGO Off Bag position manual l a a y Mechanical ventilation ventilation Bm tm Go Not autoclavable 4 ls Network connector YH Flow control NO Air supply connector lt N20 supply connector 280 600kPa Sample gas re
32. onto the AGSS bracket Connect the 30 mm male conical connector of the transfer tube to the gas inlet of the receiving system Connect the AGSS outlet to the hospital s waste gas disposal system using the AGSS active scavenging tube AGSS active scavenging tube which is connected ES with the hospital s waste gas disposal system 13 36 3 Connect the 30 mm female conical connector of the transfer tube to the AGSS waste gas outlet on the anesthesia machine NOTE o Remove the AGSS transfer and receiving system from the main unit when transporting or moving the anesthesia machine 13 10 3 Waste Gas Disposal System The AGSS transfer and receiving system is of high flow and low vacuum type which is in compliance with ISO 8835 3 1997 The applicable pump rate ranges from 50 to 80 L min Before use make sure that the waste gas disposal system is high flow disposal system and is able to reach the flow range Before use make sure that the connector of the waste gas disposal system is BS6834 1987 standard connector For details about specifications refer to B LOAGSS Transfer and Receiving System Specifications NOTE e Do not block the pressure compensation opening of the AGSS transfer and receiving system during test 13 37 NWARNING This AGSS transfer and receiving system cannot be used with flammable anesthetic agent Gas inside the AGSS may overflow when the gas flow exceeds 100 mL min if th
33. or Flow for trigger type Turn the control knob to set Trigger Level to the appropriate value Push the control knob to confirm the setting Select Ok to activate the current setting AJ m pP p To cancel the current setting and exit the current menu select Cancel x or push the Normal Screen key E PSV Insp Termination Level Inspiration termination level refers to the percentage of inspiration flow to the maximum inspiration flow during inspiration in the PSV mode To set PSV Insp Termination Level do as follows 1 Select the Vent Mode shortcut key PSV gt gt PSV Insp Termination Level 2 Push the control knob and turn it to set PSV Insp Termination Level to the appropriate value 3 Push the control knob to confirm the setting 4 Select Ok to activate the current setting 5 To cancel the current setting and exit the current menu select Cancel x or push the Normal Screen key E Backup Mode Active When PSV mode is applied alone the PCV backup mode is available If within the preset time Backup Mode Active no spontaneous breathing occurs or the spontaneous breathing 1s not strong enough to reach Trigger Level the PCV backup mode is activated automatically when the time for Backup Mode Active is up to enable mechanical ventilation forcibly To set Backup Mode Active do as follows 1 Select the Vent Mode shortcut key PSV gt gt Backup Mode Active 2
34. range 0 to 10 L min N20 range 0 to 10 L min Accuracy lt 10 of the indicated value under 20 C and 101 3 kPa for flow between 10 of full scale or 300 mL min whichever is greater and full scale Electronic flowmeters Type Rotameter Range 0 to 10 L min Accuracy lt 10 of the indicated value under 20 C and 101 3 kPa for flow between 10 of full scale or 300 mL min whichever is greater and full scale calibrated at 100 02 Total flowmeter Gas supply 02 in the system Flow 0 to 10 L min Accuracy 5 of full range under 20 CC and 101 3 kPa for flow between 10 of full scale or 300 mL min whichever is greater and full scale calibrated at 100 O2 pressure compensation not provided 02 N20 link system Mechanical proportion control device 02 concentration not lower than 25 B 6 Breathing System Specifications System leakage and system compliance System leakage Not greater than 150 mL min at 3 kPa System compliance lt 4 mL 100Pa in adult mode Sodalime canister Not greater than 50 mL min at 3 kPa leakage Auxiliary O2 supply APL valve leakage Not greater than 50 mL min The scale of APL valve is 75 cmH 0 CO absorber canister Volume Approximately 1350 ml Water collection cup Can be disassembled independently Interface and connector E Male 22 mm conical connector incorporating a coaxial female 15 mm Expiration end l conical connector a Male 22 mm conical connector incorpora
35. settings for ventilator parameters are changed this alarm is disabled temporarily within nine breathing cycles or one minute whichever 1s less after being set Decrease settings for tidal volume or breath rate or increase high alarm limit MV is lower than the low alarm limit setting If ventilation mode is switched or settings for ventilator parameters are changed this alarm is disabled temporarily within nine breathing cycles or one minute whichever 1s less after being set Increase settings for tidal volume or breath rate or decrease low alarm limit Two triggering conditions are met simultaneously 1 Paw is lower than PEEP 3 cmH O for more than 20 seconds 2 TVe is lower than 10 ml for more than 20 seconds Increase tidal volume and breath rate settings or apply manual ventilation No breath has been detected within the last 120 seconds Check the patient s condition Use manual ventilation mode to help the patient breathe Check 1f the tubes fall off Rate is higher than the high alarm limit setting If ventilation mode is switched or settings for ventilator parameters are changed this alarm is disabled temporarily within nine breathing cycles or one minute whichever 1s less after being set Decrease breath rate setting or increase high alarm limit Rate is lower than the low alarm limit setting If ventilation mode is switched or settings for ventilator parameters are changed this alarm is disabled tem
36. test must be performed when the system is in standby status o Before doing the breathing system leak test make sure that the breathing system is correctly connected and the breathing tubes not damaged 1 Make sure that the system is Standby If not press the D key and select Ok from the pop up menu to enter standby status 2 Connect the Y piece on the breathing tube to the leak test plug on the breathing system Occlude the gas outlet of the Y piece 3 Turn the O flow control to set O flow to 0 15 0 2 L min 4 Push the O flush button to fill the bellows folding bag rising to the top 5 Select the Maintenance shortcut key and then select Breathing System Leak Test gt gt 6 Select Start to start the breathing system leak test The screen prompts Performing leak test 7 After a successful test the screen shows Leak Test Passed Otherwise the message Leak Test Failure Please try again is displayed In this case you need to check that the breathing system 1s correctly connected and the tubes are not damaged before doing the leak test again 8 Select X to exit the current menu NOTE eo During the leak test if you select Stop test is stopped Then the message Leak Test Stopped Leak test is unfinished is displayed This indicates invalid test instead of test failure o Incase of leak test failure check all possible leak sources including bellows breathing tubes and sodalime canister Check that t
37. the Vent Mode Setup menu Select PCV in the Vent Mode Setup menu After confirming the selection the Pinsp shortcut key the first key from the left in the parameter setup shortcut keys area 1s highlighted Make sure that Pinsp is appropriately set for the patient Push the control knob to confirm the setting so as to start PCV mode NOTE When it is necessary to switch over to PCV mode confirm the setting of Pinsp first Otherwise the system works in the previous ventilation mode If the setting of Pinsp is not confirmed for 10 s the screen returns to the previous mode automatically 4 4 4 4 Parameter Setup Shortcut Keys Area in PCV Mode When selection of PCV mode is confirmed the parameter setup shortcut keys area at the bottom of the screen is automatically switched over to the parameter setup area in this mode The following figure shows all related parameters to be set in PCV mode Plimit cmH2O PEEP comio 30 OFF 5 6 5 1 Pinsp Pressure control level of inspiration 2 Rate Breath rate 3 LE Ratio of inspiratory time to expiratory time 4 TIP TI Percentage of inspiratory plateau time in inspiratory time this shortcut key 1s disabled in PCV mode 5 Plimit Pressure limit level 6 PEEP Positive end expiratory pressure 4 4 4 5 Set Parameters in PCV Mode You can use the shortcut keys and control knob to set the parameters in PCV mode The following takes setting of Pinsp as an exam
38. the current menu For details about displaying the CO2 waveform refer to 5 3 3 2Display CO2 Waveform 8 15 8 5 3 Measurement Limitations Measurement accuracy may degrade due to Leakage or internal leakage of the sample gas Mechanical shock Cyclic pressure which is greater than 10 kPa 100 cmH20 Other interference source if available 8 5 4 Zero the Sensor Zeroing the sensor aims to eliminate the effect of baseline drift on the readings during the measurement so as to ensure measurement accuracy For mainstream CO2 module zero the sensor when l 2 3 The adapter is replaced The sensor is re connected to the module The message CO2 Zero Required is displayed In this case check the airway adapter for blockage If a blockage is detected clear or replace the adapter To zero the sensor do as follows l 2A Connect the sensor to the CO2 module Access the Gas Module Setup gt gt menu and set Working Mode to Measure The message CO2 Warmup is displayed After warm up is finished connect the sensor to a clean dry airway adapter The adapter should be vented to the air and isolated from CO2 sources including ventilator the patient s breathing and your own breathing Select Zero from the Gas Module Setup gt gt menu and the screen displays C02 Zero Running A typical zeroing takes about 15 to 20 seconds This message disappears after zeroing is completed N WARNING
39. ti 9 5 O la 9 6 SOARES OS DAS ais 9 6 AIN A E ae 9 6 DG Mame AMES LC ACEN once a a dodo o ea at 9 6 9 7 Measurement LIMAS a sris cies tots char a EA A AEA AE AA TETARA A 9 7 TES OO MOO UNO e a 9 7 9 SCENES Sample AS ae dete aca ieee ee eee 9 8 Dl ONG all tla LC ble ad et i gees Sac chs iets a et Stet at 9 8 10 BSUS GIO PLING sain sea a wavs A as nha cas TEONE EEEIEE EETTISET 10 1 TOU THA OGG 1 A ss isa a Se aes eee ee eee eee ees 10 1 102 Identiyths BIS Mio dul terri ahem neem etenees 10 1 HO Reiser Biot MORA AO A dd te a 10 2 104 Understand BIS Parameters aa 10 3 US Prepare to Measure BS iS naar 10 4 06 Continuots Impedance Check ses id e ii de tec dio dere ue Udo 10 5 TOT Cyclic Impedance EN casara illa 10 6 TOS BIS Sensor C heck WI OM donna 10 6 PO OSE BIS Smoon R i cere eiaa e R se EOR E OO EE 10 7 LO LO Restore Deals A AA 10 7 10 11 SctbBlS Related Wave ONS irlanda 10 8 E sstwsasedeteacaeists seueuedesaosstedessbatecssessteccusbetesseeces 11 1 Tee oa AA e AA O A E 11 1 EEA ar AA A A A 11 1 MAZA A bee tae 11 2 IZ Alarm AC AT A A ATE 11 2 A 200 AA O O a 11 2 1223 Alarm TONES adri 11 3 A N 11 3 11 24 Flashing Alarm Numero ad 11 3 ERAS AA ANASTASIO LS ii 11 3 ESSE EN OU adan 11 4 MAS MA A a 11 4 114 1 Set Ventilator Alarm LIMIS ersero iero a AA Contender Sada rin leis 11 4 MICA 2 SUC OZ Allain Lams taa A 11 4 MASSA Ma Sara orar rara 11 5 IELA SSB ISA AS A A 11 5 ESSE IC Vel en oaws Seca sessuscucaetsataetenn A 11 5 11
40. to reset the parameter value 4 4 3 6 Parameter Range and Default Value in VCV Mode 20 to 100 ml 5 ml TV 20 to 1500 ml 100 to 300 ml 10 ml 300 to 1500 ml 25 ml 4 4 4 Pressure Control Ventilation PCV 4 4 4 1 Description Pressure control ventilation hereinafter referred to as PCV mode is a basic fully mechanical ventilation mode In the PCV mode each time mechanical ventilation starts Paw rises rapidly to the preset Plimit Then gas flow slows down through the feedback system to keep Paw constant until expiration starts at the end of inspiration The tidal volume delivered in the PCV mode changes based on patient pulmonary compliance and airway resistance In the PCV mode you need to set Plimit to prevent high airway pressure from injuring the patient In the PCV mode you can also select to set PEEP to improve expiration of end tidal carbon dioxide and to increase oxygenation of breathing process 4 4 4 2 Waveforms The following figures show the Paw waveform and flow waveform in the PCV mode Paw Pinsp Flow Inspiration Time Expiration Time Generally in the PCV mode the Paw waveform rises sharply during inspiration and stays at the plateau for a relatively long time without peak The flow waveform declines in the same period In the PCV mode tidal volume is measured instead of preset 4 4 4 3 Start PCV Mode Select the Vent Mode shortcut key to open
41. turned on for the first time If the current CO2 module is Standby you must push the O key or select the User Setup shortcut key Gas Module Setup gt gt Working Mode Measure to start the CO2 module When the anesthesia machine restarts the CO2 module automatically continues with the previously selected working mode During standby the working components of the CO2 module such as gas pump and infrared source are automatically turned off to extend the service life of the module 8 3 2 2 Set Pump Rate You can set patient Pump Rate to either High or Low N WARNING Please consider the patient s actual bearing capability and select the appropriate pump rate when setting the pump rate 8 3 2 3 Set Unit In the Gas Module Setup gt gt menu select Unit and toggle between mmHg and kPa 8 3 2 4 Set Gas Compensations N WARNING o Make sure that the appropriate compensations are used Inappropriate compensations may cause inaccurate measured values and result in misdiagnosis 1 Access the Gas Module Setup gt gt menu 2 Set the following compensations based on the actual conditions 02 Comp 9 N20 Comp Des Comp The total of the concentrations of the above three gas compensations cannot be greater than 100 8 3 2 5 Set Humidity Compensation The CO2 module is configured to compensate CO2 readings for either Body Temperature and Pressure Saturated Gas BTPS
42. when deemed necessary To manually start a zero calibration enter the Gas Module Setup gt gt menu and then select Zero You do not need to disconnect the sensor from the breathing system when performing the zeroing 8 3 7 Calibrate the Sensor For CO2 module a calibration should be performed once a year or when the measured value has a great deviation 8 4 Use a Microstream CO2 Module NOTE This section is only applicable to the anesthesia machine configured with microstream CO2 module 8 4 1 Prepare to Measure CO2 1 Plug the sampling tube into the sampling tube connector and then connect the CO2 components as shown below Tr A A A 2 By default the microstream CO2 module is in measure mode The CO2 Warmup iA y message appears on the screen when the CO2 module is plugged in 3 After warm up is finished you can perform CO2 measurements 8 4 2 Make CO2 Settings By selecting the User Setup shortcut key and then Gas Module Setup gt gt you can make CO2 settings described below 8 8 8 4 2 1 Set Working Mode The default working mode of the CO2 module is Measure when the anesthesia machine is turned on for the first time If the current CO2 module is Standby you must push the O key or select the User Setup shortcut key Gas Module Setup gt gt Working Mode Measure to start the CO2 module When the anesthesia machine restarts the CO2 module automatica
43. whether or not the anesthesia machine is currently on In case of power failure the anesthesia machine will automatically be powered by the internal batteries When AC power source is restored within the specified time power supply is switched from battery to AC automatically to ensure continuous system use On screen battery icon indicates the battery statuses as follows m indicates that the batteries operate normally The solid portion represents the current charge level of the batteries in proportion to its maximum charge level m lt A indicates low battery and the batteries need to be charged m 44 lt indicates too low battery and the batteries need to be charged immediately The capacity of the internal battery is limited If the battery capacity is too low a high level alarm will be triggered and the Low Battery Voltage message displayed in the technical alarm area In this case apply AC power to the anesthesia machine 2 12 3 System Controls and Basic Settings 3 1 Display Control 1 Alarm lamp High level alarms the lamp quickly flashes red Medium level alarms the lamp slowly flashes yellow Low level alarms the lamp turns yellow without flashing 2 Menu shortcut key s Push the menu shortcut key to access the corresponding menu 3 Control knob Push the control knob to select a menu option or confirm your setting Turn the control knob clockwise or counterclockwise to scroll throu
44. which may increase airway resistance 5 Install the canister support into the canister Depress the canister support buckle to lock the canister 6 Assemble the sodalime canister NWARNING e Do not reuse the sodalime canister sponge which must be replaced every time the sodalime canister is replaced eo The sodalime canister sponge must be in place to prevent dust and particles from entering the breathing system o When re installing the sodalime canister after changing the sodalime make sure that the canister is locked reliably and installed in position 13 18 NOTE eo The sodalime which is poured in cannot exceed the MAX level marked on the sodalime canister 13 2 Install the Breathing Tubes NOTE o When installing the breathing tube hold the tube connector at both ends of the tube to prevent damage of the tube eo Do not reuse the filter to prevent cross contamination o Install the filter as described in this manual to prevent dust and particles from entering the patients lungs and prevent cross contamination 1 The following figure shows the filter at the patient connection 2 Connect the two ends of the breathing tubes to the inspiration expiration connectors on the breathing system 13 19 3 Connect the filter to the Y piece 13 3 Install the Manual Bag Connect the manual bag to the manual bag port on the breathing system E The anesthesia machine is configured wit
45. 1 kV for input output lines 23 m 1 kV differential mode 2 kV common mode Compliance level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 23 m 1 kV differential mode 2 kV common mode 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 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 HZ magnetic field IEC 61000 4 8 Note Ur is the AC mains voltage prior to application of the test level lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur 95 dip in Ur for 5 s lt 5 Ur 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 s Mains power quality should be that of a typical commercial or hospital environment If the user of the equipment requires continued operation during power mains interruptions it is recommended that the equipment be powered from an uninterruptible power supply UPS Power frequency magnetic fields should be at levels cha
46. 2 1 Alarm Lamp If an alarm occurs the alarm lamp will flash The flashing color and frequency match the alarm level as follows W High level alarms the lamp quickly flashes red NW Medium level alarms the lamp slowly flashes yellow NW Low level alarms the lamp turns yellow without flashing 11 2 11 2 2 Audible Alarm Tones The anesthesia machine uses different alarm tone patterns to match the alarm level W High level alarms triple double triple double beep NW Medium level alarms triple beep NW Low level alarms single beep 11 2 3 Alarm Message When an alarm occurs an alarm message will appear in the technical or physiological alarm area The alarm message uses a different background color to match the alarm level NW High level alarms red NW Medium level alarms yellow NW Low level alarms yellow The prompt messages displayed in the technical alarm area have no background color For physiological alarms the asterisk symbols before the alarm message match the alarm level as follows W High level alarms Kk NW Medium level alarms W Low level alarms 11 2 4 Flashing Alarm Numeric If an alarm triggered by an alarm limit violation occurs the numeric of the measure parameter in alarm will flash once every second 11 2 5 Alarm Status Symbols Apart from the aforementioned alarm indicators the anesthesia machine still uses the following symbols telling the alarm status a LX indicates ala
47. 2 refer to the highest and the lowest CO2 values measured respectively within the configured time period 10 s 20 s or 30 s 8 4 2 5 Restore Defaults Select Defaults from the Gas Module Setup gt gt menu Then all the menu options except Working Mode are restored to the factory default configurations 8 4 2 6 Set CO2 Waveform 1 Select the waveform area to access the waveform setup menu 2 Select Waveform and select CO2 3 Select Sweep and set waveform sweep speed to an appropriate value The greater the value is the faster the waveform sweeps the wider the waveform is 4 Select Scale and toggle between 9 40 60 and 80 if the unit is mmHg 9 5 0 7 5 and 10 0 if the unit is or kPa 5 Select to exit the current menu For details about displaying the CO2 waveform refer to 5 3 3 2Display CO2 Waveform 8 4 2 7 Set Automatic Standby Time For microstream CO2 module you can set a period of time after which the CO2 module enters the standby mode if no patient breath is detected since the last patient breath detected To set the automatic standby time access the Gas Module Setup gt gt menu and select Auto Standby min 8 4 3 Measurement Limitations Measurement accuracy may degrade due to Leakage or internal leakage of the sample gas Mechanical shock Cyclic pressure which is greater than 10 kPa 100 cmH20 Other interference source if available 8 4 4 Scavenge the Sample
48. 22 ACGO connector 13 1 2 Circuit Adapter Diagram Nn nan A W N l 7 3 8 jj 9 10 5 11 Bag mechanical ventilation linked 7 Locking catch switch Pressure sampling connector s 8 ACGO connector Heating module 9 Fresh gas inlet Drive gas connector 10 APL valve gas outlet Circuit switch 11 Circuit support guide s Circuit adapter base 13 3 NOTE o The heating module does not work when the anesthesia machine is battery powered e Do not overbear the bag arm such as depressing it forcibly or hanging heavy objects onto it o When the difference between the reading on the airway pressure gauge and the Paw value displayed is great please contact us 13 1 3 Install the Breathing system 1 Set the locking catches on the circuit adapter to the m position 2 Align the guide pin holes on the circuit block with the matching guide pins on the circuit adapter 13 4 3 Push the breathing system into the circuit adapter with force to let the breathing system connected to the adapter seamlessly 4 Set the locking catches on the circuit adapter to the fi position and make sure that the breathing system is safely locked N WARNING o Set the locking catches to the fi position after the breathing system is installed onto the circuit adapter and make sure that the breathing system is reliably locked If not the breathing system will be disconnected from the circuit adapter during us
49. 5 7 NOTE eo As required by the relevant international rules and regulations anesthetic agent concentration monitoring needs to be performed when the anesthesia machine is used on the patient If your anesthesia machine is not configured with such monitoring function use a qualified monitor for anesthetic agent concentration monitoring 5 3 3 CO2 Concentration Monitoring If your anesthesia machine is configured with CO2 module you can monitor FiCO2 and EtCO2 by setting up the CO2 module If your anesthesia machine is configured with AG module the system can also monitor FiCO2 and EtCO2 5 3 3 1 Display CO2 Parameters If your anesthesia machine is configured with CO2 module CO2 related parameters are displayed as shown below W FiO2 Fraction of inspired oxygen E EtCQO2 End tidal carbon dioxide E FiCQ2 Fraction of inspired carbon dioxide 5 3 3 2 Display CO2 Waveform If your anesthesia machine is configured with CO2 or AG module a CO2 waveform is displayed as shown below mnHa 5 8 5 3 3 3 Other Settings For details refer to 8C02 Monitoring and 9AG and O2 Concentration Monitoring NOTE o As required by the relevant international rules and regulations CO2 concentration monitoring needs to be performed when the anesthesia machine is used on the patient If your anesthesia machine is not configured with such monitoring function use a qualified monitor for CO2 concentration monitorin
50. 50 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz Note 3 An additional factor of 10 3 1s used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if 1t is inadvertently brought into patient areas Note 4 These guidelines may not apply in all situations Electromagnetic propagation 1s affected by absorption and reflection from structures objects and people FOR YOUR NOTES C 6 D Alarm Messages This chapter lists only the most important physiological and technical alarm messages Some messages appearing on your ventilator display may not be included Note that in this chapter Column L stands for the default alarm level H for high M for medium and L for low indicates that the alarm level is user adjustable For each alarm message corresponding actions are given instructing you to troubleshoot problems If the problem persists contact your service personnel AA stands for any of the five anesthetic agents Des desflurane Iso isoflurane Enf enflurane Sev sevoflurane or Hal halothane D 1 Physiological Alarm Messages Ventilator Paw Too High H Ppeak is higher than the Paw high alarm limit setting Decrease tid
51. ATA 8 1 8 2 dden y COMO E A 8 2 Sa Use a pidestream O2 Module erario tati a 8 3 Sd Prepare tO Measure CO ti taco jes 8 3 A A af 112 4 tee ae E eee Tete tee a eet en eee oI 8 4 8 3 3 Measurement Limitations ee 8 6 Oe al OUDICS OO UNC S 4 22 seinen PO met sane Doe hee oat eee Ree ath Sc bec at T 8 6 8 3 5 ca venge tie Sample assi 8 7 2500 7 ClO E eee Rete eee eed 8 7 5 7 Calibrate the Sensor cick hee ee eee ee a aa 8 7 Usea Microstreamn OZ MOG ule nina Ad chat an 8 8 SA Prepare to Moas re C O2 ns ais 8 8 SA A ceed OB O os 8 8 8 4 3 Measurement Limitations sciences de 8 11 SAS cayendo tine Sample GAS sopeta aaia e ANN 8 11 AA T 8 12 8 4 6 Calibrate AA O E E A E 8 12 8 4 7 Onidion Information A cd 8 12 6 0 Use a Mansite CO Modena daa daa dada retin det 8 13 931 Prepare to Measure C O2 reda iE E E ds 8 13 82 Make CO2 SENINE S oenina a E O 8 14 8 3 3 Measurement Limitations sssi mr ienie naa TN A N TN 8 16 SoA EOE SENSO trizas 8 16 B59 Calibrate Me Sensor said aed chee hs Cie brdodes 8 16 9 AG and 02 Concentration Monitoring ssccccccccsssssssssscccccssssssscsscccssccssssssscccsseeeees 9 1 FAT O 2 stee seat hie O ania aah O O Ae aoe EA 9 1 OD Understand MAC Vanessa 9 2 A Ca ea ah TA T MOE S geerenne mee teeper term eae Bor a a Crs oe 9 3 94 Prepare LO MEI Ure A sake easiest E cots oia 9 3 E A 9 5 AA let eae olen re ae at etd 9 5 OLAS ELMO ias 9 5 DS OZ COMPAS AMOR A ii 9 5 De SEL WIKE Mode ta eta hate tia eri
52. E 2 Abbreviations m NO N20 PSV Pressure support ventilation Pressure support level E 3 C3 SIMV Synchronized intermittent mandatory ventilation SIMV PC Synchronized intermittent mandatory ventilation Pressure control SIMV VC Synchronized intermittent mandatory ventilation Volume control SIMV Rate Frequency of SIMV F Factory Defaults This chapter lists the most important factory default settings which are not user adjustable When necessary you can restore the factory default settings F 1 CO2 Module CO module alarm limits Factory default settings Alarm Level Med F 1 1 Mainstream CO2 Module 02 Comp OFF F 1 2 Microstream CO2 Module CO2 Setup Factory default settings Humidity Comp Wet F 1 F 1 3 Sidestream CO2 Module CO2 Setup Paw Unit Working Mode Pump Rate N20 Comp O2 Comp Des Comp Humidity Comp F 2 AG Module AG Setup Agent Pump Rate 02 Comp Working Mode Unit Gas Module Alarm Limits Alarm Level EtCO2 High Limit mmHg EtCO2 Low Limit mmHg FiCO2 High Limit mmHg FiCO2 Low Limit mmHg EtN20 High Limit EtN20 Low Limit FiN20 High Limit FiN20 Low Limit EtHal High Limit EtHal Low Limit FiHal High Limit FiHal Low Limit EtEnf High Limit EtEnf Low Limit FiEnf High Limit FiEnf Low Limit EtIso High Limit EtIso Low Limit Filso Low Limit EtSev High Limit EtSev Low Limi
53. IMV PC NW Parameter setup shortcut keys in SIMV VC mode in P omo 30 5 Peupp cmHO PEEP omi20 15 OFF 6 7 2 3 4 y 1 TV Tidal volume 2 SIMV Rate Frequency of SIMV 3 Tinsp Time of inspiration 4 Finsp Flow of inspiration 5 Plimit Pressure limit level 6 Psupp Pressure support level 7 PEEP Positive end expiratory pressure NW Parameter setup shortcut keys in SIMV PC mode l pe 3 4 5 6 7 1 Pinsp Pressure control level of inspiration 2 SIMV Rate Frequency of SIMV 3 Tinsp Time of inspiration 4 Finsp Flow of inspiration 5 Plimit Pressure limit level 6 Psupp Pressure support level 7 PEEP Positive end expiratory pressure 4 14 NOTE When SIMV mode either SIMV VC or SIMV PC is selected pressure support ventilation PSV mode is used for triggering outside of the trigger window Therefore you also need to set the parameters in PSV mode appropriately Psupp Finsp and PSV Insp Termination Level 4 4 5 5 Set Parameters in SIMV Mode Similar to setting the parameters in VCV and PCV modes you can use the shortcut keys and control knob to set the parameters in SIMV mode The following takes setting of TV as an example 1 Select the TV shortcut key 2 Push the control knob and turn it to set TV to the appropriate value 3 Push the control knob to confirm the setting 4 Set other parameters in this mode in the similar way N
54. MHz to 800 MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The ISM Industrial Scientific and Medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if 1t is inadvertently brought into patient areas c 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 anesthesia machine is used exceeds the applicable RF compliance level above the anesthesia machine should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating
55. OTE o Ifthe parameter value is adjusted outside of the range the system prompt message area displays Parameter Settings Outside the Safety Range eo Confirm the adjustment of one parameter before adjusting another parameter If you want to restore the value before adjustment you have to reset the parameter value In SIMV SIMV VC or SIMV PC mode you also need to set a E Trigger Window Select the Vent Mode shortcut key SIMV VC gt gt or SIMV PC gt gt Trigger Window Push the control knob and turn it to set Trigger Window to the appropriate value Push the control knob to confirm the setting Select Ok to activate the current setting To cancel the current setting and exit the current menu select Cancel or push the Normal Screen key 4 15 Da Se E Trigger Level In the SIMV VC mode select the Vent Mode shortcut key SIMV VC gt gt gt Trigger Level Or in the SIMV PC mode select the Vent Mode shortcut key gt SIMV PC gt gt Trigger Level Or in the PSV mode select the Vent Mode shortcut key PSV gt gt Trigger Level Select Pressure or Flow for trigger type Turn the control knob to set Trigger Level to the appropriate value Push the control knob to confirm the setting Select Ok to activate the current setting To cancel the current setting and exit the current menu select Cancel x or push the Normal Screen ke
56. Pressure IE asas srt 6 8 DA A A ca 6 9 60 1 Bellows Testers pi os 6 9 6 8 2 Breathing System Leak Test in Mechanical Ventilation Status ooocnnnnnnnn 6 10 6 8 3 Breathing System Leak Test in Manual Ventilation Status cccccccccccccinnnnnnm 6 11 es Ad RE o A ee nn Re a ee ee ee eT 6 11 AN AP A 6 12 Oe Prepate tor Alarm Tests tene tee rieto ete coin ente eo elena OLE tas 6 12 6 9 2 Test the 02 Concentration Monitoring and AlarmMsS ccccncnnnnnnnnnnnnnnnnnnnnninnnnnno 6 13 6 9 3 Test the Low Minute Volume Ada 6 13 6 94 Test the Apnea Alarm RS 6 14 6 9 5 Test the Sustained Airway Pressure Alarm cccccccceeceeeeeeeeeeeeeseeeseeeeeeeeeeees 6 14 6 9 6 Test the High Paw Alani A A 6 14 G97 Test te Low Paw A eet oe o um E eens 6 15 6 9 3 Test the AG Module Alarm A ea ae ias 6 15 6 10 Preoperatiy Prep araOns 422 023 iets Sci a atea 6 15 A A PP om E E EEY 6 16 7 User WAMU nan AAA ARA 7 1 Tod Ne Dalle UIC AAA A A AO 7 1 a a AAA terete enter tts ote at era mee eran eee Sree eR eT Serre EI 7 2 MEC ALA Y Sy Ste OA isa 7 3 TA ELOY Sensor Ea I ad 7 3 P OU sao oa OLA 10 EE ARA o On II II E A 7 5 MENA 7 5 EA NN 7 6 76 Water Bulld up In the Flow Ses ias 7 7 10 L Prevent Waler Buld UD 7 7 16 2 Clear Water BA e ts e ere ea 7 8 A CAUSA o in o e O 7 8 TSAGSS Transter Tube MADE A as 7 10 S CO2 WOM ORG A A AA A EEE A 8 1 coal IB 04 1000 610 676 0 Renae Ne ite ore E Or Ren EO Bem O Or mene EOE Be DOSE nee EN aT Pu eS
57. The BIS component using on our monitor is purchased from Aspect Medical System It is important to recognize this index is derived using solely that company s proprietary technology Therefore it is recommended that clinicians have reviewed applicable information on its utility and or risks in published articles and literature web site information from Aspect Medical Systems Inc or contact that company itself at www aspectmedical com if you have clinical based BIS questions relating to this module portion of the patient monitor Failure to do so could potentially result in the incorrect administration of anesthetic agents and or other potential complications of anesthesia or sedation We recommend that clinicians also review the following practice advisory that includes a section on BIS monitoring The American Society of Anesthesiologists Practice Advisory for Intraoperative Awareness and Brain Function Monitoring Anesthesiology 2006 104 847 64 Clinicians are also recommended to maintain current knowledge of FDA or other federal based regulatory practice or research information on BIS and related topics The Bispectral Index is a complex technology intended for use only as an adjunct to clinical judgment and training The clinical utility risk benefit and application of the BIS component have not undergone full evaluation in the pediatric population 10 2 10 4 Understand BIS Parameters BIS monitoring provides the following pa
58. V PC mode is selected and inspiration triggering is performed currently 3 MV amp TVe alarm off icon Displays the MV amp TVe alarm off icon when MV amp TVe alarm is switched off 3 3 10 11 12 13 14 15 16 17 Physiological alarm area Displays physiological alarm messages Apnea alarm off icon area Displays apnea alarm off icon APNEA when apnea alarm is switched off in non mechanical ventilation mode Alarm silence icon area Displays alarm silence icon and 120 s countdown time System time area Displays system time of the anesthesia machine Technical alarm area Displays technical alarm messages When multiple alarms occur they are displayed cyclically Power supply state icon area Displays power source or battery icon The icon DOM is displayed when the anesthesia machine is powered by AC power source The battery icon is displayed when the anesthesia machine 1s battery powered to indicate battery capacity For details refer to2 3 Batteries Vent Mode shortcut key Used to select mechanical ventilation mode Alarm Setup shortcut key Used to change the alarm settings for the anesthetic ventilator gas modules or BIS module Screens shortcut key Used to set user screen User Setup shortcut key Used to change the settings for TV compensation O2 monitoring source gas module BIS module screen sound etc Maintenance shortcut key Used to perform leak test calibrate O2 senso
59. WATO EX 65 Anesthesia Machine Operator s Manual CE Marking CE The product bears CE mark indicating its conformity with the provisions of the Council Directive 93 42 EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive The product is in radio interference protection Group I Class B in accordance with EN55011 The product complies with the requirement of standard EN60601 1 2 Electromagnetic Compatibility Medical Electrical Equipment Revision History This manual has a revision number This revision number changes whenever the manual is updated due to software or technical specification change Contents of this manual are subject to change without prior notice Revision 1 0 is the initial release of the document NW Revision number 1 0 NW Release time 2009 1 Copyright 2009 Shenzhen Mindray Bio Medical Electronics Co Ltd All rights reserved AN WARNING Federal Law USA restricts this device to sale by or on the order of a physician Intellectual Property Statement SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD hereinafter called Mindray owns the intellectual property rights to this product and this manual This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray nor the rights of others Mindray intends to maintain the contents of this manual as confidential informat
60. a Module taa noia 13 31 15 6 1 Install the E OZM odulS 0 A A a EEEEA 13 31 13 62 Install the AC Modales co a 13 31 15 60 Installthe BUS Modular ie 13 32 Oe 7 PME UMALIC CONE 13 32 13 7 1 Connect the Pipeline Gas Supplies ee EEE 13 33 13272 lista lithe Gas Clint 13 34 ER E 13 34 ASA iaa 13 34 3 1OAGSS Transter and Receiving ISO A 13 35 I SOIC OMPONe MS atada 13 35 13 1 O 2 ASSemble EC AGS Sirera lares lorena erstes 13 36 13 10 93 Waste Gas DIS DOS cs 13 37 14 Cleaning and Disidencia 14 1 14 1 Clean and Disinfect the Anesthesia Machine HOUSIN8 ooooocconooononononononooonononnonnnnnnnnnos 14 2 14 2 Disassemble the Breathing System Cleanable Parts ccccceessssseesseeeessseseesseees 14 2 Es A SOS OF satoraiesetalecasete Cersestes elev aeadecateecalecaictne Cleaves Culrua eed caine cloce tie Saeeaesectecaeeed ocak 14 3 A Ors Site E ewan A A Rater eee as 14 4 AB e et 14 5 ADA ATA ES iaa 14 6 14 23 gt AA a A A AN 14 6 420 BElO WS ASSCINDIY tte 14 7 O tts dcntats dca ats se abn son beta cientate scutes ciated 14 8 4 2 8 Expiratory Check Valve Asma aia 14 9 14 2 9 Inspiratory Check Valve Assembly 000ccccccceeseeeeeeeeeeeeeeeeeeeseeeeeeeeeeees 14 9 V2 AO Soda lime aise rated aaa 14 10 IAAL Water Collection CU rematar alar lares 14 11 EA A NS O 14 12 14 2 13 AGSS Transfer and Receiving SySteMO oooconononcnnnononononaononnnonono nono nono nn nnnnnnos 14 13 14 3 Clean amp Disinfect and Re install the Br
61. a cs nari A esata aeu baba ted 5 3 me ibe id 5 4 D2 ORES CU DE A A AE AE E 5 5 Jo Para Meer MOM ONNE latido da dla a 5 5 3 3 1 02 Concentration Montoro seres nr T T TN 5 5 5 3 2 Anesthetic Agent AA Concentration Monitoring 0ccccccceeeeeeeeeeeeeeeeees 5 7 5 3 3 CO2 Concentration Momtonne iia 5 8 o A ase dead E E 5 9 5 3 5 Tidal Volume Monitoring coooccccncnnnnnnnnnnnnnnanononnnn nono nono non nono corno non non nn nn ono non n nn cnn nnnos 5 10 5 35 01 idal Volume Compensa io 5 12 5 3 7 Volume Montornes irii eneee cee ec hee OENE OOE 5 13 do 0 Breall Rate Montos aca ita Paar anne Pecan a 5 13 is E E N 5 14 3A Display Electronic lO rasiona aT O ON 5 16 S2 OP TOME OOD sissies ana AE EE E eS 5 16 ELCANO TEST ai oda 6 1 6 1 Preoperative LESS CAC is 6 1 Oslo LES MES IS A A ees 6 1 SP leo Y do Es 0 A OO A O A Uta Gata 6 2 6 3 Power Falureu lara RCS Che deman silis 6 2 APDE O 6 3 OA OZ Pipeline VCS tos e 6 3 A2 NORDE ie TC aina geod neta aca et a gc 6 4 ASA E cae eS Se eee oe ete mn DER RT ee DPR ERIN Ea td 6 4 OSC ynder La e eae En ce ee SE NEE IT SST OTE SOTO OTE ISOTONIC 6 4 6 5 Gheck the Cylinder in Full SAUS rastereti ee 6 4 63 202 Cylinder High Pressure Leak Testa airada aii 6 5 6 5 3 N2O Cylinder High Pressure Leak Test oocccnnnccnccococococonocininnnnnnnnnnnnnnnnnnnnnos 6 5 6 6 tlow Commo AA ae ees ose 6 5 eRe Without SEA ei o o e er ener non o le eng et lao 6 5 IN EI Re ee ee eee 6 7 6 7 Vaporizer ac
62. a maintenance or service procedure The following table indicates when a test must be done Test Item Test Intervals Pipeline tests Every day before the first patient Cylinder tests Flow control system tests Inspect the system Before each patient Alarm tests Power failure alarm test Breathing system tests O2 Flush Test Preoperative preparations Inspect the AGSS NOTE eo Read and understand the operation and maintenance of each component before using the anesthesia machine eo Do not use the anesthesia machine if a test failure occurs Contact us immediately eo A checklist of the anesthetic system should be provided including aneshetic gas delivery system monitoring device alarm system and protective device which are intended to be used for the anesthetic system whether they are used alone or assembled together 6 2 Inspect the System NOTE Make sure that the breathing system is correctly connected and not damaged The top shelf weight limit is 30 kg Make sure that l m SS se E 10 The anesthesia machine is undamaged All components are correctly attached The breathing system is correctly connected and the breathing tubes are undamaged The vaporizers are locked in position and contain sufficient agent The gas supplies are connected and the pressures are correct Cylinder valves are closed on models with cylinder supplies The necessary emergency equipment is available and in goo
63. ace the sodalime Clean the sodalime canister and change the sodalime canister sponge regularly Otherwise the sodalime powder built up inside the sodalime canister will go into the breathing system Clean the mouth of the sodalime canister regularly Sodalime particles sticking on the mouth may cause breathing system leak Before installing the sodalime canister inspect the canister mouth canister support and seal for sodalime particles If there is clear it to prevent breathing system leakage NOTE The sodalime canister should only be used with air oxygen nitrous oxide halothane enflurane isoflurane sevoflurane and desflurane Change sodalime when necessary to prevent the build up of non metabolic gases when the system is not in use Before installing the sodalime canister check that the seal between the breathing system and the sodalime canister is in good condition If not replace the seal immediately 13 13 13 1 8 1 Assemble the Sodalime Canister 1 The following figures show the components of a soda Pcie Sodalime peyote tes 1 1 te A Canister support arte Ji y i see eet a F ihi al Sodalime canister Canister handle m o Ww gt Canister support buckle Press the buckle as shown in the figure to remove the canister support 13 14 2 Before installing the sodalime canister inspect the canister mouth canister support and seal for sodalime particles If th
64. achine is battery powered you can select less brightness to save battery capacity 3 3 2 Adjust Sound Volume 3 3 2 1 Key Sound Volume 1 Select the User Setup shortcut key and select Screen and Audio Setup gt gt 2 Select Key Sound Volume and select the appropriate value ranging from 0 to 10 for key sound volume The value 0 is for audio off and 10 for the loudest 3 3 2 2 Alarm Sound Volume 1 Select the User Setup shortcut key and select Screen and Audio Setup gt gt 2 Select Alarm Sound Volume and select the appropriate value ranging from 1 to 10 for alarm sound volume The value 1 is for the lowest and 10 for the loudest 3 5 3 3 3 Set System Time 1 Select the Maintenance shortcut key User Maintenance gt gt Set System Time gt gt 2 Set Date and Time 3 Select Date Format and toggle between YYYY MM DD MM DD YYYY and DD MM YYYY 4 Select Time Format and toggle between 24 h and 12 h CAUTION e Changing date and time will affect the storage of trends and log information It may also cause loss of data 3 3 4 Set Language l Select the Maintenance shortcut key and select User Maintenance gt gt 2 Select Language and select the desired language 3 Restart the anesthesia machine to activate the language setting 3 3 5 Set Unit l Select the Maintenance shortcut key and select User Maintenance gt gt 2 Select Paw U
65. ailable 9 8 Troubleshooting If the gas inlet including watertrap sampling tube and airway adapter is occluded by condensed water airway occlusion will be prompted on the screen To remove the occlusion Check the airway adapter for occlusion and replace if necessary Check the sampling tube for occlusion or kinking and replace if necessary Check the watertrap for water build up Empty the watertrap If the problem persists replace the watertrap If the problem persists internal occlusions may exist Contact your service personnel 9 9 Scavenge the Sample Gas Metal chip Exhaust tube To scavenge the sample gas to the waste gas disposal system depress the metal chip and then plug the exhaust tube to the ports marked A lt sample gas return to the AGSS on the anesthesia machine as shown in the above picture WARNING o When using the AG module to perform AG measurements on the patients who are receiving or have recently received anesthetic agents connect the outlet to the waste gas disposal system to prevent the medical staff from breathing in the anesthetic agents 9 10 Calibrate the AG Module Calibrate the AG module once a year or when the measured value has a great deviation Contact us for calibration service 1 0 BIS Monitoring 10 1 Introduction Bispectral index BIS monitoring is for use on adult and pediatric patients within a hospital or medial facility providing patient care to moni
66. al volume setting or increase Paw high alarm limit setting F102 Too High a F102 Too Low H FiO2 is lower than the low alarm limit setting Increase O2 flow in the fresh gas or decrease low alarm limit Ppeak is lower than the Paw low alarm limit setting for 20 seconds Increase tidal volume setting or decrease Paw high alarm limit setting F102 is higher than the high alarm limit setting Decrease O2 flow in the fresh gas or increase high alarm limit M TVe Too High M TVe is higher than the high alarm limit setting If ventilation mode is switched or settings for ventilator parameters are changed this alarm is disabled temporarily within nine breathing cycles after being set Decrease tidal volume setting or increase high alarm limit TVe Too Low M TVe is lower than the low alarm limit setting If ventilation mode is switched or settings for ventilator parameters are changed this alarm is disabled temporarily within nine breathing cycles after being set Increase tidal volume setting or decrease low alarm limit TVe Below Control Range MV Too High MV Too Low Apnea Alarm Volume Apnea gt 2 min Rate Too High Pressure Limiting In the VCV mode TVe is lower than the minimum tidal volume setting for five continuous breathing cycles Check the patient s condition pneumatic circuit connection and flow sensor MV is higher than the high alarm limit setting If ventilation mode is switched or
67. ally compensates for the loss of tidal volume arising from breathing system compliance and system leakage and eliminates the effect of fresh gas as well This is called tidal volume compensation In the VCV mode if tidal volume compensation is turned off or failed the anesthesia machine can continue delivering gas stably but cannot compensate for the effects of fresh gas flow and breathing system compliance losses 4 4 3 2 Waveforms The following figures show the Paw waveform and flow waveform in the VCV mode Paw ee ee aaa aaa Ppeak i PEEP Flow Inspiration TEN Time Expiration Time r A Generally in the VCV mode the flow waveform is at a constant flow during inspiration and the Paw waveform rises in the same period 4 4 3 3 Start VCV Mode 1 Select the Vent Mode shortcut key to open the Vent Mode Setup menu 2 Select VCV in the Vent Mode Setup menu 3 After confirming the selection the TV shortcut key the first key from the left in the parameter setup shortcut keys area is highlighted 4 Make sure that TV is appropriately set for the patient Push the control knob to confirm the setting so as to start VCV mode NOTE eo When it is necessary to switch over to VCV mode confirm the setting of TV first Otherwise the system works in the previous ventilation mode If the setting of TV is not confirmed for 10 s the screen returns to the previous mode automatica
68. and the patient Disinfection Steam autoclavable or disinfectable B 1 B 2 Environmental Specifications Main unit Item Temperature C Related humidity Barometric pressure non condensing kPa Operating 10 to 40 15 to 95 70 to 106 Transport storage 20 to 55 10 to 95 50 to 106 AG module Item Temperature C Related humidity Barometric pressure non condensing kPa 10 to 40 15 to 95 70 to 106 20 to 55 10 to 95 70 to 106 B 3 Power Requirements External AC power supply Auxiliary output supply with isolation transformer Lithium ion battery 5 min at least powered by new fully charged batteries after the Time to shutdown first low power alarm 60 min in case of one battery or 120 min in case of two batteries Operating time powered by new fully charged batteries at 25 C ambient temperature Approximately 8 hours in running status or standby mode B 4 Physical Specifications Main unit 1355 x 700 x 610 mm height x width x depth double vaporizer not including breathing system 1355 x 950 x 610 mm height x width x depth double vaporizer including breathing system Weight lt 120 kg including trolly without vaporizers or cylinders Top shelf Weight limit 30 kg Size 480 x 430 mm width x depth Worktable Size Height 860 mm Area 1012 mm DIN handle Size Length 370 mm Drawer 270 X 350 X 170 mm length x width x height Size Length 320 mm he
69. ask Sil Flex Silicone Size 1 Infant Large 15mm OD M6Q 150003 Mask Sil Flex Silicone Size 2 Child 22mm ID M6Q 150004 Mask Economy Silicone Size 3 Child Large 22mm ID M6Q 150005 Mask Economy Silicone Size 4 Adult 22mm ID M6Q 150006 Mask Economy Silicone Size 5 Adult Large 22mm ID M6Q 150007 Aircushion Mask Size 2 w valve Infant Large 15mm M6Q 150009 Aircushion Mask Size 3 w valve Child 22mm M6Q 150010 Aircushion Mask Size 4 w valve Child Large 22mm M6Q 150011 Aircushion Mask Size 5 w valve Adult 22mm M6Q 150012 Aircushion Mask Size 6 w valve Adult Large 22mm M6Q 150013 O sensor O sensor cable 0601 20 78941 O sensor 0611 10 45654 Flow Sensor Expiratory flow sensor assembly 0601 30 78894 060 1 30 69700 Inspiratory flow sensor assembly Sodalime canister Sodalime canister 0601 30 78957 0601 20 78976 Sponge for sadalime canister Vaporizer Vaporizer Halothane5 Selectatec Pour Fill 0621 30 78724 062 1 30 78723 Vaporizer Sevoflurane8 Selectatec Pour Fill Vaporizer Desflurane18 Selectatec Pour Fill 0621 30 78722 Vaporizer Enflurane5 Selectatec Pour Fill 0621 30 78721 Vaporizer Isoflurane5 Selectatec Pour Fill 0621 30 78720 Vaporizer Sevoflurane8 Selectatec Quick Fill 0621 30 78725 Vaporizer Enflurane7 Selectatec Keyed Filler 062 1 30 78726 Vaporizer Isoflurane5 Selectatec Keyed Filler 0621 30 78727 Cylinder pressure reducer Pressure reducer fo
70. at the equipment connecting cables and accessories are in correct working order and operating condition The equipment must be connected to a properly installed power outlet with protective earth contacts only If the installation does not provide for a protective earth conductor disconnect it from the power line Use AC power source before the batteries are depleted To avoid explosion hazard do not use the equipment in the presence of flammable anesthetic agent vapors or liquids Do not open the equipment housings All servicing and future upgrades must be carried out by the personnel trained and authorized by us only Do not rely exclusively on the audible alarm system for patient monitoring Adjustment of alarm volume to a low level may result in a hazard to the patient Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring The physiological parameters and alarm messages displayed on the screen of the equipment are for doctor s reference only and cannot be directly used as the basis for clinical treatment Dispose of the package material observing the applicable waste control regulations and keeping it out of children s reach To avoid explosion hazard do not use flammable anesthetic agent such as ether and cyclopropane for this equipment Only non flammable anestheti
71. ate Too Low FiO2 23 PEEP 0 cmH20 12 11 17 25 Rate Too Low Tve 300 mL Ppeak 18 cmH20 na Rate Too Low Rate 15 BPM I E 1 2 MTS Rate Too Low MY 4 5 Limin Polat 15 cmH20 12 09 16 44 Rate Too Low EtC02 38 mmHg FICO 2 2 mmHg Review the previous item The alarm logbook records all physiological alarm messages which are arranged in chronological order The latest event 1s placed at the foremost In the Alarm Logbook window you can l Select Prev or Next to review the previous or next item 1 se os 2 Move the cursor to the w position Push the knob and enter the number of alarm message you want to review NOTE eo The stored alarm logbook is not deleted when the anesthesia machine suffers power failure or is switched off 12 3 FOR YOUR NOTES 12 4 1 3 Installations and Connections NWARNING Continuous use of desiccated sodalime may endanger patient safety Adequate precautions should be taken to ensure that the sodalime in the sodalime canister does not become desiccated Turn off all gases when finished using the system When electrosurgical equipment is used keep the electrosurgical leads away from the breathing system the O sensor and other parts of the anesthesia machine Keep backup manual ventilation and simple respirator with mask available in case the electrosurgical equipment prevents safe use of the ventilator In addition make sure of the correct operations of all life support an
72. atory time If the patient does not inspire within the Trigger Window the ventilator delivers volume controlled breathing to the patient at the end of Trigger Window Spontaneous breathing outside of Trigger Window can acquire pressure support E SIMV PC SIMV PC means to deliver pressure controlled breathing to the patient by phase at the preset intermission In the SIMV PC mode the ventilator waits for patient s next inspiration based on the specified time interval The sensitivity depends on Trigger Level optional flow and pressure If Trigger Level is reached within the trigger waiting time called synchronous Trigger Window the ventilator delivers pressure controlled breathing synchronously with the preset tidal volume and inspiratory time If the patient does not inspire within the Trigger Window the ventilator delivers pressure controlled breathing to the patient at the end of Trigger Window Spontaneous breathing outside of Trigger Window can acquire pressure support If Trigger Level is reached outside of Trigger Window the ventilator delivers pressure supported ventilation based on the preset Psupp 4 11 4 4 5 2 Waveforms E SIMV VC The following figures show the Paw waveform and flow waveform in the SIMV VC mode Paw a ss A Within the trigger Outside of the window trigger window SIMV cycle Flow Within the trigger Outside of the window trigger window A Ll gt If no ventila
73. based on gas flow The default is high resolution mode The scale range of the standard resolution mode is 0 to 10 L min and that of the high resolution mode 0 to 6 L min To select the electronic flowmeter with desired resolution select the electronic flowmeter area to access the Display Selection menu Flowmeter Flowmeter 10 E eE G 4 When spirometry loop and gas modules are configured you can select to display either spirometry loop or electronic flowmeter In this case select the electronic flowmeters area to open the Display Selection menu and then select the desired spirometry loop or electronic flowmeter 5 5 Spirometry Loop Spirometry loops reflect patient lung function and ventilation as well such as compliance over inflation breathing system leak and airway blockage The system provides two spirometry loops P V Paw volume loop and F V flow volume loop Only one loop is displayed at a time P V loop or F V loop To switch over between the two loops select spirometry loop area and select the desired loop The scales of volume flow and Paw are adjusted automatically The following figures show an F V loop and a P V loop F Loop Limin combed oT r m a an al 5 16 6 Preoperative Test 6 1 Preoperative Test Schedules 6 1 1 Test Intervals Perform the preoperative tests listed below at these events 1 Before each patient 2 When required after
74. ble the O2 sensor before calibrating it Re install the O2 sensor after making sure that there is no water build up in the O2 sensor and its installation part eo The O calibration is not required if no O sensor is configured or used 7 5 1 21 O2 Calibration NOTE Perform O calibration when the measured value of O concentration has a great deviation or when the O sensor is replaced The O calibration must be performed when the system is Standby If the calibration fails check for technical alarm and troubleshoot it if there is Then do the calibration again In case of repeated calibration failures replace the O sensor and do the calibration again If it still fails contact your service personnel or us Obey the relevant stipulations about biohazard when disposing the discarded O sensor Do not burn it 7 5 To calibrate at 21 O do as follows Make sure that the system is Standby If not press the 0 key and then select Ok from the pop up menu to enter standby status Select the Maintenance shortcut key O2 Sensor Cal gt gt 21 02 Cal gt gt to open the 02 21 Cal menu Remove the O sensor from the breathing system and leave 1t exposed to room air for two to three minutes For details about how to disassemble the flow sensor refer to 14 2 1 02 Sensor Select Start from the menu to start to calibrate at 21 O2 The screen prompts Calibrating During the calibration if y
75. c agents which meet the requirements specified in IEC 60601 2 13 can be applied to this equipment This anesthesia machine can be used with halothane enflurane isoflurane sevoflurane and desflurane Only one of the five anesthetic agents can be used at a time Do not touch the patient table or instruments during defibrillation 1 2 WARNING Use appropriate electrodes and place them according to the instructions provided by the manufacturer The display restores to normal within 10 seconds after defibrillation 1 1 3 Cautions CAUTION eo To ensure patient safety use only parts and accessories specified in this manual o At the end of its service life the equipment as well as its accessories must be disposed of in compliance with the guidelines regulating the disposal of such products eo Magnetic and electrical fields are capable of interfering with the proper performance of the equipment For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements Mobile phone X ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation o This system operates correctly at the electrical interference levels identified in this manual Higher levels can cause nuisance alarms that may stop mechanical ventilation Pay attention to false alarms caused by high intensity electrical fields
76. cable to AION 03 AG module only equivalent to the interference of secondary AG to primary AG B 20 B 14 BIS Module Specifications EEG Measured parameters BIS 0 to 100 SQI Calculated parameters TP BIS High Limit low limit 2 to 100 1 BIS Low Limit 0 to high limit 2 B 21 FOR YOUR NOTES B 22 C enc This anesthesia machine meets the requirements of IEC 60601 1 2 2001 A1 2004 NOTE Using accessories sensors and cables other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the equipment The anesthesia machine or its components should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the anesthesia machine or its components should be observed to verify normal operation in the configuration in which it will be used The anesthesia machine needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below Other devices may affect this equipment even though they meet the requirements of CISPR When the input signal is below the minimum amplitude provided in technical specifications erroneous measurements could result Use of portable or mobile communications devices will degrade the performance of the equipment C Guidance and Declaration Electromagnetic Emissions The anesthesia machine is s
77. cautions e Do not use the sodalime canister with chloroform or trichloroethylene Disposable sodalime canister is a sealed unit which should not be opened or refilled e Avoid skin or eye contact with the contents of the sodalime canister In the event of skin or eye contact immediately rinse the affected area with water and seek medical assistance e Changing the sodalime during ventilation may result in breathing system leakage if the anesthesia machine does not have BYPASS function o If the anesthesia machine has BYPASS function be sure to install and lock the sodalime canister in place Failure to do so will result in repeated inhalation of the patient s expired CO2 e CO2 concentration monitoring is strongly recommended when the anesthesia machine has BYPASS function o Before installing a sodalime canister inspect the color of the sodalime in the canister to determine when to change the sodalime 13 12 WARNING Inspect sodalime color during the surgery or at the end of a case During non use sodalime may go back to the original color Refer to the sodalime labelling for more information about color changes Adequate precautions should be taken to ensure that the sodalime in the sodalime canister does not become desiccated Turn off all gases every time when finished using the system If the sodalime completely dries out it may give off carbon monoxide CO when exposed to anesthesia agents For safety repl
78. cifications Contact us for service assistance For further information about the product contact us We can provide documents about some parts depending on the actual condition 7 1 7 2 Maintenance Schedule NOTE These schedules are the minimum frequency based on typical usage of 2000 hours per year You should service the equipment more frequently if you use it more than the typical yearly usage Minimum frequency Maintenance Clean the external surfaces 21 02 calibration O sensor in breathing system Monthly 100 O calibration breathing system O sensor Clear water built up inside the waterstraps of CO2 module and AG module During cleaning Inspect the parts and seals for damage Replace or repair as necessary and setup Annually Every three years As necessary Replace the seal on the vaporizer manifold and that on the breathing system port Contact us for details CO2 module calibration AG module calibration Replace the built in lithium ion batteries Contact us for details Before installing the cylinder use a new cylinder gasket on cylinder yoke Empty the water collection cup If there is water built up in it Replace the sodalime in the canister if sodalime color change is detected Replace the O2 sensor if a great deviation of the measured value by the O2 sensor occurs and the problem persists after multiple calibrations Replace the flow sensor if the seal for the flow se
79. cmH20 you will feel clicks as the v turns Turn clockwise to increase O sensor connector Rotary handle Sodalime canister The sodalime inside the canister absorbs the CO the patient exhales which enables cyclic use of the patient exhaled gas 2 2 2 Rear View Power supply we oe eels Os Oe ges e aS 10 11 12 Cylinder connector s Equipotential stud Fan Mains inlet Network connector CIS 12 V power supply connector Speaker Auxiliary O2 supply ACGO Auxiliary Common Gas Outlet switch acco Set the switch to the position to stop mechanical ventilation Then fresh gas is sent to the externally connected manual breathing system through the ACGO outlet and the technical alarm of ACGO On is triggered The system monitors airway pressure and O concentration instead of volume Set the switch to the Y position to apply mechanical or manual ventilation to the patient through the breathing system Module slot CO AG and BIS modules mentioned in this manual can be inserted into the slot and identified The CO and AG modules cannot be used simultaneously AGSS outlet AGSS Transfer and Receiving System Anesthesia information system CIS 2 9 This rear view is based on the situation that the anesthesia machine is configured with anesthesia information system CIS 1 Display 2 Rail 3 Mounting bracket 4 Keyboard 5 CIS ma
80. d condition Equipment for airway maintenance and tracheal intubation 1s available and in good condition Applicable anesthetic and emergency drugs are available The casters are not damaged or loose and the brake s is set and prevents movement 11 Make sure the breathing system 1s locked in the fi position WA 13 The AC mains indicator and the battery indicator come on when the power cord is connected to the AC power source If the indicators are not on the system does not have electrical power The anesthesia machine is switched on or off normally 6 3 Power Failure Alarm Test Set the system switch to the position Disconnect the AC mains Make sure that the AC mains indicator is extinguished and the battery indicator is flashing Meanwhile the prompt message Battery in Use is displayed Reconnect the AC mains Make sure that the AC mains indicator is illuminated and the battery indicator stops flashing and continues illuminated Meanwhile the prompt message Battery in Use disappears o Set the system switch to the O position 6 4 Pipeline Tests NOTE Do not leave gas cylinder valves open if the pipeline supply is in use Cylinder supplies could be depleted leaving an insufficient reserve supply in case of pipeline failure 6 4 1 02 Pipeline Test So ae a Close all cylinder valves and connect an O supply if the anesthesia machine is equipped with cylinders Set the system s
81. d monitoring equipment Do not use antistatic or conductive masks or breathing tubes They can cause burns if they are used near high frequency electrosurgical equipment This equipment must be installed by the factory authorized engineer This anesthesia machine has waste gas exhaust ports The operator of the machine should pay attention to the disposal of the residual breathing gas scavenged CAUTION The operational environment and the power source of the equipment shall comply with the requirements in B 2 Environmental Specifications and B 3 Power Requirements 13 1 Install the Breathing System NOTE Pay attention to the disposal of the breathing system after equipment use the detection of the sodalime in the canister and the anesthetic agent in the vaporizer to ensure the normal operation of the equipment 13 1 13 1 1 Breathing System Diagrams t i a 4 gt 1 2 3 10 4 5 11 6 12 7 13 8 9 13 2 Oo 0 NN A WO N a peek ek Bellows housing 12 Expiration connector Bag arm 13 Inspiration connector Bag mechanical ventilation switch 14 Water collection cup APL valve 15 Locking hook Inspiratory check valve 16 Drive gas connector Expiratory check valve 17 Guide pin hole Plug for O sensor O sensor optional 18 Locking catch retainer Rotary handle 19 Pressure sampling connector s Sodalime canister 20 APL valve gas outlet Airway pressure gauge 21 Fresh gas inlet Leak test plug
82. e 12 BPM 9 ELE 1 2 9 Plimit 30 cmH O PEEP OFF Push the O flush button to fill the bellows folding bag rising to the top Turn the O flow control to set the O flow to 0 5 to 1 L min Press the key and select Ok from the pop up menu to exit the standby status Make sure that The ventilator displays the correct data The folding bag inside the bellows inflates and deflates normally during mechanical ventilation 6 12 6 9 2 Test the O2 Concentration Monitoring and Alarms NOTE 10 This test is not required if no O sensor is configured Set the bag mechanical ventilation switch to the bag G gt position Remove the O sensor After two to three minutes make sure that the sensor measures approximately 21 O in room air Select the Alarm Setup shortcut key and then Ventilator gt gt Set the FiO low alarm limit to 50 Make sure that a low FiO alarm occurs Set the FiO low alarm limit back to a value less than the measured FiO value and make sure that the alarm cancels Put the O sensor back in the breathing system Select the Alarm Setup shortcut key and then Ventilator gt gt Set the FiO high alarm limit to 50 Connect the manual bag to the manual bag port Push the O flush button to fill the manual bag Make sure that the sensor measures approximately 100 Oz Make sure that a high FiO alarm occurs Set the FiO high alarm limit to 100 and make sure that t
83. e tube between the waste gas disposal system and the AGSS is occluded the extract flow of the waste gas flow system is insufficient or the waste gas disposal system malfunctions In this case it is recommended not to use the AGSS 13 38 1 4 Cleaning and Disinfection N WARNING e Obey applicable safety precautions o Read the material safety data sheet for each cleaning agent o Read the operation and service manual for all disinfection equipment o Wear gloves and safety glasses A damaged O sensor can leak and cause burns contains potassium hydroxide o Reuse of undisinfected breathing system or reusable accessories may cause cross contamination o The operations described in 6 Preoperative Test must be performed before patient use every time the anesthesia machine has been disassembled for cleaning and disinfection or has been reassembled eo To prevent leaks avoid damaging any component in case of disassembling and reassembling the breathing system Ensure the correct installation of the system especially of the seal Make sure of the applicability and correctness of the cleaning and disinfection methods eo Disassemble and reassemble the breathing system as described in this manual For further disassembly and reassembly contact us Improper disassembling and reassembling may cause breathing system leak and compromise normal system use NOTE e Clean and disinfect the equipment as required before it is put into use for
84. e which can cause serious fresh gas leak and inaccurate tidal volume measurement 13 5 NOTE eo If itis hard to push the breathing system into or out of the circuit adapter you need to apply some lubricant M6F 020003 Dupont Krytox high performance fluorine lubricating grease to the seal on the pneumatic connector to reduce friction 13 1 4 Install the Bag Arm 1 Align the bag arm with the connector on the breathing system k 13 6 2 Turn the locking nut clockwise to tighten the bag arm 13 1 5 Install the Bellows 1 Attach the bottom ring of the folding bag to the bellows base on the breathing system and make sure that the bag 1s tightly connected to the base A Folding bag 13 7 2 Align the bellows housing bayonet tabs with the slots on the breathing system and then lower the bellows housing Make sure that the housing is depressing the seal evenly 3 Hold the bellows housing tightly and turn it clockwise until it stops Make sure that the side of the housing marked with scale is facing the operator WARNING o Before installing the bellows housing check that the sealing component on the breathing system is in position If not you must install the sealing component properly before installing the bellows housing 13 8 13 1 6 Install the Flow sensor 1 Make sure that the direction of arrow on the flow sensor is same to that on the breathing system and the side with sil
85. e O pipeline supply or close the O cylinder valve Make sure that 9 N O and O flows stop The O flow stops last Air flow continues if Air supply is available Gas supply alarms occur on the ventilator Turn all the flow controls fully clockwise minimum flow Reconnect the O pipeline supply or open the O cylinder valve Set the system to Standby 6 7 Vaporizer Back Pressure Test N WARNING Use the Selectatec series vaporizers only Make sure that the vaporizers are locked when doing the test During the test the anesthetic agent comes out of the fresh gas outlet Use a safe and approved procedure to remove and collect the agent To prevent damage turn the flow controls fully clockwise minimum flow or OFF before using the system Before the test make sure that the vaporizers are correctly installed For details about vaporizer installation refer to 13 4 Install the Vaporizer l Za gt Connect the O pipeline supply or open the O cylinder valve Turn the O flow control and set the O flow to 6 L min Make sure that the O flow stays constant Adjust the vaporizer concentration from 0 to 1 Make sure that the O flow must not decrease more than 1 L min through the full range Otherwise install a different vaporizer and try this step again If the problem persists the malfunction is in the anesthesia system Do not use this system Test each vaporizer as per the steps above NOTE Do n
86. e assembly tube connecting the hospital s waste gas disposal system to the AGSS main unit Tube length approximately 4 m 15 4 0000 10 11215 009 000093 00 009 000094 00 MO5 010001 06 0010 10 42672 0010 10 42673 6800 30 50761 0611 30 67693 0611 30 67692 A 1 Pneumatic Circuit System A 1 1 Pneumatic Circuit Diagram A Theory of Operation J9ZLIOAdBA J9ZLIOABA at lt esodstp ses ISEM ser EE 3 NETA oF A 1 2 Parts List OCN TN e IC TN DI r fi Mechanical overpressure valve 110 O2 flow sensor cmH O Pop Off valve Scavenging reservoir and sound arrestor CO ONE E e a A 2 A 1 3 Description Gas supplies The anesthesia machine has pipeline and cylinder gas supplies available Pipeline gas supplies O2 N20 and Air go into the system through pipeline connectors 1 3 and 4 respectively The pipeline pressure ranges between 280 and 600 kPa Cylinder gas supplies O and N20 go into the system through cylinder connectors 2 and 5 respectively The O2 and N20 cylinder pressures are 6 9 to15 MPa and 4 2 to 6 MPa respectively which is decreased to 300 to 500 kPa through regulator 6 Every connector is clearly marked to prevent erroneous gas connection All connectors have filters and check valves Color coded gauges show the pipeline and cylinder pressures Pressure relief valve 7 functions to prevent too high supply pressure Fresh gas When system
87. e patient breathe Parameter monitoring is enabled Insp Valve Failure Inspiratory valve connection or control failure Use manual ventilation mode to help the patient breathe Parameter monitoring is enabled Failure manual ventilation mode to help the patient breathe PEEP Safety Valve M PEEP safety valve connection or control failure Use Parameter monitoring is enabled Only mode to help the patient breathe Parameter monitoring 1s For Monitoring M Mechanical ventilation failed Use manual ventilation enabled Restart the machine this alarm occurs when O flush button is not pushed O2 Flush Failure Oxygen flushing lasted too long more than 15 seconds If contact your service personnel Replace O2 sensor O sensor malfunction Replace the O sensor Patient Circuit Leak M A leak was detected in the breathing system Check the connection between the breathing system and the flow sensor Pressure M Patient pressure monitoring failure Use manual Monitoring ventilation mode to help the patient breathe Channel Failure Volume Monitoring M Flow sensor monitoring was disabled or ACGO was Disabled switched on Make sure that ACGO is switched off Use manual ventilation mode to help the patient breathe Calibrate Flow Last calibration of the flow sensor and inspiratory valve D 6 Sensor failed Or great drift occurred to the flow sensor and inspiratory valve Use manual ventilat
88. e surface of the O sensor which can result in invalid O concentration measurement In this case you need to take out the O sensor remove the water condensed on its surface and reinstall it into the breathing system 1 Refer to the methods recommended in the table of 14 3 Clean amp Disinfect and Re install the Breathing System to clean and disinfect the O2 sensor 2 When the O sensor is fully dry refer to 14 2 1 O2 Sensor to install it in the reverse order 14 3 11 AGSS Transfer and Receiving System 14 3 11 1 Filter Shake the removed filter to get rid of the dust and other contamination until satisfactory cleaning effect 1s achieved 14 3 11 2 Float Refer to the methods recommended in the table of 14 3 Clean amp Disinfect and Re install the Breathing System to clean and disinfect the float 14 3 11 3 Spoiler Refer to the methods recommended in the table of 14 3 Clean amp Disinfect and Re install the Breathing System to clean and disinfect the spoiler 14 21 NWARNING e Do not autoclave the AGSS NOTE Oo Make sure that the float is fully dry before installing it onto the AGSS after cleaning Even a very amount of liquid may cause the float to stick to the guide bar or sight glass resulting in inaccurate flow indication O Immerse disinfect and clean the AGSS by strictly following the concentration specified in the Instructions for Use provided by the disinfectant supplier 14 22 1 5 Accessorie
89. eathing System oooooncnncoconooooooooooonorononnnononnnos 14 15 PA Ml AAA A Et tan Peg 14 17 Az Water Cole cOn 14 17 14 333 Manqal Bas ee ee 14 17 Ass Ache acai MEAG Katia shied ashe o eta iia asta AS teens 14 18 14 3 5 Inspiratory and Expiratory Check Valves Assembly ccccceeeeeeeeeeens 14 18 OBE WOW AS Se MIM Dy ee oa Das A A ese tien eee 14 18 1A 337 Soda e O aniSter cic a os ente o e DO 14 19 143S Breathing Tubes a e an ae Garand 14 20 AD OW SENSO cris 14 20 A A A OR aa a ante RE E E aces a a ees 14 21 14 3 11 AGSS Transfer and Receiving System ccccccccccceeeeeeeeeeeeeeeeeeeeeeeeeeees 14 21 E casnas o ica naonana a a a Ea EO aaa Eaa KO a a Aaa a a Eaa Eaa a 15 1 A Theory of O DECO iaa cciciencaass A 1 RS AAA A A 1 AZ BlecticalSysten UCI A 4 B Product SpeCiiCatiGuis vescissciscztsscsstcastcsaccasasiatiasssasesasasaataasesasesisesastaasasaacsisasastaastiisenenseelets B 1 BL Sales peciica tons ii a B 1 B 2 Environmental SpecificatiODS ooooooocccccnnnnnnnnnnnnnnnnnnnnnnnnnnoncnnnnnnnnnnnneneneneneneneneneneneness B 2 Bo POW ERRE e e eae e cd B 2 B 4 Physical pecrH CONS enen E iS B 3 B 5 Pneumatic Circuit System Specifications ure curare ieie ea A E B 4 B26 breathing System SpeCiuiCalOMs idas iisidicda B 5 BCAA PEC AO oda B 7 B S Ventilator ACCUIACY inr aa E OE EAE ENE B 9 Teo AMC SEC UIC Hy AN ONIZG A E B 10 B 10 AGSS Transfer and Receiving System SpecIfiCatlODS ooocoooccccnnnnnnnnnnnnnn
90. edance of the signal electrodes plus the reference electrode This is done continuously and does not affect the EEG wave As long as the impedances are within the valid range no prompt message about this check is given NW The impedance of the ground electrode This is done every ten minutes and takes approximately four seconds It causes an artifact in the EEG wave and the message BIS Ground Checking is displayed during the check If the ground electrode does not pass this check another check is initiated This continues until the ground electrode passes the check If the continuous impedance check interferes with other measurements 1t can be switched off To do this 1 Select the User Setup shortcut key and then BIS Module Setup gt gt 2 Select Cont Imped Check and then OFF CAUTION o Switching off the continuous impedance check off will disable automatic prompt to the user of impedance value changes which may lead to incorrect BIS values Therefore this should only be done if the check interferes with or disturbs other measurements 10 5 10 7 Cyclic Impedance Check This measures the exact impedance of each individual electrode It causes a disturbed EEG wave and a prompt message 1s displayed on the screen NW The cyclic impedance check is automatically initiated when a sensor is connected To manually start a cyclic impedance check manually you can either Select Cyc Imped Check in the
91. elivery device anesthetic ventilator O2 monitor CO2 monitor and AG monitor where m The pressure restriction device expiratory volume monitor and breathing system with alarm system comply with GB 9706 29 and IEC 60601 2 13 m The pressure measurement device and anesthetic ventilation system comply with ISO 8835 2 The AGSS transfer and receiving system complies with ISO 8835 3 The anesthetic gas delivery device complies with ISO 8835 4 The anesthetic ventilator complies with ISO 8835 5 The O2 monitor complies with ISO 7767 1997 and ISO 21647 2004 The CO2 monitor complies with ISO 9918 1993 and ISO 21647 2004 The AG monitor complies with ISO 11196 1996 and ISO 21647 2004 B 1 Safety Specifications Class I equipment with internal electrical power supply Type of protection against Where the integrity of the external protective earth ground in electric shock the installation or its conductors is in doubt the equipment shall be operated from its internal electrical power supply batteries Degree of protection against oe BF defibrillation proof electric shock Degree of protection against Ordinary equipment without protection against explosion not hazards of explosion for use with flammable anesthetics Degree of protection against Ordinary equipment without protection against ingress of harmful ingress of water water IPX0 IEC 529 Electrical connections between Non electrical connections the equipment
92. enced status all the alarm indicators work normally except audible alarm tones In the 120 s alarm silenced status if an alarm occurs the current silenced status is finished automatically and audible alarm tones are restored When the 120 s countdown time is up the 120 s alarm silenced status will be finished and audible alarm tones restored If the system is already in the alarm silenced status when the alarm of 02 Supply Failure occurs alarm silenced status will be finished automatically and a high level technical alarm will be generated In this case the 120 s alarm silence key is disabled It returns to normal when the alarm of 02 Supply Failure disappears 11 9 2 Cancel 120 s Alarm Silence In the alarm silenced status pressing the 120 s alarm silence key or triggering a new alarm will finish the current silenced status and restore audible alarm tones Besides the alarm silence symbol and 120 s countdown time will disappear from the upper right corner of the screen 11 10 When an Alarm Occurs When an alarm occurs do as follows l A 3 4 5 Check the patient s condition Determine the alarming parameter or alarm category Identify the alarm source Take proper actions to eliminate the alarm condition Make sure the alarm condition is corrected For details about how to troubleshoot alarms refer to D Alarm Messages 11 7 FOR YOUR NOTES 1 2 Trend and Logbook 12 1 Trend Graph A tr
93. end graph is used to review the trend of parameter values within a specific time period The trend is reflected through a curve Every point on the curve corresponds to the parameter value at a specific time point You can review TVe MV Ppeak F10 gt EtCOz Plat PEEP Pmean Rate and BIS data within a maximum of 24 hour operating time When the anesthesia machine is restarted the trend graph is recorded anew Select the Maintenance shortcut key Trend and Logbook gt gt Trend Graph gt gt to access the window as shown below Trend Graph E 1500 B 3 0 0 1000 F o i D B 18 q o s OO I of oO aa Browse Resolution Selecta trend parameter for viewing A Y axis B Parameter value C Parameter combo box D X axis E Trend graph F Cursor G Cursor time EH To select the parameter for recall highlight the parameter combo box Push the control knob to select the desired parameter from TVe MV Ppeak F102 and EtCO2 MH Select 44 or PP on both sides of Browse to move the cursor one page to the left or right to navigate through the trend graph at large resolution NW Select 4 or on both sides of Move Cursor to move the cursor one step to the left or right to navigate through the trend graph at small resolution The time indicating your current position is displayed above the cursor It changes automatically as the cursor moves E Select Resolution and toggle between 5 s 30 s
94. er cap must be refitted before using the vaporizer 1 Remove the protective cap from an empty bottle Insert the bottle nozzle into the drain funnel Rotate the bottle to align the bottle filler keys with the index slots in the drain funnel and screw the drain funnel onto the empty bottle 2 Remove the vaporizer filler block cap 3 Fully insert the drain funnel into the keyed drain slot and unscrew the drain plug Continue to drain the vaporizer until empty Close the drain plug and tighten and withdraw the drain funnel 4 Unscrew the drain funnel from the bottle and refit the bottle cap and the vaporizer filler block cap 13 28 13 5 Install Replace the Gas Cylinder To install change a gas cylinder do as follows 1 Turn the handle of the cylinder valve clockwise Close the cylinder valve on the cylinder to be replaced Handle of the cylinder valve Die 3 4 Remove the used cylinder and the used gasket Gasket 5 Point the cylinder outlet away from all items that can be damaged by a release of high pressure gas Quickly open and close the cylinder valve This removes dirt from the cylinder outlet 6 7 Install a new gasket 8 Align the cylinder post with the index pins 9 Close the yoke gate and tighten the tee handle 10 Do a high pressure leak test For details refer to section 6 5 Cylinder Tests NWARNING eo Do not leave gas cylinder valves open if the pipeline supply is in use
95. erclockwise to disconnect the tube from the top cover Then remove the transfer tube to dismount the AGSS transfer and receiving system from the main unit A a Nut 2 Rotate the top cover counterclockwise to separate it from the sight glass 14 13 3 Take out the nut fixed plate and filter screen by turn N D y lt lt Fixed plate Filter screen 14 2 13 2 Float 1 Disconnect the waste gas disposal system from the top cover 2 Rotate the top cover counterclockwise to separate it from the sight glass 3 Take out the sight glass Sight glass 4 Take out the float Float 14 14 14 2 13 3 Spoiler After taking out the float remove the spoiler Spoiler 14 3 Clean amp Disinfect and Re install the Breathing System O Parts marked 134 C are autoclavable Metal and glass parts can be steam autoclaved Maximum recommended temperature is 134 C By using autoclave to solidify bacterioprotein rapidly quick and reliable sterilization can be achieved Suffered from 15 to 20 minutes of 1 05 kg cm steam pressure and 121 C temperature all bacteria and most brood cells are killed Such parts are cleanable by hand Rinse and dry all parts of the breathing system except the O sensor completely by using mild detergent pH ranging from 7 0 to 10 5 The flow sensor is plastic For details about cleaning procedure refer to 14 3 9 Flow Sensor N WARNING eo Do no
96. ere is please clear it Canister seal Canister support Canister mouth 3 Align the sodalime canister with the mounting slot Canister mounting slot 4 Push the sodalime canister into the mounting slot 13 15 5 Turn the rotary handle clockwise for 90 degrees 6 Let the rotary handle fall to lock the sodalime canister 13 16 CAUTION Remember to do a breathing system leak test after reinstalling the sodalime canister 13 1 8 2 Change the Sodalime NOTE A gradual color change of the sodalime in the canister indicates absorption of carbon dioxide The color change of the sodalime is only a rough indicator Use carbon dioxide monitoring to determine when to change the sodalime Follow local regulations regarding disposal of hospital waste when the sodalime has changed color If left standing for several hours it may regain its original color giving a misleading indication of activity TM Medisorb sodalime is recommended Disassemble the sodalime canister by referring to 13 1 58 14ssemble the Sodalime Canister in the reverse order Pour out the sodalime which has changed color Press the canister support buckle to remove the canister support Replace the sodalime canister sponge Canister support Sodalime canister sponge 13 17 4 Pour new sodalime into the sodalime canister When pouring prevent the sodalime from falling on the venthole of the canister support
97. essure relief system in the rear of the sensor limiting the internal pressure build up due to N2O dissolving in the electrolyte to a figure well within the capacity of the sealing system Test data shows that sensors are unaffected by months of operation in 100 N20 Cross interference tests with 10 CO2 balance 02 show virtually no interference from CO2 Temperature Dependence The rugged design of O2 sensor means they are resistant to damage from extremes of high or low temperature Even so the sensor must never be exposed to temperatures at which the electrolyte will freeze approx 25 C or temperatures which will harm the components of the sensor ie the plastic or seals gt 70 C Sensor lifetime is governed by the mass of lead available to react with oxygen and its rate of consumption High oxygen partial pressures and high temperatures will increase the sensor output current thus shortening the operating life m T e SS n NO O O rj jun 0 e is 5 O o 20 Temperature C B 12 CO2 Module Specifications Mainstream CO2 Module Specifications Mainstream CO module Measurement mode Mainstream Measurement range Accuracy 0 to 40 mmHg 2 mmHg Measurement range and 41 to 70 mmHg 5 of the reading accuracy 71 to 100 mmHg 8 of the reading 101 to 150 mmHg 10 of the reading 0 to 69 mmHg 0 1 mmHg Resolution 70 to 150 mmHg 0 25 mmHg Mainstream CO module alarm specifications
98. esthesia information system CIS The anesthesia machine features the following Automatic leak detection Breathing system gas leak compensation and automatic compliance compensation Cylinder and pipeline connections available for gas supplies Electronic flowmeter and electronic PEEP Timer which counts the duration between the start and end of an operation Table top light Information displayed in big numerics User adjustable display screen Alarm events storage and review fault status and maintenance information recording Auxiliary O supply and active anesthesia gas scavenging system AGSS N20 cut off Modular AG CO2 and BIS modules Sample gas return to the AGSS Setting CPB alarm mode 2 2 2 2 Equipment Appearance Display and control panel 2 2 1 Front View LU Ie Li 14 ia 16 DIA 1 E 2 3 2 Et E 10 11 12 13 14 15 16 Brake Pipeline pressure gauge s Displays the pipeline pressure or the cylinder pressure after relief Total flowmeter The medium level of flowtube float indicates the current flow of the mixed gas Flow control s When the system switch is set to the ON position Turn the control counterclockwise to increase the gas flow Turn the control clockwise to decrease the gas flow Electronic flowmeter Displays the current flow of the corresponding gas Ventilator control panel Control knob Display Vaporizer A Concentration control P
99. f the AGSS connector is 30 mm with 1 20 taper ratio Please connect to the AGSS or waste gas disposal system N WARNING The PEEP outlet gives off a small amount of O2 continuously Do not occlude this outlet Otherwise the anesthetic ventilator cannot work normally o Before performing an operation on the patient equip the anesthesia machine with anesthesia gas scavenging system which complies with ISO 8835 3 to purify the air in the operating room If your anesthesia machine is not configured with active AGSS do not connect the waste gas exhaust port of the anesthesia machine to the active hospital s waste gas disposal system 13 34 13 10 AGSS Transfer and Receiving System 13 10 1 Components 1 Top cover The AGSS outlet on the top cover 1s connected with the AGSS active scavenging tube Filter screen Sight glass Float MIN mark AGSS inlet Pressure compensation opening 30 mm male conical connector E ae ee eS a oe Hook gt Transfer tube Gas reservoir pd NO 30 mm female conical connector Connected with the AGSS waste gas outlet on the left side of the anesthesia machine 13 35 OO N A YN A Y 11 12 13 10 2 Assemble the AGSS 1 Mount the AGSS bracket onto the lower left decorative plate of the anesthesia machine Install M4 socket head screws and spring washers Install fixed pins 2 Mount the AGSS system already equipped with hook
100. fect and Re install the Breathing System to clean and disinfect the inspiratory and expiratory check valves assembly 2 Immerse the check valves and their covers in the disinfectant or autoclave them Maximum recommended temperature is 134 C 3 After they are fully dry install the inspiratory and expiratory check valves with reference to 14 2 8 Expiratory Check Valve Assembly and 14 2 9 Inspiratory Check Valve Assembly in the reverse order Push the check valve into the breathing system and then turn the valve cover clockwise to tighten it NWARNING eo Do not separate the check valve diaphragm from the valve cover o When installing the check valve depress the valve forcibly to make sure that it is installed in position 14 3 6 Bellows Assembly CAUTION eo Do not soak the folding bag assembly in warm water and cleaning solution for more than 15 minutes Swelling or faster aging can occur When exposing the folding bag to air dry hang and outspread it fully to prevent tackiness 14 18 NOTE Disassemble the bellows assembly before cleaning it If not it will take a very long time to dry If autoclaving is necessary assemble the bellows assembly first Turn over the bellows assembly to autoclave it Refer to the methods recommended in the table of 14 3 Clean amp Disinfect and Re install the Breathing System to clean and disinfect the bellows assembly Place the bellows assembly in warm 40 C rec
101. filter may be blocked Check if the filter is blocked as described in 14 2 13 1 Filter 3 The waste gas disposal system is not working or the pump rate is less than 50 L min at which the AGSS works normally Check the waste gas disposal system as described in 13 10 3 Waste Gas Disposal System 6 16 Y User Maintenance 7 1 Repair Policy NWARNING Only use lubricants approved for anesthesia or O equipment Do not use lubricants that contain oil or grease They burn or explode in high O2 concentrations Obey infection control and safety procedures Used equipment may contain blood and body fluids Movable parts and removable components may present a pinch or a crush hazard Use care when moving or replacing system parts and components Do not use malfunctioning anesthesia machine Have all repairs and service done by an authorized service representative Replacement and maintenance of tube parts listed in this manual may be undertaken by a competent trained individual having experience in the repair of devices of this nature After repair test the anesthesia machine to ensure that it is functioning properly in accordance with the specifications NOTE No repair should ever be attempted by anyone not having experience in the repair of devices of this nature Replace damaged parts with components manufactured or sold by us Then test the unit to make sure that it complies with the manufacturer s published spe
102. g 5 3 4 Pressure Monitoring 5 3 4 1 Display Pressure Parameters On the normal screen the pressure related parameters are displayed as shown below E Ppeak Peak pressure W Pplat Plateau pressure E PEEP Positive end expiratory pressure 5 3 4 2 Display Paw Waveform cmH2 0 5 3 4 3 Set Paw Waveform 1 Select the Paw waveform area to access the Paw Waveform Setup menu 2 Select Waveform and select Paw 3 Select Sweep and toggle between 6 25 mm s and 12 5 mm s The greater the value is the faster the waveform sweeps 4 Select to exit the current menu 5 Set waveform scale The Paw waveform scale is automatically adjusted based on the set Plimit You can set the Paw waveform scale appropriately by setting Plimit 5 3 4 4 Set Paw Unit 1 Select the Maintenance shortcut key and select User Maintenance gt gt 2 Select Paw Unit and toggle between cmH20 hPa and mbar 3 Select PX to exit the current menu 5 3 4 5 Review Ppeak Trend For details about reviewing Ppeak trend refer to 12 Trend and Logbook 5 3 5 Tidal Volume Monitoring NOTE eo The tidal volume marked on the bellows housing is only a rough indicator It may be inconsistent with the tidal volume actually measured This is a normal phenomenon eo As required by the relevant international rules and regulations tidal volume monitoring needs to be performed when the anesthesia machine is used on the patien
103. gh the menu options or change your settings 3 1 10 11 12 MV amp TVe alarm key Incase of manual ventilation mode Push the key to switch off MV and TVe overrange alarms and apnea alarm Push the key again to switch on MV and TVe overrange alarms and apnea alarm Incase of mechanical ventilation mode Push the key to switch off MV and TVe overrange alarms Push the key again to switch on MV and TVe overrange alarms Normal screen key Push the key to close all menus displayed Standby key Push the key to enter or exit standby mode Alarm silence key To set alarm silence state push this key to enter 120 s alarm silenced status The alarm silence symbol LX and 120 s countdown time appear in the upper right corner of the screen 9 To clear alarm silence push this key again Operating state LED On when the anesthesia machine is operating 9 Off when the anesthesia machine is turned off AC power LED On when the anesthesia machine is connected to the AC power source Off when the anesthesia machine is not connected to the AC power source Battery LED On when the anesthesia machine is equipped with batteries and is connected to the AC power source and the batteries are being charged Off when the anesthesia machine is not equipped with batteries or is switched off Flash when the anesthesia machine is being battery powered Ventilator parameter setup shortcut key s Push the paramete
104. gt to open the Flow Sensor Cal menu Select Start from the menu to start to calibrate the flow sensor The screen prompts Calibrating 9 During the calibration if you select Stop calibration is stopped Then the message Calibration Stopped Calibration is unfinished is displayed This indicates invalid calibration instead of calibration failure After a successful calibration the screen shows Calibration Completed Otherwise 10 the message Calibration Failure Please try again is displayed In this case you need to do the calibration again 11 Select to exit the current menu NOTE In case of calibration failure check for sensor malfunctioning alarm and then troubleshoot it if there is If it still fails or great measurement error occurs after calibration select Defaults to restore the factory default calibration values If the measurement error is still great replace the flow sensor and repeat the above operation If the measurement error is still great contact your service personnel or US Do not calibrate the flow sensor when the system is connected to the patient 7 5 O2 Sensor Calibration N WARNING eo Do not perform calibration while the unit is connected to a patient eo The O sensor must be calibrated at the same environment pressure at which it will be used to monitor oxygen delivery in the breathing system Otherwise the measured value may be outside of the stated range Disassem
105. gured F102 is displayed together with AA concentration parameters For details refer to 5 3 2 1Display AG Parameters If CO2 module is configured F102 is displayed together with CO2 parameters For details refer to 5 3 3 1Display CO2 Parameters If no gas module is configured FiO2 is displayed together with tidal volume breath rate etc For details refer to 5 3 5 1Display Tidal Volume and Breath Rate Parameters 5 6 5 3 1 4 Display O2 Waveform If the AG module which your anesthesia machine is configured with incorporates an O2 module an O2 waveform is displayed as shown below 5 3 2 Anesthetic Agent AA Concentration Monitoring If your anesthesia machine is configured with AG module you can monitor FiAA and EtAA by setting up the AG module For details refer to 9 AG and O2 Concentration Monitoring 5 3 2 1 Display AG Parameters If your anesthesia machine is configured with AG module AG related parameters are displayed as shown below E FiN2O Fraction of inspired nitrous oxide E EtN20 End tidal nitrous oxide E FiEnf Fraction of inspired enflurane displaying the concentration of the actually selected anesthetic agent W EtEnf End tidal enflurane displaying the concentration of the actually selected anesthetic agent EtCO2 End tidal carbon dioxide FiCO2 Fraction of inspired carbon dioxide MAC Minimum alveolar concentration FiO2 Fraction of inspired oxygen
106. h bag arm es a d 13 20 13 4 Install the Vaporizer NWARNING eo If the vaporizer is incompatible with the anesthesia machine the performance of the anesthetic agent in the vaporizer will be degraded Use the vaporizer matching the anesthesia machine NOTE eo For details about how to install and use the vaporizer refer to the Vaporizer Instructions for Use 13 4 1 Assemble the Vaporizer A Locking lever B Interlock bolts C Locking shaft 1 Mount the vaporizer onto the manifold 13 21 2 Push and turn the locking lever A clockwise to lock the vaporizer in position ot 3 Make sure that the top of the vaporizer is horizontal If not remove the vaporizer and reinstall it 4 Incase of reinstalling the vaporizer try to lift each vaporizer straight up off the manifold rather than pulling forward Do not rotate the vaporizer on the manifold 5 Ifa vaporizer lifts off the manifold install it again and complete steps 1 through 3 If the vaporizer lifts off a second time do not use the system 13 22 6 With a Desflurane vaporizer NW Make sure that the vaporizer is connected to an electrical outlet Plug in the electrical input cable Push the adapter into the mounting box ME 13 23 7 Lift the hand pull block rotate it counterclockwise for 270 degrees and then release it to fix the adapter onto the mounting box Connect the power cord a
107. h patient do not exit the standby screen if mechanical ventilation related parameters are not set properly Adjust fresh gas and anesthetic agent concentrations if necessary on the standby screen and set ventilation parameters properly based on the patient s conditions before applying mechanical ventilation 4 3 Input Fresh Gas 4 3 1 Set O2 N2O and Air Inputs Connect the gas supplies correctly and ensure adequate gas pressure You can control the O2 N20 and Air flows in the fresh gas through the O2 N20 and Air flow controls Readings of the gas flow can be seen on the respective electronic flowmeter On the left hand of the electronic flowmeters 1s the total flowmeter showing the flow of the mixed gas The O and N20 flow controls constitute a chain linkage Turn the N20 flow control counterclockwise to increase the N O flow to some extent Then continuing turning the N20 flow control will cause the O flow control to turn counterclockwise together to increase the O flow keeping the O concentration in the mixed gas above 25 Turn the O flow control clockwise to decrease the O flow to some extent Then continuing turning the O flow control will cause the N2O flow control to turn clockwise together to decrease the N20 flow keeping the O2 concentration in the mixed gas above 25 NOTE This anesthesia machine can be used alone as a ventilator You can adjust O2 concentration in the breathing system through
108. h rate less than 3 rpm I E 1 2 Operating temperature approximate to the module detector 15 to 25 C or 50 to 55 C Measurement accuracy 4 mmHg 0 to 40 mmHg or 12 of the reading 41 to 99 mmHg when the breath rate is greater than 50 rpm B 13 AG Module Specifications ISO accuracy mode lt 45 s Warm up time Full accuracy mode lt 10 min Pump rate 120 150 200 mL min optional Pump rate Accuracy 10 mL min or 10 whichever is greater G CO2 02 optional N20 and any of the five anesthetic agents Des Iso as Enf Sev and Hal CO 0 to 30 O optional 0 to 100 N20 0 to 100 Range Des 0 to 30 Sev 0 to 30 Enf Iso Hal 0 to 30 0 3 ABS ISO accuracy mode N20 8 REL 2 ABS Other anesthetic agent 8 REL ses EN Enf Iso Hal Otol o to 1 Rise time Or 250m lt 250ms 2 e ooo CON E pa lt 1 to inaccuracy after continuous use of 12 months 10 to 90 Sample gas flow 200 mL min DRYLINETM watertrap Adult DRYLINETM sampling line 2 5 m Effect of interfering gas on AG measured value Concentration Quantitive effect ps 2 AG1 ECTS i lt 78 1 Multiple agent interference on CO2 N2O and O2 is typically the same as single agent Pewee ET IN o interference 2 Maximum quantitive effect of each gas at concentrations within specified accuracy ranges for each gas The total effect of all interferences shall not exceed 5 REL of gas concentration 3 Appli
109. he CO2 module is in measure mode The CO2 Startup message appears on the screen when the CO2 module is plugged in 3 After start up is finished the message CO2 Warmup is displayed The CO module is in ISO accuracy mode If you perform CO measurements during warm up the measurement accuracy may be compromised 4 After warm up is finished the CO module enters full accuracy mode NOTE o To extend the lifetime of the watertrap and CO2 module disconnect the watertrap and set the working mode of the module to standby when CO2 monitoring is not required CAUTION The watertrap collects water drops condensed in the sampling line and therefore prevents them from entering the module If the collected water reaches a certain amount you should drain it to avoid airway blockage o The watertrap has a filter preventing bacterium vapor and patient secretions from entering the module After a long term use dust or other substances may compromise the performance of the filter or even block the airway In this case replace the watertrap Replacing the watertrap once a month is recommended Or replace the watertrap when it is detected leaky damaged or contaminated 8 3 2 Make CO2 Settings By selecting the User Setup shortcut key and then Gas Module Setup gt gt you can make CO2 settings described below 8 3 2 1 Set Working Mode The default working mode of the CO2 module is Measure when the anesthesia machine is
110. he O2 sensor or O2 module 3 Select LX to exit the current menu 5 5 5 3 1 2 Set FIO2 Alarm Limits Select the Alarm Setup shortcut key and select Ventilator gt gt Set F102 high and low alarm limits in the Ventilator Alarm Limits menu When the measured F102 exceeds the alarm limit an alarm is generated Select LX to exit the current menu NOTE When the O sensor is used for the first time or is to be replaced test that O concentration is accurately monitored Calibrate the O sensor if a great error is detected When OFF is selected for 02 Sensor Monitoring O2 sensor calibration is disabled If O02 Module is selected for O02 Monitoring Source the functions related to O2 module can still be performed When ON is selected for O02 Sensor Monitoring and OFF for 02 Monitoring Source FiO2 is displayed as invalid value In this case O2 sensor calibration FiO2 alarm limit setting and alarm related to FiO2 and O2 sensor are all disabled As required by the relevant international rules and regulations O2 concentration monitoring needs to be performed when the anesthesia machine is used on the patient If your anesthesia machine is not configured with such monitoring function use a qualified monitor for O2 concentration monitoring 5 3 1 3 Display FiO2 If your anesthesia machine is configured with O2 module or 02 sensor the monitored F102 parameter is displayed If AG module is confi
111. he alarm cancels 6 9 3 Test the Low Minute Volume Alarm Make sure that MV alarm is switched on Select the Alarm Setup shortcut key and then Ventilator gt gt Set the MV low alarm limit to 8 0 L min Make sure that a low MV alarm occurs Select the Alarm Setup shortcut key and then Ventilator gt gt Set the MV low alarm limit to 2 0 L min 6 13 6 9 4 Test the Apnea Alarm Connect the manual bag to the manual bag port Set the bag mechanical ventilation switch to the bag e position Turn the APL valve control to set the APL valve to the minimum position Inflate the manual bag to make sure that a complete breathing cycle occurs Stop inflating the manual bag and wait for more than 20 seconds to make sure that the apnea alarm occurs Inflate the manual bag to make sure that the alarm cancels 6 9 5 Test the Sustained Airway Pressure Alarm Connect the manual bag to the manual bag port Turn the O flow control to set the O flow to minimum Turn the APL valve control to set the APL valve to 30 cmH20 position Set the bag mechanical ventilation switch to the bag e position Push the O flush button for approximately 15 seconds Make sure that the sustained airway pressure alarm occurs Open the patient connection and make sure that the alarm cancels 6 9 6 Test the High Paw Alarm ok e e 6 Set the bag mechanical ventilation switch to the mechanical position Select the Alarm Setup shortcut
112. he filler block Rotate the bottle to align the bottle filler keys with the slots in the filler block 4 Note the liquid level in the vaporizer sight glass and press the agent bottle firmly into the vaporizer filler against the spring valve assembly Allow the liquid to flow into the vaporizer until the maximum level mark is reached paying continuous attention to the level in the sight glass and the air return bubbles flowing into the bottle 5 Release the bottle when the vaporizer is full and the continuous stream of bubbles ceases 6 Withdraw the bottle from the vaporizer filler and replace the vaporizer filler block cap and the protective cap on the agent bottle NOTE The vaporizer volume is 250 ml at the maximum liquid level and 35 ml at the minimum liquid level 13 26 13 4 3 Drain the Vaporizer N WARNING eo Do not reuse the agent drained from the vaporizer Treat as a hazardous chemical 13 4 3 1 Pour Fill System 1 Check that the vaporizer concentration control A is in the 0 zero position 2 Unscrew the filler cap B 3 Place a bottle marked with the drug name on the vaporizer under the drain tube in the base of the filler block Undo the drain screw C to allow the liquid to run into the bottle 13 27 13 4 3 2 Quik Fil System NOTE eo To avoid spillage check that the bottle to be used for draining has sufficient capacity for the volume of liquid to be drained NWARNING o The fill
113. he leak test plug to close the breathing system 6 Push the O2 flush button repeatedly to sweep the pointer across the pressure gauge 7 Remove the plug from the patient connection and release the O2 flush button Check if the pointer goes to zero 8 Repeat the steps above if the pointer fails to go to zero 9 Ifthe pointer goes to zero re install the lens onto the gauge If not replace the airway pressure gauge 7 9 7 8 AGSS Transfer Tube Maintenance Check the tube of the AGSS transfer system Replace it if it is damaged O CO2 Monitoring 8 1 Introduction CO monitoring is a continuous non invasive technique for determining the concentration of CO in the patient airway by measuring the absorption of infrared IR light of specific wavelengths The CO has its own absorption characteristic and the amount of light passing the gas probe depends on the concentration of the measured CO When a specific band of IR light is passed through respiratory gas samples some of IR light will be absorbed by the CO molecules The amount of IR light transmitted after it has been passed through the respiratory gas sample is measured with a photodetector From the amount of IR light measured the concentration of CO 1s calculated There are two methods for measuring CO in the patient s airway 1 Mainstream measurement Uses a CO sensor attached to an airway adapter directly inserted into the patient s breathing
114. he sample gas Mechanical shock Cyclic pressure which is greater than 10 kPa 100 cmH20 Other interference source if available 8 3 4 Troubleshooting When the sampling system of the CO2 module works incorrectly check if the sampling tube is kinked If not remove the sampling tube from the watertrap Then if a prompt message indicating airway malfunction appears on the screen it means that the watertrap is occluded In this case you must replace the watertrap If no such prompt message is displayed it means that the sampling tube is occluded Then you must replace the sampling tube 8 6 8 3 5 Scavenge the Sample Gas Metal chip Exhaust tube To scavenge the sample gas to the waste gas disposal system depress the metal chip and then plug the exhaust tube to the ports marked A sample gas return to the AGSS on the anesthesia machine as shown in the above picture WARNING o When using CO2 module to perform CO2 measurements on the patient who is receiving or has recently received anesthetic agents connect the gas outlet to the waste gas disposal system to prevent the medical staff from breathing in the anesthetic agent 8 3 6 Zero the Sensor Zeroing the sensor aims to eliminate the effect of baseline drift on the readings during the measurement so as to ensure measurement accuracy For CO2 module a zero calibration is carried out automatically when necessary You can also start a manual zero calibration
115. hey are correctly connected and their connectors are undamaged When checking the sodalime canister check if there is sodalime attaching the sealing component of the canister If there is clear the sodalime eo Do not use the anesthesia machine if breathing system leak occurs Contact your service personnel or us 6 10 6 8 3 Breathing System Leak Test in Manual Ventilation Status a A A Make sure that the system 1s Standby If not press the D key and select Ok from the pop up menu to enter standby status Set the bag mechanical ventilation switch to the bag position Connect the manual bag to the manual bag port Turn the APL valve control to fully close the APL valve 75 cmH20 Turn the O flow control to set the O flow to 0 15 0 2 L min Connect the Y piece on the breathing tube to the leak test plug on the manual bag port Occlude the gas outlet of the Y piece Push the O flush button to let the pressure increase to approximately 30 cmH 0 on the airway pressure gauge Release the flush button A pressure decrease on the airway pressure gauge indicates a leak Look for and please contact your service personnel 6 8 4 APL Valve Test A oe 9 Make sure that the system is Standby If not press the D key and select Ok from the pop up menu to enter Standby Set the bag mechanical ventilation switch to the bag position Connect the manual bag to the manual bag port Connect the Y piece on the breathing tube t
116. iete tan tehiea tes 3 6 o NSU US ANN VA A a a aaa sate Saas anaeeacamtcee ace 3 6 eo Po E OD 5 PEPE EE O 3 6 3 3 6 Restore Detault Conti UTA A N a 3 6 3 3 7 Set the IP Address of Anesthesia Information System CIS cocccnnnnnnnnnininnnnnnnoo 3 7 4 Operations and Ventilation Setup ccccsscssssssssssssssssssssssssssssssssssssssssssssssssssssssssssees 4 1 AN Thi on Ne A Shee EET T E 4 1 Ay 2 Veo Vea VS UCM RARA NA 4 A E Pemne EERE A 4 2 Ah Deck Sve Or NO ana Ar TIN US cesta aca ge oc heal eget ico 4 2 432 O AMES AU nc 4 3 A AAA PE A 4 4 A 4 1 Set Manual Ventilation Mode sessions 4 4 4 4 2 Make Settings before Starting Mechanical Ventilation Mode cccccccccnnnnnnos 4 5 4 4 3 Volume Control Ventilation VOV Jerinin A 4 5 4 4 4 Pressure Control Ventilation PCV cccccccccccccccssssssseseeeececcceeeeeeeeseauaeseesees 4 8 4 4 5 Synchronized Intermittent Mandatory Ventilation SIMV occccccnnnnncnnnnnnnnnnns 4 1 4 4 6 Pressure Support Ventilation PSV o 4 17 4 start Mechanical Ventilation sesso ieee TE ETTE 4 21 is E E EEA E ETE EE E AET EET 4 22 A cba amiadesaabaget 4 22 kO OPE A E a OO EE E Sa 4 22 A Reset the TME id 4 22 ALSO Mecha tica yen aon ea aid e eds 4 23 5 User Interface and Parameter Monitoring sccsssssscccccsssssssscsscccscccssssssssscccsssesees 5 1 o AAA A A A EAA 5 1 Dal Plain Dy OS ClC cl acter hea ate ete ete neta tran naa hea oboe 5 2 SAN Cie Cid sets cicada Acas
117. ight 1045 mm Caster Four casters whose diameter is 125 mm All have brakes Display Resolution 800 x 600 pixels Brightness Adjustable LED indication AC power LED One green lit when connected to the AC power source One green lit when batteries are installed and AC power supply is Battery LED connected flashing when powered by batteries extinguished when no batteries are installed or the anesthesia machine is switched off Operating state LED One green lit when power on and extinguished when power off Audio indication Gives off alarm tones and key tones supports multi level tone Speaker modulation The alarm tones comply with the requirements of IEC60601 1 8 Gives off alarm tones in case of equipment malfunction Connector One AC mains inlet Power supply One or three auxiliary electrical outlets One CIS power supply connector One multiplexing connector to support network CIS and software Network online upgrade Implements data communication with the CIS through HL7 protocol Equipotential One equipotential grounding terminal B 5 Pneumatic Circuit System Specifications ACGO Male 22 mm conical connector incorporating a coaxial female 15 Connector mm conical connector Gas supplies Pipeline pressure range 280 to 600 KPa Pipeline connector NIST Cylinder connector PISS O2 control Alarm of O2 supply failure Lower than 220 KPa 02 flush 35 to 75 L min Air range 0 to 10 L min O2
118. iled to communicate with T the main system normally N20 Flow Too L The N20 flow control is Turn the flow control to High turned to set the flow too keep the flow within 10 high L min The O flow control is turned 02 Flow Too High L to set the flow too high Air Flow Too High L The Air flow control is turned to set the flow too high 02 N20 Ratio H Incorrect O2 N20 ratio Contact your service personnel Error Flowmeter Zero L Board or 3 way valve malfunction Contact your service Failed personnel AG Init Error H The AG module was installed improperly or malfunctioned AG Cal Failed The AG module calibration failed AG Comm Stop AG Airway The actual pump rate of the AG module is less than 20 AG module malfunction or communication failure Occluded mL min for more than one second AG Comm Error H AG module communication failure AG Hardware Error AG module hardware error AG Selftest Error i Module fault or communication failure between the T module and anesthesia machine Re plug the module restart the anesthesia machine or try to plug the module into another anesthesia machine Standby and measurement stops Remove the AG module Malfunction and contact your service personnel AG Hardware AG module hardware malfunction The AG module enters AG Watertrap Type M The watertrap of the AG module is of wrong type iame rains saaman a AG Data Limit M AG module
119. in unit A Reset key lt Press to restart the CIS B CIS switch O Press to switch on off the CIS USB connector Network connector Electrical outlet e ee Display connector 2 10 NWARNING Connect to the AC mains in compliance with B 3 Power Requirements Failure to do so may cause damage to the equipment or affect its normal operation Make sure that the jacket on the electrical outlet is already fixed to avoid power cord off during surgery NOTE If the equipment cannot be powered by the AC mains check if the fuse inside the electrical outlet is normal If AC mains supply still fails after the fuse is replaced contact the service personnel When the auxiliary electrical outlet does not work normally check if the corresponding fuse is burned Equipment connected to the auxiliary electrical outlet shall be authorized Otherwise leakage current above the allowable limit will result which may endanger the patient or operator and damage the anesthesia machine or externally connected equipment When the anesthesia machine is configured with only one auxiliary electrical outlet this electrical outlet is only used for connecting the adapter for Desflurane vaporizer When the anesthesia machine is configured with multiple auxiliary electrical outlets the equipment connected shall comply with the voltage and current specifications of the auxiliary electrical outlets All analog or digital prod
120. ins to deliver gas at the preset Finsp to make Paw rise to the preset Psupp rapidly After that the ventilator slows down the flow through the feedback system to keep Paw constant When the inspiration flow drops to the preset PSV Insp Termination Level the ventilator stops delivering gas and the patient is allowed to expire waiting for next inspiration trigger If inspiration is not triggered within the set time Backup Mode Active the system automatically switches to the backup ventilation mode PCV In the PSV mode you do not need to set TV TV depends on the patient s inspiratory force and pressure support level compliance and resistance of the patient and of the whole system The PSV mode is used only when the patient is driven by reliable breathing because breathing must be fully triggered by the patient during ventilation 4 17 When PSV mode is applied alone the PCV backup mode is available If within the preset time Backup Mode Active no spontaneous breathing occurs or spontaneous breathing is not strong enough to reach Trigger Level the PCV backup mode is activated automatically when the time for Backup Mode Active is up to enable mechanical ventilation forcibly The PSV mode can be used jointly with SIMV VC or SIMV PC 4 4 6 2 Waveforms The following figures show the Paw waveform and flow waveform in the PSV mode Paw lt Backup Mode Active Pisnp f the PSV mode is not trigge
121. ion Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden Release amendment reproduction distribution rental adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden il wmorar MINDRAY and WATO are the registered trademarks or trademarks owned by Mindray in China and other countries All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them They are the property of their respective owners Contents of this manual are subject to changes without prior notice II Manufacturer s Responsibility All information contained in this manual is believed to be correct Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance or use of this manual Mindray is responsible for the effects on safety reliability and performance of this product only if NW all installation operations expansions changes modifications and repairs of this product are conducted by Mindray authorized personnel and NW the electrical installation of the relevant room complies with the applicable national and local requirements and NW the product is used in accordance with the instructions for use Warranty This warranty is exclu
122. ion or a patient data distortion due to proper operation or mechanical problems Technical alarm messages are displayed in the technical alarm area Prompt messages As a matter of fact prompt messages are not alarm messages Apart from the physiological and technical alarm messages the anesthesia machine will show some messages telling the system status Messages of this kind are included into the prompt message category and usually displayed in the prompt message area 11 1 11 1 2 Alarm Levels By severity the anesthesia machine s alarms fall into three categories high level alarms medium level alarms and low level alarms l High level alarms Indicates that the patient is in a life threatening situation and an emergency treatment is demanded Medium level alarms Indicates that the patient s vital signs appear abnormal and an immediate treatment is required Low level alarms Indicates that the patient s vital signs appear abnormal and an immediate treatment may be required The level for all technical alarms and some physiological alarms are preset before the anesthesia machine leaves the factory and can not be changed But for some physiological alarms the level is user adjustable 11 2 Alarm Indicators When an alarm occurs the anesthesia machine will indicate it to the user through visual or audible alarm indications Alarm lamp Alarm message Flashing numeric Audible alarm tones 11
123. ion and stop O pipeline supply Turn off the O flowmeter Open the O cylinder valve Record the current cylinder pressure Close the O cylinder valve Record the cylinder pressure after one minute 9 Ifthe cylinder pressure decreases more than 5000 kPa 725 psi there is a leak Install a new cylinder gasket as described in 13 5Install Replace the Gas Cylinder Repeat steps 1 through 6 If the leak continues do not use the cylinder supply system 6 5 3 N20 Cylinder High Pressure Leak Test Refer to 6 5 2 O2 Cylinder High Pressure Leak Test to do the N2O cylinder high pressure leak test For N20 cylinder a pressure decrease of more than 700 kPa 100 psi in one minute represents a leak 6 6 Flow Control System Tests 6 6 1 Without O2 Sensor N WARNING eo Sufficient O in the fresh gas may not prevent hypoxic mixtures in the breathing system eo If N O is available and flows through the system during this test use a safe and approved procedure to collect and remove it o Incorrect gas mixtures can cause patient injury If the O2 N20 Link system does not supply O and N20 in the correct proportions do not use the system NOTE e Slowly open the cylinder valves to avoid damage Do not adopt flow controls forcibly NOTE o After doing the cylinder tests close all cylinder valves if cylinder supplies are not used eo Turn the flow controls slowly Do not turn further when the flow indicated on the flowme
124. ion cup for water before using the anesthesia machine If there is water build up clear it without delay 7 6 2 Clear Water Build up The water built up inside the flow sensor will result in inaccurate measured value of tidal volume and trigger the TV Comp Disabled alarm If there is water built up inside the flow sensor remove the sensor and clear the water Then reinstall the sensor for use NWARNING eo Check water build up inside the flow sensor every time before system use Pooled water in the flow sensor causes erroneous readings o Make sure that all breathing system parts are dry ever time when the breathing system is cleaned and disinfected 7 7 Airway Pressure Gauge Zeroing If manual or mechanical ventilation stops and the pointer of airway pressure gauge fails to go to zero the airway pressure gauge will indicate incorrect pressure In this case you need to zero the airway pressure gauge as follows 1 Stop manual or mechanical ventilation Connect a breathing tube to the breathing system and let the breathing tube patient connection open to the air Make sure that the folding bag falls to the bottom 2 Remove the lens by digging out the lens buckle with a small flathead screwdriver 3 Use a screwdriver to adjust the zeroing screw letting the pressure gauge pointer go to Zero Zeroing point 4 Set the bag mechanical ventilation switch to the mechanical position 5 Plug the Y piece into t
125. ion mode to help the patient breathe Calibrate the flow sensor and inspiratory valve Calibrate PEEP Last calibration of the Paw sensor and PEEP valve failed Valve Or great drift occurred to the Paw sensor and PEEP valve Use manual ventilation mode to help the patient breathe Calibrate the Paw sensor and PEEP valve that the reading on the O sensor is 21 Calibrate the O2 Calibrate O2 L Last calibration of the O sensor failed Or O Sensor concentration was measured outside of the range Check sensor again or replace it L O2 Sensor Unconnected The O sensor was not connected to the cable or was not connected properly Make sure that the O sensor is correctly connected to the cable O2 Sensor Error M 02 sensor fault The measured O2 concentration is less than 5 Replace the O2 sensor Flow Sensor Flow sensor monitoring failure The equipment could Failure work but with low accuracy Calibrate the flow sensor again or replace it TV Comp Disabled L Tidal volume compensation was disabled Calibrate the flow sensor Pinsp Not Achieved An error occurred to the breathing system or the ventilator failed to supply the patient with required pressure Check the breathing system connections Check the set values consecutive six times Look for leaks of the breathing system Make sure that sufficient tidal volume is supplied Check I E Plimit and TV set value Sensor Zero Failed L
126. key and then Ventilator gt gt Set the Paw low alarm limit to 0 cmH O and Paw high alarm limit to 5 cmH20 Make sure that a high Paw alarm occurs Set the Paw high alarm limit to 40 cmH O Make sure the high Paw alarm cancels 6 14 6 9 7 Test the Low Paw Alarm A A a a A Set the bag mechanical ventilation switch to the mechanical position Select the Alarm Setup shortcut key and then Ventilator gt gt Set the Paw low alarm limit to 2 cmH O Disconnect the manual bag from the Y piece patient connection Wait for 20 seconds View the alarm area and make sure that a low Paw alarm occurs Connect the manual bag to the manual bag port Make sure the low Paw alarm cancels 6 9 8 Test the AG Module Alarm A a Refer to 13 6 2Install the AG Module and then refer to9 4Prepare to Measure AG Disconnect the gas sampling tube and connect the tube to the standard gas bag filled with AA 5 CO2 must be contained AA stands for any of the five anesthetic agents Des desflurane Iso isoflurane Enf enflurane Sev sevoflurane or Hal halothane Select the Alarm Setup shortcut key and then Gas Module gt gt Set the EtAA high alarm limit to be lower than the concentration of the standard gas Make sure that a high EtAA alarm occurs Set the EtAA low alarm limit to be higher than the concentration of the standard gas Make sure that a low EtAA alarm occurs 6 10 Preoperative Preparations l a i o ee a
127. kscreen is facing upward 2 Insert the flow sensor horizontally 3 Align the inspiration expiration connectors and their locking nuts with the flow sensor connectors 13 9 4 Tighten the locking nuts clockwise ipi N WARNING Tighten the locking nuts when installing the flow sensor Failure to do so may result in invalid measurement eo Exert care when moving the anesthesia machine to prevent the flow sensor from getting damaged The end of inspiration expiration connectors which connects the breathing tube shall be kept downward to prevent condensed water from entering the breathing system 13 1 7 Install the O2 Sensor NWARNING Before installing the O sensor check that the seal on the sensor is in good condition If no seal is installed or the seal is damaged replace the O sensor When installing the O sensor turn it tightly to avoid breathing system leak Install the O sensor manually Using a wrench or other tool may damage the O Sensor 13 10 1 Align the threads of the O sensor with the O sensor connector marked 0 on the breathing system and turn the sensor clockwise to tighten 1t 4 ee f 2 Insert one end of the O sensor cable into the sensor jack 13 11 3 Insert the other end of the O sensor cable into the O sensor connector marked 0 on the circuit adapter 13 1 8 Install the Sodalime Canister WARNING e Obey applicable safety pre
128. l C Steam autoclave at maximum 134 C 14 16 14 3 1 Breathing system Refer to methods recommended in the table of 14 3 Clean amp Disinfect and Re install the Breathing System to clean and disinfect the breathing system 2 Make sure that the breathing system 1s fully dry before installing it with reference to 13 1 3Install the Breathing system in the reverse order 14 3 2 Water Collection Cup 1 Refer to the methods recommended in the table of 14 3 Clean amp Disinfect and Re install the Breathing System to clean and disinfect the water collection cup 2 Make sure that the water collection cup is fully dry before installing it with reference to 14 2 11 Water Collection Cup in the reverse order Align the water collection cup with the matching threaded hole on the breathing system Turn the water collection cup counterclockwise to tighten it 14 3 3 Manual Bag 1 Refer to the methods recommended in the table of 14 3 Clean amp Disinfect and Re install the Breathing System to clean and disinfect the manual bag 2 When the manual bag is fully dry refer to 13 3 Install the Manual Bag to install it 14 17 14 3 4 Breathing Mask Refer to the methods recommended in the table of 14 3 Clean amp Disinfect and Re install the Breathing System to clean and disinfect the breathing mask 14 3 5 Inspiratory and Expiratory Check Valves Assembly 1 Refer to the methods recommended in the table of 14 3 Clean amp Disin
129. l The battery is being used Battery Undetected M No battery is installed Or the battery is not connected to the power module Contact your service personnel Power System H The communication between the power Restart the Comm Error system and the main control board stops machine If for one second the problem persists Power System H The communication between the power contact your Comm Stop system and the main control board stops for 10 seconds service ersonnel Power System H Power system watchdog error or Flash d Selftest Error error or power supply voltage error H Power supply voltage error Voltage Error System DOWN for H The voltage of either battery is lower than 10 2V and the battery depletion AC power source 1s not connected Connect to the AC Power Supply power source immediately In case of power failure apply manual ventilation to the patient If the batteries cannot be fully charged within 24 hours contact your service personnel Power Board High H The temperature of the power board is over 95 degrees Temp Stop using the machine for a period of time If the alarm message still remains after the machine is restarted i contact your service personnel Breathing Circuit H The breathing system is not installed Or it is not correctly Raaba il connected to the base Contact your service personnel Keyboard Init Error H nii al your service personnel
130. l non uniform magnetic field In the presence of paramagnetic oxygen the glass spheres are pushed further away from the strongest part of the magnetic field The strength of the torque acting on the suspension is proportional to the oxygen concentration From the strength of the torque the concentration of oxygen 1s calculated The measurement provides 1 An EtCO gt waveform 2 Measured parameters EtCO gt FiCO2 EtN2O FiN2O EtAA FiAA and MAC where AA stands for any of the five anesthetic agents Des desflurane Iso isoflurane Enf enflurane Sev sevoflurane or Hal halothane NOTE o Perform AG monitoring when using this anesthesia machine to ensure patient safety If your anesthesia machine is not configured with AG module use the monitor with CO monitoring function in compliance with the relevant international standard to perform AG monitoring 9 2 Understand MAC Values Minimum alveolar concentration hereinafter referred to as MAC is a basic index indicating the depth of inhaled anesthesia The ISO 21647 defines MAC as follows alveolar concentration of an inhaled anesthetic agent that in the absence of other anesthetic agents and at equilibrium prevents 50 of subjects from moving in response to a standard surgical stimulus The following table lists 1 MAC of various inhaled anesthetic agents Des Iso Enf Sev Hal N O MAC nitrous oxide can only be reached in a hyperbaric chamber NOTE
131. line before removing the tube If the Drive Gas Pressure Low alarm occurs when the gas supply pressure is greater than 200 kPa contact your service personnel or us 13 32 NWARNING o The anesthesia machine stops gas delivery when the supply gas pressure is lower than 200 kPa 13 7 1 Connect the Pipeline Gas Supplies The anesthesia machine provides three O2 N20 and AIR pipeline supply connectors which are connected to three tubes of different colors and cannot be exchanged Connect the pipeline gas supplies as follows 1 Check that the seal at the tube connector is in good condition before connecting the gas supply tube If damaged do not use the tube Replace the seal to avoid leakage 2 Align the tube connector with the matching gas supply connector at the back of the anesthesia machine and then insert it 13 33 13 7 2 Install the Gas Cylinder For details refer to 13 5Install Replace the Gas Cylinder 13 8 CIS Connector The anesthesia machine can be connected to an anesthesia information system CIS which is to be installed serviced and updated by Mindray authorized or approved personnel For details refer to the Instructions for Use accompanying the CIS 13 9 Scavenging The scavenging assembly is located on the left side of the work table There are two outlets labeled AGSS and PEEP as shown below 1 The PEEP outlet gives off the exhaust gas indoors directly 2 The outside diameter o
132. lly o Before activating a new mechanical ventilation mode make sure that all related parameters are set appropriately 4 4 3 4 Parameter Setup Shortcut Keys Area in VCV Mode When selection of VCV mode is confirmed the parameter setup shortcut keys area at the bottom of the screen is automatically switched over to the parameter setup area in this mode The following figure shows all related parameters to be set in VCV mode Rate BPM TIP TI Plimit cmH20 PEEP cmH20 12 DFF 30 OFF l 2 3 4 5 y 1 TV Tidal volume 2 Rate Breath rate 3 LE Ratio of inspiratory time to expiratory time 4 TIP TI Percentage of inspiratory plateau time in inspiratory time 5 Plimit Pressure limit level 6 PEEP Positive end expiratory pressure 4 4 3 5 Set Parameters in VCV Mode You can use the shortcut keys and control knob to set the parameters in VCV mode The following takes setting of TV as an example 1 Select the TV shortcut key 2 Push the control knob and turn it to set TV to the appropriate value 3 Push the control knob to confirm the setting 4 Set other parameters in this mode in the similar way NOTE Ifthe parameter value is adjusted outside of the range the system prompt message area displays Parameter Settings Outside the Safety Range eo Confirm the adjustment of one parameter before adjusting another parameter If you want to restore the value before adjustment you have
133. lly continues with the previously selected working mode During standby the working components of the CO2 module such as gas pump and infrared source are automatically turned off to extend the service life of the module 8 4 2 2 Set Unit In the Gas Module Setup gt gt menu select Unit and toggle between mmHg and kPa 8 4 2 3 Set Humidity Compensation The CO2 module is configured to compensate CO2 readings for either Body Temperature and Pressure Saturated Gas BTPS to account for humidity in the patient s breath or Ambient Temperature and Pressure Dry Gas ATPD 1 Access the Gas Module Setup menu and select Humidity Comp 2 Select either Wet for BTPS or Dry for ATPD depending on which compensation applies For CO the humidity compensation can be set to Wet or Dry l Dry P mmHg CO vol x P 100 2 Wet P mmHg CO vol x P 47 100 where P partial pressure vol CO concentration P ambient pressure and CO2 unit is mmHg For microstream CO2 module humidity compensation is switched on or off based on the actual situations 8 4 2 4 Set Maximum Hold In the CO2 parameter area EtCO2 and FiCO2 values are refreshed in real time To set EtCO2 and FiCO2 1 Access the Gas Module Setup gt gt menu 2 Select Max Hold and select Single Breath EtCO and FiCO are calculated based on each breath 10 s 20 s and 30 s EtCO and FiCO
134. module After a long term use dust or other substances may compromise the performance of the filter or even block the airway In this case replace the watertrap Replacing the watertrap once a month is recommended N WARNING Do not apply adult watertraps to neonatal patients Otherwise patient injury could result Make sure that all connections are reliable Any leak in the system can result in erroneous readings due to patient breathing gas mixed with ambient air 9 4 9 5 Make AG Settings By selecting the User Setup shortcut key and then Gas Module Setup gt gt you can make AG settings described below 9 5 1 Set Anesthetic Agent As M type AG module cannot identify the type of anesthetic agent automatically you need to set Agent to select the correct type of anesthetic agent before venting the anesthetic agent 9 5 2 Set Pump Rate In the Gas Module Setup menu you can select Pump Rate and then select either High Med or Low 9 5 3 Set O2 Compensation If the AG module is not integrated with O module you need to select to set O compensation based on the actual conditions Access the Gas Module Setup gt gt menu and select O2 Comp The options include W OFF when the amount of O in the ventilation gas mixture is less than 30 E Other options selects an appropriate value according to the amount of O2 in the ventilation gas mixture If the AG module is integrated with O module
135. n Plak cmk20 Paupp 12 1 2 60 30 z 1 Pinsp Pressure control level of inspiration 2 Rate Breath rate 3 LE Ratio of inspiratory time to expiratory time 4 Finsp Flow of inspiration 5 Plimit Pressure limit level 6 Psupp Pressure support level 7 PEEP Positive end expiratory pressure NOTE o The first three parameter setup shortcut keys in PSV mode are enabled for the PCV backup mode If PCV is not triggered when start up time for the backup mode is up the system is switched over from PSV mode to PCV mode automatically 4 4 6 5 Set Parameters in PSV Mode You can use the shortcut keys and control knob to set the parameters in PSV mode The following takes setting of Psupp as an example 1 Select the Psupp shortcut key 2 Push the control knob and turn it to set Psupp to the appropriate value 3 Push the control knob to confirm the setting 4 Set other parameters in this mode in the similar way NOTE o If the parameter value is adjusted outside of the range the system prompt message area displays Parameter Settings Outside the Safety Range eo Confirm the adjustment of one parameter before adjusting another parameter If you want to restore the value before adjustment you have to reset the parameter value 4 19 In PSV mode you also need to set E Trigger Level 1 Select the Vent Mode shortcut key PSV gt gt Trigger Level Select Pressure
136. nalysis 8 13 8 5 2 Make CO2 Settings By selecting the User Setup shortcut key and then Gas Module Setup gt gt you can make CO2 settings described below 8 5 2 1 Set Working Mode The default working mode of the CO2 module is Measure when the anesthesia machine is turned on for the first time If the current CO2 module is Standby you must push the O key or select the User Setup shortcut key Gas Module Setup gt gt Working Mode Measure to start the CO2 module When the anesthesia machine restarts the CO2 module automatically continues with the previously selected working mode During standby the working components of the CO2 module such as gas pump and infrared source are automatically turned off to extend the service life of the module 8 5 2 2 Set Unit In the Gas Module Setup gt gt menu select Unit and toggle between mmHg and kPa 8 5 2 3 Set Gas Compensations N WARNING Make sure that the appropriate compensations are used Inappropriate compensations may cause inaccurate measured values and result in misdiagnosis 1 Access the Gas Module Setup gt gt menu 2 Set the following compensations based on the actual conditions E Balance Gas Room Air when air predominates in the ventilation gas mixture N20 when N20 predominates in the ventilation gas mixture E 02 Comp 9 OFF when the amount of O2 in the ventilation gas mixture is less than 30
137. ne or more of the following USA patents 4 755 675 5 300 859 5 657 750 5 857 461 and international equivalents USA and international patents are pending No Implied License Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized CO2 sampling consumables which would alone or in combination with this device fall within the scope of one or more of the patents relating to this device and or CO2 sampling consumable 8 12 8 5 Use a Mainstream CO2 Module NOTE This section is only applicable to the anesthesia machine configured with mainstream CO2 module 8 5 1 Prepare to Measure CO2 1 Connect the sensor to the CO2 module 2 By default the mainstream CO2 module is in measure mode The CO2 Warmup message appears on the screen when the CO2 module is plugged in 3 After warm up is finished connect the sensor to the airway adapter 4 Perform a zero calibration by referring to8 5 4Zero the Sensor 5 After the zero calibration is finished connect the airway as shown below PM Connect to the a Fr an A ee Nr 2 anesthesia machine Connect to the patient 5 Make sure that there are no leakages in the airway and then perform CO2 measurements NOTE Always position the sensor with the adapter in an upright position to avoid collection of fluids on the windows of the adapter Large concentrations of fluids at this point will obstruct gas a
138. nit and toggle between cmH20 hPa and mbar If the anesthesia machine is configured with CO or AG module you can set the display units of FiCO2 and EtCO2 For details refer to 8 CO2 Monitoring 3 3 6 Restore Default Configurations 3 3 6 1 Restore the Factory Default Configuration of the Ventilator To restore the factory default configuration of the ventilator do as follows 1 Select the Maintenance shortcut key User Maintenance gt gt gt Ventilator Defaults 3 6 2 Select Ok from the pop up menu After Ok is selected the following settings restore their default values User screen Ventilator parameters Alarm limits of ventilator related parameters O2 monitoring source Alarm sound volume and key sound volume Screen brightness Paw display unit 3 3 6 2 Restore the Factory Default Configuration of the Gas Module If the anesthesia machine is configured with CO or AG module you can directly restore the factory default configuration of the corresponding module For details refer to 8 CO2 Monitoring and 9 AG and O2 Concentration Monitoring 3 3 6 3 Restore the Factory Default Configuration of the BIS Module If the anesthesia machine is configured with BIS module you can directly restore the factory default configuration of the corresponding module For details refer to 10 BIS Monitoring 3 3 Set the IP Address of Anesthesia Information System CIS To set the IP address of anesthesia informa
139. nnnnnnnnnnnnnos B 10 Bat SENSE PEC CAI on B 11 B 12 02 Module Specifications A B 14 BISAO Module SpectHica loans si cd cd sd es B 17 B 14 BIS Module SpeciticaOO Sudeste B 21 CEMC AAA E O C 1 Di Alavi Mess ae in caida D 1 DD Phystiolopical Alarmi Mesas ss D 1 D Z Technical Alar MCSSaG es 0 ass D 4 E Symbols and ADDreviations oommmoccsonmsssssssssccnsccnoccacacinoorsscssonorososecancccnccononoresesenass E 1 Eoy MDO kc renee ea ene E RE RC EET ER EOE SOR NER OC E 1 EZADI EV AON ena meee eeeeeee aes euee E 3 EFactory DEUSTO aa F 1 PICO NN I ica F 1 EZAG MOE A A io F 2 O taunt A E PO O O EA F 3 EAN CA F 4 FOR YOUR NOTES 1 Safety 1 1 Safety Information DANGER o Indicates an imminent hazard that if not avoided will result in death or serious injury WARNING eo Indicates a potential hazard or unsafe practice that if not avoided could result in death or serious injury CAUTION eo Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage NOTE eo Provides application tips or other useful information to ensure that you get the most from your product 1 1 1 1 1 Dangers There are no dangers that refer to the product in general Specific Danger statements may be given in the respective sections of this manual 1 1 2 Warnings N WARNING Before putting the system into operation the operator must verify th
140. nsor is damaged the membrane inside the flow sensor is cracked or distorted or the flow sensor is cracked or distorted Replace the transfer tube if it is damaged 7 3 Breathing System Maintenance When cleaning the breathing system replace any parts that are visibly cracked chipped distorted or worn For details refer to 13 Installations and Connections and 14 Cleaning and Disinfection 7 4 Flow Sensor Calibration NOTE e Do not perform calibration while the unit is connected to a patient eo During calibration do not operate the pneumatic parts Do not move or press the breathing tubes especially o During calibration the drive gas pressure must be kept above 0 3 MPa Otherwise calibration failure may result To calibrate the flow sensor do as follows 1 Make sure that the supply gas pressure is normal 2 Turn off all fresh gas inputs 3 Set the bag mechanical ventilation switch to the position 4 Remove the folding bag from the bellows and reinstall the bellows housing 5 Plug the Y piece into the leak test plug to close the breathing system KS D ok 20 SS nt tune eee 6 Remove the water collection cup For details refer to 14 2 11 Water Collection Cup Make sure that the system is Standby If not press the D key and then select Ok from the pop up menu to enter standby status Select the Maintenance shortcut key and then select Flow Sensor Cal gt
141. o the leak test plug on the manual bag port Turn the APL valve control to let the pressure of APL valve stay at 30 cmH30 Push the O2 flush button to inflate the manual bag Make sure that the reading on the airway pressure gauge is with the range of 20 to 40 cmH gt 0O Turn the APL valve control to the MIN position Set the O flow to 3 L min Turn any other gases off 10 Make sure that the reading on the airway pressure gauge is less than 5 cmH2O 11 12 Push the O flush button Make sure that the reading on the airway pressure gauge does not exceed 10 cmH20 Turn the O flow control to set the O flow to minimum Make sure that the reading on the airway pressure gauge does not decrease below 0 cmH 0 6 11 6 9 Alarm Tests The anesthesia machine performs a self test after started The alarm lamp flashes yellow and red once in turn and then a beep is given Then the display shows the start up screen and enters the standby screen after 30 seconds This means that audio and visual alarm indicators begin to work normally 6 9 1 Prepare for Alarm Tests l o ND Connect a test lung or manual bag to the Y piece patient connection Set the bag mechanical ventilation switch to the mechanical IE position Set the system switch to the position Set the system to Standby Set the ventilator controls as follows Ventilation mode select the Vent Mode shortcut key and then VCV 9 TV 500ml 9 Rat
142. ommended temperature mild detergent such as soap water Carefully wash the assembly to prevent damage of the parts Rinse the assembly with clean warm water Autoclave the cleaned bellows housing Maximum recommended temperature is 134 C Hang the disinfected bellows assembly upside down and dry at a room temperature less than 70 C Look for damaged parts after the bellows assembly is fully dry Then install the assembly with reference to 13 1 5Install the Bellows Connect the bellows assembly ventilator and breathing system Perform preoperative test before system use For details refer to 6 8 1 Bellows Test 14 3 7 Sodalime Canister NOTE It is recommended to apply the high level disinfection procedure after the intermediate level disinfection is completed Refer to the methods recommended in the table of 14 3 Clean amp Disinfect and Re install the Breathing System to clean and disinfect the sodalime canister Pour the sodalime into the sodalime canister when the canister is fully dry Refer to 13 1 8 Install the Sodalime Canister to install the canister onto the breathing system 14 19 14 3 8 Breathing Tubes and Y Piece NOTE When installing or cleaning the breathing tube hold the tube connectors at both ends of the tube to prevent damage to the tube Refer to the methods recommended in the table of 14 3 Clean amp Disinfect and Re install the Breathing System to clean and disinfect the breathing tubes and
143. oo high TVe too low MV too high MV too low Rate too high Rate too low EtCO2 too low FiCO2 too low EtN20 too low FiN20 too low EtHal too low FiHal too low EtEnf too low FiEnf too low EtIso too low Filso too low EtSev too low FiSev too low EtDes too low and FiDes too low 11 7 Set MV amp TVe Alarm l Push the MV amp TVe alarm key when MV amp TVe alarm is turned on The message MV amp TVe Alarm Off is prompted and the icon MVE TVE ZX 1s displayed on the screen Push the MV amp TVe alarm key again and the message MV amp TVe Alarm On is prompted NWARNING MV amp TVe alarm is not triggered when MV amp TVe alarm is turned off Exert care when using MV amp TVe alarm 11 8 Set Apnea Alarm In non mechanical ventilation mode l Ze Push the MV amp TVe alarm key when apnea alarm is turned on The message Apnea Alarm Off is prompted and the icon APNEA is displayed on the screen Push the MV amp TVe alarm key again and the message Apnea Alarm On is prompted When apnea alarm is turned off if the anesthesia machine detects breathing waveforms the system automatically turns on apnea alarm 11 9 Alarm Silence 11 9 1 Set 120 s Alarm Silence Pressing the 120 s alarm silence key will set the system to alarm silenced status Sound alarm will be disabled Besides the alarm silence symbol and 120 s countdown time will appear in the upper right corner of the screen NOTE In the 120 s alarm sil
144. ot perform test on the vaporizer when the concentration control is between OFF and the first graduation above 0 zero as the amount of anesthetic drug outputted is very small within this range 6 8 Breathing System Tests NWARNING Objects in the breathing system can stop gas flow to the patient This can cause injury or death Make sure that there are no test plugs or other objects in the breathing system Do not use a test plug that is small enough to fall into the breathing system Make sure that the breathing system 1s correctly connected and not damaged Make sure that the check valves in the breathing system work correctly The inspiratory check valve opens during inspiration and closes at the start of expiration The expiratory check valve opens during expiration and closes at the start of inspiration 6 8 1 Bellows Test t ae Se Set the system to Standby Set the bag mechanical ventilation switch to the mechanical ventilation position Set all flow controls to minimum Close the breathing system at the patient connection Push the O flush button to fill the bellows folding bag rising to the top Make sure that the pressure must not increase to more than 15 cmH20 on the airway pressure gauge The folding bag should not fall If it falls it has a leak You need to reinstall the bellows 6 8 2 Breathing System Leak Test in Mechanical Ventilation Status NOTE Breathing system leak
145. ou select Stop calibration is stopped Then the message Calibration Stopped Calibration is unfinished is displayed This indicates invalid calibration instead of calibration failure After a successful calibration the screen shows Calibration Completed Otherwise the message Calibration Failure Please try again is displayed In this case you need to do the calibration again Select X to exit the current menu 7 5 2 100 O2 Calibration NOTE If the calibration fails check for technical alarm and troubleshoot it if there is Then do the calibration again In case of repeated calibration failures replace the O sensor and do the 21 O2 calibration again Calibrate at 100 02 again after 21 O2 calibration is completed If it still fails contact your service personnel or us To calibrate at 100 Os do as follows JE Make sure that 21 O calibration is already completed successfully and that no 02 Supply Failure alarm occurs Make sure that the system 1s Standby If not press the D key and then select Ok from the pop up menu to enter standby status Select the Maintenance shortcut key 02 Sensor Cal gt gt 100 O2 Cal gt gt to open the 02 100 Cal menu Make sure that the patient is disconnected from the system 7 6 a a ee 10 11 12 Position the patient O sensor connector to the air Turn on ACGO Turn on the O inlet and adjust the flow above 8 L min Tu
146. ow sensors horizontally 14 8 14 2 8 Expiratory Check Valve Assembly 1 Turn the check valve cover counterclockwise to remove it 2 Pull out the check valve 14 2 9 Inspiratory Check Valve Assembly For details about how to disassemble the inspiratory check valve assembly refer to 14 2 8 Expiratory Check Valve Assembly 14 9 14 2 10 Sodalime Canister 1 Hold and pull up the rotary handle for 90 degrees 2 14 10 3 Pull off the sodalime canister from the lifting device al 4 To reassemble the canister refer to 13 1 8 Install the Sodalime Canister NWARNING e Sodalime is a caustic substance and is a strong irritant to eyes skin and respiratory system Affected parts should be flushed with water If irritation continues after flushed by water seek medical assistance immediately 14 2 11 Water Collection Cup 1 Hold the water collection cup and turn it clockwise 2 Remove the water collection cup 14 11 14 2 12 Breathing system 1 Hold the breathing system with one hand 2 Pull up the locking catches on the circuit adapter with the other hand to unlock it Ss 14 12 NOTE eo If itis hard to push the breathing system into or out of the circuit adapter you need to apply some lubricant to the seal on the pneumatic connector to reduce friction 14 2 13 AGSS Transfer and Receiving System 14 2 13 1 Filter 1 Turn the nut on the AGSS active scavenging tube count
147. ple 1 Select the Pinsp shortcut key 2 Push the control knob and turn it to set Pinsp to the appropriate value 3 Push the control knob to confirm the setting 4 Set other parameters in this mode in the similar way NOTE o Ifthe parameter value is adjusted outside of the range the system prompt message area displays Parameter Settings Outside the Safety Range eo Confirm the adjustment of one parameter before adjusting another parameter If you want to restore the value before adjustment you have to reset the parameter value 4 10 4 4 4 6 Parameter Range and Default Value in PCV Mode Pinsp 5 to 60 cmH20 1 cmH20 15 cmH20 4 to 100 BPM Plimit 10 to 100 cnH20 l cmH20O 30 cmH20 PEEP OFF 4 to 30 cmH2O l cmH20 OFF 4 4 5 Synchronized Intermittent Mandatory Ventilation SIMV This anesthesia machine supports two modes of SIMV SIMV volume control SIMV VC and SIMV pressure control SIMV PC 4 4 5 1 Description E SIMV VC SIMV VC means to deliver volume controlled breathing to the patient by phase at the preset intermission In the SIMV VC mode the ventilator waits for patient s next inspiration based on the specified time interval The sensitivity depends on Trigger Level optional flow and pressure If Trigger Level is reached within the trigger waiting time called synchronous Trigger Window the ventilator delivers volume controlled breathing synchronously with the preset tidal volume and inspir
148. porarily within nine breathing cycles or one minute whichever 1s less after being set Increase breath rate setting or decrease low alarm limit Paw is greater than Plimit Increase Plimit or decrease TV or Rate D 2 AG EtCO2 Too High The measured value has risen above the high alarm limit or module EtCO2 Too Low fallen below the low alarm limit Check the patient s physiological condition Make sure that patient type and FiCO2 Too High alarm limit settings are correct 02 Tw Low e EXITO Enzo Tootow e F20 Tw High nao tw Law e EMO sia Too Low e a too e CTO ent Too nien Ent Toron Fent Too mien 0 Frato tou e Enso Too nien so uo Low e ESO Fie Too Low Eser tonen 0 EsevTuo Lov e sev Tonie riser Toton 0 ESOO oeste Low 0 Foes Tonen 0 FiDes Too Low CO EtCO2 Too High module EtCO2 Too Low FiCO2 Too High BIS BIS Too High module BIS Too Low D 2 Technical Alarm Messages RT Clock Need H There is no button cell available in the system or the Reset battery is empty Replace with a new button cell H RT Clock Not Exist EN RT chip malfunction Contact your service personnel Low Battery H The battery voltage is too low The system is operational Voltage Connect the AC mains immediately In case of power failure use manual ventilation mode to help the patient breathe If the batteries cannot be fully charged within 24 hours contact your service personne
149. r TP TP numeric which only monitors the state of the brain indicates the power in the frequency band 0 5 30Hz The useful range is 40 100db 7 Burst Count BC A burst means a period at least 0 5 second of EEG activity followed and preceded by inactivity The BC numeric helps you quantify suppression by measuring the number of EEG bursts per minute This parameter is intended for the BIS module with the Extend Sensor only 10 5 Prepare to Measure BIS 1 Connect the BISx model to the BIS module BIS module iig BISx Patient cable o i BIS sensor 2 Use the attachment clip to secure the BISx model near but not above the level of the patient s head 3 Connect the BISx model to the patient cable 4 Attach the BIS sensor to the patient following the instructions supplied with sensor NOTE o Make sure that the patient s skin is dry A wet sensor or salt bridge could result in erroneous BIS and impedance values 10 4 5 Connect the BIS sensor to the patient cable As soon as a valid sensor is detected the impedances of all electrodes are measured automatically and the impedance value for each electrode is displayed in the sensor check window CAUTION e Do not attach the BISx model to the patient s skin for a long time Otherwise the BISx heats while on the patient and may cause discomfort 10 6 Continuous Impedance Check By default this check is switched on It checks E The combined imp
150. r and flow sensor view trend graph trend table and alarm logbook and set language system time pressure unit IP address etc Timer setup shortcut key Used to start stop and reset the timer Parameter setup shortcut keys area Used to set the parameters related to the selected mechanical ventilation mode The arrangement of the shortcut keys in this area varies depending on the selected mechanical ventilation mode For details refer to 4 Operations and Ventilation Setup System prompt message area 3 4 Displays information about system operating state 18 Parameter amp graph area Displays the parameters waveforms spirometry loops or electronic flowmeter graphs which the anesthesia ventilator gas module or BIS module monitors Different types of screens are displayed based on the actual system configuration or screen layout settings For details refer to 5 User Interface and Parameter Monitoring 3 3 Basic Settings This chapter covers only general settings of the anesthesia machine such as language screen brightness system time etc Parameter settings and other settings can be referred to in the respective sections 3 3 1 Adjust Screen Brightness 1 Select the User Setup shortcut key and select Screen and Audio Setup gt gt 2 Select Screen Brightness and select the appropriate value ranging from 1 to 10 for screen brightness The value 10 is for the brightest and 1 the least bright If the anesthesia m
151. r high pressure cylinder M6Q 020039 Sidestream CO module DRYLINE Watertrap Adult pediatric Reusable 9200 10 10530 Sampling Line Adult 2 5m Adult pediatric Disposable 9200 10 10533 DRYLINE Airway Adapter Straight Adult pediatric Disposable 9000 10 07486 Microstream CO module Sampling line XS04620 adult pediatric disposable 0010 10 42560 Sampling line XS04624 adult pediatric high humidity disposable 0010 10 42561 Sampling line 007768 adult pediatric long disposable 0010 10 42563 Sampling line 007737 adult pediatric long high humidity disposable 0010 10 42564 0010 10 42562 Sampling line 006324 infant neonatal high humidity disposable Sampling line 007738 infant neonatal long high humidity disposable 0010 10 42565 Mainstream CO module AG module Airway adapter Adult pediatric Disposable straight 9000 10 07486 Airway adapter Adult pediatric Disposable elbow 9000 10 07487 Watertrap Adult pediatric Reusable 9200 10 10530 Sampling Line Adult 2 5m Adult pediatric Disposable 9200 10 10533 Power cord Power cord European style 5m Power cord British style 5m Power cord American style 5m Battery Lithium battery DK MR 644 BIS module BIS sensor adult BIS sensor pediatric BIS patient cable adult pediatric AGSS transfer tube assembly tube connecting the anesthesia machine to the AGSS main unit Tube length approximately 0 5 m AGSS active scavenging tub
152. r setup shortcut key to change the corresponding setting Turn the control knob to change the specific setting and push the control knob to activate the selected setting Display screen Refer to 3 2Display Screen for details 3 2 Display Screen This anesthesia machine adopts a high resolution color TFT LCD to display various parameters and graphs such as ventilation parameters and pressure flow volume waveforms Depending on how your anesthesia machine is configured it may display gas module parameters and waveforms BIS parameters BIS trend waveform spirometry loops etc The following is a standard display screen For descriptions of other screens refer to5 User Interface and Parameter Monitoring l 2 3 4 5 6 7 8 S IMV Mvatve gt lt _ APNEA X 2008 11 18 16 49 23 J VC YR ate T 00 L Ou cmHeO oe Flowmeter 10 a Do 02 NO AR 17 Wy amp TVe Alarm off crmH20 10 11 12 13 14 15 mi SIMY Rate a 5 Ep Linin J iit crn Ho0 ae crmH20 PEEP emHro 16 500 10 15 60 30 15 1 Ventilation mode prompt area Displays the current ventilation mode If manual ventilation is selected for the bag mechanical ventilation switch E is displayed in this area If mechanical ventilation is selected for the bag mechanical ventilation switch the currently selected mechanical ventilation mode is displayed 2 Lung icon area The icon MIN is displayed when SIMV VC or SIM
153. racteristic of a typical location in a typical commercial or hospital environment Guidance and Declaration Electromagnetic Immunity The anesthesia machine is suitable for use in the specified electromagnetic environment The customer or the user of the anesthesia machine should assure that it is used in such an environment as described below Immunity test Conduced RF IEC61000 4 6 IEC60601 test level 3 Vrms 150 kHz to 80 MHz Outside ISM bands 10 Vrms 150 kHz to 80 MHz In ISM bands 10Vrms V2 Compliance Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the system including cables than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter Recommended separation distances Radiated RF 10V m 10 V m TE 12 Jp 80 MHz 800 MHz IEC61000 4 3 80MHz El El 2 5GHz P 2yr 800 MHz 2 5 GHz El Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range j Interference may occur in the vicinity of equipment marked with the following Ke symbol Note 1 At 80
154. rameters for display as shown below Non Extend sensor Extend sensor 1 Bispectral Index BIS The BIS numeric reflects the patient s level of consciousness Typically it ranges from 40 to 60 for a patient under general anesthesia during surgery The patient 1s widely awake The patient is underdosed but still unlikely to become aware The patient is overdosed and in deep hypnosis The EEG waveform is displayed as a flat line and the patient has no electrical brain activity 6 The patient is under general anesthesia and loses consciousness 2 Signal Quality Index SQD The SQI numeric reflects signal quality and provides information about the reliability of the BIS SEF TP and SR numerics during the last minute It ranges from 0 to 100 9 0to15 the numerics cannot be derived 9 15to50 the numerics cannot be reliably derived 9 50to 100 the numerics are reliable 3 Electromyograph EMG EMG bar graph reflects the electrical power of muscle activity and high frequency artifacts The minimum possible EMG is about 25 dB EMG lt 55 dB this is an acceptable ECG EMGS lt 30 dB this is an optimal EMG 4 Suppression Ratio SR SR numeric is the percentage of time over the last 63 second period during which the EEG is considered to be in a suppressed state 10 3 5 Spectral Edge Frequency SEF The SEF is the frequency below which 95 of the total power is measured 6 Total Powe
155. rating lives Typical sensor drift rates are less than 1 per month when O2 sensor is exposed to gas in typical applications Thus a sensor with a starting signal of 12mV in 210mBar oxygen will typically still be showing a signal greater than 10mV as it approaches the end of its life B 12 Under conditions where liquid condensation may occur care is needed to ensure the gas access Humidity Effects holes do not become blocked If liquids form in the region of the gas access hole the flow of gas to the sensor will be restricted With gas access restricted a low signal will result If a sensor shows signs of being affected by condensation normal operation may be restored by drying the sensor with a soft tissue Under no circumstances should these sensors be heated to dry them out Changes in humidity levels which affect the O2 partial pressure will correspondingly alter the output signal of the sensor Pressure Effects Since the sensor measures O2 partial pressure the output will rise and fall due to pressure changes which affect the O2 partial pressure Thus an increase in pressure of 10 at the sensor inlet will produce a 10 increase in signal output Nitrous oxide is highly soluble in neutral and alkaline solutions Where the sensor is exposed to high levels of nitrous oxide the solubility of this gas can in fact cause the internal pressure to increase to the point where the seals fail O2 sensor incorporates a patented pr
156. rces that affect the ambient pressure Restart the anesthesia machine machine application site meets the environmental specifications Check for special sources that affect the ambient pressure Restart the anesthesia machine CO2 Low M The barometric pressure is less than 428 mmHg Check Barometric the airway connections Make sure that the anesthesia D 11 CO2 Hardware H Errors occurred to Error 1 External A D sampling 2 5 V 2 12V power supply voltage 3 Internal A D sampling 2 5 V 4 Pump 5 3 way valve CO2 Sampleline M Anerror or occlusion occurred to the sampling line Occluded CO2 Zero Failed H Deviation of gain input signal is too great to be adjusted Namely it cannot be adjusted within the normal range 3 5 V 100 mV CO2 Cal Failed M The difference between the measured standard gas concentration and the specified standard gas concentration exceeded 40 of the specified standard gas concentration Or an illegal calibration parameter was obtained The normal parameter calibration range 1s within 0 2 to 2 5 The measured value is outside of the measurement range FiCO2 Overrange H Contact your service personnel CO2 Check Airway ee Airway error CO2 No Make sure if the sampling line is already connected Sampleline CO2 Main Board CO2 module malfunction Re plug the module or restart Error the anesthesia machine CO2 Check Sensor M or Main Board CO2 Replace M Scrubber amp P
157. red within the Back Mode Active the PCV mode is Psupp activated automatically Flow Insp Termination 4 4 6 3 Start PSV Mode 1 Select the Vent Mode shortcut key to open the Vent Mode Setup menu 2 Select the Vent Mode shortcut key and then PSV gt gt to open the PSV Setup menu 3 Select Ok directly in the PSV Setup menu Or you can set Backup Mode Active Trigger Level and PSV Insp Termination Level followed by selecting Ok After Ok is selected the Psupp shortcut key the second key from the right in the parameter setup shortcut keys area is highlighted 4 Make sure that Psupp is appropriately set for the patient Push the control knob to confirm the setting so as to start PSV mode NOTE o When it is necessary to switch over to PSV mode confirm the setting of Psupp first Otherwise the system works in the previous ventilation mode If the setting of Psupp is not confirmed for 10 s the screen returns to the previous mode automatically o Before activating a new mechanical ventilation mode make sure that all related parameters are set appropriately 4 18 4 4 6 4 Parameter Setup Shortcut Keys Area in PSV Mode When selection of PSV mode is confirmed the parameter setup shortcut keys area at the bottom of the screen is automatically switched over to the parameter setup area in this mode The following figure shows all related parameters to be set in PSV mode BPM PER Finep Lmi
158. rm silenced El MVE TVe 3 indicates MV amp TVe alarm switched off EN APNEA indicates apnea alarm switched off 11 3 11 3 Set Alarm Volume 1 Select the User Setup shortcut key 2 Select Screen and Audio Setup gt gt and then Alarm Sound Volume to select an appropriate value ranging from 1 to 10 The value 1 is for the lowest and 10 for the loudest WARNING eo Do not rely exclusively on the audible alarm system when using the anesthesia machine Adjustment of alarm volume to a low level may result in a hazard to the patient Always keep the patient under close surveillance 11 4 Set Alarm Limits NOTE e Analarm is triggered when the parameter value is higher than the High Limit or lower than the Low Limit o When using the anesthesia machine always keep an eye to whether the alarm limits of a specific parameter are set to the appropriate values 11 4 1 Set Ventilator Alarm Limits 1 Select the Alarm Setup shortcut key and then Ventilator gt gt 2 Set High Limit and Low Limit respectively for each parameter 3 Select X to exit the current menu 11 4 2 Set CO2 Alarm Limits 1 Select the Alarm Setup shortcut key and then Gas Module gt gt 2 Set High Limit and Low Limit respectively for each parameter 3 Select X to exit the current menu 11 4 11 4 3 Set AG Alarm Limits 1 Select the Alarm Setup shortcut key and then Gas Module gt gt 2 Set High Limit
159. rn off other gas supplies After two to three minutes select Start from the menu to start to calibrate at 100 O The screen prompts Calibrating During the calibration if you select Stop calibration is stopped Then the message Calibration Stopped Calibration is unfinished is displayed This indicates invalid calibration instead of calibration failure After a successful calibration the screen shows Calibration Completed Otherwise the message Calibration Failure Please try again is displayed In this case you need to do the calibration again Select to exit the current menu Turn off ACGO 7 6 Water Build up in the Flow Sensor 7 6 1 Prevent Water Build up Water comes from the condensation of exhaled gas and a chemical reaction between CO2 and the sodalime in the sodalime canister At lower fresh gas flows more water builds up because More CO2 stays in the sodalime canister to react and produce water More moist exhaled gas stays in the breathing system and sodalime canister to produce condensed water Check the inspiratory and expiratory flow sensors when abnormal flow waveform or unstable tidal volume fluctuation is detected Check the sensor for water If there is water build up clear it before use To prevent water build up solutions are l Water condensation in the flow sensor can be eased using a filter between the flow sensor and the patient Check the water collect
160. s J N WARNING Use only accessories specified in this chapter Using other accessories may cause incorrect measured valued or equipment damage eo Disposable accessories can not be reused Reuse may degrade performance or cause cross contamination o Check the accessories and their packages for damage Do not use them if any sign of damage is detected eo Parts which are intended to contact patients must comply with the biocompatibility requirement of S010993 1 to prevent any adverse reactions arising from such contact Disposal of the accessories shall comply with the applicable waste control regulations Connector PSF elbow 22F 22 15mm durable M6Q 030031 PSF Wye 22Mx2 22 15mm durable M6Q 030028 Manual bag Latex Free Breathing Bag 1 Liter M6Q 120030 Latex Free Breathing Bag 2 Liter M6Q 12003 1 Latex Free Breathing Bag 3 Liter M6Q 120032 Silicone Breathing Bag 1 Liter w loop end 22F M6Q 120025 Silicone Breathing Bag 2 Liter w loop end 22F M6Q 120026 Silicone Breathing Bag 3 Liter w loop end 22F M6Q 120027 Breathing tube Silicone breathing tube Adult 100cm M6G 020040 Silicone breathing tube Pediatric 100cm M6G 020041 Pediatric breathing tube assembly including breathing tube Y connector L M6G 040004 connector filter manual bag Adult breathing tube assembly including breathing tube Y connector L M6G 040003 connector filter manual bag 15 1 Mask M
161. s O pressure decreases o Set the system switch to the O position 6 6 2 With 02 Sensor Do as described in 6 9 2 Test the O2 Concentration Monitoring and Alarms before testing To do the flow control system tests l 2 4 5 Connect the pipeline supplies or slowly open the cylinder valves Turn all flow controls fully clockwise minimum flow Set the system switch to the position Do not use the system if low battery or other ventilator failure alarms occur Adjust all gas flows to minimum Steps 6 and 7 are only for systems with N20 NWARNING During steps 6 and 7 the O sensor used must be correctly calibrated and the Link system should be kept engaged Adjust only the test control N20 in step 6 and O in step 7 Test the flows in sequence N20 then O2 Test the O2 N20 Link system with flow increasing Turn the N20 and O flow controls fully clockwise minimum flow Slowly turn the N20 flow control counterclockwise Make sure that the O flow increases The measured O concentration must be gt 21 through the full range Test the O2 N2O Link system with flow decreasing Turn the N20 flow control and set the N20 flow to 9 0 L min Turn the O flow control and set the O flow to 3 L min or higher Slowly turn the O flow control clockwise 10 11 12 Make sure that the N20 flow decreases The measured O concentration must be gt 21 through the full range Disconnect th
162. semble the breathing system cleanable parts first before cleaning the system 14 2 14 2 1 O2 Sensor 1 Remove one end of the O sensor cable from the 0 connector on the anesthesia machine Unplug the other end of the cable from the O sensor 2 14 3 14 2 2 Manual Bag Remove the manual bag from the manual bag port on the breathing system as shown below E The anesthesia machine is configured with bag arm 14 2 3 Breathing Tubes NOTE eo When disassembling the breathing tube hold the tube connectors at both ends of the tube to prevent damage to the tube eo Do not reuse the filter Follow local regulations regarding disposal of hospital waste when the filter is discarded 1 Remove the filter from the Y piece 2 Disconnect the breathing tubes from the inspiration expiration connectors on the breathing system 14 5 14 2 4 Airway Pressure Gauge Pull off the airway pressure gauge as shown below F 14 2 5 Bag Arm 1 Loosen the locking nut counterclockwise 2 Remove the bag arm from the breathing system 14 2 6 Bellows Assembly 1 Turn the bellows housing counterclockwise 2 Lift off and remove the housing 3 Remove the folding bag from the bellows base 14 7 14 2 7 Flow Sensor 1 Turn the locking nuts counterclockwise ad ys I _ i 2 Pull out the inspiration expiration connectors and their locking nuts 3 Pull out the fl
163. setting of TV is not confirmed for 10 s the screen returns to the previous mode automatically To start SIMV PC do as follows 1 Select the Vent Mode shortcut key to open the Vent Mode Setup menu 2 Select SIMV PC gt gt in the Vent Mode Setup menu 3 Select Ok directly in the SIMV PC Setup menu Or you can set Trigger Level and PSV Insp Termination Level before selecting Ok After Ok is selected the shortcut key the first key from the left in the parameter setup shortcut keys area is highlighted 4 Make sure that Pinsp is appropriately set for the patient Push the control knob to confirm the setting so as to start SIMV PC mode NOTE eo You can not set Trigger Window when entering the SIMV PC gt gt menu for the first time e When it is necessary to switch over to SIMV PC mode confirm the setting of Pinsp first Otherwise the system works in the previous ventilation mode If the setting of Pinsp is not confirmed for 10 s the screen returns to the previous mode automatically 4 13 4 4 5 4 Parameter Setup Shortcut Keys Area in SIMV Mode When selection of SIMV mode is confirmed the parameter setup shortcut keys area at the bottom of the screen is automatically switched over to the parameter setup area in this mode The specific parameters vary depending on SMIV modes namely SIMV VC and SIMV PC Their unique difference lies in the first parameter which is TV for SIMV VC and Pinsp for S
164. sive and is in lieu of all other warranties expressed or implied including warranties of merchantability or fitness for any particular purpose Exemptions Mindray s obligation or liability under this warranty does not include any transportation or other charges or liability for direct indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel This warranty shall not extend to E Any Mindray product which has been subjected to misuse negligence or accident or WE Any Mindray product from which Mindray s original serial number tag or product identification markings have been altered or removed or EW Any product of any other manufacturer MI Return Policy In the event that 1t becomes necessary to return a unit to Mindray follow the instructions below 1 Return authorization Contact the Customer Service Department and obtain a Customer Service Authorization number This number must appear on the outside of the shipping container Returned shipments will not be accepted if the number is not clearly visible Please provide the model number serial number and a brief description of the reason for return 2 Freight policy The customer is responsible for freight charges when this product is shipped to Mindray for service this includes customs charges
165. sodalime in the canister before using the anesthetic agent Replace the sodalime immediately if obvious color change is detected For details about how to use the anesthetic agent refer to the Vaporizer Instructions for Use 4 4 Set Ventilation Mode 4 4 1 Set Manual Ventilation Mode 1 Turn the APL valve control to adjust the pressure in the breathing system within the appropriate range 2 Set the bag mechanical ventilation switch to the E gt position The ventilation mode prompt area displays the icon for manual ventilation mode Besides the system prompt message area displays Manual Vent 3 Push the O flush button O to inflate the bag 1f necessary In the manual ventilation mode you can use the APL valve to adjust the breathing system pressure limit and gas volume in the manual bag When the pressure in the breathing system reaches the pressure limit set for the APL valve the valve opens to release excess gas The following figures show the Paw waveform and flow waveform in the manual ventilation Inspiration Expiration Time Time Paw Flow mode NOTE o When using the anesthesia machine on the patient make sure that manual ventilation mode is available 4 4 2 Make Settings before Starting Mechanical Ventilation Mode l Make sure that the system is Standby 2 Set the appropriate Plimit value in the parameter setup shortcut keys area 3 Check the ACGO switch to make sure that i
166. spectral index W SQI Signal quality index E EMG Electromyograph If your anesthesia machine 1s configured with BIS module on the special screen BIS related parameters are displayed as shown below Non Extend sensor Extend sensor BIS Bispectral index SQI Signal quality index EMG Electromyograph SR Suppression ratio SEF Spectral edge frequency TP Total power BC Burst count 5 14 5 3 9 2 Display BIS EEG Waveform If your anesthesia machine is configured with BIS module BIS EEG and BIS Trend waveforms are displayed as shown below BIS EEG waveform 100uY BIS EEG BIS Trend waveform mir MI 5 3 9 3 Set BIS EEG Waveform 1 Select the waveform area to access the waveform setup menu 2 Select Waveform and select BIS EEG 3 Select Sweep and set waveform sweep speed to an appropriate value The greater the value is the faster the waveform sweeps the wider the waveform is 4 Select Scale and set waveform scale to an appropriate value 5 Select Filters and toggle between ON and OFF 6 Select to exit the current menu 5 3 9 4 Other Settings For details refer to 10 BIS Monitoring 5 4 Display Electronic Flowmeter Gas flow can be displayed either in a standard resolution mode or high resolution mode These two resolution modes vary in scale and accuracy Switchover between the standard resolution mode and the high resolution mode can be performed manually
167. ssure automatically 9 4 Prepare to Measure AG 1 Select the appropriate watertrap according to patient type and attach it to the watertrap fixer 2 Connect one end of the gas sampling tube to the watertrap 3 Connect the other end of the gas sampling tube to the patient via the airway adapter Connect the exhaust tube to the gas outlet on the module to scavenge the sample gas to the waste gas disposal system Y AG module OF Airway adapter Exhaust tube Gas sampling tube Connect to the patient By default the AG module is in measure mode The message AG Startup appears on the screen when the AG module is plugged in After start up is finished the message AG Warmup is displayed The AG module is in ISO accuracy mode If you perform AG measurements during warm up the measurement accuracy may be compromised After warm up is finished the AG module enters full accuracy mode CAUTION Position the airway adapter properly so that the part connecting to the gas sampling tube is pointing upwards This prevents condensed water from entering the gas sampling tube and causing an occlusion as a result The watertrap collects water drops condensed in the sampling tube and therefore prevents them from entering the module If the collected water reaches a certain amount you should drain it to avoid airway blockage The watertrap has a filter preventing bacterium vapor and patient secretions from entering the
168. switch 22 is opened flowmeter 26 is connected to the gas supplies Regulator 24 decreases the gas pressure to 200 kPa to ensure constant pressure supplied for the flowmeter Pressure switch 23 monitors the O supply pressure If the O2 supply pressure is lower than 220 kPa an alarm appears on the ventilator display If the O supply pressure is lower than 100 kPa N20 is cut off automatically through the O N20 cut off valve which does not impact Air supply The flowmeter is equipped with O2 N2O chain linkage which keeps the O concentration not lower than 25 at the fresh gas outlet The mixed gas of O Air and N20 goes from the flowmeter outlet through the vaporizer 29 that is ON and carries some amount of anesthetic agent to form fresh gas The fresh gas goes from check valve 30 to ACGO selector switch 32 When the ACGO selector switch is opened mechanical ventilation stops The fresh gas is delivered directly through the breathing system inlet and mechanical pressure relief valve 54 prevents pressure too high in ACGO On status When the ACGO selector switch is closed the fresh gas is delivered to the breathing system to be used by the patient during mechanical ventilation The O output from the O flush button 19 directly goes to the breathing system without going through the flowmeter assembly and vaporizer Anesthetic ventilator This anesthetic ventilator is a pneumatically driven microprocessor controlled anesthesia delivery system The
169. system 2 Sidestream microstream measurement Samples expired patient gas at a constant sample flow from the patient s airway and analyzes it with a CO sensor built into the CO module The measurement provides 1 CO waveform 2 End tidal CO EtCO gt value the CO value measured at the end of the expiration phase 3 Fraction of inspired CO FiCO gt the CO value measured during inspiration NOTE eo Perform CO monitoring when using this anesthesia machine to ensure patient safety If your anesthesia machine is not configured with CO module use the anesthesia machine with CO monitoring function in compliance with the relevant international standard to perform CO monitoring 8 1 8 2 Identify CO2 Module Sidestream CO module microstream CO module and mainstream CO module are shown below from left to right Microstream 1 CO setup key Measure standby key Gas outlet CO watertrap fixer Sampling tube connector a ae A CO sensor connector If you measure CO using AG module refer to 9 AG and 02 Concentration Monitoring 8 3 Use a Sidestream CO2 Module NOTE This section is only applicable to the anesthesia machine configured with sidestream CO2 module 8 3 1 Prepare to Measure CO2 1 Attach the watertrap to the watertrap fixer and then connect the CO2 components as shown below Watertrap fixer Sampling tube Watertrap La CA de T 2 By default t
170. t FiSev High Limit FiSev Low Limit EtDes High Limit EtDes Low Limit F 3 BIS Module BIS module alarm limits Alarm Level BIS Low Limit F 4 Ventilator Ventilator Setup Factory default settings VCV Mode TIP TI PEEP 20 PCV Mode Plimit cmH20 Rate BPM PSV Mode 15 Pinsp cmH20 Rate BPM FE Finsp L min Plimit cmH20 Psupp cmH20 PEEP cmH20 Backup Mode Active s Trigger Level 2 cmH 0 pressure triggered 3 0 L min L min flow triggered Trigger Level 2 cmH 0O pressure triggered 3 0 L min L min flow triggered Ventilator alarm limits FiO2 High Limit 100 F102 Low Limit TVe High Limit ml TVe Low Limit ml MV High Limit L min 10 Paw High Limit cmH 0 30 Paw Low Limit cmH20 P N 046 000203 00 1 0
171. t BIS Trend for Waveform Select Trend Length and toggle between 6 min 12 min 30 min and 60 min Select to exit the current menu For details about displaying the BIS related waveforms refer to 5 3 9BIS Monitoring 10 8 1 1 Alarms 11 1 Introduction Alarms triggered by a vital sign that appears abnormal or by technical problems of the anesthesia machine are indicated to the user by visual and audible alarm indications NOTE When the anesthesia machine is started the system detects whether alarm lamp and audible alarm tones function normally If yes the equipment gives a beep and the alarm lamp flashes yellow and red once in turn If not do not use the equipment and contact us immediately When multiple alarms of different levels occur simultaneously the anesthesia machine will select the alarm of the highest level and give visual and audible alarm indications accordingly 11 1 1 Alarm Categories By nature the anesthesia machine s alarms fall into three categories physiological alarms technical alarms and prompt messages l Physiological alarms Physiological alarms also called patient status alarms are triggered by a monitored parameter value that violates set alarm limits or an abnormal patient condition Physiological alarm messages are displayed in the physiological alarm area Technical alarms Technical alarms also called system status alarms are triggered by a device malfunct
172. t If your anesthesia machine is not configured with such monitoring function use a qualified monitor for tidal volume monitoring 5 3 5 1 Display Tidal Volume and Breath Rate Parameters If your anesthesia machine is configured with CO2 or AG module tidal volume and breath rate related parameters are displayed as shown below 5 10 If your anesthesia machine is not configured with CO2 or AG module tidal volume and breath rate related parameters are displayed as shown below MV Minute ventilation TVe Expired tidal volume Rate Breath rate FiO2 Fraction of inspired oxygen 5 3 5 2 Display Flow Waveform Linin 5 3 5 3 Set Flow Waveform 1 Select the flow waveform area to access the Flow Waveform Setup menu 2 Select Waveform and select Flow 3 Select Sweep and toggle between 6 25 mm s and 12 5 mm s The greater the value is the faster the waveform sweeps the wider the waveform is 4 Select Scale and toggle between 30 60 and 120 The unit is L mm The flow ranges corresponding to the waveform scales are 30 30 to 30 L min 9 60 60 to 60 L min 120 120 to 120 L min 5 Select to exit the current menu 5 3 5 4 Set MV and TVe Alarm Limits 1 Select the Alarm Setup shortcut key and select Ventilator gt gt 2 Set MV high and low alarm limits in the Ventilator Alarm Limits menu 3 Set TVe high and low alarm limits as required
173. t 3 MAC value was less than 3 Mixed Agent and M More than more anesthetic agents were detected ant the MAC gt 3 MAC value was not less than 3 module and anesthesia machine Re plug the module restart the anesthesia machine or try to plug the module into another anesthesia machine CO2 Comm Stop H CO module malfunction or communication failure CO2 Comm Error CO module communication failure CO2 Temp The temperature of the module crosses the range Use the Overrange module after it is kept away from the heat source or its temperature falls within the normal range CO2 Sensor High The temperature of the sensor assembly is too high gt 63 M Temp ll C Check stop using or replace the sensor CO2 Sensor Low M Temp CO2 High Airway The temperature of the sensor assembly is too low lt 5 C Check stop using or replace the sensor Paw is too high gt 790 mmHg An error occurred to the Press alrway pressure Check the patient connection and breathing system Then restart the anesthesia machine CO2 Low Airway M Paw is too low lt 428 mmHg An error occurred to the Press airway pressure Check the patient connection and breathing system Then restart the anesthesia machine CO2 High Barometric The barometric pressure is greater than 790 mmHg Check the airway connections Make sure that the anesthesia machine application site meets the environmental specifications Check for special sou
174. t is OFF 4 Set the bag mechanical ventilation switch to the position 5 Ifnecessary push the O flush button O to inflate the bellows NOTE o The default mechanical ventilation mode of the anesthesia machine is VCV Other mechanical ventilation modes are optional For the ventilation mode not configured for your anesthesia machine operations of the corresponding menu options are disabled 4 4 3 Volume Control Ventilation VCV 4 4 3 1 Description Volume control ventilation hereinafter referred to as VCV mode 1s a basic fully mechanical ventilation mode In the VCV mode each time mechanical ventilation starts gas is delivered to the patient at a constant flow which reaches the preset TV within the gas delivery time To ensure a certain amount of TV the resulted airway pressure Paw changes based on patient pulmonary compliance and airway resistance In the VCV mode as long as Paw is less than Plimit and the gas delivery flow is kept constant expirations starts immediately after Plimit is reached In the VCV mode you need to set Plimit to prevent high airway pressure from injuring the patient In this mode you can select to set TIP TI to improve patient pulmonary gas distribution and PEEP to improve expiration of end tidal carbon dioxide and to increase oxygenation of breathing process To ensure the set tidal volume gas delivery the ventilator adjusts gas flow based on the measured inspiratory volume dynamic
175. t th hi Auxi Ctrl Module H Selftest ROM error P E a after recovery to normal In case Hardware Error 03 of recovery failure after repeated Auxi Ctrl Module Selftest internal AD module Pressure M The auxiliary control board detected pressure monitoring Monitoring error Restart the machine restart contact your service Hardware Error 04 error Auxi Ctrl Module H Selftest watchdog Hardware Error 05 error Auxi Ctrl Module The communication between the auxiliary control module personnel Comm Error and the main control board stops for three seconds Restart the machine the machine Electronic Flowmeter H DVCC power failure seftest Contact your service Flowmeter H AVDD power failure seftest Hardware Error 02 re Flowmeter H VC power failure seftest error Hardware Error 03 hl NA Flowmeter H CPU selftest error Hardware Error 04 Flowmeter H RAM selftest error Hardware Error 05 Auxi Ctrl Module H The communication between the auxiliary control module Comm Stop and the main control board stops for 10 seconds Restart AG module Flowmeter H Flash selftest error Hardware Error 06 Flowmeter H Watchdog selftest error Hardware Error 07 Flowmeter Cal H Air O and N20 data empty Data Error 01 Flowmeter Cal H Air O and NO data error Data Error 02 Flowmeter Comm XX module failed to Error communicate with the main Flowmeter Comm H The electronic flowmeter Stop fa
176. t the other end of the adapter to the power source Try to turn on more than one vaporizer at the same time NOTE For details about how to use the Desflurane vaporizer refer to Instructions for Use of Desflurane vaporizer Test each possible combination If more than one vaporizer turns on at the same time remove the vaporizers install them again and complete steps 1 through 7 13 24 13 4 2 Fill the Vaporizer WARNING eo Make sure that the correct anesthetic agent is used The vaporizer is designed with the specific anesthetic agent named on it and further indicated by color coded labelling The concentration of the anesthetic agent actually output will vary if the vaporizer is filled with the wrong agent 13 4 2 1 Pour Fill System 1 Check that the vaporizer concentration control A is in the 0 zero position Check that the drain screw C is fully tightened 2 Unscrew the filler cap B 3 Allow the liquid to flow into the vaporizer slowly Pay attention to the liquid level during filling Stop filling when the maximum level mark is reached 4 Tighten filler cap B properly 13 25 13 4 2 2 Quik Fil System 1 Check that the vaporizer concentration control is in the off 0 position 2 Remove the protective cap from the anesthetic agent bottle filler checking that the bottle and filler mechanism are not damaged 3 Remove the vaporizer filler block cap and insert the bottle nozzle into t
177. t use talc zinc stearate calcium carbonate corn sarch or equivalent materials to prevent tackiness These materials can go into the patient s lungs and airways and cause irritation or injury e Do not put both of the breathing system and the O2 sensor in liquid or autoclave them Inspect all parts for deterioration Replace them if necessary 14 15 All parts of the breathing system can be cleaned and disinfected The cleaning and disinfection methods are different for different parts You need to select the appropriate method to clean and disinfect the parts based on the actual situations to avoid cross contamination This table is our recommended cleaning and disinfection methods for all parts of the breathing system Intermediate level disinfection High level disinfection Breathing tubes and Y piece Breathing mask Flow sensor Bellows assembly Inspiratory and expiratory check valves assemblies O sensor Canister assembly Canister connection block assembly Water collection cup Bag arm BYPASS assembly Breathing system Manual bag AGSS assembly X indicates that this disinfection method is applicable A Clean with a damp cloth soaked in mild detergent and then wipe off the remaining detergent with a dry lint free cloth B Flush with water first then soaked in water and cleaning solution water temperature 40 C recommended for approximately three minutes and wipe with 70 ethano
178. ter is outside of the range to avoid damaging the control valve When the flow control is turned to the minimum the reading indicated on the flowmeter should be zero To do the flow control system tests 1 Connect the pipeline supplies or slowly open the cylinder valves 2 Turn all flow controls fully clockwise minimum flow 3 Set the system switch to the position 4 Do not use the system if low battery or other ventilator failure alarms occur 5 Adjust all gas flows to minimum 6 Test the O2 N2O Link system with flow increasing Turn the N20 and O flow controls fully clockwise minimum flow Then turn the N20 flow control counterclockwise and set the N20 flow control to the rates shown in the table The O flow must meet the requirement listed in the following table N20 flow L min O2 flow L min ooo w o S Ta 7 Test the O2 N20 Link system with flow decreasing Turn the N20 and O flow controls and set the N20 flow to 9 0 L min and the O flow to above 3 L min respectively Then slowly turn the O flow control clockwise and set the N20 flow control to the rates shown in the table The O flow must meet the requirement listed in the following table N20 flow L min 02 flow L min gt o h ws 1 5 0 6 8 Disconnect the O pipeline supply or close the O cylinder valve NOTE 9 When 0 supply is disconnected alarms for 02 Supply Failure and Drive Gas Pressure Low occur a
179. the 02 flow control The O2 concentration in the fresh gas may be quite different from that in the breathing system The total flowmeter is calibrated based on 100 O2 The accuracy of the flowmeter may degrade with other gas or mixed gas When viewing the readings on the total flowmeter keep your visual angle at the same level of the float The reading of a same scale may vary when viewed at a different angle If the readings shown on the electronic flowmeters differ from that on the total flowmeter the former shall prevail and the latter is an approximate value 4 3 2 Set Anesthetic Agent NOTE 4 3 2 1 You do not need to perform this operation if inspiratory anesthetic agent is not used This anesthesia machine can be mounted with vaporizers corresponding with halothane enflurane isoflurane sevoflurane and desflurane Only one of the five vaporizers can be opened at a time because the vaporizers are featured with interlock Select the Desired Anesthetic Agent Determine the anesthetic agent to be used and then fill the vaporizer For details refer to 13 4 2 Fill the Vaporizer Mount the vaporizer filled with anesthetic agent onto the anesthesia machine For details refer to 13 4 Install the Vaporizer 4 3 2 2 Adjust the Concentration of Anesthetic Agent Push and turn the concentration control on the vaporizer to set the appropriate concentration of anesthetic agent NOTE Inspect the color of the
180. the D key in standby mode and then select Ok from the pop up menu 5 1 2 Normal Screen On the normal screen parameter graph area and waveform area are divided Parameter graph area Waveform area The structure of these two areas varies depending on the configurations 5 1 2 1 Parameter amp graph Area This area displays parameters and spirometry loops or electronic flowmeters as well The parameter amp graph combinations displayed vary depending on the configurations l Parameter information displayed includes NW Ventilator parameters The following parameters may be displayed simultaneously depending on the configurations of gas module and BIS module CO2 parameters AG parameters a E BIS parameters 2 Graph information displayed includes E Spirometry loops NW Electronic flowmeters For details refer to the respective sections of this chapter 5 1 2 2 Waveform Area This area displays waveforms monitored The waveform combinations vary depending on the configurations The waveforms displayed include Paw waveform Flow waveform CO2 waveform a a NW Volume waveform a E AG module related waveforms a BIS module related waveforms For details refer to the respective sections of this chapter 5 3 5 1 3 Special Screen Special screen includes big numerics screen and measured values screen The screen layout iS Parameter amp graph Big numerics measured area values sharing area
181. the anesthesia machine d Field strengths should be less than or equal to 3 Vrms outside the ISM bands between 150 kHz and 80 MHz and less than or equal to 10 Vrms within the ISM bands Recommended Separation Distance between Portable Mobile RF Communications Equipment and the Anesthesia Machine The anesthesia machine is suitable for use in an electromagnetic environment in which radiated RF disturbance are controlled The customer or the user of the anesthesia machine can help prevent electromagnetic interference by maintaining a minimum distance between portable mobile RF communications equipment transmitters and the anesthesia machine as recommended below according to the maximum output power of the communications equipment Rated Separation distance in meters m according to frequency of the transmitter a 150 kHz to 80 150 kHz to 80 80 MHz to800 800 MHz to 2 5 GHz output power MHz MHz of transmitter W Outside ISM bands In ISM bands je ll For transmitters rated at a maximum output power not listed above the recommended separation distance D in meters m can be determined using the equation applicable to the frequency of the transmitter where P 1s the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz to 800 MHz the separation distance for the higher frequency range applies Note 2 The ISM Industrial Scientific and Medical bands between 1
182. the first time eo To help prevent damage refer to the manufacturer s data if you have questions about a cleaning agent eo Do not use organic halogenated or petroleum based solvents anesthetic agents glass cleaners acetone or other harsh cleaning agents eo Do not use abrasive cleaning agents such as steel wool silver polish or cleaner Keep all liquids away from electronic parts eo Do not permit liquid to go into the equipment housings 14 1 NOTE eo Do not soak synthetic rubber parts for more than 15 minutes Swelling or faster aging can occur e Only autoclave parts marked 134 C eo Cleaning solutions must have a pH of 7 0 to 10 5 14 1 Clean and Disinfect the Anesthesia Machine Housing 1 Clean the surface of the anesthesia machine housing with a damp cloth soaked in mild detergent such as 70 ethanol 2 After cleaning the housing remove the remaining detergent by wiping with a dry lint free cloth N WARNING Seeping liquid into the control assembly can damage the equipment or cause personal injury When cleaning the housing make sure that no liquid flows into the control assemblies and always disconnect the equipment from the AC mains Reconnect the AC mains after the cleaned parts are fully dry NNOTE e Use only soft dry and lint free cloth to clean the display Do not use any liquid for display cleaning 14 2 Disassemble the Breathing System Cleanable Parts You need to disas
183. the system calculates compensation directly using the 02 concentration detected by the O module In this case O02 Comp is set to OFF permanently and is not user adjustable 9 5 4 Set Working Mode The default working mode of the AG module is Measure when the anesthesia machine 1s turned on If the current AG module is Standby you must push the key or select the User Setup shortcut key Gas Module Setup gt gt Working Mode gt Measure to start the AG module When the anesthesia machine restarts the AG module automatically continues with the previously selected working mode When Working Mode is set to Measure the message AG Startup appears on the screen After start up is finished the message AG Warmup is displayed The AG module is in ISO accuracy mode After warm up is finished the AG module enters full accuracy mode 9 5 5 Set CO2 Unit In the Gas Module Setup gt gt menu select CO2 Unit and toggle between mmHg and kPa 9 5 6 Restore Defaults Select Defaults from the Gas Module Setup menu Then all the options in this menu except Working Mode are restored to the factory default configurations 9 5 7 Set CO2 Waveform 1 Select the waveform area open the corresponding menu 2 Select C02 for Waveform 3 Select Sweep and set waveform sweep speed to an appropriate value The greater the value is set to the faster the waveform sweeps the wider the waveform 1s
184. the timer select the timer setup shortcut key and then Stop The timer setup shortcut key displays the time when timing stops NOTE o When timing stops if you select Start from the Timer Setup menu the timer starts timing from the time when timing last stopped 4 6 3 Reset the Timer To reset the timer select the timer setup shortcut key and then Reset The timer setup shortcut key displays 00 00 00 NOTE o In timing status if you select Reset from the Timer Setup menu the timer is stopped and reset 4 22 4 7 Stop Mechanical Ventilation To stop mechanical ventilation do as follows l Make sure that the breathing system is set up and the APL valve is set properly before stopping mechanical ventilation The APL valve adjusts the breathing system pressure limit during manual ventilation Its scale shows approximate pressure Set the bag mechanical ventilation switch to the e position This selects manual ventilation and stops mechanical ventilation ventilator 4 23 FOR YOUR NOTES 4 24 5 User Interface and Parameter Monitoring 5 1 Screen Layout Depending on module and functional configurations user screens differ in parameter graph area and parameter setup shortcut keys area User screens fall into four categories Standby screen Normal screen Big numerics screen Measured values screen The standby screen is switched over through the Standby key D on the panel You can
185. ting a coaxial female 15 mm Inspiration end l conical connector Male 22 mm conical connector incorporating a coaxial female 15 mm Bag end conical connector Airway pressure gauge Range 20 to 100 cmH20 Accuracy 2 5 of full range APL valve Range l to 75 cmH20 Tactility indication Above 30 cmH 0 1 to 30 cm H20 0 to 145 89 30 to 75 cm H20 145 8 to 292 59 Pressure flow data APL valve completely open Flow L min APL pressure cmH 0O dry APL pressure cmH 0 moist Rotation range Minimum pressure to open the APL valve 3 10 20 30 40 50 70 Expiratory resistance egy doip oinssaig ac om O YN Y E O Cu O jo a Y o wa PEEP Mechanical a Manual Flow L min Mechanical E Manual 1 cmH20O PCV PSV 1 cmH 0O PSV SIMV VC SIMV PC 20 to 100 ml 5 ml VCV 100 to 300 ml 10 ml SIMV VC 300 to 1500 ml 25 ml Rate TIP TI Finsp Trigger Window SIMV Rate Tinsp Inspiratory Trigger Level PSV Insp Termination Level Backup Mode Active 4 to 100 BPM 1 BPM 510 90 SIMV PC SIMV VC 4 to 60 BPM 1 BPM SIMV VC SIMV PC VCV PCV PSV VCV PCV PSV VCV PSV SIMV VC SIMV PC PSV SIMV VC SIMV PC Pressure 1 cmH O Pressure PEEP 20 cmH 0O to PEEP 1 cmH O Flow 0 5 to 15 L min Flow 0 5 L min 5 5 to 60 PSV SIMV VC SIMV PC PSV PEEP setting range Type Range
186. tion occurs within the Trigger Window SIMV VC PSV E SIMV PC The following figures show the Paw waveform and flow waveform in the SIMV PC mode Paw Within the trigger Outside of the window trigger window Pinsp Psupp Trigger Level SIMV cycle Trigger Level Lriggered by triggered by pressure pressure Qutside of the trigger window Within the trigger window e Trigger Level triggered by flow Flow no ventilation occurs within the Trigger Window SIMV PC PSV 4 12 4 4 5 3 Start SIMV Mode You can select SIMV VC or SIMV PC as required To start SIMV VC do as follows 1 Select the Vent Mode shortcut key to open the Vent Mode Setup menu 2 Select SIMV VC gt gt in the Vent Mode Setup menu 3 Select Ok directly in the SIMV VC Setup menu Or you can set Trigger Level and PSV Insp Termination Level before selecting Ok After Ok is selected the shortcut key the first key from the left in the parameter setup shortcut keys area 1s highlighted 4 Make sure that TV is appropriately set for the patient Push the control knob to confirm the setting so as to start SIMV VC mode NOTE eo You can not set Trigger Window when entering the SIMV VC gt gt menu for the first time e When it is necessary to switch over to SIMV VC mode confirm the setting of TV first Otherwise the system works in the previous ventilation mode If the
187. tion system CIS do as follows 1 Select the Maintenance shortcut key User Maintenance gt gt Set IP Address gt gt 2 Inthe Set IP Address menu set the correct IP address of the CIS 3 Select Ok to activate the IP address setting FOR YOUR NOTES 3 8 4 Operations and Ventilation Setup NWARNING Before using this anesthesia machine on the patient make sure that the system is correctly connected and in good condition and that all the tests described in 6 Preoperative Test are already completed In case of test failure do not use the system Have a qualified service representative repair the system 4 1 Turn on the System 1 Connect the power cord to the AC power source Make sure that the AC power LED is illuminated 2 Set the system switch to ON Make sure that both the operating state LED and battery LED are illuminated the battery is being charged or fully charged 3 The alarm lamp flashes yellow and red once in turn and then a beep is given 4 The display shows the start up screen and then enters the standby screen after half a minute NWARNING eo Do not use the anesthesia machine if it generates alarms during start up or fails to operate normally Contact your service personnel or us 4 2 Turn off the System To turn off the system do as follows 1 Confirm that system use is finished 2 Set the system switch to OFF NOTE o For the first mechanical ventilation of eac
188. to account for humidity in the patient s breath or Ambient Temperature and Pressure Dry Gas ATPD 1 Access the Gas Module Setup menu and select Humidity Comp 2 Select either Wet for BTPS or Dry for ATPD depending on which compensation applies For CO the humidity compensation can be set to Wet or Dry 1 Dry P mmHg CO vol x P 100 2 Wet P o mmHg CO vol x P 47 100 where partial pressure vol CO concentration P ambient pressure and Foo unit is mmHg For CO2 module humidity compensation is switched on or off based on the actual situations 8 3 2 6 Restore Defaults Select Defaults from the Gas Module Setup gt gt menu Then all the menu options except Working Mode are restored to the factory default configurations 8 5 8 3 2 7 Set CO2 Waveform Select the waveform area to access the waveform setup menu Select Waveform and select CO2 Select Sweep and set waveform sweep speed to an appropriate value The greater the value is the faster the waveform sweeps the wider the waveform is Select Scale and toggle between 40 60 and 80 if the unit is mmHg 9 5 0 7 5 and 10 0 if the unit is or kPa Select to exit the current menu For details about displaying the CO2 waveform refer to 5 3 3 2Display CO2 Waveform 8 3 3 Measurement Limitations Measurement accuracy may degrade due to Leakage or internal leakage of t
189. tor the state of the brain by data acquisition of EEG signals The BIS a processed EEG variable may be used as an aid in monitoring the effects of certain anesthetic agents Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall during general anesthesia or sedation The BISx equipment must be used under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use The measurement provides 1 BIS EEG and BIS Trend waveforms 2 Measured parameters BIS SQI EMG SR SEF and TP 10 2 Identify the BIS Module BIS BIS setup key Baa Check sensor key gt Y Indicator BIS BIS cable connector A O TORRE R ERROR TE 10 1 10 3 Safety Information For patients with neurological disorders patients taking psychoactive medication and children under one year of age BIS values should be interpreted cautiously N WARNING The conductive parts of sensors and connectors should not come into contact with other conductive parts including earth To reduce the hazard of burns in the high frequency surgical neutral electrode connection the BIS sensor should not be located between the surgical site and the electro surgical unit return electrode The BIS sensor must not be located between defibrillator pads when a defibrillator is used on a patient
190. turn port to the AGSS Upward Pop off valve 1 5 ce VGA connector O supply connector 280 600kPa Table top light A y AGSS outlet AGSS NY PEEP outlet European community representative CAUTION HOT Lock or unlock as the arrow shows Unlock the lifting device Do Not Crush Please align CE marking gt Cylinder ce Manufacture date 10 Manufacturer Serial number APL valve Maximum level of the sodalime canister AS Lock the lifting device 11 3kg MAX Max weight 11 3 kg 30kg MAX Max weight 30 kg Type BF applied part The anesthesia machine Defibrillation proof protection AlR DRIVE is driven by Air against electric shock wo The following definition of the WEEE label applies to EU member states only This symbol indicates that this product should not be treated as household waste By ensuring that this product is disposed of correctly you will help prevent bringing potential negative consequences to the environment and human health For more detailed information with regard to returning and recycling this product please consult the distributor from whom you purchased it For system products this label may be attached to the main unit only 1 6 2 The Basics 2 1 System Description 2 1 1 Intended Use The anesthesia machine is intended to provide breathing anesthesia for adult pediatric and infant patients during surgery
191. ucts connected to this system must be certified passing the specified IEC standards such as IEC 60950 for data processing equipment and IEC 60601 1 for medical electrical equipment All configurations shall comply with the valid version of IEC 60601 1 1 The personnel who are responsible for connecting the optional equipment to the I O signal port shall be responsible for medical system configuration and system compliance with IEC 60601 1 1 as well 2 11 2 3 Batteries NOTE o Use batteries at least once every month to extend their life Charge the batteries before their capacities are worn out o Inspect and replace batteries regularly Battery life depends on how frequent and how long it is used For a properly maintained and stored lithium battery its life expectancy is approximately 3 years For more aggressive use models life expectancy can be shortened We recommend replacing lithium batteries every 3 years o The operating time of a battery depends on equipment configuration and operation For example starting module monitoring frequently will shorten the operating time of the batteries o Incase of battery failure contact us or have your service personnel replace it Do not replace the battery without permission The anesthesia machine is designed to operate on battery power whenever AC power becomes interrupted When the anesthesia machine is connected to the AC power source the batteries are charged regardless of
192. uitable for use in the specified electromagnetic environment The customer or the user of the anesthesia machine should assure that it is used in such an environment as described below Emissions test Radio frequency RF emissions CISPR 11 Radio frequency RF emissions CISPR 11 Harmonic emissions EC60601 1 2 2001 A 1 2004 EN 61000 3 2 2000 Voltage fluctuations flicker emissions IEC 60601 1 2 2001 A1 EN 61000 3 3 1995 A 1 2001 2004 Compliance Electromagnetic environment guidance The anesthesia machine uses RF energy only for 1ts internal function Therefore 1ts RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The anesthesia machine is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Guidance and Declaration Electromagnetic Immunity The anesthesia machine is suitable for use in the specified electromagnetic environment The customer or the user of the anesthesia machine should assure that it is used in such an environment as described below Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst EFT IEC 61000 4 4 Surge IEC 61000 4 5 IEC60601 test level 6 kV contact 8 kV air 2 kV for power supply lines
193. ump CO2 Replace M Sensor CO2 15V e BIS BIS Init Error Init Error Module malfunction or communication failure between module BIS Selftest Error e the module and main unit Re plug the module restart the BIS Comm Stop Fal machine or plug the module onto other main unit BIS Comm Error ER BIS ALM LMT M The alarm limits are changes accidentally Contact your ERR service personnel D 12 BIS Overrange H The measured value is outside of the measurement range SQI Overrange JH Contact your service personnel Rovere BIS High Imped M Check sensor connections Re connect the sensor BIS DSC Error BIS DSC signal reception error Check the DSC BIS DSC Malf a ee BIS DSC switched off due to malfunction Check the DSC BIS No BIS No Cable Connect Connect the BIS cable BIS cable BIS No Sensor penosa Some Connect the sensor BIS Wrong Sensor Check or replace the sensor oe SQIKS0 L SQL is too low Check the patient s condition and sensor SQIK15 A connection BIS Sensor Expired Replace the sensor BIS Sensor Failure M Put the sensor again or replace the sensor BIS Sensor Too L Replace the sensor Many Uses Disconnect Reconn H Re plug the BIS module ect BIS D 13 FOR YOUR NOTES E Symbols and Abbreviations E 1 Symbols a eB decide fe lem OOCOCOSOSOSOCOCCCS hPa hPa E 1 z o o pe poo fewe CE IE C S fas SOS fe Jesmo SSS f PUTA toria fe Jorm SSCS
194. ury to the patient In addition the ventilator has a built in pressure safety valve 12 which opens when the inspiratory pressure exceeds approximately 100 cmH O 10 kPa to avoid sustained airway pressure A 2 Electrical System Structure A 2 1 Electrical Block Diagram Eire A 2 2 Parts List AC mains filter 2 Electrical outlet 3 2 Fuse 1 4 Isolation transformer board 7 AC conversion board Fuse 2 Power board Battery assembly System switch Fan for the power board o Power signal conversion board Rotary encoder Speaker Membrane keyboard l l l 12 Alarm lamp board l 14 l l Key control board l 0 1 3 5 6 7 Invertor board TFT display Network interface board ETE rote gina 2 Power supply conversion board of the anesthesia information system Anesthesia information system PEEP valve inspiratory valve safety valve Monitoring valve engine board 3 Monitored signal detection board and auxiliary monitor board Three way valve for pneumatic circuit block VTPLUS Switch signal Bag mechanical ventilation switch O supply pressure switch 0 l 3 5 6 7 8 9 0 3 5 6 7 FOR YOUR NOTES A 6 B Product Specifications The anesthesia machine is integrated with pressure restriction device expiratory volume monitor breathing system with alarm system pressure measurement device anesthetic ventilation system AGSS transfer and receiving system anesthetic gas d
195. ush and turn the concentration control to set the concentration of anesthetic agent B Locking lever Turn the locking lever clockwise to lock the vaporizer in position Gas supply connector s 0 N20 and AIR connectors are provided System switch B PA Set the switch to the position to enable gas flow and to turn on the system Set the switch to the O position to disable gas flow and to turn off the system Cylinder pressure gauge s High pressure pressure gauge s that displays cylinder pressure before relief O flush button Push to supply high flows of O to the breathing system Auxiliary electrical outlet Three auxiliary electrical outlets are provided when the anesthesia machine is configured with an isolation transformer Drawer lock Worktable with drawer Breathing system j D gt y S C ya E 9 5 SS oe ae E 10 La 12 13 O sensor connector Inspiration connector Expiration connector Inspiratory check valve Expiratory check valve Bellows housing Sample gas return port to the AGSS Manual bag port Bag mechanical ventilation switch Select the e position to use bag for manual ventilation Select the position to use ventilator for mechanical ventilation APL airway pressure limit valve Adjusts breathing system pressure limit during manual ventilation The scale shows approximate pressures Above 30
196. witch to the position Set the flow controls to mid range Make sure that all pipeline pressure gauges show 280 to 600 kPa Disconnect the O supply As O pressure decreases alarms for O2 Supply Failure and Drive Gas Pressure Low should occur Make sure that the O gauge goes to zero 6 4 2 N20 Pipeline Test Connect an O supply before doing the N20 pipeline test For details refer to 6 4 102 Pipeline Test NOTE When doing the N20 pipeline test connect O supply first to enable N20 flow control o Different from O pipeline supply when N20 supply is disconnected no alarms related to N20 pressure occur as N20 pressure decreases 6 4 3 Air Pipeline Test For details about Air pipeline test refer to 6 4 102 Pipeline Test NOTE o Different from 02 pipeline supply when Air supply is disconnected no alarms related to Air pressure occur as Air pressure decreases 6 5 Cylinder Tests You do not need to perform cylinder tests if the anesthesia machine is not equipped with cylinders 6 5 1 Check the Cylinder in Full Status o l Set the system switch to the O position and connect the cylinders to be checked 2 Open each cylinder valve 3 Make sure that each cylinder has sufficient pressure If not close the applicable cylinder valve and install a full cylinder 4 Close all cylinder valves 6 5 2 O2 Cylinder High Pressure Leak Test a A A A ae o Set the system switch to the O posit
197. y PSV Insp Termination Level In the SIMV VC mode select the Vent Mode shortcut key SIMV VC gt gt gt PSV Insp Termination Level Or in the SIMV PC mode select the Vent Mode shortcut key gt SIMV PC gt gt PSV Insp Termination Level Or in the PSV mode select the Vent Mode shortcut key PSV gt gt PSV Insp Termination Level Push the control knob and turn it to set PSV Insp Termination Level to the appropriate value Push the control knob to confirm the setting Select Ok to activate the current setting To cancel the current setting and exit the current menu select Cancel x or push the Normal Screen key 4 16 4 4 5 6 Parameter Range and Default Value in SIMV Mode 20 to 100 ml 5 ml SIMV VC TV TV 20 to 1500 ml 100 to 300 ml 10 ml 300 to 1500 ml 25 ml 21060 BPM 1 BPM SIMV VC 20 to 85 L min 1 L min 10 to 100 emH20 1 emH20 30 cmH20 5 to60cmH20 Temo 15 cmH20 OFF 4 to 30 PEEP 1 cmH20 OFF cmH20 Trigger Window 5 to 90 5 Trigger 20 to 1 cmH20 1 cmH2O 2 cmH20 PSV Insp Ae 5 to 60 5 25 Termination Level 4 4 6 Pressure Support Ventilation PSV 4 4 6 1 Description Pressure support ventilation hereinafter referred to as PCV mode is an auxiliary breathing mode which needs patient s spontaneous breathing to trigger mechanical ventilation When the patient s spontaneous inspiration reaches the preset Trigger Level the ventilator beg
198. y control board 1s notified to zero Use manual ventilation mode to help the patient breathe Contact your service personnel Ventilator Comm H The ventilator module failed to communicate with the Error main system Contact your service personnel Ventilator Comm The ventilator module failed to communicate with the Stop main system normally Unreliable monitoring Use manual ventilation mode to help the patient breathe Contact your service personnel D 5 Low Drive Gas Pressure H The pressure of drive gas is low Unreliable monitoring Use manual ventilation mode to help the patient breathe Contact your service personnel manual ventilation mode to help the patient breathe Make 02 Supply Failure H The O pressure is low If Air supply is connected use sure that O supply with sufficient pressure is connected H Sustained Airway The Paw in the breathing system is greater than sustained Pressure airway pressure alarm limit for 15 seconds Check if the tubes are bent blocked or broken Paw lt 10 cmH2O H Paw is less than 10 cmH O Check if the patient is breathing spontaneously Increase fresh gas flow Check if there is high flow gas flowing through the AGSS If yes check the negative pressure relief valve on the receiver ACGO On ACGO 1s switched on Switch off ACGO PEEP Valve Failure M PEEP valve connection or control failure Use manual ventilation mode to help th

Mindray Wato EX-65 Anaesthesia Machine

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