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I

CE Marking

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.

Revision number:

1.0

Release

time:

200

9

-1

© Copyright 200

9

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.

WARNING

z

Federal Law (USA) restricts this device to sale by or on the order of a physician.

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Summary of Contents for WATO EX-65

Page 1: ...WATO EX 65 Anesthesia Machine Operator s Manual ...

Page 2: ......

Page 3: ...N60601 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 Revision number 1 0 Release time 2009 1 Copyright ...

Page 4: ...e 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 and WATO are the registered trademarks or trademarks owned by Mindray in China and other countries All...

Page 5: ...with the instructions for use Warranty This warranty is exclusive 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 f...

Page 6: ...olicy The customer is responsible for freight charges when this product is shipped to Mindray for service this includes customs charges 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 Keji 12th Road South Hi tech Industrial Park Na...

Page 7: ...tegral 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 in this manual serve as exa...

Page 8: ...VI FOR YOUR NOTES ...

Page 9: ...rol 3 1 3 2 Display Screen 3 3 3 3 Basic Settings 3 5 3 3 1 Adjust Screen Brightness 3 5 3 3 2 Adjust Sound Volume 3 5 3 3 3 Set System Time 3 6 3 3 4 Set Language 3 6 3 3 5 Set Unit 3 6 3 3 6 Restore Default Configurations 3 6 3 3 7 Set the IP Address of Anesthesia Information System CIS 3 7 4 Operations and Ventilation Setup 4 1 4 1 Turn on the System 4 1 4 2 Turn off the System 4 1 4 3 Input Fr...

Page 10: ...g 5 5 5 3 2 Anesthetic Agent AA Concentration Monitoring 5 7 5 3 3 CO2 Concentration Monitoring 5 8 5 3 4 Pressure Monitoring 5 9 5 3 5 Tidal Volume Monitoring 5 10 5 3 6 Tidal Volume Compensation 5 12 5 3 7 Volume Monitoring 5 13 5 3 8 Breath Rate Monitoring 5 13 5 3 9 BIS Monitoring 5 14 5 4 Display Electronic Flowmeter 5 16 5 5 Spirometry Loop 5 16 6 Preoperative Test 6 1 6 1 Preoperative Test ...

Page 11: ... Alarm 6 15 6 9 8 Test the AG Module Alarm 6 15 6 10 Preoperative Preparations 6 15 6 11 Inspect the AGSS 6 16 7 User Maintenance 7 1 7 1 Repair Policy 7 1 7 2 Maintenance Schedule 7 2 7 3 Breathing System Maintenance 7 3 7 4 Flow Sensor Calibration 7 3 7 5 O2 Sensor Calibration 7 5 7 5 1 21 O2 Calibration 7 5 7 5 2 100 O2 Calibration 7 6 7 6 Water Build up in the Flow Sensor 7 7 7 6 1 Prevent Wat...

Page 12: ...n 9 1 9 2 Understand MAC Values 9 2 9 3 Identify AG Modules 9 3 9 4 Prepare to Measure AG 9 3 9 5 Make AG Settings 9 5 9 5 1 Set Anesthetic Agent 9 5 9 5 2 Set Pump Rate 9 5 9 5 3 Set O2 Compensation 9 5 9 5 4 Set Working Mode 9 5 9 5 5 Set CO2 Unit 9 6 9 5 6 Restore Defaults 9 6 9 5 7 Set CO2 Waveform 9 6 9 6 Change Anesthetic Agent 9 6 9 7 Measurement Limitations 9 7 9 8 Troubleshooting 9 7 9 9 ...

Page 13: ...IS Alarm Limits 11 5 11 5 Set Alarm Level 11 5 11 6 Set Cardiopulmonary Bypass CPB Alarm 11 5 11 7 Set MV TVe Alarm 11 6 11 8 Set Apnea Alarm 11 6 11 9 Alarm Silence 11 7 11 9 1 Set 120 s Alarm Silence 11 7 11 9 2 Cancel 120 s Alarm Silence 11 7 11 10 When an Alarm Occurs 11 7 12 Trend and Logbook 12 1 12 1 Trend Graph 12 1 12 2 Trend Table 12 2 12 3 Alarm Logbook 12 3 13 Installations and Connect...

Page 14: ...e Gas Disposal System 13 37 14 Cleaning and Disinfection 14 1 14 1 Clean and Disinfect the Anesthesia Machine Housing 14 2 14 2 Disassemble the Breathing System Cleanable Parts 14 2 14 2 1 O2 Sensor 14 3 14 2 2 Manual Bag 14 4 14 2 3 Breathing Tubes 14 5 14 2 4 Airway Pressure Gauge 14 6 14 2 5 Bag Arm 14 6 14 2 6 Bellows Assembly 14 7 14 2 7 Flow Sensor 14 8 14 2 8 Expiratory Check Valve Assembly...

Page 15: ... Pneumatic Circuit System Specifications B 4 B 6 Breathing System Specifications B 5 B 7 Ventilator Specifications B 7 B 8 Ventilator Accuracy B 9 B 9 Anesthetic vaporizer B 10 B 10 AGSS Transfer and Receiving System Specifications B 10 B 11 O2 Sensor Specifications B 11 B 12 CO2 Module Specifications B 14 B 13 AG Module Specifications B 17 B 14 BIS Module Specifications B 21 C EMC C 1 D Alarm Mes...

Page 16: ...8 FOR YOUR NOTES ...

Page 17: ...s a potential hazard or unsafe practice that if not avoided could result in death or serious injury CAUTION z Indicates a potential hazard or unsafe practice that if not avoided could result in minor personal injury or product property damage NOTE z Provides application tips or other useful information to ensure that you get the most from your product ...

Page 18: ...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 z The physiological parameters and alarm messages displayed on the scre...

Page 19: ... requirements Mobile phone X ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation z 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 fiel...

Page 20: ...ntrols z Keep this manual close to the equipment so that it can be obtained conveniently when needed z The software was developed in compliance with IEC 60601 1 4 The possibility of hazards arising from software errors is minimized z This manual describes all features and options Your equipment may not have all of them ...

Page 21: ...al description Not autoclavable Power On Power Off Reset Standby Alarm silence key MV TVe alarm key Normal screen key O2 flush button ACGO On ACGO Off Bag position manual ventilation Mechanical ventilation Lock Unlock Network connector Flow control USB connector O2 sensor connector Air supply connector N2O supply connector Upward Pop off valve Sample gas return port to the AGSS ...

Page 22: ...CE marking Type BF applied part Defibrillation proof protection against electric shock The anesthesia machine is driven by Air 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 consequence...

Page 23: ...sonnel who have received adequate training in its use WARNING z 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 z 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 w...

Page 24: ...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 anesthesia information system CIS The anesthesia machine features the following Automatic leak detection Breathing system gas leak compensation and automatic compliance compensation Cylinder and pipeline c...

Page 25: ...2 3 2 2 Equipment Appearance 2 2 1 Front View Display and control panel ...

Page 26: ...the concentration control to set the concentration of anesthetic agent B Locking lever Turn the locking lever clockwise to lock the vaporizer in position 10 Gas supply connector s O2 N2O and AIR connectors are provided 11 System switch Set the switch to the position to enable gas flow and to turn on the system Set the switch to the position to disable gas flow and to turn off the system 12 Cylinde...

Page 27: ...2 5 Breathing system ...

Page 28: ... ventilation Select the position to use ventilator for mechanical ventilation 10 APL airway pressure limit valve Adjusts breathing system pressure limit during manual ventilation The scale shows approximate pressures Above 30 cmH2O you will feel clicks as the v turns Turn clockwise to increase 11 O2 sensor connector 12 Rotary handle 13 Sodalime canister The sodalime inside the canister absorbs the...

Page 29: ...2 7 2 2 2 Rear View Power supply ...

Page 30: ...cted manual breathing system through the ACGO outlet and the technical alarm of ACGO On is triggered The system monitors airway pressure and O2 concentration instead of volume Set the switch to the position to apply mechanical or manual ventilation to the patient through the breathing system 10 Module slot CO2 AG and BIS modules mentioned in this manual can be inserted into the slot and identified...

Page 31: ...2 9 Anesthesia information system CIS ...

Page 32: ...nfigured with anesthesia information system CIS 1 Display 2 Rail 3 Mounting bracket 4 Keyboard 5 CIS main unit A Reset key Press to restart the CIS B CIS switch Press to switch on off the CIS C USB connector D Network connector E Electrical outlet F Display connector A B C C D E F ...

Page 33: ...e 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...

Page 34: ...r AC power becomes interrupted When the anesthesia machine is connected to the AC power source the batteries are charged regardless of 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 auto...

Page 35: ...owly 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 through the menu options or change your settings ...

Page 36: ...ar alarm silence push this key again 8 Operating state LED On when the anesthesia machine is operating Off when the anesthesia machine is turned off 9 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 10 Battery LED On when the anesthesia machine is equipped with batteries and is connected to the ...

Page 37: ...refer to5 User Interface and Parameter Monitoring 1 Ventilation mode prompt area Displays the current ventilation mode If manual ventilation is selected for the bag mechanical ventilation switch 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 is displa...

Page 38: ...10 Vent Mode shortcut key Used to select mechanical ventilation mode 11 Alarm Setup shortcut key Used to change the alarm settings for the anesthetic ventilator gas modules or BIS module 12 Screens shortcut key Used to set user screen 13 User Setup shortcut key Used to change the settings for TV compensation O2 monitoring source gas module BIS module screen sound etc 14 Maintenance shortcut key Us...

Page 39: ...ect the User Setup shortcut key and select Screen and Audio Setup 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 machine 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 Setu...

Page 40: ...elect Language and select the desired language 3 Restart the anesthesia machine to activate the language setting 3 3 5 Set Unit 1 Select the Maintenance shortcut key and select User Maintenance 2 Select Paw Unit and toggle between cmH2O hPa and mbar If the anesthesia machine is configured with CO2 or AG module you can set the display units of FiCO2 and EtCO2 For details refer to 8 CO2 Monitoring 3...

Page 41: ... 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 7 Set the IP Address of Anesthesia Inf...

Page 42: ...3 8 FOR YOUR NOTES ...

Page 43: ...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 WARNING z 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...

Page 44: ...2 flow control clockwise to decrease the O2 flow to some extent Then continuing turning the O2 flow control will cause the N2O flow control to turn clockwise together to decrease the N2O flow keeping the O2 concentration in the mixed gas above 25 NOTE z This anesthesia machine can be used alone as a ventilator You can adjust O2 concentration in the breathing system through the O2 flow control z Th...

Page 45: ...ent to be used and then fill the vaporizer For details refer to 13 4 2 Fill the Vaporizer 2 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 z Inspect t...

Page 46: ...entilation mode Besides the system prompt message area displays Manual Vent 3 Push the O2 flush button to inflate the bag if 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 ...

Page 47: ...disabled 4 4 3 Volume Control Ventilation VCV 4 4 3 1 Description Volume control ventilation hereinafter referred to as VCV mode is 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 ...

Page 48: ...cts 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 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 ...

Page 49: ...automatically switched over to the parameter setup area in this mode The following figure shows all related parameters to be set in VCV mode 1 TV Tidal volume 2 Rate Breath rate 3 I E 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 Mod...

Page 50: ... PEEP OFF 4 to 30 cmH2O 1 cmH2O OFF 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...

Page 51: ... key to open the Vent Mode Setup menu 2 Select PCV in the Vent Mode Setup menu 3 After confirming the selection the Pinsp 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 PCV mode NOTE z When it is necessary to switch over to PCV m...

Page 52: ...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 example 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 paramet...

Page 53: ...e and inspiratory 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 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 ventilat...

Page 54: ... Waveforms SIMV VC The following figures show the Paw waveform and flow waveform in the SIMV VC mode SIMV VC PSV SIMV PC The following figures show the Paw waveform and flow waveform in the SIMV PC mode SIMV PC PSV ...

Page 55: ...in the previous ventilation mode If the 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 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 selecti...

Page 56: ...which is TV for SIMV VC and Pinsp for SIMV PC Parameter setup shortcut keys in SIMV VC mode 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 Parameter setup shortcut keys in SIMV PC mode 1 Pinsp Pressure control level of inspiration 2 SIMV Rate...

Page 57: ...l knob to confirm the setting 4 Set other parameters in this mode in the similar way NOTE z If the parameter value is adjusted outside of the range the system prompt message area displays Parameter Settings Outside the Safety Range z 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...

Page 58: ... current setting and exit the current menu select Cancel or push the Normal Screen key PSV Insp Termination Level 1 In the SIMV VC mode select the Vent Mode shortcut key SIMV VC PSV Insp Termination Level Or in the SIMV PC mode select the Vent Mode shortcut key SIMV PC PSV Insp Termination Level Or in the PSV mode select the Vent Mode shortcut key PSV PSV Insp Termination Level 2 Push the control ...

Page 59: ...tient s spontaneous breathing to trigger mechanical ventilation When the patient s spontaneous inspiration reaches the preset Trigger Level the ventilator begins 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 Terminat...

Page 60: ...cut key and then PSV 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 contr...

Page 61: ... 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 Psup...

Page 62: ...el 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 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 ...

Page 63: ... Active 5 to 30 s 5 s 30 s Pressure 20 to 1 cmH2O 1 cmH2O 2 cmH2O Trigger Level Flow 0 5 to 15 L min 0 5 L min 3 L min PSV Insp Termination Level 5 to 60 5 25 PSV 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 on the panel and then selecting Ok from the pop up menu to exit the standby s...

Page 64: ... the timer setup shortcut key and then Stop The timer setup shortcut key displays the time when timing stops NOTE z 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 z In timing s...

Page 65: ... 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 2 Set the bag mechanical ventilation switch to the position This selects manual ventilation and stops mechanical ventilation ventilator ...

Page 66: ...4 24 FOR YOUR NOTES ...

Page 67: ... numerics screen Measured values screen The standby screen is switched over through the Standby key on the panel You can easily switch between the other three types of screen by using the Screens shortcut key NOTE z This manual describes all functions and modules Some of the operations may be inapplicable to your equipment z All illustrations in this manual serve as examples only They may not nece...

Page 68: ...he following figure shows the standby screen In standby status the following changes occur to the system Displaying monitored parameters and waveforms is disabled The system is in standby status The ventilator stops supplying gases The parameters can be set When the standby status exits the system will operate based on the final settings in standby status Physiological alarms are cleared automatic...

Page 69: ...ator parameters The following parameters may be displayed simultaneously depending on the configurations of gas module and BIS module CO2 parameters AG parameters BIS parameters 2 Graph information displayed includes Spirometry loops 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 combinati...

Page 70: ...ng area 5 1 3 1 Parameter graph Area This area may display CO2 parameters AG parameters BIS parameters 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 When screen layout is set to big numerics this area is displayed as shown below ...

Page 71: ...e is configured with an O2 sensor select Maintenance User Maintenance Set O2 Sensor Monitoring Then select ON from the pop up menu to monitor the patient s FiO2 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 O2 Sensor or O2 Module 1 Select the User S...

Page 72: ...e O2 sensor calibration FiO2 alarm limit setting and alarm related to FiO2 and O2 sensor are all disabled z 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 monitor...

Page 73: ...tration 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 FiN2O Fraction of inspired nitrous oxide EtN2O End tidal nitrous oxide FiEnf Fraction of inspired enflurane displaying the concentration of the actually selected anesthetic agent EtEnf End tidal enflurane displaying the concentration of the act...

Page 74: ...hesia 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 FiO2 Fraction of inspired oxygen EtCO2 End tidal carbon...

Page 75: ... use a qualified monitor for CO2 concentration monitoring 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 Ppeak Peak pressure Pplat Plateau pressure PEEP Positive end expiratory pressure 5 3 4 2 Display Paw Waveform 5 3 4 3 Set Paw Waveform 1 Select the Paw waveform area to access the Paw Waveform Setup...

Page 76: ... Tidal Volume Monitoring NOTE z 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 z As required by the relevant international rules and regulations tidal volume monitoring needs to be performed when the anesthesia machine is used on the patient If your anesthesia machine is not configu...

Page 77: ... 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 3...

Page 78: ...d 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 curren...

Page 79: ...cale and toggle between 500 1000 and 1500 The volume ranges corresponding to the waveform scales are 500 0 to 500 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 Ventil...

Page 80: ...n below BIS Bispectral index SQI Signal quality index EMG Electromyograph If your anesthesia machine is 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 ...

Page 81: ...veform 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 F...

Page 82: ...pirometry 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 br...

Page 83: ...he system Alarm tests Power failure alarm test Breathing system tests O2 Flush Test Preoperative preparations Inspect the AGSS Before each patient NOTE z Read and understand the operation and maintenance of each component before using the anesthesia machine z Do not use the anesthesia machine if a test failure occurs Contact us immediately z A checklist of the anesthetic system should be provided ...

Page 84: ...t for airway maintenance and tracheal intubation is available and in good condition 9 Applicable anesthetic and emergency drugs are available 10 The casters are not damaged or loose and the brake s is set and prevents movement 11 Make sure the breathing system is locked in the position 12 The AC mains indicator and the battery indicator come on when the power cord is connected to the AC power sour...

Page 85: ...upplies could be depleted leaving an insufficient reserve supply in case of pipeline failure 6 4 1 O2 Pipeline Test 1 Close all cylinder valves and connect an O2 supply if the anesthesia machine is equipped with cylinders 2 Set the system switch to the position 3 Set the flow controls to mid range 4 Make sure that all pipeline pressure gauges show 280 to 600 kPa 5 Disconnect the O2 supply 6 As O2 ...

Page 86: ...ipeline test refer to 6 4 1O2 Pipeline Test NOTE z Different from O2 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 1 Set the system switch to the position and connect the cyl...

Page 87: ...linder 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 N2O 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 WARNING z Sufficient O2 in the fresh gas may not prevent hypoxic mixtures in the breathing system z If N2O is available...

Page 88: ...to minimum 6 Test the O2 N2O Link system with flow increasing Turn the N2O and O2 flow controls fully clockwise minimum flow Then turn the N2O flow control counterclockwise and set the N2O flow control to the rates shown in the table The O2 flow must meet the requirement listed in the following table Step N2O flow L min O2 flow L min 1 0 6 0 2 2 1 5 0 5 3 3 0 1 0 4 7 5 2 5 7 Test the O2 N2O Link s...

Page 89: ...s flows to minimum Steps 6 and 7 are only for systems with N2O WARNING z During steps 6 and 7 the O2 sensor used must be correctly calibrated and the Link system should be kept engaged z Adjust only the test control N2O in step 6 and O2 in step 7 z Test the flows in sequence N2O then O2 6 Test the O2 N2O Link system with flow increasing Turn the N2O and O2 flow controls fully clockwise minimum flo...

Page 90: ... agent comes out of the fresh gas outlet Use a safe and approved procedure to remove and collect the agent z 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 1 Connect the O2 pipeline supply or open th...

Page 91: ...d and not damaged 2 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 1 Set the system to Standby 2 Set the bag mechanical ventilation switch to the mechanical ventilation positio...

Page 92: ...athing 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 is correctly connected and the tubes are not damaged before doing the leak test again 8 Select to exit the current menu NOTE z During the leak test i...

Page 93: ...rsonnel 6 8 4 APL Valve Test 1 Make sure that the system is Standby If not press the key and select Ok from the pop up menu to enter Standby 2 Set the bag mechanical ventilation switch to the bag position 3 Connect the manual bag to the manual bag port 4 Connect the Y piece on the breathing tube to the leak test plug on the manual bag port 5 Turn the APL valve control to let the pressure of APL va...

Page 94: ...entilation switch to the mechanical position 3 Set the system switch to the position 4 Set the system to Standby 5 Set the ventilator controls as follows Ventilation mode select the Vent Mode shortcut key and then VCV TV 500 ml Rate 12 BPM I E 1 2 Plimit 30 cmH2O PEEP OFF 6 Push the O2 flush button to fill the bellows folding bag rising to the top 7 Turn the O2 flow control to set the O2 flow to 0...

Page 95: ...alarm cancels 6 Put the O2 sensor back in the breathing system 7 Select the Alarm Setup shortcut key and then Ventilator Set the FiO2 high alarm limit to 50 8 Connect the manual bag to the manual bag port Push the O2 flush button to fill the manual bag Make sure that the sensor measures approximately 100 O2 9 Make sure that a high FiO2 alarm occurs 10 Set the FiO2 high alarm limit to 100 and make ...

Page 96: ...nual bag port 2 Turn the O2 flow control to set the O2 flow to minimum 3 Turn the APL valve control to set the APL valve to 30 cmH2O position 4 Set the bag mechanical ventilation switch to the bag position 5 Push the O2 flush button for approximately 15 seconds Make sure that the sustained airway pressure alarm occurs 6 Open the patient connection and make sure that the alarm cancels 6 9 6 Test th...

Page 97: ...tup shortcut key and then Gas Module 4 Set the EtAA high alarm limit to be lower than the concentration of the standard gas 5 Make sure that a high EtAA alarm occurs 6 Set the EtAA low alarm limit to be higher than the concentration of the standard gas 7 Make sure that a low EtAA alarm occurs 6 10 Preoperative Preparations 1 Make sure that the ventilator parameters and alarm limits are set to appl...

Page 98: ...float disassemble and assemble the float again or replace the float NOTE z 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 filter may be blocked Check if the filter is blocked as described in 14 2 13 1F...

Page 99: ...presentative 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 z No repair should ever be attempted by anyone not having experience in the repair of d...

Page 100: ...the seal on the vaporizer manifold and that on the breathing system port Contact us for details CO2 module calibration AG module calibration Every three years Replace the built in lithium ion batteries Contact us for details As necessary 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 ...

Page 101: ...is connected to a patient z During calibration do not operate the pneumatic parts Do not move or press the breathing tubes especially z 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 ven...

Page 102: ... 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 10 After a successful calibration the screen shows Calibration Comple...

Page 103: ...ivery in the breathing system Otherwise the measured value may be outside of the stated range z Disassemble 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 z The O2 calibration is not required if no O2 sensor is configured or used 7 5 1 21 O2 Calibration NOTE z Perform O2 calibration when the ...

Page 104: ...screen shows Calibration Completed Otherwise the message Calibration Failure Please try again is displayed In this case you need to do the calibration again 7 Select to exit the current menu 7 5 2 100 O2 Calibration NOTE z If the calibration fails check for technical alarm and troubleshoot it if there is Then do the calibration again z In case of repeated calibration failures replace the O2 sensor...

Page 105: ...nu 12 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...

Page 106: ...at 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 ventilat...

Page 107: ...lug 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 If the pointer goes to zero re install the lens onto the gauge If not replace the airway pressure gauge Zer...

Page 108: ...7 10 7 8 AGSS Transfer Tube Maintenance Check the tube of the AGSS transfer system Replace it if it is damaged ...

Page 109: ...on of CO2 is calculated There are two methods for measuring CO2 in the patient s airway 1 Mainstream measurement Uses a CO2 sensor attached to an airway adapter directly inserted into the patient s breathing system 2 Sidestream microstream measurement Samples expired patient gas at a constant sample flow from the patient s airway and analyzes it with a CO2 sensor built into the CO2 module The meas...

Page 110: ...ainstream CO2 module are shown below from left to right 1 CO2 setup key 2 Measure standby key 3 Gas outlet 4 CO2 watertrap fixer 5 Sampling tube connector 6 CO2 sensor connector If you measure CO2 using AG module refer to 9 AG and O2 Concentration Monitoring 1 2 4 3 5 6 1 1 2 2 3 ...

Page 111: ...ge appears on the screen when the CO2 module is plugged in 3 After start up is finished the message CO2 Warmup is displayed The CO2 module is in ISO accuracy mode If you perform CO2 measurements during warm up the measurement accuracy may be compromised 4 After warm up is finished the CO2 module enters full accuracy mode NOTE z To extend the lifetime of the watertrap and CO2 module disconnect the ...

Page 112: ...n 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 turned on for the first time If the current CO2 module is Standby you must push the key or select the User Setup shortcut key Gas Module Setup Working Mode Measure to start the CO2 module When the anesthesia machine restarts the CO2 module automatically ...

Page 113: ...aturated 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 CO2 the humidity compensation can be set to Wet or Dry 1 Dry 100 2 2 amb co P vol CO mmHg P 2 Wet 100 47 2 2 amb CO P vol CO mmHg P wher...

Page 114: ...aveform 8 3 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 cmH2O 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 wate...

Page 115: ...thing 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 when deemed necessary To manually start a zero calibration enter the Gas Module Set...

Page 116: ...ctor and then connect the CO2 components as shown below 2 By default the microstream 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 you can perform CO2 measurements 8 4 2 Make CO2 Settings By selecting the User Setup shortcut key and then Gas Module Setup you can make CO2 settings described below Sampling tub...

Page 117: ...nit In the Gas Module Setup 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 ...

Page 118: ... 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 40 60 and 80 if the unit is mmHg 5 0 7 5 and 10 0 if the unit is or kPa 5 Select to exit the current men...

Page 119: ...s to the waste gas disposal system depress the metal chip and then plug the exhaust tube to the ports marked sample gas return to the AGSS on the anesthesia machine as shown in the above picture WARNING z 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...

Page 120: ...alibration should be performed once a year or when the measured value has a great deviation 8 4 7 Oridion Information 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 one or more of the following USA patents 4 755 675 5 300 859 5 657 750 5 857 461 and international equivalen...

Page 121: ...s 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 5 Make sure that there are no leakages in the airway and then perform CO2 measurements NOTE z Always position the sensor with the adapter in an upright position to avoid collection of fluids on the windows of...

Page 122: ...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 menu select Unit and toggle between mmHg and kPa 8 5 2 3 Set Gas Compensations WARNING z Make sure that the appropriate compensations are used Inappropriate compensations may cause inaccurate measured values and result in misdiagnosis 1 Access t...

Page 123: ...ighest 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 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 S...

Page 124: ...ear or replace the adapter To zero the sensor do as follows 1 Connect the sensor to the CO2 module 2 Access the Gas Module Setup menu and set Working Mode to Measure The message CO2 Warmup is displayed 3 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 yo...

Page 125: ...ated Oxygen does not absorb IR light as other breathing gases and is therefore measured relying on its paramagnetic properties Inside the O2 sensor are two nitrogen filled glass spheres mounted on a strong rare metal taut band suspension This assembly is suspended in a symmetrical non uniform magnetic field In the presence of paramagnetic oxygen the glass spheres are pushed further away from the s...

Page 126: ...are from ISO 21647 which are published by the U S Food and Drug Administration for a healthy 40 year old male patient z 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 is 1 0 N i i i AgentVol EtAgent MAC Where N stands for the number of all an...

Page 127: ...module is configured with the function of compensating barometric pressure 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 AG setup key Gas outlet AG watertrap fix...

Page 128: ...e and causing an occlusion as a result z 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 z The watertrap has a filter preventing bacterium vapor and patient secretions from entering the module After a long term use dust or other substan...

Page 129: ...tup menu and select O2 Comp The options include OFF when the amount of O2 in the ventilation gas mixture is less than 30 Other options selects an appropriate value according to the amount of O2 in the ventilation gas mixture If the AG module is integrated with O2 module the system calculates compensation directly using the O2 concentration detected by the O2 module In this case O2 Comp is set to O...

Page 130: ...to the faster the waveform sweeps the wider the waveform is 4 Select Scale to change the select CO2 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 to exit the current menu For details about displaying the CO2 waveform refer to 5 3 3 2Display CO2 Waveform 9 6 Change Anesthetic Agent If the anesthetic agent used changes the AG module i...

Page 131: ...chanical shock Cyclic pressure which is greater than 10 kPa 100 cmH2O Other interference source if available 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 occlus...

Page 132: ...e picture WARNING z 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 ...

Page 133: ...n 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...

Page 134: ...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 an...

Page 135: ... is displayed as a flat line and the patient has no electrical brain activity 2 Signal Quality Index SQI 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 0 to15 the numerics cannot be derived 15 to 50 the numerics cannot be reliably derived 50 to 100 the numerics are reliable 3 El...

Page 136: ...ppression 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 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...

Page 137: ...prompt message about this check is given 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 continu...

Page 138: ...mpedances 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 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 in the BIS Module Setup menu The graphic in the...

Page 139: ... impedance is within valid range No action necessary 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 menu and toggle between 10 s 15 s and 30 s The smoothing rate defines how the anesthesia machine averages the BIS value A smalle...

Page 140: ...eps the wider the waveform is 4 Select Scale and set waveform scale to an appropriate value 5 Select Filter and toggle between ON and OFF 6 Select to exit the current menu To set BIS Trend waveform 1 Select the waveform area open the corresponding menu 2 Select BIS Trend for Waveform 3 Select Trend Length and toggle between 6 min 12 min 30 min and 60 min 4 Select to exit the current menu For detai...

Page 141: ...alarms fall into three categories physiological alarms technical alarms and prompt messages 1 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 2 Technical alarms Technical alarms also calle...

Page 142: ... 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 numeri...

Page 143: ...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 High level alarms Medium level alarms 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 ...

Page 144: ...nce 11 4 Set Alarm Limits NOTE z An alarm is triggered when the parameter value is higher than the High Limit or lower than the Low Limit z 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 2 Set High Limit and Low Lim...

Page 145: ... or AG alarm level toggles between High and Med To set the alarm level for BIS select the Alarm Setup shortcut key BIS Module Alarm Level The BIS alarm level toggles between High Med and Low NOTE z For this anesthesia machine only alarm levels for the parameters related to CO2 AG or BIS module can be set Alarm level for other parameters is factory configured 11 6 Set Cardiopulmonary Bypass CPB Ala...

Page 146: ...TVe alarm key when MV TVe alarm is turned on The message MV TVe Alarm Off is prompted and the icon is displayed on the screen 2 Push the MV TVe alarm key again and the message MV TVe Alarm On is prompted WARNING z MV TVe alarm is not triggered when MV TVe alarm is turned off Exert care when using MV TVe alarm 11 8 Set Apnea Alarm In non mechanical ventilation mode 1 Push the MV TVe alarm key when ...

Page 147: ...alarm of O2 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 O2 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...

Page 148: ...11 8 FOR YOUR NOTES ...

Page 149: ... axis B Parameter value C Parameter combo box D X axis E Trend graph F Cursor G Cursor time To select the parameter for recall highlight the parameter combo box Push the control knob to select the desired parameter from TVe MV Ppeak FiO2 and EtCO2 Select or 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 Select or on ...

Page 150: ...a maximum of 24 hour operating time When the anesthesia machine is restarted the trend table is recorded anew Select the Maintenance shortcut key Trend and Logbook Trend Table to access the window as shown below Select Resolution and toggle between 30 s 1 min 5 min and 30 min to view the trend table To browse the trend table Select Left or Right to scroll left or right to view more measured values...

Page 151: ...y Trend and Logbook Alarm Logbook The alarm logbook records all physiological alarm messages which are arranged in chronological order The latest event is placed at the foremost In the Alarm Logbook window you can 1 Select Prev or Next to review the previous or next item 2 Move the cursor to the position Push the knob and enter the number of alarm message you want to review NOTE z The stored alarm...

Page 152: ...12 4 FOR YOUR NOTES ...

Page 153: ...ll life support and monitoring equipment z Do not use antistatic or conductive masks or breathing tubes They can cause burns if they are used near high frequency electrosurgical equipment z This equipment must be installed by the factory authorized engineer z This anesthesia machine has waste gas exhaust ports The operator of the machine should pay attention to the disposal of the residual breathi...

Page 154: ...13 2 13 1 1 Breathing System Diagrams 14 15 16 17 18 19 20 21 22 1 2 3 4 5 6 7 8 9 10 11 12 13 ...

Page 155: ...Locking catch retainer 8 Rotary handle 19 Pressure sampling connector s 9 Sodalime canister 20 APL valve gas outlet 10 Airway pressure gauge 21 Fresh gas inlet 11 Leak test plug 22 ACGO connector 13 1 2 Circuit Adapter Diagram 1 Bag mechanical ventilation linked switch 7 Locking catch 2 Pressure sampling connector s 8 ACGO connector 3 Heating module 9 Fresh gas inlet 4 Drive gas connector 10 APL v...

Page 156: ...hanging heavy objects onto it z 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 position 2 Align the guide pin holes on the circuit block with the matching guide pins on the circuit adapter ...

Page 157: ...on and make sure that the breathing system is safely locked WARNING z Set the locking catches to the 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 use which can cause serious fresh gas leak and inaccurate tidal volume measurement ...

Page 158: ... 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 ...

Page 159: ...kwise 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 is tightly connected to the base Folding bag Bellows base Seal ...

Page 160: ...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 z 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 ...

Page 161: ...rection of arrow on the flow sensor is same to that on the breathing system and the side with silkscreen is facing upward 2 Insert the flow sensor horizontally 3 Align the inspiration expiration connectors and their locking nuts with the flow sensor connectors ...

Page 162: ...n 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 WARNING z Before installing the O2 sensor check that the seal on the sensor is in good condition If no seal is installed or the seal is damaged replace the O2 sensor z When installing the O2 sensor turn it tightly to avoid breathing system...

Page 163: ...11 1 Align the threads of the O2 sensor with the O2 sensor connector marked on the breathing system and turn the sensor clockwise to tighten it 2 Insert one end of the O2 sensor cable into the sensor jack ...

Page 164: ... eye contact immediately rinse the affected area with water and seek medical assistance z Changing the sodalime during ventilation may result in breathing system leakage if the anesthesia machine does not have BYPASS function z 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 ...

Page 165: ...wise the sodalime powder built up inside the sodalime canister will go into the breathing system z Clean the mouth of the sodalime canister regularly Sodalime particles sticking on the mouth may cause breathing system leak z 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 NO...

Page 166: ...er 1 The following figures show the components of a sodalime canister A Sodalime B Canister support C Sodalime canister D Canister handle E Canister support buckle Press the buckle as shown in the figure to remove the canister support E B C D A ...

Page 167: ...nister mouth canister support and seal for sodalime particles If there is please clear it 3 Align the sodalime canister with the mounting slot 4 Push the sodalime canister into the mounting slot Canister support Canister seal Canister mouth Canister mounting slot ...

Page 168: ...13 16 5 Turn the rotary handle clockwise for 90 degrees 6 Let the rotary handle fall to lock the sodalime canister ...

Page 169: ...ime z 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 z TM Medisorb sodalime is recommended 1 Disassemble the sodalime canister by referring to 13 1 8 1Assemble the Sodalime Canister in the reverse order 2 Pour out the sodalime which has c...

Page 170: ...r support buckle to lock the canister 6 Assemble the sodalime canister WARNING z Do not reuse the sodalime canister sponge which must be replaced every time the sodalime canister is replaced z The sodalime canister sponge must be in place to prevent dust and particles from entering the breathing system z When re installing the sodalime canister after changing the sodalime make sure that the canist...

Page 171: ...the tube to prevent damage of the tube z Do not reuse the filter to prevent cross contamination z Install the filter as described in this manual to prevent dust and particles from entering the patient s 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...

Page 172: ...ilter to the Y piece 13 3 Install the Manual Bag Connect the manual bag to the manual bag port on the breathing system The anesthesia machine is configured with bag arm The anesthesia machine is not configured with bag arm ...

Page 173: ... anesthetic agent in the vaporizer will be degraded Use the vaporizer matching the anesthesia machine NOTE z For details about how to install and use the vaporizer refer to the Vaporizer Instructions for Use 13 4 1 Assemble the Vaporizer 1 Mount the vaporizer onto the manifold A Locking lever B Interlock bolts C Locking shaft ...

Page 174: ...ove the vaporizer and reinstall it 4 In case 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 If a 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 ...

Page 175: ...13 23 6 With a Desflurane vaporizer Make sure that the vaporizer is connected to an electrical outlet Plug in the electrical input cable Push the adapter into the mounting box ...

Page 176: ...r end of the adapter to the power source 7 Try to turn on more than one vaporizer at the same time NOTE z For details about how to use the Desflurane vaporizer refer to Instructions for Use of Desflurane vaporizer 8 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 ...

Page 177: ...tic 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 ...

Page 178: ...e 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 ce...

Page 179: ...hemical 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 ...

Page 180: ...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...

Page 181: ... gas cylinder do as follows 1 Turn the handle of the cylinder valve clockwise Close the cylinder valve on the cylinder to be replaced 2 Turn the tee handle counterclockwise 3 Fully loosen the tee handle to open the yoke gate Handle of the cylinder valve Tee handle ...

Page 182: ...nstall 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 WARNING z 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 z Use a new gasket wh...

Page 183: ...ing 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 ...

Page 184: ...nd N2O O2 and O2 For details refer to 2 2 Equipment Appearance WARNING z Use medical grade gas supplies only Other types of gas supplies may contain water oil or other contaminants z When the central piping system fails one or more equipment connected may stop work Make sure that cylinders are available z When gas supplies are cut off there is still pressure inside the pipeline Remember to release...

Page 185: ...ubes 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 3 Make sure tha...

Page 186: ...EP outlet gives off the exhaust gas indoors directly 2 The outside diameter of the AGSS connector is 30 mm with 1 20 taper ratio Please connect to the AGSS or waste gas disposal system WARNING z The PEEP outlet gives off a small amount of O2 continuously Do not occlude this outlet Otherwise the anesthetic ventilator cannot work normally z Before performing an operation on the patient equip the ane...

Page 187: ...SS active scavenging tube 2 Filter screen 3 Sight glass 4 Float 5 MIN mark 6 AGSS inlet 7 Pressure compensation opening 8 30 mm male conical connector 9 Hook 10 Transfer tube 11 Gas reservoir 12 30 mm female conical connector Connected with the AGSS waste gas outlet on the left side of the anesthesia machine 11 1 2 8 3 9 10 12 4 7 5 6 ...

Page 188: ...acket 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 with the hospital s waste gas disposal system Install M4 socket head screws and spring washers Install fixed pins Transfer tube ...

Page 189: ... 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 10AGSS Transfer...

Page 190: ...z Gas inside the AGSS may overflow when the gas flow exceeds 100 mL min if the 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 ...

Page 191: ... 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 z 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 NO...

Page 192: ...aining detergent by wiping with a dry lint free cloth WARNING z 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 NOTE z Use only soft dry and lint free cloth ...

Page 193: ...14 2 1 O2 Sensor 1 Remove one end of the O2 sensor cable from the connector on the anesthesia machine Unplug the other end of the cable from the O2 sensor 2 Turn the O2 sensor counterclockwise to take it out ...

Page 194: ...14 2 2 Manual Bag Remove the manual bag from the manual bag port on the breathing system as shown below The anesthesia machine is configured with bag arm The anesthesia machine is not configured with bag arm ...

Page 195: ...oth ends of the tube to prevent damage to the tube z 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 ...

Page 196: ...14 6 14 2 4 Airway Pressure Gauge Pull off the airway pressure gauge as shown below 14 2 5 Bag Arm 1 Loosen the locking nut counterclockwise 2 Remove the bag arm from the breathing system ...

Page 197: ...14 7 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 ...

Page 198: ...14 8 14 2 7 Flow Sensor 1 Turn the locking nuts counterclockwise 2 Pull out the inspiration expiration connectors and their locking nuts 3 Pull out the flow sensors horizontally ...

Page 199: ... 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 ...

Page 200: ...14 10 14 2 10 Sodalime Canister 1 Hold and pull up the rotary handle for 90 degrees 2 Turn the rotary handle for 90 degrees counterclockwise ...

Page 201: ...NING z 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 ...

Page 202: ...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 3 Remove the breathing system from the circuit adapter with both hands ...

Page 203: ...o 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 counterclockwise 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 2 Rotate the top cover counterclockwise to separate it from the sight glass Nut ...

Page 204: ...by turn 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 4 Take out the float Float Nut Fixed plate Filter screen Sight glass ...

Page 205: ...most brood cells are killed Such parts are cleanable by hand Rinse and dry all parts of the breathing system except the O2 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 WARNING z Do not use talc zinc stearate calcium carbonate corn sarch or equivalent materials to prevent tackiness T...

Page 206: ...B C Breathing tubes and Y piece Breathing mask Flow sensor Bellows assembly Inspiratory and expiratory check valves assemblies O2 sensor Canister assembly Canister connection block assembly Water collection cup Bag arm BYPASS assembly Breathing system Manual bag AGSS assembly indicates that this disinfection method is applicable A Clean with a damp cloth soaked in mild detergent and then wipe off ...

Page 207: ...nd 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...

Page 208: ...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 WARNING z Do not separate the check valve diaphragm from the valve cover z When installing the che...

Page 209: ... Hang the disinfected bellows assembly upside down and dry at a room temperature less than 70 6 Look for damaged parts after the bellows assembly is fully dry Then install the assembly with reference to 13 1 5Install the Bellows 7 Connect the bellows assembly ventilator and breathing system 8 Perform preoperative test before system use For details refer to 6 8 1 Bellows Test 14 3 7 Sodalime Canist...

Page 210: ...the methods recommended in the table of 14 3 Clean Disinfect and Re install the Breathing System to clean and disinfect the flow sensor CAUTION z Do not autoclave the flow sensor z Do not use high pressure gas or brushes to clean the flow sensor z Do not use cleaning solvents that are not approved for use with polycarbonates z Do not clean the interior surface of the flow sensor Use a damp cloth o...

Page 211: ...ystem 1 Refer to the methods recommended in the table of 14 3 Clean Disinfect and Re install the Breathing System to clean and disinfect the O2 sensor 2 When the O2 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 cle...

Page 212: ...to 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 z Immerse disinfect and clean the AGSS by strictly following the concentration specified in the Instructions for Use provided by the disinfectant supplier ...

Page 213: ...plicable waste control regulations Description PN 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 120031 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 S...

Page 214: ...ensor cable 0601 20 78941 O2 sensor 0611 10 45654 Flow Sensor Expiratory flow sensor assembly 0601 30 78894 Inspiratory flow sensor assembly 0601 30 69700 Sodalime canister Sodalime canister 0601 30 78957 Sponge for sadalime canister 0601 20 78976 Vaporizer Vaporizer Halothane5 Selectatec Pour Fill 0621 30 78724 Vaporizer Sevoflurane8 Selectatec Pour Fill 0621 30 78723 Vaporizer Desflurane18 Selec...

Page 215: ...eam CO2 module Airway adapter 6063 adult disposable 0010 10 42662 Airway adapter with flat nose 6421 adult disposable 0010 10 42663 Airway adapter 7007 adult pediatric reusable 0010 10 42665 Airway adapter 6312 neonatal disposable 0010 10 42664 Airway adapter 7053 neonatal reusable 0010 10 42666 Mask 9960STD adult 0010 10 42670 Mask 9960LGE adult large size 0010 10 42671 Mask 9960PED pediatric 001...

Page 216: ...sensor adult 0010 10 42672 BIS sensor pediatric 0010 10 42673 BIS patient cable adult pediatric 6800 30 50761 AGSS AGSS transfer tube assembly tube connecting the anesthesia machine to the AGSS main unit Tube length approximately 0 5 m 0611 30 67693 AGSS active scavenging tube assembly tube connecting the hospital s waste gas disposal system to the AGSS main unit Tube length approximately 4 m 0611...

Page 217: ...A 1 A Theory of Operation A 1 Pneumatic Circuit System A 1 1 Pneumatic Circuit Diagram Waste gas disposal vaporizer vaporizer Patient Driven by O2 Driven by Air optional ...

Page 218: ...low sensor 13 Pop Off valve 40 Scavenging reservoir and sound arrestor 14 PEEP safety valve 41 Bag mechanical ventilation switch 15 Pressure switch 42 Manual bag 16 Proportional PEEP valve 43 APL valve 17 Expiratory valve 44 Modular rack supporting gas module 18 Pneumatic resistor 45 Bellows assembly 19 O2 flush valve 46 Auxiliary O2 supply 20 Pressure switch 37 kPa 47 Airway pressure gauge 21 Flo...

Page 219: ...ain linkage which keeps the O2 concentration not lower than 25 at the fresh gas outlet The mixed gas of O2 Air and N2O 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 ...

Page 220: ... 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 a...

Page 221: ... inspiratory valve safety valve 10 Fan for the power board 29 Monitoring valve engine board 11 Power signal conversion board 30 Monitored signal detection board and auxiliary monitor board 12 Alarm lamp board 31 Three way valve for pneumatic circuit block 13 Rotary encoder 32 VTPLUS 14 Speaker 33 Switch signal 15 Membrane keyboard 34 Bag mechanical ventilation switch O2 supply pressure switch 16 K...

Page 222: ...A 6 FOR YOUR NOTES ...

Page 223: ...997 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 Type of protection against electric shock Class I equipment with internal electrical power supply Where the integrity of the external protective earth ground in the installation or its conductors is in doubt the equipment sha...

Page 224: ... to 106 B 3 Power Requirements External AC power supply Input voltage 100 to 240 V 100 to 120 V 220 to 240 V Input current 8 5 to 3 5 A 8 5 A 3 5 A Input frequency 50 60 Hz Leakage current 500μA Fuse T10 AL 250V Power cord 5 m Auxiliary output supply with isolation transformer Output voltage 220 to 240 V 100 to 120 V Output frequency 50 60 Hz 50 60 Hz Output current outlet 1 1 6A 3 8A Output curre...

Page 225: ...ning status or standby mode B 4 Physical Specifications Main unit Size 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 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 m...

Page 226: ...nd key tones supports multi level tone modulation The alarm tones comply with the requirements of IEC60601 1 8 Buzzer Gives off alarm tones in case of equipment malfunction Connector Power supply One AC mains inlet One or three auxiliary electrical outlets One CIS power supply connector Network One multiplexing connector to support network CIS and software online upgrade Implements data communicat...

Page 227: ...tem Flow 0 to 10 L min Accuracy 5 of full range under 20 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 O2 N2O link system Type Mechanical proportion control device Range O2 concentration not lower than 25 B 6 Breathing System Specifications System leakage and system compliance System leakage...

Page 228: ... female 15 mm conical connector Airway pressure gauge Range 20 to 100 cmH2O Accuracy 2 5 of full range APL valve Range 1 to 75 cmH2O Tactility indication Above 30 cmH2O Rotation range 1 to 30 cm H2O 0 to 145 8 30 to 75 cm H2O 145 8 to 292 5 Pressure flow data APL valve completely open Flow L min APL pressure cmH2O dry APL pressure cmH2O moist 3 0 23 0 24 10 0 25 0 25 20 0 27 0 27 30 0 28 0 28 40 0...

Page 229: ...Plimit 10 to 100 cmH2O 1 cmH2O All modes Pinsp PEEP 5 to 60 cmH2O 1 cmH2O PCV PSV SIMV PC Psupp 5 to 60 cmH2O 1 cmH2O PSV SIMV VC SIMV PC PEEP OFF 4 to 30 cmH2O 1 cmH2O All modes TV 20 to 1500 ml 20 to 100 ml 5 ml 100 to 300 ml 10 ml 300 to 1500 ml 25 ml VCV SIMV VC Manual Mechanical Pressure drop kPa Flow L min Manual Mechanical Flow L min Pressure drop kPa ...

Page 230: ...sure 1 cmH2O Flow 0 5 L min PSV SIMV VC SIMV PC PSV Insp Termination Level 5 to 60 5 PSV SIMV VC SIMV PC Backup Mode Active 5 to 30 s 5 s PSV PEEP setting range Type Integrated electronic PEEP Range OFF 4 to 30 cmH2O increment 1 cmH2O Ventilator performance Drive pressure 280 to 600 kPa Peak flow 100 L min Range of flow valve 1 to 100 L min Ventilator monitored parameters MV 0 to 100 L min TV 0 to...

Page 231: ...g 2 0 cmH2O PEEP monitoring accuracy 0 to 30 cmH2O 2 0 cmH2O or 10 of the displayed value whichever is greater 30 cmH2O not defined Alarm settings Parameter Setting range Remark High Limit 20 to 100 FiO2 Low Limit 18 to high limit 2 The specified high limit shall always be greater than the low limit High Limit 5 to 1600 mL TVe Low Limit 0 to high limit 5 mL The specified high limit shall always be...

Page 232: ...demark of Datex Ohmeda Inc B 10 AGSS Transfer and Receiving System Specifications AGSS transfer and receiving system Size 443 x 145 x 140mm height x width x depth Type of disposal system High flow disposal system Applicable standard ISO 8835 3 1997 Pump rate 50 to 80 L min Pressure relief device Pressure compensation opening to the air Filter Stainless screen with hole diameter of 140 150μm State ...

Page 233: ...n at 0 40 C Pressure range 50 to 200 KPa Related humidity 0 to 99 100 O2 concentration output drift Over one year of typical value 5 Material White ABS 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 Gas under test Error O2 50 He 50 O2 1 80 N2 O 20 O2 1 to 1 5 4 Halothane ...

Page 234: ... 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 operating lives Typical senso...

Page 235: ...sed 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 pressure 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...

Page 236: ...m drift 0 8 mmHg within 4 hours Long term drift accuracy specification retained within 120 hours Mainstream CO2 module alarm specifications CO2 alarm limits Range mmHg Accuracy mmHg Step mmHg EtCO2 High Limit low limit 2 to 150 EtCO2 Low Limit 0 to high limit 2 FiCO2 High Limit 0 to 150 1 1 Microstream CO2 Module Specifications Microstream CO2 module Measurement mode Microstream Measurement range ...

Page 237: ... specifications CO2 alarm limits Range mmHg Accuracy mmHg Step mmHg EtCO2 High Limit low limit 2 to 99 EtCO2 Low Limit 0 to high limit 2 FiCO2 High Limit 0 to 99 1 1 Sidestream CO2 Module Specifications Sidestream CO2 module Measurement mode Sidestream Measurement range Accuracy 0 to 40 mmHg 2 mmHg 41 to 76 mmHg 5 of the reading Measurement range and accuracy 77 to 99 mmHg 10 of the reading Resolu...

Page 238: ...gh limit 2 mmHg FiCO2 High Limit 0 to 99 mmHg 1 mmHg Effect of interfering gas on CO2 measured value Gas Concentration Accuracy N2O 60 Hal 4 Sev 5 Iso 5 Enf 5 1 mmHg Des 15 2 mmHg Additional error caused by gas interference when measured at 0 to 40 mmHg Typical accuracy measurement conditions are 1 Measurement starts when the module warm up state ends 2 Ambient pressure 750 to 760 mmHg room temper...

Page 239: ...10 whichever is greater Gas CO2 O2 optional N2O and any of the five anesthetic agents Des Iso Enf Sev and Hal CO2 0 to 30 O2 optional 0 to 100 N2O 0 to 100 Des 0 to 30 Sev 0 to 30 Range Enf Iso Hal 0 to 30 ISO accuracy mode CO2 N2O Other anesthetic agent 0 3 ABS 8 REL 2 ABS 8 REL Gas Range REL Accuracy ABS 0 to 1 0 1 1 to 5 0 2 5 to 7 0 3 7 to 10 0 5 CO2 10 Not specified 0 to 20 2 N2O 20 to 100 3 ...

Page 240: ...Enf Iso Hal 5 Not specified CO2 250 ms N2O 250 ms O2 500 ms Enf 350 ms Rise time Des Sev Iso Hal 300 ms Delay time 4 s Update time Once per second Calibration Once per year Calibration stability 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 ...

Page 241: ...t 0 0 to high limit 0 2 0 1 EtEnf High Limit low limit 0 2 to 5 0 EtEnf Low Limit 0 0 to high limit 0 2 FiEnf High Limit low limit 0 2 to 5 0 FiEnf Low Limit 0 0 to high limit 0 2 0 1 EtIso High Limit low limit 0 2 to 5 0 EtIso Low Limit 0 0 to high limit 0 2 FiIso High Limit low limit 0 2 to 5 0 FiIso Low Limit 0 0 to high limit 0 2 0 1 EtSev High Limit low limit 0 2 to 8 0 EtSev Low Limit 0 0 to...

Page 242: ... Methane 1 0 1 0 1 0 0 5 Methoxyflurane Unspecified Unspecified Unspecified Unspecified 1 Multiple agent interference on CO2 N2O and O2 is typically the same as single agent 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 Applicable to AION 03 AG ...

Page 243: ...rameters EEG BIS 0 to 100 Calculated parameters SQI EMG SR SEF TP Impedance range 0 to 999 kΩ Sweep speed 6 25 12 5 25 or 50 mm s Input impedance 50 MΩ Noise RTI 0 3 µV 0 25 to 50 Hz Input signal range 1 mV EEG bandwidth 0 25 to 110 Hz Patient leakage current 10 µA BIS alarm limits Range Step Unit BIS High Limit low limit 2 to 100 BIS Low Limit 0 to high limit 2 1 ...

Page 244: ...B 22 FOR YOUR NOTES ...

Page 245: ... the anesthesia machine or its components should be observed to verify normal operation in the configuration in which it will be used z The anesthesia machine needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below z Other devices may affect this equipment even though they meet the requirements of CISPR z When the input...

Page 246: ...stablishments 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 belo...

Page 247: ...els characteristic of a typical location in a typical commercial or hospital environment Note UT is the AC mains voltage prior to application of the test level 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 environmen...

Page 248: ...r 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 it is inadvertently brought into patient areas c Field strengths from fixed transmitters such as base stations for...

Page 249: ...2 00 12 00 23 00 For transmitters rated at a maximum output power not listed above the recommended separation distance D in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz to 800 MHz the separation distance for the higher f...

Page 250: ...C 6 FOR YOUR NOTES ...

Page 251: ...igh alarm limit setting Paw Too Low H Ppeak is lower than the Paw low alarm limit setting for 20 seconds Increase tidal volume setting or decrease Paw high alarm limit setting FiO2 Too High M FiO2 is higher than the high alarm limit setting Decrease O2 flow in the fresh gas or increase high alarm limit FiO2 Too Low H FiO2 is lower than the low alarm limit setting Increase O2 flow in the fresh gas ...

Page 252: ... are met simultaneously 1 Paw is lower than PEEP 3 cmH2O 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 Volume Apnea 2 min H 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 if the tubes fall off R...

Page 253: ...o Too Low FiIso Too High FiIso Too Low EtSev Too High EtSev Too Low FiSev Too High FiSev Too Low EtDes Too High EtDes Too Low FiDes Too High AG module FiDes Too Low EtCO2 Too High EtCO2 Too Low CO2 module FiCO2 Too High BIS Too High BIS module BIS Too Low The measured value has risen above the high alarm limit or fallen below the low alarm limit Check the patient s physiological condition Make sur...

Page 254: ...rd stops for 10 seconds Power System Selftest Error H Power system watchdog error or Flash error or power supply voltage error Power Supply Voltage Error H Power supply voltage error Restart the machine If the problem persists contact your service personnel System DOWN for battery depletion H The voltage of either battery is lower than 10 2V and the AC power source is not connected Connect to the ...

Page 255: ...ontrol board Ventilator Hardware Error 12 H Safety valve control failure by the main control board Unreliable monitoring Use manual ventilation mode to help the patient breathe Contact your service personnel Auxi Ctrl Module Error H No message of test completion is received after 10 second wait during the auxiliary control board pressure effectiveness and safety valve control effectiveness test No...

Page 256: ...ry valve connection or control failure Use manual ventilation mode to help the patient breathe Parameter monitoring is enabled PEEP Safety Valve Failure M PEEP safety valve connection or control failure Use manual ventilation mode to help the patient breathe Parameter monitoring is enabled For Monitoring Only M Mechanical ventilation failed Use manual ventilation mode to help the patient breathe P...

Page 257: ...pment could 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 L 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 TV Not Achieved L The tidal volume was...

Page 258: ...re Error 04 H Selftest internal AD error Auxi Ctrl Module Hardware Error 05 H Selftest watchdog error Auxiliary control module hardware selftest error The safety protection mechanism may be ineffective It is recommended to use the machine after recovery to normal In case of recovery failure after repeated restart contact your service personnel Auxi Ctrl Module Comm Error H The communication betwee...

Page 259: ...orrect O2 N2O ratio Contact your service personnel Flowmeter Zero Failed L Board or 3 way valve malfunction Contact your service personnel AG Init Error H The AG module was installed improperly or malfunctioned AG Cal Failed H The AG module calibration failed AG Comm Stop H AG module malfunction or communication failure AG Airway Occluded H The actual pump rate of the AG module is less than 20 mL ...

Page 260: ...it settings are outside of the range EtAAALM LMT ERR M The EtAA alarm limit settings are outside of the range FiAAALM LMT ERR M The FiAA alarm limit settings are outside of the range AG No Watertrap L The AG watertrap fell off from the anesthesia machine AG Zero Failed L The AG module zeroing failed AG Change Watertrap M The AG watertrap was changed EtCO2 Overrange H FiCO2 Overrange H EtN2O Overra...

Page 261: ...h Temp M The temperature of the sensor assembly is too high 63 Check stop using or replace the sensor CO2 Sensor Low Temp M The temperature of the sensor assembly is too low 5 Check stop using or replace the sensor CO2 High Airway Press M Paw is too high 790 mmHg An error occurred to the airway pressure Check the patient connection and breathing system Then restart the anesthesia machine CO2 Low A...

Page 262: ...System Error H Multiple system errors occurred CO2 No Watertrap M The CO2 watertrap fell off or was not connected EtCO2 Overrange H FiCO2 Overrange H The measured value is outside of the measurement range Contact your service personnel CO2 Check Airway M Airway error CO2 No Sampleline L Make sure if the sampling line is already connected CO2 Main Board Error H CO2 Check Sensor or Main Board M CO2 ...

Page 263: ...C BIS DSC Malf H BIS DSC switched off due to malfunction Check the DSC BIS No Cable L Connect the BIS cable BIS No Sensor L Connect the sensor BIS Wrong Sensor Type L Check or replace the sensor SQI 50 L SQI 15 L SQI is too low Check the patient s condition and sensor connection BIS Sensor Expired L Replace the sensor BIS Sensor Failure M Put the sensor again or replace the sensor BIS Sensor Too M...

Page 264: ...D 14 FOR YOUR NOTES ...

Page 265: ...c cubic centimeter cm centimeter cmH2O cmH2O dB decibel fahrenheit g gram hr hour Hz hertz hPa hPa inch inch k kilo kg kilogram kPa kilopascal L litre lb pound m meter mAh microampere hour mbar mbar mg milligrams min minute ml milliliter mm millimeters mmHg millimeters of mercury ms millisecond mV millivolt ...

Page 266: ...t per million s second V volt VA volt ampere Ω ohm µA microampere µV microvolt W watt minus percent per divide or to power plus equal to less than greater than less than or equal to greater than or equal to plus or minus multiply copyright ...

Page 267: ... FiO2 Fractional concentration of O2 in inspired gas Flow Flow Hal Halothane I E Inspiratory time Expiratory time ratio Iso Isoflurane MAC Minimum alveolar concentration Manual Manual ventilation MV Minute volume N2O N2O O2 Oxygen Paw Airway pressure PCV Pressure control ventilation PEEP Positive end expiratory pressure Pinsp Pressure control level of inspiration Plimit Pressure limit level Pmean ...

Page 268: ...ventilation Pressure control SIMV VC Synchronized intermittent mandatory ventilation Volume control SIMV Rate Frequency of SIMV Tinsp Time of inspiration TIP TI Percentage of inspiratory plateau time in inspiratory time TV Tidal volume VCV Volume control ventilation Volume Gas volume TVe Expired tidal volume TVi Inspired tidal volume ...

Page 269: ...actory default settings Alarm Level Med EtCO2 High Limit mmHg 50 EtCO2 Low Limit mmHg 15 FiCO2 High Limit mmHg 4 F 1 1 Mainstream CO2 Module CO2 Setup Factory default settings Paw Unit mmHg Working Mode Measure Max Hold 10 s Balance Gas Room Air O2 Comp OFF AG Comp 0 F 1 2 Microstream CO2 Module CO2 Setup Factory default settings Paw Unit mmHg Working Mode Measure Max Hold 20 s Auto Standby min 0 ...

Page 270: ... default settings Agent AA Pump Rate Low O2 Comp OFF Working Mode Measure Unit mmHg Gas Module Alarm Limits Alarm Level Med EtCO2 High Limit mmHg 50 EtCO2 Low Limit mmHg 15 FiCO2 High Limit mmHg 4 FiCO2 Low Limit mmHg 0 EtN2O High Limit 55 EtN2O Low Limit 0 FiN2O High Limit 53 FiN2O Low Limit 0 EtHal High Limit 3 0 EtHal Low Limit 0 0 FiHal High Limit 2 0 FiHal Low Limit 0 0 EtEnf High Limit 3 0 ...

Page 271: ...EtSev High Limit 6 0 EtSev Low Limit 0 0 FiSev High Limit 5 0 FiSev Low Limit 0 0 EtDes High Limit 8 0 EtDes Low Limit 0 0 FiDes High Limit 6 0 FiDes Low Limit 0 0 F 3 BIS Module BIS Setup Factory default settings Smoothing Rate 30 s Cont Imped Check ON Cyc Imped Check OFF BIS module alarm limits Alarm Level Med BIS High Limit 70 BIS Low Limit 20 ...

Page 272: ...OFF PEEP cmH2O OFF PCV Mode Plimit cmH2O 30 Pinsp cmH2O 15 Rate BPM 12 I E 1 2 PEEP cmH2O OFF PSV Mode Pinsp cmH2O 15 Rate BPM 12 I E 1 2 Finsp L min 60 Plimit cmH2O 30 Psupp cmH2O 15 PEEP cmH2O OFF Backup Mode Active s 30 Trigger Level 2 cmH2O pressure triggered 3 0 L min L min flow triggered PSV Insp Termination Level 25 ...

Page 273: ... pressure triggered 3 0 L min L min flow triggered PSV Insp Termination Level 25 Ventilator alarm limits FiO2 High Limit 100 FiO2 Low Limit 21 TVe High Limit ml 1000 TVe Low Limit ml 5 MV High Limit L min 10 MV Low Limit L min 2 0 Rate High Limit BPM 40 Rate Low Limit BPM 2 Paw High Limit cmH2O 30 Paw Low Limit cmH2O 4 ...

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