Aeonmed Aeon 7500 User manual

Anesthetic Apparatus
Typ Anastazja 7500
0297
User’s Manual
01/2008
FARUM S.A.
Adres: 74 Jagiellońska street, 03-301 Warszawa,Poland Heandquarter (0-22) 811 14 11 Sales Department (0-22) 811 06 79 Fax. (0-22) 811 40 59 Tel./Fax. (0-22) 811 19 22 www.farum.com.pl
ANASTAZJA 7500 User Manual
User Responsibility
This product will perform in conformity with the description contained in the operating manual and accompanying labels and /or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This product must be checked periodically. Do not use product if defective. Replace all broken, missing, worn, distorted or contaminated parts. If repair or replacement becomes necessary, a telephone call or written request for service advice should be made to the nearest Aeonmed customer service center. This product or any of its parts must be repaired in accordance with the written instructions provided by Aeonmed and by Aeonmed trained personnel. The product must not be altered without the prior written approval of Aeonmed. The user of this product shall assume the full responsibility for any malfunction resulting from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than Aeonmed personnel.
NOTE:
Each FARUM S.A. product has a serial number, such as
Anastazja7500 xxxx-xxxxx
ANASTAZJA 7500: machine model
the first xxxx : the year of manufacturing
the second xx : the month
the third xxx : equipment number
2 01/2008
Statement
FARUM S.A. holds the copyrights to this manual, which is non-public published, and reserves the rights to keep it as a secure document. Refer to this manual when operating, maintaining and repairing FARUM S.A. products only. Anyone other than FARUM S.A. may not make it known to others.
Proprietary materials protected by the copyright law are included in this manual. Any section of it cannot be reproduced, copied, or translated into other languages without any prior written approval from FARUM S.A. who reserves the copyright.
Everything written in this manual is considered to be correct. FARUM S.A. is not legally responsible for any mistakes printed within and any damages caused by incorrect installation and operation. FARUM S.A. does not supply privileges endowed by the patent law to any other parties. FARUM S.A. is not legally responsible for the results caused by patent law breaking and any rights of the third party violating.
Refer to this manual before any FARUM S.A. product is used. The manual includes operating procedures which must be performed with cautiously, operations that may result in non-normal working conditions and the dangers which may damage equipment or cause bodily harm. FARUM S.A. is not responsible for the security, reliability and function of the equipments in case that the dangers, damages and non-normal phenomenon mentioned in this manual happen. Free repairs for these malfunctions will not be provided by FARUM S.A..
FARUM S.A. have the rights to replace any content in this manual without notice.
Manufacturer Responsibility:
FARUM S.A. is responsible for the security, reliability and function of the equipments when to following conditions are adhered to:
Installation, adjustments, mending and repairs must be performed by individuals
authorized by FARUM S.A.;
Necessary electrical equipment and the working environment must be in accordance with
the national standards, professional standards and the requirements listed in this manual;
Equipment must be used as instructed in the operating instructions.
CAUTION: This equipment is not for family use.
CAUTION: Malfunctioning equipment may become invalid and cause bodily injury if a set of effective and approving repairing proposals cannot be submitted by the institution which is responsible for using this equipment.
The paid theoretical framework diagram will be supplied according to customer requirements by FARUM S.A., plus calibrating method and other information to help the customer, under the assistance of qualified technicians, repair the equipment parts where can be done by customer himself based on the stipulation by FARUM S.A..
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ANASTAZJA 7500 User Manual
Warranty:
Manufacturing techniques and materials:
For a period of three months from the date of original delivery, the components and assemblies of this product is warranted to be free from defects manufacturing techniques and materials, provided that the same is properly operated under the conditions of normal use and regular maintenance. The warranty period for other parts is three years. Expendable parts are not included. FARUM S.A. obligation under the above warranties is limited to repairing free of charge.
Free Obligations:
FARUM S.A. obligation under the above warranties does not include the freight and
other fees;
FARUM S.A. is not responsible for any direct, indirect or final product broken and
delay which result from improper use, alteration by using the assemblies unratified and maintenance by anyone other than FARUM S.A.;
This warranty does not apply to the followings:
Improper use
Machines without maintenance or machines broken
The label of FARUM S.A. original serial number or mark is removed or replaced
Other manufacturers’ product
Security, reliability and operating condition:
FARUM S.A. is not responsible for the security, reliability and operating condition of this product in case that:
The assemblies are disassembled, extended and readjusted
This product is not operated correctly in accordance with the manual instruction. The
power supply used or operating environment does not follow the requirements in this manual.
2 01/2008
Return
Follow the steps in case that the product needs to be returned to FARUM S.A.:
1. Obtain the rights of return
Contact with the customer service of FARUM S.A. by informing them the number and type of the product. The number is marked on the surface of the product. Return is unacceptable if the number cannot be identified. Enclose a statement of the number, type and the reason of return as well.
2. Transportation charges
Transportation and insurance charges must be prepaid by the user for transporting the product to FARUM S.A. for repairing. (Customers charges is added with regard to the products sold to non-Chinese mainland users)
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Contents
STATEMENT ............................................................................................................................... 1
1 INTRODUCTION............................................................................................................... 1-1
1.1 WHATS ANASTAZJA 7500?..............................................................................................1-1
1.1.1 Range for used ......................................................................................................... 1-1
1.2 SYMBOLS USED IN THE MANUAL AND IN THE EQUIPMENT ......................................................1-3
2 ANESTHETIC SYSTEM CONTROL ................................................................................ 2-1
2.1 ANESTHETIC SYSTEM.......................................................................................................... 2-1
2.2 THE BREATHING SYSTEM MODULE ....................................................................................... 2-5
2.2.1 Absorber cycle .......................................................................................................... 2-7
2.2.2 Bellows Assembly................................................................................................... 2-10
2.3 VAPORIZER CONTROL ....................................................................................................... 2-11
2.4 VENTILATOR CONTROL...................................................................................................... 2-11
2.4.1 Front Panel ............................................................................................................. 2-11
2.4.2 Keys........................................................................................................................ 2-12
2.4.3 Indicators ................................................................................................................ 2-12
2.4.4 Knob ....................................................................................................................... 2-12
2.4.5 Display Screen........................................................................................................2-13
2.4.6 Rear Panel.............................................................................................................. 2-15
2.5 MENU .............................................................................................................................. 2-17
2.5.1 Operating Guide ..................................................................................................... 2-17
2.5.2 Menu diagram......................................................................................................... 2-20
3 OPERATING GUIDE......................................................................................................... 3-1
3.1 STARTING SYSTEM ............................................................................................................. 3-1
3.1.1 Alarm Limit Set ......................................................................................................... 3-3
3.1.2 Restore Default Set .................................................................................................. 3-6
3.1.3 Ventilation Mode Set................................................................................................. 3-9
3.1.4 Ventilator Control Set..............................................................................................3-10
3.2 STARTING AUTO VENTILATION ........................................................................................... 3-11
3.3 SHUTTING OFF AUTO VENTILATION.................................................................................... 3-12
3.4 ALARM ............................................................................................................................. 3-13
3.4.1 Alarm tone .............................................................................................................. 3-13
3.4.2 Alarm Silence..........................................................................................................3-13
3.5 WAVEFORM ...................................................................................................................... 3-14
4 PREOPERATIVE CHECKOUT......................................................................................... 4-1
4.1 ANASTAZJA7500 PREOPERATIVE CHECKOUT PROCEDURES..................................................4-1
4.1.1 System Checkout ..................................................................................................... 4-2
4.1.2 Mains failure alarm test ............................................................................................4-2
4.2 TESTING THE GAS SUPPLY PIPELINE AND THE GAS CYLINDER ................................................. 4-3
4.3 MONITORING FLOW CONTROL............................................................................................. 4-5
4.3.1 Monitoring without oxygen........................................................................................ 4-5
4.3.2 Monitoring with Oxygen ............................................................................................ 4-7
4.4 INSTALLING AND TESTING OF VAPORIZER .............................................................................. 4-9
4.4.1 Installation................................................................................................................. 4-9
4.4.2 Testing Vaporizer Back Pressure ............................................................................. 4-9
4.5 TESTING ALARM................................................................................................................ 4-10
4.6 TESTING THE BREATHING SYSTEM.....................................................................................4-12
4.6.1 Checking Oxygen flush Switch ............................................................................... 4-12
4.6.2 Testing Breathing System....................................................................................... 4-12
4.6.3 Testing APL Valve................................................................................................... 4-12
4.7 TESTING VENTILATOR .......................................................................................................4-13
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ANASTAZJA 7500 User Manual
5 INSTALLING AND CONNECTING................................................................................... 5-1
5.1 INSTALLING PRODUCT .........................................................................................................5-2
5.1.1 Shelf..........................................................................................................................5-2
5.1.2 Breathing circuit limb ................................................................................................ 5-2
5.1.3 Absorber cycle ..........................................................................................................5-2
5.1.4 The bellows Assembly base ..................................................................................... 5-2
5.2 INSTALLING ABSORBER .......................................................................................................5-3
5.2.1 When to replace absorbent ......................................................................................5-3
5.2.2 Disassembling Absorber...........................................................................................5-4
5.2.3 Filling Absorbent .......................................................................................................5-4
5.3 CONNECTING TUBES AND LINES ...........................................................................................5-5
5.4 CONNECTING GAS AND ELECTRICITY ...................................................................................5-6
5.4.1 AC inlet .....................................................................................................................5-6
5.4.2 Auxiliary mains socket outlet .................................................................................... 5-7
5.4.3 Serial Port .................................................................................................................5-7
5.4.4 Pipeline gas supply inlet ........................................................................................... 5-8
5.4.5 Cylinder gas supply inlet...........................................................................................5-8
5.5 HOW TO INSTALL GAS CYLINDER (TESTING HIGH PRESSURE LEAK) ......................................... 5-9
5.6 CONNECT GAS SCAVENGING TRANSFER & RECEIVING SYSTEM............................................. 5-10
6 CLEANING AND STERILIZING....................................................................................... 6-1
6.1 CLEANING AND STERILIZATION OF PRE-USE FIRST ................................................................. 6-2
6.2 CLEANABLE BREATHING SYSTEM COMPONENTS...................................................................6-2
6.3 ABSORBER ......................................................................................................................... 6-3
6.3.1 Auto cleaning with agent or disinfector ..................................................................... 6-3
6.3.2 Manual cleaning........................................................................................................6-3
6.3.3 Advanced Sterilizing .................................................................................................6-3
6.4 ABSORBER ASSEMBLY.........................................................................................................6-4
6.5 THE BELLOWS ASSEMBLY....................................................................................................6-4
6.5.1 Disassembling .......................................................................................................... 6-5
6.5.2 Testing Function........................................................................................................6-8
6.5.3 Assembly lists .........................................................................................................6-10
6.5.4 Cleaning and Sterilizing .......................................................................................... 6-11
6.5.5 Regular Maintenance..............................................................................................6-12
7 USER MAINTENANCE..................................................................................................... 7-1
7.1 REPAIR POLICY................................................................................................................... 7-1
7.2 MAINTAINING OUTLINE AND SCHEDULE ................................................................................7-2
7.2.1 User maintenance.....................................................................................................7-2
7.2.2 Permissive Repairing................................................................................................7-2
7.2.3 Useful life estimation.................................................................................................7-3
7.3 MAINTAINING THE BREATHING SYSTEM ................................................................................7-3
7.3.1 Replace O2 sensor....................................................................................................7-3
7.3.2 Calibrate O2 sensor .................................................................................................. 7-4
7.3.3 Calibrate flow sensor .............................................................................................. 7-11
7.3.4 Calibrate flow valve.................................................................................................7-14
7.4 MAINTAINING OXYGEN SENSOR.......................................................................................... 7-15
7.4.1 Technical requirements...........................................................................................7-15
7.4.2 Recommended O2 sensor ...................................................................................... 7-15
7.5 REPLACING FUSES............................................................................................................7-16
7.5.1 Replacing fuse of mains supply .............................................................................. 7-16
7.5.2 Replacing fuse of auxiliary mains socket outlets....................................................7-17
7.5.3 Replacing fuse of ventilator .................................................................................... 7-17
7.6 MAINTAINING BATTERY ......................................................................................................7-18
8 ALARM AND TROUBLESHOOTING............................................................................... 8-1
8.1 ABOUT ALARM..................................................................................................................... 8-1
8.2 ALARM MESSAGE LIST ......................................................................................................... 8-2
8.2.1 Technical alarm.........................................................................................................8-2
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8.2.2 Functional alarm ....................................................................................................... 8-3
8.3 TROUBLESHOOTING............................................................................................................ 8-4
8.3.1 Anesthesia machine troubleshooting and analyzing ................................................ 8-4
8.3.2 MV300 Troubleshooting and Analyzing .................................................................... 8-5
8.4 DEFAULT SETTING............................................................................................................... 8-6
9 ACCESSORIES ................................................................................................................ 9-1
9.1 THE BREATHING SYSTEM..................................................................................................... 9-1
9.2 THE ABSORBER ASSEMBLY ................................................................................................. 9-1
9.3 OTHERS............................................................................................................................. 9-2
10 SPECIFICATIONS AND OPERATION THEORY ....................................................... 10-1
10.1 GAS CIRCUIT OF ANASTAZJA 7500 ................................................................................. 10-1
10.2 SYSTEM TECHNICAL SPECIFICATION ................................................................................... 10-3
10.2.1 Drive ....................................................................................................................... 10-3
10.2.2 Flow ........................................................................................................................ 10-3
10.2.3 Classification...........................................................................................................10-4
10.3 POWER SUPPLY ................................................................................................................10-4
10.3.1 Power cord.............................................................................................................. 10-5
10.4 ELECTROMAGNETIC COMPATIBILITY ................................................................................... 10-5
10.5 PHYSICAL SPECIFICATION................................................................................................ 10-10
10.6 ENVIRONMENT REQUIREMENTS ....................................................................................... 10-10
10.7 BREATHING SYSTEM TECHNICAL SPECIFICATIONS.............................................................. 10-11
10.8 ANESTHESIA VENTILATOR................................................................................................10-12
10.8.1 Operation Theory.................................................................................................. 10-12
10.8.2 Performance of ventilator .....................................................................................10-13
10.8.3 Setting ventilation mode ....................................................................................... 10-14
10.8.4 Setting ventilating parameters .............................................................................. 10-14
10.8.5 Gas dynamics performance.................................................................................. 10-14
10.8.6 Setting alarm parameters ..................................................................................... 10-15
10.8.7 Volume..................................................................................................................10-15
10.8.8 Monitoring performance........................................................................................ 10-16
10.8.9 O2 monitoring specification ................................................................................... 10-17
01/2008 iii
1 Introduction
1.1 What’s ANASTAZJA 7500?
ANASTAZJA 7500 is a compact and integrated anesthesia transmitting system. The breathing machine not only provides patients in operation with auto ventilation, but also monitors and displays the patient’s various parameters. The ventilator used in the system is controlled by a microprocessor.
The anesthetic ventilator controlled by microprocessor of ANASTAZJA 7500 includes monitor internally, volume mode, and other functions optional. It can be used for communication with cardiac blood vessel and monitor of breathing gas by serial interface.
Not all the optional functions available may be included in the manual. It is also possible to add other equipment to the top or middle of this system for added functions. For more information with respect to the existing product, please feel free to contact the local representatives.
WARNING: The user of ANASTAZJA 7500 must be professional and trained.
WARNING: ANASTAZJA 7500 is unsuitable for use in a magnetic resonance
imaging (MRI) environment.
1.1.1 Range for used
ANASTAZJA 7500 is applicable for patients of over 25 Kg with standard set and for child of over 12 Kg with cycles and CO2 monitoring device of child.
WARNING: ANASTAZJA 7500 is not to be used with infant.
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ANASTAZJA 7500 User Manual
Figure 1-1 ANASTAZJA 7500
1-2 01/2008
1 Introduction
1.2 Symbols Used in the Manual and in the Equipment
Warnings and Cautions indicate all the possible dangers in case of violation of the
stipulations in this manual. Refer to and follow them.
WARNING: indicates potential hazards to operators or patients
CAUTION: indicates potential damage to equipment
Instead of illustrations, other symbols may also be utilized. Not all of them may necessarily appear in the equipment and manual. The symbols include:
CAUTION: This manual complies with EN 1041.
ONPower
OFFPower
Stand-by
Stand-by or preparatory state for a part of the equipment
ON only for part of the equipment
OFF only for part of the equipment
Direct Current
Alternating Current
Protectively earth
Type B equipment
Type BF equipment
Type CF equipment
Warning or Caution, ISO 7000-0434
NOTE: refer to the manual, IEC601-1
This way up
Dangerous Voltage
Input
Output
Earth
Frame or chassis ground
Date of manufacture
SN
01/2008 1-3
CE Representative
Serial Number
Address of manufacture
ANASTAZJA 7500 User Manual
Equipotential
Alarm Silence
Movement in one direction
Lock
Close drain valve
Inspiration flow
View the reading on the top of float
Reservoir bag location/manual ventilation
Movement in two directions
Unlock
Open drain valve (release liquid)
Expiration flow
134ºc
Autoclavable
Auto ventilation
Gas cylinder
Oxygen flush
CE Representative
The system, with this label under the stipulations in the operating manual, complies with the requirements related from 93/42/EEC. xxxx is the certificate number used by FARUM S.A. quality system to certify authorizations
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2 Anesthetic System Control
2.1 Anesthetic system
CAUTION: The anesthetic system is intended to be used with the following
monitoring devices, alarm systems, and protection devices:
-- pressure measuring in accordance with 8.1 of ISO 8835-2;
-- pressure limitation device in accordance with 51.101.1 of IEC60601-2-13;
-- exhaled volume monitor in accordance with 51.101.4 of IEC60601-2-13;
-- breathing system integrity alarm system in accordance with
51.101.5 of IEC60601-2-13;
-- continuing pressure alarm in accordance with 51.101.6 of IEC60601-2-13;
-- O2 monitor in accordance with ISO 9918.
WARNING: To avoid explosion hazards, flammable anesthetic agents such as
ether and cyclopropane shall not be used in this anesthetic workstation. Only anesthetic agents which comply with the requirements for non-flammable anesthetic agents as specified in this manual.
Halothane, desflurane, sevoflurane, enflurane,and isoflurane have been found to be non-flammable agents.
WARNING: Independent means of ventilation (e.g. a self-inflating manually
powered resuscitator with mask) should be available whenever the anesthetic system is in use.
WARNING: Do not use antistatic or electrically-conductive breathing tubes and
mask.
WARNING: Leakage and douse of liquid, such as anesthetic agent, bring on
dangerous states or malfunctions inside device.
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ANASTAZJA 7500 User Manual
Figure 2-1 ANASTAZJA 7500 (front view)
1 Drawer 2 Reservoir Bag
3 Oxygen Flush 4 Absorber cycle
5 Common Gas Outlet 6 Air pipeline pressure gauge
7 N2O pipeline pressure gauge 8 O2 pipeline pressure gauge
9 Autoclavable Bellows Assembly 10 Flowmeters
Display Screen of anesthetic
11
ventilator
12 Enflurane Vaporizer
13 Isoflurane Vaporizer 14 O2 cylinder pressure gauge
15 N2O cylinder pressure gauge
Figure 2-1 each control function on the front view of Anastazja7500
Item Diagram Description
Press Oxygen Flush button to
3 Oxygen Flush
supply O2 to the breathing system with high flow rate
Common gas
5
outlet
connects the anesthesia machine to the breathing system
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10 Flow Control
2 Anesthetic System Control
Turn the knob counterclockwise to increase the flow; turn clockwise to decrease the flow.
Read top of float when the flowmeter is being read.
Figure 2-2 ANASTAZJA 7500 (side view)
Figure 2-2 each control function on the side view of Anastazja7500
Item Diagram Description
1
Castorwith break
Push down to lock, and pull up to unlock.
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ANASTAZJA 7500 User Manual
Figure 2-3 Anastazja7500 (back view)
1 Auxiliary mains socket outlet 2 Power socket
3 Anesthetic ventilator unit 4 N2O cylinder
5 O2 cylinder 6 Nameplate
7 Air pipeline 8 N2O pipeline
9 O2 pipeline
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2 Anesthetic System Control
2.2 The Breathing system module
CAUTION: Any adult anesthetic ventilator system used together with the
anesthetic gas supply system must be in accordance with ISO 8835-2.
Figure 2-4 Breathing system module
1 Absorber mount release handle
2 Absorber (Carbon dioxide absorbent)
3 Exhalation Port / patient circuit connector
4 Exhalation valve
5 Airway pressure gauge
6 Bellows assembly (auto ventilation)
7 APL (adjustable pressure limit) valve
8 Inhalation valve
9 Manual reservoir bag/auto ventilation switch
10 Inhalation Port/Patient circuit port
11 Manual reservoir bag port
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ANASTAZJA 7500 User Manual
Figure 2-4 the breathing system components function control
Item Diagram Description
2
Absorber mount release
7 APL valve
Two soda lime canisters are applied with a volume of 1500 ml for each so that it can be continuously used for 6-8 hours at full load. The water from the reaction is drained via the water collector underneath.
Adjust the pressure limit of the breathing system during the manual ventilation process. The readings are approximate. The colors represent different pressure zones. Green represents safety zone; yellow represents transition zone; red represents high pressure zone. Adjusting ranges between 0.19-6 kPa.
Auto ventilation “off” gas into reservoir bag
Manual reservoir
9
bag/auto ventilation switch
Auto ventilation “on” gas into bellows
2-6 01/2008
Select manual ventilation (reservoir bag) or auto ventilation (ventilator).
2 Anesthetic System Control
2.2.1 Absorber cycle
2.2.1.1 Structure
The functions of absorber cycle: absorb carbon dioxide; vent exhaust gas; assistant respiration; monitor airway pressure; drain water generated by chemistry etc.
Figure 2-5 Absorber cycle
1. APL valve 7. Lower absorber
2. Inhalation valve 8. Upper absorber
3. Inspiratory port 9. Expiratory port
4. Bag/Ventilator Switch 10. Exhalation valve
5. Reservoir Bag 11. Fixation module
6. Handle 12. Airway Pressure Gauge
2.2.1.2 Principle
Gas flow schematic diagram, see Figure 2-6.
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ANASTAZJA 7500 User Manual
Bag operating
1-Expiratory gas of patient;
2-Sampling airway pressure;
3-via exhalation valve
(unidirectional);
4-bypass switch (normal close);
5-enter into absorber;
6-leave absorber;
7-fresh gas compensation;
8-Bag/Ventilator (Bag ”ON”);
9-APL valve sampling path;
10- via exhalation valve;
(unidirectional);
11-Inspiratory gas
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2 Anesthetic System Control
Ventilator operating
1-Expiratory gas of patient;
2-Sampling airway pressure;
3-via exhalation valve
(unidirectional);
4-bypass switch (normal close);
5-enter into absorber;
6-leave absorber;
7-fresh gas compensation;
8-gas of patient
9- Bag/Ventilator (Bag ”OFF”);
10- via exhalation valve;
(unidirectional);
11- Inspiratory gas
Figure 2-6 Gas flow schematic diagram
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ANASTAZJA 7500 User Manual
2.2.2 Bellows Assembly
2.2.2.1 Ports
Figure 2-7 Ports of bellows assembly
1 Breathing system connector 2 Exhaust gas port 3 Driven gas connector 4 Adapter
WARNING: Never connect exhaust gas port with sub-atmospheric system
directly. Or else leakage of breathing system generates.
The adapter can be used to connect the waste gas scavenging system to the bellows assembly if the standard pipeline is used in the waste gas scavenging system.
2.2.2.2 ventilating circulation
Inhalation primary phase:
Exhalation primary phase:
Exhalation end phase:
1 Exhalation valve
2 Driving gas
6 Driving gas
7 From patient circuit
3 Gas of patient circuit
4 Spill-over valve
5 To patient circuit
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8 Excess gas of patient circuit
2 Anesthetic System Control
2.3 Vaporizer Control
Refer to operating and maintenance manual of vaporizer for more details.
WARNING: Anesthetic vapour delivery device used with anesthetic system
must be in accordance with ISO 8835-4.
2.4 Ventilator Control
CAUTION: Anesthetic ventilator accords with ISO 8835-5.
CAUTION: Monitoring conditions of this system: Ambient temperature: 29℃℃;;;;
Air temperature: 30℃℃;;;;Air humidity: 30%; Gas component: Oxygen.
CAUTION: If the temperature of sensor is lower than dew point of breathing
gas, vapour may coagulate on the surface of sensor, and oxygen concentration monitored may be lower than practice value.
Optional function: SIMV mode, P-V loop and V-Flow loop can be added by code.
2.4.1 Front Panel
Front panel consists of display screen, keys, indicators, and a knob.
Figure 2-8 Front Panel
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ANASTAZJA 7500 User Manual
2.4.2 Keys
Mains switch key
Alarm silence key Press the key, alarm mutes for 110 seconds.
Manual mode key
Menu key
2.4.3 Indicators
Running Indicator The indicator brightly as ventilator operating.
AC Indicator The indicator brightly as AC power effectively;
Press the key and hold on for 2 second, you can start or shut off ventilator.
Press the key, change original ventilation mode to manual mode; Press again, back to the original ventilation mode.
Press the key, a “Menu” window appeared on the display screen, more details refer to section 2.5.
The indicator dark as AC power failure.
2.4.4 Knob
The user may use the rotary knob to select the menu item and modify the setup. It can be rotated clockwise or counter-clockwise and pressed like other buttons. The user may use the knob to realize the operations on the screen and in the system menu and parameter menu.
The rectangular mark on the screen that moves with the rotation of the knob is called “cursor”. Operation can be performed at any position at which the cursor can stay.
Operating method:
Move the cursor to the item where the operation is wanted
Press the knob
One of the following four situations may appear:
The background color of cursor may become into the contrast color, which
implies that the content in the frame can change with the rotation of the knob.
Pull down menu or dialogue box may appear on the screen, or the original menu
is replaced by the new menu.
Save setup.
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2 Anesthetic System Control
2.4.5 Display Screen
The display of the ventilator is a color TFT, which can display the monitoring and setting parameters, waveforms, alarm information as well as displayed on the screen. See Figure 2-9.
The screen has three areas: information area (1), monitoring area (2), and parameter setup area (3).
Figure 2-9 Display Screen
2.4.5.1 Information area
Information area lies on the top part of the screen, which is used to display the current status of the ventilator and the patient. The information area contains following components:
Figure 2-10 Information area
1 Alarm bell
When alarm appears, the color of alarm bell accords with the background color of the upper prior alarm message; press alarm silence key, “X” dashed line appears on the alarm bell, and 110 seconds counts down. More details refer to section 8.1.
2 Alarm messages
Technical alarm and functional alarm supplied by the system, and not more than two alarm messages displayed on the top of the screen. More details refer to section 8.2.
3 Power supply
Two kinds of power supply: AC power external and internal battery.
4 Ventilation mode
Five ventilation modes: VCV mode, Pressure mode, SIMV mode, Manual mode, and Standby mode.
Turn and press the knob to setup ventilation mode required, and press again to save it.
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2.4.5.2 Monitoring area
Monitoring area has two parts: Patient parameter and waveform.
Patient parameter is fixedly displayed in the left side of the monitoring area. It includes seven parameters:
Tidal volume MV: Minute volume
VT:
f: Respiratory frequency P
P
: Pressure at the end of
plat
: Peak value of airway pressure
peak
FiO2: Oxygen concentration
inspiratory pause time
C: compliance
Waveform is displayed in the right side of the monitoring area. It has four types:
Flow-t waveform, V-t waveform, Paw-V loop and V-FLOW loop.
More details refer to section 3.5.
2.4.5.3 Parameter setup area
Parameter setup area lies on the bottom part of the screen. It includes:
VT: Tidal volume f: Breaths per minute
I:E: Inspiration to expiration time TP: Inspiratory pause time
P
: Maximum airway pressure limit
limit
V
: Triggering flow sensitivity
sens
setting
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2.4.6 Rear Panel
2 Anesthetic System Control
Figure 2-11 Rear Panel
1 Display Power interface
2 Battery
3 O2 Sensor interface
4 Exhaust Port
5 Driven Gas Outlet
6 Fuse
7 Signal interface
8 P&V interface of sampling parallel line
Item Description
Use display power cable and signal cable to connect relevant interface of rear panel with interfaces on rear of display screen respectively.
Display power interface and signal interface: provide power supply
1&7
Display Power interface and Signal interface
and signal to the display.
2 Battery Refer to section 7.6
RJ 11 standard interface.
O2 Sensor
3
Interface
Use oxygen sampling line to connect O2 sensor with O2 sensor interface.
Oxygen concentration value measured by O2 sensor is transmitted to the ventilator through O2 sensor interface.
If no O2 sensor in the breathing system, the alarm message “No O2 sensor!” will be shown in the display screen.
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Don’t block exhaust port.
It is only a outlet of driven gas. Safety valve inside exhaust port may
4 Exhaust Port
be used to limit maximum of airway pressure. When airway pressure exceeding the maximum, the safety valve will open and exhaust for protecting airway of patient.
The maximum airway pressure is 6 kPa.
Size: male 16 mm taper
Use thread-tube to connect driven gas outlet with driven gas inlet of bellows.
5 Driven Gas Outlet
6 Fuse
8 P&V interface
Inspiratory phase: gas from ventilator drives bellows to make fresh gas enter into the airway;
Expiratory phase: return gas from the airway drives bellows to make gas from ventilator exhaust through exhaust port.
250V 1A 5X20(T), more details refer to section 7.5.3
Connect sampling parallel line to P&V interface, the other end to probe.
It provides basis for monitoring and troubleshooting that the real time airway pressure is transmitted to the ventilator.
Parameter monitored such as VT and MV, are calculated by ventilator basing on the flow via the probe.
CAUTION Ensure sampling line and probe connect
right, avoid liquid entering and leakage.
—— Probe of sampling and sampling parallel line
Flow of breathing cycle is measured by means of pressure difference.
Avoid water entering into the probe and sampling parallel line in the process of operating, otherwise parameter monitored will be affected.
Ensure airtightness of sampling system, if sampling device is aging,
Accessory relatively
please replace it.
Sterilization: cleaning it with sterilizing agent, then swing it
mechanically. The formation and preparation of the agent must be done in accordance with the direction given by the manufacturer.
—— O2 Sensor
Operation condition: 0.5 to 2.0 Bar. More details refer to section 7.4
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2 Anesthetic System Control
2.5 Menu
2.5.1 Operating Guide
Calibrate or carry out other process, explanation will be displayed on the screen.
A demonstration like the following steps:
Step 1
Press ”MENU” key, then display a menu window on the screen.
Step 2
Press knob to select “Return”.
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Step 3
Turn the knob to select option required such as “Wave”.
Step 4
Press the knob, then a pull down menu appears.
Step 5
Turn the knob to select option required.
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Step 6
Press the knob to save new setup.
Go to next setup or exit “System” menu.
2 Anesthetic System Control
Step 7
Exit “System” menu:
Turn the knob to select”Return”, and then press it.
Step 8
Exit “Menu”:
1. Turn the knob to select “Exit” menu, and then press it, or
2. Press “MENU” key directly.
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2.5.2 Menu diagram
See Figure 2-12. Some functions are optional.
Press ”MENU” key, the Menu window displaying on the screen.
Turn the knob to select a submenu.
Figure 2-12 Menu diagram
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3 Operating Guide
3.1 Starting System
Step 1 Connect power supply
Plug the power cord into AC power outlet. The power indicator light will be bright when power is connected.
Step 2 Power-on self-test
Press power ON/OFF key and last 2 seconds:
Display start, “RUN” indicator light brightly, and enter LOGO interface; See Figure 3-1
Later, self-testing interface appears. See Figure 3-2
If self-testing succeeds, the display works normally and the system is situated stand-by mode.
If failure, alarm message is displayed on the screen. Please carry out operation in accordance with the prompt information.
Figure 3-1 LOGO interface
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Figure 3-2 Self-testing
Figure 3-3 Self-test failure
WARNING if any unwonted malfunction appears, change bag / ventilator
switch to manual mode, stop mechanical ventilating.
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3.1.1 Alarm Limit Set
Step 1
Press ”MENU” key, then display a menu window on the screen.
Step 2
3 Operating Guide
Turn the knob to select “Alarm_set” submenu.
Step 3
Press the knob to select “Return”.
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Step 4
Turn the knob to select option required.
Step 5
Press the knob, the grounding of option displays different color and high brightness.
Step 6
Turn the knob to adjust the value.
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Step 7
Press the knob to save the new adjustment.
Go to next setup or exit “Alarm_set” menu.
Step 8
Exit “Alarm_set” menu:
3 Operating Guide
Turn the knob to select ”Return”, and then press it.
Step 9
Exit “Menu”:
1. Turn the knob to select “Exit” menu, and then press it, or
2. Press “MENU” key directly.
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3.1.2 Restore Default Set
Restore default setting includes:
Wave and P_unit items in the system submenu;
All items in the alarm_set submenu.
In a state of default, waveform display and pressure unit is “Flow-t” and ” 0.1kPa” respectively; about details of alarm setting refer to section 8.4.
Step 1
Press ”MENU” key, then display a menu window on the screen.
Step 2
Press the knob, the cursor point to “Return” automatically.
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Step 3
Turn the knob to select “Default”.
Step 4
Press the knob, and then display a dialogue box on the menu.
3 Operating Guide
Step 5
Turn the knob to select “Yes”, and then the state of “Wave” and “P_Unit” restore default setup. See section 8.4.
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Step 6
Exit “System” menu:
Turn the knob to select ”Return”, and then press it.
Step 7
Exit “Menu”:
1. Turn the knob to select “Exit” menu, and then press it, or
2. Press “MENU” key directly.
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3.1.3 Ventilation Mode Set
Current ventilation mode shown at top right corner of the display, with arrow pointed up. See figure 3-4.
Standby mode
VCV mode
Pressure mode
SIMV mode
Manual mode
Step 1
Turn the knob; make cursor point to the current ventilation mode.
Figure 3-4
3 Operating Guide
CAUTION Exit the menu before carrying out this step.
Step 2
Press the knob to make sure the grounding changed.
Step 3
Turn the knob to select ventilation mode required.
Step 4
Press the knob to save the setup.
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3.1.4 Ventilator Control Set
1. Standby mode: all parameters can be adjusted.
2. SIMV mode: f
replace f; TP and Plimit displays “- -”, it means unadjusted.
IMV
Adjustable range:
VT: 0, 50 ~ 1500 mL
f
: 1 ~ 40 times
IMV
TI: 0.5 ~ 4.0s
Vsens: 1 ~ 30L/min
3. VCV mode: Plimit and Vsens displays “- -”, it means unadjusted.
According to VT, f, I:E, TP, the flow of inspiratory phase can be calculated by the following formula:
Flow= VT ×(I+E)× f/(1000*I)(L/min)
Gas flow limit: lower: 5L/min; upper: 75L/min
4. Pressure mode: TP and Vsens displays“- -”, it means unadjusted.
5. Manual mode: all parameters displays“- -”, it means unadjusted.
Steps of setting refer to section 3.1.3.
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3 Operating Guide
3.2 Starting Auto Ventilation
WARNING: Before getting started, make sure to set the patient circuit installing
and controlling correctly.
The following procedures assume that the system is in on position and manual reservoir gas ventilating mode.
Step 1
Make sure the control settings coincide with the clinical settings.
Step 2
Set the reservoir bag / ventilator switch to auto ventilation position.
Step 3
Select auto ventilation. Refer to section 3.1.3.
Step 4
Fill the bellows with O2 flush if necessary.
Auto ventilation ON (gas goes to the bellow)
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3.3 Shutting Off Auto Ventilation
Step 1
Before stopping the auto ventilation, make sure the setting of manual circuit is complete, and the setting of APL valve is correct.
This valve is used to adjust the pressure limit of the breathing system during the manual ventilation period.
Step 2
Set the reservoir bag / ventilation switch to reservoir bag position
Select Manual ventilation, stop auto ventilation (ventilator).
Auto ventilation OFF
(gas goes to the reservoir bag)
CAUTION: Take the monitoring reading of the anesthetic ventilator rather than
the observed reading of the bellows.
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3 Operating Guide
3.4 Alarm
Alarm message displays on the top of screen.
The grounding of top prior alarms is red, but the grounding of middle prior and the lowest prior ones are yellow.
3.4.1 Alarm tone
Judging prior level from the tone of alarms:
Top prior: 5 tones, 2 hurry, 9 seconds interval, repeat
Middle prior: 3 tones, 6 seconds interval, repeat
Low prior: 2 tones
3.4.2 Alarm Silence
When alarming, press alarm silence key, eliminate sound for 110 seconds.
During the silence, spare time displayed on the screen.
Details about alarm messages refer to chapter 8.
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3.5 Waveform
1 Paw-t waveform
Y-Axis: airway pressure; X-Axis: time. More details refer to section 10.8.8.
Figure 3-5 Paw-t waveform
2 Flow-t waveform
Flow scale: -90 to 90L/min. Time scale: 0 to 15s.
Time-Axis: Positive inspiratory direction above 0L/min level; minus expiratory direction below 0L/min level; no gas flow on 0L/min level.
Figure 3-6 Flow-t waveform
3 V-t waveform
Y-Axis: Tidal volume, range: 0 to 1.2L.
Waveform of respiratory phase presents saw-shaped.
See Figure 3-7, (1) inspiratory phase; (2) expiratory phase.
Figure 3-7 V-t waveform
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4 Paw-V Loop (Optional)
Y-Axis: pressure; X-Axis: tidal volume. See Figure 3-8.
Figure 3-8 Paw-V loop
5 V-FLOW Loop (Optional)
3 Operating Guide
Y-Axis: flow; inspiratory flow above 0L/min level; expiratory flow below 0L/min level.
X-Axis: tidal volume. See Figure 3-9.
Figure 3-9 V-FLOW loop
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4 Preoperative Checkout
4.1 Anastazja7500 Preoperative Checkout procedures
Test interval Preoperative Checkout should be done in the following situation:
Before use of the first patient each day.
Before use of each patient.
After repair or maintenance.
Test schedule is given in the table below:
Before use of the first patient each day Before use of each patient
System check:
Power failure alarm test:
Gas pipeline and gas cylinder test:
Flow control test:
Vaporizer installation and test
Alarm test:
Breathing system test:
Ventilator test:
WARNING: Do not use this system before the operation and maintenance
manual are read and understood.
Whole system connection
All warnings and cautions
Using guide of each system module
Testing method of each system module
Before using this system:
Breathing system test:
Ventilator test:
Complete all tests of this section
Test all the rest of system modules
If test failure, do not use this system. Please contact service representative.
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4.1.1 System Checkout
WARNING: make sure the breathing circuit is connected correctly and in good
condition.
Make sure:
1 Equipment is in good condition.
2 All the components are correctly connected.
3 Breathing circuit is correctly connected and in good condition; there is sufficient
absorbent in the breathing system.
4 Vaporizer is in lock position and is filled with sufficient anesthetic.
5 The connection and pressure of pipeline gas supply system are correct.
6 The connected cylinder valve should be closed if there are backup cylinders.
WARNING: Do not leave the cylinder valves open during pipeline gas supply
period; otherwise, cylinder gas supply will be used up and lead to insufficient supply in case of pipeline malfunction.
7. The required emergency device is ready and in good condition.
8. The device for airway maintenance, organ cannula are ready and in good condition.
9. The applicable anesthetic and emergency medicine are ready.
10. Make sure the truckles are tight and locked and free of motion.
11. Connect the power cord to the AC power outlet. The power indicator light will light up when power is connected.
If failure, that means no electric power supplying. Exchange other sockets, close breaker, or replace power cord.
4.1.2 Mains failure alarm test
1 Press power ON/OFF key lasting 2 seconds, stand-by interface appears after
self-test.
2 After operating 5 minutes, pull out power cord.
3 Make sure that power off failure alarm occurs, it has the following characteristics:
Alarm sound;
“Mains Failure!” message displays on the screen;
Mains icon flickering.
4 Connect power cord again.
5 Make sure the alarm eliminate.
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4 Preoperative Checkout
4.2 Testing the gas supply pipeline and the gas cylinder
CAUTION: A user must confirm that gas supply is connected correctly; there
is no any disconnection, leakage, faulty connection in gas circuits and pressure indicates correctly. Stop using and check gas connections if abnormal.
CAUTION: To prevent from damage:
Open cylinder valve slowly.
Never control the flow with excessive force.
Skip step 2 if the system is not using cylinder gas supply.
1 Disconnect all pipeline gas supply and close all the cylinder valves.
If the readings of the pipeline pressure gauge and cylinder pressure gauge are not zero.
switch on O2 supply.
Adjust flow control to middle range.
Make sure all the pressure gauges are reset to zero except the O2 pressure
gauge.
Switch off O2 supply.
Make sure the O2 pressure gauge is reset to zero. The low O2 supply alarm
should be on when pressure drops.
2 Make sure cylinders are fully filled:
Open each cylinder valve.
Make sure the pressure of each cylinder is high enough. In case the pressure is
insufficient, close the corresponding cylinder valve and install a fully filled cylinder.
3 Test cylinder high pressure leak one by one.
4 Close flowmeters.
5 Open the cylinders.
6 Record the cylinder pressures.
7 Close the cylinder valves.
8 Begin to record the pressures after one minute. If O2 pressure drops to 5000kPa, it
means there is a leakage:
If leakage exists, according to direction of section 5.5, replace a new sheet gasket, and then tighten T handle.
Perform this step again. If leakage exists all the same, do not use this system.
9 Step 5 ~ 7 should be repeated for all the cylinders. N2O pressure drop in one minute
should not exceed 700kPa.
10 Close all the cylinder valves.
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CAUTION: Do not leave the cylinder valves open during pipeline gas supply
period; otherwise, cylinder gas supply will be used up and lead to insufficient supply in case of pipeline malfunction.
11 Connect pipeline gas supply.
12 Check pipeline pressure according to the table below:
ANSI (U.S. and International), Australia, Canada,
345kPa (50psig)
France and Japan
ISO, Italy, Scandinavia, South Africa, Spain and Switzerland 414kPa (60psig)
Austria and Germany 500kPa (75psig)
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4 Preoperative Checkout
4.3 Monitoring Flow Control
WARNING: Refer to Step 1 to 13 of monitoring without oxygen for monitoring
without oxygen.
Refer to Step 1 to 13 of monitoring with oxygen for monitoring with oxygen.
4.3.1 Monitoring without oxygen
WARNING: The monitoring system cannot be replaced by link system. The
fresh gas containing enough oxygen may not avoid the existence of low oxygen mixture in the breathing circuit.
If N2O exists, it will pass through the system during the test, which should be securely collected and removed.
Patients may be injured by improper gas mixture. The link system should not be used if a proper ratio of O2 and N2O is not possible.
The following procedures can test whether the link system has serious malfunction; however, it cannot determine whether the calibration is correct.
CAUTION: The gas flow switch should be adjusted slowly. Do not turn it hard
when the reading of the flowmeter goes beyond the maximum or minimum flow rate; otherwise, the control valve can be damaged and the control will not work.
Follow the steps to test the flow control:
1. Connect the pipeline gas supply or open the cylinder valves slowly.
2. Turn clockwise all the flow control till the end (minimum flow).
3. Turn on mains switch.
4. Do not use this system if the battery is not fully charged or other ventilator failure alarm occurs.
5. Make sure:
The oxygen flow is between 25mL/min and 75mL/min.
No gas flowing in any other flow tube.
Step 6 and step 7 are only applicable for the N2O system test.
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WARNING: During Step 6 to Step 7, keep link systems working state.
Only adjust testing of control (N2O in step 6 and O2 in step 7).
Adjust flow according to order (N2O firstly O2 secondly).
If adjustable range exceeds, please adjust flow control to the nearest place and perform this step again.
6. To test the flow increase of the link system:
Turn clockwise the N2O and O2 flow control till the end (minimum flow).
Turn counterclockwise the N2O flow control slowly.
Set N2O flow control to the rate described in the following table. The O2 flow must be
higher than the minimum flow limit.
Set N2O flow to
(liters per minute):
O2 flow must be higher than the minimum flow
(liters per minute):
0.6 0.2
1.5 0.5
3 1.0
7.5 2.5
7. This step tests the function of the Link System when flow is reduced, you should:
Set N2O flow to
(liters per minute):
O2 flow must be higher than the minimum flow
(liters per minute):
6.0 2.0
3.0 1.0
0.6 0.2
8. Adjust full flow of all the gas to ensure that the flowmeter float must move smoothly.
9. Shut off the oxygen supply either by closing the oxygen cylinder valve, or by disconnecting the oxygen pipeline supply.
10. Make sure:
As pressure decreases, the oxygen-supply failure alarm must continuously sound.
Disconnect the flow of nitrous oxide and oxygen to be sure that the oxygen flow will be
the last to stop.
Air flow remains.
If the oxygen is the driving gas of the ventilator, the oxygen-supply failure alarm must
continuously sound.
11. Turn all of the flow control valve knobs completely clockwise to the minimum flow.
12. Reconnect oxygen pipeline supplies or slowly open the oxygen cylinder valve.
13. Turn off mains supply.
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4 Preoperative Checkout
4.3.2 Monitoring with Oxygen
WARNING: The monitoring system cannot be replaced by link system. The
fresh gas containing enough oxygen may not avoid the existence of low oxygen mixture in the breathing circuit.
If N2O exists, it will pass through the system during the test, which should be securely collected and removed according to safe and eligible methods.
Patients may be injured by improper gas mixture. The link system should not be used if a proper ratio of O2 and N2O is not possible.
CAUTION: Before continuous testing, perform test of the O2 monitoring
device according to step 8 in section 4.6.
Follow the steps to test the flow control:
1. Connect the pipeline gas supplies, or slowly open the cylinder valve.
2. Turn all of the flow control valve knobs completely clockwise to the minimum flow.
3. Turn on mains switch.
4. Do not use this system if the battery is not fully charged or other ventilator failure alarms occur.
5. Make sure:
The oxygen flow is between 25mL/min and 75mL/min.
No gas flowing in any other flow tube.
Step 6 and step 7 are only applicable for the N2O system test.
WARNING: During Step 6 to Step 7, keep link systems working state.
Only adjust testing of control (N2O in step 6 and O2 in step 7).
Adjust flow according to order (N2O firstly O2 secondly).
The oxygen sensor being used must be calibrated correctly.
6 To test the flow increase of the link system:
Turn clockwise the N2O and O2 flow control till the end (minimum flow).
Turn counterclockwise the N2O flow control slowly.
Make sure that the oxygen flow is increasing. The concentration of the oxygen tested
must ≥ 21% during the complete process.
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7 To test the flow increase of the link system:
Set the nitrous oxide flow to 9.0L/min.
Set the oxygen flow to 3/min or higher.
Turn the flow control valve knob of the oxygen clockwise slowly.
Be sure that the oxygen flow is getting reduced. The concentration of the oxygen
tested must ≥
21% during the complete process.
8 Adjust all of the gas full flow to ensure that the flowmeter floats must move smoothly.
9 Shut off the oxygen supply either by closing the oxygen cylinder valve, or by disconnecting
the oxygen pipeline supply.
10 Make sure:
As pressure decreases, the oxygen-supply failure alarm must continuously sound.
Disconnect the flow of nitrous oxide and oxygen to be sure that the oxygen flow will be
the last to stop.
Air flow remains.
If oxygen is the driving gas of the ventilator, the oxygen-supply failure alarm must
continuously sound.
11 Turn all of the flow control valve knobs completely clockwise to the minimum flow.
12 Reconnect oxygen pipeline supplies or open the oxygen cylinder valve slowly.
13 Turn off mains supply.
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4 Preoperative Checkout
4.4 Installing and testing of vaporizer
4.4.1 Installation
WARNING: Do not take the vaporizer away from the bypass valve with its
locking lever locked.
Do not use more than one vaporizer at the same time in this system.
Install vaporizers in accordance with the following steps:
1. The vaporizer must be disassembled and reinstalled if its top is not horizontal.
2. Set the locking lever of the vaporizer so that it is locked.
3. Try to lift the vaporizer directly upwards so as to separate itself from the bypass valve, but
do not pull the vaporizer forwards. Be careful not to rotate it on the bypass valve.
4. As the vaporizer is taken away from the bypass valve, reinstall the vaporizer and then
follow step 1 to step 3. Do not use this system if you cannot put return the vaporizer to a horizontal position on the bypass valve.
5. Try on opening two vaporizers at the same time.
Testing any possible instance of each combination.
If more than one vaporizer can be opened at the same time, disassemble and reinstall
them, then perform step 1 to step 5.
4.4.2 Testing Vaporizer Back Pressure
CAUTION: About performance testing of vaporizer refer to relevant instruction
for use.
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4.5 Testing alarm
1 Connect reservoir bag to patient end.
2 Set bag/ventilator switch to ventilator control.
3 Turn on mains switch.
4 Set control options:
Ventilation mode: VCV mode
Ventilator: VT: 700ml
f: 20bpm
I:E: 1:2
Plimit40cmH2O
Anesthetic machine: O2 flow: minimum flow (25-75mL/min)
All other gas: close
Press O2 flush button to inflate bellows.
5 Set bag/ventilator switch to bag control, and then set to ventilator control again. Make sure:
Auto ventilation start.
Display right data on the screen.
Bellow assembly up and down during auto ventilation.
6 Adjust O2 flow to 5L/min.
7 Make sure:
Pressure at the end of expiration is 0cmH2O approximately.
Right data displayed on the screen.
Bellow assembly up and down during auto ventilation.
8 Test O2 monitoring and alarm:
Remove O2 sensor from the absorber cycle, and confirm that O2 concentration measured in the room air is about 21%.
Adjust lower limit of O2 concentration to 50%, and confirm that “FiO2 low!!” alarm occurs.
Adjust lower limit of O2 concentration to 21% again, and confirm that the alarm eliminates.
Put O2 sensor back to the absorber cycle.
Adjust upper limit of O2 concentration to 50% again.
Press O2 flush to charge the breathing system, and confirm that “FiO2 high!!” alarm
occurs.
Adjust upper limit of O2 concentration to 100%, and conform that the alarm eliminates.
Let O2 sensor pass pure O2 for 2 minutes, and conform that O2 concentration
measured is about 100%.
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4 Preoperative Checkout
9 Test low minute volume alarm:
Turn to “Alarm_set” menu.
Adjust lower limit of MV to 6L/min, and conform that “Minute Volume Low!!” alarm
occurs.
Turn to “Alarm_set” menu again.
Adjust lower limit of MV to 10L/min, and conform that the alarm eliminates.
10 Test high airway pressure alarm:
View P
Adjust lower limit of Paw to below P
Adjust lower limit of Paw to above P
on the screen.
peak
, and conform that “Paw high!!!” alarm occurs.
peak
, and conform that “Paw high!!!” alarm
peak
eliminates.
11 Test low airway pressure alarm:
Remove reservoir bag form the absorber cycle.
Other alarm occurs, such as “Minute volume low!!”.
Make sure that “Paw low!!” alarm occurs.
12 Test continuous high airway pressure alarm:
Set control options:
APL valve: Set to the maximum value
Bag / Ventilator switch: Bag
Set bag / ventilator switch to bag control, auto ventilation should stop.
Block up patient end and press O2 flush button.
Make sure that “Paw continuous high!!!” alarm occurs after 15 seconds approximately.
13 Turn off mains supply.
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4.6 Testing the Breathing System
Refer to the operating manual and:
Verify the non-return valve in the Breathing circuit module works normally:
The non-return exhalation valve will ascend during the exhalation period while it will descend during the inhalation period.
WARNING: Objects in the breathing system can interrupt or disrupt the
delivery of breathing system gas, resulting in possible patient death or injury:
Do not use any testing plug small enough to slip completely into the breathing system.
4.6.1 Checking Oxygen flush Switch
Press the oxygen flush button (the sound of gas should be heard from the fresh gas outlet) then release. The button must immediately drop back to its position and stop delivering the gas.
4.6.2 Testing Breathing System
Turn the switch of the anesthesia machine to Manual Bag. Pressure gauge is zeroed. APL Valve knob should be fully clockwise to the maximum. Connect the wye connector to the test lung.
Occlude the manual reservoir bag on the port below the switch. Press the oxygen flush button or open the flowmeter to make the indication of the pressure gauge achieve 3KPa, then release the button and close the flowmeter. After 20 seconds observation, the pressure indicated by the pressure gauge must not exceed 0.3KPa.
4.6.3 Testing APL Valve
Adjust the positions of every switch and knob according to the method of testing Breathing System Leak. Open the oxygen flow to 5 liters per minute. Adjust the APL valve to position the pressure of the pressure gauge in different places respectively. The common gas outlet must overflow some gas as the pressure is stable.
WARNING: Be sure that there is no any testing plug or foreign objects in the
Breathing System.
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4 Preoperative Checkout
4.7 Testing Ventilator
1 Connect the test lung to the patient circuit port.
2 Set the Reservoir bag / Ventilator switch to the Reservoir bag position.
3 Turn on mains switch.
4 Set control options:
Ventilation mode: VCV mode
Ventilator: VT: 700ml
f: 20bpm
I:E: 1:2
Plimit40cmH2O
Anesthetic machine: O2 flow: less than 200mL
All other gas: close
Press O2 flush to charge bellows.
5 Set the bag / Ventilator switch to ventilator control.
6 Press the Oxygen flush button to inflate the bellows.
7 Ensure:
Auto ventilation start.
No low pressure alarm.
Ventilator displays the correct data.
The bellows ascend and descend during the period of auto ventilation
8 Set the O2 flow control to 5L/min.
9 Ensure:
Ending expiratory pressure is about 0 cmH2O.
Ventilator displays the correct data.
The bellows inflate and scavenge during the period of auto ventilation.
10 Set the ventilator control and alarm limits to the proper clinical level.
11 Turn off mains supply and close all valves of gas cylinders if not to use the system.
12 Ensure that the things in the following table should be prepared completely.
Apparatus: Airway maintenance
Manual ventilation Organ cannula
anesthesia and emergent drugs applicably
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13 System preparation:
Close all vaporizers.
Open the APL valve.
Set the bag / ventilator switch to bag control.
Set all the flow controls to the minimum.
Be sure that the breathing system connects correctly
WARNING: Be sure that the breathing system connects correctly.
WARNING: Flush the anesthesia machine for at least one minute by using O2
with 5L/min flow speed to remove unnecessary mixed gas and objects in the system before connecting the equipment to the patient end.
WARNING: Anesthesia equipment must be connected to the waste gas
scavenging system to outlet the waste gas to prevent the staff working in the operating rooms from injury.
This requirement must be followed in the testing and clinical application.
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5 Installing and Connecting
CAUTION: O2 monitoring must be used on this equipment. For the related
stipulations, refer to local standards.
CAUTION: According to the European standard EN 740 and International
Standard IEC 60601-2-13 / ISO 8835-1, this equipment must use expiratory volume monitoring, O2 monitoring (in accordance with EN 12342 or ISO 7767) and CO2 monitoring (in accordance with EN 864 or ISO 9918).
CAUTION: Anesthetic monitoring (in accordance with ISO 21647:2004) must
be made as the anesthetic vaporizer is being used according to the European standard EN 740 and International Standard IEC 60601-2-13 / ISO 8835-1.
WARNING: Operating room environment can be influenced by the expiratory
gas. Some unexpected dangers may occur if the anesthetic has been not tested for a long time. The operator must dispose of expiratory gas in a timely fashion according as required, and examine other items to minimize the chances of danger and malfunction.
WARNING: Be sure the gas pipeline supply hoses and the breathing circuit
components are non-poisonous, do not cause patient allergy, and do not create dangerous by-product through reaction with the anesthesia gas or the anesthetic.
WARNING: To prevent generating wrong data and malfunction, please use the
cables, hoses, and tubes from FARUM S.A..
CAUTION: It is dangerous if there is anesthetic in the absorber. Measures
must be made to prevent the soda lime in the absorber from drying. Turn off all the gas supplies after finishing using the system.
CAUTION: This system can be operated correctly under IEC 60601-1-2
interference. Higher-level interference may cause alarm and result in auto ventilation suspension.
CAUTION: To avoid equipment false alarm caused by high strength electric
field:
Put the electricity surgical conducting wire far from the place
where the breathing system and the O2 sensor are put on.
Do not put the electricity surgical conducting wire on any parts
of the anesthetic system.
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CAUTION: To protect the patient, as the electricity surgical equipment is being
used:
Monitor and ensure that all the life supporting and monitoring
equipment are operated correctly.
Ensure that the backup manual ventilator can be used
immediately in case that electricity surgical equipment cannot secure the use of ventilator.
Never use electrical conduction masks or hoses.
5.1 Installing Product
5.1.1 Shelf
Unpack the bottom package, take out the shelf and lock its truckles so it cannot move freely.
5.1.2 Breathing circuit limb
Connect the breathing circuit limb to its mounting tracks, then tighten the screws.
5.1.3 Absorber cycle
When installing, hold the top plate of the breathing circuit with both hands, connect the position fixing hole to the limb post, sit it on the limb post, then tighten the knob .
1 knob 2 fixing hole 3 bolt hole
5.1.4 The bellows Assembly base
Connect the bellows assembly base to the bolt hole (3) of the absorber cycle, then tighten the screws.
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5 Installing and Connecting
5.2 Installing Absorber
CAUTION: The ANASTAZJA 7500 shall comply with configurations and
conditions under which clause 24 of the General Standard IEC 601-1.
WARNING: Follow the proper security measures:
Do not use the absorber if the anesthetic is chloroform or
trichloroethylene.
Avoid to let the skin or eyes touch the materials in the absorber.
Clean the affected part immediately and seek medical attention if materials come in contact with skin or eyes.
Do not replace absorber during the period of ventilating.
Replace the absorbent often to prevent the deposition of
non-metabolism gas as the system is not on.
Check the color of the absorbent after finishing each case. The
original color of the absorbent may be restored when not in use. Refer to the labels of the absorbent for the details.
Carbon monoxide is released if completely dried absorbent
contact with the anesthetic. Replace the absorbent for security.
Perform leakage testing of breathing system in bag control
mode after disassembling the absorber.
The absorber in this system can be used repetitious.
The capacity of each absorber is 1500mL. It is recommended to use Medisorb absorbent.
Only air, oxygen, carbon monoxide, halothane, enflurane, isoflurane, sevoflurane and can desflurane be used for the absorber.
5.2.1 When to replace absorbent
Changed color of the soda lime in the absorbent indicates that it has absorbed the carbon dioxide; however, this color is not 100% accurate. To decide whether to replace the absorbent, use CO2 monitoring machine.
Remove the changed-color absorbent immediately. The soda lime will restore its original color several hours later and that may mislead the operator.
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5.2.2 Disassembling Absorber
The absorber is reusable. Follow the disassembling procedures:
Turn on drain valve to get rid of water
1
generated by chemical reaction.
2 Rotate the handle clockwise to
disassemble the absorber.
5.2.3 Filling Absorbent
1 Remove the absorbent of absorber.
2 Cleaning and sterilization refer to section 6.3.
3 Fill the absorber with fresh absorbent after dryness. Wipe soda lime fell on the edge of
absorber, and then install it back. Make sure the airtightness is well, and that no leakage and spillage.
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5 Installing and Connecting
5.3 Connecting tubes and lines
CAUTION: CO2 monitor (in accordance with ISO 9918) should be connected at
elbow bend of patient end.
CAUTION: Anesthetic agent monitor (in accordance with ISO 21647:2004)
should be connected at pipe T installed inspiratory port.
CAUTION::::
O2 sensor should be connected at pipe T installed inspiratory port.
1 O2 sensor connector
2 pipe T
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5.4 Connecting Gas and Electricity
WARNING: IEC 60601-1-1 applies both for combination of items of medical
electrical equipment and for combinations of at least one item of medical electrical equipment with one or more items of non-medical electrical equipment. Even if there is no functional connection between the individual pieces of equipment, when they are connected to an auxiliary mains socket outlet they constitute a medical electrical system. It is essential that operators are aware of the risks of increased leakage currents when equipment is connected to an auxiliary mains socket outlet.
WARNING: The equipment connected to the power outlet will increase electric
current leakage. Test electric current leakage regularly.
WARNING: A malfunction of the central gas supply system may cause more
than one or even all devices connected to it to stop their operation simultaneously.
CAUTION: Disconnect the anesthetic workstation from the gas supply after
use to prevent contamination or pollution of the pipeline system.
CAUTION: Only the medical gas supply should be used. Other types of gas
supply may contain water, oil or other pollutants.
WARNING: All connectors of gas supply have different dimensions and
structures. It can avoid wrong operation occurs.
5.4.1 AC inlet
AC Power:
230VAC 50Hz;
5.5A Max.
Fuse:
250V6A, 5X20F
Clasp can stop power cord breaking off.
WARNING Switch the anesthesia machine to backup battery in case of AC
failure alarm, and prompt alarm message displaying on the screen.
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5 Installing and Connecting
5.4.2 Auxiliary mains socket outlet
CAUTION Auxiliary mains socket outlets operator- accessible should be not
more than four when in use ANASTAZJA 7500.
This label displays the voltage of the power supply and the rated ampere value of the circuit breaker.
Fuse: 250V 2A φ5X20(F) Maximum current outlet: 1.5A (each); 4.5A (total)
5.4.3 Serial Port
RS-232 port on the rear of display can permit serial inlet and outlet of command and data.
Signal Standard: RS232C (EIA-574)
Signal Definition: DTE configuration
Interface: DB9/M
DB-9 Connector Pin Out
Pin # Signal Name Signal Description
1 CD Carrier Detect
2 RXD Receive Data
3 TXD Transmit Data
4 DTR Data Terminal Ready
5 GND Signal Ground / Common
6 DSR Data Set Ready
7 RTS Request To Send
8 CTS Clear To Send
9 RI Ring Indicator
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5.4.4 Pipeline gas supply inlet
Pressure inlet: 280 to 600 kPa
Pipeline connector: DISS (Diameter-indexed safety system) and NIST
(non-interchangeable screw-threaded).
It can prevent wrong connection generating.
5.4.5 Cylinder gas supply inlet
Cylinder connector: PISS (Pin-indexed safety system)
It can prevent wrong connection generating.
WARNING: The connecting procedures of O2 and N2O to the rear of the
anesthesia system have been provided. Each has a different dimension to avoid user’s misoperation. A continuous pressure monitoring device is installed in the front of the anesthesia system to monitor each gas that connects with hospital supply pipelines.
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5 Installing and Connecting
5.5 How to install gas cylinder (Testing high pressure leak)
CAUTION: Do not turn the cylinder valve on when the pipeline gas supply is
being used. The gas supply of the cylinder may be used out in case of pipeline failure so that the backup supply may be insufficient.
1 Turn the handle T of the cylinder valve clockwise until it is tight. Close the valve of the
cylinder to be changed.
2 Release the yoke piece, then disassemble the cylinder.
3 Remove the valve cap from the new cylinder.
4 Keep the cylinder inlet away from all the objects which could be damaged by the release of
high pressure gas.
5 To clear the cylinder valve of any debris, use the cylinder wrench to briefly open, then close
the cylinder.
6 Install the cylinder.
Align index pin with the basic hole of the gas cylinder.
Close yoke piece and screw handle T.
7 Perform the high pressure leak test:
Disconnect the pipeline gas supply.
Close flowmeter.
Open the cylinder.
Close the cylinder.
Record the pressure of the cylinder.
If the pressure of the O2 cylinder drops more than 5000 KPa (725PSi) after one minute,
the high pressure circuit has an unacceptable leak.
If the pressure of the N2O cylinder drops more than 690 KPa after one minute, the high pressure circuit has an unacceptable leak.
Repairing gas leak
Install a fresh cylinder gasket and tighten the connector.
Repeat this step. Do not use this system in case of continuous gas leak.
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5.6 Connect gas scavenging transfer & receiving system
There are two ports releasing exhaust gas in this system. Connect the two ports to gas scavenging transfer and receiving system with tubes.
1. APL valve
2. Exhausting port of bellows assembly
See the following figure; number 2 is the exhausting port.
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6 Cleaning and sterilizing
WARNING: Use a cleaning and sterilizing schedule that conforms to your
institution’s sterilization and risk-management policies.
Refer to the material safety data policy of each agent.
Refer to the operating and maintaining manual of all the
sterilizing equipments.
Wear safety gloves and safety goggles. The O2 sensor may
leak and burn (by Chlorine Potassium Oxide) if damaged. Do not inhale fumes.
Do not inhale fume.
CAUTION: To prevent damage:
Refer to the data supplied by the manufacturer if there are any
questions about the agent.
Never use any organic, halogenate or oil base solvent,
anesthetic, glass agent, acestone or other irritant agents.
Never use any abrasive agent to clean any of the components
(i.e. Steel wool, silver polish or agent).
Keep liquids far from the electrical components.
Prevent liquid from entering the equipment.
Do not immerse the synthetic rubber components more than
15 minutes: any longer will cause inflation, or accelerating aging.
Only the components marked 134 are pressure-resistant and
heat-resistant.
The PH value of the cleaning solution must be from 7.0 to 10.5.
WARNING: Talc, zinc stearate, calcium carbonate, or corn starch that has been
used to prevent tackiness could contaminate a patient’s lung or esophagus, causing injury.
CAUTION: Never immerse the circuit O2 sensor or flow sensor connector in
the liquid.
Never dispose the circuit O2 sensor connector by using hot press.
Do not clean the inner surface of the flow sensor. Clean the outer surface by using a damp cloth.
Check if there is damage in the components. Replace if necessary.
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6.1 Cleaning and sterilization of pre-use first
Main unit
Breathing system components
Absorber cycle Washing, refer to section 6.4
Bellows assembly Washing refer to section 6.5.4
Clean the machine’s panel and all surfaces with soft cloth soaked with the water soluble sterilizing agent.
Sterilize main unit with ultraviolet radiation. Do not use acetic hyctro peroxide or formaldehyde steaming.
Refer to section 6.2
6.2 Cleanable Breathing System Components
Threaded tubes (contacted with patient),mask, Y piece connector, elbow bend, reservior bag
Threaded tubes and bag (repetitious)
Pipe T Washing to sterilize
Designed for using only once, not need to sterilize. The waste should be recovered. When to replace these expendable, products with medical level and equal specification should be selected to use.
Washing to sterilize
Sampling probe and parallel lines of flow
Components marked 134℃ are pressure-resistant and heat-resistant and can be cleaned by hand or by machine (by using the mild agent with PH < 10.5). Scrub them thoroughly, then air out to dry.
Clean the bellows assembly by disassembling them, or they will take longer to dry. To dry, hang the bellows by from its top disk while spread fully. Moisture remaining in the folds of the bellows may make the bellows tacky.
Reassemble the bellows assembly prior to the hot-press disposal. Put the bellows assembly up side down when the hot-press disposal is being processed.
Clean with soap before use of each patient, and then washing in disinfecting solution after airing.
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6 Cleaning and sterilizing
6.3 Absorber
Refer to “Disassembling the Absorber” in the section 5.2.2
WARNING: The dry absorber may be very dangerous with the presence of any
anesthetic. Take proper measures to avoid dry soda lime in the absorbent. Switch off all gas supplies after use.
6.3.1 Auto cleaning with agent or disinfector
Clean the absorber in the agent or disinfector according to the cleaning procedure.
Put the absorber in the heat-up room with the maximum temperature as 80ºC or with the room temperature.
Higher-level sterilization is recommended if the agent and disinfector cannot sterilize equipment.
6.3.2 Manual cleaning
Rinse the absorber.
Immerse the absorber completely in the sink with water and agent about three minutes at a temperature of 40 ºC (104).
Rinse the absorber.
Higher-level sterilization must be performed after cleaning by hand.
6.3.3 Advanced Sterilizing
The absorber must be cleaned before advanced sterilizing.
The absorber can be placed in high temperature and high pressure conditions. The maximum temperature recommended is 134ºC (273).
Put the soda lime into the absorber after being dried, and then tighten the knob. Clear all soda lime debris.
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6.4 Absorber assembly
1 Inhalation valve and exhalation valve
Dismount the cover of the inspiration and expiratory valves by rotating it counter clockwise, then clean all parts of them with the gauze soaked with water soluble sterilizing agent, after all parts cleaned and dried recover it in original integration. Then one must check the leakage and the movement of the inspiration and expiration valves in accordance with the required regulation and checking procedure. Please handle all parts with care preventing any damage.
2 Absorber module
Either vapouring (not more than 50ºC) or immersion sterilization can be used in practice, in case of immersion all sterilized parts must be dried with the high pressure air or oxygen before reuse.
6.5 The Bellows Assembly
This section is about disassembling, assembling, cleaning and sterilizing the bellows assembly. Read all content of this section before disassembling, assembling, cleaning and sterilizing the bellows assembly to avoid equipment malfunction and patient injury.
CAUTION: The material of the bellows is made of latex.
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6 Cleaning and sterilizing
6.5.1 Disassembling
To disassembling the bellows assembly:
(To assemble the bellows assembly, perform the steps in “Disassembling the bellows assembly” in reverse order):
1 Loosen the screws from the bellows assembly base, then remove the bellows assembly.
2 Turn counterclockwise and remove the bellows housing.
3 Detach the bellows from the base plate.
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4 Detach the top plate from the bellows.
5 Remove the bellows assembly’s adapter ring.
6 Push the locking spring to the center, and then remove the plate.
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6 Cleaning and sterilizing
7 Remove the pop-off valve diaphragm and the pop-off valve seat.
WARNING: Do not remove bellows assembly seat from diaphragm of the
pressure relief valve. This can distort the seat or diaphragm and cause injury to the patient.
8 Push to the center, then remove the locking spring.
9 Remove the seal.
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6.5.2 Testing Function
WARNING: Do not use any object small enough to slip completely into the
system when occluding the breathing system for test purposes.
WARNING: Always check the breathing system components for foreign
objects before using on a patient.
This test is to ensure all the components are installed correctly. It cannot replace the system test. The bellows assembling can be installed in case they requirement testing. Otherwise, they need to be disassembled to check and replace broken components, then reassembled and tested.
Hold the bellows assembly in hands vertically upwards to occlude the driving gas port before installing.
Invert the bellows assembly. If the descending velocity of the bellows top is no more than 100 ml/min, this could be because the driving gas port is not properly sealed, bellows or seal is not installed correctly or other component are broken and that the descending velocity exceeds the limit.
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6 Cleaning and sterilizing
Open the driving gas port to make the bellows fully spread, and then occludes the breathing system connector.
Turn the bellows assembly so it faces vertically upwards. If the descending velocity of the bellows top is no more than 100 ml/min this could be because the bellows or pop-off valve is not installed correctly or other component are broken and the descending velocity exceeds the limit.
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6.5.3 Assembly lists
1. housing 5. locking spring
2. bellows 6. seal
3. rim 7. bellows base
4. spill-over valve 8. holder
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6 Cleaning and sterilizing
6.5.4 Cleaning and Sterilizing
Follow the machine and sterilizer manufacturer’s cleaning recommendations.
1 Cleaning
1) Disassembling.
WARNING: Never separate the diaphragm and the valve seat in a pop-off valve.
2) To prevent component damage, clean them lightly. Put the recommended nonenzyme mild agent used for latex and plastic in hot water.
CAUTION: Do not immerse them more than 15 minutes to prevent inflation or
aging.
3) Rinse using clean hot water, and then dry.
CAUTION: Dry by hanging while fully spread. If moisture is left in the bellows,
they may become tacky.
4) Check the components if they are broken or damp, then perform the assembling and function test.
5) Connect the bellow assembly, ventilator and breathing system.
6) Perform the preoperative check.
2 Sterilizing
Cleaning and sterilizing must be performed at the same time. Follow instructions for the common bellows assembly sterilization methods.
Sterilizing after general patient use:
Clean the inner and outer parts of the bellows assembly in a soap-and-water solution. Rinse thoroughly in cold water, and dry with soft cloth. Immerse plastic and latex instruments in 70-80% ethyl alcohol for half an hour. Take them out using the aseptically transmits pliers, then store in clean containers. Repeat this step before next use. Components made of metal and glass can be sterilized with high pressure steam. When the steam pressure is increased by the autoclave, the rising temperature can concrete the bacterium protein rapidly to kill bacteria. In
1.05 KG/CM2 steam pressure, the temperature rises to 121C. All bacteria and most sorus can
be killed if this temperature is maintained for 15-25 minutes.
Sterilizing after special infection or infectious patient use:
Open pulmonary TB, pulmonary abscess, pseudomonas, tetanus aeruginosa infection, gas gangrene or infectious hepatitis is included. Used bellows assembly components must be completely sterilized according to preliminary and final disposal procedures.
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1) Preliminary disposal: Perform in accordance with the isolated disposal stipulation. Collect and leave all the used bellows assembly components during the operation process in the operating room. Immerse the bellows assembly components in the 1:1000 benzalkonium bromide or 1-5% cresol for 30 minutes after finishing the operation.
2) Final disposal: perform the final sterilizing disposal after the bellows assembly components are processed by the above-mentioned preliminary disposal:
Scrub the bellows assembly in a soap-and-water solution. Thoroughly rinse in cold water, and dry;
If conditions permit, suffocating the components directly contacted with patients with formald or oxirane is preferred, or perform immersing sterilization respectively. For example: the components used by open pulmonary TB patients must be immersed in 3% cresol for 30 minutes; the components used by tetanus aeruginosa infection patients must be immersed in 0.2% potassium permanganate for 30 minutes; the components used by gas gangrene patients must be immersed in 0.1% chlorhexidine for 30 minutes; the components used by pulmonary abscess patients must be immersed in 0.1% benzalkonium bromide for 60 minutes; the components used by pseudomonas patients must be immersed in 0.1% benzalkonium bromide for 120 minutes;
the components being immersed need to be rinsed by water and dried for next use;
scrub and rinse the components indirectly contacted with patients with 1-3% phenol
solution or soap-and-water solution and water. Irradiate them by using the ultraviolet ray for 30 minutes if necessary.
6.5.5 Regular Maintenance
WARNING: Do not perform any tests and repairs when the equipment is being
used to avoid patient injury.
Perform the following check every 30 days to be sure that component worn by use and daily cleaning are replaced in time.
Test by eyes
Separate the bellows assembly and anesthesia machine Disassemble the bellows assembly
WARNING: Never separate the diaphragm and the valve seat in a pop-off valve
Check each component carefully to check for cracks, distortion, dissolution, inflation and other physical changes. Replace them if necessary.
Assemble the bellows assembly, and then perform the leak test.
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7 User Maintenance
WARNING: To avoid fire:
Use the lubricant approved for anesthesia or O2 equipments’
use.
Never oil or grease any anesthesia or O2 equipment. In general,
oils and greases oxidize readily, and – the presence of O2 – are highly flammable.
All the covers or housings for the system use must be made of
static proof material, as static material may cause fire.
WARNING: Follow sterilizing control and security stipulations because used
equipment may contain blood and body fluids.
WARNING: Movable components and detachable parts can cause injury. Use
caution when system components and parts are being moved or replaced.
WARNING: No shock and strong vibration should happen during
transportation because the glass cover of flowmeter is fragile.
WARNING: Disposal of waste or invalidated apparatus must be in accordance
with the relevant policies in local government.
7.1 Repair Policy
Do not use malfunctioning equipment. Make all necessary repairs, or have the equipment serviced by an authorized FARUM S.A. Service Representative. After repair, test the equipment to ensure that it is functioning properly, in accordance with the manufacturer’s published specifications.
To ensure full reliability, have all repairs and service done by an authorized FARUM S.A. Representative. If this is not possible, replacement and maintenance of parts in this manual should be performed by a competent, trained individual with experience in Anesthesia Systems repair, and appropriate testing and calibration equipment.
CAUTION: No repair should ever be undertaken or attempted by anyone
without proper qualifications and equipment.
It is recommended that you replace damaged parts with components manufactured or sold by FARUM S.A.. After any repair work, test the unit to ensure it complies with the manufacturer’s published specifications.
Contact the nearest FARUM S.A. Service Center for service assistance. In all cases, other than where FARUM S.A. warranty is applicable, repairs will be made at FARUM S.A. current list price for the replacement part(s) plus a reasonable labor charge.
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7.2 Maintaining Outline and Schedule
The following schedule is a recommended minimum standard based upon normal usage and environmental conditions. Frequency of maintenance for the equipment should be higher if your actual schedule is more than the minimum standard.
7.2.1 User maintenance
Minimum maintaining Standard
Daily Clean the outer surface.
weekly Perform 21% O2 sensor calibration.
Planned maintaining Standard
Ventilate the system, open flowmeter, and make sure that the float move up and down smoothly. It can prevent blocking and clinging.
monthly Perform 100% O2 sensor calibration.
Test leakage of bellows assembly. (refer to section 6.5.2)
When cleaning and installing Check if any components are broken, and replace or
repair them if necessary.
As required Replace new gasket of cylinder gas supply.
Perform flow sensor calibration when flow waveform is unusual.
Replace O2 sensor (one year generally).
Open the drain valve and replace absorbent in the absorber.
7.2.2 Permissive Repairing
Minimum maintaining Standard
6 months Test electric current leakage.
6 months Test mechanical safety valve.
Planned maintaining Standard
12 months Perform the maintenance, checking, testing, calibrating
and replacing of the components stipulated in this manual by qualified individuals.
Notes: This is the recommended minimum maintaining level. Perform the local policies if they are equal to or higher than those in this manual.
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7 User Maintenance
7.2.3 Useful life estimation
CAUTION: The useful life of the following parts should be considered in
normal environment and operating requirements.
Sampling probe and parallel lines 1500 times
Threaded tubes used repetitiously Not less than 1 year
Power cord, cables, sampling line of O2 sensor
Bellows assembly (except bellows) 1500 times
Drain valve 5000 times
Battery 1 year
Lamp tubes of display 50,000 hours
Pipelines, pipe T 8 years
Main unit 8 years
8 years
7.3 Maintaining the Breathing System
Parts that are broken, crushed, worn or distorted must be replaced immediately when cleaning the breathing system.
Refer to the sections corresponding to reassembly and testing.
7.3.1 Replace O2 sensor
WARNING: Comply with the relevant rules about biohazard when to dispose
sensor. No burning.
Replacement steps:
1 Pull out the connector of sampling line from O2 sensor.
2 Pull out the O2 sensor from the pipe T.
3 Replace it with a new one, and connect the sampling line to O2 sensor.
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7.3.2 Calibrate O2 sensor
WARNING: Do not perform the calibration steps when the system connected
with patient.
When to calibrate O2 sensor, ambient pressure must be equal with monitoring pressure of delivering O2 in the patient circuit.
If operating pressure is not equal with calibrating pressure, the accuracy of reading may exceed range stated.
7.3.2.1 Calibrate 21% O2 sensor
It will cost more than 3 minutes to perform 21% O2 sensor calibration.
Before performing 100% O2 sensor calibration, 21% O2 sensor calibration must be finished.
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Step 1
Press “MENU” key, a menu window appears on the screen.
Step 2
Turn the knob to select “Cal.” submenu.
7 User Maintenance
Press the knob, the cursor appears on the “Return”.
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Step 3
Turn the knob to select “Oxygen Sensor”.
Press the knob, a new menu named “Oxygen Sensor Calibration” cover the original.
Please attention to the message on the menu.
Step 4
Press the knob, a new window named “21% Oxygen Sensor Calibration” cover the original.
Perform the operation in accordance with the prompt on the screen.
Disassemble O2 sensor from absorber cycle, and put it in the air not less than 3 minutes.
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Step 5
Press the knob to perform the calibration.
In the process of calibration, the word “Calibrating” displays on the screen.
“CAL. finish.” will be displayed on the window after the calibration succeed. Then put O2 sensor back to the patient circuit according to the prompt on the window, and perform 100% calibration.
7 User Maintenance
If 21% calibration failure, the word “CAL fault” displays on the window.
If the calibration failure occurs:
Repeat these steps to calibrate it again.
If still failure, perform 100% oxygen sensor calibration (step 7). And then calibrate 21% O2 sensor again when the 100% calibration succeeded. If not, replace O2 sensor and then recalibrate it.
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Step 6
Exit to “21% Oxygen Sensor Calibration” menu; please turn the knob to select “Return”.
Press the knob, back to ” Oxygen Sensor Calibration” menu.
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7 User Maintenance
7.3.2.2 Calibrate 100% O2 sensor
It will cost more than 3 minutes to perform 21% O2 sensor calibration.
Before performing 100% O2 sensor calibration, 21% O2 sensor calibration must be finished.
WARNING: Never to perform the calibration when the system connected with
patient.
Step 7
Turn the knob to select ”100%” option.
Press the knob, a new window named “100% Oxygen Sensor Calibration” cover the original.
Perform the operation in accordance with the prompt on the screen.
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Step 8
Press the knob to perform the calibration.
In the process of calibration, the word “Calibrating” displays on the screen.
“CAL. finish.” will be displayed on the window after the calibration succeed.
If 100% calibration failure, the word “CAL fault” displays on the window.
If the calibration failure occurs:
Recalibrate it.
Reduce airway pressure and try it
again.
If failure still exists, replace O2 sensor and perform 21% calibration.
Step 9
Press “MENU” key to exit directly.
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7.3.3 Calibrate flow sensor
Step 1
Press “MENU” key, a menu window appears on the screen.
7 User Maintenance
Step 2
Turn the knob to select “Cal.” submenu.
Press the knob, the cursor appears on the “Return”.
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Step 3
Turn the knob to select “Flow sensor”.
Press the knob, a new window named “Flow Sensor Calibration” covers the original.
Pay attention to the prompt on the screen.
Step 4
Press the knob to perform the calibration.
In the process of calibration, the word “Calibrating” displays on the screen.
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“CAL. finish.” will be displayed on the window after the calibration succeeds.
Step 5
Turn the knob to select “Return” option.
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Press the knob, back to “Cal.” menu.
Step 6
Exit: Select “Return” and press knob, then turn to “Exit” menu and press it again; or press the “MENU” key directly.
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7.3.4 Calibrate flow valve
Make sure:
Pressure range of driven gas (oxygen): 280 to 600kPa
All connections of tubes and lines should be correct
Leakage of breathing system should comply with the requirements in section 4.6
Operating 5min. at least in VCV mode: Vt500, f20, I:E1:2, TpOFF
Calibrating:
Press “MENU” key, and perform flow sensor calibration according to the steps of section7.3.3.
Input “2020” on the following figure, and press “OK”, then the calibrating starts until “Calibration finish” displays on the window. And the ventilation mode becomes standby.
During the calibrating process, press the “MENU” key to exit and the calibrating will cease.
If the calibration failure, it may be because the increase of tidal volume monitored is non-linear, just contact eligible service representative.
If password is wrong, see the following figure.
To calibrate flow valve when there be a difference of 30% between the value of tidal volume monitored and the settings.
7-14 01/2008
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