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Content 1 Safety Information ...................................................................... 1-1 2 Notices ........................................................................................ 2-1 2.1 2.2 2.3 2.4 2.5 2.6 2.7
Warranty Notice .....................................................................................................2-1 Copyright Notice ....................................................................................................2-1 EMC Notice.............................................................................................................2-1 MRI Notice..............................................................................................................2-1 Intended Use Notice...............................................................................................2-2 IEC Classification.....................................................................................................2-2 Declaration of Conformity Notice ..........................................................................2-2
3 Equipment Symbols ..................................................................... 3-1 4 Introduction ................................................................................ 4-1 4.1 4.2
General description ................................................................................................4-1 Abbreviations and Definitions ................................................................................4-2
5 Theory of Operation .................................................................... 5-1 5.1
Pneumatic System ..................................................................................................5-1 5.1.1 Pneumatic Theory ..........................................................................................5-1 5.1.2 Main Pneumatic Assemblies Overview ..........................................................5-3 5.2 Electrical System.................................................................................................. 5-12 5.2.1 Electrical Box ............................................................................................... 5-12 5.2.2 Expiratory Valve Heating Module ................................................................ 5-13 5.2.3 Rear Panel View........................................................................................... 5-14 5.2.4 Display Inside View...................................................................................... 5-15 5.2.5 ARM platform circuit board......................................................................... 5-16 5.2.6 Display interface board ............................................................................... 5-17 5.2.7 Interface Board ............................................................................................ 5-18 5.2.8 Mother Board .............................................................................................. 5-19 5.2.9 Core Board................................................................................................... 5-21 5.2.10 Main Control Board ..................................................................................... 5-22 5.2.11 Power Supply Board .................................................................................... 5-23 5.2.12 System Wiring Diagram ............................................................................... 5-24 5.3 Software System .................................................................................................. 5-30 5.3.1 Software Units and Their Relationship ........................................................ 5-30 5.3.2 Structure of the Software System ............................................................... 5-31 5.3.3 Hardware and Software Interface ............................................................... 5-32
6 Disassemble and Functional Testing ............................................ 6-1 6.1
General ...................................................................................................................6-1 i
6.2
Main Assemblies Disassemble ...............................................................................6-1 6.2.1 Disassembling of the Display from the Host ..................................................6-1 6.2.2 Disassembling of the Host from the Trolley ...................................................6-2 6.2.3 Disassembling of the Arm Assembly from the Host .......................................6-3 6.2.4 Disassembling of the Humidification Assembly from the Host ......................6-4 6.3 Disassembling of Maintenance Spare Parts ...........................................................6-5 6.3.1 Disassembling of Oxygen Sensor ....................................................................6-5 6.3.2 Disassembling of Pressure Sensor Board .......................................................6-6 6.3.3 Disassembling of Supply O2 Assembly............................................................6-7 6.3.4 Disassembling of TSI Mass Flow Sensor .........................................................6-9 6.3.5 Disassembling of Differential Pressure Transmitter .................................... 6-10 6.3.6 Disassembling of Diaphragm and Scale Board ............................................ 6-12 6.3.7 Disassembling of Core Board and Main Control Board ............................... 6-13 6.3.8 Disassembling of Components in the Display ............................................. 6-14 6.3.9 Disassembling of Electric Panel Assembly................................................... 6-16 6.3.10 Disassembling of One-way Diaphragm........................................................ 6-17 6.3.11 Disassembling of Fan Filter Cotton .............................................................. 6-18 6.3.12 Disassembling of Filter Element of Gas Inlet............................................... 6-19 6.3.13 Disassembling of Filter (Part No.:130003930)............................................. 6-20 6.4 Functional Testing ............................................................................................... 6-21
7 User Maintenance ....................................................................... 7-1 7.1
7.2
7.3
7.4 7.5
7.6
ii
Cleaning and Disinfection .......................................................................................7-2 7.1.1 Cleaning and Disinfecting Agents/ Autoclaving..............................................7-3 7.1.2 Cleaning and Disinfection Methods ...............................................................7-3 7.1.3 Cleaning and Disinfection of Components .....................................................7-4 Regular Maintenance .............................................................................................7-6 7.2.1 Maintenance Principles ..................................................................................7-6 7.2.2 User Maintenance ..........................................................................................7-6 7.2.3 Service Life of Product/Accessories................................................................7-7 Maintenance in Operation and Transportation......................................................7-8 7.3.1 Transportation ................................................................................................7-8 7.3.2 Storage ...........................................................................................................7-9 Fuse Replacement ..................................................................................................7-9 Battery Maintenance........................................................................................... 7-10 7.5.1 Battery Specification ................................................................................... 7-10 7.5.2 Precautions.................................................................................................. 7-11 7.5.3 Battery Storage ............................................................................................ 7-11 7.5.4 Battery Replacement ................................................................................... 7-11 7.5.5 Battery Charging and Calibration ................................................................ 7-12 Oxygen Sensor ..................................................................................................... 7-12 7.6.1 Oxygen Sensor Replacement ....................................................................... 7-12 7.6.2 Oxygen Sensor Calibration .......................................................................... 7-13 7.6.3 Technical Specifications of Oxygen Sensor .................................................. 7-13
7.6.4 Oxygen Sensor Maintenance....................................................................... 7-14 7.7 Paramagnetic Oxygen Sensor (optional) ............................................................. 7-14 7.7.1 Paramagnetic Oxygen Sensor Calibration ................................................... 7-15 7.7.2 Technical Specifications of Paramagnetic Oxygen Sensor ........................... 7-15 7.8 Disposal ............................................................................................................... 7-16 7.9 Manufacturing techniques and materials: .......................................................... 7-16 7.10 Free Obligations: ................................................................................................. 7-17 7.11 Security, reliability and operating condition: ...................................................... 7-17 7.12 Return.................................................................................................................. 7-17
8 Pre-Use Test ................................................................................ 8-1 8.1 8.2
Pre-use test procedure ...........................................................................................8-1 Pre-use test failure analysis ....................................................................................8-2
9 Network ...................................................................................... 9-1 9.1 9.2 9.3 9.4 9.5 9.6
10
Overview ................................................................................................................9-1 What is Exported? ..................................................................................................9-1 Establishing a Connection ......................................................................................9-1 Interface Instructions .............................................................................................9-2 Transmits and Receives Data ..................................................................................9-4 Troubleshooting .....................................................................................................9-5
Service Menu ....................................................................... 10-1 10.1
Calibration ........................................................................................................... 10-2 10.1.1 Calibration operation guidance ................................................................... 10-2 10.1.2 Calibration failure analysis .......................................................................... 10-8 10.2 Event/Alarm Log .................................................................................................. 10-9 10.3 Machine Information ........................................................................................ 10-10 10.4 Language ........................................................................................................... 10-10 10.5 Test Page............................................................................................................ 10-10 10.5.1 Demo ......................................................................................................... 10-11 10.5.2 Vlt. Monitor ............................................................................................... 10-11 10.5.3 Schematic .................................................................................................. 10-12 10.5.4 Cali. Data ................................................................................................... 10-13 10.5.5 Service Timer ............................................................................................. 10-13 10.5.6 Error Code ................................................................................................. 10-14 10.5.7 PT100 Cali. ................................................................................................. 10-14 10.6 Update ............................................................................................................... 10-15 10.7 Optional............................................................................................................. 10-16
11
Troubleshooting................................................................... 11-1 11.1
Technical Error ..................................................................................................... 11-1 11.1.1 Technical Test Error Code ............................................................................ 11-1 11.1.2 Other Errors................................................................................................. 11-4 iii
11.1.3
Service Tools ................................................................................................ 11-4
12
Appendix A Contact & Ordering Information ....................... 12-1
13
Appendix B Diagrams and Schematics.................................. 13-1
14
Appendix C Specifications .................................................... 14-1
15
Appendix D Spare parts and configurations ......................... 15-1
iv
1 Safety Information
1 Safety Information The operator of this ventilator must recognize their full responsibility for choosing appropriate ventilation settings to ensure proper ventilation and patient safety. The responsibility for the selection of the appropriate level of patient monitoring depends solely on the equipment operator. All the monitoring information is for reference only; it should not be used as the sole basis for therapeutic or diagnostic decisions. Whenever a patient is connected to the ventilator, constant attention by qualified medical personnel is required in order to provide immediate corrective action in case of a malfunction and alarm occurrence. Terms This manual uses three special indicators to convey information of a specific nature. They include:
WARNING:
Identify conditions or practices that could result in serious adverse reactions or potential safety hazards.
CAUTION:
Identify conditions or practices that could result in damage to the ventilator or other equipment
NOTE:
Identify supplemental information to help you better understand how the ventilator works.
WARNING: Do not use the system until you have read and understood this manual including:
All connections of the system All warnings and cautions Operation procedure of each and every component of the system Test procedure of each and every component of the system
WARNING: The VG70 Ventilator System is intended for use by authorized and trained medical personnel only.
WARNING: The users must familiarize themselves with the operation and use of this machine prior to first clinical use with a patient. 1-1
WARNING: To ensure proper servicing and avoid the possibility of physical injury, only qualified personnel should attempt to service or make authorized modifications to the ventilator.
WARNING: An authorized service engineer must first install the ventilator and run Aeonmed’s installation procedure, which includes calibration of various system components, before you connect a patient to the ventilator.
WARNING: If a fault is detected in the VG70 ventilator so that its life support functions are no longer assured: start ventilation using an independent ventilation device (resuscitation bag) without delay, if necessary with PEEP and/or increased inspiratory O2 concentration.
WARNING: Before activating any part of the ventilator, be sure to check the equipment for proper operation and, if appropriate, run PUT (pre-use test) as described in this manual,
WARNING: The VG70 ventilator is not intended to be a comprehensive monitoring device and does not activate alarms for all types of dangerous conditions for patients on life-support equipment.
WARNING: Patients on life-support equipment must be appropriately monitored by competent medical personnel and suitable monitoring devices at all times.
WARNING: An alternative source of ventilation, such as manual respiratory equipment, should always be available when using the VG70 ventilator.
WARNING: Do not connect inspiratory or expiratory circuits to the exhaust port.
WARNING: Ensure that inspiratory and expiratory circuits are connected to the correct port before operation of equipment.
WARNING: The expiratory gas pathway may become contaminated with body fluids or expired gases during normal use, and the inspiratory gas pathway may become contaminated during fault condition, such as occlusion, breath hoses disconnection.
1-2
1 Safety Information
WARNING: Disposable breathing hoses shall not be reused. Reuse of the single use hoses can cause cross infection.
WARNING: Assure that hoses used have the appropriate resistance and compliance to ensure proper therapy.
WARNING: Do not disconnect the cable between the Main Control Unit and the GUI screen while Ventilator is operating.
WARNING: The ventilator must not be connected to any anti-static or electrically conductive hoses, tubing or conduit
WARNING: Adding attachments or other components or sub-assemblies to the ventilator breathing system can change the pressure gradient across the ventilator breathing system and that such changes to the ventilation breathing system can affect the ventilator performance.
WARNING: Expiratory module is heated; use caution to avoid burns.
WARNING: Use caution when handling flammable or fragile components.
WARNING: Do not place containers of liquids (such as humidifier water reservoirs) on top of or above ventilator. Liquids getting into the ventilator can cause equipment malfunction with the risk of patient injury.
WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth. CAUTION: The breathing circuit must not be installed whenever the VG70 powers up and whenever a pre-use test is performed.
CAUTION: If the system test fails, do not use the system. Attempt to troubleshoot and fix the failure. If you are unable to fix the device, ask an authorized service representative to repair the device.
1-3
CAUTION: Check the ventilator periodically as outlined in this manual; do not use if defective. Immediately replace parts that are broken, missing, obviously worn, distorted, or contaminated.
CAUTION: Do not put ventilator into service until the patient setup is complete.
CAUTION: Measurements can be affected by mobile and RF communications equipment.
CAUTION: Do not use oxygen hoses that are worn, frayed, or contaminated by combustible materials such as grease or oils. Textiles, oils, and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen.
CAUTION: Follow your hospital infection control guidelines for handling infectious material. Aeonmed recognizes that cleaning, sterilization, sanitation, and disinfection practices vary widely among health care institutions. It is not possible for Aeonmed to specify or require specific practices that will meet all needs, or to be responsible for the effectiveness of cleaning, sterilization, and other practices carried out in the patient care setting.
CAUTION: Equipment not suitable for use in the presence of a Flammable Anesthetic mixture with Air or with Oxygen or Nitrous Oxide.
CAUTION: To avoid an electrical shock hazard while servicing the ventilator, be sure to remove all power to the ventilator by disconnecting the power source and turning off all ventilator power switches.
CAUTION: To avoid a fire hazard, keep matches, lighted cigarettes, and all other sources of ignition (e.g., flammable anesthetics and/or heaters) away from the ventilator and oxygen hoses.
CAUTION: In case of fire or a burning odor, immediately disconnect the ventilator from the oxygen supply, facility power and backup power source.
CAUTION: During operation, do not block: Speaker Holes, Exhaust Port, Air Inlet or Cooling Fan.
1-4
1 Safety Information
CAUTION: Do not use the VG70 Ventilator in a MRI environment.
CAUTION: The ventilator shall not be used in a hyperbaric chamber.
CAUTION: The ventilator shall not be used with helium or mixtures with helium.
CAUTION: Tip over hazard; use care when moving ventilator mounted to cart as device could tip over leading to injury or damage of equipment.
CAUTION: Do not use sharp objects to make selections on the LCD touch screen or panel.
CAUTION: Do not connect a VGA or USB interface while the system is in service
CAUTION: The Network interface connection is for authorized service only.
CAUTION: Batteries should be removed if equipment will not be in service for more than 6 months.
CAUTION: Do not immerse the oxygen sensor or the connector in any type of liquid.
CAUTION: When ventilator is exposed to conditions outside the specified operating environment, allow 24 hours in normal environment before using. CAUTION: Storage environment: -20℃~+60℃ and ≤95%RH.
CAUTION: Operating environment: 5℃~40℃ and 5%RH~95%RH.
CAUTION: Do not connect items that are not specified as part of the system.
CAUTION: The auxiliary outlet is only for the recommended humidifier; do not connect to any other equipment or an additional multiple socket outlets.
CAUTION: When using a humidifier, user should frequently check the water trap and look for water in the hose. If water is found in the hose, this water should be removed. 1-5
Also, it is important the water trap is positioned in a way such that it is lower than the patient tubes.
CAUTION: Connecting electrical equipment to auxiliary outlet effectively leads to creating a medical equipment system, and can result in a reduced level of safety, make sure the ME SYSTEM comply with requirements of IEC 60601-1:2005. The user who connects is responsible for the standard for the requirements applicable to the medical equipment system. CAUTION: USA Federal law restricts this device for sale by or on the order of a physician. NOTE: The user of this product shall have sole responsibility for any ventilator malfunction due to operation or maintenance performed by anyone not trained by Aeonmed.
NOTE: Usage of a filter on the expiratory side will increase the resistance of the patient circuit.
NOTE: In non-invasive (NIV) ventilation, the exhaled volume of the patient can differ from the measured exhaled volume due to leaks around the mask
NOTE: Do not sterilize or immerse the Mainstream CO2 Adapter in any fluids.
NOTE: All parts of the ventilator system are suitable for use within the patient environment.
NOTE: All gas volume, flow, and leakage specifications in this manual are expressed at STPD (standard temperature and pressure dry), except when specified with another condition.
1-6
2 Notices
2 Notices 2.1
Warranty Notice
Do not make any service repairs on this equipment during the states warranty period. Any unauthorized work immediately voids the warranty. Aeonmed will not be liable for any repairs attempted by the owner. Any such attempted repairs other than specified no warranty repairs void the warranty.
2.2
Copyright Notice
Copyright Notice: Aeonmed. This work is protected the copyright law and is the sole property of the Company. No part of this document permitted to be copied or otherwise reproduced, translated into other languages, or stored in any electronic information retrieval system, without the prior written consent of the Company.
2.3
EMC Notice
This equipment can radiate radio frequency energy ,as well can be interfered by electromagnetic If not installed and used in accordance with the instructions mentioned in the manual, electromagnetic interference may result. The equipment has been tested and found to comply with the limits set forth in EN60601-1-2 for Medical Products. These limits provide reasonable protection against electromagnetic interference when operated in the intended use environments described in this manual. The ventilator has been tested to conform to the following specifications: MIL-STD-461D: 1993, MIL-STD-462D:1993, EN 55011:2007+A2:2007, IEC 1000-4-2: 1994, IEC 1000-4-3:1994 IEC 1000-4-4:1994, IEC 1000-4-5:1994, QUASI-STATIC:1993 This ventilator is also designed and manufactured to comply with the safety requirements of IEC 60601-1, IEC 60601-2-12, CAN/CSA C22.2 No. 601.1-M90, and UL 60601-1.
2.4
MRI Notice
This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic fields. Do not operate the ventilator in a MRI environment or in 2-1
the vicinity of high-frequency surgical diathermy equipment, defibrillators, or short-wave therapy equipment. Electromagnetic interference could disrupt the operation of the ventilator.
2.5
Intended Use Notice
The VG70 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for use in a wide variety of clinical conditions. Specifically, the VG70 Critical Care Ventilator is applicable for adult and pediatric patients weighing at least 5 kg for adult and 3 Kg for child (7lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation. The VG70 Critical Care Ventilator is intended for use in hospital and hospital-type facilities. It may be used during intra-hospital transport provided that electrical power and compressed gas are supplied. WARNING: The VG70 Ventilator is not designed for use in an MRI environment. Do not use the VG70 Ventilator near an MRI machine or injury or equipment damage could result. WARNING: The user of the Ventilator must be professional and trained.
2.6
IEC Classification
Type of Equipment: Medical Equipment, Class I, Type B. Adult/Pediatric Lung Ventilator
2.7
Declaration of Conformity Notice
This medical equipment complies with the Medical Device Directive, 93/42/EEC, and the following Technical Standards, to which Conformity is declared: IEC 60601-1: The device classification is: Class I, Type B applied part (ventilator breathing circuit and mask), type BF applied part (CO2 module), ordinary enclosed equipment without protection against ingress of liquids, continuous operation ISO 80601-2-12 IEC 60601-1
2-2
3 Equipment Symbols
3 Equipment Symbols Warnings and
Cautions indicate all the possible dangers in case of violation of the
stipulations in this manual. Refer to and follow them.
Warnings Indicate potential hazards to operators or patients.
Cautions Indicate potential damage to equipment. Instead of illustrations, symbols may be utilized. Not all of these symbols may necessarily appear on the equipment or in this User manual. The symbols include:
On (Power)
Protection Class Type B
Off (Power)
Protection Class Type BF
Follow operating instructions
Warning & Caution
Protective earth ground
Dangerous voltage
EQUIPOTENTIAL connection
loudspeaker
Lock
Manufacturer
Unlock
Date of production
Inspiratory hold
Serial Number
3-1
Nebulization
Expiratory hold
Intelligent increase of oxygen
Manual inspiration
Standby
Waveform freeze
AC power
Internal Battery
USB device
Refer to documentation
Prompt message
Already online
Flow trigger
Pressure trigger
Adult
Manual trigger
NIV modes
Child
Main Menu
Invasive modes
neonate
Alarm Silence Key
Do not reuse
Disposal of Waste
The system, with this label under the stipulations in the operating manual, complies with the requirements related from 93/42/EEC. 0123 is the certificate number to certify authorizations
3-2
int.
4 Introduction
4 Introduction 4.1
General description
The VG70 Critical Care Ventilator System consists of two required components: a Main Control Unit and a Graphical User Interface (GUI). Optional Components available for the VG70 Critical Care Ventilator system are: Ventilator Cart, Gas Cylinder Transport Cart, Patient Circuit Positioning Arm, and Hose Assemblies for O2, CO2 monitoring subsystem, etc.
1
Main Control Unit
2
Humidifier
3
Patient Circuit
4
Water Trap
5
Nebulizer Tube
6
Y-piece
7
Test Lung
8
Mask
9
Connector
10
Nebulizer Connector
11
Patient Circuit Positioning Arm
4-1
4.2
Abbreviations and Definitions
(S)
Means Set Value
(M)
Means Measured Value
CPAP
Continuous Positive Airway Pressure (Set value, hereinafter “S”)
F
Breath rate (frequency) in bpm, i.e. ventilation times per minute (S) Patient’s
fspont
spontaneous respiratory frequency (Measured
value,
hereinafter “M”) Total breath rate, i.e. the sum of breath rate f and spontaneous breath
ftotal
rate fspont(M)
O2
Inspiratory O2 concentration (S & M)
I:E
The ratio of Inspiration to Expiration (M)
MV
Expiratory minute volume (M)
MVspont
Spontaneously breathed minute volume(M)
MVleak
Leakage minute volume (M)
Paw
Patient airway pressure (M) Positive End-Expiratory Pressure, which can improve the patient’s
PEEP oxygenation (S & M) PEEPi
Intrinsic Positive End-Expiratory Pressure (M)
Pinsp
Upper pressure level in PCV mode (S) Mean airway pressure. This value is updated at the end of the last
Pmean
4-2
respiratory cycle, hence, is a continuous average (M)
Ppeak
Airway pressure peak value during one ventilatory cycle (M)
Pplat
End-inspiratory airway pressure (M)
Pmin
Minimum airway pressure (M)
Psens
Pressure sensitivity (S)
4 Introduction
Psupp
Pressure support (S)
Phigh
Upper pressure level in BIVENT and APRV (S)
Plow
Lower pressure level in BIVENT and APRV (S)
T Imax
Maximum inspiratory time (S)
Tinsp
Inspiratory Time (S) Inspiratory Pause Time, to increase the inspiratory time to improve the
T pause
patient’s oxygenation (S) Trigger by flow rate (S)
VT
Tidal volume of mechanical ventilation (S)
VTE
Expiratory tidal volume (M)
VTI
Inspiratory tidal volume (M)
Esens
Expiratory trigger sensitivity (S)
ETCO2
End-expiratory CO2 concentration (M)
WOB
Work of breathing (M)
R*C
Time constant (M)
Leak%
Leakage percentage (M)
Cdyn
Dynamic compliance (M)
Cstatic
Static compliance (M)
Rinsp
Inspiratoryresistance (M)
Rexp
Expiratory resistance (M)
Elastic
Elastic resistance (M)
IP21
Solid particle protection level 2; Liquid ingress protection level 1
4-3
5 Theory of Operation
5 Theory of Operation 5.1
Pneumatic System
5.1.1 Pneumatic Theory
5-1
Figure 5-1 Pneumatic Theory
5-2
5 Theory of Operation
5.1.2 Main Pneumatic Assemblies Overview
4 1
2 3
Figure 5-2 Main Airway Assemblies sketch view 1
Turbine driver
2
Expiratory valve module
3
Gas circuit module
4
Electrical box
5-3
Pneumatic Connecting Diagram
4
7
Figure 5-3 Pneumatic Connecting Diagram PU tube φ6
Silica gel tube φ2x1.5
Silica gel tube φ1x1
5-4
1
Oxygen inlet module
2
Oxygen supply module
3
Inferoanterior shell components
4
Differential pressure transmitter
5
MMB
6
Safety inspiration module
7
Exhalation valve components
5 Theory of Operation
Gas Circuit Module
1
2
3
5
4
Figure 5-4 Gas circuit module 1
Differential pressure transmitter
2
Interface board
4
Pressure sensor board
5
Fan
3
Inspiratory flow sensor
5-5
Oxygen Inlet Module Overview
Figure 5-5 Supply Oxygen Module item
Description Gas flow direction
5-6
1
Oxygen connector, connecting with oxygen supplies.
2
Low flow oxygen connector, connecting with low flow oxygen supplies.
3
Inlet filter, filtering impurities from the oxygen.
4
Pressure sensor, monitoring the pressure of high-pressure oxygen gas.
5
one-way valve
6
Regulator valve, regulating gas pressure to 0.28MPa
5 Theory of Operation
7
Connector, connecting with oxygen mixer module, supply low flow oxygen
8
Connector, connecting with oxygen mixer module, supply high pressure oxygen
9
Inlet filter
Supply Oxygen Module Overview
Figure 5-6 Oxygen Mixer Module Item
Description Gas flow direction
1
Connector, connecting with connector 7(low flow oxygen) in Figure 5-5 Supply Oxygen Module
2
Connector, connecting with Turbine and Inspiratory Control Module
3
Solenoid valve V1-V4, Flow 30L/min
4
Connector, connecting with connector 8(high pressure oxygen) in Figure 5-5 Supply Oxygen Module
5
Connector, connecting with nebulizer pipe
6
Solenoid Valve V9, controlling whether affording the oxygen to nebulizer 5-7
7
Solenoid valve V7-V8, Flow 4L/min
8
Solenoid valve V5-V6, Flow 12L/min
Turbine and Inspiratory Control Module Overview
Figure 5-7 Turbine and Inspiratory Control Module
5-8
5 Theory of Operation
Item
Description Gas flow direction
1
Inspiratory Valve, control of inspiratory flow and pressure
2
Connector, connecting with the pressure sensor of mother board
3
Air intake, including air filter
4
Mixing chamber, mixing oxygen and air
5
Muffler
6
Turbine
7
Radiator
8
Flow sensor, monitoring the volume of the gas
9
Muffler
10
Connector, connecting with safe inspiratory module
Safety Inspiratory Module Overview
5-9
Figure 5-8 Safety Inspiratory Module Item
Description Gas flow direction
5-10
1
Inspiratory connector, connecting with silica gel tube for patient
2
Oxygen sensor, monitoring the oxygen density of mixed gas
3
Relief valve
4
Emergency air inlet
5
Connector, connecting with flow sensor
6
One-way valve
7
Connector, connecting with the pressure sensor of mother board
5 Theory of Operation
Expiratory Module Overview
1
2
Figure 5-9 3
4
Figure 5-10 Item
Description Movement direction
1
Connector, connecting with pressure sensor of mother board.
2
Driving valve
3
Press the lock nut of the expiration valve, unlock, then pull out the component.
4
Water trap
5-11
5.2
Electrical System
5.2.1 Electrical Box
3
2 1
4
1
5 6 7
Figure 5-11
5-12
1
Core board
2
Main control board
3
Battery box
4
Battery
5
Power supply board
6
Mother board
7
Switch power
5 Theory of Operation
5.2.2 Expiratory Valve Heating Module
1
2
Figure 5-12
1
Temperature sensor
2
Heating resistor
5-13
5.2.3 Rear Panel View
Figure 5-13
1
CO2 module connector
2
Nurse call connector
3
DC power fuse
4
Air inlet
5
Oxygen inlet
6
Fan
7
Equipotential terminal
8
DC power input port
9
Power switch
10
AC power input socket
11
Battery cover
5-14
5 Theory of Operation
5.2.4 Display Inside View
Figure 5-14
1
Indicator light board
2
Speaker
3
Mute key board
4
Encoder board
5
Display cable
6
Display platform circuit board
7
Display connector
8
VGA connector
9
USB connector
10
NET connector
11
Touch screen controller
12
Alarm LED board
5-15
5.2.5 ARM platform circuit board
Figure 5-15
5-16
1
Power supply indicate lamp board connector
2
Backlight cable connector
3
Mute button board connector
4
Encoder board connector
5
Display cable connector
6
Interface board connector
7
Touch screen control board connector
8
Alarm light board connector
9
LVDS cable connector
10
Speaker cable connector
5 Theory of Operation
5.2.6 Display interface board
Figure 5-16
1
CN1 interface (Connect Display platform circuit board)
2
VGA interface
3
USB 2 interface
4
USB 1 interface
5
NET interface
5-17
5.2.7 Interface Board
Figure 5-17
5-18
1
Signal
2
Motor controller
3
Insp. valve
4
Turbine
5
Fan
6
Turbo tempeture sensor
7
PEEP valve
8
Expe. valve heating
9
Expe. flow sensor board
10
O2 sensor
11
Expe. valve tempeture sensor
12
TSI sensor
13
Power in
5 Theory of Operation
5.2.8 Mother Board
Figure 5-18 Front of mother board
Figure 5-19 Back of mother board
1
Core board slot
2
Reserved
3
Analogy slot
4
Lithium-ion battery 1 connector
5
Lithium-ion battery 2 connector
5-19
6
PSB slot
7
Main switch connector
8
24VDC input connector
9
DC power input connector
10
Display connector
11
Reserved
12
Reserved
13
Motor controller connector
14
Reserved
15
O2 supply pressure sensor
16
Paramagnetic oxygen sensor connector (optional)
17
Interface board signal line connector
18, 19 20
5-20
Solenoids cable connector Interface board power line connector
5 Theory of Operation
5.2.9 Core Board
Figure 5-20
1
Mother board connecting connector
2
DSP_JTAG
5-21
5.2.10 Main Control Board
Figure 5-21
5-22
1
Mother board connecting connector
2
CO2 module connector
3
Nurse call connector
5 Theory of Operation
5.2.11 Power Supply Board
3
Figure 5-22
1
Mother board connecting connector
5-23
5.2.12System Wiring Diagram BOM size and diagram： No.
BOM size
1
122007322
Fan cable
2
122007320
Interface board signal cable
3
122007321
PT100 signal cable
4
122008090
Expiration valve heating component
5
122008011
Magnetic base component
5-24
Name
Diagram
5 Theory of Operation
No.
BOM size
Name
6
122007331
Oxygen supply pressure cable
7
122007327
Expiration flow sensor cable
8
122007329
TSI sensor cable (analog)
9
122007330
TSI sensor cable (digital)
10
122007328
Oxygen sensor signal cable
Diagram
5-25
No.
BOM size
11
122007315
Valve terminal drive cable (30L)
12
122007316
Valve terminal drive cable (12L)
13
122007317
Valve terminal drive cable(4L)
14
122007319
Interface board power cable
15
122007478
Turbine driver component
5-26
Name
Diagram
5 Theory of Operation
No.
BOM size
Name
16
122007336
Switch power output cable
17
122012312
W0056 cable
18
122007486
Power lamp component
19
122007484
Speaker component
20
122007483
Mute button component
21
122012310
W0054 cable
Diagram
5-27
No.
BOM size
22
122007455
Switch mounting plate component
23
122007463
Inspiration control valve
24
122007482
Encoder component
25
122007485
Alarm lamp component
26
122007503
Copper woven mesh cable
5-28
Name
Diagram
5 Theory of Operation
No.
BOM size
Name
27
122012313
W0057 cable
28
122012311
W0055 cable
29
122009449
W0001 cable (optional)
30
122001124
W1 cable
Diagram
5-29
5.3
Software System
5.3.1 Software Units and Their Relationship User Interface Software Unit bears the responsibility of user interface of the whole software system. It includes operation interface for the users, graphic interface for showing information of the device, communication with other units, etc. Breathing Delivery Software Unit bears the responsibility of ventilation control. Power Supply Software Unit bears the responsibility of power management. The relationship between these three units is as following: User Interface SW Unit
Breathing Delivery SW Unit
Power Supply SW Unit
Figure 5-23 Software Units of NBP System In above figure, the orientation of arrow points to information is flowing to where. Furthermore, a bidirectional arrow means communication between SW units is bidirectional.
5-30
5 Theory of Operation
5.3.2 Structure of the Software System
Figure 5-24 Structure of Software Units
5-31
5.3.3 Hardware and Software Interface
Figure 5-25 Interface between Software and Hardware System
5-32
6 Disassemble and Functional Testing
6 Disassemble and Functional Testing 6.1
General
The ventilator is packaged with two cartons. One carton filled with cart. Another carton filled with ventilator main units, display, and accessories crate. Accessories crate including standard accessories and optional accessories. Standard accessories are divided into European standard and American standard, the optional accessories is changed based on order. Details please refer to Appendix D configuration List.
6.2
Main Assemblies Disassemble
6.2.1 Disassembling of the Display from the Host
Figure 6-1 To separate the display from the host: pull out the display (1) along the guide (2).
6-1
6.2.2 Disassembling of the Host from the Trolley
Figure 6-2 To separate the host from the trolley a.
Remove the screw (2);
b.
Remove the host (1) along “
c.
Remove the host installing piece (3) from the tray connector (4).
d.
Lift up the host (1);
” direction;
NOTE: When installing the host to the trolley, please align the host installing piece with the tray connector.
6-2
6 Disassemble and Functional Testing
6.2.3 Disassembling of the Arm Assembly from the Host
Figure 6-3 To separate the arm assembly from the Main Control Unit a.
Pull out the knob plunger(1);
b.
Remove the arm assembly (3) from the handrail (2).
6-3
6.2.4 Disassembling of the Humidification Assembly from the Host
Figure 6-4 To separate the humidification assembly from the host: remove the humidification assembly (1) from the guide-rail (2) along “
6-4
” direction.
6 Disassemble and Functional Testing
6.3
Disassembling of Maintenance Spare Parts
6.3.1 Disassembling of Oxygen Sensor
Figure 6-5 To separate the oxygen sensor from the host: a.
Pull out oxygen sensor cover(1);
b.
Remove the oxygen sensor(2).
6-5
6.3.2 Disassembling of Pressure Sensor Board
Figure 6-6 To remove the pressure sensor board from the host: a.
Remove the six screws (2) (Cross recessed Pan head screw M4x8);
b.
Move the side panel(1) to a side;
c.
Disconnect the cable connector of the pressure sensor;
d.
Remove the two screws (3) (Cross recessed Pan head screw M3x6);
e.
Remove the pressure sensor board (4).
Test: When you replaced the oxygen pressure sensor, turn on the machine to check if the oxygen pressure value is back to normal.
6-6
6 Disassemble and Functional Testing
6.3.3 Disassembling of Supply O2 Assembly 1
2
Figure 6-7 a. Remove the screws (Hexagon socket head cap screws M4×16) of the upper cover, and remove the upper cover (1); b. Remove the inlet link block of the oxygen inlet module, and remove the filter cover of the air inlet. c. Remove the screws (Cross recessed Pan head screw M3x6) of the lower rear cover, and remove the lower rear cover (2);
1
Figure 6-8 d. Remove the screws of the electrical box, pull out the three connectors(2, 3 4) of supply O2 module from the mother board of the electrical box (5), and then remove the electrical box (1);
6-7
1
1
2
Figure 6-9 e. Remove the four screws (1) (Cross recessed Pan head screw M3x25); f. Remove supply O2 module (2).
6-8
6 Disassemble and Functional Testing
6.3.4 Disassembling of TSI Mass Flow Sensor
Figure 6-10 To remove TSI mass flow sensor from the host: a.
Remove the six screws (2) (Cross recessed Pan head screw M4x8);
b.
Move the right cover to a side(1);
c.
Disconnect the two cables of TSI mass flow sensor;
d.
Drag out the TSI mass flow sensor along “
” direction (3).
Test: When the TSI mass flow sensor is replaced, the inspiratory valve must be calibrated. Please refer to Chapter 10.1.
6-9
6.3.5 Disassembling of Differential Pressure Transmitter 3
2
1 Figure 6-11 To remove the differential pressure transmitter from the host: a. Remove the handle (1), and then remove the host from Cart assembly; b. Remove screws, and then remove the two side covers (2); c. Remove Head cover components (3);
6-10
6 Disassemble and Functional Testing
2 1
Figure 6-12 d. Remove the Electrical box components backwards to the right place (1); e.
Remove the differential pressure transmitter (2).
Test: When the differential pressure transmitter is replaced, the inspiratory valve must be calibrated. Please refer to Chapter 8 and Chapter 10.1.
6-11
6.3.6 Disassembling of Diaphragm and Scale Board
Figure 6-13
Figure 6-14
To remove the diaphragm and the scale board from expiratory module assembly: a.
Press the button(1 in Figure 6-13);
b.
Pull out the expiratory valve core component (2 in Figure 6-13);
c.
Remove the end cover (1 in Figure 6-14) and the gasket (2 in Figure 6-14);
d.
Remove the scale board (3 in Figure 6-14) and the diaphragm (4 in Figure 6-14).
Test: When the diaphragm and scale board are replaced, the inspiratory valve must be calibrated. Please refer to the Chapter 10.1; Also perform a pre-use test and verify all test pass Refer to Chapter 8.
6-12
6 Disassemble and Functional Testing
6.3.7 Disassembling of Core Board and Main Control Board
Figure 6-15 Remove of the core board and control board: a.
Remove the four screws(1) (Cross recessed Pan head screws M3×6);
b.
Remove the electric board cover (2);
6-13
c.
Pull out the core board (3);
d.
Pull out the main control board (4).
Test: when you replaced the core board and main control board. Cut off the battery, connect the alternating current, and check if the machine operates normally.
6.3.8 Disassembling of Components in the Display a. Remove the four screws (1) (Cross recessed countersunk head screw M4×8), take off the rear shell hanger and hanging block interface board (Figure 6-16);
Figure 6-16 b. Pry the back-shell of display open with the tool. You can use the tool to pry the black circle signed places (Figure 6-17).
Figure 6-17 6-14
6 Disassemble and Functional Testing
c. Open the back-shell slowly and remove the back-shell. d. Remove the six screws (2) (Cross recessed Pan head screws M3×6), and then remove the shielding mask (1) (Figure 6-18);
Figure 6-18 e. The components in the display can be easy to be taken away.
6-15
6.3.9 Disassembling of Electric Panel Assembly
Figure 6-19 a. Remove the four screws (1) (Cross recessed Pan head screws M3×6); b. Remove the electric panel cover (2); c. Remove the power supply board component (3). Test: When any circuit board has been removed and or replaced, you must perform ad calibration on all sensors and perform a pre-use check prior to use. Please refer to Chapter 8 and Chapter 10.1.
6-16
6 Disassemble and Functional Testing
6.3.10 Disassembling of One-way Diaphragm
Figure 6-20 To remove the one-way diaphragm： a)
Remove the expiratory valve core component;
b)
Remove the one-way valve core component (1);
c)
Remove one-way diaphragm(2);
Test: When the one-way diaphragm has been replaced, the inspiratory valve must be calibrated. Please refer to chapter 8 and chapter 10.1.
6-17
6.3.11 Disassembling of Fan Filter Cotton
Figure 6-21 To remove the fan filter cotton:
6-18
a.
Remove the fan filter cotton cover(2)；
b.
Remove the fan filter cotton(1).
6 Disassemble and Functional Testing
6.3.12 Disassembling of Filter Element of Gas Inlet
Figure 6-22 To remove filter element of gas inlet: a.
Remove the filter cover(1)；
b.
Remove the filter support sleeve(2);
c.
Remove the filter element of gas inlet(3).
6-19
6.3.13 Disassembling of Filter (Part No.:130003930)
Figure 6-23 To remove the filter:
6-20
a.
Remove the two screws (1) (Hexagon socket head cap screws M4×10)；
b.
Remove the oxygen inlet connector(2);
c.
Remove the filter (3).
6 Disassemble and Functional Testing
6.4
Functional Testing
Note: Before the functional testing you need to set ventilator in standard states. Ventilator standard working states: Breathing patterns: A / C (VCV); Inspiratory time: 1 seconds; Breath-hold time: 0 seconds; Respiratory rate: 20 beats/min; Tidal volume: 400 ml; The upper pressure limit: 80 cmH2O; Pressure lower limit: 0 cmH2O; Oxygen concentration: 21%; Trigger sensitivity: -3 cmH2O; PEEP: 3 cmH2O; Gas source rated working pressure: 0.4 mpa. Test items
Alarm sound and alarm lamp test
The mute button
Test point
Inspection standards Advanced alarm: flashing red light, 10-pulse cycle play an alarm sound.
Respectively to trigger the high, middle, low-level alarm, observe warning lights and alarm sounds
Intermediate warning: flashing yellow light, 3-pulse cycle play an alarm sound. Low-level alarm: yellow light, a single alarm sound of the two pulse.
Unplug piping appear sound the alarm, press the mute button;
Press the mute button after the sound the alarm disappears, the Screen 120s countdown;
6-21
Tidal volume
In standard work status, breathing test device is connected to ventilator inspiratory port in VCV mode, after the output tidal volume is stable, record Vti monitoring values of breathing test equipment and ventilator. Tidal volume settings as the following table: Volume (mL)
Inspiratory time(s）
Frequency (bpm)
Child
20
0.2
60
Adult
500
2
10
Set the value of 20mL, the detection value is 10 ~ 30mL; Set the value of 500mL, the detection value should be 450 ~ 550mL;
PEEP
The standard working condition, connecting pipes and the simulated lung, in the loop access breath testing equipment, ventilator Set PEEP 20cmH2O, as work, set end-expiratory pressure for follows: 18cmH2O ~ 20cmH2O, other parameters default. Observed 22cmH2O; ventilator monitoring values, values and ventilator settings.
Peak velocity
Perform the calibration of the flow sensor, disconnect the breath-side piping, and the recorded value of the maximum flow rate of the ventilator.
PCV mode, respiratory rate 10 bpm, the upper pressure limit set maximum PEEP was the value of 0 cmH2O with three links breath test Pressure to equipment and ventilator connection, set the control value of the pressure level in the order of 5 levels of cmH2O, 30 cmH2O, 60 cmH2O, breathing PCV machine at the platform when the pressure of the test equipment in the record show the value and set value.
FiO2
Exhalation valve 6-22
Set the oxygen concentration in the standard working condition, followed by 21%, 60%, 100%, the value of the oxygen concentration stabilized, record the test equipment and the ventilator oxygen concentration detection value, the ventilator settings value.
Boot more than 40 minutes to check exhalation valve roots of the great circle the
Inspiratory peak flow rate of 160 to 200 the LPM
Set 30 cmH2O, as follows: 27 to 33 cmH2O;
Set the oxygen concentration of 21%: 18% ~ 24%; Set the oxygen concentration of 60%: 55% ~ 65%; Set for 100% of the oxygen concentration: 95% ~ 100% (which may appear on the arrow, shall be deemed adopted); Can be heated
6 Disassemble and Functional Testing
heating
lower half of the heating temperature; NOTE: These items relate to the external battery, the application of optional external battery, or NA.
Switched by the AC with standard and optional batteries;
Power indicator light display standard and optional the battery indicator, external power supply; two batteries with a charging, the charge indicator lights are bright;
Turned on Unplug the AC standard and optional batteries connection at the same time;
Power indication, the charge lamp is off, the screen shows the standard and optional batteries, battery powered;
Boot after 10 minutes with alone the standard battery, connect the AC;
Boot, standard battery can be charged, the display shows the standard battery charging; charging lights;
Boot after 10 minutes with alone the optional battery, connect the AC;
Boot, optional battery can be charged, the display shows the optional battery charging; charging lights;
AC, battery, display check
6-23
7 User Maintenance
7 User Maintenance WARNING: Aeonmed recognizes that cleaning, disinfection, and sterilization practices vary widely among medical institutions. It is not possible to specify or require specific practices that will meet all needs, or to be responsible for the effectiveness of cleaning, sterilization, and other practices carried out in the patient care setting.
WARNING: Use a cleaning and disinfection schedule that conforms to your institution’s disinfection and risk-management policies. • Refer to the material safety data as applicable. • Refer to the operation and maintenance manuals of all disinfection equipment. • Do not inhale fumes that may result from any disinfection process.
WARNING: Movable and removable parts may clamp or even crush your hand. Use caution when moving or replacing system components.
CAUTION: The disposal of environmentally harmful devices (such as batteries and LCD display) must be in accordance with local regulations.
WARNING: Use a cleaning and disinfection schedule that conforms to your institution’s disinfection and risk-management policies. • Refer to the material safety data as applicable. • Refer to the operation and maintenance manuals of all disinfection equipment. • Do not inhale fumes that may result from any disinfection process.
WARNING: Do not use talc, zinc stearate, calcium carbonate, corn starch or similar material to prevent sticking of the bellows, as these materials may enter the patient’s lungs or airway, causing irritation or injury.
CAUTION: To prevent system damage: • Refer to the literature supplied by the manufacturer of the cleaning agent. 7-1
• Never use organic, halogenated or petroleum-based solvents, anesthetic, glass cleaning agents, acetone or other irritant agents. • Never use abrasive agents (i.e. steel wool or silver polish) to clean components. • Keep all liquids away from electronic components. • Prevent liquid from entering the equipment. • All cleaning solutions used must have a pH between 7.0 and 10.5.
CAUTION: Never immerse the oxygen sensor or its connector in any type of liquid. • Dispose of the oxygen sensor per the manufacturer’s specification.
CAUTION: Do not wash the inner surface of the oxygen sensor.
CAUTION: Prior to use after cleaning or disinfecting, power up the system as described in section 6 and follow the on-screen Pre-Use test prompts to perform the Leak Test and Circuit Compliance Test. Discard one time use components after using. Don’t use hard brushes or other sharp tools in cleaning to avoid damage to parts. • Clean components with warm water and light detergent. • Dry the components after rinsing with water. • Check each component when cleaning and replace damaged ones. • After a component is replaced, test the ventilator first prior to putting the ventilator into service.
CAUTION: Follow the instructions of detergent manufacturer. Concentrated detergent may hurt some components. Detergent residue may cause spots and cracks, especially in high temperature disinfection.
7.1 Cleaning and Disinfection CAUTION: Before the first use clean, disinfect, and sterilize the ventilator. Disposable components must be disposed in accordance with local regulations. Don’t use hard brushes or other sharp tools in cleaning to avoid damage to parts
7-2
7 User Maintenance
7.1.1 Cleaning and Disinfecting Agents/ Autoclaving Agent • Mild dishwashing detergent • Soapy water with detergent ph between 7.0 and 10.5 • Isopropyl alcohol (70% solution)
Classification Detergent Detergent
Intermediate level disinfectant
• Window cleaning solution (with isopropyl Intermediate level disinfectant alcohol and ammonia) • Sodium hypochloride- (bleach) in water (10% solution) • Hydrogen peroxide (3% solution)
Intermediate level disinfectant Intermediate level disinfectant
• Gluteraldehyde 2% solution
High level disinfectant
• Steam autoclaving up to a maximum temperature of 134°C (273°F).
High level disinfectant
7.1.2 Cleaning and Disinfection Methods Different parts of the ventilator have their respective cleaning and disinfection methods. The following categories are defined for the parts noted in Table 7-1. The parts need to be cleaned, disinfected and thoroughly dried before reassembly. A: Wipe: If there is a potentially infectious substance on the breathing system, such as blood or secretion, wipe away the substance with disposable cloth using proper disinfectant. Use a soft cloth with a water-soluble detergent or disinfectant wipes. B: Machine washing: Automatic washing with washer and disinfecting with disinfection machine. C: Immersion disinfection: Soak in glutaraldehyde-based formulations of 2%. D: High temperature and pressure disinfection: At 121℃ for 20 minutes minimum, or at 134℃ for 8 minutes minimum. Follow the manufacturer’s instructions for high level disinfection. High-temperature disinfection does not have any cleaning effect. It should only be used on components that have already been cleaned by hand or machine and then thoroughly dried.
7-3
Table 7-1 Cleaning and disinfection methods
Part name
A
B
C
D
√
√
√
Ventilator exterior, including housing, gas supply hoses and power cord
√
All components in Figure 7-3
√
CO2 sensor, other breathing circuit parts or accessories
Follow the manufacture’s guidelines
7.1.3 Cleaning and Disinfection of Components 7.1.3.1
External Surfaces
Using a soft cloth with a water-soluble detergent or disinfectant wipes, clean the housing, gas supply hoses and power cord.
7.1.3.2
Expiratory Module
(1) Disassembly
Figure 7-1
7-4
Figure 7-2
7 User Maintenance
Figure 7-3 To remove the components from expiratory module: e.
Press the button(1 in Figure 7-1);
f.
Pull out the expiratory valve core component (2 in Figure 7-1, Figure 7-2);
g.
Remove the end cover(1 in Figure 7-3) and the gasket (2 in Figure 7-3);
h.
Remove the scale board(3 in Figure 7-3)and the diaphragm(4 in Figure 7-3);
i.
Rotate the expiratory connector (5 in Figure 7-3) clockwise;
j. Pull out one-way valve core(6 in Figure 7-3), rubber o-sealing ring(7 in Figure 7-3) and one-way diaphragm(8 in Figure 7-3); k.
Rotate the water trap (9 in Figure 7-3), then pull it out.
(2) Cleaning a. Wash each component using a mild detergent and water solution. b. Rinse with clean, hot water and allow to thoroughly dry. (3) Disinfection NOTE: Ensure that all the components have been cleaned before disinfecting. Using the Gluteraldehyde disinfection solution, follow the manufacturer’s instructions for high level disinfection and rinsing of all components while adhering to facility policies and procedures.
7-5
All the components can also be high temperature and pressure disinfected. Using an autoclave, follow the manufacturer’s instruction for high level disinfection of all the components while adhering to facility procedures. (4) Assembly Reassemble the components in the reverse order. After installation, please perform a pre-use test and verify all tests passed.
7.2
Regular Maintenance
7.2.1 Maintenance Principles Do not use a faulty machine. Ask an authorized agent of our company to carry out all necessary maintenance tasks. Test the machine after maintenance for normal operation. Every parameter should meet specifications. In order to ensure the reliability of the machine, all maintenance and repair work should be carried out by an authorized agent of our company. In case such person is unavailable, a qualified person with similar maintenance experience is acceptable for the work.
CAUTION: Person with no sufficient experience is strictly prohibited to perform maintenance. Only use products provided by Aeonmed to replace damaged items. Verify and test all items ensuring they meet specifications. Contact local service agent of our company in case support is needed. In all cases, maintenance fee is the current component price plus reasonable labor cost, except for those within warranty period.
7.2.2 User Maintenance Minimum maintenance interval
Task
Daily
Check liquid in expiratory module water trap (collected liquid volume cannot be more than half of the bottle)
Weekly
Calibrate oxygen sensor
7-6
7 User Maintenance
Minimum maintenance interval
Task
1-3 month(s)
Replace air filter
Every 6 months
Charge and discharge the batteries once (Charge time: at least 3.5h). Calibrate flow and pressure sensors;
Every year
Calibrate inspiratory valve and expiratory valve (if necessary)
Every year or after calibration
Replace the O2 sensor(actual life depends on temperature and O2 concentration)
When cleaning and installing
Check components necessary.
and
replace
or
repair
when
WARNING: If the Ventilator will not be in use for a period of more than 6 months, the internal batteries must be disconnected or removed to prevent possible damage to the equipment or risk to users or service personnel.
WARNING: The ventilator must not use, nor be connected to, any anti-static or electrically conductive hoses and tubing.
7.2.3 Service Life of Product/Accessories Service Life is defined as the time that the manufactured device can be expected to be 'serviceable' or supported by our company and the maximum time the device can be used safely. Some items within the device may require maintenance, repair or replacement within this time. Such items will be available from our company for the service life of the product. The calculation of the service life begins at the installation of the product at the customer site. Our company recommends for safe use that each device is replaced after its service life is completed.
CAUTION：The service life of the following items is based on normal operating conditions.
7-7
Mask, patient pipeline
Sterilize for 20 times at 121℃
Power supply cable, gas supply pipe
8 years
Machine
8 years
Battery
500 cycles of full charge(The battery from exhausted to full )
7.3
Maintenance in Operation and Transportation
The location of machine should be proper so that it cannot obstruct or be disturbed by medical care personnel. Fix power supply cable well to avoid failure. Use caution not to touch accidental keys on the panel, which may make tidal volume setting wrong. During transportation of the ventilator with or without a patient connected, make sure that the following conditions are fulfilled:
Gas cylinders are connected with a sufficient amount of gas, the Battery module is functioning. Follow the hospital guidelines.
Use the handles on the Mobile Cart. Transport the bed and the ventilator slowly, and watch the patient connection carefully to see that no pulling or other movement occurs.
Be careful not to tip the Mobile Cart when crossing an obstacle such as a doorstep.
7.3.1 Transportation Use care when moving machine within hospital or clinical environment.
WARNING: If Control Unit of Ventilator is dropped or damaged during transportation, equipment failure could result in patient injury.
WARNING: Tip over hazard – use care when moving Ventilator mounted to Cart as device could tip over leading to injury or damage to the equipment and possible subsequent patient injury. User can carry packaged machine while riding vehicle, plane and train. Impact, severe shock and damp should be avoided during transportation (other conditions should accord with purchase contract), with ambient temperature -20°C~+60°C and relative humidity not more than 95%. In case transportation conditions don’t agree, put the machine in specified operating environment at least 24h before using. 7-8
7 User Maintenance
7.3.2 Storage CAUTION: Do not put ventilator into the shock environment.
CAUTION: Do not lay anything heavy on the top. The machine should be stored in a room with temperature -20°C~+60°C and relative humidity –not more than 95% non-condensing, with ventilation and no corrosive gas.
CAUTION: The device should be stored in a room that is drafty where no corrosion gas exists.
CAUTION: When the storage conditions are beyond the requirements of operational environment, and the storage state is transferred into operation state, the product only can be used after being stored in environment for over 24 hours.
7.4
Fuse Replacement
WARNING：Before replacing fuse, first disconnect AC power. Otherwise, it may cause injury or even death. WARNING：When replacing fuse, make sure the new fuse is the same type and size as the old one; otherwise, the ventilator may be damaged. CAUTION: The fuse is a damageable part, and care must be taking when replacing it so no damage occurs. 1. AC Circuit Fuse Fuse replacement steps: • • • • • •
Insert screwdriver into the trench (2) of end of fuse box, see Figure 7-4. Pull out fuse holder (1). Remove the fuse (3). Load new fuse. Push the new fuse into the original position gently. Connect AC power, and then start the ventilator to test.
7-9
Figure 7-4 2.
DC Power Fuse Fuse replacement steps:
• • • • •
Insert screwdriver into the trench (1) of end of fuse box, see Figure 7-2. Pull out fuse holder (2). Remove the fuse (3). Load new fuse. Push the new fuse into the original position gently.
Figure 7-5
7.5
Battery Maintenance
7.5.1 Battery Specification Battery module - DC12V, 6.6AH, 14.4V lithium-ion battery -
Typical charge time: 3.5h
-
Typical discharge time: 2h
When the main power supply voltage is too low or the main power supply fails, two backup batteries (one is necessary, and one is optional) can protect the ventilator. When having a power failure, the ventilator can switch to battery supply automatically, and can normally work without pneumatic power supply failure. The two batteries are usually available for the ventilator working for 4 hours.
7-10
7 User Maintenance
7.5.2 Precautions Charge: When operating with AC power supply on, the system will maintain the battery automatically. Charge time is less than 3.5h. Discharge: The machine is operating on battery. In case of low battery condition, an alarm message “Low battery” will appear, notifying the user to restore AC power supply to charge batteries, otherwise the batteries will be depleted and alarm “Limited Battery Capacity” will be displayed, and eventually the system will be shut down. (For safety reason, manual power-on is required to start the machines again after an automatic shutdown). Before the machine is put into patient use, or disconnecting AC power for transport, or other purposes, check the battery power. If the battery is not fully charged, connect the ventilator to AC power for at least 3.5hours and recharge the battery until the power reaches 80%~100%.
7.5.3 Battery Storage In case the battery is to be stored for a long time, charge it fully prior to storage. To keep the battery power and prolong the battery life, please ensure that the ventilator is connected to the main power. Charge the battery every six months. Actual charging time depends on the storage environment. High humidity and high temperature environments should be avoided for storage. If battery is damaged due to improper maintenance, replace promptly, otherwise liquid leakage may corrupt the machine. Contact the manufacturer when replacing battery.
7.5.4 Battery Replacement Same model battery with CE certification is required. Make sure AC power supply is disconnected before replacing.
CAUTION: An authorized Aeonmed service representative can replace battery. If the machine will not be used for long-time, please contact Aeonmed service representatives to disconnect battery. A depleted battery should be disposed in accordance with the local policies.
7-11
7.5.5 Battery Charging and Calibration Use the battery charger supplied by our company to charge or calibrate the battery. After calibrating the battery, the ventilator can read the residual battery capacity accurately. Please charge or calibrate the battery according to the instructions of the battery charger.
CAUTION: When ‘low battery’ alarm occurs, charging should be done immediately. The VG70 Ventilator System will shut off in several minutes automatically.
7.6
Oxygen Sensor
The oxygen sensor can be used to measure the local oxygen concentration when it is connected to the ventilator or other equipment. The oxygen sensor is suitable for adult and child.
7.6.1 Oxygen Sensor Replacement Disassembly Step 1: Open outward (1), and then remove the cover.
Step 2: Pull up the crystal joint of the oxygen sensor, turn the oxygen sensor (3) anticlockwise, and then remove it.
7-12
7 User Maintenance
Assembly Inspect the oxygen sensor for damage and replace as necessary. Then reassemble the oxygen sensor.
7.6.2 Oxygen Sensor Calibration For oxygen sensor calibration, refer to section 9.1.
7.6.3 Technical Specifications of Oxygen Sensor Measure range
0 ~ 100 Vol.%
Measure accuracy
