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
<1%
Response time
<10s
Operating temperature
10℃~ 45 ℃
Pressure range
600hPa ~ 1750hPa
Humidity effect
-0.03× current humidity
Storage temperature
-20℃~ 50℃
Drift
Air: <1%/month
Reproducibility
±1%
Type
Chemical fuel cell
Expect life time
12 months
Total system response
time
<60s
Working principle of O2
monitor
The O2 monitor surveys and displays the O2 concentration in the
patient loop. The oxygen sensor component contains an oxygen
sensor, which can produce the voltage proportional to the
oxygen partial pressure (concentration) on its detection surface.
The oxygen sensor is an electrochemical device (chemical
battery). Oxygen expands in this device through a layer of film
and oxidizes the base metal electrode. The oxidation process
7-13
produces a current with an amplitude proportional to the oxygen
partial pressure indicated by the electrode sensor. The base
metal electrode is gradually exhausted during the oxidation
process.
The voltage of the sensor is influenced by the temperature of
the monitoring gas mixture. The surgical thermosensitive
resistor of the sensor automatically compensates temperature
change in the sensor.
The O2 monitor converts the sensor signal into the
corresponding oxygen percentage value by using signal
processing and circuit analysis. The system displays the value
and compares it with the stored alarm limit value. If the value
exceeds the threshold, the monitor will alarm.
NOTE: After being in a condensing atmosphere, the oxygen sensor shall be stored for
more than 24 hours in an environment equivalent to operating humidity.
7.6.4 Oxygen Sensor Maintenance
The oxygen sensor should be regularly calibrated. For the calibration interval, refer to
section 7.2.2.
To improve the life time of the oxygen sensor, when the ventilator is not in use, the oxygen
sensor should be avoided contact with the high-concentration oxygen.
The oxygen sensor is consumptive, and the period of valid is ordinarily 12 months. So the
user should pay attention to the use of the oxygen sensor. When the oxygen sensor fails,
replace it.
The recommended oxygen sensor is supplied by Aeonmed.
WARNING: Do not immerse oxygen sensor in liquid. Do not conduct autoclave or
high temperature fumigation on the oxygen sensor.
7.7
Paramagnetic Oxygen Sensor (optional)
The paramagnetic 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.
7-14
7 User Maintenance
7.7.1 Paramagnetic Oxygen Sensor Calibration
For the paramagnetic oxygen sensor calibration, refer to section 10.1.
7.7.2 Technical Specifications of Paramagnetic Oxygen
Sensor
Performance
Technology
Paramagnetic
Range
0-100% O2 (with over range -15% O2 to 200% O2)
Accuracy (Intrinsic
Error)
＜± 0.2% O2
Linearity
＜± 0.2% O2
Repeatability
＜± 0.2% O2
Zero Drift
＜± 0.4% O2 in first 24 hours, then ＜± 0.2% O2 /week, then ＜
± 0.2% O2 /month
Response Time (T10 –
T90)
8 to 20 seconds dependent on application and filter selection
(biological filter on request)
Outputs/Controls
Signal Output
Digital UART or linear mV output (0.5mV or 10mV per % O2)
Physical
Weight
70g (2.47oz)
Dimensions
Molex low profile connector: 33.5×30.0×46.1mm
(1.32×1.18×1.81”)
Diffusion Port
Aperture diameter: 15.5mm (0.61”)
Sample condition
Sample Gas Condition
Clean dry gas, free of entrained oil, particulates ＜3μm,
non-condensing
Gas Exchange
Diffusion
Ambient conditions
Operation Temperature
5℃ to 50℃ (41℉ to 122℉)
Storage Temperature
-30℃ to 70℃ (-22℉ to 158℉)
Temperature Coefficient
Within a range of 0℃ to 50℃: Zero ＜± 0.5% O2 /10℃, Span:
＜±0.5% O2 /10℃
Operating Pressure
Range
±33kPag (±5psig)
7-15
Ambient Humidity
0 to 95% non-condensing
External Power Supply
5V dc, 70mA nominal
Power Consumption
350mW
7.8
Disposal
This product must not be disposed of with your other waste. Instead, it is your
responsibility to dispose of your waste equipment by handing it over to a designated
collection point for the recycling of waste electrical and electronic equipment, or by
returning it to our company for reprocessing. The separate collection and recycling of your
waste equipment at the time of disposal will help to conserve natural resources and
ensure that it is recycled in a manner that protects human health and the environment. For
more information about where you can drop off your waste equipment for recycling,
please contact your local city office, your waste disposal service, or your product
distributor or retailer.
Correct Disposal of Batteries and O2 Sensors
WARNING: Treatment of batteries and O2 sensor:

Follow all local regulations with respect to environmental protection when disposing
of batteries and O2 sensor. These products contain toxic compounds irrespective of
physical condition. They should be disposed of according to local waste management
requirements and environmental legislation. They should not be burned since they may
give off toxic fumes.

Do not throw into fire! Risk of explosion.

Do not force open! Danger of bodily injury.
7.9
Manufacturing techniques and materials:
For a period of one year from the date of original delivery, the components and
assemblies of this product are 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 months. Expendable parts are not included. Aeonmed’s obligation under the above
warranties is limited to repairing free of charge.
7-16
7 User Maintenance
7.10 Free Obligations:
• Aeonmed’s obligation under the above warranties does not include the freight and other
fees;
• Aeonmed is not responsible for any direct, indirect or failed product or delay which
result from improper use, alteration by using unapproved assemblies and maintenance by
anyone other than Aeonmed;
• This warranty does not apply to the followings:
Improper use;
Machines without maintenance or machines broken;
The label of Aeonmed original serial number or mark is removed or replaced;
Other manufacturers’ products.
7.11 Security, reliability and operating condition:
Aeonmed is not responsible for the security; reliability and operating condition of this
product in case that:
• The assemblies are disassembled, extended, altered and/or 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.
7.12 Return
Follow the steps in case the product needs to be returned to Aeonmed:
1、Obtain the rights of return
Contact customer service of Aeonmed by informing them of the serial 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.
2、Transportation charges
Transportation and insurance charges must be prepaid by the user for transporting the
product to Aeonmed for repairing.
7-17
8 Pre-Use Test
8 Pre-Use Test
8.1
Pre-use test procedure
After power on, the machine enter Pre-use test. The user can also do all the pre-use test
items on Standby screen.
Test items on Standby screen are as follows.
Test Items
Remarks
Technical Test
After each system has completed its initialization, technical
tests will be performed, including: voltage checks at critical
points in the circuitry; data collection necessary for system
operation; test of communication between sub-systems; tests of
measurement circuits and valve control circuits.
AC/Battery test
This test will verify whether the batteries can supply enough
power to operate the ventilator normally. Please follow
instructions as displayed.
Gas supply test
Test will proceed when the hyperbaric oxygen is functional.
Oxygen sensor test.
This test requires that oxygen supply is available. If oxygen
source is not available then a message “oxygen source is
inadequate” and the test cannot be carried out.
Leak test
Internal leakage test.
Flow sensor test
Flow sensors function and accuracy test.
Pressure sensor test
Pressure sensors function and accuracy test.
Safety valve test
Safety valve function and accuracy test.
Circuit test
Circuit compliance value measurement.
CO2 Sensor test
Performed if a CO2 module is detected. An Alert shall be posted
if the test fails.
Methods for testing the function of the alarm system for conditions are specified by
IEC60601-2-12. These are to be performed at the user’s discretion.
Perform the following procedure to prove operation of the Low MVe and High Airway
pressure alarms:
1.
Turn the Power switch On.
2.
Connect a breathing circuit and test lung to VG70.
8-1
3.
Press Start Ventilation and ventilate with default settings, set O2 to 21%.
4.
After 5 breaths, observe the MVe reading on the display.
5.
Set the MVe low alarm limit to a value greater than the observed MVe reading.
6.
Verify that a low level MVe low alarm is present on the 3rd breath.
7.
Return the MVe low alarm limit to original setting.
8.
After 5 breaths, observe the Ppeak reading on the display.
9.
Set the PAW upper alarm limit to a value lower than the observed Ppeak reading.
10. Verify that a low level High Airway Pressure alarm is present after 1 breath and that a
high level High Airway Pressure alarm is present at the start of the 4th breath.
11. Return the PAW upper alarm limit to original setting.
12. Turn the Power switch OFF.
8.2
Pre-use test failure analysis
If the pre-use test failed, you need to follow the way to troubleshoot.
Pre-use test item
Possible reason and recommended action if failed:
Technical Test
See the Technical Test Error Code below.
AC/Battery Test
Make sure at least one battery is installed and charged.
Make sure the AC supply is OK.
Gas Supply Test
Make sure the oxygen supply is connected, and the pressure is
in the spec
Oxygen Sensor
Test
Perform 21% and 100% oxygen sensor test at first, and try again.
Make sure the oxygen supply is connected, and the pressure is
in the spec.
Make sure the oxygen sensor is valid and connected to the main
box.
Make sure the oxygen auto calibration valve is connected right
and no leak.
Leak Test
Calibrate Inspiratory valve at first, and try again;
Make sure machine and connected tube have no leak.
Flow Sensor Test
Calibrate Inspiratory valve at first, and try again;
Make sure machine and connected tube have no leak;
Make sure inspiratory flow sensor and expiratory flow sensor
work fine.
8-2
8 Pre-Use Test
Pre-use test item
Possible reason and recommended action if failed:
Pressure Sensor
Test
Calibrate Inspiratory valve at first, and try again;
Make sure machine and connected tube have no leak;
Make sure inspiratory pressure sensor and expiratory pressure
sensor work fine.
Safety Valve Test
Calibrate Inspiratory valve at first, and try again;
Make sure safety valve works fine;
Make sure machine and connected tube have no leak;
Make sure expiratory pressure sensor works fine.
Circuit Test
Calibrate Inspiratory valve and Expiratory valve at first, and try
again.
Make sure machine and connected tube have no leak;
Make sure expiratory pressure sensor works fine.
CO2 Sensor Test
Take off the CO2 sensor from the breath circuit, and put it in the
air.
Make sure the CO2 sensor has warmed up. The LED indicator in
the sensor turns green.
Make sure the adapter is installed into the sensor.
8-3
9 Network
9 Network
9.1
Overview
The ventilator can export patient monitoring data in HL7 format over a local area network
(LAN) using the TCP/IP transport protocol. The data can be sent to a server and then
forwarded to an Electronic Medical Records (EMR) system or sent directly to the EMR
system.
9.2
What is Exported?
Network completes ventilator local IP and port settings, specifies IP (common PC) of node
and port number that connect and send data. After doing the above settings can establish
a connection to the ventilator. This machine data is sent to the remote destination node.
Currently send data by two ways. One is sent cyclically, the period is 1second, and
sending waveform data and monitoring values. Another is sent immediately, send alarm
information, ventilation parameters, alarm limit settings and so on at the beginning of
connection. When the information is changed that send synchronal information. Detailed
data communication protocols refer to "HL7 agreement."
9.3
Establishing a Connection
Using data transmission functions require checking whether connection is open. Check by
following steps:
1) Connect the ventilator and network of purposes PC with network cable.
Connection can be achieved by two ways: First, the ventilator access network equipment,
such as Hub, switches and so on. Second, connect the ventilator and the destination PC's
network card with a network cable. Two connections use ordinary network cable.
2) Ensure that the ventilator set the IP address manually, not automatically obtain IP.
USB key board is connected to the ventilator while click two keys Win and
Esynchronously, then appear “My Device” interface, press“ control Panel”“Network and
Dial-up Connections”“PCI-E100E1”, enter the connection settings interface. Obtaining
the IP address is set to: Specify an IP address, and the ventilator is specified an IP
address.
Set IP address of ventilator and destination PC in the same network segment. Such as
9-1
PC's subnet mask is 255.255.255.0, subnet mask of ventilator also performs the same
setting, first three digits setting of ventilator IP address is the same as PC's IP address
and ensure that the final one setting is different other hosts on the network segment. Then
click “win” button, and select “reboot”, hot restart ventilator.
After this operation, ventilator enter the local IP and remote IP and click the Connect
button to complete the local IP settings by the ventilator settings →UI interface network
interface. You can enter the ventilator control panel to set without keyboard each time
3) Use “Ping” command to verify network connectivity.
Use “Ping” command to verify network connectivity on the PC. “Ping” open indicates the
network is available, you can click connection button to start data transmission. Click the
Connect button, if the ventilator displays IP settings are different the current IP, change
interface IP settings for ventilator IP, or retain the current setting. Then start data
transmission.
4) The PC starts data receiving test software to check whether the data is sent correctly.
The PC starts data receiving test software, input ventilator IP, click “connection”.
Ventilator system setting web interface, complete the above 1), 2), 3) operation, click
the “connection” that starts data transmission. Received data can be seen by PC-data
receiving software.
9.4
Interface Instructions
Click “Configurations” to enter the configurations interface. On this page, the user needs
to enter the password, as shown in Figure 9-1.
Figure 9-1
9-2
9 Network
Input the correct password to enter, Click “Site Configuration” to enter the site
configuration interface. As shown in Figure 9-2.
Figure 9-2
Various parts of the interface are described as follows:
Figure 9-3
1) Local IP Address. Each number is from 1 to 255. If the input is outside this range, a
message is displayed: “* is invalidated. Please insure the value is between 1 and 255.” If it
is not set then display 0.0.0.0.
2) Local subnet mask. If it is not set then display 0.0.0.0. This is generally filled
255.255.255.0 or 255.255.0.0. This set is the same as subnet mask of destination PC.
3) Local port. Ventilator sends data through the port. Receiver gets data from the
ventilator through the port. Port 9101 is used by default. It can use from 65535 to 5000 as
9-3
the port number, If the input is outside this range, a message is displayed:” * is invalidate.
Please insure the value is between 5000 and 65535.”
4) Remote IP address. It is the IP address of the data receiving end. Once connected, the
ventilator only sends data to this address of the host. Usually the IP and ventilator IP is in
the same segment.
5) Remote port. It is data receiving end port. Ventilator establishes a connection with the
receiver through the port, receiving end receives data through the port. This machine is
generally associated with Ventilator port. Port 9101 is used by default. It can use from
65535 to 5000 as the port number, If the input is outside this range, a message is
displayed:” * is invalidate. Please insure the value is between 5000 and 65535.”
6) “Connect”. Click this button to start data transmission. A message is displayed:
message is displayed on (8) area, while a small icon is displayed in the upper right corner
of interface within three seconds. Then all the data will be saved in the ventilator file, when
open this interface again, it will display the last settings.
7) “Disconnect”. Click this button to stop the data transfer.
8) Data sharing status. Connected, a message is displayed: “Data Share On”;
disconnected, a message is displayed: “Data Share Off”.
9) Digital input keypad. It is used to enter the digital.
9.5
Transmits and Receives Data
Data is packaged in HL7 format and transmitted by UDP packets. You can set up UDP
listening service to receive data, unpack the data according to the rules of the relevant
agreements. Detailed rules refer to "HL7 Protocol."
1) Waveform data. The period of Waveform is 1second. Receiver receives the waveform
data and saves into the buffer, and then it is drew on the interface according to the
sampling frequency (50ms). Drawing frequency and sampling frequency may be different.
It is adjusted according to the number of data in the buffer. Since the network delay and
buffer, there will be a delay drawing, the maximum delay is about 7 seconds.
2) Monitoring data. The transmission period is 1 second. Only the network latency is affect
monitoring data updates, it is generally not delay in the open network.
3) Alarm information. It sends all current alarm information when connection is established
and ventilation is started. It will also send the appropriate information when the new alarm
generates or alarm disappears.
4) Mode and ventilation parameters. It sends all current mode and ventilation parameters
when connection is established and ventilation is started. It will send the change mode
and ventilation parameters settings in the mode transitions.
5) Alarm limit. It sends all current alarm limits when connection is established and
9-4
9 Network
ventilation is started. It will send the change value when alarm limit is changed.
9.6
Troubleshooting
Right transmission data requires that network settings of ventilator is correct, receiver test
software can start normally, and network port of ventilator is installed correctly, and so on.
1) Local network settings of ventilator can refer to 9.3.
2) Receiver test software can move in windows XP and windows 7 system, if it can’t
receive data and ventilator and network cable are normally, network configuration
information may be incorrect. In this case, you can use the command:”netsh winsock
reset” that reset the network configuration and reboot the computer.
3) Ventilator network card. The above case is correctly, the network is still blocked,
namely, ping is failure. You should check that ventilator network card is properly
installed and connected. Use correct network port which is connected to the ventilator,
if you can Unicom network, show the network adapter or interface have problems.
Can replace card or connect afresh.
4) The PC's network connection is disconnected if you connect the ventilator and
computer with network cable, you should check whether the line is connected properly.
Make sure the cable is normal, then should open the ventilator screen, check the card
is properly connected.
5) If uld op is fail, make sure “remote IP Address” is the same as PC IP. If the PC uses a
wireless connection that can be disconnected, then verify properly connected.
9-5
10 Service Menu
10 Service Menu
CAUTION: On “System” of “Main Menu”, “Service” tab is reserved for service only.
Press “Service” to enter the “Service” page. On this page, the user needs to enter the
password, as shown in Figure 10-1.
Figure 10-1
Input the correct password to enter, There are six choices on this page: Calibration,
Event/Alarm Log, Machine Information, Language, Test Page and Update. The default
page is Calibration. See Figure 10-2.
Figure 10-2
10-1
10.1 Calibration
10.1.1Calibration operation guidance
The calibration choices include: 1)Pressure Sensor Calibration, 2) Flow Sensor
Calibration, 3) O2 Sensor Calibration, 4)CO2 Sensor Calibration, 5) Inspiratory valve
Calibration, 6) Expiratory Valve Calibration, 7) Atmospheric Sensor Calibration, 8) Touch
Screen Calibration, 9) Leak Test and 10) Breath Circuit test, as shown in Figure 10-2.
1) Pressure Sensor Calibration: Press “Pressure Sensor” to enter the calibration
interface. A message is displayed: “This step is to zero the pressure sensor. Please
remove the breathing circuit from the ventilator before calibration.” A legend is displayed
as well as shown in Figure 10-3.
Figure 10-3
Press “Start” to start pressure sensor calibration. A progress bar and a message
“Calibration in progress. Please Wait” will be displayed as shown in Figure 10-4.
NOTE: During this period no other operation can be performed. Pressing other areas
will have no response.
10-2
10 Service Menu
Figure 10-4
2) Flow Sensor Calibration: Press “flow sensor” to enter the interface. A message is
displayed: “This step is to calibrate the flow sensor. Please connect the insp. Port and Exp.
Port directly with a tube” as shown in Figure 10-5.
Figure 10-5
Press the “Start” button to start flow sensor calibration, the remaining procedure is the
same as the pressure sensor calibration.
3) O2 Sensor Calibration: Press “O2 sensor” to enter the interface. A message displayed:
“Please verify that the oxygen source are connected correctly. Verify that the gas inlet
pressure is within specification.” A legend will also be shown. There are two keys below
the legend: “Start 21%” and “Start 100%”. Choose the needed one and Press, as shown in
Figure 10-6. The remaining procedure is the same as described above.
10-3
Figure 10-6
4) CO2 Sensor Calibration: Press “CO2 Sensor” to enter the interface, as shown in
Figure 10-7. A message displayed: “Disconnect the CO2 sensor with the adapter from
breathing circuit and ensure it is in ambient air. Wait 1 minute for warm up after the unit is
powered on or after installing an airway adapter. Press “Zero” when the State-Area turns
green”. Please follow the prompt message to calibrate.
Figure 10-7
5) Inspiratory Valve Calibration: Press “inspiratory valve” to enter the calibration
interface. A message is displayed: “This step is to calibrate the inspiratory valve. Please
connect the Insp. Port and Exp. Port directly with a tube.” as shown in Figure 10-8. To get
a precise calibration, please connect patient tubes with a humidifier before inspiratory
valve calibration.
Click the “Start” button to start inspiratory valve calibration, the remaining procedure is the
same as the pressure sensor calibration.
10-4
10 Service Menu
Figure 10-8
6) Expiratory Valve Calibration: Press “Expiratory valve” to enter the calibration
interface. A message is displayed: “This step is to calibrate the expiratory valve. Please
connect patient circuit and test lung before calibration.” as shown in Figure 10-9.
Click the “Start” button to start expiratory valve calibration, the remaining procedure is the
same as the pressure sensor calibration.
Figure 10-9
7) Touch Screen Calibration: Press “Touch screen” to enter the calibration interface. A
message is displayed: “This step is to calibrate the touch screen. The ventilator’s screen
will disappear during the calibration. Please follow the instruction in the calibration
program.” as shown in Figure 10-10.
CAUTION: Please calibrate the touch screen periodically or when it works
abnormally.
10-5
Figure 10-10
Press the “Start” key to start, the remaining procedure is as described in steps above.
8) Leakage Test Calibration: Press “Leakage Test” to enter the test interface. A
message is displayed: “This step is to test the internal leakage of ventilator. Please
connect the Insp. Port and Exp. Port directly with a tube”, as shown in Figure 10-11.
Figure 10-11
Press “Start” to start the leakage test. A progress bar and a message “Test in progress,
please wait” will be displayed as shown in Figure 10-12.
10-6
10 Service Menu
Figure 10-12
9) Breath Circuit Test Calibration: Press “Breath Circuit Test” to enter the test interface.
A message is displayed: “This step is to test the compliance and leakage of breathing
circuit. Please connect the patient circuit to the T-piece, and plug up the patient end of the
T-piece”, as shown in Figure 10-13.
Before starting the test, ensure the patient circuit has been connected to the T-piece and
the patient end of the T-piece has been plugged up. Press the “Start” button to start the
breath circuit test.
Figure 10-13
10-7
10.1.2Calibration failure analysis
Calibration items
Possible reason and recommended action if failed:
Pressure Sensor
Make sure inspiratory pressure sensor and expiratory pressure
sensor work fine;
Make sure no gas flow pass inspiratory pressure sensor and
expiratory pressure sensor.
Flow Sensor
Make sure inspiratory flow sensor and expiratory flow sensor
work fine;
Make sure no gas flow pass inspiratory flow sensor and
expiratory flow sensor.
O2 Sensor
Calibrate Inspiratory valve and Expiratory valve at first, and try
again;
Make sure the oxygen supply is connected, and the pressure is
in the spec;
Make sure the oxygen sensor is valid and connected to the main
box.
CO2 Sensor
See Section 8.2
Inspiratory Valve
Make sure the oxygen supply is connected and work normal;
Make sure machine and connected tube have no leak;
Make sure inspiratory flow sensor and expiratory flow sensor
work fine.
Make sure inspiratory valve works fine.
Expiratory Valve
Make sure the oxygen supply is connected and work normal;
Make sure machine and connected tube and lung have no leak;
Make sure inspiratory pressure sensor and expiratory pressure
sensor work fine;
Make sure inspiratory valve and expiratory valve work fine.
Touch Screen
Trying the fewest test points calibration (4 points).
Make sure press the center of each test point (the red region).
Make sure the plastic frame of screen doesn’t constrict the
touching area of touch screen.
10-8
10 Service Menu
10.2 Event/Alarm Log
Press “Event/Alarm Log” to enter “Event/Alarm Log” page, as shown in Figure 10-14.
Figure 10-14
The middle area of this page is the message area. It can store up to 1000 messages,
including event messages and alarm messages. All messages will be listed in time
sequence. The top is the latest event or alarm message, and the bottom is the oldest. Use
the scroll bar to check all the messages. An asterisk (*) in front of an alarm message
indicates that alarm message was not displayed in the alarm message area. As shown in
Figure 10-15. The event/alarm log records all alarms and most actions.
Figure 10-15
Below is the message area of the Settings area resulting from highlighting an alarm. All
settings will be given here, as shown in Figure 10-16.
Figure 10-16
NOTE: Alarm/Event Log data is retained during a power interruption and can be viewed
when power returns.
10-9
10.3 Machine Information
Press the “Machine information” key to enter the Machine information page, this area
includes the following information, as shown in Figure 10-17.
1. Software Version:
a. UI
b. BDU
c. Power Supply
2. Runtime Hours
3. O2 Source Pressure
4. Atmospheric Pressure
Figure 10-17
10.4 Language
Press “Language” to enter the language screen. English and other languages are
available for the user to choose.
10.5 Test Page
Press “Test Page” to enter the test page. There are five choices on this page: Demo, Vlt.
Monitor, Schematic, Cali. Data, Service Timer, Error Code and PT100 Cali. as shown in
Figure 10-18.
10-10
10 Service Menu
Figure 10-18
10.5.1Demo
Press “Demo” to enter the demo setting page, as shown in Figure 10-19. In this page, the
operator can turn on or turn off the demo mode, and test the broken pixel of the screen.
Figure 10-19
10.5.2Vlt. Monitor
Press “Vlt. Monitor” to enter the vlt. monitor page, as shown in Figure 10-20. This page
displays all the BDU and PS circuit monitoring value.
10-11
Figure 10-20
10.5.3Schematic
Press “Schematic” to enter the schematic page. The schematic is as shown in Figure
10-21. In this page, the operator can control all valves and read all sensors state.
The valves (#1 to #9) and the Exp. Valve Heater shall have two states: on and OFF; The
Turbine voltage range: 0-5, the units: V, the resolution: 1; The Insp. Valve range: 0-180,
the units: LPM, the resolution: 0.5; The IP Valve range: 0-100, the units: cmH2O, the
resolution: 1.
Figure 10-21
10-12
10 Service Menu
10.5.4Cali. Data
Press “Cali. Data” to enter the cali. data page, as shown in Figure 10-22. This page
displays the calibration data of Inspiration /Expiration Sensor.
Press “Refresh” button to update the calibration data and the zero AD value of the sensor.
Press “Manual Cali.” button to display the manual calibration page; in the page, the
operator can manually calibration the Insp/Exp sensor.
Figure 10-22
10.5.5Service Timer
Press “Service Timer” to enter the service timer page, as shown in Figure 10-23. This
page displays the service time about the ventilator, the turbine runtime, and the int./opt.
battery charging/discharging circle count.
Figure 10-23
10-13
10.5.6 Error Code
Press “Error Code” to enter the Error Code interface, as shown in Figure 10-24.
Figure 10-24
10.5.7 PT100 Cali.
Press “PT100 Cali.” to enter the PT100 calibration interface, as shown in Figure 10-25.
Figure 10-25
10-14
10 Service Menu
The calibration steps are as follows.
Step 1: Press “Stop Heater” and wait for 40min to make the expiration valve to cool to
ambient temperature. Then measure and record the temperature of the expiration valve.
Step 2: Press “
” turning the key background color to yellow, adjust the value equal to
the temperature recorded at Step 1, then read the value “
value in Textbox 1.
Step 3: Press “
” and record the
” turning the key background color to yellow, adjust the value equal to
the setting temperature, then read the value “
” and record the value in
Textbox 3.(The setting temperature: the highest temperature of the expiration value
heating, default: 35℃. )
Step 4: In turn, press “Write”, “Read”, “Set Point”, “Read Point”, then determine that the
value of Textbox 2 is equal to the value of Textbox 1 and the value of Textbox 4 is equal to
the value of Textbox 3. If same, the calibration is finished; if not, carry out Step 5.
Step 5: Repeat the above steps.
10.6 Update
Press “Update” to enter the update page, as shown in Figure 10-26. In this page, the
operator can update the software.
Figure 10-26
10-15
10.7 Optional
Press “Optional” to enter the optional page, as shown in Figure 10-27. In this page, the
operator can choose configurable functions.
Figure 10-27
10-16
11 Troubleshooting
11 Troubleshooting
11.1 Technical Error
11.1.1Technical Test Error Code
The error code is made up by 8 digits hexadecimal numbers, which are four byte using
binary system. The highest two bytes are internal AD test result flag, the lowest byte are
external AD test result flag. The meaning of each bit is shown in the below table.
External
AD##(0xF
FFF00xx)
Bit 0
Bit 1
Test Point
Possible Reason and Recommended Action
Zero point of
expiratory flow rate
1. Remove the test lung and breath circuits,
perform the test again.
2. Don’s start PUT too quickly after quit from
ventilation.
3. Calibrate the pressure, flow rate sensor, Insp.
valve and Exp valve.
4. Proportional solenoid valve can’t close
completely. Replace proportional solenoid
valve.
5. Replace expiratory flow rate sensor.
Zero point of
inspiratory flow rate
1. Remove the test lung, connect Insp. port and
Exp. port directly with a tube.
2. Don’s start PUT too quickly after quit from
ventilation.
3. Calibrate the pressure, flow rate sensor, Insp.
valve and Exp valve.
4. Proportional solenoid valve can’t close
completely. Replace proportional solenoid valve.
5. Replace mother board.
1.
2.
Bit 2
Inspiratory
temperature
3.
4.
Check the cable between the mother board to
the temperature sensor
The interface IC on the mother board is
broken. Replace mother board.
The input port of external AD chip on the
mother board is broken. Replace mother
board.
Replace temperature sensor.
11-1
Bit 3
--
--
Zero point of
expiratory pressure
1. Remove the test lung, connect Insp. port and
Exp. port directly with a tube.
2. Don’s start PUT too quickly after quit from
ventilation.
3. Calibrate the pressure, flow rate sensor, Insp.
valve and Exp valve.
4. Proportional solenoid valve can’t close
completely. Replace proportional solenoid valve.
5. The amplifier on the mother board is broken.
Replace mother board.
6. The input port of external AD chip on the mother
board is broken. Replace mother board.
7. The sensor is broken. Replace mother board.
Zero point of
inspiratory pressure
1. Remove the test lung, connect Insp. port and
Exp. port directly with a tube.
2. Don’s start PUT too quickly after quit from
ventilation.
3. Calibrate the pressure, flow rate sensor, Insp.
valve and Exp valve.
4. Proportional solenoid valve can’t close
completely. Replace proportional solenoid valve.
5. The amplifier on the mother board is broken.
Replace mother board.
6. The input port of external AD chip on the mother
board is broken. Replace mother board.
7. The sensor is broken. Replace mother board.
Bit 6
Barometric pressure
1. Proportional solenoid valve can’t close
completely. Replace proportional solenoid
valve.
2. The amplifier on the mother board is broken.
Replace mother board.
3. The input port of external AD chip on the mother
board is broken. Replace mother board.
4.
The sensor is broken. Replace mother board.
Bit 7
--
--
Internal
AD(0xxxx
x00FF)
--
--
Bit 15
--
--
Bit 16
--
--
Bit 17
--
--
Bit 18
--
--
Bit 4
Bit 5
11-2
11 Troubleshooting
Bit 19
Bit 20
Expiratory valve AD
1. Poor connection between the mother board
and daughter board. Re-plug the daughter board.
2. The driver chip of expiratory valve on the
mother board is broken. Replace mother board.
3. The daughter board is broken. Replace
daughter board.
Inspiratory valve AD
1. Poor connection between the mother board and
daughter board. Re-plug the daughter board.
2. The daughter board is broken. Replace
daughter board.
Bit 21
--
--
Bit 22
--
--
Bit 23
--
--
Bit 24
--
--
Bit 25
--
--
Bit 26
--
--
Bit 27
2.5V reference
voltage
--
Bit 28
--
--
Bit 29
--
--
Bit 30
--
--
Bit 31
--
--
1. Error Codes in the Log
Error
Code
Test
Point
Possible Reason and Recommended Action
1000
T12 DC
The A5V out is out of range. Replace PS board.
1001
T1 DC
The W24V output is out of range. Replace switch PS.
1002
T13 DC
The P12V output is out of range. Replace PS board.
1004
T19 DC
The N24V output is out of range. Replace PS board.
1008
T24 DC
PS board failure. Replace PS board.
1009
T14 DC
The A12V output is out of range. Replace PS board.
1013
--
During expiratory valve heating the temperature is out of range.
Replace PS board.
2000
T31 DC
During expiratory valve heating the output voltage is out of range.
Replace PS board.
2001
T30 DC
During expiratory valve heating the output current is out of range.
Replace PS board.
3006
--
PS board communication failure. Replace PS board.
3005
--
BDU communication failure. Replace core board.
3002
--
Software mismatch failure. Update software.
11-3
11.1.2Other Errors
Alarm
sound
from
buzzer in
the PS
board
1) Communication
failure between UI to
PS board
2) No AC and battery
connected
Check if the UI are working.
Make sure the cable linking to the PS board is
OK.
Replace power supply board.
11.1.3Service Tools
Service tools are listed underside:
Sequence
number
Name
Quantity
Remark
1
Metric hex driver set
One set
----
2
#2cross screwdriver
One entries
Staff width is about
5mm
3
Multi-meter
One block
----
4
VG70 checkout frock and
its attachments for ESD
(Electro-Static Discharge)
protection)
One desk
If anyone of the electric
machine, electric
machine driver and the
main board is replaced
5
Breath pipeline cover bag
One set
----
6
Simulated lung
One entries
----
11-4
12 Appendix A
12 Appendix A Contact & Ordering Information
How to Call for Service
This service manual provides procedures for testing and maintaining the Ventilator VG70.
It is not intended to be a complete maintenance document; therefore, it contains no
detailed disassembly or reassembly instructions.
Refer any repairs or adjustments that exceed the scope of this manual to the Service
Center of Aeonmed by calling 800-810-8333.
This manual contains proprietary information. It is intended for use only by individuals
qualified in the installation and maintenance of the Aeonmed ventilator. Receipt, purchase,
or possession of this document in no way confers or transfers any other rights for the use
of this information. Disclosure or reproduction of the enclosed, without the written
permission of Aeonmed is prohibited.
This manual is intended for use only by technicians who have successfully completed
Aeonmed training on this product.
Aeonmed believes the information herein is accurate but accepts no responsibility for
errors, omissions, or misrepresentation.
12-1
13 Appendix B
13 Appendix B Diagrams and Schematics
Pneumatic diagram
13-1
14 Appendix C
14 Appendix C Specifications
System
Operating Conditions
Operating Temperature Range: +5 to +40 ℃
Relative Humidity: 5 to 95% non-condensing
Atmospheric Pressure: 700 to 1060 hPa
Non-operating Conditions
Storage Temperature Range: -20 to +60 ℃
Storage Relative Humidity: ≤95% non-condensing
Storage Atmospheric Pressure: 700 to 1060 hPa
Power Supply
Power Supply, Automatic Range Selection
Battery Backup (Standard and Optional)
Maximum Power Consumption
100-240 +/- 10% VAC 50/60 Hz
Two rechargeable battery modules, 12 V, 6.6 Ah each. Recharge time approximately
3.5hours. Battery backup time of 120minutes minimum with only standard internal
battery.
CAUTION: The Power Supply should meet the above specifications.
Ventilator
General Dimensions:
User Interface: 350 wide x 55 deep x 244 high (mm)
Ventilation Delivery Unit: 322 wide x 375 deep x 366 high (mm)
System with Cart (optional): 547 wide x 675 deep x 950 high (mm)
Weight: Total: 40kg
(Approximate) User Interface: 2.5kg
Ventilation Delivery Unit: 12.5kg
14-1
Cart: 25kg
Trigger Method: Flow and Pressure
Maximum Limited pressure: 80 cmH2O
Maximum Working pressure: 80cmH2O
Gas Supply
Supplied gases must be free of water, oil and particles
Inlet Gas Pressure
O2: 280kPa to 600kPa (41– 87PSI)
Connection Standards Available
DISS, NIST
Patient System Connectors
Male 22 mm Conical Fittings in accordance with ISO 5356-1
User Interface
Attaches to the cart, a rail, or other mounting system.
Standard Conditions Specifications
Error ranges in this document assume the following standard conditions:
Ambient pressure: 101.3 kPa (1 atmosphere)
Room temperature: 20 ℃
Dry gases in patient system
Inlet pressure: 345 kPa (50 PSI)
Inspiratory Channel
Pressure Drop
Maximum 5 cmH2O at a flow of 60 liters/min without CO2 airway adapter.
Compliance
Maximum 2 ml/cmH2O (with Fisher &Paykel MR 810 humidifier and reusable silicone adult
patient circuit)
Gas Delivery System
Microprocessor controlled valves
Gas Delivery Device
Flow Range:
14-2
14 Appendix C
1 to 180 liters/min. (Adult)
0 to 60 liters/min. (Child)
Maximum Pressure Setting: 70 cmH2O
NIV Max leakage compensation level
Adult: 60liters/min
Child: 30liters/min
Expiratory Channel
Pressure Drop (Resistance)
Maximum 5 cmH2O at a flow of 60 liters/min without CO2 airway adapter.
Compliance
Maximum 2 mL/cmH2O (with Fisher & Paykel MR 810 humidifier and reusable silicone
adult patient circuit)
PEEP Regulation
Microprocessor controlled valve
PEEP Setting Range: 0 – 35 cmH2O
Expiratory Flow Measurements
Range: 0 – 180 liters/min.
Monitoring
Expiratory Minute Volume
Range: 0 – 60 liters/min.
Accuracy: +/- 1 LPM or +/- 15% of measured value (whichever is greater)
Resolution: 0.1 liters > 1 liter/min, 0.001 liters < 1 liter/min
Expiratory Tidal Volume
Range: 0 – 4000 mL
Adult Accuracy: +/- 25 mL or ±15% of the measured value (whichever is greater)
Child Accuracy: +/- 10 mL or ±10% of the measured value (whichever is greater)
Resolution: 1 mL
O2 Concentration
Range: 18 – 100%
Accuracy: +/- 3 vol. %
14-3
Resolution: 1%
Airway Pressure
Range: -20 to 80 cmH2O
Accuracy: ± (2 cmH2O + 4% of reading)
Resolution: 1 cmH2O
14-4
15 Appendix D
15 Appendix D Spare parts and configurations
Spare parts list:
No.
Replacement
period
Remarks
Code
Description
1
122007310
NBP mother board
As needed
——
2
122007306
NBP power supply board
As needed
——
3
122007308
NBP main control board
As needed
——
4
122007309
NBP core board
As needed
——
5
122007311
NBP interface board
As needed
——
6
122005527
Gas supply pressure
board
As needed
——
7
122007482
Encoder knob
component
As needed
——
8
122007483
Mute button component
As needed
——
9
122007304
NBP display interface
board
As needed
——
10
122007303
Common display platform
core board
As needed
——
11
122007305
Common display platform
mother board
As needed
——
12
122007485
Alarm lamp component
As needed
——
13
122007486
NBP indicate lamp
component
As needed
——
14
122010401
Differential pressure
transmitter board
As needed
——
15
210003677
Turbine
As needed
——
16
210002403
Flower sensor TSI
840201
As needed
——
17
122007463
Inspiration control valve
As needed
——
18
240000089
Check valve
As needed
——
19
240000252
Electromagnetic valve
SY114-6G
As needed
——
20
240001020
Mini-electromagnetic
valve N332/2B
As needed
——
21
210003856
High rupture fuse
T250V/3.15A
As needed
——
15-1
Replacement
period
Remarks
No.
Code
Description
22
210003676
Brushless motor driver
As needed
——
23
210003693
Touch panel AMT9542
As needed
——
24
210003675
LCD
As needed
——
25
122007471
Exhalation valve
components
As needed
——
26
122007890
Exhalation valve core
assemble
As needed
——
27
210003491
Switch power supply
SNP-G169-M
As needed
——
28
210003678
Switch power supply
As needed
29
122007322
Fan cable
As needed
——
Consumables list:
No.
Code
Description
Replacement Period
Remarks
1
130000231
Valve
1 years or as needed
——
2
130001347
One-way diaphragm
1 years or as needed
——
3
130009651
Water trap
2 years or as needed
——
4
130010423
Fan filter cotton
2 years or as needed
——
5
210001975
O2 sensor
1 years or as needed
——
6
230000135
Filter element
2 years or as needed
——
7
210003734
Lithium-ion battery RC2024
2 years or as needed
——
8
130004358
Filter element
3 months or as needed
——
9
130003930
Filter
2 years or as needed
——
15-2
This manual No.: 130015826
CE mark in this manual apply only to
product with CE mark.
Directive 93/42/EEC
concerning Medical Devices
Edition 01.04
May. 2018