Avante Alta V10 User manual

Preface
Read carefully and understand the contents of this manual before using this equipment.
Intellectual property rights
The company owns the intellectual property rights of this product, this manual must be treated as
confidential information. This manual only provides references for the operation, maintenance and
repair of our products.
Without our prior written consent, no person shall use, disclose or permit others to obtain this
manual by any means, in whole or part of the information and all its intellectual property rights
(including copyright) of the Company. No person in any way shall also without prior consent in the
whole or part of this manual contents not only limited to photography, reproduction, including
copying or translation into another language.
The company holds the final interpretation rights of this manual; without prior notice, the Company
alone also reserves the right to modify the contents of this manual.
The Company reserves the right to make technical alterations without prior notice and to modify
product specifications.
Liability of manufacturer
The Company is only responsible for the safety, reliability and performance of the equipment in
the following circumstances:
◼Assembly operation, expansion, re-adjustment, improvement and maintenance by the
Company’s authorized personnel.
◼The supporting electrical equipment and environment conform to national standards, industrial
standards, and this manual’s requirements.
◼Use according to the operation instruction.
WARNING
◆Equipment failure and the possible injury to patient’s health may occur if the agency
responsible for using this equipment does not set out an effective and satisfactory
maintenance plan.
◆When a central gas supply system is used. The failure of the central gas supply system may
cause all the devices connected to the Anesthetics to stop working.
◆This system should always be used in conjunction with other vital signs monitoring equipment
and / or professional judgment of the patient's condition.
◆This equipment should be used together with the use of Anesthetics gas scavenging system,
the user should be configured to comply with ISO 80601-2-13 standard Anesthetics gas
scavenging system.
◆The Anesthetics vaporizers used should be carried out (in accordance with ISO 80601-2-55).

◆IEC 60601-1 applies to all medical electrical equipment used or part of the Anesthetics
machine in question. Even if the individual components in the device are non-functional when
they are connected to an auxiliary power outlet that forms the medical electrical system. The
operator must be aware that when the device is connected to the auxiliary power outlet
current leakage is an evaluated risk.
◆Explosion hazardous. Do not use flammable Anesthetics agent such as Ether or
Cyclopropane with this equipment. Only non-flammable Anesthetics agents which meet the
requirements specified in ISO 80601-2-13 can be used with this equipment. This Anesthetics
workstation may be used with Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane.
Only one of these Anesthetics agents may be used at a time.
◆In order to avoid false alarms caused by high intensity electric field:
◼Please keep electrical wires away from this system as well as sensitive components,
such as flow sensors and oxygen sensors.
◼Do not store/locate electrical wires on any part of this system.
◆If the following condition occurs, the company is not responsible for the safety / reliability of
this system.
◼This system is not operated correctly in accordance with the "user Manual" and qualified
personnel.
Servicing and Repairs
In order to ensure the full operational life of this device, servicing by an engineer trained by the
manufacturer should be undertaken periodically.
Always give as much of the following information as possible:
◼Type of equipment
◼Product name
◼Serial number
◼Approximate date of purchase
◼Apparent fault
Pay Services:
Where regulations beyond the scope of the warranty, the company will implement the fee-based
service agreed by both supplier and purchaser.
Even during the warranty period, the system needs to be repaired due to the following causes:
man-made damage, grid voltage exceeds the device-specified range and natural disasters.
The company is not responsible for the following (including but not limited to) caused by
the direct, indirect or final damage:
◼Abnormal use.
◼Replacement parts without the permission of the Company or by the company without

authorized personnel to repair the machine.
◼The original serial number tag or product identification markings have been altered or
removed.
Return Policy
If the need arises to return the equipment to the Company, please follow these steps:
Obtain a right of return number, please contact our customer service department, and specify the
product series number, this series of numbers has been marked on the outside shipping box or on
the equipment, if the series of numbers are non-legible, return will not be accepted. Please mark
the model name and serial number at the same time give the reason for the return.
When this system is shipped back for maintenance, users should bear the freight (including
customs fees).
Equipment life: 8 years
Company Address
Company: Avante Health Solutions
Address: 2601 Stanley Gault Pkwy Suite 101, Louisville, KY 40223
Tel: [phone]
Revision History
This manual has a revision number. This revision number changes whenever the manual is
updated due to software or technical specification change. Contents of this manual are subject to
change without prior notice.
◼Revision number: 1.1
◼Release time: 2020-10

Table of Contents
Chapter 1 Safety 9
1.1 System Safety 9
1.1.1 System Terms 9
1.1.2 Warning 9
1.1.3 Caution 9
1.1.4 Caution 10
1.2 Equipment Symbols 11
1.3 Term abbreviation and definition 13
1.4 System information 15
1.4.1 System classification 155
1.4.2 Device standards 155
1.4.3 Integral system components 156
Chapter 2 Overview 177
2.1 Introduction 177
2.1.1 Intended use 177
2.1.2 Product performance structures 177
2.2 Appearance 177
2.3 Anesthesia Ventilator 212
2.4 Battery 212
2.4.1 Battery indicator 223
2.4.2 Installing/Replacing Batteries 223
Chapter 3 Installation and Connections 245
3.1 Install CO2 Circle Absorber 245
3.1.1 Arm Installation 245
3.1.2 Install co2 circle absorber245
3.2 Install the Oxygen Sensor 26
3.3 Install breath circuit 26
3.4 Install flow sensor 26
3.5 Install the Manual Bag 27
3.6 Install the Vaporizer 27
3.7 Power connector27
3.8 Gas source connection 27
3.9 Connect the pipeline 27

Chapter 4 Pre-Operative Test 29
4.1 Pre-Operation Test Procedure 29
4.1.1 Test interval 29
4.2 System Check 29
4.3 Flow control system test30
4.4 Oxygen flush test 31
4.5 Vaporizer test 30
4.5.1 Vaporizer back pressure test 30
4.5.2 Vaporizer interlock system test 30
4.6 APL Valve Test 31
4.7 Alarm test 31
4.7.1 Prepare for alarm test 32
4.7.2 Minute volume(MV) low alarm test 32
4.7.3 PRESSURE HIGH alarm test 32
4.7.4 Continuous Pressure High alarm test 33
4.7.5 PRESSURE LOW alarm test 33
4.8 Preoperative preparations 33
Chapter 5 Basic Operation 34
5.1 Powering On the System 34
5.2 Standby Mode 34
5.3 Powering Off the System 34
5.4 Using the Touch Screen34
5.5 System Settings 34
5.5.1 Alarm volume 34
5.5.2 System time 34
5.5.3 Sign breath internal 34
5.5.4 Set the language 35
5.5.5 Set O2monitoring switch 35
5.5.6 Set patient trigger type 35
Chapter 6 Anesthesia Ventilator 36
6.1 Set up 36
6.2 Turn on the system 36
6.3 Patient Setup 36
6.3.1 Select patient type 36
6.3.2 Setting patient height 36

6.4 Standby Mode 37
6.4.1 Enter Standby Mode 37
6.4.2 Exit Standby Mode 37
6.5 Set Ventilation Mode 37
6.5.1 Volume Control Ventilation(VCV)37
6.5.1.1 Description 37
6.5.1.2 Start VCV Mode38
6.5.1.3 Parameter Setup Area in VCV Mode 38
6.5.1.4 Set Parameters in VCV Mode 38
6.5.2 Pressure Control Ventilation(PCV) 39
6.5.2.1 Description 39
6.5.2.2 Start PCV Mode40
6.5.2.3 Parameter Setup Area in PCV Mode 40
6.5.2.4 Set Parameters in PCV Mode 40
6.5.3 Pressure Regulated Volume Control(PRVC) 41
6.5.3.1 Description 41
6.5.3.2 Start PRVC Mode 42
6.5.3.3 Parameter Setup Area in PRVC Mode 42
6.5.3.4 Set Parameters in PRVC Mode42
6.5.4 Pressure Support Ventilation(PSV) 42
6.5.4.1 Description 43
6.5.4.2 Start PSV Mode43
6.5.4.3 Parameter Setup Area in PSV Mode 44
6.5.4.4 Set Parameters in PSV Mode 44
6.5.4.5 Set Back Mode 44
6.5.5 Synchronized Intermittent Mandatory Ventilation(SIMV)44
6.5.5.1 Description 44
6.5.5.2 Start SIMV Mode 45
6.5.5.3 Parameter Setup Area in SIMV Mode 46
6.5.5.4 Set Parameters in SIMV Mode 47
6.5.6 Manual/Spontaneous Mode 48
6.6 Operation of stopwatch 48
6.7 User Menus 48
6.7.1 Standby Screen 48
6.7.2 Normal Screen 49

6.7.2.1 Waveform 50
6.7.2.2 Parameter Monitoring 50
6.7.3 Modes Menu 50
6.7.4 Control Menu 51
6.7.5 Monitoring Menu 51
6.7.6 Alarms Menu 52
6.7.6.1 Alarm limits 1 52
6.7.6.2 Alarm limits 2 53
6.7.6.3 Alarm log 54
6.7.7 System Menu 55
6.7.7.1 Information Menu 55
6.7.7.2 Setup Menu 56
6.7.7.2.1 Set Alarm loundness 56
6.7.7.2.2 Set Language 57
6.7.7.2.3 Set Units 57
6.7.7.2.4 Sensor on/off 57
6.7.7.3 Setting System Time 57
6.7.8 Calibration58
6.7.8.1 Pressure Sensor Zero Calibration 58
6.7.8.2 Flow Sensor Zero Calibration 58
6.7.8.3 O2 Cell Calibration 59
6.7.9 Service Modes Menu 59
Chapter 7 Operation and ventilation setting60
7.1 Input fresh gas 60
7.1.1 N2O, O2input settings 60
7.1.2 Vaporizer and Anesthetic agent setting 590
7.2 Set Ventilation Mode 601
7.3 Ventilator settings 61
7.3.1 Set tidal volume 61
7.3.2 Set respiratory rate 61
7.3.3 Set inspiratory time 61
7.3.4 Set inspiratory & expiratory ratio 61
7.3.5 Set pressure limit level 61
7.3.6 Set PEEP 61
7.3.7 Set pressure control level61

7.3.8 Set pressure support level 61
7.3.9 Set Apnea time 62
7.3.10 Set inspiratory pause 62
7.3.11 Set Rise Time 62
7.3.12 Set Expiratory trigger sensibility62
7.4 Start To Mechanical Ventilation 62
7.5 Parameters Monitoring 62
7.5.1 FiO2monitoring 62
7.5.2 Pressure Monitoring 62
7.5.3 Tidal Volume Monitoring 63
7.5.4 Breath Rate Monitoring 63
7.5 Pulmonary function 63
7.6 Alarm setup 63
Chapter 8 Alarms 64
8.1 Introduction 64
8.2 Alarm 64
8.3 Alarm Levels 64
8.4 Alarm Indicators 65
8.5 Silence Alarms 65
8.6 Alarm message 65
Chapter 9 Cleaning and disinfection 68
9.1 Clean and Disinfect the Anesthetic Machine housing 68
9.2 Disassembling the breath system 69
9.2.1 Remove the oxygen sensor 69
9.2.2 Remove the flow sensor 69
9.2.3 Remove the breath circuit69
9.2.4 Remove the Bag Arm 69
9.2.5 Remove the bellows Assembly 69
9.2.6 Remove the absorber canister 69
9.3 Cleaning& disinfection and Re-install the CO2 Circle Absorber and bellow 70
9.3.1 Re-install the CO2 Circle Absorber 71
9.3.2 Re-install the bellows assembly 71
9.3.3 Re-install the Bag Arm 71
9.3.4 Re-install the Airway pressure gauge 71
9.3.5 Re-install the oxygen sensor 71

9.3.6 Re-install the absorber canister 72
9.3.7 Re-Install the flow sensor72
Chapter 10 User Maintenance 73
10.1 Maintenance Policy 73
10.2 Maintenance Schedule74
10.3 Pressure Sensor Zeroing 74
10.4 Flow Sensor Zeroing 74
10.5 Oxygen concentration calibration 74
10.5.1 21% O2 Calibration 74
10.5.2 100% O2calibration 75
10.6 Touchscreen Calibration 75
10.7 Fault Diagnosis and Troubleshooting 75
Chapter 11 Accessories 77
A Product Specifications 78
A.1 Safety Standards 78
A.2 Environmental Specifications 78
A.3 Pneumatic Specifications 78
A.4 Power Specifications 79
A.5 Physical Specifications 80
A.6 Breathing System Specifications 81
A.7 Ventilator Specifications81
A.8 Anesthetic Vaporizer(optional) 84
H EMC 85

Chapter 1 Safety
1.1 System Safety
1.1.1 System Terms
User’s manual warnings, cautions, and important issues.
Danger
Indicates risk –harm for the patient or serious consequences, as well as serious damage to
property caused by vigilant operation.
Warning
◆Alert may have potential risks or unsafe operation, may result in minor injury, product failure
or damage to property.
Caution
⚫Express the need to comply with instructions or steps, provide a description or explanation,
ensuring safe and efficient use of this product.
1.1.2 Warning
◆This device can only be operated and used by professional well trained authorized medical
personnel who must strictly follow the guidelines in this user manual to operate the
equipment.
◆Carefully check the machine, accessories and connections before use to ensure normal and
safe operation.
◆To avoid the risk of electric shock, the device should have the power cable grounded to
protect the main power supply outlet.
◆If the event of any abnormal situation, Anesthetics workstation should be checked
immediately. Do not attempt to self-diagnose, otherwise danger of electric shock shall be
recognized by the Company's professional and technical personnel.
◆To ensure patient safety, the audible alarms and the alarm limits are to be set appropriately.
All ventilation alarm parameters are to be set by the clinical anesthetist; other audible alarms
are to be adhered to.
◆All physiological parameters and alarm information that are used as basis for clinical
treatment can only be used as a reference for the clinician.
◆To avoid the risk of fire, keep equipment away from flammable materials.
◆Follow local regulations when disposing of package materials
1.1.3 Caution
⚫Use only approved components specified in the user manual to ensure patient safety.
⚫When worn parts, accessories or the replacement of the equipment expires, disposal in
accordance with the hospital protocol and local regulations.

⚫Electromagnetic field anesthetics workstation performance would adversely affect the use of
other devices in the vicinity. Pay attention to the relevant EMC requirements. Mobile phones,
MRI equipment, X-ray emitted electromagnetic radiation can impact device and cause
interference.
⚫Assure that the local power supply voltage and frequency are consistent with the
requirements of this equipment.
⚫In the handling and installation process, please ensure that this machine is protected from
external damage avoid collisions, dropping etc.
1.1.4 Caution
⚫For easy operation and observation, ensure that the machine is in an upright correct position.
⚫User manual should be placed in the Anesthetics workstation for easy observation.
Class I special waste
Depleted batteries must be replaced and disposed of in accordance with local regulations.
Class II special waste
The oxygen concentration sensor must be discarded and replaced according to local regulations.
Oxygen concentration sensor should not be handled as a normal waste.
Hazardous waste (infectious)
The apparatus includes some parts of waste that cannot be handled as normal waste.
All discarded (disposable) components must be dealt in accordance to hospital regulations and in
an environmentally safe manner.
Do not allow excess exhalation fluid to accumulate within the sensor probe, otherwise it will affect
the function of the ventilator.
Do not use sharp objects to touch the screen.
It is highly recommended to have at least one spare battery as a backup power source.

1.2 Equipment Symbols
Alternating current
Fuse
Dangerous voltage
General warning (yellow
background)
Type BF equipment
Type B equipment
Battery
Equipotential
AC power supply
(Indicates a connection to
mains)
Battery symbol (indicating the
battery status, display the
current remaining capacity)
Power On
Power Off
Lighting
USB interface
Inspiratory flow
Expiratory flow
Bag position/ manual
ventilation
Mechanical ventilation
Lock
Unlock
Flow control
O2Flush button
Oxygen Sensor connector
Bi-directional rotation
Spare cylinders
O2supply connector
N2O supply connector
Air supply connector
AGSS outlet
Standby button
Activate alarms（“x”
indicates the number of
active alarms）
Driver gas(The “x” is the driver
gas type:2or Air)
Audio Pause
Assisted breathing symbol
Adjust the lower limit alarm
parameters
Alarm parameter adjustment
cap

Caution
The logo appears do not touch
the interface
Do not reuse
Identifies the user needs to
perform the operation
Refer to instruction manual
Operating instructions
Date Of Manufacture
Manufacturer
Serial Number
Authorized Representative In
The European Community
Batch Code
Catalogue Number
CE marking and Notified
Body Number
(93/42/EEC in accordance
with harmonized standards)
IP21
Protected against solid foreign
objects of Φ12.5mm and
greater 1: Protection against
vertically falling water drops
Contains Or Presence Of
Natural Rubber Latex
Keep Dry
handle with care
Do not roll
upward
Temperature Limitation
Class I special waste
(Depleted of used batteries
must be in accordance
with local regulations
concerning the
replacement and
discarded)
Class II special waste
(The O2sensor must be used
in accordance with local
regulations concerning the
replacement and discarded.
Normal waste is not the way to
handle the processing of waste
O2sensor)
Hazardous waste
(infectious)
The apparatus includes
some parts of the waste is
not in a normal manner
Waste not processed properly
handle used batteries (in some
areas may not provide
recycling facilities)
Call for maintenance
Serial port interface
RS232 port interface
VGA output interface
Do not obstruct-block
Disconnect mains plug from
electrical outlet
Disconnect gas from outlet
Alarm system clear

Home position
Absorbent bypass on
1.3 Term abbreviation and definition
Abbreviation
Definition
AA
Anesthetics agent
AGSS
Anesthetics Gas Scavenging System
ACGO
Auxiliary Common Gas Outlet
APL
Adjustable Pressure Limit
BTPS
Body temperature, ambient pressure, saturated humidity conditions
BDU
Breath Delivery Unit
Cdyn
Dynamic Compliance
CO2
Carbon dioxide
DES
Desflurane
ENF
Enflurane
ET
End-tidal concentration
EtAA
End-tidal Anesthetics agent
EtENF
End-tidal Enflurane
EtHAL
End-tidal Halothane
EtDES
End-tidal Desflurane
EtSEV
End-tidal Sevoflurane
EtISO
End-tidal Isoflurane
EtN2O
End-tidal Nitrous oxide
EtCO2
End-tidal carbon dioxide
Esens
Expiratory Trigger Sensibility
Exp
Expiratory
FI
Fraction of inspired gas
FiO2
Fraction of inspired oxygen
FiAA
Fraction of inspired Anesthetics agent
FiENF
Fraction of inspired Enflurane
FiHAL
Fraction of inspired Halothane
FiDES
Fraction of inspired Desflurane
FiSEV
Fraction of inspired Sevoflurane
FiISO
Fraction of inspired Isoflurane
FiN2O
Fraction of inspired Nitrous oxide
FiCO2
Fraction of inspired Carbon dioxide
f
Frequency
ftotal
Total respiratory rate

fspn
Spontaneous respiratory rate
Fsens
Flow Trigger Sensibility
GUI
Graphic User Interface
HAL
Halothane
I:E
Inspiratory-expiratory ratio
Insp
Inspiratory
ISO
Isoflurane
L/min
L/min
kPa
kilopascal
Kg
Kilogram
MAC
Minimum alveolar concentration
Manual
Manual ventilation
MV
Minute volume
N2O
Nitrous oxide
O2
Oxygen
Paw
Airway pressure
PCV
Pressure control ventilation
PEEP
Positive end-expiratory pressure
Pinsp
Pressure control level of inspiration
Plimit
Pressure limit level
Pmean
Mean airway pressure
Ppeak
Peak pressure
Pplat
Plateau pressure
Pmin
Minimum pressure
PCV
pressure control ventilation
PRVC
pressure guaranteed ventilation - volume control ventilation
Pause
Inspiratory pause time
Psens
Pressure Trigger Sensibility
PSV
Pressure support ventilation
Psupp
Pressure support level
R
Resistance
SEV
Sevoflurane
SIMV
Synchronized intermittent mandatory ventilation
SIMV-V
Synchronized intermittent mandatory ventilation –volume control ventilation
SIMV-P
Synchronized intermittent mandatory ventilation -pressure control ventilation
SIMV-PRVC
Synchronized intermittent mandatory ventilation -pressure guaranteed
ventilation - volume control
SPONT/PSV
Pressure support ventilation with apnea backup
STPD
Standard Temperature and Pressure Dry
Tinsp
Inspiratory time
Tslope
Pressure rise time

Texp
Expiratory time
VT
Tidal volume
Vte
Expired tidal volume
Vti
Inspired tidal volume
VCV
Volume control ventilation
1.4 System information
1.4.1 System classification
This system is classified as follows:
1. Class I Equipment.
2. Type B Equipment.
3. Type BF Equipment.
4. Continuous operation.
1.4.2 Device standards
Devices used with this Anesthetics system shall comply with the following standards where
applicable:
1. Breathing system and breathing system components ISO 80601-2-13.
2. Anesthetics gas scavenging systems ISO 80601-2-13.
3. Anesthetics vapor delivery devices ISO 80601-2-13.
4. Oxygen monitors ISO 80601-2-55.
5. Carbon dioxide monitors ISO 80601-2-55.
6. Exhaled volume monitors ISO80601-2-13.
7. Anesthetics agent monitors ISO 80601-2-55.
8. Pulse oximeter monitors ISO 80601-2-61.
1.4.3 Integral system components
This Anesthetics system contains the following integral components, monitoring devices, alarm
systems, and protection devices that comply with European, international, and national standards:
Standard：
■Breathing system pressure-measuring device
■Airway pressure-limitation device
■Volume monitor
■Breathing system integrity alarm
■Anesthetics ventilator
■Breathing system
Optional：

■Oxygen Sensor
■Side stream CO2module
■IRMA CO2/AX+ module
■SpO2module
■Auxiliary Common Gas Outlet(ACGO)
■Anesthetics vapor delivery device.
■Anesthetics gas scavenging systems(AGSS)
■Auxiliary Oxygen
■Suction regulator
■Driver gas switch valve

Chapter 2 Overview
2.1 Introduction
2.1.1 Intended use
The Anesthetic machine is intended to provide breathing Anesthetics for adult, pediatric patients
during surgery.
The Anesthetics machine must only be operated by qualified anesthesia personnel who have
received the correct training for its use.
The anesthesia machine without absolute contraindications.
Warning
◆This Anesthetics machine is intended for use by qualified Anesthetics personnel only or under
their guidance. Anyone unauthorized or untrained must not perform any operation on it.
◆This product cannot be used under magnetic resonance (MRI) environment.
◆Clinical environment is the operating room, emergency room.
2.1.2 Product performance structures
The equipment consists of the Anesthetics host, Anesthetics ventilator, the patient circuit,
vaporizer, flow meters and other components.
2.2 Appearance

Front view
1. Frame
2. Anesthesia Vaporizer with Mounting bar
3. Anesthesia Ventilator
4. Handle
5. Drawers
6. Castors
7. ACGO switch
◼When ACGO switch is on: Fresh gas will be delivered to half open breathing system
through ACGO outlet.
◼When ACGO switch is off: Fresh gas will be delivered to CO2 Circle Absorber.