www.aeonmed.

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VT5230 Ventilator
User Manual

Beijing Aeonmed Co.,Ltd.

Attention
Aeonmed Inc. holds the copyrights to this non-public published manual, and reserves the rights to keep it as a
secure document. Refer to this manual when operating, maintaining and repairing Aeonmed products only.
Only Aeonmed may provide permission for the use of or copies of this document to others.

Proprietary materials protected by the copyright law are included in this manual. No section of it may be
duplicated, copied, or translated into other languages without prior written approval from Aeonmed who
reserves the copyright.

Everything written within this manual is considered to be correct, but it is not a substitute for the exercise of
professional judgment. Aeonmed is not legally responsible for any mistakes printed within and/or any damages
caused by incorrect connection and operation of equipment. Aeonmed does not supply privileges endowed by
the patent law to any other parties. Aeonmed is not legally responsible for the results caused by patent law
breaking or any rights of the third party violating.

Aeonmed has the right to revise any content in this manual without notice; and has no obligation to update
either hardware or software of the equipment described herein to the user or owner.

I
Warning for use
Welcome to use our products!

In order to use this product correctly and effectively, please read these operating instructions carefully and
completely before using the product for the first time.

When using the product, always proceed in accordance with the information provided in these operating
instructions on the basis of fully understanding the information in this manual.

This product is only for intended use as described in these operating instructions.

Only specially trained service professionals are authorized to perform the connection and service of this
product.

For any situation in the use process, please contact with us. We will provide you with warm service.

Product specifications are subject to change without notification.

II
Manufacturer(holder): Beijing Aeonmed Co., Ltd.

Manufacturer(holder) Room 405，Basement 1 to 4th Floor of 901 Unit, Building 9, No.26 Outer
address: Ring West Road, Fengtai District, Beijing 100070, China

Facility: Beijing Aeonmed Co., Ltd.

Facility address: Room 405，Basement 1 to 4th Floor of 901 Unit, Building 9, No.26 Outer
Ring West Road, Fengtai District, Beijing 100070, China
No.10 Chaobai Street, Yingbin Road West, Yanjiao Development Zone,
065201, Langfang, Hebei, China

Service: Beijing Aeonmed Co., Ltd.

Service Address: No.10 Chaobai Street, Yingbin Road West, Yanjiao Development Zone,
065201, Langfang, Hebei, China

Tel: +86-10-83681616

Fax: +86-10-63718989

Service Line: +86 800-810-8333

Website: http://www.aeonmed.com

E-mail: service@aeonmed.com

European Representative: Shanghai International Holding Corp. GmbH (Europe)

Address: Eiffestrasse 80, 20537 Hamburg Germany

Wechat Offical Account:

III
 Table of Contents

1 Introduction ............................................................................................................................................... 1-1

1.1 Manufacturer’s Responsibility .................................................................................................... 1-1
1.2 Operator’s Responsibility for Patient Safety .............................................................................. 1-1
1.3 Definitions .................................................................................................................................. 1-1
1.4 Warnings, Cautions and Notes .................................................................................................. 1-2
1.4.1 Warnings ............................................................................................................................ 1-2
1.4.2 Cautions ............................................................................................................................. 1-4
1.4.3 Notes .................................................................................................................................. 1-6
1.5 Intended Use.............................................................................................................................. 1-7
1.6 Indications for Use ..................................................................................................................... 1-7
1.7 Contraindication ......................................................................................................................... 1-7
1.8 Abbreviations and Definitions .................................................................................................... 1-8
1.9 Frequently Used Functions ........................................................................................................ 1-9
1.10 Symbols ................................................................................................................................... 1-10
1.11 VT5230 Critical Care Ventilator Quick Start Guide ...................................................................1-11
2 System Overview ...................................................................................................................................... 2-1
2.1 Ventilator Components .............................................................................................................. 2-1
2.2 User Interface Components ....................................................................................................... 2-2
2.2.1 GUI Screen Front Panel ..................................................................................................... 2-2
2.2.2 GUI Screen Rear Panel ..................................................................................................... 2-2
2.3 Main Control Unit ....................................................................................................................... 2-3
2.3.1 Front Panel ......................................................................................................................... 2-4
2.3.2 Rear Panel ......................................................................................................................... 2-5
2.4 Cart ............................................................................................................................................ 2-6
2.5 Air Compressor .......................................................................................................................... 2-6
2.6 Humidifier ................................................................................................................................... 2-7
2.7 Cylinder Kit................................................................................................................................. 2-7
3 CO2 Module ............................................................................................................................................... 3-1
3.1 CO2 Module Intended Use ......................................................................................................... 3-1
3.2 CO2 Module Specifications ........................................................................................................ 3-1
3.2.1 General ............................................................................................................................... 3-1
3.3 System Assembly Instruction ..................................................................................................... 3-4
3.3.1 Set-up ................................................................................................................................. 3-4
3.3.2 Placement of IRMA Probe .................................................................................................. 3-6
3.4 Pre-use Check ........................................................................................................................... 3-6
3.4.1 Zeroing Procedure ............................................................................................................. 3-7
3.5 Alarms ........................................................................................................................................ 3-7

IV
 3.6 Cleaning ..................................................................................................................................... 3-7
3.7 Warnings .................................................................................................................................... 3-8
3.8 Cautions ..................................................................................................................................... 3-9
3.9 Maintenance Information ........................................................................................................... 3-9
4 Setup ......................................................................................................................................................... 4-1
4.1 Connect Power Supply .............................................................................................................. 4-1
4.2 Connect Gas Source ................................................................................................................. 4-1
4.3 Connect Accessories ................................................................................................................. 4-2
4.3.1 Connect Patient circuit ....................................................................................................... 4-2
4.3.2 Connect Humidifier (optional)............................................................................................. 4-3
4.3.3 Connect Patient Circuit Positioning Arm (optional) ............................................................ 4-3
4.3.4 Connect User Interface Screen .......................................................................................... 4-4
4.3.5 Connect Cylinder Kit (optional) .......................................................................................... 4-4
5 Pre-use Test .............................................................................................................................................. 5-1
5.1 When to Carry out Pre-use Test: ............................................................................................... 5-1
5.2 How to Do the Pre-use Test ....................................................................................................... 5-1
5.3 Pre-use Test Procedure ............................................................................................................. 5-1
6 VT5230 Ventilator Operation..................................................................................................................... 6-1
6.1 Starting Up ................................................................................................................................. 6-1
6.2 Interface Layout ......................................................................................................................... 6-3
6.2.1 Standby Interface Layout ................................................................................................... 6-4
6.2.2 Main Interface Layout ......................................................................................................... 6-8
6.3 Operation of Main Manu .......................................................................................................... 6-14
6.3.1 Ventilation Mode ............................................................................................................... 6-14
6.3.2 Alarm Limits...................................................................................................................... 6-23
6.3.3 Monitoring Data ................................................................................................................ 6-26
6.3.4 Lung Mechanics ............................................................................................................... 6-27
6.3.5 P/V MANEUVER (Optional) ............................................................................................. 6-27
6.3.6 Log ................................................................................................................................... 6-32
6.3.7 System ............................................................................................................................. 6-35
6.4 Functions of Shortcut Keys ...................................................................................................... 6-54
6.4.1 Inspiratory Hold ................................................................................................................ 6-55
6.4.2 Expiratory Hold ................................................................................................................. 6-56
6.4.3 Nebulizer .......................................................................................................................... 6-57
6.4.4 Manual .............................................................................................................................. 6-59
6.4.5 Suction ............................................................................................................................. 6-60
6.4.6 Freeze .............................................................................................................................. 6-62
6.4.7 Screen Lock ..................................................................................................................... 6-62
6.4.8 Alarm Limits...................................................................................................................... 6-64
6.4.9 Print Screen...................................................................................................................... 6-65
6.5 Ventilation Parameter Set-up ................................................................................................... 6-66
6.6 Turn off the Ventilator ............................................................................................................... 6-67

V
7 Alarms and Troubleshooting ..................................................................................................................... 7-1
7.1 Alarms ........................................................................................................................................ 7-1
7.2 Alarm Message Table ................................................................................................................ 7-1
8 User Maintenance ..................................................................................................................................... 8-1
8.1 Cleaning and Disinfection .......................................................................................................... 8-2
8.1.1 Cleaning and Disinfecting Agents/ Autoclaving .................................................................. 8-2
8.1.2 Cleaning and Disinfection Methods ................................................................................... 8-3
8.1.3 Cleaning and Disinfection of Components ......................................................................... 8-3
8.2 Regular Maintenance ................................................................................................................. 8-6
8.2.1 Maintenance Principles ...................................................................................................... 8-6
8.2.2 Maintenance Overview and Schedule ............................................................................... 8-6
8.2.3 User Maintenance .............................................................................................................. 8-7
8.3 Maintenance in Operation and Transportation .......................................................................... 8-8
8.3.1 Transportation .................................................................................................................... 8-8
8.3.2 Storage ............................................................................................................................... 8-8
8.4 Battery Maintenance .................................................................................................................. 8-9
8.5 Oxygen Sensor ........................................................................................................................ 8-10
8.5.1 Oxygen Sensor Replacement .......................................................................................... 8-10
8.5.2 Oxygen Sensor Calibration .............................................................................................. 8-10
8.5.3 Technical Specifications of Oxygen Sensor ......................................................................8-11
8.5.4 Oxygen Sensor Maintenance ........................................................................................... 8-12
8.6 Disposal ................................................................................................................................... 8-12
9 Warranty .................................................................................................................................................... 9-1
9.1 Return ........................................................................................................................................ 9-1
10 Theory of Operation ........................................................................................................................ 10-1
10.1 Ventilation Modes .................................................................................................................... 10-1
10.1.1 Assist/Control Ventilation ................................................................................................. 10-1
10.1.2 Synchronized Intermittent Mandatory Ventilation............................................................. 10-6
10.1.3 Back-up Ventilation (Apnea Ventilation) ........................................................................... 10-7
10.1.4 Spontaneous/CPAP Ventilation ........................................................................................ 10-8
10.1.5 BiLevel Ventilation (BIVENT) ........................................................................................... 10-9
10.1.6 Non Invasive/ Continuous Positive Airway Pressure ..................................................... 10-10
10.1.7 Non Invasive/ Pressure Controlled Ventilation ............................................................... 10-13
11 Appendix A VT5230 Ventilator System Specifications .............................................................................11-1
11.1 System ......................................................................................................................................11-1
11.1.1 General ..............................................................................................................................11-1
11.1.2 Operating Conditions ........................................................................................................11-2
11.1.3 Non-operating Conditions .................................................................................................11-2
11.1.4 Power Supply ....................................................................................................................11-2
11.2 Ventilator ...................................................................................................................................11-3
11.2.1 General ..............................................................................................................................11-3
11.2.2 Gas Supply ........................................................................................................................11-3

VI
 11.2.3 Patient System Connectors ...............................................................................................11-4
11.2.4 User Interface Screen .......................................................................................................11-4
11.2.5 Acoustic Energy ................................................................................................................11-4
11.3 Standard Conditions Specifications ..........................................................................................11-4
11.4 Inspiratory Channel ...................................................................................................................11-4
11.5 Expiratory Channel ...................................................................................................................11-5
11.6 Monitoring .................................................................................................................................11-6
11.7 Alarms .......................................................................................................................................11-6
11.7.1 Allowed Alarm Settings .....................................................................................................11-6
11.7.2 Alarms Miscellaneous .......................................................................................................11-7
11.8 Ventilation Modes .....................................................................................................................11-8
11.8.1 Controlled Ventilation ........................................................................................................11-8
11.8.2 Supported Ventilation ........................................................................................................11-8
11.8.3 Combined Ventilation ........................................................................................................11-8
11.9 Trend Function ..........................................................................................................................11-9
11.10 Log Function ...........................................................................................................................11-10
11.11 Shortcut Key Functions ...........................................................................................................11-10
11.12 Communication/Interface ........................................................................................................ 11-11
11.12.1 Nurse call port.......................................................................................................... 11-11
11.12.2 Ethernet Port............................................................................................................ 11-11
11.12.3 RS-232 Port .............................................................................................................11-12
11.12.4 Nebulizer Output Port ..............................................................................................11-12
11.12.5 CO2 Port ..................................................................................................................11-12
11.13 Accessories.............................................................................................................................11-12
11.14 Ventilating Parameters: Default Values and Allowed Settings (Standard Configuration) .......11-13
11.15 Delivery Accuracy ...................................................................................................................11-16
12 Appendix B Pneumatic Diagram- VT5230 Ventilator ...................................................................... 12-1
13 Appendix C EMC Guidelines ........................................................................................................... 13-1

VII
 1 Introduction

1 Introduction
Review all information in this manual thoroughly before attempting to use the equipment.
This equipment must be used under the supervision of a physician.

1.1 Manufacturer’s Responsibility

Aeonmed is responsible for the security; reliability and functions of the equipment, only when the following
requirements are strictly adhered to:

• Only individuals authorized by Aeonmed may perform connection, adjustments and repairs.
• Necessary electrical equipment and the working environment must be in accordance with the national
standards, professional standards and the requirements listed in this manual.
• Equipment must be used as instructed in this manual.

CAUTION: This equipment is not for home use.

Aeonmed will supply service information to help the customer, under the guidance of qualified technicians, to
repair the equipment.

1.2 Operator’s Responsibility for Patient Safety

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/or alarm occurrence.

1.3 Definitions

This manual uses three special indicators to convey information of a specific nature.

1-1
They include:

WARNING: Indicates a condition that can endanger the patient or the ventilator operator.

CAUTION: Indicates a condition that can damage the equipment.

Indicates points of particular emphasis that make operation of the ventilator more
NOTE: efficient or convenient.

1.4 Warnings, Cautions and Notes

1.4.1 Warnings

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 VT5230 Ventilator System is intended for use by authorized and trained medical
personnel only.

WARNING: The user must familiarize themselves with the operation and use of this machine prior to
first clinical use with a patient.

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 connect the ventilator and run Aeonmed’s
connection procedure, which includes calibration of various system components, before you connect a
patient to the ventilator.

WARNING: If a fault is detected in the VT5230 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, see section 4.

1-2
 1 Introduction

WARNING: VT5230 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 VT5230 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 using
equipment on patient.

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.

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.

1-3
 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 mains with
protective earth.

1.4.2 Cautions

CAUTION: The breathing circuit must not be connected whenever the VT5230 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.

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.

1-4
 1 Introduction

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 VT5230 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 Exhaust Cooling Fan

CAUTION: Do not use VT5230 Ventilator in an MRI environment.

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 Aeonmed 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: Normal environment: -20 Celsius to +60 Celsius and relative humidity of 95% or below.

1-5
 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. 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.

1.4.3 Notes

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. See Section 5.3 for proper
use of Mainstream CO2 Adapter.

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
 1 Introduction

1.5 Intended Use

The VT5230 Ventilator System is intended to provide continuous ventilation treatment to patients and
monitoring of patients with respiratory failure or respiratory insufficiency, requiring respiratory support.

1.6 Indications for Use

The Aeonmed VT5230 Critical Care Ventilator is an electronically controlled, pneumatically powered machine
intended to provide continuous ventilation to patients with respiratory failure or respiratory insufficiency,
requiring respiratory support.

Aeonmed VT5230 Critical Care Ventilator should only be used by:

• Professional health care providers,

• Technicians that have received training in the use of this system

The Aeonmed VT5230 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for
use in a wide variety of clinical conditions. Specifically, the Aeonmed VT5230 Critical Care Ventilator is
applicable for adult and pediatric patients, who require the following types of ventilator 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 Aeonmed VT5230 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.

1.7 Contraindication

WARNING: The Aeonmed VT5230 Critical Care Ventilator is not intended for use in areas with risk of
explosion. Do not operate the ventilator in the presence of flammable anesthetics.

WARNING: The Aeonmed VT5230 Critical Care Ventilator is not designed for use in an MRI environment.
Do not use the VT5230 near an MRI machine; injury or equipment damage could result.

WARNING: To avoid risk of electric shock, this equipment must only be connected to a mains supply with
protective earth.

NOTE: See Section 1.4 (Warnings, Cautions and Notes) for all environmental warnings.

1-7
1.8 Abbreviations and Definitions

(S) Means Set Value

(M) Means Measured Value

CPAP Continuous Positive Airway Pressure (S)

f Breath rate (frequency) in bpm, i.e. ventilation times per minute (S)

fspont Patient’s spontaneous respiratory frequency ( M)

ftotal Total breath rate, i.e. the sum of breath rate f and spontaneous breath rate fspont (M)

O2 Inspiratory O2 concentration (S & M)

I:E The ratio of Inspiration to Expiration (M)

MVe Expiratory minute volume (M)

MVespont Spontaneously breathed minute volume (M)

MVleak Leakage minute volume (M)

Paw Patient airway pressure (M)

PEEP Positive End-Expiratory Pressure, which can improve the patient’s oxygenation (S&M)

PEEPi Intrinsic Positive End-Expiratory Pressure (M)

Pinsp Upper pressure level in PCV mode (S)

Pmean Mean airway pressure. This value is updated at the end of the last 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)

Psupp Pressure support (S)

Phigh Upper pressure level in BIVENT and APRV (S)

Plow Lower pressure level in BIVENT and APRV (S)

P0.1 Occlusion Pressure

Tispont Maximum inspiratory time (S)

Tinsp Inspiratory Time (S)

Tpause Inspiratory Pause Time, to increase the inspiratory time to improve the patient’s
oxygenation (S)

Trigger by flow rate (S)

1-8
 1 Introduction

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)

Tc Time constant (M)

Leak% Leakage percentage (M)

Cdyn Dynamic compliance (M)

Cstatic Static compliance (M)

Rinsp Inspiratory resistance (M)

Rexp Expiratory resistance (M)

Elastance Elastic resistance (inverse of compliance) (M)

IP21 Solid particle protection level 2; Liquid ingress protection level 1

1.9 Frequently Used Functions

(1) Power ON / OFF Switch

(2) Connect patient hoses and gas supply

(3) Pre-Use Test

(4) Settings

(5) Start Ventilation/Standby

(6) Monitoring data

(7) Alarm, Event/Alarm log

(8) Calibration

(9) Cleaning and disinfection

(10)Breathing Circuit Components

(11)System interconnections for gas supply

(12)Humidifier and system interconnections

(13)Nebulizer and system interconnections

1-9
1.10 Symbols

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) Warning & Caution

Attention: Please refer to Product

Specifications and Relevant Dangerous voltage
Standards

Protective earth ground loudspeaker

EQUIPOTENTIAL connection Manufacturer

Lock Date of production

Unlock Serial Number

Inspiratory hold Expiratory hold

Nebulization Manual inspiration

Intelligent increase of oxygen Waveform freeze

Standby int. Internal Battery

AC power ext. Extended Battery

USB device Already online

Prompt message Pressure trigger

Flow trigger Manual trigger

1-10
 1 Introduction

Adult Child

NIV modes Invasive modes

Main Menu Alarm Silence Key

Protection Class Type BF Refer to documentation

This mark means that pneumatic

and electric device rubbish is not
allowed to be dealt as unclassified Follow operating instructions
city rubbish and should be collected
separately.

The system, with this label under

the stipulations in the operating
manual, complies with the
Neonate
requirements related from
93/42/EEC. 0123 is the certificate
number to certify authorizations

1.11 VT5230 Critical Care Ventilator Quick Start Guide

Review all information in the Operator’s Manual before attempting to use this equipment.

1. Connect Power Supply

Connect to AC Power Source or Utilize Battery

1-11
 2. Connect Gas Source

3. Power on Ventilator

Switch Ventilator on by turning to:

4. Technical Test

5. Pre-use Test initializes

6. Select New Patient

1-12
 1 Introduction

7. Prepare Patient Circuit

8. Connect CO2 Module (optional)

9. Connect IRMA Airway Adapter (optional)

10. Set Appropriate Ventilation Settings

1-13
 2 System Overview

2 System Overview

2.1 Ventilator Components

The Aeonmed VT5230 Critical Care Ventilator System consists of two required Components: a Main Control
Unit and a Graphical User Interface (GUI). Optional Components available for the Aeonmed VT5230 Critical
Care Ventilator system are: Cart, Air Compressor, Humidifier, Drawer & Extended Battery Backup
Assembly, Gas Cylinder Transport Holder, Patient Circuit Positioning Arm, Hose Assemblies for O2 and Air,
and CO2 monitoring subsystem, CO2 Interface Adapter – IRMA (Adult/Pediatric), and CO2 Interface Adapter –
IRMA (Infant).

Figure 2-1 VT5230 profile

1 Main Control Unit 2 Humidifier 3 Air Compressor

4 Connector 5 Nebulizer Connector 6 Y-Piece

Patient Circuit
7 8 Mask 9 Test Lung
Positioning Arm

10 Nebulizer Tub 11 Patient Circuit 12 Water Trap

2-1
The GUI controls ventilator settings: Settings can be selected and adjusted by using a finger on the screen
and/or the encoder knob. The GUI verifies that all combinations of settings are obtainable and will notify the
user of any setting limitations.

Breathing parameters are continuously measured by transducers and controlled by a feedback system in the
Breathing Delivery Unit. The ventilator responds to a difference between the actual measured value of a
parameter and the preset or calculated value by adjusting gas delivery to achieve the target value.

2.2 User Interface Components

2.2.1 GUI Screen Front Panel

The GUI screen front panel includes:

1 Alarm Lamp
2 Touch Screen
3 Alarm Silence Hard Key
4 Encoder Knob

Figure 2-2 GUI screen front panel

The Alarm silence hard key enables the user to silence alarms for 2 minutes. Pressing a location on the GUI
screen will either bring up a sub-menu or will highlight a ventilator parameter or shortcut key. Rotating the
encoder knob when the ventilator parameter is selected allows the user to scroll through the available range.

2.2.2 GUI Screen Rear Panel

1. Main cable: This cable connects the GUI screen and the main control unit.

CAUTION: Do not disconnect this cable when the ventilator is operating.

2. VGA interface: For connection of a VGA display which will display the same information as the GUI screen.
Display resolution of 1024*768, 60Hz is suggested.

2-2
 2 System Overview

CAUTION: Do not connect VGA interface when

the system is in service.

3. USB interface: Only external storage devices of

low power consumption are permissible for this USB
interface.

CAUTION: Do not connect to the USB

interface when the Aeonmed VT5230 Critical Care
Ventilator is in use on a patient.

4. Network Interface: For connection to external

equipment such as electronic health record. Refer to
Figure 2-3 GUI screen rear panel
Section 11.12, Communication/interface
for additional information.

5. Speaker: This is the main alarm speaker of the user interface.

CAUTION: Do not block the speaker holes.

2.3 Main Control Unit

The main control unit is responsible for control of the Aeonmed VT5230 Critical Care Ventilator. It has
interfaces on the front and rear panels including pneumatic and electronic interfaces.

2-3
2.3.1 Front Panel

Figure 2-4 Main control unit front panel

1. Exhaust port: Patient expiratory gas is released through this port to room air.

CAUTION: Do not block this port.

CAUTION: Do not connect inspiratory or expiratory limb circuit to this port.

2. Indicators

AC power supply indicator: Green light is on when the AC power supply is available.

Internal/Extended battery charge indicator: Yellow light is on when the internal or extended battery is being
charged.

3. Inspiratory port: Delivers gas from the ventilator to the patient inspiratory limb hose.

CAUTION: Do not connect expiratory limb circuit to this port.

4. Expiratory module latch: A latch that is used to lock or unlock the expiratory module.

WARNING: Do not operate this latch or remove the expiratory module while the Ventilator is in use on a
patient.

5. Nebulizer output port: For nebulizer device connection.

2-4
 2 System Overview

6. Expiratory module: To remove the Expiratory module: Activate the latch (4) on the right part of front cover
(i.e. unlock it) and then take out the Expiratory module. After cleaning or high level disinfection, insert the
module in the proper position until the locking latch returns to the locked state.

NOTE: Use caution when inserting the expiratory module to avoid leakage. A system leak test must be
done before the machine is put into patient use.

CAUTION: Expiratory module is heated to prevent water condensation, use caution due to high
temperature.

7. Expiratory Port

CAUTION: Do not connect inspiratory limb circuit to this port.

8. Water trap cup: Collects condensed water to prevent it from going into expiratory valve.

2.3.2 Rear Panel

Figure 2‑5 Rear panel

2-5
 Power Supply 3 Internal Battery
1 2 AC Inlet
Switch Cover Lock
Internal Battery Oxygen Sensor
4 Fuse 5 6
Cover Cover
Exhaust Gas
7 Air Inlet 8 Oxygen Inlet 9
Release Port
Nurse Call
10 Serial Number Label 11 Cooling Fan 12
Connector
Connector for GUI CO2 Module
13 14 15 RS 232 Connector
Screen Cable Connector
Equipotential
16
Terminal

CAUTION: Do not connect any device to the RS 232 interface; for service use only.

CAUTION: The Equipotential Terminal is used to connect various parts of the equipment or of a medical
equipment system to the same potential. When connected, it shall comply with the IEC
60601-1: 2005

WARNING: Never block the ports of the exhaust cooling fan! Clean the filter regularly! Ventilator
should not be covered or positioned in such a way that the operation or performance of the
Ventilator is adversely affected (e.g. positioned next to a curtain that blocks the flow of
cooling air, thereby causing the ventilator to overheat).

WARNING: Use caution when handling flammable and/or damageable components. Call for
authorized service support when necessary.

2.4 Cart

A cart may be used to mount the Aeonmed VT5230 Critical Care Ventilator.

The cart includes an optional auxiliary AC panel.

2.5 Air Compressor

An optional Air Compressor MC340 may be mounted onto the cart.

2-6
 2 System Overview

The air compressor can supply medical compressed air. The filter of the air compressor should be cleaned
regularly.

2.6 Humidifier

An optional Humidifier, like the Fisher & Paykel MR850, or similar product, should be used with the Aeonmed
VT5230 Critical Care Ventilator. Aeonmed may supply humidifiers in your area – talk with your Aeonmed Sales
Representative if you need more information.

2.7 Cylinder Kit

An optional Gas Cylinder Mounting Kit is available that holds 2 US E cylinders (one O2 and one AIR).

2-7
 3 CO2 Module

3 CO2 Module

3.1 CO2 Module Intended Use

The mainstream CO2 module is intended to be connected to the Aeonmed VT5230 Critical Care Ventilator for
display of real time and derived monitoring data of CO2.

The mainstream CO2 module is intended to be connected to a patient breathing circuit for monitoring of
inspired/expired gases during recovery and respiratory care. It may be used in the intensive care unit, patient
room and emergency medicine settings for adult and pediatric patients.

The CO2 module is not intended to be used as the only means of monitoring a patient. It must always be used
in combination with alternate monitoring systems.

3.2 CO2 Module Specifications

3.2.1 General

Description Extremely compact infared mainstream CO2 probe.

Dimensions (WxDxH) 38 x 37 x 34 mm (1.49 x 1.45 x 1.34 in)

Cable Length 2.50 m ±0.02 m (8.2 ft ±0.07 ft)

Weight < 25 g (cable excluded)

Operating temperature 0 to 40°C / 32 to 104°F

Storage and transportation

-40 to75°C, -40 to 167°F
temperature

Operating humidity 10 to 95% RH, non-condensing

(1)
Storage and Transportation humidity 5 to 100% RH, condensing

525 to 1200 hPa

Operating atmospheric pressure
(525 hPa corresponding to an altitude of 4,572 m / 15000 feet)

Storage and transportation pressure 500 to 1200 hPa

Withstands repeated 1.8 m (5.9 ft) drops on a hard surface.

Mechanical strength
Complies with requirements for road ambulances according to
EN1789:2007 (clause 6.4) and requirements for shock and vibration

3-1
 according to ISO 80601-2-55 (clause 21.102, transport).

Surface temperature (at ambient temp.

Max 41°C / 106°F
23°C)

Disposable adult/pediatric:
Adds less than 6 ml dead space
Pressure drop less than 0.3 cm H2O @ 30 LPM
Airway adapters
Disposable infant:
Adds less than 1 ml dead space
Pressure drop less than 1.3 cm H2O @ 10 LPM

NOTE 1: After being in a condensing atmosphere, the unit shall be stored for more than 24 hours in an
environment equivalent to the operating humidity. The humidity range 50 – 100% is valid within
the temperature range of -40 to 40°C only.

Gas analyzer
2-9 channel NDIR type gas analyzer measuring at 4 to 10 µm.
Probe Pressure, temperature and full spectral interference
correction.

Calibration Zeroing recommended when changing Airway adapter.

Warm-up time Full accuracy within 10 seconds

Rise time (@ 10 L/min) ≤ 90 ms

Total system response time < 1 second

Accuracy specifications – during standard conditions
1)
Range

Gas CO2 (%) Accuracy

0 – 15 ±(0.2 vol% + 2% of reading)

CO2
15 – 25 Unspecified

NOTE 1: Gas concentration reported in units of volume percent.

3-2
 3 CO2 Module

Accuracy specifications – during all conditions1)

Gas Accuracy
CO2 ±(0.3 vol% + 4% of reading)

NOTE 1: The accuracy specification is valid for the operating temperature and humidity conditions
specified, except for interference specified in the table “Interfering gas and vapor effects”
below.

Interfering gas and vapor effects

Gas or vapor Gas level CO2

3) 1)
N2O 60 vol% –
3) 1)
HAL 4 vol% –
3) 2)
ENF, ISO, SEV 5 vol% +8% of reading
3) 2)
DES 15 vol% +12% of readin
3) 2)
Xe (Xenon) 80 vol% -10% of reading
3) 2)
He (Helium) 50 vol% -6% of reading

Metered dose inhaler

3) Not for use with metered dose inhaler propellants
propellants
3) 1)
C2H5OH (Ethanol) 0.3 vol% –
3) 1)
C3H7OH (Isopropanol) 0.5 vol% –
3) 1)
CH3COCH3 (Acetone) 1 vol% –
3) 1)
CH4 (Methane) 3 vol% –
4) 1)
CO (Carbon monoxide) 1 vol% –
4) 1)
NO (Nitrogen monoxide) 0.02 vol% –
4) 1)
O2 100 vol% –

NOTE 1: Negligible interference, effect included in the specification “Accuracy, all conditions” above.

NOTE 2: Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2
readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50
vol%. Helium, the measured CO2 concentration will typically be (1-0.06) * 5.0 vol% = 4.7 vol %
CO2.

3-3
 NOTE 3: According to the ISO 80601-2-55 standard.

NOTE 4: In addition to the ISO 80601-2-55 standard.

CAUTION: The presence of oxygen can cause some interference in the CO2 measurement. This is
known as spectral broadening, and must be compensated. The Ventilator performs the O2
compensation automatically for IRMA CO2. Use valid O2 sensor, mount O2 sensor and
connect cable to ventilator correctly, maintain regularly. Otherwise etCO2 accuracy may be
affected.

CAUTION: The presence of nitrous oxide can cause some interference in the CO2 measurement. This is
known as spectral broadening. Aeonmed VT5230 Critical Care Ventilator is not intended for
use with nitrous oxide gas, and there is no compensation performed. Therefore, if nitrous
oxide gas is used with Aeonmed VT5230 Critical Care Ventilator, the etCO2 accuracy will be
affected.

3.3 System Assembly Instruction

3.3.1 Set-up

1. Plug the IRMA connector into the CO2 module connector on Ventilator rear panel and switch the power on.

2. Snap the IRMA probe on top of the IRMA airway adapter. It will click into place when properly seated.

3. A green LED indicates that the IRMA probe is ready for use.

3-4
 3 CO2 Module

4. Connect IRMA/airway adapter 15 mm male connector to the breathing circuit Y-piece.

5. Connect the IRMA/airway adapter 15 mm female connector to the patient’s endotracheal tube.

Alternatively, connect a HME (Heat Moisture Exchanger) between the patient’s endotracheal tube and
the IRMA probe. Placing a HME in front of the IRMA probe protects the airway adapter from secretions and
effects of water vapor and eliminates the need of changing the adapter. It allows free positioning of the
IRMA probe as well.

3-5
6. Unless the IRMA probe is protected with a HME always position the IRMA probe with the status LED
pointing upwards.

3.3.2 Placement of IRMA Probe

When connecting IRMA probe to an infant patient circuit it is important to avoid a direct contact between the
IRMA probe and the infant’s body.

If, for whatever the reason, the IRMA probe is in direct contact with any parts of the infant’s body an insulation
material shall be placed between the IRMA probe and the body.

WARNING: The IRMA probe is not intended to be in patient contact.

3.4 Pre-use Check

Always verify CO2 readings and waveforms on the monitor before connecting the airway adapter to the patient
circuit. Perform the tightness check of the patient circuit with the IRMA probe snapped on the IRMA airway
adapter.

3-6
 3 CO2 Module

3.4.1 Zeroing Procedure

WARNING: Incorrect probe Zeroing will result in false gas readings.

In order to secure high precision of the IRMA probe measurements the following zeroing recommendations
should be followed.

Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe without connecting the
airway adapter to the patient circuit, and then performing a Pre-use Test on the Aeonmed VT5230 Critical Care
Ventilator, which transmits a Zero reference command to the IRMA probe. The green LED on the probe will be
blinking for approximately 5 seconds while zeroing is in progress.

Special care should be taken to avoid breathing near the airway adapter before or during the Zeroing
procedure. The presence of ambient air (21% O2 and 0% CO2) in the IRMA airway adapter is of crucial
importance for a successful Zeroing. If an “Inaccurate CO2 zeroing!!” alarm should appear directly after a
Zeroing procedure, the procedure must be repeated.

Always wait at least 10 seconds after changing the IRMA adapter before running the Pre-use test to allow the
CO2 sensor to warm up.

Zeroing needs to be performed ONLY when an offset in gas values is observed, or when an unspecified
accuracy message is displayed.

3.5 Alarms

The IRMA probe LED status is as follows:

Steady green light System OK

Blinking green light Zeroing in progress

Steady red light Sensor error

Blinking red light Check adapter

Refer to Section 7, Alarms and Troubleshooting, for EtCO2 low and high signal alarms.

3.6 Cleaning

The IRMA probe can be cleaned using a cloth moistened with maximum 70% ethanol or maximum 70%
isopropyl alcohol.

Remove the disposable IRMA Airway Adapter prior to cleaning the IRMA probe.

3-7
 CAUTION: The airway adapters are non-sterile devices. Do not autoclave the devices as this will damage
them.

CAUTION: Never sterilize or immerse the IRMA probe in liquid.

3.7 Warnings

• The IRMA probe is intended for use by authorized and trained medical personnel only.

• The IRMA probe must not be used with flammable anesthetic agents.

• Disposable IRMA airway adapters shall not be reused. Reuse of the single use adapter can cause cross
infection.

• Used airway adapters shall be disposed of in accordance with local regulations for medical waste.

• Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6 ml dead space to
the patient circuit

• Do not use the IRMA Infant airway adapter with adults as this may cause excessive flow resistance.

• Measurements can be affected by mobile and RF communications equipment. Assured that the IRMA
probe is used in the electromagnetic environment specified in this manual.

• Do not place the IRMA airway adapter between the endotracheal tube and an elbow as this may allow
patient secretions to block the adapter windows and result in incorrect operation.

• To keep secretions and moisture from pooling on the windows sensor port, always position the IRMA
probe in a vertical position with the LED pointing upwards.

3-8
 3 CO2 Module

• Do not use the IRMA airway adapter with metered dose inhalers or nebulized medications as this may
affect the light transmission of the airway adapter windows.

• The IRMA probe is intended only as an adjunct in patient assessment. It must be used in conjunction with
other assessments of clinical signs and symptoms.

• Incorrect probe zeroing will result in false gas readings.

• Replace the adapter if rainout/condensation occurs inside the airway adapter

• Use only PHASEIN manufactured IRMA airway adapters available from your Aeonmed representative.

• The IRMA probe is not intended to be in patient contact.

3.8 Cautions

• Never sterilize or immerse the IRMA probe in liquid.

• The IRMA airway adapters are non-sterile devices. Do not autoclave the devices as this will damage them.

• Do not apply tension to the probe cable.

• Do not operate the IRMA probe outside the specified operating temperature environment.

• (U.S.): Federal law restricts this device to sale by or on the order of a physician

3.9 Maintenance Information

The IRMA probe is permanently calibrated at the factory and requires verification in regular intervals using a
service reference instrument.

WARNING: Never put ventilator into service until patient setup is completed.

Clinical safety has been a major consideration in design of the machine, but operator should still be very
cautious when operating the machine.

3-9
 CAUTION: In case any measured value seems suspect, operator should first examine the patient’s
vital signs using other means, and then check the ventilator.

3-10
 4 Setup

4 Setup
This section describes the connection and preparation of the ventilator.

4.1 Connect Power Supply

The machine can work with one of 2 power supply sources: internal battery and AC power supply. An icon on
the right upper part of screen displays the supply being used. When operating on battery, all functions except
expiratory port heater are the same as under AC operation. Expiratory port heater is disabled in battery
operation to improve battery run time. If “low battery” is displayed when the internal or extended battery is in
use, the AC power supply must be connected to charge the battery, otherwise the Aeonmed VT5230 Critical
Care Ventilator may lose power.

Figure 4-1 Connect power supply cable to AC inlet

After connecting the AC power supply, the AC power supply indicator will be shown indicating the battery is
being charged. A typical charge period is 4 hours, and in some situations the charge period may be up to 12
hours. The power supply indicator is lit orange during periods of charging.

Remove AC Power supply cord from wall connection to disconnect ventilator from AC MAINS.

4.2 Connect Gas Source

Aeonmed VT5230 Critical Care Ventilator can be connected to multiple gas sources: bottled oxygen, central
supply O2 or Air or Air compressor. The gas source pressure must be between 280 - 600 kPa (41 – 87 psi) for
both air and oxygen. Low pneumatic pressure will impair some functions of the ventilator.

4-1
Connect the air supply hose to the air inlet and connect the oxygen supply hose to the oxygen inlet. There are
diameter limits on the two inlets to prevent miss-connection.

Oxygen and Air connected to the high pressure input ports of the Aeonmed VT5230 Critical Care Ventilator will
be used as Fresh Gas and will be supplied to the patient.

4.3 Connect Accessories

4.3.1 Connect Patient circuit

This figure shows the connection of patient circuit, including inspiratory port, water trap, inspiratory tube,
Y-piece, breathing hoses and expiratory filter.

CAUTION: Assure patient hoses used have the appropriate resistance so that patient receives proper
therapy.

NOTE: When adding attachments or other components to the Aeonmed VT5230 Critical Care Ventilator
breathing system, the pressure gradient across the breathing system, measured with respect to
the patient connect port, may increase.

4-2
 4 Setup

4.3.2 Connect Humidifier (optional)

Figure 4-2

Connect humidifier (1) into channel of mounting block（2）.

4.3.3 Connect Patient Circuit Positioning Arm (optional)

Figure 4-3

4-3
Connect positioning arm (2) onto mounting block (1). Stuff spring pin in positioning arm.

4.3.4 Connect User Interface Screen

Figure 4-4

Slide User Interface (1) into mount (2) and connect cable (3) to the connector on the rear of the Ventilator
Control unit.

4.3.5 Connect Cylinder Kit (optional)

Figure 4-5

4-4
 4 Setup

Connect O2 cylinder/regulator (2) into the right side of holder (1). Secure cylinder using strap (3). Repeat for Air
Cylinder/regulator on the left side.

Note: The kit includes only the mounting brackets and attachments. User must supply the Gas Cylinders with
Gas Regulators and hoses compatible with the Aeonmed VT5230 Critical Care Ventilator Gas Inlet
Connections and at the proper Pressure per VT5230 Specifications.

4-5
 5 Pre-use Test

5 Pre-use Test

5.1 When to Carry out Pre-use Test:

• Before use of Aeonmed VT5230 Critical Care Ventilator on a new patient

• After patient hose or patient filter replacement
• After maintenance or repair

WARNING: Do not use the system until you have read and understood all the operation and
maintenance manuals of the components.

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.

CAUTION: The following measures should be taken to minimize risks in Aeonmed VT5230 Critical Care
Ventilator system.

5.2 How to Do the Pre-use Test

For doing the pre-use test, there are two methods: one is after starting up, which refers to section 6.1; and
another is in the standby mode, which refers to section 6.2.1.3.

5.3 Pre-use Test Procedure

After power on and technical test, the machine will enter the pre-use test following display of the power-on
page. Items included: Gas supply test, Leak test, Flow sensor test, Pressure sensor test and Safety valve test.
in the power-on self-test: For details on testing, please refer to Section 6.1.

There is also a “Pre-Use Test” key on Standby screen. There are more than test items in the “Pre-Use Test”
page. Items included:

5-1
Test Items Remarks

After each system has completed its initialization technical tests will be performed,
including: voltage checks at critical points in the circuitry; data collection necessary
Technical Test
for system operation; test of communication between sub-systems; tests of
measurement circuits and valve control circuits.

This test will verify whether the batteries can supply enough power to operate the
AC/Battery test
ventilator normally. Please follow instructions as displayed.

Test will proceed when at least one supply (O2 or Air) is functional. An Alert will be
Gas supply test
posted if only one supply is functional.

This test requires that both gas supplies (O2 or Air) are available. If one source is not
available then a message “Air (or oxygen) source is inadequate” and the test cannot
Oxygen sensor test.
be carried out. If only one gas is available then an Alert will be posted at test
conclusion.

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.

Patient compliance test Circuit compliance value measurement.

CO2 Sensor test Performed if a CO2 module is detected. An Alert will be posted if the test fails.

Below is a method for testing the function of the alarm system for conditions specified by ISO80601-2-12.
Alarm system tests are to be performed at the user’s discretion.

Perform the following procedure to verify operation of the Low MVe and High Airway pressure alarms:

1. Connect Aeonmed VT5230 Critical Care Ventilator to an Air source.

2. Set the Power switch to ON.

3. Connect a breathing circuit and test lung to Aeonmed VT5230 Critical Care Ventilator.

4. Press Start Ventilation and ventilate with default settings except set O2 to 21%.

5. After 5 breaths, observe the MVe reading on the display.

6. Set the MVe low alarm limit to a value greater than the observed MVe reading.

7. Verify that a low level MVe low alarm is present on the 3rd breath.

8. Return the MVe low alarm limit to original setting.

5-2
 5 Pre-use Test

9. After 5 breaths, observe the Ppeak reading on the display.

10. Set the PAW upper alarm limit to a value lower than the observed Ppeak reading.

11. 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.

12. Return the PAW upper alarm limit to original setting.

13. Set the Power switch to OFF.

5-3
 6 VT5230 Ventilator Operation

6 VT5230 Ventilator Operation

6.1 Starting Up

Step 1: Connect to AC power supply

Connect power supply cable to power supply socket on the wall, and the AC power supply indicator will be lit
green.

Figure 6-1 Connect power supply

Step 2: Switching on

To switch ventilator on, actuate the power switch of ventilator from “ ” to “ ”. The machine will then be
turned on; initialization of the GUI Display, Main Control unit and other systems will start the power-on interface
and then the company logo will be displayed.

Figure 6-2 Switching on

6-1
 Figure 6-3

NOTE: After ventilator power up, if O2 sensor is not plugged in or it has a failure and O2 monitoring is
enabled, the alarm “Oxygen Sensor Failure!” shall be displayed.

Step 3: Technical test

After each system has completed its initialization, technical test will be performed, including voltages tests,
data tests, communications tests, AD and DA converter tests, and valve control tests. The ventilator is not
operational during this period.

The technical test should be performed for 10 seconds then wait for all results to be sent to GUI. If all tests
pass, the technical test finished and continue to the pre-use test. If some test fail or waiting timed out, the
failure information shall be displayed on screen, the “Test” and “Skip” button’s state will change to enable. User
can choose “Test” to do technical test again, or choose “Skip” to skip technical test.

Figure 6-4 Technical test

6-2
 6 VT5230 Ventilator Operation

Step 4: Pre-use test

After the unit has finished the technical test, it shall enter into the pre-use test routine.

Test Items include: Gas supply test, Leak test, Flow sensor test, Pressure sensor test and Safety valve test.
The pre-use test is an interactive test requiring the user to read and follow screen prompts. See Figure 6-4 for
sample screen. Along the bottom of the screen shall be 2 buttons: Test and Skip.

Test Items shall be performed one by one. If all tests pass, it shall enter Standby screen. If some tests fail, the
failed information shall be displayed on screen, the “Test” button’s state change to enable. Choose “Test” to do
the test again, or choose “Skip” to enter Standby screen.

Figure 6-5 Pre-use screen

NOTE: The ventilator does not support patient ventilation during the pre-use, since the Inspiratory valve is
closed, and Expiratory valve is opened.

6.2 Interface Layout

After the Power-on self-check is finished or the “Skip” key has been clicked. Press the green key with the text

“Start ventilation” ( ) to enter the currently selected ventilation mode and the blue key will change to

orange with text “standby” on it ( ). After pressing and holding the standby key for 4 seconds, it will go
back to “Start Ventilation” again.

6-3
6.2.1 Standby Interface Layout

In the standby interface (see Figure 6-6), the user can set the information of the new patient, see the
information of the previous patient, and do the pre-use test.

Figure 6-6

6.2.1.1 New Patient

a) Patient Settings

Step 1: Choose patient type (Adult, Child or Neonate, default is Adult)

Step 2: Ventilation type (Invasive or NIV, default is Invasive), Ideal Body Weight (default is 50kg) and
Ventilation mode. See example in Figure 6-7.

NOTE: In the Ventilation Mode area, there is a “Setting” key. Pressing the “Setting” key will enter the Mode
of main menu.

6-4
 6 VT5230 Ventilator Operation

Figure 6-7

b) Patient Information

Click the Patient Information key to enter patient information for a new patient. In this page, the user can enter
the patient’s name, Medical Record Number, Admission Date, Birth Date and Height (cm). There is a small
keyboard on the right side of the Patient Information. The format of the admission date and birth date is
YYYY/MM/DD, and the default date is the computer date. In the lower right corner, there is “Clear” key to clear
all the information. See the example in Figure 6-8.

Figure 6-8

6-5
6.2.1.2 Previous Patient

For the Previous Patient key, the same content displays as for a new patient, except the Patient Type and Vent
Type appear on the Patient Settings page and the Patient information cannot be changed, as shown in Figure
6-9.

Figure 6-9

6.2.1.3 Pre-use Test

Click the Pre-Use test key to enter the pre-use test page. There are ten tests that must be done before the
ventilator is connected to a patient: Technical test, AC/Battery Test, Gas Supply Test, Oxygen Sensor Test,
Leak Test, Flow Sensor Test, Pressure Sensor Test, Safety Valve Test, Circuit Test, and CO2 Sensor Test. as
shown in Figure 6-10.

There is a label with “√” at the front of each test item. Touch the test item can change the selected state of it. At
the bottom of items there is a label with “√” and text “Select All”, touch it can select all test items.

NOTE: Before the ventilator is connected to a patient, we suggest that the user do all tests.

6-6
 6 VT5230 Ventilator Operation

Figure 6-10

6.2.1.4 Calibration

Click the calibration key to enter the calibration page, as shown in Figure 6-11. In this page, the user can
calibrate O2 sensor and flow sensor.

Figure 6-11

6-7
6.2.2 Main Interface Layout

The main interface can be divided into six parts: Parameter setup area, Short Cut keys area, Patient Measured
Parameters area, Patient Waveforms area, Information area and User Message Prompts area, as shown in
Figure 6-12.

Figure 6-12

Figure 6-13 shows the actual operational screen layout of the ventilator.

6-8
 6 VT5230 Ventilator Operation

Figure 6-13

6.2.2.1Information Area

The Information area includes seven sections: Ventilation Mode, Alarm Messages, Network and USB
connection, Trigger, Patient Type and weight, AC and Battery indicators, and Time.

Figure 6-14

Ventilation Mode area: Displays the current mode of Ventilation.

Alarm Messages area: When there is no alarm message, this area is same background color as other screen
areas; when a technical or functional alarm occurs, the background color will change to either red or yellow and
text information will be displayed.

Network and USB connection indicator area: Displays the Network and USB connection status.

6-9
AC and Battery indicators area: Displays the AC, internal battery and extended battery connection status.

Trigger area: Displays the current ventilator trigger type. There are three trigger types: Pressure Trigger, Flow
Trigger, and Manual Trigger. If there is currently no trigger in use, the trigger symbol will disappear.

CAUTION: If the trigger sensitivity is set too high, a self-triggering (auto-triggering) condition may be
reached. Triggering will then be initiated by the system and not by the patient. This should
always be avoided by decreasing the trigger sensitivity. This is also important during
transport as the movement of the body and the breathing system may lead to false triggering.

Patient Type and weight area: Displays the current patient’s type ( , or ) and current
patient’s weight.

Time area: Displays the current time. There are two formats, 12-hour or 24-hour.

6.2.2.2User Message Prompts Area

If no prompt message is displayed, this area will have the same background color as other parts of the screen.
If a prompt message is available, it will have a flashing bulb icon in front of the relevant prompt message.

Figure 6-15

6.2.2.3Patient Waveform Area

At center of the screen, the Patient Waveforms area is the main display area. In the default state, this area will
display two waveforms, Pressure and Flow, and two Loops. See the example in Figure 6-16.

6-10
 6 VT5230 Ventilator Operation

Figure 6-16

6.2.2.4Patient Measured Parameters Area

This area displays parts of the monitored patient parameters which are very important. When in Standby,
monitoring values of all parameters shall be displayed as “---”. The background color for Parameters with alarm
limits shall change between black and red when a high-level alarm occurs. The flash rate shall be at 2 Hz ± 10 %
and it shall be synchronized with the high-level alarm displayed in the Alarm Message Area. All the parameters
can be changed to other parameters by a sub menu which on the monitor. The parameters were separated into
3 groups, each group contain 2 parameters.
The parameters shall be divided into 3 groups: Group 1, 2 and 3. See example in Figure 6-17.

6-11
 Figure 6-17

6.2.2.5Ventilation Parameter Set-up Area

The ventilation parameter setup area is at the bottom of the screen. The breathing parameters settings
necessary for the current ventilation mode are displayed in this area. See the example as shown in Figure 6-18.

If the ventilation parameter setup items for the selected Ventilation mode do not fit in this space, the “ ” key
will allow the user to access and change the other setup items.

6-12
 6 VT5230 Ventilator Operation

Figure 6-18

6.2.2.6Shortcut Keys Part

The ventilator has shortcut keys to access many ventilator operations, including Inspiratory Hold, Expiratory
Hold, Nebulizer, Manual breath delivery, Suction, Primt Screen, Freeze, Screen Lock, Alarm Limits, Main Menu
and Standby/Start Ventilation.

6-13
 Figure 6-19

6.3 Operation of Main Manu

Click “Main Manu” of the shortcut key on the right side of the screen, the user can set Mode, Alarm Limits,
Monitoring Data, Lung Mechanic, P/V Toll, Log, System. Specific operation is as follows.

6.3.1 Ventilation Mode

6.3.1.1Ventilation Mode Set-up

Step 1: Click in the shortcut keys area to enter the Main Menu, then click to enter
mode Setup interface, as shown in Figure 6-20.

6-14
 6 VT5230 Ventilator Operation

Figure 6-20

Step 2: Click the mode you want, for example:

Click [VCV] to enter the [VCV] mode setup page. The [VCV] key will become grey as shown in Figure 6-21. The
user can then set every parameter of VCV mode.

Figure 6-21

Step 3: Click [Accept], now VCV mode is set as the ventilation mode.

NOTE: The setup procedures of other modes are similar to the one above.

WARNING: If “Accept” is not clicked, the screen will return to the main menu after 10 seconds, and the
last setup changes made will have no effect.

6-15
6.3.1.2Mode Descriptions

Backup ventilation mode is included for: SPONT+PSV, SIMV (VCV) +PSV, SIMV (PCV) +PSV, SIMV
(PRVC) +PSV, and BIVENT+PSV. To setup the PSV mode, the user must set Psupp setting to a value
not equal to 0, then “+PSV” will be added to the bottom of the mode name, as shown in Figure 6-22.
Remember that mode changes are only in effect after Accept is pressed, as shown in Figure 6-23.

Figure 6-22

Figure 6-23

The spontaneous ventilation modes include: SPONT+PSV, SIMV (VCV) +PSV, SIMV (PCV) +PSV, SIMV
(PRVC) +PSV, and BIVENT/PSV. When apnea takes place under SIMV mode, the backup ventilation
mode will be VCV. When apnea takes place under SPONT/PSV, BIVENT/PSV and SIMV (PCV)
ventilation, the backup ventilation mode will be PCV (pressure controlled ventilation); if apnea takes place
under SIMV(PRVC), the backup ventilation mode will be PRVC.

There are two measures for recovery from apnea: patient triggering and operator resetting.

The system will prompt the user to store ventilation parameter settings when ventilation mode selection setup
is finished. If “Cancel” is clicked, the default ventilation mode will be applied for adult/child, and a message
displayed “Backup ventilation parameters are not set, default mode PCV working”, as shown in Table 6-1.

6-16
 6 VT5230 Ventilator Operation

Table 6-1

Factory default setup Setup range Adjustment

Parameter
Adult Child Neonate Adult Child Neonate step

VCV, PCV,
VCV, PCV,
PRVC(optional),
PRVC(optional),
SIMV (VCV) ,
SIMV (VCV) ,
SIMV (PCV,
SIMV (PCV,
PRVC)(optional)
PRVC)(optional),
, PCV,
Mode PCV PCV PCV BIVENT(optional) ---
BIVENT(optiona SPONT/CPAP
, SPONT,
l), SPONT,
NIV/CPAP(option
NIV/CPAP(optio
al),
nal),
NIV/PCV(optional
NIV/PCV(option
)
al)

5mL for
under
100mL(incl.)
,
VT(mL) 400 80 --- 50-2500 10-300 ---
10mL for
over 100mL,
50mL over
1000mL

f(bpm) 15 30 30 1-120 2-120 2-120 1

f(SIMV)(bpm) 4 20 --- 1-60 1-60 --- 1

f(NIV/PCV)
15 30 --- 4~20 4~40 --- 1
(bpm)

PEEP(cmH2O) 5 5 5 0-50 0-50 0-50 1

CPAP(cmH2O) 5 5 5 2-20 2-20 2-20 1

O2 40% 40% 40% 21%-100% 21%-100% 21%-100% 1%

Pinsp(cmH2O) in
20 10 10 0-(100-PEEP) 0-(100-PEEP) 0-(90-PEEP) 1
invasive modes

Pinsp(cmH2O) in
5 5 --- 5-(32-PEEP) 5-(32-PEEP) --- 1
NIV/PCV

Tpause(s) 0 0 --- 0-4 0-2.5 --- 0.1

Tslope(s) 0.1 0.1 0.1 0-2 0-2 0-2 0.1

6-17
 Factory default setup Setup range Adjustment
Parameter
Adult Child Neonate Adult Child Neonate step

Trigger mode , Psens , Psens , Psens ---

Psens(cmH2O) -3 -3 -3 -20-0 -20-0 -20-0 1

( LPM) 2 2 2 0.3-20 0.5-20 0.5-20 0.5

TInsp(s) 1 0.6 0.6 0.1-12 0.1-5 0.2-5 0.1

I:E 1:2 1:2 1:2 1:10~4:1 1:10~4:1 1:10~4:1 0.5

Psupp (cmH2O)
in invasive 0 0 0 0-(90-PEEP) 0-(90-PEEP) 0-(90-PEEP) 1
modes

Psupp (cmH2O)
0 0 --- 0-(32-CPAP) 0-(32-CPAP) --- 1
in NIV/CPAP

Phigh(cmH2O) 15 15 --- 5-90 5-90 --- 1

Plow (cmH2O) 5 5 --- 0-50 0-50 --- 1

Thigh(s) 1 0.6 --- 0.2-30 0.2-30 --- 0.1

Tlow(s) 3 1.4 --- 0.1-30 0.2-30 --- 0.1

Esens 25% 25% 25% 5%-80% 5%-80% 5%-80% 1%

1.99 + (1.99 +
(0.02x (0.02x
0.4 sec to 0.4 sec to
High Spont IBW)) IBW))
--- (1.99 + (0.02 x (1.99 + (0.02 x --- 0.1
Insp Time sec) or sec) or
IBW)) sec IBW)) sec
5 sec if 5 sec if
no IBW no IBW

0.5 for under

10,
1 for over 10,
IBW(kg) 50 15 3 7-150 3.5-35 2.5-8
5 for over 50,
10 for over
100

TC OFF OFF OFF ON, OFF ON, OFF ON, OFF ---

Compliance
ON ON ON ON, OFF ON, OFF ON, OFF ---
compensation

Pipe diameter
7.5 5.0 5.0 5-12 2.5-8 2.5-8 0.5
(mm)

6-18
 6 VT5230 Ventilator Operation

All modes in the mode menu include trigger type selection: pressure or flow. User can also set the value for
Psens or Vsens that choose the trigger type. See Figure 6-24.

Figure 6-24

Tube compensation (ATC) will be available only in pressure modes (PCV, SIMV (PCV), SPONT CPAP
and BIVENT). Select tube compensation “ON” and the “ON” key will become white as an acknowledgement,
as shown in Figure 6-25.

Figure 6-25

Select the tube type in this interface: ET (Endotracheal Tube) or TT(Tracheotomy Tube), and the selected
one will become grey as shown in Figure 6-25.

6-19
Tube inside diameter (mm) and Tube compensation amount (%) may be modified after being clicked.
Click “Accept” to store the new value.

Tube inside diameter ranges are: 5 to 12mm for adult, 2 to 5-8mm for child; increment: 0.5mm for both adult
and child.
SBT function is optional, and is available only when SPONT CPAP ventilation mode is operating, Choose
SPONT CPAP mode, enter SPONT CPAP function settings interface, as shown in Figure 6-26.

Figure 6-26

Click the SBT button to enter Sub menu: Alarm, Settings and Monitoring, as shown in Figure 6-27.
In this page, the user can set the alarm limit of f, RSBI and PEEP and the alarm volume, and also view the
alarm log.

Figure 6-27

6-20
 6 VT5230 Ventilator Operation

Click “Settings” to enter into the settings interface, where the user can set the parameters of Psupp, PEEP, O2
concentration and Time, as shown in Figure 6-28.

Figure 6-28

Click “Monitoring” to enter into the monitoring interface, where the user can view the trend of RSBI and fspont,
as shown in Figure 6-29.

Figure 6-29

Sigh function is only available for VCV mode and SIMV(VCV) mode for adult and child patients. Sigh function
can be set On or Off in VCV and SIMV(VCV) submenu and a prompt will be given “ “High Airway Pressure!”
and “High Inspiratory Tidal Volume!” alarms may occur during sigh ventilation, please set alarm limits properly.”
As shown in Figure 6-30.

6-21
 Figure 6-30

Lung Recruitment function is optional, and is available for VCV mode and SIMV(VCV) mode for adult and child
patients. The screen for the adult is as shown in Figure 6-31. The screen for the child is as shown in Figure
6-32.

Figure 6-31

6-22
 6 VT5230 Ventilator Operation

Figure 6-32

6.3.2 Alarm Limits

Click “Alarm Limits” in the “Main Menu” to enter the “Alarm Limits” menu interface, as shown in Figure 6-33.

Figure 6-33

The Alarm Limits setting includes:

Paw: high and low limits of patient airway pressure (unit: cmH2O)

MVe: high and low limits of minute volume (unit: LPM)

Vti: high limit of tidal volume for Inspiratory (unit: mL)

PEEP: high and low limits of positive pressure at expiratory end (unit: cmH2O)

6-23
Tapnea: apnea duration (unit: s)

fspont: rate of spontaneous breaths (unit: bpm)

etCO2: high and low limits of CO2 concentration at the end of Expiration (unit: kPa, % or mmHg)

The limit setup ranges are shown in the following table:

1 to 60L, OFF, 0.1step, default 30L for Adult and Child, and 2.0L for
High limit of flow volume per minute
Neonate.

OFF, 0.1 to 40L, 0.1 step, default 1L for Adult and 0.5L for Child and
Low limit of flow volume per minute
Neonate.

Adult: 5 to 4000mL, OFF. Step: 5mL for<100mL (incl.), 10mL

for >100mL, default 700mL
High limit of tidal volume
Child and Neonate: 5 to 400mL, OFF, Step 5mL for <100mL (incl.),
10mL for>100mL, default 150mL for Child and 40mL for Neonate.

5 to 110cmH2O for Adult and Child, 5 to 100cmH2O for Neonate, step

High limit of airway pressure
1 cmH2O, default 40cmH2O.

Low limit of airway pressure OFF, 1 to 80 cmH2O, step 1 cmH2O, default 5 cmH2O.

High limit of PEEP 1 to 50 cmH2O, OFF, step 1 cmH2O, default 7 cmH2O.

Low limit of PEEP OFF, 1 to 50 cmH2O, step 1 cmH2O, default 3 cmH2O.

10 to 60s, OFF, step 1s, default 20s for Adult and Child, and 15s for
High limit of apnea duration
Neonate.

Adult and Child: 10 to 120BPM, OFF, step 1bpm, default OFF.

High limit of spontaneous breath rate
Neonate: 5 to 120BPM, OFF, step 1bpm, default 45.

Only for NIV modes: 0.4 to 2s for child, 0.4 to 5s for adult. Step 0.1s,
High limit of max. Inspiratory duration
default: 5s for adult, 2s for child.

0.1%～13.3% (1mmHg～100mmHg or 0.1kPa～13.3kPa), default:

High etCO2
6.5% (49mmHg or 6.5kPa)

OFF, 0.1%～13.2% (OFF, 1mmHg～99mmHg or OFF, 0.1kPa～

Low etCO2
13.2kPa), default: 4.0% (30mmHg or 4.0kPa)

CAUTION: Do not set alarm limit parameter to extreme values that can render the alarm system useless.

NOTE: The “default” values are manufacturer-configured alarm presets, user-configured alarm presets
can be made different from the manufacturer-configured alarm presets in [Configurations] menu.

6-24
 6 VT5230 Ventilator Operation

WARNING: When selecting “New patient”, confirm all alarm limits parameters are appropriate prior to
use on each patient

NOTE: To set alarm parameter to “OFF”, set the data display to the lowest or highest value. Press the
encoder knob, turn encoder knob one more click and confirm by pressing encoder knob once
more.

NOTE: All alarm limit setting parameters are retained during power interruption and can be restored when
power returns.
Alarm volume can be adjusted to 5 levels: 20%, 40%, 60%, 80%, 100%. The default volume is 20%.

NOTE: If [Alarm volume] requires adjustment, the procedure is as follows (the same procedure is used for
other alarm parameter setup):

Step 1: Click “Alarm volume” when the key’s background color becomes yellow, then you can adjust the level
of alarm volume, as shown in Figure 6-34.

Figure 6-34

Step 2: Turn the encoder knob left or right to adjust the alarm volume, press the encoder knob to confirm when
proper value is reached. Background color will return to its original color, as shown in Figure 6-35.

Figure 6-35

6-25
 CAUTION: If the encoder knob is not pressed at the end, the system will go back to the original value
after 10 seconds, i.e. the new setting will have no effect.

CAUTION: In the case of an alarm during operation, the following cases may have occurred:

1) Improper breathing parameter setting or alarm limit setting;

2) Leakage in patient circuit; turn off the machine first and then check. In case of no resolution, contact
service representative.

3) Problems with patient;

4) Power supply failure or ventilator failure.

In case there is not sufficient gas volume given to the patient, disconnect the ventilator from the patient, use
artificial respiration or other emergency devices for the patient. Check the machine thoroughly.

6.3.3 Monitoring Data

Click “Monitoring Data” on main menu to enter “Monitoring Data” interface. The parameters are listed in four
columns in this interface, as shown in Figure 6-36. All parameters will be also shown in the main interface.

Figure 6-36

6-26
 6 VT5230 Ventilator Operation

6.3.4 Lung Mechanics

Click “Lung Mechanics” on “Main Menu” to enter “Lung Mechanics” page. On this page, you can select the test
items on the left (from the top down): Rinsp, C static, PEEPi and P0.1/NIF. The results of last test for the five
parameters are listed on the right. The default menu is Rinsp test menu in the middle, as shown in Figure 6-37.

Figure 6-37

Step 1:

In “Rinsp” test menu, the basic information is displayed in the middle of the screen, which includes the result of
last and current inspiratory Resistance measurement. The result with date and time of last measurement is on
the left, and the result of current measurement with time and date is on the right, as shown in Figure 6-37. If the
measurement is not started, the results are “--”.

Step 2:

When the measurement is completed, current measured values with date and time will be present. “Start” key
appears again for another measurement.

NOTE: The test procedures of parameter C static PEEPi, and P0.1/NIF are similar to “Rinsp”.

6.3.5 P/V MANEUVER (Optional)

Selecting “P/V MANEUVER” under the Main Menu shall open a screen that contains 2 sub-menus, Test 1 and
Test 2, as shown in Figure 6-38. The P/V MANEUVER measures the static compliance of the patient. Test 1
measures the static compliance in inspiration phase. Test 2 measures the static compliance both in inspiration
phase and expiration phase.

6-27
 Figure 6-38

Step 1: Test 1

When selecting “Test 1”, a screen will open showing 3 parameters (Ram, Vt, and Ptop), 4 buttons (Point 1,
Point 2, Start, and Cancel) and a Paw-V loop. The “Cancel” button, “Point 1” button and “Point 2” button are
disabled, as shown in Figure 6-34.

By pressing the “Start” button the measurement starts, the “Start” button, “Ram” parameter setting, “VT”
parameter setting and “Ptop” parameter setting are disabled and the “Cancel” button is enabled. During the
measurement the P/V loop draws an inspiration loop,, as shown in Figure 6-39.

Figure 6-39

During a P/V MANEUVER measurement, pressing the “Cancel” button stops the measurement. After pressing
the “Cancel” button or after the measurement is finished, the “Cancel” button will be disabled, the “Start” button
and the 3 parameters will be enabled, as shown in Figure 6-40.

6-28
 6 VT5230 Ventilator Operation

Figure 6-40

By pressing the “Point 1” button, a green cursor line on the P/V loop graphic will be displayed. Rotating the
navigator knob will move the cursor line along the X axis and the corresponding P1 Paw and P1 VT values are
displayed on the right side of P/V loop. The patient Compliance is calculated, as shown in Figure 6-41.

Figure 6-41

By pressing the “Point 2” button, a red cursor line on the P/V loop graphic will be displayed. Rotating the
navigator knobwill move the cursor line along the X axis the corresponding P2 Paw and P2 VT values are
displayed on the right side of P/V loop. The patient Compliance is calculated, as shown in Figure 6-42.

6-29
 Figure 6-42

Step 2: Test 2
When selecting “Test 2”, a screen will open showing 5 selectable parameters (Ram, VT, Ptop, Tpause and End
Peep), 4 buttons (Point 1, Point 2, Start and Cancel) and a P/V loop in the screen. The “Cancel” button, “Point 1”
button and “Point 2” button are disabled, as shown in Figure 6-43.

Figure 6-43

By pressing the “Start” button the measurement starts. While the measurement takes place, the “Start” button,
“Ram” parameter setting, “VT” parameter setting and “Ptop” parameter setting, “Tpause” parameter setting and
"End Peep" parameter setting are disabled And the “Cancel” button is enabled. During the measurement the
P/V loop draws an inspiration and expiration loop, as shown in Figure 6-44.

6-30
 6 VT5230 Ventilator Operation

Figure 6-44

During a P/V MANEUVER measurement, pressing “Cancel” button shall stops the measurement. After
pressing the “Cancel” button or after the measurement is finished, the “Cancel” button will be disabled, the
“Start” button and 3 parameters will be enabled, as shown in Figure 6-45.

Figure 6-45

By pressing the “Point 1” button a green cursor line on the P/V loop graphic will be displayed. Rotating the
navigator knobwill move the cursor line along the X axis and the corresponding P1 inspiration phase Paw value,
P1 inspiration phase VT value, P1 expiration phase Paw value and P1 expiration phase VT value are displayed
on the right side of P/V loop, as shown in Figure 6-46.

6-31
 Figure 6-46

By pressing the “Point 2” button, a red cursor line showing on the P/V loop graphic will be displayed. Rotating
the navigator knob will move the cursor line along the X axis and the corresponding P2 inspiration phase Paw
value, P2 inspiration phase VT value, P2 expiration phase Paw value and P2 expiration phase VT value are
displayed on the right side of P/V loop. The Patient Compliance is calculated, as shown in Figure 6-47.

Figure 6-47

6.3.6 Log

Click the “Log” tab on “Main Menu” to display the log screen. There are two keys on the left of the page:
Event/Alarm and Trend. The default page is Event/Alarm, as shown in Figure 6-48.

6-32
 6 VT5230 Ventilator Operation

Figure 6-48

In the “Event/Alarm” screen, 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 are 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 6-49. The event/alarm log records all alarms and most actions.

Figure 6-49

Below is the Settings area for a highlighted alarm. An example settings are is given below in Figure 6-50.

Figure 6-50

NOTE: Alarm/Event Log data is retained during a power interruption and can be viewed when power
returns.

6-33
Click the “Trend” button to display the trend screen. There are two trend types: graphical trend and tabular
trend, See Figure 6-47 & Figure 6-48.The default is tabular trend. Choose the graphical trend to get more
information.

In “tabular Trend”, a chart shall be displayed with parameter titles and units horizontally across the top, with
time and date displayed on the left. Current time shall be at the beginning (top). At 30 second intervals, data
shall be written into the chart. Additional pages shall be provided in order to accommodate all 8 configured
parameters. When press the parameters on the titles, there should be a sub menu displayed. User can change
the parameters on the titles by the sub menu. See Figure 6-51.

Figure 6-51

In “Trend graphi”, the first page displayed is a trend of pressure-related parameters, including Ppeak, Pplat,
PEEP and Pmean, with timeline within 72h. See Figure 6-52.

Figure 6-52

6-34
 6 VT5230 Ventilator Operation

Each graph shall have parameter as a title, the units of the parameter and range scale. Six time bases shall be
1, 3, 6, 12, 24, and 72.The displayed parameter for each Trend graph shall be selected from a pop-up menu
that will give the user 8 parameters to choose from. The 8 parameter choices in the pop-up menu shall be
configured in the Systems tab. “Zoom In” and “Zoom Out” keys shall be available so that there is better
resolution of the Graphs. “Left Arrow” and “Right Arrow” keys shall be available to move a measuring line to the
left or right. The measured value shall be displayed to the right of the parameter label on the right side of each
graph. .“Zoom In” shall decrease the time base. “Zoom Out” shall increase the time base. A Tabular trend key
shall be available for the user to select.

NOTE: The X-axis is timeline for all trend maps and Y-axis is the corresponding parameter units.

The waveform on trend map is refreshed from left to right, with latest data on the very left. Y-axis is set for full
scale range display.

6.3.7 System

Click “System” key to enter the System interface, as shown in Figure 6-53.

Figure 6-53

There are four keys on the left of the page: Settings, Configurations, Machine Information and Service.

6.3.7.1Settings

Click “settings” to enter the settings interface, as shown in Figure 6-54.

6-35
 Figure 6-54

You can set the Gas standard, time and date, unit setting, send data, dead space compensation and
compliance compensation in this page,

1. Gas standard:

There are two Gas Standard options available to the user: BTPS (Body Temperature and Pressure
Saturated) and ATP (Ambient Temperature and Pressure). When selected, the key background
color shall be gray. The default is BTPS and it is chosen with a dot.

2. Time and date:

Date format: YYYY/MM/DD,

Time format: 24hours;

When the date/time format is modified, all date/time areas on the screen will be modified simultaneously.
Modify date by clicking directly the numerical value at electronic calendar

3. Unit setting:

Pressure unit: Two options: cmH2O and hPa. When a unit is selected, all pressure units are converted to
this unit, such as pressure unit in parameter setting area and parameter monitor area.
Default: cmH2O
CO2: Three options: mmHg, kPa and %. When a unit is selected, all CO2 units are converted to
this unit.
Default: mmHg.
Weight unit: Two options: kg and lb. When a unit is selected, all body weight units are converted to this
unit.
Default: kg

6-36
 6 VT5230 Ventilator Operation

4. Compliance compensation: ON or OFF.

5. Send data: ON or OFF.

6. Dead space compensation: ON or OFF.

6.3.7.2Configurations

Click “Configurations” key to enter the configuration interface, as shown in Figure 6-55.

Figure 6-55

There are two choices in this page: Screen Brightness and Site configuration. The default page is “Screen
Brightness” page.

6.3.7.2.1 Screen Brightness

In “Screen Brightness” page, click the screen to choose day or night. As shown in Figure 6-55. Day is the
default.

6.3.7.2.2 Site Configuration

Step 1

Click “Site Configuration” to enter this page. Set a 4 digit numeric password in the dialog box to have protected
access to set Configuration. As shown in Figure 6-56.

6-37
 Figure 6-56

Step 2

After entering the password correctly, configure the sub menu: As shown in Figure 6-57.

1) Ventilation
2) Alarms
3) TC
4) NetWork
5) Others
6) Load/Save

Figure 6-57

6-38
 6 VT5230 Ventilator Operation

(1) Ventilation:

a. Settings:

Click “Ventilation” key, the background color will change to gray and the default page “settings” will be
displayed, as shown in Figure 6-57. User can configure this page for 1) Vent Type, 2) Ventilation Mode, 3)
Patient Type, 4) Start-Up value for Vt based on weight?, and 5) Inspiratory time. Touching the key to
choose the relative setting will remove the previously selected configuration. Only one choice shall be selected
per setting. A selection shall also be provided to enable the user to restore the initial settings to factory defaults.
Pressing the “Restore” key shall immediately restore all displayed choices to their factory default.

I. Vent type: Invasive or NIV (Non-Invasive), the factory default is Invasive.

II. Ventilation Mode: VCV, PCV, PRVC, SIMV (VCV), SIMV (PCV), SIMV (PRVC), BIVENT, and
SPONT/CPAP for invasive mode, and for NIV are NIV/CPAP and NIV/PCV. The factory default is
PCV for Invasive mode and NIV/CPAP for NIV mode.

III. Patient Type: Adult or Child. The factory default is Adult.

IV. Start-up value for Vt based on weight? : Yes or No. The factory default is No.

V. IBW (ideal Body Weight): Adult or Child. The default for adult is 50Kg (110 lbs) and for child is 15Kg
(33 lbs).

VI. Inspiratory time: Tinsp or I:E. The factory default is Tinsp.

After setting all the values needed, press the “Save” key, otherwise all the settings are lost. Another key
“Restore” is under the “Save” key, pressing it restores all displayed choices to their factory default.

b. Parameters:

Selecting “Parameters” key, will display a parameters configuration page. This includes the adult and child
initial parameter settings. The user can configure for 1)Vt, 2) f, 3) Tinsp, 4) Pinsp, 5) fsimv, 6) Tslope, 7)
PEEP, 8) Psupp, and 9) O2. As shown in Figure 6-58.

6-39
 Figure 6-58

Each setting key represents a location that the user can select. Touching the key will change the background
color of the key, indicating that it has been chosen and can be changed by rotating the encoder knob left or
right to adjust the value. When the selection reaches its maximum or minimum allowable setting, further
rotation shall result in the minimum or maximum value displayed continuously. Pressing the key or the encoder
knob again confirms the change.

NOTE: Touching any other keys (or touchable area), will deselect the change and the parameter will
be restored to the original setting. The background color will return to normal if the encoder knob
is not pressed within 2 seconds

After setting all the values needed, the user will press the “Save” key. Pressing the “Restore” key restores all
displayed settings to their factory default.

About the range of the parameters setting, please refer to Table 6-1.

(2) Alarms

Click the Alarms key to enter the alarms configuration page. There are three pages and six configurable alarms
on this screen: 1) Paw, 2) fspont, 3) PEEP, 4) Tapnea, 5) MVe and 6) etCO2, See Figure 6-59.

6-40
 6 VT5230 Ventilator Operation

Figure 6-59

Each setting key represents a location that the user can select. Touching the key to choose or change the
value, enter the upper and lower limits needed for each alarm, then press the Save key to confirm. There are
three configurable alarms available for the user in the second page: 1) MVe, 2)Tispont, 3)Vti, as shown in
Figure 6-60. There are seven configurable alarms available for the user in the second page: 1) Paw, 2)
etCO2, 3) fspont, 4) PEEP, 5) Tapnea, 6) MVe, and 7) Vti, as shown in Figure 6-61. You can change the alarm
limits based on whether the patient is an adult or child, then press the Save key to save the new alarm limits.

Also there is a Restore key under the Save key. Pressing the Restore key restores all displayed settings to
their factory default.

Figure 6-60

6-41
 Figure 6-61

(3) TC

Click the TC (Tube Compensation) key to enter the TC configuration page. In this page, you can configure for
1) Tube Compensation, 2) Tube Type, 3) Compensation %,4) Diameter Adult and 5) Diameter Pediatric,
as shown in Figure 6-62.

Figure 6-62

1) Tube compensation: ON or OFF, the factory default is OFF

2) Tube Type: ET or TT, the factory default is ET.

3) Compensation %, including Diameter Adult or Diameter Pediatric. The range for Compensation is 0 to 100 in
1% increments and the factory default is 0. Diameter Adult range is 5.0 to 12.0 mm and the default is 7.5 mm.
Diameter Pediatric range is 2.5 to 8.0 mm and the default is 5.0 mm.

6-42
 6 VT5230 Ventilator Operation

After finishing all the settings, the user shall press the Save key. Pressing the Restore key restores all
displayed settings to their factory default.

(4) NetWork

Ventilator data is shared by NetWork. As shown in Figure 6-63.

Figure 6-63

(5) Others

Click the Others key to enter the Others configuration page. On this page, you can configure suction type, and
whether the O2 and CO2 monitoring is ON or OFF (The factory default of the two parameters is ON), as shown
in Figure 6-64.

Figure 6-64

6-43
(6) Load/Save

Click Load/Save key to enter the Load/Save page. On this page, you can input file name, as shown in Figure
6-65.

Figure 6-65

6.3.7.3Service

Click “Service” to enter the “Service” page. On this page, the user needs to enter the password, as shown in
Figure 6-66.

Figure 6-66

6-44
 6 VT5230 Ventilator Operation

Input the correct password to enter, There are seven choices on this page: Calibration, Event/alarm log,
Machine Information, Language, Test Page, Update, Optional. The default page is Calibration. See Figure
6-67.

Figure 6-67

6.3.7.3.1 Calibration

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 6-67.

1. Pressure Sensor Calibration: In “Pressure Sensor” 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 6-67.

Click “Start” to start pressure sensor calibration. A progress bar and a message “Calibration in progress,
please Wait” will be displayed as shown in Figure 6-68.

NOTE: During this period no other operation can be performed. Clicking other areas will have no
response.

6-45
 Figure 6-68

When the calibration finishes, there shall be a message that shows the current time, inspiratory valve test value
and expiratory valve test value on right side of panel, as shown in Figure 6-69.

Figure 6-69

2. Flow Sensor Calibration: Click “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
6-70.

6-46
 6 VT5230 Ventilator Operation

Figure 6-70

Click the “Start” button to start flow sensor calibration, the remaining procedure is the same as the pressure
sensor calibration.

When the calibration finishes, there shall be a message that shows the current time and flow value in LPM on
right side of pane, as shown in Figure 6-71.

Figure 6-71

3. O2 sensor calibration: Click “O2 sensor” to enter the interface. A message displayed:

“Please verify that air and oxygen sources 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 click, as shown in Figure 6-72.

6-47
 Figure 6-72

Click the “Start” button to start the O2 sensor calibration, the remaining procedure is the same as the pressure
sensor calibration.

When the calibration finishes, there shall be a message that shows the current time, 21% and 100% O2 test
voltages on right side of panel, as shown in Figure 6-73.

Figure 6-73

4. Touch Screen Calibration: Click “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 6-74.

CAUTION: Please calibrate the touch screen periodically or when it works abnormally.

6-48
 6 VT5230 Ventilator Operation

Figure 6-74

Click the “Start” key to start, the remaining procedure is as described in steps above.

5. Leakage Test and Patient Circuit Test Calibration: There are also two keys “leakage test ” and “patient
circuit test” in the calibration interface, as shown in Figure 6-75 and Figure 6-76.

Figure 6-75

First select the test. Then click “start”, the test will begin.

6-49
 Figure 6-76

The patient circuit test checks the compliance and leakage of the breathing circuit. 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. Click the “start” key, a message “test in progress, please wait.” will be displayed. After the test is
finished, the resulting compliance is displayed.

6. Expiratory valve Calibration: Click “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 6-77.

Figure 6-77

Click the “Start” button to start the expiratory valve calibration, the remaining procedure is the same as the
pressure sensor calibration.

6-50
 6 VT5230 Ventilator Operation

When the calibration finishes, if the calibration passes, the screen will show the current time and K and B
values, as shown in Figure 6-78.

Figure 6-78

7. Inspiratory valve Calibration: Click “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 6-79.

Figure 6-79
Click the “Start” button to start the inspiratory valve calibration, the remaining procedure is the same as the
pressure sensor calibration.
When the calibration finishes, if the calibration passes, the screen will show the current time, as shown in
Figure 6-80.

6-51
 Figure 6-80

8. CO2 sensor Calibration: Click “CO2 Sensor” to enter the interface, as shown in Figure 6-81. A message
displayed: “Please connect gas sensor. Please active CO2 function”. Please follow the prompt message to
calibrate. The remaining procedure is the same as described above.

Figure 6-81

9. O2 Mixer: Click “O2 Mixer” to enter the interface. In this page, please follow the screen instructions to
calibrate.

6-52
 6 VT5230 Ventilator Operation

6.3.7.3.2 Event/Alarm log

See Section 6.3.6 for detailed description.

6.3.7.3.3 Machine information

Click the “Machine information” key to enter the Machine information page, this area includes the following
information, as shown in Figure 6-82.

1. S/W revision:
a. UI
b. BDU
c. Power Supply
d. UIC
2. Runtime Hours(Zero button is to clear the runtime hours. Clicking this button, shall prompt a password
input page, as shown in Figure 6-83.)
3. Internal Battery Hours
4. Air Source Pressure
5. O2 Source Pressure
6. Atmospheric Pressure

Figure 6-82

6-53
 Figure 6-83

6.3.7.3.4 Language

Click the Language button to enter the language screen. English and other languages are available for the user
to choose.

6.4 Functions of Shortcut Keys

The ventilator has 11 shortcut keys: Print Screen, Inspiratory Hold, Expiratory Hold, Nebulizer, Manual, Suction,
Freeze, Screen Lock, Alarm limits, Main Menu and Start Ventilation/Standby. Except for Freeze, all the
shortcut keys are located on the right side of the screen, see Figure 6-84.

6-54
 6 VT5230 Ventilator Operation

Figure 6-84

6.4.1 Inspiratory Hold

Inspiratory hold is available within the period of mandatory ventilation and in all modes except full spontaneous
breath modes as SPONT/PSV, NIV/CPAP/PS and NIV/PCV.

Press the Inspiratory Hold key during the Inspiratory phase. The operation becomes active when a message
stating “Inspiratory Hold ×× s” appears with a countdown timer. As shown in Figure 6-85. Keep pressing the
Inspiratory Hold key. The expiratory phase will not start until the key is released or after 30 seconds, whichever
comes first. If the button is not released after 30 seconds, the system will go to Expiratory state automatically
and display a message “Inspiratory hold interrupted!”, As shown in Figure 6-86.

6-55
 Figure 6-85

Figure 6-86

6.4.2 Expiratory Hold

Expiratory hold is available in all modes. In Expiratory phase, press the Expiratory hold button and the
expiratory operation will become active when a message “Expiratory Hold ×× s” appears with a countdown
timer. See example in Figure 6-87.The ventilator will stay in the expiratory phase and not transition to the
inspiratory phase until either 1) the key is released or 2) 30 seconds have elapsed.

When selected during the expiratory phase, the ventilator will stay in the expiratory phase and not transfer to
the inspiratory phase until either 1) the key is released and the current expiratory phase is completed or 2) 30
seconds have elapsed.

Pressing the Expiratory Hold key for more than 30 seconds will cause a message to be displayed. See
example in Figure 6-88. Only one expiratory hold will be produced per key press. When Inspiratory hold key is
released or if the key is not released after 30 seconds, the key background will revert to normal.

6-56
 6 VT5230 Ventilator Operation

Figure 6-87

Figure 6-88

6.4.3 Nebulizer

For adult mode, the nebulizer function is available in all invasive ventilation modes. For child mode, the
nebulizer can be used only in pressure control mode. Press and hold the Nebulizer key for 3 seconds. The
background will flash from white to yellow. The nebulizer turns on and a low level alarm “Nebulizer On” is
displayed and the message “Nebulizer On, MM min SS s” with countdown timer is displayed in the message
area, as shown in Figure 6-89.

6-57
 Figure 6-89

With each press of the Nebulizer key the duration toggles back and forth, starting with an initial duration of 30
minutes, followed by 45 minutes. The nebulizer operation will not last longer than 45 minutes.

Nebulizer flow may be provided by Air, O2 or a combination of both, and the flow rate is 9L/min±1L/min.
To ensure the delivery of tidal volume, the nebulizer is switched off when inspiratory flow rate is less than
15L/min.

When the nebulizer function is active, the nebulizer output port flow will start as inspiration starts and will
continue for the duration of the inspiratory phase of the breath. When the Ventilation mode is changed or if the
delivered flow is less than 15 l/min, the nebulizer operation will be interrupted and a medium level alarm
“Nebulizer Interrupted” will replace “Nebulizer On” alarm and the countdown timer will stop.

The nebulizer operation will be cancelled by touching the nebulizer key for longer than 3 seconds in all
ventilation modes. The user has two options to clear the “Nebulizer Interrupted” alarm:

1) Remove the source of the shutdown and press the Nebulizer key to restart the Nebulizer operation. Low
level alarm “Nebulizer On” will replace “Nebulizer Interrupted” alarm and the message countdown timer will
continue;

2) Acknowledge the alarm by pressing the Alarm Silence key. Nebulizer operation is cancelled and the
“Nebulizer Interrupt” alarm is cleared. Pressing the Nebulizer key during a “Nebulizer Interrupted” condition
without removing the source of the shutdown will result in the Nebulizer not restarting.

6-58
 6 VT5230 Ventilator Operation

CAUTION: The ventilator accuracy can be affected by the gas added by use of a nebulizer.

NOTE: Nebulizer function is not suggested when breath rate is less than 12, to ensure tidal volume
delivery.

NOTE: To ensure the flow volume accuracy, the nebulizer function is disabled if the flow rate of the
delivered breath is less than 15 LPM.

CAUTION: Nebulizer use is not available in noninvasive (NIV) modes.

CAUTION: During nebulization, please connect the filter in front of the expiration valve; Inspect, clean and
replace the filter regularly. Please use and clean the filter according to the instructions of the
filter.

6.4.4 Manual

Manual Trigger is available in all ventilation modes except for SPONT. Press the manual trigger key to initiate a
manual breath control, as shown in Figure 6-90.

Figure 6-90

6-59
For VCV, PRVC, SIMV (VCV): set Vt and Tinsp, to control ventilation.

For BIVENT: set Phigh and Plow, to control ventilation switchover.

For PCV, SIMV (PCV): Set Pinsp, to control ventilation.

For modes or breath phase with PSV, set Psupp, to control ventilation.

Manual trigger is also available during backup ventilation period. When initiated during backup mode, the
ventilator will remain in backup mode.

6.4.5 Suction

Suction support is available in all invasive ventilation modes. Pressing Suction button will turn the button color
to yellow signifying the start of Suction support as shown in Figure 6-91.

Figure 6-91

If the system detects that the circuit is disconnected, ventilation will be interrupted. During sputum aspiration,
all physiological alarms will be off and audio alarms will be suspended.

NOTE: In suction process, the O2 setting button shall be disabled (grey).

In adult mode: Oxygen concentration is 100%.
In child mode: Oxygen concentration is +25% of setting or 100%，whichever is smaller.

6-60
 6 VT5230 Ventilator Operation

NOTE: In suction process, following alarms is disabled.

• Low Expiratory Minute Volume !!
• High Expiratory Minute Volume !!
• High Inspiratory Tidal Volume !
• High Airway Pressure !
• Low Airway Pressure !!!
• Low PEEP !!!
• High PEEP !!!
• Continuous Airway Pressure !!!
• High Respiration Rate !!
• High Oxygen Concentration !!
• Expiratory Hold Interrupted !
• Circuit Disconnect !!!
• Occlusion !!!
• Leakage out of range !!!
• Leakage !
• Lung Recruitment !

Open Suction

The Ventilator will provide a low flow rate when the circuit is disconnected in order to detect reconnection of
circuit. When pressing the suction support key, a message will be displayed in the message prompt area, as
shown in Figure 6-90.

The process of Suction support is performed in 3 phases as follows:

• Before aspiration of sputum – 3 minutes of increased oxygen concentration in preparation of airway

disconnection;

• Suction Phase - Airway disconnection for suction.

• Post aspiration of sputum – 2 minutes of increased oxygen concentration after reconnection of the airway.

Closed Suction
If you select Closed Section and press the suction support key, a message will be displayed in the message
prompt area, as shown in Figure 6-92.

Figure 6-92

The process of Closed Suction support is performed in one phase: 2 minutes of increased oxygen
concentration.

6-61
6.4.6 Freeze

Press “Freeze” key and the current real-time waveforms and loops freeze simultaneously in the main screen
when waveform drawing is completed. See example in Figure 6-93. Turning the encoder knob moves the
cursor over each point of the waveform and the corresponding measured value is displayed. Pressing Freeze
again will restart the waveform and any information displayed during waveform freeze will disappear, and the
Freeze key color returns to normal. Waveform Freeze will automatically end 3 minutes after touching the freeze
key or 3 minutes after the encoder was last turned, whichever occurs last.

Figure 6-93

6.4.7 Screen Lock

Press the “Screen Lock” button, displaying a message in the message prompt area. Press and hold Screen
Lock for 3 seconds to lock the screen, as shown in Figure 6-94. 3 seconds later, the background color of
Screen lock key will turn to yellow and all keys on the touch screen are locked. Instead of the pre-message, a
new message is displayed in the message prompt area “Screen Locked.” Press and hold Screen Lock for 3
seconds to unlock as shown in Figure 6-95.

6-62
 6 VT5230 Ventilator Operation

Figure 6-94

Figure 6-95

6-63
Holding for 3 seconds, the screen lock is cleared, the background color of Screen Lock key turns to normal and
a message ”Screen Unlocked” is displayed in message prompt area as shown in Figure 6-96.

Figure 6-96

6.4.8 Alarm Limits

Press the “Alarm limits” button to enter the alarm limits page in the main menu, as shown in Figure 6-97. For
detail information and operation refer to Section 6.3.2.

Figure 6-97

6-64
 6 VT5230 Ventilator Operation

6.4.9 Print Screen

Print Screen shortcut soft key is between the Suction and the Freeze shortcut soft keys，as shown in Figure
6-98. Print Screen is available after machine boot up is finished.

Figure 6-98

The Print Screen function is intended to be used with a USB Memory device attached to the back of the
monitor. With a memory device attached when the Print Screen shortcut softkey is pressed, the system saves
a copy of the screen into a JPG file and stores it on the USB device. Each subsequent press of the Print
Screen shortcut softkey will create a new JPG file with a unique filename. If the memory stick is full, a message
will be displayed stating this.

If the Print Screen shortcut softkey is pressed without a USB memory device connected, the JPG file is saved
until a USB memory device is inserted. One and only one screen capture is saved when there is no memory
device attached to the monitor.

6-65
6.5 Ventilation Parameter Set-up

NOTE: If ventilation parameter setup keys are not visible along bottom of screen, close the main menu by
pressing Main Menu key. See ventilation parameter setup in the main screen as shown in Figure
6-99.

Figure 6-99

Press the parameter key, turning it yellow. Rotate the encoder knob left or right to modify the parameter value.
Press the parameter key again or press the encoder knob to confirm the modified value. If any other area on
the screen is touched before confirmation, the new parameter selection is canceled and the previous value will
be displayed. As shown in Figure 6-100.

When ventilation mode is changed, the values of the parameter keys displayed will change to correspond to
the new ventilation mode.

6-66
 6 VT5230 Ventilator Operation

Figure 6-100

CAUTION: If the encoder knob is not pressed for confirmation, the previous value will be displayed.

The following conditions should be noticed in parameter setting:

(1) In single gas source mode, O2 setting is disabled.

(2) In order to make parameter setting more safe and reasonable, interlock mode is used for tidal volume VTI,
ventilator rate and inspiratory time TI setting. In case any one of the three parameters cannot be adjusted
to required value within limits, modify the other two first.
(3) Pressure parameter setting is subject to high pressure limit.
(4) PSUPP and PINSP are relative pressure to PEEP.

6.6 Turn off the Ventilator

(1) Disconnect the breathing hoses from the patient.

(2) Return back to Standby by pressing the Standby key for more than 3 seconds.
(3) Turn off the power switch
(4) Disconnect the gas supply.
(5) Disconnect the power cord from the power supply.

NOTE: Detachable power cord is a means to isolate circuits electrically from AC supply on all poles
simultaneously.

6-67
 7 Alarms and Troubleshooting

7 Alarms and Troubleshooting

7.1 Alarms

CAUTION: In case of alarm, monitor and support the patient first, then carry out troubleshooting
later.

An alarm message will appear in alarm information area and alarm indicator will light up. The different colors of
alarm in alarm area indicate different priority levels: red is high level (!!!, red indicator flash), yellow is medium
(!!, yellow indicator flash) or low level (!, yellow indicator constantly lit).

The operator may be positioned anywhere around the unit to view the alarm light. The alarm light is visible from
a distance of 13 feet minimum. To observe the alarm messages the operator position must be in front of the
display and within a distance of 3.2 feet minimum.

7.2 Alarm Message Table

CAUTION: Monitor and support the patient first in case of alarm and perform troubleshooting later.

CAUTION: Operation instructions are not included in the table.

CAUTION: If alarm occurs, protect patient safety first, and then go to diagnose fault or service it
necessarily.

WARNING: Never leave patient unattended when alarm silence is activated.

Alarm Message Priority Type Cause Remedy

Minute Volume
lower than the set
Minute Volume exceeds the set
High Expiratory upper limit for three
Medium Physiological upper limit for three consecutive
Minute Volume consecutive breath
breath cycles or at most 10sec.
cycles or at most
15sec.

7-1
 Alarm Message Priority Type Cause Remedy

Minute Volume
Minute Volume is lower than the higher than the set
Low Expiratory set lower limit for three lower limit for three
Medium Physiological
Minute Volume consecutive breath cycles or at consecutive breath
most 10sec. cycles or at most
15sec.

Tidal Volume exceeds the upper

limit for three consecutive breath
cycles or at most 10sec. Tidal Volume lower
A low priority High Inspiratory than the alarm limit
High Inspiratory Tidal Volume alarm will escalate for three
High Physiological
Tidal Volume to a high priority alarm when the consecutive
Tidal Volume exceeds the upper ventilation cycles or
limit for three consecutive at most 15sec.
ventilation cycles or at most
10sec.

Inspiratory Tidal
High Inspiratory Inspiratory Tidal Volume exceeds Volume is lower
Low Physiological
Tidal Volume the upper limit for one ventilation. than the alarm limit
for one ventilation.

A low priority High Airway

Pressure alarm will escalate to a
high priority alarm when Airway
Pressure exceeds the set limit
within three consecutive
ventilation cycles. Or it has
exceeded the pressure control Airway pressure is
target +3 cmH2O (or hPa) (each lower than the
High Airway
High Physiological time) for three consecutive alarm limit for three
Pressure
ventilation cycles. consecutive cycles
or at most 15sec
When the Airway pressure
exceeds the set value the
inspiratory phase changes to
Expiratory phase within 200 ms
and the pressure shall be reduced
below PEEP level.

7-2
 7 Alarms and Troubleshooting

Alarm Message Priority Type Cause Remedy

Airway Pressure exceeds the

setting limit within one ventilation.
Airway pressure is
When the airway pressure
lower than the
High Airway exceeds the setting value, the
Low Physiological alarm limit for three
Pressure inspiratory phase changes into the
consecutive cycles
expiratory phase within 200 ms
or at most 15sec
and the pressure shall be reduced
below PEEP level.

Airway pressure is
higher than the
Airway pressure is lower than the
Low Airway alarm limit for three
High Physiological set limit for three consecutive
Pressure consecutive
ventilation cycles.
ventilation cycles or
at most 15 sec.

PEEP is lower than

PEEP measurement is higher the alarm limit for
High PEEP High Physiological than the alarm limit for three three consecutive
consecutive ventilation cycles. cycles or at most
15sec

PEEP is higher than

PEEP measurement is lower than the alarm limit for
Low PEEP High Physiological the alarm limit for three three consecutive
consecutive ventilation cycles. cycles or at most
15sec.

Airway pressure is
Airway pressure has exceeded
lower than
Continuous PEEP+15cmH2O (hPa)
High Physiological PEEP+15cmH2O
Airway Pressure continuously for 15sec. Expiratory
(hPa) continuously
valve is opened for gas release.
for 5sec.

Respiration Rate is
Respiration Rate has exceeded
less than the set
High Respiration the set limit for four consecutive
Medium Physiological limit for four
Rate ventilation cycles or continuously
consecutive
for 20sec, whichever is larger.
ventilation cycles.

7-3
 Alarm Message Priority Type Cause Remedy

Oxygen
concentration is
Oxygen concentration exceeds lower than the
High Oxygen
Medium Physiological the preset oxygen concentration preset oxygen
Concentration
plus 6% continuously for 30sec. concentration plus
6% for 30sec
continuously

Typical: Oxygen
concentration is
higher than the
preset oxygen
concentration minus
Typical: Oxygen concentration is
6% or higher than
lower than the preset oxygen
18% for 30sec
concentration minus 6% or lower
continuously
than 18% continuously for 30sec.
Suction
Low Oxygen Suction Precondition Phase:
Medium Physiological Precondition Phase:
Concentration Oxygen concentration is lower
Oxygen
than 1) Adult mode: 94% or 2)
concentration is
Child mode: the set oxygen
greater than 1)
concentration plus
Adult mode: 94% or
19%continuously for 30 seconds.
2) Child mode: the
set oxygen
concentration plus
19% continuously
for 30 seconds.

Measure signals of
Oxygen Sensor Checked during pre-inspection the sensor through
Medium Physiological
Failure before use. equipment
inspection.

Make sure the

oxygen sensor is
Automatic
Oxygen sensor invalid or not valid and
Oxygen Sensor High Technical
connected re-calibrate the
Calibration Fail
oxygen sensor,
replace if necessary

Refer to Chapter
No ventilation cycles within the
Apnea High Physiological 10.1.3 for Apnea
apnea period
resetting details

7-4
 7 Alarms and Troubleshooting

Alarm Message Priority Type Cause Remedy

Oxygen supply is
Oxygen supply is lower than
Low Oxygen above 160kPa (23.2
High Physiological 160kPa (23.2 psi) continuously for
Supply Pressure psi) continuously for
5 sec.
10sec.

Oxygen supply is
Oxygen source is lower than
Low Oxygen above 160kPa (23.2
Low Physiological 160kPa (23.2 psi) when O2 is set
Supply Pressure psi) continuously for
to 21% or in standby state.
10sec.

Air supply is above

Low Air Supply Air supply is lower than 160kPa 160kPa (23.2 psi)
High Physiological
Pressure (23.2 psi) continuously for 5 sec. continuously for
10sec.

Air supply is lower than 160kPa Air supply is above

Low Air Supply (23.2 psi) continuously for 10sec 160kPa (23.2 psi)
Low Physiological
Pressure when O2 is set to 100% or in continuously for
standby state. 10sec.

When no internal
power is supplied,
the power fault
alarm is of
high-priority and
lasts for longer than
120s.

During ventilator operation, when

When an internal
an AC power failure occurs and
power is supplied,
there is no battery power, the
the ventilator
AC Failure Low Technical power board will alarm for 120
switches to internal
seconds minimum. When
power supply,
powered from batteries, an “AC
produces a
Failure” alarm would occur.
low-level alarm and
gives the prompt
message of “AC
power faulty” alarm.

Alarm cancellation
condition:
Restoration of AC.

7-5
 Alarm Message Priority Type Cause Remedy

When “Limited
Under the battery operation, the Battery Capacity”
Low Battery Medium Technical remaining battery run time is less alarm appears or
than 30min. AC power supply
starts.

Under the battery operation, the

Limited Battery AC power supply
High Technical remaining battery run time is less
Capacity starts.
than 10min.

Inspiratory period is
NIV – inspiration duration exceeds
normal under NIV
Tispont setting for three times in
mode.
succession
Maximum
Medium Physiological Within the specified
Inspiratory Time Invasive - inspiration duration
condition for two
exceeds 5 seconds for adult and 2
consecutive PSV
seconds for child for three times in
ventilation under
succession
invasive mode

Cycle AC Power – if
alarm occurs again
Internal Error, stop using
High Technical Internal computing error
code xxxx Ventilator, note
code displayed and
call for Service

Inspiratory holding
Inspiratory Hold
Low Physiological Start the inspiratory holding operation is
Interrupted
completed.

Expiratory hold
Expiratory Hold
Low Physiological Start Expiratory hold operation is
Interrupted
completed.

Nebulizer operation
Nebulizer On Low Physiological Start Nebulizer operation
is completed.

Nebulizer operation
continued or alarm
Nebulizer Nebulizer operation has been
Medium Physiological is acknowledged by
Interrupted interrupted by mode changes
pressing Alarm
Silence key

Circuit Re-connect patient

High Physiological Ventilating circuit is disconnected.
Disconnect circuit.

7-6
 7 Alarms and Troubleshooting

Alarm Message Priority Type Cause Remedy

Occlusion is
Occlusion High Physiological Ventilating circuit is occluded
removed.

When the sensor

CO2 Accuracy
High Physiological Detected by CO2 Sensor. error register is
Error
reset

When the sensor

CO2 Sensor Error High Physiological Detected by CO2 Sensor. error register is
reset

Detected by CO2 Sensor. No When the sensor

CO2 Adapter
High Physiological adapter or adapter needs to be error register is
Failure
replaced. reset

CO2 Sensor No data received from CO2 sensor Receive Data

High Physiological
Comm. Failure for more than 10 seconds resumes

EtCO2 is greater
EtCO2 is less than the alarm lower than the alarm
limit for at least 3 consecutive lower limit for 2
Low etCO2 High Physiological
ventilation cycles or for 10 consecutive
seconds. ventilation cycles or
within 10 seconds.

EtCO2 is less than

EtCO2 is greater than the alarm the alarm upper
upper limit for at least 3 limit for 2
High etCO2 High Physiological
consecutive ventilation cycles or consecutive
for 10 seconds. ventilation cycles or
within 10 seconds.

Leak is within 75%

NIV Mode only- Leak exceeds of the maximum
Leakage out of
High Physiological 75% of the maximum volume volume
range
compensation capacity compensation
capacity

The measured minute volume The measured

leak MVLEAK is 20% higher than minute volume leak
the minute volume measured on MVLEAK is in normal
Leakage Low Physiological
the expiration path for 3 range for 3
consecutive ventilation cycles or consecutive breaths
for 10 seconds. or for 10 seconds.

7-7
 Alarm Message Priority Type Cause Remedy

Cycle power. If the

Alarm Speaker Failure detected in the Alarm alarm occurs
High Technical
Failure Speaker system multiple times, call
for service.

Cycle power. If the

Communication Failure detected in Ventilator alarm occurs
High Technical
Error internal communications multiple times, call
for Service.

Inaccurate CO2
Medium Technical Zero failed during pre-use test Repeat pre-use test
zeroing

Ambient
pressure outside CO2 Adapter detects ambient
High Technical Call Service
CO2 operating pressure outside of normal range
range

Internal CO2 CO2 Adapter detects ambient

temp outside High Technical temperature outside of normal Call Service
operating range range

S/W Mismatch System detects software versions

High Technical Call Service
Error are incorrect

Exp. Valve System detects expiratory valve

High Technical Call Service
Heater Failure heater fails

Remove any
obstructions. Cycle
Fan Block High Technical System detects cooling fan failure Power. If the alarm
occurs again, call
Service.

Check to make sure

inspiratory and
expiratory circuits
have no obstruction.
BDU Failure High Technical Internal hardware failure detected Retry power-up
tests.
If this alarm
persists, Call
Service

7-8
 8 User Maintenance

8 User Maintenance
WARNING: Only authorized person is permitted to perform 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.

• Never use organic, halogenated or petroleum-based solvents, anesthetic, glass
cleaning agents, acetone or other irritant agents.

8-1
 • 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.

8.1 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

8.1.1 Cleaning and Disinfecting Agents/ Autoclaving

Agent Classification

Detergent
• Mild dishwashing detergent
Detergent
• Soapy water with detergent ph between 7.0 and
10.5

• Isopropyl alcohol (75% solution) Intermediate level disinfectant

• Window cleaning solution (with isopropyl alcohol Intermediate level disinfectant

and ammonia)

• Sodium hypochloride- (bleach) in water (10%

Intermediate level disinfectant
solution)
Intermediate level disinfectant
• Hydrogen peroxide (3% solution)

• Gluteraldehyde 2% solution High level disinfectant

8-2
 8 User Maintenance

• Steam autoclaving up to a maximum temperature High level disinfectant

of 134°C (273°F).

8.1.2 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 8-1. 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.

Table 8-1

Cleaning and disinfection methods

Part name
A B C D
Ventilator exterior, including housing, gas
√
supply hoses and power cord
All components in Figure 8-3 √ √ √ √
CO2 sensor, other breathing circuit parts or
Follow the manufacture’s guidelines
accessories

8.1.3 Cleaning and Disinfection of Components

8.1.3.1 External Surfaces

Using a soft cloth with a water-soluble detergent or disinfectant wipes, clean all outer surfaces, hoses and
cables.

8-3
8.1.3.2 Expiratory Module

(1) Disassembly

Figure 8-1 Figure 8-2

1 2 3 4

5
6
7

Figure 8-3

8-4
 8 User Maintenance

Figure 8-4

To remove the diaphragm and the scale board from expiratory module assembly:

a. Lift the button(1) (1 in Figure 8-1);

b. Pull out the expiratory valve core component (2 in Figure 8-1, Figure 8-2);

c. Unscrew the cover plat anticlockwise(1 in Figure 8-3);

d. Remove the diaphragm(2 in Figure 8-3), the scale board(3 in Figure 8-3) and the valve core(3 in Figure 8-3,
including three sealing rings 18x1.8);

CAUTION: When reassembly, connect the diaphragm on the scale board properly, as shown in Figure 8-4;

e. Rotate the breath connector anticlockwise (5 in Figure 8-3) ;

f. Pull out one-way valve core(6 in Figure 8-3, including the sealing ring 6x1.8) and one-way diaphragm(7
in Figure 8-3);

g. Rotate the water cup (8 in Figure 8-3), 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 components have been cleaned before disinfecting.

8-5
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.

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.

NOTE: When the diaphragm and scale board are reassembled, the expiratory valve must be calibrated.

NOTE: After Connection, please perform a pre-use test and verify all tests passed.

8.2 Regular Maintenance

8.2.1 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 requirement in
specification.

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.

CAUTION: Only authorized personnel are permitted to perform maintenance.

Use products of our company to replace damaged ones and test, ensuring all specifications met.

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 guarantee period.

8.2.2 Maintenance Overview and Schedule

The Aeonmed VT5230 Critical Care Ventilator maintenance is very important to provide safe use of the
Ventilator and should be carefully managed by the clinician team. Two types of maintenance are needed: User
maintenance and Service Preventive Maintenance.

User Maintenance requirements are shown below and must be followed.

8-6
 8 User Maintenance

Service Preventive Maintenance is required every year (after every 12 months of normal use) and can only be
performed by a trained professional service person. Details on this Service Preventive Maintenance can be
found in the Aeonmed VT5230 Critical Care Ventilator Service Manual.

If necessary, Aeonmed can provide circuit diagram, service part list, calibration instructions to assist authorized
service personnel.

Total operational hours of the ventilator are available on the touch screen by pressing other; then information.

8.2.3 User Maintenance

Minimum maintenance interval Task

Daily or according to hospital policy Check and drain any liquid in expiratory module water trap

Every 1 month or when soiled Replace cooling fan filter on rear of machine

Every 1 year or after a failed Replace the O2 sensor (actual life depends on temperature and O2
calibration concentration)

Notes related to User Maintenance:

NOTE: The Aeonmed VT5230 Critical Care Ventilator performs an O2 sensor calibration automatically,
every 24 hours, no operator intervention is needed.

NOTE: When the automatic oxygen sensor calibration failed, there shall be an alarm ‘Automatic Oxygen
Sensor Calibration Fail’.

WARNING: If the VT5230 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.

8-7
8.3 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 and 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

8.3.1 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 in vehicle, plane and train. Impact, severe shock and moisture
should be avoided during transportation, with ambient temperature -20°C-+60°C and relative humidity not more
than 95%. In case transportation conditions do not meet this requirement, put the machine in specified
operating environment for at least 24h before using.

8.3.2 Storage

CAUTION: Do not put ventilator into the shock environment.

CAUTION: Do not lay heavy items on the top of the ventilator.

8-8
 8 User Maintenance

The machine should be stored in a room with temperature -20°C to + 60°C and relative humidity 5% to 95%
non-condensing, with ventilation and no corrosive gases.

WARNING: If the storage environment conditions don’t agree, put the machine in specified operating
environment at least 24h before using.

CAUTION: The device should be stored at the room that is ventilated and in which no corrosive gases
exist.

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.

8.4 Battery Maintenance

• Battery specification

Internal battery module

--DC12V, 2.3AH, lead-acid battery, 2 in series

--Typical charge time: 4hours
--Typical discharge time: 1hour

NOTE: When the main power supply voltage is too low or the main power supply fails, the batteries 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.
• Precautions

Charge: When operating with AC power supply on, the system will maintain the battery automatically. Charge
time is less than 4 hours.

Discharge: Extended battery module (if connected) will supply power prior to the internal battery module when
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, otherwise the batteries will be depleted and another alarm “Limited Battery Capacity”
will be displayed, and eventually the system will shut down (for safety reason, manual power-on is required to
start the machines again after an automatic shutdown).

8-9
• Battery storage

In case the battery is to be stored for a long time, charge it fully prior to storage.

In case storage time exceeds 3 months, charge battery every 3 months.

High humidity and high temperature enviroments 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.

• Battery replacement

Same model battery with CE certification is suggested. Make sure AC power supply is disconnected before
replacing.

CAUTION: An authorized Aeonmed service representative can replace the battery. If the battery is not to
be used for a long-time, please contact an Aeonmed service representative to disconnect the
battery. The waste battery should be disposed of in accordance with the local policies.

CAUTION: When ‘battery low’ alarm occurs, charging should be done immediately. Otherwise the VT5230
Ventilator System could shut off automatically in several minutes.

8.5 Oxygen Sensor

The oxygen sensor can be used to measure the local oxygen concentration when it is connected to the
ventilator or other equipments. The oxygen sensor is suitable for adult and child.

8.5.1 Oxygen Sensor Replacement

To change the Oxygen sensor, remove the Oxygen sensor cover on the rear of the machine, replace the
connectedOxygen sensor with a new Oxygen sensor supplied by Aeonmed. Use care to assure connections
are complete. Replace Oxygen sensor cover.

8.5.2 Oxygen Sensor Calibration

For oxygen sensor calibration, refer to section 6.3.7.3.1.

8-10
 8 User Maintenance

8.5.3 Technical Specifications of Oxygen Sensor

Measure range 0-1500 mBar O2

Measure accuracy <1%

Response time <15 s (air to 100% O2)

Operating temperature -20℃ ～ +50℃

Operating pressure 0.5 - 2.0 Bar

Operating humidity 0 - 99% RH non-condensing

Storage temperature 0℃ to 20℃

Drift <200 µV

Reproducibility ±1%

Type Chemical fuel cell

6
0.94 x 10 % O2 hours at 20°C
Expect life time 6
0.6 x 10 % O2 hours at 40°C

Total system response time <60s

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 produces a current with
an amplitude proportional to the oxygen partial pressure indicated by
the electrode sensor. The base metal electrode is gradually exhausted
Working principle of O2
during the oxidation process.
monitor
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.

8-11
8.5.4 Oxygen Sensor Maintenance

The oxygen sensor should be regularly calibrated. For the calibration interval, refer to section 8.2.3.

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 valid of the oxygen sensor. When the oxygen sensor fails, please contact the manufacturer.

The recommended oxygen sensor is produced by our company.

WARNING: Do not immerse oxygen sensor in liquid. Do not conduct autoclave or high temperature

fumigation on the oxygen sensor.

8.6 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 Aeonmed, Inc. 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-sensors:

• Follow all local regulations with respect to environmental protection when disposing of batteries and
O2-sensors. 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.

8-12
 9 Warranty

9 Warranty
Manufacturing techniques and materials:

For a period of one year from the date of original delivery to the customer, the components and assemblies of
this product are warranted to be free from defects caused by manufacturing techniques and materials, provided
that the equipment is properly operated under conditions of normal use and that the equipment is regularly
maintained per requirements specified by Aeonmed. The warranty period for other parts is three months.
Consumable parts are not included in this warranty. Aeonmed’s obligation under the above warranty is limited
to repairing the equipment free of charge.

Freedom from Obligations:

• Aeonmed’s obligation under the above warranties does not include freight and other fees;
• Aeonmed is not responsible for any direct or indirect product damage or delays which result from improper
use; alteration by using assemblies in an unapproved configuration; and maintenance by anyone other
than Aeonmed or Aeonmed’s appointed representatives;
• This warranty does not apply to the following situations:
Improper use
Machines used without the proper maintenance or damaged
Aeonmed original serial number label or mark is removed or replaced

Security, reliability and operating condition:

Aeonmed is not responsible for the security; reliability and operating condition of this product in cases where:
• The assemblies are disassembled, extended and readjusted
• The product is not operated correctly in accordance with these User manual instructions.
• The AC power used or the operating environment does not follow the requirements in this manual.

9.1 Return

Follow these steps in case the product must be returned to Aeonmed:

1. Obtain the rights of return (Return Material Authorization Number)

Contact Aeonmed Customer Service and inform us of the part number and type of the product. The part
number is marked on the surface of the product. Return is not allowed if the number cannot be identified.
Receive an RMA number from Aeonmed and mark it on the exterior of the product packaging. Enclose a
statement of the product number, product type and also the reason for return.

2. Transportation charges
Transportation and insurance charges must be prepaid by the user for transporting the product to Aeonmed for
repair.

9-1
9-2
 10 Theory of Operation

10 Theory of Operation

10.1 Ventilation Modes

There are Invasive and non-invasive (NIV) ventilation modes in Aeonmed VT5230 Critical Care Ventilator. All
the modes are suitable for children and adults.

CAUTION: Nebulizer use is not available in noninvasive (NIV) modes.

Invasive ventilation modes include:

• Assist/Control ventilation (A/C) modes. These modes allow mandatory ventilation and include VCV, PCV
and PRVC.

• Synchronous Intermittent Mandatory Ventilation (SIMV) modes. These modes allow both mandatory
ventilation (including VCV, PCV and PRVC) and spontaneous ventilation (including spontaneous
ventilation and pressure support ventilation - PSV).

• Spontaneous/ Continuous Positive Airway Pressure ventilation (SPONT/CPAP) mode. This mode only
allows spontaneous ventilation.

• Bi Level ventilation (BIVENT) mode. This mode allows both mandatory ventilation (switching between high
level CPAP and low level CPAP) and spontaneous ventilation.

NIV modes, include:

• NIV/CPAP mode - SPONT/CPAP mode in NIV.

• NIV/PCV mode – A/C (PCV) mode in NIV.

10.1.1 Assist/Control Ventilation

In Assist/Control ventilation, breaths are controlled by the ventilator (mandatory) or triggered by the patient
(spontaneous) or triggered by the operator. When controlled by the ventilator, Ventilator Initiated
Mandatory (VIM) breaths are flow controlled and time cycled, thus delivering an operator set volume
(Tidal Volume) or pressure. Extra breaths, called Patient Initiated Mandatory (PIM) breaths, shall be possible if
the patient overcomes the pre-set trigger level. PIM breaths are either pressure or flow triggered. If the trigger
setting is adjusted so that the patient cannot trigger the ventilator, all breaths shall be VIM breaths, including
operator triggered breaths.

10-1
1. Volume Control Ventilation:

In VCV, VIM breaths deliver the set volume (Tidal Volume - Vt). The flow pattern is selectable between
square and descending ramp waveforms.

Figure 10-1

10-2
 10 Theroy of Operation

Figure 10-2

10-3
2. PCV Pressure Controlled ventilation

In PCV, VIM breaths deliver the set Pressure (Pinsp) using a decelerating flow pattern.

Figure 10-3

10-4
 10 Theroy of Operation

3. Pressure Regulated Volume Control Ventilation

PRVC breaths will be delivered at a set rate and set volume (VT). The flow pattern resembles PCV.
Inspiratory pressure will be regulated in PRVC to achieve the operator set volume (Tidal Volume). The
first ventilation in PRVC will have a square flow waveform and each successive ventilation will have a ramp
flow (decelerating) waveform.

Figure 10-4

PRVC ventilation operation shall be as follows:

When PRVC is selected, a volume controlled test breath, to the set tidal volume, will be delivered to the patient.
The ventilator will set the target pressure for the first pressure control breath to the end inspiratory pressure of
the test breath.

The next ventilation and all subsequent breaths will be delivered as pressure control breaths. The inspiratory
pressure will be based on the dynamic compliance of the previous ventilation and the set tidal volume.
Inspiratory pressure will be adjusted automatically by the ventilator to maintain the target tidal volume. The
maximum step change between two consecutive breaths shall be 3 centimeters of water pressure. The
maximum tidal volume delivered in a single ventilation shall be 1.5 times the Vt setting.

The test ventilation sequence shall be initiated when any of the following events occur: Entering the Mode
(PRVC) mode; Changing the set tidal volume while in PRVC; Delivered tidal volume >= 1.5 times the set
volume; Flow termination of the test ventilation; activation of any of the following alarms - High Peak Pressure
Alarm; Low Peak Pressure Alarm; Low PEEP alarm; Patient Circuit Disconnect Alarm; I-Time Limit; I:E Limit.

10-5
10.1.2 Synchronized Intermittent Mandatory Ventilation

SIMV is a ventilation mode where the patient is allowed to breathe spontaneously and the machine delivers VC
mandatory breaths in synchrony with the patient’s effort at the operator set rate and volume (or pressure).
This is accomplished by a combination of spontaneous and mandatory windows that open and close. The type
of ventilation delivered depends upon whether the event during the window is patient initiated, operator initiated
or time initiated. Spontaneous breaths occurring between mandatory breaths can be pressure supported.
Synchronized breaths shall be either pressure or flow triggered. Back-up (Apnea) ventilation shall be provided
when there is no patient trigger, mandatory ventilation or manual ventilation for a period that exceeds the
apnea alarm setting. Backup Ventilation shall be available in SIMV - See section on Backup Ventilation for
details on these modes and settings.

SIMV ventilation cycle, PIM delivered within mandatory interval and

SIMV ventilation cycle, PIM not delivered within mandatory interval

Figure 10-5

1. SIMV (VCV)

In SIMV (VCV), mandatory ventilator breaths are volume controlled. Between the mandatory breaths the
patient can breathe spontaneously. These spontaneous breaths can be pressure supported. Backup
ventilation will be PCV.

2. SIMV (PCV)

In SIMV (PCV), mandatory ventilator breaths are pressure controlled. Between the mandatory breaths the
patient can breathe spontaneously. These spontaneous breaths can be pressure supported. Backup
ventilation will be PCV.

3. SIMV(PRVC)

10-6
 10 Theroy of Operation

In SIMV (PRVC), mandatory ventilator breaths are pressure-regulated volume controlled. Between the
mandatory breaths the patient can breathe spontaneously. These spontaneous breaths can be pressure
supported. Backup ventilation will be PCV.

10.1.3 Back-up Ventilation (Apnea Ventilation)

1. Transition into Back-up Ventilation

The current Ventilation mode shall transition to Back-up Ventilation - PCV when an apnea occurs in
SPONT/CPAP mode.

The current Ventilation mode shall transition to Back-up Ventilation - PCV when an apnea occurs in BIVENT
mode.

The current Ventilation mode shall transition to Back-up Ventilation – NIV/PCV when an apnea occurs in
NIV/CPAP mode.

The current Ventilation mode shall transition to Back-up Ventilation - PCV when an apnea occurs in an SIMV
mode.

2. Characteristics of Back-up Ventilation

Apnea ventilation settings include Pinsp and Tinsp or I:E.

3. Exiting Back-up Ventilation

Two methods to exit Back-up Ventilation shall be supported: trigger by patient or reset by operator.

When in Back-up Ventilation and the patient triggers two consecutive breaths and also the Expiratory Vt >= 0.5
x Inspiratory Vt for those two breaths, then the ventilator shall return to the Ventilation mode and settings prior
to the Apnea event.

When in Back-up Ventilation and the operator resets the Apnea Alarm and confirms the reset by pressing the
Encoder Knob, then the ventilator will return to the Ventilation mode and settings prior to the Apnea event.

Mode transitions when exiting Back-up Ventilation shall occur only when an Expiratory has been completed.

10-7
10.1.4 Spontaneous/CPAP Ventilation

In SPONT/CPAP Ventilation, the patient breathes spontaneously at a pressure level determined by the PEEP
setting. Spontaneous ventilation may also be assisted by the ventilator at an operator set level of inspiratory
pressure (Pressure Support). Inspiration is initiated by the patient and terminated when the inspiratory flow falls
below an operator set percentage of the peak flow during this ventilation. During SPONT/CPAP, the patient
determines the respiratory rate, and the patient and ventilator determine the inspiratory time and tidal volume.
Ventilation detection shall be either pressure or flow triggered. PCV back-up ventilation shall be provided when
there is no patient trigger, for a period that exceeds the apnea alarm setting. (See Section on Back-up
ventilation for details)

Figure 10-6 Spontaneous/CPAP ventilation

10-8
 10 Theroy of Operation

10.1.5 BiLevel Ventilation (BIVENT)

In BIVENT, Pressure controlled breaths are provided by switching between a high and low airway pressure in
an adjustable time sequence. Spontaneous breaths can be pressure supported at the high and low pressure
levels. When the expiratory time (Tlow) is less than the inspiratory time (Thigh) the displayed ventilation
mode shall be BIVENT APRV. PCV back-up ventilation shall be provided when there is no patient trigger,
mandatory ventilation or manual ventilation for a period that exceeds the apnea alarm setting. (See Section on
Back-up ventilation for details) If there is no spontaneous breaths, I:E is calculated as the ratio of Thigh to Tlow.
During spontaneous breathing, I:E is calculated as the ratio of Tinsp to Texp, where Tinsp is the current
spontaneous breath Tinsp and Texp is the time from the end of Tinsp to the start of the next Tinsp or to the time
to the Tlow to Thigh transition, whichever comes first.

Figure 10-7 BIVENT

10-9
 Figure 10-8 BIVENT APRV

10.1.6 Non Invasive/ Continuous Positive Airway Pressure

NIV/CPAP is a spontaneous mode of operation and no ventilator controlled breaths are provided. Throughout
the ventilation cycle, an operator set pressure (CPAP) may be provided. NIV/PCV back-up ventilation shall be
provided when there are no spontaneous breaths for a period that exceeds the apnea alarm setting. (See
Section on Back-up ventilation for details). Spontaneous ventilation may also be assisted by the ventilator at an
operator set level of inspiratory pressure (Pressure Support). Inspiration is initiated by the patient and
terminated when the inspiratory flow falls below a percentage of the peak flow during this breath (Esens). End
of inspiration will also occur if the patient reaches the High Spontaneous Inspiratory Time threshold, at which
time the breath shall truncate and transition to expiration. During NIV/CPAP, the patient determines the
respiratory rate, the inspiratory time and tidal volume. Breath detection is flow triggered.

In order to use a similar terminology as other Vent modes on Aeonmed VT5230 Critical Care Ventilator, this
mode can be displayed as NIV/CPAP with PSV.

10-10
 10 Theroy of Operation

Figure 10-9

Illustration shows NIV/CPAP breaths with PS set to 0. Breaths are supported by CPAP only in this illustration.
Pressure shall rise according to the selected rise time, with target pressure 1.5 cmH2O above PEEP to improve
work of ventilating.

Figure 10-10

• This illustration shows NIV/CPAP spontaneous breaths with Pressure Support

10-11
 Figure 10-11

Pressure support will be terminated when:

• Inspiratory flow returns to zero during phase 1 of inspiration, (i.e. when the patient exhales or fights the
ventilator),
• Inspiratory flow in phase 2 of inspiration phase falls below a certain ratio (Esens) of the maximum value
previously supplied when compared to the peak inspiratory flow supplied

or

• Based on high Spont Inspiratory Time setting is exceeded

10-12
 10 Theroy of Operation

10.1.7 Non Invasive/ Pressure Controlled Ventilation

In NIV/PCV, breaths shall be controlled by the ventilator (mandatory) or shall be triggered by the patient
(spontaneous) or shall be triggered by the operator. When controlled by the ventilator, breaths shall be
pressure limited and time cycled, resulting in an operator set pressure (Pinsp) being delivered for an operator
set period (Tinsp). Extra breaths shall be possible if the patient overcomes the pre-set trigger level or if the
operator selects a manual ventilation. Patient triggered breaths shall be flow triggered.

10-13
 11 Appendix A

11 Appendix A VT5230 Ventilator System

Specifications
WARNING: Do not operate the Aeonmed VT5230 Critical Care Ventilator outside specified operating
ranges or patient injury or equipment damage could result.

NOTE: To add a measure of safety, an electronic hardware watchdog timer monitors the system operation
at all times. In cases where the system software does not respond in a safe time period, the watchdog timer will
reset the system. This enables the system software to be in control at all times.

11.1 System

11.1.1 General

This device complies with requirements of Medical Device Directive 93/42/EEC.

Standards

IEC 60601-1 (Class 1, Type B (with non-conductive breathing circuit))

ISO 80601-2-12

WARNING: Equipment not suitable for use in the presence of a Flammable Anesthetic mixture with Air or
with Oxygen or Nitrous Oxide.

Electromagnetic Compatibility (EMC)

According to IEC 60601-1-2

Patient Range

Adult weight: 7 – 150 kg (15.4 – 330.7 lbs)

Child weight: 3.5 – 35 kg (7.7 – 77.2 lbs)
Neonate weight: 2.5 – 8 kg (6 – 18 lbs)

11-1
11.1.2 Operating Conditions

Operating Temperature Range: +10 to +40 ℃

Relative Humidity: 5 to 95% non-condensing
Atmospheric Pressure: 50 kPa～106 kPa

Enclosure Protection Rating IP21 per IEC 60529

11.1.3 Non-operating Conditions

Storage Temperature Range: -20 to +60 ℃

Storage Relative Humidity: ≤95% non-condensing
Storage Atmospheric Pressure: 50 kPa～106 kPa

11.1.4 Power Supply

Power Supply, Automatic

100~240 VAC, 50~60Hz
Range Selection

Battery Backup, Internal A rechargeable battery pack with two sealed lead acid battery in series,
(Standard) 12V, 2.2 Ah Recharge time approximately 4 hours.

At 110-120 VAC: 2A, 200VA (Ventilator only); 10 A (Ventilator plus

Maximum Power Auxiliary Outlets),
Consumption At 220-240 VAC: 1A, 200VA (Ventilator only); 8 A (Ventilator plus
Auxiliary Outlets)

CAUTION: The Power Supply should meet the above specifications.

NOTE: When the main power supply voltage is too low or the main power supply fails, the batteries 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.

11-2
 11 Appendix A

11.2 Ventilator

11.2.1 General

410mm(length) x 470mm(wide) x 570mm(high)

Dimensions 536mm(length) x 690mm(wide) x 1425mm(high) (only including the cart)

536mm(length) x 582mm(wide) x 1425mm(high) (only including the cart and

the air compressor)

Total: 55 kg
User Interface: 5 kg
Weight (Approximate)
Ventilation Delivery Unit: 20 kg
Cart: 30 kg

Trigger Method Flow and Pressure

Maximum limited
110 cmH2O
pressure

Maximum working 100 cmH2O, pressure control ventilation

pressure

Sub-atmospheric
In the expiratory phase (-40 cm H2O)
pressure

Warm-up time ≥5min

Pressure compensation The ventilator has the automatic atmospheric pressure compensatory function.

11.2.2 Gas Supply

Supplied gases must be free of water, oil and particles

Inlet Gas Pressure

O2, Air: 280 kPa to 600 kPa (41 – 87 psi)

Connection Standards Available

DISS, NIST

The maximum 10 s average input flow required by ventilator for air is 60.18 LPM, for O2 is 60.69 LPM at a
pressure of 280 kPa (41 psi). For a 3 second average and at a pressure of 280kPa (41 psi), the maximum
averaged transient input flow required by the Ventilator is 64.92 LPM for air and 64.44 LPM for O2.

11-3
 CAUTION: The ventilator is a high flow device and should only be connected to a pipeline connection
designed using a diversity factor that allows for the indicated high flow at a specified number
of terminal outlets, in order to avoid exceeding the pipeline design flow, thereby minimizing
the risk that the ventilator interferes with the operation of adjacent equipment.

11.2.3 Patient System Connectors

Male 22 mm Conical Fittings in accordance with ISO 5356-1

11.2.4 User Interface Screen

Attaches to the ventilator or other mounting system.

11.2.5 Acoustic Energy

The A-weighted sound pressure level of Aeonmed VT5230 Critical Care Ventilator is 45 dB; the A-weighted
sound power level is 52 dB.

11.3 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)

11.4 Inspiratory Channel

Pressure Drop

Maximum 5 cmH2O at a flow of 60 liters/min without CO2 airway adapter.

Rated Inspiratory Gas Pathway Resistance

Less or equal to 50 cmH2O/L/s

Compliance

Maximum totally 7.5 mL/cmH2O in inspiratory and expiratory channel

11-4
 11 Appendix A

Gas Delivery System

Microprocessor controlled valves

Gas Delivery Device

Flow Range:
1 to 130 liters/min. (Adult)
0 to 60 liters/min. (Child)

Maximum Pressure Setting: 100 cmH2O

NIV Max leakage compensation level

Adult: 30 liters/min
Child: 15 liters/min

11.5 Expiratory Channel

Pressure Drop (Resistance)

Maximum 5 cmH2O at a flow of 60 liters/min without CO2 airway adapter.

Rated Inspiratory Gas Pathway Resistance

Less or equal to 20 cmH2O/L/s

Compliance

Maximum totally 7.5 mL/cmH2O in inspiratory and expiratory channel

PEEP Regulation

Microprocessor controlled valve

PEEP Setting Range

0 – 50 cmH2O for Invasive mode

2 – 20 cmH2O for NIV mode

Expiratory Flow Measurements

Range: 0 – 130 liters/min.

Because of power failure or partial loss power, the ventilatory capacity is unnormal. When the ventilator
supplies 60L/min volume, for the expiratory valve the pressure drop is 0.18kPa in inspiration, the pressure drop
is 0.11kPa in expiration.

11-5
11.6 Monitoring

Expiratory Minute Volume

Range: 0.1 – 60 liters/min.

Accuracy: +/- 0.5 LPM or +/- 8% of measured value (whichever is greater)
Resolution: 0.1LPM

Inspiratory and Expiratory Tidal Volume

Range: 0 – 4000 mL
Adult Accuracy: +/- 25 mL or ±10% 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: 15 – 100%
Accuracy: +/- 3 vol. %
Resolution: 1%

Airway Pressure

Range: -50 to 100 cmH2O

Accuracy: ± (2 cmH2O + 4% of reading)
Resolution: 1 cmH2O

Measurement uncertainty

Volume: +/- 2% of reading or +/- 20 mL (whichever is greater)

Pressure: +/- 0.75% of reading or +/- 0.1 cmH2O (whichever is greater)
O2: +/- 1%

11.7 Alarms

11.7.1 Allowed Alarm Settings

Airway Pressure (upper limit)

5 to 110 cmH2O for Adult and Child, 5 to 100cmH2O for Neonate.

High Continuous Pressure

Set PEEP level + 15 cmH2O for at least 15 sec

11-6
 11 Appendix A

O2 Concentration

Low Oxygen Concentration : <Set value - 6 vol % or <= 18 vol %

High Oxygen Concentration : >Set value + 6 vol %

Expired Minute Volume (Upper alarm limit)

1 – 60 liters/min, OFF

Expired Minute Volume (Lower alarm limit)

OFF, 0.1– 40 liters/min

Apnea Time

10 – 60 sec, OFF

Spontaneous Respiratory Frequency

10 – 120 bpm, OFF

Positive End Expiratory Pressure (Lower alarm limit)

OFF, 1 – 50 cmH2O
OFF, 1 – 20 cmH2O (NIV modes only)

End-Tidal CO2 (Upper alarm limit)

0.1% to 13.3% or 1 mmHg to 100 mmHg or 0.1 kPa to 13.3 kPa

End-Tidal CO2 (Lower alarm limit)

OFF, 0.1% to 13.2% or OFF, 1 mmHg to 99 mmHg or OFF, 0.1 kPa to13.2 kPa

11.7.2 Alarms Miscellaneous

Gas Supply

< 160 kPa (23.2 psi) +10% for 5 seconds or more

Alarm Silence

Press this key to silence alarms for two minutes.

Alarm Sound Pressure

The alarm sound pressure is above 60 dB at lowest volume setting at a distance of 1 meter from the front of the
ventilator.

11-7
11.8 Ventilation Modes

11.8.1 Controlled Ventilation

Pressure Control (PCV)

Pressure controlled ventilation

Volume Control (VCV)

Volume controlled ventilation

Pressure Regulated Volume Control (PRVC)

Pressure regulated volume controlled ventilation

NIV Pressure Control (NIV/PCV)

Noninvasive pressure controlled ventilation

11.8.2 Supported Ventilation

SPONT/CPAP+PSV

Spontaneous/Continuous positive airway pressure ventilation with pressure support ventilation

NIV/CPAP+PSV

Noninvasive/Continuous positive airway pressure ventilation with pressure support ventilation

11.8.3 Combined Ventilation

SIMV (PCV) + PSV

Synchronized intermittent mandatory ventilation based on pressure controlled ventilation with pressure support
ventilation

SIMV (VCV) + PSV

Synchronized intermittent mandatory ventilation based on volume controlled ventilation with pressure support
ventilation

11-8
 11 Appendix A

SIMV (PRVC) + PSV

Synchronized intermittent mandatory ventilation based on pressure regulated volume controlled ventilation with
pressure support ventilation at high and low pressure levels

BIVENT

Pressure controlled ventilation that allows the patient the opportunity of unrestricted spontaneous ventilating
with pressure support at high and low pressure levels

11.9 Trend Function

Peak Airway Pressure Ppeak

Plateau Airway Pressure Pplat

Mean Airway Pressure Pmean

Positive End Expiratory Pressure PEEP

Minimum Airway Pressure Pmin

Inspiratory Tidal Volume Vti

Expiratory Tidal Volume Vte

Expiratory Minute Volume MVe

Spontaneous Minute Volume MVespont

Inspiratory/Expiratory Ratio I:E

Total Ventilating Frequency f total

Spontaneous Ventilating Frequency fspont

Inspired Oxygen Concentration O2

Expiratory Resistance Rexp

Dynamic Compliance Cdyn

Rapid - shallow ventilating index RSBI

Work of Ventilating WOB

CO2 End Tidal Concentration etCO2

Leak Leak NIV

Dead Space Volume Vdaw

Spontaneous Inspiratory Time Tispont

11-9
11.10 Log Function

Event/Alarm

Alarms
Ventilator Settings
Test results
Configuration log

11.11 Shortcut Key Functions

Insp. Hold

Inspiratory Hold

Exp. Hold

Expiratory Hold

Nebulizer

Start, cycle through available nebulizer durations and stop the Nebulizer operation

Manual

Initiation of 1 breath in all ventilation modes except SPONT/CPAP

Suction

Initiate and terminate the suction support process.

Print Screen

Save a copy of the screen into a JPG file and stores it on the USB deviceFreeze

Freeze the current waveforms and loops, or unfreeze the Waveform display

Screen Lock

Lock or unlock the touch screen

Alarm Limits

Enter the alarm limits page in the main menu

Main Menu

Return to the main menu

11-10
 11 Appendix A

11.12 Communication/Interface

11.12.1 Nurse call port

The Aeonmed VT5230 Critical Care Ventilator has a modular jack configured to interface with external systems
and is wired for normally open (N.O., close on alarm) signals. Contacts close on High priority alarms, loss of
AC power and Speaker failure.

Floating DC contact
Voltage: Max. 50V
Current: Max. 200mA

Pin assignment:
1. Normally open
2. Normally open
3. Normally open
4. Common pin
5. Common pin
6. Common pin

11.12.2 Ethernet Port

Ethernet Port per IEE 802.3 to enable the Aeonmed VT5230 Critical Care Ventilator to connect to external
equipment such as an electronic health record.

CAUTION:
• connection of the Aeonmed VT5230 Critical Care Ventilator to a equipment could result in
previously unidentified risks to patients, operators or third parties;
• the facility should identify, analyze, evaluate and control these risks
• subsequent changes to the Ethernet port could introduce new risks and require additional
analysis; and
• changes to the Ethernet Port include:
• changes in Ethernet Port configuration;
• connection of additional items to the Ethernet Port;
• disconnecting items from the Ethernet Port;
• update of equipment connected to the Ethernet Port;
• upgrade of equipment connected to the Ethernet Port

11-11
11.12.3 RS-232 Port

Laptop-ready connection for user and service use in future software release.

11.12.4 Nebulizer Output Port

Output port for connection to nebulizer.

11.12.5 CO2 Port

See Section 3.2.

11.13 Accessories

Mobile Cart

115 VAC Version:

Input: 115 ± 10% VAC 60 Hz, 10A

Outputs 1 and 2: 115 ± 10% VAC 60 Hz, total 8A
Output 3: 115 ± 10% VAC 60 Hz, 2A
Circuit Breaker (for output 3 only): 250 VAC 2A 50/60 Hz

220 VAC Version:

Input: 220 +/- 10% VAC 50 Hz, 10A

Outputs 1 and 2: 220 ± 10% VAC 50 Hz, total 9A
Output 3: 220 ± 10% VAC 50 Hz, 1A
Circuit Breaker (for output 3 only): 250 VAC 2A 50/60 Hz

Weight: 30 kg

Gas Cylinder Kit

Capacity is two cylinders max, US E cylinders (one O2 and one AIR)

11-12
 11 Appendix A

11.14 Ventilating Parameters: Default Values and Allowed

Settings (Standard Configuration)

Factory Set Default Setting Range

Parameter
Neonate Child Adult Neonate Child Adult

ATC Tube
OFF OFF OFF ON/OFF ON/OFF ON/OFF
Compensation

ATC Tube Type ET ET ET ET/IT ET/IT ET/IT

ATC Tube
Compensation 80 80 80 0 – 100 0 – 100 0 - 100
(%)

ATC Tube
5.0 5.0 7.5 2.5 – 8.0 2.5 – 8.0 5.0 – 12.0
Diameter (mm)

Backup
Ventilation
10 10 20 5 – (100-PEEP) 5 – (100-PEEP) 5 – (90-PEEP)
Pressure above
PEEP

Backup
Ventilation Tinsp 0.6 0.6 1.0 0.2 – 5 0.2 – 5 0.2 - 9
(s)

Compliance
ON ON ON ON/OFF ON/OFF ON/OFF
Compensation

CPAP (cmH2O) in
--- 5 5 --- 2 – 20 2 - 20
NIV

Expiratory Trigger
Sensitivity - 25 25 25 5 – 80 5 – 80 5 - 80
Esens(%)

Flow Trigger –
2.0 2.0 2.0 0.3 - 20 0.5 - 20 0.3 - 20
Vsens (l/min)

Frequency bpm 30 30 15 2 – 120 2 – 120 1 - 120

IBW - Ideal Body

3 15 50 2.5-8 3.5 - 35 7 - 150
Weight (kg)

I:E ratio 1:2 1:2 1:2 1:10 – 4:1 1:10 – 4:1 1:10 – 4:1

Maximum
--- 60 130 --- --- ---
inspiratory flow

11-13
 Factory Set Default Setting Range
Parameter
Neonate Child Adult Neonate Child Adult

(liters/min)

Maximum
permitted
110 110 110 --- --- ---
pressure – safety
valve (cmH2O)

NIV/CPA
Mode (in NIV) --- NIV/CPAP --- --- ---
P

Mode(in Invasive
PCV PCV PCV --- --- ---
Ventilation)

Nebulizer OFF OFF OFF ON/OFF ON/OFF ON/OFF

Nebulizer Time
30 30 30 --- --- ---
(minutes)

NIV Rate Bpm) --- 30 15 --- 4 – 40 4 - 20

O2 Concentration
40 40 40 21 – 100 21 – 100 21 - 100
(%)

PEEP (cmH2O) 5 5 5 0 – 50 0 – 50 0 - 50

PEEP in NIV
--- 5 5 --- 2 – 20 2 - 20
(cmH2O)

Phigh(cm H2O) --- 15 25 --- 5 – 90 5 - 90

Plow (cm H2O) --- 5 5 --- 0 – 50 0 - 50

Press trig
sensitivity level -3 -3 -3 -20 – 0 -20 – 0 -20 - 0
(cmH2O)

Pressure level
above PEEP 10 10 20 0 – (90-PEEP) 0 – (100-PEEP) 0 – (100-PEEP)
(cmH2O)

PS above PEEP
0 0 0 0 – (90-PEEP) 0 – (90-PEEP) 0 – (90-PEEP)
(cmH2O)

PS – BIVENT (cm
--- 0 0 --- 0 – (90-PEEP) 0 – (90-PEEP)
H2O)

PS – NIV above
--- 0 0 --- 0 – (32-CPAP) 0 – (32-CPAP)
CPAP (cm H2O)

SIMV rate (bpm) 20 4 --- 1 – 50 1 - 60

11-14
 11 Appendix A

Factory Set Default Setting Range

Parameter
Neonate Child Adult Neonate Child Adult

Thigh(s) -- 0.6 1.0 --- 0.2 – 30 0.2 - 30

Tinsp(s) 0.6 0.6 1.0 0.2 – 5 0.1 – 5 0.1 - 12

Tidal Volume (ml) --- 80 400 --- 10 - 300 50 - 2500

Tlow (s) --- 1.4 3.0 --- 0.2 – 30 0.2 - 30

Tpause (s) --- 0 0 --- 0 – 2.5 0-4

Tslope(s) 0.1 0.1 0.1 0–2 0–2 0-2

Alarm Settings: Default Settings and Allowed Ranges

Factory Set Default Setting Range

Alarm Limits
Neonate Child Adult Neonate Child Adult

Airway Pressure, upper

40 40 40 5 - 100 5 - 110 5 - 110
limit (cm H2O)

Airway Pressure, lower

5 5 5 OFF, 1 - 80 OFF, 1 - 80 OFF, 1 - 80
limit (cm H2O)

PEEP/CPAP upper limit

10 10 10 1 - 50, OFF 1 - 50, OFF 1 - 50, OFF
(cm H2O)

PEEP/CPAP Low limit

OFF OFF OFF OFF,1 – 50 OFF, 1 – 50 OFF, 1 - 50
(cm H2O)

PEEP/CPAP low upper

--- 10 10 --- 2 – 20, OFF 2- 20, OFF
in NIV (cm H2O)

PEEP/CPAP low limit in

--- OFF OFF --- OFF,1 – 20 OFF,1- 20
NIV (cm H2O)

etCO2 low limit % 4.0 4.0 4.0 OFF, 0.1 – 13.2 OFF, 0.1 – 13.2 OFF, 0.1 – 13.2

etCO2 low limit mmHg 30 30 30 OFF, 1 - 99 OFF, 1 - 99 OFF, 1 - 99

etCO2 low limit kPa 4.0 4.0 4.0 OFF, 0.1 – 13.2 OFF, 0.1 – 13.2 OFF, 0.1 – 13.2

etCO2 high limit % 6.5 6.5 6.5 0.1 – 13.3 0.1 – 13.3 0.1 – 13.3

etCO2 high limit mmHg 49 49 49 1 - 100 1 - 100 1 - 100

etCO2 high limit kPa 6.5 6.5 6.5 0.1 – 13.3 0.1 – 13.3 0.1 – 13.3

Expired Minute Volume ,

0.5 0.5 1.0 OFF, 0.1 – 40 OFF, 0.1 – 40 OFF, 0.1 – 40
low limit (liters/minute)

Expired Minute Volume ,

2.0 30 30 1 – 60, OFF 1 – 60, OFF 1 – 60, OFF
high limit (liters/minute)

11-15
 Factory Set Default Setting Range
Alarm Limits
Neonate Child Adult Neonate Child Adult

Inspiratory Tidal Volume,

40 150 700 5 - 400, OFF 5 - 400, OFF 5 - 4000, OFF
high limit (ml/minute)

Inspiratory Time,
Spontaneous, high limit --- 2 5 --- 0.4 – 2 0.4 - 5
in NIV (sec)

Respiratory Frequency,
Spontaneous, Upper 45 OFF OFF 5 - 120, OFF 10 - 120, OFF OFF, 10 - 120
limit (Bpm)

Time, Apnea – until

15 20 20 10 – 60, OFF 10 – 60, OFF OFF, 10 - 60
alarm (sec)

Notes regarding Occlusion detection and Continuing Pressure events:

Occlusion detection and Continuing Pressure events occur in every ventilation mode. In the case that the
Patient Airway Pressure is positive for more than 15 seconds at an unexpected level, the system will treat this
continuing pressure event and behave accordingly.

Occlusion alarm can be tested by below method: block the Inspiratory Channel, the occlusion alarm shall occur
with two breath cycles or 5 s, whichever is greater.

Note regarding Nebulizer usage while on battery power:

The nebulizer function is disabled when the Aeonmed VT5230 Critical Care Ventilator is powered by either the
internal or external battery.

11.15 Delivery Accuracy

Airway Pressure
+/- 10% of settings or +/- 3 cmH2O (whichever is greater)

Tidal Volume
Adult Accuracy: +/- 10% of settings +/- 25 mL (whichever is greater)
Child Accuracy: +/- 10% of settings +/- 10 mL (whichever is greater)

O2 Concentration
+/- 5% full scale for all modes
21% to 90% rising time (at worst case): 3 min 22 s

PEEP
+/- 10% of settings or +/- 2 cmH2O (whichever is greater) for all modes

11-16
 11 Appendix A

Measurement uncertainty
Volume: +/- 2% of reading or +/- 20 mL (whichever is greater)
Pressure: +/- 0.75% of reading or +/- 0.1 cmH2O (whichever is greater)
O2: +/- 1%

11-17
 12 Appendix B

12 Appendix B Pneumatic Diagram- VT5230

Ventilator

12-1
12-2
 12 Appendix B

13 Appendix C EMC Guidelines

Important information regarding Electro Magnetic Compatibility (EMC):

VT5230 VENTILATOR needs special precautions regarding EMC and put into service
according to the EMC information provided in the user manual; VT5230 conforms to this IEC
60601-1-2:2014 standard for both immunity and emissions. Nevertheless, special
precautions need to be observed.

 VT5230 VENTILATOR with Following ESSENTIAL PERFORMANCE is intended used in

Professional healthcare facility environment.

 WARNING: Use of VT5230 VENTILATOR adjacent to or stacked with other equipment

should be avoided because it could result in improper operation.

Below cables information are provided for EMC reference.

Max. cable length, Cable

Cable Number
Shielded/unshielded classification
AC cable 5.0m Unshielded 1 Set AC Power

ESSENTIAL PERFORMANCE:
The parameters are set as follows:
• Ventilation Modes: VCV (Volume controlled ventilation)
• Rates of breath: 20bmp
• TI: 1.0s
• Tp: 0s
• VT: 400mL
• Airway pressure upper limit(×0.1kpa): 90cmH2O
• Airway pressure lower limit(×0.1kpa): 0cmH2O
• Psens: -3kpa
• PEEP: 3kpa
• FiO2: 21%
• Gas supply rated pressure: 0.4MPa

13-1
  WARNING: The Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of the VT5230 VENTILATOR could result in
increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.

 WARNING: Portable RF communications equipment (including peripherals such as

antenna cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the VT5230 VENTILATOR, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.”

EMI Compliance Table

Table 1 - Emission
Phenomenon Compliance Electromagnetic environment
RF emissions CISPR 11 Professional healthcare facility environment
Group 1, Class A
Harmonic distortion IEC 61000-3-2 Professional healthcare facility environment
Class A
Voltage fluctuations IEC 61000-3-3 Professional healthcare facility environment
and flicker Compliance

EMS Compliance Table

Table 2 - Enclosure Port

Phenomenon Basic EMC Immunity test levels
standard Professional healthcare facility environment
Electrostatic IEC 61000-4-2 ±8 kV contact
Discharge ±2kV, ±4kV, ±8kV, ±15kV air
Radiated RF EM field IEC 61000-4-3 3V/m
80MHz-2.7GHz
80% AM at 1kHz
Proximity fields from IEC 61000-4-3 Refer to table 3
RF wireless
communications
equipment
Rated power IEC 61000-4-8 30A/m
frequency magnetic 50Hz or 60Hz
fields

13-2
 13 Appendix C

Table 3 – Proximity fields from RF wireless communications equipment

Test frequency Band Immunity test levels

(MHz) (MHz) Professional healthcare facility environment
385 380-390 Pulse modulation 18Hz, 27V/m
450 430-470 FM, ±5kHz deviation, 1kHz sine, 28V/m
710 704-787 Pulse modulation 217Hz, 9V/m
745
780
810 800-960 Pulse modulation 18Hz, 28V/m
870
930
1720 1700-1990 Pulse modulation 217Hz, 28V/m
1845
1970
2450 2400-2570 Pulse modulation 217Hz, 28V/m
5240 5100-5800 Pulse modulation 217Hz, 9V/m
5500
5785

Table 4 – Input a.c. power Port

Phenomenon Basic EMC Immunity test levels
standard Professional healthcare facility environment
Electrical fast IEC 61000-4-4 ±2 kV
transients/burst 100kHz repetition frequency
Surges IEC 61000-4-5 ±0.5 kV, ±1 kV
Line-to-line
Surges IEC 61000-4-5 ±0.5 kV, ±1 kV, ±2 kV
Line-to-ground
Conducted IEC 61000-4-6 3V, 0.15MHz-80MHz
disturbances induced 6V in ISM bands between 0.15MHz and 80MHz
by RF fields 80%AM at 1kHz
Voltage dips IEC 61000-4-11 0% UT; 0.5 cycle
At 0º, 45º, 90º, 135º, 180º, 225º, 270º and 315º
0% UT; 1 cycle
and
70% UT; 25/30 cycles
Single phase: at 0º
Voltage interruptions IEC 61000-4-11 0% UT; 250/300 cycles

13-3
 Table 5 – Signal input/output parts Port
Phenomenon Basic EMC Immunity test levels
standard Professional healthcare facility environment
Electrostatic IEC 61000-4-2 ±8 kV contact
Discharge ±2kV, ±4kV, ±8kV, ±15kV air
Electrical fast IEC 61000-4-4 ±1 kV
transients / bursts 100 kHz repetition frequency
Conducted IEC 61000-4-6 3V, 0.15MHz-80MHz
disturbances induced 6V in ISM bands between 0.15MHz and 80MHz
by RF fields 80%AM at 1kHz

Essential Perfomance

Requirement Essential Performance

Oxygen level ALARM O2 Concentration Monitoring Range: 15 ~100%
CONDITIONS O2 Concentration Setting Range:21~100%
Allowed Alarm Settings
Low Oxygen Concentration : <Set value - 6 vol % or <= 18 vol %
High Oxygen Concentration : >Set value + 6 vol %

Expired Volume Tidal volume range: 50-2500ml

Expired volume monitoring range: 0～4000 mL
VTe-upper limit Setting alarm parameters: 1 – 60 liters/min, OFF

VTe-lower limit Setting alarm parameters: 0.1– 40 liters/min, OFF

AIRWAY PRESSURE Paw monitoring performance: 0-100cmH2O

Alarm Settings
Airway Pressure, upper limit (cm H2O) ：5 – 100
Airway Pressure, lower limit (cm H2O)：OFF, 1 - 80
PEEP Setting Range:0-50 cmH2O
Alarm Settings
PEEP/CPAP upper limit (cm H2O)：1 - 50, OFF
PEEP/CPAP Low limit (cm H2O)：OFF, 1 – 50
PEEP/CPAP low upper in NIV (cm H2O)：2- 20, OFF
PEEP/CPAP low limit in NIV (cm H2O)：OFF,1- 20
Occlusion Alarm: seting 10s-60s，off， The set apnea interval has
elapsed without the ventilator, patient, or operator triggering a breath.
The ventilator has entered apnea ventilation.

Electrical supply failure AC Failure: During ventilator operation, when an AC power failure
occurs and there is no battery power, the power board shall alarm for 120

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 13 Appendix C

seconds minimum. When powered from batteries, an “AC Failure” alarm

would occur.
INTERNAL ELECTRICAL Low battery alarm may be occur, if you power on the ventilator with it do
POWER SOURCE near not have external power supply for a long time.
depletion
Gas supply failure There is a safety suction port for emergency suction in case of gas
supply failure.
Low Oxygen Supply Pressure Alarm: Oxygen supply is lower than
160kPa (23.2 psi) continuously for 5 sec.
Low Air Supply Pressure Alarm：Air supply is lower than 160kPa
(23.2 psi) continuously for 5 sec.
Gas failure cross flow There are check valve or switch valve to limit reverse gas leakage flow
into the supply system.
Low Oxygen Supply Pressure Alarm: Oxygen supply is lower than
160kPa continuously for 5 sec.

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This manual No.: 130013786

CE mark in this manual apply only to product

with CE mark.

Directive 93/42/EEC
concerning Medical Devices

Beijing Aeonmed Co., Ltd.

Tel: +8610-83681616
Fax: +8610-63718989
E-Mail: service@aeonmed.com
Website: http://www.aeonmed.com

Edition 02.02
January 2019