Attention

Beijing Aeonmed Co., Ltd. (hereinafter referred to as "our company") 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 products only. Only our company 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 our
company 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. Our company is not legally responsible for any mistakes printed
within and/or any damages caused by incorrect installation and operation of equipment. Our
company does not supply privileges endowed by the patent law to any other parties. Our company is
not legally responsible for the results caused by patent law breaking or any rights of the third party
violating.

Any user must read this article before using the products of our company. This article exposes the
operating steps that must be read carefully. Improper use might endanger equipment or persons.
The company will not undertake the responsibility for the safety, reliability and performance if
equipment is used improperly. The company will not offer complimentary service for misused
equipment.

Our company 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 installation 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.

Company name: Beijing Aeonmed Co., Ltd.

Registered address: 11B2, Fengtai Science Park, 100070 Beijing, PEOPLE‘S REPUBLIC
OF CHINA
Production address: 11B2, Fengtai Science Park, 100070 Beijing, PEOPLE‘S REPUBLIC
OF CHINA
No.10, Chaobai St., Yanjiao Development Zone, 065201 Sanhe,
Hebei Province, PEOPLE‘S REPUBLIC OF CHINA
After-sales service unit: Beijing Aeonmed Co., Ltd.
After-sales service address: Aeonmed Mansion, No. 4 Hangfeng Road, Science City, Fengtai
District, Beijing.
Zip code: 100070
Company phone: 010–83681616
Fax 010–63718989
Service hotline: 800-810-8333
Company website: http://www.aeonmed.com
European Representative: Shanghai International Holding Corp. GmbH (Europe)
Address: Eiffestrasse 80, 20537 Hamburg Germany

ii
 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 .................................................................................................................... 1-2
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 VG70 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 Side Panel ........................................................................................ 2-3
2.3 Main Control Unit ......................................................................................................... 2-4
2.3.1 Front Panel ........................................................................................................... 2-4
2.3.2 Rear Panel ........................................................................................................... 2-5
2.4 Cart .............................................................................................................................. 2-6
2.5 Humidifier..................................................................................................................... 2-6
2.6 Cylinder Kit .................................................................................................................. 2-6
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
3.2.2 EMC...................................................................................................................... 3-4
3.3 System Assembly Instruction ...................................................................................... 3-8
3.3.1 Set-up ................................................................................................................... 3-8
3.3.2 Placement of IRMA Probe.................................................................................. 3-10
3.4 Pre-use Check ........................................................................................................... 3-10
3.4.1 Zeroing Procedure.............................................................................................. 3-10
3.5 Alarms ........................................................................................................................ 3-11
3.6 Cleaning..................................................................................................................... 3-11
3.7 Warnings .................................................................................................................... 3-11
3.8 Cautions..................................................................................................................... 3-13

iii
 3.9 Maintenance Information ........................................................................................... 3-13
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 Install Patient circuit ............................................................................................. 4-2
4.3.2 Install Humidifier (optional)................................................................................... 4-3
4.3.3 Install Patient Circuit Positioning Arm (optional) .................................................. 4-3
4.3.4 Install User Interface Screen ................................................................................ 4-4
4.3.5 Install 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 Ventilator Operation ................................................................................................................... 6-1
6.1 Starting Up ................................................................................................................... 6-1
6.2 Interface Layout ........................................................................................................... 6-3
6.2.1 Standby Interface Layout ..................................................................................... 6-3
6.2.2 Ventilator Interface Layout ................................................................................... 6-6
6.3 Operation of Main Manu ............................................................................................ 6-12
6.3.1 Ventilation Mode ................................................................................................. 6-12
6.3.2 Alarm Limits ........................................................................................................ 6-19
6.3.3 Monitoring Data .................................................................................................. 6-23
6.3.4 Lung Mechanics ................................................................................................. 6-23
6.3.5 Log...................................................................................................................... 6-25
6.3.6 System................................................................................................................ 6-28
6.4 Operation of Other Shortcut Keys ............................................................................. 6-45
6.4.1 Inspiratory Hold .................................................................................................. 6-45
6.4.2 Expiratory Hold ................................................................................................... 6-46
6.4.3 Nebulizer ............................................................................................................ 6-46
6.4.4 Manual ................................................................................................................ 6-47
6.4.5 Suction................................................................................................................ 6-48
6.4.6 Print Screen........................................................................................................ 6-49
6.4.7 Freeze ................................................................................................................ 6-49
6.4.8 Screen Lock ....................................................................................................... 6-50
6.4.9 Alarm Limits ........................................................................................................ 6-52
6.5 Ventilation Parameter Set-up .................................................................................... 6-53
6.6 Turn off the Ventilator ................................................................................................ 6-54
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 Clean and Disinfect ..................................................................................................... 8-2
8.2 Regular Maintenance .................................................................................................. 8-3
8.2.1 Maintenance Principles ........................................................................................ 8-3

iv
 8.2.2 Periodic Maintenance Schedule ........................................................................ 8-4
8.2.3 Service Life of Product/Accessories .................................................................... 8-4
8.3 Maintenance in Operation and Transportation ............................................................ 8-5
8.3.1 Transportation ...................................................................................................... 8-5
8.3.2 Storage ................................................................................................................. 8-6
8.4 Consumables Replacement ........................................................................................ 8-6
8.4.1 Fuse Replacement ............................................................................................... 8-6
8.4.2 Battery Maintenance ............................................................................................ 8-7
8.4.3 Oxygen Sensor..................................................................................................... 8-9
8.4.4 Diaphragm Replacement ................................................................................... 8-11
8.4.5 One-way Diaphragm Replacement .................................................................... 8-12
8.4.6 Oxygen Inlet Filter Replacement........................................................................ 8-13
8.4.7 Fan Filter Cotton Replacement .......................................................................... 8-14
8.4.8 Filter Element of Gas Inlet Replacement ........................................................... 8-15
8.4.9 Filter Replacement(Part No.:130003930) .......................................................... 8-16
8.5 Disposal ..................................................................................................................... 8-16
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 .............................................. 10-4
10.1.3 Back-up Ventilation (Apnea Ventilation) ............................................................ 10-5
10.1.4 Spontaneous/CPAP Ventilation ......................................................................... 10-6
10.1.5 BiLevel Ventilation (BIVENT) ............................................................................. 10-7
10.1.6 Non Invasive/Continuous Positive Airway Pressure .......................................... 10-8
10.1.7 NIV-T ................................................................................................................ 10-10
10.1.8 NIV-S/T ............................................................................................................. 10-10
11 VG70 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 ......................................................................................................... 11-4
11.2.3 Patient System Connectors................................................................................ 11-4
11.2.4 User Interface ..................................................................................................... 11-4
11.2.5 Acoustic Energy ................................................................................................. 11-4
11.3 Standard Conditions Specifications .......................................................................... 11-4
11.4 Inspiratory Channel ................................................................................................... 11-5
11.5 Expiratory Channel .................................................................................................... 11-5
11.6 Monitoring .................................................................................................................. 11-6
11.7 Alarms ........................................................................................................................ 11-7

v
 11.7.1 Allowed Alarm Settings ...................................................................................... 11-7
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
11.13 Accessories ............................................................................................................. 11-12
11.14 Ventilating Parameters: Default Values and Allowed Settings (Standard Configuration)
11-13
11.15 Delivery Accuracy .................................................................................................... 11-16
12 Pneumatic Diagram .......................................................................................................... 12-1
13 EMC .................................................................................................................................. 13-1

vi
 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

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

 Only individuals authorized by our company may perform installation, 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.

Our company 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.

The company will provide functional block diagram at the user's request for charge, accompanied by
explanation on calibration method and other information, so as to help users let appropriate technical
staff repair the equipment part that is allowed to be maintained by user as stipulated.

1-1
1.3 Definitions

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

Indicates a condition that can endanger the patient or the ventilator

WARNING: operator.

CAUTION: Indicates a condition that can damage the equipment.

Indicates points of particular emphasis that make operation of the ventilator

NOTE: more 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 Ventilator System is intended for use by authorized and trained medical
personnel only.

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

WARNING: To ensure proper servicing and avoid the possibility of physical injury, only qualified
personnel should attempt to service or make authorized modifications to the ventilator.

WARNING: An authorized service engineer must first install the ventilator and run our
company‘s installation procedure, which includes calibration of various system components, before
you connect a patient to the ventilator.

WARNING: If a fault is detected in the 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.

1-2
 1 Introduction

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
6.

WARNING: The ventilator is not intended to be a comprehensive monitoring device and does
not activate alarms for all types of dangerous conditions for patients on life-support equipment.

WARNING: Patients on life-support equipment must be appropriately monitored by competent

medical personnel and suitable monitoring devices at all times.

WARNING: An alternative source of ventilation, such as manual respiratory equipment, should

always be available when using the ventilator.

WARNING: Do not connect inspiratory or expiratory circuits to the exhaust port.

WARNING: Ensure that inspiratory and expiratory circuits are connected to the correct port
before operation of equipment.

WARNING: The expiratory gas pathway may become contaminated with body fluids or expired
gases during normal use, and the inspiratory gas pathway may become contaminated during fault
condition, such as occlusion, breath hoses disconnection.

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.

1-3
 WARNING: Expiratory module is heated; use caution to avoid burns.

WARNING: Use caution when handling flammable or fragile components.

WARNING: Do not place containers of liquids (such as humidifier water reservoirs) on top of or
above ventilator. Liquids getting into the ventilator can cause equipment malfunction with the risk of
patient injury.

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

1.4.2 Cautions

CAUTION: The breathing circuit must not be installed whenever the 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. Our
company recognizes that cleaning, sterilization, sanitation, and disinfection practices vary widely
among health care institutions. It is not possible for our company 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 the ventilator and oxygen hoses.

CAUTION: In case of fire or a burning odor, immediately disconnect the ventilator from the
oxygen supply, facility power and backup power source.

CAUTION: During operation, do not block: Speaker Holes, Exhaust Port, Air Inlet or Cooling
Fan.

CAUTION: Do not use the Ventilator in a MRI environment.

CAUTION: The ventilator shall not be used in a hyperbaric chamber.

CAUTION: The ventilator shall not be used with helium or mixtures with helium.

CAUTION: Tip over hazard; use care when moving ventilator mounted to cart as device could tip
over leading to injury or damage of equipment.

CAUTION: Do not use sharp objects to make selections on the LCD touch screen or panel.

CAUTION: Do not connect a VGA or USB interface while the system is in service

CAUTION: The Network interface connection is for authorized service only.

CAUTION: Batteries should be removed if equipment will not be in service for more than 6
months. See Section 8.5 for battery replacement guidance.

CAUTION: Do not immerse the oxygen sensor or the connector in any type of liquid.

1-5
 CAUTION: When ventilator is exposed to conditions outside the specified operating environment,
allow 24 hours in normal environment before using.

CAUTION: Storage environment: -20℃~+60℃ and 5%RH~95%RH.

CAUTION: Operating environment: 5℃~40℃ and 5%RH~95%RH.

CAUTION: Do not connect items that are not specified as part of the system.

CAUTION: The auxiliary outlet is only for the recommended humidifier; do not connect to any
other equipment or an additional multiple socket outlets.

CAUTION: When using a humidifier, user should frequently check the water trap and look for
water in the hose. If water is found in the hose, this water should be removed. 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 our company.

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 3.1.3
for proper use of Mainstream CO2 Adapter.

NOTE: All parts of the ventilator system are suitable for use within the patient environment.

1-6
 1 Introduction

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.

1.5 Intended Use

The VG70 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 VG70 Critical Care Ventilator is an electronically controlled, electronically powered machine,
which is used in ICU for the critical care, in Respiratory Department or Emergency Department for
the rescue and therapy of the patient with respiratory insufficiency, and in other departments for
providing respiratory support for the patient.

The Critical Care Ventilator should only be used by:

• Professional health care providers;

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

The Critical Care Ventilator is applicable for the patient weighing at least 3 kg (7 lbs.), who require
the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (by ET
or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes
of ventilation.

The 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 is supplied.

1.7 Contraindication

WARNING: The 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 Ventilator is not designed for use in an MRI environment. Do not use the
Ventilator 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. A ―hospital grade‖ cord must be used and connected to a ―hospital
grade‖ electrical outlet.

1-7
 NOTE: See Section 1.4 (Warnings, Cautions and Notes) for all enviromental warnings.

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)

MV Expiratory minute volume (M)

MVspont 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)

1-8
 1 Introduction

Phigh Upper pressure level in BIVENT and APRV (S)

Plow Lower pressure level in BIVENT and APRV (S)

Timax 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)

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)

Elastic Elastic resistance (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
1-9
(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

1.10 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) Protection Class Type BF

Follow operating instructions Warning & Caution

Protective earth ground Dangerous voltage

EQUIPOTENTIAL connection loudspeaker

Lock Manufacturer and Address

Unlock Date of production

Inspiratory hold Serial Number

Nebulization Expiratory hold

1-10
 1 Introduction

Intelligent increase of oxygen Manual inspiration

Standby Waveform freeze

AC power int. Internal Battery

USB device Refer to documentation

Prompt message Already online

Flow trigger Pressure trigger

Adult Manual trigger

NIV modes Child

Main Menu Invasive modes

Do not reuse Alarm Silence Key

Neonate Disposal of Waste

1.11 VG70 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. Pre-use Test initializes

5. Select New Patient

6. Prepare Patient Circuit

7. Connect CO2 Module (optional)

1-12
 1 Introduction

8. Connect IRMA Airway Adapter (optional)

9. Set Appropriate Ventilation Settings

1-13
 2 System Overview

2 System Overview

2.1 Ventilator Components

The Critical Care Ventilator System consists of two required Components: a Main Control Unit and a
Graphical User Interface (GUI). Optional Components available for the Critical Care Ventilator
system are: Cart, Battery Backup Assembly, Patient Circuit Positioning Arm, Patient Circuit
Assemblies and CO2 module, etc.

Figure 2-1 VG70 profile

1 Main Control Unit 2 Humidifier 3 Patient Circuit

4 Water Trap 5 Nebulizer Tube 6 Y-piece

7 Test Lung 8 Mask 9 Connector

Patient Circuit
10 Nebulizer Connector 11
Positioning Arm

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.

2-1
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

Figure 2-2 GUI screen front panel

1. Alarm Lamp

2. Touch Screen

3. Encoder Knob

4. Alarm Silence Hard Key

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 System Overview

2.2.2 GUI Screen Side Panel

Figure 2-3 GUI screen side 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.

CAUTION: Do not connect VGA interface when the system is in use on a patient.

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 system is in service.

4. Network Interface: For connection to external equipment such as electronic health record. Refer
to section 11.12, Communication/interface for additional information..

CAUTION: Do not connect Network Interface; only the qualified personnel can use it.

2-3
2.3 Main Control Unit

The main control unit is responsible for control of the ventilator. It has interfaces on the front and rear
panels including pneumatic and electronic interfaces.

2.3.1 Front Panel

Figure 2-4 Front panel

1. Expiratory module: To remove the Expiratory module: Press the latch (5) 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.

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

CAUTION: Do not block this port.

2-4
 2 System Overview

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

3. Expiratory port

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

4. Water trap cup: Collect condensed water to prevent it from going into expiratory valve.

5. 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.

6. Nebulizer output port: For nebulizer device connection.

7. Oxygen sensor cover

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

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

2.3.2 Rear Panel

Figure 2-5 Rear panel

2-5
 1 Battery Cover 2 CO2 Module Connector 3 Nurse Call Connector

4 Air Inlet 5 Low-flow Oxygen Inlet 6 Hyperbaric Oxygen Inlet

Vehicle-mounted Power Vehicle-mounted Power

7 Cooling Fan 8 9
Fuse Input Port

10 Equipotential Terminal 11 Power Supply Socket 12 Power Supply Switch

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.

WARNING: Never block the ports of the exhaust cooling fan and the air inlet! Clean the filter
regularly! Ventilator should not be covered or positioned in such a way that 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.

CAUTION: CO2 Module Connector is only for the specified CO2 Module, and cannot be
connected with other serial ports.

2.4 Cart

An optional cart may be used to mount the Ventilator. It applies to placing and moving the Ventilator.

The cart includes an auxiliary AC panel.

2.5 Humidifier

An optional Humidifier, like the Fisher & Paykel MR850, or similar product, should be used with the
Ventilator. Our company may supply humidifiers in your area – talk with our company‘s Sales
Representative if you need more information.

2.6 Cylinder Kit

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

2-6
 3 CO2 Module

3 CO2 Module

3.1 CO2 Module Intended Use

The mainstream CO2 module is intended to be connected to the 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 operating room,
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‖)

Cable Length 2.50 m ±0.02 m

Weight < 25 g (cable excluded)

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

Storage and transportation temperature -40 to75°C, -40 to 167°F

Operating humidity 10 to 95% RH, non-condensing

Storage and Transportation humidity 5 to 100% RH, condensing1)

525 to 1200 hPa (525 hPa corresponding to an altitude

Operating atmospheric pressure
of 4572 m / 15000 feet)

Storage and transportation pressure 500 to 1200 hPa

Withstands repeated 1.8 m drops on a hard surface.

Mechanical strength
Complies with requirements for road ambulances

3-1
 according to EN1789:2007 (clause 6.4) and
requirements for shock and vibration according to EN
ISO 80601-2-55 (clause 201.15.3.5.101).

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 cmH2O @ 30 LPM.
Airway adapters
Disposable infant:
Adds less than 1 ml dead space;
Pressure drop less than 1.3 cmH2O @ 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

Probe 2-9 channel NDIR type gas analyzer measuring at 4 to 10 µm.

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 < 3 second

Accuracy specifications – during standard conditions

Range 1)

Gas CO2 (%) Accuracy

CO2 0 – 15 ±(0.2 vol% + 2% of reading)

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

N2O 3) 60 vol% – 1)

HAL 3) 4 vol% – 1)

ENF, ISO, SEV 3) 5 vol% +8% of reading 2)

DES 3) 15 vol% +12% of readin2)

Xe (Xenon) 3) 80 vol% -10% of reading 2)

He (Helium) 3) 50 vol% -6% of reading 2)

Metered dose inhaler propellants 3) Not for use with metered dose inhaler propellants

C2H5OH (Ethanol) 3) 0.3 vol% – 1)

C3H7OH (Isopropanol) 3) 0.5 vol% – 1)

CH3COCH3 (Acetone) 3) 1 vol% – 1)

CH4 (Methane) 3) 3 vol% – 1)

CO (Carbon monoxide) 4) 1 vol% – 1)

NO (Nitrogen monoxide)4) 0.02 vol% – 1)

O2 4) 100 vol% – 1)

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. The ventilator is not intended for use with nitrous oxide gas,
and there is no compensation performed. Therefore, if nitrous oxide gas is used with the ventilator,
the etCO2 accuracy will be affected.

3.2.2 EMC

Guidance and PHASEIN’s declaration – electromagnetic emissions – for IRMA probe

The IRMA probe is intended for use in the electromagnetic environment specified below. The
customer or the user of the IRMA probe should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic Environment – Guidance

The IRMA probe uses RF energy only for its

internal function. Therefore, its RF emissions
RF emissions CISPR 11 Group 1
are very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions CISPR 11 Class B

The IRMA probe is suitable for use in all
Harmonic emissions IEC establishments including domestic and those
Not applicable
61000-3-2 directly connected to the public low-voltage
power supply network that supplies buildings
Voltage fluctuations/ flicker used for domestic purposes.
Not applicable
emissions IEC 61000-3-3

3-4
 3 CO2 Module

Guidance and PHASEIN’s declaration – electromagnetic immunity – for IRMA probe

The IRMA probe is intended for use in the electromagnetic environment specified below. The
customer or the user of the IRMA probe should assure that it is used in such an environment.

Electromagnetic
Immunity test IEC 60601 test level Compliance level
environment – guidance

Floors should be wood,

concrete or ceramic tile. If
Electrostatic discharge ±6 kV contact ±6 kV contact floors are covered with
(ESD) IEC 61000-4-2 ±8 kV air ±8 kV air synthetic material, the relative
humidity should be at least
30 %.

±2 kV for power
Electrical fast Mains power quality should be
supply lines
transient/burst IEC Not applicable that of a typical commercial or
±1 kV for
61000-4-4 hospital environment.
input/output lines

±1 kV line(s) to Mains power quality should be

Surge IEC 61000-4-5 line(s) Not applicable that of a typical commercial or
±2 kV line(s) to earth hospital environment.

Mains power quality should be

<5 % UT (>95 % dip that of a typical commercial or
in UT) for 0.5 cycle hospital environment. If the
Voltage dips, short user of the IRMA probe
40 % UT (60 % dip in
interruptions and requires continued operation
UT) for 5 cycles
voltage variations on Not applicable during power mains
70 % UT (30 % dip in
power supply input interruptions, it is
UT) for 25 cycles
lines IEC 61000-4-11 recommended that the IRMA
<5 % UT (>95 % dip probe is powered from an
in UT) for 5 sec uninterruptible power supply or
a battery.

Power frequency Power frequency magnetic

(50/60 Hz) fields should be at levels
3 A/m 3 A/m characteristic of a typical
magnetic field
location in a typical commercial
IEC 61000-4-8 or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

3-5
Guidance and PHASEIN’s declaration – electromagnetic immunity – for IRMA probe

The IRMA probe is intended for use in the electromagnetic environment specified below. The
customer or the user of the IRMA probe should assure that it is used in such an environment.

IEC 60601 test Electromagnetic environment –

Immunity test Compliance level
level guidance

Portable and mobile RF

communications equipment should be
used no closer to any part of the IRMA
probe, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2.5 GHz

Conducted RF 3 Vrms where P is the maximum output power

rating of the transmitter in watts (W)
IEC 61000-4-6 150 kHz to 80 MHz 10 Vrms
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).

Radiated RF 3 V/m 20 V/m Field strengths from fixed RF

transmitters, as determined by an
IEC 61000-4-3 80 MHz to 2.5 GHz
electromagnetic site survey, a should
be less than the compliance level in
each frequency range b Interference
may occur in the vicinity of equipment
marked with the following symbol:

3-6
 3 CO2 Module

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the IRMA probe is used exceeds the applicable RF compliance level
above, the IRMA probe should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the IRMA probe.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

Recommended separation distances between portable and mobile RF communications

equipment and the IRMA probe

The IRMA probe is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the IRMA probe can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the IRMA probe as recommended below, according to
the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter [m]

Rated maximum
output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter [W]

0.01 0.035 0.018 0.035

0.1 0.11 0.057 0.11

1 1.00 0.18 1.00

10 1.1 0.57 1.1

100 3.5 1.8 3.5

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.

3-7
 NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

WARNING: Measurements can be affected by mobile and RF communications equipment. It

should be assured that the IRMA probe is used in the electromagnetic environment specified in this
manual.

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.

3-8
 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.

3-9
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 gas 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.

3.4.1 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 using the host instrument to transmit a
Zero reference command to the IRMA probe.

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
3-10
 3 CO2 Module

crucial importance for a successful Zeroing. If an ―ZERO_REQ‖ 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 8, 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.

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

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

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

3-11
 WARNING: Disposable IRMA airway adapters shall not be reused. Reuse of the single use
adapter can cause cross infection.

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

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

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

WARNING: Measurements can be affected by mobile and RF communications equipment.

Assure that the IRMA probe is used in the electromagnetic environment specified in this manual.

WARNING: 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.

WARNING: 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.

3-12
 3 CO2 Module

WARNING: 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.

WARNING: 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.

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

WARNING: Replace the adapter if rainout/condensation occurs inside the airway adapter

WARNING: Use only PHASEIN manufactured IRMA airway adapters.

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

3.8 Cautions

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

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

CAUTION: Do not apply tension to the probe cable.

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

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.

3-13
 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.

3-14
 4 Setup

4 Setup

This section describes the installation 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 the expiratory port heater, the cooling fan and the nebulizer are the same as under
AC operation. The expiratory port heater, the cooling fan and the nebulizer are 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
Ventilator may lose power.

Figure 4-1 Install 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 3.5 hours. The power supply indicator is lit yellow
during periods of charging, and the light goes out when the battery is fully charged.

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

4.2 Connect Gas Source

Hyperbaric Oxygen Inlet of the ventilator can be connected to multiple gas sources: bottled oxygen
and central supply O2. The gas source pressure must be between 280 ~ 600 kPa (41 ~ 87 psi). Low
pneumatic pressure will impair some functions of the ventilator.
4-1
For Low-flow Oxygen Inlet of the ventilator, the gas source pressure must be less than 600kPa, and
the flow is less than 15L/min.

There are diameter limits on the two inlets to prevent miss-connection.

Oxygen connected to the high pressure input ports of the ventilator will be used as Fresh Gas and
will be supplied to the patient.

4.3 Connect Accessories

4.3.1 Install Patient circuit

Figure 4-2

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 breathing system, the breathing
resistance may increase, or the monitoring pressure of the patient connect port is higher than the
actual pressure.

4-2
 4 Setup

4.3.2 Install Humidifier (optional)

Figure 4-3

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

4.3.3 Install Patient Circuit Positioning Arm (optional)

Figure 4-4

Install positioning arm (1) onto mounting block (2).

4-3
4.3.4 Install User Interface Screen

Figure 4-5

Connect User Interface (1) to the location (2).

4.3.5 Install Cylinder Kit (optional)

Figure 4-6

Install O2 cylinder (2) into the right side of holder (1). Secure cylinder using strap (3). Repeat for the
other O2 cylinder 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 VG70 Gas Inlet Connections and at
the proper Pressure per VG70 Specifications.

4-4
 5 Pre-use Test

5 Pre-use Test

5.1 When to carry out pre-use test

 Before use of the 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.

Before you use the system you should:

• Finish all the tests in this section

• Test all components of other associated systems

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 the 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

The machine will enter the Pre-use test following display of the power-on page.

Items included in the power-on self-test:

Test Items Remarks

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

5-1
Test Items Remarks

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

Gas supply test Test will proceed when hyperbaric oxygen is functional.

Oxygen sensor test This test requires that oxygen supply is available. If oxygen source is not
available then a message ―oxygen source is inadequate‖ and the test cannot
be carried out.

Leakage test Internal leakage test.

Flow sensor test Flow sensors function and accuracy test.

Pressure sensor test Pressure sensors function and accuracy test.

Safety valve test Safety valve function and accuracy test.

Circuit compliance Circuit compliance value measurement.

test

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

Explanation of legends on the very bottom of the Self Test screen (refer to Figure 6-3): “√ (green)‖
refers to OK, ―× (red) ―failure,‖ ○ (yellow) ―skipped‖. The time of the last test is displayed on the
upper part of screen.

When all tests are completed, test results page will display test results, as well as test data and the
time of the test on the upper part of screen. A key ―Confirm‖ will be shown on the very bottom of page.
Press ―Confirm‖, then the system will enter standby mode; otherwise the Test Results page will
remain on the screen.

Below is a method for testing the function of the alarm system for conditions specified by
IEC60601-2-12. 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. Set the Power switch to ON.

2. Connect a breathing circuit and test lung to the ventilator.
3. Press Start Ventilation and ventilate with default settings except set O2 to 21%.
4. After 5 breaths, observe the MVe reading on the display.
5. Set the MVe low alarm limit to a value greater than the observed MVe reading.
6. Verify that a low level MVe low alarm is present on the 3rd breath.
7. Return the MVe low alarm limit to original setting.
8. After 5 breaths, observe the Ppeak reading on the display.
9. Set the PAW upper alarm limit to a value lower than the observed Ppeak reading.

5-2
 5 Pre-use Test

10. Verify that a low level High Airway Pressure alarm is present after 1 breath and that a high level
High Airway Pressure alarm is present at the start of the 4th breath.
11. Return the PAW upper alarm limit to original setting.
12. Set the Power switch to OFF.

5-3
 6 Ventilator Operation

6 Ventilator Operation

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.

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.

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.

6-1
 Figure 6-2 Switching on

Step 3: Pre-use test

The pre-use test is available on power up, but the user must select ―OK‖ to perform the tests -
otherwise the tests will be skipped. After pressing OK, the system will enter pre-use test screen,
which includes: voltages tests, data tests, communications tests, AD and DA converter tests, and
valve control tests. The last test time is shown in the top right corner of the screen. All the items
except ―Technical test‖ become (“√ (green)‖—pass, ―× (red)‖ —failure, or “○ (yellow)‖ —skip).
Press ―SKIP‖ to stop the 5s countdown and to enter the Standby Screen more quickly.

Figure 6-3 Pre-use Screen

6-2
 6 Ventilator Operation

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 blue 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.

6.2.1 Standby Interface Layout

In the standby interface (see Figure 6-4), the user can set the information of the new patient, see the
information of the previous patient, and do the pre-use test.

Figure 6-4

6-3
6.2.1.1 New Patient

a) Patient Settings

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

Step 2: Ventilation type (Invasive or NIV, default is Invasive), Ideal Body Weight (default is 150cm)
and Ventilation mode. See example in Figure 6-5.

NOTE: In the Ventilation Mode area, there is an ―enter‖ key. Pressing the ―Enter‖ key will enter
the Mode of main menu.

Figure 6-5

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 6-6.

6-4
 6 Ventilator Operation

Figure 6-6

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 6-7.

Figure 6-7

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 Test, Leak Test, Flow Sensor Test, Pressure Sensor Test, Safety Valve Test, Patient Circuit
Test, and etCO2 Sensor Test. as shown in Figure 6-8.

6-5
 Figure 6-8

6.2.2 Ventilator Interface Layout

The ventilator 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 6-9.

Figure 6-9

Figure 6-10 shows the actual operational screen layout of the ventilator.

6-6
 6 Ventilator Operation

Figure 6-10

6.2.2.1 Information 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 6-11

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.

6-7
Network and USB connection indicator area: Displays the Network and USB connection status.

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.

6.2.2.2 User 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 6-12

6.2.2.3 Patient Waveform Area

At center of the screen, the Patient Waveforms area is the main display area. In the default state, this
area will display three waveforms: Pressure waveform, Flow waveform and Volume waveform. See
the example in Figure 6-13.

6-8
 6 Ventilator Operation

Figure 6-13

6.2.2.4 Patient Measured Parameters Area

This area displays parts of the monitored patient parameters which are very important. When in
Standby mode, the monitoring values of all parameters will be displayed as ―---‖. The background
color for Parameters with alarm limits will change between black and red when a high-level alarm
occurs. The flash rate will be at 2 Hz ± 10 % and it will 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 6-14.

6-9
 Figure 6-14

6.2.2.5 Ventilation 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 6-15. If the ventilation parameter setup items for the selected Ventilation mode do
not fit in this space, the ―More Settings‖ key will allow the user to access and change the other setup
items.

6-10
 6 Ventilator Operation

Figure 6-15

6.2.2.6 Shortcut Keys Part

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

6-11
 Figure 6-16

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, Log, System. Specific operation is as follows.

6.3.1 Ventilation Mode

6.3.1.1 Ventilation 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 6-17.

6-12
 6 Ventilator Operation

Figure 6-17

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

Click [VCV] to enter the [VCV] mode setup page. The [VCV] key will become yellow as shown in
Figure 7-18. The user can then set every parameter of VCV mode.

Figure 6-18

Step 3: Click [Accept], now VCV mode is set as the ventilation mode. See Figure 6-19.

6-13
 Figure 6-19

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, and the last setup
changes made will have no effect.

6.3.1.2 Mode 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 6-20. Remember that mode changes are only in effect after Accept is pressed, as shown in
Figure 6-21.

Figure 6-20

6-14
 6 Ventilator Operation

Figure 6-21

The spontaneous ventilation modes include: SPONT+PSV, SIMV (VCV) + PSV, SIMV (PCV) + PSV,
SIMV (PRVC) + PSV, and BIVENT + PSV. The backup ventilation mode will be PCV.

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

When setting the above ventilation modes, the operator should set the backup ventilation mode. The
default values and the range of the parameters are shown in the Table 6-1.

Table 6-1

Factory default
Setup range
Parameter setup Adjustment step
Adult Child Adult Child

VCV, PCV, VCV, PCV,

PRVC, SIMV PRVC, SIMV
(VCV, PCV, (VCV, PCV,
Mode PCV PCV PRVC) , BIVENT, PRVC) , BIVENT, -
SPONT CPAP, SPONT CPAP,
NIV/CPAP, NIV-T, NIV/CPAP, NIV-T,
NIV-S/T NIV-S/T

5mL for under

100mL(incl.),
VT(mL) 400 80 50-2000 20-300 10mL for over
100mL, 50mL over
1000mL

f(bpm) 15 30 1-80 1-80 1

6-15
 Factory default
Setup range
Parameter setup Adjustment step
Adult Child Adult Child

f(SIMV)(bpm) 4 20 1-40 1-40 1

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

PEEP/Plow(cmH2O) 5 5 0-35 0-35 1

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

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

Pinsp(cmH2O) in
20 10 5-(70-PEEP) 5-(70-PEEP) 1
invasive modes

Pinsp(cmH2O) in
20 10 5-(50-PEEP) 5-(50-PEEP) 1
NIV-T

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

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

Trigger mode , Psens , Psens --

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

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

TInsp(s) 1 0.6 0.2-9 0.2-5 0.1

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

Psupp (cmH2O) in
0 0 0-(70-PEEP) 0-(70-PEEP) 1
invasive modes

Psupp (cmH2O) in
0 0 0-(50-PEEP) 0-(50-PEEP) 1
NIV-S/T

Phigh(cmH2O) 15 15 5-60 5-60 1

Plow(cmH2O) 5 5 0-35 0-35 1

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

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

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

1.99 + (1.99 + 0.4 sec to 0.4 sec to

High Spont Insp
(0.02x (0.02x (1.99 + (0.02 x (1.99 + (0.02 x 0.1
Time
IBW)) IBW)) IBW)) sec IBW)) sec
6-16
 6 Ventilator Operation

Factory default
Setup range
Parameter setup Adjustment step
Adult Child Adult Child

sec) or 5 sec) or 5
sec if no sec if no
IBW IBW

IBW(cm) 150 100 60-260 30-140 2

TC OFF OFF ON, OFF ON, OFF --

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

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

All modes in the mode menu include trigger type selection: pressure or flow. User can also set the
value for Psens or Vsens after choosing the trigger type. See Figure 6-22.

Figure 6-22

Tube compensation (TC) will be available only in pressure modes (PCV, SIMV (PCV), SPONT CPAP
and BIVENT). Select tube compensation ―On‖ and the ―On‖ key will become yellow as an
acknowledgement, as shown in Figure 6-23.

6-17
 Figure 6-23

Select the tube type in this interface: ET (Endotracheal Tube) or TT (Tracheotomy Tube), and the
selected one will become yellow as shown in Figure 7-23.

Tube inside diameter (mm) and Tube compensation amount (%) may be modified after being clicked.
Click ―Accept‖ to store the new value.

When tube compensation is enabled, a message will be presented on the bottom of screen: TC ON,
as shown in Figure 6-24. Also a tube icon will display in the information area, see Figure 6-25.

Figure 6 -24

Figure 6-25

Tube inside diameter ranges are: 5 to 12mm for adult, 2 to 5-8mm for child; increment: 0.5mm for
both adult and child.

6-18
 6 Ventilator Operation

Since the flow trigger is the default trigger mode, ―pressure‖ is displayed on the trigger type menu.
SIMV‘s input interface is different from that of the other modes. The SIMV setup interface is shown in
Figure 6-26, and the other modes in Figure 6-27.

Figure 6-26

Figure 6-27

After the ―pressure‖ trigger mode is selected, the Psens key can be adjusted and the Vsens key will
become gray.

6.3.2 Alarm Limits

Click ―Alarm Limits‖ in the ―main menu‖ to enter the ―Alarm Limits‖ menu interface, as shown in
Figure 6-28.

6-19
 Figure 6-28

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: L)

Vte: low limit of tidal volume for Expiratory (unit: mL)

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

Tapnea: apnea duration (unit: second)

fspont: high limits of rate of spontaneous breaths (unit: breath per minute)

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

The limit setup ranges are shown in the following table:

High limit of flow volume per minute 1 to 60L, OFF, 0.1step, default 30Lo

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

5 to 400mL for child, 5 to 4000mL for adult. Step: 5mL

Low limit of tidal volume for<100mL (incl.), 10mL for >100mL. Default: 250mL for
adult and 50mL for child.

Not less than PEEP+5 or PEEP+PCV (PSV)(Phigh)+5; 5 to

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

Low limit of airway pressure OFF, 1 to 60 cmH2O, step 1 cmH2O, default 5 cmH2O.

high limit of PEEP in Invasive

1 to 35 cmH2O, OFF, step 1 cmH2O, default 10 cmH2O.
Ventilation

Low limit of PEEP in Invasive

OFF, 1 to 35 cmH2O, step 1 cmH2O, default OFF.
Ventilation
6-20
 6 Ventilator Operation

high limit of PEEP in NIV 1 to 20 cmH2O, OFF, step 1 cmH2O, default OFF.

Low limit of PEEP in NIV OFF, 1 to 20 cmH2O, step 1 cmH2O, default OFF.

High limit of apnea duration 10 to 60s, OFF, step 1s, default 20s.

High limit of spontaneous breath rate 10 to 80BPM, OFF. Default: OFF.

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

High limit of etCO2
default 6.5% (49mmHg or 6.5kPa).

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

Low limit of etCO2
0.1kPa～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.

WARNING: A potential hazard can exist if different ALARM PRESETS are used for the same or
similar equipment in any single area, e.g. an intensive care unit or cardiac operating theatre.

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 6-29.

6-21
 Figure 6-29

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 6-30.

Figure 6-30

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.

6-22
 6 Ventilator Operation

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 6-31. All parameters will be also shown in the
main interface.

Figure 6-31

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 and PEEPi. The results of last
test for the six parameters are listed on the right, as shown in Figure 6-32.

6-23
 Figure 6-32

Step 1:

Click ―Rinsp‖ to enter the 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 6-33. If the measurement is not started, the results are ―--‖.

Figure 6-33

6-24
 6 Ventilator Operation

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 and PEEPi are similar to ―Rinsp‖.

6.3.5 Log

Click ―Log‖ on ―main menu‖ to enter log menu. There are two keys on the left of the page:
Event/Alarm and trend, as shown in Figure 6-34.

Figure 6-34

Step 1:

Click ―Event/Alarm‖ on log menu to enter the submenu, as shown in Figure 6-35.

Figure 6-35
6-25
The middle area of this page is the message area. It can store up to 1000 messages, including event
messages and alarm messages. All messages will be listed in time sequence. The top is the latest
event or alarm message, and the bottom is the oldest. Use the scroll bar to check all the messages.
An asterisk (*) in front of an alarm message indicates that alarm message was not displayed in the
alarm message area. As shown in Figure 6-36. The event/alarm log records all alarms and most
actions.

Figure 6-36

Below is the message area of the Settings area resulting from highlighting an alarm. All settings will
be given here, as shown in Figure 6-37.

Figure 6-37

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

Step 2:

Click ―Trend‖ to enter trend interface. There are two trend types: graphical trend and tabular trend,
See Figure 6-38 & Figure 6-39.The default is graphical trend. Choose the tabular trend to get more
information.

In ―Graphical Trend‖, the first page displayed is trend map of pressure-related parameters, including
Ppeak, Pplat, PEEP, with timeline within 72h. See Figure 6-38.

6-26
 6 Ventilator Operation

Figure 6-38

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.

Figure 6-39

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.

6-27
6.3.6 System

Click ―System‖ key to enter the System interface, as shown in Figure 6-40.

Figure 6-40

There are four keys on the left of the page: Settings, configurations, machine information and
service.

6.3.6.1 Settings

Click ―settings‖ to enter the settings interface, as shown in Figure 6-41.

Figure 6-41

6-28
 6 Ventilator Operation

You can set the Gas standard, time and date, unit setting, 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 yellow. The default is BTPS and it is chosen with a dot.

(2) Compliance compensation: ON or OFF.

(3) Dead space compensation: ON or OFF.

(4) 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.

Weight unit: Two options: kg and lb. When a unit is selected, all body weight units are converted to
this unit. Default: kg

CO2 unit: Three options: mmHg, kPa and %. When a unit is selected, all CO2 units are converted to
this unit. Default: mmHg.

6.3.6.2Configurations

Click ―Configurations‖ key to enter the configuration interface, as shown in Figure 6-42.

There are three choices in this page: Graphic Trend, Screen Brightness and Site configuration.

Figure 6-42

6-29
6.3.6.2.1 Graphic Trend

Click ―Graphic Trend‖ to the ―Graphic Trend‖ interface, as shown in Figure 6-43.

Figure 6-43

On this page, the Patient Measured Parameters can be set. All graphic trends recorded are chosen
from this screen. Trend 1-4 are the maps on the first page, and trend 5-8 are the maps on the second
page. Below the 8 parameter, there is a monitoring parameter list, including 18 parameters. The
Trend 1-8 can be changed according to the need from the parameter list. When a new parameter is
chosen, the parameter on the main screen will be replaced at the same time.

6.3.6.2.2 Screen Brightness

Click ―Screen Brightness‖ to enter this page, and click the screen to choose day or night. As shown in
Figure 6-44. Day is the default.

6-30
 6 Ventilator Operation

Figure 6-44

6.3.6.2.3 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 6-45.

Figure 6-45

Step 2

After entering the password correctly, configure the sub menu: As shown in Figure 6-46.

1) Ventilation;
2) Alarms;
3) TC;

6-31
4) Monitoring;
5) Network;
6) Load/Save.

Figure 6-46

(1) Ventilation

a. Settings

Click ―Ventilation‖ key, the background color will change to yellow and the default page ―settings‖ will
be displayed, as shown in Figure 7-46. 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, NIV-T and NIV-S/T. The
factory default is PCV for Invasive mode and NIV PS/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 150cm and for child is 100cm.

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.

6-32
 6 Ventilator Operation

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) Tslope, 6)
PEEP, and 7) Psupp 8) O2. As shown in Figure 6-47.

Figure 6-47

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 10 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 two pages and six
configurable alarms on this screen: 1) Paw, 2) etCO2, 3) f spont, 4) PEEP, 5) Tapnea, 6) MVe. See
Figure 6-48.

6-33
 Figure 6-48

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)
Vte. 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. As shown in Figure 6-49.

Figure 6-49

6-34
 6 Ventilator Operation

(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 Child, as shown in Figure 6-50.

Figure 6-50

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 Child. 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 Child range is 2.5 to 8.0 mm and the default is 5.0 mm.

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) Monitoring

Click the Monitoring key to enter the Monitoring configuration page. On this page, you can configure
whether the monitoring is ON or OFF, as shown in Figure 6-51.

6-35
 Figure 6-51

(5) Network

Ventilator data is shared by NetWork. As shown in Figure 6-52.

Figure 6-52

(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 6-53.

6-36
 6 Ventilator Operation

Figure 6-53

6.3.6.3 Service

Click ―Service‖ to enter the ―Service‖ page. On this page, the user needs to enter the password, as
shown in Figure 6-54.

Figure 6-54

Input the correct password to enter, There are six choices on this page: Calibration, Event/alarm log,
Machine Information, Language, Test Page and Update. The default page is Calibration. See Figure
6-55.

6-37
 Figure 6-55

6.3.6.3.1 Calibration

The calibration choices include: Pressure Sensor Calibration, Flow Sensor Calibration, O2 Sensor
Calibration, CO2 Sensor Calibration, Inspiratory valve Calibration, Expiratory Valve Calibration,
Atmospheric Sensor Calibration, Touch Screen Calibration, Leak Test and Breath Circuit test, as
shown in Figure 6-55.

(1) Pressure Sensor Calibration: Click ―Pressure Sensor‖ to enter the calibration interface. A
message is displayed: ―This step is to zero the pressure sensor. Please remove the breathing circuit
from the ventilator before calibration.‖ A legend is displayed as well, as shown in Figure 6-56.

Figure 6-56

6-38
 6 Ventilator Operation

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 6-57. After calibration, the result will
appear: Calibration succeeded or Calibration failed. If failed, restart the calibration.

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

Figure 6-57

(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 6-58.

Figure 6-58

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

6-39
(3) O2 Sensor Calibration: Click ―O2 Sensor‖ to enter the interface. A message displayed: ―Please
verify that the oxygen source are connected correctly. Verify that the gas inlet pressure is within
specification.‖ A legend will also be shown. There are two keys below the legend: ―Start 21%‖ and
―Start 100%‖. Choose the needed one and click, as shown in Figure 6-59. The remaining procedure
is the same as described above.

Figure 6-59

(4) CO2 sensor Calibration: Click ―CO2 Sensor‖ to enter the interface, as shown in Figure 6-60. A
message displayed: ―Disconnect the CO2 sensor with the adapter from breathing circuit and ensure
it is in ambient air. Wait 1 minute for warm up after the unit is powered on or after installing an airway
adapter. Press “Zero‖ when the State-Area turns green‖. Please follow the prompt message to
calibrate.

Figure 6-60

6-40
 6 Ventilator Operation

(5) Inspiratory Valve Calibration: Click ―Inspiratory Valve‖ to enter the interface. A message
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 6-61.

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

Figure 6-61

(6) Expiratory Valve Calibration: Click ―Expiratory Valve‖ to enter the interface. A message
displayed: ―This step is to calibrate the expiratory valve. Please connect patient circut and test lung
before calibration‖, as shown in Figure 6-62.

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

Figure 6-62

6-41
(7) 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 6-63.

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

Figure 6-63

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

(8) Leakage Test Calibration: Click “Leakage Test‖ to enter the test interface. A message is
displayed: ―This step is to test the internal leakage of ventilator. Please connect the Insp. Port and
Exp. Port directly with a tube‖, as shown in Figure 6-64.

Figure 6-64

6-42
 6 Ventilator Operation

Click ―Start‖ to start the leakage test. A progress bar and a message ―Test in progress, please wait‖
will be displayed as shown in Figure 6-65. After test, the result will appear: Test succeeded or Test
failed. If failed, restart the test.

Figure 6-65

(9) Breath Circuit Test Calibration: Click “Breath Circuit Test‖ to enter the test interface. A
message is displayed: ―This step is to test the compliance and leakage of breathing circuit. Please
connect the patient circuit to the T-piece, and plug up the patient end of the T-piece‖, as shown in
Figure 6-66.

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‖ button to start the breath circuit test, the
remaining procedure is the same as the leakage test.

Figure 6-66

6-43
6.3.6.3.2 Event/Alarm Log

See Section 6.3.5 for detailed description.

6.3.6.3.3 Machine Information

Click the ―Machine information‖ key to enter the Machine information page, this area includes the
following information, as shown in Figure 6-67.

1. Software Version:
a. UI
b. BDU
c. Power Supply
2. Runtime Hours
3. O2 Source Pressure
4. Atmospheric Pressure

Figure 6-67

6.3.6.3.4 Language

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

6-44
 6 Ventilator Operation

6.4 Operation of Other Shortcut Keys

The ventilator has 10 shortcut keys: Inspiratory Hold, Expiratory Hold, Nebulizer, Manual, Suction,
Freeze, Screen Lock, Alarm limits, Main Menu and Start Ventilation/Standby. The shortcut keys are
located on the right side of the screen, see Figure 6-68.

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.

Press the Inspiratory Hold key during the Inspiratory phase. The operation becomes active when a
message stating ―Inspiratory Hold‖ appears with a countdown timer. 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 6-69.

Figure 6-68

6-45
 Figure 6-69

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‖ appears with a
countdown timer. 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 6-70. 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.

Figure 6-70

6.4.3 Nebulizer

The nebulizer function is available in all ventilation modes. Press the Nebulizer key turning the key
background color to yellow. Meanwhile, 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 6-71.

Figure 6-71

Nebulizer flow may be provided by high-pressure O2, and the flow rate is 6L/min±1L/min. To ensure
the delivery of tidal volume, the nebulizer is switched off when inspiratory flow rate is less than
15L/min.

The nebulizer will start as inspiratory starts, and the nebulizer will last for the whole inspiratory cycle.
When Ventilation mode changes or if the flow is less than 15 L/min, the nebulizer operation will be

6-46
 6 Ventilator Operation

interrupted and a medium level alarm ―Nebulizer Interrupted‖ will replace ―Nebulizer On‖ alarm and
the countdown timer will stop.

CAUTION: During nebulization, please install the filter in front of the expiration valve to prevent
the nebulization drug from damaging the expiration flow sensor; inspect, clean and replace the filter
regularly.

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 or;

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.

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.

6.4.4 Manual

Manual Trigger is available in all ventilation modes. Press the manual trigger key to initiate a manual
breath control as follows, as shown in Figure 6-72.

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

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

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

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

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

6-47
 Figure 6-72 Figure 6-73

6.4.5 Suction

Suction support is available in ventilation modes. Pressing Suction button will turn the button color to
yellow signifying the start of Suction support as shown in Figure 6-73.

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.

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 6-74.

Figure 6-74

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;
6-48
 6 Ventilator Operation

• Suction Phase - Airway disconnection for suction.

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

6.4.6 Print Screen

Print Screen shortcut soft key is between the Suction and the Freeze shortcut soft keys, as shown in
Figure 6-75. Print Screen is available after machine boot up is finished.

Figure 6-75

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 soft key 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.

6.4.7 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 6-76. Turing the encoder knob
6-49
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.

Figure 6-76

6.4.8 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 6-77. 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 Screen Lock for 3 seconds to unlock the screen‖ as shown in Figure 6-78.

6-50
 6 Ventilator Operation

Figure 6-77

Figure 6-78

6-51
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
6-79.

Figure 6-79

6.4.9 Alarm Limits

Press the ―Alarm limits‖ button to enter the alarm limits page in the main menu, as shown in Figure
6-80. For detail information and operation refer to Section 6.3.2.

Figure 6-80

6-52
 6 Ventilator Operation

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 6-81.

Figure 6-81

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 6-82.

6-53
 Figure 6-82

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

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:

a) 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.

b) Pressure parameter setting is subject to high pressure limit.

c) 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

6-54
 6 Ventilator Operation

(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.

6-55
 7 Alarms and Troubleshooting

7 Alarms and Troubleshooting

WARNING: Only authorized person is permitted to perform maintenance.

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 3 meters. To observe the alarm messages the operator position must be in
front of the display and within a distance of 1 meter.

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: Except for the normal alarm settings, other default alarm settings are changed only
by changing the control program and restricted access to changing or to the storage of changes.

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.

7-1
 NOTE: In the table below, L means low level, M means medium level, and H means high lever;
for the same level, the bigger the alarm number, the higher the alarm level, such as L2 level is higher
than L1 level.

Alarm Message Priority Type Cause Remedy

Airway Pressure exceeds the

setting limit within one
Airway pressure is
ventilation.
lower than the
High Airway When the airway pressure
L1 Physiological alarm limit for three
Pressure exceeds the setting value, the
consecutive cycles
inspiratory phase changes into
or at most 15sec.
the expiratory phase within 200
ms and the pressure shall be
reduced below PEEP level.
The measured minute volume The measured
leak MVLEAK is higher than the minute volume leak
minute volume measured on the MVLEAK is in normal
Leakage L2 Physiological
expiration path for 3 consecutive range for 3
ventilation cycles or for 10 consecutive breaths
seconds. or for 10 seconds.

Low Oxygen Oxygen source is lower than Oxygen supply is

L3 Physiological
Supply Pressure 160kPa O2 is set to 21%. above 160kPa.

When no battery is
supplied or battery
is invalid, the power
fault alarm is of
During ventilator operation, high-priority and
when an AC power failure lasts for longer than
occurs and there is no battery 120s.
power, the power board will When battery is
AC Failure L4 Technical supplied, produces
alarm for 120 seconds minimum.
When powered from batteries, a low-level alarm
an ―AC Failure‖ alarm would and gives the
occur. prompt message of
―AC power faulty‖
alarm.
Alarm cancellation
condition:
Restoration of AC.
Nebulizer operation
Nebulizer On L5 Physiological Start Nebulizer operation is completed or
Interrupted.

7-2
 7 Alarms and Troubleshooting

Alarm Message Priority Type Cause Remedy

Lung recruitment
operation is
Lung recruitment L6 Physiological Start lung recruitment operation
completed or
Interrupted.

During ventilator operation,

when an AC power failure
occurs and there is the int.
battery power, an ―Int. Battery
Int. Battery Calibration required‖ alarm Calibrate the int.
Calibration L6.1 Technical occurs. battery. Then restart
required When the ventilator starts the ventilator.
running and there is the int.
battery power, an ―Int. Battery
Calibration required‖ alarm
occurs.

During ventilator operation,

when an AC power failure
occurs and there is the opt.
battery power, an ―Opt. Battery
Opt. Battery Calibration required‖ alarm Calibrate the opt.
Calibration L6.2 Technical occurs. battery. Then restart
required When the ventilator starts the ventilator.
running and there is the opt.
battery power, an ―Opt. Battery
Calibration required‖ alarm
occurs.

Expiratory hold
Expiratory Hold
L7 Physiological Start Expiratory holding operation is
Interrupted
completed.

Inspiratory holding
Inspiratory Hold
L8 Physiological Start the inspiratory holding operation is
Interrupted
completed.

When ―Limited
Under the battery operation, the
Battery Capacity‖
Low Battery M1 Technical remaining battery run time is
alarm appears or
less than 30min.
AC power supply
starts.

7-3
Alarm Message Priority Type Cause Remedy

Respiration Rate is
Respiration Rate has exceeded
less than the set
High Respiration the set limit for four consecutive
M2 Physiological limit for four
Rate ventilation cycles or continuously
consecutive
for 20sec.
ventilation cycles.

Measure signals of
Oxygen Sensor Checked during pre-inspection the sensor through
M3 Physiological
Failure before use. equipment
inspection.

Oxygen
concentration is
Oxygen concentration exceeds lower than the
High Oxygen
M4 Physiological the preset oxygen concentration preset oxygen
Concentration
+6% continuously for 30sec. concentration+ 6%
for 30sec
continuously.

Oxygen
concentration is
Oxygen concentration is lower
higher than the
Low Oxygen than the preset oxygen
M5 Physiological preset oxygen
Concentration concentration -6% or lower than
concentration- 6%
18% continuously for 30sec.
or higher than 18%
for 30sec
continuously.
Minute Volume
High Expiratory Minute Volume exceeds the set
M6 Physiological lower than the set
Minute Volume limit, after 1min of ventilation
limit for 15sec.

Minute Volume
Low Expiratory Minute Volume is lower than the
M7 Physiological higher than the set
Minute Volume set limit within 1min.
limit for 15sec.

Inspiratory period is
NIV – inspiration duration
normal under NIV
exceeds Tispont setting for three
mode.
times in succession
Maximum Within the specified
M8 Physiological Invasive - inspiration duration
Inspiratory Time condition for two
exceeds 5 seconds for adult and
consecutive PSV
2 seconds for child for three
ventilation under
times in succession
invasive mode.

7-4
 7 Alarms and Troubleshooting

Alarm Message Priority Type Cause Remedy

Nebulizer operation
continued or alarm
Nebulizer Nebulizer operation has been
M13 Physiological is acknowledged by
Interrupted interrupted by mode changes.
pressing Alarm
Silence key.

Inspiratory Tidal
Inspiratory Tidal Volume
Low Inspiratory Volume is lower
M14 Physiological exceeds the upper limit for one
Tidal Volume than the alarm limit
ventilation.
for one ventilation.

Under the battery operation, the

Limited Battery AC power supply
H1 Technical remaining battery run time is
Capacity starts.
less than 10min.

Cycle AC Power-if
alarm occurs again
Internal Error H2.1 Technical Internal computing error stop using
Ventilator, note
code displayed and
call for Service.
Cycle power. If the
Communication Failure detected in BDU alarm occurs
H2.2 Technical
Error BDU communications. multiple times, call
for Service.

Cycle power. If the

Communication Failure detected in PS alarm occurs
H2.3 Technical
Error PS communications. multiple times, call
for Service.

S/W Mismatch System detects software

H2.4 Technical Call Service.
Error versions are incorrect.

Exp. Valve System detects expiratory valve

H2.5 Technical Call Service.
Heater Failure heater fails.

Remove any
System detects cooling fan
Fan Blocked H2.6 Technical obstructions. Cycle
failure
Power. If the alarm
occurs again, call
Service.

7-5
Alarm Message Priority Type Cause Remedy

Check to make sure

inspiratory and
expiratory circuits
Internal hardware failure
BDU Failure H2.7 Technical have no obstruction.
detected.
Retry power-up
tests.
If this alarm
persists, Call
Airway pressure has exceeded Airway pressure is
Service.
Continuous PEEP+15cmH2O continuously lower than
H3 Physiological PEEP+15cmH2O
Airway Pressure for 15sec. Expiratory valve is
opened for gas release. continuously for
5sec.
Airway pressure
Airway Pressure is lower than exceeds the alarm
High Airway
H4 Physiological the set limit within three limit for three
Pressure
consecutive ventilation cycles. consecutive cycles
or at most 15sec.

Refer to Chapter
No ventilation cycles within the
Apnea H5 Physiological 11.1.3 for Apnea
apnea period.
resetting details.

Expiratory Tidal
Expiratory Tidal Volume is lower Volume is higher
Low Expiratory than the setting value for three than the setting
H6 Physiological
Tidal Volume consecutive ventilation cycles or value for three
continuously for 30s. consecutive
ventilation cycles or
continuously for
PEEP is lower than
30s.
PEEP measurement is higher the alarm limit for
High PEEP H7 Physiological than the alarm limit for three three consecutive
consecutive ventilation cycles. cycles or at most
15sec.

Circuit Ventilating circuit is Re-connect patient

H8 Physiological
Disconnect disconnected. circuit.

Occlusion is
Occlusion H9 Physiological Ventilating circuit is occluded.
removed.

7-6
 7 Alarms and Troubleshooting

Alarm Message Priority Type Cause Remedy

Leak is within 75%

NIV Mode only- Leak exceeds of the maximum
Leakage out of
H10 Physiological 75% of the maximum volume volume
range
compensation capacity. compensation
capacity.
Airway pressure is
Airway pressure is lower than higher than the
Low Airway the set limit for three consecutive alarm limit for three
H11 Physiological
Pressure ventilation cycles. consecutive
ventilation cycles or
at most 15 sec.

Low Oxygen Oxygen supply is lower than Oxygen supply is

H12 Physiological
Supply Pressure 160kPa. above 160kPa.

PEEP is higher than

PEEP measurement is lower the alarm limit for
Low PEEP H13 Physiological than the alarm limit for three three consecutive
consecutive ventilation cycles. cycles or at most
15sec.

The CO2 module is not detected

CO2 Accuracy Redetect or replace
H14 Physiological during the probation period or
Error the CO2 module.
the CO2 module fails.

Reconnect the CO2

CO2 Adapter Adapter. If alarm
H15 Physiological Detected by CO2 Sensor.
Failure occurs again,
replace the CO2
Adapter.
Check the cable
The communication between the
CO2 sensor between the CO2
H16 Physiological CO2 module and the host
Comm. Failure module and the
instrument fails.
host instrument.

Reconnect the CO2

sensor. If alarm
CO2 Sensor Error H17 Physiological Detected by CO2 Sensor.
occurs again,
replace the CO2
sensor.
Increase EtCO2 or
EtCO2 is lower than the setting
Low EtCO2 H18 Physiological reduce the setting
value.
value.

7-7
Alarm Message Priority Type Cause Remedy

Reduce EtCO2 or
EtCO2 is higher than the setting
High EtCO2 H19 Physiological increase the setting
value.
value.

7-8
 8 User Maintenance

8 User Maintenance

WARNING: Only authorized person is permitted to perform maintenance.

WARNING: Our company 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: Do not use talc, zinc stearate, calcuim 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.
 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.

8-1
 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 7 and follow the on-screen Pre-Use test prompts to perform the Leak Test and Circuit
Compliance Test.

8.1 Clean and Disinfect

CAUTION: Before the first use clean, disinfect, and sterilize the ventilator according to Table
8-1.
Table 8-1 describes how to clean and disinfect 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

Using an FDA cleared Gluteraldehyde disinfection solution; follow the manufacturer‘s instructions for
high level disinfection and rinsing of the part while adhering to facility policies and procedures.
Ensure that the part has been cleaned as described before disinfecting. Alternative method to
disinfection solution is steam autoclaving. High level disinfection of the part is accomplished, through
steam autoclaving up to a maximum temperature of 134 ºC (273 ºF). When using an autoclave,
follow the manufacturer‘s instructions for high level disinfection.

Table 8-1 Guidelines for cleaning and disinfection

Item Frequency Procedure Note

Wipe clean with a damp cloth and

water-soluble mild soap or with one of
the chemicals listed below or its
equivalent. Apply soap or chemical to
damp cloth and directly to the Be careful not to let
External surface of equipment. If necessary use damp cloth disinfectant into the
After every
ventilator and water to rinse off chemical residue. machine or power
patient
(including LCD)
• Mild dishwashing detergent supply plug.
• Isopropyl alcohol (70% solution)
• Window cleaning solution (with
isopropyl alcohol and ammonia)
• Ammonia (15% solution)

8-2
 8 User Maintenance

• Bleach (10% solution)

• Hydrogen peroxide (3% solution)

Remove Expiratory module from

ventilator and remove diaphragm and
water trap. Clean the shell, diaphragm
and water trap separately. Using an
approved Gluteraldehyde disinfection
solution, follow the manufacturer‘s
instruction for high level disinfection and
rinsing of the diaphragm, water trap and Reinstall the
shell. module after
After each cleaning and drying.
Expiratory module NOTE: The shell, diaphragm and
patient/weekly Pay attention to
water trap can also be high level assure connections
disinfected through steam autoclaving are gas tight.
up to a maximum temperature of 134°C
(273°F). Using an autoclave, follow the
manufacturer‘s instruction for high level
disinfection of the shell, diaphragm and
water trap while adhering to facility
procedures.

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.

8-3
8.2.2 Periodic Maintenance Schedule

The schedule is designed based on the typical condition, that is to say, the least maintenance times
vs 2000h operating per year. In case the actual operating time is longer than 2000h per year, the
maintenance times should be more.

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

Minimum maintenance interval Task

Daily Drain water in gas supply inlet filter, check liquid in expiratory
module water trap (collected liquid volume cannot be more
than half of the bottle).

Weekly Calibrate oxygen sensor

1-3 month(s) Clean air filter Clean cooling fan filter on rear of machine.

Every year Calibrate flow sensor and pressure sensors;

Calibrate inspiratory valve and expiratory valve (if necessary).

Every 6 months Charge and discharge the batteries once (Charge time: at least
3.5h).

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

After cleaning and installing Check components and replace or repair when necessary.

WARNING: If the Ventilator will not be in use for a period of more than 6 months, the internal
batteries must be disconnected or removed to prevent possible damage to the equipment or risk to
users or service personnel.

WARNING: The ventilator must not use, nor be connected to, any anti-static or electrically
conductive hoses and tubing.

8.2.3 Service Life of Product/Accessories

Service Life is defined as the time that the manufactured device can be expected to be 'serviceable'
or supported by our company and the maximum time the device can be used safely. Some items
within the device may require maintenance, repair or replacement within this time. Such items will be
available from our company for the service life of the product. The calculation of the service life
begins at the installation of the product at the customer site. Our company recommends for safe use
that each device is replaced after its service life is completed.

8-4
 8 User Maintenance

CAUTION: The service life of the following items is based on specified operating conditions.

Mask, patient breathing circuit Single use

Power supply cable, gas supply pipe 8 years

Machine 8 years

500 cycles of full charge(The battery from

Battery
exhausted to full )

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.

8-5
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.

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 Consumables Replacement

8.4.1 Fuse Replacement

WARNING：Before replacing fuse, first disconnect AC power. Otherwise, it will cause injury or
even death.

WARNING：When replacing fuse, make sure the new fuse is the same type and size as the old
one; otherwise, the ventilator will be damaged.

CAUTION: Fuse is a damageable part, which shall be replaced with moderate force and speed.
1. AC Circuit Fuse
Fuse replacement steps:
• Insert screwdriver into the trench (2) of end of fuse box, see Figure 8-1.
• Pull out fuse holder (1).
• Remove the fuse (3).
• Load new fuse.
• Push the new fuse into the original position gently.
• Connect AC power, and then start the ventilator to test.

8-6
 8 User Maintenance

Figure 8-1

2. Vehicle-mounted Power Fuse

Fuse replacement steps:
• Insert screwdriver into the trench (1) of end of fuse box, see Figure 8-2.
• Pull out fuse holder (2).
• Remove the fuse (3).
• Load new fuse.
• Push the new fuse into the original position gently.

Figure 8-2

8.4.2 Battery Maintenance

NOTE: One or more batteries must be used.

NOTE: Before the machine is put into patient use, the battery must be fully charged. If the battery
must not be fully charged and AC power supply fails, be careful about the battery power.

• Battery specification

Battery module:

-- DC12V, 6.6AH, 14.4V lithium-ion battery

-- Typical charge time: 3.5 hours
8-7
-- Typical discharge time: 2 hour

When the main power supply voltage is too low or the main power supply fails, two backup batteries
(one is necessary, and one is optional) can protect the ventilator. When having a power failure, the
ventilator can switch to battery supply automatically, and can normally work without pneumatic power
supply failure. The two batteries are usually available for the ventilator working for 4 hours.

• Precautions

Charge: When operating with AC power supply on, the system will maintain the battery automatically.
Charge time is less than 3.5 hours.

Discharge: The machine is operating on battery.

In case of low battery condition, an alarm message ―Low battery‖ will appear, notifying the user to
restore AC power supply to charge, 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).

Before the machine is put into patient use, or disconnect AC power for the transport or other
purposes, check the battery power. If the battery is not fully charged, connect the ventilator to AC
power for at least 3.5h and recharge the battery until the power reaches 80%~100%.

• Battery storage

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

To keep the battery power and prolong the battery life, please ensure that the ventilator is connected
to the main power. Charge the battery every six months, while the actual time depends on the
storage environment.

High humidity and high temperature environments should be avoided for storage.

• Battery replacement

Open the battery cover (See Figure 2-5), then remove the battery from its housing.

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

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

• Battery charging and calibration

Use the battery charger supplied by our company to charge or calibrate the battery. After calibrating
the battery, the ventilator can read the residual battery capacity accurately.

Please charge or calibrate the battery according to the instructions of the battery charger.

8-8
 8 User Maintenance

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

8.4.3 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.

8.4.3.1 Oxygen Sensor Replacement

Disassembly

Step 1: Open outward (1), and then remove the cover.

Step 2: Turn the oxygen sensor (3) anticlockwise, and then remove it.

Assembly

Inspect the oxygen sensor for damage and replace as necessary. Then reassemble the oxygen
sensor.

8-9
8.4.3.2 Oxygen Sensor Calibration

For oxygen sensor calibration, refer to section 6.8.3.1.

8.4.3.3 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
0.94 x 106% O2 hours at 20°C
Expect life time
0.6 x 106% 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
Working principle of O2 electrode is gradually exhausted 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.

8-10
 8 User Maintenance

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.

8.4.3.4 Oxygen Sensor Maintenance

The oxygen sensor should be regularly calibrated. For the calibration interval, refer to section 8.2.2.

To improve the life time of the oxygen sensor, when the ventilator is not in use the oxygen sensor
should be avoided contact with the high-concentration oxygen.

The oxygen sensor is consumptive, and the period of valid is ordinarily 12 months. So the user
should pay attention to the 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.

8.4.4 Diaphragm Replacement

Figure 8-3 Figure 8-4

Diaphragm replacement method:

a. Press the button(1 in Figure 8-3);

b. Pull out the expiratory valve core component (2 in Figure 8-3);

c. Remove the safety valve cover (1 in Figure 8-4) and the gasket (2 in Figure 8-4);

d. Remove the scale board (3 in Figure 8-4) and the diaphragm (4 in Figure 8-4)；

8-11
 e. Reassemble the above components in the reverse order.
Test: When the diaphragm and scale board are replaced, the inspiratory valve must be calibrated.;

Also, perform a pre-use test and verify all test pass.

8.4.5 One-way Diaphragm Replacement

Figure 8-5

The one-way diaphragm replacement method：

a. Remove the expiratory valve core component;

b. Remove the one-way valve core component (1);

c. Remove one-way diaphragm(2);

d. Reassemble the above components in the reverse order.

Test: When the one-way diaphragm has been replaced, the inspiratory valve must be calibrated.

8-12
 8 User Maintenance

8.4.6 Oxygen Inlet Filter Replacement

Figure 8-6

Replacement method of the oxygen inlet filter:

a. Remove the four screws(1) (Hexagon socket head cap screws M4×10)；

b. Remove the Inlet valve body (2);

c. Remove the oxygen inlet filter (3)

d. Reassemble the above components in the reverse order.

8-13
8.4.7 Fan Filter Cotton Replacement

Figure 8-7

The replacement method of the fan filter cotton:

a. Remove the fan filter cotton cover(2)；

b. Remove the fan filter cotton(1);

c. Reassemble the above components in the reverse order.

8-14
 8 User Maintenance

8.4.8 Filter Element of Gas Inlet Replacement

Figure 8-8
Filter element of gas inlet replacement method:

a. Remove the filter cover(1)；

b. Remove the filter support sleeve(2);

c. Remove the filter element of gas inlet(3);

d. Reassemble the above components in the reverse order.

8-15
8.4.9 Filter Replacement(Part No.:130003930)

The filter replacement method:

a. Remove the two screws (1) (Hexagon socket head cap screws M4×10)；

b. Remove the oxygen inlet connector(2);

c. Remove the filter(3);

d. Reassemble the above components in the reverse order.

8.5 Disposal

This product must not be disposed of with your other waste. Instead, it is your responsibility to
dispose of your waste equipment by handing it over to a designated collection point for the recycling
of waste electrical and electronic equipment, or by returning it to our company for reprocessing. The
separate collection and recycling of your waste equipment at the time of disposal will help to
conserve natural resources and ensure that it is recycled in a manner that protects human health and
the environment. For more information about where you can drop off your waste equipment for
recycling, please contact your local city office, your waste disposal service, or your product
distributor or retailer.

Correct Disposal of Batteries and O2 Sensors

WARNING: Treatment of batteries and O2 sensor:

8-16
 8 User Maintenance

 Follow all local regulations with respect to environmental protection when disposing of batteries
and O2 sensor. These products contain toxic compounds irrespective of physical condition. They
should be disposed of according to local waste management requirements and environmental
legislation. They should not be burned since they may give off toxic fumes.
 Do not throw into fire! Risk of explosion.
 Do not force open! Danger of bodily injury.

8-17
 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 our
company. The warranty period for other parts is three months. Consumable parts are not included in
this warranty. Our company‘s obligation under the above warranty is limited to repairing the
equipment free of charge.

Freedom from Obligations:

 Our company‘s obligation under the above warranties does not include freight and other fees;
 Our company 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 our company or our company‘s appointed representatives;
 This warranty does not apply to the following situations:
• Improper use;
• Machines used without the proper maintenance or damaged;
• Our company original serial number label or mark is removed or replaced.

Security, reliability and operating condition:

Our company 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 our company:

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

Contact our 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 our company 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

9-1
Transportation and insurance charges must be prepaid by the user for transporting the product to our
company for repair.

NOTE: Each product has a serial number, such as:

VG70 xx xx xx
Where:
VG70: Machine Model Number
xx xx xx: Equipment Number
 1st two ‗xx‘ digits – last two digits of current year
 2nd two ‗xx‘ digits indicate month product was manufactured
o Z=0, Y=1, X=2, W=3, V=4, U=5, T=6, S=7, R=8, K=9
 3rd group of ‗xxx‘ digits indicates the number unit shipping in a current month

Product serial number appears on nameplate and equipment packaging.

Manufacturer: Beijing Aeonmed Co., Ltd.

Address: Aeonmed Mansion, No. 4 Hangfeng Road, Science City,

Fengtai District, Beijing

Tel.: +(86) 10－83681616

Fax: +(86) 10－63718989

Web site: www.aeonmed.com

E-mail: service@aeonmed.com

9-2
 10 Theory of Operation

10 Theory of Operation

10.1 Ventilation Modes

There are Invasive and non-invasive (NIV) ventilation modes in the 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 – CPAP mode in NIV.

• NIV-T mode – A/C (PCV) mode in NIV.

• NIV-S/T mode – SPONT 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.

1. Volume Control Ventilation:

In VCV, VIM breaths deliver the set volume (Tidal Volume - Vt).

10-1
 Figure 10-1

Figure 10-2

10-2
 10 Theory of Operation

2. PCV Pressure Controlled ventilation

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

Figure 10-3

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.

10-3
 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.

10.1.2 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
10-4
 10 Theory of Operation

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)

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.
10-5
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 - PCV when an apnea occurs in
NIV-S/T 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, 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.

10.1.4 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)

10-6
 10 Theory of Operation

Figure 10-6 Spontaneous /CPAP ventilation

10.1.5 BiLevel Ventilation (BIVENT)

In BIVENT, breaths shall be controlled by the ventilator (mandatory). 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
Bi Vent 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)

Figure 10-7 BIVENT

10-7
 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. In NIV/CPAP,
the ventilator controls the airway pressure as the preset PEEP value.

Figure 10-9

Illustration shows NIV/CPAP. Pressure shall rise according to the selected rise time, with target
pressure 1.5 cmH2O above PEEP to improve work of ventilating.

10-8
 10 Theory of Operation

Figure 10-10

This illustration shows NIV/CPAP spontaneous breaths with Pressure Support

Figure 10-11

Pressure support will be terminated when:

10-9
• 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

10.1.7 NIV-T

In NIV-T, 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.

10.1.8 NIV-S/T

NIV-S/T is a spontaneous mode of operation and no ventilator controlled breaths are provided.
Throughout the ventilation cycle, spontaneouse ventilation may also be assisted by the ventilator at
an operator set of inspiratory pressure (Pressure Support). If the trigger time of the patient exceeds
the setting value of the apnea time, the mode will enter into back-up ventilation.

NIV-S/Td 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. In NIV/CPAP,
the ventilator controls the airway pressure as the preset PEEP value.

10-10
 11 VG70 Ventilator System Specifications

11 VG70 Ventilator System Specifications

WARNING: Do not operate the 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: The device classification is: Class I, Type B applied part (ventilator breathing tube and
mask), type BF applied part (CO2 module), ordinary enclosed equipment without protection against
ingress of liquids, continuous operation
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 (cm)

Adult: 30 – 250
Child: 30 – 250

NOTE：Leakage from VBS COMPLIANCE：

• 50 ml/min at 20 hPa for a VENTILATOR intended to provide DELIVERED VOLUME less than 50
ml;
• 100 ml/min at 40 hPa for a VENTILATOR intended to provide DELIVERED VOLUME between
11-1
 300 ml and 50 ml;
• 200 ml/min at 50 hPa for a VENTILATOR intended to provide DELIVERED VOLUME greater
than 300 ml.

11.1.2 Operating Conditions

Operating Temperature Range: +5 to +40℃

Relative Humidity: 5 to 95% non-condensing
Atmospheric Pressure: 700 to 1060 hPa

Enclosure Protection Rating IP21 per IEC 60529

11.1.3 Non-operating Conditions

Storage Temperature Range: -20 to +60 C

Storage Relative Humidity: 5 to 95% non-condensing
Storage Atmospheric Pressure: 700 to 1060 hPa

11.1.4 Power Supply

Ventilator

Power Supply 100-240 +/- 10% VAC 50/60 Hz

Vehicle-mounted Power 12-24 VDC

Two rechargeable lithium-ion battery modules, 14.4 V,

6.6 Ah each. Recharge time approximately 3.5 hours.
Battery Backup (Standard)
Battery backup time of 60 minutes minimum with only
standard internal battery.

Maximum Power Consumption 200VA

AC Circuit Fuse UDA3.15

Vehicle-mounted Power Fuse GDA012

11-2
 11 VG70 Ventilator System Specifications

Cart

115V 2A 60Hz
Socket 220V 1A 50Hz
Humidifier
230V 1A 50/60Hz
Output Fuse 250V H3.5A
115V 5A 60Hz
Ventilator 220V 5A 50Hz
230V 5A 50/60Hz
115V 8A 60Hz
Input 220V 8A 50Hz
230V 8A 50/60Hz

CAUTION: Vehicle-mounted power conforms to IEC 60601-1.

CAUTION: The Power Supply should meet the above specifications.

WARNING: Connecting any equipment that has not been supplied as a part of the ventilator
system to the socket of the cart may generate the risk.

11.2 Ventilator

11.2.1 General

User Interface: 350 wide x 55 deep x 244 high (mm)

Dimensions Ventilation Delivery Unit: 322 wide x 375 deep x 366 high (mm)
System with Cart (optional): 547 wide x 675 deep x 950 high (mm)

Total: 40 kg
User Interface: 2.5 kg
Weight (Approximate)
Ventilation Delivery Unit: 12.5 kg
Cart: 25 kg

Trigger Method Flow and Pressure

Maximum limited pressure 80 cmH2O

Maximum working pressure 80cmH2O

Warm-up time ≥20 min

The ventilator has the automatic atmospheric pressure

Pressure compensation
compensatory function.

11-3
11.2.2 Gas Supply

Supplied gases must be free of water, oil and particles.

Inlet Gas Pressure

O2: 280 kPa to 600 kPa (41 – 87 PSI)

Connection Standards Available

DISS, NIST

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

CAUTION: The ventilator is a high flow device and should only be connected to a pipeline
installation 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

Attach to the ventilation delivery unit, the head mast, or other mounting system.

11.2.5 Acoustic Energy

The A-weighted sound pressure level of the 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 C
 Dry gases in patient system
 Inlet pressure: 345 kPa (50 PSI)

11-4
 11 VG70 Ventilator System Specifications

11.4 Inspiratory Channel

Pressure Drop

Maximum 5 cmH2O at a flow of 60 liters/min.

Rated Inspiratory Gas Pathway Resistance

Less or equal to 50 cmH2O/L/s

Compliance

Maximum 2 mL/cmH2O (With Fisher & Paykel MR 810 Humidifier and Patient Circuit of reusable
silica gel).

Gas Delivery System

Microprocessor controlled valves.

Gas Delivery Device

Flow Range:
Adult: 1 to 180 liters/min
Child: 0 to 60 liters/min

Maximum Pressure Setting: 70 cmH2O

NIV Max leakage compensation level

Adult: 60 lpm
Child: 30 lpm

11.5 Expiratory Channel

Pressure Drop (Resistance)

Maximum 5 cmH2O at a flow of 60 lpm.

Rated Expiratory Gas Pathway Resistance

Less or equal to 20 cmH2O/L/s

Compliance

Maximum 2 mL/cmH2O (With Fisher & Paykel MR 810 Humidifier and Patient Circuit of reusable
silica gel).

PEEP Regulation

Microprocessor controlled valve

11-5
PEEP Setting Range

0 ~ 35 cmH2O

Expiratory Flow Measurements

Range: 0 ~ 180 lpm.

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.

11.6 Monitoring

Inspiratory and Expiratory Minute Volume

Range: 0 ~ 60 lpm.
Accuracy: +/- 1 LPM or +/- 15% of measured value (whichever is greater)
Resolution: 0.1 lpm > 1 lpm, 0.001 lpm < 1 lpm

Inspiratory and Expiratory Tidal Volume

Range: 0 ~ 4000 mL
Adult Accuracy: +/- 25 ml or ±15% of the measured value (whichever is greater)
Child Accuracy: +/- 10 ml or ±10% of the measured value (whichever is greater)
Resolution: 1 mL

O2 Concentration

Range: 18 ~100%
Accuracy: +/- 3 vol. %
Resolution: 1%

Airway Pressure

Range: -20 to 80 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%

Airway Pressure and Flow Rate Waveform

Filtering of 5 samples is performed for smoothing.

11-6
 11 VG70 Ventilator System Specifications

11.7 Alarms

11.7.1 Allowed Alarm Settings

Airway Pressure (upper limit)

5 to 80 cmH2O

High Continuous Pressure

Set PEEP level + 15 cmH2O for at least 15 sec

O2 Concentration

Set value +/- 6 vol % or <= 18 vol %

Expired Minute Volume (Upper alarm limit)

1 ~ 60 liters/min; OFF

Expired Minute Volume (Lower alarm limit)

0.1 ~ 40 liters/min; OFF

Apnea Time

10 ~ 60 sec; OFF

Respiratory Frequency

10 ~ 80 bpm; OFF

Low End Expiratory Pressure

1 ~ 35 cmH2O; OFF
Or 1 ~ 20 cmH2O; OFF (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 (29 psi) +10% for 5 seconds or more

11-7
Alarm Silence/reset

Press this key to silence alarms for two minutes. This key also resets latched alarms.

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.

11.8 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

Noninvasive Pressure Control (NIV-T)

Noninvasive pressure controlled ventilation

11.8.2 Supported Ventilation

Pressure Support (PS)/CPAP

Pressure supported ventilation / Continuous positive airway pressure ventilation

NIV Pressure Support (PS) / CPAP

Noninvasive pressure supported ventilation / Continuous positive airway pressure ventilation

11.8.3 Combined Ventilation

SIMV (PCV) + PS

Synchronized intermittent mandatory ventilation based on pressure controlled ventilation with

pressure support

SIMV (VCV) + PS

11-8
 11 VG70 Ventilator System Specifications

Synchronized intermittent mandatory ventilation based on volume controlled ventilation with

pressure support

SIMV (PRVC) + PS

Synchronized intermittent mandatory ventilation based on pressure regulated volume controlled

ventilation with pressure support 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

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

Oxygen Concentration O2

Expiratory Resistance Rexp

Dynamic Compliance Cdyn

Rapid - shallow ventilating index RSBI

Work of Ventilating WOB

Leak Leak NIV

11-9
11.10 Log Function

Alarm/Event Log

Alarms
Ventilator Settings
Shortcut key functions

Service Page

Technical alarms
Test results
Calibration results
Configuration log

11.11 Shortcut Key Functions

Insp. Hold

Inspiratory Hold

Exp. Hold

Expiratory Hold

Nebulizer

Start and stop the Nebulizer operation

Manual

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

Suction

Initiate and terminate the suction support process.

Disconnection detection – Automatic
Reconnection detection – Automatic
Pre-oxygenation – Max.3 minutes
Active Suction phase – Max.2 minutes
Post-oxygenation – 2 minutes

Freeze

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

Screen Lock

Lock or unlock the touch screen

11-10
 11 VG70 Ventilator System Specifications

Main Menu

Return to the main menu

11.12 Communication/Interface

11.12.1 Nurse Call Port

The 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 VG70 to connect to external equipment such as a electronic
health record.

CAUTION:
• connection of the VG70 to an 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;
update 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 locates in the front of the ventilator. The whole nebulizer lasts
for 30 minutes.

11.13 Accessories

Mobile Cart

Weight: 25Kg

Dimensions: 547 wide x 675 deep x 950 high (mm)

Gas Cylinder Kit

Capacity is two cylinders max, US E cylinders

Humidifier

Fisher & Paykel MR850, MR810

Breath circuit

Fisher & Paykel reusable breathing circuit:

MV1006 (F&P) 900MR761 Adult Circuit Kit

MV1005 (F&P) 900MR742 Adult Single Limb Heated Circuit Kit
MV1007 (F&P) 900MR780 Adult Circuit Kit, Dual Heated 4 LPM
MV1008 (F&P) 900MR781 Infant Circuit Kit, Dual Heated 4 LPM

Other recommended breathing circuit:

Adult breathing circuit (Disposable): mask, headband, elbow,
122000761
breathing circuit etc. Produced by INSPIRED MEDICAL
Adult Breathing Circuit (silicone)-mask, headband, elbow,
122005487
breathing circuit etc. Produced by Liming Rubber
Pediatric Breathing Circuit-(silicone)-mask, headband, elbow,
122005490
breathing circuit etc. Produced by Liming Rubber
Adult breathing circuit (Disposable). Produced by INSPIRED
51005800
MEDICAL
Pediatric breathing circuit (Disposable). Produced by INSPIRED
51008400
MEDICAL
11-12
 11 VG70 Ventilator System Specifications

Oxygen Sensor: To be replaced every 2 years or as necessary. Part number: 210001975

CO2 Module

240000415 IRMA CO2 module

240000416 IRMA Adult airway adapter
240000417 IRMA Pediatric airway Adapter

11.14 Ventilating Parameters: Default Values and Allowed

Settings (Standard Configuration)

Factory Set Default Setting Range

Parameter
Child Adult Child Adult

ATC Tube
OFF OFF ON/OFF ON/OFF
Compensation

ATC Tube Type ET ET ET/Tracheotomy ET/Tracheotomy

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

ATC Tube Diameter

5.0 7.5 2.5 – 8.0 5.0 – 12.0
(mm)

Backup Ventilation
Pressure above 10 20 0 – (70-PEEP) 0 – (70-PEEP)
PEEP (cmH2O)

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

Compliance
ON ON ON/OFF ON/OFF
Compensation

CPAP (cmH2O) in
5 5 2 – 20 2 – 20
NIV

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

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

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

Frequency - VCV
30 15 1 – 80 1 – 80
bpm

IBW - Ideal Body

100 150 30 – 140 60 – 260
Weight (cm)

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

Maximum
inspiratory flow 60 180 --- ---
(liters/min)

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

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

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

Nebulizer OFF OFF ON/OFF ON/OFF

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

NIV Rate (bpm) 30 15 4 – 20 4 – 40

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

PEEP (cmH2O) 5 5 0 – 35 0 – 35

PEEP in NIV
5 5 2 – 20 2 – 20
(cmH2O)

Phigh(cmH2O) 15 15 5 – 60 5 – 60

Plow (cmH2O) 5 5 0 – 35 0 – 35

Press trig sensitivity

-3 -3 -20 – 0 -20 - 0
level (cmH2O)

Pressure level
above PEEP 10 20 5 – (70-PEEP) 5 – (70-PEEP)
(cmH2O)

11-14
 11 VG70 Ventilator System Specifications

Factory Set Default Setting Range

Parameter
Child Adult Child Adult

PS above PEEP
0 0 0 – (70-PEEP) 0 – (70-PEEP)
(cmH2O)

PS– BIVENT above

0 0 0 – (70-PEEP) 0 – (70-PEEP)
PEEP (cmH2O)

PS– NIV above

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

SIMV rate (bpm) 20 4 1 – 40 1 - 40

Thigh(s) 0.6 1.0 0.2 – 30 0.2 - 30

Tinsp(s) 0.6 1.0 0.2 – 5 0.2 – 9

Tidal Volume (mL) 80 400 20 – 300 50 – 2000

Tlow (s) 1.4 3.0 0.2 – 30 0.2 – 30

Tpause (s) 0 0 0–4 0–4

Tslope(s) 0.1 0.1 0–2 0–2

Alarm Settings: Default Settings and Allowed Ranges

Factory Set Default Setting Range

Alarm Limits
Child Adult Child Adult

Airway Pressure, high limit (cmH2O) 40 40 5 - 100 5 - 100

Airway Pressure, low limit (cmH2O) 5 5 OFF, 1 - 80 OFF, 1 - 80

PEEP Low limit in Invasive

OFF OFF 1 – 35 1 - 35
Ventilation(cmH2O)

PEEP Low limit in NIV (cmH2O) OFF OFF 1 – 20 1 - 20

PEEP high limit in Invasive Ventilation

10 10 1 – 35 1 - 35
(cmH2O)
PEEP high limit in NIV (cmH2O) OFF OFF 1 – 20 1 - 20
etCO2 low limit % 4.0 4.0 Off, 0.1 – 13.2 Off, 0.1 – 13.2
etCO2 low limit mmHg 30 30 Off, 1 - 99 Off, 1 - 99

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

etCO2 low limit kPa 4.0 4.0 Off, 0.1 – 13.2 Off, 0.1 – 13.2
etCO2 high limit % 6.5 6.5 0.1 – 13.3 0.1 – 13.3
etCO2 high limit mmHg 49 49 1 - 100 1 - 100
etCO2 high limit kPa 6.5 6.5 0.1 – 13.3 0.1 – 13.3

Expired Minute Volume, low limit (lpm) 0.5 1.0 OFF, 0.1 – 40 OFF, 0.1 – 40

Expired Minute Volume, high limit (lpm) 30 30 OFF, 1 – 60 OFF, 1 – 60

Inspiratory Tidal Volume, high limit (mL) 50 250 OFF, 5 - 400 OFF, 5 - 4000

Respiratory Frequency, Spontaneous,

OFF OFF OFF, 10 - 120 OFF, 10 - 120
Upper limit (bpm)

Time, Apnea – until alarm (sec) 20 20 OFF, 10 – 60 OFF, 10 - 60

NOTE: Regarding occlusion detection and continuing pressure events:

Occlusion detection occurs 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 as an occlusion and behave accordingly.

NOTE: Regarding Nebulizer usage while on battery power:

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

Ventilating Parameters: Default Values and Allowed Settings (Standard Configuration).

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

11-16
 11 VG70 Ventilator System Specifications

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

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 Pneumatic Diagram

12 Pneumatic Diagram

12-1
 13 EMC

13 EMC

Electromagnetic Compatibility

Changing or reassembling this equipment without our company‘s authorization may cause
electromagnetic compatibility problems. Contact our company for assistance. Designing and testing
this equipment is in accordance with the following stipulations.

WARNING: Using cell phone or other radio radiant equipment near this product may cause
malfunction. Closely monitor the working condition of this equipment if there is any radio radiant
supply nearby.

Using other electrical equipment in this system or nearby may cause interference. Check if the
equipment works normally in these conditions before using on a patient.

Use caution of the following when the ventilator is connected:

Do not put any object which is not in accordance with EN 60601-1 in the 1.5M range of patients.

A complete system current leaking test (according to EN 60601-1) must be performed after any
equipment is connected to these outlets.

If a portable all-purpose outlet is used as the alternating current supply, it must be in accordance with
EN 60601-1 and cannot be put on the floor. Using another portable all-purpose outlet is not
recommended.

Do not connect the non-medical equipment directly to the alternating current outlet on the wall. Only
the alternating current supply of the isolated transformer can be used. Otherwise, the surface leaking
current may exceed the range permitted by EN 60601-1 under the normal conditions, and
misoperation may cause injury to patients or operators.

WARNING: Do not use other power cords and if it is necessary, the selected cable must be in
accordance with IEC60601-1-2.

WARNING: The equipment should not be used adjacent to or stacked with other equipment and
if adjacent or stacked use is necessary, the equipment should be observed to verify normal operation
in configuration in which it will be used.

13-1
Guidance and manufacture’s declaration – electromagnetic emission for the Ventilator

The Ventilator is intended for use in the electromagnetic environment specified below. The customer
of the user of the Ventilator should assure that it is used in such an environment.

Emission test Compliance Electromagnetic environment – guidance

The Ventilator uses RF energy only for its internal

function. Therefore, its RF emissions are very low
RF emissions CISPR 11 Group 1
and are not likely to cause any interference in
nearby electronic equipment.

RF emission CISPR 11 Class A

The Ventilator is suitable for use in all

Harmonic emissions IEC establishments, including domestic and those
Class A
61000-3-2 directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
Voltage fluctuations/ flicker
Complies
emissions IEC 61000-3-3

Guidance and manufacture’s declaration – electromagnetic immunity for the Ventilator

The Ventilator is intended for use in the electromagnetic environment specified below. The customer
or the user of the Ventilator should assure that it is used in such an environment.

Electromagnetic
Immunity test IEC 60601 test level Compliance level
environment- guidance

Floors should be wood,

concrete or ceramic tile. If
Electrostatic
±6 kV contact ±6 kV contact floors are covered with
discharge (ESD)
±8 kV air ±8 kV air synthetic material, the relative
IEC 61000-4-2
humidity should be at least
30%.

±2 kV for power supply Mains power quality should

Electrical fast
lines ±2kV for power be that of a typical
transient/burst
±1 kV for input/output supply lines commercial or hospital
IEC 61000-4-4
lines environment.

Mains power quality should

±1 kV differential
Surge ±1 kV differential mode be that of a typical
mode ±2 kV common
IEC 61000-4-5 ±2 kV common mode commercial or hospital
mode
environment.

Voltage dips, short <5% UT (>95% dip in <5% UT (>95% dip in Mains power quality should
13-2
 13 EMC

interruptions and UT) for 0.5 cycle UT) for 0.5 cycle be that of a typical
voltage variations on 40% UT (60% dip in UT) 40% UT (60% dip in commercial or hospital
power supply input for 5 cycles UT) for 5 cycles environment. If the user of the
lines 70% UT (30% dip in UT) 70% UT (30% dip in Ventilator requires continued
IEC 61000-4-11 for 25 cycles UT) for 25 cycles operation during power mains
interruptions, it is
<5% UT (>95% dip in <5% UT (>95% dip in
recommended that the
UT) for 5 sec UT) for 5 sec
Ventilator be powered from
an uninterruptible power
supply or a battery.

Power frequency magnetic

Power frequency fields should be at levels
(50/60Hz) characteristic of a typical
3A/m 3A/m
magnetic field location in a typical
IEC 61000-4-8 commercial or hospital
environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacture’s declaration – electromagnetic immunity for the Ventilator

The Ventilator is intended for use in the electromagnetic environment specified below. The customer
or the user of the Ventilator should assure that it is used in such an environment.

IEC 60601 test Electromagnetic environment -

Immunity test
level Compliance level guidance

Portable and mobile RF

communications equipment should be
used no closer to any part of the
Ventilator, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted RF 3 Vrms 150 kHz 3 V
IEC 61000-4-6 to

80 MHz outside
ISM bands a 10V
3Vrms 150 kHz
to

13-3
Radiated RF 80MHz in ISM
banda 80 MHz to 800 MHz
IEC 61000-4-3 10 V/m
3 V/m 80 MHz
to 2.5 GHz 800 MHz to 2.5 GHz
Where P is the maximum output
power rating of the transmitter in watts
(W) according to the transmitter
manufacturer and d is the
recommended separation distance in
metres (m). b
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey ,c should
be less than the compliance level in
each frequency range .d
Interference may occur in the vicinity
of equipment marked with the
following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

a. The ISM (industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765 MHz to
6.795 MHz; 13.553MHz to 13.567MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70.
b. The compliance levels in the ISM frequency bands between 150 kHz and 80MHz and in the
frequency range 80MHz to 2.5GHz are intended to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into patient
areas. For this reason, an additional factor of 10/3 is used in calculating the recommended
separation distance for transmitters in these frequency ranges.
c. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the Ventilator is used exceeds the
applicable RF compliance level above, the Ventilator should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such
as reorienting or relocating the Ventilator.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

13-4
 13 EMC

Recommended separation distances between portable and mobile RF communications

equipment and the Ventilator

The Ventilator is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the Ventilator can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Ventilator as recommended below, according to
the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter (m)

Rated
maximum 150 kHz to
150 kHz to 80 MHz 80 MHz to 800 MHz to
output power outside ISM bands 80 MHz in ISM 800 MHz 2.5 GHz
of transmitter bands
(W)

0.01 0.17 0.12 0.12 0.23

0.1 0.37 0.38 0.38 0.73

1 1.17 1.2 1.2 2.3

10 3.7 3.79 3.79 7.27

100 11.7 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

NOTE 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are
6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66MHz to
40.70MHz.

NOTE 3: An additional factor of 10/3 is used in calculating the recommended separation

distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas.

NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

13-5
VG70 Ventilator User Manual

Version 00.00

May, 2015

PN: 130013843

Beijing Aeonmed Co., Ltd.