VG70 Ventilator User Manual V01.09 July 2020

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

When using the product, always proceed in accordance with the information provided in these operating instructions on the basis of fully understanding the information in this manual. This product is only for intended use as described in these operating instructions.

Only specially trained service professionals are authorized to perform the connection and service of this product. For any situation in the use process, please contact with us. We will provide you with warm service. Product specifications are subject to change without notification.

ii

Manufacturer(holder):

Beijing Aeonmed Co., Ltd.

Manufacturer(holder) address:

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

Facility:

Beijing Aeonmed Co., Ltd.

Facility address:

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

Service:

Beijing Aeonmed Co., Ltd.

Service Address:

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

Tel:

+86-10-83681616

Fax:

+86-10- 83681616-8130

Service Line:

+86 800-810-8333

Website:

http://www.aeonmed.com

E-mail:

[email protected]

European Representative:

HEYER Medical AG

Address:

Carl-Heyer-Str. 1/3, 56130 Bad Ems,Germany

iii

Table of Contents 1

2

3

4

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 ... 1-7 1.5 Intended Use ... 1-7 1.6 Indications for Use ... 1-7 1.7 Contraindication ... 1-8 1.8 Abbreviations and Definitions ... 1-8 1.9 Frequently Used functions ... 1-10 1.10 Symbols ... 1-10 1.11 VG70 Ventilator Quick Start Guide ... 1-12 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 CO2 Module ... 3-1 3.1 CO2 Module Intended Use... 3-1 3.2 CO2 Module Specifications ... 3-1 3.2.1 General ... 3-1 3.3 System Assembly Instruction ... 3-5 3.3.1 Set-up ... 3-5 3.3.2 Placement of IRMA Probe ... 3-7 3.4 Pre-use Check ... 3-7 3.4.1 Zeroing Procedure ... 3-7 3.5 Alarms ... 3-8 3.6 Cleaning... 3-8 3.7 Warnings ... 3-8 3.8 Cautions ... 3-10 3.9 Maintenance Information ... 3-10 Setup... 4-1 4.1 Connect Power Supply ... 4-1 v

4.2 4.3

5

Connect Gas Source ... 4-1 Connect Accessories... 4-2 4.3.1 Connect Patient circuit ... 4-2 4.3.2 Connect Humidifier (optional) ... 4-3 4.3.3 Connect Patient Circuit Positioning Arm (optional) ... 4-3 4.3.4 Connect User Interface Screen... 4-4 4.3.5 Connect Cylinder Kit (optional) ... 4-4 Pre-use Test ... 5-1 5.1 When to carry out pre-use test ... 5-1 5.2 Pre-use Test Procedure... 5-1

6

Ventilator Operation ... 6-1 6.1 Starting Up ... 6-1 6.2 Interface Layout ... 6-4 6.2.1 Standby Interface Layout ... 6-4 6.2.2 Ventilator Interface Layout ... 6-8 6.3 Operation of Main Manu ... 6-14 6.3.1 Ventilation Mode... 6-14 6.3.2 Alarm Limits ... 6-21 6.3.3 Monitoring Data ... 6-25 6.3.4 Lung Mechanics ... 6-25 6.3.5 Log ... 6-27 6.3.6 System ... 6-30 6.4 Operation of Other Shortcut Keys ... 6-47 6.4.1 Inspiratory Hold... 6-48 6.4.2 Expiratory Hold... 6-49 6.4.3 Nebulizer ... 6-49 6.4.4 Manual ... 6-50 6.4.5 Suction... 6-51 6.4.6 Print Screen ... 6-52 6.4.7 Freeze ... 6-53 6.4.8 Screen Lock... 6-53 6.4.9 Alarm Limits ... 6-55 6.5 Ventilation Parameter Set-up ... 6-56 6.6 Turn off the Ventilator ... 6-58

7

Alarms and Troubleshooting ... 7-1 7.1 Alarms ... 7-1 7.2 Alarm Message Table ... 7-1 User Maintenance ... 8-1 8.1 Cleaning and Disinfection ... 8-1 8.1.1 General rules for cleaning and disinfection... 8-1 8.1.2 Expiratory Valve ... 8-2 8.1.3 Reprocessing the expiratory valve in accordance with EN ISO 17664... 8-2 8.1.4 Cleaning and Disinfection Agents ... 8-3 8.1.5 Cleaning and Disinfection of Components ... 8-4 8.1.6 Testing before use ... 8-6

8

vi

8.1.7 Expiratory valve life span... 8-6 8.1.8 Packaged expiratory valve: life span and storage conditions ... 8-7 8.2 Regular Maintenance ... 8-7 8.2.1 Maintenance Principles ... 8-7 8.2.2 Periodic Maintenance Schedule ... 8-7 8.2.3 Service Life of Product/Accessories ... 8-8 8.3 Maintenance in Operation and Transportation... 8-9 8.3.1 Transportation ... 8-9 8.3.2 Storage ... 8-10 8.4 Consumables Replacement ... 8-10 8.4.1 Fuse Replacement ... 8-10 8.4.2 Battery Maintenance... 8-11 8.4.3 Oxygen Sensor ... 8-13 8.4.4 Paramagnetic Oxygen Sensor (optional) ... 8-15 8.4.5 Diaphragm Replacement ... 8-17 8.4.6 One-way Diaphragm Replacement... 8-18 8.4.7 Fan Filter Cotton Replacement ... 8-19 8.4.8 Filter Element of Gas Inlet Replacement ... 8-20 8.4.9 Filter Replacement(Part No.:130003930) ... 8-21 8.5 Disposal ... 8-21 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 11.2.6 Cyber Security Instruction ... 11-4 vii

11.3 11.4 11.5 11.6 11.7

Standard Conditions Specifications ... 11-5 Inspiratory Channel ... 11-5 Expiratory Channel ... 11-5 Monitoring ... 11-6 Alarms ... 11-7 11.7.1 Allowed Alarm Settings ... 11-7 11.7.2 Alarms Miscellaneous ... 11-8 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 ... 11-9 11.9 Trend Function ... 11-9 11.10 Log Function ... 11-10 11.11 Shortcut Key Functions... 11-10 11.12 Communication/Interface ... 11-11 11.12.1 Nurse Call Port... 11-11 11.12.2 Ethernet Port... 11-11 11.12.3 RS-232 Port... 11-12 11.12.4 Nebulizer Output Port ... 11-12 11.12.5 Cyber security description... 11-12 11.13 Accessories ... 11-12 11.14 Ventilating Parameters: Default Values and Allowed Settings (Standard Configuration)11-14 11.15 Delivery Accuracy ... 11-17 12 Pneumatic Diagram... 12-1 13 EMC Guidelines ... 13-1

viii

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 connection, adjustments and repairs. Necessary electrical equipment and the working environment must be in accordance with the national standards, professional standards and the requirements listed in this manual. Equipment must be used as instructed in this manual.

CAUTION: This equipment is not for home use. 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:

WARNING:

CAUTION:

NOTE:

Indicates a condition that can endanger the patient or the ventilator operator. Indicates a condition that can damage the equipment. Indicates points of particular emphasis that make operation of the ventilator 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: Before using the ventilator, carry out pre-use inspection according to Chapter 5 of this manual, and use it only after the function is confirmed to be normal. The user is responsible for the consequences of using the function without performing the function confirmation.

WARNING: Every 6 months after use, the ventilator needs a comprehensive preventive maintenance.

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.

1-2

1 Introduction

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

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

WARNING: If a fault is detected in the ventilator so that its life support functions are no longer assured: start ventilation using an independent ventilation device (resuscitation bag) without delay, if necessary with PEEP and/or increased inspiratory O2 concentration.

WARNING: Before activating any part of the ventilator, be sure to check the equipment for proper operation and, if appropriate, run PUT (pre-use test) as described in this manual, see section 5.

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.

1-3

WARNING: Assure that hoses used have the appropriate resistance and compliance to ensure proper therapy.

WARNING: Do not disconnect the cable between the Main Control Unit and the GUI screen while Ventilator is operating.

WARNING: The ventilator must not be connected to any anti-static or electrically conductive hoses, tubing or conduit

WARNING: Adding attachments or other components or sub-assemblies to the ventilator breathing system can change the pressure gradient across the ventilator breathing system and that such changes to the ventilation breathing system can affect the ventilator performance.

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

WARNING: Use caution when handling flammable or fragile components.

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

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

1.4.2 Cautions

CAUTION: The breathing circuit must not be connected 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. 1-4

1 Introduction

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.

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. 1-5

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.

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

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

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

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

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

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

1-6

1 Introduction

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 for proper use of Mainstream CO2 Adapter.

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

NOTE: All gas volume, flow, and leakage specifications in this manual are expressed at STPD (standard temperature and pressure dry), except when specified with another condition.

NOTE: Users do not need to pay attention to the "Data Lost 3008" event information in the log, which has no impact on machine performance. NOTE: Do not touch the switch while the machine is running.

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. 1-7

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.

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)

1-8

1 Introduction

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)

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) 1-9

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 (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:

1-10

1 Introduction

On (Power)

Protection Class Type B

Off (Power)

Protection Class Type BF

Follow operating instructions

Warning & Caution

Protective earth ground

Dangerous voltage

EQUIPOTENTIAL connection

loudspeaker

Lock

Manufacturer

Unlock

Date of production

Inspiratory hold

Serial Number

Nebulization

Expiratory hold

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 1-11

Adult

Manual trigger

NIV modes

Child

Main Menu

Invasive modes

Neonate

Alarm Silence Key

Do not reuse

Disposal of Waste

Ingress Protection IP21

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, DC Power Source or Utilize Battery

2. Connect Gas Source 3. Power on Ventilator Switch Ventilator on by turning to:

1-12

1 Introduction

4. Technical Test

5. Pre-use Test

6. Select New Patient

1-13