VG70 Service Manual Edition 01.04 May 2018

6.2

Main Assemblies Disassemble ...6-1 6.2.1 Disassembling of the Display from the Host ...6-1 6.2.2 Disassembling of the Host from the Trolley ...6-2 6.2.3 Disassembling of the Arm Assembly from the Host ...6-3 6.2.4 Disassembling of the Humidification Assembly from the Host ...6-4 6.3 Disassembling of Maintenance Spare Parts ...6-5 6.3.1 Disassembling of Oxygen Sensor ...6-5 6.3.2 Disassembling of Pressure Sensor Board ...6-6 6.3.3 Disassembling of Supply O2 Assembly...6-7 6.3.4 Disassembling of TSI Mass Flow Sensor ...6-9 6.3.5 Disassembling of Differential Pressure Transmitter ... 6-10 6.3.6 Disassembling of Diaphragm and Scale Board ... 6-12 6.3.7 Disassembling of Core Board and Main Control Board ... 6-13 6.3.8 Disassembling of Components in the Display ... 6-14 6.3.9 Disassembling of Electric Panel Assembly... 6-16 6.3.10 Disassembling of One-way Diaphragm... 6-17 6.3.11 Disassembling of Fan Filter Cotton ... 6-18 6.3.12 Disassembling of Filter Element of Gas Inlet... 6-19 6.3.13 Disassembling of Filter (Part No.:130003930)... 6-20 6.4 Functional Testing ... 6-21

7 User Maintenance ... 7-1 7.1

7.2

7.3

7.4 7.5

7.6

ii

Cleaning and Disinfection ...7-2 7.1.1 Cleaning and Disinfecting Agents/ Autoclaving...7-3 7.1.2 Cleaning and Disinfection Methods ...7-3 7.1.3 Cleaning and Disinfection of Components ...7-4 Regular Maintenance ...7-6 7.2.1 Maintenance Principles ...7-6 7.2.2 User Maintenance ...7-6 7.2.3 Service Life of Product/Accessories...7-7 Maintenance in Operation and Transportation...7-8 7.3.1 Transportation ...7-8 7.3.2 Storage ...7-9 Fuse Replacement ...7-9 Battery Maintenance... 7-10 7.5.1 Battery Specification ... 7-10 7.5.2 Precautions... 7-11 7.5.3 Battery Storage ... 7-11 7.5.4 Battery Replacement ... 7-11 7.5.5 Battery Charging and Calibration ... 7-12 Oxygen Sensor ... 7-12 7.6.1 Oxygen Sensor Replacement ... 7-12 7.6.2 Oxygen Sensor Calibration ... 7-13 7.6.3 Technical Specifications of Oxygen Sensor ... 7-13

7.6.4 Oxygen Sensor Maintenance... 7-14 7.7 Paramagnetic Oxygen Sensor (optional) ... 7-14 7.7.1 Paramagnetic Oxygen Sensor Calibration ... 7-15 7.7.2 Technical Specifications of Paramagnetic Oxygen Sensor ... 7-15 7.8 Disposal ... 7-16 7.9 Manufacturing techniques and materials: ... 7-16 7.10 Free Obligations: ... 7-17 7.11 Security, reliability and operating condition: ... 7-17 7.12 Return... 7-17

8 Pre-Use Test ... 8-1 8.1 8.2

Pre-use test procedure ...8-1 Pre-use test failure analysis ...8-2

9 Network ... 9-1 9.1 9.2 9.3 9.4 9.5 9.6

10

Overview ...9-1 What is Exported? ...9-1 Establishing a Connection ...9-1 Interface Instructions ...9-2 Transmits and Receives Data ...9-4 Troubleshooting ...9-5

Service Menu ... 10-1 10.1

Calibration ... 10-2 10.1.1 Calibration operation guidance ... 10-2 10.1.2 Calibration failure analysis ... 10-8 10.2 Event/Alarm Log ... 10-9 10.3 Machine Information ... 10-10 10.4 Language ... 10-10 10.5 Test Page... 10-10 10.5.1 Demo ... 10-11 10.5.2 Vlt. Monitor ... 10-11 10.5.3 Schematic ... 10-12 10.5.4 Cali. Data ... 10-13 10.5.5 Service Timer ... 10-13 10.5.6 Error Code ... 10-14 10.5.7 PT100 Cali. ... 10-14 10.6 Update ... 10-15 10.7 Optional... 10-16

11

Troubleshooting... 11-1 11.1

Technical Error ... 11-1 11.1.1 Technical Test Error Code ... 11-1 11.1.2 Other Errors... 11-4 iii

11.1.3

Service Tools ... 11-4

12

Appendix A Contact & Ordering Information ... 12-1

13

Appendix B Diagrams and Schematics... 13-1

14

Appendix C Specifications ... 14-1

15

Appendix D Spare parts and configurations ... 15-1

iv

1 Safety Information

1 Safety Information The operator of this ventilator must recognize their full responsibility for choosing appropriate ventilation settings to ensure proper ventilation and patient safety. The responsibility for the selection of the appropriate level of patient monitoring depends solely on the equipment operator. All the monitoring information is for reference only; it should not be used as the sole basis for therapeutic or diagnostic decisions. Whenever a patient is connected to the ventilator, constant attention by qualified medical personnel is required in order to provide immediate corrective action in case of a malfunction and alarm occurrence. Terms This manual uses three special indicators to convey information of a specific nature. They include:

WARNING:

Identify conditions or practices that could result in serious adverse reactions or potential safety hazards.

CAUTION:

Identify conditions or practices that could result in damage to the ventilator or other equipment

NOTE:

Identify supplemental information to help you better understand how the ventilator works.

WARNING: Do not use the system until you have read and understood this manual including:    

All connections of the system All warnings and cautions Operation procedure of each and every component of the system Test procedure of each and every component of the system

WARNING: The VG70 Ventilator System is intended for use by authorized and trained medical personnel only.

WARNING: The users must familiarize themselves with the operation and use of this machine prior to first clinical use with a patient. 1-1

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

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

WARNING: If a fault is detected in the VG70 ventilator so that its life support functions are no longer assured: start ventilation using an independent ventilation device (resuscitation bag) without delay, if necessary with PEEP and/or increased inspiratory O2 concentration.

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

WARNING: The VG70 ventilator is not intended to be a comprehensive monitoring device and does not activate alarms for all types of dangerous conditions for patients on life-support equipment.

WARNING: Patients on life-support equipment must be appropriately monitored by competent medical personnel and suitable monitoring devices at all times.

WARNING: An alternative source of ventilation, such as manual respiratory equipment, should always be available when using the VG70 ventilator.

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

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

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

1-2

1 Safety Information

WARNING: Disposable breathing hoses shall not be reused. Reuse of the single use hoses can cause cross infection.

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

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

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

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

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

WARNING: Use caution when handling flammable or fragile components.

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

WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth. CAUTION: The breathing circuit must not be installed whenever the VG70 powers up and whenever a pre-use test is performed.

CAUTION: If the system test fails, do not use the system. Attempt to troubleshoot and fix the failure. If you are unable to fix the device, ask an authorized service representative to repair the device.

1-3

CAUTION: Check the ventilator periodically as outlined in this manual; do not use if defective. Immediately replace parts that are broken, missing, obviously worn, distorted, or contaminated.

CAUTION: Do not put ventilator into service until the patient setup is complete.

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

CAUTION: Do not use oxygen hoses that are worn, frayed, or contaminated by combustible materials such as grease or oils. Textiles, oils, and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen.

CAUTION: Follow your hospital infection control guidelines for handling infectious material. Aeonmed recognizes that cleaning, sterilization, sanitation, and disinfection practices vary widely among health care institutions. It is not possible for Aeonmed to specify or require specific practices that will meet all needs, or to be responsible for the effectiveness of cleaning, sterilization, and other practices carried out in the patient care setting.

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

CAUTION: To avoid an electrical shock hazard while servicing the ventilator, be sure to remove all power to the ventilator by disconnecting the power source and turning off all ventilator power switches.

CAUTION: To avoid a fire hazard, keep matches, lighted cigarettes, and all other sources of ignition (e.g., flammable anesthetics and/or heaters) away from the ventilator and oxygen hoses.

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

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

1-4

1 Safety Information

CAUTION: Do not use the VG70 Ventilator in a MRI environment.

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

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

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

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

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

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

CAUTION: Batteries should be removed if equipment will not be in service for more than 6 months.

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

CAUTION: When ventilator is exposed to conditions outside the specified operating environment, allow 24 hours in normal environment before using. CAUTION: Storage environment: -20℃~+60℃ and ≤95%RH.

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

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

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

CAUTION: When using a humidifier, user should frequently check the water trap and look for water in the hose. If water is found in the hose, this water should be removed. 1-5

Also, it is important the water trap is positioned in a way such that it is lower than the patient tubes.

CAUTION: Connecting electrical equipment to auxiliary outlet effectively leads to creating a medical equipment system, and can result in a reduced level of safety, make sure the ME SYSTEM comply with requirements of IEC 60601-1:2005. The user who connects is responsible for the standard for the requirements applicable to the medical equipment system. CAUTION: USA Federal law restricts this device for sale by or on the order of a physician. NOTE: The user of this product shall have sole responsibility for any ventilator malfunction due to operation or maintenance performed by anyone not trained by Aeonmed.

NOTE: Usage of a filter on the expiratory side will increase the resistance of the patient circuit.

NOTE: In non-invasive (NIV) ventilation, the exhaled volume of the patient can differ from the measured exhaled volume due to leaks around the mask

NOTE: Do not sterilize or immerse the Mainstream CO2 Adapter in any fluids.

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

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

1-6

2 Notices

2 Notices 2.1

Warranty Notice

Do not make any service repairs on this equipment during the states warranty period. Any unauthorized work immediately voids the warranty. Aeonmed will not be liable for any repairs attempted by the owner. Any such attempted repairs other than specified no warranty repairs void the warranty.

2.2

Copyright Notice

Copyright Notice: Aeonmed. This work is protected the copyright law and is the sole property of the Company. No part of this document permitted to be copied or otherwise reproduced, translated into other languages, or stored in any electronic information retrieval system, without the prior written consent of the Company.

2.3

EMC Notice

This equipment can radiate radio frequency energy ,as well can be interfered by electromagnetic If not installed and used in accordance with the instructions mentioned in the manual, electromagnetic interference may result. The equipment has been tested and found to comply with the limits set forth in EN60601-1-2 for Medical Products. These limits provide reasonable protection against electromagnetic interference when operated in the intended use environments described in this manual. The ventilator has been tested to conform to the following specifications: MIL-STD-461D: 1993, MIL-STD-462D:1993, EN 55011:2007+A2:2007, IEC 1000-4-2: 1994, IEC 1000-4-3:1994 IEC 1000-4-4:1994, IEC 1000-4-5:1994, QUASI-STATIC:1993 This ventilator is also designed and manufactured to comply with the safety requirements of IEC 60601-1, IEC 60601-2-12, CAN/CSA C22.2 No. 601.1-M90, and UL 60601-1.

2.4

MRI Notice

This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic fields. Do not operate the ventilator in a MRI environment or in 2-1

the vicinity of high-frequency surgical diathermy equipment, defibrillators, or short-wave therapy equipment. Electromagnetic interference could disrupt the operation of the ventilator.

2.5

Intended Use Notice

The VG70 Critical Care Ventilator is intended for patients ranging from pediatric to adult, and for use in a wide variety of clinical conditions. Specifically, the VG70 Critical Care Ventilator is applicable for adult and pediatric patients weighing at least 5 kg for adult and 3 Kg for child (7lbs.), who require the following types of ventilatory support: Positive Pressure Ventilation, delivered invasively (by ET or Tracheotomy tube) or non-invasively (by mask) via Assist/Control, SIMV, CPAP and other modes of ventilation. The VG70 Critical Care Ventilator is intended for use in hospital and hospital-type facilities. It may be used during intra-hospital transport provided that electrical power and compressed gas are supplied. WARNING: The VG70 Ventilator is not designed for use in an MRI environment. Do not use the VG70 Ventilator near an MRI machine or injury or equipment damage could result. WARNING: The user of the Ventilator must be professional and trained.

2.6

IEC Classification

Type of Equipment: Medical Equipment, Class I, Type B. Adult/Pediatric Lung Ventilator

2.7

Declaration of Conformity Notice

This medical equipment complies with the Medical Device Directive, 93/42/EEC, and the following Technical Standards, to which Conformity is declared: IEC 60601-1: The device classification is: Class I, Type B applied part (ventilator breathing circuit and mask), type BF applied part (CO2 module), ordinary enclosed equipment without protection against ingress of liquids, continuous operation ISO 80601-2-12 IEC 60601-1

2-2

3 Equipment Symbols

3 Equipment Symbols Warnings and

Cautions indicate all the possible dangers in case of violation of the

stipulations in this manual. Refer to and follow them.

Warnings Indicate potential hazards to operators or patients.

Cautions Indicate potential damage to equipment. Instead of illustrations, symbols may be utilized. Not all of these symbols may necessarily appear on the equipment or in this User manual. The symbols include:

On (Power)

Protection Class Type B

Off (Power)

Protection Class Type BF

Follow operating instructions

Warning & Caution

Protective earth ground

Dangerous voltage

EQUIPOTENTIAL connection

loudspeaker

Lock

Manufacturer

Unlock

Date of production

Inspiratory hold

Serial Number

3-1

Nebulization

Expiratory hold

Intelligent increase of oxygen

Manual inspiration

Standby

Waveform freeze

AC power

Internal Battery

USB device

Refer to documentation

Prompt message

Already online

Flow trigger

Pressure trigger

Adult

Manual trigger

NIV modes

Child

Main Menu

Invasive modes

neonate

Alarm Silence Key

Do not reuse

Disposal of Waste

The system, with this label under the stipulations in the operating manual, complies with the requirements related from 93/42/EEC. 0123 is the certificate number to certify authorizations

3-2

int.

4 Introduction

4 Introduction 4.1

General description

The VG70 Critical Care Ventilator System consists of two required components: a Main Control Unit and a Graphical User Interface (GUI). Optional Components available for the VG70 Critical Care Ventilator system are: Ventilator Cart, Gas Cylinder Transport Cart, Patient Circuit Positioning Arm, and Hose Assemblies for O2, CO2 monitoring subsystem, etc.

1

Main Control Unit

2

Humidifier

3

Patient Circuit

4

Water Trap

5

Nebulizer Tube

6

Y-piece

7

Test Lung

8

Mask

9

Connector

10

Nebulizer Connector

11

Patient Circuit Positioning Arm

4-1

4.2

Abbreviations and Definitions

(S)

Means Set Value

(M)

Means Measured Value

CPAP

Continuous Positive Airway Pressure (Set value, hereinafter “S”)

F

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

fspont

spontaneous respiratory frequency (Measured

value,

hereinafter “M”) Total breath rate, i.e. the sum of breath rate f and spontaneous breath

ftotal

rate fspont(M)

O2

Inspiratory O2 concentration (S & M)

I:E

The ratio of Inspiration to Expiration (M)

MV

Expiratory minute volume (M)

MVspont

Spontaneously breathed minute volume(M)

MVleak

Leakage minute volume (M)

Paw

Patient airway pressure (M) Positive End-Expiratory Pressure, which can improve the patient’s

PEEP oxygenation (S & M) PEEPi

Intrinsic Positive End-Expiratory Pressure (M)

Pinsp

Upper pressure level in PCV mode (S) Mean airway pressure. This value is updated at the end of the last

Pmean

4-2

respiratory cycle, hence, is a continuous average (M)

Ppeak

Airway pressure peak value during one ventilatory cycle (M)

Pplat

End-inspiratory airway pressure (M)

Pmin

Minimum airway pressure (M)

Psens

Pressure sensitivity (S)

4 Introduction

Psupp

Pressure support (S)

Phigh

Upper pressure level in BIVENT and APRV (S)

Plow

Lower pressure level in BIVENT and APRV (S)

T Imax

Maximum inspiratory time (S)

Tinsp

Inspiratory Time (S) Inspiratory Pause Time, to increase the inspiratory time to improve the

T pause

patient’s oxygenation (S) Trigger by flow rate (S)

VT

Tidal volume of mechanical ventilation (S)

VTE

Expiratory tidal volume (M)

VTI

Inspiratory tidal volume (M)

Esens

Expiratory trigger sensitivity (S)

ETCO2

End-expiratory CO2 concentration (M)

WOB

Work of breathing (M)

R*C

Time constant (M)

Leak%

Leakage percentage (M)

Cdyn

Dynamic compliance (M)

Cstatic

Static compliance (M)

Rinsp

Inspiratoryresistance (M)

Rexp

Expiratory resistance (M)

Elastic

Elastic resistance (M)

IP21

Solid particle protection level 2; Liquid ingress protection level 1

4-3

5 Theory of Operation

5 Theory of Operation 5.1

Pneumatic System

5.1.1 Pneumatic Theory

5-1

Figure 5-1 Pneumatic Theory

5-2

5 Theory of Operation

5.1.2 Main Pneumatic Assemblies Overview

4 1

2 3

Figure 5-2 Main Airway Assemblies sketch view 1

Turbine driver

2

Expiratory valve module

3

Gas circuit module

4

Electrical box

5-3