SynoVent E3 Ventilator
Operator’s Manual
© 2010-2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved. For this Operator’s Manual, the issue date is April, 2014.
I
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.
,
,
and SynoVent are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.
II
Responsibility on the Manufacturer Party
Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this product, only if:
all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;
the electrical installation of the relevant room complies with the applicable national and local requirements;and
the product is used in accordance with the instructions for use.
WARNING
It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or personal injury.
NOTE
This equipment must be operated by skilled/trained clinical professionals.
III
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:
Malfunction or damage caused by improper use or man-made failure.
Malfunction or damage caused by unstable or out-of-range power input.
Malfunction or damage caused by force majeure such as fire and earthquake.
Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.
Malfunction of the instrument or part whose serial number is not legible enough.
Others not caused by instrument or part itself.
IV
Customer Service Department
Manufacturer: |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Address: |
Mindray Building,Keji 12th Road South,High-tech industrial |
|
park,Nanshan,Shenzhen 518057,P.R.China |
Website: |
www.mindray.com |
E-mail Address: |
service@mindray.com |
Tel: |
+86 755 81888998 |
Fax: |
+86 755 26582680 |
EC-Representative: |
Shanghai International Holding Corp. GmbH(Europe) |
Address: |
Eiffestraβe 80, 20537 Hamburg, GERMANY |
Tel: |
0049-40-2513175 |
Fax: |
0049-40-255726 |
V
Preface
Manual Purpose
This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use. Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety.
This manual is based on the maximum configuration and therefore some contents may not apply to your product. If you have any question, please contact us.
This manual is an integral part of the product. It should always be kept close to the equipment so that it can be obtained conveniently when needed.
Intended Audience
This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures, practices and terminology as required for monitoring of critically ill patients.
Illustrations
All illustrations in this manual serve as examples only. They may not necessarily reflect the setup or data displayed on your ventillator.
Conventions
Italic text is used in this manual to quote the referenced chapters or sections.
[ ] is used to enclose screen texts.
→ is used to indicate operational procedures.
Password
A password is required to access different modes within the ventilator machine.
User maintenance: 1234
VI
Table of Conetents
1 Safety................................................................................................................................. |
1-1 |
|
1.1 |
Safety Information .......................................................................................................... |
1-1 |
|
1.1.1 Dangers .............................................................................................................. |
1-2 |
|
1.1.2 Warnings............................................................................................................. |
1-2 |
|
1.1.3 Cautions ............................................................................................................. |
1-4 |
|
1.1.4 Notes .................................................................................................................. |
1-6 |
1.2 |
Equipment Symbols ........................................................................................................ |
1-7 |
2 The Basics ......................................................................................................................... |
2-1 |
|
2.1 |
System Description ......................................................................................................... |
2-1 |
|
2.1.1 Intended Use....................................................................................................... |
2-1 |
|
2.1.2 Contraindications ............................................................................................... |
2-1 |
|
2.1.3 Components ....................................................................................................... |
2-1 |
2.2 |
Equipment Appearance ................................................................................................... |
2-2 |
|
2.2.1 Front View.......................................................................................................... |
2-2 |
|
2.2.2 Rear View........................................................................................................... |
2-4 |
|
2.2.3 Air Compressor .................................................................................................. |
2-5 |
3 Installations and Connections ......................................................................................... |
3-1 |
|
3.1 |
Connect the Power Supply .............................................................................................. |
3-1 |
|
3.1.1 Connect the System Power Supply .................................................................... |
3-1 |
|
3.1.2 Connect the Main Unit Power Supply................................................................ |
3-2 |
|
3.1.3 Connect the Compressor Power Supply............................................................. |
3-3 |
3.2 |
Connect the Gas Supply .................................................................................................. |
3-4 |
3.3 |
Install the Support Arm ................................................................................................... |
3-5 |
3.4 |
Install the Water Traps..................................................................................................... |
3-7 |
3.5 |
Install the Breathing Hoses ............................................................................................. |
3-8 |
3.6 |
Install the Humidifier ...................................................................................................... |
3-9 |
|
3.6.1 Install the Humidifier onto the Ventilator........................................................... |
3-9 |
|
3.6.2 Install the Humidifier onto the Pendant ............................................................ |
3-11 |
3.7 |
Install the Nebulizer ...................................................................................................... |
3-12 |
3.8 |
Install the CO2 Module................................................................................................. |
3-13 |
3.9 |
Install the O2 Sensor ..................................................................................................... |
3-14 |
4 User Interface ................................................................................................................... |
4-1 |
|
4.1 |
Display Controls ............................................................................................................. |
4-1 |
|
4.1.1 Display ............................................................................................................... |
4-2 |
|
4.1.2 Fixed Hard Keys ................................................................................................ |
4-4 |
4.2 Waveforms Screen........................................................................................................... |
4-6 |
|
4.3 |
Spirometry Loops Screen................................................................................................ |
4-7 |
4.4 |
Graphic Trend Screen...................................................................................................... |
4-8 |
|
|
|
|
|
1 |
4.5 |
Tabular Trend Screen .................................................................................................... |
4-10 |
4.6 |
Measured Values Screen................................................................................................. |
4-11 |
4.7 |
Freeze............................................................................................................................ |
4-12 |
5 System Settings................................................................................................................. |
5-1 |
|
5.1 |
Change Display Settings ................................................................................................. |
5-1 |
|
5.1.1 Waveforms ......................................................................................................... |
5-1 |
|
5.1.2 Spirometry Loops............................................................................................... |
5-1 |
|
5.1.3 Measured Values ................................................................................................ |
5-1 |
|
5.1.4 Colors ................................................................................................................. |
5-2 |
5.2 |
Set Date and Time ........................................................................................................... |
5-3 |
5.3 |
Change Language............................................................................................................ |
5-3 |
5.4 Adjust Screen Brightness ................................................................................................ |
5-3 |
|
5.5 Adjust Key Volume ......................................................................................................... |
5-3 |
|
5.6 |
Set Unit ........................................................................................................................... |
5-3 |
|
5.6.1 Set Weight Unit .................................................................................................. |
5-3 |
|
5.6.2 Set Paw Unit....................................................................................................... |
5-4 |
|
5.6.3 Set CO2 Unit...................................................................................................... |
5-4 |
5.7 |
Turning on/off O2% Monitoring ..................................................................................... |
5-4 |
5.8 |
Select Tinsp/I:E ............................................................................................................... |
5-4 |
5.9 |
Set TV/f Source............................................................................................................... |
5-4 |
5.10 Set Sigh ......................................................................................................................... |
5-4 |
|
5.11 Set IP Address ............................................................................................................... |
5-5 |
|
5.12 Manage Configurations................................................................................................. |
5-5 |
|
|
5.12.1 Restore the Latest Configuration Automatically .............................................. |
5-5 |
|
5.12.2 Set Power-on Default Configuration................................................................ |
5-5 |
|
5.12.3 Save as User Configuration.............................................................................. |
5-6 |
|
5.12.4 Load Configuration Manually.......................................................................... |
5-6 |
5.13 View System Information.............................................................................................. |
5-6 |
|
|
5.13.1 Version Information.......................................................................................... |
5-6 |
|
5.13.2 Configuration Information ............................................................................... |
5-6 |
|
5.13.3 System Check Results ...................................................................................... |
5-6 |
|
5.13.4 Maintenance Information ................................................................................. |
5-6 |
5.14 Export............................................................................................................................ |
5-7 |
|
|
5.14.1 Export Screen ................................................................................................... |
5-7 |
|
5.14.2 Export Data ...................................................................................................... |
5-7 |
6 Start Ventilation................................................................................................................ |
6-1 |
|
6.1 |
Turn on the System ......................................................................................................... |
6-1 |
6.2 |
Preoperative Test............................................................................................................. |
6-1 |
|
6.2.1 AC Power and Battery Power Source Switch Test............................................. |
6-1 |
|
6.2.2 Pipeline Tests...................................................................................................... |
6-1 |
6.3 |
Power on Self-test ........................................................................................................... |
6-2 |
6.4 |
System Check.................................................................................................................. |
6-2 |
6.5 |
Select Patient................................................................................................................... |
6-3 |
|
|
|
|
2 |
|
6.6 |
Ventilation Type .............................................................................................................. |
6-4 |
|
6.6.1 Invasive Ventilation............................................................................................ |
6-4 |
|
6.6.2 NIV (non-invasive ventilation) .......................................................................... |
6-5 |
|
6.6.3 Set Ventilation Type ........................................................................................... |
6-5 |
6.7 |
Ventilation Mode............................................................................................................. |
6-6 |
|
6.7.1 Ventilation Mode and Parameter Setup .............................................................. |
6-6 |
|
6.7.2 Apnea Ventilation ............................................................................................... |
6-7 |
|
6.7.3 IntelliCycle......................................................................................................... |
6-8 |
|
6.7.4 V-A/C ................................................................................................................. |
6-8 |
|
6.7.5 P-A/C ............................................................................................................... |
6-10 |
|
6.7.6 CPAP/PSV......................................................................................................... |
6-11 |
|
6.7.7 V-SIMV and P-SIMV....................................................................................... |
6-13 |
|
6.7.8 PRVC................................................................................................................ |
6-16 |
|
6.7.9 DuoLevel.......................................................................................................... |
6-17 |
|
6.7.10 APRV.............................................................................................................. |
6-19 |
6.8 |
Change Alarm Limits .................................................................................................... |
6-20 |
6.9 |
Ventilate the Patient....................................................................................................... |
6-20 |
6.10 Ventilation Parameters Monitoring ............................................................................. |
6-21 |
|
6.11 Enter Standby .............................................................................................................. |
6-23 |
|
6.12 Turn the System off..................................................................................................... |
6-24 |
|
7 CO2 Monitoring ............................................................................................................... |
7-1 |
|
7.1 |
Introduction..................................................................................................................... |
7-1 |
7.2 |
Prepare to Measure CO2 ................................................................................................. |
7-2 |
7.3 |
Make CO2 Settings ......................................................................................................... |
7-3 |
|
7.3.1 Set Working Mode.............................................................................................. |
7-4 |
|
7.3.2 Set Pump Rate.................................................................................................... |
7-4 |
|
7.3.3 Set Unit .............................................................................................................. |
7-4 |
|
7.3.4 Set Humidity Compensation .............................................................................. |
7-5 |
|
7.3.5 Restore Defaults................................................................................................. |
7-5 |
|
7.3.6 Set CO2 Waveform ............................................................................................ |
7-5 |
7.4 |
Measurement Limitations................................................................................................ |
7-5 |
7.5 |
Troubleshooting .............................................................................................................. |
7-6 |
7.6 |
Zero the Sensor ............................................................................................................... |
7-6 |
7.7 |
Calibrate the Sensor ........................................................................................................ |
7-6 |
8 Special Functions.............................................................................................................. |
8-1 |
|
8.1 |
Manual Breath................................................................................................................. |
8-1 |
8.2 |
Expiration Hold............................................................................................................... |
8-1 |
8.3 |
Inspiration Hold .............................................................................................................. |
8-2 |
8.4 |
Nebulizer......................................................................................................................... |
8-2 |
8.5 |
O2↑................................................................................................................................ |
8-3 |
8.6 |
Suction ............................................................................................................................ |
8-3 |
8.7 |
P0.1 ................................................................................................................................. |
8-4 |
8.8 |
NIF .................................................................................................................................. |
8-4 |
|
|
|
|
3 |
|
8.9 PEEPi .............................................................................................................................. |
8-5 |
8.10 P-V Tool ........................................................................................................................ |
8-5 |
9 Alarms ............................................................................................................................... |
9-1 |
9.1 Introduction..................................................................................................................... |
9-1 |
9.2 Alarm Categories............................................................................................................. |
9-1 |
9.3 Alarm Levels ................................................................................................................... |
9-2 |
9.4 Alarm Indicators.............................................................................................................. |
9-2 |
9.4.1 Alarm Lamp ....................................................................................................... |
9-2 |
9.4.2 Audible Alarm Tones.......................................................................................... |
9-3 |
9.4.3 Alarm Message................................................................................................... |
9-3 |
9.4.4 Flashing Alarm Numeric .................................................................................... |
9-3 |
9.4.5 Alarm Status Symbol.......................................................................................... |
9-4 |
9.5 Set Alarm Volume ........................................................................................................... |
9-4 |
9.6 Set Alarm Limits ............................................................................................................. |
9-4 |
9.7 Set Apnea Time ............................................................................................................... |
9-5 |
9.8 Alarm Silence.................................................................................................................. |
9-5 |
9.8.1 How to Set Alarm Silence .................................................................................. |
9-5 |
9.8.2 How to Cancel Alarm Silence ............................................................................ |
9-5 |
9.9 Alarm Reset..................................................................................................................... |
9-6 |
9.10 Nurse Call ..................................................................................................................... |
9-6 |
9.11 Alarm Test ..................................................................................................................... |
9-7 |
9.11.1 Battery in Use Alarm........................................................................................ |
9-7 |
9.11.2 Battery Depletion Alarm .................................................................................. |
9-7 |
9.11.3 Paw Too High Alarm........................................................................................ |
9-8 |
9.11.4 TV Not Achieved Alarm................................................................................... |
9-8 |
9.11.5 MV Too Low Alarm ......................................................................................... |
9-8 |
9.11.6 O2 Supply Pressure Low Alarm....................................................................... |
9-8 |
9.11.7 Air Supply Pressure Low Alarm....................................................................... |
9-9 |
9.11.8 Airway Obstructed Alarm................................................................................. |
9-9 |
9.11.9 FiO2 Too High Alarm....................................................................................... |
9-9 |
9.11.10 FiO2 Too Low Alarm ..................................................................................... |
9-9 |
9.11.11 EtCO2 Too High Alarm.................................................................................. |
9-9 |
9.11.12 EtCO2 Too Low Alarm ................................................................................ |
9-10 |
9.12 Alarm Logbook ........................................................................................................... |
9-10 |
9.13 When an Alarm Occurs ................................................................................................ |
9-11 |
10 Cleaning and Disinfection............................................................................................ |
10-1 |
10.1 Methods for Cleaning and Disinfection ...................................................................... |
10-2 |
10.2 Disassemble the Ventilator’s Cleanable Parts ............................................................. |
10-4 |
10.2.1 Expiration Valve Assembly ............................................................................ |
10-4 |
10.2.2 Expiration Valve Flow Sensor........................................................................ |
10-5 |
10.2.3 Water Trap ...................................................................................................... |
10-6 |
10.2.4 Breathing Hoses ............................................................................................. |
10-7 |
10.2.5 Nebulizer........................................................................................................ |
10-8 |
|
|
4 |
|
10.2.6 Humidifier...................................................................................................... |
10-9 |
10.2.7 O2 Sensor..................................................................................................... |
10-12 |
11 Maintenance................................................................................................................... |
11-1 |
11.1 Repair Policy................................................................................................................ |
11-1 |
11.2 Maintenance Schedule.................................................................................................. |
11-2 |
11.3 Pressure and Flow Zeroing........................................................................................... |
11-3 |
11.4 Flow Sensor Calibration............................................................................................... |
11-4 |
11.5 O2 Concentration Calibration ...................................................................................... |
11-5 |
11.6 CO2 Module Calibration.............................................................................................. |
11-6 |
11.7 Touch Screen Calibration ............................................................................................. |
11-7 |
11.8 Battery Maintenance .................................................................................................... |
11-7 |
11.8.1 Battery Use Guidance...................................................................................... |
11-8 |
11.8.2 Battery Performance Conditioning.................................................................. |
11-9 |
11.8.3 Battery Performance Checking........................................................................ |
11-9 |
11.8.4 Battery Recycling.......................................................................................... |
11-10 |
11.9 Electrical Safety Inspection........................................................................................ |
11-10 |
11.9.1 Auxiliary Electrical Outlet Test ..................................................................... |
11-10 |
11.9.2 Electrical Safety Inspection Test ................................................................... |
11-11 |
11.10 Water Build-up in the Flow Sensor .......................................................................... |
11-12 |
11.10.1 Prevent Water Build-up ............................................................................... |
11-12 |
11.10.2 Clear Water Build-up................................................................................... |
11-12 |
12 Accessories .................................................................................................................... |
12-1 |
A Theory of Operation....................................................................................................... |
A-1 |
A.1 Pneumatic System ......................................................................................................... |
A-1 |
A.2 Electrical System........................................................................................................... |
A-6 |
B Product Specifications..................................................................................................... |
B-1 |
B.1 Safety Specifications ...................................................................................................... |
B-1 |
B.2 Environmental Specifications......................................................................................... |
B-2 |
B.3 Power Requirements....................................................................................................... |
B-2 |
B.4 Physical Specifications................................................................................................... |
B-3 |
B.5 Pneumatic System Specifications................................................................................... |
B-4 |
B.6 Ventilator Specifications................................................................................................. |
B-5 |
B.7 Ventilator Accuracy ........................................................................................................ |
B-7 |
B.8 Alarms ............................................................................................................................ |
B-9 |
B.9 Special Functions ......................................................................................................... |
B-10 |
B.10 CO2 Module Specifications ........................................................................................ |
B-11 |
B.11 Compressor Specifications ......................................................................................... |
B-12 |
B.12 O2 Sensor Specifications ............................................................................................ |
B-12 |
C EMC ................................................................................................................................ |
C-1 |
D Alarm Messages.............................................................................................................. |
D-1 |
|
|
5 |
|
D.1 Physiological Alarm Messages...................................................................................... |
D-1 |
D.2 Technical Alarm Messages............................................................................................ |
D-2 |
E Factory Defaults .............................................................................................................. |
E-1 |
E.1 CO2 Module ................................................................................................................... |
E-1 |
E.2 Alarm .............................................................................................................................. |
E-1 |
E.3 Ventilation Mode ............................................................................................................ |
E-2 |
F Symbols and Abbreviations............................................................................................. |
F-1 |
F.1 Symbols........................................................................................................................... |
F-1 |
F.2 Abbreviations .................................................................................................................. |
F-3 |
6
1 Safety
1.1 Safety Information
DANGER
Indicates an imminent hazard that, if not avoided, will result in death or serious injury.
WARNING
Indicates a potential hazard or unsafe practice that, if not avoided, could result in death or serious injury.
CAUTION
Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.
NOTE
Provides application tips or other useful information to ensure that you get the most from your product.
1-1
1.1.1 Dangers
There are no dangers that refer to the product in general. Specific “Danger” statements may be given in the respective sections of this manual.
1.1.2 Warnings
WARNING
The ventilator must only be operated and used by authorized medical personnel well trained in the use of this product. It must be operated strictly following the Operator’s Manual.
Before putting the system into operation, the operator must verify that the equipment, connecting cables and accessories are in correct working order and operating condition.
To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth.
Use AC power source before the batteries are depleted.
To avoid explosion hazard, do not use the equipment in the presence of flammable anesthetic agent, vapors or liquids.
Do not place the ventilator adjacent to any barrier, which can prevent cold air from flowing, resulting in equipment overheat.
Do not open the equipment housings. All servicing and future upgrades must be carried out by the personnel trained and authorized by us only.
Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level may result in a hazard to the patient. Remember that alarm settings should be customized according to different patient situations and always keeping the patient under close surveillance is the most reliable way for safe patient monitoring.
The physiological parameters and alarm messages displayed on the screen of the equipment are for doctor’s reference only and cannot be directly used as the basis for clinical treatment.
Dispose of the package material, observing the applicable waste control regulations and keeping it out of children’s reach.
All staff should be aware that disassembling or cleaning some parts of the ventilator can cause risk of infection.
Maintenance mode should be used only when the equipment is not connected to a patient.
1-2
WARNING
Positive pressure breathing may be accompanied by some side effects such as barotrauma, hypoventilation, hyperventilation etc.
Using the ventilator in the vicinity of high-frequency electrosurgery units, defibrillators or short-wave therapy equipment may impair correct functioning of the ventilator and endanger the patient.
Do not use antistatic or conductive masks or breathing hoses. They can cause burns if they are used near high frequency electrosurgical equipment.
Do not use the ventilator in a hyperbaric chamber to avoid potential fire hazard due to an oxygen-enriched environment.
If the equipment internal monitoring system malfunctions, an alternative plan must be available to ensure adequate level of monitoring. The operator of the ventilator must be responsible for proper patient ventilation and safety under all circumstances.
As required by the relevant rules and regulations, oxygen concentration should be monitored when the equipment is used on the patient. If your ventilator is not configured with such monitoring function or this function is turned off, use a monitor which complies with the relevant international rules and regulations for oxygen concentration monitoring.
When auxiliary electrical outlets are configured, the voltage and current specifications of the devices connected to the electrical outlets must be within the permissible ranges for those of the electrical outlets. When the protection grounding is defective, connection of equipment to the auxiliary electrical outlet may increase the patient leakage current to values exceeding the allowable limits.
When the auxiliary electrical outlet does not work normally, check if the corresponding fuse is burned.
All analog or digital products connected to this system must be certified passing the specified IEC standards (such as IEC 60950 for data processing equipment and IEC 60601-1 for medical electrical equipment). All configurations shall comply with the valid version of IEC 60601-1-1. The personnel who are responsible for connecting the optional equipment to the I/O signal port shall be responsible for medical system configuration and system compliance with IEC 60601-1-1 as well.
Do not touch the patient when connecting the peripheral equipment via the I/O signal ports or replacing the oxygen cell to prevent patient leakage current from exceeding the requirements specified by the standard.
This product must be operated by doctors, respiration therapist or other specially trained and authorized personnel. Anyone unauthorized or untrained must not perform any operation on it.
This equipment is not suitable for use in an MRI environment.
1-3
WARNING
When the ventilator input system fails or has faults, please contact us immediately for specified personnel to service the ventilator.
Use the humidifiers with a CE mark or recommended by us only.
The ventilator cannot use He and O2 mixed gas.
Do not move the ventilator before removing the support arm from it, in order to avoid the ventilator getting tilted during the movement.
Nebulization or humidification can increase the resistance of breathing system filters and that you need to monitor the filter frequently for increased resistance and blockage.
The ventilation accuracy can be affected by the gas added by use of a nebulizer.
The ventilator shall not be used with nitric oxide.
The ventilator shall not be used with helium or mixtures with Helium.
For non-invasive ventilation, the exhaled volume of the patient can differ from the measured exhaled volume due to leaks around the mask.
Check if the alarm limit settings are appropriate before taking measurement.
The mains plug is used to isolate the ventilator circuits electrically from the SUPPLY MAINS not to position the ventilator so that it is difficult to operate the plug.
No modification of this equipment is allowed.
Do not touch the patient when connecting the peripheral equipment via the I/O signal ports or replacing the oxygen cell to prevent patient leakage current from exceeding the requirements specified by the standard.
RJ45 port is used for software upgrades by the personnel trained and authorized by us only. Do not connect it to other devices or internet.
1.1.3 Cautions
CAUTION
The ventilator must be inspected and serviced regularly by trained service personnel.
To ensure patient safety, always prepare pulmotor for use.
Always have a special person attend and monitor the operation of the equipment once the ventilator is connected to the patient.
During the operation of the ventilator, do not disassemble the expiration valve and expiratory flow sensor, which, however, can be disassembled in standby mode.
1-4
CAUTION
To ensure patient safety, use only parts and accessories specified in this manual.
At the end of its service life, the equipment, as well as its accessories, must be disposed of in compliance with the guidelines regulating the disposal of such products.
Magnetic and electrical fields are capable of interfering with the proper performance of the equipment. For this reason make sure that all external devices operated in the vicinity of the equipment comply with the relevant EMC requirements. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.
This system operates correctly at the electrical interference levels identified in this manual. Higher levels can cause nuisance alarms that may stop mechanical ventilation. Pay attention to false alarms caused by high-intensity electrical fields.
Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the equipment’s label or specified in this manual.
Always install or carry the equipment properly to avoid damage caused by drop, impact, strong vibration or other mechanical force.
The ventilator or its part should be positioned so that is easy to view.
The ventilator is intended to be used in the patient environment.
Additional MULTIPLE SOCKETOUTLET or extension cord shall not be connected to the system.
When pushing the ventilator over the obstacles such as threshold, force the ventilator downwards to avoid getting tilted.
1-5
1.1.4 Notes
NOTE
Put the equipment in a location where you can easily see the screen and access the operating controls.
Keep this manual close to the equipment so that it can be obtained conveniently when needed.
The software was developed in compliance with IEC 60601-1-4. The possibility of hazards arising from software errors is minimized.
This manual describes all features and options. Your equipment may not have all of them.
Humidifier and nebulizer are independent devices which shall be purchased separately if necessary. When using the humidifier and nebulizer, refer to their use methods specified by their manufacturers.
1-6
1.2 Equipment Symbols
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Alternating current |
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Battery |
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Equipotential |
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Fuse |
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RS-232 port |
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CO2/calibration connection |
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O2↑button |
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O2 sensor connector |
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Video input/output |
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VGA output connection |
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connection |
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Network connection |
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USB port |
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Air supply connection |
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Oxygen supply connection |
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Pneumatic outlet |
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Flow sensor |
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Expiratory port |
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Inspiratory port |
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Unlock |
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Nebulizer connection |
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Compressor status indicator |
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Nurse call connection |
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Compressed air outlet (of |
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Central pipeline gas supply |
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the compressor) |
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inlet (of the compressor) |
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Manufacture date |
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Manufacturer |
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Serial number |
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Caution |
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Refer to instruction |
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General warning sign |
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manual/booklet |
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1-7
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Type BF applied part. |
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Defibrillation-proof |
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No pushing |
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protection against electric |
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shock. |
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IP21 |
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IP21 |
Degrees of protection |
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Protective earth (ground) |
provided by enclosure (IP |
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Code) |
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The following definition of the WEEE label applies to EU member states only. |
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This symbol indicates that this product should not be treated as household |
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waste. By ensuring that this product is disposed of correctly, you will help |
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prevent bringing potential negative consequences to the environment and |
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human health. For more detailed information with regard to returning and |
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recycling this product, please consult the distributor from whom you purchased |
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it. |
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* For system products, this label may be attached to the main unit only. |
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The product bears CE mark indicating its conformity with the provisions of the |
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Council Directive 93/42/EEC concerning medical devices and fulfils the |
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essential requirements of Annex I of this directive. |
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1-8
2 The Basics
2.1 System Description
2.1.1 Intended Use
The Ventilator is intended to provide ventilation assistance and breath support for adult, pediatric and infant patients with respiratory insufficiency or respiratory failure in the hospital or other medical institutions. Ventilation may be delivered via mask or tracheotomy. This product must be operated by doctors, respiration therapist or other specially trained and authorized personnel. Anyone unauthorized or untrained must not perform any operation on it.
2.1.2 Contraindications
There are no absolute contraindications for this product. However, for some patients who suffer from special diseases, special ventilation is required or treatment has to be carried out before mechanical ventilation. Otherwise, hazards may be resulted.
2.1.3 Components
The ventilator consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, software, display, CO2 module), cart, support arm, air compressor, and breathing hoses (refer to chapter 12 Accessories).
Connect the patient to the ventilator via the patient breathing circuit.
The applied part of the ventilator is breathing masks.
2-1
2.2 Equipment Appearance
2.2.1 Front View
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1
2-2
1.Caster and brake
The four casters of the ventilator have brakes.
2.Compressor
3.Inspiratory water trap
Collects condensed water in the hose.
4.Expiratory water trap
Collects condensed water in the hose.
5 Test lung
6.Expiratory hose
7.Inspiratory hose
8.Support arm
Supports the patient’s breathing hoses.
9.Display
10.Expiratory filter
Prevents water and bacteria inside the patient hoses from entering the ventilator’s internal pneumatic circuit.
11.Water trap at the expiratory port
12.Inspiratory filter
Prevents water and bacteria inside the patient hoses from entering the ventilator’s internal pneumatic circuit.
2-3
2.2.2 Rear View
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1.RS-232 port
Connects to the medical-grade external device via RS-232 protocol to implement the communication between the ventilator and external device.
2.Oxygen supply connection (with filter water trap)
3.Air supply connection (with filter water trap)
4.CO2/calibration connection
One multiplex connector for calibrating inspiratory and expiratory flows and supplying power for the external CO2 analyzer.
5.Fan
6.AC mains inlet
7.VGA connection
The ventilator provides a D-Sub 15, female video output connector, which connects to an external display and outputs VGA visual signals same to the primary display. This connection allows for interfacing to an externally located 24 bits, 800 x 600, SVGA monitor, which should be a medical grade monitor.
2-4
8.USB port
9.Network connection
One multiplex connector for network and software online upgrade.
10.Nurse call connection
Connects to the hospital’s calling system and outputs nurse call signals when an alarm occurs.
11.Inspiratory dust filter
12.Fan filter (filter at air intake vent)
13.Equipotential stud / lug
Provides a ground point. Eliminates the ground potential difference between different devices to ensure safety.
2.2.3 Air Compressor
The air compressor has standby function. In the standby mode, the compressor starts to deliver compressed air to the ventilator automatically if the hospital central pipeline gas supply fails. The compressor stops delivering compressed air automatically when the central pipeline gas supply returns to normal.
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1.Power indicator
The power indicator is lit when the compressor is connected to power supply and the power switch is turned on.
2.Status indicator
The status indicator is lit when the central pipeline gas supply is applied.
3.Alarm indicator
The alarm indicator is lit when the compressor internal temperature is abnormally high. In this case, the compressor may shut off at any time and stop delivering gas.
2-5
4.Pressure gauge
The pressure gauge indicates the air pressure at the compressed air outlet.
5.Compressed air outlet
6.Central pipeline gas supply inlet
7.Power switch
8.Mains power inlet (with fixing pressure plate)
9.Air intake vent (with dust filter)
10.Hourmeter
The hourmeter indicates the accumulated running time of the compressor (not including the accumulated running time when the central pipeline gas supply is applied)
NOTE
Burn-in is required for the compressor before delivery. The reading indicated by the compressor hourmeter shall be less than 150 hours at the time of delivery.
2-6
3 Installations and Connections
WARNING
Do not use antistatic or conductive masks or breathing hoses. They can cause burns if they are used near high frequency electrosurgical equipment.
To ensure optimum performance of the ventilator, re-do system check each time when accessories or components like hose, humidifier, and filter are replaced.
Adding accessories or other components to the ventilator can increase system inspiratory and expiratory resistance.
3.1Connect the Power Supply
3.1.1 Connect the System Power Supply
A
B
C
3-1
A. AC power cord |
B. AC Power cord retainer C. |
Screw |
1.Plug the AC power cord into the AC power outlet.
2.Place the AC power cord retainer above the power outlet and align the retainer with the screw holes.
3.Tighten the two screws.
3.1.2 Connect the Main Unit Power Supply
A
B
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A. Main unit power cord B. Main unit power cord retainer |
C. Screw |
1.Plug the main unit power cord into the power outlet.
2.Place the main unit power cord retainer above the power outlet and align the retainer with the screw holes.
3.Tighten the two screws.
3-2
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