Mindray Mindray SynoVent E5 VentilatorOperator Operator's Manual PDF
Mindray Mindray SynoVent E5 VentilatorOperator Operator's Manual PDF
Mindray Mindray SynoVent E5 VentilatorOperator Operator's Manual PDF
Operator’s Manual
© 2010-2014 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
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.
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.
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: [email protected]
Tel: +86 755 81888998
Fax: +86 755 26582680
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 Contents
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
1
4.3 Spirometry Loops Screen ................................................................................................ 4-7
4.4 Graphic Trend Screen ...................................................................................................... 4-8
4.5 Tabular Trend Screen .................................................................................................... 4-10
4.6 Measured Values Screen.................................................................................................4-11
4.7 Freeze ............................................................................................................................ 4-12
2
6.4 System Check .................................................................................................................. 6-2
6.5 Select Patient ................................................................................................................... 6-3
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 .......................................................................................................... 6-18
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 ..................................................................................................... 6-23
3
8.7 P0.1 ................................................................................................................................. 8-4
8.8 NIF .................................................................................................................................. 8-4
8.9 PEEPi .............................................................................................................................. 8-5
8.10 P-V Tool ........................................................................................................................ 8-5
4
10.2.4 Breathing Hoses ............................................................................................. 10-7
10.2.5 Nebulizer ........................................................................................................ 10-8
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
5
C EMC ................................................................................................................................ C-1
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.
To avoid the risk of electric shock, this equipment must only be connected to
supply mains with protective earth.
The equipment must be connected to a properly installed power outlet with
protective earth contacts only. If the installation does not provide for a protective
earth conductor, disconnect it from the power line.
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 SOCKET- OUTLET 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.
1-6
1.2 Equipment Symbols
Alternating current Battery
Equipotential Fuse
Video input/output
VGA output connection
connection
1-7
Refer to instruction
General warning sign
manual/booklet
The following definition of the WEEE label applies to EU member states only.
This symbol indicates that this product should not be treated as household
waste. By ensuring that this product is disposed of correctly, you will help
prevent bringing potential negative consequences to the environment and
human health. For more detailed information with regard to returning and
recycling this product, please consult the distributor from whom you purchased
it.
* For system products, this label may be attached to the main unit only.
The product bears CE mark indicating its conformity with the provisions of the
Council Directive 93/42/EEC concerning medical devices and fulfils the
essential requirements of Annex I of this directive.
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.
2-1
2.2 Equipment Appearance
2.2.1 Front View
7
6
11 10
12
5
4
3
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
13
5
2
6
3
4 1
9
11
12
8
10
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
2-4
connection allows for interfacing to an externally located 24 bits, 800 x 600, SVGA
monitor, which should be a medical grade monitor.
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.
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.
1 2 3 4
5 6 7 8 9 10
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.
2-5
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.
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.
A. Screw plug
B. Screw
C. Display connection line (with two fixing knobs)
D. Video input/output connection
3-1
1. Put the display onto the ventilator and align the display with the screw holes.
2. Install the three screws to fix the display.
3. Insert the three screw plugs.
4. Connect the display connection line to the Video input/output port and tighten the two
fixing knobs.
B
C
3-2
A. Screw
B. Display bracket base disk
C. Fixing block
D. ICU pendant pole
E. Knob for fixing block
1. Loosen the knob for fixing block. Put the fixing block onto the ICU pendant pole.
2. Tighten the knob for fixing block.
3. Put the display onto the display bracket base disk and align the display with the screw
holes.
4. Install three screws to fix the display.
5. Put the three plugs under the display bracket into the three holes on the ventilator unit.
6. Connect the display connection line to the main unit. For details, refer to step 4 of 3.1.1.
3-3
3.2 Connect the Power Supply
3.2.1 Connect the System Power Supply
A
B
C
3-4
3.2.2 Connect the Main Unit Power Supply
A
B
C
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.
3-5
3.2.3 Connect the Compressor Power Supply
Plug the compressor power cord into the auxiliary electrical outlet specially for compressor
directly.
3-6
3.3 Connect the Gas Supply
A
B
3-7
The ventilator works normally under supply pressure of 280 to 650 kPa. Supply pressure of
less than 280 kPa can impair the performance of the ventilator and even cease ventilation.
Supply pressure between 650 and 1000 kPa can impair the performance of the ventilator but
will not cause any hazard arising from high pressure gas.
E D
F
B
A
1. Loosen the fixing block knob. Place the fixing block onto the handle on the side of the
ventilator.
2. Tighten the fixing block knob.
3-8
3. Adjust the support arm.
Support arm joint E or G: To adjust the bending angle of the support arm
downward, push and hold the blue button on support arm joint E or G with
one hand and hold the support bar and press it downward with the other hand.
Support arm joint E or G can be adjusted for up to 130°. To adjust the bending
angle of the support arm upward, only lift the support bar to the desired position
Support arm joint F: pull support arm joint F upward or downward to the desired
position.
Hold the bottom of support arm or the suport bar beside support arm joint G and
push it leftward or rightward with force to rotate the support arm to the desired
position.
4. Place the breathing hoses onto the hose hook.
NOTE
Operate support arm joint E or G with both hands as shown below. Operate with
only one hand will bring some risk.
3-9
3.5 Install the Water Traps
A B
Rotate to push in the water trap upward. Make sure that the water trap is installed in place.
3-10
3.6 Install the Breathing Hoses
B
A
D
C
3-11
3.7 Install the Humidifier
Note
Install the humidifier which complies with the specification. The humidifier
assembly and its installation steps described here are only for reference.
F E
D A
C
B
3-12
3. Mount the filters onto the inspiratory and expiratory ports.
4. Connect the inspiratory filter to the humidifier inlet via the hose.
5. Connect the humidifier outlet to the water trap via the hose. Then, connect the water trap
to the Y piece via the hose.
6. Connect the expiratory filter to the water trap via the hose. Then, connect the water trap
to the Y piece via the hose.
7. Place the breathing hoses onto the support arm hook.
3-13
3.7.2 Install the Humidifier onto the Pendant
A
B
C
G
D
F E
1. Loosen the knob for fixing block. Put the fixing blocking onto the pendant beam.
2. Tighten the knob for fixing block.
3. Align the humidifier sliding wheel with the humidifier bracket fixed seat and slide in the
humidifier.
4. Tighten the screws.
5. Install the breathing hoses. For details, refer to steps 3 through 7 in 3.7.1.
3-14
WARNING
When installing the humidifier, make sure that the humidifier connector shall be
lower than the ventilator’s breathing connectors and the patient when installing
the humidifier.
C
A
B
Note
The nebulizer assembly and its installation steps described here are only for
reference.
3-15
WARNING
Nebulization yields the best performance at flow of 6 L/min. Nebulizers with other
flows can create significant errors in tidal volume and oxygen mix.
B
A
C
D E F
G
1. Place the CO2 module mounting plate onto the ventilator’s handle. Then tighten the
fastening screws.
3-16
2. Place the CO2 module onto the mounting plate and align with the screw holes. Then
tighten the three fastening screws.
3. Connect the connection line at the back of the CO2 module to the ventilator’s
CO2/calibration connection.
4. Connect one end of the sampling line to the water trap and then mount the water trap
onto the CO2 module. Connect the other end of the sampling line to the patient.
C
B
A
3-17
FOR YOUR NOTES
3-18
4 User Interface
4.1 Display Controls
3
1
2 2
4
The control unit is characterized by the small number of operating elements. Its main
elements are:
1. Display (touch screen)
The display shows the software screen of the ventilator system. You can select and
change settings by touching the screen.
2. Fixed hard keys
The fixed hard keys are provided for rapid access to the ventilator’s major functions.
3. Alarm LED
The alarm LED indicates the priority of an active alarm by flashing different colors at
different frequencies.
4-1
4. AC power LED and battery LED
indicates the AC power LED.
Lit: when the ventilator is connected to the AC power source.
Extinguished: when the ventilator is not connected to the AC power source.
indicates the battery LED.
Lit: when the battery is being charged or is already fully charged and the ventilator
is operating on AC power source.
Flash: when the ventilator is operating on battery power.
Extinguished: when the ventilator is not connected to the AC power source, or the
ventilator is not equipped with battery, or the ventilator battery is faulty.
4.1.1 Display
The ventilator display shows ventilation parameters, pressure/flow/volume waveforms and
spirometry loops etc.
The following is an example of waveforms screen. Display screen may vary subject to the
configurations.
1 2 3 4 6 8
5
12 9
11
10
4-2
1. Ventilation mode field
Displays Standby or active ventilation mode, and ventilation assist.
2. NIV/ intubation icon field
prompt is displayed underneath the icon. The icon for inspiratory trigger is , which
is prompted for one second.
5. Alarm silence symbol and countdown field
Displays the time remaining in the 120s alarm silence period and alarm silence symbol
as well.
displays the symbol . Select the alarm message field at this moment to access the
[Current Alarm] menu which displays all current alarm messages, alarm occurrence
time, and alarm priority.
7. Prompt message field
Displays the active prompt message.
8. System time/battery
Displays current system time and battery status.
9. Parameter field
Displays measured parameters values of the ventilator.
10. Parameter setup quick key field
Displays ventilation setting parameters for the current mode of ventilation.
4-3
11. Ventilation mode setup field
Displays keys for setting ventilation mode.
12. Waveforms/spirometry/trends/measured values filed
Displays waveforms, spirometry loops, graphic trend, tabular trend, or measured values.
1
14
2
13
12 3
11 4
10
5
9
6
8
7
4-4
Latching alarms: the system continues displaying the alarm message even if the alarm
conditions end except that:
Alarm audio disappears;
Alarm LED stops flashing and is permanently lit with the same color;
Alarm message is displayed without background color;
The alarmed parameter measured value stops flashing.
3. Alarm Setup key
Push to access the alarm setup menu to set parameter alarm limits, alarm volume etc.
4. Standby key
Push to pop up a dialog box to confirm whether to enter Standby.
5. Freeze key
Push to enter or cancel freeze status. For details, refer to 4.7Freeze.
6. Menu key
Push to open system main menu or close screen menu.
7. Control knob
Push the control knob to select a menu option or confirm your setting. Turn the control
knob clockwise or counterclockwise to scroll through the menu options or change your
settings.
8. System switch
Push and hold/push the system key to turn on/off the system.
9. Manual Breath Key
Push to deliver manual ventilation.
10. Exp. Hold key
In non-standby status, push and hold this key to allow the patient to remain in expiration
status and prevent the patient from inspiration. The screen shows [Exp. Hold Active].
Expiration Hold is active for a maximum of 30 seconds.
11. Insp. Hold key
In non-standby status, push and hold to allow the patient to remain in inspiration status
and prevent the patient from expiration. The screen shows [Insp. Hold Active].
Inspiration Hold is active for a maximum of 30 seconds.
12. Nebulizer key
Push to access nebulizer related menu and start nebulization after completing the
relevant settings. The LED in the upper left corner of this key is lit.
4-5
13. O2↑key/suction
In non-standby status, push to start O2↑function and the LED in the upper left corner
of this key is lit. The screen shows the remaining O2↑ time. When O2↑is active, push
this key again to stop O2↑. During O2↑, removing the breathing hoses enters suction
screen.
14.
When pushed, the LED in the upper left corner of this key is lit and the ventilator enters
locked status. The prompt message field displays [Panel Locked. Push the Lock key to
unlock the panel]. During this period, only the Alarm Reset key, Alarm Silence key,
Manual Breath key, O2↑key, and key are enabled while the touchscreen and
other fixed hard keys are disabled. Push the key again to unlock.
4-6
4.3 Spirometry Loops Screen
Select [Spirometry] to access the spirometry loops screen as shown below.
Spirometry loops reflect patient lungs function and ventilation condition as well, such as the
patient’s lungs compliance, over-inflation, breathing system leakage and airway blockage.
The system provides three types of spirometry loops: P-V (pressure-volume) loop, F-V
(flow-volume) loop, and F-P (flow-pressure) loop. The three types of loops come from
pressure, flow, and volume waveforms data.
Up to two types of spirometry loops are displayed at a time. To select the desired loop:
1. Select [Spirometry] on the main screen.
2. Select the desired loop to be displayed.
The ventilator provides the function of reference loop. Selecting [Save] saves the current F-V
loop, P-V loop, and F-P loop as reference loop and displays the time on which the reference
loop is saved. Selecting the time button views the reference loop saved at that time moment.
Selecting [Hide Ref.] hides the reference loop which is being displayed.
The ventilator saves reference loops at up to four time moments. If reference loops at four
4-7
time moments are already saved, when [Save] is selected again, the system automatically
clears the oldest reference loops except the loops being viewed and saves the current loops as
reference loops.
You can access the following graphic window by selecting [Trends] and/or selecting the
button for switching between [Tabular] and [Graphic].
1 2 3 4 5 6 7 8
15 14 13 12 11 10 9
1. Graphic scale
2. Graphic trend
3. Event mark field, displaying event marks in the current trend window. Alarm events of
different priorities are represented by different mark colors. Red event mark indicates a
high priority alarm event and yellow a medium or low priority alarm event.
4. Time scale axis, displaying time scale information on the time axis.
4-8
5. Cursor
6. Time field, displaying the time corresponding to the cursor.
7. Parameter area, displaying parameter values at the time corresponding to the cursor.
8. Vertical scroll bar, indicating the position of the currently displayed parameter in the
entire parameter sequencing.
9. Button for switching between graphic trend and tabular trend
10. Button for parameter grouping. Options are [All], [Pressure], [Volume], [Time] and
[Other]. [Pressure] parameters include Ppeak, Pplat, Pmean, and PEEP. [Volume]
parameters include TVi, TVe, TVe spn, MV, MVspn, and MVleak. [Time] parameters
include ftot, fmand, and fspn. [Other] parameters include Ri, Re, Cdyn, RSBI, WOB,
FiO2, FiCO2 and EtCO2.
11. Window time button, which can be set to 1h, 3h, 6h, 12h, 24h, 48h, and 72h.
12. Cursor control button for moving the cursor left or right.
13. Horizontal scroll bar control button for moving the horizontal scroll bar left or right.
14. Horizontal scroll bar, indicating the position of the currently displayed trend data in the
entire trend database.
15. Vertical scroll bar control button for moving the vertical scroll bar up and down.
4-9
4.5 Tabular Trend Screen
Tabular trend depicts the changes in parameter measured values in tabular form over a
specific period of time.
You can access the following tabular window by selecting [Trends] and/or selecting the
button for switching between [Tabular] and [Graphic].
1 2 3 4
11 10 9 8 7 6 5
1. Event mark field, displaying event marks in the current trend window. Alarm events of
different priorities are represented by different mark colors. Red event mark indicates a
high priority alarm event and yellow a medium or low priority alarm event.
2. Time field, displaying the time corresponding to the cursor
3. Cursor column, displaying parameter values measured at the time corresponding to the
cursor. Alarm events of different priorities are represented by different background
colors. Red event mark indicates a high priority alarm event and yellow a medium or
low priority alarm event.
4. Vertical scroll bar, indicating the position of the currently displayed parameter in the
entire parameter sequencing.
5. Button for switching between graphic trend and tabular trend
4-10
6. Button for parameter grouping. Options are [All], [Pressure], [Volume], [Time] and
[Other]. [Pressure] parameters include Ppeak, Pplat, Pmean, and PEEP. [Volume]
parameters include TVi, TVe, TVe spn, MV, MVspn, and MVleak. [Time] parameters
include ftot, fmand, and fspn. [Other] parameters include Ri, Re, Cdyn, RSBI, WOB,
FiO2, FiCO2 and EtCO2.
7. Resolution button, which can be set to 1 min, 5 min, 10 min, 15 min, 30 min, and 1h.
8. Horizontal scroll bar, indicating the position of the currently displayed trend data in the
entire trend database.
9. Cursor control button for moving the cursor left or right.
10. Horizontal scroll bar control button for moving the horizontal scroll bar left or right.
11. Vertical scroll bar control button for moving the vertical scroll bar up and down.
4-11
4.7 Freeze
The freeze function features to pause on-screen waveforms and spirometry loops refreshing
in real-time and review short-time patient data so that you can have a close examination of
the patient’s status within this time period.
4-12
View frozen spirometry loops
You can turn the control knob clockwise or counter clockwise to move the cursor to view the
frozen spirometry loops.
4-13
FOR YOUR NOTES
4-14
5 System Settings
5.1 Change Display Settings
5.1.1 Waveforms
1. Push the Menu key. Select [Display] and then [Waveforms].
2. Select the waveforms to be displayed.
3. Select [Draw Wave] and toggle between [Curve] and [Fill].
[Curve]: the waveform is displayed as a curved line.
[Fill]: the waveform is displayed as a filled area.
Parameter
Area 1
Parameter
Area 2
Parameter
Area 3
5-1
5.1.4 Colors
To change the colors of waveforms, waveform related parameters, waveform related
spirometry loops, and waveform related alarm limits:
1. Push the Menu key. Select [Display] and then [Color].
2. Select the desired color. The colors of waveforms, waveform related parameters,
waveform related spirometry loops also change. Dark color of the selected color is
suggested for the color of waveform related alarm limits.
The following table lists the waveforms, waveform related parameters, waveform related
spirometry loops and waveform related alarm limits.
Waveform Waveform related parameters Waveform Waveform
related related
spirometry loop alarm limits
Paw Ppeak, Pmean, Pplat, PEEP, NIF, PEEPi, P-V loop, F-P loop Ppeak
P0.1
Flow MV, MVleak, MVspn, TVe, TVi, TVspn, F-V loop MV, TVe,
ftot, fmand, fspn, Vtrap ftot
Volume / / /
/ FiO2 / FiO2
CO2 EtCO2, FiCO2 / EtCO2,
FiCO2
Alarm limits
Waveform Parameter
5-2
5.2 Set Date and Time
1. Push the Menu key. Select [System] and then [Time].
2. Set the date and time.
3. Select [Date Format] and toggle between [YYYY-MM-DD], [MM-DD-YYYY] and
[DD-MM-YYYY].
4. Select [Time Format] and toggle between [24 h] and [12 h].
5-3
5.6.2 Set Paw Unit
1. Push the Menu key. Select [System] and then [Unit].
2. Select [Paw Unit] and toggle between [cmH2O], [hPa], and [mbar].
5-4
5.11 Set IP Address
If your ventilator needs to upgrade the software, follow these steps to set the IP address:
1. Push the Menu key. Select [Maintain] → [User] → enter the required password →
[Setup] → [IP Address].
2. Set the IP address. IP address has four step boxes. The setting range of each of the box is
0 to 255.
5-5
5.12.3 Save as User Configuration
You can change the ventilator’s settings based on the actual requirement and save the
changed settings as user configuration.
1. Push the Menu key. Select [Maintain] → [User] → enter the required password →
[Config].
2. If the current patient type is adult, select [Save as User Adu Config]. If the current
patient type is pediatric, select [Save as User Ped Config].
5-6
5.14 Export
The ventilator’s export function means to export some data to USB memory.
To export screenshot,
1. Insert the USB memory to the USB port of the ventilator.
2. Select the desired screen to be exported and then push the Freeze key to capture the
screen.
3. Push the Menu key. Select [Tool] → [Export] → [Export Screen]. The system
checks the availability of USB memory. If the USB memory is available and has
sufficient space, the system exports the last captured screen.
To export data,
1. Insert the USB memory to the USB port of the ventilator.
2. Push the Menu key. Select [Tool] → [Export] → [Export Data]. The system checks
the availability of USB memory. If the USB memory is available and has sufficient
space, the system exports patient information, log, trend and other data.
5-7
FOR YOUR NOTES
5-8
6 Start Ventilation
6.1 Turn on the System
1. Plug the power cord into the AC power outlet. Make sure that the AC power LED is lit.
6-1
6.2.2.2 Air Pipeline Test
1. Connect an air supply or air compressor gas supply.
2. Connect the test splint lung.
WARNING
To ensure optimum performance of the ventilator, re-do system check each time
when accessories or components like hose, humidifier, and filter are replaced.
Push the Standby key. Standby screen appears after your confirmation. The standby screen
displays the last system check time. Select [Syst. Check]. Connect air and oxygen supplies
and block the patient wye as prompted. Select [Ok] to start system check item by item.
6-2
System check items include:
O2 flow sensor test: test the O2 inspiratory valve and O2 flow sensor;
Air flow sensor test: test the Air inspiratory valve and Air flow sensor;
Expiratory flow sensor test;
Pressure sensor test: test the pressure sensors at the inspiratory and expiratory ports;
Expiration valve test;
Safety valve test;
O2 sensor test;
Leakage (mL/min);
Compliance (mL/cmH2O);
Circuit resistance (cmH2O/L/s).
When system check is being performed, the system prompts [Running] on the right side of
the current check item. In this case, if you select [Skip], the system stops check of this item
immediately and displays [Cancel]. Check of the next item begins at the same time. If you
select [Stop], the system stops check of the current item and also check of the remaining
items, and displays [Cancel].
When checks of all items are completed, if you select [Retry], the system starts a new round
of check. When [Exit] is selected, the system exits check and enters standby screen.
6-3
6.6 Ventilation Type
The ventilator provides two ventilation types: invasive and non-invasive. Invasive ventilation
is the default ventilation type.
The calculated leakage is compensated up to 80 % of the set tidal volume in invasive mode.
6.6.1.1 ATRC
ATRC refers to automatic tube resistance compensation function, which the ventilator can
adjust the input pressure to keep the pressure of the tube end and pressure set on the
ventilator to be the same as possible for endotracheal intubation or tracheotomy intubation of
the different tube diameters that the user chooses.
WARNING
ATRC function may induce autotriggering. If autotriggering occurs, first check the
patient, breathing circuit, and other settings as possible causes before lowering the
Compensate setting or disabling ATRC.
If intubation type and pipe diameter are set incorrectly, it may cause harm to
patients. Please set intubation type and pipe diameter correctly.
6-4
6.6.2 NIV (non-invasive ventilation)
NIV, whose full name is non-invasive ventilation, means to ventilate the patient by using a
nasal mask or breathing face mask instead of by endotracheal intubation or tracheostomy.
In NIV, all ventilation modes for adult patients and pressure related ventilation modes for
pediatric patients are enabled. The disabled ventilation modes in NIV appear grey.
The calculated leakage is compensated up to 200% of the set tidal volume but not more than
2 L maximum in NIV mode.
current mode+ mask icon +NIV is displayed in the upper left corner of the screen,
indicating that non-invasive ventilation is set up successfully.
NOTE
NIV can be selected only in Standby.
6-5
6.7 Ventilation Mode
NOTE
The ventilator creates negative pressure in the expiratory phase due to patient’s
active inspiration. There is no limit pressure for negative pressure in the expiratory
phase. Instant negative pressure is caused by patient’s active inspiration. In the
inspiratory phase, high pressure alarm limit is available. When high pressure
alarm limit is reached, the ventilator releases pressure immediately. Pressure in the
inspiratory phase is generated by the ventilator gas delivery.
The P-A/C and P-SIMV are the recommended ventilation modes for use with a
closed-suction catheter. And the settings are decided by the operator according to
the patient situation.
Displays keys for setting ventilation mode. Selecting displays more keys for
setting ventilation mode. The ventilator can be configured with the following ventilation
modes: V-A/C, P-A/C, CPAP/PSV, V-SIMV, P-SIMV, PRVC, DuoLevel and APRV.
Your machine may have different ventilation modes.
2. Parameter setup quick key field
Displays ventilation setting parameters for the current mode of ventilation. Selecting
can be set here. Ventilation parameters vary subject to the ventilation mode.
6-6
5. Set other parameters in the same way.
6. Select [Ok] when parameter setup is completed.
Apnea ventilation the ventilator provides is manifested differently subject to the ventilation
mode for the purpose of matching the doctor’s ventilation strategy to the maximum.
In the SIMV mode, if patient apnea occurs, the ventilator ventilates the patient at the apnea
ventilation frequency in place of the previous SIMV frequency (while other parameter
settings are kept unchanged). During apnea ventilation, same to the previous SIMV mode, the
ventilator allows patient spontaneous breathing or trigger to support ventilation. In the SIMV
mode, apnea ventilation can be turned off by setting the apnea ventilation switch. When
apnea ventilation is turned off, the message “Apnea Vent Off” is displayed in the prompt
message field all the time.
In the CPAP/PSV, DuoLevel or APRV mode, if patient apnea occurs, the ventilator applies
pressure control ventilation at the preset apnea pressure and ensures that the actual breathing
frequency is not lower than the preset apnea ventilation frequency. During apnea ventilation,
the ventilator still allows patient spontaneous breathing or trigger to support ventilation. If
patient spontaneous breathing does not occur any longer, the actual breathing frequency is
equal to the preset apnea ventilation frequency.
6-7
6.7.3 IntelliCycle
IntelliCycle intelligent synchronous technology means to adjust Exp% dynamically by
adaptive algorithm through extracting and analysing the feature of the waveforms when
Exp% is set to Auto in CPAP/PSV, V-SIMV, P-SIMV and DuoLevel modes. According to the
lung properties of the patient, it can adjust Exp% to the best value intelligently to improve the
synchronization between the patient and the device, make the patient more comfortable
during breathing, reduce the time to adjust the settings during treatment, and reduce the
workload of medical staffs and ensure the excellent synchronous effect at the same time.
6.7.4 V-A/C
V-A/C is volume-assist/control ventilation mode. In V-A/C, fixed tidal volume is delivered to
the patient at the inspiratory flow within the inspiration time. The airway pressure varies
according to the resistance and compliance of the patient’s lungs and thorax. When the
airway pressure reaches the preset pressure limit level, it is held at this level. Expiratory
phase is switched to and pressure is fully released only when the airway pressure exceeds the
pressure alarm high limit.
V-A/C supports synchronous trigger in expiratory phase. Namely, when the ventilator detects
patient inspiratory effort, it delivers next mechanical ventilation in advance.
The following figures show typical waveforms in V-A/C mode.
Paw
Pplat Plimit
PEEP
Breathing cycle
Flow
Insp. flow
In V-A/C under non-NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [TV]: Tidal volume
6-8
3. [Tinsp] or [I:E]: Time of inspiration or ratio between the inspiratory and
expiratory time
4. [f]: Breathing frequency
5. [Flow]: Inspiratory flow
6 [Plimit]: Pressure limitation
7. [Assist]: Assisted trigger
8. [F-Trig] or [P-Trig]: Inspiration trigger level
9. [PEEP]: Positive end-expiratory pressure
10. [△int.PEEP] or [Sigh]: Intermittent positive end-expiratory pressure
11. [ATRC]: Automatic tube resistance compensation
In V-A/C under NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [TV]: Tidal volume
3. [Tinsp] or [I:E]: Time of inspiration or ratio between the inspiratory and
expiratory time
4. [f]: Breathing frequency
5. [Flow]: Inspiratory flow
6 [Plimit]: Pressure limitation
7. [Assist]: Assisted trigger
8. [F-Trig] or [P-Trig]: Inspiration trigger level
9. [PEEP]: Positive end-expiratory pressure
10. [△int.PEEP] or [Sigh]: Intermittent positive end-expiratory pressure
6-9
6.7.5 P-A/C
P-A/C is pressure-assist/control ventilation mode. In P-A/C, the airway pressure rises to the
preset inspiratory pressure level within the Time of pressure rising and is held at this level
until inspiration time is expired. Then expiration is switched to. When the airway pressure is
held at the preset inspiratory pressure level, delivered gas flow changes with the resistance
and compliance of the patient’s lungs. During the inspiratory phase, when the delivered
volume exceeds the tidal volume high alarm limit, the system switches to expiratory phase
immediately. During the expiratory phase, synchronous trigger is supported. Specifically,
next mechanical ventilation can be delivered in advance when patient inspiratory effort is
detected.
The following figures show typical waveforms in P-A/C mode.
Paw
Tslope
Insp. pressure
PEEP
Flow
Time
In P-A/C under non-NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [Pinsp]: Pressure control level of inspiration
3. [Tinsp] or [I:E]: Time of inspiration or ratio between the inspiratory and
expiratory time
4. [f]: Breathing frequency
5. [Tslope]: Time of pressure rising
6 [PEEP]: Positive end-expiratory pressure
7. [Assist]: Assisted trigger
8. [F-Trig] or [P-Trig]: Inspiration trigger level
9. [ATRC]: Automatic tube resistance compensation
6-10
In P-A/C under NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [Pinsp]: Pressure control level of inspiration
3. [Tinsp] or [I:E]: Time of inspiration or ratio between the inspiratory and
expiratory time
4. [f]: Breathing frequency
5. [Tslope]: Time of pressure rising
6 [PEEP]: Positive end-expiratory pressure
7. [Assist]: Assisted trigger
8. [F-Trig] or [P-Trig]: Inspiration trigger level
6.7.6 CPAP/PSV
PSV, pressure support ventilation, is a pressure mode. The system delivers a PSV when it
detects that patient inspiratory effort reaches the preset inspiration trigger level. Time of
pressure rising and pressure support level are set by the user. At the beginning of inspiratory
phase, patient airway pressure rises to the preset pressure level within the preset Time of
pressure rising and is held at this pressure level until patient inspiratory flow is detected to
reach the expiration trigger level. In PSV, when the airway pressure is held at the preset
pressure level, delivered gas flow changes with the resistance and compliance of the patient’s
lungs.
△Papnea
△Psupp
Insp. trigger
Tslope Time
Flow
Exp. trigger
Insp. trigger
Apnea time
I:E=1:2
6-11
In CPAP (continuous positive airway pressure ventilation), the airway pressure is held at the
user-set positive pressure level throughout the ventilation cycle. The patient breathes
spontaneously and determines his own breathing frequency, tidal volume, and breath time.
The system starts apnea ventilation when detecting that the period of time when patient does
not perform continuous spontaneous breathing exceeds the preset apnea time.
PEEP
Tslope
Time
Flow
Time
Apnea time
I:E=1:2
In CPAP/PSV under non-NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [Tslope]: Time of pressure rising
3. [△Psupp]: Pressure support level
4 [PEEP]: Positive end-expiratory pressure
5. [Exp%]: Expiration trigger level
6. [ΔPapnea]: Pressure of apnea ventilation
7. [fapnea]: Frequency of apnea ventilation
8. [F-Trig] or [P-Trig]: Inspiration trigger level
9. [ATRC]: Automatic tube resistance compensation
In CPAP/PSV under NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [Tslope]: Time of pressure rising
3. [△Psupp]: Pressure support level
4 [PEEP]: Positive end-expiratory pressure
6-12
5. [Exp%]: Expiration trigger level
6. [ΔPapnea]: Pressure of apnea ventilation
7. [fapnea]: Frequency of apnea ventilation
8. [Tinsp]: Inspiration time
9. [F-Trig] or [P-Trig]: Inspiration trigger level
△Psupp
Insp. trigger
Time
Flow
Time
6-13
P-
SIMV+PSV
SIMV cycle SIMV cycle
5s 5s 5s
Paw Trigger Trigger Trigger
Pressure Pressure
window window window
control control
? Psupp
Insp. trigger
Time
Flow
Time
In V-SIMV under non-NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [TV]: Tidal volume
3. [Tinsp]: Time of inspiration
4. [fSIMV]: Frequency of SIMV
5. [Flow]: Inspiratory flow
6 [Plimit]: Pressure limitation
7 [PEEP]: Positive end-expiratory pressure
8. [Exp%]: Expiration trigger level
9. [△Psupp]: Pressure support level
10. [Tslope]: Time of pressure rising
11. [F-Trig] or [P-Trig]: Inspiration trigger level
12. [fapnea]: Frequency of apnea ventilation
13. [Apnea Vent]: Apnea ventilation switch
14. [ATRC]: Automatic tube resistance compensation
In V-SIMV under non-NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [TV]: Tidal volume
3. [Tinsp]: Time of inspiration
6-14
4. [fSIMV]: Frequency of SIMV
5. [Flow]: Inspiratory flow
6 [Plimit]: Pressure limitation
7 [PEEP]: Positive end-expiratory pressure
8. [Exp%]: Expiration trigger level
9. [△Psupp]: Pressure support level
10. [Tslope]: Time of pressure rising
11. [F-Trig] or [P-Trig]: Inspiration trigger level
12. [fapnea]: Frequency of apnea ventilation
13. [Apnea Vent]: Apnea ventilation switch
In P-SIMV under non-NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [Pinsp]: Pressure control level of inspiration
3. [Tinsp]: Time of inspiration
4. [fSIMV]: Frequency of SIMV
5. [Tslope]: Time of pressure rising
6 [PEEP]: Positive end-expiratory pressure
7. [Exp%]: Expiration trigger level
8. [△Psupp]: Pressure support level
9. [fapnea]: Frequency of apnea ventilation
10. [F-Trig] or [P-Trig]: Inspiration trigger level
11. [Apnea Vent]: Apnea ventilation switch
12. [ATRC]: Automatic tube resistance compensation
In P-SIMV under NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [Pinsp]: Pressure control level of inspiration
3. [Tinsp]: Time of inspiration
4. [fSIMV]: Frequency of SIMV
5. [Tslope]: Time of pressure rising
6 [PEEP]: Positive end-expiratory pressure
7. [Exp%]: Expiration trigger level
6-15
8. [△Psupp]: Pressure support level
9. [fapnea]: Frequency of apnea ventilation
10. [F-Trig] or [P-Trig]: Inspiration trigger level
11. [Apnea Vent]: Apnea ventilation switch
6.7.8 PRVC
PRVC implements volume control by way of pressure control ventilation. In PRVC, a
relatively low pressure level is held as much as possible during the inspiratory phase and the
gas volume delivered is guaranteed to be equal to the set tidal volume. Pinsp will vary
according to the tidal volume setting and resistance and compliance of the patient’s lungs.
The ventilator adjusts Pinsp each time at a maximum increment of 3 cmH2O and the
maximum pressure does not exceed the pressure high alarm limit -5 cmH2O.
The first PRVC delivered is experimental ventilation mode for the purpose of calculating
compliance and resistance of the system and patient’s lungs based on which pressure level is
acquired. This pressure level will then be used for tidal volume control in the subsequent
ventilation cycles.
The following figures show typical waveforms in PRVC mode.
Experimental
ventilation
Paw
Paw≤alarm high limit-5cmH2O
↑Differential pressure≤3
cmH2O
Time
Flow
Time
In PRVC under non-NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [TV]: Tidal volume
3. [Tinsp] or [I:E]: Time of inspiration or ratio between the inspiratory and
expiratory time
6-16
4. [f]: Breathing frequency
5. [Tslope]: Time of pressure rising
6 [PEEP]: Positive end-expiratory pressure
7. [Assist]: Assisted trigger
8. [F-Trig] or [P-Trig]: Inspiration trigger level
9. [ATRC]: Automatic tube resistance compensation
In PRVC under NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [TV]: Tidal volume
3. [Tinsp] or [I:E]: Time of inspiration or ratio between the inspiratory and
expiratory time
4. [f]: Breathing frequency
5. [Tslope]: Time of pressure rising
6 [PEEP]: Positive end-expiratory pressure
7. [Assist]: Assisted trigger
8. [F-Trig] or [P-Trig]: Inspiration trigger level
6-17
6.7.9 DuoLevel
DuoLevel is double level positive airway pressure ventilation. In DuoLevel, the ventilator
delivers positive airway pressure at two pressure levels alternatively during mechanical
ventilation or spontaneous breathing. The patient can breathe spontaneously at either pressure
level. During the low pressure phase, pressure support can be set. Trigger window is available
during both high and low pressure phases. The trigger window during the low pressure phase
is the later 5 seconds of low pressure time (Tlow) while the trigger window during the high
pressure phase is the later 1/4 of high pressure time (Thigh). Within the trigger window of
low pressure phase, inspiratory trigger transforms to high pressure gas delivery. Within the
trigger window of high pressure phase, expiratory trigger transforms to low pressure gas
delivery.
The following figure shows typical waveform in DuoLevel mode.
¼
Paw Thigh
Thigh Tlow Trigger
window
5s
5s Trigger
Trigger window
window PSV
Phigh
Tslope Plow
Time
In DuoLevel under non-NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [Phigh]: High pressure
3. [Thigh]: Time of high pressure
4. [Plow]: Low pressure
5. [Tlow]: Time of low pressure
6. [Tslope]: Time of pressure rising
7. [Exp%]: Expiration trigger level
8. [△Psupp]: Pressure support level
9. [ΔPapnea]: Pressure of apnea ventilation
10. [fapnea]: Frequency of apnea ventilation
11. [F-Trig] or [P-Trig]: Inspiration trigger level
12. [ATRC]: Automatic tube resistance compensation
6-18
In DuoLevel under NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [Phigh]: High pressure
3. [Thigh]: Time of high pressure
4. [Plow]: Low pressure
5. [Tlow]: Time of low pressure
6. [Tslope]: Time of pressure rising
7. [Exp%]: Expiration trigger level
8. [△Psupp]: Pressure support level
9. [ΔPapnea]: Pressure of apnea ventilation
10. [fapnea]: Frequency of apnea ventilation
11. [F-Trig] or [P-Trig]: Inspiration trigger level
6.7.10 APRV
APRV is airway pressure release ventilation. It can be seen as periodical, short period airway
pressure release in CPAP mode.
Paw
Thigh Tlow
Phigh
Tslope
Plow
Time
In APRV under non-NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [Phigh]: High pressure
3. [Thigh]: Time of high pressure
4. [Plow]: Low pressure
5. [Tlow]: Time of low pressure
6-19
6. [Tslope]: Time of pressure rising
7. [ΔPapnea]: Pressure of apnea ventilation
8. [fapnea]: Frequency of apnea ventilation
9. [ATRC]: Automatic tube resistance compensation
In APRV under NIV, you need to set the following ventilation parameters:
1. [O2%]: Oxygen concentration
2. [Phigh]: High pressure
3. [Thigh]: Time of high pressure
4. [Plow]: Low pressure
5. [Tlow]: Time of low pressure
6. [Tslope]: Time of pressure rising
7. [ΔPapnea]: Pressure of apnea ventilation
8. [fapnea]: Frequency of apnea ventilation
WARNING
Before use on the patient, check that the oxygen concentration in the delivered gas
is consistent with the set value.
Select [Start Ventilation] when in Standby and the system begins to ventilate the patient
according to your settings.
6-20
6.10 Ventilation Parameters Monitoring
WARNING
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.
NOTE
All the parameter values are calculated based on the real-time flow and pressure
waveforms data. For real-time flow and pressure data, five-point moving average
filter (FIR low pass filter) is adopted at original sampling rate of 250 Hz with about
24 Hz of cutoff frequency (3 db) and 10 ms of delay.
The conditions to which the tidal volume and minute volume the ventilator displays
correspond are temperature, ambient pressure, and saturated water vapor status.
Setting Description
parameter
TV The gas volume the patient inspires or expires each time during resting breathing.
O2% The volume percentage of oxygen in the mixed gas delivered to the patient.
Flow The gas delivered flow that the ventilator will use during the inspiratory phase.
Phigh Available only in DuoLevel and APRV modes. Phigh is the high pressure level at
which the patient can spontaneously breathe and is an absolute value.
Plimit The pressure limit level at which the airway pressure is held during the inspiratory
phase until the start of expiratory phase.
Plow Available only in DuoLevel and APRV modes. Plow is the low pressure level at
which the patient can breathe spontaneously.
6-21
ΔPsupp The pressure support level in pressure support mode and is relative to PEEP or
Plow.
Thigh Available only in DuoLevel and APRV modes. Thigh is the time that the
ventilator will hold the high pressure level.
Tlow Available only in DuoLevel and APRV modes Tlow is the time that the ventilator
will hold the low pressure level.
F-Trig/P-Trig Pressure trigger and flow trigger included. When the trigger level is detected, the
ventilator starts to enter the inspiratory phase. When F-Trig is active, at the late
stage of exhalation the ventilator delivers a base flow from the inspiratory limb to
the expiratory limb. The base flow is essential for flow trigger. The ventilator
adjusts base flow from 2 to 20 L/min automatically to maintain PEEP and
establish baseline for patient triggering.
Δint.PEEP Available only in V-A/C mode. It indicates the positive end expiratory pressure
added in the sigh cycle, and is relative to PEEP.
Exp% Inspiratory termination level. The ventilator is switched to the expiratory phase
when the inspiratory flow drops to peak flow*Exp%. When the value of Exp% is
set to Auto, the IntelliCycle function is turned on.
Assist This parameter is available in V-A/C, P-A/C and PRVC modes to turn on or turn
off the assisted trigger function. When this function is turned on, the patient is
allowed to trigger mechanical ventilation at the end of expiration.
ATRC This parameter is available in all the ventilation modes except NIV to set the
ATRC function.
Monitored Description
parameter
6-22
TVe The expired tidal volume in one cycle.
The pressure drop in the first 100 ms when the patient starts spontaneous
P0.1 breathing.
Intrinsic PEEP(The PEEPi value displayed has already included PEEP value and
PEEPi is the actual airway pressure).
Vtrap The volume of trap gas in the lungs produced by intrinsic PEEP.
6-23
FOR YOUR NOTES
6-24
7 CO2 Monitoring
7.1 Introduction
CO2 monitoring is a continuous, non-invasive technique for determining the concentration of
CO2 in the patient’s airway by measuring the absorption of infrared (IR) light of specific
wavelengths. The CO2 has its own absorption characteristic and the amount of light passing
the gas probe depends on the concentration of the measured CO2. When a specific band of IR
light is passed through respiratory gas samples, some of IR light will be absorbed by the CO2
molecules. The amount of IR light transmitted after it has been passed through the respiratory
gas sample is measured with a photodetector. From the amount of IR light measured, the
concentration of CO2 is calculated. End tidal CO2 concentration reading is using the highest
values respectively of the temporal CO2-curve.
The rated respiration rate range of etCO2 module is 0 to 120 bpm, and the data sample rate is
50 Hz. The method used to determine the rated respiration rate range: Utilize a valve to
permit switching between the two sampling gases at different frequencies (simulating the
range of specified breath rates).Record the etCO2 value presented for each frequency. From a
diagram of end-tidal value over frequency, the frequency at which the gas analyzer is no
longer able to resolve etCO2 according to specification is identified.
7-1
NOTE
As required by the relevant rules and regulations, carbon dioxide concentration
should be monitored when the equipment is used on the patient. If your ventilator
is not configured with such monitoring function, use a monitor which complies
with the relevant international rules and regulations for carbon dioxide
concentration monitoring.
Sampling line
Water trap
2. By default, the CO2 module is in measure mode. When the CO2 module is connected,
the [CO2 Startup] message is displayed on the screen.
3. After start-up is finished, the [CO2 Warmup] message is displayed. The CO2 module is
in ISO accuracy mode. If you perform CO2 measurements during warm-up, the
measurement accuracy may be compromised.
4. After warm-up is finished, the CO2 module enters full accuracy mode.
It needs about 2 minutes after powering on the ventilator till the point that the CO2 module
enters full accuracy mode.
7-2
NOTE
To extend the lifetime of the water trap and CO2 module, disconnect the water
trap and set the working mode of the module to standby when CO2 monitoring is
not required.
The CO2 measurement can be used, with specified accessories, with intubated and
non-intubated adult, pediatric. With patients, a sample of the respiratory gas is
drawn from the patient's breathing circuit through an airway adapter and a gas
sampling line.
CAUTION
The water trap collects water drops condensed in the sampling line and therefore
prevents them from entering the module. If the collected water reaches a certain
amount, you should drain it to avoid blocking the airway. Dispose of accumulated
fluids in accordance with the hospital policy or your local regulations.
The water trap has a filter preventing bacterium, vapor and patient secretions
from entering the module. After a long-term use, dust or other substances may
compromise the performance of the filter or even block the airway. In this case,
replace the water trap. Replacing the water trap once a month is recommended.
Or, replace the water trap when it is detected leaky, damaged or contaminated.
7-3
7.3.1 Set Working Mode
The default working mode of the CO2 module is [Measure] when the ventilator is turned on
for the first time. If the current CO2 module is Standby, push the Menu key. Select [System]
and then [CO2]. Set [Working Mode] to [Measure] to start the CO2 module. When the
ventilator restarts, the CO2 module automatically continues with the previously selected
working mode.
When Standby, the working components of the CO2 module such as gas pump and infrared
light source are automatically turned off to extend the service life of the module.
WARNING
Take the patient’s actual bearing capability into consideration and select the
appropriate pump rate when setting the pump rate.
7-4
7.3.4 Set Humidity Compensation
The CO2 module is configured to compensate CO2 readings for either Body Temperature and
Pressure, Saturated Gas (BTPS), to account for humidity in the patient’s breath, or Ambient
Temperature and Pressure, Dry Gas (ATPD).
where,
PCO 2 = partial pressure, vol % = CO2 concentration, Pamb = ambient pressure, and
unit is mmHg.
For CO2 module, humidity compensation is switched on or off based on the actual situations.
1. Push the Menu key. Select [System] and then [CO2].
2. Set [Humidity Comp] to [ON] or [OFF] in either BTPS or ATPD.
Measurement accuracy may be affected by the breath rate and I/E ratio as follow:
etCO2 is within specification for breath rate ≤ 60 bpm and I/E ratio ≤ 1:1;
etCO2 is within specification for breath rate ≤ 30 bpm and I/E ratio ≤ 2:1.
Measurement accuracy is unspecified for breath rate larger than 60 bpm.
7-5
7.5 Troubleshooting
When the sampling system of the CO2 module works incorrectly, check if the sampling line
is kinked. If not, remove the sampling line from the water trap. Then, if a prompt message
indicating airway malfunction appears on the screen, it means that the water trap is occluded.
In this case, you must replace the water trap. If no such prompt message is displayed, it
means that the sampling line is occluded. Then you must replace the sampling line.
For CO2 module, a zero calibration is carried out automatically when necessary. You can also
start a manual zero calibration when deemed necessary. To manually start a zero calibration,
push the Menu key. Select [System] → [CO2] → [Zero]. You do not need to disconnect
the sensor from the breathing system when performing the zeroing.
7-6
8 Special Functions
8.1 Manual Breath
Push the Manual Breath key and the ventilator system delivers one breath to the patient in
accordance with the current ventilation mode.
NOTE
Pressing the Manual Breath key during inspiratory phase cannot initiate a manual
breath.
Manual breath function is disabled in CPAP mode and is supported when apnea
ventilation occurs.
Manual breath is disabled in standby status.
Push and hold the Exp. Hold key. The ventilator starts the Expiration Hold function and the
screen shows [Exp. Hold Active]. Release the Exp. Hold key. The ventilator terminates the
Expiration Hold function. Expiration Hold is active for a maximum of 30 seconds. If the Exp.
Hold key is pushed and held for more than 30 seconds or is released, the ventilator terminates
the Expiration Hold function automatically.
During Expiration Hold, the ventilator calculates PEEPi automatically and displays the
calculation results in the box as shown below.
NOTE
There is at least one inspiratory phase between two expiration holds.
The system responds to Exp. Hold key pressing operation only in non-standby
status.
Expiration Hold function is disabled in CPAP mode and is supported when apnea
ventilation occurs.
8-1
8.3 Inspiration Hold
Inspiration Hold means to extend the patient’s time of inspiratory phase manually and to
prevent the patient from expiration for a certain period of time.
Push and hold the Insp. Hold key. The ventilator starts the Inspiration Hold function and the
screen shows [Insp. Hold Active]. Release the Insp. Hold key. The ventilator terminates the
Inspiration Hold function. Inspiration Hold is active for a maximum of 30 seconds. If the Insp.
Hold key is pushed and held for more than 30 seconds, the ventilator terminates the
Inspiration Hold function automatically.
During Inspiration Hold, the ventilator calculates Cstat and Pplat automatically and displays
the calculation results in the box as shown below.
NOTE
There is at least one expiratory phase between two inspiration holds.
The system responds to Insp. Hold key pressing operation only in non-standby
status.
Inspiration Hold function is disabled in CPAP mode and is supported when apnea
ventilation occurs.
8.4 Nebulizer
During nebulization, aerosolized medicament is inhaled by the patient for the purpose of
therapy.
Push the Nebulizer key and set the appropriate nebulization time. Select [Ok] to start
nebulization. When the nebulizer is started up, the nebulizer indicator lamp is illuminated and
the screen prompt message filed displays the remaining nebulization time.
When the set nebulization time expires or the Nebulizer key is pushed again, the ventilator
terminates nebulization.
NOTE
CO2 cannot be measured in the aerosolized medicament environment. CO2 module
sampling and monitoring are suspended when the nebulizer is started.
Nebulization is disabled in V-A/C, V-SIMV and PRVC modes when patient type is
pediatric.
Aerosolized medication may occlude the expiration valve and flow sensor. Please
have them checked and cleaned after nebulization.
8-2
NOTE
Nebulization may cause fluctuation in the patient’s FiO2.
8.5 O2↑
The O2↑function means to deliver oxygen with concentration higher than the normal level.
When the O2↑key is pushed, the ventilator starts the O2↑ function. The O2↑indicator
lamp is illuminated and the screen prompt message filed displays the remaining O2↑ time.
O2↑ is active for a maximum of two minutes. When O2↑ is functioning, the [O2%]
parameter in the parameter setup quick key field displays the currently set oxygen
concentration.
When two minutes of O2↑ expires or the O2↑key is pushed again, the ventilator
terminates O2↑ function. Removing the breathing hoses during O2↑starts the suction
function.
NOTE
When O2 supply pressure is low, this function is not initiated, and is terminated
automatically if this function is initiated already.
8.6 Suction
The ventilator provides a suction procedure to help the patient to complete suction.
1. Push the Menu key and select [Procedure].
2. Select [Suction] to access the suction procedure screen and activate the suction function.
When the suction procedure is activated, the system performs O2↑function and
prompts [O2↑ Active. Please disconnect the patient after adequate O2 is
delivered.]. If the patient hoses are not disconnected within the specified time, the
suction procedure will end automatically.
After the patient hoses are disconnected, the system prompts [The patient is
disconnected. Please reconnect the patient after suction is completed.] and
stops ventilating the patient. In this case, manual sunction can be applied to the
patient.
After manual suction applied to the patient, re-connect the patient hoses. The
system performs O2↑function and prompts [O2↑Active. The patient is
reconnected.].
To stop an active suction procedure during O2↑, select [Exit] or push the O2↑key.
8-3
8.7 P0.1
P0.1 is the pressure drop within the first 100 ms after a patient starts spontaneous breathing.
1. Push the Menu key. Select [Tool] and select [Procedure].
2. Select [P0.1] to access the P0.1 measure screen.
3. Select [Start]. The system starts P0.1 measurement and prompts [Measurement
Active].
4. After the measurement is completed, the measurement result is displayed. The ventilator
can display the last three measurement results.
5. After the measurement is completed, waveforms and spirometry data are frozen
automatically.
NOTE
During P0.1 measurement, pushing the Freeze key does not produce freezing
operation.
If no operation is performed on P0.1 measurement screen within three minutes, the
measurement screen exits automatically.
8.8 NIF
NIF is the maximum negative pressure generated by the patient’s spontaneous breathing
within a period of time.
1. Push the Menu key. Select [Tool] and select [Procedure].
2. Select [NIF] to access the NIF measure screen.
3. Push and hold the [Press and Hold] button on the screen or the Exp. Hold key on the
display. The system starts NIF measurement.
4. Release the [Press and Hold] button or the Exp. Hold key. The measurement is
completed. The measurement result is displayed. The ventilator can display the last three
measurement results.
NOTE
During NIF measurement, pushing the Freeze key does not produce freezing
operation.
If no operation is performed on NIF measurement screen within three minutes, the
measurement screen exits automatically.
8-4
8.9 PEEPi
The PEEPi measure function supports measurement of two parameters—PEEPi and Vtrap.
PEEPi is the positive end-expiratory pressure produced by the trapped gas and Vtrap is the
trapped gas volume.
1. Push the Menu key. Select [Tool] and select [Procedure].
2. Select [PEEPi] to access the PEEPi measure screen.
3. Select [Start]. The system starts PEEPi measurement and prompts [Measurement
Active].
4. After the measurement is completed, the measurement result is displayed. The ventilator
can display the last three measurement results.
5. After the measurement is completed, waveforms and spirometry data are frozen
automatically.
8-5
The typical ventilation curves with static P-V tool function are shown below:
Pressure
Pmax
PEEP
adjusted to PEEP
Pstart
Time
Insp. time Exp. time
Flow
Expiration
at constant
flow
Gas delivered Time
at constant flow
Turning point in
Volume expiration
branch
8-6
NOTE
The P-V tool function is disabled in the following cases: patient type of Ped,
CPAP/PSV, NIV or apnea vent mode, within one minute after nebulization or
suction, within one minute after last P-V loop test.
The P-V tool function is not recommended when there is great leakge or when the
patient has spontaneous breathing. The relevent characteristic points the P-V tool
function provides are only for your reference.
8-7
6. After the measurement is completed, the system enters Analysis screen. Characteristic
points are displayed automatically on the P-V loop. You can set the desired positions of
[Cursor 1] and [Cursor 2]. When you select [Cursor 1] or [Cursor 2], the selected
cursor turns red. You can move the position of the cursor via the control knob to
determine the characteristic points. The system also displays the volume value and
pressure value of the inspiration and expiration branches corresponding to the cursor
position and displays the compliance of these branches, as shown below.
7. Select [History] to select the desired loop in the accessed list. The system only displays
the history loop you are viewing.
8. Select [Ref. Loop] to select the desired loop in the accessed list. The system displays the
reference loop you are viewing and the current loop as well.
8-8
9 Alarms
9.1 Introduction
Alarms, triggered by a vital sign that appears abnormal or by technical problems of the
ventilator, are indicated to the user by visual and audible alarm indications.
NOTE
When the ventilator is started, the system detects whether audible alarm tones and
alarm lamp function normally. If yes, the equipment gives a beep, also the alarm
lamp flashes red and yellow successively. If not, do not use the equipment and
contact us immediately.
When multiple alarms of different levels occur simultaneously, the ventilator
selects the alarm of the highest level and gives visual and audible alarm indications
accordingly.
9-1
9.3 Alarm Levels
By severity, the ventilator’s alarms fall into three categories: high level alarms, medium level
alarms and low level alarms.
1. High level alarms
Indicates that the patient is in a life threatening situation and an emergency treatment is
demanded.
2. Medium level alarms
Indicates that the patient’s vital signs appear abnormal and an immediate treatment is
required.
3. Low level alarms
Indicates that the patient’s vital signs appear abnormal and an immediate treatment may
be required.
The level for all technical alarms and physiological alarms are preset before the ventilator
leaves the factory and are not user adjustable.
9-2
9.4.2 Audible Alarm Tones
The ventilator uses different alarm tone patterns to match the alarm level:
High level alarms: broadcasts the high level alarm sound.
Medium level alarms: broadcasts the medium level alarm sound.
Low level alarms: broadcasts the low level alarm sound.
NOTE
The ventilator’s alarm signal sound pressure level is lower than 85 dB.
For physiological alarms, the asterisk symbols (*) before the alarm message match the alarm
level as follows:
High level alarms: ***
Medium level alarms: **
Low level alarms: *
9-3
9.4.5 Alarm Status Symbol
Apart from the aforementioned alarm indicators, the ventilator still uses the following
symbols telling the alarm status:
WARNING
Do not rely exclusively on the audible alarm system when using the ventilator.
Adjustment of alarm volume to a low level may result in a hazard to the patient.
Always keep the patient under close surveillance.
Push the Alarm Setup key and select [Alarm Limits]. You can set the alarm limits for Paw,
MV, ftot, TVe, FiCO2, or EtCO2. Among these parameters, the low alarm limits for some
parameters are factory-preset and are not user adjustable.
9-4
9.7 Set Apnea Time
Push the Alarm Setup key and select [Alarm Limits]. Set Tapnea to an appropriate value. If
no breathing activity is detected longer than the set Tapnea, an apnea alarm is triggered.
NOTE
When alarm is silenced, all the alarm indicators work normally except audible
alarm tones.
When alarm is silenced, if a new technical or physiological alarm occurs, the
current alarm silenced status ends automatically and audible alarm tones are
restored.
When the 120 s countdown time is up, the current alarm silenced status is cancelled
and audible alarm tones are restored.
9-5
9.9 Alarm Reset
Latching alarms: the system continues displaying the alarm message even if the alarm
conditions end except that:
Alarm audio disappears;
Alarm LED stops flashing and is permanently lit with the same color;
Alarm message is displayed without background color;
The alarmed parameter measured value stops flashing.
Push the Alarm Reset key to clear all latched alarms when alarm latching is switched on.
NOTE
There are three latching alarms: Apnea ventilation, Battery in Use, Pressure
Limited.
9-6
[Continuous]: indicates that the nurse call signal lasts until the alarm ends, i.e. the
duration of a nurse call signal equals to that of the alarm.
4. Select [Contact Type] and toggle between [Normally Open] and [Normally Closed].
[Normally Open]: normally open signals are used to trigger the nurse call function.
[Normally Closed]: normally closed signals are used to trigger the nurse call
function.
5. Select [Alarm Level] and set the alarm level for nurse call signals triggered alarm.
6. Select [Alarm Type] and select the alarm type to which nurse call signals triggered
alarm belongs.
If no setting is made for [Alarm Level] or [Alarm Type], nurse call signals will not be
triggered whatever alarm occurs.
WARNING
Do not rely exclusively on the nurse call system for alarm notification. Remember
that the most reliable alarm notification combines audible and visual alarm
indications with the patient’s clinical condition.
Use the specified nurse call cable when connecting with the hospital’s nurse call
system through the nurse call connection port. Failure to do so may burn the
machine and produce electric shock hazard.
9-7
3. Connect the test lung to the ventilator, and start the ventilation normally.
4. For the ventilator configured with one battery, the battery capacity is depleted after 90
minutes’ ventilation (for the ventilator configured with two batteries, the battery
capacity is depleted after 180 minutes’ ventilation). [System DOWN for battery
depletion!] alarm is triggered.
5. Reconnect the AC power.
6. Check if [System DOWN for battery depletion!] alarm is reset, and the ventilator is
powered by AC power.
9-8
9.11.7 Air Supply Pressure Low Alarm
1. Connect high pressure O2 supply and air supply to the ventilator.
2. After the ventilation is normal, close the high pressure air supply, and check if [Air
Supply Pressure Low] alarm is triggered.
9-9
3. After the CO2 test module finishes the preheating and enters in the working status,
connect the CO2 of 3% to 7% to the simple port of the sidestream CO2 module or the
airway adapter of the mainstream CO2 module. Set the EtCO2 high alarm limit to be
lower than the concentration of the standard gas.
4. Check if [EtCO2 Too High] alarm is triggered.
To access the Alarm Logbook window, push the Alarm Setup key and select [Alarm
Logbook]. In the Alarm Logbook window, you can:
1. Select [Scroll] to view the alarm events item by item.
2. Select [Alarm Level] and select the desired level of alarms to be displayed. The options
include all level, high level, medium level, and low level.
NOTE
After the ventilator is started up, if [Same Patient] is applied, the system will store
the previous alarm log and continue recording. If [New Patient] is applied, the
system will clear the previous alarm log and record anew.
9-10
9.13 When an Alarm Occurs
When an alarm occurs, do as follows:
1. Check the patient’s condition.
2. Determine the alarming parameter or alarm category.
3. Identify the alarm source.
4. Take proper actions to eliminate the alarm condition.
5. Make sure the alarm condition is corrected.
9-11
FOR YOUR NOTES
9-12
10 Cleaning and Disinfection
WARNING
Obey applicable safety precautions.
Read the material safety data sheet for each cleaning agent.
Read the operation and service instructions for all disinfection equipment.
Wear gloves and safety glasses. A damaged O2 sensor can leak and cause burns
(contains potassium hydroxide).
Reuse of undisinfected reusable accessories or components may cause
cross-contamination.
To prevent leaks, avoid damaging any component in case of disassembling and
reassembling the breathing system. Ensure the correct installation of the system.
Make sure of the applicability and correctness of the cleaning and disinfection
methods.
Disassemble and reassemble the breathing system as described in this manual. For
further disassembly and reassembly, contact us. Improper disassembling and
reassembling may cause breathing system leak and compromise normal system use.
Seeping liquid into the control assembly can damage the equipment or cause
personal injury. When cleaning the housing, make sure that no liquid flows into the
control assemblies and always disconnect the equipment from the AC mains.
Reconnect the AC mains after the cleaned parts are fully dry.
Do not use talc, zinc stearate, calcium carbonate, corn starch or equivalent
materials to prevent tackiness. These materials can go into the patient’s lungs and
airways and cause irritation or injury.
NOTE
Clean and disinfect the equipment as required before it is put into use for the first
time. Refer to this chapter for the cleaning and disinfection methods.
To help prevent damage, refer to the manufacturer’s data if you have questions
about a cleaning agent.
Do not use organic, halogenated, or petroleum based solvents, anesthetic agents,
glass cleaners, acetone, or other harsh cleaning agents.
Do not use abrasive cleaning agents (such as steel wool, silver polish or cleaner).
Keep all liquids away from electronic parts.
10-1
NOTE
Do not permit liquid to go into the equipment housings.
Only autoclave parts marked 134ºC.
Cleaning solutions must have a pH of 7.0 to 10.5.
The expiration valve assembly and patient hose of the gas pathways through the
ventilator can become contaminated with body fluids and expired gases during both
NORMAL CONDITION and SINGLE FAULT CONDITION.
All parts of the ventilator can be cleaned and disinfected. The cleaning and disinfection
methods vary from parts to parts. You need to select the appropriate method to clean and
disinfect the parts based on the actual situations to avoid cross-contamination between the
ventilator user and the patient.
This table is our recommended cleaning and disinfection methods for all parts of the
ventilator, including use for the first time and use after many times.
Ventilator Housing
Ventilator housing (including touch
Each patient ① A* or D*
screen)
Power cord and supply gas hose Each patient ① A* or D*
Every four weeks/as
Fan filter (filter at air intake vent) ② D*
necessary*
Inspiratory dust filter Weekly/as necessary* ② D*
Cart and support arm Each patient ① A* or D*
Expiration valve assembly
B*
Expiration valve flow sensor Each patient/weekly ② Note: soaked in
glutaraldehyde solution.
Expiration valve assembly
Each patient/weekly ② B* or C*
(including check valve)
10-2
Patient hose
Patient hose (including water trap
Each patient/weekly ② B* or C*
and Y piece)
Compressor
Housing Each patient ① A* or D*
Every 250 hours/as
Filter at air intake vent ② D*
necessary*
Other
Refer to the cleaning and disinfection
Nebulizer Each patient/weekly methods provided by the nebulizer
vendor.
Refer to the cleaning and disinfection
Humidifier Each patient/weekly methods provided by the humidifier
vendor.
Cleaning methods (Wipe and Bath Immersion):
① Wipe: wipe with a damp cloth immersed in alkalescent detergent (soap water etc.) or alcohol
solution and then wipe off the remaining detergent with a dry lint free cloth.
② Immersion: flush with water first and then immersed in alkalescent detergent (soap water etc.)
(water temperature 40ºC recommended) for approximately three minutes. Finally clean with water and
dry completely.
Disinfection methods (Autoclave):
A* Wipe: wipe with a damp cloth immersed in medium- or high-efficiency detergent (alcohol or
isopropyl alcohol etc.) and then wipe off the remaining detergent with a dry lint free cloth.
B* Immersion: immersed in medium- or high-efficiency detergent (alcohol or isopropyl alcohol etc.)
for more than 30 minutes (recommended time). Then clean with water and dry completely.
C*Steam autoclave at maximum 134℃ for more than 20 minutes (recommended time).
D* Ultraviolet radiation for 30 to 60 minutes (recommended time).
As necessary*: shorten the cleaning and disinfection intervals if the equipment is used in
dusty environment to ensure that the equipment surface is not covered by dust.
The table below lists the cleaning and disinfecting agents and autoclaving process that may
be used on the ventilator.
Name Type
Ethanol (75%) Intermediately efficient disinfectant
Isopropanol(70%) Intermediately efficient disinfectant
Glutaraldehyde (2%) Highly efficient disinfectant
Soap water (pH value of 7.0~10.5) Disinfectant
Clean water Disinfectant
Steam autoclave* Highly efficient disinfection
Steam autoclave*: The maximum temperature of this disinfection method can reach 134℃
(273ºF). Some parts cannot be steam autoclaved.
10-3
10.2 Disassemble the Ventilator’s Cleanable Parts
10.2.1 Expiration Valve Assembly
10-4
10.2.2 Expiration Valve Flow Sensor
B C
A. Flow sensor
To disassemble the flow sensor:
Pull out the flow sensor horizontally from the expiration valve assembly.
To install the flow sensor:
Insert the flow sensor horizontally into the expiration valve assembly in the direction as
the arrow shows.
B. Expiration valve cover assembly
To disassemble the expiration valve cover assembly
Rotate the expiration valve cover assembly to remove it from the expiration valve
assembly.
To install the expiration valve cover assembly
Insert the expiration valve cover assembly into the expiration valve assembly and rotate
the expiration valve cover assembly until they are fully engaged.
C. Water trap
To disassemble the water trap
Pull down the water trap to take it out.
To install the water trap
Push up the water trap to the position.
NOTE
Make sure that the arrow shows the gas flow direction when inserting the flow
sensor into the expiration valve assembly horizontally.
10-5
10.2.3 Water Trap
A B
A. Water trap on the breathing hose B. Water trap on the expiration valve assembly
10-6
10.2.4 Breathing Hoses
B
A
D
C
10-7
10.2.5 Nebulizer
C
A
B
Note
The nebulizer assembly and its installation steps described here are only for
reference.
10-8
WARNING
Nebulization yields the best performance at flow of 6 L/min. Nebulizers with other
flows can create significant errors in tidal volume and oxygen mix.
10.2.6 Humidifier
Note
Install the humidifier which complies with the specification. The humidifier
assembly and its installation steps described here are only for reference.
F E
D A
C
B
10-9
A. Humidifier B. Humidifier sliding wheel
C. Humidifier bracket fixed seat D. Screw
E. Humidifier inlet F. Humidifier outlet
To disassemble the humidifier:
1. Remove the hoses connected to the humidifier.
2. Remove the screws.
3. Lift off the humidifier from the humidifier bracket fixed seat.
10-10
10.2.6.2 Humidifier Installed onto the Pendant
A
B
C
G
D
F E
10-11
To install the humidifier:
1. Loosen the knob for fixing block. Put the fixing blocking onto the pendant beam.
2. Tighten the knob for fixing block.
3. Align the humidifier sliding wheel with the humidifier bracket fixed seat and slide in the
humidifier.
4. Tighten the screws.
5. Install the breathing hoses. For details, refer to steps 3 through 7 in 10.2.6.1.
WARNING
When installing the humidifier, make sure that the humidifier connector shall be
lower than the ventilator’s breathing connectors and the patient.
10.2.7 O2 Sensor
C
B
A
10-12
11 Maintenance
11.1 Repair Policy
WARNING
Obey infection control and safety procedures. Used equipment may contain blood
and body fluids.
Movable parts and removable components may present a pinch or a crush hazard.
Use care when moving or replacing system parts and components.
Only use lubricants approved for ventilation or O2 equipment.
Do not use lubricants that contain oil or grease. They burn or explode in high O2
concentrations.
Do not use malfunctioning ventilator. Have all repairs and service done by an authorized
service representative. Replacement and maintenance of the parts listed in this manual may
be undertaken by a competent, trained individual having experience in the repair of devices
of this nature.
After repair, test the ventilator to ensure that it is functioning properly, in accordance with the
specifications.
NOTE
No repair should ever be attempted by anyone not having experience in the repair
of devices of this nature.
Replace damaged parts with components manufactured or sold by us. Then test the
unit to make sure that it complies with the manufacturer’s published specifications.
Contact us for service assistance.
For further information about the product, contact us. We can provide documents
about some parts depending on the actual condition.
11-1
11.2 Maintenance Schedule
Minimum frequency Maintenance
During cleaning and setup Inspect the parts for damage. Replace as necessary.
Several times a day or as Check the breathing hoses and water traps for water build-up. Empty
necessary water build-up if there is.
Daily or as necessary Clean the external surfaces.
Calibrate the O2 sensor.
Check the filter water trap at the O2 gas supply inlet (drain the water
manually). If there is water build-up, press the spring pin upward at the
bottom of the water trap to drain the water (if water is drained in
ventilation status, water may splash. It is recommended to drain the
water in gas cut-off status and use a container for drainage to prevent
water from splashing onto the electrical plug underneath). After water
drainage is completed, the spring pin returns to the original position
automatically. If cracks or leaks are found on the water trap, contact the
service personnel.
Check the filter water trap at the Air gas supply inlet (drain the water
manually). If there is water build-up, rotate the black handle at the
bottom of the filer water trap gently (clockwise or counterclockwise).
The water can be drained when the handle is rotated at the almost
vertical position (if water is drained in ventilation status, water may
splash. It is recommended to drain the water in gas cut-off status and
use a container for drainage to prevent water from splashing onto the
electrical plug underneath). After water drainage is completed, return
the black handle at the bottom to the original position to prevent
leakage (rotate to the horizontal level clockwise or counterclockwise).
If cracks or leaks are found on the water trap or if the handle at the
bottom cannot be rotated or has cracks, contact the service personnel.
Before each use or after Perform system self-test. Check the breathing system resistance and
continuous use of two leakage.
weeks
Check every half a year Check the charging and discharging of the lithium battery every half a
and replace every three year and replace the lithium battery every three years.
years
11-2
Minimum frequency Maintenance
Annually or as necessary Calibrate the inspiration valve and expiratory flow sensor.
Calibrate the pressure sensor and expiration valve.
Calibrate the CO2 module.
Check the check valves, including supply gas check valves,
spontaneously inspiratory check valve, and expiratory check valve.
Check the mechanical pressure relief valve.
Check the supply gas seals.
Check the alarm duration of the backup alarm system (buzzer).
11-3
11.4 Flow Sensor Calibration
NOTE
Do not perform calibration while the unit is connected to a patient.
During calibration, do not operate the pneumatic parts. Do not move or press the
breathing hoses especially.
Make sure that the system is Standby. If not, push the Standby key to enter
standby screen.
It is recommended not to connect the humidifier to the ventilator before the
calibration.
Calibrate the flow sensor when the measured value has a great deviation or when the flow
sensor is replaced.
Follow these steps to calibrate the flow sensor:
1. Make sure that Air and O2 supplies are connected.
2. Connect the breathing hoses and insert the Y piece into the leak test plug to close the
breathing circuit.
3. Push the Menu key. Select [Calibrate] and select [Flow]. Select [Calibrate] on the
right side to start flow sensor calibration. The message [Calibrating] is displayed.
4. During the calibration, if you select [Stop], the ongoing calibration will stop and the
message [Calibration Stopped! Calibration is unfinished.] is displayed.
5. After a successful calibration of both Air and O2 supplies, the screen shows
[Calibration Completed!]. Otherwise, the message indicating calibration failure is
displayed. In this case, you need to do the calibration again.
NOTE
In case of calibration failure, check for sensor malfunctioning alarm and then
troubleshoot it if there is. If it still fails or great measurement error occurs after
calibration, replace the flow sensor and repeat the above operation. If the
measurement error is still great, contact your service personnel or us.
11-4
11.5 O2 Concentration Calibration
NOTE
Do not perform O2 concentration calibration while the unit is connected to a
patient.
Make sure that the system is Standby. If not, push the Standby key to enter
standby screen.
Calibrate the O2 sensor when the measured O2 concentration has a great deviation or when
the O2 sensor is replaced.
NOTE
If the calibration fails, check for technical alarm and troubleshoot it if there is.
Then do the calibration again. In case of repeated calibration failures, replace the
O2 sensor and do the calibration again. If it still fails, contact your service
personnel or us.
Handle and dispose of the O2 sensor according to your biohazard policies. Do not
incinerate.
11-5
11.6 CO2 Module Calibration
NOTE
Make sure that the system is Standby. If not, push the Standby key to enter
standby screen.
Hose
Sampling line
Pressure relief
valve
Ventilator
Gas cylinder
4. Vent the sampling line to the CO2 opening the cylinder pressure relief valve.
5. Input the vented CO2 concentration in the entry box.
6. The measured CO2 concentration is displayed. After the measured CO2 concentration
becomes stable, select [Calibrate] to calibrate the CO2 module. The message [CO2 Cal.
Running] is displayed.
7. After a successful calibration, the screen shows [CO2 % Calibration Completed!].
Otherwise, the message [Calibration Failure! Please try again.] is displayed. In this
case, you need to do the calibration again.
11-6
11.7 Touch Screen Calibration
NOTE
Make sure that the system is Standby. If not, push the Standby key to enter
standby screen.
1. Push the Menu key. Select [Calibrate] and select [Touchscreen]. Select [Calibrate] on
the right side.
11-7
On-screen battery icon indicates the battery statuses as follows:
The capacity of the internal battery is limited. If the battery capacity is too low, power supply
failure will occur and a high-level alarm [Low Battery Voltage!] will be triggered. In this
case, apply AC power to the ventilator.
11-8
11.8.2 Battery Performance Conditioning
Condition batteries when they are put into use for the first time. A complete battery
conditioning cycle is: uninterrupted charging, followed by uninterrupted discharging until the
ventilator shuts off, and then uninterrupted charging. Condition batteries regularly to
maintain their service life.
NOTE
Condition batteries every time when they have been used for three months or when
the battery running time becomes noticeably shorter.
Over time and with the use of the battery, the actual battery capacity will decrease.
For an old battery, the battery full icon does not indicate that the battery capacity
or battery running time still meets the requirement specified. When conditioning
batteries, replace the battery when its running time becomes noticeably shorter.
11-9
NOTE
If the running time of the battery is too short after fully charged, the battery may
be damaged already or defective.
If obvious signs of damage are detected on the battery or the battery recharging is
failed, replace the battery and recycle it properly.
WARNING
11-10
11.9.2 Electrical Safety Inspection Test
1. Perform protective earth resistance test:
a. Plug the probes of the analyzer into the protective earth terminal and equipotential
terminal of the AC power cord.
b. Test the earth resistance with a current of 25 A.
c. Verify the resistance is less than 0.1ohms (100 mohms).
d. Plug the probes of the analyzer into the protective earth terminal of the AC power
cord and the protective earth terminal of any auxiliary outlet. Repeat steps b and c.
e. If the resistance is larger than 0.1ohms (100 mohms) but less than 0.2ohms (200
mohms), disconnect the AC power cord and plug the probe that is previously plugged in
the protective earth terminal of the AC power cord into the protective earth contact of
the power outlet. Repeat steps a to d.
2. Connect the compressor, if configured, to the auxiliary electrical outlet.
3. Perform the following earth leakage current tests:
normal polarity;
reverse polarity;
normal polarity with open neutral; and
reverse polarity with open neutral.
4. Verify the maximum leakage current does not exceed 500 μA (0.5 mA) in the first two
tests. While for the last two tests, verify that the maximum leakage current does not
exceed 1000 μA (1 mA).
NOTE
Make sure the safety analyzer is authorized by certificate organizations (UL, CSA,
or AMAI etc.). Follow the instructions of the analyzer manufacturer.
If cart is not configured, do not perform auxiliary outlet related tests, and the
above mentioned AC power outlet should refer to the power outlet of the
equipment.
11-11
11.10 Water Build-up in the Flow Sensor
11.10.1 Prevent Water Build-up
The patient’s exhaled warm and moist gas is condensed all the way when it flows along the
expiratory hose. The condensed water remains on the hose wall and finally enters the water
trap. When the patient’s exhaled gas arrives at the expiration valve, it is not easily condensed
in the expiration valve assembly since the heater is heating the expiration valve all the time.
If the heater, however, malfunctions, or is not working efficiently, condensed water may also
appear at the expiration valve and expiratory flow sensor, compromising the accuracy of
measured values.
Check the expiratory flow sensor when abnormal flow waveform or unstable tidal volume
fluctuation is detected. Check the sensor for water. If there is water build-up, clear it before
use.
If there is water built up inside the flow sensor, remove the sensor and clear the water. Then
reinstall the sensor for use.
WARNING
Check water build-up inside the flow sensor every time before system use. Pooled
water in the flow sensor causes erroneous readings.
Make sure that all breathing system parts are dry every time when the breathing
system is cleaned and disinfected.
11-12
12 Accessories
WARNING
Use only accessories specified in this chapter. Using other accessories may cause
incorrect measured values or equipment malfunction.
Disposable accessories can not be reused. Reuse may degrade performance or
cause cross-contamination.
Check the accessories and their packages for damage. Do not use them if any sign
of damage is detected.
Parts which are intended to contact patients must comply with the biocompatibility
requirement of ISO10993-1 to prevent any adverse reactions arising from such
contact.
Disposal of the accessories shall comply with the applicable waste control
regulations.
The reusable accessory kit can be disinfected for 50 times.
The humidifier shall be used with a ventilator to provide warm and humidified
gases for patients.
Note
All the accessories listed are validated for use with this specific ventilator. And the
hosptial is responsible for ensuring the compatibility of the ventilator and the
accessories before use. The incompatible parts can result in degraded performacne.
12-1
Accessories Description PN Manufacturer
Silicone breathing tube,
082-000555-00
Adult, 600mm SAINT-GOBA
tube
Silicone breathing tube, IN
M6G-020039---
Adult, 450mm
Reusable Y type Reusable Y type connector
040-000735-00 VADI
Breathing connector (adult)
tube L type
Reusable L type connector 040-000736-00 VADI
kit(adult) connector
(115-00 water
Reusable water trap(56ml) 040-000734-00 VADI
4501-00) trap
straight
Reusable straight connector 040-000737-00 VADI
connector
extension Extension tube (with
040-000738-00 VADI
tube connectors at both ends)
Silicone breathing tube,
082-000556-00
Child, 600mm SAINT-GOBA
tube
Silicone breathing tube, IN
082-000557-00
Child, 450mm
Y type Reusable Y type connector
040-000740-00 VADI
Breathing Reusable connector (child)
tube kit Breathing straight
Reusable straight connector 040-000737-00 VADI
tube connector
kit(child) L type
Reusable L type connector 040-000736-00 VADI
(115-00 connector
4502-00) water
Reusable water trap(30ml) 040-000739-00 VADI
trap
straight
Reusable straight connector 040-000741-00 VADI
connector
straight
Reusable straight connector 040-000742-00 VADI
connector
Silicone breathing tube,
082-000558-00
infant, 600mm SAINT-GOBA
tube
Reusable Silicone breathing tube, IN
082-000559-00
Breathing infant, 450mm
tube Y type Reusable Y type connector
040-000743-00 VADI
kit(infant) connector (infant)
(115-00 L type
Reusable L type connector 040-000736-00 VADI
4503-00) connector
straight
Reusable straight connector 040-000737-00 VADI
connector
12-2
Accessories Description PN Manufacturer
straight
Reusable straight connector 040-000742-00 VADI
connector
water
Reusable water trap(30ml) 040-000739-00 VADI
trap
Disposable breathing tube
040-000755-00
Disposable Breathing (adult) Vincent
tube kit Disposable breathing tube medical
040-000756-00
(child)
Vincent
Filter Disposable filter (round) 040-000757-00
medical
Nebulizer Disposable jet nebulizer set 040-000799-00 VADI
New Sil-Flex Silicone Mask
040-000818-00 GALEMED
#5, Adult Large, 22F.
New Sil-Flex Silicone Mask
040-000819-00 GALEMED
#4, Adult, 22F.
New Sil-Flex Silicone Mask
040-000820-00 GALEMED
#3, Child Large, 22F.
Sil-Flex Silicone Face Mask
040-000821-00 GALEMED
#2, Child
Inflatable anesthesia mask
M6Q-150013--- GALEMED
(Adult Large)
Mask
Inflatable anesthesia mask
M6Q-150012--- GALEMED
(Adult)
Inflatable anesthesia mask
M6Q-150011--- GALEMED
(Child Large)
Inflatable anesthesia mask
M6Q-150010--- GALEMED
(Child)
Inflatable anesthesia mask
M6Q-150009--- GALEMED
(infant Large)
Inflatable anesthesia mask
040-000759-00 GALEMED
(infant)
Silicone head harness (adult) 040-000760-00 GALEMED
Silicone head harness (child) 040-000761-00 GALEMED
Head Harness
Silicone head harness
040-000762-00 GALEMED
(infant)
Clipped Test Lung(adult) 040-000744-00 VADI
Test lung
Test Lung (infant) 040-000745-00 VADI
12-3
Accessories Description PN Manufacturer
Humidifier(VADI/230V/adu
115-004505-00 VADI
lt humidification chamber)
Humidifier(VADI/230V/adu
115-004506-00 VADI
lt auto-feeding chamber)
Humidifier(VADI/230V/
pediatric humidification 115-004507-00 VADI
chamber)
Humidifier(VADI/115V/adu
115-004508-00 VADI
lt humidification chamber)
Humidifier(VADI/115V/adu
115-004509-00 VADI
lt auto-feeding chamber)
Humidifier
Humidifier(VADI/115V/
pediatric humidification 115-004510-00 VADI
chamber)
Humidifier(MR850/230V/ad
115-004511-00 Fisher&Paykel
ult/heating/tube)
Humidifier(MR850/115V/ad
115-004513-00 Fisher&Paykel
ult/heating/tube)
Humidifier(MR810/230V/ad
115-004515-00 Fisher&Paykel
ult /tube)
Humidifier(MR810/115V/ad
115-004516-00 Fisher&Paykel
ult /tube)
Air tube assembly 115-008200-00 AMVEX
Gas supply tube assembly(O2, Air)
O2 tube assembly 115-008201-00 AMVEX
Oxygen sensor Oxygen sensor 040-000708-00 CITY
Sampling Line, Adult 2.5m Artema
sample line 9200-10-10533
(Adult/pediatric,Disposable) Medical
DRYLINE Watertrap Artema
CO2 module Water trap 9200-10-10530
(Adult/pediatric, Reusable) Medical
accessories1
DRYLINE Airway Adapter
Artema
Airway adapter (Straight, Adult/pediatric, 9000-10-07486
Medical
Disposable)
1
Note: The CO2 module accessory material that contacts the patients has undertaken the bio-compatibility
test and is verified to be in compliance with ISO 10993-1.
12-4
A Theory of Operation
A.1 Pneumatic System
A.1.1 Pneumatic Circuit Diagram
Patient
Nebulizer
Humidifier
Atmosphere
PEEP valve
Air Inlet
O2 Inlet
A-1
A.1.2 Parts List
A-2
A.1.3 Description
This product is pneumatically driven, microprocessor controlled ventilator. As the
integration of electronics, pneumatics, mechanics, software and other subjects, the ventilator
can partially or fully replace the ventilation function of the patient. During the inspiratory
phase, the inspiration valve opens. High pressure Air and O2 supplies enter the ventilator,
pass through an Air and O2 mixer, and become fresh gas with specific concentration of O2,
and specific flow or pressure. The fresh gas enters the patient’s lungs through hose. During
the expiratory phase, the inspiration valve is closed while the expiration valve opens. The
gas is expired by the patient’s efforts.
The O2 and Air supply connectors are designed as required by the relevant standard to
prevent from wrong connection. Filter (F1/F2) filters the water, oil, and other foreign
substance in the supplied gas. Pressure switch (PS1/PS2) monitors the pressure of supply
gas and gives an alarm in case of low supply gas pressure. Check valve (CV1/CV2) ensures
unidirectional gas flow. Regulator (REG1/REG2) reduces and stabilizes the pressure of
supply gas to ensure that the inspiratory proportional valve at the rear end outputs stable and
repeatable flow.
Proportional solenoid valve PSOL1/ PSOL2() is controlled by drive current. Different drive
currents correspond to different flows of solenoid valve so as to achieve accurate control of
inspiratory flow. Dust filter (F3/F4) is placed before flow sensor to stabilize gas flow,
facilitating measurement by sensor. Flow sensor (Q1/Q2) is hot-wire flow sensor for
accurate measurement of gas passing through and does not require calibration.
After flowing through the flow control subsystem, O2 and Air are mixed in the gas mixing
system. Make sure that O2 and Air are evenly mixed before flowing through O2 sensor
(OS). Otherwise, the measured value by the O2 sensor is not consistent with the actual O2
concentration. Inspiratory safety valve (SV) is controlled by electromagnet. When the
ventilator works normally, the electromagnet is powered on and the safety valve is closed.
When the pressure in the inspiratory path exceeds the preset pressure, the electromagnet is
powered off, the safety valve opens, and the gas is released through pressure relief valve
(RV1). When the system is powered off, all electronically controlled components inside the
ventilator cannot work. In this case, the electromagnet is in power-off status and the safety
valve opens. The patient inspires the ambient air through the spontaneously inspiratory path.
Check valve (CV3) ensures the unidirectional gas flow and prevents repeated breathing
during the patient’s spontaneous inspiration. Inspiratory pressure sensor (PI) monitors the
pressure in the inspiratory path. Zeroing three-way valve (SOL1) zeroes the inspiratory
pressure sensor periodically. RV2 is mechanical pressure relief valve. It releases pressure
when the pressure exceeds 110±10cmH2O. RV2 opens to release pressure when the airway
pressure reaches the release pressure to ensure the patient safety.
A-3
Nebulizer control valve (NCV) is a two-way solenoid valve which has two statuses:
connected and disconnected. Resistor (R1) is an orifice. When NCV is connected,
continuous flow of 6 to 9 L/min is produced. Such flow enters the nebulizer through the
connector on the front panel of the ventilator. The nebulizer aerosolizes medication which
enters the respiratory tract with the inspiration of the patient.
The fresh gas produced by the ventilator is delivered to the patient’s lungs through patient
hose.
Expiration valve (EV) is pneumatically controlled. The expiration valve closing pressure is
controlled by PEEP valve and R3. When the control current given by the system to PEEP
valve is zero, the expiration valve is fully open. When the system gives some control current
to the PEEP valve, PEEP produces some flow, which produces pressure together with R3 to
push the expiration valve diaphragm to close the valve port. The patient’s expired gas must
overcome the valve closing pressure to go through the valve port. This dynamic process
finally ensures that the preset pressure goes throughout the patient’s inspiration and
expiration processes. Expiratory pressure sensor (PE) monitors the expiration valve closing
pressure.
Regulator (REG3) at the front end of PEEP is used to stabilize pressure to prevent change of
valve closing pressure caused by change of PEEP front end pressure. SOL3 is a three-way
valve for Air/O2 connection selection. Air is preferred for expiration valve control gas.
When Air is not available or Air pressure is relatively low, O2 is selected to ensure that
expiration valve pressure can be controlled.
During the inspiratory phase, the system gives control current to the PEEP valve to close the
valve at a certain pressure level, so as to ensure that the delivered Air and O2 mixed gas
from the ventilator goes first into the patient. If an accident happens during the mixed gas
delivery process which causes the delivered gas pressure to be greater than the limit
pressure, excess pressure is released from the expiration valve to ensure the patient safety.
During the expiratory phase, the system gives zero control current or relatively small
control current to the PEEP valve, which indicates that the expiration valve is fully open or
produces a certain valve closing pressure. When the expiration valve is fully open, it is
equivalent to the situation that the patient’s expired gas is directly open to the air (same to
the expiration of a normal person). When the expiration valve has some valve closing
pressure (PEEP), it is equivalent to the situation that the patient’s expired gas is always kept
at a positive pressure, which is clinically significant.
A-4
Check valve (CV4) ensures the unidirectional gas flow. When the patient inspires
spontaneously, gas goes from the ambient air, through check valve (CV3) of the inspiratory
safety module, patient hose, and into the patient’s respiratory tract. At this point, CV4 is
closed. When the patient expires spontaneously, gas flows out of the patient’s respiratory
tract, through the patient hose, expiration valve, CV4, expiratory flow sensor, and into the
ambient air. CV4 opens. At this point, CV4 is open while CV3 is closed. It can be seen from
this process that the co-effort made by CV3 and CV4 ensures the unidirectional gas flow
during the patient’s spontaneous breathing and prevents repeated breathing.
Expiratory heater (EXH HTR) is a heating device which heats the expiration valve, check
valve, and expiratory flow sensor to prevent the expired gas from condensation which
compromises the measurement accuracy.
Expiratory flow sensor (Q3) is a flow sensor based on the principle of differential pressure.
Diaphragm-type sensor is characterized by high sensitivity and low requirement for electric
circuit. After long term of use, however, the diaphragm will be distorted. Therefore,
periodical user calibration is necessary to ensure measurement accuracy. When the gas
passes through the expiratory flow sensor, differential pressure is produced on both sides of
the diaphragm. Flow information is acquired based on the differential pressure after
collected and processed by differential pressure sensor (PQ3).
Expiratory pressure sensor (PE) measures the expiratory pressure. SOL2 is a zeroing
three-way valve. Small flow is formed at the rear end of R2 and flows into the expiratory
circuit continuously, for the purpose of flushing the pressure sampling line so as to prevent
water from condensing in the sampling line, which compromises pressure measurement
accuracy.
A-5
A.2 Electrical System
A.2.1 Electrical Block Diagram
26 25 24
28 23
27
29 22
30 21
1 8 9 10 20
2 7 11 19
16
3 6 13 12 18
4 5 14 15 17
A-6
A.2.2 Parts List
A-7
FOR YOUR NOTES
A-8
B Product Specifications
The ventilator is already integrated with expiratory volume monitor, pressure measurement
device, and pressure release device. It has a built-in gas mixer and is equipped with alarm
system, O2 monitor, and CO2 monitor, where:
The expiratory volume monitor, pressure measurement device, and pressure release
device comply with IEC60601-2-12 .
The expiratory volume monitor, pressure measurement device, and pressure release
device comply with IEC80601-2-12.
The built-in gas mixer complies with ISO11195.
The alarm system complies IEC 60601-1-8.
The O2 monitor complies with ISO21647.
The CO2 monitor complies with ISO21647.
The O2 monitor complies with IEC80601-2-55.
The CO2 monitor complies with IEC80601-2-55.
B-1
B.2 Environmental Specifications
Main unit
B-2
B.4 Physical Specifications
System noise
A-weighted sound pressure level (LpA) ≤45 dB(A)
System noise
A-weighted sound power level (LWA) ≤53 dB (A)
Main unit
470 x 430 x 500 mm (height x width x depth) (excluding CO2 module)
Dimensions
1340 x 560 x 730 mm (height x width x depth) (excluding hoses)
Approximately 25 kg (excluding CO2 module )
Weight
Approximately 45 kg (excluding hoses)
Caster
4 casters with diameter not less than 100 mm. At least two front casters
Caster
have brakes.
Display
Type Color active matrix TFT LCD
Size 12.1"
Resolution 800 x 600 pixels
Brightness Adjustable
Touch screen Available, anti-glare
LED indicator
One (yellow and red. When high and medium level alarms occur
Alarm LED
simultaneously, it flashes red only)
AC power LED One (green; lit when connected to the AC power supply)
One (green; lit when batteries are installed and AC power supply is
Battery LED connected; flashing when powered by batteries; extinguished when no
batteries are installed or AC power supply is not connected.)
Operating status LED One (green; lit when powered on and extinguished when powered off)
Audio indicator
Gives off alarm tones and key tones; supports multi-level tone
Speaker modulation. The alarm tones comply with the requirements of
IEC60601-1-8.
Buzzer Gives off auxiliary audio alarm in case of speaker malfunction.
Connector
Network connector One multiplex connector supporting network and software online upgrade.
Connects to medical-grade external device via RS-232 protocol to
RS-232 connector
implement the communication between the ventilator and external device.
B-3
CO2/calibration One multiplex connector for calibrating inspiratory and expiratory flows
connector and supplying power for the external CO2 analyzer.
Nurse call connector Provides digital signals to drive the hospital’s nurse call system.
Outputs VGA video signals with the same contents to the primary display
VGA connector
and connects to the external display.
B-4
Not greater than 6 cmH2O at 60 L/min flow (adult reusable
breathing hose )
Not greater than 6 cmH2O at 30 L/min flow (pediatric reusable
Expiratory resistance
breathing hose )
Not greater than 6 cmH2O at 5 L/min flow (infant reusable
breathing hose)
Resistance: < 2 cmH2O at 60 l/min
Particle size: Captures particles of 0.3 mm (micron) with > 99.99%
Bacterial filter
efficiency
Dead space:< 80 mL
Leakage
Not greater than 200mL/min@50cmH2O
Leakage Not greater than 100mL/min@40cmH2O
Not greater than 50mL/min@20cmH2O
1
Note: It refers to the inspiratory flow which can be setted for Volume Control modes.
2
Note: It refers to the maximum inspiratory flow for Pressure Control and Pressure Support Ventilation
modes.
B-5
Plow 0 to 50 1 cmH2O
Thigh 0.2 to 30 0.1 s
Tlow 0.2 to 30 0.1 s
Trigger 0.5 to 15 0.1 L/min
-10 to -0.5 0.5 cmH2O
△int.PEEP OFF, 1 to 40 1 cmH2O
Exp% Auto, 10 to 85 5 %
△Papnea Provides pressure apnea setting. Refer to Pinsp specification.
fapnea Pediatric: 1 to 100 1 bpm
Adult: 1 to 100
Weight
Pediatric 3 to 35 0.5 kg
Adult 10 to 200 1 kg
Monitored parameters
B-6
P0.1 -20 to 0 0.1 cmH2O
PEEPi 0 to 120 0.1 cmH2O
FiO2 15 to 100 1 %
B-7
TVi 0 ml~100 ml: ±(10 ml + 3% of reading)
TVe 100 ml~4000 m: ±(5 ml + 8% of reading)
TVe spn ±15% of reading or ±15 mL, whichever is greater (NIV)
MV
MVspn ±8% of reading or ±0.3 L/min, whichever is greater
MVleak
ftot
fmand ±5% of reading or ±1bpm, whichever is greater
fspn
Rinsp 0 to 50: ±10 cmH2O/(L/s)
Rexp Other range: not defined.
Cstat 0 to 100: ±10 mL/cmH2O or ±20% of the displayed value,
whichever is greater
Cdyn
Other range: not defined.
0 to 1000: ±20 1/(min·L)or ±15% of the displayed value, whichever
RSBI is greater
Other range: not defined.
WOB No declaration
NIF ±(2 cmH2O + 4 % of the actual reading)
P0.1 ±(2 cmH2O + 4 % of the actual reading)
PEEPi No declaration
21% to 100%: ±3 vol.%;
FiO2
Other range: not defined.
the responded time of the oxygen concentration in the delivered
volume to change from a volume fraction of 21 % to 90 %:
when reusable adult pipeline is used, TV=500ml, f=10bpm,I:E=1:2,
Oxygen concentration ≤ 40 s ;
controlling responded time when reusable pediatric pipeline is used, TV=150ml, f=20bpm,
I:E=1:2,≤ 60 s ;
when reusable infant pipeline is used, TV=30ml, f=30bpm,
I:E=1:2,≤ 40 s .
B-8
B.8 Alarms
B.8.1 Settable Alarms
Alarm settings
B-9
B.9 Special Functions
Function Specification
Inspiration Push and hold the Insp. Hold key to activate this function.
Hold Inspiration Hold is active for a maximum of 30s.
Expiration Push and hold the Exp. Hold key to activate this function.
Hold Expiration Hold is active for a maximum of 30s.
O2↑ O2↑is delivered for a fixed 2 min.
During O2↑, O2 concentration for adult patients is 100% and that for pediatric
patients is 1.25 times of the currently set O2 concentration or 100%, whichever is
less.
Suction Phase 1: O2↑before suction. Delivering 100% O2 lasts for a maximum of 120 s. O2
concentration for adult patients is 100% and that for pediatric patients is 1.25 times
of the currently set O2 concentration or 100%, whichever is less. When patient
disconnection is detected, the system enters next phase automatically.
Phase 2: suction. Suction lasts for a maximum of 120s. When patient reconnection is
detected, the system enters next phase automatically.
Phase 3: O2↑after suction. Delivering 100% O2 lasts for a maximum of 120s. O2
concentration for adult patients is 100% and that for pediatric patients is 1.25 times
of the currently set O2 concentration or 100%, whichever is less.
Nebulizer Supports jet nebulizer;
Supports to set nebulizer time ranging from 1 to 60 min.
Manual One breath is delivered in the expiratory stage.
Breath Manual breath is not responded if delivered in the inspiratory stage or when the
expiratory stage is not finished.
Sigh Sigh is started once every three minutes in V-A/C. Sigh started within two
continuous ventilation cycles is effective.
Volume A sigh is delivered every 100 breaths or 7 minutes (whichever is earlier) in V-A/C
sigh mode. Tidal volume of 1.5 times of the set value is delivered every 100 breaths.
Screen Prevents ventilator settings and values displayed from being changed due to
Locking inadvertent key clicking.
B-10
B.10 CO2 Module Specifications
CO2 module
Measurement range Accuracy
B-11
B.11 Compressor Specifications
Compressor Specifications
Input voltage 220 to 240 V 110 to 120 V
Input frequency 50/60Hz 60Hz
Input current 3A 6A
Output pressure range 300 to 450 kPa
Noise Less than 50dB (A)
Continuous flow ≥30 L/min at output pressure of 300kPa
Peak flow Greater than 180 L/min for more than 0.8 seconds at one
barometric pressure
Dew point Lower than the room temperature by 5℃ at flow of 30 L/min
B-12
Effect of interfering gas
Air supply
Solid membrane
Diffusion barrier
Cathode
Anode
O2 2 H 2 O 4e 4OH
2 Pb 4OH 2 PbO 2 H 2 O 4e
B-13
Overall the cell reaction may be represented as:
2 Pb O2 2 PbO
O2 sensor is current generator, and the current is proportional to the rate of oxygen consumption
(Faraday's Law). This current can be measured by connecting a resistor across the output terminals
to produce a voltage signal. If the passage of oxygen into the sensor is purely diffusion limited, by
the solid membrane diffusion barrier, then this signal is a measure of the oxygen partial pressure.
Signal Stability
O2 sensor has highly stable outputs over their operating lives. Typical sensor drift rates are less
than 1% per month when O2 sensor is exposed to gas in typical applications. Thus a sensor with a
starting signal of 12mV in 210mBar oxygen will typically still be showing a signal greater than
10mV as it approaches the end of its life.
Humidity Effects
Under conditions where liquid condensation may occur, care is needed to ensure the gas access
holes do not become blocked. If liquids form in the region of the gas access hole, the flow of gas
to the sensor will be restricted. With gas access restricted, a low signal will result. If a sensor
shows signs of being affected by condensation, normal operation may be restored by drying the
sensor with a soft tissue. Under no circumstances should these sensors be heated to dry them out.
Changes in humidity levels which affect the O2 partial pressure will correspondingly alter the
output signal of the sensor.
Pressure Effects
Since the sensor measures O2 partial pressure, the output will rise and fall due to pressure changes
which affect the O2 partial pressure. Thus an increase in pressure of 10% at the sensor inlet will
produce a 10% increase in signal output. Nitrous oxide is highly soluble in neutral and alkaline
solutions. Where the sensor is exposed to high levels of nitrous oxide, the solubility of this gas can
in fact cause the internal pressure to increase to the point where the seals fail. O2 sensor
incorporates a patented pressure relief system in the rear of the sensor, limiting the internal
pressure build up due to N2O dissolving in the electrolyte to a figure well within the capacity of
the sealing system. Test data shows that sensors are unaffected by months of operation in 100%
N2O. Cross-interference tests with 10% CO2 (balance O2) show virtually no interference from
CO2.
Temperature Dependence
The rugged design of O2 sensor means they are resistant to damage from extremes of high or low
temperature. Even so, the sensor must never be exposed to temperatures at which the electrolyte
will freeze (approx. -25°C), or temperatures which will harm the components of the sensor, ie. the
plastic or seals (>70°C). Sensor lifetime is governed by the mass of lead available to react with
oxygen and its rate of consumption. High oxygen partial pressures and high temperatures will
increase the sensor output current, thus shortening the operating life.
B-14
Life (% of 20°C Figure)
Life = 1192/exp(2+0.0239* Temperature)
)
Temperature(°C))
B-15
FOR YOUR NOTES
B-16
C EMC
SynoVent E5 ventilator is in compliance with IEC 60601-1-2 for EMC.
The essential performance verified during the immunity testing comprised of Vdel control
accuracy, Vdel monitoring accuracy, monitoring of the airway pressure, CO2 Accuracy and O2
Accuracy.
NOTE
Using accessories other than those specified may result in increased
electromagnetic emission or decreased electromagnetic immunity of the equipment.
The ventilator or its components should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the ventilator or its
components should be observed to verify normal operation in the configuration in
which it will be used.
The ventilator needs special precautions regarding EMC and needs to be installed
and put into service according to the EMC information provided below.
Other devices may interfere with this equipment even though they meet the
requirements of CISPR.
When the input signal is below the minimum amplitude provided in technical
specifications, erroneous measurements could result.
Use of portable or mobile communications devices can degrade the performance of
the equipment.
C-1
Guidance and manufacture’s declaration - electromagnetic emissions
The SynoVent E5 ventilator is intended for use in the electromagnetic environment specified
below. The customer or the user of the SynoVent E5 ventilator should assure that it is used in such
an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The SynoVent E5 ventilator uses RF energy only
CISPR 11 for its internal function. Therefore, its RF
emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
RF emissions Class B
CISPR 11
Harmonic emissions Class A The SynoVent E5 ventilator is suitable for use in
IEC 61000-3-2 all establishments, including domestic
establishments and those directly connected to
Voltage fluctuations/flicker Complies
the public low-voltage power supply network
emissions
that supplies buildings used for domestic
IEC 61000-3-3
purposes.
C-2
EMC
C-3
EMC
symbol: .
C-4
EMC
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
a. The ISM (Industrial, Scientific and Medical) bands between 150 kHz and 80 MHz are 6.765
MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to
40.70 MHz.
b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range 80 MHz to 2,5 GHz are intended to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into patient
areas. For this reason, an additional factor of 10/3 has been incorporated into the formulae used in
calculating the recommended separation distance for transmitters in these frequency ranges.
c. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the SynoVent E5 ventilator is used exceeds the applicable RF
compliance level above, the SynoVent E5 ventilator should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the SynoVent E5 ventilator.
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
C-5
EMC
C-6
D Alarm Messages
This chapter lists physiological and technical alarm messages.
Note that in this chapter:
Column P stands for the default alarm level: H for high, M for medium and L for
low.
For each alarm message, corresponding actions are given instructing you to
troubleshoot problems. If the problem persists, contact your service personnel.
Ventilator Paw Too High H Airway pressure exceeds the set pressure high alarm limit.
parameters Check the hoses for occlusion, increase pressure alarm
limit, or decrease gas volume delivered.
Paw Too Low H Real time airway pressure lasts 15s during mechanic
ventilation, or is equal to or more than the alarm limit
(PEEP+4 cmH2O) during one mechanic ventilation cycle.
FiO2 Too High H The inspired O2 concentration is higher than the FiO2
high alarm limit for at least 20s.
Check the Air supply and calibrate the O2 sensor.
FiO2 Too Low H The inspired O2 concentration is lower than the FiO2 low
alarm limit for at least 20s or is lower than 18%.
Check the O2 supply and calibrate the O2 sensor.
TVe Too High M The measured TVe value is greater than or equal to TVe
high alarm limit for six continuous mechanical ventilation
cycles.
Check the ventilation setting parameters. Check the
expiratory flow sensor for water build-up. Perform zero
calibration.
MV Too High H The measured MV value is greater than or equal to MV
high alarm limit.
Check if trigger sensitivity setting is too low. Check if the
tidal volume setting or breathing frequency setting is too
high.
MV Too Low H The measured MV value is lower than MV low alarm
limit.
Check if the tidal volume setting or breathing frequency
setting is too low. Check the hoses for leakage.
Apnea H The time of failure to detect respiration exceeds Tapnea.
D-1
Apnea ventilation H Apnea ventilation mode is started when the time of failure
to detect respiration exceeds Tapnea. When this alarm is
triggered, press [Alarm Reset] key and the alarm
disappears. The system returns to the previous ventilation
mode.
ftot Too High M The total breathing frequency is greater than ftot high
alarm limit.
Check the ventilation parameter settings. Especially, check
if the trigger level setting is normal. Check for leakage
which results in mis-trigger.
Pressure Limited L The airway pressure reaches Plimit.
Increase Plimit or decrease TV setting. Check the hoses
for leakage.
When this alarm is triggered, press [Alarm Reset] key
and the alarm disappears.
CO2 EtCO2 Too High M The measured parameter value exceeds the alarm limit.
module EtCO2 Too Low M Check the patient’s physiological condition. Make sure
that patient type and alarm limit settings are correct.
FiCO2 Too High M
System Low Battery M Battery voltage is lower than the threshold value.
Voltage Connect AC power supply immediately .In case of power
failure, apply manual ventilation mode to help the patient
to breathe. If the batteries cannot be fully charged within
24 hours, contact your service personnel.
Battery in Use L The system is currently powered by batteries. Connect AC
power supply. When this alarm is triggered, after
connecting to the power, press [Alarm Reset] key and the
alarm disappears.
System DOWN for H Battery capacity is depleted and the system will shut down
battery depletion! in a few minutes.
Connect AC power supply immediately. In case of power
failure, apply manual ventilation mode to help the patient
to breathe. If the batteries cannot be fully charged within
24 hours, contact your service personnel.
Battery Undetected M No batteries are installed.
Power Supply H Internal power supply voltage is abnormal. Restart the
Voltage Error ventilator. If the problem persists, contact your service
D-2
personnel.
RT Clock Need L There is button cell available in the system but the clock is
Reset reset in case of power failure. Contact your service
personnel.
RT Clock Not H There is no button cell available in the system or the
Exist battery has no capacity.
The clock chip is faulty. Contact your service personnel.
IP Address L This message is displayed when there are conflicts
Conflict between IP address settings and disappears until the
conflicts are resolved. Set IP address again.
Loading Default L Loading configuration is failed.
Config. Failed Reload the configuration. If the problem persists, contact
your service personnel.
Restoring Last L Restoring configuration is failed.
Config. Failed Restart the ventilator or reload the configuration. If the
problem persists, contact your service personnel.
SD Storage Card L Storage card is not available or is failed.
Error Replace the storage card.
Insp. Hold L This alarm is triggered when the Insp. Hold key is pressed
Interrupted and held longer than the time limit. The alarm is cancelled
when the Insp. Hold key is released.
Exp. Hold L This alarm is triggered when the Exp. Hold key is pressed
Interrupted and held longer than the time limit. The alarm is cancelled
when the Exp. Hold key is released.
Keyboard Comm H Keyboard malfunction. Contact your service personnel.
Stop
Keyboard Selftest H Keyboard selftest error. Contact your service personnel.
Error
Ventilator Reset H One of ventilator modules is powered on abnormally. Push
Error the Alarm Reset key to cancel this alarm.
When this alarm is triggered, press [Alarm Reset] key and
the alarm disappears.
Key Error M This alarm is triggered when the hard key or rotary
encoder is pressed and held for more than 35s.
Memory Error H The memory has an error. Restart the ventilator. If the
problem persists, contact your service personnel.
PCON2 Selftest H The key control board has an error during power-on.
Error Restart the ventilator. If the problem persists, contact your
service personnel.
D-3
Ventilator Air Supply H The supply gas pressure is low.
parameters Pressure Low Check the status of supply gas. If the alarm continues
O2 Supply H although supply gas is normal, contact your service
Pressure Low personnel.
No Gas Supply H Air supply pressure low and O2 supply pressure low occur
Pressure every second simultaneously.
1. Make sure that the patient is in safe ventilation status.
2. Check the actual pressures of Air and O2 supplies.
3. Check that Air and O2 supply devices and connections
are in good condition.
4. Check Air and O2 supply pressure switches.
Airway Leak? L The airway is leaky. Check the airway for leakage and
restore it to good condition.
Airway H The airway is obstructed.
Obstructed? Check the airway for leakage and restore it to good
condition.
Tube H The tube is disconnected.
Disconnected? Restore tube connection.
TV Not Achieved L Tidal volume is less than the set tidal volume by over
70%.
Check ventilation setting parameters to see if the
ventilation volume is too large. Check if the supply gases
are normal. Check if the expiratory flow sensor has a
deviation and perform zero calibration. Check the hoses
for leakage.
Pinsp Not L Inspiratory pressure is less than the set inspiratory pressure
Achieved by over 70%.
Check ventilation setting parameters to see if the
inspiratory pressure is too large. Check if TV high alarm
limit is set too low. Check if the supply gases are normal.
Check the hoses for leakage.
Sustained Airway H The airway pressure measured by any pressure sensor is
Pressure greater than or equal to the set PEEP+15 cmH2O for 15s
continuously.
Check the breathing circuit for occlusion. Check if the
expiratory time is too short.
PEEP Too High H The measured PEEP exceeds PEEP+5 cmH2O within any
fully mechanical ventilation cycle.
Check the breathing circuit for occlusion. Check if the
expiratory time is too short.
Tinsp too Long L In PSV mode, the gas delivery time exceeds 4.5s for adult
and 1.5s for pediatric for three continuous cycles. This
alarm is not triggered if pressure sensor or flow sensor is
faulty.
D-4
Check for leakage. Check if the expiratory trigger
sensitivity is too low.
Ctrl Module L Restart the ventilator. If the problem persists, contact your
Comm Error service personnel.
Ctrl Module H
Comm Stop
Ctrl Module H
Selftest Error
Protection Module L
Comm Error
Protection Module H
Comm Stop
Protection Module H
Selftest Error
Heating Module L
Failure
Fan Failure M
Pressure Sensor H
Failure
Exp. Flow Sensor H
Failure
Internal M
temperature too
high
O2 Sensor Failure M Replace the O2 sensor.
O2 Sensor L The O2 sensor is not connected. Re-connect the O2 sensor.
Unconnected
Please calibrate O2 L Calibrate the O2 sensor.
sensor.
Please perform H Calibrate the flow sensor.
flow calibration.
Please perform H Calibrate pressure.
pressure
calibration.
Air Insp. Limb H The ventilator air limb supply is abnormal.
Failure Check the gas supply and perform system test. If the alarm
is not cancelled, contact your service personnel.
O2 Insp. Limb H The ventilator O2 limb supply is abnormal.
Failure Check the gas supply and perform system test. If the alarm
is not cancelled, contact your service personnel.
Insp. Gas Temp H The gas temperature exceeds 45℃. Restart the ventilator.
Too High If the problem persists, contact your service personnel.
Buzzer Failure L The buzzer is faulty. Restart the ventilator. If the problem
persists, contact your service personnel.
D-5
Nebulizer Valve M The nebulizer valve is faulty. Restart the ventilator. If the
Failure problem persists, contact your service personnel.
3-way Valve M The 3-way valve is faulty. Restart the ventilator. If the
Failure problem persists, contact your service personnel.
Insp. Temperature H The inspiratory temperature sensor is faulty. Restart the
Sensor Failure ventilator. If the problem persists, contact your service
personnel.
Volume Limited L In pressure mode, the inspired tidal volume exceeds the
high alarm limit. Expiration is switched to when the high
limit is reached.
Check for leakage or change parameter. Decrease pressure
setting or increase tidal volume alarm limit.
Ctrl Module Init H The control module selftest is passed at power-on. But
Error monitoring module system software’s sending parameter
configuration to monitoring module is failed. Restart the
ventilator. If the problem persists, contact your service
personnel.
Protection Module H The protection module selftest is passed at power-on. But
Init Error protection module system software’s sending parameter
configuration to protection module is failed. Restart the
ventilator. If the problem persists, contact your service
personnel.
CO2 CO2 Init Error H An error occurs during CO2 module initialization.
The CO2 module is not installed properly or is faulty
module
Contact your service personnel.
CO2 Selftest Error H An error occurs during CO2 module selftest.
Restart the ventilator. If the problem persists, contact your
service personnel.
CO2 Comm Stop L CO2 module malfunction or communication failure
occurs.
Restart the ventilator. If the problem persists, contact your
service personnel.
CO2 Comm Error H CO2 module communication failure. Restart the ventilator.
If the problem persists, contact your service personnel.
CO2 Sensor High L The temperature of the sensor assembly is too high
Temp (>63℃). Check, stop using or replace the sensor.
CO2 Sensor Low L The temperature of the sensor assembly is too low (<5℃).
Temp Check, stop using or replace the sensor.
CO2 High Airway L The airway pressure is too high (>790 mmHg).
Pressure Check the pneumatic connections. Make sure that the
ventilator application site meets the environmental
specifications. Check for special sources that affect the
ambient pressure. Attempt to restart the ventilator.
D-6
CO2 Low Airway L The airway pressure is too low (<428 mmHg).An error
Pressure occurred to the airway pressure. Check the patient and
pneumatic connections. Attempt to restart the ventilator.
O2 High L The barometric pressure is greater than 790 mmHg.
Barometric Check the pneumatic connections. Make sure that the
ventilator application site meets the environmental
specifications. Check for special sources that affect the
ambient pressure. Attempt to restart the ventilator.
CO2 Low L The barometric pressure is less than 428 mmHg.
Barometric Check the pneumatic connections. Make sure that the
ventilator application site meets the environmental
specifications. Check for special sources that affect the
ambient pressure. Attempt to restart the ventilator.
CO2 Hardware H Errors may occur to:
Error 1. External A/D sampling 2.5V
2. 12V power supply voltage
3. Internal A/D sampling 2.5V
4. Pump
5. 3-way valve
Restart the ventilator. If the problem persists, contact your
service personnel.
CO2 Sampleline L An error or occlusion may occur to the sampling line.
Occluded Check the CO2 pneumatic line.
CO2 Zero Failed L Deviation of gain input signal is too great to be adjusted.
CO2 System Error L The alarm can be triggered by multiple system errors.
Restart the ventilator. If the problem persists, contact your
service personnel.
CO2 No Watertrap L The water trap is disconnected or is not connected
properly.
Check the water trap.
EtCO2 Overrange L The measured parameter value is outside the measurement
FiCO2 Overrange L range (error range is counted).
Do the test after zeroing and calibration. If the problem
persists, contact your service personnel.
D-7
FOR YOUR NOTES
D-8
E Factory Defaults
This chapter lists the most important factory default settings which are not user-adjustable.
When necessary, you can restore the factory default settings.
E.2 Alarm
Alarm Factory default setting
Paw high limit 50 cmH2O
MV high limit TV*f*1.5
MV low limit TV*f*0.8
TVe high limit TV setting value x 2
ftot high limit OFF
Tapnea 15s
Alarm Volume 2
E-1
E.3 Ventilation Mode
Ventilation mode Factory default setting
V-A/C
TV Adult: 7 kg/mL x IBW and 100 ml, whichever is greater; pediatric:
7 kg/mL x IBW (round down) (when TV/f source is IBW or height
& gender)
Adult: 500 ml; pediatric: 50 ml (when TV/f source is patient type)
O2% 40%
Plimit 40 cmH2O
PEEP 3 cmH2O
△int.PEEP OFF
Sigh OFF
Tinsp Adult: 1.7s; pediatric: 0.7s
I:E 1:2
Assist ON
F-Trig Adult: 2.0 L/min; pediatric: 1.0 L/min
Flow Adult: 20 L/min; pediatric: 8 L/min
f Adult: 12 bpm; pediatric: 29 bpm
ATRC (only in non-NIV OFF
mode)
Tube diameter (only in 8.0mm
non-NIV mode)
Compensation proportion 80%
(only in non-NIV mode)
Compensation of expiration ON
(only in non-NIV mode)
P-A/C
O2% 40%
PEEP 3 cmH2O
Pinsp 15 cmH2O
Tinsp Adult: 1.7s; pediatric: 0.7s
I:E 1:2
Tslope 0.2s
Assist ON
F-Trig Adult: 2.0 L/min; pediatric: 1.0 L/min
E-2
f Adult: 12 bpm; pediatric: 29 bpm
ATRC (only in non-NIV Off
mode)
CPAP/PSV
O2% 40%
PEEP 3 cmH2O
△Psupp 0 cmH2O
Tslope 0.2s
F-Trig Adult: 2.0 L/min; pediatric: 1.0 L/min
Exp% Auto
△Papnea 15 cmH2O
fapnea Adult: 12 bpm; pediatric: 29 bpm
Tinsp (only in NIV mode) Adult: 1.7s; pediatric: 0.7s
ATRC (only in non-NIV OFF
mode)
Tube diameter (only in 8.0mm
non-NIV mode)
Compensation proportion 80%
(only in non-NIV mode)
Compensation of expiration ON
(only in non-NIV mode)
V-SIMV
TV Adult: 7 kg/mL x IBW and 100 ml, whichever is greater; pediatric:
7 kg/mL x IBW (round down) (when TV/f source is patient
weight)
Adult: 500 ml; pediatric: 50 ml (when TV/f source is patient type)
O2% 40%
fSIMV Adult: 5 bpm; pediatric: 20 bpm
Plimit 40 cmH2O
PEEP 3 cmH2O
△Psupp 0 cmH2O
Tinsp Adult: 1.7s; pediatric: 0.7s
Tslope 0.2s
F-Trig Adult: 2.0 L/min; pediatric: 1.0 L/min
Exp% Auto
Flow Adult: 20 L/min; pediatric: 8 L/min
fapnea Adult: 12 bpm; pediatric: 29 bpm
E-3
Apnea ventilation ON
ATRC (only in non-NIV OFF
mode)
Tube diameter (only in 8.0mm
non-NIV mode)
Compensation proportion 80%
(only in non-NIV mode)
Compensation of expiration ON
(only in non-NIV mode)
P-SIMV
O2% 40%
fSIMV Adult: 5 bpm; pediatric: 20 bpm
Pinsp 15 cmH2O
PEEP 3 cmH2O
△Psupp 0 cmH2O
Tinsp Adult: 1.7s; pediatric: 0.7s
Tslope 0.2s
F-Trig Adult: 2.0 L/min; pediatric: 1.0 L/min
Exp% Auto
fapnea Adult: 12 bpm; pediatric: 29 bpm
Apnea ventilation ON
ATRC (only in non-NIV OFF
mode)
Tube diameter (only in 8.0mm
non-NIV mode)
Compensation proportion 80%
(only in non-NIV mode)
Compensation of expiration ON
(only in non-NIV mode)
PRVC
TV Adult: 7 kg/mL x IBW and 100 ml, whichever is greater; pediatric:
7 kg/mL x IBW (round down) (when TV/f source is patient
weight)
Adult: 500 ml; pediatric: 50 ml (when TV/f source is patient type)
f Adult: 12 bpm; pediatric: 29 bpm
O2% 40%
Plimit 40 cmH2O
PEEP 3 cmH2O
Tinsp Adult: 1.7s; pediatric: 0.7s
E-4
I:E 1:2
Assist ON
F-Trig Adult: 2.0 L/min; pediatric: 1.0 L/min
ATRC (only in non-NIV OFF
mode)
Tube diameter (only in 8.0mm
non-NIV mode)
Compensation proportion 80%
(only in non-NIV mode)
Compensation of expiration ON
(only in non-NIV mode)
Duolevel
O2% 40%
△Psupp 0 cmH2O
Tslope 0.2s
Phigh 15 cmH2O
Plow 5 cmH2O
Thigh Adult: 1.7s; pediatric: 0.7s
Tlow Adult: 3.3s; pediatric: 1.4s
F-Trig Adult: 2.0 L/min; pediatric: 1.0 L/min
Exp% Auto
△Papnea 15 cmH2O
fapnea Adult: 12 bpm; pediatric: 29 bpm
ATRC (only in non-NIV OFF
mode)
Tube diameter (only in 8.0mm
non-NIV mode)
Compensation proportion 80%
(only in non-NIV mode)
Compensation of expiration ON
(only in non-NIV mode)
APRV
O2% 40%
Tslope 0.2s
Phigh 15 cmH2O
Plow 5 cmH2O
Thigh Adult: 1.7s; pediatric: 0.7s
Tlow Adult: 3.3s; pediatric: 1.4s
E-5
△Papnea 15 cmH2O
fapnea Adult: 12 bpm; pediatric: 29 bpm
ATRC (only in non-NIV OFF
mode)
Tube diameter (only in 8.0mm
non-NIV mode)
Compensation proportion 80%
(only in non-NIV mode)
Compensation of expiration ON
(only in non-NIV mode)
E-6
F Symbols and Abbreviations
F.1 Symbols
A ampere
Ah ampere hour
bpm Breaths per minute
ºC centigrade
cc cubic centimetre
cm centimeter
cmH2O centimeter of water
dB decibel
℉ fahrenheit
g gram
hr hour
Hz hertz
hPa hectopascal
inch inch
k kilo-
kg kilogram
kPa kilopascal
L litre
lb pound
m meter
mAh milliampere hour
mbar millibar
mg milligram
min minute
ml milliliter
mm millimeter
mmHg millimeter of mercury
ms millisecond
mV millivolt
mW milliwatt
F-1
nm nanometer
ppm part per million
s second
V volt
VA volt ampere
Ω ohm
µA microampere
µV microvolt
W watt
- minus
% percent
/ per;divide;or
~ to
^ power
+ plus
= equal to
< less than
> greater than
≤ less than or equal to
≥ greater than or equal to
± plus or minus
× multiply
© copyright
F-2
F.2 Abbreviations
APRV Airway Pressure Release Ventilation
ATPD Ambient Temperature and Pressure Dry
BTPS Body Temperature and Pressure Saturated
Cdyn Dynamic Compliance
Flow Flow
f Breathing Frequency
fapnea Frequency of Apnea Ventilation
fmand Mandatory Frequency
fspn Spontaneous Frequency
fSIMV Frequency of SIMV
MV Minute Volume
MVspn Spontaneous Minute Volume
MVleak Leakage Minute Volume
F-3
Plimit Pressure Limit Level
Sigh Sigh
SIMV Synchronized Intermittent Mandatory Ventilation
TV Tidal Volume
TVe Expired Tidal Volume
TVe spn Spontaneous Expired Tidal Volume
TVi Inspired tidal Volume
Volume Gas Volume
Vtrap Volume of Trap Gas
V-A/C Volume - Assist/Control Ventilation
V-SIMV Volume - Synchronized Intermittent Mandatory Ventilation
F-4
P/N: 046-000991-00 (10.0)