Ventilator: CCV-700B User'S Manual

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CCV-700B Ventilator

USER’S MANUAL
Safety Guide

1. Before operating the ventilator, please read this manual thoroughly, and make sure
that all the cautions and instructions are strictly followed.
2. To avoid any unexpected ill effects on patients in case the power is cut off suddenly,
make sure the ventilator is equipped with a built-in backup battery before operation.
3. Main power supply to the ventilator should be equipped with a protective ground. If
this cannot be ensured, apply the backup battery.
4. DO NOT operate the ventilator under circumstances that contain flammable, explosive
or narcotic air, since the unit is not explosion proof. Do not let liquid enter the
mechanism since the unit is not waterproof. If there is any liquid splashing on the unit,
please wipe it immediately.
5. Before putting the ventilator into use, make sure it has been cleaned thoroughly and
disinfected, and each function is in good order. NEVER continue to operate the
ventilator which has been detected to be malfunctioning.
6. Before being connected to the windpipe of a patient, the ventilator should be
stationed, adjusted and tested on a simulated lung firstly.
7. The electrical wire and breathing tubes should be well laid in order not to interfere with
personnel’s movements in the sickroom. The airway cannot be under any pressure in
case it is out of shape and blocked. Do not move the ventilator casually when it is in
use so as to avoid such accidents as the airway or wire falling off and the oxygen
cylinder toppling over.
8. There must be qualified medical personnel guarding on the spot during the operation
of the ventilator. Pay attention to the working status of ventilator and humidifier,
meanwhile, pay attention to the patient’s Life Indicator and vigor analyzing data, and
adjust the ventilator to the most appropriate status for the patient.
9. Although the ventilator is considered technically mature and highly reliable in design,
any instruments have the possibility to malfunction unexpectedly. For the sake of the
patient’s safety, please do prepare a standby ventilator of good and reliable
conditions.
Figure & Type Matter

DANGER:Denotes that it should be alert to high danger.

WARNING:Denotes that it should be alert to moderate danger.

NOTE:Denotes that it should attend slight danger.

The Equipment of Type B.

Check the random file.

Through the CE Certificate.


Contents
1. Overview················································································· 2

2. Structure and operating principle··············································· 2

3. Technical ················································································3

4. Installation and commissioning·················································· 4

5. Use and Operation···································································· 6

6. Troubleshooting······································································· 9

7. Safety Protection and Accident Handing······································10

8. Washing and Disinfection·························································· 11

9. Care and Maintenance······························································· 12

10. Transportation and Storage······················································ 12

11. Others···················································································· 12
1.Overview
1.1Scope of Application and Main Features

The CCV-700B ventilator is an electrically controlled pneumatic ventilator integrating

such functions as time, volume cycling, pressure limit, etc. It is mainly intended for

providing ventilation support to a critically ill patient during the life threatening phase and

ensuring the going-through of the dangerous period by the patient and smooth treatment

of primary diseases for recovery. Also it provides an alternation in case of irreversible

lesions in respiratory muscles or irreversible damage to upper airway to maintain the

respiratory function of the patient, and also provides ventilation assistance for the patient

during the recovery from a disease or operation. Its main features are as follows:

A.Gas drive and electrical control, time-pressure switching and pressure limit control.

B. A high-brightness LED digital display is used to present the control frequency, tidal

volume, throughput, overall respiratory rate, spontaneous breathing frequency, etc.

C.A highly sensitive and responsive pressure sensor and a flow sensor are used to

measure, control and display the airway pressure and gas flow rate and the ventilator is

equipped with automatic throughput compensation.

D.In case of an abnormality to the ventilator or misoperation, the ventilator can raise a

visual-audible alarm to automatically protect itself.

1.2 Requirements for Ambient Conditions


The CCV-700B ventilator is a mobile medical device as specified in the Environment

Requirements and Test Methods for Medical Electrical Equipment to operate in Climatic

Environment Group II and Mechanical Environment Group II. Its normal operating

conditions are as follows:

——Ambient temperature: 10 ~ 40℃, relative humidity: no higher than 80%.

——Atmosphere pressure: 86kPa ~ 106kPa

— — Gas source requirement: medical oxygen source with a pressure ranging from

280 to 600kPa and a flow rate of 50L/min (containing no fresh air).

——Power supply requirements: AC 220V±10%, 50±1Hz and 30VA, well grounded.


2.Structural Characteristics and Operating Principles

The CCV-700B ventilator is gas driven by medical compressed oxygen and compressed
air. In the inspiratory phase, two streams of compressed gas (compressed oxygen and
compressed air) flow into a high performance air-oxygen mixer to form a mix of oxygen
and air with a certain pressure. Such mix of oxygen and air flows into a high performance
electrically controlled inspiratory proportional valve and is delivered through the
inspiratory circuit of the ventilator into the airway in the patient for mechanical ventilation.
In the expiratory phase, the gas exhaled by the patient reaches the expiration control
valve through a filter and an expiratory circuit to be discharged into the atmosphere.
During such process, a high performance proportional valve, a highly sensitive flow
sensor, a pressure sensor and a single-chip microcomputer control system are used and
control in the time fixed, volume controlled and constant pressure modes is realized by
adjusting the airway pressure and airway flow applied to the patient in a closed loop
mode.

3.Technical Features

3.1 Main Performances

3.1.1 Basic Functions

——End-inspiratory plateau;

——Sigh (deep breath);

3.1.2 Ventilation Modes

——SIPPV
——IPPV
——IMV
——SIMV

——PEEP

——SPONT

——SIGH
——MANUAL
3.2 Technical Data
—Tidal volume range: no less than 50 to 1200ml, permissible deviation: ±20 %.
——Maximum minute ventilation: ≥ 18 L/min, permissible deviation: ±20 %.

——Ventilator compliance: ≤30 Ml/kPa

— — Controlled ventilation (IPPV) frequency range: 0 ~ 99times/min, permissible

deviation: ±15 %.

——I:E ratio: 4:1~1:4

——Maximum safety pressure: ≤6.0 KPa

——Oxygen consumption: the variation in the gas pressure in the cylinder should be

less than or equal to 1.5MPa/h when the ventilator operates on a 12250KPa / 40L medical

oxygen cylinder continuously for one hour.

——Ptr: -0.4 ~ 1.0 KPa, permissible deviation: ±0.15 KPa

— — Time to switch between controlled and assisted ventilation modes: 6s,

permissible deviation: +1 s, -2 s.

——IMV frequency range: 1 ~ 12 times/min, permissible deviation: ±15%.

——PEEP range: no less than 0.1 ~ 1.0kPa.

——Sigh (deep breath): the inspiration time should be no less than 1.5 times of the

original setting.

——Duration of end expiration plateau: 0.1~1.0s,

——Pressure limit range: 1.0~6.0kPa, permissible deviation: ±20 %

— — The presentation of the spontaneous breathing frequency, overall respiratory

rate and ventilation capacity is refreshed once every minute.

— — Continuous operation duration: the ventilator can operate continuously on a

24-hour basis on an AC utility main.

——Main unit net weight: 15kg, dimension (L*W*H): 390*320*310 (mm).


3.3 Alarm System

Alarm
Alarm Item Alarm Condition Alarm Form
Level
The gas source
Low gas pressure drops to a
source level below
pressure 0.2MPa.
Range: 1.0 ~
Upper
6.0KP a, Immediate alarm; “high level alarm”
airway
High permissible indicator flickers raising an audible
pressure
deviation: ±20% alarm.
limit
(90% of set value)
Continuous The airway The maximum delay is no longer than
positive pressure exceeds 17s. The “high level alarm” indicator
pressure 15hpa. flickers raising an audible alarm.
The alarm will be raised after one
Low tidal breathing cycle. The “medium level
Lower than 50ml
volume alarm” indicator flickers raising an
audible alarm.
The airway
Lower pressure drops to The alarm will be raised after a delay
airway 0.5KPa. The of 4 to 15s. The “medium level alarm”
pressure Medium permissible indicator flickers raising an audible
limit deviation is ±0.2 alarm.
KPa.
Upper The throughput is Immediate alarm. The “medium level
throughput higher than alarm” indicator flickers raising an
limit 18L/min. audible alarm.
Battery The battery voltage
voltage is lower than 10.5V.

3.4 Battery
This ventilator is equipped with an internal backup power supply of the voltage 12V ± 10%,

rated capacity 7Ah and maximum current 2A. The fully recharged battery can support the

operation of this ventilator for a duration of no less than 30min. In case of a utility main

failure, this ventilator can automatically switch to operate on the internal power supply.

3.5 Operating Noise Level


The noise level when this ventilator normally operates is no higher than 65 dB.

3.6 Safety Requirements


In accordance with the classification requirements in GB 9706.1-2007 Medical Electrical

Devices Part 1: General Safety Requirements:


A)By electric shock protection type

——Type I device.

——Internal power supply device.

B)By degree of electric shock protection

——Type B application

C)By degree of protection against liquid intrusion

——Common (IPX0)

D)By operating mode

——Continuous operation.

E)This product is not equipped with an application part for protection against defibrillation

and discharge effects.

F)This product is not equipped with signal output and input parts.

G)This product is a movable device.


H)This product is not explosive-proof and thus cannot be used in an environment with
combustible and explosive anesthetic gases.

4 Installation and Commissioning

Caution: this ventilator should be installed, commissioned,


inspected and used by professionals with certain qualifications
to avoid unexpected faults or damages.

4.1 Preparations Prior to Installation


Confirm that this ventilator and its fittings are in complete and good condition free from

damage during transportation and that contents of the packing box are consistent with the

packing list. Keep properly the damping cushions in the packing box for use in another

transportation.

Learn how to use the front and rear control panels of this ventilator . Check the position of

the pointer of the pressure gauge. If the pointer is not at zero point, then adjust the zero

point adjustment screw on the pressure gauge by using a screwdriver.

Check the medical compressed oxygen source and make sure that its pressure ranges
from 280 to 600KPa and flow rate is 50L/min. If you supply oxygen with a cylinder, then

you also need to check and make sure that the cylinder is sufficient of oxygen, and that

the pressure reducer on the cylinder functions well and is correctly installed.

Check and make sure that the single-phase AC power supply used for this ventilator is of

the AC 220V±10% voltage and securely grounded for protection and make sure that the

emergency battery is already connected correctly.

Before the first use, you need to check whether the corresponding components are

washed and disinfected following the method as specified in Section 8 of this user

manual.

4.2 Installation and Pre-adjustment of Ventilator


1)Install the ventilator support holder onto the ventilator bracket and mount casters at four
corners of the bracket base.
2)Connect the base plate of the ventilator on the support holder of the frame by using
screws.
3)Install the battery box on the frame and connect the lead wires of the battery to the
terminal screws on the rear panel of the ventilator.

4)Connect two gas guiding screw tubes to the inspiration outlet and expiration inlet of the

ventilator respectively, connect the other ends of these tubes to a tee tube and connect

that tee tube to a test lung.

5)Connect the pressure signal interface on the tee tube to the “pressure signal input

interface” on the front panel of the ventilator circuit casing by using a tube.

6)Install the flow sensor between the “expiration screw tube adapter” and screw tube and
connect the output signal wire of the sensor to the “flow signal input interface” on the front
panel of the ventilator circuit casing.
7)Turn the “tidal volume adjustment” knob to the middle position.
8)Set the IPPV frequency to 20times/min.
9)Set the “inspiration triggering pressure” to -0.2 kPa.
10)Set the airway pressure limit to 4.0kPa.
11)Connect the medical compressed oxygen source with a pressure ranging from 280 to
600kPa.
12)When the above adjustment is completed, you can connect the power supply of the
ventilator.
4.3 Test Operation of Ventilator
After connecting the gas source and power supply of the ventilator and turning on the
power to start up the ventilator, you should observe:
1)That the ventilator operates in the ventilation mode in which it is shut down previously.
2)Such parameters as “spontaneous breathing frequency”, “overall respiratory rate”,
“throughput”, etc. have to be displayed one minute after the startup as they are refreshed
once every minute.
3)The indication of the airway pressure does not exceed 4.0kPa.
4)The expiration indicator and inspiration indicator flicker alternatively and you can hear
the close-open sound of the solenoid valve in the ventilator. The frequency at which the
solenoid valve closes and opens and the indicators flicker is the indicative value of the
“control frequency”. Also, you can see that the height of the water column in the test lung
increases and decreases alternatively at the control frequency.
5) The indicative value of the tidal volume on the test lung is substantially the same as that
of the “tidal volume” on the ventilator and relative error between both does not exceed
±20 %.

4.4 Inspection and Alarm


——Block the tee tube to increase the pressure in the airway and you should observe
that the ventilator generates an audible-visual alarm signal when the airway pressure
increases to the upper pressure limit.
— — Cut off the oxygen supply from the oxygen cylinder for a normally operating
ventilator and you should observe that the airway pressure indication drops. When the
airway pressure indication drops to a level below the lower airway pressure limit, after a
delay of 5 to 8s the ventilator generates an audible-visual alarm signal.
——A normally operating ventilator will raise a buzzing alarm when the power supply
is interrupted.
——The duration of the inspection alarm sound should be no shorter than 120s.
——In case of an alarm, continuously press the jog dial twice and the alarm will be
silenced. But, if the fault is not eliminated, the alarm buzz will sound again within a time no
longer than 120s.

5 Use and Operation


5.1 Attention for Use
1)Prior to the use of this ventilator, you must check and read its use record and washing
and disinfection record and make sure that it is not only in good condition with good
performance but also is thoroughly washed and disinfected.
2)Prior to use, you must check and confirm whether the power supply and gas source in
the field comply with requirements in accordance with the description in 4.1, and must
check whether all functions of the ventilator are normal in accordance with descriptions in
4.3 and 4.4.
3 ) Prior to use of this ventilator on a patient, you must adjust properly all operating
parameters by connecting it to a test lung. For details, see 5.2.
4)Medical staffs must provide field monitoring during the use of this ventilator. While pay
attention to the operating status of this ventilator, the monitoring physician must pay
attention to the vital signs and blood gas analysis data of the patient and adjust the
ventilator to the operating status most adapting to the needs of the patient for optimal
medical effect.
5)If oxygen is supplied with an oxygen cylinder, you may use an oxygen pressure reducer.
You should adjust the pressure regulation handle to the minimum level position, then turn
on the main switch on the oxygen cylinder and then slowly adjust the pressure regulation
handle until the desired pressure is reached. Turn off the gas source and then the power
to shut down the ventilator.
6 ) Prior to startup, check the pressures of the air source and oxygen source and they
should be stabilized at a level around 0.4MPa.

5.2 Setting of Ventilation Modes


5.2.1 Operation of Ventilator
Startup Interface
Turn on the power of the ventilator and you can see our LOGO on the ventilator screen.
When this screen stays for 5s, the system enters the self-test interface.

Self-test Interface

The system will automatically test four parameters: 1. Whether the pressure of the air

source ranges from 280 to 600kPa. 2. Whether the oxygen source pressure ranges rom

280 to 600kPa. 3. Whether the oxygen concentration sensor fails. 4. Whether the

pressure sensor fails.

If self-test of the above mentioned four parameters is passed, a “√” mark will be displayed

following each parameter, the screen stays for 3s and then the system automatically

enters the weight setting interface. If any of these parameters fails the self test, such
parameter will be shown in red background with a “×” mark, and the ventilator will halt on

the self-test screen and wait for medical staffs to solve and confirm the problems of the

parameter. The medical staffs may feed back the problems to our After-sales Service for

solution. With the “×” problem unsolved, you can press and hold the Mode key to

mandatorily enter the next weight setting interface of the ventilator.

Danger: if self-test is not passed, forcing the ventilator to


operate may disable some functions of the ventilator to operate
and in turn cause the test data of the overall machine to be
abnormal.

Caution: if self-test is not passed under the condition that the air
source is not connected and only the oxygen source is
connected, you can mandatorily have the ventilator operate.

Operating Interface

After entering the operating interface, the ventilator starts to operate at the preset

parameters.

The operating interface consists of the testing area, waveform area, status

information and alarm message.

The status information includes the current operating mode, inspiratory-expiratory


switching status, system power status and system time;

The alarm message is the prompt information sent by the ventilator after it identifies an

abnormality. An alarm message in red indicates a high priority alarm and an alarm

message in yellow indicates a medium priority alarm.

The waveform area includes the pressure-time and flow-time waveforms.

The testing area includes parameters needing to be set in various modes and
real-time parameters tested. Such parameters are defined as follows:

Tidal volume: expiratory tidal volume measured.

Frequency: this refers to the overall respiration rate and is namely the mechanical
control frequency.

Spontaneous breathing frequency: this refers to the frequency of breathing initiated


by the patient spontaneously which is detected by the anesthetic respirator within 1
minute.

Peak pressure value: maximum pressure in the airway during each breath cycle.

Oxygen concentration: concentration of oxygen in the gas delivered by the


anesthesia machine to the patient.

Throughput: accumulative sum of tidal volumes in each minute.

Airway resistance: pressure difference generated per unit of flow rate in the airway.

Lung compliance: this refers to the change in the lung volume which is caused when
unit pressure changes.

Mode Setting Interface


If you press the Mode key on the operating interface, then the parameter setting
interface pops up,

Operation method for parameter setting interface: move the jog cursor to the option
needing to be set, press the jog key and the corresponding option is reversely displayed.
Select the corresponding value by moving cursor left or right and press the jog

The same parameter in different modes will be greyed or transformed. If a parameter


is incorrect and this influences the interlocking conditions, the parameters not meeting the
interlocking conditions will be displayed in red and the “OK” button will be greyed to
prevent mis-operation.

Upon completion of setting of all parameters, turn the cursor to the OK key, press the
jog key and the ventilator operates at the newly set parameters. If you select Return, then
the ventilator continues to operate at the original parameters and switch to the operating
interface.

Alarm Setting Interface


If you press the Alarm key on the operating interface, the alarm setting interface pops
up, as shown in the figure below:

For the setting method for the alarm setting interface, you can refer to the instructions
for the setting of the modes and parameters. The contents and sequence of the setting on
the alarm setting interface are as follows:

Upper tidal volume limit: 0.01-2.00 L

Lower tidal volume limit: 0.00-1.80 L.

Upper peak pressure limit: 1-60 hPa

Lower peak pressure limit: 0-50 hPa

Upper oxygen concentration limit: 21-100%

Lower oxygen concentration limit: 18-80%

Volume setting: 1-10, increase of the number means the volume increases
Alarm history query: as shown in the figure above, the specific time when
different alarms occur will be shown if you press the “Alarm History” key, a
maximum of 100 alarms can be stored, the alarm is in the “time->alarm contents”
format and also high and medium level alarms will be shown in red and yellow
respectively.

Upon completion of setting of all alarm parameters, turn the cursor to the OK key, press
the jog key and the ventilator operates at the new alarm parameters. If you select Return,
then the ventilator continues to operate at the original parameters and switches to the
operating interface.

System Setup Interface

If you press and hold the System key for 3s on the operating interface, the system setup
interface pops up

Upon completion of setting of all system parameters, turn the cursor to the OK or
Return key, press the jog key and the ventilator switches to the operating interface.
Instructions for Film Panel Switches

6 functional keys are located on the front panel of the ventilator and are as defined

below:

Silence key: in case of an alarm, pressing this key can keep the alarm silenced for

120s. If the time is up and the alarm is not disarmed, then the ventilator continues to

sound the alarm.

System key: if you press and hold this key for more than 2s, then the system setting

menu pops up in the middle of the screen.

Mode key: if you press this key on the operating interface, then the parameter setting

menu pops up in the middle of the screen.

Alarm key: if you press this key on the operating interface, then the alarm setting

menu pops up in the middle of the screen.

Standby key: If you press and hold this key for more than 2s on the operating

interface, the ventilator stops operating. If you press and hold this key for more than

2s again, the ventilator immediately operates at the parameters as set on the system.

5.2.3 SIPPV Mode

The SIPPV mode is the default mode in which the ventilator operates when it is

started up.

Such mode is mainly intended for patients with no or weak and intermittent spontaneous
breathing. If the patient shows no spontaneous breathing, the respirator provides

intermittent positive pressure ventilation of the patient following the set parameters, and

this ventilation mode is namely called controlled ventilation mode. When the spontaneous

breathing is recovered to a certain extent, the ventilation by the respirator is automatically

synchronized with the spontaneous breathing in the patient, and this ventilation mode is

namely called assisted ventilation mode. The control ventilation and assisted ventilation

modes are switched to each other at an interval of 6s.

Operating parameters should be preset on the test lung following the procedures as

follows:

1)Connect the gas source and power and confirm that the ventilator operates in the

“Assisted/controlled” mode and the corresponding indicators go on.

2)Adjust the “Adjust IPPV Frequency” knob and the “Control Frequency” digital display

will provide the corresponding indication.

3)Select an I:E ratio according to the needs of the patient.

4)Adjust the “Adjust Tidal Volume” knob, observe the “Tidal Volume” indicator and set the

tidal volume to the value as needed. For adult patients, make the initial setting based on

the value of 10mL per kg of body weight and then fine tune the value according to the

actual conditions of the patient.

5)The airway pressure indicator shows the variation in the airway pressure in real time.

Carefully adjust the “Airway Pressure Limit” according to the airway pressure peak to set

the airway pressure limit to a level slightly higher than the peak pressure.

6 ) Set the “Inspiration Triggering Pressure”. When the spontaneous breathing in the

patient is recovered to a certain extent, the inspiration triggering pressure will provide a

ventilation synchronization signal to the respirator. At the same time, each time when the

patient takes a breath spontaneously the inspiration triggering pressure indicator flickers

once. Generally, the inspiration triggering pressure can be set to be a level 0.1kPa lower

than the minimum airway pressure when the patient has no spontaneous breathing.

7 ) Adjust the “PEEP” knob, observe the minimum airway pressure displayed when

expiration ends and judge whether the setting of the PEEP is appropriate or not. The

adjustment range is 0.1~1.0 kPa.


8) After selecting the “Sign” button and select this function, the Sigh indicator goes on and

the ventilator provides one ventilation at a big tidal volume (no less than 1.5 times of the

set value) at an interval of 80 ventilations.

Only upon completion of the above setting can you remove the test lung and connect the

ventilator with the patient.

After connecting the ventilator with the airway in the patient, you should carefully

observe the symptoms and lung inflation of the patient and further fine adjust the

operation status of the respirator according to the monitor instrument and arterial blood

and gas analysis data to achieve the optimal ventilation effect.

5.2.4 Controlled” Mode


This mode is only intended for patients with no spontaneous breathing.

Press the “Select Ventilation Mode” key to enable the “Control” indicator to be on and the

ventilator enters this operating mode. The “Spontaneous Breathing Frequency” digital

display provides no presentation due to the condition that no spontaneous breath is taken

and other displays still show the corresponding contents. The setting of the operating

parameters in this mode is the same as that in 5.2.1.

In this mode, you can still select (or not select) the PEEP and Sigh functions.

5.2.5 IMV Mode


This ventilation mode is intended for spontaneously breathing patients. It can gradually
reduce the patient’s dependency on the ventilator to facilitate weaning of the patient from
the ventilator. In this mode, the mandatory ventilation of the patient is performed once at a
certain interval. Upon completion of mandatory ventilation, the next mandatory ventilation
is performed a certain period of time later. During the interval between two mandatory
ventilations, the patient can spontaneously breath at his own breathing rate.

5.2.6 Manually Controlled Ventilation” Mode

In the event that the AC power supply to the ventilator is down, the ventilator can operate

the emergency battery. The output voltage of the battery gradually drops during operation.

If such output voltage drops to a level which is insufficient to drive the ventilator to operate,

you should replace the battery with one with sufficient power in time. If you cannot replace
with a new battery or in an urgent case when you cannot find a new battery, you can apply

the “Manually Controlled Ventilation” mode.

Such mode needs to be operated by a physician with rich clinical experiences. That

physician should press the “Manually Controlled Ventilation” button at a certain rhythm to

simply maintain the respiration of the patient. Each time the physician presses the button

the ventilator ventilates the patient once and such parameters as the ventilation time, tidal

volume, circuit pressure, etc. are completely manually controlled by the physician.

When pressing the button, the physician must pay close attention to the lung inflation of

the patient and indication on the airway pressure gauge. The ventilator uses an pneumatic

pressure gauge and such gauge will not be affected in case of a sudden power supply

failure.

5.3 Use of Humidifier


The humidifier is not a standard accessory of this ventilator and the user needs to
optionally purchase it according to actual requirements.
For a patient using an artificial airway or using a ventilator for a long time, a humidifier
should be connected in series on the ventilation tube to increase the temperature and
humidity of the mixed gas. The internal water temperature of the humidifier should be
carefully adjusted according to the patient’s needs. Generally, the water temperature of
the humidifier should ensure that the temperature of the gas inhaled by the patient ranges
from 32 ℃ to 35 ℃ and does not exceed 40 ℃ . Although the humidity is higher if the
temperature is higher, a too high temperature will cause adverse reactions to the patient
and respiratory tract burn to occur in severe cases.
During the use of the humidifier, you should also always pay attention to the outlet
temperature and water volume in the humidifier to prevent dry burning.

5.4 Operation Time Extension Upon Power Failure


This ventilator is capable of extending the operation time in case of power failure: when
the AC power supply is down, the ventilator will automatically switch to operate on the
battery. At this time, the “Operation on Battery” indicator goes on. After the AC power
supply is resumed, the ventilator will automatically switch to operate on AC power supply,
the “Operation on Battery” indicator goes out and the ventilator power circuit charges the
battery in a trickle manner.
What needs to be noted is that the battery has limited capacity and can be only used as
emergency battery. If you need to have the ventilator operate on the battery for a long time,
you must select one with large capacity (battery pack).
For the further description of the use and maintenance of the battery, please refer to
Section 9.2 of this user manual.

5.5 Shutdown Operations


When the patient’s various vital indexes comply with the shutdown requirements, you can
wean the ventilator.
Before weaning the ventilator, you should remove the tee tube connected with the patient
and observe the spontaneous breathing by the patient. Only after the spontaneous
breathing is completely recovered can you remove the mask or extract the endotracheal
tube and then shut down the ventilator. You must not shut down the ventilator and then
remove the tee tube.

The ventilator should be immediately washed and disinfected after it is used and then
should be necessarily serviced and maintained.

6.Troubleshooting

Symptom Possible Cause Solution


Flow sensor is interfered by strong Avoid impellers in the flow
light sensor from direct strong light
Re-connect the flow sensor or
Flow sensor is in poor contact
replace the plug
Ventilation circuit connection is Re-connect the ventilation
incorrect circuit
Check whether the humidifier
Ventilation circuit leaks and the
Ventilator tidal is tightened and whether the
patient shows oxygen deficit
volume is not ventilation circuit leaks
stable or Remove, wash and air dry
Water vapor exists in the impellers
displayed impellers
Pressurize the compressed air
source and ensure the air
Air source pressure is too low
source pressure ranges from
0.35 to 0.5MPa
PEEP setting is inappropriate Set a correct PEEP
Inspiration triggering pressure Set a correct inspiration
setting is inappropriate triggering pressure
Inspiration plateau setting is Set a correct inspiration
inappropriate plateau
Flow sensor is damaged Replace the flow sensor
Indication Input air source pressure is too low Adjust the air source pressure
from the Check the circuit connector
oxygen Respiratory circuit leaks and re-install, and replace the
pressure leaking cannula.
gauge or
laughing
Internal pressure regulator valve is Re-adjust the pressure
pressure
in malfunction regulator valve or replace
gauge is
inaccurate
The machine Adjust the operating frequency
The frequency setting is too high or
operating to the correct level and set the
the inspiration triggering pressure
frequency is inspiration triggering pressure
is inappropriately set
too fast to be negative
Lower tidal
Set the tidal volume to the
volume limit Tidal volume is set to be too low
appropriate range.
alarm
Upper tidal
Set the tidal volume to the
volume limit Tidal volume is set to be too high
appropriate range.
alarm
The ventilator The tidal volume and I:E ratio are Adjust the I:E ratio and tidal
airway not properly adjusted. volume
pressure The upper pressure limit is not Adjust the upper pressure limit
alarm and The patient’s spontaneous
Set a correct the inspiration
airway breathing conflicts with the
triggering pressure
pressure mechanical ventilation
limits icons
are
highlighted
and the upper The patient suffers tracheospasm Sputum suction of the patient
airway or airway resistance is increased by is recommended and
pressure limit secreta expectorant should be used
alarm
continues to
be on
The ventilator The tidal volume value is set to be
Adjust the tidal volume
airway too small.
pressure The pressure of the oxygen
Set a correct lower pressure
alarm icon is cylinder or central oxygen supply is
limit
highlighted insufficient
and the airway The pressure of the oxygen Replace the oxygen cylinder
pressure cylinder or central oxygen supply is or increase the air source
lower limit insufficient pressure
alarm
continues to The oxygen cylinder reducer or Replace the oxygen cylinder,
be on. oxygen conveyance circuit is in reducer and oxygen
malfunction conveyance circuit.
Pressure signal tube is separated Re-connect the signal tube or
or water is accumulated in the tube drain the water
The battery power is exhausted or
Continuous Replace with battery with
battery is damaged after the AC
audible alarm sufficient capacity
power supply is down.
Black screen Inverter is damaged Replace the inverter
of ventilator LCD screen is damaged Replace the LCD screen
LCD screen wires are in poor
Blank screen Re-connect LCD screen wires
contact
of ventilator
Control block is damaged Replace the control block
Rapid oxygen The spring of the rapid oxygen
Adjust or replace spring and
supply valve supply valve is snapped and the
apply Vaseline to the seal ring
does not seal ring is dry or valve contains
and clear sundries.
provide gas sundries.
Rapid oxygen
Seal ring is aged or rapid oxygen
supply valve
supply valve cannot retract after Re-adjust, install or replace it
outputs gas all
being pressed
the time
Humidifier AC power is not connected Re-connect the AC power
cannot work Fuse is burnt out Replace the fuse
Humidifier is
heating all the Heating rod is damaged Replace the heating rod
time
Battery works AC power plug is not connected Connect the power plug
when the grid Fuse is burnt out Replace the fuse
power is Junction panel or power cord is Replace junction panel or
normal damaged power cord

7.Safety Protection and Accident Handling


7.1 Sealing Performance of Respiratory System
Adjust the tidal volume of the ventilator to 500mL, I:E ratio to 1:2, ventilation frequency to

20 and upper pressure limit to 4kPa. Block the patient end of the tee tube. Under this

condition, the upper airway pressure limit alarm should occur each time when the

ventilator provides ventilation; otherwise, the respiratory system has leakage.


In case of leakage, you should replace gas circuit components one by one to eliminate
faults and identify the damaged components.

If the problem cannot be solved after these measures are taken, please notify MINA

Medical and its authorized service agency to handle this

7.2 Safety Valve Release Pressure


The safety valve release pressure has been set to be within the range from 5.5 to 6kPa
before leaving factory.

Remove the power plug of the ventilator from the AC power outlet, open the ventilator and

expose the safety valve on the ventilation circuit, and seal the patient end of the tee tube

and inlet and outlet on the ventilator back panel. Press and hold the Manually Controlled

Ventilation button and observe the airway pressure gauge. When the pressure gauge

indication should range from 5.5 to 6kPa, the safety valve begins to release gas. If the

pressure gauge indication is too high or low when the safety valve operates, please

contact MINA Medical or its authorized service agency for adjustment and repair.

7.3 Humidifier
During the use of the humidifier, you should pay attention to observing the temperature of
the output gas and water volume in the humidifier. If the patient inhales gas with too high
temperature, adverse reactions will occur and even respiratory tract burn will be caused. If
the water volume is insufficient, then the humidifier may be burnt out.

7.4 Ventilation Circuit


If the humidifier is used for a long time, water will be accumulated in the ventilation circuit.
Such water should be removed in time.

7.5 Fuse
The fuse of the ventilator (fuse tube) is installed on the rear panel.
If the “Operate on Battery” indicator goes on (indicating that the ventilator is powered by
the battery) and the power grid is not down, then we can judge that the fuse is burnt out.
You must replace the fuse following the procedures as below.
1)Do not turn the power switch of the ventilator in operation. You can simply extract the
plug of the ventilator from the power outlet and the ventilator automatically switches to
operate on the battery and then replace the fuse.
2) Screw off the cover of the fuse seat by using a screwdriver and replace the fuse.
3)Fuse tube specification: 1A glass casing fuse tube of Φ5×20 mm dimension.

7.6 Improper Operations and Consequence Handling


Improper operations on the ventilator include:
1. Adjust the tidal volume to a too high level, adjust the airway pressure limit knob to a too
great extent (which can cause barotrauma to the patient).
2. Adjust the tidal volume to a too low level and adjust the airway pressure limit knob to a
too small extent (which can cause oxygen deficit to the patient due to the hypoventilation).
The above mentioned two cases can be corrected by adjusting the corresponding knobs.
3. Use a power supply which is not grounded and this may cause the machine to carry
static electricity and cause electric shock to the patient or operator. The solution is to use
a grounded power supply.

8.Washing and Disinfection of Ventilator

8.1Washing and Disinfection Procedures


The ventilator in use should be routinely disinfected, which means that you should replace

the respiratory cannula of the patient with a new or disinfected tube and wash and

disinfect. Also, you can alternately use two ventilators.

After the patient does not use the ventilator, you should ultimately disinfect it: thoroughly
wash and disinfect the ventilator and then install it for reuse. The ventilator which is not
used for a long time must be washed and disinfected before it is reused.
Work records for the washing and disinfection should be kept for archiving and query.

8.2 Important Points of Washing and Disinfection


Important points to be washed and disinfected include screwed ventilation tube, mask,
flow sensor impellers connected on the expiration tube, etc.

8.3 Washing Method


1.Washing of ventilator inlet filter screen: flush the filter screen by using clean water to
remove thoroughly the dust attached to the screen. Then swing the screen to get rid of the
water and put it to the original position. The ventilator should be usually replaced and
washed once every 24 hours.
2.Washing of screwed ventilation tube, mask and flow sensor impellers: remove
thoroughly dirt on the internal wall of the circuit by using neutral washing fluid. Pay special
attention to clearing sputum scab, bloodstain, oil stain and other dirt residues in the tube.
Then wipe and wash them clean by using clean water.
3.Cleaning of ventilator: wipe off the dirt and dust falling on the ventilator casing and
caster supports by using a soft cloth dipped with warm water or neutral washing fluid and
then dry by wiping with dry cloth. Intrusion of any liquid into the machine is not allowed
during the cleaning process.

8.4 Disinfection Methods


Method I: Soak such items as respiratory circuit, mask, etc. which have been washed
clean in a disinfectant for 30 to 60min (note that the silicone product is easily damaged if it
is soaked in the disinfectant for a too long time). Common disinfectants include
bromogeramine, peracetic acid, 84 Disinfectant, etc. Flush the disinfectants inside and
outside the circuit off by using sterilizing salt water or distilled water and hang them to air
dry.
Method II: Disinfect such items as respiratory circuit, mask, etc. which have been washed
clean in the ethylene oxide disinfection box.

9.Care and Maintenance

9.1 Care and Maintenance of Ventilator


You must not use a functionally faulty device. You should ensure that any maintenance
service of this ventilator is completed by MINA medical. Upon completion of maintenance,
you must check that various performances of this ventilator are consistent with the
description in this user manual.
This ventilator must be thoroughly cleaned and disinfected once every six months by
specially designated personnel. Maintenance records should be archived. You must
thoroughly check its performances before restarting up it when it has been used for more
than six months.
The “troubleshooting” methods provided in this user manual are basic methods for solving
faults of the ventilator. If faults cannot be still eliminated by using such methods or faults
occur repeatedly, then you should notify MINA Medical or its authorized service agency for
repair.

9.2 Care and Maintenance of Battery


After use, you should charge the battery in time at an interval no longer than 12h. The
charging current must comply with the requirements in the Instructions for Use of the
battery.
If the battery has not been discharged for 6 consecutive months, one treatment charge
and discharge maintenance operation must be performed on it, which means that you
should have the ventilator operate on the battery until the battery cannot continue to drive
the ventilator. Then sufficiently charge the battery.
You should not place the battery close to a heat source (such as a heating radiator) and
under direct strong sunlight. You should not put any object on the battery box to prevent
battery temperature from being too high which will cause it to be damaged. The battery
box surface should be kept clean. In case of liquid falling down on the battery box, you
should immediately wipe it off and make sure that the liquid is not splashed onto the
battery; otherwise, you should wipe the battery clean.
The battery must be kept vertical during transportation and use. Keeping its top down or it
horizontal is strictly prohibited. You should avoid strong vibration.

10.Transportation and Storage

10.1Transportation Conditions
——The original packing box and damping cushion of the ventilator should be used
as specified.
— — Standardize the transportation based on the indications and symbols on the

packaging box. These indications and symbols are:


——Do Not Turn Over
——Handle with Care
——Keep dry
——The packaging box must be protected by cover in case of open air transportation
to protect from sunlight and rain wetting or intensive vibration. It is strictly prohibited
to keep top down and throw it.

10.2 Storage Conditions


——Ambient temperature: -10 ~ 40 ℃;
——Relative humidity: no higher than 90 %
——Atmospheric pressure: 86 kPa ~ 106 kPa.
——It should be stored in a room without corrosive gas and well ventilated.

11.Others
The pressure reducer used on the oxygen cylinder and humidifier for warming and
humidifying the output gas of the ventilator are not standard configuration of the ventilator
and need to be otherwise purchased.
You are welcomed to make consultation by call and letter, and when necessary we can
provide further technical data.

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