Vincent Medical Manufacturing inspired VHB10A User manual

Vincent Medical Manufacturing Co., Ltd.

1.0 Introduction
3.0 Foreseeable Safety Warnings
4.0 Temperature Control
5.0 Installation and Operating Instructions
2.0 Specifications
2.1 Power Requirements
2.2 Dimension and Weight
2.3 Environment
3.2 Symbols
4.1 Temperature Setting Range
4.2 VHB10A Humidifier Power
4.4 Alarm List
5.1 Installation of VHB10A Humidifier and Chamber
5.2 Operation
5.3 Removal of Humidification Chamber
5.4 Replace the Filter Paper for VHC25 Chamber
4.3 VHB10A Heater Plate Temperature
3.3 Product Assembly Drawing
3.4 Explanation of Symbols on the User Interface (front label)
2.4 Useful Information
2.5 Average Failure-Free Operation Time
3.1 Attentions, Cautions and Warnings
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6.0 Safety Characteristics
6.1 Mechanical Protection Against Overheating
7.0 General Maintenance
7.1 Basic Inspection
7.2 Cleaning the Humidifier
7.3 Storage and Transportation
8.0 Trouble-Shooting
9.0 Performance Parameters of VHB10A Humidifier
10.0 EMC Related Explanation
10.1 Guidance and Manufacturer Declaration
Electromagnetic Emissions
10.2 Guidance and Manufacturer Declaration-Electromagnetic
Immunity-for ALL ME EQUIPMENT and ME SYSTEMS
10.3 Guidance and Manufacturer Declaration-Electromagnetic
Immunity-for ME EQUIPMENT and ME SYSTEMS that are
Not LIFE-SUPPORTING
10.4 Recommended Separation Distances Between Portable and
Mobile RF Communication Equipment and ME EQUIPMENT
or ME SYSTEMS for EQUIPMENT and ME SYSTEMS that
are Not LIFE-SUPPORTING.
10.5 Warnings

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VHB10A Humidifier is a temperature controlled type humidifier, it is
intended to be used with Ventilator or Air-supply device by connecting a
humidifier with humidification chamber and breathing circuit between
Ventilator and Air-supply device, heated humidification is supplied to the
patient end.
VHB10A humidifier is equipped with temperature control system.
Different temperature ranges can be set, the lowest being 45℃, while the
highest one is 80℃. When temperature is set, The humidifier will maintain
heater plate temperature automatically and continuously adjust.
VHB10A Humidifier has safety controls, maintains the set temperature
to prevent overheating. Overheating can cause injury to patients and
damage to the humidifier.
VHB10A Humidifier is suitable for use when the air flow is stable (this
should be 5L/min), In an unstable air flow environment, the air tempera-
ture and humidity may not achieve expected values.
2.1 Power Requirements
2.1.1 Operation Voltage: 220-240V~
2.1.2 Rated Frequency: 50-60HZ
2.1.3 Power Consumption: 100VA+15%
2.1.4 Rated Current: 0.6A Maximum at 230V
2.2 Dimension and Weight
Length: 200mm / Width: 140mm / Height: 100mm; Weight: 1.2 kg
Note: Not including the humidification chamber
2.3 Environment
It is recommended that the humidifier should be fixed via the bracket
on the back of the humidifier. The equipment shall be operated in
environment free from vibration, dust, corrosive or explosive gases, and
the temperature and humidity should be non-extreme.
Introduction

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Humidification should be used in the horizontal position.
Throughout the operation, the humidifier and the chamber cannot be
tilted over the maximum allowable angle indicated in the instructions of
the use for the humidifier chamber.
Environment Temperature :18℃to 28℃
Relative Humidity: 15-95%, non-condensing
Pressure: 86-106kpa
Read carefully and understand this operator manual thoroughly before
using the VHB10A.These information are applicable to the humidifier and
all other equipments or accessories used in connection with the humidi-
fier.
3.1 Attentions, Cautions and Warnings:
"Warnings" means the preventive measures mentioned are necessary
to protect patients, end-user & humans from life-threatening harm.
"Cautions" means the preventive measures are necessary to protect the
equipments."Attentions" means those preventive measures, procedures,
2.5 Average Failure-Free Operation Time is 1,000 hours
2.4 Useful Information
When replacing the fuse, make sure to replace with correct type and
rated value fuse, which is provided by the manufacturer or contact your
The detailed technical information can be found in the
maintenance manual.
Safe, reliable and correct use of this humidifier is based on but not
limited to the following requirements:
To setup and use the equipment, please use in accordance to the
operator manual and in the operator manual and in accordance with
the prescription of the physician.
Maintenance and Inspection should be carried out by qualified and
trained technicians.
Use parts recommended by Vincent Medical Manufacturing Co., Ltd.
Use appropriate power source, ensure the correct grounding is done.
local supplier.

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steps and techniques that are regarded as important and needed to
be emphasized.
Warning:
This equipment can only be used by trained personnel: the humidifier
and its accessories can only be used under the prescriptions and
guidance of physicians, and be operated by the trained clinicians /
physicians. This equipment can only be sold to qualified physicians, or
be bought through the prescription of physicians.
Warning:
Comply to the best practice: the instructions written in this operator
manual cannot be used to replace the already established medical
procedure or the best practice adopted by physicians. The best
practice established by the medical organization and /or independent
association should always be followed.
Warning:
Before the use of the equipment, user must thoroughly understand the
usage, application and safety procedure information relevant to the
equipment.
Warning:
Install: When adding water to the humidification chamber, do not let
the water to exceed the maximum water level. Otherwise, the water
may enter the breathing circuit.
Warning:
Do not add water that exceeds 37℃into the humidification chamber.
Warning:
Do not use the VHB10A with air flow less than 5L/min.
Warning:
Operation: Make sure the air delivered to patient is at the temperature
as prescribed by the physicians. Periodic Regular Temperature inspection
must be performed. Delivering overheated gas to patient may cause
burn or harm to the patients.

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Operation: Before connecting the equipment to the patient, make sure
the ventilator or the air delivering device is operating normally, and is
inspected for proper flow and pressure.
Danger of Explosion: Do not use the equipment with the flammable
gas or anesthetic agents, as such use may lead to explosion.
Danger of Burn: Do not touch the heater plate. The heater plate may
be hot (over 85℃)，and may cause burns. In order to avoid being burnt,
before touching or cleaning the heater plate, make sure the heater plate
is cooled for a sufficiently long time.
Recommended Accessories: Use humidification chamber, breathing
circuits and other accessories as recommended by manufacturer only.
Use of those accessories that are not recommended may cause the
degradation of humidifier performance or affect the patient safety.
Danger of Electric Shock: If the system is not correctly earthed,
electric shock may occur. The system use 220-240V alternating
current, please check and ensure correct voltage of machine as per
country. The earth wire must not be removed. Only when the earth wire
is connected to the marked socket, earthing can be assured.
Cleaning and Maintenance: Before and during the cleaning of the
humidifier, the electric power should be switched off.
Warning:
Warning:
Warning:
Warning:
Warning:
Warning:

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Maintenance or repair: The maintenance or repair should be carried
out by a qualified technician that is familiar with the equipment, electronic
circuits and medical electrical equipments, and is trained for mainte-
nance or repair. As danger of electric shock may occur, all repair works
should be done by appropriate personnel.
When used outside the specified ambient temperature range or
humidity performance of the device can be compromised.
Do not soak or disinfect the humidifier.
Please contact qualified technicians for technical support and
service.
During usage, operation snould be stopped if the breathing circuit
is filled with condensed water. If this is the case, it is recommended
For the cleaning /disposal method for humidification chambers,
breathing circuits and Ventilator or other gas supply, please refers to the
related and specific manuals.
At the end of service life, dispose of the device in accordance with
local laws and regulations.
When the humidification system exposed is to, for example, electrocau-
tery, electrosourgery, defibrillation, X-ray (gamma radiation), infrared
radiation, conducted transient magnetic fields including magnetic
resonance imaging (MRI),and radiofrequency interference, these may
adversely affect its function.
Warning:
Warning:
Warning:

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Authorized
representative
in the European
Community
to use breathing circuits with water traps.
After a period of time, if use condensed water will be generated in
the breathing circuit. The condensed water should be removed from the
breathing circuit carefully. It is recommended that the breathing circuit
should be installed with a water trap to help remove the condensed water.
3.2 Symbols
The following symbols are used in the product, their meanings are
explained below:
0197
Electrial Shock Hazard
Refer to qualified service
personal
Altemating
Current
IPX1
Dip proof protection
to IPX1
Refer to
instruction
manual / booklet
Protective earth
(ground) “OFF”(power) “ON”(power)
Do not discard
WEEE collection
(EU only)
Caution
CE marking
Type BF Applied
Part
Manufacturer

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Heater
plate
Button Screw
Connecting
line
Screw
Screw
1
2
4
3
5
6
7
8
10
9
11
12
13
14
16
15
17
18
19
20
22
21
23
24
25
26
28
27
29
30
31
33
32
Top case
Thermostat
assembly
Main PCB
assembly
Cord clamp
Screw
Gasket
Nut
Registered
information label
Bracket
Power cord
assembly
Transpatent
rubber foot
Power switch
Bottom case
Micro switch
assembly
Power
connector
wire assembly
Power supply
PCB assembly
Heater plate
temp. detector
assembly
Knob
Front
label
Button
seat
Chamber lock
Spring
Transformer
Power label
Internal
bracket
Inside Bracket
Stretch gasket
Washer

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3.4 Explanation of the symbols on user interface (front label)
VHB10A User interface
4.1 Temperature Setting Range
The range for heater plate
temperature setting:
45℃~80℃
4.1.2 Heating Indicator
When the humidification
chamber is installed to the humidifier, the indicator on the right will
Iight on in green continuously to indicate heating is in process.
4.1.1 Power Indicator
When power switch is on,
the left power indicator will
Iight on in green continuously.
4.2 VHB10A Humidifier Power
The maximum power is 100VA + 15%
4.3 VHB10A Heater Plate Temperature
VHB10A Humidifier's temperature can be adjusted in the range of
45~ 80℃(Normal Working Condition); A thermostat is installed to
limit the temperature of the heater plate to be less than (95±7)℃,
If the electric circuit is faulty,( the alarm buzzer will turn on if heater
℃.
4.4 Alarm list
The alarms above are technical alarms. The heating indicator will be
flashing in red, and the alarm sound level is of a range of 50-60dB.
Alarm priority # Alarm description Mute Alarm delay
NO <10s
<10s
NO
High Malfunction of
heater plate probe
The overheating
protection switch
(Thermostat)is off
High
plate higher than(95±7)

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5.0 Installation and Operating Instruction
5.1 Installation of VHB10A Humidifier and Chamber.
5.1.1 Use the accessories provided with the equipment for the
installation.
5.1.2 Inspect the humidifier, ensure the humidifier is clean and dry.
5.1.3 Add sterilized water into the chamber, until the water level reach
the maximum water level line indicated on the chamber. Please
read the chamber instructions to understand the details related
to the use of chamber.
5.1.4 Slide the chamber into the humidifier slot, then use the chamber to
press down the button at the top of the humidifier until the button
springs back up indicating the chamber is firmly in place.
1.Slide the chamber
into the slot of the
humidifier
2.Press down
the button

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The patient end
Thermometer
Heater base
rotalitneV
Humidifier Water trap
Water trap
Breathing tube circuit
retaeH
tne
mecalp
EXP
INSP
5.1.5 Connect the air supply breathing tube to the inlet of the chamber.
5.1.6 Connect the inspiratory limb to the outlet of the chamber
5.1.8 Switch on the ventilator or air-supply equipment.
5.1.9 Plug the power cord to the suitable alternating current socket with
earthing, the power source should have rated power as specified as
per this instruction. Now the humidifier and chamber is ready .
Before use, if you have any questions on how to use the humidifier
properly, please contact Vincent Medical Mfg. Co., Ltd. or your local
supplier.
VHB10A is intended for use in conjunction with gas supply, such as
iVent 201or other ventilator which meets the requirements of IEC 60601-1
and IEC 60601-1-2.
5.1.7 Install the temperature monitoring device (thermometer,
temperature sensor, etc.) to the patient end of the inspiratory limb.
.

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The following additional accessories are required: Humidification
chamber (e.g.: VHC20), breathing circuits (e.g.:51003200). Choice will
depend on application. Please contact your local supplier or Vincent
Medical Manufacturing Co., Ltd for recommendations.
Caution:
Do not soak the humidifier in liquid.
Warning:
1) When installing the chamber, make sure the humidifier and chamber is
at a position lower than the patient.
2) When using the humidifier, if the chamber is tilt at an angle larger than
the maximum allowable angle, the water in the chamber may flow directly
to the patient's breathing circuit, or the air delivering device.
3) Do not add water beyond the maximum water level as indicated on the
humidification chamber.
4) Before switch on the humidifier, make sure air is flowing through the
chamber and the breathing circuit.
5) Do not use the device with the flammable anesthetic gases, as this
may cause explosion.
6) Use the device only with the Vincent Medical Manufacturing Co., Ltd.
humidification chambers and breathing circuits as recommended by the
5.2 Operation
5.2.1 Ensure the power cord of the humidifier is connected to an alternat-
ing current power source with proper earthing.
5.2.2 Ensure the proper installation of humidifier, air-supply, temperature
monitoring equipment and humidification chamber are all correctly
connected in accordance to section 5.1.4, 5.1.6 and 5.1.7.
5.2.3 Switch on the ventilator or air-supply device. Check the air-supply
for flow rate and pressure. Ensure the air supply in use is in correct
condition.
5.2.4 Turn on the power switch located in the lateral side of the equipment.
Select and confirm the appropriate power (temperature) option, and
manufacturer.

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If an appropriate humidification chamber is not used and / or the
instructions in the operator manual is not strictly followed, the performance
of the equipment cannot be guaranteed.
1) Before switching on the humidifier, ensure there is air flowing through the
humidification chamber.
2) If the airway temperature is not monitored, or the system is not set
correctly, the temperature of gas delivered to patient may exceed 41℃.
3) After a long period of use, condensed water may be formed in the
patient breathing circuit. It is recommended to remove the condensed
water from the breathing circuit carefully or the humidifier should
the operation mode of the humidifier. Heater plate temperature
setting range: 45 ~ 80 degree Celsius.
5.2.5 Refer to the relevant section of this manual for the humidifier control,
monitor, alarm and setting information.
5.2.6
5.2.7 Periodic check on the gas temperature at the patient end of inspira-
tory limb must be done, to ensure the temperature is appropriate
and prescribed to ensure patient safety.
5.2.8 If the gas flow is interrupted, the humidifier must be first turned off.
Once the gas flow has recovered, follow the instructions in section
5.1 to switch on the humidifier and let the gas flow pass through the
chamber again.
After warm up (warm up means gas temperature reach the setting
temperature from 23±2℃, which takes approximately 15 ~ 20
minutes for the gas temperature to be stabilize), confirm and ensure
the gas is delivered to the patient end through the inspiratory tube
and the desired temperature level is achieved. Independent equip-
ment can be used to monitor the variation caused by flow rate,
temperature setting and / or length of the breathing tube.

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2.Slide the chamber
out of the slot of the
humidifier
1.Press down
the button to
release
be positioned at a lower level. It is also recommended that the breathing
circuit should be equipped with water trap to collect condensed water.
4) Do not touch the heater plate.The surface temperature of the heater
plate may exceed 85 ℃.
5) Before connecting the breathing circuit to patient, make sure the
temperature indicated in the patient airway is correct.
6) The equipment must not be used with flammable anesthesia gas, as
using this may cause explosion.
7) If the air flow is interrupted, please switch off the humidifier.
8) Do not add water beyond the maximum level as indicated on the
humidification chamber. Use the the humidification chamber in
accordance to the instructions in the operator manual.
5.3 Removal of humidification chamber
5.3.1 Turn off the humidifier through the power switch at the side of the
equipment.
5.3.2 Disconnect the breathing tube at the outlet of the chamber.
5.3.3 Disconnect the breathing tube at the inlet of the chamber.
5.3.4 Press down the button at the top of the humidifier, slide out the
chamber from the humidifier slot, then remove the chamber from
the humidifier.
1) After the humidifier is switched off, the water inside the chamber is still
at a very high temperature.

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2) Do not touch the heater plate, the surface temperature of the heater
plate may exceed 85 ℃.
5.4 Replace the Filter paper in the VHC25 humidilication chamber
(lf applicable)
Regarding to the detail of install/remove the filter paper in the humidifi-
cation chamber, please refer to the instructions for VHC25 chamber.
6.1 Mechanical protection against overheat
In any operating condition, if the heater plate temperature is (95+7)℃
or above, the thermostat will automatically interrupt the power supply to
the heater plate. To resume the function of the heater plate, the reset
button at the bottom of the equipment must be pressed.
lf the above situation happens repeatedly, please contact qualified
technician for technical support.
7.1 Basic inspection
Everytime before use, inspection on the whole system is recommend-
ed. Visual inspection on humidifier, heater plate, accessories in use
and power cord should be performed by qualified and trained technicians /
clinicians / physicians at least every month. If necessary, the damaged
parts should be replaced.
7.2 Cleaning the humidifier
Make sure the power is switched off, after that, use a soft towel to
clean the surface of the humidifier. Ensure the heater plate surface is
clean, and no excessive wear. When cleaning the equipment, make sure
the cleaning agent does not enter the inside of the humidifier, Do not
sterilized the humidifier. The humidifier and its electric components are not
suitable for the hospital standard sterilization, such as Autoclaving or EtO
sterilization.
-

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-20 45
between 15%~80%
1) Use the VHC
series chamber as
recommended by
Vincent Medical
Manufacturing Co., Ltd.
3) Contact local suppler
Vincent Medical
Manufacturing Co., Ltd
2) Contact local suppler
or Vincent Medical
Manufacturing Co., Ltd.
2) Micro-switch failure
1) The overheating
protection switch
(hermostat) is off
3Storage and transportation
no power
The heating indicator
is flashing in red,
alarm is sounding.
2
) Malfunction of heater
plate probe
2) Contact local supplier
or Vincent Medical
Manufacturing Co., Ltd.
1 The humidification
chamber is not installed
correctly,so the
microswitch under the
heater plate is not
pressed
1

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10A
length of
10A
compatible
A