VHB15A

OPERATOR’S
Revision: A Issued Date: 18 Jan.2018

Thank you for purchasing the VHB15A humidifier.

VHB15A Software released version: 2
Before using this product, please read the manual.

Intellectual Property Rights

This manual and its corresponding Intellectual Property Rights belong to
VINCENT MEDICAL MANUFACTURING CO., LTD.
Without Vincent Medical Manufacturing Co., Ltd.’s written consent, any
individual or organization must not copy, modify, translate or use any part of
the manual.
 01

05

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09

Information

3.4 Routine Inspection

Chapter 4 HUMIDIFIER SETUP
11

12

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12

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15

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22
Chapter 1 INTRODUCTION
1.1 Intended Use
The VHB15A humidifier is intended to warm and humidify breathing gases
delivered to patients. The humidifier automatically maintains the temperature
and relative humidity settings as selected by the healthcare professionals.
1.2 Main Performance And Technical Specification
Ratings：220-240 V ,50/60 Hz.
Power：320VA, Heater Wire：24 V ,80 VA (MAX).
Heater Plate Over-Heating Cut-off Temp.:118±7℃.
Dimension: Length 204mm / Width 150 mm / Height 159 mm.
Weight: 1.9kg without Humidification Chamber.
Patient Side Temp. Range:
Invasive Mode: 35-40℃, Default 39℃.
Noninvasive Mode: 30-37℃, Default 34℃.
Display: LCD.
Probes of temperature-humidity data cable detection range: 0-150℃,
Accuracy:± 0.5℃(in 20-45℃ temperature range).
Alarm system
1. All the alarms conditions are high priority.
2. All the alarms conditions are technical alarm conditions
3.The maximum alarm condition delay for patient side low temp., chamber outlet
low temp., patient side low humidity and is 22 min. When the humidifier
starts up and no delay for alarm signal generation.The maximum alarm condition
delay for patient side low temp., chamber outlet low temp., patient side low
humidity and is 2 min. after the humidifier is consistency and no delay for alarm
signal generation.
4. The maximum alarm condition delay for malfunction of probe of chamber outlet
or patient side alarm is 10min, and no delay for alarm signal generation.
5. If multiple alarm conditions occur at the same time, the system will alarm
following the ranking as shown in line "Alarm priority" of the table in section
6.2, till all the alarm conditions are clear.
6. Sound Pressure Level exceed 50dBA @ 1m.

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7. Operator’s position should be less than 30cm away from the device.
Specific ALARM CONDITION and its priority should be legible from
operator’s position.

80
℃ ℃

-
℃ 70
℃

Please refer to section 6.2 for the complete alarm information.

environment ℃
Humidity performance of VHB15A can be compromised
when used outside the specified environment temperature.
Recommended flow range: Invasive Mode: 5 to 60 L/min;
Non-invasive
Mode: 5 to 120 L/min.
p Non-invasive
℃
Warm-up time: ≤25minutes (from a starting temperature of 23±2 °C)

/ Sensor

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1. The following additional accessories are required for the operation of the
humidifier: Humidification Chamber (e.g.VHC20), Breathing Circuits
(e.g.HBC03). Choice of humidification chamber and breathing circuit will
depend upon application as set by qualified physicians / clinicians. You can
also contact your local supplier or Vincent Medical Manufacturing Co., Ltd.
for humidification chamber and breathing circuit options.
2. The gas supply and patient interface are required for the whole system,
such as a ventilator or air-supply device.
3. This machine should be earthed correct for protection against electric
shock. The earth wire must not be dismantled or removed. And the
machine is properly grounded only when the earth wire is connected to the
marked socket.
4. Only use breathing circuits that are prescribed by physicians or clinicians.
5. Use only items that have been specified as part of humidification system
or specified as being compatible with the humidification system.
6. Always refer to manuals accompany with accessories or conjunction gas
supply for the respective information for safety measures, operation,
adjustment, cleaning, sterilization, and disinfection procedures,
maintenance and permissible environmental conditions of use including
conditions for transport and storage .

PC
PC
/ Senor PC
PC
Operator’s PC
PC

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 09 10 16

08
Previous Settings
Mode: Invasive
Patient:39℃ Chamber:36℃ 07 11
In/Exp:1:1.3 15
06
Default Settings

02 Select OK Enter
05

03 04 12 13 14

Start-up interface Working interface

Selection signal Confirmation signal

Default settings
Parameters selection
frame

Previous settings

12
13 14

15 16
Inspiratory/Expiratory -

humidification

-
Mute any alarm, set time or enter
Inspiratory/Expiratory mode setting.

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 to

in 0.1°C steps.
in 1% steps(maximum of 99%).

Start-up Interface Description

Previous settings Setting of the previous patient end

temperature and Inspiratory/Expiratory ratio
Default settings Manufacturer default patient end
temperature and Inspiratory/Expiratory ratio
Setting Parameters For selecting Previous Setting or
Selection frame Default Setting by user
(highlight in red color)
Selection Signal Indication for user to press ▲ or ▼
to select
Confirmation Signal Indication for user to press OK to
confirm the chosen setting

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 Caution

IPX1 -

s h Refer to instruction
r manual / booklet

Authorized representative
in the European Community

Serial number

Fragile, handle with care

DHM Day/Hour/Minute Manufacturer

U.S. Federal law restricts this device to sale by or on the order of a physician.

2.3 Cautions & Warnings

Safe and reliable use of this humidifier is dependent on, but is not limited to
the following requirements:
1) Read Carefully and fully understand the information provided in the
manual before using the VHB15A humidifier. Use in accordance with the
instructions in the manual and as per clinical prescription.
2) Use only the correct fuse provided by Vincent Medical Manufacturing Co.,
Ltd.
3) Proper maintenance and inspection of the device should be done by
qualified and trained technical personnel.
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4) Use the appropriate parts recommended by Vincent Medical manufacturing

Co., Ltd.
5) Use the appropriate power supply and ensure proper grounding.
Warning! The device should only be operated by trained personnel under
guidance of a physician. The device can only be sold to qualified clinicians or
physicians.
Warning! Comply with best practice: Instructions for Use are not a substitute
for established medical procedures. “Best practices" of medical groups and/or
the independent association should always be followed.
Warning! Before using the device, the user must understand the use of the
device, its applications and safety requirements.
Warning! VHB15A is intended to be used in conjunction with gas supply,
such as iVent 201 or other Air-Supply device which shall meet the
requirements of IEC 60601-1 and IEC 60601-1-2.
Warning! Do not pour water above the maximum water level marked on the
humidification chamber. Over-filled water may enter the patient's breathing
circuit.
Warning! Do not pour water that greater than 37℃ or less than 10℃ into
humidification chamber.
Warning! Heated humidifier is not recommended to use at less than 5LPM.
of gas flow, when used with non-heated circuits.
Warning! Ensure that invasive mode is set for patients that have bypassed
airways.
Warning! Operation: Ensure that the temperature of gas delivery to the
patient meets the prescription of the clinician. Conduct regular verification on
the operating temperature. Transmitting overheated gas may burn, or cause
other hazards to the patients.
Warning! Operation: Ensure correct connections and operation settings

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of the device, ventilator or other gas delivery devices to the humidifier before
connecting the device to the patient. Ensure the appropriate flow and
pressure of gas has been checked.
Warning! Explosion Hazards: Do not use the device with flammable gases
or anesthetic agents.
Warning! Do not touch the heater plate. The heater plate may be hot (over
85℃) and may cause burns, Before touching or cleaning the heater plate,
ensure that the heater plate has sufficiently cooled down for a long while.
Warning! Recommended Accessories: Only manufacturer recommended
humidification chambers, respiratory circuits and other accessories should
be used. The use of the ones which are not recommended by Vincent

Medical Manufacturing Co., Ltd. may impair performance or compromise

safety.
Warning! Electric Shock Hazard: Risk of electric shock may occur if the
system is not properly grounded. The system uses 100VAC. power supply
and contains a separate ground wire. The ground wire must not be
dismantled or removed. Connect the ground wire to the marked socket to
ensure the system is reliable and properly grounded.
Warning! Cleaning and Maintenance: The system should be turned off and
disconnected from the power supply before cleaning the device.
Warning! Technical maintenance and/or repair should only be conducted
by qualified and trained staff.
Warning! Do not soak or sterilize the heated humidifier.
Warning! During extended use, the respiratory circuit will produce water
condensation. The water should be carefully removed from the breathing
circuit. It is recommended that the breathing circuit should be installed with
a water trap to help removal condensate water.

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Warning! Keep the connectors of temperature-humidity data / sensor

cable and heater wire adaptor dry at all time.

2.4 Environmental Conditions

This product should not be exposed to excessive vibration, dust, corrosive

or combustible gases. During use, this product should always be placed in

a horizontal position. The recommended environmental conditions for

operation are:

Environment temperature: 18-28℃.

Relative humidity: 15-93% non-condensing.

Atmospheric pressure: 86-106 kPa.

Warning! The operation of high frequency surgical apparatus, shortwave

or microwave equipment in the vicinity of the humidifier may adversely

affect its function. It is recommended that the humidifier should be removed

away from such devices.

2.5 Safety Features

If thermostat is tripped (Over-Heat Cutoff Temp.: 118±7℃), the audio alarm

will come on and the device will automatically shut-off.

Caution: If this occurs, please contact a qualified service technician.

2.6 Environmental Protection

At the end of service life, dispose of the device in accordance with local laws

and regulations.

Chapter 3 STORAGE AND MAINTENANCE

3.1 Cleaning the humidifier

Ensure that the device is off and disconnected from power supply. Use a

soft damp cloth to clean the surface of the humidifier. After each use,

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please wipe clean data / sensor cable with 75% alcohol. Ensure the cleaning
liquid does not enter the inside of the humidifier during cleaning.
The humidifier cannot be sterilized. Do not apply any hospital sterilization on
the humidifier and electrical components, such as autoclaving or ethylene
oxide gas sterilization.
Warning:

Do Not immerse the humidifier in any liquid

Do Not sterilize the humidifier

Do Not use organic solvents to clean the surface of humidifier

Do Not immerse the temperature and humidity data / sensor cable in liquid

Do Not use caustic liquids or cleansers to clean the temperature and

humidity data / sensor cable

Note: The cleaning / disinfection / sterilization method for accessories or
gas supply, please refers to their manual.
3.2 Storage and Transportation
Storage and transportation temperature should be -20℃ to 55℃, relative
humidity:15-93%, Atmospheric pressure 86-106Kpa.
Please keep original packaging of the system for storage and transportation
protection.
3.3 Battery Information
One 3V Lithium/manganese dioxide battery is installed in the device for the
real time clock. Only a trained personal should service or replace the battery.
Incorrect replacement or service would not ensure correct function.
3.4 Routine Inspection
Before each use, visual inspection on the whole device is recommended.
Check alarm signals before each use. Plug in mains supply, then switch on
the product without pluging in the temperature-humidity data / sensor cable.
After press OK, the symbol will be displayed, and the audio alarm
will be on.
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Chapter 4 HUMIDIFIER SETUP
1. Install the Humidification Chamber (A) onto humidifier base and connect

the breathing circuit (B) (Refer to the manuals of the humidification chamber

and breathing circuit for further details).

2. Connect the plug of temperature-humidity data / sensor cable (C) to the

blue socket on the humidifier base until a click is heard.

3. Push the chamber outlet probe (D) and patient side probe (E) into the

breathing circuit. Ensure the patient side probe parallels to breathing circuit

and also ensure the probes are fully engaged and depressed all the way.

4. Connect the plug of heater wire adaptor (F) to the red socket on the

humidifier base until a click is heard. Connect the other ends (G,H) of heater

wire adaptor to the heater wire circuits(I,J).

The humidifier system is now set up and ready for use. The humidifier will

default to Invasive Mode.

Note: 1. When using with non-heater
wire circuit, skip 4.
2. Connection between Gas supply/Ventilator

breathing
circuits
and ventilator
please refer to the
manual of ventilator or gas supply.

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 OFF

Press the ▲ or ▼ button to select the settings option.

For selecting “Previous settings”, press to enter a working interface.
For selecting the “Default settings”, press to enter the next interface
to set invasive or non-invasive mode.
Notes: A warning signal “De – De” will be sounded and will flash
with red light to remind user of making setting selection if the user did
not make the selection after 10 seconds.

- Mode
-

or wait for 3 seconds

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5.3.2 Set temperature
(1) Patient side temperature setting
When the temperature icon shows “ ”, Press for 3 seconds and
the system enters the temperature setting mode. When the
temperature symbol “℃” is flashing on the display, the patient-side
temperature can be set. In Invasive mode, the default temperature is
39℃. Press or for increasing or decreasing the temperature by
0.5℃ intervals in the range of 35-40℃; In Non-Invasive mode, the
default temperature is 34℃. Press or for increasing or decreasing
the temperature by 0.5℃ intervals in the range of 30-37℃. After setting,
press . After 10 seconds with no response during setup
process, the system will exit the setting mode and return to the main
page without saving all the parameters.
(2) Chamber air outlet temperature setting
When the temperature icon shows“ ”, Press for 3 seconds and
the system enters the temperature setting mode. When the
temperature symbol “℃” is flashing on the display, chamber air outlet
temperature can be set. In Invasive mode, the default temperature is 36
℃, then the patient temperature is 39℃. Press or for increasing
or decreasing the temperature by 0.5℃ intervals in the range of 34~43
℃; In Non-Invasive mode,the default temperature is 31℃, and the
patient temperature is 34℃. Press or for increasing or
decreasing the temperature by 0.5℃ intervals in the range of 30~32
℃. After setting, press . After 10 seconds with no response
during setup process, the system will exit the setting mode and
return to the main page without saving all the parameters.

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Press for 3 seconds and the system enters the temperature setting
mode. Then press to enter the "IN/EXP" setting mode, the default ratio

is 1:1.3. Press or for increasing or decreasing the proportion of EXP

in the range of 1 to 1.5. After setting, press . After 10 seconds with no

response during setup process, the system will exit the setting mode and

return to the main page without saving the parameter.

When condensate in expiratory limb increases, increase the

proportion of EXP.

During operation press the Temperature Mode Button to monitor

temperature of the chamber air outlet side. After 5 seconds, the system will

automatically show the temperature of the patient side.

5.3.5 Non-dual Heater Wire Operation

When using single limb heater wire circuits or non heater wire circuits,
in the working interface, the error message indicator should display
or , press the OK button to confirm, display for the
use of single limb heater wire circuits, show for the use of non
heater wire circuits.

When alarm sounds, press mute button to silence. After correcting the

malfunction, the system alarm will reset as normal. Alarm will sound again

within 1.5 minutes if identified malfunction is not corrected.

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to mute

Chapter 6 REPAIR

Warning! Repairs must be carried by authoinzed trained technician.

6.1 Repair Instruction

For any issue regarding repairing or replacement of parts please contact

Vincent Medical Manufacturing Co., Ltd. or your local supplier. Installers and

operators must comply with the instructions of the equipment installation,

operation, inspection and maintenance.

Maintenance personnel must be authorized by Vincent Medical

Manufacturing Co., Ltd. Vincent Medical Manufacturing Co., Ltd. is not

responsible for the safety and reliability of the equipment or device

performance if the repairs are not carried by authorized trained technician or

the following:

Modifying or repairing the device without authority from Vincent

Medical Manufacturing Co., Ltd.

Non-recommended factory parts are used

Electrical power source is not compatible with local regulations

Use of device not in accordance with the instruction manual

We recommend that you obtain the following information from any

personnel performing maintenance or repairs:

Nature and scope of maintenance and/or repairs to be conducted

Changes or modification to the device

Maintenance date

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 Maintenance staff or company name

Maintenance staff signature

Any repairs or maintenance conducted by non-qualified personnel

and not in conformance with the manual is a violation of the warranty.

6.2 Troubleshooting

Refer below for troubleshooting guidance.

Note: In below diagram, red indicates that the parts/symbols are flashing.

Possible Cause of the

Priority Malfunction
1 Patient-side Turn the power off, wait for
temperature > high the temperature to decline
temperature alarm limit and then turn on the power.
(invasive 41℃, non-invasive If red flashing continues,
The patient-side
38℃) disconnect and use new
temperature data
display on the LCD unit. Contact local supplier.
will flash in red.
Patient side Press to mute the alarm
2
temperature < low and extend the heating time.
temperature alarm (invasive Verify ambient temp. is not
34℃, non-invasive 29℃) below operating range. If
yes, check the air
conditioning whether the
room temperature is too cold.

7 Malfunction of the patient Replace

side probe temperature-humidity
data / sensor cable.
The patient-side
temperature will
display as “--” and
flash in red

3 The chamber outlet 1.Check whether the

temperature<29℃ temperature probe is
(Only for invasive mode) installed correctly.
The chamber outlet
temperature data 2．Check if the chamber
displayed on the has water or not
LCD will lower than
29℃ and flash in
red

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 6 Malfunction of the Replace the data / sensor cable.
chamber outlet probe

The chamber outlet

temperature data
will display as “--”
and flash in red

Relative humidity 4 1. Flow or room temp. 1.Check the flow or room temperature
data on LCD will exceeds allowable range if it’s in the range recommended.
flash in red 2. Data /sensor cable failure 2.Check temperature-humidity
3. Chamber run out of water data / sensorcable and replace if
results in humidity less it is damaged. Otherwise press
than 80% (Invasive) or 70% to mute the alarm.
(Non-invasive) for 2 mintues If alarm recurs, contact
continuously after start up maintenance or local supplier.
for 20 minutes. 3.Check if water-out or not.
5 Humidification Add water to the humidification
chamber has no water. chamber and restart the product.

Temperature-humidity 1.Securely plug in the

8
data / sensor cable is
temperature-humidity data
unplugged, or
senso rcable.
Malfunction of
2.Replace the temperature-
temperature-humidity
data / sensor cable probe humidity data / sensor cable.

1.Chamber is not installed

9 or incorrectly installed. 1.Install chamber correctly
2.Heater plate is damage 2.Contact maintenance
or open circuit.
3. Thermal cut-out at the
bottom of heater plate
(exceeds 118±7℃)

10 1.Heater wire adapter is 1.Securely plug in heater wire adapter

not plugged in. 2.Replace the heater wire circuit
2.Malfunction of heater
wire circuit.

Not Malfunction of heater Contact maintenance or local

alarm plate sensor supplier
Chamber symbol
is flashing

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The electromagnetic compatibility (EMC) of the VHB15A humidifier is

designed according to IEC60601-1-2 Medical Electrical Equipment Part 1-2

General Requirement on safety, Collateral Standard Requirements and

Tests for Electromagnetic Compatibility and the device complied with the

requirements.

VHB15A
VHB15A

VHB15A

The model VHB15A is suitable for use in all

establishments other than domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.

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 VHB15A
VHB15A

±8 kV contact ±8 kV contact
±2 kV,±4 kV,±8 kV, ±2 kV,±4 kV,±8
±15 kV air kV,±15 kV air

±0.5 kV & ±1 kV ±0.5 kV & ±1 kV

differential mode differential mode
±0.5 kV,±1 kV&
±0.5 kV,±1 kV&±2 kV ±2 kV common
common mode mode

100% UT 100% UT
(100% dip in UT.) (100% dip in UT.)
for 0.5 cycle for 0.5 cycle
100% UT 100% UT VHB15A
(100% dip in UT.) (100% dip in UT.)
for 1 cycle for 1 cycle
30% UT 30% UT VHB15A
(70% dip in UT.) (70% dip in UT.)
for 25/30 cycles for 25/30 cycles
100% UT 100% UT
(100% dip in UT.) (100% dip in UT.)
for 250/300 cycle for 250/300 cycle

30 A/m 30 A/m

UT

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 VHB15A
VHB15A

3 Vrms
3 Vrms
150 kHz to 80 MHz
150 kHz to 80 MHz
6 Vrms in ISM
6 Vrms in ISM
bands VHB15A
bands
3 V/m
3 V/m
80MHz to 2.7 GHz
80MHz to 2.7 GHz
385MHz-
385MHz-
5785MHz Test
5785MHz Test
specifications for
specifications for
ENCLOSURE
ENCLOSURE
PORT
PORT
IMMUNITY to
IMMUNITY to
RF wireless
RF wireless
communication
communication
equipment
equipment
(Refer to table 9 of
(Refer to table 9 of
IEC 60601-1-
IEC 60601-1-2:2014)
2:2014)

NOTE 1
NOTE 2

VHB15A
VHB15A

VHB15A

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 VHB15A

VHB15A

NOTE 1

NOTE 2

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Chapter 8 USE AND WARRANTY PERIOD

Do not disassemble the device. The warranty period is 1 years from since

the date of purchase. The warranty period for the temperature-humidity data

/ sensor cable is 6 months. During the warranty period, the warranty is void

under the following conditions:

1. An error caused by operating the unit in a non-prescribed conditions or

applications.

2. Damage or injury caused by not complying with the provisions of the

power supply requirements,

3. Damage or injury caused by installation, modification or repair from

Non-authorized service engineers or technicians.

4. Damage or injury caused by natural disasters such as fire earthquake,

power surge, lightning, flood, etc.

5. When the machine develops a fault, please contact your supplier or

manufacturer for maintenance.

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 Flats B2 & C2, 7/F., Hang Fung Industrial Building, Phase 2, 2G Hok Yuen
Street, Hung Hom, Kowloon, Hong Kong

+852 2365 5688

+852 2765 8428

Website:www.inspired-medical.com

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Bd. Général Wahis 53 1030 Brussels, BELGIUM 0197
Tel: +(32) 2.732.59.54 Fax: +(32) 2.732.60.03