VADI VH-1500 User manual

2460
Manual
Read instruction carefully before use
Made In Taiwan
VA-1-VH-1500-EN.MDR
2021.12.23
VH-1500
Respiratory Humidifier

Table of contents
1. General Information....................................1
2. Product Specification ..............................2-4
3. Troubleshooting ..........................................5
4. Intended Use................................................6
5. Controls and indicators...............................7
6. Installation..............................................8-10
7. Disposition .................................................11
8. Clean...........................................................11
9. Maintenance ..............................................11
10.Warnings...................................................12
11.Optional Accessories ........................13-14

1. General Information
VADI Medical Technology Co., Ltd. Yangmei
No. 198, Lane 298, Huandong Road, Zhongshan Village,
Yangmei District, Taoyuan City 32665, Taiwan
TEL: [phone] E-mail: [email protected]
FAX: [phone] Website: www.vadimedical.com.tw
MedNet EC-REP IIb GmbH
Borkstrasse 10, 48163 Münster, Germany
MedNet SWISS GmbH
Bäderstrasse 18, 5400 Baden, Switzerland
CH
-1-

2. Product Specification
Dimensions：17.5cmX13.5cmX14cm
Weight：1100g
I/P: 100-120Vac, 50/60 Hz Sine Wave, 180W or
200-240Vac, 50/60 Hz Sine Wave, 180W
(Please refer to the mark on device.)
Device disconnection：pull out the power cord of this device
from socket.
Max. operating pressure：20kPa
Warm-up time：less than 30min.
This device life time is 3 years.
Operating Environment Temperature:
18~26℃, Humidity RH:15%~95%, Pressure: 700 to 1060hPa
Storage Temperature: 25~40℃, Humidity RH:15%~95%
without condensation
Transport Temperature: -10~60℃, Humidity RH:15%~95%
without condensation, Pressure: 595 to 1013 hPa
Humidity Output: >33mg/l within recommended flow range.
Standard Compliance: IEC/EN/ES 60601-1, IEC/EN 60601-1-2,
IEC 60601-1-8, ISO 80601-2-74
Alarm Sound Pressure: > 45dB
Classified as：Class I, Type BF, IPX1
-2-

-3-
Switzerland Authorized
Representative
H
Symbols Glossary
Symbol Title and Meaning
MD
Manufacturer
Consult instructions for use
Medical device
Batch code
Catalogue number
Date of manufacture
Use-by date
TYPE BF Applied Part
(inhalation tube)
2460
Caution
Hot surface may exceed 75℃
Drip-proof
Alarm
Caution
Electrical Shock Hazard.
Refer to qualified service Personnel.
CE Mark
Power On/Off (Standby)
Serial number
UDI
Unique device identifier
SN
Temperature limit
Storage Humidity limitation
EU Authorized Representative
Protective earth
Fragile, handle with care
Handle with care
This side up
Keep dry
Use no hooks
Caution

0123456789
stand by 45℃ 48℃ 52℃ 56℃ 60℃ 64℃ 68℃ 71℃ 75℃
Power Level Heater plate
Temperature(℃)
Flow rate range
(LPM)
Temperature at
patient Y(℃)
3
5
8
52
60
71
5~40
5~40
5~40
26~30
30~34
33~36
Heater control: settings from 0 to 9. Power Level settings:
Max. Flow : 40 LPM
Max. Delievered Gas Temp. : 37.9℃ @15LPM
(Power Level : 9, room temperature 23℃± 2℃, 120cm-silicone circuit)
Performance : Temperature difference between heater plate and
patient’s side (room temperature 23℃± 2℃, silicone circuit length
22mmID / 120cm, VADI chamber G-314004):
Temperature accuracy:±3℃
Over-heated protection:
if the heater temperature exceeds 95±6℃, the power to the
heated plate is discontinued and the Power-on/off will not be
operative.
Low Temperature Alarm:
30 min after operation, the temperature of the heater plate is 5℃
lower than setting. The display will be shown “L” and emit an alarm.
High Temperature Alarm:
While the temperature of heater plate is over 85±3℃, the display will
be shown “H” and emit an alarm.
-4-

3. Troubleshooting
Alarm Priority: MID
-5-
ALARM CONDITIONS
REQUIRED ACTION
The Low Temperature alarm
activates when the humidifier
detects a low temperature in the
aluminum tray.
Check the temperature of
aluminum tray is normally.
The High Temperature alarm
activates when the humidifier
detects a low temperature in the
aluminum tray.
Check the temperature of
aluminum tray is normally.

4. Intended Use
A respiratory humidifier is a device that is intended to heat and warm
breathing gases before they enter a patient’s airway.
The product has 9 temperature settings.
The highest power level presents the highest level of vaporized
water.
Notes
1. If sticky sputum takes place under high heater level, humidifier with
servo-control is recommended for usage.
2. For patients with low temperature (ex. infants) respiratory
humidifier with servo-control is recommended for usage.
3. The VH-1500 can be used in all age which is upper airway
malfunction, include in neonatal, child, and adult.
4. The VH-1500 can be applied on any ventilator which include
in servo control, invasive ventilation. The VH-1500 can
provide maximal flow rate is 40 LPM.
5. The VH-1500 accessories can comply adult (ID/OD 22 mm),
child (ID/OD 15 mm), neonate (ID/OD 12 mm) ventilator
connector.
The reprocessing of the accessories:
● Breathing circuit:
1. Dismantle all components except the stainless steel spring
attached to the body of water trap.
2. Clean the parts with low flow running water, using a soft
brush to remove all foreign material. (for example, soil or
organic matter)
3. Sterilization by autoclave: 132℃/ 4minutes.
● Chamber:
1. Clean the parts with low flow running water, using a soft
brush to remove all foreign material. (for example, soil or
organic matter)
2. Sterilization by autoclave: 132℃/ 4minutes.
-6-

5. Controls and Indicators
Device control panel has 3 main buttons, power level
corresponding with temperature scheme.
Power On: Press the “Power On” button to turn on. Press the on/off switch
again to turn off the humidifier.
＋Heating-power Up (silence button)：
increase the heating level by pressing the button.(press this button to cut off
the alarm signal; alarm continues signal after 2 minutes)
－Heating-power Down：
decrease the heating level by pressing the button.(press this button to cut off
the alarm signal; alarm continues signal after 2 minutes)
The scheme of power level shows the temperature of heater plate.
Notes
1. ０Heater level is Stand by, heater plate is not heated.
2. If the over temperature protection is activated, the heater plate is not
heated; the control panel shows 『H』.
3. Temperature at patient’s side will be different from the heater plate's, due
to tubing size, length, flow rate and room temperature affection.
Comment：Thermometer is recommended to use for more accurate
temperature data on patient’s side.
Power on
Scheme of Power
level corresponding
to temperature
＋Heating
Power up
(silence button)
－Heating
Power down
(silence button)
PWR Lv.
℃
48
45
52 56 60 64 68 71 75
1 2 3 4 5 6 7 8 9
PWR Lv.
PWR Lv.
℃
48
45
52 56 60 64 68 71 75
1 2 3 4 5 6 7 8 9
PWR Lv.
-7-

6. Installation
6.1 Slide the device on
the bracket .
(Fig.1)
6.2 Slide chamber onto
the heater base.
(Fig.2)
Note
-Choose the appropriate chamber.
6.3 Add distilled water into
chamber.(Fig.3) or stab distilled
water with the needle of IV-SET
and connect the tube to
humidification chamber.(Fig.4)
(Fig.1)
(Fig.3) (Fig.4)
(Fig.2)
-8-

6.4 Connect the tube from gas supply to
inlet port of chamber and the
inspiratory part of circuit to the
outlet port.
Notes
1. Water level should not exceed the highest level and should
not be less than the lowest level.
2. Device cannot be lean over 10°.
3. Condensed water in circuit is not acceptable.
4. Connect water trap is recommended.
5. Water level exceed in chamber may result water
condensation in breathing circuit.
6. Do not touch the heater plate while operation.
-9-

6.5 To change power level,
press heating-power
up/down buttons
accordingly.
Notes
1. Water vapor in humidification chamber is observed during
normal operation.
2. If there is no flow, turn off the humidifier.
3. Water traps are recommended for use to collect water
condensation due to differences in temperature.
4. Absorbent paper is recommended for usage to increase the
temperature and moisture performance.
5. It is not allowable to heat the chamber without distilled water.
-10-

7. Disposition
Please dispose humidifier according to the local rules of the
disposition of electronic devices.
8. Clean
The heated plate may be wiped with a damp cloth with using
clean water or 75% ethyl alcohol.
9. Maintenance
1. Check the power cord for damage, replace if necessary.
2. Check the heater plate for scratching, dirt or moisture;
replace if necessary.
3. Conduct cleaning when necessary.
-11-

10. Warnings
1. The product is intended for use by qualified medical staff with
medical gloves.
2. Please follow waste disposal guideline locally.
3. The device is intended to be used in a professional
healthcare facility environment e.g. hospitals.
Cautions
1. Use any blanket to cover the breathing circuit is not allowed.
2. NO MODIFICATION of this humidifier is allowed by user.
3. DO NOT try to dismantle or/and repair the humidifier by
yourself if it is malfunction. Please contact local distributor
for the service.
4. To avoid the risk of electric shock, this equipment must only
be connected to supply mains with protective earth.
5. The AC power plug is served to easily connect and
disconnect the humidifier. Do not use the receptacle that is
difficult to disconnect the humidifier.
6. Warning against servicing and maintenance while the ME
EQUIPMENT is in use.
7. Serious incident in relation to this product must be reported to
VADI, distributor and applicable competent authorities.
-12-

11. Optional Accessories
Breathing Circuit:
(A) G-316002
Disposable Adult Breathing Circuit (150cm/22mmID)
(B) G-316002-01
Disposable Pediatric Breathing Circuit (130cm/15mmID)
(C) G-316002-00
Disposable Neonatal Breathing Circuit (150cm/12mmID)
-13-

Chamber
Item number
G-314001
G-314001-0
G-314001-B
G-314001-C
G-314003-P
G-314002
G-314003
G-314004
G-314005
E-4011-07-2
E-4011-07-3
Description
Accessories-Absorbent paper for G-314005
Disposable humidifier chamber
Disposable humidifier chamber
Disposable humidifier chamber
Disposable humidifier chamber
Disposable humidifier chamber
Reusable humidifier chamber
Reusable humidifier chamber
Reusable humidifier chamber
Reusable humidifier chamber
Accessories-Absorbent paper for G-314004
-14-