mtts Beluga-V1 Manuale utente
Beluga User manual
User Manual
Effective date: March 2020
Issue Number: 00 Version: 03 EN
Issue Date: March 2020 www.mtts-asia.com
Beluga
ventilator
Model: Beluga - V1
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Beluga User manual
Contents
Company Information
Introduction
Device Description
Warnings
Setup
Operation
Alarm System
Cleaning
Maintenance
Explanation of Symbols
Warranty Policy
04
05
06
09
10
12
18
19
20
22
24
26
03
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Beluga User manual
Beluga Ventilator is a standalone ventilator intended to provide positive pressure
ventilation during resuscitation of infants. The device contains a built-in pump to
generate positive end-expiratory pressure (PEEP) and Peak Inspiratory Pressure
(PIP) without necessity of any external air sources. An integrated blender and oxygen
monitoring function also allows oxygen-rich (>21% O2) air with accurate Fraction of
inspired oxygen (FiO2) to be safely delivered to the patient.
Introduction
05
Company Information
04
MEDICAL TECHNOLOGY TRANSFER AND SERVICES Co., LTD
House No. 26, Alley 41, An Duong Vuong Street, Tay Ho District, Hanoi City, Vietnam
Tel: +84 24 3766 6521
Fax: +84 24 3718 8050
Email: assistanc[email protected]
www.mtts-asia.com
PROMETEO SRL
Via Mantova 9
38122 Trento
Italy
This user manual is intended for health care professionals.
manual, accessory Directions for Use, all precautionary information, and
WARNING - a warning statement refers to the conditions when the possibility
of injury to the patient or user exists if a procedure is not followed correctly.
NOTE - a note statement provides additional information intended to clarify
points, procedures or instructions.
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06
Device Description Device Description
07
Overview Control Panel
1 Power Button Touch and hold this button to turn off the device
2 Realtime Pressure Graph Plots measured pressure in realtime
The graph will be expand in look screen
3 Timer Displays Procedure Timers
4 Status Bar Displays Infomation about locking, battery charging conditions
5Pressure Measurement Displays Measured Pressure
6FiO2 Measurement Displays Measured FiO2
7 Setting Button Touch this button to enter Setting screen
8Lock Button Touch this button to lock the screen
9Up and Down Buttons Touch and hold these buttons to adjust a setpoint. The setpoint can be
selected by touching but 10, 11, or 12
Beluga Ventilator functions are controlled by touch screen.
1
2
34
6
9
7
8
10
5
1112
Front view
Side view
Mixed gas outlet
Control panel
Power button
Oxygen inlet
12VDC inlet
Hatch
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08
Device Description Warnings
09
10 PIP Setpoint Touch this button to select PIP setpoint
11 FiO2 Setpoint Touch this button to select FiO2 setpoint
12 Ventilation Rate Setpoint Touch this button to select Ventilation rate setpoint
Devices starts with PIP setpoint of 0 cmH2O. When selected, it is automati-
cally set to 20 cmH2O.
When PIP setpoint step size is set greater than 1, touching and holding the
Up/Down buttons will only increase/decrease the value once.
manual,accessory Directions for Use, all precautionary information, and speci-
oxygen-enriched environments, or nitrous oxide.
Do not modify this equipment without authorization of the manufacturer.
(19°C to 37°C) or humidity range (30%RH to 90%RH) can compromise
performance.
Do not operate the device if any of the components appear to be damaged or
broken. Damaged or broken components should be discarded and replaced.
Do not position the device in a location that reduces its ventilation.
Do not block any of the air vents on the back of the device.
The presence of electro-surgical devices, shortwave or microwave equipment
near this device could lead to electrical interference that would negatively
affect the function of the device.
Using tubing or other breathing circuit components without cleaning or disin-
fection between patients can result in infections.
result in serious injury to the patient or operator or damage to the device.
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1. Attach the T-piece circuit, gas hose
Setup
10
Setup
11
A. Attach the T-piece circuit to the mixed gas outlet in the front of the device.
B. Attach the compressed oxygen source to the CGA 1240 oxygen inlet.
2. Plug in and power up
A. The connector plugs into the side of the device and then directly into the power
outlet in the wall.
B. Press the Power Button to turn the device ON.
Only use T-piece circuit and power supply unit provided by MTTS.
The gas sources must provide pressure within the range of 10 to 60 psi
(0.7 to 4.1 bar). If the gas sources are outside of this range, the device may
not be able to produce the desired %FiO2.
Attaching the compressed oxygen will not waste any oxygen. The machine will
not use any compressed oxygen until you increase the FiO2 setpoint.
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Operation
12
Start the device
Touch PIP Setpoint to start the device.
The device will start immediately with default PIP Setpoint of 20 cmH2O.
13
Operation
Adjust parameters
B. FiO2
Select FiO2 Setpoint circle, then touch Up/Down button to adjust FiO2.
A. PIP
Select PIP setpoint circle, then touch and hold Up/Down button to adjust PIP.
The red horizontal level will move up/down according to the change.
C. Ventilation Rate (VR)
Select VR Setpoint circle, then touch Up/Down button to adjust VR.
Metronome can be disabled in Setting panel.
Ventilation rate is used by metronome only.
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Operation
14
Operation
15
Setting screen
Lock/unlock the screen
The screen can be locked by touch and hold the lock button. On the locked screen,
all setpoints will disapear and the graph will expand. To unlock the screen, touch and
hold the unlock button.
screen, touch Setting button on the unlocked screen. To return the unlocked screen,
touch the Return button on the Setting screen.
Resuscitate patient
A. Fit T-piece to resuscitation mask and place over the baby’s mouth and/or nose.
B. Resuscitate by placing and removing thumb over the PEEP cap to allow inspiration
and expiration.
Following features are available on the Setting screen:
Calibrate oxygen sensor
Goto the Device information screen
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Operation
16
Calibrate oxygen sensor
To calibrate oxygen sensor, touch the ‘O2 Calib’ button on the Setting screen. The
process will take 1-2 minutes to complete. After calibration, the FiO2 reading should
be 21%.
Disconnect oxygen source before calibration.
Oxygen sensor must be calibrated at least every 3 months. It is recommended
to calibrate the sensor before each use.
Operation
Turning off the device
17
The device can be turned off by Power button either on the screen or in front of the
device. Press and hold the button for 1.5 second.
The Setting screen and available features may vary depending on the soft-
ware version.
Enable/disable metronome
Lock/unlock autorotate function
Adjust PIP step size
Adjust alarm volume
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18
Alarm system
Alarm Cause Effect
HIGH PRESSURE Measured pressure higher than the
PIP setpoint by 4 cmH2O
Device adjusts pressure by itself
Pressure >14 cmH2O for longer
than 5 seconds
No effect
HIGH FiO2 Measured FiO2 higher than the
setpoint by 6 %FiO2
Device controls oxygen valve to regulate FiO2
PRESSURE SENSOR FAILURE Pressure sensor disconnected or
faulty
No effect
OXYGEN SENSOR FAILURE Oxygen sensor disconnected or
faulty
Oxygen valve closed
LOW BATTERY Battery remaining capacity is low No effect
List of alarms:
All the alarms listed above are conisdered MEDIUM PRIORITY (ref. IEC 60601-1-8).
In order to verify the operation of auditory and visual alarms, perform the following
procedure:
1. On the unlocked screen, set PIP to 20 cmH2O
2. Occlude the mixed gas outlet for 10 seconds.
3. Check pressure audible alarm sounds
Alarm system test
General
Cleaning
Comply with hospital, local and national guidelines for product cleaning fre-
quencies.
Ensure oxygen supply is turned off and disconnected from Beluga Ventialator
before performing cleaning procedures.
Cleaning shall be performed at ambient condictions.
Before cleaning, remove and discard all used disposable products using rec-
ommended method of disposal.
Dust all surfaces with clean damp soft cloth.
Clean all plastic surfaces with mild detergent solution (maximum 2% in wa-
ter).
Dry all the surfaces after cleaning with a clean soft cloth or paper towel.
Ensure that no part of Beluga Ventilator is immersed in any cleaning liquid or
cleaning solution.
Do not use abrasive cleaning solutions.
Ensure all Beluga Ventilator parts and accessories are checked before re-
turning the device to service.
19
The reusable resuscitation circuit includes a number of parts that must be com-
pletely disassembled and sterilized before use. These parts include:
Component Recommended sterialization method
Silicone tube Autoclaving
PEEP valve Low-temperature plasma sterilization OR
soak disinfection with 1:500 chlorine-containing disinfectant
Mask Autoclaving
Indice
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