USER MANUAL
LUNG VENTILATOR
LEISTUNG LUFT 3
R 04-04 (69) REV. 06
GMP CERTIFICATE
ISO 9001:2008
ISO 13485:2003/EN ISO 13485:2012
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LUNG VENTILATOR
LEISTUNG LUFT 3
Manufacturing, Distribution and Technical Support by:
LEISTUNG EQUIPAMENTOS LTDA.
Street: 202, João Ropelatto
City: Jaraguá do Sul – SC
District: Nereu Ramos
Zip Code: 89265-520
Phone: +55 47 3371-2741
Fax: +55 47 3371-9267
VAT No.: 04.187.384/0001-54
I.E.: 254.417.108
Op Auth.: GHL3983MX9H2
GMP Certificate
ISO 13485:2003/EN ISO 13485:2012
ISO 9001:2008
Website: www.leistungbrasil.com
E-mail: leistung@leistungbrasil.com
Technical Responsible:
Eng. Mateus Emrich Monnerat
CREA/SC 088984-3
ANVISA registration:
Technical name: Pressure and Volume Lung Ventilator
Commercial name: Lung Ventilator Leistung Luft 3
ANVISA registration no.:: 80203470012
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CONTENTS
CONTENTS .................................................................................................................................... 3
GUIDELINES AND LEISTUNG EQUIPAMENTOS LTDA.’S STATEMENT ON ELECTROMAGNETIC
COMPATIBILITY (EMC) .................................................................................................................. 8
SIMBOLOGY ............................................................................................................................... 12
1 – MEANING OF THE STANDARDIZED SYMBOLS, PRINTED ON THE EQUIPMENT, INTERNAL AND
EXTERNAL .............................................................................................................................................. 12
2 – MEANING OF THE STANDARDIZED SYMBOLS, PRINTED ON THE EQUIPMENT’S PACKING .............. 13
3 – MEANING OF THE SYMBOLS, PRINTED ON THE EQUIPMENT’S USER MANUAL ............................... 15
CHAPTER 1 - PRESENTATION ....................................................................................................... 16
WARNINGS, PRECAUTIONS AND NOTES................................................................................................ 19
WARNINGS ............................................................................................................................................ 19
PRECAUTIONS........................................................................................................................................ 20
NOTES .................................................................................................................................................... 21
CHAPTER 2 – INTRODUCTION ...................................................................................................... 22
VENTILATOR SPECIFICATIONS ............................................................................................................... 23
ELECTRONIC BLENDER OPERATION (AIR-O2 MIXER) .............................................................................. 29
FIO2 READING......................................................................................................................................... 29
CHAPTER 3 – ASSEMBLY AND CONNECTION ................................................................................ 30
EQUIPMENT ASSEMBLY ......................................................................................................................... 30
SCREEN CONNECTION ........................................................................................................................... 31
POWER SOURCE CONNECTION ............................................................................................................. 31
EQUIPMENT CONNECTION .................................................................................................................... 33
CONNECTION TO THE GAS SUPPLY SOURCE .......................................................................................... 33
BREATHING CIRCUIT .............................................................................................................................. 35
ARTICULATED ARM ASSEMBLY .............................................................................................................. 37
CHAPTER 4 – INSTRUCTIONS, CONTROLS AND ALARMS ............................................................... 37
INSTRUCTIONS OF USE .......................................................................................................................... 38
SCREEN CALIBRATION ........................................................................................................................... 38
TOUCH SCREEN CALIBRATION ............................................................................................................... 39
PATIENT PARAMETERS .......................................................................................................................... 41
CIRCUIT .................................................................................................................................................. 41
SELF-TEST............................................................................................................................................... 41
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LAST PATIENT BUTTON .......................................................................................................................... 42
SCREEN .................................................................................................................................................. 42
ICON PANEL ........................................................................................................................................... 43
ALARMS AREA........................................................................................................................................ 44
INFORMATION AREA ............................................................................................................................. 44
OPERATIVE AREA ................................................................................................................................... 45
KIND OF TRIGGER .................................................................................................................................. 45
OPERATIVE INFORMATION.................................................................................................................... 45
SELECTION CONTROLS ........................................................................................................................... 45
STANDBY MODE .................................................................................................................................... 45
AIRWAY PRESSURE BAR (BARGRAPH) ................................................................................................... 46
DYNAMIC MONITORING AREA AND ALARMS ........................................................................................ 46
GRAPHICS AREA ..................................................................................................................................... 46
ÁDJUSTMENT AREA ............................................................................................................................... 47
WAVEFORMS ......................................................................................................................................... 47
SQUARE FLOW WAVEFORM (CONTÍNUOUS) ........................................................................................ 47
DESCENDING RAMP 50% FLOW WAVEFORM ........................................................................................ 48
DESCENDING RAMP FLOW WAVEFORM ............................................................................................... 48
ASCENDING RAMP FLOW WAVEFORM ................................................................................................. 48
SINUSOIDAL FLOW WAVEFORM (ROUND) ............................................................................................ 48
SENSIBILITY ............................................................................................................................................ 48
DIRECT ACCESS AREA ............................................................................................................................. 48
MAIN MENU AREA ................................................................................................................................. 50
VENTILATORY MODES ........................................................................................................................... 52
VOLUME CONTROLLED VENTILATION – (VCV)....................................................................................... 52
PRESSURE CONTROLLED VENTILATION – (PCV) ..................................................................................... 53
SUPPORT PRESSURE VENTILATION OR CONTINUOUS POSITIVE AIRWAY PRESSURE – (PSV/CPAP) ...... 53
SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION BY VOLUME WITH SUPPORT PRESSURE –
SIMV (VCV)+PSV .................................................................................................................................... 53
SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION WITH SUPPORT PRESSURE – SIMV
(PCV)+PSV .............................................................................................................................................. 54
PRESSURE REGULATED WITH VOLUME CONTROLLED – (PRVC) ............................................................ 54
NON-INVASIVE VENTILATION (NIV) ....................................................................................................... 54
MANDATORY MINUTE VENTILATION WITH PRESSURE – (MMV+PSV) .................................................. 54
BIPHASIC PRESSURE VENTILATION – (BIPHASIC) ................................................................................... 54
PRESSURE SUPPORT VENTILATION WITH ASSURED TIDAL VOLUME – (PSV+VT) .................................. 54
NEONATAL VENTILATORY MODES......................................................................................................... 55
CONTINUOUS FLOW .............................................................................................................................. 55
NASAL CPAP ........................................................................................................................................... 55
HFNC – HIGH FLOW NASAL CANNULA ................................................................................................... 55
BACKUP VENTILATION ........................................................................................................................... 55
LUNG MECHANICS ................................................................................................................................. 56
GRAPHICS .............................................................................................................................................. 59
REMOTE MONITORING ......................................................................................................................... 61
FUNCTIONAL SETUP .............................................................................................................................. 61
OPERATIVE SETUP ................................................................................................................................. 62
CHAPTER 5 - ALARMS.................................................................................................................. 63
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ALARM AUDIO INHIBITION (SILENCE) .................................................................................................... 63
HIGH PRIORITY ALARM CONDITION ...................................................................................................... 64
1 - MICROPROCESSOR ........................................................................................................................... 64
2 – LOW GAS SUPPLY PRESSURE ............................................................................................................ 64
3 – LOW BATTERY .................................................................................................................................. 64
4 – MAXIMUM INSPIRATORY PRESSURE ............................................................................................... 64
5 - INTERRUPTED CYCLE ALARM ............................................................................................................ 64
6 - MINIMUM INSPIRATORY PRESSURE ................................................................................................. 64
7 – DISCONNECTION OF THE PATIENT CIRCUIT ..................................................................................... 65
8 – DISCONNECTION OF THE PROXIMAL FLOW SENSOR ....................................................................... 65
9 – HIGH PRESSURE OF SUPPLY GASES .................................................................................................. 65
MEDIUM PRIORITY ALARM CONDITION ................................................................................................ 65
10 – MINIMUM FIO2 .............................................................................................................................. 65
11 – MAXIMUM FIO2.............................................................................................................................. 65
12 - APNEA ALARM ................................................................................................................................ 65
13 – MINIMUM TIDAL VOLUME ............................................................................................................ 66
14 – MAXIMUM RESPIRATORY FREQUENCY.......................................................................................... 66
15 – MINIMUM RESPIRATORY FREQUENCY .......................................................................................... 66
16 – POWER OUTAGE ............................................................................................................................ 66
LOW PRIORITY ALARM CONDITION ....................................................................................................... 66
17 - MAXIMUM TIDAL VOLUME ............................................................................................................ 66
18 - I:E RATIO INVERSION ...................................................................................................................... 66
19 – PEEP ALARM................................................................................................................................... 66
20 – MINIMUM MINUTE VOLUME ........................................................................................................ 67
21 - MAXIMUM MINUTE VOLUME ........................................................................................................ 67
COLORS AND MEANINGS OF THE LUMINOUS INDICATIONS ................................................................. 71
SETUP OF THE ALARMS, SOUND AND LUMINOUS SIGNALS ON THE SCREEN ........................................ 71
CHAPTER 6 – EXHALATION VALVE, PATIENT CIRCUIT AND PROXIMAL SENSOR.............................. 73
EXHALATION VALVE............................................................................................................................... 73
PATIENT CIRCUIT ................................................................................................................................... 74
PROXIMAL SENSOR................................................................................................................................ 74
CHAPTER 7 – CLEANING, DISINFECTION AND STERILIZATION ........................................................ 76
DISASSEMBLY OF THE EXHALATION VALVE AND THE PATIENT CIRCUIT ................................................ 76
CLEANING .............................................................................................................................................. 77
DRYING .................................................................................................................................................. 77
STERILIZATION ....................................................................................................................................... 78
PHYSICAL METHOD................................................................................................................................ 78
USEFUL LIFE OF ACCESSORIES ............................................................................................................... 79
ANNEX 1 – VENTILATOR LUFT3’S ACCESSORIES ............................................................................ 80
OPTIONAL ACCESSORIES (NOT INCLUDED WITH THE EQUIPMENT) ...................................................... 83
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ANNEX 2 – PREVENTIVE MAINTENANCE ...................................................................................... 84
ANNEX 3 – BLOCK DIAGRAM ....................................................................................................... 86
ANNEX 4 – WARRANTY ............................................................................................................... 87
ANNEX 5 – GLOSSARY ................................................................................................................. 88
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GUIDELINES AND LEISTUNG EQUIPAMENTOS LTDA.’S
STATEMENT ON ELECTROMAGNETIC COMPATIBILITY (EMC)
Guidelines and Manufacturer’s Statement – Electromagnetic Emission
The Lung Ventilator Luft 3 is designated for use in electromagnetic environments as specified below.
It is recommended that the user or client of the Lung Ventilator Luft 3 ensures that the equipment is
being used in such environment.
Compliance
Electromagnetic Environments – Guidelines
RF Emissions
ABNT NBR IEC CISPR11
Group 1
The Lung Ventilator Luft 3 utilizes RF energy only for its
internal functions. However, its RF emissions are very low and it
is not likely to cause any interference on nearby electronic
equipment.
RF Emissions
ABNT NBR IEC CISPR11
Class A
Harmonic Emissions IEC
61000-3-2
Class A
Emission Tests
Emissions due to
fluctuation of the
voltage/flickering IEC
61000-3-3
Complies
The Lung Ventilator Luft 3 is suitable for use in al
lestablishments other than domestic, and may be used in
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings
used for domestic purposes, provided the following warning is
heeded:
Warning: This equipment is designated for use only by
healthcare professionals. This equipment may cause radiointerference or interrupt the operation of nearby equipment.
It may be necessary to adopt mitigation procedures, such as
reorientation or reallocation of the Lung Ventilator Luft 3,
or the blindage of the place.
 IN ORDER TO AVOID RF INTERFERENCE, THE LUNG VENTILATOR LUFT 3
SHALL NOT BE USED WHEN STACKED OVER OTHER EQUIPMENT. IN CASE THAT IS
NEEDED, IT IS RECOMMENDED TO OBSERVE THE NORMAL USE OF THE EQUIPMENT.
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Guidelines and Manufacturer’s Statement – Electromagnetic Immunity
The Lung Ventilator Luft 3 is designated for use in electromagnetic environments as specified below.
It is recommended that the user or client of the Lung Ventilator Luft 3 ensures that the equipment is
used in such environment..
Electromagnetic environment Emission tests
Test Level ABNT
Level of
Guidelines
NBR IEC 60601
Compliance
Electrostatic discharges
(ESD)
± 6 kV by contact
± 8 kV by air
IEC 61000-4-2
Fast transient burst / Pulse
train (“Burst”)
± 2 kV at supply lines
IEC 61000-4-4
± 1kV at input/output
lines
Surges
± 1 kV line(s) to line(s)
IEC 61000-4-5
± 2 kV line(s) to
ground
< 5% Ut
(> 95% voltage drop in
Ut) per 0.5 cycles.
± 6 kV by
contact
± 8 kV by air
± 2 kV at supply
lines
± 1kV at
input/output
lines
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
ground
< 5% Ut
Floors should be wooden, concrete or
ceramic. If the floor is covered by
synthetic
material,
the
relative
humidity shall be of at least 30%.
The quality of the power supply
should be that of a typical commercial
or hospital environment.
The quality of the power supply
should be that of a typical commercial
or hospital environment.
(> 95% voltage
drop in Ut) per
0.5 cycles.
40% Ut
40% Ut
Power outage, short
interruptions and voltage
variations on the power
supply input lines.
IEC 61000-4-11
(60% voltage drop in
Ut) per 5 cycles
(60% voltage
drop in Ut) per 5
cycles
70% Ut
70% Ut
(30% voltage drop in
Ut) per 25 cycles.
(30% voltage
drop in Ut) per
25 cycles.
Quality of the power supply should be
that of a typical commercial or hospital
environment. If the user of the Lung
Ventilator Luft 3 requires continuous
operation during power interruption, it
is recommended that the Lung
Ventilator Luft 3 is supplied by an
uninterrupted power supply or a
battery.
< 5% Ut
< 5% Ut
(> 95% voltage drop in
Ut) per 5 seconds.
Magnetic fields at the
power supply frequency
IEC 61000-4-8
3A/m
(> 95% voltage
drop in Ut) per 5
seconds.
3A/m
Magnetic fields on the supply
frequency should be at levels
characteristic of a typical hospital or
commercial environment.
Ut IS THE POWER SUPPLY VOLTAGE ALTERNATED BEFORE THE APPLICATION
OF THE TEST LEVEL.
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Guidelines and Manufacturer’s Statement – Electromagnetic Immunity
The Lung Ventilator Luft 3 is designated for use in electromagnetic environments as specified below. It is
recommended that the user or client of the Lung Ventilator Luft 3 ensures that the equipment is being used in
such environment.
Immunity tests
Test level
ABNT NBR IEC 60601
Level of
Compliance
Electromagnetic environment Guidelines
Portable and Mobile RF equipment should not
be used close to any part of the Lung Ventilator
Luft 3, including cables, from a separation
distance lower than the recommendation,
calculated out of the applicable equation for the
transmitter's frequency.
RF Conducted
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz out of
ISM bandsa
Recommended separation distance:
d= 1,17 [ P ] ½
3V
d= 1,20 [ P ] ½
10 Vrms
Radiated RF
IEC 61000-4-3
150 kHz to 80 MHz out of
ISM bandsa
10 V
d=1,20 [ P ] ½ 80 MHz até 800 MHz
10 V/m
80 MHz up to 2,5 GHz
10 V/m
d= 2,30 [ P ] ½ 800 MHz até 2,5 GHz
where P is the maximum nominal power output
of the transmitter in watts (W), according to the
transmitter's manufacturer, and d is the
separation distance recommended in meters
(m).
It is recommended that the field intensity
established by the RF transmitter, as
determined through an electromagnetic
inspection on the placeC is lower than the
compliance level in each frequency band D.
Interference may occur around the equipment
marked with this symbol:
NOTE 1
At 80 MHz and 800 MHz, the highest frequency band is applied.
NOTE 2
These guidelines may not be applicable in every situation. The electromagnetic propagation is affected by the
absorption and reflection of structures, objects and people.
A
In the ISM (Industrial, Scientific and Medical) frequency bands between 150 kHz and 80 MHz are 6.765 MHz up to 6.795
MHz; 13.553 MHz up to 13.567 MHz; 26.957MHz up to 27.283 MHz and 40.66 MHz up to 40.70 MHz.
B
The compliance levels on the ISM frequency bands between 150 kHz and 80 MHz and the frequency range between 80 MHz
up to 2,5 GHz are intended to reduce the probabibly that the mobile and portable communication devices cause interference if
inadvertly brought to the patient’s environment. For this reason an additional factor of 10/3 is used to calculate the
recommended separation distance for transmitters in this frequency range.
C
The field intensities established by fixed transmitters, such as base radio stations, phones (cellular / wireless), portable ground
radios, amateur radios, AM and FM transmission and TV transmission cannot be theoretically predicted with accuracy. To asses
the electromagnetic environment due to fixed RF transmitters, it is recommended to consider an electromagnetic inspection of
the place. If the field intensity measure at the place in which the Lung Ventilator Luft 3 is used exceeds the level of compliance
used above, the Lung Ventilator Luft 3 should be observed to verify if the operation is regular. If an abnormal performance is
detected, additional procedures may be necessary, such as reorienting or reallocation of the Lung Ventilator Lut 3.
D Over
the frequency range of 150 kHz up to 80 MHz, the field intensity must be lower than 3 V/m.
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Recommended separation distance between the portable and mobile RF equipment
and the Lung Ventilator Luft 3
The Lung Ventilator Luft 3 is intended for use in electromagnetic environments in which irradiated RF
disturbances are controlled. The client or customer of the Lung Ventilator Luft 3 may help preventing
electromagnetic interferences by keeping a minimum distance between the portable or mobile RF communication
equipment (transmitters) and the Lung Ventilator Luft 3 as recommended below, according to the maximum
communication equipment's output power.
Separation distance according to the transmitter's frequency (meters) m
150 kHz up to
80 MHz out of
ISM Bands
150 kHz up to
80 MHz in the
ISM Bands
80 MHz up to
800 MHz
800 MHz up to
2,5GHz
d= 1,17 [ P ] ½
d= 1,20 [ P ] ½
d= 1,20 [ P ] ½
d= 2,30 [ P ] ½
0,01
0,12
0,12
0,12
0,23
0,1
0,37
0,37
0,37
0,72
1
1,17
1,20
1,20
2,30
10
3,70
3,79
3,79
7,27
100
11,70
12,00
12,00
23,00
Transmitter's
maximum nominal
output power
W
For transmitters with a nominal output power which is not listed above, the recommended separation distance d in
meters (m) may be determined by using the applicable equation of the transmitter's frequency, where P is the
transmitter's maximum nominal output power in watts (W), according to the transmitter's manufacturer.
NOTE 1
In 80 MHz and 800 MHz, the separation distance is applied to the higher frequency range.
NOTE 2 In the ISM (Industrial, Scientific and Medical) frequency bands between 150 kHz and 80 MHz are 6.765
MHz up to 6.795 MHz; 13.553 MHz up to 13.567 MHz; 26.957MHz up to 27.283 MHz and 40.66 MHz up to 40.70
MHz.
NOTE 3 An additional factor of 10/3 is used to calculate the recommended separation distance for transmitters
in the ISM frequency bands between 150 kHz and 80 MHz and on the frequency range of 80 MHz up to 2.5 GHz
to reduce the probability of interference that mobile communication equipment may cause if inadvertently taken
into patient areas.
NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by the
absorption and reflection of structures, objects and people.
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SIMBOLOGY
1 – MEANING OF THE STANDARDIZED SYMBOLS, PRINTED ON THE
EQUIPMENT, INTERNAL AND EXTERNAL
Symbol
Standard/Norm
Description
IEC 60417-5032
Alternating Current
IEC 60417-5031
Direct Current
IEC 60417-5017
Functional Ground Terminal
IEC 60417-5019
Protective Ground Terminal
ISO 7000-0434A
Attention! Consult the documents
IEC 60417-5264
Connected (Connection to Internal or
External Power Source)
IEC 60417-5265
Disconnected (Disconnection to Internal
or External Power Source)
IEC 60417-5840
Type B Equipment
IEC 60878
ISO 3864-B.3.6a
Risk of Electrical Shock
IEC 60417-5016
Fuse
ISO 7010-M002
Consult Instructions of Use
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2 – MEANING OF THE STANDARDIZED SYMBOLS, PRINTED ON THE
EQUIPMENT’S PACKING
Symbol
Standard
Description
ISO 780:1997 (E) No. 1
FRAGILE
Handle carefully
ISO 780:1997 (E) No. 3
THIS SIDE UP
Indicate the position of the
package’s up side
ISO 780:1997 (E) No. 4
PROTECT FROM SUNLIGHT
The package must be kept out of
sunlight
ISO 780:1997 (E) No. 6
PROTECT AGAINST RAIN
The package must be kept out of
rain
ISO 780:1997 (E) No. 14
MAXIMUM STACKING UP
Indicates the maximum number of
packages that can be stacked up
for transport and storage
ISO 780:1997 (E) No. 2
DO NOT USE HOOKS
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ISO 780:1997 (E) No. 8
DO NOT ROLL THE PACKAGE
ISO 780:1997 (E) No. 17
TEMPERATURE LIMIT
Indicates the limit temperature for
stocking and handling the package
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3 – MEANING OF THE SYMBOLS, PRINTED ON THE EQUIPMENT’S USER
MANUAL
Symbol
Standard
Description
IEC 60878
ISO 3864-B.3.6a
RISK OF ELECTRICAL SHOCK
ISO 7010-W001
ISO 7000-0434A
--------------------
WARNING!
Condition before which there is a
possibility of production damage to
the operator or others.
ATTENTION!
Condition before which there is the
possibility of damaging the
equipment, its accessories or others.
NOTE
Specifies important observations
which need to be considered for a
correct use of the equipment.
MANUFACTURER
EN 980
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CHAPTER 1 - PRESENTATION
In the User Manual the necessary information for the correct use of the LUFT 3 ventilator are
presented. The indicators related to the application and the regulation, mentioned in this manual, are
for orientation only. The physician shall adapt it, according to his/her own criteria, to the patient's need.
GENERAL
MODEL
ANVISA Registry
Luft 3
No: 80203470012
MEDICAL DEVICE CLASSIFICATION
OPERATION MODE
Classification according to the type against electrical shock
(Isolation).
Classification according to the type of protection against
electrical shock.
Level of protection against harmful water penetration
CLASS III
Continuous Operation
CLASS I
Internally Energized Device
TYPE B
IP22
EQUIPMENT not suitable to use near an ANESTHETIC MIXTURE THAT IS
FLAMMABLE WITH AIR, OXYGEN (O2) or NITROUS OXIDE (NO2).
PHYSICAL CHARACTERISTICS
Dimensions
PARAMETERS
VALUES
Height
1.473 mm
Width
550 mm
Depth
530 mm
Equipment’s Weight
28,0 Kg
Case’s Weight
10,0 Kg
Monitor’s Weight
5,4 Kg
Trolley’s Weight
12,6 Kg
EXTERNAL POWER SUPPLY
VOLTAGE – CURRENT
100V – 240V ~ 0,6A – 0,29A
FREQUENCY
47 to 63 Hz.
POWER
70 VA
250V ~ 2,0A 20mm SB (Slow)
FUSE
INTERNAL POWER SUPPLY
Battery Commutation
Voltages lower than 90 Vac.
Nominal Voltage
10,8V ~ 11,1V
Nominal Capacity
Type
Autonomy
13,2Ah
Lithium battery (Li+)
Complete Battery
Charge
360 minutes autonomy
77ºF (25ºC)
Working Temperature Range
Discharge
-20ºC ~ +60ºC
Charge
0ºC ~ +45ºC
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Storage
-20ºC ~ +60ºC
Nominal Working Temperature
+25ºC ± 3ºC
Voltage Fluctuation
12,6 Vdc to 25°C
Lifespan
300 to 500 cycles
Charging Time
15 hours
Partial charge time
4 hours
(for 2 hours of autonomy)
TOTAL AUTONOMY IS GUARANTEED FOR SPECIFIC CONDITIONS OF POWER
CONSUMPTION. THE PARTIAL CHARGE TIME WAS CONSIDERED WITH THE
BATTERY PARTIALLY DISCHARGED AND ASSESSED THE CHARGE TIME
NECESSARY TO RETAKE MORE THAN 2 HOURS OF AUTONOMY.
TO TEST THE BATTERY YOU MUST CYCLE THE EQUIPMENT OPERATING ON THE
BATTERY FOR 5 MINUTES AND CHECK THE SYMBOL THAT INDICATES THE
BATTERY CHARGE LEVEL. IN CASE THE COLOR IS GREEN OR YELLOW, THE
BATTERY IS IN GOOD CONDITIONS OF USE.
SPECIFICATIONS INFORMED BY THE MANUFACTURER.
INTERNAL BATTERY AND FUSE ARE NOT REPLACEABLE BY THE OPERATOR.
RISK OF ELECTRICAL SHOCK. THE CASE MUST BE REMOVED ONLY BY QUALIFIED
PERSONNEL.
THE SWITCHING FOR THE INTERNAL BATTERY HAPPENS AUTOMATICALLY,
WITHOUT EXTERNAL INTERVENTION. IT DOES NOT INTERFERE THE EQUIPMENT'S
OPERATION, BUT TRIGGERS AN ALARM AS EXPLAINED ON CHAPTER 5 - ALARMS.
WHENEVER THE EQUIPMENT IS CONNECTED TO THE EXTERNAL ELECTRICAL
SOURCE THE BATTERY IS RECHARGING.
ELECTRICAL OUTPUT FOR THE MONITOR
VOLTAGE – CURRENT
12 V
5A
POWER
60 VA
THE OUTPUT CURRENT FOR THE DISPLAY IS LIMITED IN 5A BY THE POWER
SUPPLY'S OVERLOAD FUNCTION, WHICH ALSO PROTECTS THIS PLUG AGAINST
ELECTRICAL DEAD-SHORTS AND OVERHEATING.
PNEUMATIC INPUTS
OXYGEN (O2)
DISS 9/16” – 18 input
AIR
DISS 3/4” – 16 input
PRESSURE
250 – 700 kPa (2,5 - 7 bar)
FLOW
Up to 180 L/min
USE ONLY MEDICAL GRADE GASES.
ALWAYS USE THE FILTER FOR THE COMPRESSED AIR NETWORK.
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VALUES
+10ºC to 35ºC
+2ºC to 40ºC (*)
10% to 95%
Operation
Non condensable
Relative Humidity
0% to 95%
Storage - Transport
Non condensable
Operation
40 – 100 kPa
Atmospheric Pressure
Storage - Transport
40 – 100 kPa
THE VOLUME AND PRESSURE MEASURES ARE STANDARIZED BY THE
BAROMETRIC PRESSURE AT SEA LEVEL (BTPS) AND THEY ARE COMPENSATED
IN FUNCTION OF THE ALTITUDE.
Environment Temperature
Operation
Storage - Transport
(*) THE VENTILATOR'S STORAGE FOR LONG PERIODS AT TEMPERATURES
HIGHER THAN 27ºC OR WITHOUT ELECTRICAL CONNECTION FOR PERIODS
LONGER THAN TWO MONTHS MAY AFFECT THE INTERNAL BATTERY'S LIFESPAN.
IN CASE OF STORAGE OF THE VENTILATOR FOR LONG PERIODS, IT IS
RECOMMENDED TO REMOVE THE INTERNAL BATTERY IN ORDER TO AVOID
LEAKAGES. REQUEST AUTHORIZED TECHNICAL SUPPORT'S SUPPORT.
THE EQUIPMENT LUFT3 COMPLIES WITH THE FOLLOWING STANDARDS:
ABNT NBR IEC 60601-1 – Electromedical equipment – Part 1: General safety prescriptions.
ABNT NBR IEC 60601-1-2 – Electromedical equipment - Part 1-2: General requirements for
basic safety and essential performance – Collateral standard: Electromagnetic compatibility –
requirements and assay.
ABNT NBR IEC 60601-1-4 - Electromedical equipment - Part 1-4: General safety prescriptions
- Collateral standard: Programmable electromedical systems.
ABNT NBR IEC 60601-1-8 - Electromedical equipment - Part 1-8: General requirements for
basic safety and essential performance - Collateral standard: General requirements, assays
and guidelines for alarm systems in electromedical equipment and electromedical systems.
ABNT NBR IEC 60601-2-12 - Electromedical equipment - Part 2-12: Particular prescriptions
for lung ventilator safety – Critical care ventilators.
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WARNINGS, PRECAUTIONS AND NOTES
WARNINGS
TO AVOID THE RISK OF ELECTRICAL SHOCK, THIS EQUIPMENT SHALL BE
CONNECTED ONLY TO ONE SOURCE OF POWER SUPPLY WITH PROTECTIVE
GROUNDING.
CONSTANT ATTENTION OF SPECIALIZED PERSONNEL IS REQUIRED WHENEVER
THE PATIENT IS CONNECTED.
WHENEVER THE EQUIPMENT IS IN USE, AN ALTERNATIVE WAY OF VENTILATION
MUST BE AVAILABLE.
OPERATIONAL PROBLEMS REQUIRE IMMEDIATE CORRECTIVE ACTION.
THE ALARMS DO NOT IMPLY TOTAL SAFETY IN CASE OF A DEFECT IN THE
EQUIPMENT.
THE PROFESSIONAL IN CHARGE OF ITS USE SHALL, ACCORDING TO HIS/HER
OWN CRITERION AND KNOWLEDGE, USE THE EQUIPMENT ACCORDING TO THE
NEEDS OF THE PATIENT.
DO NOT USE ANTI-STATIC TUBES NOR ELECTRICAL CONDUCTORS IN THE
PATIENT CIRCUIT.
DO NOT STERILIZE THE EQUIPMENT WITH ETHYLENE OXIDE. THERE IS A HIGH
PROBABILITY TO OCCUR IRREVERSIBLE DAMAGE IN THE VENTILATOR
COMPONENTS.
THE EQUIPMENT MUST BE CONNECTED TO AC VOLTAGE WITH PROTECTIVE
GROUND CONNECTION.
THE EQUIPMENT MAY BE AFFECTED BY HIGH FREQUENCY ELECTROMAGNETIC
INTERFERENCE (SUCH AS CELLULAR, WIRELESS TELEPHONE, DEFIBRILLATORS,
ELECTRO-SURGICAL KNIVES, MAGNETIC RESONANCE, ETC.). USE LAST
CHAPTER'S TABLE OF EMISSION GUIDELINES AND ELECTROMAGNETIC IMMUNITY
TO DETERMINE THE CORRECT SEPARATION DISTANCE.
THE USE OF ACCESSORIES AND CABLES OTHER THAN THE SPECIFIED, WITH
EXCEPTION TO THE ONES FURNISHED BY LEISTUNG AS SPARE PARTS FOR
INTERNAL COMPONENTS, MAY RESULT IN AN INCREASE OF THE EMISSION OR
THE REDUCTION OF THE LUFT 3's IMMUNITY.
BEFORE THE FIRST UTILIZATION AND AFTER THE UTILIZATION IN EACH PATIENT,
IT IS NECESSARY TO CLEAN THE VENTILATOR. TO STERILIZE THE ACCESSORIES,
FOLLOW THE INSTRUCTIONS ON CHAPTER 7 – .
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DANGER OF ELECTRICAL SHOCK: NEVER DISASSEMBLE THE CASE OF THE
EQUIPMENT. IN THE EVENT OF PROBLEMS OF DIFFICULTIES, CONTACT AN
AUTHORIZED TECHNICAL SERVICE.
THE EQUIPMENT MUST BE SUPPLIED BY BATTERY WHEN THERE IS DOUBT
ABOUT THE INTEGRITY OF THE GROUND CONNECTOR, TAKING CARE NOT TO
EXCEED THE BATTERY LIFE.
ONLY CONNECT TO THE EQUIPMENT ITEMS WHICH ARE SPECIFIED AS BEING
PART OF LUFT 3 OR WHICH ARE COMPATIBLE.
THE COMPANY RESPONSIBLE FOR THE EQUIPMENT SHALL DO ALL THE
SPECIFIED PROCEDURES OF CLEANING, STERILIZATION AND DISINFECTION.
THE COMPANY RESPONSIBLE FOR THE EQUIPMENT SHALL ASSURE THAT THE
ASSEMBLY OF THE LUFT 3 AND ANY MODIFICATION DURING ITS WORKING TIME
WILL FOLLOW THE EVALUATION REQUIREMENTS OF THE RULE NBR IEC 60601-1:
2010.
NO CHANGE IN THIS EQUIPMENT IS ALLOWED.
PRECAUTIONS
IN CASE OF FAILURE OF ELECTRICAL SUPPLY OR INPUT GAS, THE VENTILATOR
ENABLES SPONTANEOUS VENTILATION. THE RESISTANCE OF THE EXPIRATION
BRANCH WITH THE EQUIPMENT WITHOUT SUPPLY IS 3.0 cmH2O/L/s AT 30 L/min.
AND 3.2 cmH2O/L/s AT 60 L/min. THE RESISTANCE OF THE INSPIRATION BRANCH
IS LOWER THAN 5 cmH2O/L/s AT 60 L/min.
DURING THE WARRANTY PERIOD, THE PERMANENCE OR MOVEMENT OF THE
EQUIPMENT SHALL BE PERFORMED WITH ITS ORIGINAL PACKAGING, WITH ITS
CORRESPONDING INTERNAL PROTECTION; OTHERWISE IT WILL RESULT IN LOSS
OF THE WARRANTY.
NEVER STERILIZE THE VENTILATOR. THE INTERNAL COMPONENTS ARE NOT
COMPATIBLE WITH THE STERILIZATION TECHNIQUES.
FOLLOW THE INSTRUCTIONS FOR THE EQUIPMENT CLEANING AND
COMPONENTS STERILIZATION AS SHOWN ON CHAPTER 7 – OF THIS MANUAL.
NEVER OPERATE THE EQUIPMENT EXPOSED TO DIRECT HEAT OR SUNLIGHT.
NEVER COVER OR POSITION THE EQUIPMENT IN A WAY THAT BLOCKS THE AIR
ENTRY FOR COOLING.
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TO ENSURE THE ELECTRICAL PROTECTION AND TO AVOID RISK OF FIRE, NEVER
CHANGE THE FUSE. IN CASE THE EQUIPMENT STOPS WORKING, CONTACT THE
AUTHORIZED TECHNICAL SERVICE.
THE IMPROPER REPLACEMENT OF FUSES NULLIFIES THE WARRANTY AND
REPRESENTS A RISK FOR THE OPERATION OF THE EQUIPMENT, THE SAFETY OF
THE OPERATOR AND THE PATIENT.
NOTES
THE VENTILATOR IS A MEDICAL EQUIPMENT AND SHALL BE OPERATED BY A
QUALIFIED AND TRAINED PROFESSIONAL, UNDER THE DIRECT SUPERVISION OF
A PHYSICIAN.
BY THE END OF THE EQUIPMENT'S LIFETIME, DO NOT DISCARD ITS
COMPONENTS IN REGULAR TRASH CANS. FOR THAT, CONTACT:
WWW.LEISTUNGBRASIL.COM.
ELECTRIC DIAGRAMS, CIRCUIT DIAGRAMS, COMPONENT LISTS, DESCRIPTIONS,
CALIBRATION INSTRUCTIONS, AS WELL AS TRAININGS CAN BE PROVIDED BY
LEISTUNG EQUIPAMENTOS LTDA. BY AN AGREEMENT BETWEEN THE PARTS.
LEISTUNG EQUIPAMENTOS LTDA. IS A COMPANY OF CONTINUOUS IMPROVING
IN ITS PRODUCTS, AND TECHNICAL SPECIFICATIONS MAY CHANGE WITHOUT
PREVIOUS NOTICE.
IN CASE YOU FACE ANY MALFUNCTION, PLEASE COMMUNICATE LEISTUNG
EQUIPAMENTOS LTDA.'s TECHNICAL SERVICE.
THE COMPANY RESPONSIBLE FOR THE EQUIPMENT IS THE ENTITY WHICH
LEGALLY AND MORALLY RESPONDS FOR THE USE AND MAINTENANCE OF THE
LUNG VENTILATOR LUFT 3. THIS ENTITY MAY BE, FOR EXAMPLE, A HOSPITAL
AND A PHYSICIAN OR A LEGAL PERSON.
THE COMPANY RESPONSIBLE FOR THE EQUIPMENT IS THE ENTITY WHICH
LEGALLY AND MORALLY RESPONDS FOR THE USE AND MAINTENANCE OF THE
LUNG VENTILATOR LUFT 3. THIS ENTITY MAY BE, FOR EXAMPLE, A HOSPITAL
AND A PHYSICIAN OR A LEGAL PERSON.
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CHAPTER 2 – INTRODUCTION
The ventilator LUFT 3 was developed to be among the most complete lung ventilators in the
market, the equipment LUFT 3 features a 17” screen which allows adjustment of inclination and
rotation with resistive touch screen panel displaying an image of 800x600 pixels in a useful image area
of 335 cm x 270 cm, showing an intuitive and user-friendly interface of easy operation, offering quick
and safe ajudstment for each ventilatory parameters, as well as it offers a pleasing operation for the
professional and allows more attention towards the patient.
The LUFT 3 provides all necessary ventilation modes for therapies in Adult, Pediatric and
Noenatal patients, besides an advanced lung mechanics menu for the correct diagnosis, offering high
quality ventilation adapted for each patient, able to be used on the most complex and demanding
therapies, ventilating from premature neonatal patients (0,3kg) to patients with morbid obesity
(>300kg) in an efficient and reliable way.
The ventilator consists of a flexible breathing circuit, a controlling system, a gas source, the
monitor and the alarms. The controlling system (microcontroller) regulates the pressure, the volume
and the positive pressure respiration flow delivered to the patient, as well as the fraction of inbreathed
oxygen (FiO2) based on the value of the selected control variables. The sensors disposed within the
ventilator and within the breathing circuit are able to measure the pressure or flow in the airway and
provide feedback so that it automatically adjusts its output.
The communication interface allows the user to know and to configure the information of the
control parameters, variables of the monitoring and condition of the alarms. The Touch Screen
technology enables a great ease of handling which allows the operator access to all parameters of the
equipment quickly, accurately and securely, making the work of the professional nice and smooth,
allowing the same to focus on the patient treatment. The equipment has an operating system with
preset or custom settings. The alarm system has warnings and reminders, clear and oriented to help
in the safe decision-making of the professional.
The equipment power may be sourced both from the electrical network and from the internal
battery. The internal battery's power shall be used for short-term ventilations or during failures of the
electrical network.
The ventilator receives gases (Air and O2) from the room's medical gas network whose flow to
the patient may be regulated by flow control valves, in order to reach the FiO2 you want provide to the
patient, the air and oxygen are internally mixed. The gas mixture is delivered to the patient through a
flexible breathing circuit consisting of two branches of corrugated silicone tracheas and a system for
quick and safe interconnection, which prevents any possibility of error.
It also includes a default parameters configuration which ensures a fast and safe ventilation
start, therefore avoiding the self-cycling and allowing a patient recovery without major interferences .
Pulmonary insufflation during mechanical ventilation occurs when a flow of air is applied in the
airway this additional pressure increases the intrapulmonary pressure and produces a transpulmonary pressure gradient between the alveoli and the pleural space. The control of the inspiratory
and expiratory phase is performed through the exhalation valve which operates actively.
The ventilator LUFT 3 is designated to ventilate by positive pressure adult, pediatric and
neonatal patients. It is intended to operate in hospital environments, more specifically Intensive Care
Units (ICU) with proper electrical installations and proper medical gases installations. The equipment
is not intended to be used in transportation outside the hospital nor homecare.
It shall be used only by trained personnel and under the supervision of healthcare
professionals. The device may be used in invasive mode as well as non-invasive mode. However,
LEISTUNG EQUIPAMENTOS excludes from its production and commercialization process
endotracheal and tracheostomy tubes, facial and endonasal masks, suction probes, etc.
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Contraindications for the use
The application of mechanical ventilation is associated to the possibility of emerging complications.
The knowledge of them is responsibility of the professional in charge of the equipment and exceeds
the level of information contained in this manual.
VENTILATOR SPECIFICATIONS
LUFT 3 CONFIGURATIONS
Adult – Pediatric –
Neonatal
Adult – Pediatric
Pediatric – Neonatal
VENTILATION MODES
PATIENT
TYPE
VENTILATION
VOLUME CONTROLLED (VCV)
ASSISTED /
CONTROLLED
PRESSURE CONTROLLED
(PCV)
PRESSURE REGULATED
VOLUME CONTROL (PRVC)
PRESSURE SUPPORT
(PSV)
ADULT
CONTINUOUS POSITIVE
PRESSURE (CPAP)
SPONTANEOUS
AND
NON INVASIVE (NIV)
PEDIATRIC
HFNC – HIGH FLOW NASAL
CANNULA
SIMV (VCV) + PSV
SIMV (PCV) + PSV
VARIÁBLES
MINUTE (MMV) + PSV
PSV + ASSURED TIDAL
VOLUME
BIPHASIC PRESSURE
(APRV+PSV)
NEONATAL
ASSISTED /
VOLUME CONTROLLED (VCV)
CONTROLLED
PRESSURE CONTROLLED
(PCV)
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CONTINUOUS FLOW
PRESSURE SUPPORT (PSV)
CPAP
SPONTANEOUS
Nasal CPAP
HFNC – HIGH FLOW NASAL
CANNULA
VARIÁBLES
SIMV (PCV) + PSV
SPECIFICATIONS
Backup Ventilation
Emergency Ventilation
FIO2:
Inspiratory Time
I:E Ratio
Frequency
Tidal Volume
Minute Volume
Sensibility
Pressure Controlled (PCV)
Pressure Support (PSV)
Inspiratory Pressure
Rise Time
Expiratory Sensibility
Apnea Time
PEEP / CPAP
Nebulization
TGI
Inspiratory Flow
Base Flow
Expiratory Flow
Sigh (VCV mode)
AUTOMATIC Inspiratory Pause (VCV mode)
Manual Inspiratory Pause
Manual Expiratory Pause
O2 100%
PCV or VCV in adult, pediatric and neonatal
In all ventilation modes
21 to 100%
0,1 to 30,0 seconds
5:1 - 1:99
1 - 180 R.P.M.
2,0 to 2500 ml
0,01 to 25,0 l
 BY FLOW: 0,2 to 15 L/min

BY PRESSURE: -0,2 to -15,0 cm H2O (compensated
PEEP)
1 to 80 cm H2O over PEEP (with adjustable “Rise Time”)
0 to 80 cm H2O over PEEP (with adjustable “Rise Time”)
-10 to 120 cmH2O
6 levels
Adjustable from 5 to 80% of the initial flow
5 to 60 seconds
0 to 50 cm H2O
1 to 20 min. synchronized with the inspiratory phase and
with automatic compensation of the insp. volume and FiO 2
Synchronized with the expiratory phase
On VCV: Automatic adjustment from 0 to 200 L/min.
On PCV e PSV: from 0 to 200 L/min.
Continuous flow on neonatal: 2 to 15 L/min.
Inspiratory flow on neonatal: 0 to 30 L/min.
Maximum flow in any mode of 250 L/min.
Off up to 50 L/min.
Up to 200 L/min.
Cycles per hour, quantity, maximum tidal volume and
manual trigger
0,1 to 2,0 seconds with plateau value
0,1 to 30 seconds
0,1 to 30 seconds
Oxygenation for aspiration maneuver with synchronized
system - 1 to 20 min
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Flow waveform
Automatic bypass of the AIR – O2 network
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Square / 100% Descending ramp / 50% Descending ramp
/ Sinusoidal / Ascending Ramp
In case of failure in one of them, the equipment continues
operating normally
Adjusted in 120 cmH2O
Inspiratory pressure inner safety valve
Regulatory pressure valve of Air and O2 input
Internally incorporated in the equipment
Maintains the equipment in standby without changing the
programmed values
Standby
Scales
Automatic updated for vertical and horizontal readings
Freeze
Possibility of reading graphics
RS232 signal connector
USB signal connector
For external communication with software and signals
input
For equipment's Service and Software update.
THE CONDITIONS UNDER WHICH IT IS EXPRESSED FLOW, VOLUME AND LEAKAGE
SPECIFICATIONS, ARE EXPRESSED IN “STPD” CONDITIONS (OPERATION TEMPERATURE
OF 20º AND ATMOSPHERIC PRESSURE OF 101,3 KPA), EXCEPT THOSE ASSOCIATED WITH
THE VENTILATOR’S RESPIRATORY SYSTEM, WHICH ARE EXPRESSED IN BTPS CONDITIONS
(ENVIRONMENTAL ATMOSPHERIC PRESSURE AND OPERATION TEMPERATURE OF 37ºC).
ALL THE MEASURED VENTILATORY VARIABLES ARE FILTERED AT 30 Hz AND CONDITIONED
USING ANALOGICAL AND DIGITAL DATE PROCESSING TECHNIQUES.
THE ACCURACY OF THE PRESSURE MEASUREMENTS IS ± 2% OF FULL SCALE (120 cmH2O)
+ 4% OF THE ACTUAL READING. THE REST OF THE SPECIFIED VALUES HAVE A MAXIMUM
ERROR OF +/- 10%.
THE EQUIPMENT HAS A SAFETY VALVE THAT OPENS WHEN IT REACHES THE MAXIMUM
PRESSURE OF 120 cmH2O, RELEASING THE EXCESSIVE PRESSURE.
NEGATIVE PRESSURE (SUB-ATMOSPHERIC) IS NOT AVAILABLE IN THE EXPIRATORY
PHASE.
WHEN ADDING ACCESSORIES OR OTHER COMPONENTS OR SUBASSEMBLIES TO THE
VENTILATION SYSTEM OF THE LUNG VENTILATOR (BREATHING SYSTEM DELIMITED BY
THE GAS INPUT PORTS AND THE PATIENT CONNECTION PORT AND/OR EXHAUST PORT),
THE PRESSURE GRADIENT BETWEEN THE VENTILATOR’S VENTILATION SYSTEM AND THE
PATIENT CONNECTION PORT MAY INCREASE.
OUTPUT PARAMETERS (MONITORING)
AIRWAY PRESSURE: PEAK, PLATEAU, MEAN, BASE (PEEP)
INSPIRATORY TIME
EXPIRATORY TIME
I:E RATIO AND SPONTANEOUS BREATHINGS
INSPIRATORY PAUSE
INSPIRED / EXHALED TIDAL VOLUME (DISTAL & PROXIMAL) TOTAL AND SPONTANEOUS
INSPIRATORY PEAK FLOW (DISTAL & PROXIMAL)
EXPIRATORY PEAK FLOW (DISTAL & PROXIMAL)
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DYNAMIC COMPLIANCE
TOTAL, CONTROLLED AND SPONTANEOUS FREQUENCY
GRAPHICAL INDICATOR OF SPONTANEOUS AND MECHANICAL CYCLES
TOTAL, CONTROLLED AND SPONTANEOUS MINUTE VOLUME (DISTAL & PROXIMAL)
FiO2 CONCENTRATION
INSPIRATORY AND EXPIRATORY TIME CONSTANT
COMPRESSIBLE VOLUME
TI/TTOT RELATION
etCO2 (OPTIONAL)
CO2 INSPIRED (OPTIONAL)
TOTAL LEAKAGE
VENTILATION LEVEL (mL/Kg)
LUNG MECHANICS
AUTOPEEP
DYNAMIC COMPLIANCE
STATIC COMPLIANCE
INSPIRATORY RESISTANCE
EXPIRATORY RESISTANCE
SLOW VITAL CAPACITY
P0.1 (AIRWAY OCCLUSION PRESSURE)
P-V CURVE WITH LOW FLOW
TOBIN INDEX
STRESS INDEX
WORK OF BREATHING
ALARMS
MAXIMUM AIRWAY INSPIRATORY PRESSURE
MINIMUM AIRWAY INSPIRATORY PRESSURE
MAXIMUM AND MINIMUM EXHALED TIDAL VOLUME
MAXIMUM AND MINIMUM EXHALED MINUTE VOLUME
APNEA WITH ADJUSTABLE TIME
MAXIMUM RESPIRATORY FREQUENCY
MINIMUM RESPIRATORY FREQUENCY
PATIENT CIRCUIT DISCONNECTION
PROXIMAL FLOW SENSOR DISCONNECTION
MAXIMUM AND MINIMUM PEEP AND CONTINUOUS PRESSURE
GAS SUPPLY SOURCE (AR - O2) (HIGH & LOW PRESSURE)
POWER OUTAGE
LOW BATTERY CHARGE
MICROPROCESSOR (INOPERATIVE VENTILATOR)
INTERRUPTED CYCLE IN PRESSURE MODES
MAXIMUM AND MINIMUM FiO2
INVERTED I:E RATIO
THE ALARMS ARE TRIGGERED IN PRIORITY ORDER WITH AUDIBLE WARNINGS AND/OR
MESSAGES ON THE SCREEN.
GRAPHICS
PRESSURE – TIME
FLOW – TIME
VOLUME – TIME
CO2 – TIME (OPTIONAL)
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VOLUME – PRESSURE LOOP
FLOW – VOLUME LOOP
PRESSURE – FLOW LOOP
CO2 – VOLUME LOOP (OPTIONAL)
TENDENCY CURVES (UP TO 72 HOURS)
PEAK AND BASE PRESSURE
FLOW
TIDAL VOLUME
MINUTE VOLUME
FREQUENCY
DYNAMIC COMPLIANCE
ALARMS LOG
LAST 1000 ALARMS AND EVENTS WITH DATE AND TIME
OTHER MENUS
INDICATION MENU OF HOURS OF USE AND SERVICES PERFORMED
ALTITUDE ADJUSTMENT FOR VOLUME COMPENSATION
POSSIBILITY OF EXCHANGING THE LANGUAGE
ALARM AUDIO VOLUME ADJUSTMENT
CIRCUIT CHANGE/TEST
INITIAL SELF-TESTS
ALTITUDE COMPENSATION
ATMOSPHERIC PRESSURE CAPTURE
OXYGEL CELL DETECTION
PATIENT CIRCUIT SELF-TEST
VERIFICATION OF HOURS OF USE
SENSORS CALIBRATION
PROXIMAL SENSOR DETECTION
PROXIMAL SENSOR CALIBRATION
CIRCUIT LEAKAGE MEASUREMENT
CIRCUIT COMPLIANCE MEASUREMENT
EXPIRATORY FLOW SENSOR CALIBRATION
OXYGEN CELL CALIBRATION
INTERNAL FLOW SENSORS CALIBRATION
PROPORTIONAL AIR VALVE TESTS
PROPORTIONAL O2 VALVE TESTS
PEEP CONTROL VALVE TESTS
DETECTION AND INITIALIZATION OF THE CAPNOGRAPH (OPTIONAL)
OTHER VENTILATOR SAFETY CHARACTERISTICS
AUTOMATIC COMPENSATION OF GASES
LEAKAGE COMPENSATION IN ALL VENTILATORY MODES (NIV)
SAVED LOG OF EVENTS AND ALARMS EVEN AFTER POWER FAILURE
WARNING OF MAINTENANCE NEEDED BY HOURS OF USE
POSSIBILITY OF OPERATION WITHOUT FLOW SENSOR
POSSIBILITY OF OPERATION WITHOUT PROXIMAL SENSOR
POSSIBILITY OF OPERATION WITHOUT OXYGEN CELL
THE LINE TEST (SELF-TEST) IS PERFORMED BY THE OPERATOR WHENEVER THE
EQUIPMENT IS TURNED ON.
ONCE THE SELF-TEST IS FINISHED, THE DEVICE PERFORMS A CALIBRATION WITHOUT
THE OPERATOR'S INTERVENTION.
WHEN IT'S NECESSARY, THE EQUIPMENT PERFORMS AN AUTOMATIC CLEANING ON THE
FLOW SENSORS (EXHALATION VALVE) WITHOUT HAVING ITS REGULAR OPERATION
INTERRUPTED.
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IN CASE OF LEAKAGE IN THE PATIENT CIRCUIT DURING THE INITIAL TEST (SELF-TEST),
THE EQUIPMENT WILL DISPLAY ON THE SCREEN A MESSAGE INDICATING THE LEAKAGE
VALUES. FOR THE CORRECT OPERATION OF THE EQUIPMENT, IT IS IMPORTANT TO HAVE
NO LEAKAGE IN THE PATIENT CIRCUIT.
DURING THE EXHALATION FLOW TEST, THE GAS LINES (AIR AND O2) MUST DELIVER A
MINIMUM FLOW OF 100 L/MIN, SO THAT IT DOES NOT INTERFERE THE OPERATION OF THE
SAME. IN CASE OF BAD CONNECTION, WRONG ASSEMBLY OR INVERSION OF THE
SENSORS, THE EQUIPMENT WILL DISPLAY ON THE SCREEN A MESSAGE INDICATING
FLOW READING ERROR, AND THE OPERATOR SHALL CONFIRM WHETHER THE
EQUIPMENT WILL WORK WITH OR WITHOUT EXHALATION FLOW READINGS.
BY THE END OF THE CIRCUIT’S COMPLIANCE TEST THE EQUIPMENT DISPLAY ON THE
SCREEN THE VALUE TO BE AUTOMATICALLY COMPENSATED IN ml/cmH2O. THE VALUE
MEASURED DURING THE LINE TEST IS AVAILABLE FOR CONSULTATION ON THE
EQUIPMENT’S MENU. IF NECESSARY THE TEST CAN BE RUN AGAIN WITH THE
EQUIPMENT TURNED ON AT THE OPTION OF THE MENU “CIRCUIT CHANGE/TEST” AND A
NEW CIRCUIT COMPLIANCE VALUE IS MEASURED AND COMPENSATED.
ALL THE MEASURED AND/OR COMPUTED VENTILATORY VARIABLES, WHICH ARE
DISPLAYED OR USED FOR CONTROL ARE SAMPLED AT A FREQUENCY OF 30HZ AND
PROCESSED BY DIGITAL AND ANALOGIC PROCESSING TECHNIQUES.
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ELECTRONIC BLENDER OPERATION (AIR-O2 MIXER)
FiO2 (Fraction Inpired Of Oxygen) indicates the amount of Oxygen that is mixed with the gas breathed
by the patient. Generally speaking, it may vary from 21% (79% Nitrogen and 21% O2) up to 100%
(pure Oxygen), for example a FiO2 of 60% means that 60% of the volume breathed by the patient will
be oxygen and the other 40% of the volume will be nitrogen and other gases.
The FiO2 found in the Lung Ventilator LUFT 3 is generated by an electronic blender system, which
dispenses any external mixer. The mixture is performed by two proportional actuators, known as
Proportional Valves, named this way because they control proportionally the AIR and O2 flows that
passes through each one of them. Each flow is read by their respective pneumotachographs (device
used for flow measuring), which send to the CPU the current value of the flow generated by the
Proportional Valves. The FiO2 value is given by the fraction of gas delivered through each Proportional
Valve, where each one of them is responsible only by part of the total inspired gas volume. This
system is very accurate because it works with physical values well known, such as volume, pressure
and flow and the variations on the Oxygen concentration on the Ambient Air are small, as well as the
percentage of the Oxygen 100% provided. This is enough for the control to calculate the value of the
flow that each valve will have to deliver to the patient, therefore obtaining, with a very low error
chance, the correct FiO2.
Picture 1
FIO2 READING
The FiO2 is performed through a permanent, non-consumable internal sensor which monitors the
patient’s FiO2 in the inspiratory branch and does not need maintenance or replacement. The
permanent internal sensor is standard with the Lung Ventilator LUFT3.
It is possible to monitor the FiO2 through the option of a oxygen cell (Galvanic technology) or through a
Paramagnetic cell which is internally installed in the casing.
In case the galvanic cell is used, the equipment performs the verification of the integrity and calibration
during the equipment’s initial test. In case it is identified any damage on the oxygen cell, the
equipment automatically switches for the permanent internal sensor without damage or loss on the
patient’s FiO2 monitoring. For the maintenance of the oxygen cell, the equipment must be sent to the
authorized technical support. The permanent internal sensor does not require maintenance and its
calibration is performed during the preventive maintenance.
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CHAPTER 3 – ASSEMBLY AND CONNECTION
EQUIPMENT ASSEMBLY
Picture 2
Picture 3
1. Assemble the equipment over the 2 sockets of the trolley, as marked in the figure above.
2. To fix the equipment, release the back nuts, remove the back cover and thread the locknut, as on
the pictures below, after securing the equipment, fit the back cover and lock it with the nuts again.
Picture 4
Picture 2
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Picture 6
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3. Place the monitor over the equipment through a movement rod, as on the pictures below, fixing in a
way that it is firm and safe.
Picture 3
Picture 4
THE ASSEMBLED EQUIPMENT HAS LIMITATIONS REGARDING THE RISK OF
TIPPING (FALLING), AND MAY BE TILTED IN A MAXIMUM OF 5 DEGREES DURING
ITS USE.
WHEN MOVING THE ASSEMBLED EQUIPMENT, PRECAUTIONS SHALL BE TAKEN
WHEN INCLINING THE DEVICE TO PREVENT IT FROM TIPPING OVER.
THE TRANSPORTATION OF THE EQUIPMENT SHALL BE PERFORMED IN ITS
ORIGINAL PACKAGING, WITH THE TROLLEY AND THE LCD SCREEN
DISASSEMBLED.
SCREEN CONNECTION
The cable inputs are different to guarantee there are no mistakes during installation. Plug the cables
on the monitor and equipment according to the numbers on the pictures below.
Picture 10
Picture 5
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POWER SOURCE CONNECTION
The power source connection may be found at the rear of the case.
On the ventilator’s case, the operating voltage values are displayed together with the nominal current
and nominal power of the equipment. You will also find the values corresponding to the fuses, as
indicated on the picture below.
A power source with external battery may be connected to the power source connection, doubling the
equipment’s autonomy time.
Picture 11
THE EQUIPMENT IS EQUIPPED WITH 2A 20mm SB DELAYED FUSES, FIT FOR
POWERING FROM 100V UP TO 240V~.
ELECTRICAL CHARACTERISTICS OF THE DEVICE MAY BE FOUND ON THE
CHAPTER 1 - PRESENTATION OF THIS MANUAL.
THE INPUT POWER SUPPLY IS UNIVERSAL AND THE EQUIPMENT OPERATES ON
ANY VOLTAGE RANGE (100V UP TO 240V) WITHOUT THE NEED OF INTERVENTION
FROM THE OPERATOR, EVEN WHEN THERE IS A REDUCTION OF LINE VOLTAGE
DURING THE NORMAL OPERATION.
CHECK WHETHER THE EQUIPMENT IS CONNECTED TO A GROUNDED POWER
OUTLET IN ORDER TO GUARANTEE THE CORRECT OPERATION OF THE
EQUIPMENT. NEVER TURN ON THE DEVICE WITHOUT GROUND CONNECTION.
THE ELECTRICAL INSTALLATION IN WHICH THE VENTILATOR WILL BE CONNECTED
MUST COMPLY WITH THE TECHNICAL STANDARD NBR 13534, WHICH
ESTABLISHES THE MINIMUM CONDITIONS OF THE ELECTRICAL INSTALLATIONS IN
ASSISTANCE HEALTH CARE ESTABLISHMENTS.
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EQUIPMENT CONNECTION
Picture 12
On the front part of the equipment, there are the inputs for the following connections:
A – Exhalation Valve
B – Patient Circuit
C – Nebulizer
D – Capnograph
E – Proximal Sensor
F – RS232 communication connector
RS232 Communication Connector for communication with software and accepts sensor connection for
oximetry.
CONNECTION TO THE GAS SUPPLY SOURCE
The connection to the gas sources is found on the rear of the case.
On the ventilator's case, the corresponding Air and Oxygen (O2) inputs are indicated.
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Picture 13
AIR INPUT
Male connector DISS 3/4” –16
OXYGEN INPUT (O2)
Male connector DISS 9/16”-18
AT THE EDGE OF THE PRESSURE TUBES, THE CORRESPONDING FEMALE
CONNECTORS SHALL BE USED .
THE SCREWABLE CONNECTIONS USED IN THE GAS INPUTS ARE FOLLOWING THE
STANDARD CGA V5 WHICH ESTABLISHES THE RULES FOR MINIMAL EXIGIBLE
CONDITIONS FOR THIS TYPE OF CONNECTION.
THE AIR AND OXYGEN INPUTS ARE MANUFACTURED WITH VALVES THAT
PREVENT REVERSE FLOW OF GASES THROUGH THE INPUT PORTS AND THE GAS
CROSSFLOW.
INPUT PRESSURE
250 – 700 kPa (2,5 to 7 bar)
250 – 700 kPa (2,5 to 7 bar)
60 L/min.
180 L/min.
AIR
OXYGEN (O2)
MINIMUM FLOW SUPPLY
MAXIMUM FLOW
DO NOT USE THE EQUIPMENT IN THE PRESENCE OF FLAMMABLE ANESTHETIC
GASES. THERE IS DANGER OF EXPLOSION AND/OR FIRE.
THE USE OF COMPRESSED, CLEAN AND DRY AIR AND OXYGEN IS A MUST IN
ORDER TO AVOID CONTAMINATION THAT AFFECTS THE OPERATION OF THE
EQUIPMENT.
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IN CASE OF FAILURE IN ONE OF THE GAS SUPPLY SOURCES (AIR OR O2) THE
EQUIPMENT CONTINUES OPERATING WITH THE REMAINING GAS SOURCE (AIR OR
O2).
THE LUNG VENTILATOR LEISTUNG LUFT 3 SUPPORTS INPUT PRESSURE UP TO
1000 KPA (10,2 BAR), IT IS NOT NECESSARY TO USE EXTERNAL REGULATING
VALVES UNTIL THIS PRESSURE.
BREATHING CIRCUIT
Use the breathing circuit according to your need: Adult, Pediatric or Neonatal. The difference is in the
diameter of the tubes, which interferes in the resistance of the breathing circuit. On the front of the
equipment there are connections for:
- Exhalation Valve
- Breathing Circuit
- Proximal Sensor
- Nebulizer
- Capnograph
- Connector
Picture 14
ON RESPIRATORY CIRCUITS WHICH CONTAIN WATER TRAPS ON THEIR
BRANCHES (INSPIRATORY/EXPIRATORY), VERIFY THEIR HERMETICITY TO
PREVENT LOSS OF VOLUME IN THE CIRCUIT.
WHEN THE CALIBRATION OF THE PATIENT LINE IS PERFORMED, THE NEBULIZER
SHALL NOT BE CONNECTED ON IT.
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VERIFY THE CORRECT POSITION OF THE EXHALATION VALVE'S DIAPHRAGM.
CHECK CHAPTER 6 – exhalation valve, patient CIRCUIT and proximal .
FOR EFFECT OF THE STANDARD NBR IEC 60601-1, THE PATIENT CIRCUIT
IS CONSIDERED APPLIED PART, TYPE B.
THE CONNECTORS OF THE PATIENT CIRCUIT ARE CONICAL TYPES 22mm IN
ADULT AND 15mm IN NEONATAL AND THEY ARE IN ACCORDANCE WITH THE
STANDARD ISO 5356-1 (NBR13475), WHICH DETERMINES THE MIMIMAL EXIGIBLE
CONDITIONS FOR THIS KIND OF CONNECTORS.
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ARTICULATED ARM ASSEMBLY
1- Hold the assembled articulated arm.
Picture 15
2- Position the arm over the support, located at the laterals of the
trolley. Screw the arm until it is firm.
Picture 16
3- Even with the arm fixed on the trolley, it can be easily turned for
either of the sides.
Picture 17
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CHAPTER 4 – INSTRUCTIONS, CONTROLS AND ALARMS
INSTRUCTIONS OF USE
When the equipment is turned on the initial page is displayed, where you can select the kind of patient
to ventilate, the gender, height, theoretical weight, ventilatory volume per kilogram and you can also
select the kind of patient interface and its dimensions.
Picture 18
SCREEN CALIBRATION
On the back part of the screen there is its calibration
panel. The panel contains five buttons, when the
monitor is turned on, a led light will remain lit.
To calibrate the screen press the key
indicated
on the rear panel, the screen will begin to calibrate
automatically.
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Picture 19
LUNG VENTILATOR
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By pressing the button
R 04-04(69)
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there are several functions of configuration, with the keys
to navigate through the functions and pressing the button
to enter and enable the functions. The button
to return and the button
turns the screen on and off.
It is possible to adjust the screen’s angle of view and rotation. To adjust the screen’s angle it’s
necessary to hold firmly the LCD monitor’s border and move the screen to the desired position, then
the screen will remain in that position. It is possible to adjust the LCD monitor on the vertical to adapt it
to the operator’s height, making the visualization clear and the handling of the touch screen practical
for people of any stature. It is also possible to adjust the monitor on the horizontal, with the rotation of
the z axis of the equipment.
TOUCH SCREEN CALIBRATION
In order to calibrate the Touch Screen, the equipment must be in its Initial Page (picture 18). Press the
button which is behind the equipment as indicated on the picture below:
Picture 20
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After pressing the Touch Screen calibration button and the equipment’s screen will turn black with a
yellow cross, press the center of the yellow cross and hold it until it turns green, as shown on the
picture below:
Picture 21
Touch again the center of the second yellow cross until its color turns green, as shown on the picture
below, as soon as the cross’ color changes to green, the screen will be calibrated and it will return to
the Initial Page (Picture 18).
Picture 22
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PATIENT PARAMETERS
The selection of the kind of patient influences
the options of ventilatory modes and the
values of the initial working parameters.
Once the patient is selected (adult, pediatric
and neonatal), this choice will be marked with
the blue color, according to
the pictures (Picture 23,
Picture 24 and Picture 25),
and everything else will be
on the grey color, the same
happens with the choice of
Picture 24
Picture 23
the patient's gender. In case it is needed to
change the parameters, you shall select the
new option. This will automatically cancel the
previous selection.
The Height, Weight and Volume are
adjusted with the keys Up-Down, located in
the same field selected. When Adult is
selected, it is needed to inform the height
and the ventilatory volume per kg. The
equipment will calculate the theoretical
weight. In case of Pediatric or Neonatal
patients, it is needed to inform the weight
Picture 25
and ventilatory volume of the latter.
CIRCUIT
When selected Tube or Cannula, it will activate
the diameter configuration of the same, in case of
selecting Mask, it becomes selectable directly
between Active or Passive humidification. The
equipment will automatically compensate the kind
of circuit used accordingly to the selected
configuration.
Picture 6
SELF-TEST
Once the Patient and the Circuit information are set, the patient circuit
must be installed on its proper connections (as it is shown on Picture 14).
Picture 27
The Y connector's output shall be blocked and the Initial Page's green
color button “Start Test” shall be pressed (Picture 27). The equipment will perform a test on the patient
circuit, verifying if there is any leakage. The wrong obstruction of the output may cause the equipment
to warn about leakages on the system. During the initial self-test the equipment will read the patient
circuit’s compliance, this value is informed on the screen and automatically compensated.
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Check if the Exhalation Valve (Picture ) is correctly assembled, with its transparent membrane intact,
and check if the sensor is not inverted, otherwise the equipment will not be able to make the flow
readings.
In case there is any circuit leakage during the self-test, the equipment will display on the screen a
message “ The equipment presented leakage bigger than 4 L/min at 60 cmH2O”. It is extremely
important not to have any leakage in the patient circuit in order to make the equipment work correctly .
During the test of the gases lines (Air and O2) the test should deliver a flow bigger than 100 L/min, In
case the pressure is out of the specified range, a warning will be displayed on the screen with the
message “Input pressure lower than 3,0 kg/cm²”.
During the line test the equipment will perform the calibration of the expiratory flow sensor, in case
there is any detection of failure the equipment will inform with 3 possible messages indicating the
specific failure or possible solution and will give the option of operating without the expiratory flow
sensor, if chosen not to use the expiratory flow sensor, the equipment will present on the screen only
the reading of inspired flow. “Error on the flow reading. Possible inversion of the exhalatory valve’s
hoses” indicating that the silicon hoses of the exhalation valves are inverted (Picture 85). The second
possible message will be “Erro on the flow reading. Check the exhalation valve” indicated that the
internal flow reading membrane (Picture 85) of the exhalation valve is damaged. The third indicates
“Error on the flow reading. Error value: 15, 35 or 80 L/min.” Indicating that the input flow is limited, not
reaching the value specified on the screen, the suggestion is to check the pressure and flow of the
gases network.
When the equipment’s circuit Compliance Test is finished, the screen display the values which will be
compensated by the equipment. After some time of use in a patient, some characteristics measured
during the initial circuit and peripherals test may have changed due to circumstances such as
temperature, humidity and stowage. As a consequence, it may be needed to run the command “Circuit
Test”. For this, it is not necessary to turn off the equipment. To access this command, go to “Menu,
Configurations, Change/Test the Circuit”. The variations on the circuit may be significant within the
first two operating hours, tending to establish soon afterwards.
In case a message is displayed on the screen asking for the preventive maintenance, the
corresponding icon will appear on the Icon Panel (Picture 30). You can carry on with the test by
pressing “Continue”.
WHEN THE PATIENT CIRCUIT IS CALIBRATED, THE NEBULIZER SHOULD NOT BE
CONNECTED.
IT IS RECOMMENDED TO RESPECT THE ESTIMATED HOURS FOR THE CONTROL
AND CALIBRATION OF THE EQUIPMENT'S INTERNAL ELEMENTS IN ORDER TO
ASSURE ITS CORRECT OPERATION FOR A PROPER VENTILATION AND TO AVOID
SEVERE FAILURES.
LAST PATIENT BUTTON
By pressing this key when you turn on the device, it will automatically
retrieve the configuration from the last patient, searching the
parameters stored on the equipment's internal memory.
Picture 28
SCREEN
Once the ventilator passes through the line test, the main page is displayed. The same is presented in
such a way that it allows the operator a quick localization of the information which the professional
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needs to see, enabling high operability. The screen is divided by sectors in distinct areas: Icon Panel,
Alarm Area, Dynamic Monitoring Area and Alarms Configuration, Information Area, Operative Area,
Adjustment Area, Graphics Area, Direct Access Panel and Menu with applications and configuration
options.
Picture 29
ICON PANEL
Initially, three icons are displayed on the panel, but more
can be displayed depending on the operation that is been
performed or due to a certain situation, for example, upon
the activation of an alarm.
Clock: Indicates the date and time when the equipment
was turned on and the current time.
Hand: Enables/Disables the Touch function from the
screen, thus changing the icon.
Plug/Battery: Indicated that the equipment is connected
on the power grid or on the battery, changing the icon on
the screen. The battery symbol is a bar proportional to the
Picture 30
battery charge which varies from 0 to 100%. The color of
the proportional bar changes accordingly to the charge level range, being green the safe level, yellow
is not recommended to initiate the transport without power supply and red to connect the equipment to
the power as soon as possible.
Volumetric Capnography: This icon indicates that the Volumetric Capnography function
is active. It enables the monitoring of the volumetric capnography curves, upon continuous
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visualization on the screen, registering the Carbon Dioxide (CO2) elimination in relation to the exhaled
volume.
Oximeter: This icon indicates that the Oximeter function is active, performing the reading
of the Heart Rate, SpO2 and also SpO2/FiO2.
Alarm: Indicates that new alarm notifications were triggered on the equipment. A list with
the alarm logs will be displayed if you touch that icon.
Configuration: This icon is displayed on the panel in case preventive maintenance is
needed.
Silence: This icon is displayed on the panel when the audio alarm is inhibited (check
CHAPTER 5 - ALARMS).
ALARMS AREA
On the top part of the screen, the alarm messages are displayed. According to its priority level, it will
display a Red message (HIGH PRIORITY ) or Yellow (LOW PRIORITY ALARM CONDITION ). Ver
CHAPTER 5 - ALARMS.
Picture 31
INFORMATION AREA
Picture 82
It is divided in 3 parts:
1. Operative area;
2. Kind of trigger;
3. Operative information.
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OPERATIVE AREA
In this area, it is indicated the ventilatory mode in which the equipment is working and the selected
kind of patient.
Picture 9
KIND OF TRIGGER
The kind of trigger is represented by three icons. The first one
indicates that the equipment is in Standby mode, the second one
indicates that the patient is breathing by him/herself and the third
one indicates that the patient is breathing through the ventilator.
Picture 34
OPERATIVE INFORMATION
Area where additional information is displayed, such as Theoretical Weight or Height of the Patient,
Interface Tube or Canulla and its dimensions, Active Humidification or Passive, Oxygen Cell Active or
Inactive, operative guide, etc. This information may vary according to the ventilatory mode and its
aplication in use. For example, some data can be visualized according to the picture below.
Picture 105
SELECTION CONTROLS
On the bottom right part of the screen, there is the Control Panel which allows you to increase or
decrease the adjustable functions of the equipment and confirm or cancel the modification on the
values.
“ACCEPT”
Picture 36
“DECREASE”
“CANCEL”
“INCREASE”
STANDBY MODE
Picture 11
In order to access the Standby mode, just press its icon. This mode keeps the
equipment in sleep mode and with the alarms function disabled, until it is
reconnected to the patient, without losing the operative parameters.
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AIRWAY PRESSURE BAR (BARGRAPH)
At the right of the monitoring area, there is a vertical bar in white color which indicates the
Pressure in the Airway. On its left, in red, it's the configured values of the alarms for Maximum
and Minimum Pressure.
DYNAMIC MONITORING AREA AND ALARMS
The parameters resulted from the ventilation can be monitored on
two numeric columns on the left side of the screen. The column on
the left shows the parameters that have an alarm .
- Maximum and Minimum Pressure
- Maximum and Minimum Tidal Volume
- Maximum Frequency
- Maximum and Minimum Minute Volume
- FiO2
- Ventilation Level
In red, in a smaller size, there are indicators of the maximum and
minimum values set to trigger the alarms.
Picture 12
In order to adjust them, you need to touch the value you wish
to change and press “+” or “-”, according to your
needs, and then press the keys to “Confirm” or
“Cancel” this selection.
The value of the Tidal Volume (V.Tidal) informed on
the screen corresponds to the value measured by the Picture 40
expired volume sensor during the patient's expiration.
When the ventilator works without the Tidal Volume sensor, this value is
Picture 39
informed in RED because it refers to the value delivered by the ventilator
during the inspiration, instead of the value measured during expiration. Below the Tidal Volume is
presented the Ventilation Level that indicates to the operator the tidal volume in relation to the
theoretical weight expressed in mL/Kg and updated cycle by cycle.
At the column on the right, there are parameters which do not have an alarm. On this panel, there are
six movable buttons colored in a light grey color and an arrow in black color to the left. They move
themselves when you press that arrow.
GRAPHICS AREA
In the graphics area, up to 5 curves can be seen:
Curve of Pressure – Time: The Pressure – Time graphic shows the changes produced on the airway
pressure. The pressure is represented in centimeters of water column (cmH2O) and the time is
expressed in seconds (s).
Curve of Flow – Time: The Flow – Time graphic shows the gradual changes produced on the
inspiratory flow. The flow is represented in liters per minute (L/min.) and the time is expressed in
seconds (s).
Curve of Volume – Time: The Volume – Time graphic shows the gradual changes of delivered
volume to the patient. The volume is expressed by liters (L) and time by seconds (s).
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Curve of Volume – Pressure: Besides the information about the volume, pressure and compliance,
it's possible to indicate the PEEP need or its increase, when the ventilation has to designate an
important part of the generated pressure and the volume to obtain a recruitment and opening of the
airway. The pressure is represented in centimeters of water column (cmH2O) and the pressure is
expressed in liters (L).
Curve of Flow – Volume: With these loops it's diagnosed the flow obstruction standards, showing up
as a depression. If we see it during the expiratory phase, we have an expiratory obstruction; if we see
it during both phases, the obstruction is inspiratory and expiratory. The flow is represented in liter per
minute (L/min.) and the volume is expressed in liters (L).
ÁDJUSTMENT AREA
Picture 41
At the lower part of the screen there are the parameters programmable by the operator. To modify
them, you must press over the icon of the desired parameter, to change the values you must press
“+” or “-” on the selection control panel and afterwards “confirm” or “cancel” it. Note that when a
function is selected it changes its color according to the picture below and when the values are
changed the blue bar increases or decreases its height accordingly.
Picture 42
WAVEFORMS
The flow of a mechanical ventilator is quantified by the inspiration waveforms. These waveforms
demonstrate how the ventilator delivers air to the patient. In controlled modes the inspiratory phase is
identified by a graphic in blue color and the spontaneous modes are identified by a graphic in orange
color, for all modes the expiratory phase is identified by a graphic in white color. When the patient
performs an effort enough to trigger the equipment, this cycle is spontaneous, it has the orange color
and therefore the monitored parameters in this cycle are spontaneous, as for example, the respiration
frequency. The pattern of flow waveform may be changed on the VCV mode in order to suit the
ventilatory demand or the physical conditions of the patient's respiratory system. On the pressure
modes, you cannot change the waveform pattern (The flow is adjustment by equipment’s control
system based on the patient’s physical compliance and resistance characteristics). There are five
waveform patterns that may be used.
SQUARE FLOW WAVEFORM (CONTÍNUOUS)
With this adjustment, the flow accelerates fastly and reaches a flow value which
will be maintained during inspiration. The delivered flow will be constant and will
produce a volume waveform like an ascending ramp, and pressure curve will be
made of a stair step and an ascending ramp, the peak inspiratory pressure will
happen at the end of the inspiration. The value of the delivered flow will be
lower than the other flow waveforms shapes. Usually the value of the peak
pressure will be higher in this waveform than in comparison with the
Picture 43
descending and descending 50% waves, with exception to a patient with
elevated resistance. The value of the flow will be automatically calculated by the equipment according
the pro programmed volume and inspiratory time.
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DESCENDING RAMP 50% FLOW WAVEFORM
This waveform uses a fast flow acceleration followed by a slow deceleration.
This pattern may request higher flows to obtain the programmed value. This
waveform may be used to provide a better distribution of the inspired air. This
waveform promotes a reduction of the inspiratory pressure in patients with high
resistance when compared with the descending flow waveform.
Picture 14
DESCENDING RAMP FLOW WAVEFORM
This flow waveform uses a fast flow acceleration followed by a deceleration
until zero. This flow waveform may required much higher flows to obtain the
programmed value. This wave may be used to provide a better distribution of
the inspired air.
Picture 15
Picture 16
ASCENDING RAMP FLOW WAVEFORM
This waveform starts with a zero flow and increases linearly until it reaches a
peak value, followed by a fast cut of the flow.
In relation to this ascending ramp waveform pattern, the corresponding patterns
for pressure and volume are seen as an upward concave shape In relation to
this ascending ramp waveform pattern, the corresponding patterns for pressure
and volume are seen as an upward concave shape. The peak pressure value
will be the highest in this flow waveform.
SINUSOIDAL FLOW WAVEFORM (ROUND)
This kind of waveform accelerates the flow slowly to a maximum value at the
middle of the inspiratory time and reduced towards the end of the expiration.
The maximum airway pressure is reduced here. This wave can be used without
generating a high airway pressure as happens when using square flow
Picture 17
waveform.
SENSIBILITY
Sensibility is the threshold value that mus be reached by the patient to perform the
trigger of the inspiratory cycle, the measuring of the patient’s inspiratory efforts
and may be monitored through the reduction of the pressure or the variation of the
air flow which occurs during the patient’s effort to breathe. By touching the
sensibility icon it is possible to switch between trigger by pressure (cmH2O) or by
Picture 18
flow (L/min.) and also adjust the desired valued for triggering the equipment. On
the controlled ventilation modes, such as the VCV, PCV and PRVC, the sensibility acts to provide
gases to the patient in case the same makes an effort sufficient to trigger the next cycle.
DIRECT ACCESS AREA
This area includes the most frequent options of use, allowing an easy and quick access. To access
these options, just touch the desired icon. When the options are enabled (according to the operative
mode), the icons and letters will be displayed in dark blue color; when they are not enabled, they will
be displayed in white color and their icon will not be displayed.
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Nebulizer: When accessing this function, the
ventilator will request you for the programming of
time of operation, once established, the the
oxygen output flow is activated synchronized with
the inspiration. It is informed, in green, the
programmed time and in red the total time of
operation. This output is automatically deactivated
once the time set by the operator is reached, or
manually by repeating the process and choosing
the time 0 s.
Picture 50
Oxygen: The goal is to simplify the handling of
the equipment during the procedures on the
airway and/or alveoli recruitment maneuvers
sebsequent to a depressurization, besides
facilitating the initial ventilation of the patient when
the same enters the unit until his/her clinical and
semiological evaluation. (The maximum FiO2
alarm shall be turned off, as explained on the
CHAPTER 5 - ALARMS). By pressing the button
100% Oxygen, it starts a sequence to ventilate
the patient with pure oxygen, where the operator Picture 19
can choose between 1 up to 20 minutes. As soon as the time is selected,
the ventilator will display on the message area, in green the time elapsed
since when this modality was turned on and in red the remaining time until
its completion.
Picture 49
The disconnection of the ventilator can be done without modifying the equipment's operation and by
silencing all the alarms automatically for 30 seconds. Changes in ventilatory parameters and the base
pressure (PEEP), always respecting the ventilatory mode in which the procedure has started, are
allowed. Once the selected time is completed, the equipment will return to the fraction of inspired
oxygen used before starting this function. To manually abort this procedure, the operator will have to
access again the option 100% Oxygen and select the time 0 (zero).
Manual Trigger: It starts the ventilatory cycle at the moment the user
wants. It is used to increase the level of manual ventilation. Its use will
change the resulting Respiratory Frequency and consequently the I:E ratio
(for maneuvers of oxygenation for suction with synchronized system). The
manual trigger will only be allowed by the equipment after the end of the
exhalation of the patient, avoiding the double cycle and the increase of the
inspiratory pressure.).
Inspiratory Pause: The inspiratory pause is a
prolongation of the programmed inspiratory time
(from 0.10 up to 2s), during which the exhalation
Picture 52
valve remains closed, the pressure remains
constant and the flow is zero. It is available on the VCV mode, because on
the PCV mode, when there is a time cycled variable, the same function can
be obtained with the prolongation of the inspiratory time. Once the pause is
established, the ventilator informs (in the functions area) the resulting
Inspiratory Pause and the resulting Plateau Pressure. To activate the manual
pause press and maintain pressed the button during the desired time, the
equipment will perform the manual inspiratory pause. Similarly for the Picture 53
manual expiratory pause.
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Expiratory Sensibility: On the PSV mode and the combined modes which
includes Support Pressure, it's possible to adjust the value of the flow which
generates the change from the inspiratory phase to the expiratory phase
(cycled). It is expressed in percentage of the inspired peak flow's value and
may be adjusted between 5% and 80%. The flow has a descending wave
shape, the ventilator cycles when the selected threshold is crossed by the
flow. A smaller expiratory sensibility value will cause the increment of the
inspiratory time. A low expiratory sensibility may difficult the cycling in case
leakages in the patient circuit happen due to the fact that the leakage can be
bigger than the selected threshold.
Picture 54
Graphics Freeze: It freezes the graphics
displayed on the screen, showing the grid with vertical and horizontal
dashed cursors, making it easier to read the curve values, keeping active
the patient monitoring using the output values and the Airway pressure bar.
To unfreeze press the key again.
Detect
Capnography:
Pressing
“Detect
Capnography” after connecting the sensor will
make the equipment identify that the sensor is
connected and the symbol will change to
Picture 55
“Volumetric Capnography”.
Picture 56
Volumetric Capnography: It is the graphic record, easy and non-invasive
of the CO2 concentration on the gas that is exhaled during the ventilatory
cycle. This record can be done according to the partial CO2 pressure
exhaled at the end of the expiration (ETCO2), which will be influenced by
the following factors:
1- Metabolic CO2 production;
2- The transportation performed by pulmonary perfusion;
3- The elimination by pulmonary ventilation.
Measurement is performed by using a capnograph which utilizes infrared spectrograph in a line
arrangement or “MAIN-STREAM”. The use of this parameter is very broad, as it allows to estimate the
level of ventilation, detection of asynchrony, correct placement of the endotracheal tube, etc. The
measurement of the level of ETCO2 related to the exhaled volume by the patient gives origin to the
volumetric capnography, which will allow to establish other variables such as dead anatomic space,
dead alveolar space and effective ventilation level.
Maximum Inspiratory Time: The change from the inspiratory to the expiratory phase can also occur
when the inspiratory time exceeds the value programmed by the operator in T. Ins. Max.
MAIN MENU AREA
By pressing the word “Menu", the screen will slide to the MAIN MENU, where there are 6 options. The
wanted option shall be pressed, after 10 seconds the menu will be hidden.
VENTILATORY MODES
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-VCV
-PCV
-PSV/CPAP
-SIMV(VCV)+PSV
-SIMV(PCV)+PSV
-PRVC
-NIV
-MMV+PSV
-PSV+ASSURED VT
-BIPHASIC
LUNG MECHANICS
-AutoPEEP
-Compliance - Resistance
-Low Flow PV Curve
-Slow Vital Capacity
-P0.1
-Tobin Index
-Stress Index
GRAPHICS
Picture 20
-From 1 to 5 curves
-Scale/Time
REMOTE MONITORING
-Alarms Log
-Trends
-Lung Mechanics
-Patient Circuit Compliance
FUNCTIONAL SETUP
-PEEP Alarm
-Sighs
-TGI
-Circuit Change/Test
OPERATIVE SETUP
-Maintenance
-Language
-Altitude Compensation
-Date/Time
-Sound Level
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VENTILATORY MODES
By selecting a ventilatory mode, the
operator is determining what kind of
variable he wants to control during
the inspiration. Access the “Menu
of Ventilatory Modes”, where the
desired mode is selected (pressing
“…next” allows the visualization of
the remaining ventilatory modes)
and the selection is confirmed,
displaying on the screen the
selected parameters, curves and
resulting values. All the modes
available on the equipment (AdultPediatric-Neonatal) have a pre-set
configuration from the factory: these
configurations are average values
and must be adjusted by the
physician
to
become
values
appropriated for each patient. The
ventilator does not interrupt its
operation during the change from
one mode to another.
The ventilatory modes are divided in
basic modes and integrated modes;
in the first group, it is included the
ventilation modes controlled by
pressure and support pressure. In Picture 60
Picture 59
Picture 61
these modes, you can control only
one variable continuously while in the integrated modes, although controlling one variable at a time,
you can change the kind of control according to the characteristics of the patient's ventilation.
The inspiratory flow can be adjusted directly or indirectly by the user, through the configuration of
ventilatory variables such as volume, inspiratory time, I:E ratio, flow waveform or directly by the flow
itself, depending on the ventilatory mode. When the flow is adjusted indirectly, by adjusting the
variables previously mentioned, the resultant of this flow is equated by the equipment and informed on
the screen in blue color. On the ventilatory modes with pressure control where the flow is equated and
directly controlled by the equipment based on the compliance and resistance conditions of the patient,
the operator may perform an adjustment on the peak flow, adjusting the control variable “Rise Time”.
The expiratory flow is adjustable for each kind of patient (adult, pediatric and neonatal). It is
automatically adjusted for leakage compensation by the user or to adjust the PEEP value which will
influence on the expiratory resistance.
VOLUME CONTROLLED VENTILATION – (VCV)
In this mode, the ventilator controls the volume delivered to the patient, integrating the air volume and
the inspiratory time selected by the operator, i.e., it behaves like a flow controller cycling per volume.
The inspiratory flow is adjustable and indicated in blue color during the adjustment of volume or
inspiratory time. Therefore, to perform changes on the flow speed, you shall modify the tidal volume or
the inspiratory time, or even both of them together, according to the necessary ventilation.
When controlling the flow, it is possible to choose among constant flow waveforms, descending
waveforms, sinusoidal or ascending, being then possible to observe the consequent modifications on
the peak flow and the morphology of the curves of Pressure – Time and Flow – Time.
The resulting pressure is the free variable, which will be determined based on the physical and
mechanical conditions of the respiratory system. The inspiratory cycle trigger can be time, flow or
pressure because it is an assisted-controlled mode.
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PRESSURE CONTROLLED VENTILATION – (PCV)
In this mode the ventilator will positively pressurize the patient's respiratory system during the
inspiratory time programmed by the operator. To obtain it, once the established pressure level is
reached, it will start a deceleration on the speed of the flow. This deceleration is the consequence of
the respiratory system's physical condition and is not controlled by the ventilator. It is therefore a
pressure controlled mode and cycled by time, being possible for the operator to manually change the
peak flow or the “Rise Time”. The resulting tidal volume is the free variable and consequently this kind
of ventilation requires an increased pathophysiological analysis of the patient, whom shall be
permanently monitored by trained staff, as well as a correct programming of the volume alarms.
The beginning of the ventilatory cycle can occur by time, flow or pressure because it is an assistedcontrolled mode. As the inspiratory flow is resulting from the equipment's programming and from the
physical conditions of the respiratory system, the produced flow waveform is invariably decelerated,
observing variations on the flow's speed by the end of an inspiration, i.e. the inspiration can be
finished without the flow reaching the zero value; reaching the zero value coincided with the end of the
inspiration or before that.
SUPPORT PRESSURE VENTILATION OR CONTINUOUS POSITIVE AIRWAY
PRESSURE – (PSV/CPAP)
It is a mode developed to adapt the ventilator to the spontaneous ventilation of the patient, being the
level of pressure exchange over the base pressure the only control variable that must be programmed.
Because it is a mode controlled by the patient, the flow speed will adapt not only to the physical
conditions of the system, but also to the inspiration and exhalation efforts of the patient, respecting the
established pressure level. Due to this, it is defined as a spontaneous mode, assisted by the flow and
limited by the pressure.
As a spontaneous mode, the beginning of the inspiration will only happen upon detection of a signal of
flow or pressure generated by the patient, finishing as standard when the flow speed slows to 25% of
the initial speed. This value can be changed by the operator in about (percentages 80, 75, 70, 65, 60,
55, 50, 45, 40, 35, 30, 25, 20, 15, 10, 5) to adjust the end of the inspiration with the conditions and/or
needs of the patient. As safety parameters, it is stipulated a criterion of maximum inspiratory time
(adjustable) and a criterion of pressure (5 cmH2O over the maximum programmed pressure) which, in
case of detection, will make the equipment pass to the exhalation phase.
Once the control variable is the pressure level and the free variable is the volume, it is worth reminding
that (in constant physical conditions) the latter will be proportional to the patient's inspiratory effort and
the programmed support pressure.
In case of programming 0 (zero) support pressure, pressure changes will not happen over the
established base, therefore you will get a level of continuous positive airway pressure (CPAP), being
the main difference in relation to the PSV the fact that the volume exchange during the inspiration will
depend only on the patient, as the same will not receive any flow assistance. “To adjust this mode, the
back-up ventilation shall be previously programmed”.
SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION BY VOLUME
WITH SUPPORT PRESSURE – SIMV (VCV)+PSV
It is a ventilatory alternative which with you can start the weaning from the mechanical ventilation, its
function is to lower the quantity of the ventilator's mandatory ventilations in order to have the patient
spontaneously ventilate in each cycle, synchronizing the beginning of the mandatory cycle with the
patient's inspiration effort. The mandatory ventilations will be controlled by volume (SIMV/VCV),
reminding you that the function of the mandatory ventilations are of assuring a level of ventilation and
oxygenation, avoiding any ventilatory contingence.
One of the historical disadvantages of this mode was the muscular fatigue produced by the patient
having to spontaneously breathe without any kind of assistance, so that nowadays this ventilation is
assisted with support pressure (PSV).
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SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION WITH SUPPORT
PRESSURE – SIMV (PCV)+PSV
It allows spontaneous ventilations with support pressure and mandatory ventilations by controlled
pressure, resulting in a descending flow and always respecting the inspiratory time and the frequency
programmed by the operator.
The support pressure and the controlled pressure are different on the fact that the support pressure
finishes when it reaches the minimum patient flow (adjustable through the exhalation sensibility) and
the controlled pressure is limited to the inspiratory time programmed by the operator.
PRESSURE REGULATED WITH VOLUME CONTROLLED – (PRVC)
It is an Assist/Control mode in which the operator must establish the desired tidal volume and the
maximum pressure control level. Once initiated, the ventilator will automatically change the level of
control pressure in order to assure the volume requested by the user. The main advantage of this
mode is that you can assure the tidal volume with lower pressure level.
NON-INVASIVE VENTILATION (NIV)
This ventilatory mode gives the operator the possibility to ventilate the patient without invading his
airway. The operational functioning is similar to the support pressure mode, with the following
differences:
- In case of leakage, there is compensation (up to 50 L/min) without producing self-triggering .
- It is possible for the operator to manually establish the time limit variable in order to get a better
expiratory synchrony.
MANDATORY MINUTE VENTILATION WITH PRESSURE – (MMV+PSV)
In this mode, the ventilators works operationally as in the support pressure mode, with the difference
that the operator establishes a minimum minute volume which shall ventilate the patient, in case he
doesn't reach this value, the ventilator will increase the support pressure in order to increase the
ventilation and reach the desired value.
BIPHASIC PRESSURE VENTILATION – (BIPHASIC)
On the mode Biphasic Pressure, there are two levels of pressure in the airways, which are switching
between themselves, and the patient can breathe spontaneously with an independent support
pressure level. It is equivalent to a Support Pressure + PEEP mode, however with two PEEP values, a
high one and a low one which go switching according to an established time for each one.
PRESSURE SUPPORT VENTILATION WITH ASSURED TIDAL VOLUME –
(PSV+VT)
To use this mode, the operator shall set a tidal volume, which will be established as a minimum value
for each patient's inspiration. With this ventilation mode, once the patient initiates the inspiration, the
ventilator will control the pressure through the flow assist (PS), however, in case it is reached the flow
value in which the exhalation phase should pass and the desired volume was not reached yet, it will
behave as a flow controller until it insufflates the establish air quantity set by the operator.
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NEONATAL VENTILATORY MODES
It contains the ventilatory modes VCV, PCV, PSV, PSV/CPAP, Nasal CPAP, SIMV, Continuous Flow
and HFNC. The modes (VCV, PCV, PSV, SIMV and HFNC) conceptually work in the same way as on
the adult and pediatric categories and the operator shall adapt the programmed values to the category
of patient which is being ventilated. In neonatal the guaranteed volume is performed by the ventilatory
mode VCV, where the lung volume in each cycle is controlled and guaranteed by the equipment
according to the programming of the operator.
CONTINUOUS FLOW
In this operative mode, the operator shall establish the flow speed, the inspiratory pressure limit (P
CONT), the inspiratory time and the respiratory frequency. Once establishes all these values, the
equipment will deliver flow at a fixed speed, closing totally or partially the active exhalation valve (to
avoid surpassing the programmed pressure) during the inspiratory time established by the operator.
During this mode the equipment has the possibility of performing a measurement of the delivered tidal
volume only when the neonatal proximal flow sensor is connected. This ventilatory mode is also
known as TCPL (Time Controlled with Pressure Limit).
NASAL CPAP
This mode allows the user to establish the CPAP level and connect it to the patient through a nasal
cannula. The ventilator will compensate the leakage, keeping the pressure level established and
allowing the spontaneous ventilation of the patient.
HFNC – HIGH FLOW NASAL CANNULA
This mode allows the user to establish the flow level and the concentration of inspired O2 through the
adjustment of the FiO2 connecting the patient through a nasal cannula. The ventilator will compensate
the leakages, maintainin the level of flow and FiO 2 established and allowing the patient’s spontaneous
ventilation.
BACKUP VENTILATION
In case one wishes to visualize the configured parameters in Back Up ventilation during the patient's
ventilation, he shall enter the “Menu”, “Ventilatory Modes”, by selecting the current mode the
backup ventilation window will automatically open with the configured parameters.
The goal of the backup ventilation is to ensure the patient’s ventilation during a spontaneous
ventilatory mode in case of a prolonged apnea or any eventuality which difficults the equipment from
recognizing the patient’s inspiratory effort. The backup ventilation is available in all ventilatory modes.
I.e., in all the ventilatory modes the lung ventilator will send controlled ventilatory cycles in case the
patient does not perform efforts which trigger the inspiratory sensibility, maintaining the oxygenation of
the patient.
In spontaneous ventilatory modes its programming is extremely important, since once the patient does
not perform efforts, the equipment will respect the programmed time and configuration, delivering the
backup ventilation (support). The parameters to adjust are:
Ventilatory Modes: As default, the equipment proposes a mode controlled by volume, however the
operator can choose for a ventilation mode controlled by pressure.
Apnea Time: The maximum tolerable time by the ventilator without the patient starting an inspiration,
once this time is elapsed, the equipment will send a sound and light alarm, ventilating the patient in a
mode which is controlled, determined and programmed by the operator.
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Phase variables time and cycling: Ti, Fr, Vol. or Pres.
The peep level continues being the one programmed in advance by the time the apnea occurred.
For the equipment to operate in the desired spontaneous mode, the operator will have to “confirm”
the backup ventilation from the Control Panel.
If the selected mode is PSV/CPAP, NIV, (MMV)+PSV, (PSV + Assured VT), Nasal CPAP, Biphasic,
will show the window for “Backup Ventilation”, where the programming is mandatory To confirm the
programming the operator must press the key “confirm”.
If the selected mode is SIMV(VCV)+PSV, SIMV(PCV)+PSV, (Biphasic), the ventilator will give the
operator the possibility of using the backup ventilation; for this, it must be “confirmed” or “canceled”
on the Control Panel. The ventilator will automatically leave this mode in case the patient recovers his
spontaneous ventilation
In the controlled modes such as VCV, PCV and PRVC the backup ventilation is adjusted by the
respiratory frequency in which the patient’s minimum respiratory frequency is determined, in case the
patient has spontaneous responses and surpasses the inspiratory sensibility threshold, the respiratory
frequency will be higher than programmed, but it will never be less than the programmed backup
frequency.
LUNG MECHANICS
It is accessed from the “Main Menu”. The
equipment cannot be in Standby mode because
there will be no access to the icon.
AutoPEEP: The function is defined as the
persistence of a positive alveolar pressure at the end
of the expiration, not intentional, due to the presence
of a pulmonary expiratory volume higher than the
residual functional capacity foreseen. It occurs in
patients undergoing mechanical ventilation as a
consequence of initiating an inspiratory phase with
positive pressure, before the exhalation time was
sufficient for the complete exhalation of the
previously inspired volume. The result of this
phenomenon is a progressive increase in the
pulmonary volume and pleural pressure with each
breath.
The function is not evident, being possible to change
sharply the alveolar dynamics and constitute a
recognized risk in situations that affect the flow
during the expiration, leading to an unnecessary
increase of the respiratory system’s mechanical
work.
To perform the measurement of the AutoPEEP
Picture 62
function, press “Menu, Lung Mechanics” and Picture 63
“AutoPEEP”. When you select the icon the
measurement of the function's value starts, where the ventilator will perform an exhalation pause up to
2.0 seconds with the exhalation valve closed in three consecutive cycles, and then showing on the
graphical display the residual PEEP value that stays on the lung by the end of the expiration cycle.
The results will be informed on the area D (functions area) during 30s, as on the picture below.
Picture 64
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Compliance and Resistance: The compliance of the respiratory system is defined as the variation of
volume per unit of pressure change. The function explores the thoracic lung distensibility and the
airway resistance through the relation of the values obtained of the Peak Pressure, Plateau, PEEP
and Tidal Volume.
For the static compliance, the volume variations refer to the static plateau pressure, and for the
dynamic compliance the volume variation refers to the peak inspiratory flow. The dynamic mechanical
properties relates to the situations in which the flow varies over the time, while the static properties
highlights the absence of flow.
In order to access the function “Compliance and Resistance”, press “Menu, Lung Mechanics” and
“Compliance and Resistance”, as soon as a new lateral window opens, put the “V.Tidal” value,
then “confirm” and press “Start”. The values will appear as on the picture below.
Picture 65
PV Curve with Low Flow: The ventilator will measure the lower and upper inflection points of the
pressure curve per time through continuous insufflation of constant flows using low flow. To request
the measurement of inflection points, the “Low Flow PV Curve” must be selected on “Menu, Lung
Mechanic”. This feature prompts the operator to establish the Maximum Tidal Volume, Maximum
Pressure and Flow which shall insufflate the patient's lungs during the maneuver. After placing the
requested values, press the key “confirm”, the equipment will perform a prolonged expiration, leading
the pressure from the base value to zero, so that afterwards it insufflates the air on the pre-determined
flow until it reaches the established pressure and/or volume value. This way, it eliminates the resistive
components from the airway, thus allowing the equipment to automatically establish the lower and
upper inflection points which will be displayed on the screen as graphical forms.
Slow Vital Capacity: The Vital Capacity is the maximum volume that can be exhaled after the
maximum inspiration. The tool provides the maximum lung capacity through slow inspirations of the
patient. To use this tool you must select “Menu, Lung Mechanic”, “Low Vital Capacity” and the
equipment will display on the upper quadrant the values of CRV current (tidal) and CRV best,
displaying the values in Liters.
P0.1: The function P0.1 is a parameter used during the process of weaning from the mechanical
ventilation and is defined as the airway occlusion pressure in during the first 100ms of the inspiration.
To use this tool you must select “Menu, Lung Mechanic”, “P0.1” and the equipment will show the
values on the upper quadrant of the screen.
According to the III Brazilian Consensus on Mechanical Ventilation (2007), P0.1 values greater than 6
cmH2O predict weaning failure.
Tobin Index (RSBI): The Tobin Index or RSBI (Rapid Shallow Breathing Index) is measured by the
relation between the respiratory frequency and the tidal volume. In order to use this tool, the ventilator
must be in Assisted Mode with maximum PEEP of 5 cmH2O and Support Pressure between 8 cmH2O
and 10 cmH2O. After adjusting these parameters, select the option “Tobin Index” on the “Menu,
Lung Mechanics” and the equipment will display the measured value on the upper quadrant of the
screen.
According to the III Brazilian Consensus on Mechanical Ventilation (2007), Tobin Index values greater
than 104 cpm/L predict weaning failure.
TOBIN INDEX'S VALUE MAY BE AFFECTED BY FACTORS SUCH AS: PEEP VALUE
AND SUPPORT PRESSURE HIGHER THAN THE ONES DETERMINED BY THE
MANUFACTURER.
Stress Index: By selecting this option, the ventilator will establish a constant flow wave until delivering
the Tidal Volume selected by the operator. Soon it will perform an analysis of the growing pendent of
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the Pressure – Time curve, establishing n as the “Optimal Level of Distensibility”, which will allow the
user to know the lung distensibility level by the following way:
- n smaller than 1: The lung can continue increasing its volume.
- n bigger than 1: The lung is over distended.
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GRAPHICS
In order to access the graphics menu, select “Menu,
Graphics” and a screen will appear indicating the number of
graphics to be displayed on the equipment's screen.
The graphics are presented with color differentiation between
the inspiratory and the expiratory phase. In inspiratory phase
the equipment-controlled trigger cycles are showed in blue color
and the spontaneous trigger cycles are presented in orange
color, the expiratory phase is always in white color.
One Curve:
Picture 68
Two Curves:
Picture 66
Picture 67
Picture 69
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Four Curvas:
Picture 71
Five Curves:
Picture 70
Picture 72
Scale/Time:
Through this option, the operator is able to indirectly select the number of
ventilatory cycles which will be displayed on the ventilator's screen, being its
main utility the better visualization and interpretation of the graphics displayed
by the ventilator.
In case one wishes to change one of the graphics, or even select another
function, pressing any curve on the screen will show another screen as on the
picture aside which will allow you to change the selected curve or to select
another function which is displayed there. When the Capnography is enabled,
the function “CO2 Time” will be displayed in blue color.
Picture 73
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REMOTE MONITORING
Within the option Remote Monitoring it is possible to select
the options:
Alarms Log: It will display a list with the events and alarms that were
produced since the moment the equipment was turned on, where it
shows the time, date and the kind of event or alarm that is activated
and its priority level. It shows initially the 5 first events, as on the
picture below. After turning off the equipment this log remains
stored in the memory and may be consulted when restarting
the lung ventilator.
Picture 76
Trends: By accessing the option Trends, it is displayed in a graphic
the stored variables according to the availability on the equipment.
By pressing over the desired function, a window will open where the
equipment provides 4 options of visualization: 8, 16, 24 or 72 hours.
The vertical scale is automatically acomodated by the ventilator and
cnanot be modified by the user. The measured variables are
displayed in while color, while the red line shows the time during
which the ventilator remained in Stanby.
Picture 74
Picture 75
Lung Mechanics: On this window are presented numerical trends, showing the measured
values of the last lung mechanics reading performed, having as goal to provide the operator
with reference data, before performing a new exploration of the respiratory system.
Circuit compliance value: Displays the compliance value measured during
the initial line test or during the last circuit test.
FUNCTIONAL SETUP
PEEP Alarm: In this option it is possible to change the values of the PEEP
alarm. The operator can choose to work within the limits of 2, 4, 6, 8 and 10
cm/H2O.
THE ALARM WILL BE TRIGGERED WHENEVER THE
PRESSURE IS BELOW OR ABOVE THE FIXED VALUE
FOR PEEP, BEING ITS ACTIVATION IMMEDIATELY OR
THROUGH PRIORITY, HAVING AS A MAXIMUM TIME 5
SECONDS.
TGI (Intratracheal Gas Insufflation): Once this option is selected, the
ventilator will send a flow of 6 L/m during the expiratory phase through the
same output used by the nebulizer, without a time limit. The pure oxygen
flow used may change the gas mixture which is provided to the patient. This
variation can be lowered by adjusting the FiO2 value.
Sighs: The option Sighs allow you to program:
 Sighs/Cycle (Sigh Quantity): the quantity of consecutive sighs (from
1 to 3) which happened in each cycle.
Picture 76

Cycles/Hour: the quantity of times (5, 10, 15, 20) in which the sigh
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Picture 78
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cycle will repeat in an hour.
 V. Tidal: enters the value of additional volume (the same will be added to the already
programmed volume) which will be delivered by the ventilator with each sigh.
Change/Test of Circuit: It allows to repeat the Circuit Tests without the need to restart the ventilator
when you change some component of the patient/ventilator interface, or when there are doubts about
the hermeticity of the circuit.
OPERATIVE SETUP
Maintenance: In this option it's visualized the software version, the hours
of use of the ventilator, as well as the corresponding hours to do the
maintenances.
THE MANUFACTURER RECOMMENDS TO RESPECT
THE PREDICTED HOURS FOR THE CONTROL AND
CALIBRATION OF THE EQUIPMENT'S INTERNAL
ELEMENTS IN ORDER TO ENSURE ITS CORRECT
OPERATION FOR A PROPER VENTILATION OF THE
PATIENT AND THE PREVENTION OF SERIOUS
FAILURE. (CHECK ANNEX 2 – PREVENTIVE
MAINTENANCE).
Language: In this option the operator can select in which language he
wants the equipment. There are three options: Portuguese, English and
Spanish.
IT IS IMPORTANT TO REMIND THAT, IN ORDER TO
PERFORM THE LANGUAGE CHANGE ON THE
EQUIPMENT, THE OPERATOR NEEDS TO RESTART
THE MACHINE.
Picture 79
Altitude Compensation: In order to have a better accuracy on the
measurement of the flow and volume, the equipment performs a correction Picture 80
according to the height above sea level at the place of its operation. For
that, it is necessary to perform an altitude compensation. The adjustment is done in MASL (meters
above sea level). The compensation can be up to 6000 masl.
THE MANUFACTURER RECOMMENDS TO PERFORM THE
ALTITUDE ADJUSTMENT FOR THE CORRECT OPERATION OF THE
EQUIPMENT, IN CASE THAT IS NECESSARY.
Date/Time: In this function you can configure the options: Time (24h format), Minutes, Day, Month and
Year (two last numbers).
Sound Level: This function adjusts the equipment's sound volume in a 20 to 20 scale and the loudest
volume is 100.
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CHAPTER 5 - ALARMS
The alarms are used to watch the relation between the patient and the equipment, triggering when for
some reason it reaches values of risk for the patient. The purpose of this section is to define the
alarms categories, visual and auditory indicators and the urgency level of the operator's response.
ALARM AUDIO INHIBITION (SILENCE)
The operator will be able to momentarily silence the alarm, but always persisting the visual indication,
for that the operator shall touch the Alarm indication. Touching it once, it triggers the inhibition for 30
seconds; touching quickly twice it triggers the inhibition for 60 seconds; continuously holding it (for
longer than 2 seconds), it cancels the Audible Alarm inhibition.
Picture 81
For indication of the Alarm's Audio Inhibition, the picture below (a bell crossed by a dashed X, symbol
IEC 60417-5576) shows on the Icons Area (Picture 30), and it stays there for as long as the inhibition
persists.
If during this time a new or different condition of the alarm happens, it will be announced by eliminating
the previous silence condition.
The following description of the alarms is in sequence of Priority, from the Highest (Microprocessor) to
the Lowest (Maximum Minute Volume).
Adjustable Sound Level: This function adjusts the volume of the equipment's Audible Alarms in a
scale of 20 to 20 and the highest volume is 100. This function may be found at “Menu” in “Operative
Setup”.
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HIGH PRIORITY ALARM CONDITION
Picture 82
1 - MICROPROCESSOR
This alarm is activated if a critical failure happens, preventing the microprocessor of controlling the
equipment (inoperative ventilator). It lights a visual warning and triggers a continuous audible signal.
Simultaneously, all the gas supply valves are disconnected and the anti-suffocation valve is enabled,
which allows the environmental air input in the patient's circuit.
2 – LOW GAS SUPPLY PRESSURE
This alarm is activated if the pressure of any of the supply gases is below 2,5 kg./cm2.
This alarm is automatically canceled once the supply pressure is reestablished. It can't be manually
changed, however it can be silenced for 60 seconds through the SILENCE option.
3 – LOW BATTERY
This alarm is activated when the battery’s tension is lower than 10.8 V while the equipment is without
external power supply. In case a battery failure is identified and turns the battery inoperative this alarm
will be triggered.
This alarm cancels itself automatically when reestablishing the battery charge.
4 – MAXIMUM INSPIRATORY PRESSURE
This alarm is activated if the airway pressure surpasses the value fixed on the Maximum Pressure
Limit control.
It triggers the sound and a light indication that indicates High Inspiratory Pressure, it is deactivated if
the cause that activated the alarm returns to values lower than the adjusted limit.
5 - INTERRUPTED CYCLE ALARM
Available only on the modes with pressure control (PCV, PS). It will be activated in case the inspiration
is interrupted by the Pressure Limit variable, indicating possible causes to the user, such as high rise
time or airway obstruction.
The pressure limit variable acts when the instantaneous pressure exceeds the programmed pressure
in 15 cmH2O, for a pre-determined initial period.
Its goal is to prevent hypoventilation or possible inadequacies of the equipment to the patient
6 - MINIMUM INSPIRATORY PRESSURE
This alarm is activated if, by the end of an inspiration, the pressure didn't reach the value fixed on the
Low Inspiratory Pressure control.
It activates the sound and the visual indication of Low Inspiratory Pressure. Once the alarm is
activated, by reestablishing the pressure it automatically deactivates the sound and the visual
indication on the screen.
It may indicate excessive leakage or disconnection of the patient line.
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LUNG VENTILATOR
LEISTUNG LUFT 3
R 04-04(69)
Rev. 06
7 – DISCONNECTION OF THE PATIENT CIRCUIT
This alarm is activated when the equipment cannot maintain the values of minimum pressure and
PEEP due to a disconnection of the patient circuit, activating the sound and light indication, by
connecting back the circuit and restablishing the pressure, the alarm is automatically deactivated.
8 – DISCONNECTION OF THE PROXIMAL FLOW SENSOR
Available on the modes where the proximal sensor is applicable, this alarm immediately indicates that
there is poor connection or disconnection between the connector of the proximal sensor and the
equipment, activating a sound indication and light indication on the screen. Once the proximal sensor
is connected again, the sound and screen indications are deactivated.
9 – HIGH PRESSURE OF SUPPLY GASES
This alarm is activated if the pressure of any of these supply gas inputs (air or oxygen) is higher than
7,0 kg/cm2.
This alarm cancels itself automatically when normalizing the supply pressures.
MEDIUM PRIORITY ALARM CONDITION
Picture 83
10 – MINIMUM FIO2
If upon mixing the O2 does not reach the minimum programmed value within the first 5 cycles, the
visual and audible alarms will be activated; they can be silenced during 5 ventilatory cycles while the
condition that generated it shall be fixed.
11 – MAXIMUM FIO2
It is triggered when the value of the FiO2 keeps above the value adjusted by the operator.
The maximum FiO2 alarm can be disabled. This allows the operation with O2 concentrations equal to
100%.
12 - APNEA ALARM
See apnea and back up ventilation.
The Apnea alarm is triggered if the time between two consecutive inspiratory efforts to trigger the
equipment is higher than the established apnea time. The equipment automatically changes to the
Backup Ventilation mode, until the patient's demand is reestablished or another ventilation mode is
selected.
It activates the intermittent sound and the intermittent red warning indicating Apnea. It can be silenced
through the Silence option.
If the cause of the alarm activation disappears, it will silence automatically.
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LUNG VENTILATOR
LEISTUNG LUFT 3
R 04-04(69)
Rev. 06
13 – MINIMUM TIDAL VOLUME
It establishes minimum admissible value of inspired tidal volume. If the resulting value of inspired tidal
volume maintains low for 3 ventilatory cycles, it activates the alarm with light, sound and messages on
the screen.
14 – MAXIMUM RESPIRATORY FREQUENCY
It activates if the resulting frequency is higher than the value established on the alarm.
When there is leakage or disconnection of the circuit, it may activate an auto-cycling, which triggers
the alarm.
15 – MINIMUM RESPIRATORY FREQUENCY
It is activated if the resulting frequency is lower than the established value on the alarm and higher
than the apnea gap time. In case the apnea gap time is exceeded, the apnea alarm will trigger and
the ventilator enter in backup ventilatory mode. This alarm is automatically cancelled with the retake of
the spontaneous respiratory frequency of the patient in a value superior to the alarm.
16 – POWER OUTAGE
This alarm is activated in case of a power outage while the equipment is on.
This alarm is automatically turned off when the power is reestablished .
LOW PRIORITY ALARM CONDITION
Picture 84
17 - MAXIMUM TIDAL VOLUME
It established the maximum acceptable inspired tidal volume. If the resulting value of inspired tidal
volume remains high during 3 ventilatory cycles, the alarm is triggered with audible indications and
messages on the screen.
18 - I:E RATIO INVERSION
It activates when the inspiration time is longer than the exhalation time. Due to this condition, it may be
part of the ventilatory strategy, it does not indicate messages on the screen nor the sound alarms are
activated, this condition makes the color which with are monitored the values become red, warning the
operate of the occurred.
19 – PEEP ALARM
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LEISTUNG LUFT 3
R 04-04(69)
Rev. 06
It activates when the value of PEEP is different in ± 4 cmH2O of the programmed value, to adjust this
alarm it is enough to set the desired PEEP, and the ventilator will calcualte the necessary values of
Maximum and Minimum PEEP.
20 – MINIMUM MINUTE VOLUME
The value of minute volume remains below the value of the alarm established by the operator during 5
consecutive respiratory cycles.
21 - MAXIMUM MINUTE VOLUME
The value of the minute volume remains above the value of the alarm established by the operator
during 5 consecutive respiratory cycles.
THE ALARMS OF THE INPUT GASES, POWER OUTAGE AND LOW VOLTAGE ARE
ONLY ACTIVATED WHEN THE EQUIPMENT IS OPERATIONAL. THE ALARMS ARE NOT
TRIGGERED IN STANDBY MODE.
THE SOUND PRESSURE LEVEL OF THE ALARMS, MEASURED AT 1M AWAY FROM
THE EQUIPMENT IS APPROXIMATELY 80DB.
THE PRE-ADJUSTED ALARM VALUES ARE AVERAGE VALUES AND THEY SHALL BE
ADJUSTED FOR EACH PATIENT, DEPENDING ON THE CLINICAL CASE AND THE
SITUATION OF USE. THE USE OF PRE-ADJUSTED ALARM VALUES MAY BE
DANGEROUS FOR THE PATIENT DEPENDING ON THE CASE AND ITS USE.
IT IS RECOMMENDED FOR THE OPERATOR OR USER TO CHECK THE EQUIMENT,
ALARMS CHECKING LIST, ESPECIALLY IN EVENTUAL OPERATOR OR USER
CHANGES.
AFTER COMPLETE POWER
RETURN, THE EQUIMENT
CONFIGURATION.
OUTAGE/BATTERY DISCHARGE AND FURTHER
RESTARTS WITH THE STANDARD ALARM
IT SHALL BE AVOIDED TO ADJUST THE ALARMS IN EXTREME VALUES, THIS MAY
TURN THE ALARMS USELESS FOR THE PATIENT'S SAFETY.
EVERY TIME THAT A CONTROL VARIABLE IS ADJUSTED, ADAPT THE ALARMS'
LIMITS ACCORDING TO THE VALUES OF THIS VARIABLE.
IN CASE THE VENTILATOR BECOMES INOPERATIVE, A MESSAGE WILL BE
DISPLAYED ON THE INFORMATION AREA RECOMMENDING THE EQUIPMENT TO BE
RESTARTED.
RELATION OF ALARM, POSSIBLE CAUSE AND NECESSARY ACTION
Description
Cause
Necessary Action
1. Microprocessor
- Serious failure of the
equipment, it is immediately
triggered after the occurrence.
- It is caused by the crashing of
the ventilator's central
processing board.
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- Don't use the ventilator in case
this failure occurs;
- Contact the technical support.
LUNG VENTILATOR
LEISTUNG LUFT 3
2. Low Supply Gas Pressure
- The pressure of the High Air
Pressure supply, O2 or the
Oxygen cylinder is lower than
2.5kg/cm²; it triggers
automatically after the
occurrence.
3. Low Battery
- The ventilator operates without
power supply and the battery's
tension is lower than 10.8 V, it
triggers immediately after the
occurrence.
4. Max. Insp. Pressure
- During the inspiration, the
airway pressure surpasses the
maximum value established, it is
triggered
Immediately after the
occurrence.
5. Interrupted Cycle
- - The instantaneous inspiratory
pressure surpasses in 12
cmH2O the programmed
pressure, it is immediately
triggered after the occurrence.
6. Min. Insp. Pressure
- By the end of an inspiration,
the pressure does not surpass
the minimum value established,
it immediately triggers after the
occurrence.
7. Patient Circuit Discon.
- Equipment cannot maintain
the values of minimum pressure
and PEEP due to a
disconnection of the patient
circuit, trigger immediately after
the occurrence.
8. Discon. of Proximal Sensor
- Indicates that there is a poor
connection or disconnection
between the proximal sensor’s
connector and the equipment,
trigger immediately after the
occurrence.
9. High Supply Gas Pressure
- The high pressure line of Air,
O2 or the Oxygen cylinder is
higher than 7,0 kg/cm².
- Low gas supply pressure;
- There are more equipment
using AIR than the network can
bear;
- Pressure regulator of O2
cylinder cannot supply enough
flow;
- Battery is discharged or in a
poor state of conservation;
- Use of the equipment for a
long period of time without
external power supply;
- Poor adaptation of the patient
to the adjusted ventilatory
parameters;
- Change of the airway physical
conditions;
- Airway obstruction;
- Patient's cough;
- Patient circuit's tube partially
or totally obstructed.
R 04-04(69)
Rev. 06
- Verify the High Pressure Gas
network;
- Adapt the network to the
demand of necessary gas;
- Change the regulator or adjust
it (depending on each model).
- Change the O2 cylinder.
- Supply external power, proper
electrical grid;
- Contact the authorized
technical service to change the
battery;
- Verify the patient's condition;
- Check the ventilator's adjusted
parameters;
- Verify the patient circuit;
- Evaluate the Respiratory
Mechanics;
- Correct the Alarm's Limit of the
ventilatory parameters, if
needed.
- Poor adaptation of the patient
to the ventilator;
- Airway obstruction;
- Patient's cough;
- Programmed Rise Time is too
high;
- Verify the patient's condition
- Check the ventilator's adjusted
parameters;
- Verify the patient / ventilator
interface;
- Lower the Rise Time;
- Evaluate the synchrony
between patient/ventilator;
- Leakage or disconnection of
the patient circuit;
- Excessive inspiratory effort;
- Verify the patient circuit;
- Verify if the exhalation valve is
correctly assembled.
- Leakages or disconnection of
the patient circuit.
- Check the patient circuit;
- Check if the exhalation valve is
assembled correctly.
- Poor connection ir
disconnection of the
equipment’s proximal sensor.
- Check the connection of the
proximal sensor with the
equipment.
- Low network line pressure;
- Pressure network adjustment
higher than the supported;
- Pressure regulator of the Air
- Check the high pressure gas
netweork;
- Adequate the gas network
pressure of the hospital;.
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LEISTUNG LUFT 3
or O2 cylinder is damaged with
pressure higher than 7,0
kgf/cm²;
10. Minimum FIO2
- The value of FiO2 maintains
itself below the established
value of alarm, triggers after
three consecutive ventilatory
cycles.
11. Maximum FIO2
- The value of FiO2 maintains
itself above the established
value of alarm, triggers after
three consecutive ventilatory
cycles.
12. Apnea Alarm
- O tempo compreendido entre
dois esforços inspiratórios
consecutivos é superior ao
tempo de apneia estabelecido,
aciona imediatamente após a
ocorrência.
13. Minimum Tidal Volume
- The Volume's value remains
below the established value of
the alarm during 3 consecutive
ventilatory cycles, triggers after
the third cycle.
14. Maximum Respiratory
Frequency
- The respiratory frequency is
higher than the established
value. It triggers immediately
after the occurrence.
15. Minimum Respiratory
Frequency
- The spontaneous respiratory
frequency is lower than the
programmed value and higher
than the selected apnea value.
16. Power outage
- Failure of the power supply.
It is triggered immediately after
the occurrence.
17. Maximum Tidal Volume
- The exhaled volume remains
above the adjusted volume's
value. It is triggered after 3
consecutive cycles.
R 04-04(69)
Rev. 06
- Replace the regulator or adjust
it (depending on each model).
- There is no connected AIR or
pure O2 at the ventilator’s input.
- End of the lifespan of the
Oxygen concentration reading
cell.
- Check the gas inputs;
- Contact the Authorized
Technical Support for
replacement of the cell.
- There is no connected AIR or
pure O2 at the ventilator’s input.
- End of the lifespan of the
Oxygen concentration reading
cell.
- Check the gas inputs;
- Contact the Authorized
Technical Support for
replacement of the cell.
- The patient is not
spontaneously breathing/
- Obstruction on the
patient/ventilator interface;
- Adjusted time for apnea is too
low;
- Trigger sensibility is too high;
- AutoPEEP presence;
- Failure on the exhalation flow
sensor.
- Leakage or disconnect of the
patient circuit.
- Increase of the airway
resistance or reduction of the
lung's compliance value.
- The patient is spontaneously
breathing at a high frequency;
- Leakages or disconnection
may cause the auto-trigger.
- The patient is spontaneously
breathing at a low frequency;
- Programmed inspiratory
sensibility is high and the
patient doesn’t match the
necessary effort.
- The power line voltage is
below the specified value;
- The cable that connects to the
power line was disconnected or
broken;
- Internal fuse is blown;
- The airway resistance or the
pulmonary compliance may
have improved (in pressure
control modes).
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- Evaluate the patient's condition
(consider changing to a
mandatory mode);
- Verify the patient/ventilator
interface;
- Evaluate the Synchrony
between the patient/ventilator;
- Calibrate or replace the
expiratory flow sensor.
- Evaluate the patient's
condition.
- Verify the ventilatory
parameters;
- Correct the Alarm's limit if
necessary;
- Evaluate the condition of the
patient;
- Verify the ventilatory
parameters;
- Verify the patient/ventilator
interface;
- Correct the alarm's limit if
necessary.
- Evaluate the condition of the
patient;
- Verify the ventilatory
parameters;
- Correct the alarm's limit if
necessary;
- Arrange power line as per the
specifications;
- Verify the power line cable;
- Contact an Authorized
Technical Support.
- Evaluate the patient's
condition.
- Verify the ventilatory
parameters;
- Correct the Alarm’s limit if
necessary;
LUNG VENTILATOR
LEISTUNG LUFT 3
18. I:E Ratio Inversion
- The inspiratory time is longer
than the exhalation time, it is
triggered immediately after the
occurrence.
19. PEEP Alarm
- The value of PEEP remains
below or above the established
value.
It is immediately triggered after
the occurrence..
20. Minimum Minute Volume
- The value of the minimum
minute volume remains below
the one established by the
operator.
It is triggered after 5 consecutive
cycles.
21. Maximum Minute Volume
- The value of the minute
volume remains above the value
established by the operator.
It is triggered after 5 consecutive
cycles.
- Adjust of inspiratory time
longer than the exhalation time.
R 04-04(69)
Rev. 06
- Verify the ventilatory
parameters.
- Excessive leakages on the
patient circuit;
- Failure of the exhalation flow
sensor.
- If being used, verify the
bacteriological filter and change
it if necessary;
- Verify if the exhalation valve is
correctly assembled.
- Leakages or disconnections of
the patient circuit (in volume
control modes);
- Increase of the airway
resistance, or reduction of the
lung's compliance (in pressure
control modes);
- Evaluate the patient's
condition;
- Verify the ventilatory
parameters;
- Correct the Alarm's limit if
necessary;
- The patient is spontaneously
breathing at a high frequency;
- Leakages and disconnections
may cause the auto-trigger;
- Failure on the exhalation flow
sensor;
- Accumulated water on the
exhalation flow sensor;
- Evaluate the patient's
condition;
- Verify the ventilatory
parameters;
- Verify the patient/ventilator
interface;
- Correct the Alarm's limit if
necessary;
- Calibrate or change the
exhalation flow sensor.
THE CHART ABOVE IS INDICATED IN RELATION TO THE PRIORITY OF ALARM'S
TRIGGERING, CONSIDERING 1 AS THE HIGHEST PRIORITY AND 19 AS THE
LOWEST PRIORITY.
WHEN TWO ALARMS CONDITIONS ARE SIMULTANEOUSLY TRIGGERED, THE
VENTILATOR WILL TRIGGER THE ONE WITH THE HIGHEST PRIORITY, ACCORDING
TO THE RANKING INDICATED ON THE CHART ABOVE (RELATION OF ALARM,
POSSIBLE CAUSE AND NECESSARY ACTION).
THE ALARM SYSTEM HAS ITS PRIORITIES FIXED, AS WELL AS THE DELAYS AND
THE CHARACTERISTICS INDICATED ON THE CHART ABOVE ( RELATION OF ALARM,
POSSIBLE CAUSE AND NECESSARY ACTION), IT CANNOT BE CHANGED BY THE
OPERATOR OR ANY OTHER METHOD.
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LEISTUNG LUFT 3
R 04-04(69)
Rev. 06
COLORS AND MEANINGS OF THE LUMINOUS INDICATIONS
These signals were developed in accordance with the Standard IEC 60601-1-8, see the chart with the
meanings of the Alarms from that standard:
COLOR
ALARM
PRIORITY
Red
High
Yellow
Medium
Yellow
Low
MEANING
The announced failure may cause
Death or Irreparable Harm
immediately or in the mediumterm, or Immediately Irreparable
Harm.
The announced failure may cause
Death or Irreparable Harm in the
long-term; Repairable Harm in the
medium-term or Lesser Harm or
discomfort immediately.
The announced failure may cause
Repairable Harm in the long-term
or Lesser Harm or Discomfort in
the medium or long-term.
Position of the Operator
Danger. It requires an
immediate response from the
operator.
Caution. It requires a
response from the operator.
Caution. It requires a
response from the operator.
SETUP OF THE ALARMS, SOUND AND LUMINOUS SIGNALS ON THE SCREEN
COLOR
ALARM
PRIORITY
LUMINOUS SIGNAL ON THE
SCREEN
AUDIBLE SIGNAL
Red
High
Intermittent Alarm Signal
10 pulses with 10 seconds
interval
Yellow
Medium
Intermittent Alarm Signal
3 pulses with 10 seconds
interval
Yellow
Low
Continuous Alarm Signal
2 pulses with 20 seconds
interval
STANDARD ALARMS SETUP
Max. P. = 40 cmH2O
Min. P. = 5 cmH2O
VCV
ADULT
PCV
PSV
(VCV/PCV) + PSV
Max. Vol. = 0,600 L
Min. Vol. = 0,150 L
Max. Minute Vol. = 15 L
Min. Minute Vol. = 1 L
Max. Freq. = 30 cpm
PEEP = 4 cmH2O
Apnea = 15 seconds
PEDIATRIC
VCV
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Max. P. = 30 cmH2O
LUNG VENTILATOR
LEISTUNG LUFT 3
R 04-04(69)
Rev. 06
PCV
Min. P. = 5 cmH2O
PSV
Max. Vol. = 0,4 L
(VCV/PCV) + PSV
Min. Vol. = 0,05 L
Max. Minute Vol. = 10 L
Min. Minute Vol. = 0,5 L
Max. Freq. = 30 cpm
PEEP = 4 cmH2O
Apnea = 15 seconds
ALARMS CHECKING LIST
Max. P.
Min. P.
VCV
ADULT
PCV
PSV
(VCV/PCV) + PSV
Max. Vol.
Min. Vol.
Max. Minute Vol.
Min. Minute Vol.
Max. Freq.
PEEP
Apnea
Max. P.
Min. P.
VCV
PEDIATRIC
PCV
PSV
(VCV/PCV) + PSV
Max. Vol.
Min. Vol.
Max. Minute Vol.
Min. Minute Vol.
Max. Freq.
PEEP
Apnea
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LUNG VENTILATOR
LEISTUNG LUFT 3
R 04-04(69)
Rev. 06
CHAPTER 6 – EXHALATION VALVE, PATIENT CIRCUIT AND
PROXIMAL SENSOR
EXHALATION VALVE
The picture below shows the assembly of the exhalation valve.
Picture 85
WHEN ASSEMBLYING THE EXHALATION VALVE, PUT THE MEBRANE
(DIAPHRAGM) AS SHOWN ON THE PICTURE WITH THE CURVE SALIENCE DOWN.
THE BIGGER HOSE MUST BE ON THE EXTERNAL SIDE OF THE EXHALATION
VALVE, AT THE TERMINALS MARKED WITH A SALIENT DOT.
DO NOT DRY NOR CLEAR THE EXHALATION VALVE WITH COMPRESSED AIR.
DO NOT INSERT IN THE EXHALATION VALVE PIERCING OR CUTTING MATERIALS.
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LUNG VENTILATOR
LEISTUNG LUFT 3
R 04-04(69)
Rev. 06
PATIENT CIRCUIT
The picture below shows the assembly of the patient circuit.
Picture 86
PROXIMAL SENSOR
The proximal sensor must be connected to the Y Connector and the Endotracheal Tube in
such a way that the reading hoses of the sensor stay upwards and the connection with the patient is
higher than the side connected to the Y Connector, as shown on the picture below:
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LEISTUNG LUFT 3
R 04-04(69)
Rev. 06
Picture 87
WHEN COMPONENTS OF THE BREATHING CIRCUIT, OTHER COMPONENTS OR
SUBASSEMBLIES FOR THE VENTILATOR'S RESPIRATORY SYSTEM ARE ADDED,
THE PRESSURE GRADIENT THROUGH THE VENTILATOR'S RESPIRATORY SYSTEM,
MEASURED IN RELATION TO THE PATIENT’S CONNECTION INPUT, MAY INCREASE.
UPON REDOING THE CIRCUIT TEST (SELF-TEST), THIS GRADIENT IS
AUTOMATICALLY CORRECTED BY THE EQUIPMENT.
A BAD CLOSURE OF THE MEMBRANE (DIAPHRAGM) MAY CAUSE THE READING OF
THE EXHALED PARAMETERS TO BE WRONG.
THE MEMBRANE (DIAPHRAGM) MUST BE LEANED AGAINST THE COVER'S
ACCOMODATION FOR WHICH IT IS CONVENIENT TO FIRST PUT IT ON THE COVER
AND MAKE SURE IT IS WELL LEANED AND ONLY THEN SCREW THE COVER ON THE
BODY.
AT THE END OF THE SCREWING, DON'T MAKE A STRONG ADJUSTMENT OF THE
COVER TO THE BODY. ADJUST IT SOFTLY.
VERIFY IF THE TWO PLASTIC TUBES ARE COMPLETELY CLEAR OF HUMIDITY, SO
THAT THEY CAN CORRECTLY MEASURE THE PRESSURE DIFFERENCES.
WHEN STERILIZING THE VALVE, DO NOT DISCONNECT THE PLASTIC TUBES
BECAUSE THEY HAVE DEFINED POSITIONS AND TO AVOID DEFORMING THE
INTERNAL MEMBRANE (TRANSPARENT), BECAUSE THIS ONE IS RESPONSIBLE
FOR ESTABLISHING THE PRESSURE DIFERENCES WHICH THE EQUIPMENT
MEASURES IN ORDER TO ESTABLISH THE PATIENT'S OUTPUT PARAMETERS. IF
THE MEMBRANE IS FOLDED OR DAMAGED THE MEASURING WILL NOT BE
CORRECT.
IT MUST BE KNOWN THAT DURING THE USE OF THE EQUIPMENT IN A PATIENT,
AFTER A DETERMINED PERIOD OF TIME, THE PARAMETERS MEASURED AT THE
INITIAL TEST OF THE BREATHING CIRCUIT AND PERIPHERALS, MAY VARY DUE TO
THE TEMPERATURE, HUMIDITY, PLACE, ETC... THE VARIATIONS ON THE CIRCUIT
MAY BE MORE SIGNIFICATIVE WITHIN THE FIRST HOURS OF OPERATION,
STABILIZING LATER.
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LUNG VENTILATOR
LEISTUNG LUFT 3
R 04-04(69)
Rev. 06
CHAPTER 7 – CLEANING, DISINFECTION AND STERILIZATION
The Exhalation Valve and the Patient Circuit are classified as semi critical articles, which makes it
necessary to perform a high level disinfection or sterilization for the reuse. Once the material, for any
circumstance contacts sterile tissue or vascular system, it shall be sterilized. To perform this, the
procedures indicated on this protocol shall be followed, according to the classification of the valve after
its use, which are:
DISASSEMBLY OF THE EXHALATION VALVE AND THE PATIENT CIRCUIT
The Exhalation Valve and the Patient Circuit must be disassembled before the beginning of the steps
below for a better effectiveness of the procedures. In order to do that, follow the instructions below:
1.
2.
3.
4.
Remove the exhalation valve from the patient circuit;
Remove the exhalation valve's cover from its body by unscrewing it;
Extract the silicon membrane;
The complete disassemble of the Exhaust Valve will result in 6 components (as picture below):
Valve’s Cover, Silicon Membrane, Valve’s Body, Flow Sensor and Hose;
5. The complete disassemble of the Patient Circuit (Picture 86) will result in some components
(depending on the circuit): Patient Circuit's Tracheas (4x) or (5x), Y Connector, Connectors (if
there are) and Drains (if there are).
Picture 88
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LUNG VENTILATOR
LEISTUNG LUFT 3
R 04-04(69)
Rev. 06
CLEANING
It is the process which aims at removing visible dirt – organic and inorganic and, hence removal of the
microbial load. The cleaning of components such as valve, patient circuit, proximal sensor should
always precede the process of disinfection or sterilization, being the most important process of the
decontamination. If there is dirt on the valve, on the circuit, or the proximal flow sensor, it won't have
success in the next procedures.
The valve and the circuit must be cleaned for every patient, initially following the disassemble
recommendations as per the disassembly item. After this first step, we recommend to follow the
instructions mentioned below:
EXHALATION VALVE – PROXIMAL SENSOR

Immerse the components in detergent solution, preferably using a multi-enzymatic
detergent in a solution of 3 ml for each liter of water during 5 minutes;

Rinse the components with plenty of clean water, removing all the solution with the aid of
a sponge.
PATIENT CIRCUIT

Perform the washing in a validated thermo-disinfector using enzymatic detergent and
purified water, heated at 45°C ±5°C, during 55 minutes and finishing with 3 rinses.
OS AGENTES DE LIMPEZA MUITAS VEZES CONTÊM ADITIVOS QUE PODEM
DANIFICAR OS MATERIAIS UTILIZADOS NA VÁLVULA EXALATÓRIA. NO CASO DE
QUALQUER DÚVIDA, FORNECEDOR/FABRICANTE DEVE SER CONTATADO.
NÃO É ACONSELHÁVEL A UTILIZAÇÃO DE ÁGUA EM JATO E /OU ÁGUA SOB
PRESSÃO PARA O ENXÁGUE DOS COMPONENTES, UMA VEZ QUE PODEM
OCORRER DANOS QUE COMPROMETAM O FUNCIONAMENTO DA VÁLVULA.
A ESPONJA UTILIZADA PARA A REMOÇÃO DE SUJIDADE APÓS A IMERSÃO EM
SOLUÇÃO DEVE SER MACIA, COM AUSÊNCIA DE PALHAS DE AÇO.
RECOMENDAMOS CUIDADOS NA MANIPULAÇÃO DA MEMBRANA DE SILICONE
PARA QUE A MESMA NÃO DOBRE NEM DANIFIQUE.
RECOMENDA-SE O ENXÁGUE COM ÁGUA TRATADA, LIVRE DE CONTAMINANTES,
ENDOTOXINAS E MINERAIS.
OS COMPONENTES PODEM SER LIMPOS EM LAVADORAS ULTRASSÔNICAS QUE
SÃO POTENCIALIZADAS PELO ULTRASSOM.
DRYING
Drying is an important process, because the humidity interferes on the processes of disinfection and
sterilization. We recommend the drying for each component as described below:
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LEISTUNG LUFT 3
R 04-04(69)
Rev. 06
VALVE DRYING METHODS
COMPONENTS
Air Dryer
(warm or cold)
Valve’s body
X
X
X
Valve’s cover
Flow sensor
Clean cloth
(ex: compress)
X
X
X
Membrane
Medicinal Compressed Air
X
X
DRYING OF THE VALVES MUST BE PERFORMED ACCORDING TO THE STANDARDS
OF SERVICE FOR RESPIRATORY COMPONENTS DRYING, PAYING ATTENTION TO
THE MAXIMUM TEMPERATURE SPECIFIED IN EACH PROCESS.
AFTER DRYING, THE COMPONENTS MUST BE INSPECTED TO VERIFY THE
AUSENCE OF DIRT. THE NEXT STEPS SHALL BE TAKEN ONLY IF THE
COMPONENTS ARE COMPLETELY CLEAN AND FREE OF ORGANIC AND INORGANIC
MATTER.
THE CLOTH USED FOR DRYING MUST BE SOFT, MUST NOT RELEASE FIBERS AND
MUST BE MADE OF A LIGHT COLOR IN ORDER TO FACILIATE THE VISUALIZATION
OF THE MATERIAL'S DIRT.
PATIENT CIRCUIT


Dry in automatic dryers, operating in 60°C ± 10°C for 60 minutes.
After drying the materials must be packed in cirurgical-grade paper, with an indicator of
sterilization printed in transparent plastic filme with identification of sterilization date,
sterilization validity, lot number, customer’s name and description of the material.
STERILIZATION
It is the process which destroys all kinds of microbial life and is performed by physical or chemical
procedures. The methods indicated for the sterilization of the components are:
THE STERILIZATION METHODS ARE FOLLOWED ACCORDING TO THE STANDARDS
ISO 17664, ISO 11135-1 AND ISO 17665-1
PHYSICAL METHOD
PATIENT CIRCUIT
Autoclave Under Saturated Steam Pressure: The tracheas must be sterilized in proper
individual packages without touching the chamber walls, during 4 minutes at 134°C / 137°C.
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EXHALATION VALVE
General specifications:
o Pre-conditioning
Vacuum..........................................3 pulses
Humidification................................3 steam discharges
o Sterilization cycle
Time..........................................15 minutes
Temperature................................134°C
Pressure.......................................2,2 bar
o Drying cycle
High pressure vacuum..............20 minutes
IT IS RECOMMENDED THE USE OF INDICATORS OF THE STERILIZATION PROCESS TO
CONTROL THE PERFORMANCE RESULTS OF THE STERILIZATION CYCLE.
PERSONAL PROTECTIVE EQUIPMENT USED BY PROFESSIONALS THAT WILL
PERFORM THE PROCEDURES MENTIONED ABOVE IS DETERMINED AND INSPECTED
BY THE HEALTH SERVICE ACCORDING TO THE STANDARDS AND STANDARDIZED
ROUTINES BY THE SAME.
USEFUL LIFE OF ACCESSORIES
EXHALATION VALVE
Maximum Number of Cleaning/Sterilization cycles: 50 cycles.
PATIENT CIRCUIT
Maximum Number of Cleaning/Sterilization cycles: 6 cycles.
DO NOT PILE THE TRACHEAS, DO NOT LEAN THEM AGAINST THE CHAMBER
WALLS, AND DO NOT PUT THE PIECES WITHOUT THE PROPER PACKAGE.
THE RESPIRATORY CIRCUIT, THE EXHALATION VALVE AND THE ACCESSORIES,
SUCH AS THE ASPIRATION BOTTLE AND THE HUMIDIFER, SHALL BE CLEANED,
STERILIZED AND DISINFECTED BEFORE THE FIRST USE.
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ANNEX 1 – VENTILATOR LUFT3’S ACCESSORIES
Illustrative images
DESCRIPTION
ARTICULATED ARM
FUNCTION
ARTICULATED SUPPORT FOR THE PATIENT
CIRCUIT
MONITOR’S POWER SUPPLY CABLE
CABLE FOR POWER SUPPLY INPUT OF THE
MONITOR
TOUCH CONTROLLER CABLE
SIGNAL CABLE TO CONTROL THE TOUCH
SCREEN
POWER CABLE
ELECTRICAL POWER SUPPLY
NOTE: ONLY THE CABLE INCLUDED WITH
THE EQUIPMENT SHALL BE USED
VIDEO CABLE
CABLE FOR VIDEO SIGNALS
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PATIENT CIRCUIT (ADULT
CIRCUIT)
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THE PATIENT CIRCUIT IS BUILT UNDER THE
STANDARD ISO 5367 AND REGISTERED AT
THE MINISTRY OF HEALTH BY THE
MANUFACTURER
AIR FILTER
AIR INPUT COALESCENT FILTER
HIGH PRESSURE HOSE
(MEDICAL AIR)
GAS SUPPLY (MEDICAL AIR)
STANDARD LENGTH: 3 METERS
OPTIONAL LENGTH: SPECIAL
MEASUREMENT
HIGH PRESSURE HOSE
(MEDICAL OXYGEN)
GAS SUPPLY (MEDICAL OXYGEN)
STANDARD LENGTH: 3 METERS
OPTIONAL LENGTH: SPECIAL
MEASUREMENT
USER MANUAL
INFORMATION ABOUT THE FUNCTIONS,
REQUIREMENTS AND OPERATION OF THE
EQUIPMENT
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LOCKNUT
USED TO FASTEN THE EQUIPMENT ON THE
TROLLEY
TROLLEY
SUPPORT DESK FOR THE EQUIPMENT, ON
WHEELS WITH A BRAKE SYSTEM
TEST RESISTANCE
IT SIMULATES THE RESISTANCE TO VERIFY
THE CYCLING OF THE EQUIPMENT
EXHALATION VALVE
ONLY THE MODEL SUPPLIED WITH THE
VENTILATOR LUFT3 MUST BE USED
Merely illustrative images.
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OPTIONAL ACCESSORIES (NOT INCLUDED WITH THE EQUIPMENT)
Must be acquired separately.
OPTIONAL
PATIENT CIRCUIT WITH EXHALATION VALVE
AND NEBULIZER (PEDIATRIC/NEONATAL
CIRCUIT)
INTERFACE EQUIPMENT-PATIENT
NOTE: ONLY THE MODEL PROPER FOR THE
VENTILATOR LUFT 3 SHALL BE USED
TEST LUNG (ADULT)
VERIFICATION OF OPERATION AND
CYCLING OF THE EQUIPMENT
TEST LUNG (NEONATAL)
VERIFICATION OF OPERATION AND
CYCLING OF THE EQUIPMENT
CAPNOGRAPHY SENSOR
“MAINSTREAM” SENSOR FOR
CAPNOGRAPHY
PROXIMAL SENSOR
PROXIMAL FLOW READING
LUFT 3 SOFTWARE
SOFTWARE WHICH ALLOWS CONNECTION
OF THE EQUIPMENT WITH A COMPUTER
Merely illustrative images
THE USE OF ACCESSORIES AND CABLES WHICH ARE NOT SPECIFIED BY
LEISTUNG EQUIPMENTOS LTDA. MAY RESULT IN ELECTROMAGNETIC
EMISSION INCREASING OR IMMUNITY REDUCTION OF THE EQUIPMENT.
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ANNEX 2 – PREVENTIVE MAINTENANCE
A preventive maintenance shall be performed according to the following schedule:
Maintenance
1st
2nd
3rd
4th
5th
Hours of Use
3500
7000
10500
14000
17500
It is recommended to contact Leistung Equipamentos to send the equipment after exceed the hours of
the chart above or 1 year after performing the last preventive maintenance.
The preventive maintenance shall be performed by qualified personnel and respecting its
corresponding protocols.
To access the function which indicated the preventive maintenances press “Menu”, “Operative
Setup”, “Maintenance”.
LUFT 3 RUNS AN AUTO-TEST OF THE BATERRY CONDITION EVERY 5 MINUTES,
HOWEVER IT IS RECOMMENDED TO DISCONNECT IT FROM THE POWER GRID
(NETWORK) AT LEAST ONCE IN A MONTH, LEAVING IT ON ITS AUTONOMY, FOR
MAINTENANCE AND FOR TESTING THE BATTERY CONDITION.
THE MANUFACTURER DOES NOT TAKE RESPONSABILITY FOR ANY DAMAGE
CAUSED OR SPECIAL DAMAGES.
WHEN THE HOURS OF USE EXCEED THE HOURS INDICATED ON THE CHART
ABOVE, THE EQUIPMENT WILL DISPLAY AN AUTOMATIC MESSAGE WHEN TURNING
ON THE EQUIPMENT WITHOUT BLOCKING ANY FUNCTIONS.
ALARMS SYSTEM INTEGRITY TEST
1 – With the test lung connected to the equipment, turn the “VCV” mode on; on the alarms area
configure the P.max for a value lower than the peek value displayed on the screen. It shall trigger the
alarm “MAXIMUM INSPIRATORY PRESSURE”.
2 – Adjust the alarm value of P.max for a value higher than the Peak showed on the screen and
disconnect the test lung. It shall trigger the alarm “MINIMUM INSPIRATORY PRESSURE”.
3 – Adjust the alarm value of F.max for a value lower than the one displayed on the screen, after 10
cycles it shall trigger the alarm “MAXIMUM INSPIRATORY FREQUENCY””.
4 – Adjust the alarm value of Minimum Volume for a value higher than the one showed in “Vt”, it
shall trigger the alarm “MINIMUM TIDAL VOLUME”.
5 – Adjust the alarm value of Maximum Volume for a value lower than the one showed in “Vt”, it shall
trigger the alarm “MAXIMUM TIDAL VOLUME”.
6 – Disconnect the Pneumotachograph from the exhalation valve, it shall trigger the alarm “PEEP”.
Connect it again.
7 – Select one of the spontaneous mode (PSV), after elapsing the adjusted Apnea time, it shall trigger
the “APNEA CONDITION” alarm”.
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8 - Disconnect the high pressure Air hose from the gas inlet, it shall trigger the “LOW O2/AIR INPUT
PRESSURE”. Put the air hose again and repeat this procedure with the OXYGEN hose, it shall trigger
the same alarm.
9 – Disconnect the power supply cable from its jack, it shall trigger the alarm “POWER FAILURE”.
10 – Keeping the equipment without power connection for about 75% of its autonomy shall trigger the
alarm “LOW BATTERY”.
IT IS RECOMMENDED TO PERFORM THIS TEST ALONG WITH THE PREVENTIVE
MAINTENANCE, ALREADY DESCRIBED ON THE BEGINNING OF THIS CHAPTER.
EACH TEST IS INDEPENDENT AND MAY BE PERFORMED OUTSIDE THE
SUGGESTED ORDER. THE TIME BETWEEN THE PARAMETERS ADJUSTMENT AND
THE ALARMS TRIGGERING CAN VARY IN EACH TEST.
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ANNEX 3 – BLOCK DIAGRAM
The picture below represents the Ventilator LUFT3's pneumatic diagram.
Picture 89
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ANNEX 4 – WARRANTY
This equipment has a warranty of 12 (twelve) months, counting from the date of the purchase, being
them 03 (three) months corresponding to the legal term and 09 (nine) months the contractual term,
where Leistung is responsible for any failure or manufacturing defect.
The warranty will only have validity with the presentation of this term duly stamped and signed by
LEISTUNG EQUIPAMENTOS LTDA., accompanied with the corresponding Invoice.
On the process of observing irregularities within the warranty time, shall the purchaser in possession
of the mentioned documents report it to the aftersales service of LEISTUNG EQUIPAMENTOS LTDA.
through the Phone: +55 47 3371-2741 or through the e-mail posvendas@leistungbrasil.com.
The installation of the equipment is purchaser's responsibility and will have to be made in the exact
terms as described on the instructions manual, under penalty of losing the warranty. The same will
happen (warranty loss) if the use and handling of the equipment do not follow the technical
specification described on the manual, including the preventive maintenance periods.
Beside the already established, it will also cause the loss of warranty, the occurrence of the following
situations caused by the purchaser or third parties:
a) Finish of the warranty time;
b) The identification level is changed, damaged or removed from the equipment, as well as
its seal;
c) When the installation, use and maintenance of the equipment is not performed according
to the specifications of the instructions manual;
d) When it is observed that the damages were caused by circumstances related to the
deficiency of the electrical and/or pneumatic installation, or by fluctuations/differences of tension in
which the equipment is operated;
e) When the defects are caused by drops, hits or any other kind of external damage, or also
by the bad use of the equipment;
f) When it is detected the opening of the equipment by people other than LEISTUNG
EQUIPAMENTOS LTDA.'s technical support.
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ANNEX 5 – GLOSSARY
ALARM: It is a light or audio signal, or both kinds, that occurs when there is any variation on the equipment.
ASSISTED EXPIRATION: It is the expiratory flow generated by the negative switch at trans-respiratory pressure due to an
external agent (such as a respiratory pressure drop to a value lower than the reference value).
ASSISTED INSPIRATION: It is the inspiratory flow generated by positive switch at trans-respiratory pressure due to an external
agent (such as an increment in the respiratory pressure generating a value higher than the reference value).
ASSISTED VENTILATION: It is the process of providing a respiration with positive pressure as a reaction of the patient's
inspiratory effort.
AUTOPEEP: It is the pulmonary pressure at the end of the expiration ;
COMPLIANCE: It is the relation between volume and pressure.
CYCLE: Ending a mechanically supported inspiration .
EXPIRATORY PHASE (EXPIRATION): It is the part of the ventilatory cycle which covers from the beginning of the expiratory
flow until the beginning of the inspiratory flow.
EXPIRATORY TIME: It is the duration of the expiratory phase, expressed in seconds.
FLOW: Traffic gas rate that gets in and out of the lungs.
I:E RATIO: It is the relation between the inspiration time and the expiratory time.
INSPIRATORY PHASE (INSPIRATION): The part of the ventilatory cycle which covers from the beginning of the inspiratory
flow until the beginning of the expiratory flow. In the inspiratory phase, it is included any inspiratory pause .
INSPIRATORY TIME: It is the duration of the inspiratory phase, expressed in seconds. As the inspiratory time increases, the
mean respiratory pressure and the I:E ratio increases too.
LIMIT: To establish a maximum value of pressure, volume and flow during the inspiration with mechanical support (or
expiration), the maximum volume pre-established for the pressure, volume or flow during an assisted inspiration (or expiration).
NEBULIZER: An aerosol generator that requires a gas source to nebulize liquid medicines.
NON-INVASIVE VENTILATION: Ventilation technique performed through facial mask.
PEEP: Positive End-Expiratory Pressure.
SENSIBILITY: It is the measurement of the patient's effort to start a cycle.
SIGHS: It is a number of additional respirations performed during a defined time interval.
SPONTANEOUS BREATHING: It is the breathing started and finished by the patient.
STATIC COMPLIANCE: It is the relation between the volume and the pressure in spots without gas flow.
TGI: Tracheal Gas Insufflations during the expiration.
TRANS-RESPIRATORY PRESSURE: The difference of pressure between the respiratory airway and the surface of the body.
VOLUME: Space occupied by material measured in cubic millimeters or liters.
WEANING: Gradual reduction of ventilation support.
WOB: Work of Breathing.
Jaraguá do Sul, February 19, 2018.
_____________________________
MATEUS EMRICH MONNERAT
TECHNICAL RESPONSIBLE
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