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Graphnet: User'S Instruction Manual
Graphnet: User'S Instruction Manual
Graphnet: User'S Instruction Manual
ii Contents
1
Introduction
GraphNet is a microprocessor controlled ventilator incorporating the most The GraphNet ventilator provides the following ventilation modes:
advanced ventilation support modes.
Adult and Pediatric Patients
Intended use: This equipment is intended to be used in hospitals and
hospital type facilities that provide supervised professional health care for • Volume-Controlled Ventilation (VCV), Assist/Control
adult, pediatric or infant patients requiring short or long term invasive and • Pressure-Controlled Ventilation (PCV), Assist/Control
noninvasive respiratory support, covering a variety of clinical conditions. • Pressure Support Ventilation (PSV)
• Continuous Positive Airway Pressure (CPAP)
Operation: It is based on the control of two proportional electro-valves • SIMV (VCV) + PSV
manufactured with high-quality components, connected by an electronic • SIMV (PCV) + PSV
circuit to a microcontroller. • Mandatory Minute Ventilation (MMV) + PSV
• PSV + VT Assured
Monitoring: It features a color TFT-LCD 12.1" 800×600 dots screen • Airway Pressure Release Ventilation (APRV)
displaying, in real time, pressure, volume and flow waveforms; • Noninvasive Ventilation (NIV)
pressure/volume loops (with simultaneous calculation of dynamic • Pressure-Regulated Volume Control (PRVC)
compliance), pressure/flow loops, and flow/volume loops; as well as
numerical patient data and constant indication of oxygen concentration Neonatal Patients
delivered by the ventilator, with the appropriate alarms. The data are • Volume-Controlled Ventilation (VCV), Assist/Control
programmed according to the selected mode, and the resulting data are on • Pressure-Controlled Ventilation (PCV), Assist/Control
permanent display. It is also possible to analyze trend curves over the last 72 • Pressure Support Ventilation (PSV)
hours, exhaled tidal volume, minute volume, airway pressure, respiratory • CPAP + PSV
frequency, peak inspiratory flow, dynamic compliance, expiratory time • SIMV (VCV) + PSV
constant, and end expired CO2 (optional). Also, the most recent 660 alarm • SIMV (PCV) + PSV
events remain stored and cannot be erased. • Time Cycled-Pressure Limited (TCPL)
• TCPL/SIMV + PSV
Complementary studies: During ventilation, some respiratory mechanic • Continuous Flow CPAP for Nasal NIV
tests can be performed. These include auto-PEEP, Inflexion Points on the P/V
Curve (P/Vflex), Dynamic and Static Compliance, Inspiratory and Expiratory Backup Ventilation: For adult and pediatric patients, it is programmed
Resistance, Trapped Volume, Non-Forced Vital Capacity, Pimax, P0.1 and volume (VCV) or pressure (PCV). For infant patients, it is programmed
Physiological VD/VT. volume (VCV), pressure (PCV), or Time Cycled and Pressure Limited (TCPL).
Other Features: In spontaneous modes, the patient can breathe with a Leak compensation: Featured in all ventilation modes. For NIV, it is
minimum respiratory effort, according to flow sensitivity or selected automatically activated; for other modes, it must be activated through the
pressure. The trigger system is highly efficient, satisfying an inspiratory flow ventilatory adjuncts.
demand of up to 180 L/min with the selected oxygen concentration. The
control panel design and the direct interactive programming of the selected
mode of operation make this ventilator a user-friendly device.
Alarms y safety features: The visual and audible alarm signals are
accompanied by screen message indicating possible causes. In addition, the
equipment features a complete safety system in order to ensure correct
operation and to protect the patient from inappropriate actions.
Introduction 1
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2 Introduction
2
Warning-Caution-Note
In this Manual, you will frequently find text accompanied by a sign indi-
cating it is a WARNING, a CAUTION or a NOTE on the topic being dealt WARNING
with. They should be taken into account when using this device.
The indications relative to the application and regulation of the con-
trols mentioned in this manual are to be used as guidelines. The profes-
Definition of Terms sional in charge of its application, should, according to his knowledge and
experience, adapt this mechanical equipment to the patient’s needs.
WARNING:
WARNING
It means there is a possibility of personal injury to oneself or others.
The GraphNet is a life-sustaining device. Do not rely solely on the
CAUTION: ventilator performance. It is mandatory to perform frequent and ad-
equate clinical supervision of the patient. Also, an alternative way of ven-
It means there is a possibility of damaging the equipment or a neigh- tilation should be provided.
boring device.
WARNING
NOTE:
Do not use the ventilator in presence of flammable anesthetic gases. It
Indicates specific points of interests to be taken into account for a cor- may result in an accident due to an explosion or fire.
rect application.
WARNING
Next, there are some examples of remarkable warnings.
Do not use antistatic neither electrically conductive tubes in the
breathing circuit and gas supply.
WARNING
WARNING
WARNING
Every time a patient is connected to a ventilator, constant care by spe-
cialized personnel is required. This is due to two reasons: The interruption of external electric power is an emergency. If the
problem persists for some minutes an alternative ventilatory system
1) Some operation problems require immediate corrective action. should be used.
2) An alarm, or any combination of alarms, does not mean total safety
in case of any problem in the ventilatory system.
Warning-Caution-Note 3
WARNING WARNING
The operation with internal battery has a limited time. When this hap- Only clean, filtered and dry compressed air and oxygen must be
pens replace the power source or QUICKLY CHANGE to an alternative used to prevent any contamination of the ventilator or its malfunctioning(1).
method of ventilation.
WARNING
WARNING
Do not use any device that could restrict the flow or the pressure,
The responsibility to provide a correct and safe electric power to any extent, between the supply outlet and the pressure tubes. There-
supply is exclusively of the user, and not of the company TECME. fore, DO NOT USE pressure regulators with shutoff valve nor any rotame-
ter or ball positive displacement flowmeter/liter meter.
WARNING
WARNING
Never begins a ventilatory procedure when the equipment is
turned ON and the battery icon indicates very low load. DO NOT USE the If the OXYGEN source is not sufficient, the ventilator will not
ventilator until the load is completed maintaining the connection to the accept the initial calibration.
main source of electrical energy.
The operation of the ventilator in these conditions can produce serious
WARNING
defects. Before this happens it should be provided an alternative way of
ventilation. The calibration of the equipment using only air is not possible.
WARNING WARNING
Ventilator malfunction may occur when operated in the close When the Vent Inop alarm is activated, do not intent to use the
vicinity of a device that emits high frequency (for example, cellular or ventilator again. An alternative system of ventilation should immediately
wireless telephone, defibrillator) or of therapy devices with emission of be provided.
short waves. The device should be sent to an authorized service.
WARNING
Maintenance warning
Every 5000 running hours a tool icon appears on the right superior
part of the screen indicating the opportunity of service.
Likewise, emissions of magnetic resonance devices can damage the venti- The presence of the icon on the screen is deleted by the authorized Ser-
lator permanently. vice once the maintenance protocol is carried out.
(1)
In accordance to: Compressed Gas Association CGA G-7-1990
Compressed Air for Human Respiration and CGA G-7.1-1997
Commodity Specification for Air.
4 Warning-Caution-Note
CAUTION CAUTION
Prior to operating the Ventilator for the first time, the battery If, when turning the ventilator on after being unplugged for an
must be charged by connecting the ventilator to an external power source extended period of time the “Depleted Battery” signal appears, the inter-
for a period of at least eight (8) hours. nal battery must be recharged by plugging the ventilator into a power
source for a minimum of eight (8) hours.
CAUTION
NOTE
When the oxygen sensor is used for the first time, it should be
exposed to ambient air at least 20 minutes before connecting it to the To discard the whole device or disused parts or elements pro-
ventilator. vided by other suppliers, follow the requirements of the institutional au-
thority.
CAUTION
NOTE
To replace the exhalation valve diaphragm, always use original
spare part. Similar parts can produce valve malfunction. When the ventilator operates with battery, there is no communi-
cation for the RS-232 outlet.
CAUTION
NOTE
The calibration test should be made without the nebulizer con-
nected in the circuit. The altitude adjustment need be accomplished only once, unless
the ventilator is moved and the new location varies by more than 150 m
(500 feet) from the original location.
CAUTION
If the ventilator does not pass any one of the operational tests NOTE
does not apply it to a patient.
In the modes where PSV is combined with PCV, the rise time
regulation influences both modes.
CAUTION
Warning-Caution-Note 5
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6 Warning-Caution-Note
3
Assembly and Installation Procedures
The GraphNet Ventilator and the associated patient circuit are shipped in
a clean but not sterile condition.
The complete assembly consists of the following components:
Quantity Description
1 GraphNet Ventilator with water trap filter for
high pressure air inlet (located on the rear)
1 Four-wheel cart
1 Support bar with set screw and washer
1 Tray with set screw and hex wrench
1 Extension arm with tubes holder
1 Expiratory valve with expiratory flow sensor (pneumotachograph)
1 Reusable respiratory circuit, adult, pediatric or neonate (optional)
1 Oxygen sensor with cord
1 Test lung
1 Nebulizer with connector
1 Power cord Patient
1 Oxygen supply high pressure hose (3 m) Exhalation Valve
with DISS connector
1 Air supply high pressure hose (3 m)
with DISS connector
1 Capnograph (optional)
Water
trap
Wye
Connector
Nebulizer Water
trap
WARNING
NOTE: The following accessories are Heater
Do not use antistatic neither elec- optional and are not manufactured
trically conductive tubes in the breathing neither provided by TECME.
circuit and gas supply. - Reusable or discarded breathing
circuit; adult, pediatric or neonate.
- Heater-humidifier.
- Capnograph
CAUTION
Prior to operating the Ventilator for the first time, the battery must
WARNING
be charged by connecting the ventilator to an external power source for a
period of at least eight (8) hours. Never begin a ventilatory procedure when the equipment is turned
ON and the battery icon indicates very low load. DO NOT USE the ventila-
CAUTION tor until the load is completed maintaining the connection to the main
source of electrical energy.
Do not try to replace a battery while the ventilator is "ON". Always
The operation of the ventilator in these conditions can produce serious
switch off the ventilator before replacing the battery.
defects. Before this happens it should be provided an alternative way of
ventilation.
CAUTION
In case of battery discard follow the institutional requirements. The
discarded unit should not be thrown to fire. Explosion may result.
CAUTION
When turning the ventilator on after being unplugged for an ex-
tended period of time the "Battery depleted" or "BAT INOP" signal ap-
pears, the internal battery must be recharged by plugging the ventilator
into a power source for a minimum of eight (8) hours. Reappearance of
the "Low Battery" or "BAT INOP" signal after the battery has been re-
charged indicates the need to replace the battery. Call an authorized ser-
vice.
Gas inlet connectors The responsibility to provide a correct and safe compressed Oxygen
and Air supply is exclusively of the user, and not of TECME company.
AIR: Male DISS 3/4"-16
OXYGEN: Male DISS Pressure range at the Air and Oxygen supply
9/16"-18 AIR: 3.5 to 7 bar (approx. 50-100 psi)
Pressure tubes OXYGEN: 3.5 to 7 bar (approx. 50-100 psi)
connectors CAUTION
AIR: Female DISS 3/4"-16
(in each end). The gas installation must be capable of providing flows of no less
OXYGEN: Female DISS than 120 L/min (compressor) and up to 180 L/min.
9/16"-18 (in each end).
NOTE
It is convenient for the wall
gas installation to have the Within the above-mentioned pressure limits, it is not necessary for
corresponding male con- the gases to have equal pressures. The internal system makes the neces-
nectors. sary adjustments for a correct working of the ventilator.
WARNING
Connection between the ventilator and the Only clean, filtered and dry compressed air and oxygen must be used
supply source to prevent any contamination of the ventilator or its malfunctioning(1).
➪ First, connect the air filter to WARNING
Air Filter the ventilator AIR inlet,
tightening it by hand. Do not use any device that could restrict the flow or the pressure,
to any extent, between the supply outlet and the pressure tubes. There-
Flow direction ➪ In the exit of the filter
fore, DO NOT USE pressure regulators with shutoff valve nor any rotame-
drainage, connect a tube of
ter or ball positive displacement flowmeter/liter meter.
sufficient longitude in or-
der to send the condensed
WARNING
From air To ventilator water to a container.
supply If the OXYGEN source is not sufficient, the ventilator will not accept
➪ Then, connect the air pres-
sure tube with the female the initial calibration.
3/4"-16 connector to the Ventilation with a single gas
filter inlet, tightening by
hand. The other end of the It is possible to initiate the calibration of the respiratory circuit and start
pressure tube is connected the ventilation of the patient using only compressed oxygen. This action
to the air pressure supply must be considered exceptional and of extreme necessity. During the op-
(central supply or compres- eration in these conditions, the alarm of lack of compressed air could not
sor). be silenced.
➪ Connect the oxygen pres-
sure tube end to the venti-
Automatic drain
system lator OXYGEN inlet. The
other end is connected to
the oxygen pressure supply.
CAUTION
Some breathing circuits may have water traps in the middle of the
inspiratory and/or expiratory path. Make sure these devices are airtight.
Any leak may cause a volume loss in the circuit.
While the ventilator is being used, make sure the circuit is always con-
nected to the patient and free from any obstructions. However, the fact
that no monitoring can replace the need for a close clinical observation by
trained personnel must be taken into account.
CAUTION
When the oxygen sensor is used for the first time, it should be exposed
to ambient air at least 20 minutes before connecting it to the ventilator.
✔ Nebulizer, if necessary.
WARNING
Do not use antistatic neither electrically conductive tubes in the
breathing circuit and gas supply.
The expiratory valve has a diaphragm inside. Once the valve is completely
assembled, it is screwed into the cabinet’s lower connection.
CAUTION
It is important to position the diaphragm correctly for the proper
operation of the ventilator. The diaphragm must be fitted into the valve
body so that the ring is left on the outer part. Cover it by screwing the
cover tightly.
NOTE
The altitude adjustment need be accomplished only once, unless
the ventilator is moved and the new location varies by more than 150 m
(500 feet) from the original location.
To make this operation, follow the next instructions:
➪ After the initial calibration procedure or during any other stage,
press the [Menu] key and select the Altitude Compensation row.
➪ The screen will show:
Sectors
The ventilation mode selection key is on the upper left
side.
On the upper left corner are the power source
indicators.
On the right hand side of the panel are the alarm light
indicators and the alarm control keys. There are also
other keys common to all operations (Menu, Control
and Escape)
To the center and to the top, there is the 12.1”-high
definition screen, which shows curves, graphs and
numeric data in a dynamic way. All of these represent
the equipment features and the patient’s response and
the capability to adapt its interface to the different
setting requirements.
Below the screen, there is a set of control keys used to
select the variables shown on the screen right above
each of the keys. They can also be used to change their
corresponding values.
The labeled keys located at the bottom of the
panel are common to all modes of operation.
On the lower hand right side, there is a rotary knob
to change the values or data selected by both
counter and clockwise rotations, and accepted by
pressing it slightly.
Description 15
1. Power Source • SIMV (PCV) + PSV
Synchronized Intermittent Ventilation with Pressure-Controlled manda-
• AC Wall Power tory inspiration, and with Pressure Support Spontaneous Inspiration.
• Battery • MMV + PSV
The LED which is lit shows the power source being used: Main AC Power Mandatory Minute Ventilation with Pressure Support Ventilation. The
Supply, internal Battery. Mandatory Minute Ventilation is a spontaneous ventilation mode with
pressure support. The difference in relation to the standard pressure
2. Ventilation Modes support is the automatic control of the pressure level. In MMV, the
initial pressure support level is set by the operator. The target minute
The followings described ventilation modes correspond to the Adult (ADL) volume to be maintained is selected. If the patient becomes depressed,
and Pediatric (PED) groups. The Neotatal ventilation mode is described the ventilator will gradually adjust the level of the inspiratory pressure
in Chapter 7. of each breath so as to reach the target minute volume.
The first selection of any mode should be done when the Operative Mode • PSV + VT Assured
menu is displayed after the calibration procedure. After this, the mode Pressure support with tidal volume assured. In this mode, the aim is to
selection is made pressing the [Mode] key on the left upper corner of the comply with a minimal tidal volume. The operator regulates the pressure
panel. support level and the target tidal volume. During inspiration, if the
• VCV Assist/Control target tidal volume is not attained when the flow has descended to the
Mode with specific regulation of the tidal volume. Breaths are started selected % of the peak flow, the ventilator changes the descend-
by the ventilator or by the patient. The end of inspiration depends on ing ramp flow wave to a rectangular wave (constant flow). As a result,
the values set by the operator. the inspiratory pressure increases until the volume are reached and, at
The patient’s inspiratory effort may start the inspiratory phase. The trig- that moment, the inspiration ends.
gering sensitivity may be pressure or flow regulated. A basic rate is also • APRV
regulated to ensure ventilation in case of a reduction in the inspiratory The Airway Pressure Release Ventilation is a mode which ventilates
effort. applying periodic switching between two adjustable levels (P-high and
• PCV Assist/Control P-lower) of continuous positive airway pressure (CPAP) during preset
Mode with specific regulation of the inspiratory pressure, where the periods of time. Spontaneous breathing can be done without restric-
breaths are started by the ventilator or by the patient. Inspiration is tion at both levels. The two levels of positive pressure, alternating to
controlled by pressure, triggered by time or by the patient’s inspiratory intervals of time selected by the operator, produce intermittent disten-
effort (pressure or flow sensitivity), pressure limited and time-cycled sion and passive decompression of the lungs. At the same time, and so
(given by the set inspiratory time or by the combination of the rate and much during the upper or lower level, the patient can breathe sponta-
the I:E ratio). The end of inspiration depends on the values set by the neously with or without pressure support.
operator. • NIV
• Pressure Support/CPAP Noninvasive ventilation (NIV) is referred as ventilatory support
A pressure-controlled spontaneous ventilation mode, where the patient through the upper airway using a mask or a similar device. This tech-
starts the inspiratory phase (sensitivity by pressure or flow) and cycled nique is differentiated from the invasive one that uses a tracheal tube,
primarily by flow (5% to 80% of the peak flow in 5 percent steps). a laryngeal mask, or a tracheotomy. This ventilator performs noninvasive
As a safety measure, the inspiratory phase also ends by pressure or ventilation with positive pressure and leaks compensation.
by time. • Pressure Regulated Volume Control (PRVC)
In CPAP, the flow varies to keep the set continuous positive pressure It is an assist/control mode used to obtain a target current volume
level. No mechanical positive-pressure breaths are delivered. The through the regulation of pressure controlled breaths.
patient's inspiratory effort is controlled with the sensitivity system. The
inspiratory flow demand can be regulated with the Rise Time control. Backup Ventilation
• SIMV (VCV) + PSV A programmable mode to assure ventilation in case of inspiratory weak-
Synchronized Intermittent Ventilation with Volume-Controlled manda- ness or apnea in the spontaneous ventilation modes such as Pressure Sup-
tory inspiration, and with Pressure Support Spontaneous Inspiration. port, SIMV in its two forms, MMV and PSV with VT Assured.
16 Description
3. Knob [TI] Inspiratory Time
It changes the inspiratory time at a rate of one tenth of a second in the
When a key corresponding to any variable is pressed, the set value will modes enabled. The I:E ratio is automatically modified.
highlight. With the knob the figure is increased or reduced. Pressing the The inspiratory time shown in the CPAP, Pressure Support, MMV and
knob, the value is accepted and the area returns to normal video. PSV+VT Assured modes is the resulting time and cannot be changed.
If a key is pressed and the value is not changed within 15 seconds, the
reverse video of that number returns to normal. This avoids any accidental [PEEP/CPAP]
maneuver. It is enabled in all modes. It programs a reference value for the positive
end expiratory pressure. The result obtained is checked in the PEEP
If during a change, that change is not accepted, pressing the [Esc] key the airway pressure reading.
number returns to the preceding value and the ventilator continues with
the prior programming. [I:E] I:E Ratio
It produces variations in the ratio of one tenth of the change unit, and
4. Controls Keys changes the inspiratory time automatically.
The inversion of the I:E Ratio may only be programmed in the PCV con-
The control keys activate the variables enabled to change or to accept the trolled mode.
setting depending on the selected ventilation mode.
[f ] Machine Rate - bpm
After the selection of the ventilation mode appear on the screen, with It establishes the rate of the mandatory inspirations. When the program-
default values, all ventilator parameters relate with the patient’s category ming includes the introduction of an inspiratory time, the changes in the
(adult, pediatric or neonatal), including default values of some rate produce automatic variations of the I:E Ratio; however, the inspira-
alarms.
tory time does not vary.
On the lower part of the screen are displayed the parameters which take [Sensitivity] Pressure-Flow
part of the selected ventilation mode. The innominate key positioned It is enabled in all the modes. There are two options: 1) Flow-triggered
below each parameter is activated in such a manner that pressing the key (Vtr) and 2) Pressure-triggered (Ptr) Sensitivity. The default value is
the sector will highlight. The parameter can be changed by turning the the flow-triggered option. By pressing the key again, the pressure-trig-
knob. Then push the knob to accept the change, or press the Esc key to gered option is enabled. In both cases, the values may be varied by using
abort the operation. the knob.
Down to the left of the screen appears the leading parameter of the se- [Expiratory Sensitivity]
lected ventilation mode: Volume (VT) or Pressure (PCV-PSV). Some param- Active in all spontaneous modes. Varying the percentage of the peak
eters always appear on the same place. These are present, with some flow it is possible to regulate the end of the inspiration. This way, the
exceptions, in almost all ventilation modes. expiratory trigger is obtained. The variations go from 5% to 80% of the
[VT] Tidal Volume peak inspiratory flow in steps of 5%. By default setting, the program
This key is enabled in the modes where volume is the main variable or establishes a 25% to finish the inspiration.
when it participates in a combined mode. [vE] Minute Volume
It is only enabled in the Mandatory Minute Ventilation mode.
[PCV] Pressure-Controlled
It is enabled in the PCV Assist/Control mode and when it is combined with [Rise Time]
other modes. It regulates the pressure level with values above PEEP. Selecting the icon, the pressurization can be changed with the knob. This ac-
tion takes place during pressure-controlled or pressure support ventilation.
[PSV] Pressure Support
It is enabled in the PSV mode alone or when combined with another [Flow Waveform]
mode. It regulates the pressure level with values above PEEP. In the volume mode, the flow waveform may be changed. By default, the
flow is descending ramp (decelerating flow). In the modes where the main
[FIO2]
variable is the pressure (PCV or Pressure Support), the flow is a descending
It is enabled in all modes. It produces variations in the oxygen concentra-
ramp type and cannot be changed.
tion of the outgoing gas leaving the ventilator. It is enabled in all modes.
Description 17
• Graphic Auto Scaling
5. Common Keys
• Trends
Above de control knob and below the innominate keys there are
several keys with specific functions. • Loops Saved
18 Description
To select a respiratory mechanic maneuver from a menu: To access an explanation of a selected field or a key as to achieve the in-
• AutoPEEP formation of the function or programming limits of each parameter.
• Dynamic and Static compliance
• Inspiratory and Expiratory resistance
• Trapped Volume
• Non-Forced Vital Capacity
• P0.1 While the graphics are active, [VERT] changes the vertical scale in two
• P/Vflex sizes depending on the graphic. The [HORZ] key changes the time from 6
• Pimax to 12 seconds and vice versa in the pressure and flow waveforms; in the
• Physiological VD/VT case of loops, it cganges the volume scale.
When this key is pressed a screen with six icons is opened representing It only freezes the graph being shown. The values and the airway pressure
the different number of configurations that the graphic interface can adopt. bars remain activated.
The selection is made by turning the knob.
During this period, any change of parameters is disabled.
Original screen showing the Pressure, Volume and Flow waveforms and the
Tidal Volume/Pressure and Flow/Tidal Volume loops. Pressing [Freeze]+[Ctrl] will keep the present loop as a reference loop.
Pressure and Flow waves.
Pressure, Volume and Flow waves.
Loops: Tidal Volume/Pressure, While one mode is on, if this key is pressed, a manual inspiration is started
Flow/Tidal Volume and Pressure/Flow. with the values of the selected mode. By pressing [Ctrl] first, a sigh starts if
it is programmed.
Patient additional data and Pressure,
Volume and Flow curves.
Right Bar
Instantaneous airway pressure
It shows the displacement of a digital bar. Furthermore, it displays,
through a red pointing, the set maximum and minimum alarm limits.
The lower part of the screen shows the parameters which take part of the
selected ventilation mode. Each parameter is activated pressing the in-
nominate key positioned below, then, the sector will get another colour.
Left Bar
The parameter can be changed turning the knob, and accepted pushing Battery
it or abort the operation pressing the [Esc] key. Indicates the level of charge.
Lung Icon
Patient Data Monitoring Activated in each spontaneous breath. Also, during
The upper area of the screen shows the resulting data according to the autocycling.
selected ventilation mode, and the default or set value of alarms, also, Peak
according to the ventilation mode and category of a patient. It shows the maximum pressure reached breath by breath.
Plateau
It shows the pressure maintained during inspiration when an
inspiratory pause has been programmed (VCV mode) or re-
sult of the Inspiratory Pause procedure.
Peak Flow - L/min- Mean
The Peak Flow is expressed in liters per minute. In all modes, it shows the It shows the last 10 breaths average of the mean airway pres-
maximum gas flow delivered by the ventilator and measured by the inter- sure.
nal pneumotachograph. PEEP
Inspiratory Time (Ti -s-) It shows the end pressure of the expiratory phase with or
The Inspiratory Time is expressed in seconds and corresponds to the total without PEEP.
time, set plus added (i.e.: inspiratory pause). High and Low Pressure Alarm Limits
High and low alarm levels characters. The setting is made
trough the [Alarm Setting] key.
20 Description
5
Breathing Circuit Verification
and Calibration
When the ventilator is started, the operating system of the ventilator Stage 2
makes a self-diagnosis of the program and of the electronic circuit.
During this test there are also a series of processes, some automatic ones A menu with the patient's options appears on the screen.
and others should be begun or accepted by the operator. These processes
have the purpose to check the operation of critical components, to cali-
brate the device and to present a menu of options to make the choice of
the different modes that could be used. This verification includes five
stages:
Stage 1
It comprises:
a) Confirmation of the integrity of the RAM and EPROM memories of the
electronic circuit and the Vent Inop alarm.
b) Test of operation of the proportional valves.
The selection is made by the control knob and is accepted by pressing the
knob.
The selection causes the default values of the parameters to
developed and produced by Tecme S.A. be displayed and the values for the backup and the emergency ventilation
to be within the average range for each group.
When a ventilation of any category of patient is going on, the change to
other group is only made in this initial screen. It means that the ventilator
should be turned off and then turned on again.
In order to change the type of humidified to be used, the knob is turned. Also it is possible to connect the Y in the conical metallic piece of the ped-
It is accepted pressing the control. The election of humidified, Active or estal as one is seen in the next picture.
Passive, allows to compensate the tidal volume according to the temperature.
In case of modifying the type of humidified during the ventilation of the pa-
tient, the user will be able to change, by means of the [Menu] key, the option
of humidification without making a new calibration of the circuit.
CAUTION
It is not possible to do calibration only using COMPRESSED AIR.
Stage 5
Accepted the previous stage, in the screen appears the progress of the
breathing circuit calibration process. WARNING
With this situation, the ventilation procedure could be carrying out
but, if the leak is significant, it can produce danger in the control of the
ventilation. It is convenient to inspect the circuit carefully, to change the
damaged sector or to close the breach in convenient form.
If the leak is more than 10 L/min, as a safety measure, the ventilator becomes
inoperative. Until the defect is not solved, the ventilator cannot be pro-
grammed. In the screen the following message appears:
The objective of this test is the calibration of the expiratory flow sensor,
the expiratory valve, the PEEP function, to detect the presence of leaks
and determine the oxygen supply quality. The bar indicates the progres-
sion of the test. Oxygen sensor test
During the final stage of the calibration process a test of the integrity of
CAUTION the oxygen sensor takes place which is located in the beginning of the
This calibration test should be made without the nebulizer con- respiratory circuit. This test includes two parts:
nected in the circuit. 1) To verify the presence of the sensor. If the sensor is not placed, the
message is the one of greater 10 L/min of gas leak shown before.
In this case the equipment will not continue the calibration procedure.
WARNING
This recalibration should be carried out with the breathing circuit
disconnected from the patient and closing the Y connector.
WARNING
The alarm default and setting values in the different
ventilatory modes must be checked and readjusted according to the patient
conditions.
Rise Time
The speed of the inspiratory pressurization may be varied by means of the
key corresponding to the rise time and the control knob, thus enabling a WARNING
better adjustment of the ventilator to the patient’s demand and lung
mechanics. The set pressure value is always above the PEEP, i.e., the total pres-
sure is equal to the set one plus the PEEP value.
Regulation
In the PCV mode, a broken line simulates the appearance Other parameters
of the pressure waveform. The change of shape is made The alarm default values, which depend on whether the ADULT or PEDI-
pressing the key below and turning the control knob to ATRIC option was selected, will be displayed on the screen. The
one or other side, making an increase or decrease the change of any value is accomplished through the [Alarm Settings] key.
pressurization speed, and the slope of the line shown on
The flow waveform is the descending ramp type and cannot be changed.
the screen serves as a guide.
The programming of nebulization is optional. The 100% O2 procedure is
This regulation is empirical and the result depends on the characteristics
available. Sighs and inspiratory pause are not operative. The beginning of
of the ventilated lung and on the regulated pressure. The simultaneous
an inspiration may be triggered with the [Manual] key.
visualization of the pressure waveform facilitates the achievement of an
appropriate setting.
A brief time will produce a quick pressurization, generating a rectangular
pressure waveform (characteristic of the pressure modes) and a deceler-
ated expiratory flow waveform.
Under certain circumstances, the rise up to a given pressure may be too
abrupt leaving a saw-tooth-like trace. These situations are solved by
modifying the rise time of the pressure waveform.
NOTE
In the modes where PSV is combined with PCV, the rise time regu-
lation influences both modes.
2) Inspiration
This sector includes: a) pressurization period and b) set pressure holding
period.
a) Pressurization
In this ventilator, the pressure support is programmed directly, alone or in
combination with other modes. The flow produced by the ventilator towards the respiratory circuit makes
the pressure begin to rise in the patient-ventilator system faster or slower.
The pressure support may be analyzed in three sectors of the respiratory The rise will be fast or slow depending on the peak flow. This peak flow
cycle: a) Beginning of Inspiration; 2) Inspiration and 3) End of Inspiration. acts as a system pressurization factor.
3) End of Inspiration
The inspiratory phase ends when during inspiration three types of
changes take place:
1) When the progressive decrease of the inspiratory flow reaches a given
percentage of the peak flow.
The tracings observed in the figure have the typical aspect of this ventila-
tory mode. The pressure rises quickly keeping a plateau while the demand
Other parameters
lasts. Simultaneously, the flow drops progressively until the point corre-
sponding to the percentage of the peak flow which will mark the end of The alarm default values, which depend on whether the ADULT or
the inspiratory phase. In this case, it is 25%. PEDIATRIC option was selected, will be displayed on the screen.
The change of any value is accomplished through the [Alarm Settings]
The pressure peak is 1 cm H2O higher than the set PS value. When Rise Time
key.
is appropriately set, a pressure peak 10% over the set one is accepted.
The programming of nebulization is optional.
Besides the expiratory time (TE), the inspiratory time (TI) is displayed. The
position of the TI value means that it is an inspiratory time with spontane- The 100% O2 procedure is available. The flow waveform is of the descend-
ous breaths, and that in this mode it is not programmed with the corre- ing ramp type and cannot be changed. The expiratory sensitivity may be
sponding key. The monitoring of TI during spontaneous ventilation is very varied between 5% and 80% in 5% steps.
useful to adjust the ventilator. Sighs and inspiratory/expiratory pause are not operative. The beginning
The monitoring of the tidal volume and of the minute volume is the main of an inspiration may be triggered with the [Manual] key. In the lung
objective of the procedure. The tidal volume is updated breath by breath. mechanics, only Vital Capacity and P0.1 tests are operative.
The minute volume is updated with each change of the graph cursor screen.
Monitoring
The upper part of the screen exhibits, breath by breath, the resulting values
of: Inspiratory Peak Flow, Inspiratory Time, I:E Ratio, Breathing Frequency,
Exhaled Tidal Volume and Minute Volume.
The left part of the screen shows the resulting airway pressures: Peak, Mean
and PEEP (CPAP level). The lung icon is shown in each effective inspiration.
Other parameters
The alarm default values, which depend on whether the ADULT or
PEDIATRIC option was selected, will be displayed on the screen.
The change of any value is accomplished through the [Alarm Settings]
key.
PEEP, nebulization, 100% O2, inspiratory pause and sighs for VCV can be
programmed. The flow type can be changed. Manual pressing produces a
mandatory inspiration. In the respiratory mechanics, only the Vital Capac-
ity and P0.1 tests can be performed. Backup Ventilation, by default, is
OFF, but it can be set ON.
When programming the pressure support, the Rise Time may be varied.
The expiratory sensitivity can be changed by means of a dedicated key.
Other parameters
The alarm default values, which depend on whether the ADULT or
PEDIATRIC option was selected, will be displayed on the screen.
The change of any value is accomplished through the [Alarm Settings]
key.
The activation of PEEP, nebulization, and 100% O2 can be programmed.
Manual pressing produces a mandatory inspiration. In the respiratory me-
chanics, only the Vital Capacity and P0.1 tests can be performed. Backup
Ventilation, by default, is OFF, but it can be set ON. The changes in the
Rise Time affect both PCV and PSV. To vary the expiratory sensitivity of
PSV, press [Menu] to have access to the change.
Other parameters
The alarms default values, those that depend on the patient's category,
are shown in the screen. The change of values is carried out by means of
the [Alarm Settings] key. This mode has, in addition, a non-compensated
leak alarm, and a mask disconnection alarm nonadjustable by the user.
Pressing the [Manual] key produces the beginning of an inspiration.
The respiratory mechanics is disabled. The 100% O2 control is disabled.
Other parameters
The alarm default values, which depend on whether the ADULT or
PEDIATRIC option was selected, will be displayed on the screen.
The change of any value is accomplished through the [Alarm Settings]
key.
PEEP, nebulization, and 100% O2 can be programmed. Manual pressing
starts an inspiration. In the respiratory mechanics, only the Vital Capacity
and P0.1 tests can be performed.
When programming the pressure support, the Rise Time may be varied.
The expiratory sensitivity can be changed by means of a dedicated key.
Condition
Controls and programming limits:
Thus, when the volume inspired by patient reaches or exceeds the target Other parameters
volume, the end of inspiration is cycled by flow as in an ordinary PSV. If
the inspired tidal volume is not reached when the flow reaches the set The alarm default values, which depend on whether the ADULT or PEDI-
percentage of the initial one, then the flow changes to constant flow and ATRIC option was selected, will be displayed on the screen. The
completes the target volume with a pressure increase. change of any value is accomplished through the [Alarm Settings] key.
PEEP, nebulization, and 100% O2 can be programmed. Manual pressing
produces a mandatory inspiration. Sighs are cancelled. In the respiratory
mechanics, only the Vital Capacity and P0.1 tests can be performed.
WARNING
In this mode, the airway pressure may rise to undesirable values
during the inspiratory phase (inadequate combination of parameters);
therefore, it is convenient to set the maximum pressure alarm limit at a
value close to the selected pressure support level.
Rise Time and the percentage of the flow change from decelerated to
continuous may be varied when programming the pressure support. The
rise time is regulated with the dedicated key in combination with de
knob.
The flow change in relation to the percentage of the peak flow, may be
adjusted from 5% to 80% in 5 percent steps.
Given the same conditions of lung compliance and resistance, a high per-
centage produces a brief inspiration (less inspiratory time), and a low per-
centage extends the inspiratory time.
When the mode has just been programmed, the default percentage is
25%. It can be changed by means of a dedicated key.
Other keys
They are operatives for general programming:
[FIO2]
With 0.50 as default value
[O2 100%]
For pre and post tracheobronchial suction oxygenation.
Alarm Limits
The alarm default values, which depend on whether the ADULT or
PEDIATRIC option was selected, will be displayed on the screen.
The change of any value is accomplished through the [Alarm Settings]
key. When this mode is activated, the ventilator delivers the patient a VCV
As in the other modes, once accepted all the values the following message respiration with the set target volume, a 0.5 sec. inspiratory pause and
appears: rectangular flow waveform. With the data gathered, the ventilator
estimates the system’s compliance and established the required pressure
Backup Ventilation level to reach the target current volume.
In this mode, the Backup Ventilation, by default, is OFF, but it can be set
ON. The first breath is delivered with the estimated pressure, and during the
Lung Mechanics following ones, the ventilator will either increase or decrease the pressed
level in order to keep the target volume.
In the lung mechanics, only Vital Capacity and P0.1 tests are operatives.
The pressure is regulated automatically from a minimum of 5 cmH2O
above PEEP up to a maximum of 5 cmH2O below the Maximum Pressure
alarm limit. These adjustments are made in steps which may reach to a
maximum of 3 cmH2O.
In case that the target current volume is not obtained since the maximum
limit (5 cmH2O) has been reached below the maximum pressure alarm
The maximum pressure alarm should be set accurately since it will When the TV obtained by the patient exceeds 100% the
determine the PCV regulation maximum limit. It should not be set below targ et TV f or o ne sa me pressu re
PEEP+10 cmH2O, and the PEEP should not be above the Maximum
Pressure alarm limit -10 cmH2O.
The minimum pressure alarm limit should be checked regularly since it can
activate in case of an automatic reduction of the pressure level below set.
Parameters to be set:
WARNING
In this mode, the airway pressure may rise to undesired values
during the inspiratory phase (inadequate combination of parameters);
therefore, the maximum pressure alarm limit should be properly
regulated.
In PCV, PSV/CPAP and SIMV (PCV) + PSV, the ventilator works as a pressure
controller with descending ramp flow, regulation of the Rise Time and
expiratory sensitivity for PSV. In TCPL, the ventilator works with continu-
ous flow, time cycled and regulation of the inspiratory pressure.
NOTE
In NEO, the following modes are inactive:
• MMV
• PSV+VT Assured
• APRV
Neonatal Programming 43
VCV Programming In this ventilator, when entering the mode selection, the descending ramp
flow is taken automatically by the program as the default flow waveform.
This decision was made considering that the GraphNet ventilator is de-
Controls and programming limits: signed to make it easier for the patient to adapt him/herself to the assist or
spontaneous modes.
Constant Flow Waveform
The constant flow produces a square waveform.
During the inspiratory phase, the pressure devel-
oped in the airway shows two sections. First there
is an initial fast increase as a result of a sudden
pressurization of the circuit as a consequence of
the continuous flow, which is considered to be a
reflection of the system resistive properties (resis-
Other parameters tance x flow). The second section has a less sharp
The programming of PEEP, sighs, inspiratory pause and nebulization is op- though progressive rise, and it depends on the
tional. The 100 O2 procedure is available. flow derived from the inspiratory time and the
regulated volume, and represents the system’s elastic properties.
When the programming is started, the descending ramp flow waveform
The pressure continues to rise until the end of inspiration, a point which coin-
(decelerating flow) is active by default, but may be changed at any mo-
cides with the stoppage of the flow.
ment. The descending ramp waveform produces the highest peak flow in
comparison to other waves, and may be more appropriate for patients with
assist ventilation. Inspiratory Pause
By pressing [Menu], selecting Ventilatory adjuncts and then the Inspira-
WARNING
tory Pause line, the following appears on the screen:
The volume control key [VT] regulates a drive reference value
which will not necessarily show the expired volume. This difference may
be as a result of multiple factors: circuit compliance, system air tightness,
positive end expiratory pressure, etc.
44 Neonatal Programming
Pressure-Controlled Ventilation (PCV)
Controls and programming limits:
The limit of the inspiratory pressure is adapted with the [PCV] key from 2
to 70 cm H2O.
For further information on the form of acting and the effects in the mode
PCV, consult the ventilator’s Programming chapter of this Instructions
Manual.
Pressure Control
With the [PCV] key, the inspiratory pressure limit is set from 2 to 70 cm H2O.
The default value is of 8 cm H2O.
Ti
It may be changed at rates of 0.1 s. The initial default value is 0.5 second.
When a value is changed, the set breathing rate is maintained while si-
multaneously the I:E ratio changes. Conversely, when the I:E ratio is
changed, variations depending on the set breathing rate are obtained.
I:E Ratio
Generally, this is a parameter which depends on the set inspiratory time
and rate. However, it may be directly programmed. By changing it, varia-
tions in the inspiratory time are produced.
Rate
Adjustable from 1 to 150 breaths per minute. It is a fixed parameter which
is not influenced by changes of the inspiratory time neither of the I:E ra-
tio. The initial default value is 18 cycles per minute.
Sensitivity
It has two options, it may be triggered by flow or by a negative variation
of pressure in the breathing circuit.
The flow-triggered sensitivity is taken as initial default value set at 2 L/
min; the variations are at a rate of 1 L/min at a time. The pressure-trig-
gered Sensitivity may be varied from 0.5 cm H2O up to 10 cm H2O below
PEEP.
Neonatal Programming 45
FIO2 Pressure Support/CPAP
It may be changed at the rate of one unit. By pressing the [FIO2] and [Ctrl]
keys successively, variations of 10 units are attained with the Selection Pressure support ventilation is a spontaneous ventilation mode where the
key. Initially, 0.50 is the default value. patient begins and ends the inspiratory phase; this means that he keeps con-
Rise Time trol of the frequency, the duration of the inspiration and of the tidal volume.
Since the ventilator’s cycling rate has not been set, these are modes with
completely spontaneous ventilation. Therefore, it is necessary to program
a backup mode which guarantees basic ventilation in case the ventilatory
inspiration cannot be triggered or if the inspiratory effort stops (apnea).
The backup menu appears on the screen the first time the mode is accepted.
46 Neonatal Programming
Continuous Positive Airway Pressure SIMV (VCV) + PSV
(CPAP) (SIMV [Volume-Control Ventilation] with
The programming of CPAP is the same of the Pressure of Support with PSV 0
Pressure Support)
(zero), and with PEEP set in an appropriate level. This mode contains synchronized intermittent ventilation with volume-controlled
It is a spontaneous breathing mode where the patient ventilates in a mandatory inspiration and spontaneous inspirations with pressure support.
continuous positive pressure system. There are no mechanical positive-
pressure breaths delivered, but the inspiration of the patient causes that the
ventilator generates a flow proportional to the demand. The patient’s effort
that open the flow valves is regulated by a sensitivity control.
During the inspiration, the airway pressure graphic shows a slight reduction
in relation to the base line of the continuous positive pressure and, during the
exhalation, an ascent of this pressure, that is to say, an inverse waveform as
seen during intermittent positive pressure.
The positive pressure level is regulated with the PEEP/CPAP key. The others
useful controls are the Rise Time to regulate the available inspiratory flow,
and the Sensitivity to adapt the inspiratory triggering to the effort of the
patient. When the ventilator does not sense airway pressure oscillations, it
assumes an apnea state beginning to ventilate with the Backup mode
previously programmed. The response time or of the “apnea time” is
adjustable between 5 and 60 seconds; 15 seconds is the default value.
Monitoring
The upper part of the screen exhibits, breath by breath, the resulting values
of: Inspiratory Peak Flow, Inspiratory Time, I:E Ratio, Breathing Frequency,
Exhaled Tidal Volume, Minute Volume and sent %O2.
The left part of the screen shows the resulting airway pressures: Peak, Mean
and PEEP (CPAP level). The lung icon is shown in each effective inspiration. Controls and programming limits:
Other parameters
PEEP, nebulization, 100 O2 and inspiratory pause can be programmed. The
flow type can be changed. Manual pressing produces a mandatory inspira-
tion. Backup Ventilation, by default, is OFF, but it can be set ON.
When programming the pressure support, the Rise Time may be varied.
The expiratory sensitivity can be varied from 5 to 80% in 5% steps.
Neonatal Programming 47
SIMV (PCV) + PSV Time Cycled-Pressure Limited (TCPL)
(Synchronized Intermittent Mandatory Ventilation
It is a mode that works with continuous flow, time cycled and with regula-
with Pressure Support) tion of the inspiratory pressure. It is programmed by means of Options of
the Combined Modes group.
In this form of synchronized ventilation, the patient receives pressure-con- NOTE: In this mode there is reading of the exhaled VT.
trolled inspirations, delivered at a preset inspiratory time and rate during Alarms: High and Low Tidal Volume are operative.
mandatory breathing. During spontaneous breathing, the patient may be
aided with pressure support.
This mode can work with or without backup programming. When backup
ventilation is not programmed, in the event of apnea the ventilation is
guaranteed by the mandatory rate and regulated parameters.
48 Neonatal Programming
Time Cycled-Pressure Limited + SIMV/PSV Continuous Flow CPAP (Nasal NIV)
In this form of synchronized ventilation, the patient receives during the It is a spontaneous ventilation mode with adjustable continuous flow and
mandatory breathings inspirations similar to those of the TCPL mode, sent positive pressure in the respiratory circuit. There are no cycles with venti-
with preestablish inspiratory time and rate. During the expiratory time, latory support, but when the ventilator does not sense inspiratory efforts
the patient can breathe spontaneously from the regulated base flow. begin to provide a programmed backup ventilation.
NOTE: In this mode there is reading of the exhaled VT. This procedure is applicable in invasive ventilation as well as in noninvasive
through nasal prongs, having the aptitude to allow compensation of
leaks (up to 10 L/min) to maintain the regulated positive pressure.
50 Neonate Programming
8
Respiratory Mechanics auto-PEEP
The respiratory mechanics program of the GraphNet ventilator includes
the following measurements: General
It is also referred to as intrinsic PEEP, is the dynamic unintended pulmo-
nary hyperinflation which occurs with mechanical ventilation when the
time interval between successive breaths is not enough to reestablish the
balance of the respiratory system.
It is an occurrence which may not be detected just by examining the pa-
tient. One way of assuming its presence is by analyzing the flow wave-
form during mechanical ventilation. If during expiration, the flow tracing
does not return to the baseline level before the next inspiration, it is very
likely that auto-PEEP may have developed. It may also develop during
mechanical ventilation with inverse I:E ratio.
Some tests are run breath by breath, such as dynamic compliance, the If there is suspicion of auto-PEEP, it is convenient to proceed to its investi-
value of which is displayed on the pressure/volume loop screen. gation.
This chapter deals with general aspects applied to these determinations as
well as with the instructions for the tests procedures. The compliance and Operation
resistance are run as a whole because the calculations are made during
the same maneuver with volumetric breaths and inspiratory pause. The test for auto-PEEP is available in all categories with controlled ventila-
As it will be seen when dealing with each specific option, the number of tion.
tests that may be executed depends on the ventilatory mode being used.
NOTE
If the patient has spontaneous or assisted breaths the test is not
carried out and the auto-PEEP is not calculated.
NOTE
In the assisted and spontaneous modes (PSV-CPAP, SIMV, APRV, Procedure
MMV, PSV+VT Assured and VNI) the auto-PEEP, Dynamic and Static Com- It is measured through a static maneuver. The patient must remain under
pliance, Inspiratory and Expiratory Resistance and P/Vflex cannot be controlled ventilation (by volume or pressure). The breathing efforts may
carried out. change the measurement; therefore, if the patient is alert, it is important
to instruct him in relation to the procedure so as to attain maximum relax
If some of these tests are selected, in the screen appears the following during the maneuver.
warning:
This function is not allowed in this mode.
Respiratory Mechanics 51
Expiratory pause Compliance and Resistance
For the auto-PEEP maneuver, the ventilator makes automatically, during
0.75 seconds an occlusion of the expiratory valve at the end of the The compliance of the respiratory system is one of the variables most
expiratory phase, thus producing an expiratory pause so as to measure the frequently measured during mechanical ventilation. Through this
accumulated transpulmonary pressure. maneuver, static compliance and dynamic compliance are determined.
In the next figure, the arrow shows the beginning of the test. Operation
The measurement of compliance and resistance are available in all
categories but not in spontaneous or assisted breaths and are carried out
simultaneously with the inspiratory and expiratory resistance.
Static Compliance
Static compliance is equal to the change in pressure necessary to produce
a given change in the volume (dV/dP). This ventilator calculates it as
follows:
VT
Static Compliance = ———————————
Pplateau – PEEP
Where CC is the ventilator circuit compliance.
Compliance and resistance are parameters of the lung mechanics which
are closely related to the pulmonary volume in relation to which they
were measured. The value attained in this measurement is absolute and is
not expressed in relation to the specific pulmonary volume in relation to
which it was measured, which is important at this moment of interpreting
the results.
The measurement is made in a respiration with the tidal volume range the
patient is being ventilated with, since both the compliance and the
Sequence resistance vary in relation with the tidal volume.
• Press [Resp Mech] key. In adults, the normal static compliance value varies between 0.06 and 0.10
• Select auto-PEEP by using the control knob. L/cm H2O (60-100 mL per each centimeter of insufflation pressure water)
• Press PAUSE Key to start. Dynamic Compliance
After this, the measurement begins. The result is displayed on the screen Dynamic compliance is calculated based on the pressure change which
as Total PEEP and auto-PEEP. takes place during the insufflation of a known volume according to the
When the maneuver finishes, the ventilator continues the ventilation with following formula:
the originally programmed mode. VT
The last result is kept in memory, and it is displayed in a new maneuver. Dynamic compliance = —————————
Pmax – PEEP
Expiratory Resistance
The measurement of the expiratory resistance is useful to assess the
response of bronchodilators in ventilated patients who suffer from
obstructive respiratory diseases. The modes with spontaneous respiration (SIMV, CPAP, MMV, PSV + VT
The formula used for its calculations is as follows: Assured, APRV and NIV) are not studied.
CTexp In order to measure compliance, the ventilator must be in controlled
Expiratory resistance = —————————————- ventilation (VCV or PCV). The test starts with an inspiratory pause of 0.75
Static Compliance seconds followed by an expiratory pause. The results are shown
simultaneously for dynamic and static compliance as well as for both
The expiratory resistance assesses the resistive characteristics of the
resistances. The compliance values are expressed in mL/cm H2O, and
airways during expiration and which is why it is not affected by the type
resistance in cm H2O/L/s.
of inspiratory flow wave used; this makes it possible to measure it during
the pressure modes. The expiratory resistance is almost always higher than It is expected that during the inspiratory pause, the alveolar pressure (distal
the inspiratory one since during its measurement several factors different pressure) enters in equilibrium with the airway pressure (proximal pressure).
from those participating in the inspiratory resistance are involved. Because the measurement during pressure-controlled ventilation is made
with descending ramp type flow, the result should be taken into account
when interpreting the data.
Sequence
• Press the [Resp Mech] key.
• Select Compliance, Inspiratory Resistance and Expiratory Resistance using the
knob.
• Press the knob to accept.
• Press Pause key to start
At the end of the maneuver, the ventilator returns to the original ventilatory mode.
Respiratory Mechanics 53
Trapped Volume Slow Vital Capacity
Vital capacity is the amount of air which may be expired after a maximum
Trapped volume is denominated to the amount of air that is within the
inspiration, and serves to assess the ventilatory reserve.
lungs due to the dynamic pulmonary hyperinflation, nondeliberate, that
happens in the mechanical ventilation when the time interval between The test of Slow Vital Capacity is available in Adult and Pediatric
successive breathings is insufficient to restore the position of balance of categories. The maneuver is inactive in the Neonatal category.
the respiratory system. The trapped volume can be measured, when suspi-
cion of its presence exists or autoPEEP or intrinsic PEEP has been verified. Procedure
For this test, the ventilator automatically selects the CPAP mode with PSV
0 (zero). The patient must be encouraged to make a maximum inspiration,
NOTE and then to exhale slowly up to the maximum possible expiration. The
maneuver must be slow.
The assisted and spontaneous modes are not studied. If the pa-
tient makes spontaneous ventilation, the calculation of trapped volume When Vital Capacity is selected, the screen changes to the flow/volume
does not take place. loop. The result shows the value of the last maneuver (Current) and the
best volume obtained after several tests (Best).
Procedure
In order to carry out the maneuver the GraphNet respirator makes a ma-
neuver static. The patient must remain with controlled ventilation (vol-
ume or pressure). The respiratory efforts alter the measurement,
therefore, if the patient is alert, it is important to instruct it with respect
to the procedure to obtain, during the maneuver, a maximum relaxation.
The obtained value is shown in screen. When another maneuver takes
place, the previous value is shown.
Sequence
•Press the [Resp Mech] key.
•Select Vital Capacity.
•Press the knob to accept.
•Press Pause key to start.
The ventilator changes the original ventilatory mode to CPAP + PSV = 0. The flow/
volume loop is displayed on the screen. After this, the measurement begins.
As many measurements as desired will be made during a period of no more
than 90 seconds. After this time, the ventilator automatically returns to the
original ventilatory mode. If more measurements are required, another
sequence should be started.
54 Respiratory Mechanics
Occlusion Pressure During the First 100 ms Inflexion Points of the P/V curve (P/Vflex)
of Inspiration (P0.1) The changes in the pulmonary mechanics that happen in the acute
respiratory failure can be monitored by means of a serial measurement of
The purpose of this test is to assess the patient’s capacity to resume
the inflection points of the Pressure/Volume curve. The method used by
spontaneous ventilation by measuring the inspiratory pressure during 100
the GraphNet ventilator for this investigation, is the low constant flow
milliseconds (P0.1). In this ventilator, the measurement of P0.1 is available
technique. With this approach, the lower inflection point (Lip) and the
in ADL and PED categories. The maneuver is inactive in the Neonatalt
upper inflection point (Uip) can be figured out.
category.
The data from the Lip have application in the setting of the ideal PEEP
The determination of P0.1 does not require the patient’s cooperation;
level able to avoid an alveolar collapse or lung injuries by the successive
furthermore, it needs an unnoticed occlusion maneuver to take place.
collapse and opening of the alveoli (atelectrauma). The Uip represents the
transition towards the pulmonary over distension, showing the maximum
Procedure limit of pressure and volume that can be set during the mechanical
When selecting the test in the Respiratory Mechanics menu, the ventilator ventilation.
changes to CPAP mode with zero PSV. At the beginning of the maneuver, Like a complementary datum, during this maneuver also the average
the ventilator analyzes the respiratory cycle during two breaths, identifying value of the compliance is attained (Cmax).
inspiration and expiration. During the last expiration, there is occlusion of
the inspiratory valve, while the expiratory valve remains open. Procedure
The measurement of P0.1 begins when the ventilator detects a pressure
drop of –0.5 cm H2O in relation to the baseline pressure level. As from this Measurement of P/Vflex is available in VCV and PCV modes of ADL and
moment, the count of 100 ms begins and P0.1 is measured. PED categories. The patient must be intubated and ventilated with
controlled mode, that is to say, without spontaneous breathing.
At the end of the maneuver, the ventilator returns to the original ventilatory
mode and the screen freezes showing the value obtained for P0.1. After pressing [Respiratory Mechanics] key, select P/Vflex option. An X/Y
axe appears in the screen where the curve will be traced during the test.
Respiratory Mechanics 55
On the right of the screen, it can be seen the default values of the Maximum Inspiratory Pressure (Pimax)
pressure (Pmax) and the tidal volume (Vmax) allowed during the
procedure. Both values also compose the scales of the grid. These values Pimax is an index which assesses the maximum contractile capacity that the
can be changed by the operator. Pressing the [Menu] key the line of Pmax inspiratory muscles, especially of the diaphragm.
changes to reverse video allowing the change. Once accepted one goes to
the Vmax line and a change can be made, if it is necessary. Pimax not only reflects the function of the respiratory muscles in isolation,
but it may also be affected by the modifications that may occur at any
The maneuver begins when the knob is pressed producing the point where the muscular contraction generates (central nervous system,
following actions: conduction pathways, neuromuscular junction, mechanical situation of the
1) The ventilator makes a 3 seconds expiratory pause with zero PEEP. muscle, peripheral receptors, etc.)
2) The low flow insufflation (4 L/min) starts with 100% O2. Procedure
3) An ascending curve is drawn progressively.
Pimax measurement can be performed in cooperative or non cooperative
4) The maneuver ends when the set volume or pressure is reached, anyone patients.
is first. The test can be stopped pressing [Esc] key.
When selecting the test in the Respiratory Mechanics menu, the ventilator
5) At the end of the test, the ventilation of the patient is reassumed with enters the CPAP mode automatically with PSV=5 and PEEP=0. At the
the mode and parameters programmed. beginning of the maneuver, the ventilator analyzes the respiratory cycle
6) To the left of the grid, it is shown the following results: during 2 breaths, identifying inspiration and expiration. During the last
Lip: xx cm H2O expiration, there is occlusion of the inspiratory valve, while the expiratory
Uip: xx cm H2O valve remains open.
Cmax: xx mL/cm H2O
56 Respiratory Mechanics
Sequence
• Press [Resp.Mech.] key.
Physiological VD/VT calculation
• Select Pimax from the menu on the screen. NOTE: For this calculation to be made, the Capnograph must be
• Press knob to accept. connected.
• Press Pause key to start
This option allows the measurement of the Physiological Dead Space. The
Bohr-Enghoff equation is applied. An arterial blood sample must be
The ventilator changes the original ventilatory mode for
obtained in order to measure the PaCO2.
PSV=5 and PEEP =0, after this, the measurement begins as previously
explained. The operator must follow the steps below:
During the measurement, the screen will show negative deflections of the
airway pressure during the occlusion. Enter the Respiratory Mechanics menu and select the physiological
VD/VT calculation option.
The measurement may finish in 2 ways:
Press (Enter) to save the current patient’s PeCC>2.
• Automatically, 20 seconds after the occlusion
Immediately, after this, the arterial blood sample must be
• Manually, at any moment, by pressing the [Esc] key. extracted, which will allow to obtain the PaCC>2 by means of
At the end of the maneuver, the ventilator returns to the original the right analysis.
ventilatory mode and the screen freezes showing the value obtained for • Once the PaCC>2 value is obtained, enter the physiological VD/VT
Pimax. menu again, press Enter and then turn the knob until the number matching
To return to the Respiratory Mechanics menu or to the original screen, the PaCC>2 value and press the knob (Enter) again to confirm the value
press [Esc] again. entered.
• The screen will show the calculated physiological VD/VT value
and will be saved with date and time and remain on the
screen until the next measurement is conducted.
Respiratory Mechanics 57
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58 Respiratory Mechanics
9
Trends
The possibility of seeing the tendencies graphs adds an important tool for Once selected it is possible to be acceded to 3 screens of tendencies that
the analysis of the ventilatory follow-up of the patients. The graphics, in show to 3 parameters each.
continuous up-to-date, include to the following parameters:
Trends 59
The parameters to select are the above mentioned but the EtCO2 trend is
only available when the Capnography option has been acquired.
Being in one of the screens of Trend another screen can be returned to
the trend menu by pressing the [Graphics] key. By means of the [ESC] key
one leaves to main screen.
The screen of trends shows a cursor which activates automatically. Moving
horizontally the cursor with the control knob, it is possible to pass to dif-
ferent graphics zones making a reading of the values and the hour of
such an event. Pressing the knob it is possible to modified the steps of
displacement of the cursor from 1 minute to 3, 9, 12, 24 or 72 minutes de-
pending of the selected time scale.
The horizontal scale can be modified pressing the [Horz] key (the first
horizontal axis is put in red) and then turning the control knob. In this
manner the screen visualization can be changed in 1, 3, 6, 12, 24 and 72 hs.
If [Horiz] + [Ctrl] is pressed, it will be able to make a displacement (scroll)
of the screen by means of the knob in steps of 30 min with the intention of being
placed in some point of interest. The three graphics change the horizontal
scale at the same time and the change is accepted pressing the knob.
The vertical scale can be modified pressing the [Vert] key and then turn-
ing the control knob to modify the range. The first vertical axis changes to
red. To jump between the graphs presses the [Vert] key again. The
changes are accepted pressing the control knob.
Pressing the [Vert] + [Ctrl] key the position of the reference zero line of
the selected scale can be modified. The trends can be copy in a computer
by means of the VisualNet® software to be save and to be analyzed in
detail.
The next pictures show some trends with the cursors indicating
parameter's values.
60 Trends
10
Capnography
The Capnography function is an optional procedure in the GraphNet
ventilator. It allows to the monitoring of the CO2 Curves/Time and
Volumetric Capnography by means of continuous visualization in the
screen. In addition, there are other derived parameters, such as ETCO2,
VD/VT ratio, serial dead space (VD), alveolar tidal volume (VA), minute
alveolar volume (VA min), CO2 tidal volume and CO2 removal (VCO2). All
the results are shown in the screen with permanent update.
Implementation
In order to activate this optional function, the software key should be
acquired in TECME to place it in the memory of the ventilator (1). It is a
simple procedure that it can be made by the user.
A Capnostat 5 (optional accessory) provided on demand (Respironics
®
Capnograph Components
1. CO2 Sensor
2. Ventilator input socket
3. Cable and capnograph connector
4. Adapter CAUTION
The adapter has two circular windows that must be maintained
clean to get a correct reading . For the same reason, if an aerosol method
is used, a deposit of aerosol drug in the windows of the adapter also can
alter the operation of the device.
CAUTION
When a passive humidifier is used, it must be connected between
the patient and the adapter with the intention to reduce water conden-
sation in the windows of the adapter.
_____________________
(1) www.tecme.com.ar
Capnografhy 61
Capnograph connection Other functions of the Capnograph Menu
Place the CO2 sensor in the adapter (a click will be perceived when it is The Capnograph menu shows other options that are used less frequent.
placed correctly).
Sensor initialization
When the sensor is connected while the ventilator is working will appear
CAUTION a message of State: Sensor ERROR. In this case, the sensor should be acti-
Before turning the ventilator on, connect the capnograph to the vated. In order to do it the control knob should move to the option Acti-
ventilator in the input socket located on the right and on the patient’s gas vation of Sensor and press the control. If the activation is correct the state
outlet. of the sensor will change to State: Sensor OK, otherwise will continue
showing ERROR.
The sensor's heating begins when the ventilator is turned on. Once the
When the sensor is connected but persists the state of ERROR, is necessary
process is complete the “Sensor OK” message is shown on the screen.
to perform the activation. Within the activation process also the sending
The Capnography screen activates automatically when the Capnograph is of the barometric pressure data and the compensation of the oxygen mix-
connected. During heating, a displacement of the baseline may occur ture (FIO2) takes place.
toward negative values and the low C02 alarm may also be activated. These
situations are corrected once the heating period is over. Saving sensor parameters
The CO2 screen shows, on the left side: Pressure, Volume, Flow and This option is used in the case of receiving the message "Sensor not initial-
CO2/Time curves, whereas the volumetric Capnography curve is located in ized". When positioning in the option “Save sensor parameters” and to
the right lower side (CO2/Volume). The numeric data and the messages press the control knob, the ventilator would send only the values of the
related to the operation of the capnography are shown in the upper part. barometric pressure and the compensation of oxygen of the equipment.
By pressing the Graphics key, and selecting the CO2 screen, the Its utility is in which it is not necessary to do the boot again, but will only
capnography screen is entered when the current screen shows other send the parameters previously named. When in the equipment the pa-
graphs. rameters of barometric pressure and/or FIO2 are modified, these changes
would be sent automatically to the sensor.
Zero: In case of receiving the message “Zero required”, the calibration to
zero of the sensor should be doing. By means of the zero the sensor will
accommodate its optical characteristics to the different types of adapters.
In case of changing the adapter, it is recommendable to make a zeroing
with the intention of keeping an optimal precision in the measurements.
In order to adjust zero, the sensor and adapter should be disconnect from
the patient and to expose it to the ambient air (the adapter does not have
to contain CO2 residues), positioned in option zero value and when the
conditions are the previously mentioned ones comes to press the control.
The zeroing can last 30 seconds at the most.
Reset: it is used in exceptional situations when the necessity exists to
reinitiate the sensor without having to make a disconnection and later
reconnection of the sensor.
62 Capnography
Messages that can appear Results: The data with the result are shown in the following screen:
Breathing CO2 not detected: This message appears in case of detecting
breathings that do not contain CO2.
CO2 out of rank: It appears when the detected CO2 value is higher than
150 mm Hg. In case this error persists, a zeroing should be done.
Check airway adapter: It usually appears when the sensor is withdrawn
of the adapter or when there is an optical blockade of the windows of the
adapter. It can also be caused by a fault in the zeroing in case of changing
adapter or when CO2 persists inside the adapter at the time of zeroing.
Correction: To clean adapter or if this still clean a zeroing should be made.
Sensor fault: It can appear when a deviation of the power source out of
factory calibration or outside the operation specifications happens. Cor-
rection: To control if the sensor is correctly connected to the ventilator. If
the error persists, contact to the Authorized Service.
Sensor not initialized: It happens when the barometric pressure or the
compensations by gases was not performed at the time of turning on the
ventilator. Correction: To initialize the sensor or to keep parameters from
the sensor by means of the dedicated options in menu of Capnograph.
Zero in progress: It appears when the zeroing to begin.
ETCO2: Partial CO2 pressure at the end of expiration
Make a zeroing: When there is an inconvenience during a zeroing (ex:
Vd/Vt: Ratio between the Serial dead space and the current volume.
dirty adapter) Correction: To repeat the adapter zeroing.
Heating Sensor: The sensor has still not reached the operating tempera- Vd: Serial or anatomical Dead space volume of each breath.
ture or when the temperature is unstable, which can happen at the begin- Va: Alveolar volume of each breath.
ning of operation.
VtCO2: CO2 expired volume per breath.
Overheated sensor: Internal temperature of the sensor over operation
rank. Correction: To verify that the sensor it is not exposing to external VCO2 (STPD): CO2 elimination per minute corrected at STPD
sources of heat (lamps or stoves). In case of persisting to contact to the PeCO2: Mean expired CO2 partial pressure.
Service.
Capnografhy 63
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64 Capnography
11
Care and Maintenance
All parts in contact with the patient are easily disassembled for a com-
plete cleaning. Thus, the different parts are then conveniently sterilized CAUTION
and reassembled, being ready for later use. Ethylene oxide IS TOXIC. All components must be completely dried
The procedures indicated herein for the decontamination and cleaning of before packing them for sterilization with ethylene oxide. After steriliza-
the device are to be used as a guideline. These guidelines may be adapted tion, they must be appropriately aired to dissipate the residual gas ab-
to the protocols on methods and frequency of each department bearing sorbed by the material. Follow the manufacturer’s recommendations as to
in mind the warnings stated herein. the aeration period.
WARNING
The ethylene oxide may alter the surface of the plastic materials
and accelerate the aging of the rubber components.
CAUTION
The valve has in the
middle internal part a membrane,
the integrity of which is essential
for an adequate reading of the
expired volume. When cleaning
this piece, be careful not to dam-
age the membrane. Diagram of the Respiratory Circuit
The expiratory valve has a dia-
phragm inside. When completely
assembled, it is screwed into the
lower connection of the enclosure.
WARNING
Every time the exhalation valve
is cleaned it should be completely
disassembled.
CAUTION
A correct position of the dia-
phragm is essential for a correct
operation of the ventilator. The
diaphragm must be placed in the
body of the valve so that the ring
is looking outwards. Close with the
threaded cover tightly.
CAUTION
To replace diaphragm, always
use original spare part. Similar
parts can produce valve malfunc- NOTE
tion. To discard the whole device or disused parts or elements provided
by other suppliers, follow the requirements of the institutional authority.
➩ Alarms test: lamps and sound (Ctrl + Alarm Settings). To avoid any damage to the tubes, connect and disconnect them by hold-
ing them only from the silicone cuff. Do not pull or bend them from the spiral
➩ Replacement of the exhalation valve. part. Avoid any exposure to Ultraviolet (UV) light.
➩ Inspection and verification of the operation of each key and the screen.
Cleaning procedure
➩ Disassembling of the oxygen and air supply inlet with cleaning or
To avoid any damage to the tubes, follow the cleaning procedure indicated below.
change of the porous metallic filters. The tubes must be cleaned with soft detergent followed by water cleaning before
➩ Verification of FIO2 (oxygen concentration) with and appropriated disinfection. Any of the following disinfection methods is satisfactory:
measuring device. • Autoclave – 132°C/ 270°F • Pasteurization – 75°C / 170°F
➩ Verification of sensors. • Ethylene Oxide – 55°C / 131°F • Hydrogen peroxide gas plasma
➩ Verification of updates of software. The exact process must follow in each case the standard hospital or institutional procedure.
➩ Control of the battery. The following solutions MUST NOT be used. They may cause disintegration of
the tubes:
➩ Verification of panel LEDs.
Hypochlorite Formaldehyde
➩ Opening of back cover and cleaning of the fan. Chlorinated hydrocarbons Inorganic acids
➩ Visual verification of internal manifolds. Phenol (>5%) Acetone
Aromatic hydrocarbons
➩ Cleaning of contacts and internal connections.
The tubes must be inspected to ensure there is no damage after disinfection. Care
➩ Pressure control of internal regulators. must be taken, as recommended in all autoclave procedures, to clean all organic
➩ Recalibration of the pneumatic set including proportional valves. material from the tubes appropriately and to remove all residues of the cleansers
used. This is extremely important when an autoclave procedure follows disinfec-
➩ Final control of operation. tion with concentrated or diluted solutions. Any residual solution may cause
breaking or rupture of the material.
It is important to avoid the use of solutions containing chloride in the disinfection.
The polyester may break or form small holes after prolonged exposure to chlori-
nated solutions.
Maintenance warning The damage process may be accelerated if the tube is sterilized in autoclave or
dry-heated with residues of these solutions.
Every 5000 running hours a tool icon appears on the right superior An appropriate handling of the tubes is also important. Any contact of the tubes
part of the screen indicating the opportunity of service. The presence of with hot elements, shelves, etc. while in autoclave must be avoided. When the
the icon on the screen is eliminated by the authorized Service once the tubes are put away, it is important to avoid prolonged exposure to UV light. This
maintenance protocol is carried out. has a degeneration effect on the material of the tubes and, with time, it may
cause rupture or holes.
Operational Test 69
Pressure Operative Mode Apnea Alarm for Spontaneous Ventilation
Select [PCV Assist/Control] with the [Mode] key. Select Pressure Support Ventilation (PSV) with the [Menu] key.
Accept default settings pressing the control knob. Verify the functioning Accept default settings pressing the control knob.
changing the rise time. The Backup ventilation menu is displayed. Leave and accept default set-
ting pressing the [Esc] key.
Alarm and Safety Tests The Pressure Support Ventilation is ready to start. Squeeze the bag gently.
The ventilation waveforms are displayed.
Patient Disconnect (Low Pressure)
Stop squeezing. After 15 seconds the audible alarm should sound and in
Disconnect the test lung from the circuit. A patient disconnects warning, the same time an apnea warning will be displayed, and the ventilator will
activating the Low Pressure Alarm, will be displayed after 10 seconds and switch to apnea ventilation mode.
the alarm will sound with a displayed message. Reconnect the test lung.
Start squeezing the bag. PSV will resume.
The alarm will turn OFF and the LED will remain lighting until the [Esc]
key is pressed. The apnea parameters: mode, time and SIMV with or without backup, can
be changed.
High Pressure
Return to VCV and resume volume ventilation.
Set the alarm limit to 30 cm H2O. During inspiration squeeze the bag
strongly and quickly. A high-pressure warning will be displayed and the Silence
alarm will sound immediately. At the same time, the expiratory valve will Push the [Silence] key to silence audible alarms. The alarm silence LED
open decompressing the circuit. will turn on. The light and sound OFF will remain 30 or 60 seconds accord-
Release the test lung. The alarm will turn OFF and the LED will remain ing to the press sequence: one for 30 s, twice for 60 s.
lighting until the [Esc] key is pressed.
AC Disconnect
High and Low Tidal Volume Disconnect the AC power cord from the outlet. The warning screen will
These alarms are active in all modes. appear as the alarm sounds and the left LED of the Alarm row will light.
The signal will remain until the power AC is reconnect.
Start VCV with default parameters. Select High Tidal Volume alarm and
decrease the setting to 300 mL. A High Tidal Volume warning will be dis- The icon of the battery that appears in the screen indicates the remaining
played after 10 seconds and the alarm will sound. Press [Silence] on the load.
keypad and reset the high tidal volume alarm using the procedure de-
High and Low Minute Volume
scribed above 400 mL.
These alarms are active in Mandatory Minute Ventilation mode only.
The Low Tidal Volume alarm is checked in the same manner as the High
Tidal Volume, except the Low Tidal Volume setting is selected and in- Start MMV + PSV with default parameters. Select High Minute Volume
creased to a level above 400 mL. A Low Tidal Volume warning will be dis- alarm and decrease the setting to 5-6. Squeezing rapid the bag, the
played after 10 seconds and the alarm will sound. minute exhaled volume will increase. A High Minute Volume warning will
be displayed after 10 seconds and the alarm will sound. Press [Silence] on
Press [Silence] on the keypad and reset the low tidal volume alarm to 200 mL.
the keypad and reset the high minute volume alarm using the procedure
High Rate described above to 10-12.
Set the alarm limit to 20 bpm. Simulate spontaneous breaths squeezingthe bag The Low Minute Volume alarm is checked in the same manner as the High
in such a manner to get more than 20 bpm. After 30 seconds, aHigh Rate Minute Volume, except the Low Minute Volume setting is selected and
warning will be displayed and the alarm will sound.Press [Silence] on the keypad increased to a level above 6 and the bag is squeezed slowly. A Low
and reset the High Rate alarm. Clear thealarm LED by pressing the [Esc] key. Minute Volume warning will be displayed after 10 seconds and the alarm
will sound.
Press [Silence] on the keypad and reset the low minute volume alarm to 3-4.
The Functional Tests are now complete. If all tests were
acceptable, the ventilator is ready for use.
70 Operational Test
Operational Verification Test
In addition to the Ventilator Operation Tests performed by the user, the
ventilator performs an automated Operational Verification Test each time
the power is turned ON and during the breathing circuit calibration pro-
cess. To perform the Operational Verification Test the ventilator builds
pressure by applying constant pressure of ~ 40 cm H2O, and tests for a
patient circuit leaking.
When a leak of gas exists for any part of the circuit less than 10 L/min, it is
warned with the following message:
ATTENTION:
A LEAK OF xx L/MIN WAS DETECTED
IT CAN PRODUCE ERRORS IN:
EXPIRATORY VOLUME, PEEP AND SENSITIVITY
IF THE LEAK IS SOLVED: RECALIBRATE THE CIRCUIT
When a leak is less than 10 L/min, and you proceed to program and to venti-
late, it appears in permanent form, to the foot of the square of graphics, the
following message:
THERE IS A CIRCUIT LEAK OF xx L/MIN
If the leak is more than 10 L/min, as a safety measure, the ventilator be-
comes inoperative. Until the defect is not solved, the ventilator cannot be
programmed. In the screen the following message appears:
ATTENTION
ESCAPE ABOVE 10 L/MIN
IMPOSSIBILITY OF MAINTAINING SUITABLE VENTILATION
CAREFULLY INSPECT THE PATIENT’S CIRCUIT
Operational Test 71
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72 Operational Test
Technical Data and Specifications 13
Application Pneumatic Requirements
Invasive and noninvasive ventilation of adult, pediatric and neonate Oxygen: Pressure: 3.5 to 7 bar (approx. 50-100 psi). Connector: DISS(1) 9/16"-18.
patients, including premature. Air: Pressure: 3.5 to 7 bar (approx. 50-100 psi). Connector: DISS(1) 3/4"-16.
NOTE
WARNING Within these limits, gases may have different pressures. The gases
Do not use this ventilator in presence of flammable anesthetics.
must supply a flow of up to 180 L/min.
There may be danger of explosion or fire.
Classification Environment
Risk: Class IIb (Council Directive 93/42/EEC); Class III (MERCOSUR/GMC/RES. Storage Temperature: From -5°C to 70 °C.
N° 40/00) Operating temperature: From 15 to 35 °C.
Electric isolation: Class I, Type B Relative Humidity: 0% to 95%, non-condensing.
Protection: IP21 Ventilation Modes
Operation: Continuous ventilator Adult and Pediatric Patients
Execution Characteristics • Volume-Controlled Ventilation (VCV), Assist/Control
• Pressure-Controlled Ventilation (PCV), Assist/Control
Software: Developed by TECME, TECME’s proprietary software.
• Pressure Support Ventilation (PSV)
Hardware: 200 MIPS ARM 9 32 bits microcontroller. • Continuous Positive Airway Pressure (CPAP)
- Digital analog and watchdog protection. • SIMV (VCV) + PSV
- Digital control of the battery. • SIMV (PCV) + PSV
• Mandatory Minute Ventilation (MMV) + PSV
- Digital backlight control.
• PSV + VT Assured
- Digital audio processor. • Airway Pressure Release Ventilation (APRV)
Memory: Total memory capacity: 512 Kb. • Noninvasive Ventilation (NIV)
• Pressure-Regulated Volume Control (PRVC)
Panel with Screen
Neonatal Patients
Waterproof elastic sheet. Keys with microswitch. 12"1 TTF-LCD 800x600 dots
• Volume-Controlled Ventilation (VCV), Assist/Control
screen; 262,144 colors, antiglare. SVGA 2Mbyte Memory Video Controller.
• Pressure-Controlled Ventilation (PCV), Assist/Control
Connectivity • Pressure Support Ventilation (PSV)
- RS-232C Type with DB-9 connector. • CPAP + PSV
• SIMV (VCV) + PSV
Power Requirements • SIMV (PCV) + PSV
Main current • Time Cycled-Pressure Limited (TCPL)
• TCPL/SIMV + PSV
110 to 220 VAC 50-60 Hz. Automatically switchable voltage.
• Continuous Flow CPAP for Nasal NIV
Internal battery Backup Ventilation: For adult and pediatric patients, it is programmed
12 VDC; 4.4 Ah. Automatic recharge. Can supply 2 hours 30 minutes of volume (VCV) or pressure (PCV). For infant patients, it is programmed
power when fully charged. Charge level indicator. volume (VCV), pressure (PCV), or Time Cycled and Pressure Limited (TCPL).
(1) According to: Compressed Gas Association CGA V-5-2000,
Diameter-Index Safety System (USA).
Technical Data and Specifications 73
Parameter Selection Alarms
(Depending on the operative mode and patient category: adult, All the alarms are visual and audible, and are accompanied by a screen
pediatric, neonatal) message. The system maintains stored with a name, date and hour the
last 600 events in a printable and nonerasable registry.
Tidal Volume: 5 to 2500 mL
Minute Volume: 1.0 to 45 L/min
High Priority Signals
Inspiratory Time: 0.1 to 30 s (30 s in APRV) High Inspiratory Pressure: 10 to 120 cm H2O.
Precision
Parameter Limit (max–min) Precision
Default
Standard Accessories (direct regulation Steps of Increment
setting Limits
or result)
• Reusable adult breathing circuit ( 22 mm) with water traps,exhalation change Control
flow sensor with expiratory valve. ADL: 0.050 – 2.5 ADL: 0.010 ADL: 0.400 ± 10% Precalibrated screen
Tidal Volume pneumotach related
PED: 0.005 – 0.300 PED: 0.001 (*) PED: 0.050
• Flex arm for breathing circuit. (Liters)
NEO: 0.005-0.050 NEO: 0.001 (*) NEO: 0.020
VT<20ml
with differential
± 2ml+10% transducer
• Air and oxygen high pressure hose with DISS connectors. ADL: Up to 45 ADL: 6.0 Precalibrated screen
Minute Volume pneumotach related
PED: Up to 45 0.100 PED: 4.0 ±10%
• Compressed air water trap. (Liters)
NEO: NA NEO: NA
with differential
transducer
• Test lung. Inspiratory Time (**)
ADL: 1.0
0.1 – 30 (APRV) 0.01 PED: 0.6 ± 0.06 s Crystal quartz
(seconds)
• Power cord. NEO: 0.5
I:E Ratio NA
• Pedestal: Four-wheel stand. (enabled in PCV)
5:1 a 1:599 0.1:0.1 Crystal quartz
Inspiratory Pause
Warranty Period (enabled in VCV)
0, 0.25, 0.5, 0.75, 1.0,
1.25, 1.5, 1.75, 2.0
0.25 0 (OFF) ± 0.06 s Crystal quartz
(seconds)
One year warranty on material and workmanship. Precalibrated screen
Continuous Flow: pneumotach related
2 – 40 L/min 1 L/min 8 L/min ±10%
NEO (L/min) with differential
transducer
Pressure Limited: 2 – 70 cm H2O 1 cm H2O 10 cm H2O ±2 Pressure transducer
NEO (cm H2O) cm H2O
Manual
7 s max
Inspiratory Pause (sec)
Manual
20 s max
Expiratory Pause (sec)
Precision
P re s s u re P e a k , P la te a u , M e a n a n d P E E P ± 2 c m H 2O o 1 0 % Control Limit (max–min) Default Precision
Increment
E x p ire d T id a l V o lu m e ± 10% Event Steps of change setting Limits Control
In s p ira to ry F lo w ± 10%
High Inspiratory ADL: 40
M in u te V o lu m e ± 10% ±2
Pressure 10 (>min) – 120 1 PED: 30 Pressure transducer
cm H2O
R a te P ro g ra m m e d a n d S p o n ta n e o u s ± 1 bpm (cm H2O) NEO: 25
In s p ira to ry T im e ± 0 .0 6 s Low Inspiratory ADL: 5
±2
Pressure 1 (or <max) – 9 1 PED: 5 Pressure transducer
cm H2O
E x p ira to ry T im e ± 0 .0 6 s (cm H2O) NEO: 2
I:E R a tio NA ADL: >VTmin 3.0 ADL: 0.050 ADL: 0.600 Precalibrated screen
High Tidal Volume (1) pneumotach related
PED: >VTmin 0.5 PED: 0.010 PED: 0.075 ±10 %
O 2 P e rc e n ta g e ± 3 V o l% (L) (2) with differential
NEO: >VTmin 0.1 NEO: 0.005 NEO: 0.050
transducer
ADL: 0.010 <VTmax ADL: 0.010 ADL: 0.150/0.200 Precalibrated screen
Low Tidal Volume (1) pneumotach related
PED: 0.001 <VTmax PED: 0.005 PED: 0.025 ±10 %
(L) (2) with differential
NEO: 0.001 <VTmax NEO: 0.001 NEO: 0.005/0.010
transducer
Precalibrated screen
High Expired ADL: >min – 50 ADL: 0.5 ADL: 9.0
pneumotach related
Minute Volume PED: >min – 50 PED: 0.5 PED: 6.0 ±10 %
with differential
(MMV only) (L) NEO: NA
transducer
Low Expired ADL: 1 – <max ADL: 0.5 ADL: 4.5
±10 Variable orifice
Minute Volume PED: 1 – <max PED: 0.5 PED: 3.0
Vol% pneumotach
(MMV only) (L) NEO: N/A
High: 25 – 110 High: 60 ± 3 Vol
Oxygen % 1% Oxygen sensor
Low: 18 – 95 Low: 40 %
Oxygen
18% or less NA NA NA Oxygen sensor
not adequate
Precalibrated screen
NIV mask pneumotach related
NA NA NA ±10 %
disconnection with differential
transducer
Precalibrated screen
ADL: 50 L/min
pneumotach related
NIV leak NA NA PED: 30 L/min ±10 %
with differential
NEO: 10 L/min
transducer
Apnea
5 to 60 5 15 ± 0.06 s Crystal quartz
(seconds)
Loss of PEEP ADL - PED: 2 ±2
(cm H2O) OFF, 2, 4, 6 cm H2O Pressure transducer
NEO: 2
ETCO2 (mmHg) Max: >min – 150 1 Max: 50 ± 0-40:2 Sensor de capnografía
Mín: 1-<Máx Min: 30 41-70: ±5% Capnostat 5
71-100:±8%
101-150:±10%
(1) 1 to 30 increments 0.001 L; 30 to 100 increments 0.005 L, and >100 increments 0.01 L
(2) 1 to 30 increments 0.001 L; 30 to 100 increments 0.005 L
RF EMMISIONS The me equipment or me system uses RF energy only for its internal
Group 1
CISPR 11 function. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Separation distances according to frequency of transmitter
RF EMMISIONS CLASS B B
CISPR 11 150 kHz to 80 MHz outside 150 kHz to 80 MHz in ISM 80 MHz to 800 MHz 80 MHz to 2,5 GHz
Rated maximum output ISM bands. bands
Harmonic power of transmitter
emissions CLASS A A (W)
IEC 61000-3-2
0.01 0.12 0.12 0.12 0.23
Voltage 0.1 0.37 0.38 0.38 0.73
fluctuations COMPLIES COMPLIES 1 1.17 1.2 1.2 2.3
flicker emissions 10 3.69 3.79 3.79 7.27
IEC 61000-3-3 100 11.67 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
Guidance and manufacturer´s declaration - electromagnetic inmunity
in meters can be determined using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
The me equipment or me system is intended for use in the electromagnetic environment specified below. The NOTE 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.725 MHz
customer or the user of the me equipment or me system should assure that it is used in such an environment. to 6.795 MHz; 13.553 MHz; 26.957 MHz; and 40.66 MHz to 40.70 MHz.
NOTE 3: An additional factor of 10/3 has been incorporated into the formulae used in calculating the
Inmunity test IEC 60601 test Electromagnetic enviroment - guidance recommended separation distance for transmitter in the ISM frequency bands between 150 KHz and
level 820 MHz in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile portable
communications equipment could cause interference if it is inadvertently brought into patient areas.
Electrostatic
discharge 8EDS) 6 k V contact NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic
IEC 61000-4-2 8 k V air material, the relative humidity should be al least 30 %. absorption and reflection from structures, objects and people.
2 Kv for power
Electrical fast supply lines; 1Kv Mains power quality should be that of a typical commercial or hospital environment.
transient/ burst IEC for input /
61000-4-4 output lines
1 Kv line (s) to
Surge
line (s); 2 Kv
IEC 61000-4-5 line to earth Mains power quality should be that of a typical commercial or hospital environment
< 5 % U t ( > 95
% dip in Ut for
0,5 cycle)
Voltage dips, short 40 % Ut (60 % Mains power quality should be that of a typical commercial or hospital
interruptions and dip in Ut ) for 5
voltage variations environment. If the user of the me equipment or me system requires
cycles.
on power supply 70 % U t ( 30 % continued operation during power mains interruptions, it is
input lines. dip in Ut) for 25 recommended that the me equipment or me system be powered from
IEC 61000-4-11 cycles an uninterruptible power supply or a battery.
< 5 % Ut ( > 95
Power
frecuency 3 A /m
(50/60 HZ) Power frequency magnetic fields should be at levels characteristic of a typical
magnetic field location in a typical commercial or hospital environment.
IEC 61000-4-8
Paw cmH2O
40
Record of events 30
All the events are recorded in permanent non erasable memory. The list 20
of events appear in Alarm Activated trough the [Menu] key with date and 10
time in a sequence of up to 660 events. The data can be copied to a PC.
0
Silence 30-60 s 1s
When the Silence key is pressed once, the sound stops for 30 seconds; by
pressing it twice successively, there is a 60 second silence. The light indica-
tor and the screen message are not stopped. Any alarm event, while per- Analysis of the airway pressure during the respiratory cycle. (See the text).
sist, can not be permanently silenced.
Alarms 79
Change of alarm limits Default value:
ADL: 40 cm H2O
Initially, the alarms have values established by default de- PED: 30 cm H2O
pending on the ventilation mode and category of patient. NEO: 25 cm H2O
Before beginning the ventilation or during the procedure, Value change: With the [Alarm Settings] key.
the limits of the modifiable alarms by the user can be repro- Screen message: HIGH PRESSURE
grammed by means of the [Alarm Settings] key. Pressing Help: CAUSES
BREATHING CIRCUIT OR AIRWAY OBSTRUCTION
When pressing the key a menu appears with the listing of the alarms. HIGH TIDAL VOLUME
LOW ALARM LIMIT
Turning the control knob, in each end of line will appear the present limits.
HIGH INSPIRATORY PEAK FLOW OR Ti LOW
Pressing the knob the values are enter and it is possible to be changed
PATIENT-VENTILATOR ASYNCHRONY
rotating the knob and accepting or not the change.
The audible alarm signal recovers automatically if the pressure returns to
an inferior value to the limit. The light signal does not disappear until the
Description [Esc] key is pressed.
The signals of alarm are grouped in three categories: Low inspiratory pressure (Adjustable by the user)
1) High Priority Definition: Minimum allowed airway pressure limit.
When the inspiratory pressure does not reach the set value, the low in-
2) Medium Priority spiratory pressure alarm is activated. It is generally activated when one
segment of the patient’s circuit is disconnected. It has high priority, and
3) Low Priority must be programmed in all modes. It is automatically restored.
Selection: In all the modes.Ventilator action: It is activated when the
High Priority Signals (warning) ventilator senses an airway pressure lesser than the set limit.
Signal type: Audible, light and warn in the screen.
They are those that require of an immediate action. They are character- Silence: It can be temporarily silenced.
ized to be activated in instantaneous form. The alarms that are activated Setting limits: From 1 to 99 cm H2O.
with signals of High Priority are the following ones: Default value: 5 cm H2O in ADL and PED patients; 2 cm H2O in NEO.
Value change: With the [Alarm Settings] key.
High inspiratory pressure (Adjustable by the user)
Screen message: LOW INSP. PRESSURE
Definition: Maximum allowed airway pressure limit. Pressing Help: CAUSES
When the alarm is activated, inspiration ends and the expiratory valve are CIRCUIT LEAKS
opened instantaneously. When the alarm is activated and the event has HIGH ALARM LIMIT
been overcome, the light signal and the screen message remain on until FLOW SENSOR HIGH HOSE DISCONNECTION
the [Esc] key is pressed. It is the alarm with highest priority, and must be
The audible alarm signal recovers automatically if the pressure returns to
programmed in all modes.
a superior value of the set limit. The light signal does not disappear until
Selection: In all the ventilatory modes.
the [Esc] key is pressed.
Ventilator action:
1) Immediately activated when the inspiratory pressure reaches the set limit. Low inlet pressure of both gases (Nonadjustable by the user)
2) Immediate opening of the expiratory valve with breathing circuit Definition: Warns an inappropriate or lack pressure of both feeding
decompression to PEEP level. gases (oxygen and air).
Signal type: Audible, visual and warn in the screen. Ventilator action: It is activated immediately when the air and oxygen
Silence: It can be silenced temporarily. supply pressure is reduced below 2 bar.
Setting limits: From 10 to 110 cm H2O Signal type: Audible, visual and warn in the screen.
Silence: It cannot be silenced.
80 Alarms
Screen message: LOW AIR AND OXYGEN PRESSURE Vent Inop (Nonadjustable by the user)
Pressing Help: ACTION Definition: Important alteration of electronic circuit or software (technical
KEEP GAS PRESSURE BETWEEN 3.5 AND 7 bar failure).
Automatic reposition if the pressure returns above the limit. The light Ventilator action: The ventilator stops to work. The screen fades. Con-
signal does not disappear until the [Esc] key is pressed. tinuous light and audible signal is activated.
Signal type: Audible and continuous light of the Vent Inop LED. No
Low inlet pressure of one gas (Nonadjustable by the user)
screen message.
Definition: Warns an inappropriate or lack pressure of one of the feed- Silence: It cannot be silenced.
ing gas (oxygen or air). Consequences: The alarm indicates a serious alteration of the hardware or
Ventilator action: It is activated immediately when the air or oxygen software and the device should not be used. Attention of specialized Service
supply pressure is reduced below 2 bar. Simultaneously the gas with more should be requested.
pressure passes to replace the deficient gas.
Signal type: Audible, visual and warn in the screen. WARNING
Silence: It cannot be silenced. When the Vent Inop alarm is activated, do not intent to use the ventilator
Screen message: LOW AIR OR OXYGEN PRESSURE again. An alternative system of ventilation should immediately be pro-
Pressing Help: ACTION vided.
KEEP GAS PRESSURE BETWEEN 3.5 AND 7 bar The device should be sent to an authorized service.
Automatic reposition if the pressure returns above the limit. The light
signal does not disappear until the [Esc] key is pressed. Mask disconnection during NIV (Nonadjustable by the user)
Definition: It is a condition where the ventilator senses a mask disconnec-
Depleted battery (Nonadjustable by the user) tion in noninvasive ventilation mode in ADL and PED and Continuous
Definition: It is an indication that the utility time of operation with bat- Flow CPAP in NEO.
tery could be very brief or null. Ventilator Action:
Ventilator action: There is not direct action. • Warn 5 seconds after mask disconnection.
Signal type:1) Light and warn in the screen. • Activation when the expiratory flow sensor doesn't detect gas flow.
2) Icon indicating charge level. • The ventilator stops flow.
Silence: It cannot be silenced. Signal type: Audible and warn in the screen.
Screen message: DEPLETED BATTERY Silence: It can be temporally silenced.
Pressing Help: ACTION: Screen message: MASK DISCONNECTION
AN ALTERNATIVE SYSTEM OF VENTILATION
SHOULD BE PROVIDED FIO2 18% or below
Definition: Oxygen source inappropriate.
Continuous pressure (Nonadjustable by the user)
Ventilator Action: It is activated immediately when the FIO2 is below
Definition: Maintenance of 5 cm H2O of pressure above PEEP/CPAP in the 18%.
ventilatory breathing circuit for more than 15 seconds. Signal type: Audible and warn in the screen.
Ventilator action: Decompression of the breathing circuit to the set baseline. Screen message: O2 CONCENTRATION BELOW 18%
Signal type: Light and warn in the screen. STOP VENTILATION
Silence: It cannot be silenced. CHECK OXYGEN SOURCE
Screen message: CONTINUOUS PRESSURE
Pressing Help: ACTION: Maximum and Minimum ETCO2.
LOOK FOR BREATHING
Definition: it determines the partial pressure of expired CO2 (ETCO2).
TUBE OCCLUSION
Ventilator Action: immediate screen message and alarm activation.
Regulation limit: 1 to 150 mmHg in steps of 1
Default values: 30 and 50 mmHg
Value change: with the alarm settings key.
Alarms 81
Medium Priority Signals (caution) Setting limits: From 0.001 L up to the low value of the VT high.
Default value:
They are activated with a time delay. In some the time is operator’s ad- ADL: 0.200 L; PED: 0.025 L; NEO: 0.005 L
justable, in other the time is fixed. The alarms that are activated with Value change: With the [Alarm Settings] key.
signals of Medium Priority are the following ones: Screen message: LOW TIDAL VOLUME
CAUSES:
VT high (Adjustable by the user) DISCONNECTION
Definition: Maximum allowed limit of the tidal volume impelled by the ventilator. CIRCUIT LEAKS
HOSE DISCONNECTION OR OBSTRUCTION OF THE FLOW SENSOR
The values are displayed below the expired tidal volume (on top of the
HIGH ALARM LIMIT
screen). The default values are 50% over, and 50% below the pro-
CHANGES IN THE BREATHING SYSTEM IMPEDANCE (PRESSURE MODES)
grammed tidal volume, respectively. These values may be changed. The
first time the key is pressed, the change of the maximum limit is activated; The audible signal of the alarm is suspended if the pressure returns to a
the second time, the change for the minimum limit is enabled. superior value to the limit. The light signal does not disappear until the
Selection: It must be programmed in all modes. [Esc] key is pressed.
Ventilator action: It is activated when the tidal volume of successive External power loss (Nonadjustable by the user)
breathing stays more than 10 seconds above the set limit.
Signal type: Audible, light and warn in the screen. Definition: Failure in the electric power of the main line. It is activated
Silence: It can be silenced temporarily. when the current key of the device is in the ON position and the following
Setting limits: From 0.010 L up to 3.0 L. events happen:
Default value: 1) Power loss of the main line.
ADL: 0.600 L; PED: 0.075 L; NEO: 0.050 L 2) Unplugged of connection cable from mains, and
Value Change: With the [Alarm Settings] key. The audible signal is sus- 3) Burned entrance fuse.
pended when the pressure recovers accepted limits. The light signal does Ventilator action: Instantaneous commutation to internal battery source
not disappear until the [Esc] key is pressed. of energy. The indicative LED of the front panel lights.
Screen message: HIGH TIDAL VOLUME Signal type: Audible, light and warn on the screen.
Pressing Help: CAUSES: Silence: It cannot be silenced.
LOW ALARM LIMIT SETTING Screen message: POWER LOSS
CHANGES IN THE BREATHING SYSTEM IMPEDANCE (PRESSURE Pressing Help: ACTION:
MODES)
RESTORE ELECTRIC POWER
SUPERIOR HOSE DISCONNECTION OF THE FLOW SENSOR
USE AN ALTERNATIVE WAY OF VENTILATION
The audible signal of the alarm is suspended if the pressure returns to an
Automatic reposition if the electric power recovers. The light signal does
lower value to the limit. The light signal of the alarms sector does not
not disappear until the power returns.
disappear until the [Esc] key is pressed.
VT low (Adjustable by the user) O2 concentration high (Adjustable by the user)
Definition: Minimum allowed limit of the tidal volume impelled by the ventilator. Definition: Maximum allowed limit of the oxygen concentration supply
The values are displayed below the expired tidal volume (on top of the by the ventilator. The High alarm limit of the breathing gas oxygen con-
screen). The default values are 50% over, and 50% below the pro- centration delivered to the patient is automatically set 20% above the
grammed tidal volume, respectively. These values may be changed. The FIO2 setting. The limits values can be changed pressing the [Menu] key
first time the key is pressed, the change of the maximum limit is activated; and selecting OXYGEN CONCENTRATION line.
the second time, the change for the minimum limit is enabled. Selection: In all the modes.
Selection: In all the modes. Ventilator Action: It is activated when the oxygen concentration of suc-
Ventilator action: It is activated when the tidal volume stays more than cessive breathing stays more than 30 seconds above the set limit.
10 seconds below the set limit. Signal type: Audible and warn in the screen.
Signal type: Audible, light and warn in the screen. Silence: It can be silenced temporarily.
Silence: It can be silenced temporarily. Setting limits: 25 a 110%.
82 Alarms
Default value: 60% Action: It is activated immediately when the fan stops.
Value change: With the [Alarm Settings] key. Signal type: Audible, and warn in the screen.
Screen message: HIGH OXYGEN CONCENTRATION Silence: It cannot be silenced temporarily.
Screen message: FAN FAILURE
O2 concentration low (Adjustable by the user) Operator Action: Check the fan correct functioning looking for foreign
Definition: Minimum allowed limit of the oxygen concentration supply materials obstructing the blades. If the failure persists, the ventilator
by the ventilator. The Low alarm limit of the breathing gas oxygen con- should be replaced.
centration delivered to the patient is automatically set 20% below the
FIO2 setting. The limits values can be changed pressing the [Menu] key Low Priority Signals (alert)
and selecting OXYGEN CONCENTRATION line.
Ventilator Action: It is activated when the oxygen concentration of suc- They are activated with a time delay, in some the time is adjustable for
cessive breathing stays more than 30 seconds below the set limit. the operator, and in other the time is fixed. The alarms that are activated
Signal type: Audible and warn in the screen. with Low Priority Signals are the following ones:
Silence: It can be silenced temporarily.
Setting limits: 18 a 95%. f max (Adjustable by the user)
Default value: 40% Definition: It set the limit for the maximum allowed breathing frequency
Value change: With the [Alarm Settings] key. mechanic or spontaneous. The value is displayed on the upper part of the
Screen message: LOW OXYGEN CONCENTRATION screen. It is enabled in all modes with a default value of 30 cycles per
minute in ADL and PED and 40 in NEO.
Backup (Adjustable by the user) Selection: In all the modes.
Definition: It is a condition where the ventilator considers a breathing stop Ventilator action: It is activated 30 seconds after surpassed the set limit.
during spontaneous ventilation modes after an adjustable period of time. Signal type: Audible, light and I warn in the screen.
Selection: In Pressure Support, Continuous Positive Airway Pressure and Silence: It can be silenced temporarily.
Combined Modes (optional in SIMV). Default value: 30 bpm for all categories.
Ventilator action: Change to the selected backup mode at 5 to 60 se- Value change: With the [Alarm Settings] key.
conds according to the set time and a breathing rate of 6 per minute. Screen message: MAXIMUM BREATHING RATE ALARM
Signal type: Audible, light and warn in the screen. Pressing Help: CAUSES:
Silence: It can be silenced temporarily. AUTOCYCLING
Default value: 15 seconds in all the categories. LOW ALARM LIMIT SETTING
Value change: Pressing the [Menu] key. CIRCUIT LEAKS
Screen message: APNEA ALARM ACTIVATED The alarm resets automatically if the frequency returns to an inferior value to
BACKUP VENTILATION IN USE the limit. The light signal does not disappear until the [Esc] key is pressed.
The alarm resets automatically if the patient returns to spontaneous venti-
lation. The light signal does not disappear until the [Esc] key is pressed. Low PEEP (Adjustable by the user)
Definition: Descent of the PEEP pressure below the set value during ven-
NIV circuit leak (Nonadjustable by the user) tilation with expiratory positive pressure or continuous positive pressure.
Definition: Non-compensated circuit leak Selection: In all the modes.
Action: Warns after 5 seconds. Ventilator action: Light and audible signal and message in the screen after
Signal type: Audible and screen message. 15 seconds of persisting the alteration.
Screen message: CIRCUIT LEAK Signal type: Audible, and warn in the screen.
MORE THAN xx L/MIN Silence: It can be silenced temporarily.
NONCOMPENSABLE Limits: 2, 4, 6 cm H2O below the PEEP limit. In OFF it is disabled.
Fan Failure (Nonadjustable by the user) Default value: ADL and PED: 4 cm H2O; NEO: 2 cm H2O.
Value change: With the [Alarm Settings] key.
Definition: Detention of the fan’s operation with possibilities of electronic circuit Screen message: LOW PEEP
overheating.
Alarms 83
Pressing Help: CAUSES: Pressing Help: CAUSES:
CIRCUIT LEAKS HIGH ALARM LIMIT
LOW ALARM LIMIT CHANGES IN THE PATIENT RESPIRATORY MECHANICS
Automatic reset if the pressure returns above the limit. The light signal DISCONNECTION OF THE FLOW SENSOR LOWER TUBE
does not disappear until the [Esc] key is pressed. UPPER OR LOWER TUBE FLOW SENSOR OBSTRUCTION
84 Alarms
15
Other Features
Classification Variables for the Respiratory Phases
To classify a ventilator it is necessary to know which it is the control vari- They involve the events which take place during a ventilatory cycle, that
able that puts on in action to make an inspiratory phase. The control vari- is: 1) change from expiration to inspiration, 2) inspiration, 3) change from
ables that can be used are: Pressure, Time, Volume and Flow. Generally, in inspiration to expiration, and 4) expiration.
each inspiration a single control variable is used, but the ventilator can
also control more than a variable in different times. Change from Expiration to Inspiration
In the volume and pressure modes, the beginning of an inspiration may
be triggered by time - as a function of the respiratory frequency (adjust-
Criteria for determining the control variable able between 1 and 150 cycles per minute) and by pressure or flow. In the
(modify from R.L.Chatburn(1)) spontaneous modes, inspiration is triggered by pressure or by flow.
When triggered by pressure, inspiration begins when the patient’s effort
The ventilator is a
can produce a pressure decrease in the breathing circuit higher than the
The ventilator is a The ventilator is a
Pressure Time Volume one set with the sensitivity control. The decrease level may be adjusted
Controller Controller Controller from 0.5 up to 10 cm H2O below the base pressure (compensated
no yes yes PEEP).
Observation
and
Does pressure waveform
yes Does volume waveform
no
Is volume measured directly When the flow-triggered mode is selected, a continuous flow is originated
change when patient change when patient (by volumetric displacement
previous resistance and compliance resistance and compliance rather than by flow in the ventilator during the expiratory phase. In this case, inspiration is
knowledge change? change? transducer)?
triggered when a difference between the flow sent by the ventilator and
no the flow coming out of the expiratory pneumotachograph is detected.
The ventilator is a The flow sensitivity may be set from 0.5 to 15 L/min.
Fow
GraphNet Controller If inspiration is not triggered by the patient in the assist/control, SIMV and
backup ventilation modes, the ventilator will start the inspirations triggered
by time according to the selected base respiratory frequency.
According to this concept, the GraphNet ventilator is a pressure or flow Inspiration
controller. The inspiration is triggered by pressure, flow, time or manually.
During the Pressure-Controlled (PCV) and Pressure-Support (PSV and com-
It is pressure, volume or flow limited, and pressure, volume, flow or time
binations) ventilatory modes, inspiration is limited by pressure. In the
cycled. In noninvasive ventilation has capacity of leak compensation up to
Mandatory Minute Volume mode, the pressure is variable depending on
50 L/min in ADL, 30 L/min in PED and up to 10 L/min in NEO.
the different working characteristics of this ventilatory mode. The inspira-
tory flow in the pressure-modes is automatically set in relation to the in-
spiratory time and the regulated pressure level, but it may be modified
with the Rise Time control.
Inspiration in the CPAP/Support Pressure mode may work in two ways.
One is the conventional way, where the inspiratory flow is generated by
means of a demand system which maintains the preset PEEP/CPAP level
(0 to 50 cm H2O).
Other Features 85
The other one adds PSV as a way of assisting the patient’s inspiration. The Inspiratory Waveforms
pressure level may be set from 0 to 100 cm H2O.
In the volume mode, the flow is controlled by the inspiratory time, the The inspiratory waves are those corresponding to pressure, flow and volume.
preset volume and the selected flow waveform. The tidal volume may be Flow Waveforms
set between 5 and 2500 mL with a flow availability of up to 180 L/min.
The inspiratory time can be set between 0.1 and 3 s (30 s in APRV). There are two waveforms: descending ramp and rectangular.
86 Other Features
Modifications of the Inspiratory Flow
In the Volume controlled modes, the Inspiratory Pause may be pro-
grammed between 0.25 and 2 seconds. In the pressure controlled modes,
the pause function is not enabled.
In all cases, depending on the operative mode used, the flow is calculated
taking into account the preset tidal volume, pressure and/or inspiratory
time.
When the waveform is the rectangular type, the flow is relatively constant In the Pressure modes (PCV and PSV), the peak flow may be modified
and the peak flow is equivalent to the mean calculated flow. If the wave- with the Rise Time to adjust the flow to the patient’s demand. In the
form is the descending ramp type, the inspiratory flow begins with the Volume-Controlled mode, the Rise Time is not enabled.
maximum peak and decreases lineally.
In the Pressure Support Ventilatory mode with VT Assured, the pressure
and flow control are combined during the inspiration.
Pressure Waveforms
The inspiratory pressure waveform has two types: ascending ramp wave-
form for the VCV mode with constant flow and rectangular waveform for
the pressure modes. In the volume mode, when changing the rectangular
flow waveform, pressure waveforms are produced with a shape character-
ized by the flow which generates them.
Figure 4-4. Operative Mode: Pressure
Support with VT Assured . Note the
Volume waveform. change of the descending ramp flow
waveform to constant flow; simulta-
The volume waveform depends on the type of flow generated. The volume neously, there is a pressure increase
increases proportionally with the pressure.
until the target tidal volume is reached.
Other Features 87
Control Subsystems Safety Mechanisms
Circuit Controls The ventilator’s safety mechanisms comprise the devices which constitute it
and the operative system which governs the microprocessor. Their function
The gas flow for the patient is regulated by two proportional valves (for
is to preserve the integrity of the procedure, making it safe and reliable.
air and for oxygen), connected each one with a Silverman type pneumot-
achograph. The valves work simultaneously during each breath mixing the
gases to obtain the regulated FIO2. Ventilator Components
The microprocessor receive signals from the inspiratory flow and airway Safety valve: It is located at the beginning of the breathing circuit. It is
pressure, and control the orders for the adjusted variables and the output factory preset. It is opened when the pressure within the patient’s circuit
signals. The airway pressure transducer is connected at the beginning of reaches, for any reason, 120 ±3 cm H2O. The gas enters into an internal gas
the patient’s circuit. This transducer also handles the feedback signals collector and is expelled to the outside.
which are used for the pressure trigger, the cycling and the alarm levels, Electronic circuit: When the microprocessor detects any failure in the
and for the control of the pressure waveform in the Pressure-Controlled, electronic circuit, not only is the alarm for technical failure activated but
Pressure Support and Mandatory Minute ventilation modes. also the ventilator enters into inoperative mode and all solenoid valves
The flow data is obtained by differential transducers related to internal are deactivated.
and expiratory pneumotachograph. The expiratory pneumotachograph is Inspiratory relief valve (anti-asphyxia): Located at the beginning of
a variable hole type one. the breathing circuit. It is opened when there is a power failure or an
Control Valves inoperative state, thus enabling the aspiration of ambient air.
The gas flow to the patient is regulated by the above-mentioned propor- Operation gases exhaust: The operation gases which normally or even-
tional valves. The flow control is capable of sending flows of up to tually escape from some of the internal mechanisms, are directed to a
180 L/min when the gas supply is coming from a central installation, and common collector from where they are expelled to the outside.
of 120 L/min when the air is supplied by a semi-portable autonomous Low supply pressure of the compressed air: The lack of pressure of
compressor. the compressed air (command gas) is compensated by the compressed
The expiratory valve is governed by two solenoid valves, one used for the oxygen through a connecting valve. The corresponding alarm is triggered.
closing and opening (beginning and end of the inspiratory phase). The
other is a proportional low flow valve which regulates the partial closure WARNING
of the expiratory valve to produce positive end expiratory pressure. The The beginning of the calibration of the equipment only using air is
microprocessor coordinates the activities of these valves, timing their not possible.
actions.
Low supply pressure of the compressed oxygen: The lack of pressure
The valve system also has four solenoid valves which actuate synchro- of the oxygen is compensated by the compressed air. The corresponding
nously every 15 minutes to restore (atmospheric pressure) the differential alarm is triggered.
and pressure transducers. At the same time, another solenoid valve allows
the passage of the calibrated flow of the compressed air in order to purge WARNING
the expiratory pneumotachograph lines and to prevent any water or hu-
If the source of OXYGEN PROVISION is not sufficient, the ventilator
midity from entering into the transducers.
will not accept the initial calibration.
Airway pressure monitoring: There are two pressure transducers located
one at the beginning (proximal pressure) and the other at the end of the
patient’s service circuit (distal pressure). The proximal transducer commands
the pressure in the Pressure-Controlled (PCV) and Pressure Support (PSV)
Modes, the limits of the maximum and minimum airway pressure, and the
positive end expiratory pressure (PEEP). It also originates the values for the
Peak, Plateau, Mean and PEEP Airway Pressure. The distal transducer is
involved in the plotting of the pressure waveforms.
88 Other Features
Voltage: The power source is self-regulated for alternate current from Watchdog
110 to 220 volts.
Automatic Zero Reset: The pressure transducers are zeroed every 15 The watchdog is an independent system used to supervise the electronic
minutes or when the operator activates this function ([Ctrl] + [Ctrl]). circuit operation. It is not related to the Backup Ventilation, and it has a
factory preset pressure-controlled ventilatory mode that cannot be
Line Purge: In order to avoid any obstruction of and/or humidity in the
changed.
internal transducers, air is injected through the tubes connecting the expi-
ratory pneumotachograph during the automatic zeroing. It enters into operation:
Internal Battery: The internal battery is recharged automatically while 1) 30 seconds after turning on the ventilator, if the first screen is not accepted.
the equipment is connected to the mains. If there is an interruption of the
2) When the microprocessor loses control of the program sequence regu-
AC power during the operation, the ventilator is energized instanta-
lating the ventilation.
neously by the battery.
When it enters into operation, a signal which starts this emergency venti-
WARNING latory mode is activated.
The operation with internal battery has a limited time. When this Emergency Ventilation
happens replace the power source or QUICKLY CHANGE to an alternative The following ventilation mode is activated for any category (adult, pedi-
method of ventilation. atric and neonatal):
Other Features 89
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90 Other Features
Warranty
This equipment is sold under the terms of the warranty specified below, which applies only to the purchaser who buys the
equipment, new, directly from TECME or from the manufacturer’s official distributors, agents or representatives.
TECME guarantees that this equipment is free from manufacturing defects or defects in the material for a period of
one year as from the delivery date and provided that it is operated and maintained correctly under normal operating condi-
tions and in accordance with the instructions specified in this manual. Under this warranty, TECME obliges itself to
change or repair those parts which, once examined by the manufacturer, prove to be defective or show alterations.
TECME does not assume responsibility for any consequent or special damages resulting thereof.
The above warranty is rendered invalid if the equipment has been repaired or altered by unauthorized persons or if said
equipment has been subject to abuse, misuse, negligence or accidents.
TECME is bound by this warranty agreement only when the following requirements are met:
1) TECME is notified promptly in writing by a letter from the purchaser explaining the defect or fault that has been
found.
2) The defective unit is sent by prepaid carriage and within the period of time specified in this warranty.
TECME does not assume any responsibility for any extension that any sales firm can grant of the warranty’s time limit,
unless there is a special agreement.
Warranty 91