Graphnet: User'S Instruction Manual

You might also like

Download as pdf or txt
Download as pdf or txt
You are on page 1of 96

GraphNet

Invasive and Noninvasive Ventilation

User's Instruction Manual

Part No.: 3179L1V


M-IP-0002 REV:00
The use of this device in patients must be supervised by a specialized doctor. Like any Agency Requirements
instrument, it is important to have a clearly knowledge of his handling, as well
as of the functional characteristics and possibilities. Therefore, read and understand Designed to meet applicable requirements of:
the entire user’s manual before operating this System. If you have any questions con-
cerning the use of this System, contact your distributor.
• UNE-EN 794-1:1997. Lung Ventilators. Part 1: Particular requirements for
The indications relative to the application and regulations of the controls mention- critical care ventilators.
ed in this manual, shuld be take as a guideline. The doctor in charge of his application,
• UNE-EN 794-1/A1:2001. Lung Ventilators. Part 1: Particular requirements
will have, with his knowledge and criterion, to adapt this mechanical device to the
requirements of the patient.
for critical care ventilators. Amendment 1.
• IEC 60601-2-12:2001. Medical electrical equipment. Part 2-12: Particular
The development and improvement of TECME'S products are permanent. The man-
requirements for the safety of lung ventilators. Critical care ventilators.
ufacturer reserves the right to carry out any modification of the characteristics or
the design without previous notice. • IEC 60601-1:2005 Medical electrical equipment. General requirements
for safety.
• IEC 60601-1-2 Medical electrical equipment. Part 1-2: General require-
TECME S.A. GraphNet® ments for safety. Collateral standard: Electromagnetic Compatibility.
Requirements and test.
Calle Pública s/n
Av. La Voz del Interior 5500 • IEC 60601-1-2/A1:2004. Medical electrical equipment. Part 1-2: General
requirements for safety. Collateral standard: Electromagnetic Compatibil-
X5008HJY - Bº Los Boulevares
ity. Requirements and test. Amendment 1.
Córdoba
Argentina • UNE-EN 60601-1-8:2005 Medical electrical equipment Part 1-8: Norm
General requirements for safety. Collateral standard - Alarm system -
Tel: (+54-351) 569 - 1828/ 1860/ 1861/ 1871 Requirements and test.
E-mail:technical.assistance@tecme.com.ar • UNE-EN 60601-1-8:20051/A1:2006 Medical electrical equipment
www.tecme.com.ar Part 1-8: General requirements for safety. Collateral standard - Alarm
system - Requirements and test. Amendment 1.
• IEC 60601-1-4/A1:2000. Medical electric equipment.
ANMAT PM 1116-6
Part 1-4: General requirements for safety. Collateral standard: Program-
Technical Directoring mable electrical medical systems.
Lic. Julieta Catania • IEC 60601-1-41/A1:2000. Medical electric equipment. Part 1-4: General
Clinic Biochemistry requirements for safety. Collateral standard: Programmable electrical
medical systems. Amendment 1.
• UNE-EN 980:2004. Graphical Symbols for use in the labeling of medical
devices.
Authorized Representative:
Exportadora de Electromedicina, S. L.
Almagro, 36 - 3º
28004 Madrid - España

Quality System Certification Quality System Certification


Contents
Chapter 1 Chapter 5
Introduction ............................................................................... 1 Breathing Circuit Verification and Calibration .................... 21
Adult and Pediatric .......................................................................... 1 Chapter 6
Neonatal ........................................................................................... 1 Adult and Pediatric Programming ......................................... 25
Backup Ventilation .......................................................................... 1 Operative Mode Selection ............................................................. 25
Definition of Terms .......................................................................... 3 Volume-Controlled Ventilation (VCV) ........................................ 26
Chapter 2 Pressure-Controlled Ventilation (PCV) ....................................... 28
Warning-Caution-Note .............................................................. 3 Pressure Support Ventilation (PSV) ............................................ 30
Continuous Positive Airway Pressure (CPAP) ............................ 33
Chapter 3
SIMV [Volume-Control Ventilation] with Pressure Support ..... 33
Assembly and Installation Procedures .................................... 7
SIMV [Pressure-Controlled Ventilation] with Pressure Support .. 34
Cart Assembly ................................................................................... 8
Noninvasive Ventilation (NIV) .................................................... 35
Connection of the Power Supply .................................................... 8
Mandatory Minute Ventilation with Pressure Support ............. 36
External Power Supply .................................................................. 8
Pressure Support Ventilation with Tidal Volume Assured ........ 37
Internal battery ............................................................................. 9
Airway Pressure Release Ventilation (APRV) .............................. 39
Battery charge condition ........................................................... 9
Pressure-Regulated Volume Control (PRVC) ...............................40
Connection of the Gas Supply ....................................................... 10
Backup Ventilation ..................................................................... 42
Pressure range at the Air and Oxygen supply ........................... 10
Chapter 7
Ventilation with a single gas ...................................................... 10
Neonatal Programming........... ................................................ 43
Breathing Circuit Assembly ........................................................... 11
Volume-Controlled Ventilation (VCV)...........................................43
RS-232C Connector ........................................................................ 13 Control Keys and programming limits for VCV..........................44
Use of the RS-232C ...................................................................... 13 Pressure-Controlled Ventilation (PCV) .......................................... 45
Date and Time Setting .................................................................. 13 Control Keys and programming limits for PCV .......................... 45
Flow and Volume Correction According to Ambient Pressure Pressure Support/CPAP .................................................................. 46
(Altitude Compensation) ............................................................... 13 Control Keys and programming limits for PSV ......................... 45
Chapter 4 Continuous Positive Airway Pressure (CPAP) ................................ 45
Description ............................................................................... 15 SIMV (VCV) + PSV...........................................................................46
Sectors ............................................................................................ 15 SIMV (PCV) + PSV ........................................................................... 48
1. Power Source ............................................................................. 16 Control Keys and programming limits for SIMV + PSV ............. 48
2. Ventilation Modes ..................................................................... 16 Time Cycled-Pressure Limited (TCPL) ........................................... 48
3. Knob ........................................................................................... 17 Control Keys and programming limits for TCPL ........................ 48
4. Controls Keys ............................................................................. 17 Time Cycled-Pressure Limited + SIMV/PSV .................................... 49
5. Common Keys ............................................................................ 18 Control Keys and programming limits for TCPL + SIMV/PSV ..... 49
6. Screen Information .................................................................... 20 Continuous Flow CPAP (Nasal NIV) ............................................. 49
Backup Ventilation .........................................................................50
Contents i
Chapter 8
Chapter 15
Respiratory Mechanics ............................................................. 51
Other Features ......................................................................... 85
auto-PEEP ......................................................................................... 51
Classification .................................................................................. 85
Compliance and Resistance ............................................................. 52
Variables for the Respiratory Phases ............................................ 85
Trapped Volume..............................................................................54
Control Subsystems ........................................................................ 88
Slow Vital Capacity .......................................................................... 54
Safety Mechanisms ........................................................................88
Occlusion Pressure During the First 100 ms of Inspiration (P0.1) ...... 55
Ventilator Components ..............................................................88
Inflexion Points of the P/V curve (P/Vflex) ...................................... 55
Operative System ........................................................................88
Maximum Inspiratory Pressure (Pimax)...........................................56
Watchdog ....................................................................................89
Physiological VD/VT calculation......................................................57
Chapter 9 Warranty ...................................................................................91
Trends........................................................................................59
Chapter 10
Capnography.............................................................................61
Implementing.................................................................................61
Results.............................................................................................63
Chapter 11
Care and Maintenance .............................................................65
Respiratory circuit .......................................................................... 66
Internal Battery ..............................................................................67
Air Filter .......................................................................................... 67
Maintenance and revision every 5000 hours or once a year .......68
Chapter 12
Operational Test ...................................................................... 59
Chapter 13
Technical Data and Specifications ...........................................73
Chapter 14
Alarms .......................................................................................79
Characteristics ................................................................................79
High Priority Signals (warning) ..................................................80
Medium Priority Signals (caution) ..............................................82
Low Priority Signals (alert) ..........................................................83

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
This page intentionally left blank

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

The GraphNet is a restricted medical device to be operated by quali- WARNING


fied medical personnel under the direction of a qualified medical practi-
tioner. The ground connection is important to guarantee the correct opera-
tion of the equipment.

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

The ventilator cabinet should not be subjected to sterilization


with ethylene oxide gas. Irreparable damage of its components can take
place.

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

Do not use solvents, acetone, chloroform or strong acid sub- NOTE


stances or chlorinated solvents to clean the plastic parts or the respiratory
tubes. In Continuous Flow CPAP Mode of NEO category the Respiratory
Mechanics tests are not available.
CAUTION
NOTE
In case of battery discard follows the Institutional requirements.
The discarded unit should not be thrown to fire. Explosion may result. In the assisted and spontaneous modes (PSV-CPAP, SIMV, APRV, MMV,
PSV+VT Assured and VNI) the auto-PEEP, Dynamic and Static Compliance,
Inspiratory and Expiratory Resistance and P/Vflex cannot be carried out.
CAUTION

The exhalation 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 damage the membrane.

Warning-Caution-Note 5
This page intentionally left blank

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

Assembly and Installation Procedures 7


Cart Assembly Connection of the Power Supply
It comprises three stages: The power inlet and the ON-OFF switch are on the back panel. To prevent
inadvertent disconnection, fix the power cord using the 2.5 mm hex tool.
1) Fix the vertical bar in the rolling base with the Allen screw adjusting with the
hex tool.
Notice that the wheels with brake and the heater-humidifier support
should be placed forward.
2) Place the tray in the superior part of the bar making coincide the me-
tallic block in the neckline of the bar. Adjust the fixation screw with the 5
mm hex tool.

3) Place the protection ring together with the hook-support, adjusting


External Power Supply
with the hex tool the four Allen screws through the holes of the posterior Connect to power AC 220-110V in a three-pole socket (one to earth). Do not
part of the bar. disconnect the ground wire of the cable nor cancel the ground connection.
Securing the ventilator
WARNING
Place the ventilator on the tray. Secure it with the screw coming from The ground connection is important to guarantee the correct op-
below on the right of the tray, as indicated in the next figure. eration of the equipment.
External power failure
The interruption of the mains power supply usually is a result of three
events:
1) Lack of power of the main line.
2) Connection cable unplugged from the main line.
3) Burned entrance fuse.
Anyone of these factors produces the instantaneous change to electric
power of the battery. Simultaneously the corresponding alarm, with high
priority visual and audible sign, is activated.

Support of the Breathing Tubes WARNING


The support end is placed on the lateral side of the protection ring. The The interruption of external electric power is an emergency. If the
support nut is tightened. The two articulated segments are placed in the problem persists for some minutes an alternative ventilatory system
desired position and the nuts are tightened. should be used.

8 Assembly and Installation Procedures


Battery charge condition
WARNING All the time, the Internal Battery indicator showing the state of the battery
The responsibility to provide a correct and safe electric power sup-
charge appears on the bottom of the waveform area of the LCD screen.
ply is exclusively of the user, and not of the company TECME.
Internal battery
The GraphNet contains an internal battery that can supply up to 2h 30 min
of power depending on ventilator settings and battery charge level.
The ventilator automatically switches to the internal backup battery when
electrical power supply failure is detected. The internal battery is charged
during ventilator operation if attached to an AC power source. This can be
either in standby mode or when the ventilator is turned off.

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.

Assembly and Installation Procedures 9


Connection of the Gas Supply WARNING

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.

10 Assembly and Installation Procedures


Breathing Circuit Assembly Inspiratory Path
The inspiratory path covers the section of the patient’s circuit which be-
WARNING gins in the ventilator and finishes in the fitting connecting to the patient.
The breathing circuit tubes and the heater-humidifier are not pro- ✔ Oxygen sensor. The oxygen sensor is connected in the first part of the
vided by TECME. The following instructions are only a guide to the circuit. It is protected by a cap located underneath and to the center of
user. the cabinet.
To maintenance and disinfection, refer to the manufacturer's instructions
and recommendations.
The Figure on page 7 shows the circuit’s components. The setup of the
circuit is the same for adults, children or neonate. The difference is marked
by the diameter of the tubes: 22 mm for adults, 15 mm for pediatric, and 10
mm for neonate's patients.

Patient’s Circuit and Complementary Parts


The patient’s circuit comprises the set of parts and tubes carrying the res-
piratory gas from the ventilator to the patient and from the patient to
the expiratory valve.

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.

The patient’s circuit comprises:


✔ Inspiratory path with O2% sensor and heater-humidifier.
✔ The section going to the humidifier.
✔ Wye Connector to the Patient.
✔ Expiratory path. ✔ The section going from the humidifier up to the fitting connecting to the
✔ Expiratory valve and flow sensor. patient. This section may have a device to accumulate condensed water.
✔ Capnograph. The humidifier outlet is a 22 mm male connecting to a 22 mm L-con-
nector port. The other end is connected to the next section.

✔ Nebulizer, if necessary.

Assembly and Installation Procedures 11


Wye Connector to the Patient
The piece connecting to the patient is a Y connector. The intermedi-
ary of the tracheal tube is connected to the 15 mm female port of the
piece.
Expiratory Path
The expiratory path begins at the wye and may be constituted by two
tubes interconnected by a water trap. This section ends at the connection
with the expiratory flow sensor.

WARNING
Do not use antistatic neither electrically conductive tubes in the
breathing circuit and gas supply.

Expiratory Valve and Flow sensor


CAUTION
The expiratory flow sensor (pneumotachograph) is part of the expiratory
valve assembly. It has a free 22 mm male lower end where the last tube To replace diaphragm, always use original spare part. Similar parts
of the patient’s breathing circuit is connected. can produce valve malfunction.
The small lateral tubes of the sensor are connected as follows; the lower NOTE
one to P1 and the upper tube to P2 on the cabinet bottom. This connec-
tion enables the transmission of the pressures to the internal differential To discard the whole device or disused parts or elements provided
transducer for expiratory volume and flow integration. The upper tube by other suppliers, follow the requirements of the institutional authority.
also transmits the airway pressure.
WARNING
CAUTION Removing the identification label with the serial number
involves losing the warranty as well as any other right regarding
In the inner middle part of the flow sensor there is a transparent
maintenance care.
membrane, the integrity of which is essential for an adequate reading of
the expired volume.

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.

12 Assembly and Installation Procedures


RS-232C Connector Flow and Volume Correction According to
It is a serial outlet which accepts a DB9 9-pin connector. It is prepared to Ambient Pressure
send signals to other devices by means of an up to 15 meter long cable. (Altitude Compensation)
Use of the RS-232C
Flow and volume of the driving gas and that measured during expira-
In order to connect it to a compatible personal computer and print tion, will have variation according to the atmospheric pressure (or alti-
data to a file using VisualGraph program. Request the corresponding tude) of the place where the ventilator is in operation.
cable and software from TECME.
Flows and volumes should have correction to keep reference to ambient
pressure of the used place. The correction is made introducing the average
value of the local ambient pressure.

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:

MEAN AMBIENT PRESSURE


965 mbar (724 torr)
NOTE ➪ The change will take place simultaneously in mbar and torr units
turning the Control Knob.
The ventilator must be connected to the main power source to en- ➪ When the reached figure correspond to the mean one, press the
able the communications between the computer and the ventilator. When Control Knob. The value is permanently memorized. Later on, it can
the ventilator operates with battery, there is no communication for the be changed, if necessary, for a new value following the same proce-
RS-232 outlet. dure.
➪ Each time the ventilator is turned ON, the Flow and the driving or
CAUTION
exhaled Volume will be corrected according to the previously set
Connecting this medical device to a printer according IEC 60601-1-1 value.
is a sole responsibility of the user. It is not necessary to make new
Standard Atmosphere changes because the local fluctuations
International Civil Aviation Organization (ICAO)
Date and Time Setting Atmospheric Pressure
of the barometric pressure won’t in-
Altitude (m)
mb mm Hg
fluence in significant form the results,
In order to set the date and the current time get the Date and Time 0 1013 760 unless the device has a different loca-
Setting screen through the [Menu] key. 500 955 716 tion with important change in the
Date: The change is made using the Control Knob for each portion of the
1000 899 674
altitude. As a guide, see the following
1500 845 634
line dd/mm/yy. After the change (or not) press the knob. 2000 795 596
table:
Time: Same as above using the hh/mm/ss format. 2500 747 560
3000 702 525
3500 658 493
4000 616 462
4500 577 433

Assembly and Installation Procedures 13


This page intentionally left blank

14 Assembly and Installation Procedures


4
Description
The front panel of the GraphNet ventilator has control keys which regulate
the ventilatory parameters and complementary keys with specific functions.
The screen represents different respiratory variables in real time. The wave-
forms are derived from the changes produced in the ventilator and in the
patient.

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

This function key is used in combination with others:


• [Ctrl] + [Alarm Settings] = 1) Alarms Test. 2) Screen help when an
alarm is active.
• [FIO2] + [Ctrl] = Change of a value in steps of ten units.
• [Ctrl] + [Ctrl] = Reset all sensors (zeroing).
• [Ctrl] + [Manual Trigger] = Programmed sighs in VCV.
• [Ctrl] + [Freeze] = Maintain a reference loop.
• [Ctrl] + [Graphic] = 1) Screen clear. 2) It erases a reference loop if present.

It is a key with multiple functions, used alone or in combination with other


When pressing this key a list of options opens up to different functions keys. One of its functions is to reset any alarm once it has been activated.
and data:
It is also used to:
• Backup ventilation settings
• Go out, cancel or abort the current operation, returning to the
• Ventilatory adjuncts
main screen.
Get access to: Expiratory Sensitivity (PSV)
• Exit an open menu and to return to the graph mode.
Inspiratory Pause (VCV)
Sighs (VCV) • Cancel a maneuver.
Volume compensation
Humidifier in use
Leak compensation
It stops the ventilator without changing the programmed mode and set-
• Trends
tings. To accept the action, the knob should be pressed. By pressing [Esc],
• Activated alarms
the ventilator starts working again..
Up to 660 saved events that can be partially printed.
• Tools
Get access to: Pressure units option (cm H2O, mbar, hPa)
Suction period
Time of use and software version It opens the gas outlet for the nebulizer for 30 minutes. It automatically
Sound volume stops when the inspiratory peak flow is less than 20 L/min.
Oxygen sensor calibration With flow triggered sensitivity, automatically changed to pressure-trig-
Breathing circuit calibration gered ventilation while nebulization is on.
Date and time setting
Help
• Capnography
- CO2 waves mode
- Sensor initialization In all modes, when pressing [O2 100%], the FIO2 value changes to 1.0 [oxy-
- Save sensor settings gen 100%) and it is maintained for 150 seconds. The aim is to produce
- Sensor reset oxygenation prior and after tracheal aspiration.

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.

Capnography, shows the numeric


Pressing the key the period of the present phase will be maintained. The
data and the Pressure, Volume,
maximum time is 7 seconds for the inspiratory phase and 20 seconds for
Flow curves, CCVtime and the expiratory one. It is canceled in PSV/CPAP and SIMV modes.
Volumetric Capnography.

Graphic auto scaling


The auto scale option allows to automatically and dynamically
changing pressure, volume and flow
scales (vertical) of the curves and loops, showing the maximum The key is used to set the alarm limits adjustable by the user. Pressing the
possible scale on the screen in order key appears a menu with the alarms that can be changed by the user.
to have a better display of the graphics.
The auto scale option is inactive by default (Auto scale: No).
To activate it, enter Menu and select Auto scale.
The value is changed by turning the knob (Auto scale: Yes)
Pressing the key once stops sound 30 s; pressing twice successively stops
Selecting the maximum scale be aware about a missinterpretation of the sound 60 s. Some alarms cannot be silenced (See chapter Alarms).
displayed graphic.
Description 19
6. Screen Information Expiratory Time (Te -s-)
The Expiratory Time is expressed in seconds. It is the resulting value in all
This description refers to the parameters which are displayed on the modes.
screen. The parameters settings and the result data are distributed on the
four sides of the screen: I:E Ratio
It produces variations in the ratio of one tenth of the change unit, and
a) Lower part: Programming settings. changes the inspiratory time automatically. The inversion of the I:E Ratio
b) Upper part: Patient data monitoring. may only be programmed in the PCV controlled mode.
c) On the right: Pressure bar graph.
f total -bpm-
d) On the left: Battery status, airway pressure monitoring and pressure Total rate expressed in breaths per minute. The value appears in all venti-
alarms limits. lation modes.
Programming Settings Expired Tidal Volume (VT -L)
They correspond to the main control keys depending on the category of Expired volume, breath by breath.
patient and of the ventilatory mode. Expired Minute Volume (vE -L/min-)
Expired minute volume. It is displayed in all modes. It is updated with
every change of the tracings on the screen.

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.

Breathing Circuit Verification and Calibration 21


Stage 3 Stage 4
After accept the previous stage, the following screen appears. A type of After accept the previous stage, the following screen appears:
humidified should be selected, active or passive.

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.

To make a correct calibration, a complete arrangement of the breathing


circuit, including a heater (if used), should be connected between the ventila-
tor outlet and the exhalation valve. In this case, all the circuit will be checked.

22 Breathing Circuit Verification and Calibration


Calibration and ventilation using oxygen 100% Breathing circuit leaks
Like exceptional procedure and of extreme necessity, it is possible to cali- This test, besides the calibration, also checks the integrity of the patient’s
brate the circuit and to initiate the ventilation of the patient only using circuit. When a leak of gas exists for any part of the circuit less than 10 L/
OXYGEN as provision gas. During the operation, the alarm of lack of com- min, it is warned with the following message:
pressed air could not be silenced.

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.

Breathing Circuit Verification and Calibration 23


2) To verify if the gas connected towards oxygen is O2. In this case the defect
is announced with a warning indicating that the oxygen concentration is
not apt to ventilate. In this condition, the equipment will not continue the
calibration procedure unless the user accepts this situation.
Recalibration
If during the ventilation of a patient it is necessary to change and to
recalibrate the breathing circuit, you can get the calibration screen
through the [Menu] key going to the TOOLS row. In this way the pro-
gramming data in use are not lost.

WARNING
This recalibration should be carried out with the breathing circuit
disconnected from the patient and closing the Y connector.

24 Breathing Circuit Verification and Calibration


6
Adult and Pediatric Programming
Operative Mode Selection When the control knob is pressed in one of the Operative Mode present in
the menu selection, and depending on the mode selected and the category,
When the calibration process is completed, the screen shows the scheme all the participant sectors of such mode will be activated with default values,
for the sector of pressure, volume, flow and loops graphs with an active to facilitate its programming. These first values may be accepted in all by
neutral line, the bar of airway pressure and a menu with the operative pressing de control knob and the ventilator will start functioning.
modes whose selection is made with the control knob. If any value is to be changed before the ventilator starts, the correspond-
ing key placed below is pressed, the value of that parameter changes to
inverse video. The change is made turning the knob, and then it is ac-
cepted by pressing the knob. Then, the sector returns to normal video. If
10 seconds after pressing a key, the value is not accepted (whether it is
modified or not), the value remains unchanged.
A given operative mode may be completely programmed and stored in
the temporary memory before starting a particular mode. All the data
remains stored as long as the equipment is not turned off. To program
any mode, there are certain mandatory controls, to which the values must
be assigned and accepted before they can begin to operate.

WARNING
The alarm default and setting values in the different
ventilatory modes must be checked and readjusted according to the patient
conditions.

Adult and Pediatric Programming 25


Operative Modes Volume-Controlled Ventilation
(Pediatric and Adult) (VCV)
The operative modes that can be programmed with the GraphNet for It includes the ventilatory mode with specific regulation of tidal volume.
ADULT and PEDIATRIC categories are: The inspiratory pressure is variable, and it depends on the respiratory
impedance to regulated volume ratio.
1) VCV (Assist/Control) During this mode, the ventilator works as a flow-controller where the
selected flow waveform is sustained during any variation of the lung com-
2) PCV (Assist/Control)
pliance/resistance.
3) PSV/CPAP
In this mode, the ventilator is cycled by time, and the inspiratory flow is
4) SIMV with Volume + Pressure Support automatically calculated and regulated. This means that for a given vol-
5) SIMV with Pressure + Pressure Support ume, the variations of the inspiratory flow are obtained by means of the
6) Noninvasive Ventilation regulation of the inspiratory time. It also explains why the end of inspira-
tion is marked by a quick pressure drop without an inspiratory plateau,
7) Mandatory Minute Ventilation + Pressure Support unless it is specifically regulated.
8) Pressure Support with VT Assured
In the volume mode, the way of generating the inspiratory flow may be
9) Airway Pressure Release Ventilation changed by means of the key below of the flow waveform screen icon.
10) Pressure Regulated Volume Control (PRVC) They are constant flow and descending ramp.
11) Backup ventilation
The Neonatal category is described in Chapter 7.
In order to program an operative mode, there are specific commands for
that mode and others that can be used for all modes.
Within the commands, there are ones that are of mandatory use in all
modes, as well as other, also common but they are of non required use.
Required Commands
• VCV, PCV or PSV
• Sensitivity
• Fraction of Inspired Oxygen
• PEEP
• High Inspiratory Pressure Alarm
• Low Inspiratory Pressure Alarm
• High and Low Tidal Volume Alarm
• Maximum Total Breathing Rate Alarm
Non Required Commands
Correspond to optional commands or of occasional use:
• Manual Trigger
• Nebulizer
• O2 100%
• Pause Insp/Exp

26 Adult and Pediatric Programming


Descending Ramp Flow Waveform
VCV Programming
It is also called “decreasing” or “decelerating flow”. The descending ramp
flow waveform begins at the calculated peak value and decreases lineally Controls and programming limits:
until zero is reached. In response to this decelerating flow, the pressure and
volume waveforms are quite similar to those of the pressure control mode
(PCV). However, in the VCV mode, the flow decrease is preset, while in PCV it
is entirely determined by the lung mechanics.
In this ventilator, when entering the mode selection, the descending ramp flow
is taken automatically by the program as the default flow waveform. This deci-
sion was made considering that the GraphNet ventilator is designed to make it
easier for the patient to adapt him/herself to the assist or spontaneous modes.
During volume assist ventilation, (inspiration triggered by the patient), the
high peak flow produced by the descending ramp flow meets the post-trigger
Other parameters
demand (post-trigger phase) better than the constant flow. It also pro-
duces a lower pressure peak and higher mean pressure, with the intention to The alarm default values, which depend on whether the ADULT or
get an improvement of oxygenation. PEDIATRIC option was selected, will be displayed on the screen. The
change of any value is accomplished through the [Alarm Settings] key.
Constant Flow Waveform
The programming of PEEP, sighs, inspiratory pause and nebulization is
The constant flow produces a square
optional. The 100% O2 procedure is available.
waveform.
When the programming is started, the descending ramp flow waveform
During the inspiratory phase, the pres-
sure developed in the airway shows two (decelerating flow) is active by default, but may be changed at any mo-
sections. First there is an initial fast in- ment. The descending ramp waveform produces the highest peak flow in
crease due to a sudden pressurization of comparison to other waves, and may be more appropriate for patients
the circuit due to the continuous flow, with assist ventilation.
which is considered to be a reflection of
the system resistive properties WARNING
(resistance x flow). The second section The volume control key [VT] regulates a drive reference value
has a less sharp though progressive rise, which will not necessarily show the expired volume. This difference may
and it depends on the flow derived from
be due to multiple factors: circuit compliance, system air tightness, posi-
the inspiratory time and the regulated
tive end expiratory pressure, etc.
volume, and represents the system’s
elastic properties.
The pressure continues to rise until the end of inspiration, a point which coin- In volume-control ventilation, the patient may start the inspiration with
cides with the stoppage of the flow.
its own effort, but if he presents with weak efforts or apnea, the ventila-
During assisted ventilation with constant flow, the observation of the pressure tor starts the inspiration according to the set rate.
waveform may help interpret any patient-ventilator asynchrony. In this instance
the pressure curve shows a concavity in the rising portion as a consequence of a
flow demand higher than that generated by the ventilator.
Selection of the Flow Waveform
The selection of one or another flow waveform depends on the specific circum-
stances arising when trying to find the most appropriate way of adjusting the venti-
lator to the patient’s needs. The rectangular waveform is the classic one, where the
volume is attained with a comparatively low flow, and with the lowest pressure
peak. The decelerating (descending ramp) flow waveform is appropriate in patients
with respiratory assistance, where the high peak flow may better satisfy the
patient’s demands; this waveform is the one producing the highest mean pressure.

Adult and Pediatric Programming 27


Sigh Pressure-Controlled Ventilation
The programming of sighs and inspiratory pause (in each phase) is only
operative in the volume-control mode.
(PCV)
By pressing [Menu], selecting Ventilatory adjuncts and then the Sigh line, In the Pressure-Controlled Ventilation mode (PCV), the GraphNet ventila-
the following menu appears on the screen: tor works as a positive pressure controller because the pressure waveform
remains the same when the patient’s compliance or resistance changes.
Turning the control knob, the ap- The switching from inspiration to expiration is normally regulated by time
propriate value is selected, and each (inspiratory cycling by time) or by pressure if the maximum safety pressure
line is accepted pressing the Knob. limit is reached. As in all pressure controlled modes, during PCV, the venti-
The notice of programmed sigh is latory volume is variable and depends on the lung size, the present pres-
displayed over the name of the mode sure gradient at the beginning of inspiration between the upper airway
being used. and the alveoli, the respiratory system compliance and the available in-
spiratory time.
The waveform of the pressure developed during inspiration is rectangular,
WARNING
being the flow of the descending ramp type (decelerating flow). The typi-
The sigh volume is added to the already programmed tidal volume, cal pressure plotting shows a quick lineal increase until the set pressure
so that: Total Volume = Tidal Volume + Sigh Volume limit is reached. Pressure is maintained constant during the set inspiratory
time.
To cancel the sigh function, select OFF under Number. In this mode, the peak flow is high and corresponds to the value of the
peak flow displayed on the screen.
Inspiratory Pause
By pressing [Menu], selecting Ventilatory adjuncts and then the Inspira-
tory Pause line, the following appears on the screen:

The inspiratory pause time is selected


using the control knob with varia-
tions every 0.25 seconds up to 2 sec-
onds. The notice of programmed
pause is displayed over the wave's
area. Simultaneously, the value of
the plateau pressure is displayed.
To cancel the inspiratory pause
function, select OFF under TIME.

28 Adult and Pediatric Programming


The progressive fall of flow observed during inspiration is entirely deter- PCV Programming
mined by the lung mechanics. Therefore, in those conditions character-
ized by low resistance and low compliance, the flow may reach the zero
line far before the end of inspiration. On the contrary, when resistance is Controls and programming limits:
normal and compliance is normal or high, the inspiratory flow may be
high at the end of inspiration, in particular if the inspiratory time is brief.
The advantage attributed to the PCV mode is the way in which the in-
spiratory pressure is controlled so that the regulated pressure is not ex-
ceeded. Depending on the regulated inspiratory time and on the lung
mechanics, the alveolar pressure will be closer or farther away from the
regulated pressure but it will never be higher.

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.

Adult and Pediatric Programming 29


Pressure Support Ventilation 1) Beginning of Inspiration
The inspiratory phase always begins (or is triggered) by the patient’s in-
(PSV) spiratory effort. The trigger sensitivity control makes the patient’s effort
be greater or smaller. A good target is to try to achieve a greater sensitiv-
General Operation ity without autocycling, so that the effort will be minimized.
One of the most outstanding characteristics of the GraphNet ventilator is The sensitivity is regulated by the flow variations (flow-triggered) or by
the way the pressure support is programmed and operated. This feature the pressure changes (pressure-triggered).
allows a greater efficiency in the adjustment of the ventilator controls to
the patient’s ventilatory needs. Flow Trigger Sensitivity (btr)
Pressure support ventilation is a spontaneous ventilation mode where the When flow sensitivity is selected, the ventilator makes a continuous flow
patient begins and ends the inspiratory phase; this means that he keeps pass through the respiratory circuit during the expiratory phase. Inspira-
control of the frequency, the duration of the inspiration and of the tidal tion begins when the microprocessor detects a difference between the
volume. As in all modes limited by pressure, the tidal volume (VT) is vari- flow coming into the respiratory circuit and the one leaving. The differ-
able, depending on the regulated pressure in relation to the respiratory ence is produced when the patient's aspirates part of this continuous
system impedance, as well as to the patient’s demand. flow.
The difference between the flow entering the circuit and the one leaving
necessary to produce an inspiration may be set from 0.5 to 15 L/min. The
continuous flow is twice the selected difference. For example, for a flow
sensitivity of 3 L/min, a continuous flow of 6 L/min is produced in the cir-
cuit; if in the connection to the patient 3 L/min or more are aspired, an
inspiratory cycle is triggered.
In all modes, the flow sensitivity is the default parameter. Even when the
flow sensitivity is selected, the beginning of an inspiratory phase may be
marked by a drop in the pressure waveform.
Pressure Trigger Sensitivity (Ptr)
In pressure-triggered sensitivity, the inspiration is triggered when a pressure
fall equal or greater than the selected one is detected in the respiratory circuit.
When pressure sensitivity is selected, and a PEEP value is set, a continuous
flow is also produced during the expiratory phase. This continuous flow is
intended to avoid a PEEP fall during prolonged expiratory periods due to
the patient’s circuit and/or to the expiratory valve, but it is not directly
involved in the sensitivity process.

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.

30 Adult and Pediatric Programming


Regulation of the pressurization speed (“Rise Time”) 2) When the inspiration lasts more than 2 s in adult (ADL), 2 s in pediatric
The regulation of the pressurization speed, i.e., of the pressure rise time (PED) and 1 second in NEO categories.
allows a better adjustment of the inspiratory flow to the demand, and of 3) When the pressure rises abruptly more than 14% plus 5 cm H2O over
the patient’s post-trigger phase. This regulation is obtained by means of the set one in all categories.
the Rise Time control. The mechanism mentioned first is the usual one for the end of inspiration.
A brief time will produce a quick pressurization, which will generate a The other two are exceptional forms to protect the ventilation from unde-
rectangular pressure waveform, characteristic of the mode, and a deceler- sirable effects.
ated expiratory flow waveform.
Regulation of the Expiratory Sensitivity (End of Inspiration)
If the peak flow is too high for the patient’s and/or circuit conditions,
During PSV, whether alone or in a combined mode, the percentage of the
there may be a failed inspiration and the tidal volume could be low.
peak flow may be regulated to produce the end of inspiration. There-
When there is an increase of the airway resistance, the increase up to a fore, by regulating this percentage, the expiratory sensitivity, that is the
given pressure may be too abrupt causing a saw-tooth-like plotting. expiratory trigger, may be controlled. The range of change goes from
On the opposite end, a very low Rise Time in relation to the patient’s and/ 5% to 80% in 5 percent steps.
or circuit conditions, could result in a ventilatory tidal volume lower than
By default, the program takes a 25% of the peak flow to end the inspira-
expected.
tion. This percentage can be changed by means of a dedicated key.
Between these two situations there is significant variability, and by han-
dling this variability, it is possible to adjust the peak flow to the patient’s By changing the percentage, the flow waveform is modified, thus allowing
demands and conditions. a better adjustment of this ventilatory mode to the patient’s demand.
The Rise Time is graphically represented by an icon with broken line which
slope is indicating the magnitude of the peak flow. There is not any
value because the peak flow is variable and depends on the system im-
pedance, both of the ventilator and of the patient. When there are no
obstructions in the circuit, the generated flow may be varied up to
180 L/min according to patient's demand.
The Rise Time may be regulated both in the Pressure Support mode alone
and in PSV of the combined modes. When the pressure support is com-
bined with Pressure-Controlled Ventilation (PCV), the regulated rise time
affects both modes.
b) Set Pressure Holding Period
Once the pressure value is achieved, the pressure is held stable while the
flow demand is greater than the one selected as end of inspiration. If the
rise time has been set higher than necessary, a brief pressure peak may be
observed at the beginning of the plateau and, as mentioned before, if the
change is excessive, a spiked pressure waveform is produced and there is
ineffective ventilation.

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.

Adult and Pediatric Programming 31


Pressure Support Monitoring PSV Programming
In the GraphNet ventilator, the PSV monitoring is continuous. The mea-
Since Pressure Support Ventilation is a spontaneous ventilation mode,
sured and resulting values of these parameters are on the left and at the
where the patient starts the inspiration with his own effort, it may hap-
top of the screen. Those on the left correspond to the airway pressures.
pen that, during ventilation, the effort decreases or stops. When there is
The figure below shows the simultaneous plotting of the airway pressure,
deficiency of stimulus, the ventilator does not cycle, therefore, in this
volume, flow, pressure/volume and flow/volume loops.
mode, the Backup Ventilation must be programmed. When the PSV mode
is selected, a message is displayed on the screen addressing the program-
ming of the backup ventilation first. The PSV can only be programmed
once the backup ventilation has been programmed.
Generally, PSV is used after a controlled or assist mode, when there is
already a reference as to the tidal volume and pressure used. These data
are important to set the initial ventilation values. In order to achieve a
tidal volume similar to the one used, an approximately equal support
pressure must also be regulated.
With the first breaths, if necessary, the pressure will be varied looking for
the required volume. Also, by modifying the expiratory sensitivity, the
resulting volume is changed.
Controls and programming limits:

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.

32 Adult and Pediatric Programming


Continuous Positive Airway Pressure SIMV (VCV) + PSV
(CPAP) (SIMV [Volume-Control Ventilation] with
It is a spontaneous breathing mode where the patient ventilates in a
Pressure Support)
continuous positive pressure system. There is no mechanical positive-pres-
This mode comprises synchronized intermittent ventilation with volume-
sure breaths delivered, but the inspiration of the patient causes that the
controlled mandatory inspiration and spontaneous inspirations with pres-
ventilator generates a flow proportional to the demand. The patient’s effort
sure support.
that opens the flow valves is regulated by a sensitivity control.
In this synchronized ventilation mode, during mandatory breathing, the
The ventilator maintains an active pneumatic control of the continuous
patient receives a preset volume provided at a preset inspiratory time and
positive pressure by means of the action of a proportional valve on the
rate. During spontaneous breathing, the patient breathes with pressure
diaphragm of the exhalation valve.
support.
During the inspiration, the airway pressure graphic shows a slight reduction
The flow waveform of the mandatory inspirations may be changed during
in relation to the base line of the continuous positive pressure and, during the
ventilation.
exhalation, an ascent of this pressure, that is to say, an inverse waveform to
the observed 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.
Programming
The programming of CPAP is the same of the Pressure of Support with PSV
0 (zero), and with PEEP set in an appropriate level.

Controls and programming limits:

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.

Adult and Pediatric Programming 33


SIMV (VCV) + PSV Programming SIMV (PCV) + PSV
The programming is done by entering the values which correspond to the (SIMV [Pressure-Controlled Ventilation]
volume-control ventilation mode on the one hand, and the spontaneous
mode (PSV) on the other.
with Pressure Support)
Controls and programming limits: This mode is characterized by synchronized intermittent ventilation with
pressure-controlled mandatory inspiration and spontaneous inspirations
with pressure support.
In this synchronized ventilation mode, during mandatory breathing, the
patient receives pressure-controlled inspirations, with a decelerating flow,
provided at a preset inspiratory time and rate. During spontaneous
breathing, the patients breathe with pressure support.

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.

34 Adult and Pediatric Programming


SIMV (PCV) + PSV Programming Noninvasive Ventilation
Controls and programming limits:
(NIV)
Noninvasive ventilation (NIV) is referred as ventilatory support through
the upper airway using a mask or a similar device. This technique is differ-
entiated from the invasive one that uses tracheal tube, laryngeal mask, or
tracheotomy to provide ventilation.

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.

This ventilator performs noninvasive ventilation with positive pressure and


leaks compensation. It is a mode controlled by pressure that combines charac-
teristics of PCV and PSV. The inspiratory pressure is adjustable up to 110 cm
H2O, and it is possible to add PEEP from 2 to 50 cm H2O.
The system can compensate leaks according to the patient's category. This
feature allows stabilizing the regulated pressure and triggering sensitivity
avoiding autocycling and thus improving patient-ventilator synchrony. This
mode has two ways to end of the inspiration: 1) The classic PSV criteria, from
5% to 80% of the peak flow, and 2) Maximum inspiratory time setting.
As a backup, a minimum respiratory frequency can be set in order to guaran-
tee the continuity of ventilation in case of reduction of the inspiratory effort.
The monitored expired tidal volume is an "estimated" of which the patient
receives, and its calculation considers eventual leaks.

Adult and Pediatric Programming 35


NIV Programming MMV with PSV
(Mandatory Minute Ventilation with
Controls and programming limits:
Pressure Support)
It is a totally spontaneous ventilatory mode where the patient breathes
with pressure support at a preset value, and there is regulation of a
minimum minute volume. During each respiration the microprocessor makes
an analysis combining tidal volume and respiratory rate to do a projection
of the minute volume. A correction is made by varying the pressure support.

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.

Any reduction of the spontaneous breathing is automatically sensed by


the ventilator and the mechanical ventilatory support is increased without
the need of the operator being involved. On the other hand, an increase
in the spontaneous breathing will produce a decrease of the ventilator-
driven ventilation.
The pressure variations are of one or two centimeters of water to avoid
any abrupt rise or drop. Since the minute volume depends on the tidal
volume demanded by the patient and on the spontaneous breathing rate,
once the target minute volume is reached, there are usual variations
above or below the target.

36 Adult and Pediatric Programming


The fact that the maximum and minimum alarm limits for the tidal vol-
ume and the minute volume and those of the airway pressure are opera-
PSV with VT Assured
tive, ensures a protection against eventual undue increases either in the (Pressure Support Ventilation with
pressure and/or in the volume.
Tidal Volume Assured)
MMV with PSV Programming The objective of this mode is to guarantee a minimum tidal volume from
a pressure regulated inspiration in case of an eventual reduction of the
breathing effort.
Controls and programming limits:
It is a spontaneous ventilatory mode where the patient breathes with
pressure support at a given value combined with the regulation of the
minimum tidal volume. If during each breath, the set volume is not
reached, the descending ramp flow changes to continuous flow. This ef-
fect produces a rise in the inspired volume until the target volume is
reached with a concomitant rise in the airway pressure.

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.

Adult and Pediatric Programming 37


In the following table, the operation of this mode is described by compar- PSV with VT Assured Programming
ing the volume attained by the patient with the volume set as target.

Condition
Controls and programming limits:

Variable Patient’s VT > Set VT Patient’s VT < Set VT

Control Pressure Pressure ® Volume

Trigger Patient (pressure or flow) Patient (pressure or flow)

Limit Pressure Pressure ® Flow

Cycling Flow Volume

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.

38 Adult and Pediatric Programming


Airway Pressure Release Ventilation
Controls and programming limits:
(APRV)
The Airway Pressure Release Ventilation is a mode which ventilates apply-
ing periodic switching between two adjustable levels (P-high and P-low) of
continuous positive airway pressure (CPAP) during preset periods of time.
Spontaneous breathing is possible without restriction at both levels, with
or without pressure support (PSV). In the GraphNet this mode can be
implemented in the adult (ADL) and pediatric (PED) category.
The two levels of positive pressure, alternating to intervals of time selected
by the operator, produce intermittent distension and passive decompres-
sion of the lungs. At the same time, and so much during the upper or
lower level, the patient can breathe spontaneously with or without pres- [PEEP/CPAP]
sure support. According to the regulation of the upper and the lower pres- The default values are of 5 and 0 cm H2O for P-high and P-lower CPAP,
sure time, it can be administer ventilation with inverse I:E ratio. respectively. In the screen, the first value appears in the normal place of
PEEP/CPAP. The second appears under the previous one.
To change the CPAP values the [PEEP/CPAP] key it is pressed once to modify
the high value or twice for the lower, with change of the number to inverse
video. With the control knob it can be increased or decreased the value,
accepting pressing the knob. The low value can be same but not bigger
that the high.
[Ti]
This key comply a double function by means of which it can be ad-
justed the time value of the high and lower CPAP pressure period. The
values for default are 5 and 1.5 seconds respectively. In the screen, the
values appear one above the other one in the place that corresponds at
the Inspiratory Time.
To change the time values the [Ti] key should be pressed one or twice,
enabling the number of the high or low time respectively.
With the control knob it can be increase or decrease the value,
accepting pressing he knob.
[I:E]
The key is disabled for programming, however, the value that corresponds
to the relationship between the high and the low CPAP time is shown in
the screen.
[PSV] - [Rise Time]
During the period of high and low CPAP, the patient can have spontaneous
ventilation with or without pressure support. As default there is 5 cm H2O of
pressure support but it can be changed from 0 to 50 cm H2O.
The pressurization of the beginning of the inspiration is regulated with
the Rise Time keys.

Adult and Pediatric Programming 39


[Sensitivity]
Key used to regulate the trigger sensitivity during the spontaneous Pressure Regulated Volume
breathing. For default, the sensitivity is for flow of 3 L/min.
[Epiratory sensitivity]
Control (PRVC)
It is an assist/controlled mode used to obtain a target current volume
It is present in all the modes of spontaneous ventilation. It is possible to
through the regulation of pressure controlled breaths.
make variation of the inspiratory peak flow to get the end of the inspirato-
ry phase. This way, the control of the expiratory sensitivity is obtained, that
is, the expiratory trigger. The variations go from 5% to 80% of the
inspiratory peak flow in steps of 5%. By preestablish adjustment, the
program sets a reduction of 25% to finalize the inspiration.

[f ] Machine Rate - bpm


The key is disabled for programming, however, the value of rate of the
high to low CPAP is shown as breathing frequency in the screen. If the
patient has spontaneous ventilation, the resulting frequency is shown in f
total screen sector.

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

40 Adult and Pediatric Programming


or minimum (5 cmH2O above PEEP) a medium priority alarm will be The pressure regulation mechanism will restart:
activated to warn the operator about this event.
. Each time the PRVC is entered into.
Each time the target current volume is changed.
The Screen message is: “Target Volume not reached”
When returning to Stand by

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:

• Target current volume


• Ti
• Breathing frequency
• Trigger sensitivity
• PEEP
• FiO2
• Rise Time

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.

Adult and Pediatric Programming 41


Backup Ventilation Programming Backup Ventilation
The programming of backup ventilation depends on the category of
In all spontaneous modes, the Backup ventilation must be programmed patient. In ADULT and PEDIATRIC can be set with VCV (volume)
first, since it will automatically replace the mode being used when the or PCV (pressure) modes. In NEONATAL the PCV, VCV or
ventilator detects a failure in the spontaneous breathing during the set TCPL modes can be used.
apnea time. However, in both SIMV, it is possible to choose to cancel the
command used to enter into backup ventilation, since the rate of manda- Changing ventilatory parameters in the backup mode
tory inspiration remains as protective measure in case of apnea.
The modes in which it is necessary to program the backup ventilation are: The changes can be done: 1) during the operation of the mode or 2) when
the mode is not active.
• Pressure Support Ventilation (PSV) and CPAP.
• Volume-controlled SIMV, with pressure support. 1) The changes of parameters while the backup is driving to the ventilator
• Pressure-controlled SIMV, with pressure support. they are doing directly by means of the keys qualified like any other
• Mandatory minute ventilation with pressure support. mode. The values shown in the screen correspond to this mode.
• Pressure support ventilation with volume assured.
2) Pressing the Menu key and entering the line Backup.
When selecting one of these modes, and after accepting the values, the
following message appears on the screen: If the patient recovers the inspiratory effort while the ventilation of
backup is working, the ventilation with the mode programmed initially is
started again, the alarm sound is suspended but the light signal continues
until the [Esc] key is pressed.

The operative mode can be selected between VCV or PCV.


The apnea time default value is 15 seconds. It may be changed from 5 to 60
every 5 seconds.In SIMV, either the activation of the backup ventilation with
alarm (ON) or
no backup ventilation (OFF) may be chosen. The default option for both
SIMV and APRV modes is OFF (backup ventilation deactivated). One of the
two options is chosen turning the control knob. Accept pressing the knob.
Action: When there is no inspiratory effort or when it is weak, the apnea
alarm will be activated after the selected elapsed time (5 to 60 seconds).
The ventilator will automatically enter into Backup Ventilation if it has
been programmed, and this is indicated by the following message:
APNEA ALARM ACTIVATED
BACKUP VENTILATION IN USE
The alarm sounds for 5 seconds while the message and light remains on. If the
cause persists, the sound is activated every 10 seconds for 5 seconds, and this
sequence continues until the cause disappears, or the operative mode is changed.
If the patient recovers the inspiratory effort while the backup ventilation is
on, the ventilation in the programmed mode is resumed, the sound stops but
the light for Apnea continues on until the [Esc] key is pressed.

42 Adult and Pediatric Programming


Neonatal Programming
7
When NEO is selected and the calibration of the breathing Volume-Controlled Ventilation (VCV)
circuit is completed, a menu to select an Operative Mode is shown:
It includes the ventilatory mode with specific regulation of tidal volume.
The inspiratory pressure is variable, and it depends on the respiratory
impedance to regulated volume ratios.
During this mode, the ventilator works as a flow-controller where the
selected flow waveform is sustained during any variation of the lung com-
pliance/resistance.
In this mode, the ventilator is cycled by time, and the inspiratory flow is
automatically calculated and regulated. This means that for a given vol-
ume, the variations of the inspiratory flow are achieved by means of the
regulation of the inspiratory time. It also explains why the end of inspira-
tion is marked by a quick pressure drop without an inspiratory plateau,
unless it is specifically regulated.
In the volume mode, the way of generating the inspiratory flow may be
changed by means of the key below of the flow waveform screen icon.
They are constant flow and descending ramp.
These modes have some specific operational characteristics,
which are different to the Adult and Pediatric divisions. These fea-
tures allow to adapt the ventilator controls to meet the ventilatory needs
of patients with a very low body weight as well as those ranging to 10 kg.

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

Nebulizer: Is inactive in NEO, except in TCPL mode.

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.

In volume-control ventilation, the patient may start the inspiration with


its own effort, but if he presents with weak efforts or apnea, the ventila-
tor starts the inspiration according to the set baseline rate.
The inspiratory pause time is selected us-
Descending Ramp Flow Waveform ing the control knob with variations every
It is also called “decreasing” or “decelerating flow”. The descending ramp 0.25 seconds up to 1 second. The notice of
flow waveform begins at the calculated peak value and decreases lineally programmed pause is displayed over the
until zero is reached. In response to this decelerating flow, the pressure wave's area. Simultaneously, the value of
and volume waveforms are quite similar to those of the pressure control the plateau pressure is displayed.
mode (PCV). However, in the VCV mode, the flow decrease is preset, while To cancel the inspiratory pause function,
in PCV it is entirely determined by the lung mechanics. select OFF under TIME.

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.

The speed of the inspiratory pressurization may be varied by means of the


Rise Time, thus enabling a better adjustment of the ventilator to the
patient’s demand and lung mechanics.
Volume Compensated
The value of the exhaled volume showed in the upper line of the screen,
includes the compressed volume in the breathing circuit. When the
breathing circuit is calibrated, the calculation of the circuit compliance is
made. Keeping in mind this compressible volume, it is possible to subtract
it and to know the volume directed to the patient.
Through the [Menu] key, and in the corresponding row, it can be acti-
vated or deactivate the reading of the compensated tidal volume.
The value appears in the same place with the advice of
VT Compensated or Not Compensated.
This volume value is an orientation of the ventilatory tidal volume, but it
also depends on other factors like leaks of the circuit or around the tra-
cheal tube.

Controls and programming limits:

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.

Controls and programming limits: Controls and programming limits:

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.

Continuous Flow Setting


Pressing the corresponding key the flow can be set from 2 to 40 L/min; 8
Controls and programming limits: L/min is the default value.
PEEP
The obtained value is exhibited in the PEEP pressure. Modification
in the PEEP pressure can also be attained increasing or decreasing the
continuous flow.
In addition to the mentioned parameters, set the FIO2 and Alarms. Except
high and low Tidal Volume, all the alarms are accessible by the user.
Backup Ventilation
The backup mode is pressure controlled (PCV) with leaks compensation up
to 10 L/min and the following parameters:
PCV: 8 cm H2O; Ti: 0,5 s; Rate: 18 bpm; PEEP: the programmed one.
These values can be changed.
Neonatal Programming 49
Alarms Backup Ventilation
As in all other modes, there are general alarms which are automatically To program Pressure Support/CPAP alone or combined with SIMV (with
activated, and alarms which are specifically regulated. The alarms that are the option SIMV OFF), it is necessary first to program the backup mode.
regulated are the following: This backup mode work with VCV, PCV or TCPL.
Breathing rate (f max) Initially, when selecting a mode with spontaneous ventilation, the follow-
ing menu appears in the screen:
It can be set from 0 to 160 bpm. It has a set delay time of 30 seconds. The
initial default value is 30 bpm.
High and Low Tidal Volume
To regulate in all the modes, but less in Continuous Flow CPAP. The high
volume is regulated from 10 up to 100 mL, with changes of 10 mL. The
low volume from 1 up to 99 mL, with changes of 1 mL up to 10 and after
to 10 mL.
The initial default values are 25 mL and 5 mL respectively.
High Inspiratory Pressure
It is immediately activated. It interrupts the inspiratory time and opens
the expiratory valve. It is regulated by steps of 1 cm H2O from 10 to 120.
The initial default value is 25 cm H2O.
Low Inspiratory Pressure
The default values, or the already accepted ones, can be changed with the
It generally gives the alert on a disconnection or important leak. The acti- [Alarm Settings] key. The changes of each line are accepted with the
vation delay time is of 10 seconds. It is set at steps of 1 cm H2O from 3 to knob. The accepted line is marked in inverted video. With [Esc] key, it can
99. The initial default value is 5 cm H2O. go out, with or without change of a parameter.
PEEP Loss The operative mode for the backup in NEO is with VCV, PCV or
When a PEEP value is programmed, the default value is automatically set TCPL.
at a pressure of 4 cm H2O below the set PEEP; the alarm will be activated
In SIMV there is the option to opt among activation of the backup ventila-
with a delay of 10 second. This value appears on the upper part of the
tion (ON) or without backup ventilation (OFF). In this last case, the rate of
curves panel.
the mandatory inspiration is as ventilatory guarantee. By default, is in
The value may be changed to 2 or 6 cm H2O, or the alarm may be dis- OFF.
abled. This change is made through the [Alarm Settings] key.
When it exists lack or weakness of the inspiratory effort, the apnea alarm
will be activated after the selected time (5, 10, 15, 30, 60 seconds). The
ventilator changes automatically to Backup Ventilation as it has been pro-
grammed.
If the patient recovers the inspiratory effort while the backup ventilation
is working, the ventilation is renewed as programmed, the sound is sus-
pended but the luminous sign of Apnea continues until the [Esc] key is
pressed.
If the cause is overcome, the ventilation is renewed with the programmed
mode. The sound is suspended but the luminous sign of the sector Alarms
remains until the [Esc] key pressed.

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

Dynamic compliance is a global index which makes reference to the


general patient’s respiratory impedance, without making any distinctions
between its items (Pel and Pr).
In this ventilator, the dynamic compliance is shown in real time, breath by
breath, on the screen corresponding to the Pressure/Volume loop.
52 Respiratory Mechanics
Inspiratory Resistance Procedure
The inspiratory resistance is calculated by means of the following formula: The measurements of both compliance as well as of both resistances are
Pmax – Pplateau done altogether as requested by the Respiratory Mechanics menu.
Inspiratory resistance = ————————— In the next figure, the arrow shows the beginning of the test.
VT/Ti
Where VT/Ti is the mean inspiratory flow.
Similar to other respiratory mechanics measurements, the inspiratory
resistance needs the patient’s passive inflation with a known tidal volume,
a rectangular flow wave and an inspiratory pause. Those conditions are
important to validate the measurement. In VCV Mode a descending ramp
flow wave can also be used, in this case the Inspiratory Resistance will be
omitted.
The measurement of inspiratory resistance is omitted during the pressure-
controlled ventilation mode (PCV) because the changes in Pmax and
Pmax – Pplateau are not useful to assess the changes in the airways
resistance because the inspiratory flow characteristics.

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

To leave the program, press the [Esc] key.


Comments
In some cases the test could fail to show results of Lip. This is because the
program omits the calculation of the lower inflection point when it is
below 4 cm H2O.
As far as the value of the upper inflection point is, depends on the charac-
teristics of the ventilated lung in relation to the volume limit set for the
test.

The airway continues to be occluded for 20 seconds, during which Pimax is


measured.
Pimax is calculated as the greatest airway pressure fall which takes place
during occlusion. The result is expressed as absolute value, taking as
reference the baseline pressure level.

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
This page intentionally left blank

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:

• Airway Peak Pressure


• Respiratory Rate
• Peak Inspiratory Flow
• Tidal volume
• Volume minute
• Dynamic Compliance
• PEEP
• CTesp
• EtCO2 (optional)

The program allows to combine three variables to be shown in a single


screen. They are possible to be combined up to three groups according to
convenience of the situation. The trend function is acceded by means of
the [Menu] key.
In addition, an option exists to accomplish a combination of graphs of
trends according to preferences. In this case, select "Settings".

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
®

Inc.) is the instrument used to obtain data. It is a maintenance free device,


which does not need calibration nor use titled gases. The zero calibration
takes control from the ambient air whenever the adapter that connects the
sensor between the airway and the ventilator is changed.

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
This page intentionally left blank

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.

Respiratory circuit WARNING


Special care must be taken when cleaning and making aseptic the respira- The ventilator should not be subjected to sterilization with ethylene
tory circuit, including breathing tubes, expiratory valve, expiratory pneu- oxide gas. Irreparable damage of its components can take place.
motachograph and humidifier. These parts must be routinely changed and
replaced by sterile or disinfected elements. CAUTION
After removing them from the ventilator, the patient’s circuit must be
Do not use solvents, acetone, chloroform or strong acid substances or
disassembled to expose all surfaces before cleaning. All parts to be disin-
chlorinated solvents to clean the plastic parts or the respiratory tubes.
fected or sterilized must be carefully cleaned to remove all rests of mate-
rial adhered to them (blood, tissue products or other residues). Clean all Refer to the heater-humidifier manufacturer manual for the cleaning and
parts using soft detergent solutions and then rinse them preferably with sterilization of the device.
distilled water.
CAUTION
Do not submerge the humidifier base in any kind of liquid. The electric
WARNING components may cause a short circuit.
The breathing circuit tubes and the heater-humidifier are no parts
made or processed by TECME. It is also important for the assembly and reassembly to be correctly done
To maintenance and disinfection, refer to the manufacturer's instructions for a correct working of the ventilator.
and recommendations.
If the components are sterilized using ethylene oxide or known chemical
solutions (quaternary ammonium compounds) use the products according
to the manufacturer’s instructions and recommendations. Make sure the
compounds are compatible with the plastic material.

WARNING
The ethylene oxide may alter the surface of the plastic materials
and accelerate the aging of the rubber components.

Care and Maintenance 65


Expiratory valve and flow sensor
The expiratory flow sensor (pneumotachograph) is part of the expiratory CAUTION
valve assembly. The lower 22 mm free end constitutes the tap to which
the last tube of the patient’s respiratory circuit is connected. The pneumotachograph incorporated to the expiratory valve has a
transparent membrane inside.
The small side tubes of the sensor are connected as follows, the lower one Make sure the membrane is not bent or damaged so that the
to P1 and the upper one to P2 on the base of the enclosure. This commu- measurement of expiratory flow and volume is correct.
nication transmits pressures to the internal differential transducer for the
integration of the expired volume and flow. The upper tube also trans- Membrane
mits the airway pressure.

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.

66 Care and Maintenance


Internal Battery Air Filter
The GraphNet contains an internal battery that can supply 2 hours 30 min- The air filter has an automatic drainage system for the condensed water.
utes of power depending on ventilator settings and battery charge level. Nevertheless, the following steps should be followed for its normal opera-
The ventilator automatically switches to the internal backup battery when tion:
electrical power supply failure is detected. The internal battery is charged ➪ Connect the filter according to the
during ventilator operation if attached to an AC power source. This can be Disassembled instructions explained in chapter 3
either in standby mode or when the ventilator is turned off. Air Filter “Assembly and Installation Proce-
dures”.
CAUTION ➪ Always keep the device vertically.
If, when turning the ventilator on after being unplugged for an ➪ Use, if necessary, a tube connected
extended period of time the “Depleted Battery” signal appears, the inter- in the exit of the drainage in order to
nal battery must be recharged by plugging the ventilator into a power collect the water in a container. The
source for a minimum of eight (8) hours. Filter tube must have 8 mm (5/16 in) of diam-
element eter and not more than 5 m (16.5 ft) of
Reappearance of the “Depleted Battery” signal after the battery has been length. Be sure not to have any up-
Lock ward turns in the drain line which
recharged indicates the need to replace the battery.
would prevent drainage.
➪ Change the filter unit every two
WARNING years or before the pressure fall is
Never begins a ventilatory procedure when the equipment is greater to 1 bar (0,1 MPa).
turned ON and the battery icon indicates very low load. DO NOT USE the ➪ To change the filter element pull
ventilator until the load is completed maintaining the connection to the down the frontal lock and turn the
main source of electrical energy. bowl guard towards any side until the
If the battery icon continuously persists in a middle position, the battery || marks are in front. Throw down-
should be changed. wards. Unscrew the filter element and
replace it by a new one.
CAUTION
In case of battery discard follows the Institutional requirements.
The discarded unit should not be thrown to fire. Explosion may result.

Care and Maintenance 67


Maintenance and revision every 5000 hours or Respiratory Circuit Tubes
once a year Cleaning and Handling Instructions
(Procedure made by the specialized technician)
WARNING
➩ Inspection and verification of the operation of Proportional Valves.
Recalibration if necessary. The following description and instruction are included with the only pur-
pose to make clear the handling and maintenance of a determined type of tubes
➩ Substitution of the expiratory valve. that can be used in the respiratory circuit. These tubes are not made by TECME.
➩ Inspection and verification of the operation of each key and the
Reusable plastic tubes with smooth interior
screen.
These respiratory circuit tubes are manufactured with material for high tempera-
➩ Disassembly of the air and oxygen supply inlet, with cleaning or ture. The chemical composition is a polyester elastomer (Hytrel®). It incorporates at
change the porous metallic filters. each end an integral silicone rubber cuff.
➩ Verification of the FIO2 (oxygen concentration).
Recalibration if it is necessary. CAUTION

➩ 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.

68 Care and Maintenance


12
Operational Test
This section covers a series of tests performed by the user, to verify proper General Tests
operation of the GraphNet ventilator. They must be performed the first
time the ventilator is set up and prior to connecting the ventilator to a Oxygen System
patient.
Check the Oxygen concentration displayed on the analyzer after two min-
utes. The concentration should be between 45% and 55%. Press the
CAUTION
[O2 100%] key. The oxygen analyzer should display 95% or higher after
If the ventilator does not pass any of the following tests do not 10 breaths.
apply it to a patient.
Rate
Ventilator Preparation Using the watch, count the number of breaths delivered during one
minute. Observed rate on ventilator should match the timed rate.
The following equipment is needed:
Tidal Volume
1. Ventilator with appropriate breathing circuit
Check the VT displayed on the screen and compares it with the set VT.
2. Test lung (1000 mL suggested)
Change the VT to 500 and 250 mL and check again. Any difference should
3. Oxygen analyzer
be less than ± 10%.
4. Watch with second hand
PEEP
Set PEEP at 5 cm H2O. Observe if the base pressure waveform is kept
When ready: straight.
1. Connect the air and oxygen hose and electrical cord to the appropriate
sources. NOTE
2. Connect the external oxygen analyzer in line and attach the test lung. Keep the set PEEP during the rest of the test. This maneuver will
3. Turn the ventilator on and select ADL pressing the control help the test lung handling.
knob.
Trigger Sensitivity
4. Start the calibration breathing circuit as indicated.
Check patient triggering by squeezing the test lung and releasing. The
5. When the programming screen appears, select VCV ventilation. ventilator should deliver a breath. Reset flow sensitivity to 0.5 L/min. This
6. Start ventilation pressing the control knob. setting should not produce autocycling.
The ventilator will begin to operate with the default parameters. Change to pressure trigger to -0.5 cm H2O and verify there is not
8. Allow the ventilator to run for at least two minutes with default param- autocycling.
eters (see “Programming“ chapter). Manual
9. Perform functional test as described in next section.
Press the [Manual] breath key on the keypad. The ventilator should de-
liver a breath.
Flow Waveform
Press the key successively changing the waveform and verify the shape of
the flow curve.

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
This page intentionally left blank

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.

I:E Ratio: 5:1 to 1:599 Low Inspiratory Pressure: 1 to 99 cm H2O.


Machine Rate: Adult Patient: 1 to 100 bpm Low Inlet Pressure of Both Gases: Below 2 bar.
Pediatric and Neonate Patient: 1 to 150 bpm Low Inlet Pressure of One Gas: Below 2 bar.
FIO2: 0.21 to 1.0 Depleted Battery: Audible and screen message.
High continuous pressure: Exceeded set PEEP level +5 cm H2O for more
O2 100%: Supply 100% oxygen to suction.
than 15 seconds.
Inspiratory Sensitivity: Flow-Triggered: 0.5 to 15 L/min
Technical Failure: Electronic or software failure.
Pressure-Triggered: 0.5 to 20 cm H2O below PEEP
Disconnection: Audible and screen message.
Expiratory Sensitivity for PSV: 5% to 80% of peak flow in steps of 5%
PEEP/CPAP: 0 to 50 cm H2O Oxygen not adequate: When O2% is 18% or less.
Pressure-Controlled Ventilation (PCV): 2 to 100 cm H2O ETCO2 max/min: Determines the exhaled C02 partial pressure limits.
Pressure Support Ventilation (PSV): 0 to 100 cm H2O Medium Priority Signals
Inspiratory Pause(VCV): 0 to 2 s, in steps of 0.25 s High Tidal Volume: Up to 3.0 L.
Sigh (Volume mode): Low Tidal Volume: From 0.01 L.
- Rate: 5, 10, 15 or 20 per hour Power Loss: Audible signal and screen message while the ON/OFF Switch
- Multiple sighs: 1, 2 or 3 is ON.
- Sigh volume: 0.1 to 2.0 L Oxygen Concentration: High limit: 25 to 100%.
Low limit: 19 to 95%.
- Maximum pressure limit
Backup: Elapsed time 5 to 60 s, with 5 s steps.
Manual Inspiration: One inspiration
NIV Circuit Leak: ADL: > 50 L/min; PED: > 30 L/min; NEO: > 10 L/min
Flow Waveform (VCV): Descending ramp or rectangular.
(CPAP continuous flow).
Inspiratory Flow (resultant): From 2 to 180 L/min Fan failure: Activate when there is a defective function or a stop is detected.
Continuous flow (NEO): 2 - 40 L/min Low Priority Signals
Limited Pressure-TCPL (NEO): 2 - 70 cm H2O f max: 3 to 160 bpm.
Maximum Limited Pressure (Plim, max): 120 cm H2O (±3) (Relief valve) PEEP Loss: 2, 4, 6 cm H2O and OFF.
High Exhaled Minute Volume: Up to 50 L/min.
Low Exhaled Minute Volume: From 1.0 L/min.
Alarm Complement
Silence: 30 or 60 seconds by pressing the key once or twice successively.

74 Technical Data and Specifications


Other Controls O2 100%
Begins oxygenation sequence for suction
Modes
It opens a list of the selectable ventilatory modes. Pause Insp/Exp
Pressing the key the period of the present phase will be maintained, for the
Knob inspiratory phase, up to 7 seconds and 20 seconds for the expiratory phase.
To make settings changes. Pushing the knob confirms the change or se- Oxygen Monitoring Sensor
lects a field.
Connected in the first part of the respiratory circuit to monitor the oxygen
Esc concentration of the gas sent to the patient. The result is digitally displayed.
To go out, cancel or abort the current operation, returning to the previ-
ous function. Graphic
To have access to the pressure, flow, volume waveforms and pressure/
Ctrl volume and flow/volume loop graphs.
To activate functions in combination with other keys.
Scale
Menu To change the vertical and horizontal scale of the scalars or loops.
Key to obtain different functions or data:
Freeze
• Backup ventilation settings
To freeze the waveforms. However, neither the resulting values nor the
• Ventilatory adjuncts airway pressure bar of the airway are frozen.
- Expiratory sensitivity (PSV)
- Inspiratory pause (VCV) Help
- Sighs (VCV) To access an explanation of a selected field or parameter.
- Volume compensation (NEO) Manual Insp.
- Humidifier in use
To start an inspiratory phase. By pressing [Ctrl] first, a sigh starts if it is
• Trends programmed.
Up to 24 hs of: Airway pressure, Breathing rate, Peak flow, Tidal
Volume, Minute, Dynamic Compliance, Expiratory Time Constants Respiratory Mechanics
and, as an optional, End Expiratory CO2. • auto-PEEP
• Dynamic and Static compliance
• Activated alarms: Up to 660 saved events in printable sheets
• Inspiratory and Expiratory resistance
• Tools • Trapped volume
- Pressure units conversion • Non-Forced Vital Capacity
- Suction period • P0.1
- Time of use and software version • P/Vflex
- Sound volume • Pimax
- Oxygen sensor calibration • Physiological VD/VT Calculation.
- Breathing circuit calibration
- Date and Time setting Internal Battery
- Altitude Compensation Internal built-in battery that can supply 2 hours 30 minutes of power de-
pending on ventilator settings and battery charge level. The charge level is
Standby shown permanently on the screen as an icon. The ventilator automatically
To stop the ventilator. The programmed settings and mode are “in standby”. switches to the internal backup battery when power AC failure is detected.
Nebulizer Altitude Compensation
Flow to nebulizer during 30 minutes. It stopped when the inspiratory flow To increase the accuracy of volume measurement, the ventilator includes
is less than 20 L/min. a correction table for altitude adjustment.

Technical Data and Specifications 75


Pressure Units Conversion Controls Table
Selection of units in cm H2O, mbar or hPa.

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

ADL: Ptr 1.5 cm H2O


• Operating instruction manual Flow 3 L/min wtr: Variable orifice
Inspiratory Sensitivity Flow: 0.5 to 15 PED: Ptr 1.5 cm H2O pneumotach
Ptr: 0.5 NA
Optional Accessories (wtr: L/min; Ptr: cm H2O) Pressure: –0.5 to –20 Flow 3L/min
NEO: Ptr 1.5 cm H2O Ptr: Pressure
• Heated humidifier. Flow 1L/min transducer

• Capnograph Capnostat 5® (Respironics Inc.) Mandatory Rate


1 – 150 1
ADL: 12
PED: 25 ±1 bpm Crystal quartz
(bpm)
NEO: 30
• Pediatric circuit ( 15 mm). Precalibrated screen
• Neonate circuit ( 12 mm). Inspiratory Flow
(L/min)
0.2 – 180 On Demand ±10% pneumotach related
with differential
transducer
• Capnostat 5® Capnograph. (Respironics Inc.) Proportional valves
FIO2 0.21 – 1.0 0.01 0.50 ±0.03
calibration
Dimension and Weight Pressure Controlled ADL: 15
±2
(PCV) 2 – 100 1 PED: 8 Pressure transducer
Height: 32 cm/12.6 in (cm H2O) NEO: 8
cm H2O

Height including cart: 131 cm/51.6 in Pressure Support


(PSV) 0 – 100 1
ADL: 5
PED: 5
±2
cm H2O Pressure transducer
(cm H2O NEO: 5 o 10%
Width: 34 cm/13.4 in Precalibrated screen
5% to 80% of
Depth: 29 cm/11.4 in Expiratory Sensitivity
(enabled in PSV)
peak flow in 5% 25% NA
pneumotach related
with differential
steps of 5 percent
transducer
Weight not including cart: 9.5 kg/25.5 lb (approximately) ADL: 5
PEEP / CPAP ±2
Weight including cart: 21.6 kg/47.6 lb (approximately) (cm H2O)
0 – 50 1 PED: 5
NEO: 3
cm H2O Pressure transducer

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)

(*) Pressing [Ctrl] will be 0.01 L increments


(**) Pressing [Ctrl] will be 0.1 s increments

76 Technical Data and Specifications


M o n ito re d P a r a m e te rs T a b le Alarms Table
P a ra m e te r O b s e rv a tio n s E x a c titu d e

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%

High Breathing ADL - PED: 30


3 – 160 1 . ±1 bpm Crystal quartz
Rate (bpm) NEO: 40
While the ventilator is working, the interruption of the main electric power produces automatic
Loss of Main
commutation to operation for battery. The interruption can be made by the operator for transfer
Power
of the equipment or to be a fortuitous fact.
Battery Depleted Very low charge level. Replace for an alternative ventilation method.
Technical Failure The operation is suspended. Replace for an alternative ventilation method.

(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

Technical Data and Specifications 77


Recommended separation distances between portable and mobile RF communications equipment
Guidance and manufacturer´s declaration - electromagnetic emissions and the me equipment or me system.
The me equipment or me system is intended for use in the electromagnetic environment specified
The me equipment or me system is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled.
below.The customer or the user of the me equipment or me system should assure that it is used in The customer or the user of the me equipment or me system can help prevent electromagnetic interference by maintaining a minimum
such an environment. distance between portable and mobile RF communications equipment (transmitters) and the me equipment or me system as
recommended below, according to the maximum output power of the communications equipment.
Emmisions test Compliance Electromagnetic environment - guidance

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

78 Technical Data and Specifications


14
Alarms
Characteristics Pressure alarms
All the alarms have visual and audible signals, and are associated by a Operation procedure
message on the screen. The alarms have activation priority and follow an
order in accordance with that priority. In all cases, the High Inspiratory The data for the High and Low programmed pressure limits are analyzed
Pressure Alarm is considered the one with highest priority. by the microprocessor in each respiratory cycle during the airway pressure
rise. For the PEEP limit (baseline PEEP], the programmed data are ana-
Some alarms have programmable limits by the user, for example, the high lyzed during the decrease in the airway pressure.
and low pressures limits, volumes, rate, etc, others do not have program-
mable settings and they cannot be changed by the user. They activate 90
automatically after certain time, for example, battery low charge, low High and
50
supply pressure of some gas, disconnection of the VNI mask, etc. Low limits PEEP

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.

Light signal Activation time


There are three LEDs on the top right of the front panel. The upper one The low pressure alarm is activated after ten seconds from the absence of
illuminates with red light when a high priority alarm is activated. The reception of a pressure greater than the regulated limit. This alarm acts
middle LED flashes intermittently with yellow light when the event is of indicating, mainly, disconnection of some sector of the respiratory circuit,
medium priority and it is permanently illuminated when the event has a or an important inspiratory gas leak.
low priority. The alarm of the high pressure limit acts without delay, when the airway
In any case, if the cause of alarm has been solved, the light pressure reaches the regulated limit value. Simultaneously produces the
signal continues to be illuminated until [Esc] is pressed. end of the inspiratory phase and the opening of the expiratory valve. If
The triangle shaped signal will light in case of a ventilator the maximum limit is surpassed again, the alarm stays activates, with
inoperative state derived of an important alteration of the sound and flashing light signal. If the pressure in the airway returns at the
electronic circuit or software. preestablish levels, the sound of the alarm is suspended after 5 seconds,
but the light indication stays until the [Esc] key is pressed. The “loss
of PEEP” alarm activates after ten seconds from the reception, in the expi-
ratory phase, of a pressure below to the regulated limit (2, 4 or 6 cm H2Ò
below the PEEP value).

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

VE high (Adjustable by the user)


Definition: Exhaled minute volume bigger that the selected in Manda-
tory Minute Ventilation mode (MMV). The values are displayed below the
expired minute volume (on top of the screen). The alarm is only enabled
in the MMV (Mandatory Minute Ventilation) mode.
The default values are 40% over, and 20% below the programmed
volume, respectively. These values may be changed. The first time the key
is pressed, the high limit may be changed; the second time the low limit
may be changed.
Ventilator action: Warns after 10 seconds if the alteration persists. It
generally indicates loss for the breathing circuit or disconnection.
Signal type: Audible, light and warn in the screen.
Silence: It can be silenced temporarily.
Set limits: From 1 to 50 L/min.
Limit change: With the [Alarm Settings] key.
Screen message: HIGH MINUTE VOLUME
Pressing Help: CAUSES:
LOW ALARM LIMIT SETTING
CHANGE IN THE PATIENT RESPIRATORY MECHANICS
DISCONNECTION OF THE UPPER FLOW SENSOR TUBE

VE low (Adjustable by the user)


Definition: Exhaled minute volume smaller that the one selected in Man-
datory Minute Ventilation mode (MMV). The values are displayed below
the expired minute volume (on top of the screen). The alarm is only en-
abled in the MMV (Mandatory Minute Ventilation) mode.
The default values are 40% over, and 20% below the programmed
volume, respectively. These values may be changed. The first time the key
is pressed, the high limit may be changed; the second time the low limit
may be changed.
Ventilator action: Warns after 10 seconds. It generally indicates loss for
the breathing circuit or disconnection.
Signal type: Audible, light and warn in the screen.
Silence: It can be silenced temporarily.
Regulation limits: From 1.0 L/min.
Value change: With the [Alarm Settings] key.
Screen message: LOW MINUTE VOLUME

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.

Change from Inspiration to Expiration


Inspiration ends when one of the four variables (pressure, flow, time or
volume) reaches the set or calculated value.
Inspiration is cycled by pressure when the high pressure limit (alarm limit)
has been reached. The limit may be set between 10 and 120 cm H2O. In
Pressure Support, it is also cycled by pressure when the pressure rises
abruptly 5 cm H2O over the preset one (cough, sudden expiratory effort).
When using pressure modes, inspiration is cycled by flow when it falls to
25% of the peak flow value (default value), and it may be changed from
5% to 80% in 5% steps. In Pressure Support with VT Assured, the decel-
erating flow may change to constant flow when the target volume
has not been reached during inspiration; this causes a pressure increase
until the target volume is completed and, consequently, inspiration is
cycled by volume.
In the volume-controlled (VCV) or pressure-controlled (PCV) modes, inspi-
ration may be cycled by time. In the volume mode, the inspiratory time
may be extended between 0.25 and 2.0 seconds when the Inspiratory
Pause is used. Figure 4-1. Volume-Controlled operative mode. To the
right, the flow in descending ramp. To the left, rectangular
In the volume mode, one to three successive sighs may be programmed,
flow waveform with a pressure waveform in ascending ramp.
with volumes between 0.1 and 2.0 L, and 5, 10, 15 or 20 events per hour.
The set sigh volume is added to the already set tidal volume.
In the Volume-Controlled mode, any of the flow waves can be selected. In
Expiration the Pressure modes, the flow waveform is the descending ramp type and
The PEEP airway pressure may be set between 0 and 50 cm H2O by cannot be changed.
adjusting the PEEP/CPAP control.

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.

Figure 4-2. Pressure-Controlled


operative mode (PCV). Rectangular
pressure waveform with inspiratory
flow in descending ramp. Figure 4-3. Volume-Controlled
Operative Mode (VCV) with a
0.75 second inspiratory pause.

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):

Operative System • Ventilatory Mode: Pressure-Con- • FIO2: 100%. Change disabled


trolled Ventilation (PCV). It cannot • PEEP: 0 (zero). Disabled.
The operative system, which regulates the functions of the microproces- be changed.
• Silence Control: Operative
sor, is designed with algorithms which prevent or avoid the execution of • Inspiratory pressure (PCV): 15 cm
any maneuver which may have unfavorable effects. H2O. This value may be changed. • Maximum Pressure Alarm: 30 cm
H2O. The value may be changed.
Memory test: Every time the equipment is turned on, a test of the RAM • Rise Time: At 25% for all categories.
• Minimum Pressure Alarm: 5 cm
and EPROM memories is run, thus ensuring the integrity of the operative • Inspiratory time: 0.8 s. The value H2O. The value may be changed.
system. may be changed
• VT (high and low) and bE values
PEEP and Flow Calibration: Every time the equipment is turned on, the • Rate: 15 bpm. The value may be and alarm: Disabled.
expiratory valve is electronically calibrated to regulate the positive end changed.
• Monitor: disabled.
expiratory pressure. There is also a calibration of the flows which go • Pressure Sensitivity: -1.5 cm H2O
through the expiratory pneumotachograph.
Parameter limits: Every parameter involved in the ventilation has mini- Message on Screen and Audible Signal
mum and maximum limits that cannot be exceeded.
When Watchdog is activated, a continuous alarm sound may be heard and
Values acceptance: All selected and changed values need to be accepted the following message is displayed on the screen:
by pressing the control knob, within a maximum time of 5 seconds.
EMERGENCY VENTILATION
Alarm limits : Each alarm has preset or programmed limits. When they are 1) DISCONNECT THE VENTILATOR CONNECTION TO THE PATIENT
exceeded, in some cases the action is instantaneously suppressed (e.g.:
2) TURN THE VENTILATOR OFF
maximum pressure limit) or in other cases, there is activation delay time
(e.g. PEEP loss), depending on the alarm hierarchy. 3) TURN THE VENTILATOR ON
4) PREPARE IT FOR CONNECTION
Alarm activation indicators : When an alarm is activated, there is not only
a light and audible signal but also the screen shows a message indicating IF THE PROBLEM CONTINUES, DO NOT USE THE EQUIPMENT
the name of the activated alarm. Pressing the [Help] key will be an expla- AND SEND IT TO AN AUTHORIZED SERVICE CENTER.
nation of the possible cause and suggestions for the solution of the prob-
lem.

Other Features 89
This page intentionally left blank

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

You might also like