Manual de Intrucciones Oximag PDF

Instruction Manual
OXYMAG – EMERGENCY AND TRANSPORT

VENTILATOR
Part Number: 1600185 Rev: 06

Software version 1.n
 Copyright 2012
Magnamed Tecnologia Médica S/A

Rua São Paulino, 221 – Vila Mariana
CEP: 04019-040 – São Paulo – SP – Brasil
Tel: +55 (11) 5081-4115 / Fax: +55 (11) 5084-5297
E-mail: magnamed@magnamed.com.br
Website: www.magnamed.com.br
CNPJ: 01.298.443/0001-73 Inscrição Estadual: 149.579.528.111

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1 Revision History
Elaborated by: Checked by: Approved by:
Neusa Wataru Tatsuo

Date (dd/mm/yyyy) Date (dd/mm/yyyy) Date (dd/mm/yyyy)
11/01/2012 16/01/2013 18/01/2013
REV DESCRIPTION (dd/mm/yy)

01 Initial Revision 29/04/10
02 Ventilation modes description revision 17/08/10
Rev: Techincal specification, parameters adjustment procedure, material 07/10/10
03
compatibility to oxygen, air and compressed air
Standards – exclude MIL STD 810F include IEC 60601-1-4 – Change in the 03/05/11
04
initialization screen – based on Portuguese REV 09
Phasein information and accessory list revision, inclusion of Masimo sensor 10/02/12
05
information and changes on Ventilation Mode Screen
Description of mean of the initials three beeps and periodic maintenance symbol; 11/01/13
06
Indication of disabling of flow sensibility when the NIV function is activated.
MAGNAMED OxyMag – Emergency and Transport Ventilator – Part Number 1600185 – Rev 06
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2 Definitions and Informations
Warning
 Warns the user about the possibility of injury, death or other serious adverse reaction due
to the misuse of the equipment.
Caution
 Warns the user about the possibility of equipment failure associated with the use or
misuse. Like equipment malfunction, damage or third party property damage and
indirectly to patient injury.
Notes
 These notes state important information.
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The OxyMag is a microprocessed electronic lung ventilator to be used as a ventilatory support for patients
under rescue, transport or emergency situations. It provides a gas mixture of oxygen (O 2) with ambienta ir (Air)
with oxygen concentration from 35 to 100%; the device achieves the flow and pressure control in the patient‘s
respiratory circuit to provide adequate modes of ventilation according to the condition of the patient. The
available ventilation modes are:
 VCV – Volume Controlled Ventilation (can be assisted);
 PCV – Pressure Controlled Ventilation (can be assisted);
 PLV – Pressure Limited Ventilation (can be assisted) – Available in Neonatal mode;
 V-SIMV – Synchronized Intermittent Mandatory Ventilation with Pressure Support and Volume
Controlled cycle;
 P-SIMV – Synchronized Intermittent Mandatory Ventilation with Pressure Support and Pressure
Controlled cycle;
 CPAP/ PSV – Continuous Positive Airway Pressure with - Pressure Support Ventilation;
 DualPAP – Two CPAP Pressure Levels (with Pressure Support) – According to the adjustments it is
possible to get the APRV (Airway Pressure Release Ventilation)
This ventilator can be employed in a NIV (Non Invasive Ventilation) with facial mask. Within certain limits
leakages are compensated. It is a resource that can be turned on or off for all ventilation modes.
Basic Characteristics:
 All systems integrated in one single pneumatic electronic module with less volume and weight
avoiding tube interconnections that reduces the reliability in emergency and transport situations.
 Digital Electronic Flow Control System that ensures precise flow to the patient;
 ―Venturi‖ system with intelligent control system to get precise oxygen concentration;
 Intelligent Alarm Systems with all safety features required by national and international standards;
 Power supply backup system keeps the OxyMag operating up to 5 hours when fully charged.
This device should be operated only by qualified and trained professionals for its use. See below the
recommendations and important information to use the device safely and with efficacy.
Warning
 This symbol indicates that the instruction manual should be read for more details
and information.
 This manual should be read completely, carefully, for correct and safe use of this
equipment and to provide maximum safety and the best resources to the patients.
 Observe all the Warnings and Cautions in this manual and in the labeling of the device.
 This device should be used only for the purposes specified in Intended Use (chapter 3.1)
together with an appropriate vital signs monitor.
 This device was designed to be operated under constant surveillance of a qualified
professional. Inclusively in volume limited ventilation.
 To avoid the risk of explosion, do not use the Ventilator in the presence of flammable
anesthetic agents and do not put oil or flammable grease on the equipment.
 This device could be adversely affected and suffer from interference of certain
transmission equipments, such as cellular phones, walkie-talkies, wireless telephones,
pager transmitters, high-frequency surgical equipment (diathermy), defibrillators or
short-wave therapy equipment. Do not use these transmission equipments near the
Ventilator Module (see specifications – chapter 10).
 This device should not be used in Nuclear Magnectic Ressonance (MRI, NMR, NMI)
otherwise it can be adversely affected and cause harm in patient.
 Avoid noxious substances in the ambient, because this device apirates ambient air to
ventilate the patient with concentrations adjusts below 100% of O2.
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 After longtime use of this device in ambient with dust, substitute the ambient air filter
according to the procedure in chapter 13.4.
 The applied parts are not affected by defibrillation.
 This device should not be used in Hyperbaric Chamber, because it could affect the correct
working of the device and cause adverse effects to the patient.
 Before first time using or after each patient do a cleaning procedure according to the
procedures presented in chapter 11.
 Turn on the device and do the verification procedures and basic adjustment – follow the
instructions according to the procedures presented in chapter 7.
 Alarms and Alerts should be promptly attended in order to maintain the integrity of the
device and the safety of the patient.
 Anti-static or electrically conductive hoses should not be used.
 Ventilation parameters should be checked after the beginning of the patient ventilation.
 Right after the beginning of the patient ventilation check the ventilation parameters shown
on the display.
 Use only accessories and part from MAGNAMED listed in this manual. They were
tested and approved to be used together with this device. Otherwise it can affect the
correct working of the device.
 During long lasting use of this device in patients with excess of secretion or in respiratory
circuits with the use of a heated humidifier it is necessary to check the cleanliness and non
obstruction of the flow sensor frequently.
 The ventilator has an internal battery backup system.
o Connect the AC/DC Power converter to a inlet according to your contry

standard;
o To keep the battery charged it should be connected to a power supply.
o Completely recharge the battery after using it without power supply or after long
period of storage.
o The recharge battery alarm should be promptly attended. Carry out its recharge
before the next use of the device, otherwise any electrical power failure should
interrupt its working.
o If in a long lasting use of the device with battery backup, occurs a LOW BATTERY
alarm, provide IMMEDIATE connection to an electrical power supply, if it is not
possible then DISCONNECT the equipment from the patient and provide adequate
means for the patient ventilation.
 The correct connection of the flow sensor tubing and the absence of obstructions are
extremely important for the correct operation of the ventilation control system. It should be
frequently checked during the patient ventilation.
 After turning on the electronic ventilator, will be require the selection of patient with this
the ventilator will setup the best initial ventilation for this patient, and then CONNECT THE
CORRECT CORRESPONDENT FLOW SENSOR as the paciente selectioned, in order that
the patient’s ventilation is correctly monitored.
 It is possible to use de device without the proximal flow sensor (5001748). In this condition
a message “Sensor OFF” will be shown in the message and status area of the screen and
all the monitored parameters that depends on this sensor (VT, MV, Frequency, Vins, Tinsp,
I:E, Texp, Cest, Cdyn, Res, Leakeage Volume, VxT graph) WILL NOT be presented. In the
volume controlled ventilation modes the volume can vary up to ±10%. Re-connecting the
corresponding flow sensor according to the type of the patient to the respiratory circuit
will restablish the ventilation monitoring and all parameters will be presented on screen.
 The respiratory circuit components MUST UNDERGO a high-level disinfections or
sterilization process before its next use, when they are REUSABLE.
 All parts and components that have contact with fluids originating from patients (for
example: respiratory circuit), are potentially contaminated. These are named semi-critical
components and they must undergo a high-level disinfections or sterilization process
before being discarded (at the end of their lifetimes), or be discarded as potentially
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infected hospital waste.

 All applied parts of the Ventilator are manufactured with non toxic material, including latex.
 All common accessories, not exclusive for Magnamed Products, like masks, respiratory
circuits, nebulizer, heated humidifiers, HME filters among others should obey local
regulations.
 Never obstruct the pressure ports and its line. The measured pressures in these ports are
used by the ventilation monitoring system of the patient.
 Do not use the device if a problem could not be solved.
 Make available one manual ventilation device in case of complete discharge of the battery
or by oxygen cylinder low pressure or in case of general failure of the device.
 Always use officially approved oxygen cylinders and pressure regulator valves that attend
local government requirements.
 For appropriate ventilation take into account the respiratory circuits dead spaces,
compliances and resistances especially when adjusting the ventilator for low tidal
volumes.
Caution
 The ventilator does not emit an electromagnetic wave that affects the nearby equipments.
 Do preventive maintenance annually or according to the use hours specified, whichever
comes first.
 Change the ambient air filter every 500 hours of use or at short intervals if the ambient in which
it is being used has too much particulates (heavy dust).
 All services or maintenance of the Transport Ventilator should be done by qualified, trained
and authorized by MAGNAMED.
 Use only parts, pieces, cables, sensors, filters and respiratory circuit according to
specification and acquired from MAGNAMED. For acquisition inform the part number
presented in chapter 12.
Notes
 Discard the removed parts from the equipment according to your institution disposing parts protocol
and follow local government recommendations regarding environmental protection, especially in case
of electronic garbage or electronic parts (like batteries).
 The technical specifications of MAGNAMED’s products are subject to changes without
previous notice.
 Pressure Units:
1 mbar (milibar) = 1 hPa (hectoPascal) = 1,016 cmH2O (centímeters of Water)
In practical these units are not differentiated and can be used as:
1 mbar = 1 hPa ≈ 1 cmH2O
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3 Index
1 REVISION HISTORY ................................................................................................................................ 3
2 DEFINITIONS AND INFORMATIONS ...................................................................................................... 4
3 INDEX ........................................................................................................................................................ 8
4 DESCRIPTION ........................................................................................................................................ 12
4.1 INTENDED USE ...................................................................................................................................... 12
4.2 LABELING .............................................................................................................................................. 14
4.3 W ORKING PRINCIPLE ............................................................................................................................. 14
4.4 OTHER CHARACTERISTICS ..................................................................................................................... 15
5 UNPACKING THE PRODUCT................................................................................................................ 17
5.1 INITIAL CHECKLIST ................................................................................................................................. 17
5.2 COMPONENT LIST.................................................................................................................................. 17
6 COMPONENTS IDENTIFICATION ......................................................................................................... 19
6.1 COMPONENTS IDENTIFICATION ............................................................................................................... 19
6.2 DISPLAY AREA IDENTIFICATION .............................................................................................................. 26
6.2.1 Ventilation Modes ....................................................................................................................... 26
6.2.2 Alarms, Monitor and Status ........................................................................................................ 27
6.2.3 Monitor, Menus and Graphs ....................................................................................................... 27
6.2.4 Ventilation Parameters Setup..................................................................................................... 27
7 PREPARATION FOR USE ..................................................................................................................... 28
7.1 OXYMAG ASSEMBLY SETUP................................................................................................................... 28
7.2 ELECTRICAL POWER CONNECTION ......................................................................................................... 38
7.3 CHECK BEFORE USE.............................................................................................................................. 39
7.3.1 Initial Procedures ........................................................................................................................ 39
7.3.2 Turn on the device ...................................................................................................................... 40
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7.3.3 Normal Initialization Sequece ..................................................................................................... 42
7.3.4 Test Sequece ............................................................................................................................. 50
7.3.5 Diagnóstico de Falha .................................................................................................................. 52
8 INSTRUCTIONS OF USE ....................................................................................................................... 54
8.1 VENTILATOR ADJUSTMENTS ................................................................................................................... 54
8.2 VENTILATION MODE AND PARAMETER ADJUSTMENT ................................................................................ 56
8.3 AVAILABLE ALARMS ............................................................................................................................... 73
8.4 PATIENT MANUAL VENTILATION .............................................................................................................. 77
8.5 ALARMS ADJUSTING SCREEN .................................................................................................................. 77
9 VERTICAL SUPPORT - INSTALATION ................................................................................................ 80
10 TROUBLESHOOTING ............................................................................................................................ 82
11 CLEANING AND DISINFECTION .......................................................................................................... 84
11.1 OXYMAG VENTILATOR....................................................................................................................... 84
11.2 CLEANING, DISINFECTION AND STERILIZATION PROCEDURES .............................................................. 85
12 ACCESSORIES AND PARTS ................................................................................................................ 87
13 PREVENTIVE MAINTENANCE .............................................................................................................. 95
13.1 INDICATES PREVENTIVE MAINTENANCE NEED ..................................................................................... 95
13.2 CHECKING ........................................................................................................................................ 95
13.3 INTERNAL LI-ION BATTERY................................................................................................................. 96
13.4 INTERNAL O2 CONCENTRATION MEASUREMENT CELL ......................................................................... 96
13.5 AMBIENT AIR FILTER SUBSTITUTION ................................................................................................... 96
13.6 SENDING THE VENTILATOR TO MAINTENANCE SERVICE ....................................................................... 98
14 TECHNICAL SPECIFICATIONS ............................................................................................................ 99
14.1 CLASSIFICATION................................................................................................................................ 99
14.2 STANDARDS ...................................................................................................................................... 99
14.3 SPECIFICATIONS ............................................................................................................................... 99
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14.3.1 Electrical Characteristics ...................................................................................................... 100
14.3.2 Connection to Oxygen Supply ............................................................................................. 100
14.3.3 Environmental and Physical Specifications ......................................................................... 101
14.3.4 Ventilation Modes................................................................................................................. 101
14.3.5 Ventilation Parameter Adjustment Specifications ................................................................ 102
14.3.6 Ventilation Monitor Specification .......................................................................................... 104
14.3.7 Safety and Alarm Systems ................................................................................................... 105
14.3.8 Oxygen concentration x respiratory circuit pressure ............................................................ 107
14.3.9 Performance Specifications ................................................................................................. 107
14.3.10 Calibration and Maintenance Specification: ......................................................................... 107
14.3.11 Expiratory Limb Resistence Specification: ........................................................................... 108
14.4 PNEUMATIC SCHEMATICS ................................................................................................................ 109
14.5 ELECTRONIC CONTROL BLOCK DIAGRAM ......................................................................................... 110
14.6 ELETROMAGNETIC COMPATIBILITY ................................................................................................... 110
15 IRMA CO2 SENSOR (PHASEIN) - OPTIONAL ................................................................................... 115
15.1.1 Instructions of Use ............................................................................................................... 115
15.1.2 Sensor Assembly ................................................................................................................. 115
15.1.3 Sensor Positioning ............................................................................................................... 117
15.1.4 Sensor Zeroing Procedure ................................................................................................... 118
15.1.5 LED Information ................................................................................................................... 118
15.1.6 Sensor Cleaning Procedure ................................................................................................. 118
15.1.7 Preventive Maintenance ...................................................................................................... 118
15.1.8 Technical Specifications ...................................................................................................... 120
15.1.9 Phasein Acessories ............................................................................................................. 122
16 OXIMETER (MASIMO) - OPTIONAL.................................................................................................... 123
16.1.1 Principle of Operation .......................................................................................................... 123
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17 SYMBOLS ............................................................................................................................................. 127
18 TERMS AND ABBREVIATIONS .......................................................................................................... 130
19 BIOCOMPATIBILITY DECLARATION ................................................................................................. 132
20 WARRANTY.......................................................................................................................................... 133
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4 Description
4.1 Intended Use
MAGNAMED’s OxyMag – Electronic Emergency and Transport Ventilator is a device for ventilatory
support for neonates to adult patients with respiratory insufficiency, volume controlled, pressure controlled and
time cycled. It is intended to be used in patients with tidal volume from 3 mL.
Available ventilation modes are:

 VCV – Volume Controlled Ventilation (can be assisted);
 PCV – Pressure Controlled Ventilation (can be assisted);
 PLV – Pressure Limited Ventilation (can be assisted) – Available in Neonatal mode (weight ≤ 6,0Kg);
 V-SIMV – Synchronized Intermittent Mandatory Ventilation with Volume Controlled cycle (+Pressure
Support);
 P-SIMV – Synchronized Intermittent Mandatory Ventilation with Pressure Controlled cycle (+Pressure
Support);
 CPAP/PSV – Continuous Positive Airway Pressure with Pressure Support Ventilation;
 DualPAP – Two CPAP Pressure Levels (with Pressure Support) – According to the adjustments it is
possible to get the APRV (Airway Pressure Release Ventilation)
This ventilator can be employed in a NIV (Non Invasive Ventilation) with facial mask. Within certain limits
leakages are compensated. It is a resource that can be turned on or off for all ventilation modes.
Warning
 In CPAP/PSV (Continuous Positive Airway Pressure with support pressure) to disable the
pressure suporte setup ∆PS = OFF;
During CPAP/PSV ventilation it is possible to establish a backup ventilation in case of APNEA, the ventilation
mode can be chosen among VCV, PCV, PLV (Neonatal) or OFF.
Warning
 When in CPAP/PSV is setup the parameter BACKUP as OFF the backup ventilation is
desabled;
This ventilator can be used in a Non Invasive Ventilation (NIV) with facial mask.
This ventilator can be used with oxygen inhalation mask as well.
This ventilator has an LCD color display with touch screen to present the parameters to be adjusted, ventilation
monitored data, graphs, curves and information of alarm and alerts.
This ventilator has an internal oxygen concentration measurement cell and the presentation of the value as
well as alarm limits activation.
Avalilable adjustable alarms:
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 High Pressure
 Low Pressure
 High Frequency
 Low Frequency
 High PEEP
 Low PEEP
 Apnea
 High Minute Volume
 Low Minute Volume
 High EtCO2
 Low EtCO2
 High Inspired CO2
 High Heart Rate
 Low Heart Rate
 Low SpO2
Alarms related to the device and the ventilation:
 Low Battery
 Low Inlet Pressure
 Disconnection (in respiratory circuit)
 Obstruction (in respiratory circuit)
 Apnea
 AC Input Fail
Alarms related to externa sensors:
 Capnography
o Attention IRMA adaptor
o Resest IRMA
o Change IRMA
o CO2 out of scale
o IRMA reading failure
o Calibrate IRMA
 SpO2 Sensor
o SpO2 Sensor (Sensor out of finger)
o Check SpO2
o Low PI
o Search pulse
o Activating SPO2
o Demo SPO2
It incorporates a ventilation monitor that presents the following curves and monitored parameters:
 Pressure x Time Curve
 Flow x Time Curve
 Volume x Time Curve
 Volume x Pressure Loop
 Flow x Volume Loop
 CO2 x Time Curve
 SpO2 x Time Curve
 Instantaneous pressure bargraph
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 Maximum Pressure
 Mean Pressure
 PEEP
 Intrinsic PEEP
 Plateau Pressure
 Tidal Volume (Expired Volume)
 Inspired Volume
 Minute Volume
 Leakage Volume (only when NIV is activated)
 Static Compliance
 Dynamic Compliance
 Airway Resistance
 Inspiratory Time
 Expiratory Time
 I:E Ratio
 Total Respiratory Frequency
 Spontaneous Respiratory Frequency
 Spontaneous Minute Volume
 Spontaneous Volume
 FiO2
This device can be used to ventilate patients:

 In emergency for field assistance, primary assistance, rescue in which the patient can be transported
through terrestrial way or by helicopter.
 After surgery, in post anesthesia recovery room.
 Intra-hospital transportation: The patient can be transported internally, from one department to another
for (MRI or other procedure).
 Inter-hospital transportation: The patient can be transported by ambulance or helicopter.
4.2 Labeling
Information presented in the external label of the device:
Figure 1- Rótulo externo do produto
4.3 Working Principle
The OxyMag – transport and emergency ventilator is composed by:

 Electronic Control Board – it has microprocessor to control the pneumatic system for lung
ventilation and for man-machine interface.
o Pneumatic System Control:
The pneumatic system is consisting of one pressure reducing valve that regulates the
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pressure at the inlet (Oxygen cylinder or oxygen pipeline) to internal working pressure.
The regulated pressure is applied to the inlet of solenoids. One is used to control the
active overpressure relief valve. Two to calibrate the zero of the flow sensor and the
other two valves control the flow of oxygen to determine the oxygen concentration in the
gas mixture. According to the current applied to these valves it can be obtained a flow at
a determined concentration of oxygen.
The control systems of these valves are carried out by high performance digital circuits
that reduce the electrical energy consumption enhancing the efficiency of the battery
backup system.
There are three more pressure transducers to measure the given flow to the patient,
pressure in the respiratory circuit and to monitor the patient ventilation.
Basically the system control microprocessor receives commands from the central
command and translates them to timing information to the valve control system in order
that the respiratory cycle occurs accordingly to that. The signals from the transducers
are interpreted to carry out a precise ventilation control through corrections on the
opening of the demand and exhalation valves.
o Command and Interface System:
This system is controlled by a second microprocessor that acquires the keyboard data,
touch screen position or turn and confirms button information to get the desired
operator‘s adjustment for the device. The adjustment results and data received from the
pneumatic control system are presented in a color LCD, for both numerical data and
graphs.
Once the necessary adjustment is done by the operator it is sent to the pneumatic
control system that carries out the ventilation control.
During the process of patient ventilation the pneumatic control system sends
continuosly the main monitored ventilation of the patient, like instantaneous pressure,
instantaneous volume, instantaneous flow, tidal volume, mean pressure, inspiratory
and expiratory time, respiratory frequency among others. The received data by the
central command and adjustments are presented on the LCD.
Another function done by the central command is to receive information about the alarm
conditions and put them in priority order and present them on the display as well as
sounding it.
 Electrical Power Supply;
o The electrical energy to the OxyMag is provided by an external power converter AC/DC
that converts 100 – 240 VAC to +12VDC, and it should be connected to the electrical
source in order that the device recharges its battery.
o The OxyMag can be connected directly to a +12VDC power supply (like car battery or
car‘s internal power supply).
 Battery system backup;
o The battery backup system is composed by an intelligent charger and a Li-Ion battery.
Caution
 Do not remove the battery. Look for an authorized technical assitance to substitute it or for
maintenance.
 To dispose the batteries follow the applicable local legislation.
4.4 Other Characteristics
This device can be provided with the following optional acessories:

 Vertical adapter for ambulance or helicopter;
 Transport backpack or hand bag;
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 Oxygen cylinder support kit;

 Quick hose connection and adapter;
 CO2 sensor;
 SpO2 sensor;
 Adult Silicone Respiratory Circuit;
 Infant Silicone Respiratory Circuit;
 Neonatal Silicone Respiratory Circuit;
 HME Filter
 Adult Facial Mask
 Infant Facial Mask
 Neonatal Facial Mask
 Neonatal Nasal Prong for CPAP;
 Heated Humidifier;
 Trolley with front wheel lock system;
 Respiratory Circuit Support Arm;
 Manual Rescusitator
This device can be used with the following accessories since all of them are in accordance on local regulation:
 Nasal prongue to Neonate CPAP with it respiratory circuit
 Single use Limbo Respiratory Circuit with 1,8m with maximum resistance of 3,69 mbar/(L.s-1) in the
inspiration and 4,39 mbar/(L.s-1) in the expiration.
 Respiratory circuits with hose with resistency less than 0,3 mbar/(L.s-1).
 Blender with flow of 120 ml/min and out pressure of 60psi
 Adult, Infant and Neonate simple face mask
 HME elliptic filter 88x58x28
 Aluminium cylinder to oxygen M9 to transport hand bag:
o Diameter = 11,13 cm
o Height=27,20 cm
o Volume = 1,7L
o Oxygen capacity = 255L
17
5 Unpacking the Product
5.1 Initial Checklist
Item Verification Approved

Check the integrity of the packing case. Note if there are wrinkles, holes or
other damages.
Notes
1  If the packing case were found damaged communicate this fact OK NOK
immediately to the responsible of the transportation company and to
Magnamed.
 Do not open the package.
2 Open the packing case carefully following the indications on the package OK NOK
3 Verify the content. OK NOK
5.2 Component List
The following items are provided integrating the equipment and are for its exclusive use only.
Item Part Number Description QTY Unit Photo or Figure
OXYMAG –
EMERGENCY AND
1 1600185 1 PC
TRANSPORT
VENTILATOR
18
Item Part Number Description QTY Unit Photo or Figure
FLOW SENSORS ADU

2 5001748 INF NEO 1 PC
AUTOCLAVABLE
AC TO DC
CONVERTER 100 TO
3 2402568 1 PC
240 VAC TO 4PIN 12
VDC
CIRCUITO
RESPIRATORIO
4 1703218 01 PC
ADULTO 1,2M
AUTOCLAVÁVEL
5 3902647 O2 DISS X2 HOSE 1 PC
AMBIENT AIR FILTER

6 1702656 ENVELOPE WITH 3 1 PC
UNITS FOR OXYMAG
INSTRUCTION
7 1600185-NE-22-RR 1 PC
MANUAL
19
6 Components Identification
6.1 Components Identification
Figure 2 - OxyMag Front Panel
1 COLOR LIQUID CRYSTAL DISPLAY WITH TOUCH SCREEN
Visual presentation of graphs, adjusted parameters and monitored parameters like Volume, Pressure, Flow
and Frequency.
2 ROTATE AND CONFIRM BUTTON

This button is used for the majority of the adjustments that is carried out in OxyMag. When a parameter is
selected, and this button is rotated clockwise or counter clockwise the value of the parameter is changed.
The confirmation of the new value is done by pressing this button.
When no parameter is selected if the button is pressed it will change the parameter adjusting screen, showing
the next set of available parameters to be adjusted.
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Figure 3- Rotate and Confirm Button
Notes
 Select the parameter to be adjusted on the screen by touching the corresponding button with your
fingertip.
 The selected button will change to CYAN background allowing the changes of the parameter value.
 Adjust the desired value rotating the button clockwise or counter clockwise.
 To confirm the new value just press the rotary button or touch again the screen on the highlighted
button.
 When the button returns to its original background color the adjusted parameter will be set.
Warning
 If there is no confirmation by pressing the button, after 10 seconds the original parameter
value will be shown meaning that there is no change to the paramenter.
3 KEYBOARD
The buttons of the keyboard allows quick access to some functions of the ventilator. The function of each key is
detailed below.
.
4 HANDLE
This handle allows transporting the ventilator during emergency and rescue operations. At the back of the
ventilator there is a support that can be easily adapted to a patient transportation stretcher.
5 ALARM INDICATOR LIGHT - RED

The alarm indicator light blinks when there is an alarm event. When in alarm silence mode it will remain lighted.
21
6 7
10
11
Figure 4- Emergency and Transport Ventilator Keyboard
6 LOCK TOUCH SCREEN KEY
This key allows locking or unlocking the touch screen. When the display commands are locked, press this key
by 2 s to release them. To lock the screen simply press this key once or wait for 30 s without touching the
screen.
7 GREEN LED – POWER SUPPLY CONNECTION INDICATOR
The green led will be lighted when the DC (17) or (21) is connected to a +12VDC AC/DC Converter.
8 HOLD KEY (PAUSE)
This key allows that inspiration hold manouvres where done, this resource is usefull in thorax X- ray and for
expiration time extension, that is useful to measure Intrinsic PEEP.
If pressed during the inspiratory time of the respiratory cycle, the inspiration will be held for 5s more, after this
period, at the top of the screen, it will be presented the value of the CEST. Otherwise if the key is pressed during
the expiratory time, the expiration will be held for more 5s, after this period the Intrinsic PEEP value will be
presented at the monitoring area on the top of the screen.
9 MANUAL TRIGGER KEY

By pressing this key it is possible to trigger a respiratory cycle. It is active in the following ventilation modes
VCV, PCV, V-SIMV, CPAP/PSV, P-SIMV (start a cycle of support pressure.
10 O2 100% KEY
Pressing this key the oxygen concentration will be 100% during the next 90 seconds. This resource can be
used to airway secretion pre-aspiration and post-aspiration procedures. When this key is pressed when the
ventilator is in STAND-BY the following screen will appear and an oxygen flow can be set.
22
Viewer of
adjusted value
Adjusted
Value
Monitored
value
Figure 5– O2 Flowmeter for Inhalation
Use the rotary knob to set to the desired flow value. This value will be shown on the screen as adjusted value.
11 PAGE KEY
Pressing this key the parameters key will be changed to the next set for the corresponding ventilation mode.
Figure 6– Right lateral view
12 FLOW SENSOR CONNECTOR

This connector is used to flow sensor tubing connection. The blue point indicates the proximal tubing
connection of the flow sensor.
Caution
23
 Use only accessories and part from MAGNAMED listed in this manual. They were tested
and approved to be used together with this device. Otherwise it can affect the correct working
of the device. See chapter 12 for accessories part number.
13 INSPIRATORY FLOW CONNECTOR 22M/15F
This is the inspiratory flow standard connector. Connect the inspiratory limb of the patient‘s respiratory circuit.
14 EXPIRATORY VALVE
This is the patient‘s respiratory circuit expiratory limb connection.
15 CO2 SENSOR CONNECTOR
PHASE IN‘s CO2 sensor connector or SpO2 MASIMO connector – This sensors are optionals
Figure 7- CO2/SpO2 sensor connector pin identification
Figure 8– Rear view of the OxyMag – Emergency and Transport Ventlator
16 BASE ELECTRICAL SUPPLY CONNECTOR
24
This plug is used with the support base for the OxyMag. This is a +12VDC input. Note the indication of the
polarity and the voltage stamped.
Caution
 Use only AC/DC converter acquired from Magnamed.
 This connector should be used with the horizontal or vertical mechanical adapter kit from
Magnamed.
17 LABEL
This label shows Magnamed‘s information as well as the European Authorized Representative, month and
year of manufacturing and the serial number of the device.
18 INMETRO LABEL
This is comformity and security INMETO label.
Figure 9- Left lateral view of the OxyMag – Emergency and Transport Ventilator
19 OXYGEN INLET
Connect the oxygen hose to this connector. The inlet pressure should be in the range of 60 to 150 psi (414 to
1034 kPa). DISS Standard Connector (ABNT NBR-11906:1992).
20 SERIAL COMMUNICATION CONNECTOR

Serial Communication – RS-232 – DB-9 female connector. Do not use – factory configuration only.
25
21 AC/DC CONVERTER INLET (+12VDC)
Electrical power supply inlet +12VDC – AC/DC external converter plug.
Figure 10- DC +12V Inlet connector pin identification
Caution
 Use only AC/DC converter acquired from Magnamed.
22 ON/OFF SWITCH
ON/OFF Switch
23 AMBIENT AIR FILTER
Ambient air filter to clean the air mixed to the oxygen to provide oxygen concentrations below 100%. To
change the filter refer to the instructions on chapter 13.4.
Caution
 Use only filters acquired from Magnamed.
 Change the ambient air filter every 500 hours of use or at short intervals if the ambient in which
it is being used has too much particulates (heavy dust).
 When this filter is saturated it enhances the ambient air entrance resistance and the minimum
concentration of oxygen (35% of O 2) will not be achieved. In this case change the filter for a
new one.
The command central system is responsible for the operation and monitoring of the device. It incorporates the
following systems:
 Ventilator‘s adjustment and command system
 Ventilation monitor system
 Alarms and alerts system
26
6.2 Display Area Identification
Figure 11 - OxyMag’s four display area
Figure 12- Graphs and Mode Adjusting Area
6.2.1 Ventilation Modes

(1) Ventilation Mode Key. In the superior part of the key there is an indication of the selected patient:
ADU  Adult; INFInfant; NEONeonate
(2) Active Mode Indication, in the above sample the active ventilation mode is VCV – Volume
Controlled Ventilation.
(3) NIV activation indication (when active there will be leakeage compensation)
27
6.2.2 Alarms, Monitor and Status

(4) 2 minutes silence alarm key
When activated the alarm silencing is presented in this bargraph to indicate how long the alarm
silencing will last
(5) MV - Minute Volume Monitor or VT – Tidal Volume or PMAX – Maximum Pressure
(6) STAND-BY – Pressing this key at least for 2 seconds the ventilator will stop ventilation and goes to
STAND-BY mode.
(7) Message area and OxyMag‘s battery charge status
(8) Alarms and alerts messages
(9) When a lock sign appears means that the touch screen is disabled. Press the LOCK key for at
least 2 seconds to enable the touch screen.
(10)Internal battery remaining charge indicator
6.2.3 Monitor, Menus and Graphs
(11)Pressure bargraph – Bargraph that presents the instantaneous pressure in the respiratory circuit
and the Maximum Inspiratory Pressure above the bargraph in Cyan
(12)Graphs, numerical ventilation parameters and menu presenting area
6.2.4 Ventilation Parameters Setup
(13) Ventilation parameter setup bar
28
7 Preparation for Use
7.1 OxyMag Assembly Setup
OK Item Assembly Sequence Ilustration

1 Insert the ambient air filter in the indicated
compartment at the left side of the ventilator.
2 Install a diaphragm and an exhalation valve in

adequate conditon for use as shown in the figure.
3 Prepare the patient‘s respiratory circuit connecting

firmly the inspiratory limb to the inspiratory flow
connector.
Caution
 Use adequate respiratory circuit
according to patient. There are two types
of respiratory circuit (Neonate and
Adult/Infant)
29

4 The expiratory limb of the respiratory circuit should be
connected firmly to the exhalation valve.
30

5 Connect the flow sensor according to the patient.
Warning
 For correct patient’s ventilation

monitoring it is extremely important that
the flow sensor’s pressure sensor lines
are without obstruction and correctly
connected. It is important to check it
frequently during the patient ventilation.
 Notice that in ALL respiratory circuits the
use of the coorect flow sensor is of VITAL
IMPORTANCE.
 Remember that when CO2 sensor
(optinonal) and the HME filter is attached
to the circuit there will be an increase in
the inspiratory and expiratory circuits
resistance consequently the counter
pressure to the inspiratory flow (see
graphs of the O2 concentration x flow x
counter pressure in chapter 14), also be
aware that there will be a dead space
increase.
 All the connections should be done
FIRMLY to avoid leakages.
31

6 When using the CO2 sensor (optional) carry out the
assembly of it right after the flow sensor as shown in
the sequences of the figure beside
Connect the CO2 sensor airway adapter then connect
firmly the set to the flow sensor.
32

7 When using the respiratory circuit with the CO2 sensor
and the HME (Heat and Moisture Exchange) filter do
the assembly as shown in the figure.
Caution
 Use only FILTERS specified in this
manual.
33

8 When using the respiratory circuit for NIV (Non
Invasive Ventilation) with mask, as well as the HME
filter and CO2 sensor follow the sequence indicated in
the figure.
Caution
 Use Maks specified by Magnamed in this
manual.
 Use Masks adequate for each patient
(neonate, infant or adult).
9 When using the respiratory circuit for NIV with mask

without the HME filter do the assembly as shown.
34

10 When using the respiratory circuit for NIV without filter
do the assembly as shown.
35

11 When using the respiratory circuit for NIV with mask
and HME filter do the assembly as shown.
36

12 Connect the flow sensor silicone line as indicated in
the figure.
Warning
 The CORRECT connection of these

tubings is extremely important to the
patients ventilation monitoring.
 IMPORTANT: There is a indication with
two circles, one bigger than another, in
the device indicating the correct
connector position to fit on the device.
13 When using the CO2 sensor (Capnograph) connect

the cable to the right panel of the OxyMag as
indicated in the figure.
Caution
 The CAPNOGRAPH connector has a
BLUE indication ring.
 Use only CO2 SENSOR (optional) acquired
from MAGNAMED.
37

14 Connect the AC/DC Converter to the equipment and
to the AC outlet.
Caution
 Use only original AC/DC power converter
acquired from Magnamed
38

15 Connect the oxygen hose to the OxyMag Emergency
and Transport Ventilator.
Caution
 When using the oxygen cylinder make
sure that the pressure reducing valve is
regulated between 60 and 150 psi (414 to
1035 kPa).
 Pressures above 150 psi (1035 kPa) can
damage the equipment.
7.2 Electrical Power Connection
The equipment should be connected to an electrical power source through the AC/DC adapter to an outlet that
fulfills the requirements of local government regulations.
The internal battery should be always charged and ready to use in an event of electrical power supply failure or
for use in external operations, to achieve this it should be kept connected to an electrical power supply that will
charge it even if it is turned off.
After long lasting use of the equipment with internal battery it will be necessary to recharge it completely
preparing it for the next use.
If the equipment remains disconnected from the power supply for more than one month, it is advisable to make
a complete recharge.
Warning
 In long lasting use of the OxyMag in battery backup, there is an alarm message indicating LOW
BATTERY, it should be connected IMMEDIATELY to a power supply. If it is not possible
DISCONNECT the ventilator from the patient and provide an adequate mean of ventilation
support for the patient.
39
7.3 Check before Use
The objective of this inspection routine is to orient the user to do a quick and simple test procedure before each
use or at minimum before each working day, warranting in this way a better reliability.
Warning
 Carry out this check before each procedure. In case of failure DO NOT USE THE
EQUIPMENT. Make the correction or provide a maintenance servicing.
7.3.1 Initial Procedures
OK Item Check
1 Check if the equipment is turned off.
2 Carry out a visual inspection of the equipment checking if all the components are intact.
3 Check if all the components are correctly connected and inserted.
4 Check the presence of the ambient air filter.
Check the firm connection of the exhalation valve. It is important to check the presence of the
5
diaphragm.
Check the firm connection of the respiratory circuit as well as checking if it is adequate for the
6
patient.
7 Check the firm connection of the flow sensor and if it is adequate for the patient to be ventilated.
8 Check the firm connection of the oxygen hose.
Check the pressure at the oxygen cylinder manometer, when it is applicable it should be
9
between 60 and 150 psi (414 to 1035 kPa).
Check the firm connection of the AC/DC adapter, when it is applicable. The OxyMag ventilator
can be used in battery backup for up the time specificated continuously under normal patient
ventilation conditions.
Warning
10
 In long lasting use of the OxyMag in battery backup, there is an alarm message
indicating LOW BATTERY, it should be connected IMMEDIATELY to a power
supply. If it is not possible DISCONNECT the ventilator from the patient and
provide an adequate mean of ventilation support for the patient.
11 Turn on the equipment and identify three initial beeps to check sound signal operation
40
OK Item Check
Turn on the equipment and select directly the type of patient through the corresponding figures.
The ventilator will start ventilating immediately. To put it in STAND-BY press the key
12
13 If all the itens where marked OK, than the equipment is ready for use.
7.3.2 Turn on the device

When the device is turned on the following screen will be shown:
Figure 13- OxyMag’s Initialization Screen
Press the key that corresponds to the type of the patient to be ventilated and connect the indicated flow sensor
to the respiratory circuit.
41
(1) Buttons to select the patiente
By pressing the Button the ventilator will start the ventilation with the configurtion as the table bellow:
Flow
Buttom Patiente (1) Initial Mode Ideal Weight
Sensor
NEONATE NEO PLV 2,8Kg
INFANT INF PCV 19,8Kg
ADULT ADU VCV 49,5Kg
(2) Flow Sensor Indication
The indication below the patient selection button shows which sensor must be used
Advertência

(1)
USE THE INDICATED FLOW SENSOR. The correct ventilation monitoring depends on the
flow sensor used in respiratory circuit.
 Even in the case of the necessity to use a different respiratory circuit that is adequate to the
patient, the FLOW SENSOR MUST BE THE INDICATED ONE.
(3) Test Button
This Button initiate device test senquency . See item 7.3.4
42
7.3.3 Normal Initialization Sequece
SEQ Procedure Screen

1 OxyMag‘s initial screen
When turning-on the ventilator check if a double
―beep‖ is heard together with a visual alarm light,
meaning that the audible and visible alarm are in
operating condition.
Waring
 If na audible double “beep” or a visual

alarm indicator is not blinking, avoid
the use of the ventilator, otherwise the
any alarm condition cannot be seen or
heard
2 Press the key corresponding to the type of patient

to be ventilated and connect the indicated flow
sensor to the patient‘s respiratory circuit. The
ventilator will be ventilate with the ventilation
modes as showed in item 7,3,2
Flow Sensor:
Neonate NEO
Pediatric INF
Adulto ADU
3 By pressing the NEONATE key the ventilator will
start with the following parameters:
Ventilation Mode PLV

Pinsp 15 hPa
-1
Freq 36 min
Tinsp 0,5 s
PEEP 5 hPa
-1
Flow 6 L.min
FiO2 80%
Flow Trigger OFF
Press Trigger OFF
43

4 By pressing the PEDIATRIC key the ventilator will
start with the following parameters:
Ventilation Mode PCV

Pinsp 15 hPa
-1
Freq 20 min
I:E Ratio 1:2
PEEP 5 hPa
FiO2 80%
Flow Trigger OFF
Pressure Trigger OFF
Rise Time 0,1 s
5 By pressing the ADULT key the ventilator will start

with the following parameters:
Ventilation Mode VCV

Vt 350 mL
-1
Freq 15 min
I:E Ratio 1:2
PEEP 5 hPa
Pmax 35 hPa
Pause 30%
FiO2 100%
Flow Trigger OFF
Pressure Trigger OFF
Flow Type Square
6 After the sequence of initialization the devicer

presents the ventilator screen. The alarm will be in
silence condition during the first two minutes. Note
the white bar over the silenced alarm symbol, as
long as the two minutes of silencing is ending the
bar reduces its size until the two minutes ends.
After this time the alarm audio will be active.
44

7
ADU
Touch the VCV button on the screen, and the

screen beside with the ventilation modes available
will be presented.
8 Touch the desired ventilation mode button on the

screen and immediately the ventilation of the
patient starts according to the initial adjustments
calculated as a function of the HEIGHT and the
IBW.
9 To adjust a parameter touch the corresponding
button and its background color will change to
CYAN indicating that it is selected.
45

10 Turn the rotary button clockwise to increment the
value and to counter clockwise direction to
decrement the value.
11
Press the rotary button to confirm or

touch the button on the screen to activate the new
value.
46

12 Touch the screen in the graph and menu area and
a screen with buttons to select graphs, data,
configurations and alarms will be presented.
If any sensor is connected in device (neither

capnograph or oximeter) will be present the first
figure in the next column.
Buttons showed wnhen any extern sensor is connected
Case oximeter is connectd will be sowed the

second figure in right side.
Buttons showed when oximeter is connected
On the other hand if the capnograph is connected

than the third figure in right column will be showed.
Buttons showed when capnograph is connected
47

13
ALAR M
Touch the ALARM button and the

screen beside will be presented.
Touch the alarm to be adjusted and use the rottary
button to adjust and confirm the value. When the
desired value is adjusted press the rotary button to
confirm it.
To return to the graphs screen press the
button.
To automatically adjust the alarm limits, select
between OFF, 10%, 20% or 30%. In this way the
ventilatory alarm limits (pressure, PEEP, MV,
apneia abnd frequency) will be configured as Alarrm screen without extern sensor connected
follow discrebed :
- Low limits – it will receive the result of mesure
parameter value minus the percentage select in the
automatic cell.
- High limit – it will receive the result of mesure
parameter value plus the percentage select in the
automatic cell.
- Selecting OFF the alarms return to the default
limits according to the patient selecte in the
initialization.
To enable the automatic adjustment change

different from OFF it is necessary that the ventilator
is not in STAND-BY condition.
Alarrm screen with Oximeter connected
Alarrm screen with capnograph connected
48

14
Config
Touch the CONFIG button and the

screen presented in the figure beside will be
presented. In the window one can:
 Set the patient height, it define the ideal
weight (IMC=22) and redefine the patient
ventilation parameter that depends of
weight.
 NIV (Non Invasive Ventilation) resource can
be turned on or off. When in NIV the leakage
compensation will be active.
 turned on or off the extern blender
compensation. In this situation the ventilator
disable the FiO2 parmeter set and the O2
100% function.
 Select the language.
Adjustment Limits
To return to the graphics screen touch the Height [m] IdealWeigh
button. Patiente
Min Máx t P[ kg]
Warning NEONATE 0,16 0,52 ≤ 6,0

 The change in height does not remain
after the equipment is turned off
INFANT 0,53 1,08 6,0 < P ≤ 25
 The adjustment of height can be
performed in a range of values that
corresponding to the type of patient ADULT 1,09 2,5 > 25
selected in the inicialization
15 Touch the O2/CO2 tab to calibrate the O2 cell and

the CO2 sensor.
Touch the button CAL FiO2 to calibrate the oxygen

sensor.
Touch the button CO2 to calibrate the CO2 sensor.
To return to the graphics screen touch the

button.
49

15 Touch the General tab:
 To adjust:
o Audio volume
o Pressure unit
 To visualize :
o The data of last tes performed
 leakeage,
 compliance
 resistance .
o Ventilator total hours of use
o How long was the last
maintenance.
Touch the AUDIO VOLUME button to adjust the

level of alarm audio. The bar indicates the actual
level. Use the rotary button to confirm and carry out
the adjustment.
Touch the desired pressure unit

To return to the graphics screen touch the
button.
50
7.3.4 Test Sequece
Warning
 The Test Sequence MUST be done with the patient disconnected.
SEQ Procedure Tela

1 OxyMag‘s Initial Screen.
Test
Press the test button and the internal test
procedure will be activated. Follow the instructions
presented on screen.
Notice the presented messages.
2 Activating the test sequence a three ―beep‖ should be

heard together with the lightining of the alarm indicator.
If the ―beep‖ sound is not heard nor visual indication of the
alarm is seen right above the LCD display then press the
NO BUTTON, otherwise press YES BUTTON to preceed
to the next test sequence.
2.1 Pressing NO the following screen will be shown
51
SEQ Procedure Tela

3 Notice that the tests are carried out sequentialy and right
after the ending of the test there is an approved or failed
report.
Caution
 If any test shows up a Fail diagnostic then

carry out a necessary repair.
After finishing the valves testing it will be asked for

occluding the ―Y‖ connector of the respiratory circuit right
after the flow sensor.
Next
Press after verifying that the circuit is
obstructed.
4 After ending all tests notice that all the items are
APPROVED and check the compliance, resistance and
the leakage of the respiratory circuit in order to use de
ventilator.
END
Press to finish testing.
52
SEQ Procedure Tela

5 The initial screen of the ventilator will be shown.
Beyond this point continue with norma initialization of the
ventilator.
7.3.5 Diagnóstico de Falha
The table below shows the actions that can be taken in order to correct the failure condition indicated in the test
sequence. After repairs done the device should be reinitiated and another test sequence should be carried out,
in case of failure persistence contact technical service.
The consequence column indicates what could occur if the device is used with that failure.
Warning
 In case of DEVICE INOPERATIVE message the device MUST NOT be used and the techical
services should be contacted to solve the problem.
Failure Menssage Action Consequence

―Check the inlet Set the oxygen inlet pressure in  Low Inlet Pressure
O2 Flow pressure‖ the range between 60 to 150 psi Alarm Indication
(414 to 1035 Pa)
Internal
―Device Inoperative‖ Contact Technical Services  Pressure monitoring
Sensor
failure. DO NOT USE
THE DEVICE
Flow Air + O2 ―Disobstruct the Disobstruct the inspiratory limb  O2 Concentration

inspiratory limb‖ delivery error
O2 Sensor Cell ―O2 Sensor Cell Failure‖ Call techinical service to replace  O2 concentration
the internal O2 sensor cell. readings coud be erratic.
53
Failure Menssage Action Consequence

Proximal ―Sensor Error‖ Check the flow sensor and  The message ―Sensor
Sensor respiratory circuit connections. OFF‖ will be shown
indicating that the flow
sensor is not recognized
in the circuit.
 It could be a variation in
volume up to 10%.
entregue.
 Only the following
parameters will be
monitored in this
condition: Pmáx, PEEP,
P.plat., Pmean and the
graph Pressure x Time.
 The flow trigger will be
disabled.
Exhalation ―Device Inpoerative‖ Check the diaphragm of the  Pressure monitoring

Valve exhalation valve. It should be failure. DO NOT USE
Pressure replaced if damaged. THE DEVICE.
Sensor
54
8 Instructions of Use
8.1 Ventilator Adjustments
The patient‘s IBW is used to calculate the initial ventilation parameters in order to provide the best
approximation to ventilate the patient. It will be calculated as a function of the IBW:
 Volume – calculated as a function of 7 mL/Kg
 Frequency – function of the internal calculation
 I:E Ratio - 1:2
 Inspired Flow – calculated as a function of obtained TINS
The other parameters will be adjusted to the following default values:

 Maximum Pressure – 30 hPa (cmH2O)
 PEEP – 4 hPa (cmH2O)
 TPAUSE – 30 % de TINS
 Flow – Square
Table of available ventilation modes for each type of patient as a function of the IBW informed
(1)
IBW MODE Flow Sensor Available Modes
PLV,CPAP/PSV, P-SIMV,
P ≤ 6,0 Kg NEONATE NEO
DualPAP
VCV, V-SIMV,
6,0 Kg < P ≤ 25 Kg INFANT INF PCV,CPAP/PSV, P-SIMV
DualPAP
VCV, V-SIMV, PCV,
P > 25 Kg ADULT ADU CPAP/PSV, P-SIMV,
DualPAP
When selecte the patiente in the ventilator initialization the height and height values assumed by the equip,emt
follow the table below:
Initialization Type of Ideal Weight

Hright [m]
button Patient [kg]
NEONATE 0,36 2,8
INFANT 0,95 19,8
ADULT 1,50 49,5
55
After the inicialization it is possible to change the height value . To do it touch in the graphs and menu
area and select Config button , in the General tab change this parameter.The adjustment of it can be
performed in a range of values that corresponding to the type of patient selected in the inicialization , see
table below:
Heigh set
Type of Ideal Weight
[m]
Patient W[ kg]
Min Máx
NEONATAL 0,16 0,52 ≤ 6,0
INFANTIL 0,53 1,08 6,0 <W ≤ 25
ADULTO 1,09 2,5 > 25
Notes
 The selection of patiente type in the initialization will define the initial transporte ventilator config
and enable the ventilation modes for the selected patient
 Equation of Body Mass Index (BMI)
Weigh [kg]
BMI = ------------------------
2
(Height [m])
 There are three types of flow sensor:

-1
o NEO – Neonate –Ragnge -20 to +20 L.min
-1
o INF – Infant – Range -50 to + 50 L.min
-1
o ADU – Adult –Range -150 to +150 L.min
 There are three model configurations related of patient type:
Flow (1)
Type of Patiente Ideal Weight (W) Available Modes
Sensor
NEONATE W ≤ 6,0 Kg NEO PLV, CPAP/PSV, P-SIMV, DualPAP
VCV, V-SIMV, PCV, CPAP/PSV, P-SIMV,

INFANT 6,0 Kg < W≤ 25 Kg INF
DualPAP
VCV, V-SIMV, PCV, CPAP/PSV, P-SIMV,
ADULT W > 25 Kg ADU
DualPAP
 (1)
NIV (Non Invasive Ventilation) – it is a resource that can be activated in every ventilation mode
and when it is active it will compensate leakages
Warning
 USE THE INDICATED FLOW SENSOR. The correct ventilation monitoring depends on the flow
sensor used in respiratory circuit.
56
 Even in the case of necessity to use different of the respiratory circuit adequate to the patient,
the FLOW SENSOR MUST BE THE INDICATED ONE.
8.2 Ventilation Mode and Parameter Adjustment
VCV – Volume Controlled Ventilation
Description: Adjusted Parameters:
 OXYGEN CONCENTRATION;
Note  VOLUME;
 FREQUENCY (RATE);
 This Ventilation mode is not available to  I:E RATIO;
NEONATAL patients (IBW < 6.0 kg).
 INSPIRATORY PRESSURE;
 PEEP;
In this ventilation mode the ventilator controls  INSPIRATORY PAUSE (%);
the flow and cycles by volume, i.e. for each  PRESSURE TRIGGER;
inspiration cycle the ventilator sends an exact  FLOW TRIGGER;
volume to the patient since the pressure is not  FLOW WAVEFORM.
limited.
The flow can assume square, decelerating
(descending), accelerating (ascending) or
sinusoidal waveforms.
Figure 14-VCV Waveforms
After receiving all ventilation parameters, the anesthesia ventilator module calculates the T INS, TEXP, TPAUSE,
FINS according to Flow, Inspiratory Pause and Frequency getting all the ventilation controlling timing.
1 – Ventilation without Inspiratory Pause, after TINS the ventilator cycles to expiration. The reached inspiration
pressure is consequence of the sent volume and resistance and compliance of the respiratory circuit of the
57
VCV – Volume Controlled Ventilation

patient.
2 – Ventilation with Inspiratory Pause, after sending the adjusted volume the ventilator holds the cycling to
expiration and is delayed until it completes T INS, after which the ventilator cycles to expiration phase, it is
characterized by a plateau pressure (the difference level between the peak pressure and the plateau pressure
depends on the airway resistance of the patient).
3 – If the pressure trigger or flow trigger is activated, then the module seeks to synchronize the beginning of the
next inspiration phase with the patient effort, according to the set level. The information of the trigger type that
activated the inspiration cycle is sent through the serial communication interface. The detection ―window‖ of the
patient effort for synchronization, opens in the last quarter of the controlled ventilation period.
Note
 When the patient begins to manifest inspiration effort and the pressure trigger or flow trigger is
activated in the ventilator module then it begins to “assist” the breathing of the patient. Many times
this situation is denominated Assisted-Controlled Ventilation.
 In assisted-controlled ventilation the monitored respiratory frequency can be greater than the adjusted
respiratory frequency.
4 – ASCENDING (ACCELERATING) flow waveform.

5 – DESCENDING (DECELERATING) flow waveform.
6 – SINUSOIDAL flow waveform.
7 – Pressure limited ventilation representation. In this situation the ventilator module limits the pressure to the
adjusted value and consequently the adjusted volume IS NOT BEEING DELIVERED due to factors like lung
compliance. This information is sent by the serial communication as PRESSURE LIMITED.
Warning
 Reaching the pressure limit (PRESSURE LIMITED ALERT) the adjusted volume IS NOT
BEEING DELIVERED to the patient.
 The default values ar only initial reference. Readjust the ventilation parameters according to
the patient’s need.
58
PCV – Pressure Controlled Ventilation
In this ventilation mode the ventilator controls the  OXYGEN CONCENTRATION

pressure along the inspiration phase and cycles  INSPIRATORY PRESSURE;
by time, i.e., at every inspiration cycle the  I:E RATIO;
ventilator reaches the adjusted pressure and  FREQUENCY (RESPIRATION RATE);
remains in this value until the time adjusted by  PEEP;
inspiration time. The delivered volume is a  PRESSURE TRIGGER;
consequence and depends on the patient lung  FLOW TRIGGER;
physiology (compliance and resistance). Normally
 RISE TIME
in the flow x time curve it can be noticed a peak
flow that decays in time.
Figure 15- PCV Waveforms
59
After receiving all ventilation parameters, the anesthesia ventilator module calculates the T INS, TEXP according
to TINS and Frequency, getting all the ventilation controlling timing.
1, 2 – Pressure Controlled Ventilation – The ventilator seeks to reach the adjusted inspiratory pressure in the
least time and it is achieved controlling the inspiratory flow. The delivered volume is a consequence of the
patient‘s lung compliance and resistance. The ventilator remains in the adjusted inspiratory pressure during
TINS after which cycles to expiration phase keeping the adjusted PEEP (Positive End Expiratory Pressure)
value.
3 – If the pressure trigger or the flow trigger is activated, then the ventilator module seeks to synchronize the
beginning of the next inspiration cycle to the patient effort, according to the set level. The information of the
trigger type that activated the inspiration cycle is sent through the serial communication interface. The
detection ―window‖ of the patient effort for synchronization is opened in the last quarter of the controlled
ventilation period.
Note
 When the patient begins to manifest inspiration effort and the pressure trigger or flow trigger is
activated in the ventilator module then it begins to “assist” the breathing of the patient. Many times
this situation is denominated Assisted-Controlled Ventilation.
 In assisted-controlled ventilation the monitored respiratory frequency can be greater than the
adjusted respiratory frequency.
4 – The rise time can be adjusted by TRISE TIME, the initial peak flow is in general inferior to that with T RISE TIME
= 0 (it depends on the patients lung and respiratory circuit compliance and resistance).
Warning
60
PLV – Pressure Limited Ventilation
 OXYGEN CONCENTRATION;
Notes  INSPIRATORY PRESSURE;
 INSPIRATORY TIME;
 This ventilation mode is available
 FREQUENCY;
ONLY for neonate patients (IBW <
 FLOW ( );
6.0 kg).
 PEEP;
 PRESSURE TRIGGER;
In this mode the ventilator limits the  FLOW TRIGGER;
pressure and time cycle, on each
inspiratory cycle the ventilator holds the
adjustes inspiratory pressure during the
inspiratory time adjusted, the volume in this
case is a consequence of the patient‘s lung
physiology (compliance and resistance).
Observing the flow curve notice that the
flow decreases as time goes by.
Figure 16- PLV Waveforms
61
PLV – Pressure Limited Ventilation
After all the parameter has been adusted on the screen, this calculates the T INS, TEXP as a function of TINS and
Frequency getting all the timing to control the ventilation.
1, 2 – Pressure Limited Ventilation – The ventilator enhances the pressure until the adjusted inspiratory
pressure and it is done by closing the expiratory valve. It is important to notice that the rising time and the
volume are dependent on the continuous flow and the patient‘s lung physiology – compliance and resistance.
The ventilator remains on this pressure level during T INS and after that it cycles to expiration, keeping the
adjusted PEEP.
3 – If the pressure trigger or flow trigger is activated, than the ventilator seeks to synchronize the beginning of
the next inspiratory cycle with the patient‘s effort, according to the settled levels. The information about the kind
of triggering is informed in the status area of the screen. The ―window‖ of the inspiratory effort for
synchronization opens in the last quarter of the period of the respiratory cycle in the expiratory phase.
Notes
 When the patient begins to demonstrate some inspiratory effort and the flow or pressure triggering is
activated on the ventilator, it starts to ASSIST the patient. In this situation it is denominated
Assited-Controlled Ventilation.
 In Assisted-Controlled ventilation the monitored respiratory frequency can be greater than the adjusted
respiratory frequency.
 The BASE FLOW is a continuous flow during the expiratory phase to eliminate CO 2 of the respiratory
-1
circuit besides reducing the undesirable PEEP. Its minimum value is 4 L.min . When this flow is
ZEROED there will be a continuous flow of the same values as the adjusted FLOW during all the
respiratory cycle.
Warning
62
V-SIMV – Synchronized Intermittent Mandatory Ventilation – Volume Controlled Cycle
 OXYGEN CONCENTRATION
Note  VOLUME;
 FREQUENCY;
 This Ventilation mode is not available to
 INSPIRATORY TIME;
NEONATAL patients (IBW < 6.0 kg).
 INSPIRATORY PRESSURE;
 INSPIRATORY PAUSE (%);
In this ventilation mode the patient can breathe  PEEP;
spontaneously between mandatory cycles, with  ΔPS (PRESSURE SUPPORT - PEEP;
or without pressure support. The controlled  PRESSURE TRIGGER;
cycles are VCV (Volume Controlled Ventilation).  FLOW TRIGGER;
 FLOW WAVEFORM;
 RISE TIME.
 FLOW CYCLE (%)
 FLOW ( -NEONATE);
Figure 17-V-SIMV Waveform
63
V-SIMV – Synchronized Intermittent Mandatory Ventilation – Volume Controlled Cycle
After receiving all ventilation parameters, the anesthesia ventilator module calculates the TINS, TEXP, TPAUSE,
FINS according to I:E Ratio, Plateau and Frequency getting all the ventilation controlling timing.
1 – Represents one VCV (Volume Controlled Ventilation) cycle with inspiratory pause;
2 – Represents patient‘s spontaneous breathing without pressure support;
3 – Represents a VCV (Volume Controlled Ventilation) cycle after SIMV period;
4, 5 – Represents patient‘s spontaneous breathing WITH PRESSURE SUPPORT, with flow cycling, when it
reaches a value between 5% and 80% (adjusted) of the measured peak flow. The percentage of the peak flow
in which it cycles from inspiration phase to expiration phase is programmable. The rise time (T RISE TIME) also
applies to the pressure support (see PCV).
6 – If the patient makes an inspiratory effort at the end of the SIMV period (T SIMV) there will be a window to
synchronize the controlled ventilation cycle that is ―open‖ at 0.75 x TSIMV, i.e., at the last quarter of the SIMV
period a synchronization window for the mandatory cycle of the ventilation will be opened. The flow triggering
or pressure triggering information is sent by the serial communication interface.
Note
 The monitored respiratory frequency can be greater than the adjusted respiratory frequency, because
the patient can breathe spontaneously between the mandatory ventilation cycles;
 The pressure support (ΔPS) is a value above PEEP and can be adjusted between + 5 hPa and PINS
hPa.
Warning
64
P-SIMV – Synchronized Intermittent Mandatory Ventilation – Controlled Cycle PCV
In this ventilation mode the patient can breathe  OXYGEN CONCENTRATION

spontaneously between the controlled cycles,  INSPIRATORY PRESSURE;
with or without pressure support. The  INSPIRATORY TIME;
controlled cycles are PCV (Pressure Controlled  FREQUENCY;
Ventilation).  PEEP;
 ΔPS (PRESSURE SUPPORT-PEEP);
 PRESSURE TRIGGER;
 FLOW TRIGGER;
 RISE TIME;
 FLOW CYCLING (% OF PEAK FLOW)
 FLOW ( - NEONATE)
Figure 18 - P-SIMV Waveforms
65
P-SIMV – Synchronized Intermittent Mandatory Ventilation – Controlled Cycle PCV
After receiving all ventilation parameters, the anesthesia ventilator module calculates the T INS, TEXP according
to TINS and Frequency, getting all the ventilation controlling timing.
1 – Represents a PCV (Pressure Controlled Ventilation) cycle during T INS;
2 – Represents a spontaneous respiration cycle WITHOUT PRESSURE SUPPORT;
3 – Represents a PCV (Pressure Controlled Ventilation) cycle after the SIMV period;
4, 5 – Represents patient‘s spontaneous breathing WITH PRESSURE SUPPORT, with flow cycling, when it
reaches a value between 5% and 80% (adjusted) of the measured peak flow. The percentage of the peak flow
in which it cycles from inspiration phase to expiration phase is programmable. The rise time (T RISE TIME) also
applies to the pressure support (see PCV).
6 - If the patient makes an inspiratory effort at the end of the SIMV period (T SIMV) there will be a window to
synchronize the controlled ventilation cycle that is ―open‖ at 0.75 x T SIMV, i.e., at the last quarter of the SIMV
period a synchronization window for the mandatory cycle of the ventilation will be opened. The flow triggering
or pressure triggering information is sent by the serial communication interface.
Note
 The monitored respiratory frequency can be greater than the adjusted respiratory frequency, because
the patient can breathe spontaneously between the mandatory ventilation cycles;
 The pressure support (ΔPS) is a value above PEEP and can be adjusted between PEEP + 5 hPa and
PINS.
Warning
66
CPAP/PSV – Continuous Positive Airway Presure with Pressure Support Ventilation
In this mode the patient breathes spontaneously  OXYGEN CONCENTRATION;

over a continuous positive pressure and is  PEEP;
helped by pressure supported (PSV).  ΔPS (PRESSURE SUPPORT – PEEP);
Observing the flow curve note that there is a  PRESSURE TRIGGER;
peak flow and decreasdes as long as the time  FLOW TRIGGER;
goes by.  FLOW CYCLE (%);
The cycling to expiration phase occurs by flow  RISE TIME;
and can be adjuste between 5% and 80% of the
peak expiratory flow.
 BACK-UP (VCV or PCV or PLV for Neonates or
If the support pressure value (ΔPS)is set 0
NO-BACUP)
(ZERO) or the two ways of cycle trigger
 FREQUENCY (back-up VCV, PCV and PLV);
(pressure and flow) are disabled , will be enable
the purê CPAP mode, ie support pressure is  I:E RATIO (back-up VCV and PCV);
disabled. In this condition the PEEP parameter  MAXIMUM PRESSURE(back-up VCV);
will be showed as CPAP.  VOLUME (back-up VCV);
 PAUSE (back-up VCV);
 FLOW WAVEFORM (back-up VCV);
 INSPIRATORY PRESSURE (back-up PCV and
PLV);
 INSPIRATORY TIME (back-up PLV);
 FLOW ( - back-up PLV);
Figure 19 - CPAP/ PSV Waveforms (CPAP + ΔPS)
67
CPAP/PSV – Continuous Positive Airway Presure with Pressure Support Ventilation
1 and 2 – Represents spontaneous cycles with pressure support in OFF.

3, 4 and 5 – Represents spontaneous breathing cycles with pressure support > 5hPa over PEEP. The TRISE
(Rise Time) of the pressure support can be adjusted to avoid pressure overshoot by smoothing the initial flow.
The flow cycling can be adjusted to a value between 5% and 80% of the peak inspiratory flow.
6 – If patient does not breathe and after apnea time TAPNEA (s) the ventilator shows up this condition in its
display with audible alarm and initiates the backup ventilation according to the adjusted parameters and
configurations.
Note
 The pressure support (ΔPS) is a value above PEEP and can be adjusted between + 5 hPa and PINS
hPa.
 To obtain the CPAP mode with backup ventilation select a modalidade CPCP/PSV, set ΔPS=OFF and
set the backup ventilation
Warning
 The apnea alarm should be adjusted to a safe value for the patient.However this alarm can be
turned off, in this condition there is no one informstion or alarm about apea and There will be
no backup ventilation active. The operator of ventilator need know about that this condition is
indicate when Apnea = OFF;
 If the parameter BACKUP is seted to OFF, o operado need know that no backup ventilation was
seted.
68
DualPAP – Two Positive Continuous Pressure Ventilation
Description: Adjusted Parameter:
 OXYGEN CONCENTRATION
In this mode the patient breathes  PHIGH;
spontaneously over two continuous  THIGH;
positive pressure and can be assisted by  PLOW ;
a Pressure Support (ΔPS). Normally  TLOW;
observing the flow curve there is a peak  ΔPS (PRESSURE SUPPORT-PEEP);
flow that decreases during lung  PRESSURE TRIGGER;
insuflation.  FLOW TRIGGER;
 FLOW CYCLING PERCENTAGE;
The flow cycling can be adjusted from  RISE TIME;
5% to 80% of the inspiratory peak flow.  MAXIMUM PRESSURE;
According to the adjustment it is possible  FLOW ( - NEONATE);
to get the APRV – Airway Pressure
Release Ventilation.
Figure 20– DualPAP Waveforms
69
DualPAP – Two Positive Continuous Pressure Ventilation
After adjusting all the ventilation parameters the ventilator has all the timing necessary to control the
ventilation.
1 – Represents a spontaneous breathing cycle without pressure support in PLOW (Lower Continuous Positive
Airway Pressure);
2 - Represents a breathing cycle with Pressure Support above PLOW ;
3 – Represents a spontaneous breathing cycle WITH PRESSURE SUPPORT and cycles by flow, when it
reaches a value between 5% and 80% of the Peak Flow. The percentage of the peak flow in which the
cycling occurs is programmable. The rise time (TRISE TIME) also applies to the pressure support (see PCV).
3 to 4 – Represents a synchronized transition to the PHIGH (Upper Continuous Positive Airway Pressure);
4 – During PHIGH is allowed to breath spontaneously with our without pressure support.
5 – Represents a synchronized transition from PHIGH to PLOW ;
The level transitions PHIGHPLOW or PLOWPHIGH occurs during the final fourth of THIGH and TLOW respectively
and is synchronized with the patient effort. The information of which kind of trigger that activated the
transition is informed in the message and status area of the display.
Notes
 The monitored respiratory frequency can be greater than the adjusted backup respiratory
frequency, because the patient can breathe spontaneously.
 The pressure support (ΔPS) is a value above PHIGH or PLOW and can be adjusted between + 5 hPa
and PINS hPa.
 The pressre level change is synchronized.
Warning
 The default values are only initial reference. Readjust the ventilation parameters according
to the patient’s need.
70
DualPAP - APRV – Airway Pressure Release Ventilation
Description: Adjusted Parameter:
In this mode it is possible to adjust two  OXYGEN CONCENTRATION

levels of continuous positive airway  PHIGH;
pressure and it can be pressure  THIGH;
supported in both levels, besides  PLOW ;
allowing Inverted Ratio Ventilation in  TLOW;
order to get the airway pressure release  ΔPS (Pressure Support - PEEP);
ventilation.  PRESSURE TRIGGER;
 FLOW TRIGGER;
 FLOW CYCLING;
 RISE TIME
 MAXIMUM PRESSURE
 FLOW ( - NEONATE);
Figure 21 - APRV Waveforms
71
DualPAP - APRV – Airway Pressure Release Ventilation
After adjusting all the ventilation parameters the ventilator calculates all the control timing as a function of
THIGH, TLOW.
1 and 2 - Represents a spontaneous cycle without pressure support in PHIGH (Inspiratory Positive Airway
Pressure);
3 – Represents a transition from PHIGH to TLOW synchronized;
3 to 4 – Represents a THIGH timing in which airway pressure release ventilation is done;
4 – Represents a transition from PLOW to PHIGH synchronized.
The level transitions PHIGHPLOW or PLOW PHIGH occurs at the final quarter of THIGH and TLOW respectively
through patient‘s effort synchronization. The information of what kind of triggering is presented on the
message area of the color screen.
Note
 The monitored respiratory frequency can be greater than the adjusted backup respiratory
frequency, because the patient can breathe spontaneously.
 The pressure support (ΔPS) is a value above PHIGH or PLOW and can be adjusted between + 5 hPa
and PINS hPa.
 The pressure level changes are synchronized with the patient’s effort.
Warning
 The default values are only initial reference. Readjust the ventilation parameters according
to the patient’s need.
72
NIV – Non Invasive Ventilation
Description:
This resource can be activated or deactivated in the configuration menu. When it is activated it carries out
leakeage compensation up to 100% of the patient‘s minute volume and ignores the alarms: Low Minute
Volume, Apnea and Check Flow Sensor.
-1
The flow triggering is compensated to leakeage up to 30 L.min .
The rise time and flow sensibility will be disactivated to all ventilation modes.
The leakeage volume can be seen in the monitored values on the screen.
When this feature is disabled, alarms are returned to the default values according to the type of patient
configured.
Notes
 The pressure support (ΔPS) is a value above PEEP and can be adjusted between + 5 hPa and PMAX.
 The continuous flow that apparently leaks from the exhalation valve is normal and it is used to
shorten the response time of the patient’s ventilation control system.
 In this mode there is leakeage compensation through the mask.
Warning
 Use the adequate mask for each patient in order to avoid excessive leakeage.
 The APNEA alarm is DEACTIVATED.
 There is no backup ventilation when this resource is activated.
73
8.3 Available Alarms
Warning
 When receiving any alarm condition by the serial communication interface the command
interface designer should inform the alarm condition to the equipment operator.
 The alarms can be silenced completely by intentional means of the equipment operator and
this condition will be shown in the message area.
 Ceased the situation that needed silencing the alarm, it should be re-activated for patient’s
safety.
Decreasing priority order of the alarms:

Alarms Classification
HIGH PRIORITY Description

Alarm
It means that the internal battery is with low charge. Provide other means to assure
Low Battery
patient‘s ventilation.
It means that the time elapsed since the last inspiration cycle is above the apnea
Apnea
alarm time adjusted in the alarm system.
Low O2 Inlet Pressure It means that the oxygen inlet pressure is under 4 psi (276 kPa).
It means that there is some obstruction in the respiratory circuit that prevents the
Obstruction
patient from complete exhalation.
It means that there is some disconnection in the respiratory circuit, or of the flow
Disconnection
sensor lines that prevents the patient from adequate ventilation.
It means that the pressure in the respiratory circuit is above the upper limit pressure
High Maximum Pressure
adjusted in the alarm system.
It means that the pressure in the respiratory circuit is under the upper limit pressure
Low Maximum Pressure
It means that the expired CO2 is above the upper limit pressure adjusted in the alarm
High EtCO2
system.
It means that the expired CO2 is under the lower limit pressure adjusted in the alarm
Low EtCO2
system.
It means that the inspired CO2 is above the upper limit CO2i adjusted in the alarm
CO2i
system.
It means that the Heart Rate is above the upper limit Heart Rate adjusted in the alarm
High FC
system.
It means that the Heart Rate is under the lower limit Heart Rate adjusted in the alarm
Low FC
system.
It means that the oxygen saturation is under the lower limit SpO 2 adjusted in the alarm
Low SpO2
system.
74
MEDIUM PRIORITY
Description
Alarm
It means that the patient‘s minute volume is above the upper limit minute volume
High Minute Volume
It means that the patient‘s minute volume is under the lower limit minute volume
Low Minute Volume
It means that the patient‘s respiratory frequency is above the upper limit frequency
High Frequency
It means that the patient‘s respiratory frequency is under the lower limit frequency
Low Frequency
It means that the pressure at the end of expiration (PEEP) is above the upper limit
High PEEP
PEEP adjusted in the alarm system.
It means that the pressure at the end of expiration (PEEP) is under the lower limit
Low PEEP
PEEP adjusted in the alarm system.
This alarm indicates one of the following conditions: The IRMA adaptor is not
IRMA Adaptor connected or it should be replaced.
Reset IRMA Indicates that the IRMA CO2 sensor should be disconnected and reconnected.
Change IRMA Indicates that the IRMA CO2 sensor should be changed.
CO2 Out of Range Indicates that the readings of the IRMA CO2 is incorrect.
Indicates that one of the situation below:

IRMA Reading Error  The internal operating temperature is out of range or
 The ambient operating pressure is out of range
Calibrate IRMA Indicates the need of zeroing the IRMA CO2
LOW PRIORITY
Description
Alarm
AC Input Fail It means that the device is not connected to the electrical AC power.
SpO2 Sensor It means that the SpO2 sensor is connected but out of the patient‘s finger.
It means:
 Sensor is disconnected
 Sensor connnected is damaged
Check SpO2  Cable is disconnected
 Detected interference
 High environment light
 Unknown sensor or;
Low PI It means low perfusion
75
MEDIUM PRIORITY
Description
Alarm
Search Pulse It means that Oximeter is looking for pulse
Activating SpO2 It means that Oximeter being activated
DEMO SpO2 It means that Oximeter is creating demo curve
Notes
 In CPAP/PSV mode if the apnea condition alarm takes place the sound and visual alarm will be
indicated, but the audible alarm will sound two sequences of high priority alarm, however the visual
alarm will continue to indicate this condition as long as it lasts.
Alerts Messages:
Alert Description
It means that the monitored pressure in the respiratory circuit reached the
PRESSURE LIMITED adjusted maximum pressure. In this case the delivered volume to the patient
will not reach the adjusted volume.
Indicates that the proximal sensor is disconnected. In this condition all the
dependent monitoring (VT, MV, Frequency, Vins, Tins, I:E, Texp, Cest, Cdyn,
SENSOR OFF Res, , RSBi, Leakeage Volume, Volume x Time graph) WILL NOT be
presented. In volume controlled modes the delivered volumes by the device
will vary up to ±10%.
Indicates that the synchronizing window, the last quarter of the respiratory
WINDOW
cycle in modes with synchronized mandatory ventilation cycle.
Assist Fl. Trig Indicates a flow triggered assisted cycle
Assist. Pr. Trig Indicates a pressure triggered assisted cycle.
Assist. Man. Trig Indicates a manual triggered assisted cycle.
Spont Fl. Trig Indicates a flow triggered spontaneous cycle.
Spont Pr. Trig Indicates a pressure triggered spontaneous cycle.
Spont Man. Trig Indicates a manual triggered spontaneous cycle.
76
Safety and Alarm System:
Item Alarm Unity Adjustment Range
1 High Pressure Alarm hPa OFF, 1 to 80
2 Low Pressure Alarm hPa OFF, 1 to 80
3 High PEEP Alarm hPa OFF, 1 to 80
4 Low PEEP Alarm hPa OFF, 1 to 80
5 High Minute Volume Alarm L OFF, 0.1 to 100.0
6 Low Minute Volume Alarm L OFF, 0.1 to 100.0
7 Apnea Time S OFF, 5 to 60

-1
8 High Frequency Alarm min OFF, 0.5 to 200
-1
9 Low Frequency Alarm min OFF, 0.5 to 200
10 High EtCO2 mmHg OFF, 1 to 80
11 Low EtCO2 mmHg OFF, 1 to 80
12 High Inspired CO2 mmHg OFF, 1 to 80
13 High Heart Rate bpm OFF, 35 to 250
14 Low Heart Rate bpm OFF, 35 to 250
15 Low SpO2 % OFF, 40 to 100%

(1)
16 Automatic Limit Adjustment --- OFF, 10%, 20% and 30%
(1)
Aplicable only to ventilation related alarms (Maximum Pressure, PEEP, Minute Volume and Respiratory
Frequency)
Warning
 The apnea alarm should be adjusted to assure patient’s safety. In some cases the apnea alarm
can be set to ZERO (OFF), in this special condition the apnea condition information will not be
sent by the serial communication interface and no back-up ventilation will be available. The
equipment operator should be aware of this condition (The designer of the command module
should show this condition in its display).
 The Adjustment of Autmatic parameter set the alarms to a percentage of monitored value at
the time of configuration because it, this adjustment only is possible if the ventilator is notinI
Stand-by.
77
8.4 Patient Manual Ventilation

In order to carry out patient manual ventilation, the ventilator should be put in STAND-BY condition. In this
situation, if the flow sensor is connected to the patient‘s respiratory circuit, the ventilation monitor will be
completely operational including its alarm system.
Warning
 During manual ventilation watch the maximum pressure.
 Keep the alarm system activated.
8.5 Alarms adjusting screen

ALARM
To enter in alarm adjusting screen press the button ALARM on the screen. It will be presented a
screen like the one shown in the figure below.
Ventilator Status Tela Showed

Device without extern
sensor connected
(Capnograph or oximeter)
Without idicaton of
Extern sensor alarm
78
Device with capnogrph

connected
Indication of
Capnograph
alarm
Device with oximeter

connected
Indication of
oximetry
alarm
The follow figure shows the placement of inferior and superior limits adjustment in the Alarm screm.
79
Figure 22- Alarme Settingt Screen
To change the alarm limit touch the corresponding position. The selected parameter will be highlighted in cyan
indicating that the change could be done (Figure 25), to do that use the rotary knob to setup the desired value
and press it or touch the parameter position to confirm.
Figure 23 - High pressure alarm adjustment selected in CYAN
80
9 Vertical Support - Instalation
This support is an optional item and can be used in ambulances, helicopters or on the wall of hospital ambient
(emergency room, post anesthesia recovery, UTI, etc).
The following sequence shows the procedure to assemble the support on the wall.
SEQ Operation Figura

1 Install the support holder with the DC +12V
2
(3803835) on the wall (room, ambulance,
helicopter, etc) through 4 screws (3003446) item 1 1
and 4 wall bushing (3003447) item 2
2 To set the ventilator on the support follow the

sequence below:
(a) Place the ventilator holder against the wall,
right above the support holder.
(b) Slide the OxyMag down until it fits perfectly
(c) Engage the safety latch of the ventilator by
turning the eccentric two buttons at the top
until the red spots become invisible.
(d) After installing the OxyMag check if it is
firmly connected and supported.
To remove the OxyMag carry out the reverse
procedure.
Sequence to assembly of the support on the worktop.

1 Install the support holder with the DC +12V
(3803835) on the wall (room, ambulance,
helicopter, etc) through 2 screws (3003446)
according to picture at side.
81

2 To set the ventilator on the support follow the
sequence below:
(a) Attach the support of handle above the
fixture.
(b) Slide the Oxymag down until it fits
perfectly.
(c) Engage the safety latch of the ventilator by
turning the eccentric two buttons at the top
until the red spots become invisible.
(d) After installing the OxyMag check if it is
firmly connected and supported.
To remove the OxyMag carry out the reverse
procedure.
Figure 24 - OxyMag support holder installed on the wall
82
10 Troubleshooting
In this chapter the problems and its possible solutions are presented. The majority are of simple solution that
can be carried out by the equipment operator.
Warning
 Do not use the device if a problem cannot be solved.
Problem Possible Causes Solutions

1. General Electrical Failure. 1. Call for Technical Assistance
Inoperative Alarm
1. Respiratory Circuit 1. Find the disconnection point

Disconnection. and firmly reconnect it.
2. Lack of Inspiration Flow. 2. Check if there is inspiration flow

and enhance it if necessary.
3. Change in patient‘s respiratory 3. Set new parameters for

Disconnection Alarm mechanics. ventilation support.
4. Exhalation valve‘s disc 4. Place the disc in its correct

incorrectly assembled or position or replace it by a new one.
damaged.
5. Electronic pressure control 5. Call for Technical Assistance

system failure.
mechanics. ventilation support.
2. Obstruction in the respiratory 2. Remove obstructions.

circuit‘s expiratory limb or in the
High Pressure Alarm
exhalation valve.
3. Patients airway obstruction. 3. Remove obstructions or carry

out a patient‘s airway secretion
suction.
mechanics. ventilation support.
Low Pressure Alarm
2. Excessive leakage in 2. Find the leakage and correct it.
respiratory circuit
83
Problem Possible Causes Solutions

1. Battery charge ending after 1. Restablish the electrical power
using the equipment without connection immediately or
electrical power supply. disconnect the equipment from the
patient and provide means to keep
Low Battery Alarm patient‘s ventilation support.
2. Failure in the internal battery 2. Call for Technical Assistance

charger, even with the presence of
electrical power.
1. Electrical power cord 1. Re-establish the electrical
disconnection. power connection to the
equipment or use it with internal
Electrical Power Failure Alarm battery back-up to conclude short
2. Electrical power failure. term surgery.
2. Re-establish the electrical
power.
84
11 Cleaning and Disinfection
This chapter presents the cleaning, sterilization and disinfection procedures of the equipment and its
accessories.
Warning
 Before the first use of the equipment and its accessories should be cleaned, sterilized or
disinfected in an appropriate way.
Caution
 The accessories and removable parts of the anesthesia ventilator module submitted to many
cleaning, disinfection or sterilization procedure has its lifetime shortened and should be
replaced by new ones according to the table presented in chapter 11.
 The accessories and removable parts of the anesthesia ventilator module that shows some
degradation or damage signs should be replaced and its use should be avoided.
11.1 OxyMag Ventilator

The external parts of the ventilator can be cleaned with a soft cloth with appropriate germicide solution
(detergent) moisture, ensuring to completely dry and don‘t let any residue in the serial communication
connector, DC power supply connector, inspiratory flow connector, expiratory valve connector, flow sensor‘s
pressure line connector.
Establish an appropriate cleaning, disinfection or sterilization routine to the ventilator‘s parts.
A. The external parts of the ventilator can be cleaned with a soft cloth with an appropriate
germicide solution (detergent), ensuring to completely dry and don‘t let any residue in the
serial communication connector, DC power supply connector, inspiratory flow connector,
expiratory valve connector, flow sensor‘s pressure line connector. After cleaning, use a
clean soft cloth to completely dry the module.
B. The parts that come into contact with respiratory gases should be periodically
disassembled for cleaning, sterilization or disinfection procedure. This includes flow sensor
and line that accompanies the ventilator. Use appropriate germicide solution or Ethylene
Oxide.
C. Do not use abrasive agent to carry out the cleaning procedure.
D. Do not use alcohol to clean plastic parts.
E. Do not sink the Ventilator in any kind of liquid.
Warning
 Ventilator’s parts that comes into contact with patient’s fluids or mucous membranes or skin
wounds (respiratory circuit, flow sensor, etc) are potentially contaminated. These accessories
are classified as semi-critical, due to the potential risk they pose for transmitting infection and
before discarding (at the end of their lifetime) or sending them for maintenance or repair they
require a high-level disinfection procedure or be sterilized.
 In case of discard: INDICATE – HOSPITAL WASTE POTENTIALLY INFECTED
 When sending the ventilator and its parts to maintenance it should be cleaned, sterilized or
disinfected APPROPRIATELY
85
 EQUIPMENTS VISIBLY INFECTED BY PATIENT’S FLUIDS WILL BE RETURNED WITHOUT ANY

MAINTENANCE OR SERVICE PROCEDURE.
11.2 Cleaning, Disinfection and Sterilization Procedures
Contaminated
Material
Soft cloth with Washing

detergent
Sterilize Store Disinfection
Figure 25– Sequences for Cleaning, Sterilization and Disinfection
(1) Cleaning
The cleaning procedures should be done by mechanical friction with a soft cloth with soap and water moisture.
(2) Washing
ALLWAYS wash all parts before high-level disinfection or sterilization procedures. It is the most important step
in decontamination. It can be done by immersion in neutral soap and water solution or with an enzyme
detergent with temperature at 35ºC to 60ºC for 5 to 10 minutes and followed by mechanical friction for dirty and
organic material removal.
(3) Immersion Chemical Disinfection

Carry out a chemical disinfection by immersion in a 2% Glutaraldehyde solution for 40 minutes. Completely
remove chemical residues from components and parts with sterilized and distilled water, after that dry them
completely in a clean ambient.
(4) Immersion Chemical Sterilization

Carry out a chemical sterilization by immersing in a 2% Glutaraldehyde solution for 12 hours. Completely
remove chemical residues from components and parts with sterilized and distilled water, after that dry them
completely in a clean ambient.
(5) Autoclave
Carry out autoclave sterilization with the following parameters:
 Pressure: 96 kPa (14 psi)
 Temperature: 120 ºC
 Time: 15 minutes
(6) Ethylene Oxide (ETO)

Carry out sterilization with ethylene oxide according to the chemical product manufacturer‘s recommendations.
86
Description Process Cycles (Life time)
External part of the Ventilator (1) NA
Flow sensor‘s SILICONE line connector and tubing (2), (3), (4), (5), (6) 50
Autoclavable flow sensors (Polysulfone) (2), (3), (4), (5), (6) 50
Autoclavable expiratory valve (Polysulfone) (2), (3), (4), (5), (6) 50
Sterilizible flow sensors (Polycarbonate) (2), (3), (4), (6) 50
PVC tubings (2), (3), (4), (6) 50

(2), (3), (4), (5), (6)
Silicone line 50
NA – Not Aplicable
87
12 Accessories and Parts
Caution
 Use always original accessories and parts to assure safety and efficacy of the equipment.
Items, parts and accessories that goes along with the product:
Item Part Number Description QTY Unit Figure or Photograph
OXYMAG – TRANSPORT
1 1600185 AND EMERGENCY 01 PC
VENTILATOR
KIT FLOW SENSORS

ADU INF NEO
AUTOCLAVABLE
 01 Silicon Line
 01 Adult Flow
2 5001748 01 PC
Sensor
 01 Infant Flow
Sensor
 01 Neonate Flow
Sensor
+ 12V AC/DC ADAPTER

3 2402568 WITH 4 PIN 01 PC
CONNECTOR
ADULT RESPIRATORY
4 1703218 CIRCUIT 1,2M 01 PC
AUTOCLAVABLE
88
Item Part Number Description QTY Unit Figure or Photograph
5 3902647 O2 DISS X2 HOSE 01 PC
ENVELOPE WITH 3
6 1702656 AMBIENT AIR FILTER 01 PC
FOR OXYMAG
7 1600185-NE-20-RR INSTRUCTION MANUAL 01 PC
89
Optional Accessories:
Part
Item Description QTY Unit Figure or Photograph
Number
KIT FLOW SENSORS ADU
INF NEO AUTOCLAVABLE
 01 Silicone Line
 01 Adult
Autoclavable
1 5001748 Flow Sensor 01 PC
 01 Infant
Autoclavable
Flow Sensor

01 Neonate
Autoclavable
Flow Sensor
ADULT AUTOCLAVABLE
FLOW SENSOR KIT
2 5001747  01 Silicone Line 01 PC

 03 Adult
Autoclavable Flow
Sensor Kit
INFANT AUTOCLAVABLE
FLOW SENSOR KIT

 03 Infant
Autoclavable Flow
Sensor Kit
NEONATE AUTOCLAVABLE
FLOW SENSOR KIT

 03 Neonate
Autoclavable Flow
Sensor Kit
90
Part
Number
ADULT AUTOCLAVABLE
FLOW SENSORS
5 5001495  05 Silicone Lines 01 PC

 05 Adult
Autoclavable Flow
Sensors
INFANT AUTOCLAVABLE
FLOW SENSORS

 05 Infant
Autoclavable Flow
Sensors
NEONATE AUTOCLAVABLE
FLOW SENSORS

 05 Neonate
Autoclavable Flow
Sensors
ENVELOPE WITH 3
8 1702656 AMBIENT AIR FILTER FOR 01 PC
OXYMAG
91
Part
Number
MAGNAMED‘S EXHLATION
9 3800248 01 PC
VALVE DIAPHRAGM
AUTOCLAVABLE
10 3200251 EXPIRATORY VALVE 22M 01 PC
15F 30M
IRMA CO2 MAINSTREAM

11 2702597 SENSOR WITH 5 PIN 01 PC
CONNECTOR
12 3902647 O2 DISS X2 HOSE 01 PC
92
Part
Number
13 3802668 TROLLEY FOR OXYMAG 01 PC
ARTICULATED ARM TO
14 1702667 SUPPORT RESPIRATORY 01 PC
CIRCUITS
ADULT RESPIRATORY
15 1702653 CIRCUIT 1,2M 01 PC
AUTOCLAVABLE
INFANT RESPIRATORY
16 1702654 CIRCUIT 1,2M 01 PC
AUTOCLAVABLE
93
Part
Number
NEONATE RESPIRATORY
17 1702655 CIRCUIT 1,2M 01 PC
AUTOCLAVABLE
+ 12V AC/DC ADAPTER

18 2402568 01 PC
WITH 4 PIN CONNECTOR
DC 12V 4VIAS CABLE WITH

19 2802671 01 PC
AUTOMOTIVE PLUG
TRANSPORT HANDBAG
20 1702875 01 PC
FOR OXYMAG
ALUMINUM OXYGEN
21 3902630 01 PC
CYLINDER (1.7 L)
94
Part
Number
VERTICAL SUPPORT FOR

WALL, AMBULANCE AND
22 1702496 HELICOPTER WITH QUICK 01 PC
DC ELECTRICAL POWER
SUPPLY
ADULT DIGITAL SENSOR

23 1704383 01 PC
LNCS DCIP MASIMO
NEONATE REUSABLE
24 1704386 DIGITAL SENSOR LNCS
DCIP MASIMO
OXIMETER MAXIMO
25 1704384 ADAPTER CABLE WITH 5 01 PC
PINS CONECTOR
Adulto/Pediatric IRMA
26 3902414 Airways adapter 1 PC
 Box with 25 units
Neonate IRMA Airways

27 3903443 adapter 1 PC
 Box with 10 units
95
13 Preventive Maintenance
Warning
 The Ventilator is a device for life support. The maintenance or technical assistance of the
OxyMag (1600185) should be carried out by Magnamed authorized technician.
 DO NOT use this device if it is not working accordingly to the specifications contained in this
instruction manual.
13.1 Indicates Preventive Maintenance Need
The equipment displays at the home screen the periodic maintenance symbol when the
equipment works more than 5000 hours after last maintenance according to picture bellow:
Figure 26 – Initial screen with need periodic Maintenance symbol
13.2 Checking
Before use or daily checking procedure

 Equipment cleaning
 Electrical power / AC-DC Adaptor integrity
 Alarm system functioning, including audio output
 CLEAN ambient air filters installed;
 LCD Display;
 Battery charged;
 Touch Screen – working properly;
96
 Panel keys;
 Rottary button – turn and confirm;
 Correct respiratory circuit installation (including the existence of the respiratory valve diaphragm.
Warning
 Daily checking should be done with the device disconnected from the patient.
13.3 Internal Li-Ion Battery

The internal battery keeps the equipment working even if the electrical power fails. Its duration in normal
ventilation condition is specified in chapter 14.
Caution
 The battery should be substituted according to the technical specifications (chapter 14) in
order that the normal working capacity be approximately 300 minutes.
 The internal battery substitution should be carried out by trained and qualified personel only.
 The battery discharge should follow the local government regulations.
Warning
 To keep the battery charged and the equipment ready to use in case of electrical power failure
it should keep connected to a power supply.
13.4 Internal O2 Concentration Measurement Cell

The oxygen concentration sensor is a fuel cell that generates an electrical signal proportional to the oxygen
concentration present in the gas mixture administered to the patient and its intensity is due to the chemical
reaction. The duration of the cell, according to the original manufacturer specification is 10.000 hous @ 100%
O2, it means more than a year continuously using.
Caution
 The oxygen concentration measurement cell should be substituted according to the
specifications in chapter 14.
 The substitution of the oxygen concentration cell should be done by a trained and qualified
personel.
 The discharge of the oxygen concentration cell should follow the local government regulation.
13.5 Ambient Air Filter Substitution
To substitute the ambient air filter follow the procedure below:
97
(1) Remove the air filter cover at the left

side of the ventilator.
(2) Remove the old filter
(3) Clean the setting base of the filter with a
clean cotton embedded in a soap and
water solution.
Caution
 Do not use compressed air to clean,
otherwise it can introduce dust and
dirt to the gas blender system.
(4) After drying it, set a new ambient air

filter.
(5) Install the ambient air filter cover and
check if it is firmly closed.
Figure 25 - Ambient Air Filter Substitution
98
Caution
 Do not operate this device without this filter otherwise it can damage the ambient air / oxygen
blender system.
 Use only filters acquired from Magnamed, ordering information at chapter 12.
 300 g/m2 bacterial filter 99.99% efficiency for bacterial and viral filtration.
13.6 Sending the Ventilator to Maintenance Service

Before sending the products to maintenance service they should be cleaned, sterilized or disinfected according
to the orientations contained in this instruction manual (see chapter 10). The equipments and parts or
accessories that are visibly infected by patient‘s fluids will be returned without any maintenance or service
procedure.
Warning
 Ventilator’s parts that comes into contact with patient’s fluids or mucous membranes or skin
wounds (respiratory circuit, flow sensor, etc) are potentially contaminated. These accessories
are classified as semi-critical, due to the potential risk they pose for transmitting infection and
before discarding (at the end of their lifetime) or sending them for maintenance or repair they
require a high-level disinfection procedure or be sterilized.
 In case of discard: INDICATE – HOSPITAL WASTE POTENTIALLY INFECTED
 When sending the anesthesia ventilator module and its parts to maintenance it should be
cleaned, sterilized or disinfected APPROPRIATELY
 EQUIPMENTS VISIBLY INFECTED BY PATIENT’S FLUIDS WILL BE RETURNED WITHOUT ANY
MAINTENANCE OR SERVICE PROCEDURE.
99
14 Technical Specifications
14.1 Classification
Equipment Class II (IEC – 60601), energized internally, type BF for continuous operation. Equipment IPX4
splash-proof.
14.2 Standards
 ISO 13485:2003 – Medical Devices: Quality management systems – Requirements for regulatory
purposes
 ISO 9001:2008 – Quality management systems
 ISO 14971:2007 – Medical Devices: Application of risk management to medical devices
 EN 980:2008 – Symbols for use in the labeling of medical devices
 EN 60601-1-4:2006 – Medical Electrical equipment – Part 1-4: General requirements for safety –
Collateral Standards: Programmable electrical medical systems
 DIN EN 794-3: – Lung Ventilators – Part 3 – Particular requirements for emergency and transport
ventilators
 DIN EN 794-3:2009-12 – Lung Ventilators – Part 3 – Particular requirements for emergency and
transport ventilators (Includes Amendment A2:2009-12)
 IEC 62304:2006 – Medical Device Software – Software life cycle processes
 ISO 10651-3:1997 – Lung Ventilators for Medical Use – Parte 3 – Particular requirements for
emergency and transport ventilators
 ISO 5356-1:2004 Anesthetic and respiratory equipment – Conical connectors – Part1: Cones and
sockets
 ISO 5359:2008 Low-pressure hose assemblies for use with medical gases
 EN 60601-1-2:2007 Medical electrical equipment. General requirements for basic safety and essential
performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
 EN 60601-1:1990 A1:1993 A2:1995 - Medical electrical equipment - General requirements for safety
 EN 60601-1-1:2001 Medical electrical equipment. General requirements for safety. Collateral
standard. Safety requirements for medical electrical systems. Section 1.1 Collateral standard: Safety
requirements for medical electrical systems
 IEC CISPR 11 Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic
disturbance characteristics – Limits and methods of measurement
14.3 Specifications
The OxyMag Transport and Emergency Ventilator are composed by the following components:
 LCD DISPLAY with touch screen and 320 x 240 pixels;

 Electronic Control Board with:
o Present data on the display;
o RS-232C Serial Interface;
o Quick access keys to:
 HOLD;
 O2 100%;
 NEXT (Next page of adjustment parameters);
 MANUAL (Manual Inspiratory Cycle - Trigger);
 LOCK (Lock the touch screen and keys);
o Respiratory Circuit Pressure Reading;
o Respiratory Circuit Flow Reading;
100
o Inlet O2 Pressure Reading;

o Barometric Pressure Reading;
o O2 Concentration Reading;
o Intelligent Battery Charger;
 Loudspeaker to indicate alarms and alerts;
 RED LED to indicate alarm conditions;
 GREEN LED to indicate electrical power connection;
 External AC/DC Adaptor (100-240 VAC – 50 – 60 Hz  +12 VDC);
 On/Off Switch;
 Internal O2 Concentration Galvanic Measurement Cell

-1
Neonate Flow Sensor for the range 20 L.min ;

-1
Infant Flow Sensor for the range 50 L.min ;

-1
Adult Flow Sensor for the range 150 L.min .
 Respiratory Circuits for NEONATE, INFANT and ADULT;
 Plastic ABS case impact resistant.
 Handbag for transportation (Optional);
14.3.1 Electrical Characteristics
External AC/DC Adapter 100-240 VAC – 50 – 60 Hz  +12 VDC (2402568):
Item Parameter Specification Tolerance Unit

(1)
1 Electrical Voltage (50/60Hz) 100 to 240  10% VAC
2 Maximum Power Consumption 50  10% W
3 Outllet 12VDC – 4 vias 12  10% VDC
4 Current 2.5 --- A
(1)
Connector 3 (three) pins, NBR-14136:2002, where the central pin is EARTH
Internal Li-Ion Battery:

1 Internal Li-Ion Battery 11,8VDC 4000  15% mAh
2 Internal Battery Duration (with full charge) 390  15% min
3 Maximum time to recharge (ventilator and 4.0  15% h
(1)
operation)
(1)
The battery charging should be done in ambient temperature 5 to 35 ºC
 Electromagnectic Compatibility
o Imunity: IEC 60601-1-2
o Emission: CISPR11
o Aprovals: EN/IEC 60601-1
 Class IIb – According to CE/93/42/CEE anex IX
 Respiratory Accessories Class of Protection (Dischargeable or Reusables): Type BF (Body

Floating)
14.3.2 Connection to Oxygen Supply
 Oxygen Inlet – DISS male 9/16‖ 18 threads

o OPTIONAL – NIST Standard
101
 Oxygen Gas Pressure: 40 to 150 PSI (345 to 1035 KPa)

 Hoses: According to ISO 5359:2000
 The aluminum oxygen cylinder (1.7 L) lasts for 40 minutes with the device configured as:
o Adult Patient
o VCV Mode
o Volume – 500 mL
-1
o Frequency – 12 min
o I:E Ratio – 1:2
o PEEP – 5 hPa
o Pause – 30%
o FiO2 – 100%
o Flow Type - Square
All Materials that comprise the product are compatible with air, compressed air and oxygen.
14.3.3 Environmental and Physical Specifications

1 Dimensions (basic unit)
2 Height (with holder) 176 (231) 2 mm
3 Width 254 2 mm
4 Depth (with holder) 134 (185) 2 mm
5 Weight 3.25  0.1 Kgf
6 Operation
7 Temperature -10 a 50 --- ºC
8 Barometric Pressure 600 a 1100 --- hPa
9 Relative Humidity (no condensation) 15 a 95 --- %
10 Storage
11 Temperature -20 a 75 --- ºC
12 Barometric Pressure 500 a 1200 --- hPa
13 Relative Humidity (no condensation) 5 a 95 --- %
14 Oxygen Cylinder Consumption at the following
conditions:
92  10% min/LO2-CYLINDER
 Tidal Volume = 500 mL

-1
Frequency = 12 min
 O2 Concentration = 40%
14.3.4 Ventilation Modes
(1)(4)(5)
Mode Description Apnea Backup Mode
Volume Controlled Ventilation (Assisted Cycles can be

VCV NA
set)
Pressure Controlled Ventilation (Assisted Cycles can be

PCV NA
set)
Pressure Limited Ventilation – Time Cycled.
PLV NA
Available when configured to Neonate Mode (Assisted
Cycles can be set)
102
(1)(4)(5)
Mode Description Apnea Backup Mode
Synchronized Intermittent Mandatory Ventilation – IMV – Volume Controlled

V-SIMV + PS
Pressure Support can be set Intermitent Mandatory Ventilation
Synchronized Intermittent Mandatory Ventilation – IMV – Pressure Controlled

P-SIMV + PS
Pressure Support can be set Intermitent Mandatory Ventilation
PCV (adult and infant) / PLV
Continuous Positive Airway Pressure with Pressure
CPAP/PSV (neonate), OFF.
Support Ventilation
Programable by Operator
(2)
DualPAP Two Positive Continuous Pressure Ventilation Backup frequency
NIV Non Invasive Ventilation NA

(1)
Non Invasive Ventilation (NIV) with mask can be activated in all ventilation modes and in this case there is
leakeage compensation.
(2)
The APRV (Airway Pressure Release Ventilation) can be obtained through the DualPAP ventilation mode with
appropriate adjustment of the timing and pressures.
(3)
Automatic compliance and small leakage compensation in the respiratory circuit.
(5)
When the ventilator is in NEONATAL mode (IBW ≤ 6,0 Kg) the ventilation modes available are: PLV, BIPAP,
CPAP, PSV, DualPAP
14.3.5 Ventilation Parameter Adjustment Specifications

Item Parameter Specification Resolution Unit
1 Tidal Volume 100 to 1000 : 10
Adult ml
(1) 1000 to 2500: 50
10 a 2500
20 to 100:5
Infant ml
100 to 300:10
(2) -1
2 Respiratory Frequency 0 to 150 1 min
3 Rise Time 0 to 2.0 0.1 s
4 Pause 0 to 70 10 %
5 Maximum Pressure 0 to 60 1 hPa
6 Inspiratory Pressure 1 to 60 1 hPa
7 ∆PS 0 to 60 1 hPa
8 PEEP 0 to 40 1 hPa
-0,2 a -2,0:- 0,2
9 Assisted Sensibility (Pressure) OFF; -0.2 to -10 hPa
-2 a -10:- 1
-1
10 Assisted Sensibility (Flow) OFF, 0.5 to 30.0 0.5 L.min
-1
11 Inspiratory Flow (Neonate) 4 to 20 1 L.min
12 Flow Cycling in Pressure Support 5 to 80 5 %
13 O2 Concentration 35 to 100 1 % vol
0.1 to 0.7:0.01
14 Inspiratory Time 0.1 to 10 0.7 to 1:0.05 s
1 to 10:0.1
103
Item Parameter Specification Resolution Unit

Square,
Decelerated,
15 Inspiratory Flow Waveform --- ---
Accelerated,
Sinusoidal
(3)
16 CPAP 1 to 40 1 hPa
17 Hight Pressure 1 to 60 1 hPa
18 Low Pressure 0 to 40 1 hPa
19 0,20 a 0,70:0,01
Time Higth 0,20 a 59,80 0,70 a 1,00:0,05 s
1,00 a 59,80:0,10
20 0,20 a 0,70:0,01
Time Low 0,20 a 59,80 0,70 a 1,00:0,05 s
1,00 a 59,80:0,10
21 Ratio 1:4 a 4:1 1:0.1 -
(4)
22 Backup OFF;PLV;
--- -
PCV; VCV
-1
23 Inspiratory Flow (Neonate) 4 to 20 1 L.min
24 Time to apnea alarm OFF, 5 to 60 1 s
(5)
25 Height 0,16 a 0,52:0,01
0,16 a 2,50 0,53 a 1,08:0,01 Kg
1,09 a 2,50:0,01
-1
26 Flow (Flowmeter) 0 to 15 1 L.min
(1)
The adjusting the tidal volume to values less than 20ml is made using the pression adjustment monitoring
the tidal volume in the ventilator.
(2)
In the CPAP/PSV mode without support pressure and without backup, the respiratory frequency will be zero.
(3)
In the CPAP/PSV mode if the supporte pressure is disabled (∆PS equal zero or pressure ade flow trigger
equals zero) will be adjusted the parameter CPAP.
(4)
CPAP/PSV backup options. If it is set OFF the CPAP/PSV mode not start backup mode when reach the time
to apnea alarm.
(5)
Depending on the adjusted weight the ventilator will be configured to operate in:
Flow IBW-Ideal Body Height

Patiente (1) Initial Mode
Sensor Weight [m]
NEONATAL NEO PLV 2,8Kg 0,36
INFANTIL INF PCV 19,8Kg 0,95
ADULTO ADU VCV 49,5Kg 1,50
The Ideal Body Weight is calculated using the IMC equal 22 and the patiente height e can be changed in a
range of values that corresponding to the type of patient selected in the inicialization , see table below:
Heigh set Ideal Weight
Type of
[m] W[ kg]
Patient
Min Min
NEONATAL 0,16 0,52 ≤ 6,0
INFANTIL 0,53 1,08 6,0 < W ≤ 25
ADULTO 1,09 2,5 > 25
104
Caution
 Minimum Pressure Limit: 5 hPa
 The maximum pressure limits the pressure in the respiratory circuit.
o In VCV this will be the maximum pressure in the respiratory circuit. The exhalation
valve opens to the ambient to keep this maximum pressure during the inspiratory
cycle, if this maximum pressure is exceeded by 5 hPa the ventilator cycles to the
expiratory phase (pressyre cycle).
 This ventilator DOES NOT GENERATE NEGATIVE PRESSURE WHEN THE PATIENT IS
EXHALING.
14.3.6 Ventilation Monitor Specification
(1)
Item Parameter Range Resolution Tolerance Unit
Instantaneous Measured  (1 hPa or 2% of (2)
1 -20 to 100 1 hPa
Pressure reading)
 (1 hPa or 2% of
2 Maximum Inpiratory Pressure 0 to 90 1 hPa
reading)
 (1 hPa or 2% of
3 Mean Pressure 0 to 90 1 hPa
reading)
 (1 hPa or 2% of
4 Plateau Pressure 0 to 90 1 hPa
reading)
PEEP – Positive End Expiratory  (1 hPa or 2% of
5 -20 to 90 1 hPa
Pressure reading)
Intrinsic PEEP at the end of  (1 hPa or 2% of
6 -20 to 90 1 hPa
expiratory phase reading)
-1
± (2.0L.min or 5% -1
7 Measured Flow (Adult Sensor) -150 to 150 1 L.min
of reading)
-1
± (0.5L.min or 5% -1
8 Measured Flow (Infant Sensor) -50 to 50 0.5 L.min
of reading)
-1
± (0.2L.min or 5% -1
9 Measured Flow (Neonate Sensor) -20 to 20 0.2 L.min
of reading)
 (20mL or 5% of
100 to 995:5 ml
Measured Volume measured value)
10 100 a 3000
(Adult Sensor – ADU)  (0.02L or 5% of
1000 to 3000:10 L
measured value)
Measured Volume  (10mL + 5% of
11 (3) 10 to 400 2 ml
(Infant Sensor – INF) measured value)
Measured Volume  (3mL + 5% of
12 (3) 1 to 100 0.1 ml
(Neonate Sensor – NEO) measured value)
Minute Volume (MV)
 (0.18L or 3% of
13 0.1 to 99.0 0.001 (4) L
measured value)
(Adult Sensor – ADU)
Minute Volume (MV)
 (0.10L or 3% of
14 0.01 to 50.0 0.001 (4) L
measured value)
(Infant Sensor – INF)
Minute Volume (MV)-(Neonate  (0.06L or 3% of
15 0.001 to 20.0 0.001 (4) L
Sensor – NEO) measured value)
16 Inspiratory Time 0.05 to 60.0 0.01  0.01s s
105
(1)
Item Parameter Range Resolution Tolerance Unit
17 Expiratory Time 0.05 to 60.0 0.01  0.01s s
1:100.0 to
18 I:E Ratio 1:0.1  2% ---
100.0:1
 (1min + 1% of
-1
-1
19 Respiratory rate 0 to 200 0,1 min
measured value)
20 Airway Resistance – RAW 0 to 200 1 1 hPa/L/s
 (1 mL.hPa or
-1
-1
21 Dynamic Compliance 0 to 200 0,1 10% of measured mL.hPa
value)
 (1 mL.hPa or
-1
-1
22 Static Compliance 0 to 200 0.1 10% of measured mL.hPa
value)
FiO2 (Inspired Fraction of ±(1% em vol + 2%
23 0 to 100 0.1 %O2
Oxygen) of reading)
-1
± (0.2L.min or 5% -1
24 Flow(Flowmeter) 0 to 20 0.1 L.min
of reading)
25 Pipeline pressure (Ppipeline) 0 to 1500 1  3,75 psi
±(1 L/min or 10% of
26 Consumo do Oxigênio (Cos. O2) 0-180 0,1 L/min
reading)
27 SpO2 1 a 100 1 ±2% %
28 Cardiac Frequency (FC) 25 a 240 1  2% bpm
±(0,2% in volume
0 a 15:1
(8) + 2% of reading)
29 CO2 0 to 25 %vol
15 a 25: Not
Not Especificated
Especificated
(5) ±(1hPa + 2% of hPa
30 Barometric Pressure 700 to 1200 1
reading) (mbar)
(1)
When it indicates two tolerances consider the greatest one.
(2)
1 mbar (milibar) = 1 hPa (hectoPascal) = 1,016 cmH 2O (centimeters of water). In practical this units
cannot be differentiated and can be used as:
1 mbar = 1 hPa ≈ 1 cmH2O
(3)
For airway resistances above 150 cmH2O/L/s the tolerance of the expired monitored volume should be
changed to  10%. In this case the inspired volume will not change.
(4)
This tolerance was calculated to a respiratory rate of 12, 20 and 60 rpm respectively to adult, infant and
neonate sensors.
(5)
700 hPa corresponds to an altitude of 3048m
(6)
All monitored date are considered at ATPD (Ambient, Temperature and Pressure Dry).
(7)
The ventilator does not generate negative pressure in the expiratory phase.
(8)
CO2(mmHg)=CO2( %) x Patm(mmHg)x 0,75
14.3.7 Safety and Alarm Systems
 Anti-asphyxiation valve to protect against oxygen gas supply failure;

 Safety Relief Valve 100 hPa – Basic Ventilator Standard to avoid overpressure in the respiratory
circuit;
 ACTIVE overpressure valve – when an obstruction is detected it is activated to reduce the pressure in
the patient‘s respiratory circuit.
106
Item Alarm Adjust Unit

1 High Pressure Alarm OFF, 0 to 80 hPa
2 Low Pressure Alarm OFF, 0 to 80 hPa
3 High PEEP Alarm OFF; 0 to 40 hPa
4 Low PEEP Alarm OFF; 0 to 39 hPa
5 High Minute Volume Alarm OFF, 0 to 99 L
6 Low Minute Volume Alarm OFF, 0 to 99 L
7 Apnea Alarm Time 5 a 60 s
-1
8 High Respiratory Rate Alarm OFF; 0 a 150 min
9 Low Respiratory Rate Alarm OFF; 0 a 150 min-1
10 High etCO2 Alarm OFF; 0 a 80 mmHg
11 Low etCO2 Alarm OFF; 0 a 80 mmHg
12 Inspiratory CO2 Alarm OFF; 0 a 80 mmHg
Alarms related to the device and ventilation
 Low Battery Alarm;

 Low O2 Inlet Pressure
 Respiratory Circuit Obstruction
 Apnea
 AC Input Fail
Alarms related to the external sensors
 Capnographu Sensor
o Attention IRMA Adaptor
o Reset IRMA
o Change IRMA
o CO2 Out of Range
o IRMA Reading Error
o Calibrate IRMA
 SpO2 Sensor
o SpO2 Sensor (Sensor out of finger)
o Check SpO2
o Low PI
o Search pulse
o Activating SpO2
o Demo SpO2
107
14.3.8 Oxygen concentration x respiratory circuit pressure
Figure 28 – Oxygen concentration curve as function of respiratory circuit pressure
14.3.9 Performance Specifications
Item Parameter Specificaton Tolerance Unit

1 Valves Response Time T0..90 5  20% ms
-1
Maximum flow in pressure support L.min
2 180  10%
and spontaneous breathing
Time Cycled, Constant Volume and ---
3 Control Principle ---
Pressure Controlled
hours
(POH –
4 MTBF (Mean Time Between Failure) 5.000 ---
Power On
Hours)
14.3.10 Calibration and Maintenance Specification:
Item Description Specification Tolerance Unit

1 Revision and REPLACEMENT OF 5.000 or 1 year  500 Hours
DIAPHRAGM (3800248) (POH)
2 Revision and REPLACEMENT OF 10.000 or 2 years  500 Hours
O2 CELL(3902020) (POH)
3 Revision and REPLACEMENT OF 10.000 or 2 years  500 Hours
BATTERY (2702236) (POH)
108
Item Description Specification Tolerance Unit

4 Expiratory Valve (3200251) Cycles
of autoclave:
Fast: 4 minutes @ 136°C 220kPa 50 @ Fast
Normal: 20 minutes @ 120°C
96kPa e --- Cycles
Note: The processing time is after 100 @ Normal

specified temperature and pressure
stabilization
5 Revision of OxyMag 1  1 month Year
6 Calibration of OxyMag 2  1 month Year
REPLACEMENT OF AMBIENT 500
Hours
7 FILTER (1702656) (depends on how dirt is the ambient air  20
(POH)
where this equipment is used)
Notes
 Magnamed keeps available to the users (upon agreement) electrical schematics, part lists,
calibration instructions and other documents.
14.3.11 Expiratory Limb Resistence Specification:
Expiratory Resistence (hPa or cmH2O)

Respiratory Circuit + Flow
Flow Circuit + Flow
Circuit -1 Circuit + Flow Sensor + CO2
L.min Circuit Sensor + HME
(P/N) Sensor Sensor + HME
Filter
Filter
Neonate
(1702655)
5.0 0.6 1.7
Infant
(1702654)
30.0 0.4 3.4 4.1 4.3
Adult
(1702653)
60.0 0.8 1.4 3.1 3.5
Adult
(3902629)
60.0 3.8 4.4 6.1 6.5
Table - Expiratory resistence as function of the respiratory circuit type and accessories connected
109
14.4 Pneumatic Schematics
AR
AMBIENTE
VALV. FILTRO
PROP.
VALV. 30L/MIN
REGULADORA ANTI-ASFIXIA
ENTRADA
O2 VENTURI
60 a 150
45 PSI
PSI
1
10
VALV.
PROP.
200L/MIN
100% O2
PVA 9
2
%O2 8
VALV.
ON - OFF (*)
TGI /
NEBULIZADOR
SENSOR DE
FLUXO
VALV.
ON - OFF (*) SENSOR DE
FLUXO
7
PACIENTE
EXPIRAÇÃO
4
6
SOBREPRESSÃO
ALIVIO ALIVIO
3 PSI 3 PSI
(*) - Esquema apresenta as válvulas nas posições default (aparelho ligado sem condição de falha)
CONTROLE DO HARDWARE
1 CONTROLE DA VÁLVULA PROPORCIONAL 30LPM
2 CONTROLE DA VÁLVULA PROPORCIONAL
3 SOLENOIDE P/ CONTROLE DO TGI OU NEBULIZADOR
4 SOLENOIDE P/ CONTROLE SOBREPRESSÃO E FLUXO DE LAVAGEM
5 SENSOR DE FLUXO PROXIMAL
6 CONTROLE DA EXPIRAÇÃO / PEEP
7 SENSOR DE FLUXO INTERNO
8 CONCENTRAÇÃO O2
9 PRESSÃO DE VIAS AÉREAS
10 PRESSÃO DE REDE DE O2
Figure 29 – Pneumatic Schematics
110
14.5 Electronic Control Block Diagram
Figure 30 – Electronic Block Diagram
14.6 Eletromagnetic Compatibility
Changes or modifications done in this device without MAGNAMED’s permission can cause EMC
problems to this or to other devices. Contact MAGNAMED’s service assistance to get technical advice.
This equipment was designed and tested to comply with applicable EMC standards as described below.
Warning
 The use of cellular phones or other equipments emitting radio-frequency (RF) near the
equipment can cause unexpected or adverse results. Monitor the equipment working if
radio-frequency emitting devices are nearby.
 The use of other electrical equipments in the system or nearby can cause interference. Before
its use in the patient check if the equipment works properly in the defined configuration.
111
Directive and Manufacturer’s Statement – Electromagnetic Emissions
The system is adequate to be used in specified electromagnetic environment. The customer or operator should
verify that the equipment is used in environment described below.
Emission Tests Compatibility Electromagnetic Environment Directive
CISPR 11 – RF Emission Group 1 The system uses RF energy only for internal functioning. The
RF emissions are very low and are not likely to cause
interferences in nearby equipments.
CISPR 11 – RF Emission Class B The system is adequate to use in all places, including
domestic and installations directly connected to low voltage
electrical power supply of residential edifications.
Harmonic Radiation Class A
IEC 61000-3-2 Class A
Voltage fluctuation/ Compatible
Fluctuating emissions
IEC 61000-3-3
Directive and Manufacturer’s Statement – Electromagnetic Immunity
The system is adequate to be used in specified electromagnetic environment. The customer or operator should
verify that the equipment is used in environment described below.
IEC-60601-1-2 Test
Immunity Test Compatibility Electromagnetic Environment Directive
Level
IEC 61000-4-2 – ± 6 kV contact ± 6 kV contact The pavement should be of wood, ceramics or

Eletrostatic Discharge ± 8 kV air ± 8 kV air concrete. If the pavement revetment is made
(ESD) in synthetic material, the minimum relative
humidity should be 30%RH
IEC 61000-4-4 – ± 2 kV for power line ± 2 kV for power line The quality of the power electrical line should
Fast transient/ Electrical be hospital or commercial grade.
Impulse ±1 kV for input/output ±1 kV for input/output
line line
IEC 61000-4-5 - ± 1 kV differential mode ± 1 kV differential mode The quality of the power electrical line should
Overvoltage be hospital or commercial grade.
±2 kV common mode ±2 kV common mode
Voltage ―Burst‖, short < 5% UT (hole > 95% in UT) < 5% UT (hole > 95% in UT) The quality of the power electrical line should
interruptions and voltage during 0.5 cycle during 0.5 cycle be hospital or commercial grade.
variations in input power
40% UT (60% hole in UT) 40% UT (60% hole in UT)
line IEC 61000-4-11 during 5 cycles during 5 cycles
70% UT (30% hole in UT) 70% UT (30% hole in UT)

during 25 cycles during 25 cycles
< 5% UT (hole > 95% in UT) < 5% UT (hole > 95% in UT)
during 5 sec. during 5 sec.
Electrical power 3 A/m 3 A/m

frequency magnetic field
(50/60 Hz) IEC
61000-4-8 3
Note: UT is the alternating current line voltage before the test application.
112
Radiated Immunity
IEC-60601-1-2 Electromagnetic Environment Directive

Immunity Test Compatibility
Test Level Recommended Separation Distance
Any portable equipment and radio-frequency

cellular communication device should not be
used nearby any part of the system, including
cables, except at recommended separation
distance, calculated from the equations
appropriate to the transmitter frequency.
Conducted RF 3 Vrms 1 Vrms (V1) D=3.5√P

IEC 61000-4-6 150 kHz a 80 MHz at
ISM band
10 Vrms 1 Vrms (V2) D=12√P

150 kHz a 80 MHz at
ISM band
Radiated RF 10 V/m 10 V/m (E1) D=1.2√P 80 MHz to 800 MHz

IEC 61000-4-6
80 MHz to 2.5 GHz D=3.5√P 800 MHz to 2.5 GHz

According to the transmitter manufacturer, P
is the maximum nominal value of the supply in
watts (W) and D is the recommended
separation distance in meters (m).
According to the local electromagnetic
examination the permanent RF transmitter
field intensity should be lower than the
conformity levels in different frequency bands.
ISM bands (Industrial, Scientific and Medical) between 150 kHz and 80 MHz are in the range of 6.765 MHz to 6.795 MHz; 13.553 MHz to
13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
The goal of the conformities levels in ISM frequency bands between 150 kHz and 80 MHz and in the frequency band between 80 MHz and
2.5 GHz is to reduce the probability of interference caused by portable communication devices localized non-intentionally near the patients.
That is the reason to use the 10/3 additional factor to calculate the recommended separation distance of the transmitters in these frequency
bands.
It is not possible to precisely preview the permanent transmitter fields intensity such as base stations for radio telephone (wireless cellular
phones) and terrestrial mobile services, radio-amateur, AM and FM radio-diffusion and TV emission. It is advisable to carry out a local
electromagnetic examination to evaluate the electromagnetic environment due to radiofrequency transmitters. Check the normal operation
of the system if the measured field intensity in place exceeds the RF conformity level applicable described above. If an abnormal operation
occurs, it will be necessary additional measures, such as reorientation or system placement change. The field intensity in frequency bands
above the range of 150 kHz to 80 MHz should be lower than 1 V/m.
Note: This directive is not applicable to all situations. The structures, objects and persons absorption or reflection can affect the
electromagnetic propagation.
Recommended Separation Distances

The system can be used in an electromagnetic environment in which the radiated RF interferences are
controlled. The customer or the system operator can help in preventing electromagnetic interference, keeping
minimum distance between the portable equipment and cellular communication by RF (transmitters) and the
system, according to the following recommendations and accordingly to the maximum power output from
communication device.
113
Separation Distance in meters (m) according to the transmitter frequency
Transmitter‘s 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 GHz 800 MHz to 2.5
maximum output Out of ISM band In the ISM band GHz
nominal power
watt (W)
 3.5   12   12   23 
D  P D  P D  P D  P
 V1  V 2   E1  E1
0.01 0.35 1.2 0.12 0.23
0.1 1.1 3.8 0.38 0.73
1 3.5 23 1.2 2.3
10 11 38 3.8 7.3
100 35 120 12 23
The recommended separation distance D in meters (m) from the transmitters that does not have the maximum nominal output power
shown above can be determined by the applicable equation to the transmitter‘s frequency where P is the transmitter‘s nominal
maximum output supply value in watts (W), according to the transmitter‘s manufacturer.
Note 1: From 80 MHz to 800 MHz, higher frequency band separation distance is applicable.
Note 2: The ISM bands (Industrial, Scientific and Medical) in the range of 150 kHz to 80 MHz are of 6.765 MHz to 6.795 MHz; from
13.553 MHz to 13.567 MHz; from 26.957 MHz to 27.283 MHz; and from 40.66 MHz to 40.70 MHz.
Note 3: The additional 10/e factor is used to calculate the recommended transmitter separation distance in the frequency ISM bands
between 150 kHz and 80 MHz and in the frequency band of 80 MHz to 2.5 GHz to reduce the probability of interference caused by
portable communication devices localized non-intentionally near the patients.
Nota 4: This directive is not applicable to all situations. The structures, objects and persons absorption or reflection can affect the
electromagnetic propagation.
Electrical Safety
The system has connections to the display module through a serial communication cable. Below are presented
the precautions that should be observed when these devices (non-medical equipment) with the system.
Warning
 The items that does not comply with the IEC 60601-1 standards cannot be placed less than
1.5 m from the patient.
 All the items (medical or non-medical equipment) connected to the system with
input/output signal should be powered by an alternating current supply that uses separate
transformer (according to the IEC-60989 standard) or having an additional earth ground
conductor.
 Portable multiple plugs with interrupter used in alternating current supply should comply
with the IEC 60601-1-1 standard and cannot be installed on the ground. Do not use more
than one portable multiple plug with interrupter.
 Do not connect any non-medical device to the wall alternating current supply. Use an AC
power supply with appropriate transformer. Otherwise, the leakage current enhances
above the limits accepted by IEC 60601-1 standards under normal conditions of one single
failure. This can cause dangerous electrical shock to the operator or to the patient.
114
 After connecting any device in these power plugs, submit the hole system to a complete
leakage current test (according to the IEC 60601-1 standard).
 The electro-medical system operator should not touch any non-medical electrical device
and the patient simultaneously. This can cause dangerous electrical shock to the operator
or to the patient.
115
15 IRMA CO2 Sensor (Phasein) - OPTIONAL

PHASEIN IRMA ™ mainstream probe is intended for gas monitoring of adults, pediatric and infant patients in
anesthesia, intensive care and emergency care.
The IRMA probe comprises a state-of-the-art, single path, nine-channel non-dispersive infrared (NDIR) gas
bench, an ultra rapid galvanic oxygen sensor, a barometric pressure sensor, a power regulator, a CPU and a
RS-232 digital interface. The unit weighs less than 25 g.
The probe is available in various configurations for different clinical applications. Concentrations of carbon
dioxide with derived parameters such as respiration rate, waveform data and inspired/expired concentrations
of CO2.
TM
The IRMA probe snaps in place on the IRMA airway adapter that includes PHASEIN's XTp windows. The
airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements
are obtained through the XTP windows in the sides of the adapter.
Running on a standard low voltage DC, the IRMA probe is designed with portability in mind and has low power
consumption, typically less than one watt. It has been specially designed to be extremely easy to integrate in
any host device for display of real time and derived breathing gas data.
15.1.1 Instructions of Use

The CO2 ―mainstream‖ sensor IRMA was designed to be used connected to the OxyMag ventilator and to any
Magnamed‘s compatible devices. It has a function of monitoring CO2 concentration in real time.
The sensor shoud be connected to the patient respiratory circuit in order to monitor the inspired and expired
gases during anesthesia, respiratory treatment in ICU or other respiratory recovery center. It can be used in
Operating Rooms, ICU (Intensive Care Units), Emergency Rooms, Rescue and Transport Operations. It is
indicated to pediatric and adult patients.
It should not be used as a single mean to monitor the patient. It should be used jointly with other vital signals
monitoring devices and this monitorization should be interpreted by a specialist habilitated to analyze the
patient condition. The IRMA sensor was designed to be used by trained and authorized healthcare
professional.
15.1.2 Sensor Assembly

The following procedure shows how to assemble the gas monitoring sensor:
a) Connect the IRMA sensor cable to the OxyMag Ventilator‘s right panel and turn on its power;
b) Set the airway adapter to the IRMA sensor. It will click when the airway adaptor is correctly settled to
the sensor;
116
Figure 31 – Airway adapter installation

c) The GREEN LED indicates that the IRMA sensor is ready for use.
Figure 32 – GREEN LED indicats that the sensor is ready for use
d) Connect the IRMA adapter to the ―Y‖ piece of the respiratory circuit;
Figure 33 – Connecting the adaptor to the “Y” piece of the respiratory circuit
e) Connect the IRMA adaptor to the Endotracheal Tube (ET) of the patient;
117
Figure 34 – Connecting the airway adapter to the ET tube of the patient
f) In case of necessity to use a HME (Heat and Moisture Exchanger) filter set it between the IRMA
sensor and the ET tube. Setting it in this position it will protect the airway adapter from secretions and
water vapor effects, and it eliminates the necessity of adapter changes during its use.
Figure 35 – HME assembly schematics
15.1.3 Sensor Positioning

During the IRMA sensor connection to the respiratory circuit of an pediatric patient it is extremely important to
avoid the direct contact of the IRMA sensor to the patient‘s body.
If it is not possible for any reason, the direct contact should be avoided by the use of a insulating material
between the sensor and the body.
Warning
 The IRMA sensor MUST NOT HAVE direct contact with PEDIATRIC PATIENT during its use.
118
15.1.4 Sensor Zeroing Procedure
Warning
 The incorrect sensor zeroing results in incorrect measurement readings.
To assure high precision of the measured values by the IRMA sensors, the procedure of zeroing should be
followed.
The sensor zeroing should be done by setting an airway adapter to the IRMA sensor without connecting it to
the respiratory circuit. Press the start button when the gas monitoring values were stable.
Special care should be takent to avoid some respiration near the sensor before and during the zeroing
procedure. The presence of ambient air (21% of O2 and 14% of CO2) in the airway adapter is extremely
important to a successful zeroing. If an error message of ―Recalibration Required‖ shows up at the end of the
zeroing procedure, it should be restarted.
The zeroing procedure should be done after airway adapter replacement, as well as when thre is a base line
displacement (offset) in some gas measurement or when an error message of ―Indetermined Precision‖ shows
up on screen.
After turning on the sensor or changing the airway adapter, wait at least one minute before starting the zeroing
procedure in order that the IRMA sensor heats up. The GREEN LED of the sensor will blink for 5 seconds while
the zeroing is in progress.
15.1.5 LED Information
Color (State) Meaning

Steady green light System OK
Blinking green Zeroing in progress
Steady blue light Anesthetic Agent Present
Steady red light Sensor Error
Blinking red light Check Adpter
Table 1: LED Colors state and its meanings
15.1.6 Sensor Cleaning Procedure

The IRMA probe can be cleaned using a cloth moistened with ethanol or isopropyl alcohol.
15.1.7 Preventive Maintenance
The calibration gas shall be checked at regular intervals by the reference instrument.
Caution
 The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile devices. Do not
autoclave the devices as this will damage them;
 Never sterilize or immerse the IRMA probe in liquid. The IRMA sensor should not be used
in the presence of flammable anesthetic agents;
 Airway Adpters should be disposed according to loca regulations.
119
Warning
 The IRMA probe is intended for use by authorized and trained medical personnel only.
 The IRMA probe must not be used with flammable anesthetic agents.
 Disposable IRMA airway adapters shall not be reused. Reuse of the single use adapter can
cause cross infection.
 Used airway adapters shall be disposed of in accordance with local regulations for medical
waste.
 Use only PHASEIN manufactured oxygen sensor cells. Depleted oxygen sensors shall be
disposed of in accordance with local regulations for batteries.
 Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6 ml
dead space to the patient circuit
 Do not use the IRMA Infant airway adapter with adults as th is may cause excessive flow
resistance.
 Measurements can be affected by mobile and RF communications equipment. It should be
assured that the IRMA probe is used in the electromagnetic environment specified in this
manual.
 Do not place the IRMA airway adapter between the endotracheal tube and an elbow as this
may allow patient secretions to block the adapter windows and result in incorrect
operation.
 To keep secretions and moisture from pooling on the windows or oxygen sensor port,
always position the IRMA probe in a vertical position with the LED pointing upwards.
Figure 36 - Correct and incorrect positioning of the airway adapter
 Do not use the IRMA airway adapter with metered dose inhalers or nebulized medications
as this may affect the light transmission of the airway adapter windows.
 Do not try to open the oxygen sensor assembly. The oxygen sensor is a disposable
product and contains a caustic electrolyte and lead.
 The IRMA probe is intended only as an adjunct in patient assessment. It must be used in
conjunction with other assessments of clinica l signs and symptoms.
 Incorrect probe zeroing will result in false gas readings.
 Replace the adapter if rain or condensation occurs inside the airway adapter.
 Use only PHASEIN manufactured IRMA airway adapters.
 The IRMA probe is not intended to be in patient contact.
Caution
 Never sterilize or immerse the IRMA probe in liquid.
 The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile devices. Do not
autoclave the devices as this will damage them.
120
 Do not apply tension to the probe cable.

 Do not operate the IRMA probe outside the specified operating temperature environment.
 Do not leave depleted oxygen sensors mounted in the IRMA probe, even if the probe is not
in use.
 (U.S.): Federal law restricts this device to sale by or on the order of a (licensed healthcare
practitioner).
15.1.8 Technical Specifications
Intended use
The IRMA mainstream multi-gas probe is intended to be connected to other medical devices for display of real
time and derived monitoring data of CO2, N20 , O2, and the anesthetic agents Halothane, Enflurane,
Isoflurane, Sevoflurane and Desflurane.
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during
anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient
room and emergency medicine settings for adult and pediatric patients.
It is not intended to be used as the only means of monitoring a patient. It shall always be used in combination
with other vital signs monitoring devices and/or professional human judgments of patient condition. The IRMA
probe is intended to be used by trained and authorized health care professionals only.
It is only intended to be connected to medical devices approved by PHASE IN AB.
General:
Description Mainstream monitoring sensor with infrared technology
Dimensions (L x P x A) IRMA CO2: 38 x 37 x 34mm (1,49” x 1,45” x 1,34”)
Cable Length 2,50m (± 0,02m)
Weight < 25g (sem cabo);
< 38g (com cabo).

Operating Temperature IRMA CO2: 0 to 40°C / 32 to 104°F
Transport and Storage IRMA CO2: -40 to 75°C / -40 to 167°F
Temperature
Operating Humidity 10 to 95% RH, no condensation
(1)
Transport and Storage 5 to 100% RH, condensing.
Humidity
(1) After being in a condensing atmosphere, the unit shall be stored for more than 24 h in an
environment equivalent to the operating humidity.
Operating Atmospheric IRMA CO2: 525 to 1200hPa (525hPa corresponds to an altitude of 4572m or
Pressure 15000 feet).
Transport and Storage 500 to 1200hPa.
Atmospheric Pressure
Mechanical Strenght Mechanical strength withstands repeated 1 m (IRMA C02 1.8 m) drops on a hard surface.
Complies with requirements for road ambulances according to prEN1789:2004 (clause 6.4) and
requirements for shock and vibration according to EN ISO 21647:2004 (clause 21.102,
transport).
Electrical Power Supply IRMA CO2: 4,5 to 5,5 VDC, Max 1,0W (power measured at 5V and less than
350mA during 200ms).
Surface Temperature IRMA CO2:
(ambient temperature of
23°C) Max: 41°C / 106°F.
Airway Adapter Disposable adult/pediatric:
Adds less than 6 ml deadspace
121
Pressure drop less than 0.3 cm H20 @ 30 LPM
Disposable infant:
Adds less than 1 ml deadspace
Pressure drop less than 1.3 cm H20 @ 10 LPM
Data Output
Breath detection Adaptive threshold, minimum 1 vol% change in CO2 concentration
Respiration rate 0-150 bpm. The respiration rate is displayed after three breaths and the
average value is updated every breath
Fi and ET ET Fi and ET are displayed after one breath and have a continually updated
breath average. IRMA CO2: CO2.
Waveforms IRMA CO2: CO2.
Diagnostic Parameters Atmospheric Pressure, Software Revision and Serial Number.
Informations New breathing detection, apnea, check adapter, unspecified accuracy and
sensor Error.
Analisador de Gás CO2:

Sensor 2 to 9 channel NDIR type gas analyzer measuring 4 to 10µm. Temperature,
pressure and full spectral correction
Calibration Zeroing recommended when changing airway adapter. No span calibration
required for IR bench.
Warm-up time Informations about concentration is analyzed and sent within 10 seconds.
Full accuracy within 1 minute

Rise time at 10 l/min CO2 ≤ 90ms.
System total response time < 1s.
Exatidão / Acurácia das medições (sob condições padrões):

Gas typoe Range (AX+) Accuracy
CO2 0 to 15 ±(0.2 vol% + 2% of reading)
15 to 25 Unspecified
Note: Gas concentration reported in units of volume percent
Accuracy under al conditions:

Gas type Accuracy
CO2 ±(0.3 vol% + 4% of reading)
Note 1: The accuracy specification is valid for any environment condition, except in cases expressed in table
below with “Interfering Gas and Vapour Effects”
Interfering Gas and Vapour Effects

Vapour or Gas Gas Level CO2
(1 e 2)
N2O 60 vol% ---
(1)
HAL 4 vol% ---
(3)
ENF, ISO, SEV 5 vol% +8% of reading.
(3)
DES 15 vol% +12% of reading.
122
(3)
Xe (Xenon) 80 vol% -10% of reading.
(3)
He (Helium) 50 vol% -6% of reading.
Metered dose inhaler Not for use with metered dose inhaler propellants
propellants
(1)
C2H5OH (Ethanol) 0.3 vol% ---
(1)
C3H7OH 0.5 vol% ---
(Isopropanol)
(1)
CH3COCH3 1 vol% ---
(Acetone)
(1)
CH4 (Methane) 3 vol% ---
(1)
CO (Carbon 1 vol% ---
Monxide)
(1)
NO (Nitric Oxyde) 0.02 vol% ---
(5)
21 vol% 0% of reading 5.0 vol%
(5)
50 vol% -2,76% of reading 4.9 vol%
O2 (5)
(5)
Note 1: Negligible Interference, effect included in specification “Accuracy, all conditions” above.
Note 2: For probes not measuring N2O and/or O2, the concentrations are set by host.
Note 3: Interference at indicated gas level. For example, 50% of Helium typically decreases the CO 2 reading
by 6%. This mean if measuring on a mixture containing 5 vol% CO2 and 50 vol% Helium, the measured CO2
concentration will typically (1-0.06) * 5,0 vol% = 4,7 vol% CO2.
Note 4: According to the EN ISO 21647:2004 standard.
Note 5:Value showed toa true measure of 5.0% CO2.
15.1.9 Phasein Acessories

Magnamed:
Description Part Number (Magnamed)
IRMA CO2 MAIN STREAM SENSOR WITH 5 PIN CONNECTOR 2702597
Phasein:
Description Catalog Number (Phasein) Part Number (Magnamed)
IRMA Airway Adapter, Adult / 106220 3902414
Pediatric – Box: 25 units
123
16 Oximeter (Masimo) - OPTIONAL

The Masimo pulse oximeter encapsulated MS-2040 is a self-contained solution that allows a safe
measurement even in movement and low perfusion of: SpO2, pulse rate, perfusion index and PVI. This
®
oximeter is compatible with all Masimo LNCS sensors.
16.1.1 Principle of Operation

®
The masimo SET MS board pulse oximeter is based in three principles:
1. Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light
(spectrophotometry).
2. The volume of arterial blood in tissue and the light absorbed by blood changes during the pulse
(plenthysmography).
3. Arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is a major
component of noise during the pulse.
The Masimo SET MS board pulse oxirneter as well as traditional pulse oxirnetry determines SpO2 by passing
red and infrared light into a capillary bed and measuring changes in light absorption during the pulsatile cycle.
Red and infrared light-emitting diodes (LEDs) in oxirnetry sensors serve as the light sources, a photodiode
serves as the photodetector.
Traditional pulse oxirnetry assumes that all pulsations in the light absorbance signal are caused by oscillations
in the arterial blood volume. This assumes that the blood flow in the region of the sensor passes entirely
through the capillary bed rather than through any arterio-venous shunts. The traditional pulse oximeter
calculates the ratio of pulsatile absorbance (AC) to the mean absorbance (DC) at each of two wavelengths,
S660 nm and 905 nm:
S(660) = AC(660)/DC(660)
S(905) = AC(905)/DC(905)
The oximeter then calculates the ratio of these two arterial pulse-added absorbance signals:
R = S(660)/S(905)
This value of R is used to find the saturation SpO2 in a look-up table built into time oximeter‘s software. The
values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy
adult volunteers in induced hypoxia studies.
The Masimo SET MS board pulse oximeter assumes that arterio-venous shunting is highly variable and that
fluctuating absorbance by venous blood is the major component of noise during the pulse. MS board
decomposes S(660) and S(905) into an arterial signal plus a noise component and calculates the ratio of the
arterial signals without the noise:
S(660) = S1 + N1
S(905) = S2 + N2
R=S1/S2
Again, R is the ratio of two arterial pulse-added absorbance signals and its value is used to find the saturation
SpO2 in an empirically derived equation into the oxirneter‘s software. The values in the empirically derived
equation are based upon human blood studies against a laboratory co-oxirneter on healthy adult volunteers in
induced hypoxia studies.
The above equations are combined and a noise reference (N‘) is determined:
N‘ =S(660) - S(905) x R
124
If there is no noise N‗=0: then S(660)=S(905) x R which is the same relationship for the traditional pulse
oxirneter.
The equation for the noise reference is based on the value of R, the value being seeked to determine the SpO2.
The MS board software sweeps through possible a value of R that correspond to SpO2 values between 1%
and 100% and generates an N‘ value for each of these R-values. The $(660) and $(905) signals are processed
with each possible N‘ noise reference through an adaptive correlation canceler (ACC) which yields an output
power for each possible value of R (i.e., each possible SpO2 from 1% to l00%).
TM
The result is a Discrete Saturation Transform (DST ) plot of relative output power versus possible SpO2 value
as shown in the following figure where R corresponds to SpO2 = 97%:
Figura 37 – Discrte Saturation Transform (DST) curve
The DST plot has two peaks: the peak corresponding to the higher saturation is selected as the SpO 2 value.
This entire sequence isrepeated once every two seconds on the rnost recent four seconds of raw data. The MS
board SpO2 therefore corresponds to a running average of arterial hemoglobin saturation that is updated every
two seconds.
Warning
 Explosion hazard. Do not use the MS board pulse oximeter in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygenenriched
environments, or nitrous oxide.
 A pulse oxirneter should NOT be used as an apnea monitor.
 Pulse rate measurement is based on the optical detection of a peripheral flow pulse and
therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a
replacement or substitute for ECG based arrhythmia analysis.
125
 A pulse oximeter should be considered an early warning device. As a trend towards patient
deoxygenation is indicated, blood samples should be analyzed by a laboratory
co-oximeter to completely understand the patient’s condition.
 The MS board pulse oximeter is to be operated by qualified personnel only. This manual,
accessory directions for use, all precautionary information, and specifications should be
read before use.
 Electric shock hazard. Do not remove the monitor cover except to replace the battery. An
operator may only perform maintenance procedures specifically described in this manual.
Refer servicing to Magnamed in repair of this oximeter.
 As with all medical equipment, carefully route patient cabling to reduce the possibility of
patient entanglement or strangulation.
 Interfering Substances: Carboxyhemoglobin may erroneously increase readings. The level
of increase is approximately equal to the amount of carboxyhernoglobin present. Dyes, or
any substance containing dyes, that change usual arterial pigmentation may cause
erroneous readings.
 Do not use the MS board pulse oximeter or Masimo oxirnetry sensors during magnetic
resonance imaging (MRI) scanning. Induced current could potentially cause burns. The MS
board pulse oximeter may affect the MRI image, and the MRI unit may affect the accuracy
ofthe oximetry measurements.
 If the accuracy of any measurement does not seem reasonable, first check the patient’s
vital signs by alternate means and the check the MS board pulse oximeter for proper
functioning.
 The MS board can be used during defibrillation, but the readings may be inaccurate for a
short time.

® ®
Before use, carefully read the LNOP /LNCS sensor directions for use.
 Use only Masimo oximetry sensors for SpO 2 measurements. Other oxygen transducers
(sensors) may cause improper MS board performance.
 Tissue damage can be caused by incorrect application or use of an LNOP®/LNCS® sensor,
for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the
sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of
the sensor.

® ® ® ®
Do not use damaged LNOP /LNCS sensors. Do not use an LNOP /LNCS sensor with
exposed optical components.Do not immerse the sensor in water, solvents, or cleaning
solutions (the sensors and connectors are not waterprooi). Do not sterilize by irradiation,
steam, or ethylene oxide. See the cleaning instructions in the directions for use for
reusable Masimo LNOP® I LNCS® sensors.
 Do not use damaged patient cables. Do not immerse the patient cables in water, solvents,
or cleaning solutions (the patient cable connectors are not waterproof). Do not sterilize by
irradiation, steam, or ethylene oxide. Seethe cleaning instructions in the directions for use
for reusable Masimo patient cables.
Caution
 Cleaning
o Do not antoclave, pressure sterilize, or gas sterilize this oximeter.
o Do not soak or immerse the monitor in any liquid.
o Use the cleaning solution sparingly. Excessive solution can flow into the monitor
and cause damage to internal components.
126
o Do not use petroleum-based or acetone solutions, or other harsh solvents, to

clean the oximeter. These substances attack the device’s materials and device
failure can result.
 Inaccurate measurements may be caused by:
o Incorrect sensor application or use
o Signitlcant levels of dysfunctional hemoglobins. (e. g., carboxyhemoglobin or
methemoglobin)
o Intravascular dyes such as indocyanine green or methylene blue.
o Exposure to excessive illumination, such as surgical lamps (especially ones with a
xenon light source),bilirubin lamps, fluorescent lights, infrared heating lamps, or
direct sunlight (exposure to excessiveillumination can be corrected by covering
the sensor with a dmk or opaque material)
o Excessive patient movement.
o Venous pulsations.
o Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter,
or intravascular line.
 Loss of pulse signal can occur in any ofthe following situation::
o The sensor is too tight.
o There is excessive illumination from light sources such as a surgical lamp, a
bilirubin lamp, or sunlight.
o A blood pressure cuff is inflated on the same extremity as the one with a SpO2
sensor attached.
o The patient has hypotension, severe vasoconstriction, severe anemia, or
hypothermia.
o There is arterial occlusion proximal to the sensor.
o The patient is in cardiac arrest or is in shock.
127
17 Symbols
SIMBOLOS /
TEXTOS UNIFICADOS PORTUGUÊS ESPANHOL INGLÊS
CLASS I IPX1 CLASSE I IPX 1 CLASE I IPX 1 CLASS I IPX1

INTERNALLY POWERED ENERG. INTERNAMENTE ENERG. INTERNAMENTE INTERNALLY POWERED
CONTINUOUS OPERATION OPERAÇÃO CONTINUA OPERACIÓN CONTÍNUA CONTINUOUS OPERATION
PACIENTE PACIENTE PATIENT
--- CORRENTE
CONTÍNUA
CORRIENTE
CONTINUA
CONTINUOUS
TIDAL
CORRENTE CORRIENTE ALTERNATING

ALTERNADA (REDE) ALTERNA (RED) CURRENT (POWER)
ENERGIA ELÉTRICA ENERGÍA ELÉCTRICA ELETRIC ENERGY
RECOLHIMENTO DE WASTE - ELECTRICAL AND

RECOGIMIENTO DE EQUIPO ELECTRIC EQUIPMENT SHALL BE
EQUIPAMENTO ELÉTRICO /
ELÉCTRICO ELECTRÓNICO COLLECTED AND RECYCLED IN
ELETRÔNICO FEITO DE FORMA
HECHO POR SEPARADO ACCORDANCE WITH DIRECTIVE
SEPARADA 2002/96/EC
ENTRADA DC ENTRADA DC DC INPUT
LIGA ON ON
DESLIGA OFF OFF
INSP / EXP PAUSA INSPIRATÓRIA/ PAUSA INSPIRATORIA/ INSPIRATORY/

HOLD EXPIRATÓRIA ESPIRATORIA EXPIRATORY PAUSE
128
SIMBOLOS /
MANUAL DISPARO MANUAL GATILLO MANUAL MANUAL TRIGGER
O2 100% 100% OXIGÊNIO 100% OXIGENO OXYGEN 100%
INSP INSPIRATÓRIA INSPIRATORIA INSPIRATORY
EXP EXPIRATÓRIA ESPIRATORIO EXPIRATORY
SERIAL SERIAL SERIAL
IDENTIFICAR OU IDENTIFICAR O ASESORAR TO IDENTIFY OR

ACONSELHAR LIMPEZA LA LIMPIEZA O EL CAMBIO ADVISE CLEANING OR
OU TROCA DE FILTRO DEL FILTRO CHANGINGA FILTER
NEB NEBULIZADOR NEBULIZADOR TGI

TGI TGI TGI NEBULIZER
TRAVAR TECLADO TRABAR TECLADO KEYBOARD LOCK
PAGINA PÁGINA PAGE
ALARME AUDIO ALARMA AUDIO AUDIO ALARM

PAUSADO PAUSADO PAUSED
ALARME ALARMA ALARM
PROTEGIDO CONTRA PROTEGIDO CONTRA

RESPINGOS DE SALPICADURAS PROTECTED AGAINST
IPX4 ÁGUA DE AGUA
WATER SPRAYS
ATENÇIÓN! CONSULTAR ATTENTION! SEE

ATENÇÃO! CONSULTAR
DOCUMENTOS QUE ACCOMPANYING DOCUMENTS
DOCUMENTOS ACOMPANHANTES
ACOMPANAN
129
SIMBOLOS /
PARTE APLICADA PARTE APLICADA TYPE BF

TIPO BF TIPO BF APPLIED PART
EQUIPAMENTO EQUIPO CLASS II

CLASSE II CLASE II EQUIPAMENT
DATA DE FECHA DE MANUFACTURE

FABRICAÇÃO FABRICACIÓN DATE
FABRICANTE FABRICANTE MANUFACTURE
Et CO2 Co 2 CORRENTE Co 2 CORRIENTE END TIDAL CO2
O 2 INLET ENTRADA DE O 2 ENTRADA DE O 2 O 2 INLET
O2 OXIGÊNIO OXIGENO OXYGEN
FRÁGIL FRÁGIL FRAGILE
FACE SUPERIOR LADO SUPERIOR THIS SIDE

NESTA DIREÇÃO EN ESTA DIRECCIÓN UP
PROTEGER CONTRA PROTEGER CONTRA FEARS

UMIDADE LA HUMIDAD HUMIDITY
SO STENIMIENTO S
n Q UANTIDADE SEGURA SAFE STACKING
DE LA CANTIDAD DE
DE EMPILHAMENTO Q UANTITY
AMO NTANAR
LIMITES DE LIMITES DE TEMPERATURE

TEMPERATURA TEMPERATURA LIMITS
MANTENHA MANTENER KEEP AWAY

PROTEGIDO DO SOL PROTEGIDO DEL SOL FROM HEAT
MANUTENÇÃO MANTENIMIENTO PERIODIC
PERIÓDICA PERIÓDICO MAINTENANCE
130
18 Terms and Abbreviations

Terms and Terms and
Description Description
Abbreviations Abbreviations
ADU Adult I:E I:E Ratio (TINS / TEXP)
Backup Apnea Ventilation Mode IBW Ideal Body Weight
C.Dyn Dynamic Compliance INF INFANT (Pediatric)
High inspired CO2 alarm

CO2i  Man Trig Manual Trigger
adjustment
Compliance Respiratory Circuit Compliance MV Minute Volume
O2 Cons. O2 Consumption NEO Neonate
C.Stat Static Compliance NIV Non Invasive Ventilation
Continuous Positive Airway

CPAP O2 100% O2 Flush 100%
Pressure
PS Cycle Flow Cycling % Pause Inspiratory Pause
DualPAP Two CPAP Levels Ventilation PCV Pressure Controlled Ventilation
EtCO2 End Tidal CO2 PEEP Positive End Expiratory Pressure
FiO2 Inspired Fraction of O2 PEEPi Intrinsic PEEP
P. Low Low Pressure in DualPAP ventilation

Freq Total Respiratory Frequency
mode
F.Base Base Flow P. Insp Inspiratory Pressure
Fspn Spontaneous Frequency PLV Pressure LImitd Ventilation
Fl Trig
Flow Trigger Sensitivity P.Max Airway Maximum Pressure
F.Trigger
131
Terms and Terms and

Description Description
Abbreviations Abbreviations
Low Time in DualPAP ventilation

P Mean Mean Pressure T. Low
mode
High Time in DualPAP ventilation

P.Plat Plateau Pressure T. High
mode
PInlet Inlet O2 Pressure Exp. Valve Expiratory Valve
Pr Trig
Pressure Trigger Sensitivity Leakeage Respiratory Circuit Leakeage
P.Trigger
Next Next Adjustment Page VCV Volume Controlled Ventilation
Synchronized Intermittent
P-SIMV Mandatory Ventilation – PCV MVspn Spontaneous Minute Volume
cycle
CPAP + Pressure Support Synchronized Intermittent Mandatory

PSV V-SIMV
Ventilation Ventilation – VCV cycle
High pressure in DualPAP

P. High Vspn Spontaneous Volume
ventilation mode
Raw Airway Resistance Vt Adjusted Tidal Volume
Resistance Respiratory Circuit Resistance Vti Inspired Volume
Rise Time Rise Time Vte Expired Volume
Pressure Value to be added to PEEP

SpO2 Blood Oxygen Saturation % ∆PS
to set the Pressure Support
.
T.Exp Expiratory Time V Flow
T.Insp Inspiratory Time
132
19 Biocompatibility Declaration
We, under our own responsability declare that all the materials used in applied parts
(according to IEC 60601-1 definition) of the OxyMag Transport and Emergency Ventilator, is
widely used in medical area and therefore warranting their biocompatibility.
And according to ISO-10993-1 Biological evaluation of medical devices — Part 1:

Evaluation and testing – Clause 4.2.1 Non-contact devices. Medical devices that do not
contact the patient's body directly or indirectly are not included in the scope of this standard.
Warning
 All the common accessories aquired in the market SHOULD comply with LOCAL
REGULATIONS.
133
20 Warranty
The products manufactured and commercialized by MAGNAMED TECNOLOGIA MÉDICA

S/A are guaranteed against material and manufacture defect according to the paragraphs below.
The guarantee responsibility limits to the replacement, repair and labor, for parts that are defective or do not
complies with the specification contained in this instruction manual. And the warranty is limited to the products
used under normal conditions and which preventive maintenance and part substitutions and repairs are carried
out accordingly to the procedures contained in this instruction manual.
The warranty does not cover defects caused by inappropriate use or installation, accidents, inadequate
sterilization, service, installation, operation or modifications carried out by non-authorized or disqualified
personnel.
The lack of sealing label or its rupture by non-authorized or disqualified personnel voids this warranty.
The warranty is valid for a period of 365 days for the equipment, 90 days for batteries and 60 days for
accessories, if its original characteristics are maintained, and is counted from the MAGNAMED
TECNOLOGIA MÉDICA S/A Commercial Invoice issue date to the first owner of the equipment.
Parts subject to degradation or deterioration under normal use conditions, adverse use conditions, and
inappropriate use or fortuity accidents are not covered by this warranty.
This warranty does not cover eventual costs and risks with equipment transportation.
MAGNAMED TECNOLOGIA MÉDICA S/A cannot be considered by any means for any
damage including beside others, eventual, consequential or specials. There is no other explicit or implicit
guarantee other than the stated above.
134
Manufacturer
Rua São Paulino, 221 – Vila Mariana
CEP: 04019-040 – São Paulo - SP – Brasil
Tel: +55 (11) 5081-4115 Fax: +55 (11) 5084-5297
E-mail: magnamed@magnamed.com.br
Website: www.magnamed.com.br
European Authorized Representative

Obelis s.a.
Bd. Général Wahis 53
1030 Brussels, Belgium
Tel: +32.2.732.59.54
Fax: +32.2.732.60.03
E-mail: mail@obelis.net
Website: www.obelis.net
MAGNAMED Tecnologia Médica S/A

CNPJ: 01.298.443/0001-73
Inscrição Estadual: 149.579.528.111
Made in Brazil

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Instruction Manual

OXYMAG – EMERGENCY AND TRANSPORT

Part Number: 1600185 Rev: 06

Magnamed Tecnologia Médica S/A

CNPJ: 01.298.443/0001-73 Inscrição Estadual: 149.579.528.111

Elaborated by: Checked by: Approved by:

Neusa Wataru Tatsuo

11/01/2012 16/01/2013 18/01/2013

REV DESCRIPTION (dd/mm/yy)

2 Definitions and Informations

o Connect the AC/DC Power converter to a inlet according to your contry

infected hospital waste.

1 mbar (milibar) = 1 hPa (hectoPascal) = 1,016 cmH2O (centímeters of Water)

1 mbar = 1 hPa ≈ 1 cmH2O

2 DEFINITIONS AND INFORMATIONS ...................................................................................................... 4

4.1 INTENDED USE ...................................................................................................................................... 12

4.2 LABELING .............................................................................................................................................. 14

4.3 W ORKING PRINCIPLE ............................................................................................................................. 14

4.4 OTHER CHARACTERISTICS ..................................................................................................................... 15

5 UNPACKING THE PRODUCT................................................................................................................ 17

5.1 INITIAL CHECKLIST ................................................................................................................................. 17

5.2 COMPONENT LIST.................................................................................................................................. 17

6 COMPONENTS IDENTIFICATION ......................................................................................................... 19

6.1 COMPONENTS IDENTIFICATION ............................................................................................................... 19

6.2 DISPLAY AREA IDENTIFICATION .............................................................................................................. 26

6.2.1 Ventilation Modes ....................................................................................................................... 26

6.2.2 Alarms, Monitor and Status ........................................................................................................ 27

6.2.3 Monitor, Menus and Graphs ....................................................................................................... 27

6.2.4 Ventilation Parameters Setup..................................................................................................... 27

7 PREPARATION FOR USE ..................................................................................................................... 28

7.1 OXYMAG ASSEMBLY SETUP................................................................................................................... 28

7.2 ELECTRICAL POWER CONNECTION ......................................................................................................... 38

7.3 CHECK BEFORE USE.............................................................................................................................. 39

7.3.1 Initial Procedures ........................................................................................................................ 39

7.3.2 Turn on the device ...................................................................................................................... 40

7.3.3 Normal Initialization Sequece ..................................................................................................... 42

7.3.4 Test Sequece ............................................................................................................................. 50

7.3.5 Diagnóstico de Falha .................................................................................................................. 52

8 INSTRUCTIONS OF USE ....................................................................................................................... 54

8.1 VENTILATOR ADJUSTMENTS ................................................................................................................... 54

8.2 VENTILATION MODE AND PARAMETER ADJUSTMENT ................................................................................ 56

8.3 AVAILABLE ALARMS ............................................................................................................................... 73

8.4 PATIENT MANUAL VENTILATION .............................................................................................................. 77

8.5 ALARMS ADJUSTING SCREEN .................................................................................................................. 77

9 VERTICAL SUPPORT - INSTALATION ................................................................................................ 80

11 CLEANING AND DISINFECTION .......................................................................................................... 84

11.1 OXYMAG VENTILATOR....................................................................................................................... 84

11.2 CLEANING, DISINFECTION AND STERILIZATION PROCEDURES .............................................................. 85

12 ACCESSORIES AND PARTS ................................................................................................................ 87

13 PREVENTIVE MAINTENANCE .............................................................................................................. 95

13.1 INDICATES PREVENTIVE MAINTENANCE NEED ..................................................................................... 95

13.2 CHECKING ........................................................................................................................................ 95

13.3 INTERNAL LI-ION BATTERY................................................................................................................. 96

13.4 INTERNAL O2 CONCENTRATION MEASUREMENT CELL ......................................................................... 96

13.5 AMBIENT AIR FILTER SUBSTITUTION ................................................................................................... 96

13.6 SENDING THE VENTILATOR TO MAINTENANCE SERVICE ....................................................................... 98

14 TECHNICAL SPECIFICATIONS ............................................................................................................ 99

14.2 STANDARDS ...................................................................................................................................... 99

14.3 SPECIFICATIONS ............................................................................................................................... 99

14.3.1 Electrical Characteristics ...................................................................................................... 100

14.3.2 Connection to Oxygen Supply ............................................................................................. 100

14.3.3 Environmental and Physical Specifications ......................................................................... 101

14.3.4 Ventilation Modes................................................................................................................. 101