Magnamed OxyMag User manual

Operation Manual
OxyMag –Transport and Emergency Ventilator

ANVISA Registration nº 80659160004
All rights reserved by
Magnamed Tecnologia Médica S/A
Rua Santa Mônica 801/831 –Capuava
CEP: 0671-865 –Cotia –SP –Brazil
Phone/Fax: [phone]
E-mail: [e-mail]
Website: www.magnamed.com.br
CNPJ: 01.298.443/0002-54
State Registration: 149.579.528.111
Technical Responsible: Tatsuo Suzuki
Registration at CREA-SP: 0600629049
Legal Responsible: Tatsuo Suzuki
1600185-09: OxyMag –Version 3.n

3 Manual Oxymag_Rev22
Analytical Index
A.DEFINITIONS ..................................................... 5
B.WARNING ........................................................ 5
C.CAUTION.......................................................... 7
D.NOTES ............................................................. 7
1. DESCRIPTION .................................................. 8
1.1 INTENDED USE .................................................. 8
1.2 OPTIONAL ITEMS COMPATIBLE WITH THE PRODUCTS.. 9
2. UNPACKING THE PRODUCT ........................... 10
2.1 INITIAL CHECKS ............................................... 10
2.2 PARTS AND ACCESSORIES................................. 11
2.3 OPTIONAL ACCESSORIES THAT CAN BE PURCHASED
FOR OXYMAG.................................................................... 12
2.4 IDENTIFICATION OF COMPONENTS....................... 15
COMPONENTS OF TRANSPORT VENTILATOR....... 15
3. DESCRIPTION OF THE DISPLAY...................... 18
3.1 MODES .......................................................... 18
3.2 ALARMS,MONITOR AND STATUS ......................... 18
3.3MONITOR,MENUS AND CHARTS.......................... 18
3.4 SETTING THE VENTILATION PARAMETERS .............. 18
4. PREPARATION FOR USE ................................ 19
4.1 ASSEMBLING OXYMAG –TRANSPORT VENTILATION 19
4.2 NONINVASIVE VENTILATION MASK ........................ 21
4.3 POWER CONNECTION ....................................... 22
4.4 MOUNTING THE VERTICAL SUPPORT..................... 22
5. CHECKS BEFORE USE ................................... 24
5.1 INITIAL PROCEDURES ........................................ 24
5.2 VENTILATOR SETTINGS ..................................... 25
NORMAL STARTUP SEQUENCE ....................... 27
TEST SEQUENCE ......................................... 30
FAILURE DIAGNOSIS..................................... 31
6. CAPNOGRAPHY SENSOR (ETCO2).................. 32
6.1 INSTRUCTIONS FOR USE.................................... 32
6.2 ASSEMBLING THE SENSOR................................. 32
6.3 POSITIONING THE SENSOR................................. 35
6.4 PROCEDURE TO RESET THE SENSOR................... 35
6.5 INFORMATION REGARDING LED .......................... 36
6.6 PREVENTIVE MAINTENANCE OF ETCO2SENSOR .... 36
6.7 TECHNICAL SPECIFICATIONS OF THE CAPNOGRAPHY37
7. OXIMETER (MASIMO) ..................................... 41
7.1 OPERATION PRINCIPLE ..................................... 41
7.2 SENSOR ASSEMBLY ........................................... 44
8. DESCRIPTION OF MODES............................... 45
8.1 VCV –VOLUME CONTROLLED VENTILATION ..........45
8.2 PCV –PRESSURE CONTROLLED VENTILATION.........47
8.3 PLV –LIMITED PRESSURE VENTILATION.................49
8.4 V-SIMV –SYNCHRONIZED INTERMITTENT
MANDATORY VENTILATION –VOLUME CONTROLLED CYCLE .......51
8.5 P-SIMV –SYNCHRONIZED INTERMITTENT
MANDATORY VENTILATION –PRESSURE CONTROLLED CYCLE......53
8.6 CPAP/PSV –CONTINUOUS PRESSURE VENTILATION
WITH PRESSURE SUPPORT ....................................................55
8.7 DUALPAP –BI-LEVEL CONTINUOUS POSITIVE AIRWAY
PRESSURE VENTILATION ......................................................57
8.8 APRV –AIRWAY PRESSURE RELEASE VENTILATION
(MODE OBTAINED WITH INVERTED RATIO IN DUALPAP)............59
9. ALARMS AVAILABLE ......................................61
9.1 DESCRIPTION OF ALARM CONTROL .......................61
9.2 SETTING ALARMS..............................................67
9.3 MANUAL VENTILATION OF THE PATIENT .................68
9.4 ALARM TEST ....................................................68
HIGH PRESSURE ALARM:................................68
AC INPUT FAIL ALARM:...................................68
FIO2 ALARM:...............................................68
10. CLEANING AND STERILIZATION ......................70
10.1 EQUIPMENT CLEANING...................................70
EXTERNAL VENTILATOR SURFACES...................70
RESPIRATORY CIRCUIT,PROXIMAL FLOW SENSOR
AND EXHALATION VALVE.......................................................70
10.1.2.1 WASH....................................................70
10.1.2.2 RINSE ....................................................70
10.1.2.3 DRYING..................................................71
10.2 DISINFECTION ..............................................71
EXTERNAL PARTS.........................................71
RESPIRATORY CIRCUIT,EXHALATION VALVE,
PROXIMAL FLOW SENSOR AND SILICONE LINE............................71
10.3 STERILIZATION .............................................71
10.4 PROCESSING METHODS .................................72
11. PREVENTIVE MAINTENANCE..........................73
11.1 INDICATION OF THE NEED FOR PERIODIC
MAINTENANCE 73
11.2 DAILY CHECKS AND/OR PRIOR TO USE...............73
11.3 INTERNAL LITHIUM BATTERY ...........................73
11.4 INTERNAL SENSOR OF O2 CONCENTRATION ......74
11.5 REPLACING THE AMBIENT AIR FILTER ...............75
11.6 FORWARDING THE PRODUCT TO REPAIR SERVICE
76
12. DISPOSAL ......................................................77
13. TURNING OFF THE EQUIPMENT ......................78

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14. TECHNICAL SPECIFICATION........................... 79
14.1 CLASSIFICATION .......................................... 79
14.2 STANDARDS................................................ 79
14.3 SPECIFICATIONS .......................................... 80
ELECTRICAL CHARACTERISTICS ...................... 81
CONNECTING TO THE OXYGEN SUPPLY ............ 82
PHYSICAL AND ENVIRONMENTAL SPECIFICATIONS
82
EXTREME CONDITIONS .................................. 83
VENTILATION MODES.................................... 83
SETTING SPECIFICATIONS OF THE VENTILATION
PARAMETERS 84
SPECIFICATIONS OF THE MONITORING VENTILATION
PARAMETERS 87
SPECIFICATIONS OF THE SAFETY AND ALARM
SYSTEM 89
CONCENTRATION X PRESSURE IN THE BREATHING
CIRCUIT CURVE 93
PERFORMANCE SPECIFICATIONS ................ 93
SPECIFICATIONS FOR MAINTENANCE AND
CALIBRATION 94
MASK FOR NON-INVASIVE VENTILATION ....... 95
BREATHING CIRCUIT ................................ 95
HME FILTER........................................... 95
SPECIFICATIONS FOR RESISTANCE OF THE
EXPIRATORY LIMB 95
PNEUMATIC DIAGRAM ............................... 96
BLOCK DIAGRAM OF CONTROL ELECTRONICS97
ELECTROMAGNETIC COMPATIBILITY ............ 98
15. SYMBOLS.....................................................103
16. TERMS AND ABBREVIATIONS .......................107
17. STATEMENT OF BIOCOMPATIBILITY .............109
18. WARRANTY ..................................................110
19. TECHNICAL ASSISTANCE .............................111
20. TRAINING ....................................................112

5 Manual Oxymag_Rev22
Definition and Care
a. Definitions
•It is to inform the user of the possibility of injury, death or other serious adverse reaction
associated with the use or misuse of the equipment.
Caution
•It is to inform the user of the chance to occur failure in the equipment associated with the use or misuse,
such as equipment malfunction, equipment damage, or damage to third’s property, and indirectly, injury to
a patient.
Note
•Important information.
b. Warning
•Where there is the symbol read
the instruction manual for more details, this
manual should be read in its entirety,
CAREFULLY, for correct and safe use of the
equipment and to provide maximum safety
and best resources to patients. Check all
Warnings and Cautions in this manual and
on the labeling of the equipment.
•This equipment should be operated only for
the purpose specified in 1.1 Intended Use
in conjunction with appropriate monitoring;
•This equipment must be operated only by
qualified professional in the health care area
with expertise in mechanical ventilation
qualified and trained in its use, who should
watch closely during its use. Including
ventilation limited to volume.
•This equipment and the parts should go
through a cleaning process each time it is
used, including the first use, as indicated in
chapter 10 Cleaning and Sterilization.
•This equipment should pass the “Basic
adjustments and checking procedures” to
ensure the effectiveness of the equipment
and the safety of the operator and patient,
as indicated in chapter 6 Checks Before
Use.
•This equipment must remain ALWAYS
connected to a power grid so that there is
enough charge during a power outage.
•This equipment must issue three beeps
when started, demonstrating the correct
operation of audible signal.
•This equipment, parts and accessories must
be disposed according to chapter 13
Disposal;

6 Manual Oxymag_Rev22
•This equipment must be switched off with
the patient disconnected on the on/off
switch.
•This equipment should not be used with
transmission devices in the vicinity of the
transport ventilator, such as mobile phones,
point-to-point radio transmission, cordless
phones, pagers, high-frequency surgical
equipment, defibrillators, short-wave
therapies, which could stop operation of the
ventilator.
•This equipment should not be used during a
magnetic resonance imaging (MRI, NMR,
NMI), because this could cause interference,
and can cause adverse effects to the
patient.
•This equipment should not be used in areas
containing harmful substances, because it
aspirates ambient air to ventilate the patient,
once set at less than 100% O2
concentrations.
•This equipment should not be used with
flammable anesthetic agents because there
is risk of explosion.
•This equipment should not be used in
hyperbaric chambers, as this may affect the
operation of the equipment and cause
adverse effects to the patient.
•After prolonged use of the equipment in
environments with particulate matter in
suspension, replace the filter as indicated in
chapter 12.5 Replacing the Ambient Air
Filter.
•Parts applied to transport ventilator support
defibrillation.
•Alarms and Alerts should be treated
promptly in order to maintain the operation
integrity of the equipment and patient
safety, as indicated in chapter Alarms
Available.
•Do not use hoses or antistatic or electrically
conductive tubes.
•After starting ventilation, check if the
ventilation parameters indicated by the
monitoring display are appropriate.
•Use only parts, pieces and accessories
specified by MAGNAMED listed in this
manual, which have been tested and
approved for use in conjunction with this
equipment; otherwise, it can jeopardize the
operation endangering the patient or user.
•During the prolonged use of the equipment
in patients with excessive secretion or
breathing circuits using heated humidifier,
cleaning of flow sensors should be often
checked.
•It is essential for ventilation monitoring that
the flow sensor is correctly connected and
unblocked; therefore, this sensor must be
frequently checked during operation.
•When turning on the ventilator, please
inform the type of patient and this will set
the proper ventilation. Connect the flow
sensor with the type of patient informed so
that ventilation is properly monitored.
•All parts applied to Oxymag are made of
non-toxic material, latex-free, do not cause
irritation or allergy to the patient.
•Use MASKS specified by MAGNAMED with
local registration;
•Use MASK suitable for patient type.
•Always use oxygen cylinders officially
approved and pressure reducing valves that
meet local government requirements.
•Consider the dead space of the breathing
circuit to make adjustment in the ventilator,
especially for small tidal volumes.
•Have available a manual ventilation
equipment, for the case of full battery
discharge, lack of gases to the operation of
the device or general failure of the transport
ventilation.
•Test Sequence must be performed with the
patient disconnected
•Do not expose the product to extreme
temperatures beyond the specified in item
15.3.3 Physical and Environmental
Specifications during its use. The
equipment performance may be adversely
affected if the operating temperature is
beyond the specified limits.
•HME filter, HEPA filter and airway adapter

7 Manual Oxymag_Rev22
are single use. The reuse of these
accessories may cause cross
contamination.
c. Caution
Caution
•Oxymag do not emit electromagnetic waves that
interfere with the equipment operation in the vicinity.
•Oxymag must pass annual periodic maintenance or
according the hours of use as specified, whichever
comes first.
•Oxymag must have the ambient air intake filter
replaced every 500 hours of use, or at shorter
intervals, if the environment in which it is used
contains too much particulate matter in suspension.
•Oxymag should have their maintenance only carried
out by a qualified, trained technician duly authorized
by MAGNAMED.
d. Notes
Notes
•There are additional contraindications, in
addition to those specified in Warning items in
page 7 of this manual. It remains the
responsibility of the trained operator the
choice and selection of suitable respiratory
mode to each patient.
•The technical characteristics of MAGNAMED
Products are subject to change without notice
•All ventilator parts, pieces and accessories
that are subject to disposal must comply with
the recommendations of Chapter 13 Disposal.
•Pressure units:
1 mbar (millibar) = 1 hPa (hectoPascal) = 1.016 cmH2O (centimeter of water)
In practice, these units are not differentiated and can be used as:
1 mbar = 1 hPa ≈1 cmH2O

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1. Description
1.1 Intended Use
Oxymag MAGNAMED’s Transport and Emergency Electronic
Ventilator –belong to the family of equipment for ventilatory support
of neonatal, pediatric and adult patients with respiratory failure, with
controlled volume, pressure and time cycled. Intended for use in
patients from neonatal, pediatric, adult and adults with morbid
obesity.
Oxymag provides a mixture of ambient air and oxygen at
concentrations adjusted by the operator using the accurate oxygen
concentration System using the venturi principle. In addition, it
performs the control of flows and pressures in the respiratory circuit
to provide the ventilation modalities appropriate to the patient's
condition.
The possible ventilation modes of this ventilator are:
•VCV –Volume Controlled Ventilation (can be Assisted);
•PCV –Pressure Controlled Ventilation (can be Assisted);
•PLV –Pressure Limited Ventilation (can be Assisted) –
Available Weight ≤ 6.0Kg (Neonatal);
•P-SIMV –Synchronized Intermittent Mandatory
Ventilation with Pressure Controlled cycle;
•V-SIMV –Synchronized Intermittent Mandatory
Ventilation with Volume Controlled cycle;
•CPAP/PSV –Continuous Pressure Ventilation with
Pressure Support;
•DualPAP –Ventilation at two CPAP levels (with or
without Support Pressure). Adjustments can be
performed through this modality in order to obtain APRV
mode (Airway Pressure Release Ventilation);
•Noninvasive ventilation (NIV) by mask can be activated
in all ventilation modes with leakage compensation.
During ventilation in CPAP/PSV a backup ventilation can be established in the case of APNEA; this ventilation can be chosen between
VCV, PCV, PLV or OFF.
•This device should be operated only by
healthcare professional with expertise in
mechanical ventilation and qualified and
trained in its use.
•In CPAP/PSV and DUALPAP modes ∆PS =
OFF should be set to deactivate the support
pressure and BACKUP should be set to OFF
to deactivate backup ventilation. Be aware
that when adjusting parameter BACKUP to
OFF backup ventilation will be INACTIVE
during APNEA.

9 Manual Oxymag_Rev22
Pulmonary ventilation may be performed in the following conditions:
•In emergency medicine for service in the field, primary
care, rescue in which the patient can be transported by
land or air, including helicopters;
•Postoperatively, in the post-anesthetic recovery room
(PACU);
•Intra-hospital transportation: The patient can be
transported internally, from one to another department;
•Inter-hospital transportation: The patient can be
transported by road or air.
1.2 Optional items compatible with the products
This equipment is compatible with the following items:
•Nasal prong for neonatal CPAP and its breathing
circuit, both must comply local legal government
requirements;
•Breathing circuits with trachea, which resistance is
less than 0.3 mbar/(L.s-1) that comply local legal
government requirements;
•Blender with flow 120ml/min and outlet pressure 60psi
that complies local legal government requirements;
•Adult, Pediatric and Neonatal Simple Facial Masks
that comply local legal government requirements;
•HME filter that complies local legal government
requirements (to be used in accordance with the
patient being ventilated);
•Aluminum cylinder for oxygen M9 for carrying case,
that complies local legal government requirements,
namely:
oDiameter = 11.13 cm;
oHeight = 27.20 cm;
oVolume = 1.7L;
oO2 Capacity = 255L.

10 Manual Oxymag_Rev22
2. Unpacking the Product
2.1 Initial Checks
✓Make sure the packaging is intact checking for dents,
holes or other damage;
✓If the package is found damaged, please report
immediately the Responsible carrier and MAGNAMED
and DO NOT open the package.
✓Open the package carefully observing the signs in the
box;
✓Check the content in accordance with the following list
of components.
Table 1: List of components for Oxymag
List of components for Oxymag
OXYMAG
TRANSPORT AND EMERGENCY VENTILATOR
Part Number 1600185
Quantity: 1 unit
POWER OUTLET 12V
WITH 4-WAY CONNECTOR
Part Number 2402568
Quantity: 1 unit
AC CABLE
3 WAYS 1,5 M
Part Number 2802612
Quantity: 1 unit
BREATHING CIRCUIT ADULT 1
1,2m AUTOCLAVABLE
Part Number 1703218
Quantity: 1 unit
O2 EXTENSION DISS X2
2 M
Part Number 3902647
Quantity: 1 unit
EXHALATION VALVE
WITH STABILIZING RING
Part Number 3804865
Quantity: 1 unit