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: Toru Miyagi Kinjo
Registration at CREA-SP: 5061555031
Legal Responsible: Wataru Ueda
1600185-09: OxyMag –Version 3.n

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
PROTOCOL USED FOR DATA COMMUNICATION
WITH EXTERNAL DEVICES ...............................................17
3. DESCRIPTION OF THE DISPLAY.................20
3.1 MODES .....................................................20
3.2 ALARMS,MONITOR AND STATUS ....................20
3.3MONITOR,MENUS AND CHARTS.....................20
3.4 SETTING THE VENTILATION PARAMETERS .........20
4. PREPARATION FOR USE ...........................21
4.1 ASSEMBLING OXYMAG –TRANSPORT VENTILATION
21
4.2 NONINVASIVE VENTILATION MASK ...................23
4.3 POWER CONNECTION ..................................24
4.4 MOUNTING THE VERTICAL SUPPORT................25
5. CHECKS BEFORE USE ..............................27
5.1 INITIAL PROCEDURES ...................................27
5.2 VENTILATOR SETTINGS ................................28
NORMAL STARTUP SEQUENCE ..................30
TEST SEQUENCE ....................................33
FAILURE DIAGNOSIS................................34
6. CAPNOGRAPHY SENSOR (ETCO2).............35
6.1 INSTRUCTIONS FOR USE...............................35
6.2 ASSEMBLING THE SENSOR............................35
6.3 POSITIONING THE SENSOR............................37
6.4 PROCEDURE TO RESET THE SENSOR..............38
6.5 INFORMATION REGARDING LED .....................38
6.6 PREVENTIVE MAINTENANCE OF ETCO2SENSOR39
6.7 TECHNICAL SPECIFICATIONS OF THE
CAPNOGRAPHY............................................................40
7. OXIMETER (MASIMO) ................................45
7.1 OPERATION PRINCIPLE ................................45
7.2 SUMMARY OF BLOOD CALIBRATION TEST ........49
7.3 LOW PERFUSION TEST SUMMARY....................49
7.4 SENSOR ASSEMBLY ......................................49
7.5 OXIMETER SPECIFICATION.............................50
8. DESCRIPTION OF MODES..........................52
8.1 VCV –VOLUME CONTROLLED VENTILATION.... 52
8.2 PCV –PRESSURE CONTROLLED VENTILATION .. 54
8.3 PLV –LIMITED PRESSURE VENTILATION .......... 56
8.4 V-SIMV –SYNCHRONIZED INTERMITTENT
MANDATORY VENTILATION –VOLUME CONTROLLED CYCLE. 58
8.5 P-SIMV –SYNCHRONIZED INTERMITTENT
MANDATORY VENTILATION –PRESSURE CONTROLLED CYCLE60
8.6 CPAP/PSV –CONTINUOUS PRESSURE
VENTILATION WITH PRESSURE SUPPORT ........................... 62
8.7 DUALPAP –BI-LEVEL CONTINUOUS POSITIVE
AIRWAY PRESSURE VENTILATION .................................... 64
8.8 APRV –AIRWAY PRESSURE RELEASE VENTILATION
(MODE OBTAINIED WITH INVERTED RATIO IN DUALPAP) .... 66
9. ALARMS AVAILABLE.................................68
9.1 DESCRIPTION OF ALARM CONTROL ................. 68
9.2 SETTING ALARMS ....................................... 78
9.3 ALARM TEST .............................................. 78
ADJUSTABLE ALARM TEST ........................ 78
9.3.1.1 PRESSURE ALARM .................................. 78
9.3.1.2 PEEP ALARM ........................................ 78
9.3.1.3 MINUTE VOLUME ALARM (MV)................... 79
9.3.1.4 RESPIRATORY RATE ALARM ..................... 79
9.3.1.5 VOLUME ALARM ..................................... 79
9.3.1.6 FIO2 ALARM.......................................... 79
9.3.1.7 ETCO2 ALARM ...................................... 79
9.3.1.8 PULSE RATE ALARM ................................ 79
9.3.1.9 CO2 ALARM .......................................... 79
9.3.1.10 SPO2 ALARM .................................... 79
9.3.1.11 APNEA ALARM ................................... 80
CRITICAL ALARM TEST.............................. 80
9.3.2.1 DISCONNECTION................................ 80
9.3.2.2 NO AC POWER.................................. 80
9.3.2.3 LOW BATTERY ................................... 80
9.3.2.4 OBSTRUCTION................................... 80
9.3.2.5 LOW O2 SUPPLY................................ 80
9.4 MANUAL VENTILATION OF THE PATIENT........... 80
10. CLEANNING AND STERILIZATION ..............81
10.1 EQUIPMENT CLEANING ............................ 81
EXTERNAL VENTILATOR SURFACES ............ 81
RESPIRATORY CIRCUIT,PROXIMAL FLOW
SENSOR AND EXHALATION VALVE..................................... 81
10.1.2.1 WASH.............................................. 81
10.1.2.2 RINSE.............................................. 81
10.1.2.3 DRYING ........................................... 82
10.2 DISINFECTION........................................ 82
EXTERNAL PARTS .................................. 82
RESPIRATORY CIRCUIT,EXHALATION VALVE,
PROXIMAL FLOW SENSOR AND SILICONE LINE ..................... 82
10.3 STERILIZATION....................................... 82
10.4 PROCESSING METHODS........................... 83

11. PREVENTIVE MAINTENANCE ....................84
11.1 INDICATION OF THE NEED FOR PERIODIC
MAINTENANCE 84
11.2 DAILY CHECKS AND/OR PRIOR TO USE .........84
11.3 INTERNAL LITHIUM BATTERY .....................84
11.4 INTERNAL SENSOR OF O2 CONCENTRATION.85
11.5 REPLACING THE AMBIENT AIR FILTER .........86
11.6 FORWARDING THE PRODUCT TO REPAIR
SERVICE 86
12. DISPOSAL.................................................88
13. TURNING OFF THE EQUIPMENT .................89
14. TECHNICAL SPECIFICATION ......................90
14.1 CLASSIFICATION .....................................90
14.2 STANDARDS...........................................90
14.3 SPECIFICATIONS.....................................91
ELECTRICAL CHARACTERISTICS.................92
CONNECTING TO THE OXYGEN SUPPLY .......93
PHYSICAL AND ENVIRONMENTAL
SPECIFICATIONS...........................................................93
INTERNAL VOLUME OF RESPIRATORY CIRCUIT
COMPONENTS 94
EXTREME CONDITIONS.............................94
VENTILATION MODES...............................95
SETTING SPECIFICATIONS OF THE VENTILATION
PARAMETERS 95
SPECIFICATIONS OF THE MONITORING
VENTILATION PARAMETERS ............................................99
CONTROL ACCURACY ............................101
SPECIFICATIONS OF THE SAFETY AND
ALARM SYSTEM 102
CONCENTRATION X PRESSURE IN THE
BREATHING CIRCUIT CURVE ..........................................106
PERFORMANCE SPECIFICATIONS.........106
SPECIFICATIONS FOR MAINTENANCE AND
CALIBRATION 107
MASK FOR NON-INVASIVE VENTILATION 108
BREATHING CIRCUIT.........................108
HME FILTER...................................108
SPECIFICATIONS FOR RESISTANCE OF THE
EXPIRATORY LIMB 109
PNEUMATIC DIAGRAM........................110
BLOCK DIAGRAM OF CONTROL
ELECTRONICS 111
ELECTROMAGNETIC COMPATIBILITY.....112
14.4 O2 GALVANIC CELL SPECIFICATION ...........118
15. SYMBOLS ...............................................119
16. TERMS AND ABBREVIATIONS..................124
17. STATEMENT OF BIOCOMPATIBILITY ........126
18. WARRANTY.............................................127
19. TECHNICAL ASSISTANCE ........................128
20. TRAINING...............................................129

5 OxyMag_rev26
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 Cleanning 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 5 Checks Before Use.
•This equipment must remain ALWAYS
connected to a power grid so that there
is enough charge during a power
outage.

6 OxyMag_rev26
•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
12 Disposal;
•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 11.5 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 9 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.
•Oxymag and all parts applied to are
made of non-toxic material, latex-free,
do not cause irritation or allergy to the
patient. Applied parts are: patient
breathing circuit, flow sensor and
silicone line, expiratory valve, oximetry
and capnography sensor.
•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.

7 OxyMag_rev26
•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 14.3.3 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 are single use. The reuse of
these accessories may cause cross
contamination.
•During prolonged use of the equipment
in patients with excess secretion and /
or using a heated humidifier, the
condition of the flow sensor shall be
checked frequently, seeking to drain
accumulated fluid into the breathing
circuit as needed.
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
Note
•There are additional contraindications, in
addition to those specified in Warning items in
page 5 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 12 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

8 OxyMag_rev26
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 interacts with the patient through an invasive or
noninvasive interface that supplies ventilator air to the patient's
airway.
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. O2concentration
is obtained through a galvanic cell or optionally from a
paramagnetic cell by indirect contact with the patient's gas by
passing gas through the sensor. 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 OxyMag_rev26
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 OxyMag_rev26
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/3,34A
MEDICAL DEGREE
Part Number 2402568
Quantity: 1 unit
AC CABLE
3 WAYS 1,5 M
Part Number 2802612
Quantity: 1 unit
BREATHING CIRCUIT ADULT1
1,2m AUTOCLAVABLE
Part Number 1703218
Quantity: 1 unit
QUICK GUIDE
OXYMAG FAMILY
Part Number 7006467
Quantity: 1 unit
EXHALATION VALVE
WITH STABILIZING RING
Part Number 3804865
Quantity: 1 unit
DIAPHRAGM OF EXHALATION
VALVE MAGNAMED
Part Number 3800248
Quantity: 1 unit
ENVELOPE WITH 3
ENVIRONMENT FILTERS
Part Number 1702656
Quantity: 1 unit