Magnamed OxyMag Operation Manual
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Magnamed OxyMag Operation Manual

Transport and emergency ventilator
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Operation Manual
OxyMag – Transport and Emergency Ventilator

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Summary of Contents for Magnamed OxyMag

  • Page 1 Operation Manual OxyMag – Transport and Emergency Ventilator...
  • Page 2 Rua Santa Mônica 801/831 – Capuava CEP: 0671-865 – Cotia – SP – Brazil Phone/Fax: +55 (11) 4615-8500 E-mail: magnamed@magnamed.com.br 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...

  • Page 3: Table Of Contents

    Analytical Index ..........5 EFINITIONS DESCRIPTION OF MODES ......52 ........... 5 ARNING VCV – V ..52 ............. 7 AUTION OLUME ONTROLLED ENTILATION PCV – P .. 54 ............7 RESSURE ONTROLLED ENTILATION OTES PLV –L ..56 IMITED RESSURE ENTILATION DESCRIPTION ..........
  • Page 4 PREVENTIVE MAINTENANCE ....84 ONTROL ACCURACY ......101 PECIFICATIONS OF THE AFETY AND 11.1 NDICATION OF THE NEED FOR PERIODIC LARM YSTEM MAINTENANCE ONCENTRATION X RESSURE IN THE 11.2 AILY CHECKS AND OR PRIOR TO USE ..84 BREATHING CIRCUIT CURVE ..........

  • Page 5: Definitions

    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, •...
  • Page 6 • Oxymag and all parts applied to are • This equipment should not be used in made of non-toxic material, latex-free, hyperbaric chambers, as this may...

  • Page 7: Caution

    MAGNAMED. Oxymag must have the ambient air intake • filter replaced every 500 hours of use, or at d. Notes...

  • Page 8: Description

    PLV – Pressure Limited Ventilation (can be Assisted) – controlled volume, pressure and time cycled. Intended for use in Available Weight ≤ 6.0Kg (Neonatal); patients from neonatal, pediatric, adult and adults with morbid obesity. Oxymag interacts with the patient through an invasive or • P-SIMV –...

  • Page 9: Products

    Pulmonary ventilation may be performed in the following conditions: • • In emergency medicine for service in the field, primary Intra-hospital transportation: The patient can be care, rescue in which the patient can be transported by transported internally, from one to another department; land or air, including helicopters;...

  • Page 10: Unpacking The Product

    ✓ If the package is found damaged, please report of components. immediately the Responsible carrier and MAGNAMED and DO NOT open the package. : List of components for Oxymag Table 1 List of components for Oxymag OXYMAG POWER OUTLET 12V/3,34A...

  • Page 11: Parts Anda

    KIT FLOW SENSORS ADU PED NEO AUTOCLAVABLE OPERATION MANUAL 03 Silicon line, 03 Flow sensors (1 Adult; 1 Pediatric, 1 Neonatal) Part Number 1600185-NE-22-RR Quantity: 1 unit Part Number 5001748 Quantity: 1 unit 1 Accessories not available for the European Union Parts and Accessories Caution Always use original parts and accessories to ensure the safety and effectiveness of the equipment.

  • Page 12: Optional Accessories That Can Be Purchased For Oxymag

    Optional accessories that can be purchased for Oxymag Table 2: List of optional components for Oxymag. List of optional accessories for Oxymag STAND WITH CASTERS FOR ARTICULATED ARM WITH OXYMAG SUPPORT FOR BREATHING CIRCUITS Part Number 3802668 Part Number 1707302...
  • Page 13 ADULT FLOW SENSORS KIT ADULT FLOW SENSORS AUTOCLAVABLE AUTOCLAVABLE • • 03 Silicone Line 05 Silicone Lines • • 03 Adult Flow Sensors Autoclavable 05 Adult Flow Sensors Autoclavable Part Number 5001747 Part Number 5001495 NEONATAL FLOW SENSORS KIT NEONATAL FLOW AUTOCLAVABLE SENSORS AUTOCLAVABLE •...
  • Page 14 SPO2 – NEO AND PED PULSE OXIMETER SENSOR AND CABLE IRMA AIRWAY ADAPTER, ADAPTER (LNCS YI multisite SpO2 INFANT reusable sensor) CE 0413 CE 0123 Part Number 1704394 Part Number 1704410 SPO2 – ADULT PEDIATRIC PULSE OXIMETER SENSOR AND CABLE ADAPTER (LNCS DC-I SpO2 Adult Reusable Finger Clip Sensor CE 0123...
  • Page 15 Visual and graphical presentation of the setting parameters with touch screen. 2. KNOB BUTTON This button is used for most of the adjustments to be made in the Transport Ventilator Oxymag. • Select the parameters to be set on the display by directly touching the corresponding button;...
  • Page 16 16. PLUG OF POWER SUPPLY – BASE Standard connection of the inspiratory flow to the breathing circuit of the This plug is used together with the support base of Oxymag and the power patient supply system. The inlet is +12VDC. Note the polarity indication and the recorded voltage DC power.

  • Page 17: With External Devices

    For the communication protocol implementation guide, contact MagnaService. The information goes as follows: Oxymag sends the data to the answering electronic health recorder it has received. The electronic health recorder may ask questions or request data to Oxymag who immediately responds or confirms the request.
  • Page 18 100%. Filter should be replaced according to the descriptive operations manual (12.Replacing the Ambient Air Filter). • Only use power supply, parts, pieces and accessories specified by MAGNAMED listed in this manual, which were tested and approved for use in conjunction with this equipment;...
  • Page 19 Caution If there is no confirmation by pressing the button, after 10 seconds the parameter value and the button will • return to the previous state. Note For electrical insulation of the ventilator circuits from the external source, only disconnect the power supply •...

  • Page 20: Description Of The Display

    3. Description of the Display sidebar will fill until complete 2 seconds. Stand-by Modes button is shown with the symbol below: In the upper left corner there is the indication: ✓ Type patient selected: ADU→Adult; PED→Pediatric; NEO→Neonatal; • At the right top of the screen, there is the battery ✓...

  • Page 21: Preparation For Use

    Assembling Oxymag – Transport Ventilation Table 6 describes the steps to be followed by the operator (health care professional, duly trained and authorized to use the equipment) to assemble and prepare the transport ventilator. Table 6: Assembly Sequence of Oxymag Figure Assembly Sequence 1.
  • Page 22 Figure Assembly Sequence 5. Connect the power supply AC/DC to the □ equipment then to the mains. 6. Connect the oxygen hose to the transport □ ventilator. 7. Connect the appropriate flow sensor to the □ patient according to the figure. 8.

  • Page 23: Noninvasive Ventilation Mask

    • Never obstructe pressure port.The monitoring patient ventilation. measured pressure in this points are • When using Oxymag for extended time in battery, an alarm occurs which OxyMag_rev26...

  • Page 24: Power Connection

    message is LOW BATTERY, provide • When using oxygen cylinder, check if IMMEDIATE connection of power supply the pressure reducing valve is set to to the mains, if DISCONNECTING the deliver oxygen flow with pressure equipment from the patient is not according to 14.3.2 Connecting to the possible and provide appropriate means Oxygen Supply.

  • Page 25: Mounting The Vertical Support

    Pull the handle bracket on the wall, just above the invisible; fixed support; Make sure that Oxymag is fixed in placed; Slide Oxymag down until it clicks into place; To remove Oxymag, perform the reverse procedure. Figure 9: Connection of the ventilator to the fixed support...
  • Page 26 Insert the handle holder in the support above the fixed Make sure that Oxymag is fixed in place; support; To remove Oxymag, perform the reverse procedure. Slide Oxymag down until it clicks into place;...

  • Page 27: Checks Before Use

    5. Checks Before Use The purpose of this inspection routine is to guide the user in equipment before each use or at least the beginning of each performing a simple and quick procedure to test the work period. • This equipment must pass the “Checking procedures and basic settings” to ensure the effectiveness of the equipment and the safety of the operator and patient.

  • Page 28: Ventilator Settings

    Ventilator Settings The ideal weight of the patient is used to calculate the ventilator • Inspiratory Flow – calculated according to TINS setting parameters to provide the best approximation to ventilate obtained; the patient. This value is calculated using the height of the patient The other parameters will have the default value: considering the Body Mass Index (BMI) of 22.
  • Page 29 Table 8: List of values adopted by the equipment when selecting a patient Startup button Patient type Height [m] Ideal Weight P [kg] NEONATAL 0,36 PEDIATRIC 0,95 19,8 ADULT 1,50 49,5 After startup, it is possible to change the height value within the adjustment range of the patient type set by clicking on the chart area and menu and selecting the Settings button (General Tab).

  • Page 30: Normal Startup

    Normal Startup Sequence Initial screen of Oxymag – Turn on the ventilator through on-off switch on the left side of the equipment. By turning on, note that a triple “beep” goes off in conjunction with the light alarm indicator, meaning that the audible and visual alarm are operational.
  • Page 31 Table 10: List of parameters in the Neonatal mode Default Default PEEP 5 cmH2O Pinsp 15 cmH2O Pmax 35 cmH2O Rate 40 min Pause Tinsp 0,5s PEEP 5 cmH2O Flow Trigger Flow 6 L.min Pressure Trigger Wave Flow Square Flow Trigger After the startup sequence, the equipment will display the Pressure Trigger chart screen of the ventilator.
  • Page 32 • Turn on or off the sigh function. In this condition, there will To return to the screen with the button for selection of be a sigh every 100 cycles in control modes. charts, data, settings and alarms press button .

  • Page 33: Test Sequence

    Test Sequence The tests are essential to check if the equipment is operating as expected and make adjustments for the best possible performance. Remember to conduct initial tests before starting ventilation. • Test Sequence must be performed with the patient disconnected. Home screen - Press the Test button and the sequence of internal tests will be activated.

  • Page 34: Failure Diagnosis

    Failure Diagnosis The Table 13: shows the actions that can be taken to remedy the shortcomings indicated in the test sequence. The consequence column indicated what may occur if the equipment is used with failure. • If “Inoperative Device” is indicated, the use of equipment with the presence of this failure is expressly not allowed;...

  • Page 35: Capnography Sensor (Etco2)

    6.1 Instructions for Use The mainstream sensor IRMA was designed to be used connected to Oxymag ventilator and any other monitoring device compatible with this sensor. It has the function to monitor in real time the signal and the gas concentration.
  • Page 36 Figure 12: Fitting the capnography in Oxymag Attach the airway adapter to the IRMA sensor. You can hear a click when the airway adapter fits correctly to the sensor; Figure 13: Fitting airway sensor green LED indicates that the CO2 sensor is ready for use.

  • Page 37: Positioning Thes

    Figure 15: Connection of the airway adapter to the flow sensor of the breathing circuitt Connect IRMA 15-mm adult airway adapter to the Endotracheal Tube of the patient; If there is need to connect a Heat Moisture Exchanger (HME), place it between the CO2 sensor and the Endotracheal Tube. Placing the Moisture Exchanger in front of the sensor will protect the airway adapter from secretions and effects of steam, which eliminates the need to Exchange the adapter in use.

  • Page 38: Procedure Tor

    • The CO sensor must have direct contact with the patient during use. 6.4 Procedure to Reset the Sensor • The incorrect reset of the sensor will result in incorrect Reading of the measured values. To ensure high accuracy in the values measured by IRMA sensors, the following resetting recommendations should be followed. Resetting must be performed by connecting an airway adapter to IRMA sensor, without connecting them to the breathing circuit.

  • Page 39: Aintenance Of E Tco 2 Sensor

    6.6 Preventive Maintenance of EtCO Sensor The gas calibration must be checked at regular intervals by reference instrument. • The CO2 sensor is intended for the exclusive use of trained and authorized medical personnel; • The CO2 sensor should not be used with flammable anesthetic agents;...

  • Page 40: Technical S Capnography

    Caution Never sterilize or immerse the CO2 sensor in liquid; • Do not apply voltage to the sensor cable; • Do not use the CO2 sensor in environments which specifications are outside the limits stablished in the • Technical Specifications (Temperature, Humidity, etc.) Airway adapters of the CO2 sensor are non-sterile accessories.
  • Page 41 Attribute Specification Adds less than 6ml dead space; Pressure drop lower than 0.3cmH 0 at 30LPM. Pediatric (Disposable): Adds less than 1ml dead space; Pressure drop less than 1.3cmH 0 at 10LPM. OUTPUTS Breathing Detection Adaptive threshold, minimum 1% volume change in CO concentration.
  • Page 42 Attribute Specification Information on the concentration is analyzed and sent every 10 seconds. Warm-up Overall accuracy in measurements: 1 minute. Rise time (at 10 l/min) ≤ 90ms. Overall System Response Time < 1s. Note • monitoring is achieved accurately 1 minute after initialization. Table 16: Accuracy specifications of the Capnography Precision / Accuracy of measurements (under standard conditions): Gas Type...
  • Page 43 Effects of Gas and Steam Interference: Xe (Xenon) 80 vol% -10% measurement read. He (Helium) 50 vol% -6% measurement read. Propellant inhaler with dosimeter Not designed for use with propellant inhaler with dosimeter. OH (Ethanol) 0,3 vol% OH (Isopropanol) 0,5 vol% COCH (Acetone) 1 vol%...
  • Page 44 Temp RH [%] P [hPa] O part.pres ATPD [hpa] BTPS 1013 -0,7 +5,5 1013 -1,6 +4,6 1013 -4,1 +2,0 1013 63 (BTPS) -6,2 -9,0 -2,8 OxyMag_rev26...

  • Page 45: Oximeter (Masimo)

    The LNCS DC-I and LNCS YI oximetry sensors were tested and validated with the USpO2 MASIMO SET OXIMETRY CABLE and the OXYMAG equipment, in order to comply with the ABNT NBR ISO 80601-2-61 standard. 7.1 Operation Principle The MS board of Masimo SET ®...
  • Page 46 studies on human blood versus those from a co-oximetry The MS board software scans through all possible R values laboratory in healthy adult volunteers in a hypoxia-induced corresponding to SpO2 values between 1% and 100% and study. generates a N’ value for each of these R values. The signals S(660) and S(905) are processed for each possible reference The above equations are combined and a reference noise (N’) noise N’...
  • Page 47 • Risk of electric shock. Do not remove the monitor cover, except for battery replacement. The operator may perform maintenance procedures specifically described in this manual. Contact MAGNAMED technical assistance to repair this oximeter. • As with all medical equipment, position the patient cable in order to reduce the possibility of entanglement or strangling.
  • Page 48 • The oximetry sensor presents no photobiological risk. • The uSpO2 extender cable is designed for use specifically with Oxymag. • The operator shall be aware of the read delay effect, considering the averaging and signal processing time that can be up to 10 seconds for the SpO2, FC and PI parameters.

  • Page 49: Low Perfusion Test Summary

    0.02% signal strength at a fixed SpO2 setting of 83% + 2% and a fixed pulse rate setting of 80 bpm + 2 bpm. The Masimo Simulator was set at the greatest transmission setting. 7.4 Sensor assembly Connect the oximetry sensor to the Oxymag as shown in the figure: OxyMag_rev26...
  • Page 50 Figure 19: Oximeter sensor assembly 7.5 Oximeter specification Table 19 – Performance specification Specification criteria Functional SpO Pulse rate Perfusion PVI (%) (bpm) index (%) 25 – 240 bpm 0.02 – 20.0 % 0 – 100 % Display range 0.0 - 100.0 % 70 –...
  • Page 51 The pulse rate ACCURACY is defined over the full declared range, as the difference in mean square value (vqm) between paired pulse rate data, recorded with the PULSE OXIMETRY EQUIPMENT and with a reference method. The reference method used was a Biotek Index 2 ™...

  • Page 52: Description Of Modes

    8. Description of modes 8.1 VCV – Volume Controlled Ventilation Description: Set Parameters:: In this mode, the ventilator controls the volume flow and cycle, i.e., at each inspiratory cycle the ventilator delivers a precise volume to the patient, • VOLUME; provided that the pressure is not limited.
  • Page 53 Ventilation with Inspiratory Pause, after delivery of the set volume, the ventilator maintains the exhalation stopped until complete TINS after which the ventilator cycles to exhalation, the feature is the pressure plateau formation (gap between peak and plateau depends on the airway resistance). If the pressure or flow trigger is enabled, then the ventilator tries to synchronize the beginning of the next inspiration with patient effort, according to the levels established.

  • Page 54: Pcv - Pressurec

    8.2 PCV – Pressure Controlled Ventilation Description: Set Parameters: In this mode, the ventilator controls pressure and cycles on time, i.e., at each inspiratory cycle, the ventilator reaches the set pressure and remains at this • INSP PRESSURE; level until the inspiratory time set has elapsed, the volume is, therefore, •...
  • Page 55 Once all ventilation parameters are set on the ventilator, it calculates TINS, TEXP based on Rate and Ratio I:E; thus obtaining all ventilation control times. 1 and 2 Pressure Controlled Ventilation – The ventilator achieves the inspiratory pressure set in the shortest time possible, and this is accomplished by controlling the inspiratory flow.

  • Page 56: Plv -Limited Pressure

    8.3 PLV –Limited Pressure Ventilation Description: Set Parameters: In this continuous flow mode, the ventilator limits pressure and cycles on time, i.e., at • INSP PRESSURE; each inspiratory cycle the ventilator reaches the set pressure and remains at this level •...
  • Page 57 Once all ventilation parameters are set on the ventilator, it calculates TEXP based on Rate and TINS and, thus, obtain all ventilation control times. 1 e 2 Pressure Limited Ventilation – The ventilator seeks to achieve the set inspiratory pressure, and this is accomplished by occlusion of the exhalation valve.

  • Page 58: V-Simv - Synchronized

    8.4 V-SIMV – Synchronized Intermittent Mandatory Ventilation – Volume Controlled Cycle Description: Set Parameters: • VOLUME; In this mode, the patient can breathe spontaneously between the • RATE; controlled cycles, with or without the use of pressure support. Controlled • INSPIRATORY TIME;...
  • Page 59 4 and 5 Represents spontaneous breathing cycle of the patient WITH PRESSURE SUPPORT, with cycling occurring by flow, when this reaches a value between 5% and 80% of the peak value read. Peak flow percentage at which cycling of inspiratory phase occurs to the expiratory phase is programmable.

  • Page 60: P-Simv - Synchronized

    8.5 P-SIMV – Synchronized Intermittent Mandatory Ventilation – Pressure Controlled Cycle Description: Set Parameters: • INSP PRESSURE; In this mode, the patient can breathe spontaneously between the • RATE; controlled cycles, with or without the use of pressure support. The •...
  • Page 61 Once all ventilation parameters are set on the ventilator, it calculates TEXP based on TINS and Rate, thus obtaining all ventilation control times. 1 Represents a PCV (pressure controlled) cycle during TINS; 2 Represents a spontaneous breathing cycle of the patient WITHOUT PRESSURE SUPPORT; 3 Represents a PCV (pressure controlled) cycle when SIMV Period has elapsed;...

  • Page 62: Cpap/Psv - C

    8.6 CPAP/PSV – Continuous Pressure Ventilation with Pressure Support Description:: Set Parameters: In this mode, the patient breathes spontaneously on a continuous • PEEP or CPAP; positive pressure and breathing is assisted by a Pressure Support • ΔPS (Pressure Support – PEEP); (ΔPS).
  • Page 63 1 and 2 Represent spontaneous cycles with pressure support at ZERO. 3 , 4 and 5 Represent spontaneous breathing cycles of the patient with pressure support different from zero. TRISE TIME of pressure support may be adjusted so that initial flow is smoothed. If the patient enters in apnea, after TAPNEA (s) the ventilator will show this condition with alarm in its message area and alarms on screen and will initiate backup ventilation selected as settings and parameters programmed.

  • Page 64: Airway Pressure Ventilation

    8.7 DualPAP – Bi-level Continuous Positive Airway Pressure Ventilation Description: Set parameters: In this mode, the patient breathes spontaneously on two continuous • P. HIGH; positive pressure and breathing may be assisted by a Pressure Support • T. HIGH; (ΔPS). Usually by analyzing the flow curve, a flow peak is seen which •...
  • Page 65 1 Represents a spontaneous cycle without pressure support at P.Low (Low Continuous Airway Pressure); 2 Represents a breathing cycle with Pressure Support assist (above P.Low); 3 to 4 Represents a synchronized transition to P.High (High Continuous Airway Pressure); 5 Represents a transition from P. High to P. Low synchronized; Transitions of levels from P.Low P.High or P.High P.Low occur in the final quarter of T.Low and T.High, respectively, by synchronizing with the effort of the patient.

  • Page 66: Aprv -Airway

    8.8 APRV –Airway Pressure Release Ventilation (mode obtainied with inverted ratio in DUALPAP) Description: Set parameters: • P. HIGH; This mode allows spontaneous cycles on 2 levels of • T. HIGH; baseline pressure and can be achieved by appropriate • P.
  • Page 67 Once all ventilation parameters are set on the ventilator, the patient breathes spontaneously defining the control times of ventilation. 1 and 2 Represent spontaneous cycles without pressure support at P. High (High Continuous Airway Pressure); 3 Represents the transition of P.High to P.Low (Low Continuous Airway Pressure) synchronously; 3 to 4 Represents the time T.Low in which airway pressure release is performed;...

  • Page 68: Alarms Available

    Description of alarm control The alarm system of the Oxymag family ventilators are classified according to the degree of priority (low, medium, and high priority) as shown in table. Table 21: Classification of alarms according to the priority level...
  • Page 69 HIGH PRIORITY Delay Time Description It is triggered when the measured volume exceeded the alarm value set as High Volume < 3 cycles the upper limit of volume It is triggered when the measured volume exceeded the alarm value set as Low Volume <...
  • Page 70 MEDIUM PRIORITY Delay Time Description It is triggered when the minute volume of the patient has exceeded the alarm High Minute volume < 3 cycles value set as upper limit of minute volume It is triggered when the minute volume of the patient is below the alarm value Low Minute volume <...
  • Page 71 LOW PRIORITY Delay Time Description It is triggered when the equipment is disconnected from the electric mains and AC input fail < 1 second the power is switched to internal power supply. It is triggered when SpO Sensor is connected to the equipment, but is outside Sensor <...
  • Page 72 energy source must be provided immediately. The alarm will be re-initialized when connected to a source of A.C. power or external D.C. Note The actual remaining time will depend on the battery condition and parameters used in the ventilator. • b) Disconnection alarm The disconnection alarm is triggered when any kind of disconnection from the breathing circuit occurs, in order to prevent proper ventilation to the patient.
  • Page 73 • Do not use the equipment if a problem cannot be resolved. Table 23: Troubleshooting Possible Causes Solutions Problem Ventilator Inoperative Electronic failure Contact Technical Assistance / Magnamed Alarm 1. Locate the disconnection and connect Disconnection Alarm 1. Disconnection in the breathing circuit; securely; OxyMag_rev26...
  • Page 74 4. Replace the diaphragm in the correct position damaged; or replace diaphragm with a new one; 5. Failure in the electronic system of pressure control; 5. Contact Technical Assistance / Magnamed 6. Check circuit integrity and replace circuit if 6. Circuit integrity necessary 1.
  • Page 75 Possible Causes Solutions Problem 3. O2 Pressure Sensor Failure 2. Connect the O2 hose to the device. 3. Contact Magnamed Technical Assistance. 1. Inspiratory or expiratory branch obstructed 1. Clear it; Obstruction alarm 2. Patient's airway obstruction 2. Clear or aspirate the patient's airway.
  • Page 76 18%. FiO2 below 18% alarm 2. Calibrate O2 cell. 2. Unbalanced O2 cell. 3. Contact Magnamed Technical Assistance. 3. Damaged O2 cell. 1. Change the adjusted parameters of the High Minute volume 1. Volume delivered and delivered respiratory rate are...
  • Page 77 Possible Causes Solutions Problem 2. Locate the leak and correct. out of range alarm 1. Capnograph reading is incorrect. 1. Calibrate or replace the capnograph. 1. Operate the capnograph under 1. Operating ambient pressure is out of range environmental conditions stated in the technical alarm specification.

  • Page 78: Setting Alarms

    Setting Alarms ALAR M To enter the alarm setting screen, press ALARM button on the screen. One of the screens of the following table will be presented: Positioning settings of lower and upper limits on the alarm screen: Setting the Upper Limit Setting the of the Alarm Lower Limit of the Alarm...

  • Page 79: Minute Volume Alarm

    9.3.1.3 Minute volume alarm (MV) To test the operation of the high minute volume alarm, set the upper limit of the minute volume alarm so that it is less than the minute volume monitored on the unit. To test the operation of the low minute volume alarm, set the lower limit of the minute volume alarm so that it is greater than the minute volume monitored on the unit.

  • Page 80: Apnea Alarm

    Para testar o alarme de SpO2, é necessário que um oxímetro de pulso esteja conectado ao ventilador. Monte o circuito e conecte o oxímetro no dedo para que o ventilador monitore os parâmetros de oximetria. Ajuste o alarme de SpO2 de forma que este seja menor do que o SpO2 monitorado no aparelho.

  • Page 81: Cleanning And Sterilization

    10. Cleanning and Sterilization 10.1 Equipment cleaning External ventilator surfaces External ventilator surfaces of Oxymag should be cleaned with a clean, soft cloth moistened with the enzymatic detergent. Caution Ensure that no residue builds up in the equipment connections. •...

  • Page 82: Drying

    Do not use abrasive agents to carry out cleaning; • Do not use alcohol to clean the plastic parts; • Do not immerse the Oxymag in any liquid; • When sending the Oxymag without performing maintenance or repair service. maintenance...

  • Page 83: Processing Methods

    Caution The accessories and components removable from Oxymag undergoing repeated operations of sterilization • and cleaning may be degraded and should be replaced with new ones. 10.4 Processing methods Processing methods Steam Antimicrobial Component sterilization Alcohol 70° disinfectant 135ºC for 5 min Ventilator surface ✓...

  • Page 84: Preventive Maintenance

    Preventive Maintenance Caution Oxymag should have their maintenance performed only by a qualified technician, trained and authorized by • MAGNAMED. Failure to comply will void the manufacturer's warranty and obligations regarding the ventilator. Failure to perform maintenance could affect the safety and performance of the ventilator.

  • Page 85: Internal Sensor Of

    • • 1% per month degradation in measurement measuring cell should be performed only by accuracy. qualified technician, trained authorized by MAGNAMED. The oxygen concentration measuring cell • should be replaced as indicated in the Technical Specification (chapter 14). OxyMag_rev26...

  • Page 86: Replacing Thea

    (5) Install the filter cover and check if the set is firmly closed. • Use only filters, parts, pieces and operation endangering the patient or user; accessories specified by MAGNAMED listed in this manual, which have been filter when saturated generates an tested and approved for use in •...
  • Page 87 • When sending Oxymag for maintenance or repair services: check closely the disinfection process. • Equipment visibly infected by patient fluids will be returned without carrying out maintenance or repair service. OxyMag_rev26...

  • Page 88: Disposal

    12. Disposal Oxymag ventilator shall be disposed of as electrical and electronic equipment. Accessories and consumables shall be disposed of as described in the instruction for use. Follow local government recommendations for proper disposal. Caution When the need to discard parts of the ventilator may be potentially contaminated indicated as potentially •...

  • Page 89: Turning Off The Equipment

    13. Turning off the Equipment The lung ventilator Oxymag is a life support equipment and must be MANDATORILY disconnected from the patient to be turned off. The equipment should be turned off in the on/off switch, identified in Figure 5. When the equipment is turned off, a continuous audio signal will be produced indicating that the equipment has been turned off.

  • Page 90: Technical Specification

    14. Technical Specification 14.1 Classification • NBR – IEC – 60601 Class II Equipment, energized internally, BF-type for continuous operation. Protected against the ingress of solid foreign objects > 2.5 mm or bigger and splash-proof equipment - IP34. • RDC 185/01 – Classification Rule 11 Class III –...

  • Page 91: Specifications

    320 x 240 points color Liquid Crystal DISPLAY LCD 5.7” graphic with touch screen; • Control Board with: Data presentation on the display; Serial interface RS-232C for software update; Remote Diagnostics and Remote Assistance Magnamed (ARM); Quick access keys for: ✓ HOLD; ✓ O 100%;...

  • Page 92: Haracteristics

    • Carrying Case without Oxygen Cylinder, optional. • Pedestal for Oxymag, optional. • Kit blender, optional. • PEEP valve integrated in the equipment. • Automatic barometric pressure compensation • Protection fuses for fixation support and pedestal: Voltage 250V; Current 3A; Operating speed: Medium; Breaking Capacity 100 A, Size: 5mm x 20mm, Quantity: 2.

  • Page 93: Connecting To The Physical Ande

    Immunity: IEC 60601-1-2 Emission: CISPR11 Approvals: OS/IEC 60601-1 • Protection Class of Breathing Accessories (Disposable or Reusable): BF type (Body Floating). Connecting to the Oxygen Supply • Oxygen Inlet –DISS male thread 9/16” 18 wires, as per ABNT NBR 11906 OPTIONAL –NIST Thread •...

  • Page 94: Components

    Item Parameter Specification Tolerance Unit Barometric Pressure 600 - 1100 Relative Humidity (w/o condensation) 15 - 95 Temperature -25 - 75 °C Storage/ Transport Barometric Pressure 500 - 1200 Relative Humidity (w/o condensation) 5 - 95 Life time years Time to heat or cool equipment stored at extreme temperatures minutes to operate at 20 °...

  • Page 95: Ontrolled Ventilation

    • AC mains supply with frequency values 5% below or 5% above nominal may result in switching to the internal battery, but the equipment will maintain its normal operation. Caution The temperature alarm will be triggered if the environmental condition is below -10ºC or above 50ºC (low/high •...
  • Page 96 Item Parameter Specification Resolution Unit 100 to 2500: 10 Tidal Volume 20 to 2500 20 to 100: 5 Respiratory rate 0 to 150 Rise time 0 to 2,0 Pause 0 to 70 Maximum Limit Pressure 0 to 60 Inspiratory Pressure 1 to 60 Delta of support pressure (∆PS) OFF;...
  • Page 97 Item Parameter Specification Resolution Unit 0,20 to 0,70:0,01 0,70 to 1,00:0,05 High Time 0,20 to 60,0 1,00 to 10,0:0,10 10,00 to 60,0:1,0 0,20 to 0,70:0,01 0,70 to 1,00:0,05 Low Time 0,20 to 60,0 1,00 to 10,0:0,10 10,00 to 60,0:1,0 Ratio 1:4 to 4:1 1:0,1 Backup...
  • Page 98 be adjusted. In VCV, adjustment allowed is in the range between 1:4 and 4:1 Backup options for CPAP/PSV mode; for DUALPAP mode, backup options are: PLV for neonatal, PCV for adult or OFF. Setting OFF, mode will not enter in backup when time for apnea alarm is reached. For modes with controlled volume, maximum compensation is 100% flow adjusted automatically Depending on the type of patient set during startup, the ventilator will be set to operate according to the following table: (Patients smaller than 0.16m or greater than 2.5m can be ventilated in this equipment)

  • Page 99: Ventilation Parameters

    Specifications of the Monitoring Ventilation Parameters Table 31: Ventilation parameters Item Parameter Range Resolution Tolerance Unit Instant Pressure  (1 cmH2O or -20 to 100 Measured 2% reading)  (1 cmH2O or Maximum Inspiratory 0 to 90 Pressure 2% reading) ...
  • Page 100 Item Parameter Range Resolution Tolerance Unit Minute volume  (0.10L or 3% (Sensor Pediatric – 0,01 to 50,0 0,001 value PED) measured)  (0.06L or 3% Minute volume 0,001 to (Sensor Neonatal – value 0,001 20,0 NEO) measured)  ( 5% value Tidal Volume Inspired 0,001 to 0,01 to...

  • Page 101: Control Accuracy

    Item Parameter Range Resolution Tolerance Unit ± 3 bpm (low perfusion) ±(0.2% in volume 0 to 15:1 + 2% reading) 2 (8) 0 to 25 %vol Not Specified 15 to 25: Not Specified When indicated two tolerances, consider the highest value. 1 mbar (milibar) = 1 hPa (hectoPascal) = 1.016 cmH2O (centimeter of water).

  • Page 102: Alarm System

    Item Parameter Accuracy ± (2 cmH2O + 4% of Inspiratory pressure adjusted pressure) ± (2 cmH2O + 4% of PEEP adjusted PEEP) 1 Volume and pressure accuracy is preserved for circuits with resistance up to 1.9 cmH2O with 15 LPM flow and compliance up to 5 mL / cmH2O.
  • Page 103 Table 34: Priority of the alarm condition Potential result of a failure to Beginning of potential injury respond to the cause of the alarm Immediate Prompt Delayed condition HIGH PRIORITY HIGH PRIORITY MEDIUM PRIORITY Death or irreparable injury HIGH PRIORITY MEDIUM PRIORITY Repairable injury MEDIUM PRIORITY...
  • Page 104 Standard Alarm¹ Item Alarm Setting Limit Unit High Maximum OFF; 0 to 80 Pressure High PEEP OFF; 0 to 40 High 50 mL 500 mL 1.0 L Total Volume OFF; 0 to 3000 High Minute volume OFF; 0 to 99 High Time for Apnea OFF;...
  • Page 105 • Default values of the alarms are only for initial reference. Reset the alarm limits as needed by the patient. • There may be danger if different default alarm values are used for the same or similar equipment in the same area. •...

  • Page 106: Breathing Circuit Curve

    Concentration x Pressure in the breathing circuit curve Figure 29: Concentration curve in function of pressur e in the breathing circuit Performance Specifications Table 37: Performance specification Item Parameter Specification Tolerance Unit Maximum Flow in Pressure Support or  10% L.min in cycles of controlled pressure Cycled by Time, Constant Volume and...
  • Page 107 Figure 30: Influence of airway pressure on tidal volume (1) To check the influence of airway pressure on minute volume, in the graph, the tidal volume applied by the monitored respiratory rate should be multiplied. Specifications for Maintenance and Calibration Caution The processing time is after stabilizing at the specified temperature and pressure.

  • Page 108: Breathing Circuit

    Description Specification Tolerance Unit Item Autoclavable flow sensors Adult(3201100), Pediatric (3201099), Neonante (3201098)  1 month Review Year Calibration  50 500h Hours Air intake filter 500h  50 Hours If environment in which it is used contains excessive particulate matter in suspension, replace air filter at shorter intervals Mask for Non-Invasive Ventilation Specification Adult/ Pediatric connection...

  • Page 109: Expiratory Limb

    Specifications for Resistance of the Expiratory Limb Table 39: Expiratory Resistance in Function of Breathing Circuit and Accessories Aggregates Expiratory Resistance (hPa or cmH2O) Flow Breathing Circuit L x min Circuit Circuit + Flow Sensor Circuit + Flow Sensor + Circuit + Flow Sensor + CO2 Sensor + HME HME Filter...

  • Page 110: Pneumatic Diagram

    Pneumatic diagram Filter Pressure measuring point Pressure regulating valve 45 psi Humidifier (optional) Pressure sensor 150 psi Breathing circuit Proportional valve 30 LPM Capnograph (optional) Venturi system HEPA or HME filter Proportional valve 200 LPM Proximal flow sensor One-way valve (anti-asphyxiation) Expiratory valve cell Linear actuator...

  • Page 111: Electronics

    Block Diagram of Control Electronics Figure 32: Block Diagram of Electronics OxyMag_rev26...

  • Page 112: Compatibility

    Electromagnetic Compatibility Changes or modifications to this equipment not expressly approved by MAGNAMED can cause EMC problems with this equipment or another. Contact MAGNAMED to receive technical assistance. This equipment has been designed and tested to comply with applicable EMC standards as described below.
  • Page 113 Table 41: Specification of electromagnetic environment of use Compatibility Directive for Electromagnetic Environment Emission Test The system uses RF energy only for its internal RF Emissions functions. However, its RF emissions are very low Group 1 ABNT NBR IEC CISPR 11 and not likely to cause any interference in nearby electronic equipment.
  • Page 114 B) Guidelines and manufacturer’s statement – Electromagnetic immunity Oxymag is intended for use in the electromagnetic environment specified below. The buyer or user of Oxymag shall ensure that it is used in such an environment. Table 42: Electromagnetic environment for use of the system...
  • Page 115 TV broadcasts cannot be predicted theoretically with precision. . To assess the electromagnetic environment generated by fixed RF transmitters, an electromagnetic field survey should be considered. If the measured field strength at the location where Oxymag will be used exceeds the applicable RF CONFORMITY LEVEL set...
  • Page 116 Oxymag should be observed to verify that it is operating normally. If abnormal performance is detected, additional measures may be necessary, such as reorienting or relocating Oxymag. d Above the frequency range 0.15 MHz to 80 MHz, the field strength should be less than 3 V / m.
  • Page 117 Fields in the vicinity of RF wireless communication equipment The Oxymag cabinet interface has been tested as specified in the table below using the test methods specified in IEC 61000-4-3 Band Freq. test Modulation Trial level [ MHz ] [ MHz ]...

  • Page 118: O2 Galvanic Cell Specification

    14.4 O2 galvanic cell specification General specification Measure the O concentration delivered from Intended use the equipment to the patient Measuring range 0 to 100% Output sign 9 – 13 mV Response time 90% 13 s Accuracy ± 2% Linearity ±...

  • Page 119: Symbols

    15. Symbols SYMBOLS / PORTUGUÊS ESPAÑOL ENGLISH UNIFIED TEXTS PACIENTE PACIENTE PATIENT CORRENTE CONTÍNUA CORRIENTE CONTINUA CONTINUOUS TIDAL CORRENTE ALTERNADA CORRIENTE ALTERNA ALTERNATING CURRENT (REDE) (RED) (POWER) ENERGIA ELÉTRICA ENERGÍA ELÉCTRICA ELECTRIC ENERGY WASTE – ELECTRICAL AND ELECTRIC RECOLHIMENTO DE EQUIPAMENTO RECOGIMIENTO DE EQUIPO EQUIPMENT SHALL BE COLLECTED ELÉTRICO/ELETRÔNICO FEITO DE...
  • Page 120 SYMBOLS / PORTUGUÊS ESPAÑOL ENGLISH UNIFIED TEXTS IDENTIFICAR OU ACONSELHAR IDENTIFICAR O ASESORAR LA TO IDENTIFY OR ADVISE CLEANING LIMPEZA OU TROCA DE FILTRO LIMPIEZA O EL CAMBIO DEL FILTRO OR CHANGING A FILTER TRAVAR TECLADO TRABAR TECLADO KEYBOARD LOCK MANTENIMIENTO MANUTENÇÃO PERIÓDICA PERIODIC MAINTENANCE...
  • Page 121 SYMBOLS / PORTUGUÊS ESPAÑOL ENGLISH UNIFIED TEXTS MANUAL DE OPERATING INSTRUÇÃO DE USO INSTRUCCIONES INSTRUCTIONS FRÁGIL FRÁGIL FRAGILE FACE SUPERIOR NESTA LADO SUPERIOR EN ESTA THIS SIDE UP DIREÇÃO DIRECCIÓN PROTEGER CONTRA PROTEGER CONTRA LA FEARS HUMIDITY UMIDADE HUMIDAD SOSTENIMIENTOS DE LA QUANTIDADE SEGURA DE CANTIDAD DE SAFE STACKING QUANTITY...
  • Page 122 SYMBOLS / PORTUGUÊS ESPAÑOL ENGLISH UNIFIED TEXTS FUSÍVEL FUSIBLE FUSE CONFORMIDADE CE: INDICA QUE CONFORMIDAD CE: INDICA QUE CONFORMITY CE: INDICATES O SISTEMA ESTÁ EM EL SISTEMA ESTÁ EN THAT THE SYSTEM IS IN CONFORMIDADE COM A CONFORMIDAD CON LA ACCORDANCE WITH DIRETIVA DIRECTIVA DEL CONSEJO...
  • Page 123 SYMBOLS / PORTUGUÊS ESPAÑOL ENGLISH UNIFIED TEXTS EXAUSTÃO ESCAPE EXAUSTION AFERIÇÃO DA PRESSÃO MEDICIÓN DE PRESIÓN PRESSURE GAUGE Essa aferição é uma técnica de Esta medición es una técnica de This measurement is a flow and leitura de fluxo e volume. A lectura de flujo y volumen.

  • Page 124: Terms And Abbreviations

    16. Terms and Abbreviations Table 45: List of terms and abbreviations with their descriptions Terms and Terms and Description Description Abbreviation Abbreviation Adult Ratio T.Insp by TExp Backup Apnea Mode Setting Body Mass Index C.Dyn Dynamic Compliance Infant i  Alarm setting High CO inspired Man Trig...
  • Page 125 Terms and Terms and Description Description Abbreviation Abbreviation Continuous Pressure Ventilation with VMspn Spontaneous Minute Volume Pressure Support Synchonized Intermittent Mandatory P. High High pressure of DualPAP mode V-SIMV Ventilation with Controlled Volume cycle P.Low Low pressure Vspn Spontaneous Volume Airway resistance Adjusted Tidal Volume Resistance...

  • Page 126: Statement Of Biocompatibility

    This is to state, under our sole responsibility, that all materials used in parts (as defined in standard NBR IEC 60601-1) applied to Oxymag has been widely used in the medical field overtime, no effects related to toxicity or tissue effects, thus ensuring their biocompatibility.

  • Page 127: Warranty

    18. Warranty The manufactured Products and marketed by MAGNAMED TECNOLOGIA MÉDICA S/A are warranted against material and manufacture defects throughout Brazil, as provided below. The warranty period for the equipment is 12 months. For batteries and accessories, the periods of 3 months, provided that retained their original features;...

  • Page 128: Technical Assistance

    19. Technical Assistance For maintenance, please contact our technical assistance who will indicate the service nearest you or visit our website. OxyMag_rev26...

  • Page 129: Training

    Training To request training, please contact Magnamed product expert team who will indicate the authorized Representative nearest you. OxyMag_rev26...
  • Page 130 Website: www.magnamed.com.br Email: magnamed@magnamed.com.br Manufacturer / Technical Assistance / Customer Service Magnamed Tecnologia Médica S/A Rua Santa Mônica, 801 - 831 – Bairro Capuava CEP: 06715-865 – Cotia – SP – Brasil Phone/Fax: +55 (11) 4615-8500 E-mail: magnamed@magnamed.com.br Website: www.magnamed.com.br CNPJ: 01.298.443/0002-54...

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