Page 1 Operation Manual OxyMag – Transport and Emergency Ventilator US FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN...
Page 2 All rights reserved by Magnamed Tecnologia Médica S/A Santa Mônica St, 801/831 – Capuava Zip Code: 06715-865 – 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 1606880-01: OxyMag Review of this operation manual: 07...
Page 3: Table Of Contents
Table of Contents DEFINITION AND CARE ........5 6.1. VCV – V . 46 OLUME ONTROLLED ENTILATION 6.2. PCV – P RESSURE ONTROLLED ENTILATION ..........5 EFINITIONS 6.3. V-SIMV – S YNCHRONIZED NTERMITTENT ..........5 ARNING – V .. 50 ANDATORY ENTILATION OLUME...
Page 4 12.3.4. I 12.3.15. S NTERNAL VOLUME OF RESPIRATORY CIRCUIT PECIFICATIONS AINTENANCE COMPONENTS ALIBRATION 12.3.5. E ......86 12.3.16. B ....... 101 XTREME CONDITIONS REATHING IRCUIT 12.3.6. V ....... 87 12.3.17. HME F ......... 102 ENTILATION ODES ILTER 12.3.7. S 12.3.18. P ......
Page 5: Definition And Care
Definition and Care a. Definitions • This header 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 • This header 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.
Page 6 • Only use power supply, hose and breathing circuit (including exhalation valve, diaphragm, HME filter, flow sensor and flow sensor line) supplied by Magnamed which were tested and approved for use in conjunction with this equipment; otherwise, this can jeopardize the operation endangering the patient or user.
Page 7 • When turning on the ventilator, please choose the type of patient on the home screen and this will set the proper ventilation. • Oxymag and all parts applied to it are made of non-toxic material, latex-free, and do not cause irritation or allergy to the patient. Applied parts is ventilation breathing circuit.
Page 8 deterioration of health. • The ventilator shall not be used with inlet gases, which are not specified for use (e.g., helium or mixtures with helium). Such use might cause the ventilator to not function correctly, causing patient death or serious deterioration of health.
Page 9: Caution
• Oxymag does not emit electromagnetic waves that interfere with the equipment operation in the vicinity. • Oxymag must have the ambient air intake filter replaced every 500 hours of use. • Oxymag should only have their maintenance carried out by a qualified, trained technician duly authorized by MAGNAMED.
Page 10: Description
1. Description Device Description 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. O concentration is obtained through a galvanic cell 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.
Page 11: Intended Use
APNEA; this ventilation can be chosen between VCV, PCV or OFF. Intended Use Oxymag is a controlled volume, pressure and time cycled emergency and transport ventilator. It is intended for use with infant, child, and adult patients with a tidal volume from 50 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress and who require the ventilatory support.
Page 12: Unpacking The Product
MAGNAMED. DO NOT open the package. ✓ Open the package carefully observing the symbols in the box. ✓ Check the content in accordance with the following list of components. Table 1: List of components for Oxymag Part Image Description...
Page 13: Parts And Accessories
• Parts and pieces indicated in these instructions for use may be used in the patient environment. • Before use the equipment and accessories, open the packages carefully and remove the items from their packages. Optional accessories that can be purchased for Oxymag Table 2: List of optional components for Oxymag. Part Number Description...
Page 14: Oxymag
Third-party accessories compatible with Oxymag Nebulizer • Aeroneb® Solo Nebulizer System (K133360) Facial mask • Adult mask: Non-invasive ventilation in transport Indications for use environment Patient weight > 36.6 kg Patient usage type Single use Pressure source action body site...
Page 15 • Infant mask: Non-invasive ventilation in transport Indications for use environment 6 kg ≤ P < 12.4 kg Patient weight Patient usage type Single use Pressure source action body site Mouth and Nose Breathing Tube connection 22 mm conical connector According to section 13.3.3 Physical and Operating environment Environmental Specifications...
Page 16: Components Of Transport Ventilator
Components of Figures 1 and 2 1. 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 17 Components of Figures 1 and 2 5. HANDLE This handle allows the user to carry the ventilator during rescue and emergency situations. At the rear of the ventilator, there is a support that can be easily adapted to a patient stretcher. 6.
Page 18 Components of Figures 1 and 2 change the value of the desired flow. 11. FREEZE KEY Freezes the graph layout to allow the analysis of the curves. Figure 3: Right side view Table 4: Description of components of the right side of the transport ventilator. Components of Figure 3 12.
Page 19 Figure 4: Left side view Table 5: Description of the components found in the left side Description of the items in Figure 4 15. Air Inlet Filter Ambient air intake filter, which is mixed with oxygen to provide oxygen concentrations less than 100%.
Page 20 Description of the items in Figure 3 and 4 20. PLUG OF POWER SUPPLY – BASE This plug is used along with the support base of Oxymag and the power supply system. The inlet is +12VDC. Note the polarity indication and the recorded voltage DC power.
Page 21 Caution • If there is no confirmation by pressing the button, the parameter value will return to the previous value after 10 seconds. Note • For electrical insulation of the ventilator circuits from the external source, only disconnect the power supply input+12VDC of the equipment Oxymag_Rev07...
Page 22: Description Of The Display
Description of the Display Home Screen By starting the ventilator, the following screen will be displayed: It is recommended to perform the autotest before starting the ventilation. To do this, press the button “Test” and follow the instructions on the screen. For more information, see chapter 5.2.2 - Test Sequence.
Page 23: Modes
Modes In the upper left corner, there is the indicator of: • Type of patient selected: Adult; Child; Infant; • Active Mode; • NIV indication (CPAP mode). By clicking on the button, it will be displayed the available ventilatory modes. To change the mode, click on the desired mode, and set the parameters that will blink in yellow.
Page 24: Battery Status
Battery status The remaining battery charge will be displayed on this icon. Bar graph The bar graph will show the instantaneous pressure in the breathing circuit and the value of maximal inspiratory pressure at the top. Set parameters The available set parameters will be displayed on this area. To change the parameter, click on the desired parameter, adjust the value with the knob and click to confirm.
Page 25: Alarm Menu
Alarm menu 3.2.10.1 By accessing this menu, it is possible to set the alarm limits. To access the ALARM menu, press anywhere on the graph screen and select ALARM. It will be displayed the alarm limits of Pressure, Volume, PEEP, FiO2, Minute Volume, Respiratory Rate, and Apnea Time.
Page 26 • In the O cell by pressing the “Calibrate O2” tab it is possible to calibrate the O button. Note • It is not necessary to discard calibration gases. • In VENTILATOR tab it is possible to: o Set Audio volume – to set the alarm audio volume. Use the knob to change and confirm to make this adjustment.
Page 27: Preparation For Use
Table 7 describes the steps that the operator should follow (health care professional, duly trained and authorized to use the equipment) to assemble and prepare the transport ventilator. Table 7: Assembly Sequence of Oxymag Assembly Sequence 1. Insert a diaphragm in the exhalation valve, then insert the assembly into the base and press firmly and rotate clockwise to lock.
Page 28 Assembly Sequence Caution • Securely check the connection of the breathing circuit and the flow sensor. 4. Connect the power supply AC/DC to the equipment and then to the power grid. 5. Connect the oxygen hose to the transport ventilator. O2 hose Oxymag_Rev07...
Page 29: Invasive Ventilation Mask
Note • There is an indication with a larger circle and a smaller circle in the ventilator showing the fitting position of the pressure line in the equipment. • There is no specific position for the disposition between the operator and the patient, as long as the breathing circuit is mounted properly.
Page 30: Power Connection
• PROPER connection of these pressure lines are extremely important for monitoring patient ventilation. • When using the Oxymag for an extended time on battery, an alarm occurs whose message is LOW BATTERY. Provide IMMEDIATE connection of power supply to the power grid, and if DISCONNECTING the equipment from the patient is not possible, the user must provide appropriate means of ventilatory support.
Page 31: Mounting The Vertical Support
2. To place the ventilator on the support, follow the procedure below: a. Pull the handle bracket on the wall, just above the fixed support; b. Slide Oxymag down until it clicks into place; c. Press the safety lock of the ventilator turning the two eccentric buttons from the top until the red dots are no longer visible;...
Page 32 2. To place the ventilator on the support, follow the procedure below: a. Insert the handle holder in the support above the fixed support; b. Slide Oxymag down until it clicks into place; c. Activate the safety lock of the ventilator turning both eccentric buttons from the top until the red dots are no longer visible;...
Page 33: Nebulizer Assembling
Figure 11: Connection of the ventilator to the support Nebulizer assembling To connect the nebulizer, remove the HME filter from the breathing circuit and connect the tee adaptor in the inspiratory branch (1). Connect the Aerogen solo® (2) to the tee adaptor. Connect the Y (3). Connect the flow sensor and mask after Y (4) as shown in Figure 12.
Page 34: Invasive Mode
• Only nebulize drugs in a manner consistent with what the drug has been cleared for by the FDA. • Only nebulize drugs in the route of administration (e.g., oral, tracheal) that is consistent with what the drug has been cleared for by the FDA. Caution •...
Page 35 Start the invasive mode ventilation Oxymag_Rev07...
Page 36: Inspection Before Use
Inspection Before Use The purpose of this inspection routine is to guide the user in performing a simple and quick set of procedures to test the equipment before each use or at least at the beginning of each work period. •...
Page 37: Ventilator Settings
Ventilator Settings The ideal weight of the patient is used to calculate the ventilator parameters to provide the best approximation to ventilate the patient. This value is calculated using the height of the patient, considering the Body Mass Index (BMI) of 22. The following will be calculated according to the weight: •...
Page 38 Startup Patient Height Ideal Weight P button type CHILD 0.95 m (3.12 ft) 19.8 kg (43.7 lbs) ADULT 1.50 m (4,92 ft) 49.5 kg (109.1 lbs) After startup, it is possible to change the height value within the adjustment range of the patient type by clicking on the chart area and menu and select the Settings button (General Tab).
Page 39: Normal Startup Sequence
(Height [m]) Normal Startup Sequence 1. Oxymag Main Menu – Turn on the ventilator with the on-off switch on the left side of the equipment. Once it turns on, notice if a triple “beep” occurs in conjunction with the light alarm indicator. This means that the audible and visual alarm are operational.
Page 40 Default PEEP 5 cmH2O Flow Trigger Pressure Trigger Rise Time 0,1s 5. By choosing CHILD, the ventilator will start the ventilation with the following parameters: Table 12: List of parameters in the CHILD mode Default Pcontrol 10 cmH2O Rate 22 min Ratio I:E PEEP 5 cmH2O...
Page 41 Default Pause Flow Trigger Pressure Trigger Wave Flow Square 7. After the startup sequence, the equipment will display the graph screen of the ventilator. Audible alarms will be disabled in the first 2 minutes. Note that the white bar next to the alarm silence symbol is reduced over time. After 2 minutes the audible alarm will be reactivated.
Page 42: Test Sequence
Press the ALARM button and the Alarm Setting screen will appear. Select the alarm to be set and use the knob and to change the value. When the desired value is set confirm pressing the knob. To return to the secondary menu with the selection of graphs, measurements, settings, and alarms, press the button.
Page 43: Failure Diagnosis
5. After the test phase of the proximal sensor, press NEXT to continue. 6. Occlusion of the breathing circuit in the “Y” after the flow sensor will be requested. Press OK to confirm that the circuit is properly occluded. Make sure that all the test items are APPROVED and check if the data for compliance, breathing circuit resistance and leakage value are suitable for use in the ventilator.
Page 44 Fault Action Consequence Internal Failure in flow control, use not Contact Technical Assistance Sensor allowed Ensures that the oxygen supply Air Flow+ pressure is according to the Lack of flow, use not allowed specification 15.3.2 Connecting to the Oxygen Supply Cell No warranty for O Cell, use not...
Page 45 Oxymag_Rev07...
Page 46: Description Of Modes
6. Description of Modes 6.1. VCV – Volume Controlled Ventilation Description: Set Parameters: In this mode, the ventilator controls the • VOLUME; volume flow and cycle, i.e., at each • R.RATE; inspiratory cycle the ventilator delivers a • RATIO I:E; precise volume to the patient, so long that •...
Page 47 1. Ventilation without Inspiratory Pause: after TINS, the ventilator cycles to exhalation. The inspiratory pressure achieved is a consequence of the volume delivered and the resistance and compliance of the patient’s breathing circuit. 2. Ventilation with Inspiratory Pause: after delivery of the set volume, the ventilator maintains the exhalation paused until complete TINS, after which the ventilator cycles to exhalation.
Page 48 6.2. PCV – Pressure Controlled Ventilation Set Parameters: Description: In this mode, the ventilator controls • PRESSURE CONTROL; pressure and cycles on time, i.e., at each • R.RATE; inspiratory cycle. The ventilator reaches the • RATIO I:E; set pressure and remains at this level until •...
Page 49 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 50: Ontrolled Entilation Ntermittent Ontrolled Ycle
6.3. V-SIMV – Synchronized Intermittent Mandatory Ventilation – Volume Controlled Cycle Set Parameters: Description: • VOLUME; In this mode, the patient can breathe • R.RATE; spontaneously between controlled • INSPIRATORY TIME; cycles, with or without the use of pressure • PEEP; support.
Page 51 2 Represents a spontaneous breathing cycle of the patient WITHOUT PRESSURE SUPPORT; 3 Represents a VCV (volume controlled) cycle with SIMV Period elapsed; 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.
Page 52: Ontrolled Cycle
6.4. P-SIMV – Synchronized Intermittent Mandatory Ventilation – Pressure Controlled Cycle Set Parameters: Description: • PRESSURE CONTROL; In this mode, the patient can breathe • R.RATE; spontaneously between the controlled • INSPIRATORY TIME; cycles, with or without the use of •...
Page 53 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;...
Page 54: Pcv - Pressurec
6.5. CPAP/PSV – Continuous Pressure Ventilation with Pressure Support Set Parameters: Description: • PEEP or CPAP; this mode, patient breathes • ΔPS (Pressure Support – PEEP); spontaneously on a continuous positive • TRIGGER BY FLOW; pressure and breathing is assisted by a •...
Page 55 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. RISE TIME of pressure support may be adjusted so that initial flow is smoothed. 6 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 56: Alarms Available
7.1. Description of alarm control The alarm system of the Oxymag family ventilators is classified according to the degree of priority (low, medium, and high priority) as shown in table. Table 15: Classification of alarms according to the priority level...
Page 57 HIGH Delay Time Description PRIORITY Supply It is triggered when pressure of oxygen network is < 1 second Press. insufficient for equipment operation. It is triggered when there is obstruction in the breathing Obstruction circuit that prevents the complete expiration by the <...
Page 58 MEDIUM Delay Time Description PRIORITY It is triggered when the minute volume of the patient High MV has exceeded the alarm value set as upper limit of < 3 cycles minute volume It is triggered when the minute volume of the patient is Low MV below the alarm value set as lower limit of minute <...
Page 59 LOW PRIORITY Delay Time Description It is triggered when the equipment is disconnected AC input fail from the electric mains and the power is switched to < 1 second internal power supply. It is displayed when the proximal flow sensor is disconnected.
Page 60 b) Disconnection alarm The disconnection alarm is triggered when any kind of disconnection from the breathing circuit occurs, which would prevent proper ventilation to the patient. In this case, there are two criteria to check the disconnection. The first criterion is based on the measured values of positive end-expiratory pressure (PEEP).
Page 61 Delay Time Description Alert It is displayed in the event of a spontaneous trigger Spont. Fl. Trig < 1 second generated by a flow trigger Spont. Pr. It is displayed in the event of a spontaneous trigger < 1 second Trig generated by a pressure trigger Spont.
Page 62 2. Failure in the charging system with the internal battery full charged. of the internal battery, even with the presence of electric power; 2. Contact Technical Assistance / Magnamed; Restore connection 1. Disconnection to the power equipment to a power grid or use the cord;...
Page 63 Solutions Problem Device Contact Technical Assistance Electronic failure Failure Alarm Magnamed 1. Disconnection in the breathing 1. Locate the disconnection and circuit; connect securely; 2. Check if there is inspiratory flow 2. Lack of Inspiratory Flow; and increase, if necessary;...
Page 64 Low Supply 2. Connect the O hose to the 2. O hose is not connected to Press. alarm device. the equipment 3. Contact Magnamed Technical 3. O Pressure Sensor Failure Assistance. 1. Inspiratory or expiratory 1. Clear it; Obstruction branch obstructed 2.
Page 65 18%. below 2. Calibrate O cell. 18% alarm 2. Unbalanced O cell. 3. Contact Magnamed Technical 3. Damaged O cell. Assistance. 1. Change the adjusted parameters 1. Volume delivered and High MV of the ventilation mode or set the...
Page 66: Setting Alarms
Possible Causes Solutions Problem 1. Replace the cooler’s filter 1. Cooler’s filter is saturated HW: High O2 2. Contact Magnamed Technical int. 2. Internal leakage of O2 Assistance 7.2. Setting Alarms To enter the alarm setting screen, press ALARM button on the secondary menu screen.
Page 67: Peep Alarm
To test the high-pressure alarm, enter PCV mode, set PEEP to zero, Pr insp to 5 and set the upper limit of the Ppeak alarm to 5. Set up the complete circuit, ventilate and press the test balloon so that the monitored pressure is greater than the set pressure. To test the low-pressure alarm, set the lower limit of the pressure alarm so that it is higher than the pressure monitored on the device.
Page 68: Fio 2 Alarm
To test the apnea alarm, set the apnea alarm time to 3 seconds and in ventilatory mode, a low respiratory rate. Place the ventilator in normal operation and wait for the time set for the alarm to occur. 7.3.1.7. FiO alarm To test the high FiO alarm, set the upper limit of the FiO...
Page 69: Manual Ventilation Of The Cleaning And Disinfection
To test the low O pressure alarm, put the ventilator in normal operation, disconnect the oxygen source from the ventilator and observe the activation of the high priority alarm. 7.4. Manual Ventilation of the Patient To perform manual ventilation to a patient, the ventilator must be on STAND-BY. In this situation, if the flow sensor is connected to the patient’s breathing circuit, the monitoring of ventilation will be fully operational, including its alarm system.
Page 70: Cleaning And Disinfection
20 minutes. 8.2. Equipment cleaning External ventilator surfaces of the Oxymag, supply hose, touch screen, power supply and power cables, should be cleaned with a clean, soft cloth moistened with enzymatic detergents (e.g., Empower), after each patient use, or as needed.
Page 71 d) Disconnect the oxygen hose. e) Disconnect the power supply AC/DC. 2. Prepare a solution with enzymatic detergent and warm water. Check the concentration in the manufacturer´s recommendations. 3. Dampen a lint-free cloth. 4. Wipe the surfaces areas on the product and parts and remove exterior impurities by carefully scrubbing the grooves in the screws, the hole of inspiratory flow connector and the expiratory flow connector with a soft cloth.
Page 72 8.3. Disinfection External ventilator surfaces of Oxymag, the supply hose, touch screen power supply and power cables, should be cleaned with a clean, soft cloth moistened with a registered and approved Ethyl alcohol (70%) or disinfectant spray cleaner, after each patient use or as needed.
Page 73 Caution • Ensure that no residue builds up in the connections of the equipment. • Do not clean/disinfect the interior of the ventilator to avoid damaging any internal components. • Be sure to only clean around the connection ports, not inside them. •...
Page 74: Preventive Maintenance
MAGNAMED. Failure to comply will void the manufacturer's warranty and obligations regarding the ventilator. • Oxymag must pass annual periodic maintenance (every 1 year) or after 5000 hours, whichever comes first. Failure to perform maintenance could affect the safety and performance of the ventilator.
Page 75: Replacing The Ambient
• The oxygen concentration sensor should be replaced as indicated in the Technical Specification and shall be performed only by a qualified technician, trained and authorized by MAGNAMED. 9.4. Replacing the Ambient Air Filter The ambient air filter shall be replaced after 500 hours of use. To replace the ambient...
Page 76: Shipping The Product To
• When sending Oxymag for maintenance or repair services: closely follow the disinfection process. • Equipment visibly contaminated by patients’ fluid will be returned without performing maintenance or repair service.
Page 77: Replacing The Cooler
9.6. Replacing the cooler’s filter The cooler’s filter shall be replaced after 500 hours of use. To replace the cooler’s filter, follow the procedure below: (1) Remove the filter cover on the back side of the ventilator. (2) Remove the old filter. (3) Clean the filter area (4) After drying, introduce a new filter.
Page 78: Disposal
10. Disposal The Oxymag ventilator should be disposed of as any electrical equipment. Accessories and consumables should be disposed of as described in the instructions for use. Follow local government recommendations for proper disposal. Caution • When discarding ventilator components, treat components that might have been contaminated as biohazardous waste.
Page 79: Turning Off The Equipment
11. Turning off the Equipment The lung ventilator Oxymag is a life support equipment and MUST be disconnected from the patient to be turned off. The equipment should be turned off by pressing the on/off switch, identified in Figure 4. When the equipment is turned off, a continuous audio signal will be produced indicating that the equipment has been turned off.
Page 80: Technical Specification
12. Technical Specification 12.1. Classification • 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. • FDA Regulation: 868.5925 – Powered emergency ventilator: Classification: Class II Identification: A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a...
Page 81 performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems • IEC 60601-1-6:2010 (EN 60601-1-6:2010) – Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability •...
Page 82: Specifications
• 320 x 240 points color Liquid Crystal DISPLAY LCD 5.7” graphic with touch screen; • Control Board with: o Data presentation on the display; o Serial interface RS-232C for software update; o Remote Diagnostics and Remote Assistance Magnamed (ARM); o Quick access keys for: ✓ HOLD; ✓ O 100%;...
Page 83: Lectrical Haracteristics
• Breathing Circuit • Galvanic cell internal O • External source AC/DC converter AC/DC 100 – 240 VAC to +12 VDC; • Plastic Cabinet in high impact ABS resistant to blows; • PEEP valve integrated in the equipment. • Automatic barometric pressure compensation. •...
Page 84: Connecting To Theo
Item Parameter Specification Tolerance Unit Service life years The battery should be charged at room temperature, 5 - 35 ºC (41 °F – 95 °F). During the charge of the battery, the performance of the equipment is not affected. Table 20: Run time for adult, child and infant conditions Patient Condition Run time...
Page 85: Physical And Environmental
o Volume 500ml; o Pause 30%; o Rate 12rpm; o FiO 100%; o Ratio 1:2; o Square flow wave. o PEEP 5 cmH2O; Note • All materials composing the product are compatible with Oxygen, Air and Medicinal Compressed Air. 12.3.3. Physical and Environmental Specifications Table 21: Physical and environmental specifications Item...
Page 86: Internal Volume Of Respiratory Circuit Components
Item Parameter Specification Tolerance Unit Temperature -13 to 167 °F Barometric 500 to 1200 Storage/ Pressure (cmH2O) Transport Relative Humidity (w/o 5 to 95 condensation) Life time years Time to heat or cool equipment stored at extreme temperatures to minutes operate at 20 °...
Page 87: Ventilation Modes
• Do not use the ventilator in environments outside the range of temperature, humidity and pressure specified in 12.3.3. Physical and Environmental Specifications Accuracy of equipment readings may be affected. Caution • The temperature alarm will be triggered if the internal temperature of the equipment is below -10ºC (14 °F) or above 50ºC (122 °F) (low/high internal temperature –...
Page 88: Specifications
Table 23: Setting specifications of parameters. Item Parameter Specification Resolution Unit 50 to 100: 5 Tidal Volume 50 to 2000 100 to 2000: Respiratory rate 5 to 60 Rise time 0 to 2,0 Pause 0 to 70 Maximum Limit 0 to 60 Pressure Control Pressure 4 to 50...
Page 89 Item Parameter Specification Resolution Unit CPAP 4 to 20 Ratio 1:4 to 3:1 1:0,1 Backup OFF; PCV; VCV Time for Apnea Alarm 10 to 60 Flow (flow meter) 0 to 15 L.min Pressure of 150 Leak Flow Volume of 40L.min L.min Compensation 0,53 to...
Page 90 Table 24: Ratio Mode x type of patient Patient Initial Mode Ideal Weight (IBW) Height Type INFANT 9 Kg (19.8 lbs) 0.64 m (2.09 ft) CHILD 19.8 Kg (43.6 lbs) 0.95 m (3.11 ft) ADULT 49.5 Kg (109.1 lbs) 1.50 m (4.92 ft) The ideal weight is calculated using BMI = 22 and patient height can be changed according to the type of patient set at startup as table below: Table 25: Calculation of ideal weight x patient height...
Page 91: Specifications Of The System
12.3.8. Specifications of the Monitoring Ventilation Parameters The monitored parameters are calculated using the ordinary least squares (OLS) technique, which calculates the mean through the most recent values in a data series. Thus, for each value included in the averaging calculation, the oldest value is excluded. Table 26: Ventilation parameters Measurement Item...
Page 92 Measurement Item Parameter Range Resolution Unit Accuracy Inspiratory (± 20% of 0,05 to 0,01 reading) Time 60,0 Expiratory (± 20% of 0,05 to 0,01 reading) Time 60,0 1:100,0 (± 20% of Ratio I:E 1:0,1 reading) 100,0:1 Respiratory (±1 or ±10% of 0 to 200 Rate reading)
Page 93: Control Accuracy
All monitoring data are considered at ATPD (Ambient, Temperature and Pressure Dry). The Ventilator does not generate negative pressure during expiratory phase. Volume, flow specifications associated with the ventilator respiratory system are expressed in BTPS with 50% oxygen concentration. 12.3.9. Specifications of the Safety and Alarm System •...
Page 94: Oxygen Adjustment Response Time
Item Parameter Accuracy ± 15% of reading 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. The accuracy of the parameters remains independent of the adjusted oxygen concentration.
Page 95 • Anti-asphyxia valve for fault protection in gas supply; • Safety Release Valve 100 cmH2O – Basic standard of ventilators to avoid overpressure in the breathing circuit; • Overpressure Valve ACTIVE – when detecting obstructions, it is activated to reduce pressure in the patient circuit.
Page 96 Table 30: Priority of the alarm condition Potential result of a Beginning of potential injury failure to respond to the cause of the Immediate Prompt Delayed alarm condition MEDIUM Death or irreparable HIGH PRIORITY HIGH PRIORITY PRIORITY injury HIGH PRIORITY MEDIUM PRIORITY Repairable injury Bruising or...
Page 97 Alarm Medium Low Priority Feature High Priority Priority Color Yellow Cyan Constant Intermittence frequency 1.42 hz 0.71 hz Number of saved pulses 10 pulses 3 pulses 1 pulse Interval between saves 5.0 s 5.1 s 59,4 s Sound pressure range 63.5 dBA 62 dBA 56,5 dBA...
Page 98 Standard Alarm¹ Item Alarm Setting Limit Unit CHILD Time for OFF; 10 to Apnea Alarm High Respiratory OFF; 1 to Rate High OFF; 18 to ¹ Every time the equipment starts up or there is a change of patient type, or the battery power runs out without plugging the ventilator to the power grid, the alarms will assume the default values indicated for each type of patient.
Page 99 • Low Battery • Low Network Pressure • Disconnection from the Breathing Circuit • Obstruction of the Breathing Circuit • Apnea • No AC power 12.3.13. Concentration x Pressure in the breathing circuit curve O X Flow Pressure 5 Pressure 15 Pressure 30 Pressure 60 Flow [L/min]...
Page 100: Specifications For Alibration
Depending on the parameters set by the user, the ventilator might not reach certain levels. In those situations, the operator should adjust the ventilation settings, such as I:E ratio and/or pause to increase the insufflation time and allow the system to reach the desired targets.
Page 101: Breathing Circuit
Each 5000h the proportional valves and linear actuator shall be reviewed and calibrated if needed to ensure that the flow and pressure are accurate. Table 34: Specification for maintenance and calibration Description Specification Tolerance Unit Item Review and 10,000 h or 2 ...
Page 102: Hme Filter
L x min Circuit + Flow Circuit Sensor Circuit + Flow Sensor + HME Filter 0.85 15.0 30.0 1.55 ¹ Maximum resistance to assure the accuracy. The operator should ensure that the inspiratory and expiratory resistance values are not exceeded when accessories or other components or subsets of the respiratory system are added.
Page 103 • To avoid cross contamination, a HME filter following the specifications in chapter 12.3.18, with local registration. Oxymag_Rev07...
Page 104: Pneumatic Diagram
12.3.18. Pneumatic diagram Filter Over-pressure Valve High Pressure Sensor Pressure Measurement Point Poppet Valve HME filter 30LPM Proportional Valves Universal Flow Sensor 200LPM Proportional Valves Universal Connector Silicon Line Mesh Filter Measurement point (proximal pressure differential) Check Valve Zero offset valve x-1 / 6 psi Solenoid valve Venturi Tube Exhalation Valve Measurement Point Oxygen Cell...
Page 105: Block Diagram Ofc
12.3.19. Block Diagram of Control Electronics Figure 23: Block Diagram of Electronics Oxymag_Rev07...
Page 106: Electromagnetic Compatibility
12.3.20. Electromagnetic Compatibility Changes or modifications to this equipment not expressly approved by MAGNAMED can cause EMC problems with this equipment or others. Contact MAGNAMED to receive technical assistance. This equipment has been designed and tested to comply with applicable EMC standards as described below.
Page 107 A) Guidelines and manufacturer’s statement – Electromagnetic emissions The Oxymag is intended for use in pre-hospital and hospital use including intra- hospital transport. Table 37: Specification of electromagnetic environment of use...
Page 108: Electromagneticc
90 °, 135 °, 180 °, 180 °, 225 °, environment. 225 °, 270 ° and IEC 61000-4-11 – 270 ° and 315 If the user of the Oxymag 315 ° Voltage dips, short ° requires continued operation interruptions and during power mains 0% UT;...
Page 109 Note: UT is the a.c. supply voltage before application of the test level. Electromagnetic Immunity The Oxymag is intended for use in the electromagnetic environment specified below. The customer or the user of the ventilator should assure that it is used in such an environment.
Page 110 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 111: O 2 Galvanic Cell Specification
normal conditions and single-failure conditions. This may cause dangerous electrical shock to the patient or operator. • After connecting any equipment into these outlets, the system should undergo a complete test for leakage current (according to standard IEC 60601-1). • The operator of the electromedical system must not touch the non-medical electrical equipment and the patient at the same time.
Page 112 < 5% Response to 7,5% Isoflurane < 5% Response to 7,5% Enflurane < 5% Response to 9% Sevoflurane < 5% Response to 20% Desflurane < 5% Response to 10% CO Oxymag_Rev07...
Page 113: Symbols
13. Symbols SYMBOLS / MEANING UNIFIED TEXTS PATIENT CONTINUOUS TIDAL ALTERNATING CURRENT (POWER) ELECTRIC ENERGY WASTE – ELECTRICAL AND ELECTRIC EQUIPMENT SHALL BE COLLECTED AND RECYCLED IN ACCORDANCE WITH DIRECTIVE 2002/96/EC DC INPUT POWER PLUG INSPIRATORY/ EXPIRATORY HOLD MANUAL TRIGGER OXYGEN 100% SERIAL TO IDENTIFY OR ADVISE CLEANING OR CHANGING A...
Page 114 SYMBOLS / MEANING UNIFIED TEXTS KEYBOARD LOCK PERIODIC MAINTENANCE FREEZE PAGE AUDIO ALARM PAUSED ALARM PROTECTED AGAINST THE INGRESS OF SOLID IP34 FOREIGN OBJECTS > 2.5 MM AND SPLASH-PROOF EQUIPMENT TYPE BF OF APPLIED PART CLASS II EQUIPMENT MANUFACTURE DATE MANUFACTURE EUROPEAN REPRESENTATIVE ATTENTION! SEE ACCOMPANYING DOCUMENTS...
Page 115 SYMBOLS / MEANING UNIFIED TEXTS THIS SIDE UP KEEP PROTECTED FROM MOISTURE SAFE STACKING QUANTITY TEMPERATURE LIMITS KEEP AWAY FROM HEAT INLET INLET OXYGEN ALARM SETTING OFF STAND BY INSP INSPIRATORY EXPIRATORY FUSE CONFORMITY CE: INDICATES THAT THE SYSTEM IS IN ACCORDANCE WITH DIRECTIVE OF THE EUROPEAN COUNCIL 93/42 INMETRO...
Page 116 ATMOSPHERIC PRESSURE LIMITATION Indicates the range of atmospheric pressure to which the medical device can be safely exposed. MR UNSAFE Oxymag poses unacceptable risks to the patient, medical staff, or other persons within the MR environment. Oxymag_Rev07...
Page 117: Terms And Abbreviations
14. Terms and Abbreviations Table 39: List of terms and abbreviations with their descriptions Terms and Terms and Description Description Abbreviation Abbreviation Adult Setting of Inspiratory P. Insp Pressure Apnea Mode Setting Backup Low pressure P.Low Body Mass Index Maximum Pressure in the P.Max Dynamic Compliance C.Dyn...
Page 118 Terms and Terms and Description Description Abbreviation Abbreviation Synchronized Intermittent Exhaled Tidal Volume Mandatory Ventilation with V-SIMV Tidal flow Controlled Volume cycle Value to be added to PEEP Adjusted Tidal Volume ∆PS pressure to obtain Pressure Inspired Tidal Volume Support Oxymag_Rev07...
Page 119: Statement Of Biocompatibility
15. Statement of Biocompatibility In accordance with ISO 10993-1 and ISO 18562-1, the components of a ventilator are classified as indirect contact. Therefore, Oxymag was tested and approved in the following tests: • Particulate matter emission • Volatile organic compounds •...
Page 120: Technical Assistance
17. Technical Assistance For maintenance, please contact our technical assistance who will indicate the service nearest you or visit our website. • Schedule preventive maintenance only with the authorized Magnamed Service. Oxymag_Rev07...
Page 121: Training
18. Training To request training, please contact Magnamed product expert team who will indicate the authorized Representative nearest you. Oxymag_Rev07...
Page 122: Warranty
19. Warranty The manufactured Products and marketed by MAGNAMED TECNOLOGIA MÉDICA S/A are under warranty against material and manufacture defects throughout Brazil, as provided below. The warranty period for the equipment is 12 months. For batteries and accessories, the warranty period is 3 months, provided that it retained its original state; this period starts on the date of purchase by the first purchaser of the product, as stated on the Sales Invoice of MAGNAMED TECNOLOGIA MÉDICA S/A.
Page 123 Website: www.magnamed.com.br Email: magnamed@magnamed.com.br Manufacturer / Technical Assistance / Customer Service Magnamed Tecnologia Médica S/A Santa Mônica St, 801 - 831 – Bairro Capuava Zip Code: 06715-865 – Cotia – SP – Brazil Phone/Fax: +55 (11) 4615-8500 E-mail: magnamed@magnamed.com.br Website: www.magnamed.com.br...

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