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OxyMag_rev26

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 ]

[ V/m ]

380 to 390

385

Pulse, 18 Hz

430 to 470

450

FM, 1 kHz,

Deviation from ± 5kHz

704 to 787

710
745
780

Pulse, 217 Hz

800 to 960

810
870
930

Pulse, 18 Hz

1.700 to 1.990

1.720
1.845
1.970

Pulse, 217 Hz

2.400 to 2.570

2.450

Pulse, 217 Hz

5.100 to 5.800

5.240
5.500
5.785

Pulse, 217 Hz

Electrical Safety

The following are the precautions that should be observed when combining these items (non-medical equipment) with the system.

•

Items that do not meet the
requirements of standard IEC 60601-1
cannot be placed within 1.5 from the
patient.

•

All items (electromedical or non-
medical equipment) connected to the
system with input/output signal cable

must receive power from an AC source
using separate transformer (according
to standard IEC 60989) or provide
additional earth protective conductor.

•

Multiple portable sockets with switch
used on AC power supplies must
comply with IEC 60601-1-1 and cannot

be installed on the floor. Do not use
more than one power strip with
portable switch.

•

Do not connect directly the non-

medical electrical equipment to an AC
wall outlet. Use AC power supply with

its own transformer. Otherwise, the
leakage current will increase above the
levels accepted by IEC 60601- under

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.  This  may
cause  dangerous  electrical  shock  to
the patient or operator.

Содержание OxyMag

Страница 1: ...Operation Manual OxyMag Transport and Emergency Ventilator...

Страница 2: ...puava 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 Responsibl...

Страница 3: ...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 CONTROLLE...

Страница 4: ...NTS 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...

Страница 5: ...tions 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...

Страница 6: ...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...

Страница 7: ...eeded 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...

Страница 8: ...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 Synchr...

Страница 9: ...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...

Страница 10: ...or 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...

Страница 11: ...sure the safety and effectiveness of the equipment Parts and pieces indicated in this instructions for use may be used in the patient environment OPERATION MANUAL Part Number 1600185 NE 22 RR Quantity...

Страница 12: ...AY WITH CAR PLUG Part Number 2802671 VERTICAL SUPPORT FOR AMBULANCE OR HELICOPTER WITH SAFETY LATCH Part Number 1702496 CARRYING BAG FOR OXYMAG Part Number 1702875 CARRYING BAG FOR OXYMAG WITHOUT CYLI...

Страница 13: ...one Lines 05 Adult Flow Sensors Autoclavable Part Number 5001495 PEDIATRIC FLOW SENSORS AUTOCLAVABLE 05 Silicone Line 05 Pediatric Flow Sensors Autoclavable Part Number 5001494 NEONATAL FLOW SENSORS A...

Страница 14: ...T CE 0413 Part Number 1704394 SPO2 ADULT PEDIATRIC PULSE OXIMETER SENSOR AND CABLE ADAPTER LNCS DC I SpO2 Adult Reusable Finger Clip Sensor CE 0123 Part Number 1704409 SPO2 NEO AND PED PULSE OXIMETER...

Страница 15: ...kwise To confirm press the button When the button returns to its original color the parameter set will be in effect 3 KEYBOARD The keypad buttons allow quick access to the ventilator functions 4 HANDL...

Страница 16: ...procedures of secretions from the airways When the ventilator is in STAND BY after pressing this button for 2 seconds an oxygen flow meter will be displayed in the ventilator screen At the top of the...

Страница 17: ...IT network include configuration changes connection of additional items disconnection of items upgrading of equipment connected to the IT network and enhancement of equipment connected to the data co...

Страница 18: ...ft side view Table 5 Description of the components found in the left side Only use power supply parts pieces and accessories specified by MAGNAMED listed in this manual which were tested and approved...

Страница 19: ...y 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 disc...

Страница 20: ...tandby mode suspending mechanical ventilation The word STAND BY will remain flashing while the equipment is in this condition By continuing pressing the button the sidebar will fill until complete 2 s...

Страница 21: ...ter into the appropriate slot on the left side of the ventilator See chapter 11 5 Replacing the Ambient Air Filter 2 Insert a diaphragm in the exhalation valve then insert the assembly into the base a...

Страница 22: ...icated in the figure on the right Note There is an indication with a larger circle and a smaller circle in the ventilator showing the fitting position of the pressure line connector in the equipment T...

Страница 23: ...ely important for the proper functioning of the patient s ventilation monitoring and therefore it should be checked frequently during the course of ventilation of the patients Never obstructe pressure...

Страница 24: ...ready for use in a failure of the mains or for use in external operations for such your power supply should be connected to the mains to charge the battery even if the equipment remains off After prol...

Страница 25: ...of the fixed support 2 To place the ventilator on the support follow the sequence below a Pull the handle bracket on the wall just above the fixed support b Slide Oxymag down until it clicks into plac...

Страница 26: ...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 invisible d Make sure t...

Страница 27: ...alve is secure It is important to check the presence of the diaphragm Check the secure connection of the breathing circuit and the flow sensor suitable for the patient to be ventilated Check the tight...

Страница 28: ...s the modes available for each type of patient Table 7 Modes available for the types of patient Patient type Flow Sensor Modes available 1 NEONATAL NEO PLV CPAP PSV P SIMV DualPAP PEDIATRIC INF VCV V...

Страница 29: ...25 The weight of the patient considered by the equipment is the ideal body weight calculated according the height of the patient Height adjustment of the patient does not remain after turning off the...

Страница 30: ...the light alarm indicator meaning that the audible and visual alarm are operational If you do not hear a triple BEEP sound or do not see the light alarm indicator flashing avoid the use of the equipme...

Страница 31: ...r Audible alarm will be disabled in the first 2 minutes Note that the white bar next to the alarm silencing symbol is reduced over time After 2 minutes the audible alarm will be activated 8 Press the...

Страница 32: ...min 1 depending on the ventilator settings Turn on or off the extern blender compensation In this condition the device don t allow the FiO2 The FiO2 adjustment will be done directly in the blender1 Tu...

Страница 33: ...connector and the sensor connection corresponding to the last patient ventilated Press Ok when this condition is carried out After a ventilation to change the patient type in the test sequence restar...

Страница 34: ...nternal Sensor Contact Technical Assistance Failure in flow control use not allowed Ar Flow O2 Ensure that the oxygen supply pressure is according to the specification 15 3 2 Connecting to the Oxygen...

Страница 35: ...rements of portability and low power consumption typically below 1 Watt It was designed to be extremely easy to integrate with any monitoring device allowing real time visualization of Information abo...

Страница 36: ...You can hear a click when the airway adapter fits correctly to the sensor Figure 13 Fitting airway sensor c green LED indicates that the CO2 sensor is ready for use Figure 14 LED indicates if the sen...

Страница 37: ...nsor will protect the airway adapter from secretions and effects of steam which eliminates the need to Exchange the adapter in use Figure 16 Scheme to assemble the Humidifier Filter 6 3 Positioning th...

Страница 38: ...uired appears immediately after the end of the resetting this procedure must be repeated Resetting must be performed every time the airway adapter is replaced It should be also performed whenever ther...

Страница 39: ...ake sure that the sensor is used in environments according to the electromagnetic environment specifications expressed in this manual Do not connect the airway adapter between the Endotracheal Tube an...

Страница 40: ...nical Specifications of the Capnography Attribute Specification GENERAL Description Mainstream monitoring sensor with infrared technology Dimensions W x D x H IRMA CO2 38 x 37 x 34mm 1 49 x 1 45 x 1 3...

Страница 41: ...2 Diagnostic Parameters Atmospheric Pressure review of software and hardware serial number Information Detection of New Breath Apnea Check Adapter Accuracy Not Specified and Sensor Error Method to cal...

Страница 42: ...d conditions Gas Type Gas Type Gas Type CO2 0 15 15 25 0 2 vol 2 reading Not specified Note Gas concentration expressed in percent volume units Gas Type Precision Accuracy CO2 0 3 vol 4 reading Note 1...

Страница 43: ...urement read 4 7 vol 2 NOTE 1 NEGLIGIBLE INTERFERENCE INTERFERENCE EFFECTS DO NOT CHANGE VALUES IN TABLE PRECISION ACCURACY OF MEASUREMENTS UNDER ALL CONDITIONS ABOVE NOTE 2 VALUE SHOWN FOR ACTUAL CON...

Страница 44: ...OxyMag_rev26 Temp C RH P hPa H2O part pres hpa Errrel Errrel ATPD Errrel BTPS 25 23 1013 7 3 0 0 7 5 5 25 50 1013 16 0 1 6 4 6 30 80 1013 42 0 4 1 2 0 37 100 1013 63 BTPS 0 6 2 0 37 100 700 63 0 9 0 2...

Страница 45: ...d light emitting diodes LED in oximetry sensors serve as light source the photodiode serves as a photodetector Traditionally the pulse oximetry assumes that all pulsations in the light absorbance sign...

Страница 46: ...uration is selected as SpO2 value All sequence is repeated every two seconds within the most recent four seconds of data received Completing the SpO2 of the MS board corresponds to the analysis used f...

Страница 47: ...ructions of LNOP LNCS sensors Use only Masimo oximetry sensors for SpO2 measurements Tissue can be damaged by incorrect application or use of LNOP LNCS sensor for example by attaching too tight LNOP L...

Страница 48: ...liquid o Use sparingly the cleaning solution Excessive amount of solution may drip inside the monitor and cause internal damage to the components o Do not use petroleum or acetone based solutions or o...

Страница 49: ...5 Hz at an amplitude of 2 to 3 cm Test subjects were monitored with the MS 11 MS 13 pulse oximetry technology and with an ECG Blood samples were taken for the range of 70 to 100 SpO2 and compared aga...

Страница 50: ...ation criteria Functional SpO2 Pulse rate bpm Perfusion index PVI Display range 0 0 100 0 25 240 bpm 0 02 20 0 0 100 Calibration range 70 100 25 240 bpm 0 10 20 0 Calibration Standard Invasive Co Oxim...

Страница 51: ...pulse simulator Table 20 Environmental Specification Nota Esta informa o pode ser til aos m dicos especificamente Characteristic Specification Operation condition Incandescent light intensity 100 k Lu...

Страница 52: ...for NEONATAL patients weight 6 0 kg Set Parameters VOLUME RATE RATIO I E PEEP MAXIMUM PRESSURE PAUSE INSP FiO2 TRIGGER FOR FLOW TRIGGER FOR PRESSURE FLOW WAVEFORM Figure 20 VCV Curves Once all ventila...

Страница 53: ...This situation is often called Assisted Controlled Ventilation In assisted controlled ventilation the respiratory rate monitored can be higher than the respiratory rate set 4 ASCENDING or accelerated...

Страница 54: ...el until the inspiratory time set has elapsed the volume is therefore result of the physiology of the patient s lung compliance and resistance Usually when analyzing the flow curve a flow peak is seen...

Страница 55: ...to the levels set The information of what trigger activated the inspiratory cycle is reported in the status area and screen messages The detection of patient s inspiratory effort for synchronization...

Страница 56: ...ent s lung compliance and resistance Usually when analyzing the flow curve a flow peak is seen which decreases over time Note This ventilation mode is available only for NEONATAL patients reported wei...

Страница 57: ...the next inspiration with the patient effort according to the levels set The information of what type of trigger activated the inspiratory cycle is reported in the message area and screen status The...

Страница 58: ...INSPIRATORY TIME PEEP MAXIMUM PRESSURE PAUSE FiO2 PS Pressure support PEEP TRIGGER BY FLOW TRIGGER BY PRESSURE WAVEFORM OF THE FLOW CYCLING BY FLOW FLOW RISE TIME FLOW only to NEONATE Figure 23 V SIMV...

Страница 59: ...ventilation cycle which is open from 0 75 x TSIMV i e the last quarter of SIMV Period a timing window opens for the mandatory ventilation cycle The information of what type of trigger activated the i...

Страница 60: ...athe spontaneously between the controlled cycles with or without the use of pressure support The controlled cycles will be PCV Pressure Controlled Set Parameters INSP PRESSURE RATE INSPIRATORY TIME PE...

Страница 61: ...to expiratory phase is programmable Rise time TRISE TIME also applies to pressure support see PCV 6 If patient performs inspiratory effort in the end of SIMV period TSIMV there is a timing window of...

Страница 62: ...set to 0 ZERO or both cycle trigger ways pressure or flow are disabled pure CPAP mode will be activated i e without pressure support In this condition PEEP parameter will be displayed as CPAP Set Par...

Страница 63: ...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 Apnea alarm should be...

Страница 64: ...n 5 and 80 inspiratory flow peaks measured Depending on this APRV Airway Pressure Release Ventilation can be obtained Set parameters P HIGH T HIGH P LOW T LOW FiO2 PS Pressure Support PEEP TRIGGER BY...

Страница 65: ...P High P Low occur in the final quarter of T Low and T High respectively by synchronizing with the effort of the patient The information of what trigger activated the inspiratory cycle is reported in...

Страница 66: ...e relief airway obtaining APRV Airway Pressure Release Ventilation Set parameters P HIGH T HIGH P LOW T LOW FiO2 PS Pressure Support PEEP TRIGGER BY FLOW TRIGGER BY PRESSURE CYCLING BY FLOW FLOW RISE...

Страница 67: ...ls from P High P Low or P Low P High occur in the final quarter of T High and T Low respectively by synchronizing with the patient s effort The information of what type of trigger activated the inspir...

Страница 68: ...ORITY Delay Time Description Low Battery 1 second It is triggered when the internal battery is with the charge in the end Provide appropriate means of ventilatory support to the patient Apnea 1 second...

Страница 69: ...has exceeded the alarm value set as the upper limit of CO2i High FC 3 seconds It is triggered when the heart rate has exceeded the alarm value set as upper limit of FC Low FC 3 seconds It is triggere...

Страница 70: ...ue set as upper limit of PEEP Low PEEP 3 cycles It is triggered when the pressure in the end of exhalation PEEP is below the alarm value set as lower limit of PEEP CO2 out of range 3 seconds It is tri...

Страница 71: ...d SpO2 demo 3 seconds It is triggered when the oximeter is generating a demo curve Note When CPAP PSV mode is configured with pressure support and apnea condition occurs audible and visual alarm will...

Страница 72: ...alarm goes off when compliance records a value above the maximum allowed 200 mL cmH20 or does not identify when a variation of natural internal pressure occurs when delivering a certain volume of air...

Страница 73: ...nd It is displayed in the event of a spontaneous trigger generated by a flow trigger Spont Pr Trig 1 second It is displayed in the event of a spontaneous trigger generated by a pressure trigger Spont...

Страница 74: ...e 2 Clear it 3 Obstruction of the airway of the patient 3 Clear or aspirate the airway of the patient Low Battery Alarm 1 End of charge of the internal battery after use without mains 1 Immediately re...

Страница 75: ...rm 2 Perform self test High FiO2 alarm 1 FiO2 adjust is above alarm limit 2 O2 cell is out of calibration 3 Damaged O2 cell 1 Change the set FiO2 or upper alarm limit 2 Calibrate O2 cell 3 Contact Mag...

Страница 76: ...O2 cell 3 Contact Magnamed Technical Assistance High Minute volume alarm 1 Volume delivered and delivered respiratory rate are above alarm limit 1 Change the adjusted parameters of the ventilation mo...

Страница 77: ...1 The SpO2 sensor is connected to the equipment but is off the finger 1 Connect the oximeter to the patient s finger Check SpO2 alarm 1 The oximeter has no sensor attached 2 The connected sensor is de...

Страница 78: ...9 3 Alarm test Adjustable alarm test To perform alarm testing a breathing circuit and a simulator balloon are required Caution Never perform alarm testing with the patient connected to the equipment...

Страница 79: ...a o m nima acima do ajustado na modalidade 9 3 1 7 EtCO2 alarm Para testar o alarme de EtCO2 necess rio que um capn grafo esteja conectado ao ventilador Monte o circuito completo para uso com capn gra...

Страница 80: ...da rede el trica O alarme sem rede el trica de prioridade baixa dever ocorrer 9 3 2 3 Low battery Para testar o alarme de bateria baixa coloque o ventilador em funcionamento normal e desconecte o apar...

Страница 81: ...components that come in directly contact with respiratory gases shall be periodically disassembled in components as accessory list for cleaning disinfection or sterilization Circuits and parts of sil...

Страница 82: ...hol 70 The external part should be disinfected using a clean cloth moistened with alcohol 70 and internal part by immersion Important Do not soak the items to be disinfected with alcohol as it can dam...

Страница 83: ...d should be replaced with new ones 10 4 Processing methods Component Processing methods Steam sterilization 135 C for 5 min Antimicrobial disinfectant Alcohol 70 Ventilator surface x x Touch screen di...

Страница 84: ...and or prior to use Cleaning the equipment Integrity of the power cord of the AC DC converter Correct operation of the visual and audible alarm system Installation and cleaning of filters Correct dis...

Страница 85: ...portional to the oxygen concentration in the gas mixture administered to the patient and the intensity of this electrical signal is due to the chemical reaction The length of the cell as specified by...

Страница 86: ...pecified by MAGNAMED listed in this manual which have been tested and approved for use in conjunction with this equipment otherwise this can jeopardize the operation endangering the patient or user fi...

Страница 87: ...ev26 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 rep...

Страница 88: ...cal government recommendations for proper disposal Caution When the need to discard parts of the ventilator may be potentially contaminated indicated as potentially infected hospital waste Disposal of...

Страница 89: ...ORILY 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 p...

Страница 90: ...ilators EN 1789 2007 A1 2010 Medical vehicles and their equipment Road ambulances ISO 5359 2008 Amd 1 2011 EN ISO 5359 2008 A1 2011 Low pressure hose assemblies for use with medical gases IEC 60601 1...

Страница 91: ...ectronic lung ventilator consists of the following components 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 Se...

Страница 92: ...LY 12V WITH 4 WAY CONNECTOR Item Parameter Specification Tolerance Unit 1 Mains 50 60Hz 100 240 10 VAC 2 Maximum Power Consumed 40 10 W 3 Output 12VDC 4 way 12 10 VDC 4 Current 3 34 A 3 three pin conn...

Страница 93: ...of 40 minutes with the equipment configuration as follows o Adult patient o VCV mode o Volume 500ml o Rate 12rpm o Ratio 1 2 o PEEP 5 cmH2O o Pause 30 o FiO2 100 o Square flow wave Note All materials...

Страница 94: ...BLE 15F 22F 179 5 mL INTERMEDIARY 15M 15M FOR PEDIATRIC BREATHING CIRCUIT AUTOCLAVABLE 3 6 mL Y PEDIATRIC 15MM AUTOCLAVABLE WITHOUT THERMOMETER 90 16 9 mL AIRWAY ADAPTER 9 0 mL ADULT FLOW SENSOR AUTOC...

Страница 95: ...d Intermittent Mandatory Ventilation DualPAP 5 Bi level Positive Airway Continuous pressure with Pressure Support VCV PCV adult and pediatric PLV neonatal OFF Programmable by the Operator CPAP PSV Con...

Страница 96: ...sted Sensitivity Pressure OFF 0 2 to 10 0 2 to 2 0 0 2 cmH2O 2 to 10 1 10 Assisted Sensitivity Flow OFF 0 5 to 30 0 0 5 L min 1 11 Automatic Inspiratory Flow 3 0 to 150 1 L min 1 12 Inspiratory Flow N...

Страница 97: ...olume in the display of the ventilator This volume is the volume delivered to the ventilator outlet and the user should check the absence of leaks 2 In CPAP PSV mode adjusted without pressure support...

Страница 98: ...ght is calculated using BMI 22 and patient height can be changed according to the type of patient set at startup as table below Table 30 Calculation of ideal weight x patient height Patient Type Heigh...

Страница 99: ...H2O 6 Intrinsic PEEP at the end of expiration 20 to 90 1 1 cmH2O or 2 reading cmH2O 7 Flow Measured Sensor Adult 9 150 to 150 1 2 0L min 1 or 5 reading L min 1 8 Flow Measured Sensor Pediatric 9 50 to...

Страница 100: ...to 200 1 1min 1 or 1 value measured min 1 22 Airway Resistance RAW 0 to 200 1 1 cmH2O L s 23 Dynamic Compliance C Dyn 0 to 200 0 1 1 mL cmH2O 1 or 10 value measured mL cmH2 O 1 24 Static Compliance C...

Страница 101: ...h 50 oxygen concentration 10 Since pulse oximetry equipment measurements are statistically distributed it can be expected that only about 2 3 of pulse oximetry equipment measurements will be within Ar...

Страница 102: ...Valve ACTIVE when detecting obstructions it is activated to reduce pressure in the patient circuit When the ventilator is restarted or the type of patient is changed alarms will assume the default va...

Страница 103: ...ed alternately following the priority described in Table 36 In the absence of high priority alarms the medium priority alarms will be displayed alternately The alarm messages are displayed as soon as...

Страница 104: ...80 80 80 8 Automatic limit setting OFF 10 20 and 30 High OFF 9 Heart Frequency OFF 25 to 240 Low 180 120 120 bpm High 80 40 40 10 SpO2 OFF 1 to 100 Low 85 85 85 High OFF OFF OFF 11 EtCO2 OFF 0 to 80 L...

Страница 105: ...case the equipment will be powered by non interchangeable internal battery Oxygen monitoring is achieved accurately within 20 seconds of initialization Alarms related to the equipment and ventilation...

Страница 106: ...reathing circuit Performance Specifications Table 37 Performance specification Item Parameter Specification Tolerance Unit 1 Maximum Flow in Pressure Support or in cycles of controlled pressure 150 10...

Страница 107: ...ization through chemical or biological indicators Table 38 Specification for maintenance and calibration Item Description Specification Tolerance Unit 1 Review and REPLACEMENT OF DIAPHRAGMA 3800248 50...

Страница 108: ...ronment 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 22 mm...

Страница 109: ...ic 30 0 3 1 5 5 6 5 6 9 Adult 60 0 1 2 2 6 6 2 6 5 The operator shall ensure that the inspiratory and expiratory resistance values are not exceeded when adding accessories or other components or subse...

Страница 110: ...LPM 14 Capnograph optional 5 Venturi system 15 HEPA or HME filter 6 Proportional valve 200 LPM 16 Proximal flow sensor 7 One way valve anti asphyxiation 17 Expiratory valve 8 O2 cell 18 Linear actuato...

Страница 111: ...111 OxyMag_rev26 Block Diagram of Control Electronics Figure 32 Block Diagram of Electronics...

Страница 112: ...vicinity The use of other electrical equipment in the system or around the system may cause interference Before use in a patient you must check if the equipment works normally in the defined configura...

Страница 113: ...only for its internal functions However its RF emissions are very low and not likely to cause any interference in nearby electronic equipment RF Emissions ABNT NBR IEC CISPR 11 Class B The system may...

Страница 114: ...ts Quality of power supply should be that of a typical commercial or hospital environment IEC 61000 4 5 Surge 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Qual...

Страница 115: ...ge applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a The industrial scientific a...

Страница 116: ...maximum output power level not listed above the recommended separation distance d in meters m can be determined using the transmitter frequency equation Where P is the declared maximum transmitter ou...

Страница 117: ...to the system with input output signal cable must receive power from an AC source using separate transformer according to standard IEC 60989 or provide additional earth protective conductor Multiple p...

Страница 118: ...a sampling rate 7 Hz Method for calculating the gas level reading Simple moving average MMS of 64 positions acquired every 140ms Respiratory rate The Respiratory Rate is shown every 3 breaths and the...

Страница 119: ...RICO ELETR NICO FEITO DE FORMA SEPARADA RECOGIMIENTO DE EQUIPO EL CTRICO ELECTR NICO HECHO POR SEPARADO WASTE ELECTRICAL AND ELECTRIC EQUIPMENT SHALL BE COLLECTED AND RECYCLED IN ACCORDANCE WITH DIREC...

Страница 120: ...PROTEGIDO CONTRA RESPINGOS DE GUA E ENTRADA DE PARTES S LIDAS MAIOR OU IGUAL A 2 5MM PROTEGIDO CONTRA SALPICADURAS DE AGUA Y ENTRADA DE PARTES S LIDAS MAYOR O IGUAL A 2 5MM PROTECTED AGAINST WATER SP...

Страница 121: ...FE STACKING QUANTITY LIMITES DE TEMPERATURA LIMITES DE TEMPERATURA TEMPERATURE LIMITS MANTENHA PROTEGIDO DO SOL MANTENER PROTEGIDO DEL SOL KEEP AWAY FROM HEAT EtCO2 SpO2 CONEX O DE ENTRADA DO SENSOR D...

Страница 122: ...S FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN DATA DE VALIDADE FECHA DE VALIDEZ USE BY DATE N O EST RIL NO ESTERIL NON STERILE N O USAR SE A EMBALAGEM ESTIVER DANIFICAD...

Страница 123: ...TA O DE PRESS O ATMOSF RICA Indica a faixa de press o atmosf rica qual o equipamento pode ser exposto com seguran a LIMITACI N DE PRESI N ATMOSF RICA Indica el rango de presi n atmosf rica a la que el...

Страница 124: ...centage Pause Inspiratory Pause DualPAP Dual level CPAP Ventilation PCV Pressure Controlled Ventilation FiO2 O2 Inspired Fraction PED Pediatric Freq Total Respiratory Rate PEEPi Intrinsic PEEP F Base...

Страница 125: ...d Intermittent Mandatory Ventilation with Controlled Volume cycle P Low Low pressure Vspn Spontaneous Volume Res Airway resistance Vt Adjusted Tidal Volume Resistance Circuit Resistance Vti Inspired T...

Страница 126: ...fects thus ensuring their biocompatibility And according to standard ISO 10993 1 Biological evaluation of medical devices Part 1 Evaluation and testing clause 4 2 1 the ventilator its parts and access...

Страница 127: ...o the product used under normal conditions and for the purposes for which it is intended and which preventive maintenance and part replacements and repairs are carried out in accordance with the instr...

Страница 128: ...128 OxyMag_rev26 19 Technical Assistance For maintenance please contact our technical assistance who will indicate the service nearest you or visit our website...

Страница 129: ...129 OxyMag_rev26 20 Training To request training please contact Magnamed product expert team who will indicate the authorized Representative nearest you...

Страница 130: ...sil 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 European Representative CMC Medical Devices Drugs S...

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