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MAGNAMED TECNOLOGIA MÉDICA S/A

Unpacking the Product

Initial Verifications

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to MAGNAMED.

Table 1

– Initial Verifications

Stage

Procedure

Approved

Verify if the package is intact by looking for holes, or other damages.

NOK

Carefully open the package observing the box’s indications

NOK

Check the package contents.

NOK

Содержание Fleximag

Страница 1: ...Operation Manual Mechanical Ventilator Fleximag display 15...

Страница 2: ...on at ANVISA No 80659160003 All rights reserved by Magnamed Tecnologia M dica S A Rua Santa M nica 801 831 06715 865 Parque Industrial San Jos Cotia SP Brasil Tel Fax 55 11 4615 8500 E mail magnamed m...

Страница 3: ...TERISTICS 12 SAFETY CHARACTERISTICS 13 3 UNPACKING THE PRODUCT 14 INITIAL VERIFICATIONS 14 RELATION OF COMPONENTS OF FLEXIMAG 15 15 4 COMPONENT IDENTIFICATION 18 FRONT VIEW 18 BACK VIEW 19 5 PREPARATI...

Страница 4: ...9 Permanent Monitor Display Area 33 6 3 10 Area of adjustable parameters 33 SETTING THE VENTILATION 34 6 4 1 Ventilatory modes available 34 6 4 2 Ventilatory modes adjust 34 6 4 3 Non Invasive Ventila...

Страница 5: ...45 8 1 2 1 2 Rinse 46 8 1 2 1 3 Drying 46 DISINFECTION 46 8 2 1 External Parts 46 8 2 2 Respiratory circuit and exhalation valve 46 8 2 3 DISTAL flow sensor Envitec SpiroQuant A 46 STERILIZATION 47 8...

Страница 6: ...11 4 1 1 External Power Supply AC power grid 58 11 4 1 1 Internal Power Supply battery 58 11 4 1 1 External Power Supply DC 59 11 4 2 Connectors 59 PNEUMATIC SPECIFICATIONS 60 11 5 1 Pneumatic Chart 6...

Страница 7: ...98 SPECIFICATIONS OF EXPIRATORY LIMB RESISTANCE 98 SPECIFICATIONS OF MAINTENANCE AND CALIBRATION 99 ELECTROMAGNETIC COMPATIBILITY 99 11 17 1 Manufacturer declaration Electromagnetics emissions 100 11...

Страница 8: ...sion death or other serious adverse reactions associated to the use or misuse of the equipment Informs the user of the possibility of equipment failure associated to use or misuse such as the equipmen...

Страница 9: ...frequency surgical equipment diathermy defibrillators short wave therapy that may interrupt the equipment s operation Do not use these transmission devices near the ventilator This equipment must not...

Страница 10: ...ion monitoring Therefore it must be frequently verified during the patient s ventilation realization After usage the ventilator breathing system components MUST be disinfected before their next used w...

Страница 11: ...agnetic waves which interfere during the operation of equipment in their proximity Perform annual periodical maintenance or according to the specified hours of usage whichever comes first All of the V...

Страница 12: ...d also the resultant flow The oxygen concentration measurement is made through a galvanic cell sensor or optionally through a paramagnetic cell The resultant flow measurement is made through a high pr...

Страница 13: ...centration in the mixture of gases delivered through the galvanic cell or optionally non consumable paramagnetic cell Automatic altitude compensation Single distal flow sensor for all types of patient...

Страница 14: ...audiovisual alarms related to both equipment operating condition technical alarms as the ventilation process Backup energy system that allows the equipment to run using batteries for about 3 5 hours1...

Страница 15: ...please immediately report to the carrier responsible and to MAGNAMED Table 1 Initial Verifications Stage Procedure Approved 1 Verify if the package is intact by looking for holes or other damages OK...

Страница 16: ...e use of it Table 2 Components of FlexiMag Item Part Number Description Qty IMU Image 1 1103760 FLEXIMAG NEONATAL PEDIATRIC ADULT ELECTRONIC LUNG VENTILATOR 15 INCHES 01 PC 2 1703038 RESPIRATORY CIRCU...

Страница 17: ...SENSORS SPIROQUANT ENVITEC 01 PC 7 2803779 FLOW SENSOR CONNECTION CABLE EXTERNAL 01 PC 8 3800248 MAGNAMED EXHALATION VALVE DIAPHRAGM 01 PC 9 3804865 EXHALATION VALVE WITH STABILIZING RING 01 PC 10 500...

Страница 18: ...LOGIA M DICA S A Item Part Number Description Qty IMU Image 13 2804669 AC POWER CORD MONTED WITH 3 WAYS 3 0M NEW NBR STANDARD 14136 01 PC 14 110XXXX NE 20 RR Operation manual 1 PC 15 7006466 QUICK GUI...

Страница 19: ...18 MAGNAMED TECNOLOGIA M DICA S A 4 Component Identification Front view Figure 1 Front view FlexiMag 1 ALARM INDICATOR LIGHT RED 2 4 7 8 11 10 9 6 5 3 1...

Страница 20: ...CTOR 7 EXHALATION VALVE AND DISTAL FLOW SENSOR 8 DISTAL FLOW SENSOR CABLE CONNECTOR 9 CARRYING STRAP 10 PEDESTAL 11 CASTORS WITH BRAKES Back View Figure 2 Back View 1 On Off Switch 2 Input of Electric...

Страница 21: ...tor base with trundle 2 Position the diaphragm on the exhalation valve as shown in the figure Position the exhalation valve locators on the base press and rotate clockwise to lock Correctly position t...

Страница 22: ...the flow sensor and follow the instructions on the right All connections must be mounted securely to prevent leakages 4 Prepare the patient s respiratory circuit firmly connection the inspiratory limb...

Страница 23: ...s limb must be firmly connected to the exhalation valve 6 In the event the respiratory circuit is used for NON INVASIVE VENTILATION NIV without filter 7 In the event the respiratory circuit is used f...

Страница 24: ...23 MAGNAMED TECNOLOGIA M DICA S A OK Item Assembly Sequence Image 8 Connect the power cord to the equipment...

Страница 25: ...ion to the right yellow Connect an O2 hose to the indicated connection according to the illustration to the right green The valve assembly of the pneumatic system prevents cross flow of gas Pressures...

Страница 26: ...f it was not possible DISCONNECT the equipment from the patient and provide appropriate means of ventilatory support Verifications before use The object of this inspection routine is to guide the user...

Страница 27: ...ssure below 250 kPa the maximum flow will be 120 L min 9 Verify a firm connection of the electric cord when applicable The ventilator can be used in battery operation up to 210 minutes continuously un...

Страница 28: ...ng on the correspondent icon 6 1 1 Patient selection When selecting a patient option ventilator will define the type of patient and start the ventilation s parameters considering the following table T...

Страница 29: ...utton corresponding to the parameter to be set it will be selected the color will change allowing the modification of its value using the spin and confirm button To confirm the set value press the but...

Страница 30: ...on pressure value 6 3 2 Menus Selections Area In this area menus options presented are displayed on the equipment GRAPH MONITOR CONFIG ALARM and TREND Erro Fonte de refer ncia n o encon trada Erro Fon...

Страница 31: ...is displayed in this area Furthermore simply tap this button to access the screen with the full configuration of ventilator modes and their respective parameters 6 3 6 Information Area The informatio...

Страница 32: ...dicator appears during the time that audible alarm is silenced maximum of 2 minutes If during this period any other alarm appears alarm pause is automatically deactivated 6 3 8 Quick Access function a...

Страница 33: ...xpiration will be extended for up to 30s After this period the value of static compliance will be displayed P0 1 Pressure drop below the baseline pressure generated by the inspiratory effort of the pa...

Страница 34: ...imum pressure rate PEEP and FiO2 Figure 4 Parameter Monitored 6 3 10 Area of adjustable parameters In this area the adjustable parameters are displayed as active ventilation mode Six parameters are di...

Страница 35: ...uto VCV e PCV Adjustable Auto APRV PLV Adjustable Auto VCV e PCV Adjustable Auto 1 For the ways in which the backup is set to Auto whenever the time set apnea is reached the ventilator starts a ventil...

Страница 36: ...e main screen 6 4 3 Non Invasive Ventilation NIV Noninvasive ventilation NIV refers to the application of ventilatory support without invasive methods of the airways such as endotracheal intubation or...

Страница 37: ...tor s main screen because it allows to view the progress of the ventilation process through graphs bar graph of pressure and parameters monitored Available ventilation graphs o Pressure x Time Curve o...

Страница 38: ...ts The operator may choose to display the values of pressure in mbar hPa or cmH2O as follow 1 mbar milibar 1 hPa hectoPascal 1 016 cmH2O centimeter of water In a practical way these units are equivale...

Страница 39: ...atient the operator may adjust height and volume by weight on the corresponding buttons The ideal weight for patient is used to calculate some parameters of ventilation aiming to provide a closer appr...

Страница 40: ...e entry of backup ventilation There is also the option for auto setting of alarms and in order to enable it is necessary that the ventilator is not in STANDBY Standby mode and preferably the ventilati...

Страница 41: ...for selection Once defined the parameters simply set the interval you want to see the trend This interval can range from 15 minutes to 24 hours with other choices of time within the same period The g...

Страница 42: ...meters selected 4 Cursor draws over the graph allowing to analyze their points 5 Pressure Bargraph To move the cursor on the trend graph simply touch the screen to the desired position or rotate the s...

Страница 43: ...trol of PEEP Excessive leakage 6 6 3 O2 cell only galvanic cell Replacement of the cell The monitored concentration values FiO2 do not seem correct The lower and upper limits do not reach 21 and 100 O...

Страница 44: ...larm Electronic failure Request Technical Assistance High Pressure Alarm Alteration of Patient s Respiratory Mechanics Establish suitable parameters for the ventilatory support Obstruction of respirat...

Страница 45: ...second to start the ventilation and wait the ventilation stabilization to activate the automatic adjust Test failure of distal flow sensor The output of the breathing circuit was not occluded Restart...

Страница 46: ...t products to polymer 8 1 2 Components The components that come in directly contact with respiratory gases must be periodically disassembled for cleaning disinfection or sterilization 8 1 2 1 Respirat...

Страница 47: ...e done so that the solution drains by gravity Disinfection 8 2 1 External Parts The external part should be disinfected using a clean cloth moistened with alcohol 70 8 2 2 Respiratory circuit and exha...

Страница 48: ...possibility of the sensor remain infected replace it promptly Sterilization The components that get in touch with the respiratory gases must be removed for cleaning and sterilization Do not use abras...

Страница 49: ...r repair services to observe STRICTLY the disinfection process Do not use damaged patient cables Accessories and removable MAGNAMED ventilator components is damaged or signs of wear should be replaced...

Страница 50: ...g methods Component Processing methods Steam Sterilization 135 C for 5 min Antimicrobial Disinfectant Alcohol 70 Ventilator surface x X Touch screen x Silicone Breathing tube Exhalation Valve Diaphrag...

Страница 51: ...technical service note STRICTLY the process of cleaning and disinfection Verifications The following verifications must be carried out on a daily basis and whenever the equipment is to be used A Clea...

Страница 52: ...ng in chapter 11 So that there is enough capacity battery during power failure electric it is important that the equipment remains WHENEVER POSSIBLE connected to a power grid So that the battery capac...

Страница 53: ...ials polycarbonate Replace the filter when it is clogged so it does not reduce the equipment input stream O2 cell The FlexiMag device has two forms of measurement of oxygen concentration Galvanic cell...

Страница 54: ...ortional to the concentration of oxygen in the mixture gas administered to the patient and the intensity of this electrical signal is due to the torque created in the arrangement Magnetic cell This se...

Страница 55: ...ries Item Code Description Qty UMI Image 1 1703037 RESPIRATORY CIRCUIT PEDIATRIC WITH WATER TRAP Y 90 01 PC 2 1704601 RESPIRATORY CIRCUIT ADULT 1 6M STRAIGHT Y AUTOCLAVABLE 01 PC 3 1704603 RESPIRATORY...

Страница 56: ...D HUMIDIFIER 220VAC WITH ADULT CHAMBER 01 PC 8 3905085 HEPA FILTER FOR MECHANICAL VENTILATION 01 PC 9 3905204 O2 DISS X2 5M HOSE 01 PC 10 3905203 COMPRESSED AIR DISS X2 5M HOSE 01 PC 11 1705143 HME FI...

Страница 57: ...IEC 60601 2 12 2001 EN 60601 2 12 2006 Medical electrical equipment Part 2 12 Particular requirements for the safety of lung ventilators Critical care ventilators ISO 5359 2008 Amd 1 2011 EN ISO 5359...

Страница 58: ...able medical devices EN 1041 2008 Information supplied by the manufacturer of medical devices ISO 15223 1 2016 EN ISO 15223 1 2016 Medical devices Symbols to be used with medical device labels labelli...

Страница 59: ...ply 11 4 1 1 External Power Supply AC power grid Table 11 External Power Supply AC Item Specification Tolerance Energy Source Voltage 100 to 240 VAC 10 Frequency 50 to 60 Hz Fusible 1 0 A 250 V Maximu...

Страница 60: ...gh the external DC power supply The sole purpose of this entry is to allow the equipment to be powered temporarily by a source of compatible external power when there are no other alternatives In vent...

Страница 61: ...08 Oxygen Concentration 01 Pressure regulating valve 02 Regulated pressure measured Pressure sensor 03 Proportional valve control 04 Unidiretional valve Scheader 05 Solenoid for overpressure control 0...

Страница 62: ...age the equipment For lower inlet pressures than 250 kPa the maximum flow is 120 L min All materials that make up the product are compatible with oxygen gas ambient air and medical air If the network...

Страница 63: ...and sensor This heat transfer rate is translated into a voltage required to maintain the temperature at 150 C Therefore this voltage is a function of mass flow of gas through the sensor The heat tran...

Страница 64: ...m 20 to 40 C Useful Life While its calibration is successful Material MABS Disinfection Ethanol Solution 70 Mask for Non Invasive Ventilation Specification Adult Pediatric connection 22 mm Neonatal co...

Страница 65: ...64 MAGNAMED TECNOLOGIA M DICA S A Ventilation modes specifications 11 10 1 VCV VCV mandatory ventilation with volume controlled...

Страница 66: ...r RATIO or TIME INS PEEP CONCENTRATION LIMIT PRESSURE PAUSE EXPIRATORY or s PRESSURE TRIGGER FLOW TRIGGER FLOW WAVE FORM Obs Automatic Backup 1 1 Whenever the apnea set time is reached the ventilator...

Страница 67: ...the expiratory time If the patient makes inspiratory efforts and triggers are suitably set the ventilatory mode becomes assisted controlled In this situation the monitored breathing frequency can be s...

Страница 68: ...tomatic Backup 1 1 Whenever the apnea set time is reached the ventilator triggers a ventilatory cycle whose configuration is based on the current mode settings As soon as all of these ventilation para...

Страница 69: ...ory effort in order to synchronize occurs at any moment during the expiratory time If the patient makes inspiratory efforts and triggers are suitably set the ventilatory mode becomes assisted controll...

Страница 70: ...he inspiratory time The current volume becomes dependent on the preset inspiratory pressure the impedance conditions of the respiratory system and inspiratory time selected by the operator Normally to...

Страница 71: ...vel during TINS after which it cycles to expiration maintaining the adjusted PEEP pressure 3 If the pressure or flow trigger is activated the ventilator seeks to synchronize at the beginning of the ne...

Страница 72: ...re limit 5 cmH2O upward as the tidal volume delivered in the previous cycle until reaching the tidal volume specified by the operator The maximum pressure limit is 5 cm H2O below the pressure limit in...

Страница 73: ...nt s effort according to the configured trigger The patient s effort window detection to synchronize begins on the last fourth period of the controlled ventilation 7 Reached Volume By reaching the pre...

Страница 74: ...e window according to the set respiratory rate but synchronized with the patient trigger If apnea the next cycle will be triggered by time until they return the inspiratory incursions patient To obtai...

Страница 75: ...occurs by flow when this reaches a value between 25 and 75 of the read peak value 5 The peak s flow percentage in which the cycling from inspiratory phase to expiratory phase occur is programmable The...

Страница 76: ...ault values are only an initial reference Readjust the ventilation parameters according to the patient s needs The monitored respiratory frequency may be greater than the adjusted respiratory rate sin...

Страница 77: ...rding to the set respiratory rate but synchronized with the patient trigger If there is an apnea the next cycle will be triggered by time until they return the inspiratory incursions patient To obtain...

Страница 78: ...PPORTING PRESSURE whose cycling occurs by flow when this reaches a value between 25 and 75 of the read peak value 5 The peak s flow percentage in which the cycling from inspiratory phase to expiratory...

Страница 79: ...pressure will be the sum of PEEP and PS Default values are only an initial reference Readjust the ventilation parameters according to the patient s needs The monitored respiratory frequency may be gre...

Страница 80: ...he pressure support PS is set to 0 zero and cycle the trigger are both off ventilation will be characterized with pure CPAP mode which is a spontaneous ventilation mode is not assisted by the ventilat...

Страница 81: ...flow may be adjusted to a value between a peak flow of 25 to 75 6 In the event the patient enters into apnea the ventilator will present this condition through an alarm on the screen s message and al...

Страница 82: ...GNAMED TECNOLOGIA M DICA S A 1 and 2 Represents spontaneous cycles 3 If the patient does not breathe after the time for apnea the ventilator presents that condition on the display and with an audible...

Страница 83: ...s in both pressure levels and includes synchronization of possibility with the inspiratory effort of the patient When there are no spontaneous breathing DualPAP is similar to pressure control mode dif...

Страница 84: ...83 MAGNAMED TECNOLOGIA M DICA S A DualPAP Dual Continuous Positive Airway Pressure...

Страница 85: ...be the sum of this reference pressure to PS Default values are only an initial reference Readjust the ventilation parameters according to the patient s needs In the absence of spontaneous cycles when...

Страница 86: ...ing APRV Airway Pressure Release Ventilation Set parameters PR SUPERIOR T SUPERIOR PR INFERIOR T INFERIOR CONCENTRATION PS Pressure Support PEEP PRESSURE LIMIT CYCLING FLOW FLOW TRIGGER PRESSURE FLOW...

Страница 87: ...upporting pressure PS is a value above the Upper Pressure or Lower Pressure Therefore the maximum supporting pressure will be the sum of this reference pressure to PS Default values are only an initia...

Страница 88: ...120 1 cmH2O PS 0 to 120 1 cmH2O cmH2O PEEP 0 to 50 1 cmH2O cmH2O Pressure trigger 0 0 to 20 0 00 to 2 0 0 2 cmH2O 0 05 to 20 1 Flow trigger 0 0 to 30 0 00 to 1 0 0 1 L min 1 0 to 30 0 0 5 Cycled Flow...

Страница 89: ...ly L min Flow PLV 1 to 40 1 L min 1 Respiratory Rate 0 zero will only be achieved in spontaneous ways with sensitivities and apnea time alarm off 2 The minimum and maximum values of rate and I E ratio...

Страница 90: ...insic PEEP iPEEP 0 to 120 cmH2O 1 1cmH2O or 2 of read Measured Flow 5 0 to 5 0 L min 0 1 50mL min or 2 of read 20 0 to 5 0 and 5 0 to 20 0 L min 0 2 180 to 20 and 20 to 180 L min 1 Tidal Volume 2 0 to...

Страница 91: ...J L 0 01 P0 1 99 to 10 cmH2O 1 9 9 to 0 0 cmH2O 0 1 1 When two tolerances are indicated consider the higher value 2 For airway resistance greater than 150 cmH2O L s the expired volume will have its to...

Страница 92: ...tial damage 1 Immediate 2 Ready 3 Late 4 Death or irreparable injury HIGH PRIORITY HIGH PRIORITY MEDIUM PRIORITY Repairable injury HIGH PRIORITY MEDIUM PRIORITY Small Injury or discomfort MEDIUM PRIOR...

Страница 93: ...s are displayed alternately Table 21 Alarm Features Alarm Characteristics High Priority Medium Priority Visual Color Red Yellow Intermittence frequency 1 6 hz 0 7 hz Audible Number of saved pulses 10...

Страница 94: ...ow OFF OFF OFF Minute Volume OFF 0 0 to 99 High 1 0 10 20 L Low 0 5 2 3 6 Rate OFF 0 to 200 High 80 60 60 rpm Low 5 5 5 FiO2 OFF 18 to 100 High 80 80 80 Low OFF OFF OFF Apnea time OFF 0 to 60 High 15...

Страница 95: ...of oxygen is below the specified network This alarm will not be triggered if the O2 parameter is 21 and the air system is operating within the required specifications LOW PRESSURE AIR SUPPLY 1 s The...

Страница 96: ...w sensor or is disconnected Under these conditions all the monitoring that depends on this sensor VT MV Frequency Vins Tinsp I E T exp Cst DynC Res iT Volume Leak VxTime Chart will NOT be displayed In...

Страница 97: ...rompt service to solve the problem So it is terminated the situation that necessitated the total audible alarm silence one should re enable it for patient safety To silence the audible alarm press the...

Страница 98: ...ed by a pressure drop SPONTANEOUS FLOW TRIGGER 1 s It indicates the occurrence of a spontaneous trigger generated by increasing inspiratory flow SPONTANEOUS PRESSURE TRIGGER 1 s It indicates the occur...

Страница 99: ...ontrolled ventilation pressure is recommended for larger leak flows than the limit specified above In this case the maximum flow offset can be greater than 100 L min Specifications of Expiratory Limb...

Страница 100: ...irst Expiration date INDEFINITE 1 1 The expiration date is undetermined when respected and implemented regular reviews Electromagnetic Compatibility Changes or modifications to this equipment not expr...

Страница 101: ...ctromagnetic environment IEC 61000 4 2 Electrostatic discharge ESD 6 kV by contact 8 kV by air 6 kV by contact 8 kV by air Floors should be wood concrete or ceramic If floors are covered with syntheti...

Страница 102: ...edical between 150 kHz to 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b Compliance levels in the ISM bands between 150 kHz and 80 MHz...

Страница 103: ...smitters with a nominal maximum power not listed output above the distance recommended D separation in meters m can be determined using the equation applicable to the frequency of the transmitter wher...

Страница 104: ...989 or have protective conductor additional land Do not connect directly electrical equipment nonmedical the AC wall outlet Using AC power supply with own transformer Otherwise the leakage current inc...

Страница 105: ...y repairs or maintenance on that equipment necessary find only the authorized service MAGNAMED DO NOT use the equipment if it is not working according to the specifications contained in this operating...

Страница 106: ...PROOF OF DEFIBRILLATION IPX1 IPX1 INGRESS PROTECTION IPX1 FOR PROTECTION FLUID PENETRATION ATTENTION CONSULT ACCOMPANYING DOCUMENTS CONSULT OPERATING INSTRUCTIONS EQUIPMENT COLLECTION ELECTRICAL ELECT...

Страница 107: ...ls used on packaging and labeling Symbol Description FRAGILE STEERING FACE PACKAGE TOP KEEP PROTECTED FROM SUNLIGHT KEEP PROTECTED FROM MOISTURE MAXIMUM STACKING TEMPERATURE LIMITS INMETRO USE BY DATE...

Страница 108: ...ise Rise Time T Higher Higher level time Time Ins Inspiratory Time Vol Minute Minute Volume Vol Weight Weight Volume NIV or VNI Noninvasive Ventilation O2 O2 Concentration 50 to 100 de O2 O2 100 100 O...

Страница 109: ...p or VTE spont Total volume expired spontaneous Vti or VTI Total volume inhaled MV or VM Minute volume MV sp or VM spont Minute volume spontaneous WOBi Imposed Work Of Breathing The controlled pressur...

Страница 110: ...thus ensuring their biocompatibility According to ISO 10993 1 Standard Biological evaluation of medical devices Part 1 Evaluation and testing clause 5 the ventilator its parts and accessories are cla...

Страница 111: ...r its intended use and which preventive maintenances and part substitutions and repair are realized according to the instructions stated in the Product s Operation Manual by the manufacturer s authori...

Страница 112: ...111 MAGNAMED TECNOLOGIA M DICA S A 17 Technical Assistance For maintenance please contact our technical assistance that will indicate the service closest to you or consult our website...

Страница 113: ...112 MAGNAMED TECNOLOGIA M DICA S A 18 Training To request training contact Magnamed Product Specialist who will direct you to the nearest authorized representative...

Страница 114: ...rer Technical Assistance Customer Service Rua Santa M nica 801 831 06715 865 Parque Industrial San Jos Cotia SP Brasil Tel Fax 55 11 4615 8500 E mail magnamed magnamed com br Website www magnamed com...

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