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Magnamed OxyMag, Operation Manual

The Magnamed OxyMag is a cutting-edge medical device designed to provide life-saving oxygen therapy. Ensure proper usage by accessing the Operation Manual for detailed instructions. Download the manual for free from manualshive.com to learn how to operate this essential equipment safely and effectively.

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Analytical Index

 

A

.

 

D

EFINITIONS

 ................................................ 5

 

B

.

 

W

ARNING

 ................................................... 5

 

C

.

 

C

AUTION

 ..................................................... 7

 

D

.

 

N

OTES

 ........................................................ 7

 

1.

 

DESCRIPTION

 ............................................. 8

 

1.1

 

I

NTENDED 

U

SE

 ............................................. 8

 

1.2

 

O

PTIONAL ITEMS COMPATIBLE WITH THE 

PRODUCTS

  9

 

2.

 

UNPACKING THE PRODUCT

 ...................... 10

 

2.1

 

I

NITIAL 

C

HECKS

 .......................................... 10

 

2.2

 

P

ARTS AND 

A

CCESSORIES

 ............................ 11

 

2.3

 

O

PTIONAL ACCESSORIES THAT CAN BE PURCHASED 

FOR 

O

XYMAG

............................................................... 12

 

 

P

ROTOCOL USED FOR DATA COMMUNICATION 

WITH EXTERNAL DEVICES

 ............................................... 17

 

3.

 

DESCRIPTION OF THE DISPLAY

 ................. 20

 

3.1

 

M

ODES

 ..................................................... 20

 

3.2

 

A

LARMS

,

 

M

ONITOR AND 

S

TATUS

 .................... 20

 

3.3

 

M

ONITOR

,

 

M

ENUS AND 

C

HARTS

 ..................... 20

 

3.4

 

S

ETTING THE VENTILATION PARAMETERS

 ......... 20

 

4.

 

PREPARATION FOR USE

 ........................... 21

 

4.1

 

A

SSEMBLING 

O

XYMAG 

–

 

T

RANSPORT 

V

ENTILATION

 

21

 

4.2

 

N

ONINVASIVE VENTILATION MASK

 ................... 23

 

4.3

 

P

OWER 

C

ONNECTION

 .................................. 24

 

4.4

 

M

OUNTING THE VERTICAL SUPPORT

 ................ 25

 

5.

 

CHECKS BEFORE USE

 .............................. 27

 

5.1

 

I

NITIAL PROCEDURES

 ................................... 27

 

5.2

 

V

ENTILATOR 

S

ETTINGS

 ................................ 28

 

 

N

ORMAL 

S

TARTUP 

S

EQUENCE

 .................. 30

 

 

T

EST 

S

EQUENCE

 .................................... 33

 

 

F

AILURE 

D

IAGNOSIS

 ................................ 34

 

6.

 

CAPNOGRAPHY SENSOR (ETCO2)

 ............. 35

 

6.1

 

I

NSTRUCTIONS FOR 

U

SE

 ............................... 35

 

6.2

 

A

SSEMBLING THE 

S

ENSOR

 ............................ 35

 

6.3

 

P

OSITIONING THE 

S

ENSOR

 ............................ 37

 

6.4

 

P

ROCEDURE TO 

R

ESET THE 

S

ENSOR

 .............. 38

 

6.5

 

I

NFORMATION REGARDING 

LED

 ..................... 38

 

6.6

 

P

REVENTIVE 

M

AINTENANCE

 

OF 

E

T

CO

2

 

S

ENSOR

39

 

6.7

 

T

ECHNICAL 

S

PECIFICATIONS OF THE 

C

APNOGRAPHY

 ............................................................ 40

 

7.

 

OXIMETER (MASIMO)

 ................................ 45

 

7.1

 

O

PERATION 

P

RINCIPLE

 ................................ 45

 

7.2

 

S

UMMARY OF 

B

LOOD 

C

ALIBRATION 

T

EST

 ........ 49

 

7.3

 

L

OW PERFUSION TEST SUMMARY

.................... 49

 

7.4

 

S

ENSOR ASSEMBLY

 ...................................... 49

 

7.5

 

O

XIMETER SPECIFICATION

 ............................. 50

 

8.

 

DESCRIPTION OF MODES

 .......................... 52

 

8.1

 

VCV

 

–

 

V

OLUME 

C

ONTROLLED 

V

ENTILATION

 .... 52

 

8.2

 

PCV

 

–

 

P

RESSURE 

C

ONTROLLED 

V

ENTILATION

 .. 54

 

8.3

 

PLV

 

–

L

IMITED 

P

RESSURE 

V

ENTILATION

 .......... 56

 

8.4

 

V-SIMV

 

–

 

S

YNCHRONIZED 

I

NTERMITTENT 

M

ANDATORY 

V

ENTILATION 

–

 

V

OLUME 

C

ONTROLLED 

C

YCLE

 . 58

 

8.5

 

P-SIMV

 

–

 

S

YNCHRONIZED 

I

NTERMITTENT 

M

ANDATORY 

V

ENTILATION 

–

 

P

RESSURE 

C

ONTROLLED 

C

YCLE

 60

 

8.6

 

CPAP/PSV

 

–

 

C

ONTINUOUS 

P

RESSURE 

V

ENTILATION WITH 

P

RESSURE 

S

UPPORT

 ........................... 62

 

8.7

 

D

UAL

PAP

 

–

 

B

I

-

LEVEL 

C

ONTINUOUS 

P

OSITIVE 

A

IRWAY 

P

RESSURE 

V

ENTILATION

 .................................... 64

 

8.8

 

APRV

 

–

A

IRWAY 

P

RESSURE 

R

ELEASE 

V

ENTILATION 

(

MODE OBTAINIED WITH INVERTED RATIO IN 

DUALPAP) .... 66

 

9.

 

ALARMS AVAILABLE ................................. 68

 

9.1

 

D

ESCRIPTION OF ALARM CONTROL

 ................. 68

 

9.2

 

S

ETTING 

A

LARMS

 ....................................... 78

 

9.3

 

A

LARM TEST

 .............................................. 78

 

 

A

DJUSTABLE ALARM TEST

 ........................ 78

 

9.3.1.1

 

P

RESSURE ALARM

 .................................. 78

 

9.3.1.2

 

PEEP

 ALARM

 ........................................ 78

 

9.3.1.3

 

M

INUTE VOLUME ALARM 

(MV)

 ................... 79

 

9.3.1.4

 

R

ESPIRATORY 

R

ATE ALARM

 ..................... 79

 

9.3.1.5

 

V

OLUME ALARM

 ..................................... 79

 

9.3.1.6

 

F

I

O2

 ALARM

 .......................................... 79

 

9.3.1.7

 

E

T

CO2

 ALARM

 ...................................... 79

 

9.3.1.8

 

P

ULSE RATE ALARM

 ................................ 79

 

9.3.1.9

 

CO2

 ALARM

 .......................................... 79

 

9.3.1.10

 

S

P

O2

 ALARM

 .................................... 79

 

9.3.1.11

 

A

PNEA ALARM

 ................................... 80

 

 

C

RITICAL ALARM TEST

 .............................. 80

 

9.3.2.1

 

D

ISCONNECTION

 ................................ 80

 

9.3.2.2

 

N

O 

AC

 POWER

 .................................. 80

 

9.3.2.3

 

L

OW BATTERY

 ................................... 80

 

9.3.2.4

 

O

BSTRUCTION

 ................................... 80

 

9.3.2.5

 

L

OW 

O2

 SUPPLY

 ................................ 80

 

9.4

 

M

ANUAL 

V

ENTILATION OF THE 

P

ATIENT

 ........... 80

 

10.

 

CLEANNING AND STERILIZATION

 .............. 81

 

10.1

 

E

QUIPMENT CLEANING

 ............................ 81

 

 

E

XTERNAL VENTILATOR SURFACES

 ............ 81

 

 

R

ESPIRATORY CIRCUIT

,

 PROXIMAL FLOW 

SENSOR AND EXHALATION VALVE

 ..................................... 81

 

10.1.2.1

 

W

ASH

 .............................................. 81

 

10.1.2.2

 

R

INSE

 .............................................. 81

 

10.1.2.3

 

D

RYING

 ........................................... 82

 

10.2

 

D

ISINFECTION

 ........................................ 82

 

 

E

XTERNAL 

P

ARTS

 .................................. 82

 

 

R

ESPIRATORY CIRCUIT

,

 EXHALATION VALVE

,

 

PROXIMAL FLOW SENSOR AND SILICONE LINE

 ..................... 82

 

10.3

 

S

TERILIZATION

 ....................................... 82

 

10.4

 

P

ROCESSING METHODS

 ........................... 83

 

Summary of Contents for OxyMag

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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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