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MECHANICAL VENTILATOR LEISTUNG LUFT NEO

1. 15 ELECTRONIC BLENDER OPERATION AR O BLENDER 19 FIO MEASUREMENT uu L 20 CHAPTER 3 ASSEMBLY AND 0 22 1 1 4 21 POWER SOURCE 21 GAS SOURCE CONNECTION 0 1 4 U 21 BREATHING CIRCUIT 22 CHAPTER 4 INDICATORS CONTROLS AND 65 23 FRONT PANEL n 23 INDICATORS AREA UU sssnnananaanaanannnnnananaaanannnnananaaanananaa 23 SCREEN 23 NUMERIC DISPLAYS AND SUPPLYING 53 0 25 25 CONTROL riz tT E 25 CHAPTER 5 LUFT NEO
2. 72 ANNEX G GLOSSARY EEE 7 L MECHANICAL VENTILATOR KU LEISTUNG LEISTUNG LUFT NEO Reseni GUIDELINES AND DECLARATIONS OF LEISTUNG EQUIPAMENTO LTDA ABOUT ELECTROMAGNETIC COMPATIBILITY Manufacturer guidelines and declarations Electromagnetic emission LUFT NEO is designated for use in electromagnetic ambience as specified bellow It is recommended that the LUFT NEO user ensures it be utilized in such ambience Emissiontests Compliance Electromagnetic ambience guidelines Lung ventilator LUFT NEO utilizes RF energy only for its internal functions However its RF emissions are very low and it is improbable it causes any interference with nearby equipments RF emissions ABNT NBR IEC CISPR11 m Lung ventilator LUFT NEO is appropriated for all RF emissions Class A establishments but domestic and may be used in ABNT NBR IEC CISPR11 residential establishments and those directly connected to the public low voltage power distribution that supplies Harmonic emissions IEC edifications for domestic use since the following 61000 3 2 Not applicable warning IS attended Emissions due to the Warning This equipment is designated for use only fluctuation of voltage flicker by health area professional It may causes radio IEC 61000 3 3 Not applicable interference or interrupts operation of nearby equipments It may be necessary to
3. n 43 SIMV PCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE 0 44 MMV PSV MINUTE MANDATORY VENTILATION WITH PRESSURE SUPPORT 44 MINUTE VOLEUME M n 44 PSV VT PRESSURE SUPPORT VENTILATION WITH ASSURED TIDAL VOLUME 45 BIPHASIC BIPHASIC PRESSURE VENTILATION erre nnne nnn nnn nennen 45 SUPERIOR TIME cccccccccceccaceccccecccuucesuecueuucestecuacuauensaestuauensaeutuauecusuenvauecuseattauecusnanesuecesnecnsneces 45 SUPERIOR PRESSURE a cc c cece cc cccccccccccccccececccceccauecucueusueaeauecusueaeanecusnesueneausneseenesnsueseenesnentsnsas 46 88 RR I RR Ier nmmRrImRttmRttrttmRtitrxtttmetkxtztttrxttmetitetretremktettettttettttrtttririii 46 5 46 NIV NON INVASIVE VENTILATION nnne 46 BACK UP U 47 0 0 0 0 0000 000 ornano naaa rnanan AALL A EREA E ELEAL LEARAER A arrsa rss rrsraarasrarsasaa 47 APNEA TIME cccccccccccccnccecuccusceccsccucuacucceccuccuucucuauusneccuacacuanucueseusceacacuanusuvsceatacuaduauusuvsteacacusuanusueas 47 CYCLING VARIABLES kvivcccscscvcccccicccccctscasessatecccscvscccescndvcwndsccesed
4. 0 0 1 144 10 27 SELECTION SEQUENCE ADJUSTMENT AND DATA CONFIRMATION 29 6 2 30 RESPIRATORY 5 RR RR RR RARE 32 niiuiedwebsunubenniobedeuteuwuvenswenta 32 DIRECT ACCESS FUNCTIONS AREA 0 1 1 114 10 33 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO Clrhqg 34 BRIAN RER 34 34 MANUAL 0 2 2 34 ALARMS 22 34 m 35 35 CHAPTER 7 VENTILATION MODES
5. 36 VENTILATION MODE SELECTION 2 nennen nnn nnn nnn 36 VCV VOLUME CONTROLLED VENTILATION e eere nennen UU 36 ga E 37 FLOW CURVES RR I Re e 37 5 8 a a rr rarrrsrarrrrrrrrs arrsa se rrsessesersa se sage irse sss RALEA ROPAR CEER eser esegue 37 SQUARE 37 DESCENDING RAMP 38 INSPIRATORY 38 RESPIRATORY 38 TIDALVNVOLUNE 39 ccs 39 SENSIBILITY Gea ee Oe ree 39 PCV PRESSURE CONTROLLED VENTILATION J J rn nnn 40 TINMB u u EE 41 5 41 PSV CPAP PRESSURE SUPPORT VENTILATION OR CONTINUOUS POSITIVE PRESSURE42 MAXIMUM INSPIRATORY 42 SUPPORT PRESSURE ccccccccccccccucccceccccecuecucuuceauecusueuenuaesteuenucestecueuesuentauetusuentaustuauennsneceanears 43 SIMV VCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE
6. flow 0 5 up to 10 l min Sensibility By Pressure 0 5 up to 15 H2Ocm compensated PEEP 2 up to 70 HsOcm over PEEP with adjustable RISE TIME 0 up to 70 over PEEP with adjustable RISE TIME Inspiration Pressure 2upto120H Ocm Adjustable from 5 up to 80 of initial flow PEEP CPAP Opto 50 _ Nebulization Synchronizedininspiratory phase S Synchronized in expiratory phase In mode automatic adjustment In and PSV modes up to 180 l min Continuous flow in neonatology 2 up to 15 l min Inspiratory flow in neonatology 1 up to 100 l min Off up to 50 l min Expiratory Flow Up to 120 l min Inspiratory flow LL Sigh mode per hour quantity volume and maximum pressure _ Inspiratory Pause VCV mode Oupto2secondswith plateau value Manual trigger 100 Oxygenation for aspiration with synchronized system In VCV mode rectangular descendent ramp sinusoidal and Flow waveform ascending ramp In and PSV descendent ramp In case of break of one of them the equipment continues Automatic By pass of the Air O operating normally INSPIRATORY PEAK FLOW 6 of 73 1 LEISTUNG MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LUFT NEO TOTAL FREQUENCY GRAPHIC INDICATOR OF SPONTANEOUS AND MECHANICAL CYCLES EXHALED MINUTE VOLUME CONCENTRATION BREATHING MECHANICS AUTOPEEP
7. the maximum nominal power output of transmitter in watts W according to transmitter manufacturer and d is the recommended separation distance in meters m The field intensity established by RF transmitter as determined by electromagnetic inspection on the local should be less than compliance level in each frequency band P Interference may occur around the equipment marked with this symbol NOTE 1 At 80 MHz and 800 MHz applies the highest range of frequency NOTE 2 This guidance may be not applicable in all situations The electromagnetic propagation is affected by absorption and reflection of structures objects and people The field intensity established by fix transmitters like base transceiver stations telephone cellular and wireless land mobile radio amateur radio AM and FM transmitter and TV transmitter can t be predicted theoretically with accuracy To evaluate the electromagnetic environmental due to RF fix transmitters it is recommended to consider a local electromagnetic inspection If the local field intensity where the Lung Ventilator LUFT NEO is located exceeds the above applicable RF compliance level the Lung Ventilator LUFT NEO should be observed in order to verify the normal operation If an unusual performance is observed additional procedure may be necessary such as reorienting or replacement of Lung ventilator LUFT NEO B Above the frequency range of 150kHz up to 80 MHz the field i
8. The control variable in this mode is P Sup support pressure The volume variation depends on physical conditions and it will be proportional to inspiratory effort of the patient and the adjusted support pressure To adjust controlled pressure you must have in mind that Sup refers to the pressure value above the established value for PEEP 50 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO As safety procedure LUFT NEO goes to expiratory phase if the maximum inspiratory time is reached In this ventilation mode the following variables must be adjusted e FiO e Rise Time R Time e Maximum inspiratory time TI max e Support pressure P Sup e PEEP e Sensibility Sens CPAP MODE IS ACTIVATED WHEN THE SUPPORT PRESSURE OFFERED IS REDUCED AT ITS MAXIMUM SIMV PCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE SUPPORT Permits the patient to synchronize spontaneous breathings PSV with mandatory breathings PCV ensuring to patient a minimum threshold of ventilation and oxygenation This is an alternative to start mechanical ventilation weaning process This mode has the function of decreasing the quantity of mandatory ventilations and permits to patient to perform spontaneous ventilations between each pre established PCV cycle In this ventilation mode the following variables must be adjusted e e Rise Time Time e Inspir
9. COLOR MEANING RED Danger An immediate action of the operator is needed YELLOW Caution An action of the operator is necessary ALARMS PRIORITY SEQUENCE Alarms are triggered according to the following sequence from the highest to the lowest Am Prorty _ High inspiratory pressure Interrupted cycle High Priority Lowinspiratory pressure tow inspiratory pressure pressure Minimum ial exhaled voume _ 776 Maximum N m _ ALARMS DESCRIPTION HIGH INSPIRATORY PRESSURE This alarm is activated if the airways pressure overpasses the fixed value at the maximum pressure limit control The sound is activated and the light corresponding to high inspiratory pressure Resolving the cause that activated the alarm the intermittent sound is turned off after 10 seconds but the light remains turned on continually until it is turned off manually through RESET key 54 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO ALWAYS THERE IS PARTIAL OR CONTINUOUS OBSTRUCTION OF THE PATIENT CIRCUIT THIS ALARM IS ACTIVATED LOW INSPIRATORY PRESSURE This alarm is activated if upon ending respiratory cycle the pressure did not reach the fixed values at low inspiratory pressure The sound and light are activated light corresponding to low inspiratory pressure Resolving the cause that activated the alarm the intermittent sound is turned off after
10. LEISTUNG MECHANICAL VENTILATOR LEISTUNG LUFT NEO R 04 04 52 REV 01 GMP CERTIFICATE NBR ISO 9001 2008 EN ISO 13485 2003 AC 2009 L MECHANICAL VENTILATOR RU 22 LEISTUNG LUFT NEO Rev 01 VENTILADORES PULMONARES LEISTUNG Equipamentos Ltda PCy NEONATAL P im F Pine LII LII xw A E Fee RF IL TECH OPERAT 4 HOMITOR EZXL 0 50 MN 1 MU E T z E E T hae T Freq Peer Sens 0 50 5 0 60 40 12 5 1 0 0 Liman 4 or T lt lt lt gt CIFTCHLIBTI 5 E 2 of 73 MECHANICAL VENTILATOR eae LEISTUNG LUFT NEO Rev 01 Manufactured by LEISTUNG EQUIPAMENTOS LTDA Street Joao Ropelatto 202 District Nereu Ramos City Jaragua do Sul SC ZIP 89265 300 Phone 55 47 3371 2741 Fax 55 47 3371 9267 VAT No 04 187 384 0001 54 254 417 108 Op Auth GHL3983MX9H2 GMP Certificate EN ISO 13485 2003 AC 2009 NBR ISO 9001 2008 Website www leistungbrasil com E mail leistung leistungbrasil com Legal Responsible Marcelo Javier Fernandez Technical Responsible Eng Fernando Alves Negrao CREA SC 077160 5 ANVISA registration Technical Name Pressure Volume Lung Ventilator Commercial Name Mechanical Ventila
11. PSV back up ventilation is available and the operator can let it activated or deactivated At the moment that SIMV PCV PSV is selected the operator can select the option YES to activate back up ventilation or NO to deactivate it BACK UP VENTILATION PCV To set back up ventilation the following parameters must be adjusted Apnea e Apnea e Inspiratory time e Respiratory frequency e Controlled pressure 15 00 8 Tins 1 00 s To initiate the operation in spontaneous mode the operator must accept all back up configuration by pressing ENTER key over the green arrow on configuration screen In case of not accepting or pressing RESET the ventilator resumes to its previous mode Freq 30 00 c min P Con H20 Back up ventilation output is automatic if the patient retakes spontaneous breathing or manual if the operator selects any assisted controlled ventilation mode 52 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO Apnea is the period without spontaneous breathing the maximum period of time in which the ventilator waits before triggering audio and visual alarm and starting back up ventilation Apnea time may be adjusted from 5 to 60 seconds CYCLING VARIABLES To set back up ventilation the following variables must be adjusted Inspiratory time Respiratory frequency and Controlled pressure P con PEEP PEEP level duri
12. AT THE EXPIRATORY FLOW TEST THE GAS LINES AIR AND MUST GIVE A FLOW OF AT LEAST 100 l min SO THAT IT DOES NOT INTERFERES WITH ITS OPERATION IN CASE OF BAD CONNECTION WRONG ASSEMBLY OR INVERSION OF THE SENSORS THE EQUIPMENT WILL SHOW AT THE DISPLAY A MESSAGE INDICATING READING ERROR OF FLW AND THE OPERATOR MUST CONFIRM IF HE WILL WORK WITH OR WITHOUT THE EXPIRATORY FLOW READING WHEN FINISHED THE COMPLIANCE TEST OF THE CIRCUIT THE EQUIPMENT SHOWS ON THE DISPLAY THE VALUES TO BE COMPENSATED AND THE OPERATOR CAN CHOOSE ABOUT COMPENSATE OR NOT THIS VALUE THE EQUIPMENT WILL COMPENSATE ONLY IF THE OPERATOR CHOOSE YES OTHERWISE IT WILL NOT DO IT 18 of 73 1 MECHANICAL VENTILATOR LEISTUNG LUFT NEO Reti ELECTRONIC BLENDER OPERATION AR O BLENDER fraction inspired of oxygen indicates the quantity of oxygen in the gas inspired by the patient In general it may vary from 21 7996 of Nitrogen and 21 of Os to 100 pure Oxygen for example of 60 means that 6096 of the inspired volume by patient is oxygen and 40 are composed by nitrogen and other gases FiO in LUFT NEO is generated by an electronic blender system which dispenses any external device The mixture is performed by two proportional actuators known as proportional valve which has this name due to its function to control proportionally the flow of air and oxygen that passes through each one of them Each flow is measured by its respe
13. Sens Rise Time is the time the ventilator requires reaching the selected pressure Increasing or decreasing this time may assist in the comfort of the patient In LUFT NEO the Rise Time is modulated by flow i e the higher the rise time the shorter the time to reach the adjusted pressure and the shorter the rise time the longer the time to reach the selected pressure For an appropriate ventilation the rise time must be adjusted in order to provide the smallest overshoot possible IF DURING A MANDATORY OR SPONTANEOUS CYCLE THE EQUIPMENT DETECTS ANY VARIATION OF FLOW GENERATING A PRESSURE VALUE HIGHER THAN THE DETERMINED THE ALARM OF INTERRUPTED CYCLE IS ACTIVATED AND LIMITS THE PEAK PRESSURE VALUE THE CAUSE OF THIS ALARM MAY BE CORRECTED THROUGH SENSIBILITY OR RISE TIME ADJUSTMENT PSV CPAP PRESSURE SUPPORT VENTILATION OR CONTINUOUS POSITIVE PRESSURE Spontaneous ventilation mode triggered by flow or pressure through patient effort In this mode the ventilator supports the patient through maintaining a positive pressure adjusted in Sup window This maintains free to patient to control the respiratory frequency inspiratory time and inspired air volume Therefore the tidal volume depends on inspiratory effort pre established support pressure and the mechanics of the respiratory system To perform this function the ventilator upon starting increases the pressure in the circuit to a defined pressure support level
14. compensated LUFT NEO in NIV allows the operator to establish the variable of inspiratory pressure limit and has the capacity to compensate leakages until 50 l min without generating auto trigger In this ventilation mode the following variables must be adjusted e FiO e Rise Time R Time e Maximum inspiratory time max e Suport Pressure P Sup e PEEP e Sensibility Sens IN NIV THE SENSIBILITY IS MODULATED ONLY BY PRESSURE 46 of 73 L MECHANICAL VENTILATOR RU LEISTUNG LEISTUNG LUFT NEO n BACK UP VENTILATION VENTILATION Back up ventilation is available in all ventilation modes which have a spontaneous parameter Mode VCV Apnea 15 00 s In LUFT NEO the back up is obligatory in modes PSV CPAP MMV PSV PSV Vt Assured and NIV In modes SIMV VCV PSV SIMV PCV PSV and Biphasic back up ventilation is available and the operator can let it activated or deactivated At the moment that SIMV VCV PSV SIMV PCV PSV or Biphasic is selected the operator can select the option YES to activate back up ventilation or NO to deactivate 1 00 s it When the selected mode is PSV CPAP MMV PSV PSV Vt Assured or NIV the ventilator provides directly the back up ventilation configuration screen To set back up ventilation the following parameters must be adjusted Ventilation mode Apnea Inspiratory time Respiratory frequency Tidal volume or Controlled pr
15. 10 seconds but the light remains turned on continually until it is turned off manually through RESET key This alarm also indicates if there was an accidental disconnection or if the circuit was taken off from the patient MAXIMUM EXPIRED TIDAL VOLUME It establishes a maximum expired tidal volume acceptable value If the resultant value remains high during three cycles for a period of time longer than 10 seconds the alarm 15 activated with light and sound indicators and message on the screen MINIMUM EXPIRED TIDAL VOLUME It establishes a minimum expired tidal volume acceptable value If the resultant value remains high during three cycles or for a period of time longer than 10 seconds the alarm is activated with light and sound indicators and message on the screen MAXIMUM FREQUENCY is activated if the resultant frequency is higher than the fixed value in alarm When there are leakages or disconnection of the circuit it may cause a self cycle that will activate the alarm APNEA ALARM This alarm is activated if the time between two consecutive inspiratory efforts to start the ventilator is longer than the established period of apnea The ventilator switches automatically the ventilation modes from backup to controlled pressure until the patient demand is restored or another ventilation mode be selected A sound is activated and an intermittent light warning which indicates apnea It can be silenced by the silence key If th
16. EQUIPMENT UNDER BATTERY SUPPLY IN ORDER TO TEST ITS CONDITIONS IT IS RECOMMENDED TO CHANGE THE INTERNAL BATTERY EVERY FOUR YEARS THE MANUFACTURER IS NOT RESPONSIBLE FOR NORMAL OR SPECIAL DAMAGE ALARMS SYSTEM INTEGRITY TEST 1 With the test balloon connected to the equipment choose VCV at alarm board configure Pmax with a value lower than the peak value shown at the screen The Maximum Pressure alarm must be triggered 2 Adjust the Pmax value with a value higher than the peak value shown at the screen and disconnect the test balloon It must trigger Minimum pressure alarm 3 Adjust the value Fmax with a value lower than the shown one at the screen after 10 cycles it must trigger the Maximum Frequency alarm 4 Adjust the minimum volume value with a value higher than shown in Tidal Volume It must trigger the minimum VT alarm 5 Adjust the maximum volume value with a value higher lower than shown in tidal volume It must trigger the maximum VT alarm 6 Disconnect the Pneumotachograph from exalatory valve It must triggers PEEP alarm Connect it again 7 Access one of spontaneous ventilation modes PSV after elapse apnea time it must trigger the apnea alarm 69 of 73 L LEISTUNG MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LUFT NEO 8 Disconnect the air high pressure hose from the gas input It must trigger the air oxygen alarm Connect the air hose and repeat this pro
17. WARNING Condition before which there is the possibility to cause damage to operator or others ATTENTION IEC 60601 1 1994 Condition before which there is the Symbol No 348 possibility to cause damage the equipment its accessories or others NOTE Specifies important observations which need to be considered for a correct use of the equipment MANUFACTURER 65 of 73 1 MECHANICAL VENTILATOR LEISTUNG LUFT NEO Rev 0 ANNEX 2 LUFT NEO ACCESSORIES DESCRIPTION FUNCTION PATIENT CIRCUIT WITH EXHALATION VALVE PATIENT EQUIPMENT INTERFACE NOTE 1 ONLY THE MODEL INCLUDED WITH THE EQUIPMENT MUST BE USED 2 THE PATIENT CIRCUIT IS MADE ACCORDING THE STANDARD ISO 5367 AND REGISTERED AT THE HEALTH MINISTRY BY THE MANUFACTURER HIGH PRESSURE HOSE AIR AND OXYGEN GAS SUPPLY A TROLLEY SUPPORT DESK FOR THE EQUIPMENT WHITH ANTI CORROSION TREATMENT APPROVED IN SALT SPRAY TEST NBR8094 5770 HUMIDIFIER SUPPORT SUPPORT FOR HUMIDIFIER FIXING 66 of 73 L MECHANICAL VENTILATOR rer LEISTUNG LEISTUNG LUFT NEO ARTICULATED ARM 4 ARTICULATED SUPPORT FOR PATIENT CIRCUIT ELECTRIC POWER SUPPLY NOTE IT MUST BE USED ONLY THE CABLE INCLUDED WITH THE EQUIPMENT TO FIX THE EQUIPMENT WITH THE TROLLEY USER MANUAL INFORMATION ABOUT FUNCTIONS REQUIREMENTS AND OPERATION OF THE EQUIPMENT TEST RESISTANCE SIMULATES RESISTANCE TO VERIFY THE CYCLES OF THE EQUIPMENT Illustra
18. adopt mitigation procedure like reorientation or reallocation of the LUFT NEO or blindage of the local not be used stacked on others equipment If this is required it is order to avoid RF interference the Lung Ventilator LUFT NEO should recommended to be observed the normal use of equipments 7 of 73 L LEISTUNG VENTILADORES PULMONARES MECHANICAL VENTILATOR R 04 0452 LEISTUNG LUFT NEO e Manufacturer Guidance and Declaration Electromagnetic Immunity The Lung Ventilator LUFT NEO is intended for use in environment electromagnetic specified below It is recommended that the client or user of Lung Ventilator LUFT NEO ensures that it is used in such environment Electrostatic Discharges ESD IEC 61000 4 2 Fast Transient Burst Burst IEC 61000 4 4 Surges IEC 61000 4 5 Power outage short interruptions and voltage variations on the lines of power input IEC 61000 4 1 1 Magnetic fields at power line frequency Test Level Compliance ABNT NBR IEC Level 60601 6 kV by contact 8 kV by air Complies 2 kV at power lines 1kV at I O lines Complies 1 kV line s to line s 2 kV line s to ground lt 5 U gt 95 voltage drop of Ut by 0 5 cycles 40 Ut 60 voltage drop of Ut by 5 cycles 70 U Complies 30 voltage drop of Ut by 25 cycles lt 5 U gt 95 voltage drop of Ut by 5 seconds 8 of 73 Electromagnetic Envi
19. delivered to patient in each ventilation cycle PEEP PEEP Positive End Expiratory Pressure is a tool used to recruit and maintain the alveoli open besides optimizing gases exchanges and to combat lung shunts SOME PATHOLOGIES REQUIRE SPECIFIC PEEP VALUES TO RECRUIT THE ALVEOLI WITHOUT DAMAGING THEM THE USE OF PEEP GENERATES HEMODYNAMIC REPERCUSSIONS THAT MUST BE KNOWN BY THE OPERATOR SENSIBILITY During artificial ventilation a pre determined trigger variable must be reached to initiate the inspiration In VCV the ventilation may be controlled by time i e by respiratory frequency or controlled by the patient himself who triggers the cycles as his necessity In LUFT NEO the sensibility trigger is by pressure or flow The ventilator detects a drop in pressure or flow threshold which is produced by the patient effort in his airway The inspiration may be triggered if performed effort exceeds the pressure of flow threshold selected to sensibility 39 of 73 L LEISTUNG MECHANICAL VENTILATOR R 04 04 52 VENTILADORES PULMONARES LEISTUNG LUFT NEO Rev 01 Pressure 0 Pressure 0 s Flow trigger Patient effort start Sensibility threshold Flow The pressure or flow threshold is determined by the operator in the ventilator which always indicates the negative pressure under PEEP or the displaced flow in the circuit necessary to trigger the ventilator When the sensibility limit is reached the inspiratory v
20. operator must change the current volume flow waveform or inspiratory time according to necessity i e the flow delivered by the equipment is the resultant of current volume inspiratory time and flow waveform requested by the operator 36 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO The resultant pressure is free and depends exclusively on physical and mechanical conditions of the respiratory system VCV is an assisted controlled ventilation mode and its inspiratory cycles may be triggered by time flow or pressure In this mode the following variables must be adjusted FiO e Flow curve Wave e Inspiratory time T Ins Respiratory frequency Freq e Tidal volume VTidal e PEEP e Sensibility Sens FIO FiO is related to the fraction of oxygen inspired by the patient To modify FiO just select its window with ENTER and adjust the fraction between 21 and 100 FLOW CURVES LUFT NEO provides square and descending ramp flow waves Flow waves may be selected in volume controlled modes WAVEFORMS The initial work waveform in volume modes 15 always square and to change it you must access WAVEFORM in the bottom left corner of the screen press ENTER choose the requested waveform and confirm with ENTER The waveform is changed in the first cycle There are two common wave patterns wave With this adjustment the flow accelerates very fast and
21. opontaneous cycles performed by patient will be support pressure cycles with independent adjustment The tidal volume delivered in each cycle is free and depends on the respiratory mechanics pressure releasing time and patient effort In this ventilation mode the following variables must be adjusted e FiO e Rise Time R Time e Superior time T Spr e Superior pressure P Spr e Inferior time T Inf e Inferior pressure P Inf e Support pressure P Sup e Sensibility Sens SUPERIOR TIME Superior time refers to the interval of time in which the superior pressure remains constant 45 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO SUPERIOR PRESSURE Superior pressure refers to high pressure reached in each cycle The superior pressure may be compared to the sum of PEEP with controlled pressure This pressure remains constant during the selected superior time INFERIOR TIME Inferior time refers to the interval of time in which the pressure remains in the level of base pressure INFERIOR PRESSURE Inferior pressure is the base pressure which remains in this level during inferior time Inferior pressure may be compared to PEEP NIV NON INVASIVE VENTILATION NIV mode is a way to ventilate the patient without invading his airway NIV is offered through use of adapted masks NIV is similar to PSV with the difference that eventual leakage by mask patient face adaptation can be
22. reaches a flow value which will be maintained during inspiration This wave pattern permits an appropriate ratio with a normal torrential If the airway peak pressure of the patient is higher than the normal the patient feels uncomfortable the wave pattern can be inverted in order to decrease this pressure or to accommodate a more normal breathing pattern When the flow pattern is square the volume has a ramp wave and the pressure is a scale followed by a ramp 37 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO Enn DESCENDING RAMP WAVE This waveform uses a fast flow acceleration followed by a slow climbdown This waveform may request very high flows to obtain an appropriate I E ratio This wave may be used to provide a better distribution of inspired air INSPIRATORY TIME Flow L min The inspiratory time correspond to the orange color on the graph above Integrated to current volume the inspiratory time works as a flow controller volume cycled furthermore to perform changes in the velocity of the inspiratory flow the operator must change the variables inspiratory time and tidal volume RESPIRATORY FREQUENCY Refers to ventilation cycles quantity given by LUFT NEO to patient within the period of one minute 38 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO Ren TIDAL VOLUME Volume Tidal volume V Tidal represents the volume in liters
23. the alarm without affect the light indicators during a time of 1 minute If at the end of this time the cause of the alarm was not solved the sound will get started again RESET This key is used to nullify all the light and sound alarm indicators and it is maintained until any alarm is activated 35 of 73 L MECHANICAL VENTILATOR RU LEISTUNG LEISTUNG LUFT NEO a CHAPTER 7 VENTILATION MODES PEDIATRIC VENTILATION MODE SELECTION Pressing Menu key main menu is accessed The first option is for ventilation modes Pressing ENTER a list containing all the usual modes for the selected category is shown The vertical and horizontal selection keys allow selecting the desired mode When confirmed the mode by pressing ENTER are shown on the screen all the parameters related with the selected mode If the ventilator are at this moment ventilating a patient through another mode the changes are not concluded until manual inspiration key is pressed which permits to finish the previous mode and start a new one Pressing RESET all the changes are canceled and the previous mode is resumed Following there are brief descriptions of the ventilation modes VENTILATION MODES VCV VCV VOLUME CONTROLLED VENTILATION In VCV mode LUFT NEO integrates the air flow with inspiration time and delivers to patient the programmed current volume Therefore VCV is flow limited and volume cycled To perform flow changes the
24. 3 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO PPeak 50 MODES 39 Pressure H20 30 1 AUXILIARY FLOWS 3 V Tidal 2990 40 Rate lt 30 12 2 Flow L min PROFILE 33 17 REMOTE o 4 MONITORING R Time T Ins 12 Seeking a greater ease and speed handling the 17 inches LCD display is organized areas alarm area monitoring area configuration area and the graphs areas where all these information are evidenced with different colors All values in white color are possible to be adjusted through the operator s adjustments the resultant values cannot be adjusted and they are in yellow The alarm values are red colored giving to the operator a greater ease of configuration In alarms area there are the alarms of maximum pressure minimum pressure maximum volume minimum volume maximum frequency maximum minute volume and minimum minute volume as well as their resultant values In monitoring area it is possible to view the numeric values of peak pressure mean pressure and base pressure as well as inspiratory peak flow inspiratory time ratio and On the bottom of the display the parameters adjustable by the operator such as WAVEFORM RISE TIME INSPIRATORY TIME FREQUENCY TIDAL VOLUME CONTROL PRESSURE SUPPORT
25. ALARMS INSPIRATORY MAXIMUM MINIMUM AIRWAY PRESSURE DISCONNECTION OF THE PATIENT CIRCUIT MAXIMUM MINIMUM EXHALED TIDAL VOLUME APNEA WITH ADJUSTABLE TIME MAXIMUM RESPIRATORY FREQUENCY MAXIMUM MINIMUM PEEP AND CONTINUOUS PRESSURE GAS SUPPLY SOURCE AIR O POWER OUTAGE LOW BATTERY CHARGE MICROPROCESSOR INTERRUPTED CYCLE PRESSURE MODES MAXIMUM MINIMUM FIO INVERTED RATIO ALARMS ARE TRIGGERED FOLLOWING PRIORITY ORDER WITH LIGHT OR SOUND WARNINGS AND OR SCREEN MESSAGE GRAPHICS PRESSURE FLOW TIME TENDENCY CURVES LAST 18 5 PEAK AND BASE PRESSURE FLOW TIDAL VOLUME MINUTE VOLUME FREQUENCY DYNAMIC COMPLIANCE ALARMS LOG LANGUAGE SELECTION SELF TESTS PATIENT CIRCUIT LEAKAGE EXPIRATORY FLOW PEEP VALVE PATIENT CIRCUIT COMPLIANCE 17 of 73 L LEIS VENTILADOR L uc MECHANICAL VENTILATOR R 04 0462 LEISTUNG LUFT NEO ee PATIENT CIRCUIT TEST AUTOTEST IS PERFORMED BY THE OPERATOR WHENEVER THE EQUIPMENT IS TURNED ON ONCE REALIZED AUTOTEST THE EQUIPMENT MAKES THE CALIBRATION WITHOUT OPERATOR S INTERVENTION WHEN NECESSARY THE EQUIPMENT CLEANS THE FLOW SENSORS AUTOMATICALLY EXALATORY VALVE WITHOUT ITS OPERATION BE INTERRUPTED IN CASE OF LEAKAGE IN THE CIRCUIT DURING THE INITIAL TEST AUTOTEST THE EQUIPMENT SHOWS ON THE DISPLAY A MESSAGE INDICATING THE VALUES OF LEAKING FOR THE CORRECT OPERATION OF THE EQUIPMENT IT IS IMPORTANT THAT THERE IS NOT ANY LEAKING IN THE PATIENT CIRCUIT
26. ATION LIST PATIENT OPERATION MODE CHECK VCV PCV SIMV CPAP PSV ASSURED TIDAL VOLUME PSV V BIPHASIC PRESSURE MMV PSV PEDIATRIC P max P min VT max PCV SIMV CPAP PSV VT min Freq Max PEEP APNEA NEONATOLOGY CONTINUOUS FLOW 57 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO CHAPTER 10 EXHALATION VALVE AND PATIENT CIRCUIT The figure below shows the exhalation valve assembly Exalatory valve cover Flow sensor Verify if the hoses are Verify if the flow sensor connected correctly membrane is not damaged UPON ASSEMBLING THE EXALATORY VALVE PUT THE DIAPHRAGM AS Tu INDICATED IN THE FIGURE WITH THE SALIENCE DOWNWARD THE LONGER HOSE MUST BE AT EXTERNAL SIDE OF THE EXALATORY Tu VALVE IN THE TERMINALS MARKED WITH PROTRUDING POINT DO NOT DRY OR CLEAN THE EXALATORY VALVE WITH COMPRESSED AIR DO NOT INSERT IN THE BODY OF THE EXALATORY VALVE PIERCING OR CUTTING MATERIALS 58 of 73 L LEISTUNG MECHANICAL VENTILATOR R 04 04 52 on ec LEISTUNG LUFT NEO o The figure below shows the patient circuit assembly C Optional Connector mo COC C Drain Trachea B Y Connector WHEN ADDED COMPONENTS OF THE RESPIRATORY CIRCUIT OR OTHER COMPONENTS OR SUBSETS FOR THE RESPIRATORY SYSTEM THE PRESSURE GRADIENT MEASURED AT THE PORT OF CONNECTION OF THE PATIENT MAY INCREAS
27. ATION is pressed which allows finishing previous mode and initializing the new one Pressing RESET all changes are canceled and the previous mode is resumed Following is a brief description of the ventilation modes VENTILATION MODES PCV PCV PRESSURE CONTROLLED VENTILATION In the LUFT NEO delivers to patient the adjusted pressure the inspiratory flow is automatically adjusted to maintain the pressure constant during the adjusted inspiratory time Therefore PCV is pressure limited and time cycled Tus IN PRESSURE MODES THE FLOW WAVEFORM CAN NOT BE CHANGED WHICH WILL BE ALWAYS DESCENDING RAMP 49 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO The resultant volume is free depends only on physical and mechanical conditions of the respiratory system PCV is an assisted controlled ventilation mode and the inspiratory cycles may be triggered by time flow or pressure In PCV airway pressure level is the main parameter to be adjust as it will have direct influence about the tidal volume available to patient To adjust controlled pressure you must have in mind that Con refers to the pressure value above the established value for PEEP In this ventilation mode the following variables must be adjusted e FiO e Rise Time R Time e Inspiratory time T Ins e Respiratory frequency Freq e Controlled pressure P Con Sensibility
28. E UPON REMAKING THE CIRCUIT TEST THIS GRADIENT IS AUTOMATICALLY CORRECTED BY THE EQUIPMENT A BAD CLOSURE OF THE DIAPHRAGM MAY AFFECT ON THE PARAMETERS READING N GENERATING WRONG RESULTS THE DIAPHRAGM MUST LEAN ON THE COVER ACCOMODATION FOR WHICH 15 CONVENIENT TO FIRST PUT IT IN THE COVER AND ASSURE THAT IT IS WELL LEANED TO THEN THREAD IT ON THE BODY i AT THE END OF THREADING DO NOT MAKE STRONG ADJUSTMENTS 59 of 73 L LEIS MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LUFT NEO VERIFY IF THE TWO PLASTIC TUBES ARE COMPLETELY WITHOUT HUMIDITY SO IT IS POSSIBLE TO MEASURE CORRECTLY THE PRESSURE DIFFERENCE WHEN STERILIZING THE VALVE DO NOT DISCONNECT THE PLASTIC TUBES BECAUSE THEY HAVE DEFINED POSITIONS AND TO NOT DEFORM THE INTERNAL MEBRANE TRANSPARENT BECAUSE IT 15 ENCHARGED OF ESTABLISH THE PRESSURE DIFFERENCE WHICH THE EQUIPMENT MEASURES TO FIX THE OUTPUT PARAMETERS OF THE PATIENT IF THE MEMBRANE IS FOLDED OR DAMAGED THE MEASURE WILL NOT BE CORRECT THE PATIENT CIRCUIT TYPE B IS MADE BY MATERIAL CERTIFIED BY FDA FOOD AND DRUGS ADMINISTRATION WHICH ENSURES THE BIOCOMPATIBILITY OF THIS MATERIAL THE COPY OF THIS CERTIFICATE CAN BE ACQUIRED FROM THE MANUFACTURERFABRICANTE IT MUST BE OBSERVED THAT DURING THE USE OF THE EQUIPMENT AFTER A DETERMINED TIME THE MEASURED PARAMETERS AT INITIAL TEST OF THE PATIENT CIRCUIT AND PERIPHERALS TEND TO VARY BY TEMPERATURE HUMIDITY LOCATION ETC T
29. HE VARIATIONS IN THE CIRCUIT MAY BE MORE SIGNIFICANT DURING THE FIRST HOURS OF OPERATION STABILIZING AFTER THAT 60 of 73 L LEISTUNG MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LUFT NEO CHAPTER 11 CLEANING DESINFECTION AND STERILIZATION The parts in contact with the patient may be completely sterilized The protocols which define the methods and the frequency must be adapted to the procedure of decontamination and cleaning here indicated as a guide Upon removing the patient circuit of the package or always it is removed from the equipment in use it must have its parts exhalation valve tracheas drain and Y connector cleaned and sterilized Such methods are Ethylene oxide 55 Autoclave 121 249 8 F 15 p s c g 15 minutes Glutaraldehyde Until two hours of disinfection Until eight hours of sterilization Peracetic acid Enzymatic detergents cleaning THE STERILIZATION METHODS DESCRIBED ABOVE ARE RECOMMENDED FOR PATIENT CIRCUITS PROVIDED BY LEISTUNG EQUIPAMENTOS LTDA THE USE DESINFECTANT SOLUTIONS MUST BE DONE FOLLOWING MANUFACTURER RECOMMENDATIONS AND BY STERILIZATION PROTOCOLS ETHYLENE OXIDE IS TOXIC ALL THE COMPONENTS MUST BE DRY BEFORE BEING STERILIZED N THE EXHALATION VALVE ACCEPTS ANY OF THE ABOVE METHODS N FOR ANOTHER CIRCUIT CONSULT MANUFACTURER S RECOMENDATIONS AVOID THE USE OF PURE ALCOHOL CLEANSING SOLUTIONS WHICH CONTAIN
30. ISTED MODE IS SELECTED THE CONFIGURATION OF BACK UP VENTILATION IS NEEDED BECAUSE IF THE PATIENT DOES NOT MAKE ANY INSPIRATORY EFFORT THE EQUIPMENT WILL RESPECT THE SELECTED APNEA TIME TO DELIVER BACK UP VENTILATION ACCORDING TO THE CONFIGURATION PERFORMED APNEA TIME IS NOT ACTIVE IN VCV AND PCV MODES IN ALL MODES WHICH WORK WITH CONTROL PRESSURE AND SUPPORT PRESSURE THE CHANGES ARE DONE INDEPENDENTLY AND DIRECTLY BY THE OPERATOR IN ALL VENTILATION MODES OF LUFT NEO PEDIATRIC NEONATAL THERE IS A DEFAULT CONFIGURATION DEFAULT CONFIGURATION IS NONSPECIFIC AND IT MUST BE ADJUSTED BY THE OPERATOR ACCORDING TO THE PATIENT NEEDS LUFT NEO NEVER STOPS WORKING DURING CHANGING FROM A VENTILATION MODE TO ANOTHER ONE IN CASE TO CANCEL VENTILATION MODE CHANGE YOU MUST PRESS RESET KEY 48 of 73 L LEISTUNG MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LUFT NEO CHAPTER 8 VENTILATION MODES NEONATALOGY VENTILATION MODE SELECTION Pressing MENU key main menu is accessed The first option is for ventilation modes Pressing ENTER key is shown a list of all the modes available for the select category The vertical and horizontal selection keys allow selecting the requested command When confirmed with ENTER key all the related parameters with the selected mode are shown If the ventilator is operating while the operator is configuring another ventilation mode changing will not be done until MANUAL INSPIR
31. OR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO PSV VT PRESSURE SUPPORT VENTILATION WITH ASSURED TIDAL VOLUME Spontaneous mode which allows the operator to select a minimum tidal volume for each ventilation cycle the patient requests In this mode upon starting inspiratory cycle the ventilator will control the pressure through flow assistance P Sup If upon ending of previewed inspiratory period the volume delivered to patient is smaller than the determined the ventilator extend the delivery time maintaining the flow constant to complete the missing volume If the volume is bigger than expected no volume is added in such cycle The objective of this mode is to ensure delivered time bigger or equal to established In this ventilation mode the following variables must be adjusted e FiO e Rise Time R Time e Tidal volume V Tidal e Support pressure P Sup e PEEP e Sensibility Sens BIPHASIC BIPHASIC PRESSURE VENTILATION In Biphasic mode the ventilator works in two pressure levels In pre determined times occurs transitory relief from the high pressure to low pressure and after that after a pre determined time the higher pressure is reestablished For patients who do not perform spontaneous efforts Biphasic mode is similar to controlled pressure mode with relation TI TE which may be or not be inverted with the only difference of allowing the patient to trigger the spontaneous cycles in two pressure levels
32. PRESSURE PEEP and SENSIBILITY To change the values the operator must select the desired option press ENTER adjust the value and confirm it pressing ENTER again In sensibility option the operator may choose for work with SENSIBILITY BY FLOW l m or PRESSURE H2Ocm to change option go in sensibility and press ENTER then confirm the change with the side keys right left changing from to and the directional keys up down ranging work values Resultant values that remain in yellow and are located in monitoring area are not adjustable they are resultant parameters of the adjustable ones i e the values measured by the equipment Ex peak pressure base pressure and mean 24 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO pressure airways exhaled tidal volume frequency flow peak dynamic compliance inspiratory time ratio and FIO monitoring On the upper side of the screen is indicated 1 Upper left side Company s name and equipment model below there are the patient type and ventilation mode see chapters 5 and 6 2 Upper right side Date and hour the equipment was started below there are current date and hour of the equipment NUMERIC DISPLAYS AND SUPPLYING INDICATORS Peak Presssure Tiral LEISTUNG LUFT NEO counts with set of numeric displays which show the cm 20 values of pressures and base expired volume and frequency
33. SOLVENTS ACETONE CHLORINATED SUBSTANCES OR CHLOROFORM FOR CLEANING OF THE RESPIRATORY TUBES AND PLASTIC PARTS GLUTARALDEHYDE IS TOXIC FOR THE AMBIENT AND USERS IT MUST BE MANIPULATED USING EQUIPMENTS OF INDIVIDUAL PROTECTION AND MUST BE ELIMINATED FOLLOWING THE STANDARD AND PROTOCOLS OF THE HOSPITAL ETHYLENE OXIDE USE MAY ACCELERATE THE APPEARANCE OF AND 5 DERIVATIVES SUCH AS MODIFY THE PLASTIC PARTS THE VENTILATOR ITS CASE MUST NEITHER BE CLEANED WITH ETHYLENE OXIDE NOR IN AUTOCLAVE 61 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO CHAPTER 12 MOUNTING THE EQUIPMENT ON THE TROLLEY The figures sequence shows how to fix the equipment on the trolley and how to fix the display in the support arm Fit the euipament on the trolley after that fix them with the wing nut Fit the screen with the screws acording to the drawing Fit the screen arm in the trolley and then fix them according to the drawing THE ASSEMBLED EQUIPMENT HAS A LIMITATION ABOUT RISK OF FALLING MAY BE INCLINED AT A MAXIMUM OF FIVE DEGREES DURING OPERATION WHEN MOVING THE EQUIPMENT ON THE TROLLEY IT IS NECESSARY TO BE CAREFULL IN ORDER TO AVOID IT TO FALL DOWN THE TRANSPORT OF THE EQUIPMENT MUST BE DONE IN ITS ORIGINAL PACKAGE WITH THE TROLLEY AND THE LCD DISPLAY DISASSEMBLED 62 of 73 MECHANICAL VENTILATOR LEISTUNG LUFT NEO Rev 01 ANNEX 1 SIMBOLOGY 1 Mea
34. TS WHICH HAVE WATER DRAIN IN ITS BRANCHS INSPIRATORY EXPIRATORY VERIFY THE HEMERTICITY TO AVOID VOLUME LEAKAGE IN THE CIRCUIT WHEN THE CALIBRATION OF THE PATIENT CIRCUIT IS PERFORMED THE NEBULIZER MUST NOT BE CONNECTED IN IT VERIFY THE CORRECT POSITION OF THE DIAPHRAGM OF THE EXALATORY VALVE SEE CHAPTER 10 THE CONNECTORS OF THE PATIENT CIRCUIT ARE CONICAL TYPES 22mm IN PEDIATRIC AND 15mm IN NEONATAL AND THEY ARE ACCORDING WITH THE ISO 5356 1 NBR13475 STANDARD WHICH DETERMINES THE MINIMAL EXIGIBLE CONDITIONS FOR THESE CONNECTOR TYPES 22 of 73 L MECHANICAL VENTILATOR RUE rore LEISTUNG LUFT NEO Rev 01 CHAPTER 4 INDICATORS CONTROLS AND ALARMS FRONT PANEL ELECTRIC ENERGY 110 220 O 2 L Peok EO Tirol cm H 5751 LEISTUNG LUFT NEO Bose Pressure Frequency 2 ALARMS Insp Pressure Inversion mMin Insp Pressure O Peep Q Apnea O Max Frequency Air Oxygen Q VT max min Q Power Outage Q Battery Microprocessor INDICATORS AREA LEISTUNG LUFT NEO counts with a double monitoring system with graphic and numeric indications LCD SCREEN Color LCD screen shows the selected values curves and resultant values The screen has an information distribution so that permits to the operator a fast localization of the data to be read offering so a high operability 2
35. ading time of the graphics on screen STAND BY Permits to select Stand by mode which maintains the ventilator in state of repose without alarms until it gets connected to the patient again without losing the previous set operation parameters WHILE IN STAND BY ALL THE KEYS ARE LOCKED EXCEPT MANUAL INSPIRATION KEY FREEZE IMAGE Freezes the graphs currently shown on screen maintaining active patient monitoring and updating output values and airway pressure bar MANUAL INSPIRATION Each time this key is pressed a new inspiratory cycle is started It is only active at expiratory phase ALARMS AREA ALARMS Max Insp Pressure Inversion Min Insp Pressure Peep Apnea Frequency Air Oxygen VT max min Power Outage Battery Microprocessor 34 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO In this sector are the light indicators corresponding to the alarms which when activated are followed by an alert sound and by messages on screen The light indicators turns on intermittently to indicate which alarm is activated once solved the cause of the alarm the indicator will remain turned on permanently to indicate which alarm was triggered until the key RESET be pressed All the triggered alarms are registered with hour and date at the menu Alarms History See MENU key SILENCE This key is used to silence
36. agrams Circuit Diagrams component list repair instructions and training can be provided by Leistung Equipamentos Ltda by agreement between the parts Leistung Equipamentos Ltda is a company of continuous improvement in its products and technical specifications can change without previous notice 14 of 73 L MECHANICAL VENTILATOR recy LEISTUNG LEISTUNG LUFT NEO a CHAPTER 2 INTRODUCTION LUFT NEO is among the most complete lung ventilators in the world market offering a high ventilation quality adapted for each patient with great ease of operation through an extremely intuitive panel design which allows the operator to utilize all the parameters using few command keys due to its intelligent graphical interface making the work of the operator easier allowing the operator to provide more attention to the patient Suitable for pediatric and neonatal patients LUFT NEO is able to assume the most complete and rigorous therapies effectively reliable and accurate Based on an easy operative system it is interactive with the operator it has fast and safe interconnection system with the patient circuit avoiding any possibility of error starts with a default configuration which ensure a safe and accurate ventilation giving to the operator the control of the equipment and assuring sensitivity values that avoid self cycling allowing a better progress of the patient without interferences Warning messages are very easy to un
37. alve is open and a new cycle starts To choose the numeric value of the sensibility just select its window and move the cursor on the vertical direction When the presented is with negative signal and unit of measure cmHZ2O it means the sensibility is adjusted by pressure and when it is with unit of measure L min it means it is adjusted by flow To change this configuration just access its window and move the cursor on horizontal direction PCV PRESSURE CONTROLLED VENTILATION In PCV the LUFT NEO delivers to patient the adjusted pressure the inspiratory flow is automatically adjusted to maintain the pressure constant during the adjusted inspiratory time Therefore PCV is pressure limited and time cycled IN PRESSURE MODES THE FLOW WAVEFORM CAN NOT BE CHANGED WHICH WILL BE ALWAYS DESCENDING RAMP The resultant volume is free and depends only on physical and mechanical conditions of the respiratory system PCV is an assisted controlled ventilation mode and the inspiratory cycles may be triggered by time flow or pressure In this ventilation mode the following variables must be adjusted e FiO e Rise Time R Time e Inspiratory time T Ins Respiratory frequency Freq e Controlled pressure P Con e PEEP e Sensibility Sens 40 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO RISE TIME Rise Time is the time the ventilator requires reaching the selected pressure Increase or decrease thi
38. atory time T Ins Respiratory frequency Freq e Controlled pressure P Con e Support pressure P Sup e PEEP e Sensibility Sens CONTINUOUS FLOW is a ventilation mode with continuous flow time cycled and pressure limited In this mode the mandatory cycles are provided to patient however between each mandatory cycle the patient can breaths spontaneously due to the presence of continuous flow In this ventilation mode the following variables must be adjusted e e Inspiratory time T Ins Respiratory frequency Freq e Continuous flow Flow e Controlled pressure P Con e PEEP e Sensibility Sens 51 of 73 L MECHANICAL VENTILATOR LEISTUNG LEISTUNG LUFT NEO a NASAL CPAP CONTINUOUS POSITIVE PRESSURE VENTILATION Nasal CPAP is a spontaneous ventilation mode which permits the operator to establish pressure and continuous and constant flow in the breathing circuit This mode is applied in Neonatology and may be offered to patient through cannulas or nasal prongs In this ventilation mode the following variables must be adjusted e FiO e Continuous flow Flow e PEEP BACK UP VENTILATION Back up ventilation is available in all ventilation modes which have a spontaneous parameter In LUFT NEO the back up is obligatory in PSV CPAP mode When the selected mode is PSV CPAP the ventilator provides directly the back up ventilation configuration screen In SIMV PCV
39. cedure for the oxygen high pressure hose to check the same alarm 9 Disconnect the power cable from plug It must trigger power outage alarm 10 Let the equipment without electric supply for approximately 75 of battery life It must trigger battery alarm EACH TEST 15 INDEPENDENT SO IT IS POSSIBLE TO CHECK THE ALARMS IN TRIGGERING MAY VARY IN EACH TEST ANY ORDER Tus THE TIME BETWEEN THE PARAMETER ADJUSTMENT AND ALARM IT IS RECOMMENDED FOR THIS TEST BE DONE ALONG WITH PREVENTIVE MAINTENANCE DESCRIBED AT THE BEGINNING OF THIS CHAPTER 70 of 73 L MECHANICAL VENTILATOR R 04 0462 LEISTUNG LUFT NEO ANNEX 4 BLOCK DIAGRAM The following figure represents the pneumatic diagram of LUFT NEO Air inlet 17 LCD Display i Pressure sensors Sensor sensor Prop val Prop val Anti suffocation Safety SOURCE valve Patient output Prop valve Regulator nebulizer Expirat valve 71 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO ANNEX 5 WARRANTY LEISTUNG brand LUFT NEO model This equipment is guaranteed for 12 twelve months after purchase date where the factory is responsible for any defect or manufacturing failure This warranty must be stamped and signed by LEISTUNG EQUIPAMENTOS LTDA and accompanied of purchase chit The conditions for use installation and maintenance necessary for this equip
40. cludes memory test internal battery indicator LEDs etc Finished the initial sequence the categories to be ventilated are shown to be selected according to type of patient PEDIATRIC NEONATAL THIS SELECTION INFLUENCES THE OPTIONS OF THE OFFERED VENTILATION N MODES AND THE INITIAL PARAMETER VALUES OF OPERATION IS CONSIDERED PEDIATRIC PATIENTS BETWEEN 10 AND KG OF WEIGHT NEONATAL PATIENTS WITH LESS THAN 10 KG OF WEIGHT 21 of 73 L MECHANICAL VENTILATOR REIHE ne LEISTUNG LUFT NEO Rev 0 5 6 UN 7 PATIEN PEDIATRIC PATIENT CIRCUIT TEST Circuit Leakage Test Expiration Flow Test Compliance Test Line Compliance 60 cmH20 1 A ea a u adn uu MEAT Select and press lt ENTER gt Following is performed a test of the patient circuit It is necessary to install the circuit and maintain blocked the Y output during the entire test In this test is verified if there is leakage it measures and compensates the circuit compliance and is verified the PEEP control and exhalation valve flow THE INCORRECT OBSTRUCTION OF THE PATIENT OUTPUT MAY RESULT IN LEAKAGE ON THE SYSTEM IF THE EXHALATION VALVE IS ASSEMBLED INCORRECTLY OR WITHOUT ITS READING INTERNAL MEMBRANE INTERNAL MAILER THE EQUIPMENT WILL NOT BE ABLE TO READ THE EXHALATED VOLUME WHERE THE OPERATOR MAY OPT TO WORK WITHOUT THIS READING OR RESTART THE TEST Finally is accessed the operative mode
41. ctive pneumotachograph device used for flow measurement which send to CPU board the current value of the generated flows by the proportional valves The value of FiO is given by the fraction of gas delivered by each proportional valve where each one of them gets responsible only for one part of the total inspired volume This system is very accurate because once the physical quantities are very well known like volume pressure and flow and the variation of concentration of oxygen in the air are very small as well as the percentage of oxygen 100 provided is enough that the control calculates the flow value of each value will deliver to patient it is obtained with a negligible error the correct AIR INSPIRED FLOW 19 of 73 L MECHANICAL VENTILATOR aero LEISTUNG LUFT NEO Rev 01 FIO MEASUREMENT measurement is performed through measurement cells furnished along with the equipment As standard the cell that is included with the equipment is the galvanic oxygen cell which uses electrochemistry reactions for O percentage measurement in the inspired gas flow Due to this characteristic these cells has life time which starts counting from the moment it is exposed to oxygen in the air which must be replaced after its determined time The following figure illustrates the right place to put the cell As optional Leistung Equipments Ltd offers the paramagnetic oxygen cell which is installed internally
42. derstand which turns possible to take decisions respecting the alarms situation and critical parameters variation The final result is an ICU medical ventilator with a friendly interface where its handling is very easy and intuitive Ventilation modes menu is focused for pediatric and neonatal patients at the same time its configuration is simple and affective so LUFT NEO practicability and operator competence can walk together so that the maximum of LUFT NEO can be obtained perfect and natural mechanical ventilation delivering comfort and safety for adults and neonates VENTILATION MODES PATIENT TYPE VENTILATION VOLUME CONTROLLED VCV PRESSURE CONTROLLED PCV PRESSURE SUPPORT PSV SPONTANEOUS CONTINUOUS POSITIVE PRESSURE CPAP PEDIATRIC NON INVASIVE NIV SIMV VCV PCV PSV MANDATORY MINUTE MMV PSV VARIABLES PSV ASSURED TIDAL VOLUME BIPHASIC PRESSURE PRESSURE CONTROLLED ASSISTED CONTROLLED CONTINUOUS FLOW NEONATOLOGY PRESSURE SUPPORT PSV SPONTANEOUS CPAP Nasal CPAP VARIABLES SIMV PCV PSV 15 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO a SPECIFICATIONS Back lati PCV or VCV in pediatric and PCV in neonatology ackup ventilation Emergency ventilation FIO 21 to 100 electronically regulated on the panel with graphic display monitoring Inspiration Time 0 1 to 25 seconds Ventilator frequency 1 180 bpm Tidal volume 10 up to 2500
43. e cause of the alarm disappears it will be silenced automatically and the light will remain turned on in continuous form The light can be turned off pressing RESET key PEEP ALARM This alarm is activated when the PEEP value overpasses the limit established by the user To activate this alarm it is necessary to access MENU gt PEEP ALARM and select the limit value for PEEP in LOW GAS PRESSURE This alarm is activated if the pressure of any one of gases inputs is less than 2 bar This alarm 15 turned off automatically when restoring the input pressures It cannot be restore manually but can be silenced during 60 seconds pressing SILENCE key POWER OUTAGE This alarm is activated if a power outage occurs while the ventilator is operating This alarm is turned off when the power is restored It cannot be silenced manually 55 of 73 L MECHANICAL VENTILATOR recy LEISTUNG LEISTUNG LUFT NEO a LOW BATTERY This alarm is activated when the equipment is operating without external power and the internal battery reaches a charge of 75 of the nominal voltage see chapter 1 This alarm is turned off automatically when the power 15 restored It cannot be silenced manually If the power is not restored when the battery charge runs out the equipment is turned off all the gas supply valves get closed and the anti suffocation valve is enable which permits the air inlet of the ambient to the patient circuit When the power reestablished
44. e changing between inspiration phase and exhalation phase cycle To change exhalation sensibility you must press MENU and select Exhalation Sensibility option Exhalation Sensibility may be adjusted with values between 596 and 809 of inspiration flow peak SENSIBILEXP 5 SENSIBIL EXP 40 Pressure 20 Pressure cm H20 304 Flow Lmin ay 1 OF d a Fi r TA y V IF THERE IS LEAKAGE IN THE PATIENT CIRCUIT A LOW VALUE OF EXPIRATORY SENSIBILITY MAY HAMPER THE CYCLE DUE TO THE LEAKAGE BE GREATER THAN THE SELECTED INPUT VALUE 31 of 73 L MECHANICAL VENTILATOR AES LEISTUNG LUFT NEO Rev 01 RESPIRATORY MECHANICS Press MENU key and select Respiratory Mechanics option AUTO PEEP Auto PEEP is conceptualized as the persistence of an alveolar positive pressure at the end of exhalation non intentional due to the presence of a final exhalation lung volume bigger than the previewed residual functional capacity It occurs in patients submitted to mechanical ventilation in consequence of starting an inspiratory phase with positive pressure before the expiratory time is enough to a complete exhalation of the inspired volume previously Auto PEEP is not evident may changes drastically the alveolar dynamic and generates a considerable risk in situation that affects the flow during expiration leading to unnecessary increasing of the respiratory
45. essure To initiate the operation in spontaneous mode the operator must accept all back up configuration by pressing ENTER key over the green arrow on configuration screen In case of not accepting or pressing RESET the ventilator resumes to its previous mode Back up ventilation output is automatic if the patient retakes spontaneous breathing or manual if the operator select any assisted controlled ventilation mode VENTILATION MODE Refers to the selected mode for cycling during back up ventilation period VCV or PCV can be chosen To change back up mode you must press ENTER over the ventilation mode on back up ventilation screen and move the vertical cursor selecting the requested mode with ENTER key APNEA TIME Apnea is the period without spontaneous breathing the maximum period of time in which the ventilator waits before triggering audio and visual alarm and starting back up ventilation Apnea time may be adjusted from 5 to 60 seconds CYCLING VARIABLES To set back up ventilation the following variables must be adjusted Inspiratory time Respiratory frequency Tidal volume V Tidal or Controlled pressure P con TIDAL VOLUME ADJUSTMENT WILL BE AVAILABLE SELECTING VCV MODE AND P CON WILL BE AVAILABLE WHEN SELECTING PCV MODE 47 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO PEEP level during back up ventilation will be the same of the programmed in spontaneous mode WHEN ASS
46. fected by absorption and reflection from structures objects and people 10 of 73 L LEISTUNG MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LUFT NEO CHAPTER 1 PRESENTATION In this User Manual are presented the necessary information for the correct use of the Lung Ventilator LUFT NEO The indications relating to enforcement and regulations mentioned in this manual is a guideline the physician should adapt as their criterion the needs of patients GENERAL LUFT NEO Registry ANVISA No 80203470006 MEDICAL DEVICE CLASSIFICATION CLASS III OPERATION MODE Continuous operation CLASS I Classification according to type against electrical shock insulation Internally Energized Device Classification according to type of protection against electrical shock applied part Level of protection against water penetration IPX1 Equipment not suitable for use in the presence of flammable anesthetic mixture with air oxygen or nitrous oxide ern Weight with accessories EXTERNAL POWER SOURCE VOLTAGE CURRENT 90V 264V 1 5 0 50 FREQUENCY 47 up to 63 Hz POWER 130 VA FUSE 250V 2A 20mm SB Slow INTERNAL POWER SOURCE Nominal capacity 5 0Ah VRLA Sealed does not emit gas maT C 104 F 40 77 F 25 32 F 0 5 F 15 Capacity after 3 months Auto discharge 68 F 20 C Capacity after 6 months Capac
47. for the case of failure in the graphic display or visualization at distance The maximum sampling error is 10 Base Pressure Frequency cm H20 com ELECTRIC EN ERGY LEISTUNG LUFT NEO counts with an indicator of the type of power source external 110 220 internal Hei 110 220 Battery which the equipment is using Whenever the Battery O O 110 220 indicator is turned on the internal battery is being recharged ALL MEASURES USED AND SHOWN BY THE EQUIPMENT ARE EXPRESSED FOR AMBIENT TEMPERATURE AND DRY PRESSURE CONTROL AREAS In this sector there are the keys that permit to select adjust and confirm of data and also the access to options selection by screen menu 25 of 73 L MECHANICAL VENTILATOR KU 2 LEISTUNG LUFT NEO Rev 01 DIRECTIONAL KEYS Directional keys permit to move the selection cursors of menus and parameters Also is utilized for adjustment of the selected parameters lt 6 gt NA Y ENTER _ When the parameters are selected activates adjustment mode and realize the values Enter confirmation It is also utilized to activate menu options 26 of 73 MECHANICAL VENTILATOR vNTIADORES LEISTUNG LUFT NEO CHAPTER 5 LUFT NEO OPERATION Lf Select and press lt ENTER gt When starting the equipment an initialization sequence is performed which in
48. free to patient to control the respiratory frequency inspiratory time and inspired air volume Therefore the tidal volume depends on inspiratory effort pre established support pressure and the mechanics of the respiratory system To perform this function the ventilator upon starting increases the pressure in the circuit to a defined pressure support level The end of the inspiration occurs when the inspiratory flow upon reduction reaches a pre determined value called expiratory sensibility Expiratory sensibility is adjusted in MENU Expiratory Sensibility and its variation may be adjusted with values between 5 and 80 of the inspiratory peak flow Flow Pressure 0 The control variable in this mode is P Sup support pressure The volume variation depends on physical conditions and it will be proportional to inspiratory effort of the patient and the adjusted support pressure In this ventilation mode the following variables must be adjusted FiO e Rise Time R Time e Maximum inspiratory time TI max e Support pressure P Sup e PEEP e Sensibility Sens MAXIMUM INSPIRATORY TIME As safety procedure LUFT NEO goes to expiratory phase if the maximum inspiratory time is reached 42 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO SUPPORT PRESSURE In PSV airway pressure level is the main parameter to be adjusted because it will have direct influence about the tidal vo
49. he ratio too TGI Tracheal Gas Insufflations during expiration ASSISTED VENTILATION It is the process to provide a respiration with positive pressure as reaction of an inspiratory effort of the patient NON INVASIVE VENTILATION Ventilation performed through facial mask VOLUME Space occupied by material measured in cubic millimeters or liters 73 of 73
50. he change pressing MANUAL INSPIRATION While the change is not confirmed the equipment will keep working under the adjustments done before To see the operative modes which this equipment counts with see chapter 6 LUFT NEO NEVER STOPS OPERATING DURING CHANGES OF OPERATIVE MODES IN CASE OF CANCELING CHANGES JUST PRESS RESET TO DENY ALL THE CHANGING PROCESS AUXILIARY FLOWS Pressing MENU select the AUXILIARY FLOWS option in this menu it is possible to activate the auxiliary flows outputs which are NEBULIZER Selecting this option the operator can adjust the time of exit of FIO for nebulization synchronized with inspiration time this time may be 5 10 15 or 20 minutes according to the necessity This output is deactivated automatically at the end of the adjusted time or manually setting zero the time in menu IN VOLUME LIMITED MODES THE VOLUME AT THE PATIENT OUTPUT IS REDUCED TO COMPENSATE THE VOLUME AGGREGATED BY NEBULIZES FLOW TGI Selecting this option the operator may activate the output flow of tracheal gas insufflations synchronized with expiratory time To deactivate it is necessary to access the menu manually OXYGEN 10096 Selecting this option is started an oxygenation as follows 1 The operator may choose among 5 10 15 or 20 minutes to ventilate the patient with pure oxygen 2 Once selected the time the ventilator will show the value of O 10096 over selected value of and a horizon
51. ilator in each sigh Maximum pressure During sighs this value is taken as reference for activation of maximum alarm U e PEEP ALARM In this option is permitted the modification of PEEP alarm values The operator can choose to work among the limits of 2 4 6 8 10 H2Ocm THE ALARM WILL BE ACTIVATED ALLWAYS THE PRESSURE IS BELOW OR ABOVE THE FIXED VALUE OF PEEP BEING ITS ACTUATION IMMEDIATE OR THROUGH PRIORITIES WITH AS MAXIMUM THE TIME OF 5 SECONDS REMOTE MONITOR Within the remote monitor option it is possible to select the following features ALARMS LOG Shows list containing the events of alarms since the last time the equipment was turned on i e the hour the date and the cause of the alarm e TENDENCIES Shows list of available graphs Select the graph and press ENTER To see other graphs press again MENU key and select another graph of the list To exit tendencies press RESET DIRECT ACCESS FUNCTIONS AREA The area of direct access keys includes the keys more frequently used allowing a fast and easy access These keys are Freeze J Graphic GRAPHIC STAND BY FREEZE IMAGE MANUAL INSPIRATION Manual l Inspiration 33 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO Eon GRAPHIC Permits to select the graphic type to be shown on screen Airway Pressure Inspired Expired Flow Pressure Flow It also enables the operator to select the re
52. in the equipment The use of paramagnetic cell dispenses the use of galvanic one and also dispenses the periodic replacement avoiding this additional cost thus although it has a price higher than the galvanic one this difference is compensated in long term 20 of 73 1 MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO CHAPTER ASSEMBLY AND CONNECTION POWER SOURCE CONNECTION The electrical connection is located in the back of the case In its case there are indicated the voltage values of operation along with the current ones and nominal power of the equipment THE EQUIPMENT HAS INCLUDED FROM FACTORY FUSES OF 2A 20mm SB SLOW ABLE TO 90V UP TO 264V THE ELECTRICAL CHARACTERISTICS OF THE EQUIPMENT IS FOUND IN THE CHAPTER 1 OF THIS MANUAL THE SUPPLY INPUT IS UNIVERSAL THE EQUIPMENT WORKS IN WHOLE VOLTAGE RANGE 90V UP 264V WITHOUT OPERATOR S INTERVENTION EVEN WHEN THERE IS A VOLTAGE REDUCTION OF THE POWER DURING THE NORMAL OPERATION CERTIFY THAT THE CONNECTION OF THE EQUIPMENT 15 REALIZED WITH GROUNDED PLUG TO ASSURE ITS CORRECT OPERATION NEVER START THE EQUIPMENT WITHOUT GROUND CONNECTION THE ELECTRICAL INSTALLATION WHERE THE EQUIPMENT WILL BE PLACED MUST BE IN COMPLIANCE WITH THE NBR 13534 STANDARD WHICH DETERMINES THE MINIMAL CONDITIONS OF ELECTRICAL INSTALATION IN HEALTH CARE STABLISHMENTS GAS SOURCE CONNECTION OXYGEN M AIR The gas connection source is located at the back of
53. ity after 12 months Capacity affected by temperature 11 of 73 L LEISTUNG MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LUFT NEO Maximum Discharge Current 77 F 25 C Charge Floating Constant Voltage 77 F 25 C 48A 5s 13 6 13 8V 1 25A max Maximum temperature 131 F 55 C Internal fuses 4A 20mm SB SPECIFICATIONS INFORMED BY BATTERY MANUFACTURER THE INTERNAL BATTERY AND FUSE REPLACEABLE BY OPERATOR Charging Time T RISK OF ELECTRICAL SHOCK THE CASE MUST BE REMOVED ONLY BY N QUALIFIED PERSONNEL THE SWITCHING FOR INTERNALLY BATTERY OCCURS AUTOMATICALLY WITHOUT THE NECESSITY OF EXTERNAL INTERVENTION IT DOES NOT INTERFERES THE OPERATION OF THE EQUIPMENT BUT TRIGGERS AN ALARM AS EXPLAINED IN CHAPTER 9 ELECTRICAL OUTPUT VOLTAGE CURRENT 110V 0 63A FREQUENCY 40 VA 250V 0 5A T 20mm SB Slow OXYGEN AIR PRESSURE FLOW N USE ONLY MEDICAL GRADE GAS ENVIRONMENTAL SPECIFICATIONS VALUES Storage Transport 2 C up to 40 C 7 10 up to 95 0 up to 95 Storage Transport No condensable erasure 66 100 kPa Storage Transport 66 100 kPa Relative Humidity 12 of 73 L MECHANICAL VENTILATOR RU LEISTUNG LEISTUNG LUFT NEO Reseni The measure of volume and pressure is standardized by barometric pressure at sea level body temperature and water vapor saturate btps and they are adjusted in functi
54. lems or difficulties contact the authorized technical service The equipment must be supplied by battery when there is doubt about the integrity of ground connector taking care not to exceed the battery life 12 of 73 L MECHANICAL VENTILATOR R 04 04 52 roses LEISTUNG LUFT NEO Rev 1 PRECAUTIONS the warranty period the stay or movement of equipment should be performed with the original packaging with its internal correspondent protection otherwise will result in loss of warranty Never sterilize the ventilator the internal components is not compatible with sterilization techniques Follow the instructions at chapter 11 for equipment cleaning and accessories sterilization Never operate the equipment exposing it to direct heat or sunlight Never cover or place the equipment in order to block the air entry for cooling To ensure electrical protections and avoid risk of fire never change the fuses If the equipment does not work contact the Authorized Technical Support The improper replacement of the fuses nullifies warranty and represents a risk for the equipment operation operator and patient safety The ventilator is a medical device that has to be operated by qualified and trained personnel supervised by a doctor The LUFT NEO is produced with recyclable materials and should not be thrown into common landfills because it contains toxic materials to nature for this contact an authorized dealer Electric Di
55. lume received by the patient To adjust support pressure you must remind that the adjust P Sup refers to support pressure value over the established for PEEP CPAP MODE IS ACTIVATED WHEN THE SUPPORT PRESSURE OFFERED IS REDUCED AT ITS MAXIMUM SIMV VCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE SUPPORT Permits the patient to synchronize spontaneous breathings PSV with mandatory breathings VCV ensuring to patient a minimum threshold of ventilation and oxygenation This is an alternative to start mechanical ventilation weaning process This mode has the function of decreasing the quantity of mandatory ventilations and permits the patient to perform spontaneous ventilations between each pre established VCV cycle Flow Pressure In this ventilation mode the following variables must be adjusted FiO e Rise Time R Time e Inspiratory time T Ins Respiratory frequency Freq e Tidal volume VTidal e Support pressure P Sup e PEEP e Sensibility Sens 43 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO SIMV PCV PSV SYNCHRONIZED MANDATORY VENTILATION BY PRESSURE WITH PRESSURE SUPPORT Permits the patient to synchronize spontaneous breathings PSV with mandatory breathings PCV ensuring to patient a minimum threshold of ventilation and oxygenation This is an alternative to start mecha
56. ment must be followed respecting technical specifications and installation according to user manual This warranty is annulled when a The equipment identification label was modified or removed b The installation of the equipment was not performed according to instruction manual If is discovered that the damages were caused by bad electrical installation floating or voltage differences which the equipment works with d Damages due to hit or accidents of any type after purchase e is discovered intervention of any other person but technical service of LEISTUNG EQUIPAMENTOS LTDA The installation of the equipment is responsibility of the buyer LEISTUNG EQUIPAMENTOS LTDA is not responsible for bad installation and use of the equipment 72 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO 6 GLOSSARY ALARM It is a light or audio signal or both ones occurs when an unexpected event happens the equipment AUTOPEEP The lung pressure at the end of expiration CYCLE The period of a mechanical supported inspiration COMPLIANCE It is the relation between volume and pressure STATIC COMPLIANCE It is the relation between volume and pressure at locations without gas flow WEANING Gradual reduction of ventilation support ASSISTED EXPIRATION It is the expiratory flow generated by negative switch at trans respiratory pressure due to an external agent like a respiratory pres
57. ng back up ventilation will be the same of the programmed in spontaneous mode VENTILATION IS NEEDED BECAUSE IF THE PATIENT DO NOT MAKE ANY INSPIRATORY EFFORT THE EQUIPMENT WILL RESPECT THE SELECTED APNEA TIME TO DELIVER BACK UP VENTILATION ACCORDING TO THE CONFIGURATION PERFORMED IN ALL MODES WHICH WORK WITH CONTROL PRESSURE AND SUPPORT PRESSURE THE CHANGES ARE DONE INDEPENDENTLY AND DIRECTLY BY THE OPERATOR gt WHEN PSV CPAP IS SELECTED THE CONFIGURATION OF BACK UP IN ALL VENTILATION MODES OF LUFT NEO PEDIATRICO NEONATAL THERE ISA DEFAULT CONFIGURATION DEFAULT CONFIGURATION IS NOT SPECIFIC AND IT MUST BE ADJUSTED BY THE OPERATOR ACCORDING TO THE PATIENT NEEDS LUFT NEO NEVER STOPS WORKING DURING CHANGING FROM A VENTILATION MODE TO ANOTHER ONE IN CASE TO CANCEL VENTILATION MODE CHANGE YOU MUST PRESS RESET KEY AFTER LINE TEST THE EQUIPMENT COMPENSATES LEAKAGES IN THE Tuus CIRCUIT UNTIL 10 L MIN PAN THE EQUIPMENT COMPENSATES THE PATIENT CIRCUIT COMPLIANCE 53 of 73 L MECHANICAL VENTILATOR recy LEISTUNG LEISTUNG LUFT NEO a CHAPTER 9 ALARMS COLORS AND MEANINGS OF GRAPHIC INDICATORS These signals were developed according to current standards in order to be immediately known by the operator An alarm indication like Caution or Danger to patient is a criterion used by Leistung Equipamentos Lida and serves only as orientation the operator must adapt them to patient needs according to his own criterion
58. nical ventilation weaning process This mode has the function of decreasing the quantity of mandatory ventilations and permits to patient to perform spontaneous ventilations between each pre established PCV cycle THE PRESSURE SUPPORT CYCLE IS DIFFERENT FROM PRESSURE CONTROLLED AS IT FINISHES WHEN THE MINIMUM DEMAND FLOW OF THE PATIENT IS REACHED ADJUSTABLE THROUGH EXPIRATORY SENSIBILITY WHILE PRESSURE CONTROLLED CYCLE IS LIMITED BY THE ADJUSTED INSPIRATORY TIME In this ventilation mode the following variables must be adjusted e FiO e Rise Time R Time e Inspiratory time T Ins Respiratory frequency Freq e Controlled pressure P Con e Support pressure P Sup e PEEP e Sensibility Sens PSV MINUTE MANDATORY VENTILATION WITH PRESSURE SUPPORT This mode works associating PSV mode with a minute volume value determined by the operator The ventilator evaluates periodically the minute volume delivered to patient case of a minute volume smaller than determined LUFT NEO increase support pressure in order to increase the ventilation and reach the required value In this ventilation mode the following variables must be adjusted e e Rise Time R Time e Minute volume V Min e Support pressure P Sup e PEEP e Sensibility Sens MINUTE VOLUME Minute Volume refers to the volume delivered to patient within a period of one minute 44 of 73 L MECHANICAL VENTILAT
59. ning of the standardized symbols printed on the equipment internal and external Symbol Standard Description Em IEC 60601 1 1994 4 Functional ground terminal 9 Protection ground terminal d Attention Consult the documents IEC 60601 1 1994 Connected Connection to power oymbol No 417 5007 source oni or external Disconnected Disconnection from IEC 60601 1 1994 the power source internal or oymbol No 417 5008 external K wQ ET mo 63 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO 2 Meaning of the standardized symbols printed equipment package Symbol Standard Description FRAGILE Handle carefully ISO 780 1997 No 1 THIS SIDE UP ISO 780 1997 E 3 Indicates the up side of the package PROTECT AGAINST SUNLIGHT ISO 780 1997 E No 4 The package must be kept out of direct sunlight PROTECT AGAINST RAIN ISO 780 1997 E No 6 The package must be kept out of rain MAXIMUM STACKING UP Indicates the maximum number of packages can be stacked up for transport and storage ISO 780 1997 E No 14 TEMPERATURE LIMIT ISO 780 1997 E No 17 Indicates the limit temperature for storage and manipulation of the package 64 of 73 L MECHANICAL VENTILATOR recy LEISTUNG LEISTUNG LUFT NEO a 3 Meaning of symbols printed in this user manual Symbol Standard Description
60. ntensity must be less than 3 V m 9 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO Recommended separation distances between portable and mobile RF communication equipment and the Lung Ventilator LUFT NEO The Lung Ventilator LUFT NEO is intended for use in an electromagnetic environment in which irradiated RF disturbances are controlled The customer or the user of the Lung Ventilator LUFT NEO can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Lung Ventilator LUFT NEO as recommended below according to the maximum output power of the communication equipments Separation distance according to frequency of transmitter Rated maximum meters m tput f output power 150 kHz up to 80 MHz up to 800 MHz up to transmitter watts W 80 MHz 800 MHz 2 5GHz d 1 17 P d 1 17 P d 2 33 P For transmitters with a maximum rated output power not listed above the recommended separation distance din metes can be estimated using the equation applicable to the frequency of the transmitter where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range is applied NOTE 2 These guidelines may not be applied in all situations Electromagnetic propagation is af
61. on of altitude The storage of the lung ventilator for long periods at temperature greater than 27 c or without electrical connection for periods greater than 2 months may affect the internally battery life WARNINGS CAUTIONS AND NOTES WARNINGS The professional in charge of its use should using your own criterion and knowledge adjust the equipment according to the patient needs Do not use anti static tubes or electrical conductor the patient circuit Do not sterilize the equipment with ethylene oxide There is a high probability to occur irreversible damage in the ventilator components The equipment must be connected to voltage with protective earth connection The equipment may be affected by High Frequency Electromagnetic Interference such as cellular wireless telephone defibrillators electro surgical knifes magnetic resonance etc Keep these emission sources at least 3 three meters away from the equipment The use of accessories and cables other than the specified ones except accessories and cables furnished by LEISTUNG EQUIPAMENTOS LTDA spare parts for internal components may result in EMISSION increasing or IMUNITY reduction of LUFT NEO Before first utilization and after utilization in each patient it is necessary to clean the ventilator To sterilize the accessories follow the instructions on chapter 11 Electrical shock danger NEVER disassemble the ventilator case In case of prob
62. ronment Guidances Floors should be wood concrete or ceramic If the floors are covered with synthetic material relative humidity should be at least 30 Quality of power supply should be that of a typical commercial or hospital environment Quality of power supply should be that of a typical commercial or hospital environment Quality of power supply should be that of a typical commercial or hospital environment Magnetic fields at power supply frequency should be that of a typical commercial or hospital environment L LEISTUNG MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LUFT NEO Manufacturer Guidance and Declaration Electromagnetic Immunity The Lung Ventilator LUFT NEO is intended for use in environment electromagnetic specified below It is recommended that the client or user of Lung Ventilator LUFT NEO ensures that it is used in such environment Immunity tests Test level Compliance Electromagnetic Environment ABNT NBR IEC 60601 level Guidances Portable and mobile RF communication equipments must not be used close to any part of the lung ventilator LUFT NEO including cables Recommended separation distance equation with respect to the transmitter frequency d 1 17 P RF Conducted 3 Vrms IEC 61000 4 6 150 kHz up to 80 MHz d 1 17 P 80 MHz up to 800 MHz 1 2 RF Radiated d 2 33 P 800 MHz up to 2 5 GHz IEC 61000 4 3 3 V m 80 MHz up to 2 5 GHz Where
63. s time may assist in the comfort of the patient In LUFT NEO the Rise Time is modulated by flow i e the higher the rise time the shorter the time to reach the adjusted pressure and the shorter the rise time the longer the time to reach the selected pressure For an appropriate ventilation the rise time must be adjusted in order to provide the smallest overshoot possible Pressure A Rise Overshoot Y gt Time IF DURING A MANDATORY OR SPONTANEOUS CYCLE THE EQUIPMENT DETECTS ANY VARIATION OF FLOW GENERATING A PRESSURE VALUE HIGHER THAN THE DETERMINED THE ALARM OF INTERRUPTED CYCLE IS ACTIVATED AND LIMITS THE PEAK PRESSURE VALUE THE CAUSE OF THIS ALARM MAY BE CORRECTED THROUGH SENSIBILITY OR RISE TIME ADJUSTMENT CONTROLLED PRESSURE In PCV the airway pressure level is the main parameter to be adjusted because it will have a direct influence over the tidal volume available for the patient To adjust the controlled pressure you must remind that P Con adjustment refers to pressure value over established value for PEEP 41 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO PSV CPAP PRESSURE SUPPORT VENTILATION CONTINUOUS POSITIVE PRESSURE Spontaneous ventilation mode triggered by flow or pressure through patient effort In this mode the ventilator supports the patient through maintaining a positive pressure adjusted in P Sup window This maintains
64. s menu The mode is chosen by the selection keys up and down Confirmation of the selection is done through pressing ENTER and will show on the screen the necessary parameters for its use 28 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO SELECTION SEQUENCE ADJUSTMENT AND DATA CONFIRMATION Using the selection keys the parameters to be selected can be accessed When selected the option pressing ENTER the parameter has its color changed permitting its configuration by the vertical and horizontal keys To finish press again ENTER to confirm change can be canceled by pressing RESET Change is also canceled if the parameter remains selected for more than 5 seconds or without any modification Is made in its value Adjustments made in parameters will not be activated until the mode configuration is finished and the ventilation is started through pressing Manual inspiration key ONCE CONFIRMED THE VALUES THE ACTION CAN NOT BE UNDONE ALWAYS CHECK THE MODIFIED VALUES BEFORE CONFIRMING 29 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO n CHAPTER 6 MENU VENTILATION MODES A list of operative modes according to the type of selected patient is shown when the equipment is started pediatric or neonatal Select the required mode using the directional keys and press ENTER immediately it will be shown on the display the values of the new mode to be applied and confirm t
65. seeweccetetcbesecddaveecedceusebeuveceunetcensescseetes 47 PEEP evade etc care Sc accents na 48 CHAPTER 8 VENTILATION MODES 49 VENTILATION MODE U 49 PCV PRESSURE CONTROLLED VENTLILATION J J nnn Inn 49 5 of 73 L MECHANICAL VENTILATOR KU LEISTUNG LEISTUNG LUFT NEO Reseni PSV CPAP PRESSURE SUPPORT VENTILATION OR CONTINUOUS POSITIVE PRESSURE 50 SIMV PCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE SUPPORT IIIIIIIIIIIIIIII opu aun muc 51 CONTINUOUS FLOW m M 51 NASAL CPAP CONTINUOUS POSITIVE PRESSURE VENTILATION 52 BACK UP VENTILA HON mc 52 APNEA cece eee genie a 5 eel ead Liza 5 gu c 53 CHAPTER 2 E 54 COLORS AND MEANINGS OF GRAPHIC 54 ALARMS PRIORITY SEQUENGCE u u J 54 ALARMSDESGRIPTION uuu u u
66. sure drop generating a value lower than the reference value EXPIRATORY PHASE EXPIRATION The part of the ventilation cycle that includes since the beginning of expiratory flow until the beginning of inspiratory flow INSPIRATORY PHASE INSPIRATION The part of the ventilation cycle that includes since the beginning of inspiratory flow until the beginning of expiratory flow At this phase any inspiratory pause Is included FLOW Traffic gas rate that gets in and out of the lung ASSISTED INSPIRATION It is the inspiratory flow generated by positive switch at trans respiratory pressure due to an external agent like an increment in respiratory pressure generating a value higher than the reference value NEBULIZER An aerosol generator which requires a gas source to nebulizer liquid medicaments PEEP Positive End Expiratory Pressure TRANS RESPIRATORY PRESSURE The difference of pressure between airway and the surface of the body RATIO It is the relation between inspiration time and expiratory time SPONTANEOUS BREATHING The breathing started and finished by the patient SENSIBILITY It is the measurement of the patient effort to start a cycle SIGHS It is a number of additional respirations performed during a defined time intervals EXPIRATORY TIME Duration of expiratory phase in seconds INSPIRATORY TIME Duration of inspiratory phase in seconds As the inspiratory time increases the mean respiratory pressure increases and t
67. system mechanical work To request Auto PEEP measurement just press MENU key select Respiratory Mechanics option and access Auto PEEP window Upon selecting Auto PEEP window LUFT NEO starts measuring it and shows on the screen the following message _ Respiratory mechanics accepted When measurement procedure and calculus of Auto PEEP is concluded LUFT NEO shows on the upper part of the screen the value of the TOTAL PEEP Auto PEEP and PEEP Total PEEP 3 cmH20 PEEP 3 cmH20 AutoPEEP 0 cmH20 TECHNICAL OPERATIVE PROFILE Within technical operative profile are found the options Maintenance Language Sighs Hour Date and PEEP alarm e MAINTENANCE In this option are visualized the hours of use of the equipment as well as the hours of use and date corresponding to the maintenance done described in annex 3 e LANGUAGE Enables the operator to choose among the languages ENGLISH PORTUGUESE and SPANISH 32 of 73 L MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO a IT IS IMPORTANT REMIND THAT CHANGE THE LANGUAGE THE EQUIPMENT MUST BE RESTARTED SIGHS This option permits to configure Quantity of sighs quantity of consecutive sighs 1 up to 3 performed in each cycle Cycles per hour quantity of times 5 10 15 20 the sigh cycles will be repeated per hour U Uy Volume amount of additional volume it will be added with the already set volume which will be given by the vent
68. tal bar will appear on the upper right corner of the screen indicating the selected time and elapsed time 3 The equipment can be disconnected from the patient as often as needed without having its operation modified silencing for 30 seconds the alarms 30 of 73 L MECHANICAL VENTILATOR recy LEISTUNG LEISTUNG LUFT NEO 4 equipment permits changing in ventilation parameters and base pressure PEEP since initial ventilation mode used to start the process is respected To change ventilation mode canceling 100 is required 5 After elapsed the selected time the equipment will resume FIO value that was selected before the procedure start 6 exit before the end of the procedure the operator must access manually the auxiliary flows menu and set the Os 100 time as 0 OBJECTIVE Simplify handling of the equipment during the process in airways and or lung recruitment after a depressurization Facilitate initial ventilation of the patient since his clinic and semiologic progress INSPIRATORY PAUSE Pressing MENU key select Inspiratory Pause option Inspiratory pause is a brief pause 0 10 2 00 seconds at the end of inspiration during which the pressure remains constant and the flow is zero To deactivate it access again Inspiratory Pause and set to 0 EXPIRATORY SENSIBILITY PSV Modes that use PSV have flow in descending ramp waveform and allow adjusting the flow value that performs th
69. the case JN Fow max eem 9 In its case indicated corresponding inputs of air and oxygen AIR INPUT Male connector DISS 34 16 OXYGEN INPUT Male connector DISS 9 16 18 AT THE PRESSURE TIP TUBES ARE UTILIZED THE FEMALE CORRESPONDING PAN CONNECTORS 21 of 73 L LEISTUNG MECHANICAL VENTILATOR R 04 04 52 maaan runon LEISTUNG LUFT NEO THE SCREWABLE CONNECTIONS USED IN THE AIR INPUTS ARE ACCORDING WITH NBR 11906 STANDARD WHICH DETERMINES THE MINIMAL CONDITIONS FOR THIS TYPE OF CONNECTION THE AIR AND OXYGEN INPUTS OF THE EQUIPMENT ARE MADE WITH VALVES THAT PREVENT REVERSE FLOW OF GASES THROUGH THE INPUT PORTS AND THE CROSSFLOW OF GASES INPUT PRESSURE MINIMUM FLOW SUPPLY 60 l min MAXIMUM FLOW 180 l min DO NOT USE THE EQUIPMENT IN PRESENCE OF ANESTHESIC INFLAMMABLE GASES EXPLOSION AND OR FIRE DANGER IT MUST BE USED AIR AND OXYGEN COMPRESSED CLEAN AND DRY IN ORDER TO AVOID CONTAMINATION THAT AFFECTS THE EQUIPMENT AND MAY GENERATE A BAD OPERATION IN CASE OF MISSING OF ONE OF THE GAS SUPPLY AIR OR O THE EQUIPMENT CONTINUES OPERATING NORMALLY WITH THE OTHER GAS SUPPLY LUFT NEO SUPPORTS INLET PRESSURE UP 1000 KPA 10 2 KG CM PAN AVOIDING THE USE OF EXTERNAL PRESSURE REGULATORS UNTILL THIS VALUE BREATHING CIRCUIT Utilize respiratory circuit as the necessity pediatric or neonatal The difference is in the tubes diameter IN RESPIRATORY CIRCUI
70. the equipment is turned on again MICROPROCESSOR This alarm is activated if occurs a failure which prevent the microprocessor to maintain the control of the equipment A light warning and a continuous sound are activated Simultaneously all the gas supply valves get closed and the anti suffocation valve is enable which permits the air inlet of the ambient to the patient circuit DEFAULT ALARMS SETTING P 30 cmH5 O P min 05 cmH5O VOV PCV SIMV CPAP PSV _ ASSURED TIDAL VOLUME PSV 9 max 0 400 i BIPHASIC PRESSURE MMV Vo min 0 050 L PSV 35 PEDIATRICS PEEP 04 cmH O APNEA 15 seconds P 30 cmH5O P min 05 cmH5O Vol max 0 400 L Vol min 0 050 L Freq 35 cpm P max 20 P min 03 cmH2O PCV SIMV CPAP PSV Freq 45 cpm NEONATALOGY A AE 10 seconds P max 20 cmH2O CONTINUOUS FLOW P min Max 45 cpm THE DEFAULT SETTING OF ALARMS IS ADJUSTED DURING THE INITIALIZATION OF THE EQUIPMENT AND CORRESPONDS TO A MEAN VALUE OF ADJUSTMENT SCALES THE PARAMETERS ADJUSTMENT MUST BE DONE BY THE OPERATOR CONSIDERING INDIVIDUALLY EACH CLINIC CASE IT IS RECOMMENDABLE TO BE VERIFIED BY THE OPERATOR ALARMS VALUES VERIFICATION LIST ESPECIALLY IN EVENTUAL OPERATOR SWITCH 56 of 73 L LEISTUNG MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LUFT NEO ALARMS VALUES VERIFIC
71. tive photos only 67 of 73 1 MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LEISTUNG LUFT NEO eei OPTIONAL TOUCHSCREEN MONITOR Tauch PERMITS TO CONTROL THE EQUIPMENT BY TOUCHING DIRECTLY THE SCREEN HUMIDIFIER HUMIDIFICATION AND HEATING OF GAS IT MUST BE USED THE MODEL AVAILABLE AT MARKET PATIENT CIRCUIT WITH EXHALATION VALVE PATIENT EQUIPMENT INTERFACE AND NEBULIZER PEDIATRIC NEONATAL NOTE IT MUST BE USED ONLY THE APPROPRIATE MODEL FOR LUFT NEO TEST LUNG PEDIATRIC m VERIFICATION OF OPERATION AND CYCLING OF THE EQUIPMENT VERIFICATION OF OPERATION AND CYCLING OF THE EQUIPMENT SOFTWARE WHICH PERMITS THE CONNECTION OF THE EQUIPMENT WITH COMPUTER FIO ANALYSIS O2 CELL CONNECTOR come FOR O CELL CONNECTION IN PATIENT CIRCUIT Illustrative photos only 68 of 73 L LEISTUNG MECHANICAL VENTILATOR R 04 04 52 LEISTUNG LUFT NEO ANNEX PREVENTIVE MAINTENANCE lt is mandatory to be performed a preventive maintenance respecting the following chronogram Such preventive maintenance must be performed by a qualified professional and respecting the corresponding protocols At main menu the last item of the second level indicates the operation time and the registry of maintenance LUFT NEO PERFORMS AN SELFTEST OF THE BATTERY CONDITION EVERY FIVE MINUTES HOWEVER IT IS RECOMMENDED TO DISCONNECT FROM THE POWER AT LEAST ONCE A MONTH LETING THE
72. tor Leistung LUFT NEO ANVISA registration No 80203470006 3 of 73 1 MECHANICAL VENTILATOR FORTES LEISTUNG EU nie bs LEISTUNG LUFT NEO CONTENTS 1 4 GUIDELINES AND DECLARATIONS OF LEISTUNG EQUIPAMENTO LTDA ABOUT ELECTROMAGNETIC COMPATIBILITY EMC 7 CHAPTER 1 PRESENTATION ccccccccccccccccccccccccccccucneucnceuuneeunueunneueneuunueuenuuunueueneunnuens 11 PHYSICAL CHARACTERISTICS 2 ccc ccc cccccccccccccccccucccceceucuueuecuueeecuuauenuueueuceveneeuesuuenevauvenesuuenenaunas 11 WARNINGS CAUTIONS AND 5 SNR SNR RR RR RR Dua rU 13 NRIN CAO 66600 E EE 13 5 42 2 2 4 4 6 313 r4 kgrrrzrrira iua 14 14 CHAPTER 2 2 2001 1 1 1 4 15 u uu u E 15 Y us E 15 VANAN
73. u uu u 54 HIGH INSPIBATORnYPRESSUPPE a ene 54 LOW INSPIRATORY PRESSURE B 55 MAXIMUM EXPIRED TIDAL VOLUME r 55 MINIMUM EXPIRED TIDAL VOLUME 55 yysvah E T OU NC Y GG uui nuan naa 55 55 EP 8 2 ee ee 55 BO Pi FO 55 PONER e u 2 ua ux 55 COW BATTER f 56 WMG Bt cce ee eee ere 56 CHAPTER 10 EXHALATION VALVE AND PATIENT CIRCUIT 58 CHAPTER 11 CLEANING DESINFECTION AND STERILIZATION 61 CHAPTER 12 MOUNTING THE EQUIPMENT ON THE TROLLEY 62 ANNEX 1 SIMBOLOQY 63 ANNEX 2 LUFT NEO ACCESSORIES 66 ANNEX PREVENTIVE MAINTENANGE 69 ALARMSOSYSIEMINTEGRIIYTESI I u uuu uu 69 ANNEX 4 BEOCK DIAGRAM u IIIa 71 ANNEX S WARRANTY u uquna asua

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