the manual
Contents
1. 23 SCREEN ropan sus a ass 23 NUMERIC DISPLAYS AND SUPPLYING INDICATORS eese 25 CONTROL AREA anun uu E 25 DIRE GHONA S 25 ENTER 25 CHAPIERS EUFII G OPERATION u i u u u u u u u u u u usus 26 SELECTION SEQUENCE ADJUSTMENT AND DATA CONFIRMATION 28 4 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG po eee LEISTUNG LUFT1 G CHAPTER 6 2222222222222222222222222222222 22222222222 2222222222222 22252nuuruuruasuauuauuauuas 29 MENU ua uu 29 VENTILATION MODES 29 AUXILIARY FLOWS J U UU UU U UU 29 INSPIRATORY PAUSE U UU U UU UU U U sssawanasannananaa 29 EXPIRATORY SENSIBILITY PSV 29 RESPIRATORY MECHANICS U U UU U U U U 30 30 TECHNICAL OPERATIVE PROFILE U U UU U 31 DIRECT ACCESS FUNCTIONS 02. 32 STAND U UU UU U U Q ssssawamaaannanannanananananaaannnaa 32 FREEZE 32 MANUAL INSPIRATION 2 4 32 AREA 33 z NZ Ie m HO OM 33 222250 u 33 CHAPTER 7 VENTILATION MODES ADULT 34 VENTILATION MODE 5 1 34 VCV VENTILACAO CONTROLADA POR VOLUME rennen nnne nnne nnn 34 mio c 35 PESEE EA m e 35 WAVEFORMS 35 SQUARE WAVE brERrEEPE OE 35 DESCENDING RAMP 4 wania kwwa niwa 36 INSPIRATORY 2 2 0 000000000 waziwazi AAAA L ARALAR AAA nana aaar ra anena 36 RESPIRATORY 8 nikwa zwi uwana nikazi waana 36 TIDAL IIIA 37 PEEP u uuu Aa WA 37 SENSIBILITY 37 PCV PRESSURE CONTROLLED VENTILATI
3. 22 of 63 L rere uc MECHANICAL VENTILATOR Ro cents LEISTUNG LUFT1 G CHAPTER 4 INDICATORS CONTROLS AND ALARMS FRONT PANEL ELECTRIC ENERGY Baer O 110 2220 Peak Pressure Tiral Volume cm 20 la 2 J LEISTUNG U Base Pressure Frequency H20 ALARMS insp Pressure Inversion OMin Insp Pressure Peep O Apnea O Frequency Q Air Oxygen max min O Power Outage Q Battery Microprocessor INDICATORS AREA LEISTUNG LUFT1 g 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 23 of 63 MECHANICAL VENTILATOR R 044448 LEISTUNG LUFT1 G Rer 01 Prok OPERATIVE MODES Pressure cm H2Q ME PE ln L 60 AUXILIARY H20 mn FLOWS m x INSPIRATORY V Tidal L 30 20 10 P 0 E 4 6 8 10 12 5 MECHANICS PAUSE f 2 row himin TECHN OPERAT PROFILE 50 25 75 2 4 Ins Rate V Tidal 1 20 12 0 40 L S Seeking greater ease and speed in handling the 17 inches LCD display is organized in areas alarm area monitoring area configuration area and t
4. LEISTUNG MECHANICAL VENTILATOR LEISTUNG LUFT1 g 04 04 48 REV 01 GMP CERTIFICATE NBR ISO 9001 2008 EN ISO 13485 2003 AC 2009 MECHANICAL VENTILATOR LEISTUNG LUFT1 G nm 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 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 Ventilator Leistung LUFT1 g ANVISA registration No 80203470006 2 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFT1 G 2 LEISTUNG 5 quipament 05 04 2 nono OPERATIVOS FLUE iu AUZILLARE Pau T ORTA i i PERFIL ee pon lt lt lt gt gt gt wi op v 3 of 63 L MECHANICAL VENTILATOR KUTA LEISTUNG LEISTUNG LUFT1 G Ren CONTENTS CONTENTS GUIDELINES AND DECLARATIONS OF LEISTUNG EQ
5. CLASS I INTERNALLY ENERGIZED DEVICE AGAINST ELECTRICAL SHOCK INSULATION CLASSIFICATION ACCORDING TO TYPE OF TYPEB PROTECTION AGAINST ELECTRICAL SHOCK APPLIED PART LEVEL OF PROTECTION AGAINST WATER IPX1 PENETRATION EQUIPAMENT NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC MIXTURE WITH AIR OXYGEN OR NITROUS OXIDE PHYSICAL CHARACTERISTICS PARAMETERS VALUES Width Dimensions ae Depth Ventilator without the display Weight without accessories 9 200 Kg Weight with accessories 31 380 kg 11 of 63 L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 rate tnn LEISTUNG LUFT1 G EXTERNAL POWER SOURCE VOLTAGE CURRENT 90V 264V 1 5 0 50 FREQUENCY 47 UP TO63 HZ POWER 130 VA FUSE 250V 2A 20MM SB SLOW INTERNAL POWER SOURCE Nominal capacity 5 0Ah VRLA Sealed does not emit gas 104 F 40 C l 77 F 25 C Capacity affected by temperature 32 F 02C 15 C Capacity after 3 months Auto discharge 68 F 20 C Capacity after 6 months Capacity after 12 months Maximum Discharge Current 77 F 25 C Charge Floating Tempo de Carga Maximum temperature 131 F 55 C Internal fuses 4A 20mm SB SPECIFICATIONS INFORMED BY BATTERY MANUFACTURER THE INTERNAL BATTERY AND FUSE ARE NOT REPLACEABLE BY OPERATOR RISK OF ELECTRICAL SHOCK THE CASE MUST BE REMOVED ONLY BY N QUALIFIED P
6. 63 L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 VENTILADORES PULMONARES LEISTUNG LUFTI G Rev 01 Pressure 0 Pressure 0 Flow trigger Patient effort start Sensibility threshold Fiow 0 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 valve 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 2 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 LUFT1 g 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 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 is an assisted controlled ventilation mode and
7. Control PCV 2 up to 70 H2Ocm over PEEP with adjustable RISE TIME Pressure Support PSV 70 over PEEP with adjustable RISE Adjustable from 5 up to 80 of initial flow In PCV and PSV modes up to 180 l min Sigh VCV mode 0 up to 2 seconds with plateau value mode rectangular descendent ramp sinusoidal and ascending ramp In PCV and PSV descendent ramp In case of break of one of them the equipment continues Automatic By pass of the Air O net operating normally Inspiratory pressure inner safety valve Adjusted in 120 Regulating pressure valve of air and input Internally incorporated into the equipment Inspiratory Pause VCV mode Flow waveform STAND BY To maintain the configuration without cycling SCALES Automatic actualization for vertical and horizontal analysis FREEZE For graphics analysis OUTPUT PARAMETERS AIRWAY PRESSURE PEAK PLATEAU MEAN BASE PEEP E RATIO AND SPONTANEOUS BREATHINGS EXHALED TIDAL VOLUME 17 of 63 L LEISTUNG MECHANICAL VENTILATOR R 04 04048 rate tnn LEISTUNG LUFT1 G BREATHING MECHANICS ALARMS INSPIRATORY MAXIMUM MINIMUM AIRWAY PRESSURE DISCONNECTION OF THE PATIENT CIRCUIT MAXIMUM MINIMUM EXHALED TIDAL VOLUME APNEA WITH ADJUSTABLE TIME LOW BATTERY CHARGE MICROPROCESSOR INTERRUPTED CYCLE IN PRESSURE MODES INVERTED RATIO ALARMS ARE TRIGGERED FOLLOWING PRIORITY ORDER WITH LIGHT OR SOUND WARNIN
8. ambience Emissiontests Compliance Electromagnetic ambience guidelines Lung ventilator LUFT1 g 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 CISPHR 1 1 22 Lung ventilator LUFT1 g is appropriated for all 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 adopt mitigation procedure like reorientation or reallocation of the LUFT1 g or blindage of the local order to avoid RF interference the Lung Ventilator LUFT1 g should not be used stacked on others equipment If this is required it is recommended to be observed the normal use of equipments 7 of 63 L LEISTUNG VENTILADORES PULMONARES MECHANICAL VENTILATOR R 044448 LEISTUNG LUFT1 G Rer 01 Manufacturer Guidance and Declaration Electromagnetic Immunity The Lung Ventilator LUF
9. cmH20 PEEP 3 cmH20 Auto PEEP 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 EQUIPMENT MUST BE RESTARTED Tus IT IS IMPORTANT TO REMIND THAT TO CHANGE THE LANGUAGE THE 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 U U Volume amount of additional volume it will be added with the already set volume which will be given by the ventilator in each sigh Maximum pressure During sighs this value is taken as reference for activation of maximum alarm 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 ALTITUDE COMPENSATION To adjust height related to sea level where the equipment is being used CIRCUIT TEST It must done when the patient circuit is replaced changed in the initial line test TO PERFORM THIS TEST THE VENTILATOR MUST BE IN STAND BY THE ALA
10. 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 ventilator is a medical device that has to be operated by qualified and trained personnel supervised by a doctor The LUFT1 g is produced with recyclable materials and should not be thrown into PAN common landfills because it contains toxic materials to nature for this contact an authorized dealer Electric Diagrams 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 Paw technical specifications can change without previous notice 15 of 63 L MECHANICAL VENTILATOR ROUND LEISTUNG LEISTUNG LUFTI G Ren CHAPTER 2 INTRODUCTION LUFT1 g 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
11. 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 equipment must be followed respecting technical specifications and installation according to user manual This warranty is annulled when a he equipment identification label was modified or removed b The installation of the equipment was not performed according to instruction manual C 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 If is discovered intervention of any other person but technical service of LEISTUNG EQUIPAMENTO 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 62 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren ANNEX 6 GLOSSARY ALARM It is a light or audio signal or both ones that occurs when an unexpected event happens in 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 pres
12. 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 VENTILACAO CONTROLADA POR VOLUME In VCV mode LUFT1 g integrates the air flow with inspiration time and delivers to patient the programmed current volume Therefore VOV is flow limited and volume cycled To perform flow changes the 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 34 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren 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 Flow curve Wave Inspiratory time T Ins Respiratory frequency Freq Tidal volume VTidal PEEP Sensibility Sens FIO is related to the fraction of oxygen inspired by the patient To modify just select its window with ENTER and adjust the fraction between 21 and 100 FLOW CURVES LUFT1 g provides square and descending ramp flow waves Flow waves may be selected in volume contr
13. the operator to provide more attention to the patient Suitable for pediatric and adult patients LUFT1 g 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 Its 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 understand which turns possible to take decisions respecting the alarms situation and critical parameters variation VENTILATION MODES PATIEN TYPE VENTILATION VOLUME CONTROLLED VOV ASSISTED CONTROLLED PRESSURE CONTROLLED ADULT PCV AND PRESSURE SUPPORT PEDI TRIC PSV SPONTANEOUS CONTINUOUS POSITIVE PRESSURE CPAP VARIABLES SIMV VOV PSV 16 of 63 L MECHANICAL VENTILATOR LEISTUNG LEISTUNG LUFT1 G Ren SPECIFICATIONS PCV or VCV in adult and pediatric Backup ventilation Emergency ventilation FIO 21 to 100 electronically regulated on the panel with graphic display monitoring Inspiration Time 5 1 1 99 BY FLOW 0 5 up to 10 l min Sensibility BY PRESSURE 0 5 up to 15 0 cm compensated PEEP Pressure
14. values measured by the equipment Ex peak pressure base pressure and mean pressure in airways exhaled tidal volume frequency flow peak inspiratory time E ratio and monitoring 24 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren On the upper side of the screen is indicated 1 Upper left side Company s name and equipment model below there are 7 the patient type and ventilation mode see chapters 5 and 6 gt gt gt Ww Ww 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 LEISTUNG LUFT1 g counts with a set of numeric displays which show the values of pressures peak and base expired volume and frequency for the case of failure in the graphic display or visualization at distance The maximum EI sampling error is 10 Peak Presssure Tiral Volume 2 LEISTUNG LUFT1 g counts with an indicator of the type of 2200 27 power source external 110 220V or internal Battery which the equipment is using Whenever the 110 ELECTRIC ENERGY 220V indicator is turned on the internal battery is being recharged Battery O 110 220 Yea ALL MEASURES USED AND SHOWN BY THE EQUIPMENT ARE EXPRESSED FOR Paw AMBIENT TEMPERATURE AND DRY PRESSURE ATDP CONTROL AREAS In this sector there are the keys that permit to sele
15. you must remind that P Con adjustment refers to pressure value over established value for PEEP 39 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ret 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 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 e FiO
16. DARD 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 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 AN 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 LUFT1 G SUPPORTS INLET PRESSURE UP 1000 KPA 10 2 AVOIDING THE USE OF EXTERNAL PRESSURE REGULATORS UNTILL THIS VALUE BREATHING CIRCUIT UTILIZE RESPIRATORY CIRCUIT AS THE NECESSITY PEDIATRIC OR ADULT THE DIFFERENCE IS IN THE TUBES DIAMETER IN RESPIRATORY CIRCUITS 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 8 THE CONNECTORS OF THE PATIENT CIRCUIT ARE CONICAL TYPES 22mm IN ADULT AND THEY ARE ACCORDING WITH THE ISO 5356 1 NBR13475 STANDARD WHICH DETERMINES THE MINIMAL EXIGIBLE CONDITIONS FOR THESE CONNECTOR TYPES
17. ED TIME THE MEASURED PARAMETERS AT INITIAL TEST OF THE PATIENT CIRCUIT AND PERIPHERALS TEND TO VARY BY TEMPERATURE HUMIDITY LOCATION ETC THE VARIATIONS IN THE CIRCUIT MAY BE MORE SIGNIFICANT DURING THE FIRST HOURS OF OPERATION STABILIZING AFTER THAT 50 of 63 L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 racionas LEISTUNG LUFT1 G CHAPTER 10 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 C 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 OF 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 THE EXHALATION VALVE ACCEPTS ANY OF THE ABOVE ME
18. 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 46 of 63 L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 rate tnn LEISTUNG LUFT1 G ALARMS VALUES VERIFICATION LIST PATIENT OPERATION MODE CHECK P max P min VT max VOV PCV SIMV CPAP PSV VT min Freq max APNEA P max P min VT max VT min Freq max APNEA PEDIATRIC VCV PCV SIMV CPAP PSV 47 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren CHAPTER 9 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 gt UPON ASSEMBLING THE EXALATORY VALVE PUT THE DIAPHRAGM AS INDICATED IN THE FIGURE WITH THE SALIENCE DOWNWARD DO NOT INSERT IN THE BODY OF THE EXALATORY VALVE PIERCING OR CUTTING MATERIALS 48 of 63 L MECHANICAL VENTILATOR R 04 04 48 racionas LEISTUNG LUFT1 G The figure below shows the patient circuit assembly Optional Drain Trachea B E 2 AS 50 WHEN ADDED COMPONENTS OF THE RESPIRATORY CIRCUIT OR O
19. ERSONNEL 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 7 2 0f 63 L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 rate tnn LEISTUNG LUFT1 G ELECTRICAL OUTPUT VOLTAGE CURRENT 110V 0 63A POWER 40 VA FUSE 250V 0 5A T 20mm SB Slow ENVIRONMENTAL SPECIFICATIONS VALUES ENVIRONMENT TEMPERATURE STORAGE TRANSPORT 2 C up to 40 OPERATION 1096 up to 95 No condensable RELATIVE HUMIDITY 0 Up to 95 90 No condensable OPERATION 66 100 kPa ATMOSPHERIC PRESSURE STORAGE TRANSPORT 66 100 kPa 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 FUNCTION 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 STORAGE TRANSPORT 13 of 63 L MECHANICAL VENTILATOR ROUND LEISTUNG LEISTUNG LUFTI G Ren 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 sterilize the equipment with ethylene oxide There is a high probability to occ
20. GS AND OR SCREEN MESSAGE GRAPHICS PRESSURE FLOW TIME OTHER MENUS MENU OF TIME INDICATION AND EXECUTED SERVICES ALTITUDE ADJUST FOR VOLUME COMPENSATION LANGUAGE SELECTION SELF TESTS PATIENT CIRCUIT LEAKAGE EXPIRATORY FLOW PEEP VALVE PATIENT CIRCUIT COMPLIANCE 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 18 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG 147 1 s AT THE EXPIRATORY FLOW TEST THE GAS LINES AIR AND O 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 OPERATO
21. HE OPERATOR ACCORDING TO THE PATIENT NEEDS LUFT1 g NEVER STOPS WORKING DURING CHANGING FROM A VENTILATION MODE TO ANOTHER ONE Tus IN CASE TO CANCEL VENTILATION MODE CHANGE YOU MUST PRESS RESET KEY 43 of 63 L MECHANICAL VENTILATOR ROUND LEISTUNG LEISTUNG LUFTI G Ren CHAPTER 8 ALARMS COLORS AND MEANING 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 Ltda and serves only as orientation the operator must adapt them to patient needs according to his own criterion 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 SEQUENCE ALARM PRIORITY High inspiratory pressure interrupted cycle NEM High Priority Low inspiratory pressure Co wo 0 Co we or Win a exhaled volume 0 Powersource 0 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 a
22. LED 52 of 63 MECHANICAL VENTILATOR LEISTUNG LUFT1 G ANNEX 1 SIMBOLOGY 1 Meaning of the standardized symbols printed equipment internal and external Symbol Standard Description TUUS IEC 60601 1 1994 Merken v 2283 Functional ground terminal Bucher dpt 9 Protection ground terminal 2 Attention Consult the documents IEC 60601 1 1994 Connected Connection to power oymbol No 417 5007 source or external Disconnected Disconnection from IEC 60601 1 1994 the power source internal or Symbol No 417 5008 external IEC 60601 1 1994 IEC 60601 1 1994 Symbol No 878 03 01 Risk of electrical shock IEC 417 i 5212 2 Consult Instructions of use Symbol No 3 3 53 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren 2 Meaning of the standardized symbols printed on the equipment package Standard Description FRAGILE ISO 780 1997 E No 1 Handle carefully THIS SIDE UP ISO 780 1997 E No 3 Indicates of 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
23. M EXPIRED TIDAL MAXIMUM dic A LA VI L IEP AWA KI e LONGA PRE WA Bi Aa PONER OLD ACE AA BOUE SERIA EET T mm 2 m CHAPTER 9 EXHALATION VALVE AND PATIENT CIRCUIT CHAPTER 10 CLEANING DESINFECTION AND STERILIZATION CHAPTER 11 MOUNTING THE EQUIPMENT ON THE TROLLEY ANNEX L SIMBOLOQY uu ER ANNEX 2 LUFT1 G ACCESSORIES ANNEX PREVENTIVE MAINTENANGCE ALARMS SYSTEM INTEGRITY TEST u u ANNEX 4 BLOCK DIAGRANM ANNEX YA ANNEX SIA 6 of 63 L MECHANICAL VENTILATOR KEUTA LEISTUNG LEISTUNG LUFT1 G Ren GUIDELINES AND DECLARATIONS OF LEISTUNG EQUIPAMENTO LTDA ABOUT ELECTROMAGNETIC COMPATIBILITY EMC Manufacturer guidelines and declarations Electromagnetic emission The LUFT1 g is designated for use in electromagnetic ambience as specified bellow It is recommended that the LUFT1 g user ensures it be utilized in such
24. NCLUDED WITH THE EQUIPMENT LOCKNUT 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 Illustrative photos only 57 of 63 L LEISTUNG VENTILADORES PULMONARES MECHANICAL VENTILATOR LEISTUNG LUFTI1 G R 04 04 48 Rev 01 OPTIONAL TOUCHSCREEN MONITOR Monitor Touch HUMIDIFIER PATIENT CIRCUIT WITH EXHALATION VALVE AND NEBULIZER TEST LUNG PEDIATRIC CELL PERMITS TO CONTROL THE EQUIPMENT BY TOUCHING DIRECTLY THE SCREEN HUMIDIFICATION AND HEATING OF GAS IT MUST BE USED THE MODEL AVAILABLE AT MARKET PATIENT EQUIPMENT INTERFACE NOTE IT MUST BE USED ONLY THE APPROPRIATE MODEL FOR LUFT1 G VERIFICATION OF OPERATION AND CYCLING OF THE EQUIPMENT FIO ANALYSIS FOR O CELL CONNECTION IN PATIENT CIRCUIT Illustrative photos only THE UTILIZATION OF ACCESSORIES AND CABLES WHICH ARE NOT SPECIFIED BY LEISTUNG EQUIPMENTS LTDA MAY RESULT IN ELECTROMAGNETIC EMISSION INCREASING OR IMMUNITY REDUCTION OF THE EQUIPMENT 58 of 63 L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 racionas LEISTUNG LUFT1 G ANNEX PREVENTIVE MAINTENANCE Itis mandatory to be performed a preventive maintenance respecting the following chronogram Maintenance Hours of use Such preventive maintenance must be performed by a
25. ON err rrr nennen 38 BiN a Y 39 CONTROLLED PRESSURE 88 EAA n nanaonan rnanan nanna 39 PSV CPAP PRESSURE SUPPORT VENTILATION OR CONTINUOUS POSITIVE _ 40 MAXIMUM INSPIRATORY 0 0 007000 waina zimwi 40 55 8 wiza ARALARA EARLE A R ranana annann 41 SIMV VCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE 41 BACK UP VENTILATION os eaves since creatinine bein 42 VENTILATION 000 0000 42 APNEA 8888 APPEAR Lannan rnanan nnt 42 CYCLING VARIABLES Q cece cccccccccceccccececccccccececcaceccaueceauuaueneauenegueaeauecusnecesnecusneateneausuenens 42 PEEP u 43 CHAPTER 8 5 2 44 COLORS AND MEANING OF GRAPHIC INDICATORS a r 44 5 of 63 L MECHANICAL VENTILATOR LEISTUNG LEISTUNG LUFTI G Ren ALARMS PRIORITY SEQUENCE SUN KR UE 45565 55 255534 ALARMS DESCRIPTION fou HIGH INSPIRATORY 5 LOW INSPIRATORY 5 MAXIMUM EXPIRED TIDAL VOLUME ii MINIMU
26. PATIENT CIRCUIT A LOW VALUE EXPIRATORY SENSIBILITY MAY HAMPER THE CYCLE DUE TO THE LEAKAGE BE GREATER THAN THE SELECTED INPUT VALUE 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 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 LUFT1 g starts measuring it and shows on the screen the following message Respiratory mechanics accepted When measurement procedure and calculus of Auto PEEP is concluded LUFT1 g shows on the upper part of the screen the value of the TOTAL PEEP Auto PEEP and PEEP 30 of 63 L MECHANICAL VENTILATOR 77 LEISTUNG LEISTUNG LUFTI G Ren LUFT I Total PEEP 3
27. R CAN CHOOSE ABOUT COMPENSATE OR NOT THIS VALUE THE EQUIPMENT WILL COMPENSATE ONLY IF THE OPERATOR CHOOSE YES OTHERWISE IT WILL NOT DO IT FUNCIONAMENTO DO BLENDER ELETR NICO MISTURADOR AR O2 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 79 of Nitrogen and 21 of to 100 pure Oxygen for example a of 6096 means that 60 of the inspired volume by patient is oxygen and 40 are composed by nitrogen and other gases 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 respective 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 o
28. RM 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 31 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren 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 e STAND BY FREEZE IMAGE e MANUAL INSPIRATION I 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 32 of 63 L MECHANICAL VENTILATOR jai d LEISTUNG LUFT1 G Rev 01 ALARMS AREA ALARMS Max Insp Pressure Inversion Min Insp Pressure Peep Q Apnea FiO O Max Frequency O Air Oxygen Q VT max min Q Power Outage Q Battery Q Microprocessor In this sector are the light indicators corresponding to the alarms which when activated are followed
29. T1 g is intended for use in environment electromagnetic specified below It is recommended that the client or user of Lung Ventilator LUFT1 g 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 596 U gt 95 voltage drop of Ut by 0 5 cycles 40 Ui 60 voltage drop of Ut by 5 cycles Complies 70 U 30 voltage drop of Ut by 25 cycles lt 5 U gt 95 voltage drop of Ut by 5 seconds 8 of 63 Electromagnetic Environment 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
30. THER COMPONENTS OR SUBSETS FOR THE RESPIRATORY SYSTEM THE PRESSURE GRADIENT MEASURED AT THE PORT OF CONNECTION OF THE PATIENT MAY INCREASE UPON REMAKING THE CIRCUIT TEST THIS GRADIENT IS AUTOMATICALLY CORRECTED BY THE EQUIPMENT A BAD CLOSURE OF THE DIAPHRAGM MAY AFFECT ON THE PARAMETERS N READING 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 AT THE END OF THREADING DO NOT MAKE STRONG ADJUSTMENTS 49 of 63 L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 racionas LEISTUNG LUFT1 G dn 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 15 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 DETERMIN
31. THODS FOR ANOTHER CIRCUIT CONSULT MANUFACTURER S RECOMENDATIONS AVOID THE USE OF PURE ALCOHOL CLEANSING SOLUTIONS WHICH CONTAIN 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 GUM AND ITS DERIVATIVES SUCH AS MODIFY THE PLASTIC PARTS THE VENTILATOR ITS CASE MUST NEITHER BE CLEANED WITH ETHYLENE OXIDE NOR IN AUTOCLAVE 51 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren CHAPTER 11 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 DISASSEMB
32. Tidal e Support pressure P Sup e PEEP e Sensibility Sens 4 of 63 pen MECHANICAL VENTILATOR R 01 046 eee LEISTUNG LUFTI G BACK UP VENTILATION BACK UP VENTILATION VOV Apnea Back up ventilation is available in all ventilation modes which have a spontaneous parameter 15 00 s T Ins In LUFT1 g the back up is obligatory in modes PSV and CPAP In mode SIMV 1 20 s VCV PSV back up ventilation is available and the operator can let it activated or deactivated Freg At the moment that SIMV VOV PSV is selected the operator can select the S Con B option YES to activate back up ventilation or NO to deactivate it 0 400 L When the selected mode is PSV CPAP the ventilator provides directly the back up ventilation configuration screen To set back up ventilation the following parameters must be adjusted e Ventilation mode e Apnea e Inspiratory time e Respiratory frequency e Tidal volume or Controlled pressure 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 du
33. UIPAMENTO LTDA ABOUT ELECTROMAGNETIC COMPATIBILITY EMC CHAPTER 1 PRESENTATION 11 Ma niei C 11 WARNINGS CAUTIONS AND NOIES 14 WARNING 32 u u uu uu uuu P 14 PRECAUTIONS 15 NOTES u S S S 15 CHAPTER 2 INTRODUCTIONN 16 PATEN 16 ree 16 LP qM AA 16 FUNCIONAMENTO DO BLENDER ELETRONICO MISTURADOR 02 19 ELECTRONIC BLENDER OPERATION BLENDER 19 mie mibimusi 20 CHAPTER 3 ASSEMBLY AND CONNECTION 2 21 POWER SOURCE CONNEG MON xia qua Sui 21 GAS SOURCE GONNEC LION 5240 aae uS n UE 21 BREATHING CIRCUIT suas 22 CHAPTER 4 INDICATORS CONTROLS AND ALARMS 23 mii EH PANEL eee ee eee ee coe ne ee 23 INDICATORS AREA nnn gma ab de
34. ant 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 the 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 is turned off automatically when restoring the input pressures It cannot be restore manually but can be silenced during 60 seconds pressing SILENCE key 45 of 63 L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 racionas LEISTUNG LUFT1 G dn POWER OUTAGE This alarm is activated if a power outage occurs while th
35. 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 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 33 of 63 L MECHANICAL VENTILATOR 77 LEISTUNG LEISTUNG LUFTI G Ren CHAPTER 7 VENTILATION MODES ADULT 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
36. ct adjust and confirm of data and also the access to options selection by screen menu DIRECTIONAL KEYS Directional keys permit to move the selection cursors of menus and parameters Also is utilized for adjustment of the selected parameters SELECTION ENTER When the parameters are selected activates adjustment mode A lt lt lt and realize the values confirmation It is also utilized to activate Y menu options 25 of 63 MECHANICAL VENTILATOR R 044448 LEISTUNG LUFT1 G Rer 01 CHAPTER 5 LUFT1 G OPERATION select and press lt ENTER gt When starting the equipment an initialization sequence is performed which includes 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 K ADULT PEDIATRIC THIS SELECTION INFLUENCES THE OPTIONS OF THE OFFERED VENTILATION AN MODES AND THE INITIAL PARAMETER VALUES OF OPERATION IS CONSIDERED ADULT PATIENTS WITH MORE THAN 30 KG OF WEIGHT PEDIATRIC PATIENTS BETWEEN 10 AND 30 KG OF WEIGHT 26 of 63 L MECHANICAL VENTILATOR LEISTUNG LEISTUNG LUFT1 G Ren L 2 2216 LEISTUNG LUFT pe 10 03 11 VENTILATION MODES VCV Circuit Leakage Test Expiration Flow Test Line Compliance 60 cmH20 0 25 mL cmH20 Select and press lt ENTER gt Following is performed a test of the patient circuit It is neces
37. e Rise Time R Time e Maximum inspiratory time max e Support pressure P Sup e PEEP e Sensibility Sens MAXIMUM INSPIRATORY TIME As safety procedure LUFT1 g goes to expiratory phase if the maximum inspiratory time is reached 40 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren SUPPORT PRESSURE In PSV airway pressure level is the main parameter to be adjusted because it will have direct influence about the tidal volume received by the patient To adjust support pressure you must remind that the adjust Sup refers to support pressure value over the established for PEEP PAN 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 e FiO e Rise Time R Time e Inspiratory time T Ins Respiratory frequency Freq e Tidal volume V
38. e ventilator is operating This alarm is turned off when the power is restored It cannot be silenced manually LOW BATTERY This alarm is activated when the equipment is operating without external power and the internal battery reaches a charge of 7596 of the nominal voltage see chapter 1 This alarm is turned off automatically when the power is 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 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 max 40 min 05 cmH5O Vol max 0 600 I Vol min 0 150 Freq max 30 cpm 15 seconds max 30 min 05 cmH5O Vol max 0 400 Vol min 0 050 L Freq max 30 com APNEA 15 seconds PCV SIMV CPAP PSV PEDIATRIC VCV PCV SIMV CPAP PSV THE DEFAULT SETTING OF ALARMS IS ADJUSTED DURING THE INITIALIZATION OF THE
39. fter 10 seconds but the light remains turned on continually until it is turned off manually through RESET key 44 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFT1 G Ren as ALWAYS THERE IS A 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 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 or for a period of time longer than 10 seconds the alarm is 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 It is activated if the result
40. g with the current ones and nominal power of the equipment There is also indicated the corresponding fuse values 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 TO 264V WITHOUT OPERATOR S INTERVENTION EVEN WHEN THERE 15 A VOLTAGE REDUCTION OF THE POWER DURING THE NORMAL OPERATION CERTIFY THAT THE CONNECTION OF THE EQUIPMENT 15 REALIZED WITH A 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 AR The gas connection source is located at the back of the case 1 Ys Flow max 1601 AIR INPUT Male connector DISS 34 16 OXYGEN INPUT Male connector DISS 9 16 18 2l of 63 In its case are indicated corresponding inputs of air and oxygen L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 madume LEISTUNG LUFT1 G dn AT THE PRESSURE TUBES ARE UTILIZED THE FEMALE CORRESPONDING Paw CONNECTORS THE SCREWABLE CONNECTIONS USED IN THE AIR INPUTS ARE ACCORDING WITH NBR 11906 STAN
41. he 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 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 EE ratio and On the bottom of the display are the parameters adjustable by the operator such as FlO WAVEFORM RISE TIME INSPIRATORY TIME FREQUENCY TIDAL VOLUME CONTROL PRESSURE SUPPORT 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 l m to H2Ocm 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
42. hospital environment L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 racionas LEISTUNG LUFT1 G dn Manufacturer Guidance and Declaration Electromagnetic Immunity The Lung Ventilator LUFT1 g is intended for use in environment electromagnetic specified below It is recommended that the client or user of Lung Ventilator LUFT1 g ensures that it is used in such environment Immunity tests Test level Compliance Electromagnetic Environment ABNT NBR IEC 60601 level Guidance Portable and mobile RF communication equipments must not be used close to any part of the lung ventilator LUFT1 g including cables Recommended separation distance equation with respect to the transmitter frequency d 1347 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 P is 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 Interference may occur around the equipment marked with this symbol 1 At 80 MHz and 800 MHz applies the highest range of frequency NOTE 2 This guidance
43. m distance between portable and mobile RF communications equipment transmitters and the Lung Ventilator LUFT1 g as recommended below according to the maximum output power of the communication equipments Separation distance according to frequency of transmitter Rated maximum meters m output power of transmitter 150 kHz up to 80 MHz up to 800 MHz up to 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 m 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 affected by absorption and reflection from structures objects and people 10 of 63 L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 rate tnn LEISTUNG LUFT1 G CHAPTER 1 PRESENTATION In this User Manual are presented the necessary information for the correct use of the Lung Ventilator LUFT1 g 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 CLASSIFICATION ACCORDING TO
44. may be not applicable in all situations The electromagnetic propagation is affected by absorption and reflection of structures objects and people A 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 LUFT1 g is located exceeds the above applicable RF compliance level the Lung Ventilator LUFT1 g 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 LUFT1 g B Above the frequency range of 150kHz up to 80 MHz the field intensity must be less than 3 V m 9 of 63 L l LEISTUNG MECHANICAL VENTILATOR R 04 04 48 racionas LEISTUNG LUFT1 G id Recommended separation distances between portable and mobile RF communication equipment and the Lung Ventilator Luft NEO The Lung Ventilator LUFT1 g is intended for use in an electromagnetic environment in which irradiated HF disturbances are controlled The customer or the user of the Lung Ventilator LUFT1 g can help to prevent electromagnetic interference by maintaining a minimu
45. neumotachograph 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 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 procedure 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 IS INDEPENDENT SO IT IS POSSIBLE TO CHECK THE ALARMS IN ANY ORDER THE TIME BETWEEN THE PARAMETER ADJUSTMENT AND ALARM TRIGGERING MAY VARY IN EACH TEST IT IS RECOMMENDED FOR THIS TEST TO BE DONE ALONG WITH PREVENTIVE MAINTENANCE DESCRIBED AT THE BEGINNING OF THIS CHAPTER 60 of 63 L L MECHANICAL VENTILATOR R 04 04 48 27 LEISTUNG LUFT1 G Rev 01 ANNEX 4 BLOCK DIAGRAM The following figure represents the pneumatic diagram of LUFT 1 g Air inlet O inlet 17 LCD Display Pressure sensors Sensor sensor Prop val Prop val Anti suffocation Safety SOURCE valve Patient output Prop valve Regulator nebulizer Expirat valve 61 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFT1 G Ren ANNEX 5 WARRANTY LEISTUNG brand LUFT1 g model This equipment is
46. ntil 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 28 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFT1 G Ren CHAPTER 6 MENU MENU Pressing MENU it will show in the right side of the LCD display the following options VENTILATION MODES list of operative modes according to the type of selected patient Adult or Pediatric is shown when the equipment is started 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 the 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 LUFT1 G 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 for nebulization synchronized with inspiration time this time may be 5 10 15 or 20 minutes according to the necessit
47. o 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 the ratio too 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 63 of 63
48. olled modes Flow waves can be selected in volume control modes WAVEFORMS The initial work waveform in volume modes is 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 tf SQUARE WAVE Ng me With this adjustment the flow accelerates very fast and reaches flow value which will be maintained during inspiration This wave pattern permits an appropriate EE 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 35 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren Inspiratary Expiratnry Hs DESCENDING RAMP WAVE N Time 5 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 ins
49. piratory 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 current volume RESPIRATORY FREQUENCY Refers to ventilation cycles quantity given by LUFT1 g to patient within the period of one minute 36 of 63 L MECHANICAL VENTILATOR KUNGS LEISTUNG LEISTUNG LUFT1 G Ben TIDAL VOLUME Tidal volume V Tidal represents the volume in liters 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 VOV 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 LUFT1 g 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 37 of
50. 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 LUFT1 G PERFORMS AN SELFTEST OF THE BATTERY CONDITION EVERY FIVE MINUTES HOWEVER IS RECOMMENDED TO DISCONNECT FROM THE POWER AT LEAST ONCE A MONTH LETING THE EQUIPMENT UNDER BATTERY SUPPLY IN ORDER TO TEST ITS CONDITIONS IT IS RECOMMENDED TO CHANGE THE INTERNAL BATTERY EVERY FOUR YEARS THE MANUFACTURER 15 NOT RESPONSIBLE FOR NORMAL OR SPECIAL DAMAGE 59 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren 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 Tidal Volume It must trigger the minimum VT alarm 5 Ajustar o valor de alarme Vol m ximo para um valor menor que o mostrado em Vt dever acionar o alarme de VOLUME TIDAL MAXIMO 6 Disconnect the P
51. ring 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 Tus TIDAL VOLUME ADJUSTMENT WILL BE AVAILABLE SELECTING VCV MODE AND P CON WILL BE AVAILABLE WHEN SELECTING PCV MODE 42 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFT1 G Ren PEEP PEEP level during back up ventilation will be the same of the programmed in spontaneous mode 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 gt lt WHEN ASSISTED MODE IS SELECTED THE CONFIGURATION OF BACK UP PAN APNEA TIME IS NOT ACTIVE IN VCV AND PCV MODES PAN IN ALL VENTILATION MODES OF LUFT1 g PEDIATRIC ADULT THERE IS A DEFAULT CONFIGURATION DEFAULT CONFIGURATION IS NONSPECIFIC AND IT MUST BE ADJUSTED BY T
52. sary 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 N 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 modes 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 27 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren 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 Is worth noting that the adjustments made in parameters will not be activated u
53. sure 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 pressure 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 t
54. the inspiratory cycles may be triggered by time flow or pressure In this ventilation mode the following variables must be adjusted e FiO 38 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFT1 G Ren e Rise Time R Time e Inspiratory time T Ins Respiratory frequency Freq e Controlled pressure P Con e e Sensibility Sens RISE TIME Rise Time is the time the ventilator requires reaching the selected pressure Increase or decrease this time may assist in the comfort of the patient In LUFT1 g 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 appropriate ventilation the rise time must be adjusted in order to provide the smallest overshoot possible Pressure A Rise Overshoot Y E 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
55. the limit temperature for storage and manipulation of the package 54 of 63 L MECHANICAL VENTILATOR ROUND LEISTUNG LEISTUNG LUFTI G Ren 3 Meaning of symbols printed in this user manual Symbol Standard Description 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 opecifies important observations which need to be considered for a correct use of the equipment MANUFACTURER 55 of 63 L MECHANICAL VENTILATOR Ro LEISTUNG LUFT1 G ANNEX 2 LUFT1 G 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 TROLLEY SUPPORT DESK FOR THE EQUIPMENT WHITH ANTI CORROSION TREATMENT APPROVED SALT SPRAY TEST NBR8094 5770 56 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ree HUMIDIFIER SUPPORT m SUPPORT FOR HUMIDIFIER FIXING ARTICULATED ARM ARTICULATED SUPPORT FOR PATIENT CIRCUIT ELECTRIC POWER SUPPLY NOTE IT MUST BE USED ONLY THE CABLE I
56. ur irreversible damage in the ventilator components The equipment may be affected by High Frequency Electromagnetic Interference such as cellular wireless telephone defibrillators electro surgical knifes magnetic resonance etc Use table of previous section to determine the correct separation distance The use of accessories and cables other than the specified ones except accessories and cables furnished by LEISTUNG EQUIPAMENTOS LTDA as spare parts for internal components may result in EMISSION increasing or IMUNITY reduction of LUFT1 g 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 problems 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 4 of 63 L MECHANICAL VENTILATOR R 04 04 48 roses LEISTUNG LUFT1 G Rev 01 PRECAUTIONS During 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
57. xygen 10096 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 FiO INSPIRED FLOW 9 of 63 L MECHANICAL VENTILATOR KUTA LEISTUNG LUFT1 G Rev 01 FlO MEASUREMENT gt 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 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 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G 2 CHAPTER 3 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 alon
58. y 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 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 O EXPIRATORY SENSIBILITY PSV In PSV and combined modes which include support pressure it is possible to adjust the flow value which performs the changing between inspiration phase and exhalation phase cycle It is expressed in percentage of the inspiratory flow peak and may be adjusted between 5 and 80 The flow has descending ramp waveform and when the flow crosses the selected input it produces the cycle The smaller value will allow the inspiration time to be increased while the higher value shorten the inspiratory time 29 of 63 L MECHANICAL VENTILATOR R 04 04 48 LEISTUNG LEISTUNG LUFTI G Ren SENSIBIL EXP 5 Ya SENSIBIL EXP 80 Pressure cm H20 Pressure cm H20 yj 40 IF THERE IS LEAKAGE IN THE
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