Operation Manual. The Intermed and Inter names and logos are registered trademarks of Intermed Equipamento Médico Hospitalar Ltda.

Transcription

1 The and Inter names and logos are registered trademarks of Equipamento Médico Hospitalar Ltda. São Paulo Brazil 2011

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3 The ventilator must be handled and operated only by duly qualified professionals. Read this manual thoroughly before using the ventilator on patients. After the initial reading, always keep this manual on an accessible location, for future consulting. This equipment and its documents may be modified without any further notice to the user.

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5 iii Product Identification This refers to the lung ventilator, model, software version 4.nn of the brand Commercial Name: Lung Ventilator Technical Name: Pressure and Volume Ventilator ANVISA Registration no Technician in Charge: Eng. Jorge Bonassa CREA /D Legal Representative: Milton Rubens Salles Legal Representative in European Community: OBELIS S. A. Avenue de Tervuren, 34, bte Brussels, BELGIUM Ph.: +(32) / Fax: +(32) mail@obelis.net Manufacturer: Equipamento Médico Hospitalar Ltda. CNPJ [National Directory of Legal Entities]: / I.E.: Rua Santa Mônica, 980 Parque Industrial San José Cotia/SP Brazil Ph.: +55 (11) / Fax: +55 (11) website: contato@intermed.com.br Milton Rubens Salles Commercial Director Legal Representative Eng. Jorge Bonassa Technical Director Technician in Charge CREA /D

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7 v Summary 1 GENERAL SPECIFICATIONS 7 2 SAFETY WARNINGS 19 3 EQUIPMENT SET-UP 31 4 OPERATION 51 5 VENTILATION FEATURES 67 6 ALARMS AND MESSAGES 85 7 MONITORING FEATURES TROUBLESHOOTING CLEANING, DISINFECTION AND STERILIZATION PREVENTIVE MAINTENANCE ACCESSORIES, PARTS AND PIECES TERMINOLOGY, SYMBOLS AND DEFINITIONS TECHNICAL SPECIFICATIONS 187 WARRANTY TERM 205 ATTACHMENT A: PNEUMATIC SCHEME 207

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9 1. General Specifications 7 1 General Specifications

10 8 1. General Specifications Código Review 001

11 1. General Specifications General Presentation and Application The is an electronic, microprocessor-controlled ventilator, specifically developed to be used on neonatal, pediatric and adult patients under intensive care therapy. Featuring an innovative and extremely intuitive graphic interface, the enables easy interaction, thus making its operation simple, fast and objective. In addition to that, the provides a wide range of ventilation features, which enables its application on several clinical cases, from the simplest to the most complex ones. The following tools are highlighted: Exclusive mode for non-invasive ventilation NIV Expiratory sensitivity adjustment on the pressure support cycles Pressure curve slope adjustment on the controlled pressure and pressure support cycles Nebulization synchronized with the inspiratory phase and with volume and FiO 2 compensation Sigh Actuation on volume- and pressure-controlled modes Tracheal gas insufflation TGI synchronized with the expiratory phase Automatic sequence for aspiration (100% O 2 ) Automatic respiratory circuit complacence compensation

12 10 1. General Specifications 1.2. Operating Principles The features a modular design, focusing on safety and operational reliability, as well as easy maintenance. Additionally, its constitution has been modeled in order to enable future upgrades by means of mere software updates. The main modules are: Front Panel Module Electronic Actuation Module Electric Power Supply Module Pneumatic Control Module Rear Panel Module Front Panel Module The Front Panel Module is responsible for the user interface and the ventilator s main control. It consists of a liquid crystal display screen (LCD TFT), electronic boards, control button and quick access keys, and it also features a proper sealing for cleaning and disinfection. The 12-inch colored liquid crystal display screen features high resolution (XGA 1024x768), high brightness and contrast, as well as anti-reflex and abrasion (scratches) resistant touch screen surface. The screen can be activated through finger touch, also working with gloves. Control actuation is done by touching the screen and/or using the main button for adjusting and confirming parameters. Some special functions also have quick access keys. The ventilator control is independent of the interface control; each of them is performed by separate electronic boards and software. A monitoring routine independent from central processing supervises the entire system in order to prevent communication and/or control failures Electronic Actuation Module The Electronic Actuation Module consists of electronic boards and transducers and it is responsible for actuating valves, monitoring of sensors, controlling the battery system, and activating alarms. Código Review 001

13 1. General Specifications Electric Power Supply Module The Electric Power Supply Module is responsible for powering the equipment and it consists of an AC/DC stabilized power source and an internal rechargeable battery. The internal battery is a sealed lead-acid model Pneumatic Control Module The Pneumatic Control Module is responsible for the pneumatic actuation and it is basically formed by the air and oxygen flow valves and the exhalation valve, besides the anti-asphyxia valve, nebulizer/tgi actuation valve, oxygen sensor, pneumotachograph circuit and intake filters. The ventilator controls the air and oxygen flows by means of separate solenoid-actuated valves. Each gas flow rate is measured by means of independent heated film sensors, especially calibrated for air and oxygen. Based on the measured flow rate values, the values are continuously fed back in order to meet the set flow rate, volume and mixture composition (FiO 2 ) parameters. The mixture resulting from the composition of air and oxygen flow rates is continuously measured by means of an electrochemical/paramagnetic oxygen sensor located inside the equipment. During the installation, -Authorized Technical Service must configure the equipment according to the altitude of the installation location, thus enabling the equipment, based on the barometric pressure, to properly compensate the controlled and monitored gas volume and oxygen concentration parameters. The exhalation valve consists of a flexible diaphragm that actuates over a nozzle connected to the expiratory branch. The diaphragm actuation is done by means of a solenoid-actuated pilot valve. Based on the pressure values measured in the inspiratory and proximal route, the pilot valve is continuously fed back in order to keep the airway pressure at the desired value both on the inspiratory phase and on the expiratory phase. The system also has two solenoid valves one for compressed air and another for oxygen whose purpose is to keep constant the control pressure of the nebulization, TGI and anti-asphyxia valve systems. To control these systems, compressed air is preferably used; oxygen is only used in case of lack of compressed air or if the FiO 2 used is too high. When nebulization is used, the system enables the compensation of the tidal volume and of the oxygen concentration of the mixture supplied to the patient.

14 12 1. General Specifications In specific cases, when it is impossible to keep the ventilation at safe levels, an antiasphyxia/overpressure valve is opened, which opens the ventilator circuit to enable the patient s spontaneous respiration. To measure the flow rate and the volume on the external portion of the ventilator, flow sensors are used, which can be either proximal (mounted on the Y part, close to the patient connection) or distal (mounted on the exhalation valve) type. An optical coupling located on the Pneumatic Control Module identifies the type of sensor in use. The compressed air and oxygen pipelines are directly connected to the intake of the Pneumatic Control Module. In order to protect against the entry of water coming from the gas pipelines, trap filters are used and, in case of compressed air, two filters are used to provide additional safety Rear Panel Module The Rear Panel Module is formed by electrical supply connections (AC and DC), the outlet of the fan from the supply source, and the communication ports, which, along the intake of the Pneumatic Control Module, constitutes the rear panel. In addition, the Rear Panel features an Equipotential Pin, according to the DIN standard. This Equipotential Pin is intended to the connection of a potential equalization conductor, which connects the equipment to the potential equalization conductor bus of the electrical installation (when available). The equipotential pin is provided along the Lung Ventilator ix5 in anticipation of potential applications comprising the use of other devices connected to one of the communication interfaces located on the Rear Panel. Código Review 001

15 1. General Specifications Records and Certifications The lung ventilator was developed, tested and certified in accordance with the following safety standards for electromedical equipment: ABNT NBR IEC : Amendment 1:1997: Electromedical Equipment Part 1 General Requirements for Basic Safety and Essential Performance ABNT NBR IEC :2006: Electromedical Equipment Part 1-2 General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility Requirements and Trial ABNT NBR IEC :2004: Electromedical Equipment Part 2-12 Particular Prescriptions for Lung Ventilator Safety Ventilators for Critical Care Additionally, the design and manufacture of the ventilator complies with all the Brazilian and European legislation applicable to its product class. provides the documents corroborating such certifications upon previous prior request.

16 14 1. General Specifications 1.4. Equipment Classification This section features the classifications that can be applied to this product, in accordance with the safety standards listed on the previous item. Each of these classifications is followed by a brief explanation about it. The exact definitions for each of the terms mentioned in this section can be found in Chapter Terminologies, Symbols and Definitions of this manual Regarding Application Criticality Classification according to Directive 93/42/CEE Rule 9 Class IIb Equipment Equipment intended to administer or exchange energy with the human body in a potentially dangerous way Regarding Safety Against Electric Shock Classification according to Standard ABNT NBR IEC : A1:1997 Class I Equipment Equipment with electrically insulated metallic parts and a grounding terminal (plug with ground pin). Internally energized equipment Electric equipment capable of working by means of an internal battery. B-Type applied part Patient circuit providing protection against electric shock. Defibrillation-proof applied part Patient circuit protected against a cardiac defibrillator discharge Regarding Protection Against Liquid and Particle Penetration Classification according to Standard ABNT NBR IEC : A1:1997 IP24 equipment Código Review 001

17 1. General Specifications Regarding Applicable Sterilization Methods (Patient circuit) Classification according to Standard ABNT NBR IEC : A1:1997 Chemical sterilization by immersion Autoclave Ethylene Oxide Sterilization Regarding Ignition Risk Classification according to Standard ABNT NBR IEC : A1:1997 Equipment not suitable for use in oxygen-rich environments Equipment not suitable for use in environments featuring an oxygen concentration higher than 25%. In case of pressurized environments, the equipment is not suitable for use if, in such environment, the partial oxygen pressure is higher than 27.5kPa. Equipment not suitable for use in the presence of an anesthetic mixture flammable with air, oxygen or nitrous oxide Regarding Operation Mode Classification according to Standard ABNT NBR IEC : A1:1997 Equipment for continuous operation Equipment capable of operating for unlimited time without overheating.

18 16 1. General Specifications 1.5. Supply Sources Power Supply The ventilator is capable of working by means of three different types of power supply sources: External AC-type power source (power mains) External DC-type power source (external battery) Internal DC-type power source (internal battery) External AC (Alternating Current) Power Supply Source Voltage: 100V 240V (Full Range power supply automatic switching) Current: 0.3A 0.7A Frequency: 50Hz 60Hz Fuse: T2AL 250V Consumption: approximately 75VA External DC (Direct Current) Power Supply Source Voltage: 12V 14V Current: 4.0A Fuse: 4A 250V SB Internal Power Supply Source Battery type: Lead-acid Voltage: 12V Charge capacity: 9.0Ah Autonomy: up to 3 hours Pneumatic Supply Intake gases: oxygen and compressed air Connection standard: NBR Pressure range: 250kPa 600kPa (2.5kg/cm 2 6.0kg/cm 2 ) Maximum demand flow rate: 50L/min at 350kPa Intrinsic gas consumption: < 1L/min (on standby mode) Código Review 001

19 1. General Specifications Physical Features Weight Ventilator: 12kg Pedestal: 18 kg Complete Equipment (including arm and circuits): 32 kg Dimensions Height: 300 mm Width: 290 mm Depth: 400 mm Pedestal Height: 1033 mm Pedestal Finishing: Anti-corrosive epoxy paintwork Casters: Four casters, two of them with locks Weight: 18 kg Height: 1003 mm

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21 2. Safety Warnings 19 2 Safety Warnings

22 20 2. Safety Warnings Código Review 001

23 2. Safety Warnings Introduction This section aims at aggregating, in a practical way, some information about the risks resulting from the incorrect operation of the ventilator. Such information is classified into three levels, according to its criticality: Warnings They indicate conditions that may result in risks to the patient or to the operator. Throughout the text, they are preceded by the expression CAUTION. Precautions They indicate conditions that may affect or damage the equipment or its accessories. Throughout the text, they are preceded by the expression WARNING. Additional Information It indicates complementary information, which helps to understand the operation of the equipment. Throughout the text, it is preceded by the expression NOTE.

24 22 2. Safety Warnings 2.2. Warnings CAUTION! The following information indicates conditions that may result in safety risks to the patient and/or operator Operator s Responsibilities Before using the ventilator with patients, it is essential to fully read and understand this manual. Using this equipment before fully understanding its features and functions may result in risk condition both for patient and operator, and for the equipment itself. After the initial reading, keep this manual in an accessible location for future consultation. Never use this ventilator in disagreement with the specifications contained in this manual. In case of doubt, contact. This equipment must be handled and operated only by duly qualified professionals. A qualified professional must be readily available whenever this equipment is being used in order to take the necessary actions should there be an alarm or any other event. Never operate this equipment before setting up its alarms. An alarm indicates the occurrence of a situation that requires the operator s attention and should never be ignored. Always keep an alternative means of ventilation (e.g. manual resuscitator) when this equipment is being used. Before using the equipment, always perform the Initial Verification Check List, as described under Chapter Preventive Maintenance of this manual. Never use this equipment in the presence of flammable anesthetic gases. This situation poses a risk of explosion. Código Review 001

25 2. Safety Warnings Maintenance This ventilator is a life support equipment. Never entrust its maintenance to an unauthorized technician. In case of problems or difficulties, please contact. Do not use the equipment if it is not working within the specifications contained in this manual. In this case, interrupt its use and contact. In order to ensure electrical protection and avoid the risk of fire, never replace the fuse of this equipment. The improper replacement of the fuse voids the warranty and poses a risk to the operation of the equipment and to the safety of the operator and the patient. Lack of maintenance or maintenance performed by a non-accredited company will render the product a tampered product, and this will subject legally responsible people to the legal penalties; as well as the change of basic components of this equipment will constitute a fail to comply with the instructions contained in this and may affect the safety and functionality of the equipment Accessories Always use original accessories, parts and pieces in order to ensure the correct performance of this equipment and the validity of the warranty. In addition, this measure is also intended for the patient s and operator s safety. The use of non-original parts, pieces and accessories poses risk to the users, and does not meet the provisions of ANVISA Resolution RDC no. 59:2000, and the instructions contained in this. When using other equipment along this ventilator (e.g. heated humidifier), check the instructions provided with them. recommends the use of the Misty3 heated humidifier, and the IM300 humidification jar along this equipment. When accessories or other components are added to the patient circuit, system inspiratory resistance and expiratory resistance will be increased. The operator must ensure that they do not exceed the following values (measurements performed at the patient connection during spontaneous respiration and normal equipment operation):

26 24 2. Safety Warnings In neonatal use: In pediatric use: In adult use: 6cmH 2 O for 6L/min 6cmH 2 O for 30L/min 6cmH 2 O for 60L/min All components of -supplied patient circuit (silicon tubes polysulfone connections, and polycarbonate and polysulfone flow sensors) are totally latex-free and comply with the biocompatibility standards, meeting the cytotoxicity, irritation, sensitivity and hemocompatibility requirements Cleaning, Disinfection and Sterilization Disinfection is a process capable of destroying pathogenic microorganisms, but it is not capable of destroying spores. Spores are only destroyed by means of the sterilization process. Before the first use, clean and sterilize the components of the patient circuit, following the instructions shown under the Chapter Cleaning, Disinfection and Sterilization of this manual. The frequency of exchange and sterilization of these circuits is defined by the protocols observed in each hospital. After sterilizing, rinse and dry properly the components of the patient circuit in order to remove any chemical residue from them. Especially after the ethylene oxide sterilization, wait 24 to 48 hours before using the material again in order to ensure the aeration and the total removal of any residue this gas. Ensure the proper cleaning of the flow sensors, eliminating eventual solid residues deposited in its measurement ducts. The presence of such residues may affect the accuracy of such sensors. Do not reuse any component that is damaged or that is showing signs of wear Pneumatic Supply Use only medical grade gases (dry and contaminant-free) in order to avoid internal damages to the equipment and risks to the patient. Intake gases compressed air and oxygen must be in accordance with the standards ISO 8573 and RDC no. 50. Código Review 001

27 2. Safety Warnings Batteries In case the Low Internal Battery alarm is activated, immediately connect the equipment to the power mains or to an external battery Discard All replaced parts and pieces must be discarded as set forth by the local legislation where the equipment is installed. Special attention should be given when discarding the internal lead-acid type battery, which must follow its manufacturer s instructions, described on the component s body. The same attention should be given when discarding the printed circuit boards and other electronic components, which must not be discarded as normal waste, since they can be hazardous to the environment. Do not discard the electrochemical cell with the garbage. Discard it according to the local legislation where the equipment is installed Electric Safety Always use an AC power mains with ground pin connection. In case of doubts about the mains grounding system integrity, run the equipment using its internal battery or an external battery. Never cut the ground pin in the equipment plug. Never use adaptors when connecting the equipment to the AC power mains, always plug it directly into the mains outlet. Never use anti-static or electrically conductive hoses or tubes along this ventilator. Always keep the rear panel connectors protected by their insulating covers. Never disassemble the ventilator cabinet. This situation poses a risk of electric shock.

28 26 2. Safety Warnings Electromagnetic Compatibility The use of this equipment requires special precautions regarding its electromagnetic compatibility. This equipment, when exposed to situations that are adverse to its specification, can generate or suffer electromagnetic interference. In order to prevent harmful interferences, it is necessary: To observe the distances between this equipment and other possible EMI (Electromagnetic Interference) emitters. Only connect this equipment to a power outlet with protective grounding. Never cut the grounding pin from the equipment s power cord plug. Use restrictions: Radiofrequency equipment mobile or portable can interfere in the operation and performance of this ventilator. Do not use this equipment in a magnetic resonance environment or close to high frequency surgical equipment or short wave therapy equipment. The unauthorized modification of any element or component whose operation can be affected by electromagnetic fields voids the warranty of this product and may produce adverse results to its operation. Código Review 001

29 2. Safety Warnings Precautions WARNING! The following information indicates conditions that may affect or damage the equipment and/or its accessories Installation The initial assembly of this equipment must be done only by or by an -Authorized Technical Service. When in operation, never cover or position this equipment in such a way that its cooling air intake or outlet is blocked. This intake is located on the frontal lower portion of the equipment and remains unblocked when the equipment is properly mounted on its pedestal. The outlet is located on the rear panel of the equipment, where there is a warning: VENTILATION OUTPUT Do not obstruct. Never operate this equipment when it is directly exposed to heat and sunlight. After positioning the equipment for operation, lock the pedestal casters, in order to prevent it from moving inadvertently. The transportation of the ventilator can be done when it is mounted on the pedestal Maintenance This equipment features safety seals on the closing bolts. If these seals are broken by unauthorized personnel, warranty will be voided. Lack of maintenance or maintenance performed by a non-accredited company will render the product a tampered product, and this will subject legally responsible people to the legal penalties; as well as the change of basic components of this equipment will constitute the fail to comply with the instructions contained in this and may affect the safety and functionality of the equipment.

30 28 2. Safety Warnings The use of non-original parts, pieces and accessories poses a risk to the users, and does not meet the provisions of ANVISA Resolution RDC no. 59:2000, and the instructions contained in this. In order to prevent premature wear of the equipment and to ensure the safe performance and within the required specifications, the following must be performed: Initial Verification Check List It consists in checking the general condition of the equipment, as well as the aspects of cleanliness, assembly, and connections to the power and gas supply sources. It is recommended that it be performed daily or before each use, according to the instructions mentioned under Chapter Preventive Maintenance. Functional Verification Test FVT It consists of the verification of the equipment s operation, including alarm and monitoring features. It is performed by simulating failure situations, using a lung simulator. It is recommended that it be performed before using the equipment with a patient or when there are doubts about the equipment s operation, according to the instructions mentioned under Chapter Preventive Maintenance. Annual Preventive Maintenance APM It consists of the verification and eventual adjustment of the ventilator functions, as well as the replacement of parts that are worn or deteriorated due to their use, in order to extend the durability of the equipment and ensure its safe operation within the original specifications and the applicable normative requirements. The yearly performance of APM is recommended, and it must be performed only by or by an -Authorized Technical Service Cleaning, Disinfection and Sterilization Do not disconnect the measurement tubes from the flow sensor body. Never sterilize the equipment. Its internal components are not compatible with sterilization techniques. Never submerge the equipment into liquid solution or allow liquids to enter into its internal part. Código Review 001

31 2. Safety Warnings 29 Never use abrasive materials on the ventilator s surface, especially on its screen. It is recommended to clean the screen with a 70% Isopropyl Alcohol-wet gauze. Never use the following solutions for cleaning and/or disinfecting the components of the patient circuit because they can accelerate the degradation of the materials, causing the polysulfone components to crack or disintegrating the silicon tubes. Phenol (> 5%) Chlorinated Hydrocarbons Ketones Aromatic Hydrocarbons Formaldehyde Inorganic Acids Hypochlorite Quaternary Ammonium Compounds Components subjected to sterilization experience a natural degradation due to the characteristics of the processes employed. recommends no more than 50 cleaning/sterilization cycles for the parts of the patient circuit. The accessory lifetime will depend on the care given while using and handling it Pneumatic Supply At each gas intake there is a coalescent filter capable of retaining solid particles up to 0.3µm and liquid aerosols up to 0.75µm that are suspended in the gaseous mixture. These filters must be periodically inspected. Whenever required, drain the water condensed in the collection cup in order to prevent it from entering into the equipment, compromising its operation. At the compressed air intake, apart the coalescent filter, there is a pre-filter, which can be seen on the ventilator s left-hand side. Should accumulated liquid be noticed in the collection cup, perform the drainage by opening the pin located at the bottom of the cup. Pneumatic supply sources (oxygen and compressed air) must always be at a pressure between 250kPa and 600kPa, and they must be capable of providing a flow of up to 50L/min at 350kPa.

32 30 2. Safety Warnings Batteries Always use a DC power source in accordance with the specifications mentioned under Chapter General Specifications of this manual. For maximum battery autonomy, connect the equipment to the AC power mains for up to 48 hours before using it for at least 10 uninterrupted hours. After this period (48 hours), it is possible that a drop in the battery power level occurs, depending on the battery s status of use. The battery service life depends on the ventilator s use conditions (frequency and duration of ventilator and/or internal battery use, environmental conditions of temperature and humidity, etc.); therefore its condition must be periodically checked. The storage of the ventilator for extended periods at temperatures higher than 27 C, or without recharging the battery for periods longer than two months may reduce the battery service life. WARNING! All parts and pieces replaced must be discarded as set forth by the local legislation where the equipment is installed. Special attention must be given to the disposal of the internal lead-acid type battery, which must follow its manufacturer s guidelines, described on the component s body. The electrochemical cell must also be discarded according to the local legislation where the equipment is installed. WARNING! The does not charge its internal battery when connected to a DC power supply source. For maximum battery autonomy, connect the equipment to the AC power mains for up to 48 hours before using it for at least 10 uninterrupted hours. After this period (48 hours), it is possible that a drop in the battery power level occurs, depending on the battery s status of use. Código Review 001

33 3. Equipment Set-Up 31 3 Equipment Set-Up

34 32 3. Equipment Set-Up Código Review 001

35 3. Equipment Set-Up Introduction Installation The initial assembly of the equipment must be performed only by or by -Authorized Technical Service Positioning Never operate this equipment when it is directly exposed to heat and sunlight. When in operation, never cover or position this equipment in such a way that its cooling air intake or outlet is blocked. This intake is located on the frontal lower portion of the equipment and remains unblocked when the equipment is properly mounted on its pedestal. The outlet is located on the equipment s rear panel, where there is the warning: AIR OUTPUT Do not obstruct. Figure 3-1 Rear panel detail Ventilation Output After positioning the equipment for operation, lock the pedestal casters, in order to prevent it from moving inadvertently Accessories When using other equipment along this ventilator (e.g. heated humidifier), check the instructions provided with them. recommends the use of the Misty3 heated humidifier, and the IM300 humidification jar along this equipment.

36 34 3. Equipment Set-Up 3.2. Environment Specifications Room Temperature Operation: +5 C to +40 C Transportation and Storage: -20 C to +70 C WARNING! The storage of the ventilator for extended periods under temperatures higher than 27 C, or without recharging the battery for periods longer than two months may reduce the battery service life Relative Humidity Operation: 15% to 95% without condensation Transportation and Storage: 10% to 95% without condensation Atmospheric Pressure Operation: 70kPa to 106kPa (0.7atm to 1.0atm) Transportation and Storage: 50kPa to 106kPa (0.5atm to 1.0atm) Código Review 001

37 3. Equipment Set-Up Connection to the Power Source The ventilator is capable of working by means of three different types of power sources: External AC-type power source (power mains) External DC-type power source (for example, external battery) Internal DC-type power source (internal battery) External AC (Alternating Current) Power Supply Connect the equipment plug to a power mains outlet according to the specifications mentioned under Chapter General Specifications of this manual. This equipment can be connected to AC power mains ranging from 100V to 240V. The operator does not have to activate any voltage switching key. CAUTION! Always use AC power mains with grounding pin connection. In case of doubts about the power mains grounding system integrity, run the equipment using its internal battery or an external battery. Never cut the grounding pin from the equipment plug, nor use adaptors when connecting the equipment to the AC power mains. Always plug it directly into the power External DC (Direct Current) Power Supply In order to use the equipment connected to an external DC-type power source, such as an external battery, use one of the optional power cords listed under Chapter Accessories, Parts and Pieces. One end of this cord shall be connected to the equipment rear panel, on the input port with the indication DC POWER INPUT, while the other end must be connected to a DC power source according to the specifications mentioned under Chapter General Specifications of this manual.

38 36 3. Equipment Set-Up Figure 3-2 Rear panel detail Connection for external battery or DC power supply WARNING! The does not charge its internal battery when connected to a DC power source. For maximum battery autonomy, connect the equipment to the AC power mains for up to 48 hours before using for at least 10 uninterrupted hours. After this period (48 hours), it is possible that a drop in the battery power level occurs depending on the battery s status of use Internal Power Supply The has an internal battery that enables its operation even when it is not connected to any external power source. If the external power source (AC or DC) to which the is connected presents any failure or disconnection, the ventilator will automatically switch to the internal battery, keeping all functionalities active. The automatically charges its internal battery whenever it is connected to an AC power source. Código Review 001

39 3. Equipment Set-Up 37 CAUTION! In case the Low Internal Battery alarm is activated, immediately connect the equipment to the power mains, to an external battery or to an external DC power source. Otherwise, the ventilator will generate a Vent Inop alarm and will be led to an inoperative condition. Check Chapter Alarms and Messages, in this manual for more information about the internal battery charge status indications. WARNING! The battery service life depends on the ventilator s use conditions (frequency and duration of ventilator and/or internal battery use, temperature and humidity room conditions, etc.). The storage of the ventilator for extended periods under temperatures higher than 27 C, or without recharging the battery for periods longer than two months may reduce the battery service life.

40 38 3. Equipment Set-Up 3.4. Connection to the Gas Pipeline Connect the compressed air and oxygen hoses supplied with the equipment to their corresponding inputs, located on the ventilator s rear panel. Connect the other end of each of these hoses to the corresponding gas source output. Figure 3-3 Connection of the air and oxygen hoses CAUTION! Use only medical grade gases (dry and contaminant-free) in order to avoid internal damages to the equipment and risks to the patient. The equipment features internal regulating valves that ensure its operation under pressures ranging from 250kPa (2.5kg/cm 2 ) and 600kPa (6.0kg/cm 2 ). Confirm if the gas sources are kept within this pressure range during the entire time the equipment is being used, and use external pressure regulating valves when required. If necessary, it is possible to use the with only one supply gas. In this case, however, it will not be possible to adjust the oxygen concentration (FiO 2 ). In other words, if the equipment is connected to one compressed air source only, the ventilation will only be performed with 21% oxygen; on the other hand, if it is connected to one oxygen source only, then the ventilation will only be performed with 100% oxygen. The colors of the supplied gas hoses follow the Brazilian standard (compressed air - yellow / oxygen - green). For countries following the Código Review 001

41 3. Equipment Set-Up 39 European color standard, hoses can be supplied in accordance with this standard (compressed air black and white / oxygen white). WARNING! At each gas intake there is a coalescent filter capable of retaining solid particles up to 0.3µm and liquid aerosols up to 0.75µm that are suspended in the gaseous mixture. These filters must be periodically inspected. Whenever required, drain the water condensed in the collection cup in order to prevent it from entering into the equipment, compromising its operation. At the compressed air intake, apart from the coalescent filter, there is a pre-filter, which can be seen on the ventilator lefthand side. Should accumulated liquid be noticed in the collection cup, perform the drainage by opening the pin located on the bottom of the cup. Upon turning the equipment off, disconnect it from the oxygen source in order to reduce the risk of accumulating this gas inside it in case of eventual leaks. Pneumatic supply sources (oxygen and compressed air) shall be capable of supplying a flow up to 50L/min at 350kPa. Figure 3-4 Gas intake filters Block and drain details

42 40 3. Equipment Set-Up 3.5. Patient Circuit Assembly Always use original accessories, parts and pieces in order to ensure the correct performance of this equipment and the validity of the warranty. In addition to that, this measure is also intended for the patient s and operator s safety. Never use anti-static or electrically conductive hoses or tubes along this ventilator. All components of the patient circuit supplied by (silicon tubes polysulfone connections, and polycarbonate and polysulfone flow sensors) are totally latex-free and comply with the biocompatibility standards, meeting the cytotoxicity, irritation, sensitivity and hemocompatibility requirements. CAUTION! Before the first use, clean and sterilize the components of the patient circuit, following the instructions shown in Chapter Cleaning, Disinfection and Sterilization of this manual. The frequency of exchange and sterilization of these circuits is defined by the protocols observed in each hospital. When accessories or other components are added to the patient circuit, system inspiratory resistance and expiratory resistance will be increased. The operator must ensure that they do not exceed the following values (measurements performed at the patient connection during spontaneous respiration and normal operation of the equipment): In neonatal use: In pediatric use: In adult use: 6cmH 2 O for 6L/min 6cmH 2 O for 30L/min 6cmH 2 O for 60L/min Código Review 001

43 3. Equipment Set-Up Selection of the Patient Circuit and Flow Sensor Select the patient circuit and the flow sensor based on the patient s weight and the ventilatory flow parameters to be used. Proximal sensors can be used, connected at the entrance of the endotracheal pipe (Neonatal, Pediatric and Pediatric / Adult Flow Sensor), or distal, connected at the entrance of the exhalation valve (Expiratory Flow Sensor). IBW Recommended Range Flow Sensor Patient Category Up to 3kg Neonatal Proximal Neonatal From 3.1 to 20kg Pediatric Proximal Pediatric From 21 to 40kg Pediatric/Adult Proximal Pediatric More than 40kg Pediatric/Adult Proximal Adult From 10 to 40kg Expiratory Pediatric More than 40kg Expiratory Adult WARNING! In case a humidification and/or bacteriological filter is used, it should be assembled between the proximal sensor and the patient connection in order to protect the sensor against exhalation-generated humidity Exhalation Valve Connection In order to ensure the perfect assembly of the diaphragm and of the exhalation valve, proceed according to the orientation label attached on the equipment s side panel. Turn the ventilator off or press the Standby Mode key. Carefully position the diaphragm on the Gas Return output, located on the equipment s side panel. Check whether the diaphragm has its embossed part facing outwards. Insert the exhalation valve perpendicularly, following the fitting position. Turn it slightly to the right, until locking it.

44 42 3. Equipment Set-Up Figure 3-5 Exhalation valve assembling and disassembling To disassemble the exhalation valve, press the button with the instruction Push to Unlock and turn the valve body to the left. WARNING! Handle the diaphragms carefully. Before assembling them, check whether they are intact, without any tears or punctures. WARNING! Do not use the exhalation valve exhaust port for spirometry or to gage the equipment. Due to the bias flow of the ventilator, the gas exhaust volume is greater than the actual tidal volume exhaled by the patient. Código Review 001

45 3. Equipment Set-Up Tubes Assembly Assemble the selected patient circuit tubes and connectors according to following figures. Figure 3-6 Pediatric/adult (A) and neonatal (B) patient circuit assembly (A) Pediatric / Adult (B) Neonatal Figure 3-7 Side panel connections: inspiratory branch (A), expiratory branch (B), and proximal line (C) (A) Inspiratory Branch (B) Expiratory Branch (C) Proximal Line

46 44 3. Equipment Set-Up CAUTION! When assembling the proximal line, make sure that there is no type of resistance or obstruction along its length. When assembling the circuit on the ventilator, make sure that there is no obstruction on the opening of the side panel with the indication Warning: Emergency Air Intake. Do not obstruct. This is the anti-asphyxia valve intake, which opens when the equipment is not operating (Vent Inop alarm), allowing the patient to breath spontaneously. Figure 3-8 Side panel detail anti-asphyxia valve intake Flow Sensor Connection Proximal Flow Sensors Assemble the flow sensor body on the Y part, taking care so that the pressure intakes are always facing upward. Código Review 001

47 3. Equipment Set-Up 45 Figure 3-9 Proximal flow sensors assembly: neonatal (A), pediatric (B) and pediatric / adult (C) (A) Neonatal (grey) (B) Pediatric (black) (C) Pediatric/Adult (blue) Connect the other end of the sensor to the equipment s side panel, observing the assembly sequence shown below: Figure 3-10 Proximal flow sensors assembly WARNING! When connecting the flow sensor, carefully observe the two pressure intake branches. Make sure that the branch identified by a colored line along the duct is facing the Y part. The other branch, with no identification along the duct, must be facing the patient connection. Never disconnect the measurement ducts of the flow sensor s body. If this happens, discard the component.

48 46 3. Equipment Set-Up WARNING! In case a humidification and/or bacteriological filter is used, it shall be assembled between the proximal sensor and the patient connection in order to protect the sensor against exhalation-generated humidity. Expiratory Flow Sensor Assemble the Expiratory Flow sensor on the exhalation valve. Connect the other sensor end to the equipment side panel, as shown on figure Figure 3-11 Expiratory flow sensor assembly Optional: Nebulization and TGI Connection Nebulization Install a standard nebulizer on the inspiratory branch of the patient circuit, connecting its end to the auxiliary output identified as Nebulizer/TGI, located on the equipment s side panel. TGI Insert a specific catheter for this type of maneuver into the patient connection, passing through the orifice of the L -shaped connection s silicon plug shown on figure Código Review 001

49 3. Equipment Set-Up 47 Insert the catheter through the endotracheal pipe and position it close to the carina, following the protocols recommended by the hospital. Connect the other end of this catheter to the auxiliary output identified as Nebulizer/TGI, located on the equipment s side panel. Figure 3-12 Assembling the TGI catheter onto the L connector L connector Assembly of the L connector onto the proximal sensor WARNING! In case a non-invasive ventilation (NIV) is being used, use the blind plug in order to prevent leaks from occurring.

50 48 3. Equipment Set-Up 3.6. System Configurations This menu, accessed through the Setup key located on the front panel, grants access to the system information and general configurations. System Information This submenu displays information about the hardware and software installed in the ventilator. Screen Brightness The screen brightness control enables the adjustment of display s luminosity, providing more comfort to the operator/patient in rooms with less luminosity. The sleep mode option enables a secondary luminosity adjustment, always inferior to the main adjustment, which becomes effective 20 seconds after the last action of the operator on the equipment screen. The ventilator automatically assumes the main luminosity level when any alarm occurs or when the operator touches any control. Loudspeaker Volume The loudspeaker volume control makes the configuration of the volume level of the sound alarm possible. This control does not allow the muting of the alarms. O2 Sensor The O2 sensor control enables to turn off the oxygen sensor in emergency situations in which the O2 Sensor Failure is active but the equipment cannot be readily shut down. When monitoring through the sensor is turned off, a symbol will be displayed where the FiO2 monitor should be in order to highlight its inactive status. For safety reasons, whenever the equipment is initiated, the monitoring through the sensor will be automatically switched back on. Código Review 001

51 3. Equipment Set-Up 49 CAUTION! Monitoring through Oxygen sensor should only be turned off temporarily. In case the O2 Sensor Failure alarm is displayed, shut down the ventilator and contact or - Authorized Technical Service as soon as possible.

52

53 4. Operation 51 4 Operation

54 52 4. Operation Código Review 001

55 4. Operation Turning the Equipment On Autotest Routine Actuate the On/Off switch, located on the equipment s rear panel. An autotest routine will be automatically initiated and, in case no failure is detected, the equipment will subsequently start operating. In case of any failure that prevents the equipment from operating safely is detected, it will be indicated on the front panel, and the equipment will not start operating until the failure is solved. NOTE When only one of the gas sources is being used, the autotest routine will indicate a failure to the inactive gas source, but it will not prevent the operation from starting. The person responsible will evaluate whether the situation represents a safe operational condition Patient Category Selection After the autotest routine, the ventilator will automatically switch to the patient selection screen. Since the is capable of storing all set parameters into memory even when it is turned off, it is possible to make the ventilator recover the configuration of the Last Patient. In case of a new patient, it is possible to choose between Neonatal, Pediatric and Adult. Then, it is also necessary to indicate the patient s IBW (Ideal Body Weight). The patient category is used by the ventilator to automatically adjust the control scale limits. When a ventilation mode change occurs, the ventilator will automatically assume safe values for critical parameters, based on the type of patient (Standard Value), waiting for readjustments and/or confirmation by the operator. When the parameters are set above the limits typically used (Safe Limits), the ventilator will show an alert warning. However, if the operator so desires, he/she can accept the value outside the recommended range.

56 54 4. Operation Scales Neonatal patient Pediatric patient Adult patient IBW 3 kg 3 < IBW 40 kg IBW > 40 kg Ventilation Mode Selection After selecting the patient category, the ventilator switches to the ventilation mode selection screen. The offers the following ventilation modes: Ventilation Modes VCV Volume-Controlled PCV Pressure-Controlled TCPLV Time Cycled with Pressure Limited and Continuous Flow NIV Non-Invasive Ventilation Assisted / Controlled SIMV / CPAP Assisted / Controlled SIMV / CPAP Assisted / Controlled SIMV / CPAP Assisted / Controlled SIMV / CPAP Controls Selection After selecting the ventilation mode, the ventilator automatically switches to the ventilation controls selection screen Alarm Selection After selecting the control parameters, the ventilator automatically switches to the alarm limit selection screen. Código Review 001

57 4. Operation Ventilation Modes Introduction The ventilation modes are organized into two groups: basic modes and control modes. The basic modes define which respiratory cycles are available during ventilation, while the control modes define how the cycles are effectively controlled Basic Modes The basic modes define which respiratory cycles are available during ventilation. There are three types of respiratory cycles during the mechanical ventilation: Controlled Cycles, Assisted Cycles and Spontaneous Cycles. Controlled Cycle It is started by the ventilator due to a programmed respiratory rate or due to an apnea period that activates the backup system (controlled cycle started by the ventilator after the set apnea time has elapsed). The controlled cycle follows the set ventilation parameters (volume, flow, inspiratory time, etc.), according to the selected control mode. Assisted Cycle It is started by the patient due to the set inspiratory sensitivity (sensitivity). The assisted cycle follows the same ventilation parameters (volume, flow, inspiratory time, etc.) set for the controlled cycles. Spontaneous Cycle It is started by the patient due to his/her inspiratory effort. The spontaneous cycles can be assisted, or not, by the support pressure (P Supp). The ventilation parameters depend on respiratory mechanics, on the level of the patient s inspiratory effort and, when used, the set support pressure.

58 56 4. Operation NOTE Spontaneous cycle without support pressure: It may occur when the patient s effort does not exceed the set sensitivity (Sensitivity) level. In this case, the ventilator increases the flow in the circuit in order to maintain the pressure in the airway at its baseline (PEEP). Spontaneous cycle with support pressure: It only occurs when the patient s effort is enough for reaching the set sensitivity (Sensitivity). When the patient s effort is detected, the ventilator increases the flow rate in the circuit in order to increase and maintain the pressure in the airway adjusted on the support pressure level (P Supp). The offers the following basic modes of ventilation: Assist/Control Assisted/Controlled Ventilation In this mode, the ventilation assistance is performed solely by means of mandatory cycles (controlled and/or assisted). Therefore, all respiratory cycles follow the set ventilation parameters according to the control mode in use (VCV, PCV, TCPLV or NIV). The respiratory rate of the cycles is established by the operator, by adjusting the Rate. If no inspiratory efforts are detected, the ventilator will maintain a sequence of controlled cycles, following the rate set in the equipment. Upon detecting a patient s inspiratory effort, the ventilator will trigger an assisted cycle. If the patient s efforts exceed the rate programmed in the equipment, additional assisted cycles will be activated according to the patient s rate. In this case, the total respiratory rate will be greater than the one established by the operator. Código Review 001

59 4. Operation 57 SIMV/CPAP Synchronized Intermittent Mandatory Ventilation/Continuous Positive Airway Pressure Ventilation In this mode, assisted and spontaneous controlled cycles are made available. The respiratory rate of the mandatory cycles (controlled and assisted) is established by the operator, by adjusting the Rate. If no inspiratory efforts are detected, the ventilator will send a sequence of controlled cycles, following the rate set in the equipment. Upon detecting a patient s inspiratory effort, the ventilator will trigger an assisted cycle. If the patient s efforts exceed the rate programmed in the equipment, spontaneous cycles will be activated according to the patient s rate. In this case, the total respiratory rate will be greater than the one established by the operator for mandatory cycles. Spontaneous cycles can be supplied solely by the ventilator s demand system (fully spontaneous cycles), or aided by the use of support pressure (P Supp) Control Modes Control modes define how respiratory cycles are effectively controlled and sent to the patient. The features the following control modes: VCV: PCV: NIV: TCPLV: Volume-Controlled Ventilation Pressure-Controlled Ventilation Non-Invasive Ventilation Continuous Flow, Time Cycled and Pressure Limited Ventilation

60 58 4. Operation 4.3. VCV Volume-Controlled Ventilation Description In this mode, the ventilator provides inspiratory flow set on control Insp Flow until the tidal volume set on the control Tidal Vol is reached, cycling to volume. The inspiratory pressure will depend on the set parameters (Insp Flow, Tidal Vol and PEEP) and on the patient s respiratory mechanics. The provides three waveforms (Waveform) of the inspiratory flow controlled on the VCV mode: Constant Flow ( ) Decreasing Flow ( ) Sinusoidal Flow ( ) NOTE In case of decreasing flow, the value set on Insp Flow will be the mean inspiratory flow of each cycle. In this case, the initial flow (peak) will be 50% greater than the set value, and the end flow, 50% lower. Therefore, an inspiratory time and an I:E ratio equivalent to a constant flow cycle will be maintained. In case of sinusoidal flow, the value set on Insp Flow will be the mean inspiratory flow of each cycle. In this case, the initial flow (peak) will be 56% greater than the set value. Therefore, an inspiratory time and an I:E ratio equivalent to a constant flow cycle will be maintained. NOTE The VCV mode is not enabled for neonatal patients. Código Review 001

61 4. Operation 59 On the SIMV VCV mode, spontaneous cycles are interspersed with mandatory cycles, which can be assisted by support pressure P Supp. Upon detecting the patient s effort, the ventilator helps the respiration of the patient, increasing the airway pressure until the set support pressure level P Supp. The resulting flow standard is decreasing and its amplitude depends on the patient s respiratory mechanics or the patient s effort. Cycles are finalized when the inspiratory flow falls to the set cycling flow value End Flow (EndFlow). On spontaneous cycles with support pressure, the volume delivered to the patient depends on the level of the support pressure, on the cycling flow and on the patient s effort and respiratory mechanics Adjustments VCV Assist/Control VCV SIMV %O 2 % O2 %O 2 % O2 Tidal Volume Tidal Vol Tidal Volume Tidal vol Inspiratory Flow Insp Flow Inspiratory Flow Insp Flow Respiratory Rate Rate Respiratory Rate Rate Positive End-Exp. Pressure PEEP Positive End-Exp. Pressure PEEP Support Pressure P Supp Flow Sensitivity Pressure Sensitivity Sens F Sens P Flow Sensitivity Pressure Sensitivity Sens F Sens P Flow Waveform Waveform Flow Waveform Waveform Inspiratory Pause Insp Pause Inspiratory Pause Insp Pause Rise Time Slope Rise Time Slope Cycling Flow (P Supp) EndFlow Sigh Sigh Sigh Sigh Nebulizer Neb Nebulizer Neb Tracheal Gas Insufflation TGI Tracheal Gas Insufflation TGI

62 60 4. Operation 4.4. PCV Pressure-Controlled Ventilation DESCRIPTION In this mode, the ventilator continuously controls the inspiratory flow in order to reach and maintain the pressure on the patient s airway on the value set by the operator on the P Contr control. The time during which such pressure will be maintained is set by the operator on the T Insp control. NOTE The pressure levels on the circuit (P Contr) are controlled through flow valves and are limited by the exhalation valve. The joint and simultaneous operation of the flow and exhalation valves allows the patient to exhale during the inspiratory phase of the controlled pressure cycles. That is, in any of the phases (with two different positive pressure levels PEEP or P Contr), if the patient makes an inspiratory effort, the ventilator will increase the flow in the airway, in order to meet his/her inspiratory demand; if the patient exceed an expiratory effort, the ventilator will relieve the pressure in the airway, maintaining it at its set level (PEEP or P Contr). This type of control is also referred to as BIPAP (Biphasic Positive Airway Pressure). NOTE The programming of extended inspiratory times (T Insp) and low respiratory rates (Rate) on the PCV SIMV mode constitutes the ventilation mode referred to as APRV (Airway Pressure Release Ventilation). During the respiratory cycles on the PCV, NIV and other modes, using the programmed Support Pressure, the ventilator supplies a demand flow (free flow) of up to 180 L/min. Código Review 001

63 4. Operation Adjustments PCV Assist/Control PCV SIMV/CPAP %O 2 % O2 %O 2 % O2 Controlled Pressure P Contr Controlled Pressure P Contr Inspiratory Time T Insp Inspiratory Time T Insp Respiratory Rate Rate Respiratory Rate Rate Positive End-Exp. Pressure PEEP Positive End-Exp. Pressure PEEP Support Pressure P Supp Flow Sensitivity Pressure Sensitivity Sens F Sens P Flow Sensitivity Pressure Sensitivity Sens F Sens P Rise Time Slope Cycling Flow (P Supp) EndFlow Sigh Sigh Sigh Sigh Nebulizer Neb Nebulizer Neb Tracheal Gas Insufflation TGI Tracheal Gas Insufflation TGI

64 62 4. Operation 4.5. NIV Non-Invasive Ventilation Description Mode intended to non-invasive ventilation by means of masks. In this mode, the ventilator controls the airway pressure, alternating it between two operator-set levels: inspiratory pressure (P Insp) and expiratory pressure (PEEP). The transition from the inspiratory phase to the expiratory phase will be based on the inspiratory time set by the operator on the T Insp control. NOTE On both pressure levels, the joint and simultaneous operation of the flow and exhalation valves allows the patient to breath spontaneously. That is, in any of the phases, if the patient makes an inspiratory effort that does not exceed the sensitivity set on Sensitivity, the ventilator will increase the flow in the airway in order to meet his/her inspiratory demand, if the patient makes an expiratory effort, the ventilator will relieve the pressure in the airway, maintaining it at its set level (PEEP or P Insp). This type of control is also referred to as BIPAP (Biphasic Positive Airway Pressure). In this mode, leakages are automatically compensated both on ventilation and on monitoring. Additionally, the alarm adjustment ranges are suitable for noninvasive ventilation. NOTE On NIV mode, unlike the other modes, the set inspiratory pressure (P Insp) value is absolute. That is, the set value is not added to the expiratory pressure value (PEEP). Código Review 001

65 4. Operation 63 NOTE The programming of extended inspiratory times (T Insp) and low respiratory rates (Rate) on the PCV SIMV mode constitutes the ventilation mode referred to as APRV (Airway Pressure Release Ventilation). During the respiratory cycles on the PCV, NIV and other modes using the programmed Support Pressure, the ventilator supplies a demand flow (free flow) of up to 180 L/min. WARNING! When ventilating in the NIV mode, do not use masks with leak holes or built-in PEEP valves Adjustments NIV Assist/Control NIV SIMV %O 2 % O2 %O 2 % O2 Inspiratory Pressure P Insp Inspiratory Pressure P Insp Inspiratory Time T Insp Inspiratory Time T Insp Respiratory Rate Rate Respiratory Rate Rate Positive End-Exp. Pressure PEEP Positive End-Exp. Pressure PEEP Support Pressure P Supp Flow Sensitivity Pressure Sensitivity Sens F Sens P Flow Sensitivity Pressure Sensitivity Sens F Sens P Rise Time Slope Rise Time Slope Cycling Flow (P Supp) EndFlow Sigh Sigh Sigh Sigh Nebulizer Neb Nebulizer Neb

66 64 4. Operation 4.6. TCPLV Continuous Flow, Time Cycled and Pressure Limited Ventilation Description This mode is particularly indicated for the ventilation of neonatal and pediatric patients. In this mode, during the mandatory cycles, the ventilator maintains a constant flow in the airway, and the exhalation valve controls the expiratory pressure (PEEP) and the inspiratory pressure limit P Limit. In this mode, during the mandatory cycles, the pressure in the airway is simply limited, and not controlled. Depending on the values set to inspiratory flow Insp Flow and inspiratory time T Insp, and the patient s respiratory mechanics, it is possible that the pressure in the airway does not reach the intended inspiratory pressure value. The set flow Insp Flow must be enough to meet the patient s demand. The volume resulting from these adjustments may reach values around 5mL for infant patients. When the SIMV TCPLV mode is used, the spontaneous cycles can be assisted by the support pressure (P Supp). In this case, during the spontaneous cycles, the ventilator can increase the inspiratory flow beyond the set Insp Flow, in order to maintain the support pressure and meet the patient s demand. Código Review 001

67 4. Operation Adjustments TCPLV Assist/Control TCPLV SIMV %O 2 % O2 %O 2 % O2 Inspiratory Flow Insp Flow Inspiratory Flow Insp Flow Inspiratory Time T Insp Inspiratory Time T Insp Respiratory Rate Rate Respiratory Rate Rate Positive End-Exp. Pressure PEEP Positive End-Exp. Pressure PEEP Pressure Limit P Limit Pressure Limit P Limit Support Pressure P Supp Flow Sensitivity Pressure Sensitivity Sens F Sens P Flow Sensitivity Pressure Sensitivity Sens F Sens P Rise Time Slope Cycling Flow (P Supp) EndFlow Nebulizer Neb Nebulizer Neb Tracheal Gas Insufflation TGI Tracheal Gas Insufflation TGI

68

69 5. Ventilation Features 67 5 VENTILATION FEATURES

70 68 5. Ventilation Features Código Review 001

71 5. Ventilation Features CONTROLS % O2 Oxygen Concentration (%) This control enables the adjustment of the percentage of oxygen in the air/oxygen mixture sent to the patient on each cycle (FiO 2 ). Scale All patients 21% to 100% Standard value 21% Vol Contr Controlled Volume (ml) This control enables the adjustment of the tidal volume during the mandatory cycles (controlled and assisted) on the VCV modes. Scales Neonatal patient Pediatric patient Safe limits Standard value Adult patient Safe limits Standard value (not enabled) 10 to 500 ml 50 to 350 ml 200 ml 100 to 2000 ml 250 to 750 ml 500 ml NOTE The volume supplied to the patient is corrected to compensate the complacence of the respiratory circuit, the gas composition (FiO 2 and humidity) and the body temperature (BTPS). The tidal volume supplied on pressure-based ventilation modes depends both on the applied inspiratory pressure and on the lung mechanics. On infant application, this volume can be as low as 5mL, unlike the VCV modes, where the smallest adjustable tidal volume is 10mL.

72 70 5. Ventilation Features P Contr Controlled Pressure (cmh2o) This control enables the adjustment of the Controlled Pressure value superposed to PEEP, applied to the mandatory cycles on the PCV modes. For example: for a P Contr set to 20 cmh 2 O with a PEEP of 5 cmh 2 O, the final inspiratory pressure value in the airway will be 25 cmh 2 O. The Controlled Pressure is actively maintained by the simultaneous control of the flow valves and the exhalation valve during the entire respiratory cycle. The flow is automatically set to meet the patient s demand and/or compensate leakages while the pressure is relieved whenever the patient makes an expiratory effort. The pressure s rise time, from PEEP to (PEEP + P Contr) will depend on Slope rise adjustment. Scale All patients 5 to 80 cmh 2 O Safe limits Standard value 10 to (35 - PEEP) cmh 2 O 15 cmh 2 O NOTE On the PCV mode, the controlled pressure value P Contr is added to the PEEP value. Insp Flow Inspiratory Flow (L/min) This control enables the adjustment of the inspiratory flow on VCV and TCPLV modes. Besides amplitude, the VCV mode enables the selection of three different waveforms: Constant flow ( ) The value of the set flow is kept constant throughout the entire inspiratory time. Decreasing flow ( ) The initial flow (Insp Peak Flow) will be 50% greater than the set value, while the end of cycle flow will be 50% lower than the value set on Insp Flow. Therefore, the inspiratory time and the I:E ratio will be maintained equivalent to those of a constant flow cycle at a lower airway pressure. Código Review 001

73 5. Ventilation Features 71 Sinusoidal flow ( ) The initial flow (Insp Peak Flow) will be 56% greater than the set value, in order to maintain the inspiratory time and the I:E ratio equivalent to those of a constant flow cycle. Scales Neonatal patient Safe limits Standard value Pediatric patient Safe limits Standard value Adult patient Safe limits Standard value 2 L/min to 30 L/min 4 to 15 L/min 6 L/min 2 L/min to 50 L/min 10 to 30 L/min 20 L/min 2 L/min to 120 L/min 30 to 80 L/min 30 L/min T Insp Inspiratory Time (s) This control enables the adjustment of the inspiratory time on PCV, TCPLV and NIV modes. Scales Neonatal patient Safe limits Standard value Pediatric patient Safe limits Standard value Adult patient Safe limits Standard value 0.10 a 15.0 s 0.25 to 1.00 s 0.5 s 0.10 to 15.0 s 0.50 to 5.00 s on NIV mode 0.50 to 2.00 s 0.75 s 0.10 to 15.0 s 0.5 to 5.00 s on NIV mode 0.75 to 3.00 s 1.00 s

74 72 5. Ventilation Features Rate Respiratory Controlled Rate (/min) This control enables adjustment of rate of the controlled cycles supplied by the ventilator. Scales Neonatal patient Safe limits Standard value Pediatric patient Safe limits Standard value Adult patient Safe limits Standard value 0 to 180 /min 20 to 60 /min 30 /min 0 to 180 /min 0 to 40 /min on NIV mode 10 to 40 /min 20 /min 0 to 180 /min 0 to 40 /min on NIV mode 6 to 30 /min 12 /min PEEP Positive End-Expiratory Pressure (cmh2o) This control enables the adjustment of the expiratory pressure level on all modes. The PEEP expiratory pressure is actively maintained by simultaneously controlling the flow valves and the exhalation valve. The flow is automatically set to meet the patient s demand and/or compensate leakages, maintaining the functional residual capacity while the pressure is relieved whenever the patient makes an expiratory effort. Scales Neonatal patient Pediatric and adult patients Safe limits Standard value 0 to 50 cmh 2 O 0 to 50 cmh 2 O 0 to 20 cmh 2 O on NIV mode 5 to 15 cmh 2 O 5 cmh 2 O NOTE On the PCV mode, the controlled pressure value P Contr is added to the PEEP value. Código Review 001

75 5. Ventilation Features 73 CAUTION! Whenever you are about to change the PEEP, check the set value on High Pressure alarm. In case PEEP is set close to or above the set alarm value, there may be some limitation of ventilation, since the detection of High Pressure alarm cause immediate halt of current cycle. P Limit Pressure Limit (cmh2o) On the TCPLV mode, the inspiratory pressure limit P Limit acts on the mandatory cycles and also on the spontaneous ones with support pressure. In the NIV mode, there is a virtual limit of 40 cmh 2 O, which prevents combinations of pressure adjustments above this value. On VCV and PCV modes, this virtual limit is 120 cmh 2 O. Scale Neonatal and pediatric patients Safe limits Standard value 5 to 80 cmh 2 O 10 to 35 cmh 2 O 20 cmh 2 O 40 cmh 2 O on NIV mode (non-adjustable) 120 cmh 2 O on VCV and PCV modes (nonadjustable) NOTE The minimum possible P Limit adjustment will be within 5 cmh2o above the set expiratory pressure (PEEP). P Supp Support Pressure (cmh2o) This control enables the adjustment of the support pressure, superposed to PEEP, on the spontaneous cycles on the SIMV/CPAP mode. When the patient s effort is detected, the ventilator accelerates the inspiratory flow, increasing the pressure in the airway up to the resulting inspiratory pressure value (PEEP + P Supp). For example: for a Support Pressure set to 20 cmh 2 O with a PEEP of 5 cmh 2 O, the final inspiratory pressure value in the airway will be 25 cmh 2 O.

76 74 5. Ventilation Features The ventilator will finish the cycle when the inspiratory flow reaches the cycling flow value set on the EndFlow control. The pressure rise time, from PEEP to (PEEP + P Supp) will depend on the Slope rise time adjustment. Scales Neonatal patient Pediatric and adult patients Safe limits Standard value Off, 5 to 80 cmh 2 O Off, 5 to 80 cmh 2 O Off, 5 to 40 cmh 2 O on NIV mode 10 to (35 - PEEP) cmh 2 O 15 cmh 2 O NOTE On spontaneous cycles with support pressure, the pressure support P Supp value is added to the PEEP value. NOTE During the respiratory cycles on PCV, NIV and other modes using the programmed P Supp, the ventilator supplies a demand flow (free flow) of up to 180 L/min. EndFlow Support Pressure End Flow (%) This control enables the adjustment of the expiratory sensitivity of the spontaneous cycles with support pressure, using the end per flow criterion. The cut flow set value represents the percentage of the peak of the inspiratory flow (Insp Peak Flow) obtained at the beginning of the inspiration, and it will influence the duration of the inspiratory time. The smaller the cut flow, the greater the inspiratory time, and vice-versa. Scale All patients 10% to 75% Standard value 25% Código Review 001

77 5. Ventilation Features 75 NOTE 10%: longer cycle; 75%: shorter cycle. A greater cut flow value can help patients with higher airway resistance, avoiding an excessive inspiratory time increase. P Insp Inspiratory Pressure (cmh2o) This control enables the adjustment of the Inspiratory Pressure value on the NIV mode. The volume inhaled by the patient will be function of the difference between the P Insp Inspiratory Pressure set value and the PEEP. For example: for a P Insp set to 20 cmh 2 O with a PEEP of 5 cmh 2 O, the pressure that will move the tidal volume to the patient will be (20-5) = 15cmH 2 O. The Inspiratory Pressure is actively maintained by simultaneously controlling the flow valves and the exhalation valve during the entire respiratory cycle. The flow is automatically set to meet the patient s demand and/or compensate leakages, while the pressure is relieved whenever the patient makes an expiratory effort. Scales Neonatal patient Pediatric and adult patients Safe limits Standard value (not enabled) 5 to 40 cmh 2 O 10 to 35 cmh 2 O 15 cmh 2 O Slope Pressure Rise Slope (%) This control enables the adjustment of the slope of the pressure curve. The adjustment is valid for the tidal cycle pressure, whether it is P Contr, P Supp or P Insp. The slope of the curve is associated with the inspiratory flow: the higher the slope, the higher the flow, and vice-versa. Scale All patients 25% (slow) to 100% (fast) Standard value 70%

78 76 5. Ventilation Features NOTE 100% Slope: faster; 25% Slope: slower. A smaller slope can help patients with higher airway resistance, avoiding pressure oscillations. A higher slope can benefit patients presenting higher inspiratory effort. Sensitivity (cmh2o or L/min) This control enables the adjustment of the patient s inspiratory effort level required to start the assisted or spontaneous cycles. The provides the possibility of using the pressure sensitivity (Sens P) or flow sensitivity (Sens F). Only one of the sensitivity types can remain active; therefore, the Sens P adjustment automatically turns the Sens F off, and vice-versa. Scales Pressure sensitivity (Sens P) Neonatal patient Safe limits Standard value Pediatric and adult patients Safe limits Standard value 0.3 cmh 2 O to 10 cmh 2 O; Off < 5 cmh 2 O 1.0 cmh 2 O 0.5 cmh 2 O to 10 cmh 2 O; Off < 5 cmh 2 O 1.0 cmh 2 O Flow sensitivity (Sens F) Neonatal patient Standard value Pediatric patient Safe limits Standard value Adult patient Safe limits Standard value 0.2 L/min to 2 L/min; Off Off 0.5 L/min to 5 L/min; Off < 3 L/min Off 2 L/min to 15 L/min; Off < 10 L/min Off Código Review 001

79 5. Ventilation Features 77 NOTE Whenever the patient s effort reaches the set sensitivity level, the Patient Effort indicator will be displayed on the ventilator screen. WARNING! The improper pressure sensitivity (Sens P) or flow sensitivity (Sens F) adjustment may result in the autocycling of the equipment due to the occurrence of false-positive alarms or due to not detecting the patient s real efforts. WARNING! The does not allow the simultaneous adjustment of Sens P and Sens F. The adjustment of a value in any of the sensibilities (Sens F or Sens P) will automatically turn the other off (respectively, Sens P or Sens F) once it has been confirmed. Sigh (%) This control enables sending mandatory cycles with the sigh function. Sigh is characterized by the elevation of the tidal volume through the increase of the controlled volume or the controlled pressure, depending on the ventilation mode used. NOTE The Sigh function is available only on the VCV, PCV and NIV modes. Scales %Sigh Pediatric and adult patients 50% Sigh Ratio Pediatric and adult patients 1:100

80 78 5. Ventilation Features Nebulizer (L/min) This feature enables an auxiliary flow for nebulization, which shall be connected to a standard nebulizer, positioned on the inspiratory branch of the patient circuit. The nebulization flow is compensated in order to maintain the previously set oxygen volume and concentration values constant. NOTE In the VCV mode, the ventilator maintains the set tidal volume constant, automatically discounting the nebulization volume on every cycle. In the other modes, the nebulization volume is not automatically discounted. Scales Nebulization Period All patients 30 min Nebulization Flow Neonatal patient Pediatric patient Adult patient 3 L/min 6 L/min 6 L/min TGI Tracheal Gas Insufflation (L/min) This feature promotes the flushing of CO 2 retained in the airways during the exhalation, through a flow synchronized with the expiratory phase. This flow should be connected to a catheter designed for this kind of maneuver, positioned on the patient s carina. NOTE The delay in the activation of the TGI flow (TGI Delay) is intended to avoid the counterflow of gases exhaled by the patient, increasing the flushing efficiency and minimizing the risk of auto-peep occurring. Código Review 001

81 5. Ventilation Features 79 Scale TGI Delay All patients 300 ms TGI Flow Neonatal patient Pediatric patient Adult patient 3 L/min 6 L/min 6 L/min Insp Pause Inspiratory Pause (s) This control enables the activation of an inspiratory pause in the controlled and assisted cycles on the VCV mode, according to the set pause time (Insp Pause). Scale Neonatal patient Pediatric and adult patients Standard value (not enabled) 0.0 to 2.0 s 0.0 s NOTE During the inspiratory pause, in the absence of flow, the equalization between the alveolar pressure and the airway pressure occurs, monitored on the manometer. Therefore, it is possible, during the inspiratory pause, to directly check on the ventilator manometer, or on the graphic or digital display, the Plateau Pressure value (alveolar pressure at the end of inhalation, elastic pressure of the lung, plateau pressure).

82 80 5. Ventilation Features 5.2. COMPLEMENTARY FEATURES Standby Mode (Standby) This key, located on the front panel, puts the ventilator on standby mode, in other words: The ventilator suspends the operation, interrupting the ventilation functions, monitoring and alarms, except the trend curves. The operator can proceed to adjust all control and alarm parameters; The operator can access all information stored in the ventilator s memory (trend curves). To start the programmed ventilation, the operator must press the Standby Mode key again, or the Start Ventilation button on the screen. When the Standby Mode key is pressed after an oxygenation period, activated by the 100% O 2 key, an aspiration sequence is started. This sequence is described ahead, under the 100% O 2 control. The activation of this function is indicated by the corresponding LED signal. 100% O2 Oxygenation/Aspiration Maneuver This key, located on the front panel, starts a sequence of adjustments suitable to the oxygenation routine in order to help in the aspiration of patient s secretions: Phase I Pre-Oxygenation 100% O 2 (LEDs: 100% O 2 lit, Standby Mode off): The actuation of the 100% O 2 key starts the oxygenation process, adjusting the oxygen concentration of the mixture inhaled to 100% for 3 minutes. If the key is pressed again within 1 minute, the maneuver will be interrupted, immediately returning to the previously set oxygen concentration value. After 3 minutes, if the Standby Mode key is not pressed, then Phase IV is started with the oxygen concentration returning to the previously set value at a rate of 20% per minute. Phase II Aspiration Standby Mode (LEDs: 100% O 2 lit, Standby Mode lit): After actuating the Standby Mode key during Phase I sequence, the operator can disconnect the patient from the ventilator and start the aspiration procedures while the ventilator is kept on Standby Mode for up to 3 minutes. The operator can reconnect the patient and resume ventilation at any moment by pressing the Standby Mode key or the Start Ventilation button again. In case the Standby Mode key or the Start Ventilation button has not Código Review 001

83 5. Ventilation Features 81 been pressed after 3 minutes, a visual and audible signal is activated every 60sec, warning the operator to reconnect the patient to the ventilator and resume ventilation. Phase III Post-Oxygenation 100% O 2 (LEDs: 100% O 2 lit, Standby Mode off): After reconnecting the patient and actuating the Standby Mode key or the Start Ventilation button, the ventilator will maintain the oxygen concentration at 100% for 3 more minutes, or until the 100% O 2 key is pressed again, returning to the previously set oxygen concentration value at the rate of 20% per minute (Phase IV). Phase IV Weaning (LEDs: 100% O 2 flashing, Standby Mode off) The return from the 100% oxygen condition to the previously set concentration is performed gradually, at a rate of approximately 20% of O 2 per minute. Manual Insp Manual Cycle This key, located on the front panel, starts a controlled cycle on the selected mode. The ventilator ignores this command if the key is pressed during the inspiratory phase or during the initial period of 300ms of the expiratory phase. Manual Exp Pause Manual Expiratory Pause This key, located on the front panel, enables the actuation of a pause at the end of the expiratory phase of the respiratory cycle. The key can be activated at any moment, and the pause will only be activated at the end of the next exhalation. In order to make the detection of the pause easier, the indicating LED remains flashing from the moment the key is pushed until the start of the pause, remaining lit during the entire time of the pause. The pause can be activated either by a momentary or continuous touch: Momentary touch: an automatic pause will be activated at the end of the next exhalation, with a fixed duration of 200ms. Continuous actuation: while the operator keeps the key pressed, the pause will be maintained for a maximum time of 15s.

84 82 5. Ventilation Features NOTE The actuation of the expiratory pause allows the measuring of the Auto PEEP or the Occlusion Pressure P0.1 (measured 100ms after the pause start). For further information about these parameters, see the Chapter Monitoring Features of this Manual. Manual Insp Pause Manual Inspiratory Pause This key, located on the front panel, allows the actuation of a pause at the end of the inspiratory phase of the respiratory cycle. The key can be activated at any moment, and the pause will be only activated at the end of the next inspiration. In order to make the detection of the pause easier, the LED indicator remains flashing from the moment the key is pressed until the pause starts, remaining lit during the entire pause time. The pause can be activated either by a momentary or a continuous touch: Momentary touch: an automatic pause will be activated at the end of the next inhalation, with a fixed duration of 200ms. Continuous actuation: while the operator keeps the key pressed, the pause will be maintained for a maximum time of 15s. NOTE During the inspiratory pause, in the absence of flow, the equalization between the alveolar pressure and the airway pressure occurs, monitored on the manometer. Therefore, it is possible, during the expiratory pause, to directly check on the ventilator manometer, or on the graphic or digital display, the Plateau Pressure value (alveolar pressure at the end of inhalation, lung elastic pressure, plateau pressure). For more information about the monitoring of Plateau Pressure, check Chapter Monitoring Features, in this Manual. Código Review 001

85 5. Ventilation Features 83 Panel Lock Panel Lock This key, located on the front panel, allows the locking of the control panel, avoiding the non-intentional actuation of equipment functions. Only the Panel Lock key remains enabled and this is the only way of disabling this function. Audio Pause/Alarm Reset Inhibition of alarm audio and Clearing of inactive alarms This key, located on the front panel, inhibits the audible indication of active alarms for 120 seconds; it can be reactivated in case the key is pressed again within this period. This key also works as an alarm system reset, clearing the visual alarm indicators whose generating causes have already ceased. The activation of this function is indicated by the corresponding LED. NOTE The Audio Pause/Alarm Reset key does not prevent the sound activation when a new alarm generating condition occurs.

86 84 5. Ventilation Features Código Review 001

87 6. Alarms and Messages 85 6 Alarms and Messages

88 86 6. Alarms and Messages Código Review 001

89 6. Alarms and Messages Alarms Introduction The features low, medium and high priority visual and sound alarms, classified according to the urgency required for the action to be taken by the operator. Low Priority Alarm It requires a brief response from the operator. Its visual indication is in a continuous blue color and it has an associated audible indication (beep). Medium priority alarm It requires a fast response from the operator. Its visual indication is in a flashing yellow color, associated with an audible indication of 3 beeps every 25 seconds. High priority alarm It requires an immediate response from the operator. Its visual indication is in a flashing red color, associated with an audible indication of 3+2 beeps every 10 seconds. Priority High Medium Low Operator s Response Immediate Fast Brief Situation Emergency Abnormal Status Change Visual Indication Red Yellow Blue Audible Indication _ Every 10s _ Every 25s Every 60s

90 88 6. Alarms and Messages Alarm status An alarm is considered active when the condition that has generated it remains present in the system. This alarm is indicated by an audible and visual signal (Master Alarm and flashing message on the upper area of the screen). When the condition that has originated an alarm ceases to exist, it goes to the persistent status, characterized by a visual sign only (non-flashing message on the upper area of the screen). NOTE The messages with higher priority are displayed in an alternating way, according to the following list: High priority active alarms Medium priority active alarms Low priority active alarms High priority persistent alarms Medium priority persistent alarms Low priority persistent alarms When there are no items from a higher order, the next order items will be alternated until there are no messages. NOTE A numerical indicator displaying the total number of existing alarms is shown on the right-hand side of the message area whenever there is more than one simultaneous occurrence. Upon touching the screen on the visible alarm message or on the message counter, a list of active and persistent alarms will be displayed, which will be automatically closed after 5 seconds or with a new touch on the list. Audio Pause / Alarm Reset (Inhibition of alarm audio and clearing of inactive alarms) This key, located on the front panel, inhibits the audible indication of active alarms for 120 seconds; it can be reactivated in case the key is pressed again within this period. The lighting of the yellow-colored LED indicates that the audio is temporarily inhibited. Código Review 001

91 6. Alarms and Messages 89 This key also works as an alarm system reset, clearing the visual alarm indicators whose generating causes have already ceased. NOTE The Audio Pause / Alarm Reset key does not prevent alarm activation when a new alarm generating condition occurs Ventilation Alarms NOTE The adjustment ranges for each of the ventilation alarms may vary, depending on the type of patient chosen (neonatal, pediatric or adult) and the ventilation mode applied (invasive or non-invasive ventilation). Auto Set (Automatic alarm setting) This feature suggests values for the alarm limits to make the adjustment easier. The limits suggested by the ventilator depend on the type of patient chosen, as well as on the monitoring and control setting conditions during ventilation. To automatically adjust the alarms, the operator shall press the Auto Set key, check the values suggested for each alarm and confirm each of these values individually. Alarm and Event Log Screen The stores a log of all alarm occurrences and events occurred during the last 72 hours. Each register features the date, time, type and identification.

92 90 6. Alarms and Messages The list of events can be filtered to display alarms only, events only or both types of occurrences Adjustable Alarms Low Inspiratory Pressure Parameter: Low Pressure (cmh 2 O) High Priority This alarm defines the minimum airway pressure limit that must be reached during the inspiratory phase of the controlled and/or assisted and spontaneous cycles with support pressure greater than 5 cmh 2 O. Scales Neonatal patient 3 to 70 cmh 2 O Safe limits > (PEEP + 5) cmh 2 O Initial auto-set (PEEP + 10) cmh 2 O Ventilation auto-set (Peak - 5) cmh 2 O Pediatric and adult patient Safe limits Initial auto-set Ventilation auto-set 3 to 70 cmh 2 O 3 to 40 cmh 2 O on NIV mode > (PEEP + 5) cmh 2 O (PEEP + 10) cmh 2 O (Peak - 5) cmh 2 O High Inspiratory Pressure Parameter: High Pressure (cmh 2 O) High Priority This alarm defines the maximum airway pressure limit during the inspiratory phase of controlled, assisted and spontaneous cycles. If, during the inspiratory phase, the pressure limit established by the alarm is reached, the ventilator will immediately interrupt the cycle and return to the set expiratory pressure (PEEP) value. Código Review 001

93 6. Alarms and Messages 91 Scales Neonatal patient 10 to 120 cmh 2 O Safe limits (PEEP + 10) to 40 cmh 2 O Initial auto-set 30 cmh 2 O Ventilation auto-set (Peak + 5) cmh 2 O Pediatric and adult patient Safe limits Initial auto-set Ventilation auto-set 10 to 120 cmh2o 5 to 40 cmh2o on NIV mode (PEEP + 10) to 40 cmh 2 O (PEEP + 10) to 30 cmh 2 O on NIV mode 30 cmh 2 O (Peak + 5) cmh 2 O Low Minute Volume Parameter: Low Minute Vol (L) Medium Priority This alarm defines the minimum exhaled minute volume limit, considering mandatory and spontaneous cycles. Scales Neonatal patient Off; 0.01 to 2.0 L Safe limits Initial auto-set Ventilation auto-set > 0.1 L 0.2 L 40% < Minute Vol Pediatric patient Safe limits Initial auto-set Ventilation auto-set Adult patient Safe limits Initial auto-set Ventilation auto-set Off; 0.10 to 20.0 L > 0.5 L 1 L Off on NIV mode 40% < Minute Vol Off on NIV mode Off; 1.0 to 40.0 L > 2.5 L 5 L Off on NIV mode 40% < Minute Vol Off on NIV mode

94 92 6. Alarms and Messages High Minute Volume Parameter: High Vol Min (L) Medium Priority This alarm defines the maximum exhaled minute volume limit, considering mandatory and spontaneous cycles. Scales Neonatal patient 0.01 to 3.0 L; Off Initial auto-set Ventilation auto-set 1 L 40% > Minute Vol Pediatric patient Initial auto-set Ventilation auto-set Adult patient Initial auto-set Ventilation auto-set 0.10 to 30.0 L; Off 4 L Off on NIV mode 40% > Minute Vol Off on NIV mode 1.0 to 60.0 L; Off 10 L Off on NIV mode 40% > Minute Vol Off on NIV mode Low Tidal Volume (Low Exhaled Tidal Volume) Parameter: Low Tidal Vol (ml) Medium Priority This alarm defines the minimum exhaled tidal volume limit on mandatory cycles. It is activated after three consecutive mandatory cycles whose monitored exhaled tidal volume is smaller than the limit set on the alarm. Código Review 001

95 6. Alarms and Messages 93 Scales Neonatal patient Off; 1 to 50 ml Safe limits > 10 ml Initial auto-set Off Ventilation auto-set 50% < Tidal Vol Pediatric patient Safe limits Initial auto-set Ventilation auto-set Adult patient Safe limits Initial auto-set Ventilation auto-set Off; 10 to 500 ml > 50 ml Off 50% < Tidal Vol Off on NIV mode Off; 100 to 2000 ml > 200 ml Off 50% < Tidal Vol Off on NIV mode High Tidal Volume (High Exhaled Tidal Volume) Parameter: High Tidal Vol (ml) Medium Priority This alarm defines the maximum exhaled tidal volume limit on mandatory and spontaneous cycles.

96 94 6. Alarms and Messages Scales Neonatal patient 1 to 50 ml; Off Safe limits < 35 ml Initial auto-set Off Ventilation auto-set 50% > Tidal Vol Pediatric patient Safe limits Initial auto-set Ventilation auto-set Adult patient Safe limits Initial auto-set Ventilation auto-set 10 to 500 ml; Off < 350 ml Off 50% > Tidal Vol Off on NIV mode 100 to 2000 ml; Off < 1000 ml Off 50% > Tidal Vol Off on NIV mode Apnea Parameter: Apnea (s) Medium / High Priority This alarm is active on all ventilation modes and defines the maximum apnea limit (period without patient s inspiratory effort). In the event of apnea, the ventilator sends a backup cycle according to the parameters set by the user for mandatory cycles. This alarm starts with Medium Priority and evolves to High Priority in the event of three consecutive apnea periods. Scales All patients 3 to 60 seconds; Off Safe limits Initial auto-set Ventilation auto-set < 15 seconds Off T Exp + 5 seconds NOTE If the alarm is turned off and an apnea period greater than 15 seconds occurs, it will be turned on. In this case, a backup cycle will not be sent. Código Review 001

97 6. Alarms and Messages 95 Low Respiratory Rate Parameter: Low Rate (/min) Medium Priority This alarm defines the minimum respiratory rate limit, considering mandatory and spontaneous respiratory cycles. Scales Neonatal patient Off; 4 to 120 /min Safe limits Initial auto-set Ventilation auto-set > 15 /min 25 /min 30% < Resp Rate Pediatric patient Safe limits Initial auto-set Ventilation auto-set Adult patient Safe limits Initial auto-set Ventilation auto-set Off; 4 to 120 /min > 10 /min 15 /min 30% < Resp Rate Off; 4 to 120 /min > 5 /min 5 /min 30% < Resp rate High Respiratory Rate Parameter: High Rate (/min) Medium Priority This alarm defines the maximum respiratory rate limit, considering mandatory and spontaneous respiratory cycles.

98 96 6. Alarms and Messages Scales Neonatal patient 4 to 180 /min; Off Safe limits < 60 /min Initial auto-set 50 /min Ventilation auto-set 30% > Resp rate Pediatric patient Safe limits Initial auto-set Ventilation auto-set Adult patient Safe limits Initial auto-set Ventilation auto-set 4 to 180 /min; Off < 45 /min 30 /min 30% > Resp rate 4 to 180 /min; Off < 30 /min 20 /min 30% > Resp rate Low FiO2 Parameter: Low FiO2 (%) Medium Priority / High Priority This alarm defines the minimum oxygen concentration (FiO 2 ) limit measured in the gas mixture supplied to the patient. It is activated whenever the measured concentration (FiO 2 ) is below the alarm set value. Scales All patients Off; 19% to 100% Safe limits > % O2 5 Initial auto-set 19% Ventilation auto-set FiO2 5 NOTE The FiO2 Low alarm evolves to High Priority when the measured concentration value is lower than or equal to 18%. This alarm cannot be turned off. Código Review 001

99 6. Alarms and Messages 97 High FiO2 Parameter: High FiO2 (%) Medium Priority This alarm defines the maximum oxygen concentration (FiO 2 ) limit measured in the air/oxygen mixture supplied to the patient. It is activated whenever the measured concentration (FiO 2 ) is above the alarm set value. Scales All patients 19% to 100%; Off Safe limits < % O2 + 5 Initial auto-set 26% Ventilation auto-set FiO Auto-adjustable Alarms Low PEEP Medium Priority This alarm defines the minimum expiratory pressure (PEEP) limit measured in the airways. It is automatically adjusted based on the value selected on the PEEP control, and it is activated in case the difference between the airway pressure value measured during the expiratory phase (PEEP) and the PEEP value set is higher than 3 cmh 2 O, observing the following conditions: For expiratory times smaller than 15 seconds: After 3 consecutive cycles. For expiratory times greater than 15 seconds: Immediately. Automatic value All patients 3 cmh 2 O

100 98 6. Alarms and Messages High PEEP Medium Priority This alarm defines the maximum expiratory pressure (PEEP) limit measured in the airways. It is adjusted regarding the PEEP control adjustment value, being activated whenever the pressure in the airway measured during the expiratory phase is 5 cmh 2 O above the PEEP value on the current cycle, on the following conditions: For expiratory times smaller than 15 seconds: After 3 consecutive cycles. For expiratory times greater than 15 seconds: Immediately. Automatic value All patients 5 cmh 2 O High CPAP (High Continuous Positive Airway Pressure) High Priority This alarm defines the maximum airway pressure limit during the expiratory phase on mandatory and spontaneous cycles. It is automatically adjusted based on the PEEP control value. The High CPAP alarm is activated whenever the airway pressure during the expiratory phase maintains itself within 10 cmh 2 O above the set PEEP value, on the following conditions: For expiratory times shorter than 2 seconds: After 3 consecutive cycles. For expiratory times between 2 and 5 seconds: After 2 consecutive cycles. For expiratory times greater than 5 seconds: Immediately. Automatic value All patients Controlled PEEP + 10 cmh 2 O Código Review 001

101 6. Alarms and Messages 99 NOTE When the High CPAP alarm is activated, the ventilator immediately opens all the valves of the respiratory circuit, depressurizing it for a 5-second period. After this period, the normal operation of the equipment is resumed. Auto PEEP Low Priority The Auto PEEP alarm is activated if the Expiratory Flow does not reach a minimum value at the end of exhalation on 3 consecutive cycles. This minimum value is defined from the Expiratory Peak Flow value. Automatic value All patients 50% of the Expiratory Peak Flow value Auto Cycling High Priority The Autocycling alarm is activated if, during three consecutive cycles, it is detected the start of an assisted or spontaneous cycle with Expiratory Time smaller than half of the Inspiratory Time (equivalent to a I:E ratio = 2:1).

102 Alarms and Messages Technical Alarms Low O2 Pressure Low Oxygen Intake Pressure (kpa) High Priority The Low O2 Pressure alarm is activated if the oxygen intake pressure is lower than 250kPa (2.5kg/cm 2 ) and oxygen concentration (% O2) set on the ventilator is higher than 21%. If the oxygen flow is insufficient to meet the programmed demand, the ventilator will automatically compensate the flow with compressed air, eventually leading to the activation of the Low FiO2 alarm. If the oxygen intake pressure reaches levels below 120kPa (1.2kg/cm 2 ), the ventilator switches to air intake and continues operating on the Low O2 Pressure alarm condition. NOTE On the Low O2 Pressure condition, the ventilator checks the air pressure level, also activating the Low Air Pressure alarm, in case it also features a value lower than 250kPa (2.5kg/cm 2 ). Low Air Pressure Low Air Intake Pressure (kpa) High Priority The Low Air Pressure alarm is activated if the compressed air intake pressure is lower than 250kPa (2.5kg/cm 2 ) and if the oxygen concentration (% O2) set on the ventilator is lower than 100%. If the air flow is insufficient to meet the programmed demand, the ventilator will automatically compensate the flow with oxygen, eventually activating the High FiO2 alarm. If the oxygen intake pressure reaches levels below 120 kpa (1.2kg/cm 2 ), the ventilator switches to the oxygen intake and continues operation on the Low Air Pressure alarm condition. Código Review 001

103 6. Alarms and Messages 101 NOTE On the Low Air Pressure condition, the ventilator checks the oxygen pressure level, activating the Low O2 Pressure alarm, in case it also features a value lower than 250kPa (2.5kg/cm 2 ). CAUTION! If the ventilator cannot meet the required demand, even after switching to the remaining gas, the Gas Fail alarm is generated and, as a consequence, the equipment goes to an inoperative condition, also activating the Vent Inop alarm. High O2 Pressure High Oxygen Intake Pressure (kpa) High Priority: Pressure > 600 kpa The High O2 Pressure alarm is activated if the oxygen intake pressure exceeds 600kPa (6.0kg/cm 2 ). In this situation, the operator must reduce the intake pressure, using, for example, pressure reducing valves. As a safety feature, the ventilator also integrates an intake pressure relief valve mechanism for each gas, set to 650kPa (6.5 kg/cm 2 ). If the pressure exceeds this value, the valves will open to the atmosphere, limiting the ventilator supply pressure. O2 Overpressure Oxygen Intake Overpressure (kpa) High Priority: Pressure > 660 kpa On extreme situations, when the intake pressure exceeds the 660kPa limit, the alarm also starts displaying O2 Overpressure, with High Priority, besides entering the inoperative condition, the ventilator will also generate the Vent Inop alarm.

104 Alarms and Messages High Air Pressure High Air Intake Pressure (kpa) High Priority: Pressure > 600 kpa The High Air Pressure alarm is activated if the compressed air intake pressure exceeds 600kPa (6.0kg/cm 2 ). In this situation, the operator must reduce the intake pressure, using, for example, pressure reducing valves. As a safety feature, the ventilator also integrates intake pressure relief valve mechanisms for each gas, set to 650kPa (6.5 kg/cm 2 ). If the pressure exceeds this value, the valves will open to the atmosphere, limiting the ventilator supply pressure. Air Overpressure Air Intake Overpressure (kpa) High Priority: Pressure > 660 kpa On extreme situations, when the intake pressure exceeds the 660kPa limit, the alarm also starts displaying Air Overpressure, with High Priority, besides entering the inoperative condition, also generating the Vent Inop alarm. CAUTION! Whenever the O2 Overpressure or the Air Overpressure condition occurs, the ventilator will enter the inoperative condition, also generating the Vent Inop alarm. Internal Fail High Priority This alarm is activated if technical failures, which require the interruption of equipment use as soon as possible, are detected. Depending on the severity of the failure detected by the safety circuits, the ventilator can go to the inoperative condition, generating the Vent Inop alarm. In this situation, that is, when both Vent Inop and Internal Fail alarms occur simultaneously, immediately stop using the equipment. Código Review 001

105 6. Alarms and Messages 103 NOTE In the occurrence of the Internal Fail alarm, contact or -Authorized Technical Service. Vent Inop High Priority The Vent Inop alarm indicates that the ventilator is not operating and the electronic and pneumatic controls are inactive. The inoperative condition can be generated by a power or intake gas supply failure, when the following alarms are also generated: Power Fail Gas Fail O2 Overpressure Air Overpressure NOTE The return to adequate power and gas supply conditions eliminates the Vent Inop condition. The Vent Inop condition can also be generated by a technical failure, when the alarms associated with the failures indicated below are generated: Internal Fail Gas Administration Fail Regulator Pressure Fail Exhalation Valve Fail Low Internal Battery NOTE In the event of a Vent Inop alarm associated with a technical failure, immediately stop using the ventilator and contact or -Authorized Technical Service.

106 Alarms and Messages NOTE The Vent Inop alarm is associated to a full-screen indication, highlighting the presence of this alarm condition. The full-screen can be minimized by touching any point of the highlighted region. In case the alarm condition is not eliminated, the full-screen indication returns after 30 seconds. O2 Sensor Fail Oxygen Sensor Fail High Priority The O2 Sensor Fail alarm is activated in case of an oxygen sensor fail. In this case, it is impossible to measure the oxygen concentration, FiO2, of the mixture inhaled by the patient, thus disabling the corresponding numeric monitor. NOTE In case the O2 Sensor Fail alarm is activated, it is possible to actuate the disable monitoring function through the oxygen sensor until maintenance is performed. In such conditions, please contact or - Authorized Technical Service as soon as possible in order to solve the cause of the O2 Sensor Fail alarm. Additional information on this function are found under Item 3.6. Gas Fail (kpa) High Priority The Gas Fail alarm is activated when the ventilator cannot meet the minimum required demand, even after switching to the remaining gas. This condition occurs when both the air and the oxygen intake pressure is lower than 120 kpa (1.2 kg/cm 2 ). Código Review 001

107 6. Alarms and Messages 105 CAUTION! Whenever the Gas Fail condition occurs, the ventilator will be led to the inoperative condition, also generating the Vent Inop alarm. Power Fail High Priority The Power Fail alarm is activated when a failure in any internal voltage in the ventilator occurs. CAUTION! Whenever a Power Fail condition occurs, the ventilator will be led to the inoperative condition, also generating the Vent Inop alarm. Patient Disconnection High Priority The Patient Disconnection alarm is activated when a patient disconnection is detected, when the difference between the volume supplied and the exhaled one is equal to or greater than 95%. NOTE The Patient Disconnection alarm is associated to a full-screen indication, highlighting the presence of this alarm condition. The full-screen can be minimized by touching any point of the highlighted region. In case the alarm condition is not eliminated, the full-screen indication returns after 30 seconds.

108 Alarms and Messages Patient Circuit Leakage (Leakage in Patient Circuit) Low Priority The Pacient Circuit Leakage alarm is activated if a leakage in patient circuit is detected, when the difference between the supplied volume and the exhaled one is equal to or greater than 50% and lower than 95%. This alarm is not activated in the TCPLV and NIV modes. Patient Circuit Occlusion (Occlusion of the Patient Circuit) High Priority The Patient Circuit Occlusion alarm is activated when an occlusion on the inspiratory branch of the patient circuit is detected. The detection of the inspiratory occlusion is performed by measuring the inspiratory branch resistance, through the pressure difference between the internal and external proximal pressure sensors. Inadequate Flow Sensor Medium Priority This alarm is activated if the type of the flow sensor connected to the ventilator differs from the patient category, as defined by the IBW. The sensor is identified by its connector through an optical sensor. Flow Sensor Disconnection (Disconnection of the Flow Sensor) Low Priority This alarm is activated if the presence of a Proximal Flow Sensor or an Expiratory Flow Sensor is not detected. The flow sensors are identified by the connector through an optical sensor. Gas Supply Fail (Failure in Gas Supply) High Priority This alarm is activated if the controlled flow differs from the supplied flow, measured by the internal flow sensor. Depending on the severity of the failure detected by the safety circuits, the ventilator can go to the inoperative condition, generating the Vent Inop alarm. Código Review 001

109 6. Alarms and Messages 107 Standby Time Elapsed (Standby Mode Time Elapsed Limit) High Priority This alarm is activated if, after the maximum aspiration period (3 minutes), during the 100% O2 maneuver, ventilation has not been resumed through the activation of the Standby Mode key. Low Internal Battery (Low Internal Battery Charge Level) High Priority The Low Internal Battery alarm is activated when the battery autonomy is lower than 10 minutes. NOTE The estimated autonomy time after activating the Low Internal Battery alarm may vary according to the battery service life and the ventilator use mode. NOTE Apart from the indication on the ventilator screen, the occurrence of a Low Internal Battery alarm is indicated by the visual indicator Battery Level, located on the equipment front panel. This LED will flash in red, associated with a sound indication of 3+2 beeps (high priority). CAUTION! In case the Low Internal Battery alarm is activated, immediately connect the equipment to the power mains or to an external battery. Otherwise, the ventilator will be led to an inoperative condition, also generating the Vent Inop alarm.

110 Alarms and Messages Internal Battery Fail (Failure in the Internal Battery) High Priority The Internal Battery Fail alarm is activated when a failure on the internal battery or in the charging circuit is detected. AC Line Fail (Alternating Current line failure Internal Battery Input) Medium Priority The Use in Battery alarm is activated with Medium Priority when the ventilator is powered by its internal battery, due to an AC power mains failure. After this alarm has been muted by the operator, by pushing the Audio Pause/Alarm Reset key, it will be replaced by the low priority Internal Battery in Use alarm (see below). This alarm is also indicated by the Internal Battery LED on the ventilator front panel. Internal Battery in Use Low Priority The Internal Battery in Use alarm is activated with Low Priority when the ventilator is powered by its internal battery, always after the AC Line Fail alarm has been muted (see above). This alarm is also indicated by the Internal Battery LED on the ventilator s front panel. Low Setup Battery Low Priority The Low Setup Battery alarm is activated if a failure is detected on the PCI Control RAM battery, which ensures that the last setup set into the machine is kept in the memory when the equipment is turned off. This alarm is only activated when the ventilator is turned on or as soon as the failure is detected, being cancelled after the Audio Pause/Alarm Reset key has been pressed. In this case, contact or -Authorized Technical Service, which will arrange for the battery to be replaced as soon as possible because the ventilator data storage feature will be lost. Código Review 001

111 6. Alarms and Messages 109 Fan Fail Medium Priority The Fan Fail alarm is activated when a failure on the internal cooling system of the ventilator is detected. In this case, stop using the equipment as soon as possible, and contact or -Authorized Technical Service. Exhalation Valve Fail (Failure in the Exhalation Valve Control) High Priority The Exhalation Valve Fail alarm is activated when a failure on the exhalation valve control is detected. Depending on the severity of the failure, the ventilator can be led to the Internal Fail or Vent Inop condition. In this case, stop using the equipment as soon as possible, and contact or -Authorized Technical Service. Autozero Error (Error in the Flow Sensor Autozero) Medium Priority The Autozero Error alarm is activated when a failure during the autozero routine of the transducer responsible for the measurement of the external flow (Proximal Flow Sensor or Expiratory Flow Sensor) is detected. In this case, stop using the equipment as soon as possible, and contact or -Authorized Technical Service. Regulator Pressure Fail (Failure in the Regulator Pressure Control) High Priority The Pressure Regulator Fail alarm is activated when a failure on the Pressure Regulator control is detected, which is responsible for the actuation of several ventilator systems. This failure can be caused by lack of intake gas supply, when the Gas Fail alarm is also activated. In this situation, restoring the intake gases will eliminate the failure condition. The Pressure Regulator Fail can also be caused by a technical problem, when the Vent Inop alarm will also be activated. In this case, stop using the

112 Alarms and Messages ventilator immediately, and contact or -Authorized Technical Service. Keyboard Fail (Keyboard Communication Failure) Medium Priority The Keyboard Fail alarm is activated when a failure in the communication between the quick access keys and the ventilator control circuits is detected. In this case, stop using the ventilator as soon as possible, and contact or -Authorized Technical Service. Motherboard Fail Motherboard Communication Failure High Priority The Motherboard Fail alarm is activated when a failure in the communication between the motherboard and the ventilator control circuits is detected. Stop using the ventilator as soon as possible, and contact or - Authorized Technical Service. Ventilator Off Beep When turned off by means of the On/Off switch, the ventilator generates a sound until the operator presses the Audio Pause/Alarm Reset key. Código Review 001

113 6. Alarms and Messages Alarms / Possible Causes / Recommended Actions High Priority Alarms Possible Causes Recommended Actions Apnea* Inspiratory sensitivity is too high. Check whether the inspiratory sensitivity is properly set. Apnea Alarm is incorrectly set. Check whether the ventilator alarm is correctly set. * This alarm starts with medium priority, evolving to high priority after 3 consecutive apnea periods. Auto Cycling Low Internal Battery High CPAP Patient Disconnection Internal Battery Fail Motherboard Fail Detection of start of an assisted or spontaneous cycle with expiratory time shorter than half of the Inspiratory Time (equivalent to an I:E ratio = 2:1), during three consecutive cycles. Equipment malfunction. The estimated battery autonomy is shorter than 10 minutes. Obstruction of the expiratory branch. Equipment malfunction. The patient circuit is disconnected from the patient. Patient circuit leakage. Defective flow sensor. Failure on the internal battery or on the battery charging circuit. Failure in the communication between the motherboard and the ventilator control circuits or failure on the equipment internal power sources. Check whether the pressure and flow sensitivity values set on the equipment are not too low. Check whether there is any leakage in the patient circuit. Stop using the ventilator and contact or -Authorized Technical Service. Urgently charge the internal battery by connecting to an external AC power source. Check for the presence of foreign bodies or occlusion on the expiratory branch. Stop using the ventilator and contact or -Authorized Technical Service. Connect the patient back to the ventilator. Check for the presence of holes or tears on the patient circuit, or whether the parts are properly assembled. Manage for the replacement of the flow sensor. Stop using the ventilator and contact or -Authorized Technical Service. Stop using the ventilator and contact or -Authorized Technical Service.

114 Alarms and Messages High Priority Alarms Possible Causes Recommended Actions Power Fail Gas Fail Gas Supply Fail Internal Fail Regulator Pressure Fail Exhalation Valve Fail Failure on one or more ventilator internal power sources. Impossibility to meet the intake gas demand, even after switching to remaining gas. Controlled flow differing from the supplied flow, as measured by the internal flow sensor. Internal technical failures detected by the ventilator safety circuits. Failure in the Regulator Pressure control, which is responsible for the actuation of several ventilator systems. Compressed air and/or oxygen intake pressure below the specified limit. Punctured or misplaced diaphragm. Damaged or misplaced exhalation valve. Exhalation valve control failure. Stop using the ventilator and contact or -Authorized Technical Service. Ensure the air or oxygen intake pressure above 250 kpa (2.5 kg/cm 2 ) at least. Stop using the ventilator and contact or -Authorized Technical Service. Stop using the ventilator and contact or -Authorized Technical Service. Stop using the ventilator and contact or -Authorized Technical Service. Feed the compressed air and/or oxygen intake with a pressure greater than the lower specified limit of 250 kpa (2.5 kg/cm 2 ). Check the diaphragm s conditions and whether it has been properly mounted. If necessary, manage for the replacement with a new one. Check the exhalation valve conditions and whether it has been properly mounted. If necessary, manage for the replacement with a new one. Stop using the ventilator and contact or -Authorized Technical Service. Low FiO2 * Low oxygen intake pressure. Check whether the oxygen intake pressure is within the specified range from 250 kpa (2.5 kg/cm 2 ) to 600 kpa (6.0 kg/cm 2 ). Value regarding the compensation for local altitude not properly set during the installation of the equipment. Uncalibrated oxygen sensor. Contact or -Authorized Technical Service. Contact or -Authorized Technical Service. Código Review 001

115 6. Alarms and Messages 113 High Priority Alarms Possible Causes Recommended Actions * This alarm will assume the high priority condition if the concentration is lower than or equal to 18%. In other cases, the alarm will be a medium priority one. Patient Circuit Occlusion High Air Pressure Low Air Pressure High O2 Pressure Low O2 Pressure High resistance between the inspiratory and expiratory branches, resulting in the increase of the pressure difference above the acceptable limit. Compressed air intake pressure above the specified limit. Equipment malfunction. Compressed air intake pressure below the specified limit. Clogged coalescent filter. Equipment malfunction. Oxygen intake pressure above the specified limit. Equipment malfunction. Oxygen intake pressure below the specified limit. Clogged coalescent filter. Equipment malfunction. Check for the presence of foreign bodies or occlusion on the patient circuit. Feed the compressed air intake with a pressure lower than the specified upper limit of 600 kpa (6.0 kg/cm 2 ). Stop using the ventilator and contact or -Authorized Technical Service. Feed the compressed air intake with a pressure higher than the specified lower limit of 250 kpa (2.5 kg/cm 2 ). Manage for the replacement of the coalescent filter. Stop using the ventilator and contact or -Authorized Technical Service. Feed the oxygen intake with a pressure lower than the specified upper limit of 600 kpa (6.0 kg/cm 2 ). Stop using the ventilator and contact or -Authorized Technical Service. Feed the oxygen intake with a pressure higher than the specified lower limit of 250 kpa (2.5 kg/cm 2 ). Manage for the replacement of the coalescent filter. Stop using the ventilator and contact or -Authorized Technical Service.

116 Alarms and Messages High Priority Alarms High Inspiratory Pressure Low Inspiratory Pressure Possible Causes The upper respiratory airway pressure alarm limit was exceeded. The patient fights the equipment, cough. Folded respiratory pipe Secretion build-up in the patient circuit. Water build-up on the collection cups or the tracheas, if they are not correctly positioned. Alarm improperly set. Change to the patient s respiratory mechanics (increased resistance or reduced complacence) PEEP set above the alarm settings. Leakage or disconnection Leaking cuff. Punctured or misplaced diaphragm. Alarm improperly set. Change to the patient s respiratory mechanics (reduced resistance or increased complacence) On the volume controlled or time-cycled modes, the Inspiratory Flow set is insufficient to meet the patient s inspiratory effort. Recommended Actions Check patient s conditions, the ventilation curves and eventually adjust the alarm limit. Check the patient circuit pipe system. Unobstruct/aspirate the airway and/or endotracheal pipe. Drain the collection cups and check whether there is no water accumulated on the tracheas. Check whether the alarm set on the ventilator is correct. Reassess ventilation parameters (volume, inspiratory pressure, PEEP, etc.) Check whether the PEEP and alarm settings are matching. Check whether the exhalation valve is properly connected. Check the leakage on the patient circuit. Insufflate the cuff, checking whether the system is properly sealed. Check the diaphragms condition and if it was correctly positioned. If necessary, manage for the replacement with a new one. Check whether the alarm is correctly set. Reassess the ventilation parameters (volume, inspiratory pressure, PEEP, etc.) Increase the Inspiratory Flow. Código Review 001

117 6. Alarms and Messages 115 High Priority Alarms Air Overpressure O2 Overpressure Standby Time Elapsed Vent Inop Possible Causes Exhalation valve control system failure. Compressed air intake pressure well above the specified limit with risk of compromising the patient safety and damaging the equipment internal components. Equipment malfunction. Oxygen intake pressure well above the specified limit with risk of compromising the patient safety and damaging the equipment s internal components. Equipment malfunction. Not resuming the ventilation after the maximum period intended for aspiration (3 minutes), during the 100% O 2 maneuver. Detection of major failures that may compromise the patient safety and/or the operation of equipment s internal components. Lack of a minimum gas source to ventilate the patient, even on precarious conditions. Recommended Actions Contact or -Authorized Technical Service. Feed the compressed air intake with a pressure lower than the upper specified limit of 600 kpa (6.0 kg/cm 2 ). Stop using the ventilator and contact or -Authorized Technical Service. Feed the oxygen intake with a pressure lower than the upper specified limit of 600 kpa (6.0 kg/cm 2 ). Stop using the equipment and contact or -Authorized Technical Service. During the 100% O 2 maneuver, make certain that the Standby Mode key is pressed within the maximum 3-minute period intended for aspiration. Stop using the ventilator and contact or -Authorized Technical Service. Supply at least one the gas sources with a minimum pressure of 120 kpa (1.2 kg/cm 2 ) to establish the ventilation conditions on an emergency situation. Arrange the urgent restoration of the intake conditions specified for the equipment.

118 Alarms and Messages Medium Priority Alarms Possible Causes Recommended Actions Apnea* The inspiratory sensitivity is too high. Apnea Alarm is improperly set. Check whether the inspiratory sensitivity is properly set. Check whether the ventilator alarm is correctly set. * This alarm starts with medium priority then evolving to high priority after three consecutive periods of apnea. Autozero Error Keyboard Fail Fan Fail Failure during the autozero routine of the transducer responsible for the measurement of the external flow (Proximal Flow Sensor or Expiratory Flow Sensor) Failure in the communication between the keyboard board and the ventilator control circuits or detection of any key pressed for more than one minute. Internal ventilator cooling system failure. Stop using the ventilator and contact or -Authorized Technical Service. Stop using the ventilator and contact or -Authorized Technical Service. Stop using the ventilator and contact or -Authorized Technical Service. AC Line Fail Lack of AC power. Connect the equipment to an AC power source as soon as possible in order to prevent the internal battery from being fully discharged. The power cord is not properly connected. The power cord is damaged. The power outlet to which the power cord is connected does not have power. Blown power source fuse. Remove the power cord s fixation support, check whether the cable is properly connected and fix the power cord s support again. Replace the power cord. Use a different power outlet. Contact or -Authorized Technical Service to provide the replacement of the fuses. High FiO2 Low air intake pressure. Check whether the air intake pressure is within the specified range from 250 kpa (2.5 kg/cm 2 ) to 600 kpa (6.0 kg/cm 2 ). Código Review 001

119 6. Alarms and Messages 117 Medium Priority Alarms Possible Causes Recommended Actions High FiO2 (continued) Value regarding the compensation for local altitude not properly set during the installation of the equipment. Uncalibrated oxygen sensor. Contact or -Authorized Technical Service. Contact or -Authorized Technical Service. Low FiO2 * Low oxygen intake pressure. Check whether the oxygen intake pressure is within the specified range from 250 kpa (2.5 kg/cm 2 ) to 600 kpa (6.0 kg/cm 2 ). Value regarding the compensation for local altitude not properly set during the installation of the equipment. Uncalibrated oxygen sensor. Improper pneumatic supply source with low O 2 concentration. Contact or -Authorized Technical Service. Contact or -Authorized Technical Service. Provide a suitable pneumatic supply source. * This alarm will assume the high priority condition if the concentration is lower than or equal to 18%. In other cases, the alarm will be a medium priority one. High Respiratory Rate Low Respiratory Rate Respiratory rate greater than the set value. Occurrence of respiratory autocycles depending on the ventilator sensitivity adjustment. Respiratory rate lower than the set value. Ventilator does not detect the patient s effort. Ensure that the ventilator configurations are properly defined for the patient s condition and that the alarm set value is correct. Check whether the sensitivity value set in the equipment is not too low. Ensure that the ventilator configurations are properly defined for the patient s condition and that the alarm set value is correct. Check whether the sensitivity value set in the equipment is too high. High PEEP Expiration valve locked. Check the patient circuit pipe system and the exhalation valve. Increased expiratory resistance. Water build-up on the collection cups or tracheas, in case they are not correctly positioned. Check whether there is any obstruction in the expiratory branch. Drain the collection cups and check whether there is no water accumulated on the tracheas.

120 Alarms and Messages Medium Priority Alarms Possible Causes Recommended Actions High PEEP (continued) High respiratory rate Defective equipment. Check on the graph whether the expiratory time is shorter than the required for exhalation. Stop using the ventilator and contact or -Authorized Technical Service. Low PEEP Leakage or disconnection Check whether the exhalation valve is properly connected. Check leakage in the patient circuit. Improper Flow Sensor High Tidal Volume Low Tidal Volume Leaking cuff. Punctured or misplaced diaphragm. The flow sensor connected to the ventilator does not match the IBW range set in the equipment. Defective optical sensor of the flow sensor detection board. The expiratory tidal volume alarm limit has been exceeded on 3 respiratory cycles. The inspiratory tidal volume alarm limit has not been reached. Leakage or disconnection. Leaking cuff. Punctured or misplaced diaphragm. Improperly set alarm. Insufflate the cuff, checking whether the system is properly sealed. Check the diaphragm s condition and whether it was correctly positioned. If necessary, provide the replacement with a new one. Check whether the type of sensor connected matches the IBW range set in the ventilator, according to the table under Chapter 3 or Chapter 6 of this manual. Contact or -Authorized Technical Service. Check the patient s condition, the ventilation curves and eventually adjust the alarm limit. Check the patient s condition, the ventilation curves and eventually adjust the alarm limit. Check whether the exhalation valve is properly connected. Check leakage in the patient cannula or circuit. Insufflate the cuff, checking whether the system is properly sealed. Check the diaphragm s condition and whether it was correctly positioned. If necessary, provide the replacement with a new one. Check whether the ventilator s alarm adjustment is correct. Código Review 001

121 6. Alarms and Messages 119 Medium Priority Alarms High Minute Volume Low Minute Volume Possible Causes The upper minute volume alarm limit has been exceeded. Defective flow sensor. Water in the flow sensor. Equipment malfunction. The lower minute volume alarm limit has not been reached. Leakage in respiratory system. Defective flow sensor. Equipment malfunction. Recommended Actions Check the patient s condition, the ventilation curves and eventually adjust the alarm limit. Replace the defective flow sensor. Drain the humidity condensers. Dry the flow sensor. Stop using the ventilator and contact or -Authorized Technical Service. Check the patient s condition, the ventilation curves and eventually adjust the alarm limit. Establish a respiratory system without leakages. Replace the defective flow sensor. Stop using the ventilator and contact or -Authorized Technical Service.

122 Alarms and Messages Auto PEEP Internal Battery in Use Low Setup Battery Flow Sensor Disconnection Patient Circuit Leakage Low Priority Alarms Possible Causes Expiratory Flow is above the minimum flow at the end of exhalation on three consecutive cycles. Occurrence of respiratory autocycles due to the ventilator sensitivity adjustment. Lack of AC power mains. The power cord is not properly connected. The power cord is damaged. The power outlet to which the power cord is connected does not have power. Blown power source fuse. Failure in the battery of the PCI Control RAM, which ensures that the last machine setup remains in the memory. The flow sensor is not connected to the ventilator. Defective flow sensor connector. Defective optical sensor of the flow sensor detection board. Low exhaled tidal volume. Recommended Actions Properly adjust the respiratory rate. Check whether the sensitivity value set in the equipment is not too low. Connect the equipment to an AC power source as soon as possible in order to prevent the internal battery from being fully discharged. Remove the power cord s fixation support, check whether the cable is properly connected and fix the power cord s support again. Replace the power cord. Use a different power outlet. Contact or -Authorized Technical Service to provide the replacement of the fuses. Contact or -Authorized Technical Service. Connect the flow sensor to the ventilator. Provide the replacement of the flow sensor. Contact or -Authorized Technical Service. Check leakages in the patient circuit. Clogged flow sensor (with water). Check the presence of impurities in the sensor or water build-up. Defective flow sensor. Provide the replacement of the flow sensor. Código Review 001

123 6. Alarms and Messages Visual Indicators Power On (Equipment Turned On) Continuous Green color The Power On visual indicator (LED) is activated whenever the equipment is turned on by the On/Off switch located on the rear panel. AC Line (Alternating Current) Continuous Green The AC Line visual indicator (LED) is activated whenever the equipment is connected to an AC-type external power source (power mains). This indication remains active even when the equipment is turned off. DC Line (Direct Current) Continuous Green The DC Line visual indicator (LED) is activated whenever the equipment is connected to a DC-type external power source (external battery) by means of the existing external connection located on the rear panel. This indication remains active even when the equipment is turned off. Internal Battery (Status of the Internal Battery) Off / Continuous Yellow / Flashing Green The Internal Battery visual indicator (LED) remains off when the battery is charged and the equipment is connected to an external AC power source. In the absence of an AC power source, the Internal Battery visual indicator (LED) changes to the continuous yellow state, indicating that the internal battery is in use. When the AC external source is connected again, the Internal Battery visual indicator (LED) starts flashing in green color to indicate that the battery is being recharged, regardless if the equipment is turned on by the On/Off switch or not.

124 Alarms and Messages Off: Charged Internal Battery Continuous Yellow: Internal Battery in Use Flashing Green: Internal Battery being Recharged Battery Level (Internal Battery Charge Level) Continuous Green / Continuous Orange / Flashing Red The Battery Level visual indicator (LED) allows the identification the autonomy of the internal battery through its different colors: Continuous Green: Charge above 80% of total capacity Continuous Orange: Charge between 80% and 30% of total capacity Flashing Red: Charge below 30% of total capacity NOTE The Battery Level visual indicator is activated whenever the equipment is turned on by the On/Off switch or, when turned off, if it is connected to an external AC-type power source. CAUTION! When the battery charge reaches levels below 5% of the total capacity, the ventilator will be led to an inoperative condition, generating the Vent Inop alarm. Código Review 001

125 6. Alarms and Messages Messages Controls Type Window Message All Warning Warning! Values above [set value] may not be safe to the patient. Warning Warning! Values above [set value] may hide an insecure physiological condition. Tidal Vol Prohibition Note! Values above [set value] cannot be reached. Check the Insp Flow and Rate adjustment. Insp Flow Prohibition Note! Values below [set value] cannot be reached. Check the Tidal Vol and Rate adjustment. Rate Prohibition Note! Values above [set value] cannot be reached. Check the Tidal Vol and Insp Flow adjustment. T Insp Prohibition Note! Values above [set value] cannot be reached. Check the Rate adjustment. Prohibition Note! Values above [set value] cannot be reached. Check the Rate and Insp Flow adjustments. Insp Pause Prohibition Note! Values above [set value] cannot be reached. Check the Tidal Vol, Insp Flow and Rate adjustments. P Contr Prohibition Note! Pressures cannot be adjusted above 120 cmh2o. Also check the PEEP adjustment.

126 Alarms and Messages Controls Type Window Message P Supp Prohibition Note! Pressures cannot be adjusted above 120 cmh2o. Also check the PEEP adjustment. Prohibition Prohibition Note! Pressures cannot be adjusted above 40 cmh2o. Also check the PEEP adjustment. Note! Pressures cannot be adjusted above P Limit. Also check the PEEP adjustment. P Insp Prohibition Note! Pressures cannot be adjusted above 40 cmh2o. PEEP Prohibition Note! PEEP must be adjusted to at least 5 cmh 2 O below the P Limit adjustment. Prohibition Note! Pressures cannot be adjusted above P Limit. Also check the P Supp adjustment. Warning Warning! Prior to increasing PEEP, check whether the High Pressure alarm will not limit or prevent ventilation. P Limit Prohibition Note! P Limit must be adjusted to at least 5 cmh 2 O above the PEEP adjustment. High Pressure Prohibition Note! The High Pressure alarm cannot be adjusted below the Low Pressure alarm. Low Pressure Prohibition Note! The Low Pressure alarm cannot be adjusted above the High Pressure alarm. High Vol Min Prohibition Note! The High Vol Min alarm cannot be adjusted below the Low Minute Vol alarm. Low Minute Vol Prohibition Note! The Low Minute Vol alarm cannot be adjusted above the High Vol Min alarm. Código Review 001

127 6. Alarms and Messages 125 Controls Type Window Message High Tidal Vol Prohibition Note! The High Tidal Vol alarm cannot be adjusted below the Low Tidal Vol alarm. Low Tidal Vol Prohibition Note! The Low Tidal Vol alarm cannot be adjusted above the High Tidal Vol alarm. High Rate Prohibition Note! The High Rate alarm cannot be adjusted below the Low Rate alarm. Low Rate Prohibition Note! The Low Rate alarm cannot be adjusted above the High Rate alarm. Auto Set Action Attention! Please check all the suggested values before applying the changes. NOTE Prohibitions: They restrict the value adjustment, but they indicate the cause to make it easier to understand and/or overcome the limitation. Warnings: They do not restrict the value adjustment, but notify a condition of risk to the patient. Actions: They only require attention to related events.

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129 7. Monitoring Features Monitoring Features

130 Monitoring Features Código Review 001

131 7. Monitoring Features Introduction The monitoring of patient ventilation occurs in real time, on a continuous way, and it is based on flow, pressure, time, and oxygen concentration signals. From the numerical integration of flow signals, volumes are obtained. Pressure monitoring is performed close to the patient (mouth pressure or proximal pressure), through a pressure measurement pipe on the Y part of the circuit. On the, the flow monitoring can be performed both on the Y part of the respiratory circuit (proximal position), through the Neonatal, Pediatric, and Pediatric / Adult Proximal Flow Sensors, as well as on the exhalation valve (distal position), through the Expiratory Flow Sensor. The distal monitoring is performed when the suitable flow sensor is connected to the exhalation valve. In this case, the ventilator monitors the Inspiratory Flow by means of the internal flow sensors, and the exhaled flow by means of the flow sensor on the exhalation valve. The proximal monitoring is performed when Proximal Flow Sensors, suitable for each type of patient (Adult, Pediatric or Neonatal), are used. In this case, both inhaled and exhaled flows are monitored at the same point, close to the patient. This configuration is particularly suitable for monitoring neonatal and pediatric patients. The flow sensor selection must follow the type of patient, identified in the ventilator through his/her Ideal Body Weight (IBW). Recommended IBW Range Flow Sensor Patient Category Up to 3kg Proximal Neonatal Neonatal From 3,1 to 20 kg Proximal Pediatric Pediatric From 21 to 40 kg Proximal Pediatric/Adult Pediatric Above 40 kg Proximal Pediatric/Adult Adult From 10 to 40 kg Expiratory Pediatric Above 40 kg Expiratory Adult

132 Monitoring Features CAUTION! If a pneumotachograph incompatible with the informed patient weight (IBW) is connected, a medium priority alarm (Inadequate Flow Sensor) will be activated. In this case, the operator must initially check whether the weight informed on the IBW control is correct; if it is, the sensor must be replaced. CAUTION! Make certain that the flow sensors are properly cleaned, by eliminating eventual residues deposited in their measurement ducts. The presence of such residues may affect the accuracy of these sensors. WARNING! In case a humidification or bacteriological filter is used, it shall be assembled between the proximal sensor and the patient connection in order to protect the sensor against the humidity generated through the patient s exhalation. NOTE Upon acknowledging the flow sensor and periodically, at every 5 minutes, the performs a flow sensor Autozero process. Such process intends to eliminate eventual liquids found on the two ways of the sensor measurement pipe, in addition to resetting the flow zero point, in order to ensure the accuracy of the monitoring. Código Review 001

133 7. Monitoring Features Numerical Monitoring Peak Pressure Peak Pressure (cmh 2 O) It indicates the maximum inspiratory pressure of the respiratory cycle. Plateau Plateau Pressure (cmh 2 O) When an Inspiratory Pause (Insp Pause or Manual Insp Pause) is programmed, it indicates the inspiratory pressure at the end of the respiratory cycle (when the flow is null). When there is no Inspiratory Pause, it indicates the pressure during the transition from the inspiratory to the expiratory phase, at the moment when the flow is null. Mean Mean Airway Pressure (cmh 2 O) It indicates the mean airway pressure of the last 40 seconds, being updated at every 10 seconds. PEEP Positive End Expiratory Pressure (cmh 2 O) It indicates the expiratory pressure at the end of exhalation. Auto PEEP Auto PEEP Pressure It indicates the Auto PEEP pressure, which is measured 200 ms before the start of a controlled cycle. The measurement is done by momentarily pressing the Manual Exp Pause key preceding a controlled cycle (without patient s effort). The Auto PEEP indication is shown on the same field where PEEP is displayed, with the corresponding modified title and value; remaining active on the screen for 1 minute after this time, the field shows the PEEP value again.

134 Monitoring Features P 0.1 Occlusion Pressure at 100 ms It indicates the P 0.1 value, occlusion pressure measured 100 ms after the start of an inspiratory effort (assisted or spontaneous cycles). The measurement is done by momentarily pressing the Manual Exp Pause key preceding a patient s effort. The P 0.1 indication is shown on the same field where PEEP is displayed, with the corresponding modified title and value; the screen remains active for 1 minute after this time, the field shows the PEEP value again. Tidal Vol Exhaled Tidal Volume (L) It indicates the exhaled tidal volume (controlled, assisted and spontaneous) at each cycle. Minute Vol Total Exhaled Minute Volume (L) It indicates the minute volume, including controlled, assisted and spontaneous cycles. Resp Rate Total Respiratory Rate (/min) It indicates the total respiratory rate, including controlled, assisted and spontaneous cycles. Spont Resp Rate Spontaneous Respiratory Rate (/min) It indicates the respiratory rate on spontaneous cycles only. I:E I:E Ratio It shows the digital indication of the ratio between the inspiratory time and the expiratory time values for each of the respiratory cycles. Código Review 001

135 7. Monitoring Features 133 FiO2 Fraction of Inspired Oxygen (%) It indicates the oxygen concentration of the mixture inspired by the patient. The monitoring of the oxygen concentration is performed on the inspiratory branch, inside the ventilator. Insp Peak Flow Inspiratory Peak Flow It indicates the maximum Inspiratory Flow of the respiratory cycle. Exp Peak Flow Expiratory Peak Flow It indicates the maximum Expiratory Flow of the respiratory cycle. Texp Expiratory Time (s) It indicates the Expiratory Time of the respiratory cycle. Tinsp Inspiratory Time (s) It indicates the Inspiratory Time of the respiratory cycle. R Insp Airway Inspiratory Resistance (cmh 2 O/L/s) It indicates the airway resistance, measured at the start of the inspiratory phase. It is calculated from the airway pressure, PEEP, and the Inspiratory Flow. R Insp = (Paw* PEEP) / Flow* Where Flow* and Paw* are the Inspiratory Flow and the airway pressure values measured 100ms after the start of the respiratory cycle, respectively. R Exp Airway Expiratory Resistance (cmh 2 O/L/s) It indicates the airway resistance measured during the expiratory phase. It is calculated from the Plateau Pressure, PEEP, and the Expiratory Peak Flow.

136 Monitoring Features R Exp = (Plateau PEEP) / Exp Peak Flow Static C Respiratory System Static Complacence (ml/cmh 2 O) It indicates the respiratory system static complacence. It is calculated from the Plateau Pressure, the pressure at the end of the exhalation and the exhaled tidal volume. Static C = Tidal Vol / (Plateau PEEP) Dynamic C Respiratory System Dynamic Complacence (ml/cmh 2 O) It indicates the respiratory system dynamic complacence. It is calculated from the peak pressure, the pressure at the end of exhalation, and the exhaled tidal volume. Dynamic C = Tidal Vol / (Peak PEEP) Código Review 001

137 7. Monitoring Features Graphic Monitoring Graphic Screen NOTE The allows the operator to configure the screen according to his convenience, being capable of displaying up to 5 curves simultaneously in real time. Freeze This key allows momentarily freezing (stopping) graph plotting. While the function is active, a cursor will be visible, and it can be moved by rotating the Main Button, showing instantaneous values of graphic readings. Plotting will remain frozen until the key is pressed again or if there is no activity with the cursor for 60 seconds. Patient Effort Patient s Inspiratory Effort Indicator It indicates the occurrence of a patient s inspiratory effort, enough to reach the sensitivity level set by the Sensitivity control. The indication can be directly observed on the Pressure graphic or on the Flow graphic, depending on the type of set sensitivity. Bar Graph Airway Pressure (cmh 2 O) The airway pressure measurement, taken at the Y part of the patient, is shown on a linear display with a vertical bar whose height corresponds to the pressure measured at every moment. On this bar, the Peak Pressure, Mean Pressure, and PEEP values are indicated for each cycle.

138 Monitoring Features Curves and Loops The ventilator allows the visualization of the following ventilation curves: Pressure x Time Flow x Time Volume x Time Pressure x Volume Volume x Flow For the three first curves, there is a difference in curve colors in the inspiratory and expiratory phases of the respiratory cycles. It is possible to adjust the scale for each of the parameters, just touching on the corresponding axis of the graphic. The scales applied to each of the parameters of the loops (Pressure, Flow, and Volume) are the ones chosen for the ventilation curves Cognitive Screen This screen displays the main ventilation parameters in a clean and visually clear fashion. The Cognitive Screen is an important surveillance feature, since it allows the operator to immediately identify the patient s conditions, even at a distance. Lung Icon A lung-shaped icon is shown at the center of the screen, and it moves with the respiratory cycle Rate in a synchronized way. In addition to that, the amplitude of the icon s movement is directly related to the Tidal Volume of each respiratory cycle. Numerical Parameters The following parameters are shown on this screen: Tidal Vol: Exhaled Tidal Volume Resp Rate: Total Respiratory Rate Peak Pressure: Peak Pressure (Positive Inspiratory Pressure) PEEP: Positive End Expiratory Pressure Código Review 001

139 7. Monitoring Features 137 Minute Volume Bargraph The Exhaled Minute Volume is shown on a linear display with a vertical bar whose colors identify the portion of the minute volume coming from Controlled, Assisted and Spontaneous cycles Trend Screen The ventilator stores a series of ventilation parameters and displays them as trends. The trend graphics store up to 72 hours of data, and they can be visualized on 15-minute, 1-, 2-, 4-, 8-, and 12-hour scales. PEEP: Positive End Expiratory Pressure Peak Pressure: Peak Pressure (Positive Inspiratory Pressure) Tidal Vol: Exhaled Tidal Volume R Insp: Airway Inspiratory Resistance C Dyn: Respiratory System Dynamic Complacence Resp Rate: Total Respiratory Rate FiO2: Oxygen Concentration Alarm and Event Log The stores the log of all alarms and events occurred during the last 72 hours. Each record contains its date, time, type and identification indication. The list of events can be filtered to display alarms only, events only, or both types of occurrences.

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141 8. Troubleshooting Troubleshooting

142 Troubleshooting Código Review 001

143 8. Troubleshooting 141 Symptom Problem Solution The Power On light indication is off and the equipment is operating. The AC Line light indicator is off. The DC Line light indicator is off. LED is burnt. Failure in the communication with the side LED board. The power cord is not properly connected. The power cord is damaged. The power outlet to which the power cord is connected does not have power. Blown power source fuse. LED is burnt. Failure in the communication with the side LED board. The power cord is not properly connected. The power cord is damaged. The external DC power source is defective. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Remove the power cord s fixation support, check whether the cable is properly connected and fix the power cord fixation support again. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Use a different power outlet. Contact or - Authorized Technical Service to provide the replacement of the fuses. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Check whether the cable is properly connected. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Check the external DC power source operation.

144 Troubleshooting Symptom Problem Solution The Internal Battery light indicator does not light up when the ventilator is disconnected from an external AC power source. The Battery Level light indicator is off when the equipment is operating. The key light indicator and the Master Alarm light indicator (in alarm condition) are off. LED is burnt. Failure in the communication with the side LED board. LED is burnt. Battery charging system failure. Failure in the communication with the side LED board. LED is burnt. Failure in the communication with the side LED board. LED is burnt. Failure in the communication with the key board and with the Master Alarm LED board. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. Contact or - Authorized Technical Service to arrange for the repair of the ventilator.

145 8. Troubleshooting 143 Symptom Problem Solution Ventilator is auto cycling. Patient cannot trigger assisted/spontaneous cycles. Parameter and pressure graphic monitoring loss (Peak, Plateau, PEEP, Mean). The Plateau pressure features the --- indication. There is no ventilation and the High Pressure alarm is active. The Manual Insp Pause function is not activated. The ventilator does not supply the set volume (Tidal Vol and Tidal Insp Vol are smaller than the set value). The ventilator does not supply the set volume (Tidal Vol and Tidal Insp Vol are greater than the set value). Leakage in the patient circuit is causing the ventilator to auto cycle. Improperly adjusted sensitivity. Proximal pressure reading loss. When configured without Insp Pause or in the absence of the Manual Insp Pause command, the ventilator voids the Plateau pressure field. PEEP adjustment is above the High Pressure alarm adjustment. The Manual Insp Pause function is only enabled in the presence of assisted and/or controlled cycles. The High Inspiratory Pressure alarm prevents the volume from being supplied on the inspiratory period. Defective proximal flow sensor. Leaking patient circuit. The Sigh parameter is active. Check leakages in the respiratory circuit. Reduce the flow-triggered sensitivity or change from flowto pressure-triggered sensitivity. Make certain the IBW has been properly configured. Adjust the sensitivity to detect the patient s efforts. Check whether the proximal line is in perfect condition and whether it is properly connected to the equipment. Configure an Insp Pause or activate the Manual Insp Pause command to obtain an accurate Plateau pressure value. Properly adjust the PEEP and High Pressure parameters. Check whether there is a programmed respiratory rate. Check whether the alarm is correctly set. Aspirate the patient. Check whether the hygroscopic filter is saturated. Provide the replacement of the proximal flow sensor. Check the integrity and the assembly of the patient circuit and its parts. Disable this parameter.

146 Troubleshooting Symptom Problem Solution Exhaled tidal volume (Tidal Vol) is smaller than the set one or it is instable. Minute volume (Minute Vol) shows a different value from the expected one. Spontaneous minute volume (Spont Vol Minute) shows a different value from the expected one. Oxygen concentration (FiO 2 ) different from the set one. Oxygen concentration (FiO 2 ) shows indication ---. Oxygen concentration (FiO 2 ) shows symbol of an exclamation mark within a yellow triangle. I:E ratio with a different value from the one expected. Defective Expiratory Flow Sensor. This parameter is a direct consequence of the total respiratory rate (Resp Rate) and the exhaled tidal volume (Tidal Vol). This parameter is a direct consequence of the spontaneous respiratory rate (Spont Resp Rate) and the exhaled tidal volume (Tidal Vol). Low oxygen and/or compressed air intake pressure. Uncalibrated oxygen sensor. Unsuitable pneumatic supply source with low O 2 concentration. Failure in oxygen sensor. Oxygen sensor monitoring turned off The Inspiratory Pause (Insp Pause) parameter is active. Provide the replacement of the Expiratory Flow sensor. Check whether the total respiratory rate (Resp Rate) and the exhaled tidal volume (Tidal Vol) values are within expectations. Check whether the spontaneous respiratory rate (Spont Resp Rate) and the exhaled tidal volume (Tidal Vol) values are within expectations. Adjust both intake pressures within the specified range from 250 kpa to 600 kpa (2.5 kg/cm 2 to 6.0 kg/cm 2 ). Contact or - Authorized Technical Service. Provide a suitable pneumatic supply source. Contact or - Authorized Technical Service. It is also possible to temporarily turn off the oxygen sensor monitoring according to the Item 3.6 of this Operation Manual. Turn the oxygen sensor monitoring on once again according to the item 3.6 of this. If such problem occurs after the monitoring is restarted, Contact or - Authorized Technical Service. Disable the Inspiratory Pause (Insp Pause) or consider it when checking the calculation shown on the screen.

147 8. Troubleshooting 145 Symptom Problem Solution Expiratory Peak Flow (Exp Peak Flow) with different value from the expected one. Inspiratory (R Insp) and expiratory (R Exp) resistance with values different from the expected ones. Resistance Exp features the --- indication. The ratio depends on flow and respiratory rate parameters. The I:E ratio has reached the limit 3:1 (on volume-cycled modes) or 4:1 (on time-cycled modes). Obstruction in the patient circuit. Obstruction in the patient circuit. Loss of proximal pressure reading. The inspiratory resistance (R Insp) depends on Peak, PEEP and Flow parameters. The expiratory resistance (R Exp) depends on Plateau, PEEP and Flow parameters. The variation can be related to any parameter composing the calculated value. When configured without Insp Pause or in the absence of the Manual Insp Pause command, the ventilator voids the Resistance Exp field. Check whether the flow and respiratory rate parameters are within expectations. On time-cycled modes, reduce the Inspiratory Time. On volume-cycled modes, increase the flow and/or reduce the volume. Check the condition of the filters coupled to the patient circuit, if applicable. Check the water or impurity build-up in the flow sensor. Check whether the patient circuit tubes are not folded, interrupting the free flow passage. Check the condition of the filters coupled to the patient circuit, if applicable. Check the water or impurity build-up in the flow sensor. Check whether the patient circuit tubes are not folded, interrupting the free flow passage. Check whether the proximal line is in perfect condition and properly connected to the equipment. Check whether the indicated parameters are within expectations. In case of R Exp, configure an Insp Pause or press Manual Insp Pause to obtain a valid Plateau value and, consequently, a R Exp value. Configure an Insp Pause or activate the Manual Insp Pause command to obtain an accurate Resistance Exp value.

148 Troubleshooting Symptom Problem Solution Static complacence (Static C) with a different value from the expected one. Static C features the -- - indication. Dynamic complacence (Dynamic C) with a different value from the expected one. Upper controlled volume (Vol Contr) adjustment limitation prohibition message. Lower controlled volume (Vol Contr) adjustment limitation prohibition message. Leaking patient circuit. Loss of proximal pressure reading. The static complacence depends on Tidal Vol, Plateau pressure and PEEP parameters. The variation can be related to one of the parameters composing the calculated value. When configured without Insp Pause or in the absence of the Manual Insp Pause command, the ventilator voids the Static C field. Leaking patient circuit. Loss of proximal pressure reading. Dynamic complacence depends on Volume, Peak pressure and PEEP parameters. The variation can be related to any of the parameters composing the calculated value. Violation of the 3/4 rule (I:E ratio must be smaller than 3:1 on volume-cycled modes). Values lower than the limited value result in Inspiratory Time (Tinsp) < 100 ms. Check the integrity and assembly of the patient circuit and its parts. Check whether the proximal line is in perfect condition and properly connected to the equipment. Check whether the indicated parameters are within expectations. Configure an Insp Pause or press Manual Insp Pause to obtain a valid Plateau value and, consequently, a Static C value. Configure an Insp Pause or activate Manual Insp Pause command to obtain an accurate and valid Static C value. Check the integrity and assembly of the patient circuit and its parts. Check whether the proximal line is in perfect condition and properly connected to the equipment. Check whether the indicated parameters are within expectation. To enable adjustments above the rule-limited value, increase the Inspiratory Flow (Insp Flow), reduce the respiratory rate (Rate) or reduce the automatic Inspiratory Pause (Insp Pause). To enable adjustments below the rule-limited value, reduce the Inspiratory Flow (Insp Flow).

149 8. Troubleshooting 147 Symptom Problem Solution Upper Inspiratory Flow (Insp Flow) adjustment limitation prohibition message. Lower Inspiratory Flow (Insp Flow) adjustment limitation prohibition message. Upper controlled rate (Rate) adjustment limitation prohibition message. Violation of the 3/4 rule (I:E ratio must be smaller than 3:1 on volume-cycled modes). Values lower than the limited value result in Inspiratory Time (Tinsp) < 100 ms. Violation of the 3/4 or 4/5 rule (I:E ratio must be smaller than 3:1 on pressure-cycled modes, or 4:1 on time-cycled modes). To enable adjustments above the rule-limited value, reduce the controlled volume (Vol Contr), reduce the controlled rate (Rate) or reduce the automatic Inspiratory Pause (Insp Pause). To enable adjustments below the rule-limited value, increase the controlled volume (Vol Contr). To enable adjustments above the rule-limited value, reduce the controlled volume (Vol Contr), increase the Inspiratory Flow (Insp Flow) or reduce the automatic Inspiratory Pause time (Insp Pause) on volumecycled modes, or reduce the Inspiratory Time (T Insp) on time-cycled modes. Upper Inspiratory Time (T Insp) adjustment limitation prohibition message. Violation of the 4/5 rule (I:E ratio must be smaller than 4:1 on timecycled modes). To enable adjustments above the rule-limited value, reduce the controlled rate (Rate). Upper automatic Inspiratory Pause (Insp Pause) time adjustment limitation prohibition message. Violation of the 3/4 rule (I:E ratio must be smaller than 3:1 on volume-cycled modes). To enable automatic Inspiratory Pause (Insp Pause) time adjustments above the rulelimited value, reduce the controlled volume (Vol Contr), reduce the controlled rate (Rate) or increase the Inspiratory Flow (Insp Flow). Inspiratory Pause Time (Insp Pause) is automatically reset. Ventilation mode modification. Adjust a new Inspiratory Pause time (Insp Pause) every time the ventilation mode is changed, if required.

150 Troubleshooting Symptom Problem Solution Ventilator cannot be turned off by the On/Off switch. Ventilator permanently connected to the AC power mains, external battery or internal battery. Keep the Audio Pause/Alarm Reset key pressed for 10 seconds. Contact or - Authorized Technical Service to arrange for the repair of the ventilator. WARNING! In case of a failure not foreseen in this manual, stop using the equipment and immediately contact or - Authorized Technical Service.

151 9. Cleaning, Disinfection and Sterilization Cleaning, Disinfection and Sterilization

152 Cleaning, Disinfection and Sterilization

153 9. Cleaning, Disinfection and Sterilization Indicated Processes Ventilator Body The cleaning and disinfection of the exterior of the except the main display can be done using a common germicide or bactericide agent. It is recommended to clean the main display with 70% Isopropyl Alcohol-wet gauze. NOTE Never sterilize the equipment. Its internal components are not compatible with sterilization techniques. Never submerge the equipment into a liquid solution or allow liquids to enter into its internal part. Never use abrasive materials on the ventilator s surface, especially on its screen Cooling Air Intake Filter The cleanliness of the Cooling Air Filter must be periodically checked, according to the Chapter Preventive Maintenance, of this manual. If necessary, this filter must be carefully washed with warm water and neutral detergent. After the washing, it must be thoroughly rinsed and completely dried. Figure 9-1 Cooling air intake filter.

154 Cleaning, Disinfection and Sterilization Expiratory Flow Sensor WARNING! During or after cleaning / disinfecting / sterilizing: Do not direct high pressure air / water streams to the internal part Do not put any type of object in the internal part Such actions can damage the metallic film inside the sensor, compromising the reading of equipment flow Patient Circuit CAUTION! Disinfection is a process capable of destroying pathogenic microorganisms, but it is not capable of destroying spores. Spores can only be destroyed by a sterilization process. Before the first use, clean and sterilize the components of the patient circuit, following the instructions contained in this chapter. The frequency of exchange and sterilization of these circuits is defined by the protocols observed in each hospital institution. CAUTION! After the sterilization, properly rinse and dry the components of the patient circuit in order to remove any chemical residues from them. Especially after the ethylene oxide sterilization process, wait from 24 to 48 hours before using the material again in order to ensure the aeration and the complete elimination of any gas residues. Do not reuse any component that is damaged or shows signs of wear.

155 9. Cleaning, Disinfection and Sterilization 153 WARNING! Never let oils, grease and petroleum jellies touch the silicone components since these products can chemically attack them, affecting their physical properties. Components subjected to sterilization experience a natural degradation due to the characteristics of the processes employed. recommends no more than 50 cleaning/sterilization cycles for the parts of the patient circuit, even if they are performed in accordance with the conditions explicitly mentioned in this manual. Never use the following solutions for cleaning and/or disinfecting the components of the patient circuit because they can accelerate the degradation of the materials, causing cracks on the polysulfone components or disintegration of the silicone tubes. Phenol (> 5%) Chlorinated Hydrocarbons Ketones Aromatic Hydrocarbons Formaldehyde Inorganic Acids Hypochlorite Quaternary Ammonium Compounds Never disconnect the measurement ducts from the flow sensor body. If it occurs, discard the component.

156 Cleaning, Disinfection and Sterilization Indicated Process Table Part Code Material Indicated processes Tracheas (Pediatric/Adult) Silicone L + DQ L + EQ L + ETO L + AC Tracheas Silicon L + DQ L + ETO (Neonatal) Polysulfone L + EQ L + AC Proximal Line Silicon Polysulfone L + DQ L + EQ L + ETO L + AC Patient Circuit Y Connector Polysulfone L + DQ L + EQ L + ETO L + AC 90 Quarter bend Polysulfone L + DQ L + EQ L + ETO L + AC Water Collector Polysulfone Stainless Steel L + DQ L + EQ L + ETO L + AC Exhalation Valve Polysulfone L + DQ L + EQ L + ETO L + AC Exhalation Valve Diaphragm A Silicone L + DQ L + EQ L + ETO L + AC TGI / VNI Connector Polysulfone Silicone L + DQ L + EQ L + ETO L + AC Expiratory Flow Sensor Aluminum Steel membrane Silicon L + DQ L + EQ L + ETO L + AC Pediatric / Adult Flow Sensor Polycarbonate Silicon L + DQ L + EQ L + ETO Pediatric Flow Sensor Polycarbonate Silicone L + DQ L + EQ L + ETO Neonatal Flow Sensor Polycarbonate Silicone L + DQ L + EQ L + ETO

157 9. Cleaning, Disinfection and Sterilization 155 Caption L: Washing DQ: Chemical Disinfection by Immersion EQ: Chemical Sterilization by Immersion ETO: Ethylene Oxide Sterilization AC: Autoclave

158 Cleaning, Disinfection and Sterilization 9.2. Description of the Indicated Processes Washing (L) Prior to any disinfection or sterilization process, the components must be properly washed. This process consists of immersion in a neutral solution with enzymatic detergent, at a temperature between 35 C and 65 C, for approximately 10 minutes. Rinse thoroughly with distilled or filtered water and let it dry on a clean environment before proceeding with the disinfection or sterilization Chemical Disinfection by Immersion (DQ) This process consists in submerging the part into a 2% glutaraldehyde solution at room temperature for approximately 40 minutes. Rinse thoroughly with distilled and sterilized water and let it dry on a clean environment before using the component again Chemical Sterilization by Immersion (EQ) This process consists in submerging the part into a 2% glutaraldehyde solution at room temperature for approximately 12 hours. Rinse thoroughly with distilled and sterilized water and let it dry on a clean environment before using the component again Ethylene Oxide (ETO) The ethylene oxide (C 2 H 4 O) gas sterilization process must comply with standard ISO Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, dated 2007.

159 9. Cleaning, Disinfection and Sterilization Autoclave (AC) The sterilization and autoclave process must comply with standard ISO Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization, dated Below, there are some parameters suggested for this process: Condition Pressure Temperature Time Fast 220kPa (32PSI) 136 C (276.8 F) 4 minutes Normal 96kPa (14PSI) 120 C (248 F) 15 minutes

160

161 10. Preventive Maintenance Preventive Maintenance

162 Preventive Maintenance

163 10. Preventive Maintenance Introduction To prevent the premature equipment wear and achieve a safe performance within the required specifications, recommends that the following procedures be performed: Initial Verification Check List It comprises the verification of the equipment general state, as well as cleanliness, assembly, and connections to the power and gas supply sources aspects. It is recommended that it be daily performed, or before each use, according to the instructions contained in this chapter. Functional Verification Test FVT It comprises the functional verification of the equipment, as well as the operation of the alarm and monitoring features by simulating failure situations, using a lung simulator. It is recommended that it be performed before using the equipment with a patient or whenever there are doubts about the operation of the equipment, according to the instructions contained in this chapter. Annual Preventive Maintenance APM It comprises the verification and the eventual adjustment of ventilator functions, as well as replacement of parts that are worn or degraded by use, in order to extend the durability of the equipment and ensure its safe operation, within original specifications and applicable normative requirements. It is recommended that the APM be yearly performed, and it shall only be performed by or -Authorized Technical Service.

164 Preventive Maintenance Initial Verification Check List recommends performing the Check List daily or before each use, according to the following instructions: General State Check the general state of the equipment in order to ensure that it has not been dropped or damaged in such a way that its safe operation can be compromised. Make certain that the rear panel connectors are properly protected by their insulating covers. Check the status of the cooling air intake filter and, if required, wash it according to the instructions contained under Chapter Cleaning, Disinfection and Sterilization of this manual. This filter is located on the lower portion of the equipment s front panel. Power Source Connection If the equipment is connected to an external AC power source (power mains), check the general state of its power cord and plug. Make certain that it is directly connected to a grounded power mains outlet. If the equipment is connected to an external DC power source (for example, external battery), check whether it has the features contained under Chapter General Specifications of this manual. Check the internal battery charge level. For maximum battery autonomy, connect the equipment to the AC power mains for up to 48 hours before using, for at least 10 uninterrupted hours. After this period (48 hours), it is possible that a drop in the battery power level occurs, depending on its status of use. Gas Pipeline Connection Check the integrity of the air and oxygen supply hoses. Confirm that they do not have cracks and/or leaks. Only use medical grade (dry and contaminant-free) gases, in order to avoid internal damages to the equipment and risks to the patient. Check the air and oxygen intake filters. If necessary, drain the condensed water from their collection cups.

165 10. Preventive Maintenance 163 Cleaning Check the general cleanliness of the equipment. Check the cleanliness of the patient circuit. If necessary, assemble a sterilized circuit. Ensure the proper cleaning of the flow sensors, eliminating eventual solid residues deposited on their measurement ducts. The presence of such residues may affect the accuracy of these sensors. Check the state of the Cooling Air Intake filter. If necessary, wash it carefully with warm water and neutral detergent. After washing, rinse it and dry it thoroughly. Assembling Check the operation of the support arm from the patient circuit and the pedestal caster locks. Check the conservation status of the components of the patient circuit. Do not reuse any part that is damaged or worn. Check the flow sensor integrity. Never disconnect the measurement ducts from the flow sensor body. If it occurs, discard the component.

166 Preventive Maintenance Functional Verification Test FVT recommends performing the Functional Verification Test FVT before each use, or when there are doubts about the operation of the equipment, in order to check whether the ventilator and its accessories are working according to their specifications. Preferably, it is recommended to perform the FVT, setting the ventilator with the parameters that will be applied to the patient. Using a calibrated lung simulator, simulate failure situations to check the operation of alarm and monitoring features, according to the specifications contained in this manual. Below, there are some parameters that can be used as reference for performing the FVT on adult, pediatric and neonatal patients. WARNING! Do not use the equipment if it is not working within the specifications contained in this manual. In this case, interrupt its use and immediately contact or -Authorized Technical Service. NOTE For the performance of the Functional Verification Test FVT an Lung Simulator is recommended, model LS2000 or equivalent, duly calibrated.

167 10. Preventive Maintenance Adult Standard Assemble the pediatric/adult patient circuit and the Expiratory Flow sensor, according to Chapter 3 Equipment Set-Up of this manual. Connect the lung simulator into the circuit (after the flow sensor). Set the following parameters into the simulator: Resistance: 20 cmh 2 O/L/s Complacence: 50 ml/cmh 2 O Set the following parameters into the ventilator: Mode Assist/Contr VCV IBW 40 kg % O2 21 % Vol Contr 500 ml Insp Flow 30 L/min Waveform Rate 15 /min PEEP 5 cmh 2 O Sens F off Sens P off Insp Pause 0.5 s Check, on the equipment s display, if the following monitored parameters match the values shown below: Peak 25 ± 5 cmh 2 O PEEP 5 ± 1 cmh 2 O Plateau 15 ± 5 cmh 2 O Mean P 11 ± 2 cmh 2 O Tidal Vol 500 ± 50 ml Minute Vol 7.50 ± 0.75 L Resp Rate 15 ± 1 /min FiO 2 21 ± 1 % * The highlighted fields are directly influenced by the accuracy of the lung simulator used. The values shown on the table are intended for reference purposes only and have been based on a simulator with the above-described features.

168 Preventive Maintenance Set % O2 to 100%. Wait for some cycles and check on the equipment s display if the monitoring of this parameter follows such change. Check whether the pressure, flow and volume curves are compatible with the ventilation parameters and the ventilation mode in use. Set the alarm limits to values compatible with the parameters in use. Change the parameters set in the ventilator in order to generate alarm conditions, checking their performance on the monitor. WARNING! Check the correct operation of the electrochemical cell and in case any failure is detected, immediately contact or -Authorized Technical Service. The cell must be replaced every 12 months and must be discarded in compliance with the local legislation where the equipment is installed.

169 10. Preventive Maintenance Pediatric Standard Assemble the neonatal patient circuit and the pediatric proximal flow sensor, according to Chapter 3 Equipment Set-Up of this manual. Connect the lung simulator into the circuit (after the flow sensor). Set the following parameters into the simulator: Resistance: 50 cmh 2 O/L/s Complacence: 20 ml/cmh 2 O Set the following parameters into the ventilator: Mode Assist/Contr TCPLV IBW 20 kg % O2 21 % Insp Flow 15 L/min Flow Exp 5 L/min T Insp 1.00 s Rate 20 /min PEEP 5 cmh 2 O P Limit 70 cmh 2 O Sens F off Sens P off Check on the equipment s display if the following monitored parameters match the values shown below: Peak 30 ± 5 cmh 2 O PEEP 5 ± 1 cmh 2 O Mean P 11 ± 2 cmh 2 O Tidal Vol 250 ± 25 ml Minute Vol 5.00 ± 0.5 L Resp Rate 20 ± 1 /min FiO 2 21 ± 1 % * The highlighted fields are directly influenced by the accuracy of the lung simulator used. The values shown on the table are intended for reference purposes only and have been based on a simulator with the above-described features.

170 Preventive Maintenance Set % O2 to 100%. Wait for some cycles and check on the equipment s display if the monitoring of this parameter follows such change. Check whether the pressure, flow and volume curves are compatible with the ventilation parameters and the ventilation mode in use. Set the alarm limits to values compatible with the parameters in use. Change the parameters set in the ventilator in order to generate alarm conditions, checking their performance on the monitor. WARNING! Check the correct operation of the electrochemical cell and in case any failure is detected, immediately contact or -Authorized Technical Service. The cell must be replaced every 12 months and must be discarded in compliance with the local legislation where the equipment is installed Neonatal Standard Assemble the neonatal patient circuit and the neonatal flow sensor (grey), according to Chapter 3 Equipment Set-Up of this manual. Connect the lung simulator into the circuit (after the flow sensor). Set the following parameters into the simulator: Resistance: 50 cmh2o/l/s Complacence: 30 ml/cmh2o Set the following parameters into the ventilator: Mode Assist/Contr TCPLV IBW 2 kg % O2 21 % Insp Flow 5 L/min Flow Exp off L/min T Insp 1.00 s Rate 30 /min PEEP 5 cmh 2 O P Limit 70 cmh 2 O Sens F off Sens P off

171 10. Preventive Maintenance 169 Check on the equipment s display if the following monitored parameters match the values shown below: Peak 15 ± 2 cmh 2 O PEEP 5 ± 1 cmh 2 O Mean P 10 ± 2 cmh 2 O Tidal Vol 100 ± 10 ml Minute Vol 3.00 ± 0.3 L Resp Rate 30 ± 1 /min FiO 2 21 ± 1 % * The highlighted fields are directly influenced by the accuracy of the lung simulator employed. The values shown on the table are intended for reference purposes only and have been based on a simulator with the above-described features. Set % O2 to 100%. Wait for some cycles and check on the equipment s display if the monitoring of this parameter follows such change. Check whether the pressure, flow and volume curves are compatible with the ventilation parameters and the ventilation mode in use. Set the alarm limits to values compatible with the parameters in use. Change the parameters set in the ventilator in order to generate alarm conditions, checking their performance on the display. WARNING! Check the correct operation of the electrochemical cell and in case any failure is detected, immediately contact or -Authorized Technical Service. The cell must be replaced every 12 months and must be discarded in compliance with the local legislation where the equipment is installed.

172 Preventive Maintenance Annual Preventive Maintenance APM The Lung Ventilator is a high technology equipment, composed of highcomplexity electronic, mechanic and pneumatic components. As it is a lifesupport equipment and since its electronic components, as well as some of its pneumatic components, are, in their own nature, subject to deviations in their settings throughout the time, we suggest an Annual Preventive Maintenance APM to be conducted in order to check each function of the ventilator returning it to optimal performance and safety conditions whenever a deviation is detected. The Annual Preventive Maintenance APM is a service required by the customer and solely provided by or -Authorized Technical Service. The replacement of parts subject to normal wear and tear by the use is also part of APM service. The process to check and adjust the equipment is conducted in accordance with the standard ISO 9001:208 Quality Management System Requirements, using calibrated measuring equipment that are traceable to metrology standards. APM has the following characteristics: APM is a service to be requested by the customer every 12 months of equipment use; Only or an -Authorized Service can conduct interventions in products preserving the conditions of the original equipment. APM is limited to equipment, and does not include the accessories. WARNING! This equipment features safety seals on the closing bolts. If these seals are broken by unauthorized personnel, warranty will be voided.

173 10. Preventive Maintenance 171 WARNING! The battery service life depends on the ventilator s use conditions (ventilator and/or internal battery use frequency and time, environmental conditions of temperature and humidity, etc.). The storage of the ventilator for extended periods under temperatures higher than 27 C, or without recharging the battery for periods longer than two months may reduce the battery service life. WARNING! recommends the use of original accessories. The use of different parts other than those mentioned on the list of accessories is the operator s sole responsibility. All parts and pieces that need to be repaired or replaced during the maintenance process must be replaced only with original components. The use of non-original components may compromise the equipment safety, implying in product tampering and thus voiding the warranty. All parts and pieces replaced during the maintenance processes must be discarded in compliance with the local legislation where the equipment is installed. Special attention must be given to the internal lead-acid type battery, which must follow its manufacturer s guidelines, described on the side of the component.

174 Preventive Maintenance CAUTION! This ventilator is a life-support equipment. Never entrust its maintenance to an unauthorized technician. In case of problems or difficulties, contact. Never disassemble the ventilator cabinet. This situation poses a risk of electric shock. To ensure the electrical protection and avoid risk of fire, never replace the equipment fuse. The improper fuse replacement voids warranty and poses a risk to the equipment operation and to the operator s and patient s safety. Lack of maintenance or maintenance performed by a nonaccredited company will grant the product the status of tampered product, and this will subject those responsible to the sanctions provided by law; and the change of basic equipment components will constitute the non-observance of the guidelines contained in this and it may affect the safety and functionality of the equipment.

175 11. Accessories, Parts and Pieces Accessories, Parts and Pieces

176 Accessories, Parts and Pieces

177 11. Accessories, Parts and Pieces Warnings and Precautions CAUTION! Always use original accessories, parts and pieces in order to ensure the correct performance of this equipment and the validity of the warranty. In addition, this measure is also intended for the patient s and operator s safety. Never use anti-static or electrically conductive hoses or tubes along this ventilator. All patient circuit components supplied by (silicone tubes polysulfone connections, and polycarbonate flow sensors) meet the cytotoxicity, irritation, sensitivity and hemocompatibility requirements. The -supplied patient circuit provides protection against electric shock (B-TYPE applied part) and is defibrillationproof. WARNING! Components subjected to sterilization experience a natural degradation due to the characteristics of the processes employed. recommends no more than 50 cleaning/sterilization cycles for the parts of the patient circuit.

178 Accessories, Parts and Pieces Accessories Supplied Accessories Code Description (English) O 2 Hose (4-meter-long) Air Hose (4-meter-long) Pediatric / Adult Patient Circuit Neonatal Patient Circuit Pediatric / Adult Flow Sensor Pediatric Flow Sensor Neonatal Flow Sensor Expiratory Flow Sensor Exhalation Valve with Adapter Output A Exhalation Valve Diaphragm - Blue TGI / NIV Connector o Quarter Bend Optional Accessories Code Description Pedestal Articulated Arm Composed of the codes Inter 7 Plus Articulated Arm Fixed Shaft of Articulated Arm for Pedestal LS2000 Neonatal, Pediatric, and Adult Lung Simulator LS1000 Neonatal Lung Simulator LS1500 Pediatric / Adult Lung Simulator A Misty3 Heated Humidifier (110V) CA Misty3 Heated Humidifier (220V)

179 11. Accessories, Parts and Pieces 177 Optional Accessories Code Description Temperature Sensor for Misty3 Heated Humidifier IM300 Humidification Jar Air Regulating Valve O 2 Regulating Valve meter-long External Power Cord meter-long External Power Cord Neonatal Patient Circuit without drain Pediatric / Adult Patient Circuit without drain Micro Mist Nebulizer Nebulizer T Connection for Neonatal Patient Circuit (adapter)

180 Accessories, Parts and Pieces Parts and Pieces Pediatric / Adult Patient Circuit ( ) Code Description mm x 450mm Trachea mm x 750mm Trachea Proximal Line Y -Shaped Connector Water Collector o Quarter Bend Neonatal Patient Circuit ( ) Code Description mm x 450mm Trachea mm x 600mm Trachea Proximal Line Y -shaped Connector Water Collector o Quarter Bend Pediatric / Adult Patient Circuit without Drain ( ) Code Description mm x 1500mm Trachea Proximal Line Y -shaped Connector o Quarter Bend

181 11. Accessories, Parts and Pieces 179 Neonatal Patient Circuit without Drain ( ) Code Description mm x 1200mm Trachea Proximal Line Y -shaped Connector o Quarter Bend

182

183 12. Terminology, Symbols and Definitions Terminology, Symbols and Definitions

184 Terminology, Symbols and Definitions

185 12. Terminology, Symbols and Definitions Terminology The main terms used in this manual, defined by standard ABNT NBR IEC : A1:1997, are presented hereinafter: 1 - ACCOMPANYING DOCUMENTS Documents supplied along the equipment or accessory, containing all relevant information for the equipment s user, operator, and installer or assembler, especially regarding safety. 2 - CLASS I EQUIPMENT Equipment in which the electric shock protection is not only based on the basic insulation, but it has one additional safety precaution. This additional safety consists of a feature connecting the equipment to the protective grounding conductor integrated to the facility fixed wiring in order to prevent accessible metallic parts from being energized in case the basic insulation fails. 3 - B-TYPE APPLIED DEFIBRILLATION-PROOF PART Part applied in compliance with the prescriptions specified in standard ABNT NBR IEC :1994 +A1:1997 for providing protection against electric shock, especially regarding the admissible leakage current, also protected against the effects of a cardiac defibrillator discharge to the patient. 4 - PROTECTIVE GROUNDING TERMINAL Terminal connected to the conductive parts of a class I equipment for safety purposes, and foreseen to be connected to an external protective grounding system by means of a protective grounding conductor.

186 Terminology, Symbols and Definitions Simbology The meaning of the standardized symbols printed on the equipment is presented hereinafter: Symbol Reference Description IEC IEC IEC IP24 IEC ISO ISO A IEC IEC IEC IEC IEC IEC ISO 7010-M002 Alternating current Direct current Protective grounding terminal Splash-proof equipment when inclined up to 15 and protected against penetration of solid particles with diameter greater than or equal to 12.5mm Check the Operation Instructions Warning! Check ACCOMPANYING DOCUMENTS Off, for only a part of the equipment On, for only a part of the equipment Equipment with B-Type applied defibrillation-proof part Dangerous electric voltage Equipotential Pin Mandatory to follow instructions for use ISO 7010-M001 ISO 7010-P001 Generic sign to indicate a mandatory action, see adjacent message (example, reinstall the protective covers of the connectors after use) Generic sign to indicate prohibition, see adjacent message (example, do not block air passage)

187 12. Terminology, Symbols and Definitions 185 The meaning of the standardized symbols printed on the equipment packaging is presented hereinafter: Symbol Standard Description ISO 780:1997(E) Symbol No. 1 FRAGILE: The content of the packaging is fragile; therefore, it shall be handled with care. ISO 780:1997(E) Symbol No. 3 THIS SIDE UP: It indicates the position of the top of the packaging. ISO 780:1997(E) Symbol No. 4 PROTECT AGAINST SUNLIGHT: The packaging must be sheltered from sunlight. ISO 780:1997(E) Symbol No. 6 PROTECT AGAINST RAIN: The packaging must be sheltered from rain. ISO 780:1997(E) Symbol No. 14 MAXIMUM STACKING: It indicates the maximum number of identical packages that can be stacked. ISO 780:1997(E) Symbol No. 17 ISO 7000:1998 (E/F) Symbol No BS EN 980:2008 Symbol 4.6 BS EN 980:2008 Symbol 5.2 CE COMPLIANCE MARK TEMPERATURE LIMIT: It indicates the limit temperature for storing and handling the packaging as cargo being transported. RELATIVE HUMIDITY: It indicates the limit humidity for storing and handling the packaging as cargo being transported. MANUFACTURING DATE: It indicates the manufacturing date of the equipment. MANUFACTURER: It indicates the equipment s manufacturer CE COMPLIANCE: It indicates that the System complies with the European Council Directive CEE 93/42 for Medical Equipment. The xxxx stands for the certification number issued by the Certifying Entity used by the manufacturer s Quality System.

188 Terminology, Symbols and Definitions

189 13. Technical Specifications Technical Specifications

190 Technical Specifications

191 13. Technical Specifications Controls Adjustable Parameters Control Parameters % O2 (%) Vol Contr Controlled Volume (ml) P Contr Controlled Pressure (cmh 2 O) P Insp Inspiratory Pressure (cmh 2 O) P Limit System Pressure Limit (cmh 2 O) P Supp Support Pressure (cmh 2 O) Rate Mandatory Respiratory Rate (/min) PEEP Positive End Expiratory Pressure (cmh 2 O) Insp Flow Inspiratory Flow (L/min) Mode IBW Lower Limit Upper Limit Min Safe Safe Max Resolution Standard value All All VCV Ped Adu PCV All 5 10 NIV (35 PEEP) : : Ped Adu TCPLV Neo Ped VCV, PCV Ped 120 NIV Adu 40 VCV, (35 PCV, All off; 5 10 PEEP) TCPLV NIV All off; 5 10 (35 PEEP) VCV, PCV, TCPLV NIV VCV, PCV, TCPLV Neo Ped Adu Ped Adu All NIV All VCV, TCPLV Neo Ped Adu

192 Technical Specifications Control Parameters Waveform Flow Waveform T Insp Inspiratory Time (s) Sens P Pressure Sensitivity (cmh 2 O) Sens F Flow Sensitivity (L/min) Insp Pause Inspiratory Pause (s) Mode VCV PCV, TCPLV NIV All All VCV IBW Lower Limit Upper Limit Min Safe Safe Max Resolution Standard value Ped Constant Decreasing Constant Sinusoidal Adu Constant Decreasing Sinusoidal Constant : 0.05 Neo : : : : 0.05 Ped : : : : 0.05 Adu : : : : 0.05 Ped : : : 0.05 Adu : : 0.5 Neo ; off : : Ped/ : ; off Adu : Neo ; off 0.1 off Ped ; off : : 0.5 off Adu ; off : : 1.0 off Ped Adu Slope Pressure Rise Slope (%) All All End Flow End Flow (%) All All

193 13. Technical Specifications Fixed Parameters Control Parameters Mode IBW Standard value % Sigh (%) Sigh Ratio (cycles) Nebulizer Period (min) Nebulizer Flow (L/min) Nebulizer Mode TGI Delay (ms) TGI Flow (L/min) PCV Neonatal off VCV Pediatric PCV Adult NIV 50 VCV PCV All 100 NIV All All 30 All VCV PCV NIV TCPLV VCV PCV TCPLV VCV PCV TCPLV Neonatal 3 Pediatric 6 Adult 6 All Neonatal Pediatric Intermittent Synchronized Continuous All 300 Neonatal 3 Pediatric 6 Adult 6 NOTE The controlled flow and volume values are expressed in BTPS (Body Temperature and Pressure, Saturated) Pressure Limits Minimum Limited Pressure: -10 cmh 2 O ±5% Maximum Limited Pressure: 120 cmh 2 O ±5% Flow Limits Maximum Inspiratory Flow (Demand): 180L/min

194 Technical Specifications Ventilation Alarms Adjustable Physiological Alarms Alarms Prior. Mode IBW Low Inspiratory Pressure Parameter: Low Pressure (cmh 2 O) High Inspiratory Pressure Parameter: High Pressure (cmh 2 O) Low Minute Volume Parameter: Low Minute Vol (L) High Minute Volume Parameter: High Vol Min (L) High High Mediu m Mediu m VCV PCV TCPLV All 3 NIV All 3 VCV PCV TCPLV All 10 NIV All 5 VCV PCV TCPLV NIV VCV PCV TCPLV NIV Neo Ped Adult Ped Adult Lower Limit Upper Limit Auto Set Resolution Min Safe Safe Max Initial Vent. off; 0.01 off; 0.10 off; 1.0 off; 0.10 off; 1.0 (PEEP + 5) (PEEP + 5) (PEEP + 10) (PEEP + 10) (PEEP + 10) (PEEP + 10) (Peak - 5) (Peak - 5) (Peak + 5) (Peak + 5) Neo 0.01 Ped 0.10 Adult 1.0 Ped 0.10 Adult ; off 30.0; off 60.0; off 30.0; off 60.0; off : : : : : : : : : : : : : : : : : : : : : : : : : : off off off off 0.6 x Minute Vol 0.6 x Minute Vol 0.6 x Minute Vol off off 1.4 x Minute Vol 1.4 x Minute Vol 1.4 x Minute Vol off off

195 13. Technical Specifications 193 Alarms Prior. Mode IBW Low Tidal Volume (Exhaled) Parameter: Low Tidal Vol (ml) High Tidal Volume (Exhaled) Parameter: High Tidal Vol (ml) Low Resp Rate Parameter: Low Rate (/min) High Resp Rate Parameter: High Rate (/min) Low FiO2 Parameter: Low FiO2 (%) High FiO2 Parameter: High FiO2 (%) Apnea (s) Mediu m Mediu m Mediu m Mediu m Mediu m Mediu m Mediu m / High VCV PCV TCPLV NIV VCV PCV TCPLV NIV All All All Lower Limit Upper Limit Auto Set Resolution Min Safe Safe Max Initial Vent. Neo off; off Ped Adult Ped Adult off; 10 off; 100 off; 10 off; : : 50 off off Neo 1 35 Ped Adult Ped Adult : : 50 off 0.5 x Tidal Vol 0.5 x Tidal Vol 0.5 x Tidal Vol off off 50; off 500; off 2000; off 500; off 2000; off 1 off : : 50 off 100 off : : 50 off off 1.5 x Tidal Vol 1.5 x Tidal Vol 1.5 x Tidal Vol off 100 off off Neo off; Ped off; Adult off; Neo 4 60 Ped 4 45 Adult 4 30 All Off. 19 % O2 5 All All ; off 180; off 180; off x Resp Rate 0.7 x Resp Rate 0.7 x Resp Rate 1.3 x Resp Rate 1.3 x Resp Rate 1.3 x Resp Rate FiO2 5 % O2 + 5 All All Off. 60; off 1 26 FiO off (T Exp) + 5

196 Technical Specifications Auto-adjustable Physiological Alarms Alarms Prior. Mode IBW Auto Set Oxygen Low % (%) Low PEEP (cmh 2 O) High PEEP (cmh 2 O) High CPAP (cmh 2 O) Auto PEEP (cmh 2 O) High All All 18% Medium All All PEEP + 5 Medium All All PEEP + 5 High All All PEEP + 10 Medium All All Autocycling High All All End expiratory flow > 50% of Exp Peak Flow 3 consecutive assisted/spontaneous cycles with I:E > 2: Technical Alarms Alarms Prior. Mode IBW Limits Low Air Pressure Air Intake Failure (kpa) High Air Pressure High Air Intake Pressure (kpa) Air Overpressure (kpa) Low O2 Pressure Oxygen Intake Failure (kpa) High O2 Pressure High Oxygen Intake Pressure (kpa) O2 Overpressure (kpa) High All All < 250 High All All > 600 High All All > 660 High All All > 250 High All All > 600 High All All > 660 Vent Inop High All All NA Gas Fail (kpa) High All All < 120 (for both intakes) Patient Disconnection High All All NA

197 13. Technical Specifications 195 Patient Circuit Leakage Low Except TCPLV and NIV Patient Circuit Occlusion High All All NA Inadequate Flow Sensor Medium All All Flow Sensor Disconnection Disconnection of Proximal/Expiratory Flow Sensor All NA Sensor type incompatible with patient category Low All All Absence of flow signal Gas Supply Fail High All All NA Standby Time Elapsed High All All > 3min Power Fail High All All NA Internal Fail High All All NA Low Setup Battery Low All All NA Low Internal Battery High All All < 30% charge Internal Battery Fail High All All NA AC Line Fail AC Power Failure and Battery Input Medium All All NA Internal Battery in Use Low All All NA Fan Fail Medium All All NA Exhalation Valve Fail Exhalation Valve Control Failure/PIP-PEEP High All All NA Autozero Error Medium All All NA Regulator Pressure Fail Pressure Regulator Control Failure High All All NA Keyboard Fail Medium All All NA Motherboard Fail High All All NA Ventilator Off All All NA

198 Technical Specifications Monitors Measured Parameters Parameter Range Resolution Accuracy Peak Peak Pressure (cmh 2 O) PEEP Positive End Expiratory Pressure (cmh 2 O) Mean Mean Airway Pressure (cmh 2 O) Plateau Plateau Pressure (cmh 2 O) Tidal Vol Exhaled Tidal Volume (L) Minute Vol Total Minute Volume (L) Resp Rate Total Respiratory Rate (/min) Spont Resp Rate Spontaneous Respiratory Rate (/min) I:E I:E Ratio : 1 ±5% : 1 ±5% : 1 ±5% : 1 ±5% : : : : 0.1 ±10% ±10% : 1 ±5% : 1 ±5% 1:99 9.9:1 1:99 9.9:1: 1 ±5% Insp Peak Flow Inspiratory Peak Flow (L/min) Exp Peak Flow Expiratory Peak Flow (L/min) Paw Airway Pressure (cmh 2 O) ±5% ±5% : 1 ±5%

199 13. Technical Specifications 197 Parameter Range Resolution Accuracy FiO2 Inhaled Oxygen Fraction (%) Note: Oxygen monitor response time: < 20s : 1 ±3% (v/v)* * (v/v): Volume percentage. Expresses the oxygen volume per 100 units of air. Or, in practical terms, it is equal to the percentage of the upper range limit (100) Calculated Parameters Parameter R Insp Airway Inspiratory Resistance (cmh 2 O/L/s) R Exp Airway Expiratory Resistance (cmh 2 O/L/s) Static C Respiratory System Static Complacence (ml/cmh 2 O) Dynamic C Respiratory System Dynamic Complacence (ml/cmh 2 O) T Exp Expiratory Time (s) T Insp Inspiratory Time (s) P 0.1 Occlusion Pressure at 100 ms (cmh2o) Auto PEEP Auto PEEP Pressure (cmh2o) Calculation / Description R Insp = (Paw* PEEP) / Flow* Where Flow* and Paw* are respectively the inspiratory flow and airway pressure values measured 100ms after the start of the respiratory cycle. R Exp = (Plateau PEEP) / Exp Peak Flow Static C = Tidal Vol / (Plateau PEEP) Dynamic C = Tidal Vol / (Peak PEEP) It indicates the expiratory time of the respiratory cycle. It indicates the inspiratory time of the respiratory cycle. It indicates the P 0.1 value pressure measured 100 ms after the start of the inspiratory effort (assisted or spontaneous cycles). It indicates the Auto PEEP value pressure measured 200 ms before the start of a controlled cycle.

200 Technical Specifications Ventilation System / Patient Circuit Parameter Value Tolerance Inspiratory Resistance (on normal use conditions) Adult <0.7cmH 2 60L/min 10% Pediatric <0.2cmH 2 30L/min 10% Neonatal <0.03cmH 2 6L/min 10% Inspiratory Resistance (on equipment failure condition) Expiratory Resistance (on normal use condition) Adult <6cmH 2 60L/min 10% Pediatric <2cmH 2 30L/min 10% Neonatal <0.2cmH 2 6L/min 10% Adult <1cmH 2 60L/min 10% Pediatric <0.3cmH 2 30L/min 10% Neonatal <0.05cmH 2 6L/min 10% Expiratory Resistance (on equipment failure condition) Adult <3cmH 2 60L/min 10% Pediatric <0.8cmH 2 30L/min 10% Neonatal <0.06cmH 2 6L/min 10% Circuit complacence Adult 1.33mL/cmH 2 60L/min 10% Pediatric 0.60mL/cmH 2 30L/min 10% Neonatal 0.60mL/cmH 2 6L/min 10% Circuit complacence (with IM300 jar) Adult 1.96mL/cmH 2 O a 60L/min 10% Pediatric 1.08mL/cmH 2 30L/min 10% Neonatal 1.08mL/cmH 2 6L/min 10% Internal Volume of the Circuit Adult 1.025L 5% Pediatric 445mL 5% Neonatal 445mL 5% Internal Volume of the Circuit (with IM300 jar) Adult 1.425L 5% Pediatric 845mL 5% Neonatal 845mL 5%

201 13. Technical Specifications Electromagnetic Immunity Electromagnetic Emission The is intended to be used on the electromagnetic environment specified below. The customer or user must ensure the use in such environment. Emission Test Compliance Guidelines Electromagnetic Environment RF CISPR 11 Emissions Group 1 The only uses RF energy for its internal functions, such RF emission is too low and should not cause any interference in nearby electronic equipment. RF CISPR 11 Emissions Harmonic Emissions IEC Voltage Fluctuations/Flicker Emissions IEC Class A Class A Compliant The is suitable for use on all establishments, including domestic establishments and those directly connected to the public low voltage power mains that supply power for domestic use.

202 Technical Specifications Electromagnetic Immunity The is intended to be used on the electromagnetic environment specified below. The customer or user must ensure the use in such environment. Immunity Test IEC Test Level Compliance level Electromagnetic Environment Guide Electrostatic Discharge IEC ± 6 kv - contact ± 6 kv - contact ± 8 kv - air ± 8 kv - air The floor must be made of wood, concrete or ceramic. If the floor is made of synthetic material, the relative humidity shall be of 30% at least. Quick Electric Transient / Pulse Train IEC ± 2 kv for power supply line ± 1 kv for the input and ± 2 kv for power supply line ± 1 kv for the input and output The quality of the power mains must be the standard quality for commercial or hospital environment. output line line Surge IEC ± 1 kv from line to line ± 2 kv from line ± 1 kv Differential Mode ± 2 kv Common The quality of the power mains must be the standard quality for commercial or hospital environment. to ground Mode <5 % U T (>95 % dip at U T ) for 0.5 cycle <5 % U T (>95 % dip at U T ) for 0.5 cycle Voltage dips, short voltage interruptions and variations on the power mains input voltage IEC % U T (60 % dip at U T ) for 5 cycles 70 % U T (30 % dip at U T ) for 25 cycles 40 % U T (60 % dip at U T ) for 5 cycles 70 % U T (30 % dip at U T ) for 25 cycles The quality of the power mains must be the standard quality for commercial or hospital environment. If the user requires continuous operation during power shortages, it is recommended that the be powered by an uninterrupted power source or battery. <5 % U T (>95 % dip at U T ) for 5 seconds <5 % U T (>95 % dip at U T ) for 5 seconds

203 13. Technical Specifications 201 Manufacturer guidelines and statement electromagnetic immunity The is intended to be used on the electromagnetic environment specified below. The customer or user must ensure the use in such environment. Immunity Test ABNT NBR IEC Test Level Compliance Level Electromagnetic Environment - guidelines Conducted RF IEC Vrms 150 khz to 80 MHz on ISM bands a 10 Vrms Portable and mobile RF communication equipment should not be used close to any part of the, including cables, with a separation distance smaller than the recommended one, calculated from the equation applicable to the transmitter frequency. Recommended Separation Distance d = 1.2 P Radiated RF IEC V/m 80 MHz to 2.5 GHz 10 V/m d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.5 GHz where P is the maximum rated transmitter output power in watts (W), according to the transmitter manufacturer, and d is the recommended separation distance in meters (m) b. It is recommended that the field intensity from the RF transmitter, as defined by means of an electromagnetic inspection on the location c, is smaller than the compliance level on each frequency range d. Interferences may occur around the equipment identified by the following symbol:

204 Technical Specifications NOTE 1 At 80 MHz and 800 MHz, the highest frequency range is applied. NOTE 2 These guidelines may not be applicable in all situations. The electromagnetic propagation is affected by the absorption and reflection of structures, objects and persons. a The ISM bands (industrial, scientific and medical) between 150 khz and 80 MHz are MHz to MHz; MHz to MHz; MHz to MHz; and MHz to MHz. b The compliance levels on the ISM frequency bands between 150 khz and 80 MHz and on the frequency range between 80 MHz to 2.5 GHz is intended to reduce the probability of mobile and portable communication equipment causing interference if they are inadvertently brought to the patient s environment. For this reason, an additional 10/3 factor is used at the recommended separation distance calculation for transmitters on such frequency ranges. c The field intensities established by fixed transmitters, such as radio base stations, mobile land radio-telephones (mobile/wireless), land mobile radios, amateur radio, AM and FM radio transmission, and TV transmission cannot be theoretically foreseen with accuracy. In order to assess the electromagnetic environment due to fixed RF transmitters; it is recommended considering an electromagnetic inspection of the place. If the field intensity measurement on the place where the is used exceeds the RF compliance level applicable above, it is recommended to observe the for checking if the operation is Normal. If an abnormal performance is observed, additional procedures might be required, such as reorientation or relocation. d Above the frequency range from 150 khz to 80 MHz, it is recommended that the field intensity is smaller than 3 V/m.

205 13. Technical Specifications 203 Recommended separation distances between mobile and portable RF communication equipment and the The is intended for use on an electromagnetic environment where the RF perturbations are controlled. The customer or user can help preventing electromagnetic interference keeping a minimum distance between mobile and portable RF communication equipment (transmitters) and the as recommended below, according to the maximum communication equipment output power. Maximum transmitter output power [W] Separation distance [m] according to the transmitter frequency 150 khz to 80 MHz out of ISM bands d = 1.2 P 150 khz to 80 MHz on ISM bands d = 1.2 P 80 MHz to 800 MHz d = 1.2 P 800 MHz to 2.5 GHz d = 2.3 P For transmitters with a maximum rated output power not listed above, the recommended separation distance d in meters (m) can be defined using the equation applicable to the transmitter frequency, where P is the maximum rated transmitter output power in watts (W), according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the highest frequency range is applied. NOTE 2 The ISM bands (industrial, scientific and medical) between 150 khz and 80 MHz are MHz to MHz; MHz to MHz; MHz to MHz; and MHz to MHz. NOTE 3 An additional 10/3 factor is used at the recommended separation distance calculation for transmitters on ISM bands between 150 khz and 80 MHz and on the frequency range from 80 MHz to 2.5 GHz for reducing the probability of mobile/portable communication equipment causing interference, if they are inadvertently brought to the patient areas. NOTE 4 These guidelines may not be applicable to all situations. The electromagnetic propagation is affected by the absorption and reflection of structures, objects and persons.

206

207 Warranty Term 205 Warranty Term The Equipamento Médico Hospitalar Ltda. products are warranted against material and manufacturing defects and meet the published characteristics. The warranty and technical support are warranted by Equipamento Médico Hospitalar Ltda. and its Authorized Service nationwide and in countries where there is implemented Authorized Service. The warranty is limited to the exchange, repair and labor for the parts that might be defective during the warranty period. The application of this warranty is subject of Equipamento Médico Hospitalar Ltda. or -Authorized Technical Service assessment, which should confirm that the defect is covered by the terms of this warranty. The warranty does not cover defects caused by improper use, incorrect handling, improper installation, application of improper cleaning or sterilization processes, violation, changes not authorized by the manufacturer or conduction of service by non-authorized or non-qualified personnel. The equipment features safety SEALS on the closing bolts. If these seals are broken by unauthorized personnel, equipment WARRANTY will be voided. Parts subjected to wear by adverse use conditions, inadvertent use or accidents are not covered by the WARRANTY, and are not comprised in the costs of Annual Preventive Maintenances (APM), representing an additional cost. The standard warranty period is 12 months for the equipment, 180 days for the battery, and 60 days for accessories, provided regular periodic maintenances and checking are performed and their original features are maintained, counted from the date of the equipment s delivery or according to specific contract conditions that might have been agreed upon.

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209 VAS PRESSURE Output Manifold TGI NEBULIZER INSPIRATORY BRANCH EXPIRATORY BRANCH Attachment A: Pneumatic Scheme 207 Attachment A: Pneumatic Scheme FLOW SENSOR EXHALATION VALVE XDC5 EXHALATION PILOT PILOT PRESSURE FLOW-1/FLOW-2 SP5 EXHALATION PILOT PILOT FLOW VAS FLOW PROXIMAL FLOW O2 INTAKE Air INTAKE 700 kpa Relief Valve 700 kpa Relief Valve Filter Intake Manifold Intake Pressure Regulating Line (24 psi) Intake Manifold iate Manifold

210 208 Attachment A: Pneumatic Scheme

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212 Equipamento Médico Hospitalar Ltda. Equipamento Médico Hospitalar Ltda. CNPJ: / I.E.: Rua Santa Mônica, 980 Parque Industrial San José Cotia / SP Brazil Ph.: +55 (11) / Fax: +55 (11) website: contato@intermed.com.br