Tecme Neumovent Technical Manual 94

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Graph ventilator

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Technical manual

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(review 04)

MAY 2006

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CONTENT CHAPTER I GENERAL AND OPERATION FEATURES TECHNICAL DATA AND SPECIFICATIONS CONTROL PANEL SAFETY MECHANISMS CHAPTER II MAINTENANCE INSTRUCTIONS CHAPTER III TROUBLE SHOOTING CHAPTER IV SENSOR VERIFICATION CHAPTER V EQUIPMENT OPENING AND CLOSURE CHAPTER VI DETAIL OF ASSEMBLIES CHAPTER VII ELECTRONIC BOARDS: DETAIL CHAPTER VIII CALIBRATION CHAPTER IX FINAL CONTROL

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CHAPTER I

GENERAL AND OPERATION FEATURES

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Characteristics and Principles of Operation Generic definition It is a device for continuous use foreseen to control mechanically or to help the patient’s ventilation, giving a predetermined oxygen concentration in the breathing gas with an adjustable volume or pressure.

Intended use Purpose and function of the NEUMOVENT Graph Ventilator: § Lung ventilator for mechanical ventilation of medical application, electric and pneumatically driven and microprocessor-controlled. § The intended use is to provide continuous ventilation to patients requiring ventilatory support. This product is intended to be used in a wide range of patient from infants until adults and to cover a variety of clinical conditions, and to be used in short or long terms. § The device is intended for used in hospitals and hospital-type facilities that provide respiratory care for patients requiring respiratory support.

Classification Class: llb (Rule 9). Active therapeutic devices intended to administer or exchange energy to or from the human body in a potentially hazardous way. Type: Active medical Device. Operative Mode: Continuous. Life Cycle: 5 years if maintenance schedule is followed. WARNING: Do not use the ventilator in the presence of flammable anesthetics. An explosion or fire may result.

Description The NEUMOVENT Graph Ventilator comprises a system of related elements and designated to alter, transmit and apply energy directly, and in a predetermined mode, replacing or contributing with the patient's muscular capacity in the execution of the work of breathing with the intention of achieving an efficient gas exchange. This function of increase the mechanical support to the patient can be explained for the following: 1. Control Mechanism. It explains how the machine can work to increase or supplement the patient's breathing effort. 2. Control Circuit. It defines what types of devices are used to complete this task. 3. Control Variables. It defines which are the dynamic elements that control any stage in the course of the breathing cycle. 4. Breathing Phases Variables. It explains how the ventilator responds to changes that produce the beginning, the support and the end of the breathing cycle. 1. Control Mechanism To understand how the machine can control the substitution or the supplementation of the natural function of breathing, before, it is required to explain something on the mechanics of breathing. Specifically on the pressure that is necessary to exercise to make a flow enters to the airway and increase the volume of the lungs.

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In the course of an inspiration and expiration, there is a change of pressure, volume and flow. A mathematical model called Equation of the Motion of the breathing system describes this change. Equation of Motion Muscle Pressure + Ventilator Pressure =

Volume + Resistance x Flow Compliance Muscle pressure: Forces generated by the breathing muscles during the inspiration. Ventilator Pressure: Transrespiratory Pressure generated by the ventilator during the inspiration (e.g.: pressure of the airway less pressure of the surface of the body).

The combined muscle and ventilator pressure cause volume and flow to be delivered to the patient. Pressure, volume and flow change with time and hence are variables. The compliance and the resistance are the constants maintained by the respiratory system. If the patient’s ventilatory muscles are not functioning, the ventilator must generate all the pressure required to deliver the tidal volume and the inspiratory flow rate. In this case, it will control the ventilation. The NEUMOVENT Graph Ventilator is able to control the pressure waveforms like the flow waveforms. This control also can be doing in a single inspiration. 2. Control Circuit The NEUMOVENT Graph Ventilator uses an electronic circuit to perform, control and monitor the ventilation. The critical components of this system include a microprocessor, pressure sensors and servo proportional valves. 3. Control Variables As it was mentioned, the control variables of the NEUMOVENT Graph Ventilator are the Pressure and the Flow.

Criteria for determining the control variable (9)

(modify from. Chatburn )

The ventilator is a Time Controller

The ventilator is a Pressure Controller

no Observation and previous knowledge

The ventilator is a Volume Controller

yes

yes

Does pressure waveform change when patient resistance and compliance change?

yes

Does volume waveform change when patient resistance and compliance change?

no

Is volume measured directly (by volumetric displacement rather than by flow transducer)?

no NEUMOVENT Graph

The ventilator is a Fow Controller

The equation of motion establishes that if the Pressure is selected as the control variable, then the ventilator is a pressure controller. Therefore, the left side of the equation will be

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determined by the selections made in the ventilator and they won't be affected by the changes of the right side (compliance and resistance). As it will be seen, the Pressure Controlled (PCV) and Pressure Support (PSV) modes use the pressure as the control variable. If the change of volume (VT) is maintained stable when the compliance or the resistance change and simultaneously the flow are measured directly (pneumotachograph), then the ventilator is classified as a flow controller. The Volume mode of the NEUMOVENT Graph Ventilator uses the flow as the control variable. The Pressure Support mode with Volume Assured is able to change, in oneself inspiratory phase, from pressure controller to flow controller.

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4. Breathing phases variables In each one of the ventilation phases (inspiration and expiration), a particular variable is measured and used to begin, sustain and conclude the phase. In this context, pressure, volume, flow and time are referred as the phase variables.

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Principles of Operation Operative definition The NEUMOVENT Graph Ventilator is a pressure or flow controller. The inspiration is triggered by pressure, flow, time or manually. It is pressure, volume or flow limited and pressure, volume, flow or time cycled. Two proportional valves, one for air and another for oxygen regulate the flow of gas to the patient. The valves work simultaneously during each respiratory phase mixing the gases to get the set FIO2.

The microprocessor receives the airway pressure and the inspiratory flow signals, and it controls the orders for the adjusted variables and the output signals. The airway pressure sensor is connected at the beginning of the patient's circuit. This sensor also manages the feedback signals that are used for pressure triggering, alarms levels, and to control the pressure waves in the pressure controlled, pressure support and mandatory minute ventilation modes. Two differential pressure transducers related with the internal and external pneumotachographs obtain the information of the delivered and exhaled flow. The two output pneumotachographs are screen type; the expiratory is of variable orifice. Also, the signals of the first are used to control the flow waveform and the tidal volume regulated as reference.

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Control valves The mentioned proportional valves regulate the gas flow to the patient. The flow control is able to send flows up to 180 L/min when the gases are from a central-supply system, and of 120 L/min when a portable compressor provides the air. Two solenoids valves govern the expiratory valve, one for the closing and opening (beginning and end of the inspiratory phase). The other one is a low flow proportional valve that regulates the partial closing of the expiratory valve to produce positive pressure at the end of the expiration (PEEP). The activity of these valves is coordinated by the microprocessor, synchronizing its actions. The system of valves has, also, four solenoids valves that act synchronously every 15 minutes to make a system zeroing (atmospheric pressure) of all sensors. At the same time, another solenoid valve allows to pass a calibrated compressed air flow to purge the lines of the expiratory pneumotachograph to avoid the entrance of water and humidity to the sensors.

Control panel The control panel comprises the keys to select the different modes and functions. In the center there is a LCD screen where the results appear, so much in numeric data as graphic representations and messages.

Some keys have lamps to indicate activation of the required function. The graphics in real time of pressure, flow, volume, pressure/volume and flow/volume loops appear in successive

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form pressing a key. The airway pressure is represented dynamically by an analogical bar graph. The numeric values exhibited below and to the right of the screen are those programmed by the operator. Those of the superior and left part are resulting values. Some values have small characters, as the indication of high and low alarm limit of VT. Others are remarkable as the high and low-pressure limit. The mode in use is shown with highlighted video inverse characters. Above the mode in use appears, when it is programmed, the sigh and/or pauses indication. Likewise, the screen shows messages indicating an alarm state or to execute some action.

Respiratory cycle The process of insulation of gas to the lungs by means of the mechanic ventilation with the NEUMOVENT Graph Ventilator comprises four steps: 1) Start of inspiratory phase 2) Progression of inspiration 3) End of inspiration 4) Expiratory phase Start of inspiratory phase The beginning of the inspiration can be automatic (for action of the respiratory frequency control) or for the patient's initial inspiratory effort. In the first case the ventilation will be of controlled type and in second assisted type.

Pressure breathing curves where is pointed out the beginning and the end of the inspiratory phase. For selection of assist/control ventilation the Volume (VCV) or Pressure (PCV) modes are used. The spontaneous ventilation includes, in this ventilator, the Pressure Support (PSV) mode and its combinations, where the patient begins and ends the inspiration according to he/she demand. The inspiratory effort that triggers the inspiratory phase modifies the pressure of the breathing circuit or it produces variation of a continuous flow in the same circuit. In both cases the system is regulated by means of the Inspiratory Sensitivity control. From the mechanical point of view, the closing of the expiratory valve and the opening of the flow of gas mixture toward the breathing circuit and the patient characterize this stage. Progression of inspiration The duration of this stage depends on the time during which comes out flow of the ventilator toward the breathing circuit and the patient, while the expiratory valve remains closed.

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The form in the flow administration depends on the ventilatory mode and of the selected flow waveform. In the VCV mode the flow waveforms, which can be selected, are: descending ramp (decelerating), rectangular (continuous flow), sinusoidal, ascending ramp (accelerating). In the pressure modes (PCV and PSV) the flow waveform is decelerating, except in PSV with volume assured where it could be combined decelerating with continuous flow in the same inspiratory phase.

Layouts of pressure (up) and flow (below) curves. From left to right: Flow in descending ramp, rectangular, sinusoidal, ascending ramp. Notice the modifications of the curves of pressure according to the used flow. End of inspiration The suspension of the ventilator inspiratory flow depends on the time selected in the VCV and PCV modes. In the PSV mode depends on the fall of the inspired flow until a derivative percentage of the initial flow of that same inspiration is reached. The regulation of this Expiratory Sensitivity can be made from 5% up to 40% of the initial flow. The default percentage is 25%.

Flow curve during Pressure Support (PSV). In this case the inspiration finishes when the flow has diminished to 25% of the initial flow (default value). Expiratory phase It begins when the expiratory valve opens up allowing escaping the flow exhaled by the patient. This action is passive and it carries out by the elastic recoil of the lung and the thoracic cage. Generally, the expiratory flow waveform shows an inverted peak which returns with variable retard to the zero flow line. The delay in reaching the zero can be due to expiratory retard of an obstructive lung disease or for breathing circuit defects.

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The expiratory phase can be modifying adding Positive Pressure at the End of Expiration (PEEP). The NEUMOVENT Graph Ventilator produces this positive pressure by means of a digital regulation of the closing force of the expiratory valve diaphragm.

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Pressure curves during ventilation with 5 cm H2O of PEEP.

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Operative modes According to the described functional characteristics, as well as the controls and limits assigned to this device, the following operative modes have been included. These modes agree with the descriptions of the classic world literature, which is mentioned partly in "Bibliography." The division in three parts has for object to separate the groups according to the predominant variable, volume, pressure, or combined modes. The combined modes include modes with participation of the two modalities and other where objectives of tidal volume or minute volume that should be get. Following is defined and describe the form of action for each operative mode.

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Volume VCV Assist/Control Definition and Operative Proceeding: It is a ventilatory mode with specific regulation of the tidal volume. The inspiratory pressure is variable, and it depends on the respiratory impedance to regulated volume. During this mode, the ventilator works as a flow-controller where the selected flow waveform is sustained during any lung compliance/resistance variation. In this mode, the ventilator is time cycled, and the inspiratory flow is automatically calculated and regulated. This means that for a given volume, the variations of the inspiratory flow are obtained by means of the regulation of the inspiratory time. It also explains why a rapid pressure drop without an inspiratory plateau marks the end of inspiration, unless it is specifically regulated. In the volume mode, the inspiratory flow can be changed by means of the flow waveform control key. The different flows are: descending ramp, constant, sine and ascending ramp. Each of these flow waveforms also produces characteristic pressure and volume waveforms. This mode works with the Assist/Control characteristic, changing from a manner to other according to the patient's demand (inspiratory effort). If the patient’s inspiratory effort is reduced or an apnea episode is present, then, the inspiration will be triggered by time (set machine frequency). On the other hand, the patient's inspiratory effort could be enough to trigger the ventilator and begin the inspiratory phase with he/she own breathing frequency and according with the set trigger sensitivity. Specific Controls for the VCV mode: VT: Regulation of gas volume propelled by the ventilator in each inspiration. Flow Waveform: To change the flow waveform. Sigh: With selection of sigh Vt; number (1,2 or 3 successively); events per hours (5, 10, 15, 20); insp. pressure limit. Insp. Pause: With time selection from 0.25 to 2.0 seconds.

Pressure It comprises modes with specific regulation of the inspiratory pressure. It has two sub modes: 1) Pressure Controlled (PCV) Assist/Control 2) Pressure Support (PSV) and/or CPAP. In both sub modes the ascending slope of the pressure can be varied with the Rise Time control.

PCV Assisted/controlled Definition and Operative Proceeding: In the Pressure-Controlled Ventilation mode (PCV), the ventilator works as a positive pressure controller because the pressure waveform remains the same when the patient’s compliance or resistance changes. The switching from inspiration to expiration is normally regulated by time (inspiratory cycling by time) or by pressure if the maximum safety pressure limit is reached. As in all pressure-controlled modes, the ventilatory volume is variable and depends on the

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lung size, the existent pressure gradient at the beginning of inspiration between the upper airway and the alveoli, the respiratory system compliance and the available inspiratory time. The pressure waveform developed during inspiration is rectangular, being the flow of the descending ramp type (decelerating flow). The typical pressure plotting shows a rapid lineal increase until the set pressure limit is reached. Pressure is maintained constant during the set inspiratory time. It cannot be changed.

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This mode works with the Assist/Control characteristic, changing from a manner to other according to the patient's demand (inspiratory effort).

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If the patient’s inspiratory effort is reduced or an apnea episode is present, then, the inspiration will be triggered by time (set machine frequency). On the other hand, the patient's inspiratory effort could be enough to trigger the ventilator and begin the inspiratory phase with he/she own breathing frequency and according with the set trigger sensitivity.

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In PCV it is possible to regulate the pressurization, that is to say, the rising speed of the pressure until reaching the selected pressure limit. The pressurization is regulated by means of the Rise Time keys, one to increase and another to diminish the speed. Specific Controls for the PCV mode: PCV: It regulates the pressure level. Rise Time: Two keys to increase or to lower the pressurization time.

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Pressure Support

Definition and Operative Proceeding: Pressure support ventilation is a spontaneous ventilation mode where the patient begins and ends the inspiratory phase; this means that he keeps control of the frequency, the duration of the inspiration and of the tidal volume. As in all modes limited by pressure, the tidal volume (VT) is variable, depending on the regulated pressure in relation to the respiratory system impedance, as well as to the patient’s demand.

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In this ventilator, the pressure support is programmed directly, alone or in combination with other modes.

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The patient begins the inspiratory phase according to him/her inspiratory effort and set Inspiratory Sensitivity (pressure or flow). The inspiration end depends on the set Expiratory Sensitivity (40. 33, 25, 15, 10 or 5% of the initial peak flow). As a safety measure, the end of inspiration can be for pressure (3 cm H2O above the adjusted one) or time (3 seconds maximum).

Specific Controls for the PSV mode: PSV: It regulates the pressure level. Rise Time: Two keys to increase or to lower the pressurization time.

Continuous Positive pressure (CPAP) Definition and Operative Proceeding: In this mode the ventilator should generate, by means of a partial closing of the expiratory valve, a continuous positive pressure in the breathing circuit. When the patient inspires, the proportional solenoid valves will open providing a flow according to the patient's demand. In this mode, the flow varies

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to maintain the adjusted value of positive pressure. It can be programmed with or without pressure support. During the inspiratory phase, there is a decrease of the airway pressure proportional to the demand. During the expiratory phase the airway pressure tend to increase and becomes higher than the regulated base pressure. Specific Controls for the CPAP mode: PEEP/CPAP: It regulates the airway level of positive pressure.

Combined modes Group of modes in which the patient has spontaneous ventilation with mandatory inspirations inserted in synchronized form. Also it comprises modes with spontaneous ventilation and minimum objectives of tidal volume or minute volume. The combined modes that may be programmed are: §

SIMV (VCV) + PSV Synchronized intermittent ventilation with volume-controlled mandatory inspiration and spontaneous inspirations with pressure support.

§

SIMV (PCV) + PSV Synchronized intermittent ventilation with pressure-controlled mandatory inspiration and spontaneous inspirations with pressure support.

§

MMV + PSV Mandatory minute ventilation with pressure support. The ventilator has an automatic control of the pressure support level in order to guarantee minimum minute ventilation during an eventual decrease of the spontaneous breathing.

§

PSV + VT Assured Pressure support ventilation with assured tidal volume in case of an eventual reduction of the breathing effort. In this mode the objective is to guarantee a minimum tidal volume from a pressure regulated inspiration. Airway Pressure Release Ventilation (APRV)

§

It is a mode which ventilates applying periodic switching between two adjustable levels (P-high and P-lower) of continuous positive airway pressure (CPAP) during preset periods of time. Synchronized intermittent ventilation with volume-controlled mandatory inspiration and spontaneous inspirations with pressure support. (SIMV [VCV] + PSV) Definition and Operative Proceeding: This mode is a combination of spontaneous breathing with mechanical ventilation placed synchronically according the patient's demand. In this synchronized ventilation form, the patient receives during the mandatory breaths (forced) a preset volume sent with a preset frequency and inspiratory time. During the spontaneous breathings the patient ventilates with pressure support. As in the Volume (VCV) mode, the flow waveform of the mandatory inspiration can be changed in the course of the ventilation. Specific Controls for the SIMV [VCV] + PSV mode:

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VT: Regulation of the propelled volume by the ventilator in the mandatory inspiration. Flow Waveform: To change the flow waveform. PSV: Regulates the level of pressure support. Rise Time: To vary the PSV pressurization.

Synchronized intermittent ventilation with pressure-controlled mandatory inspiration and spontaneous inspirations with pressure support. (SIMV [PCV] + PSV) Definition and Operative Proceeding: Similar to the previous mode, in this synchronized ventilation form the patient receives, during the mandatory inspiration, a pressure controlled inspiration with decelerating flow which is sent to the patient in a synchronized form. During the spontaneous breathings the patient ventilates with pressure support. Specific Controls for the SIMV [VCV] + PSV mode: PCV: Regulation of the pressure of the mandatory inspiration. PSV: Regulates the level of pressure support. Rise Time: To vary the PCV and PSV pressurization.

Mandatory Minute Ventilation with Pressure Support. (MMV + PSV) Definition and Operative Proceeding: It is a spontaneous ventilatory mode where the patient breathes with pressure support at a preset initial value, and there is regulation of a minimum minute volume. During every minute, if the volume is not reached, the pressure support level increases progressively until that volume is attained. Specific Controls for the SIMV [VCV] + PSV mode: Minute Volume: Regulation of the minimum minute volume. PSV: Regulates the initial level of pressure support. Rise Time: To vary the PSV pressurization.

Pressure Support Ventilation with Tidal Volume Assured. (PSV + VT Assured) Definition and Operative Proceeding: It is a spontaneous ventilatory mode where the patient breathes with pressure support at a given value combined with the regulation of a target tidal volume. If during some breath, the set volume is not reached, the descending ramp flow changes to continuous flow. This effect produces a rise in the inspired volume until the target volume is reached with a concomitant rise in the airway pressure. Specific Controls for the SIMV [VCV] + PSV mode: VT: Regulation of the minimum tidal volume. PSV: Regulates the level of pressure support. Rise Time: To vary the PSV pressurization.

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Airway Pressure Release Ventilation (APRV) It is a mode which ventilates applying periodic switching between two adjustable levels (P-high and P-lower) of continuous positive airway pressure (CPAP) during preset periods of time. Spontaneous breathing is possible without restriction at both levels. The two levels of positive pressure, alternating to intervals of time selected by the operator, produce intermittent distension and passive decompression of the lungs. At the same time, and so much during the upper or lower level, the patient can breathe spontaneously with or without pressure support. It can by apply in ADL and PED category. Specific Controls for the APRV mode: PEEP/CPAP: The default values are of 5 and 0 cm H2O for P-high and Plower CPAP, respectively. In the screen, the first value appears in the normal place of PEEP/CPAP. The second appears under the previous one. To change the CPAP values the [PEEP/CPAP] key it is pressed once to modify the high value or twice for the lower, with change of the number to inverse video. With the key [×] of Selection sector it can be increased or decreased the value, accepting with [Enter]. The low value can be same but not bigger that the high. Ti: This key completes a double function by means of which it can be adjusted the time value of the high and lower CPAP pressure period. The values for default are 5 and 1.5 seconds respectively. In the screen, the values appear one above the other one in the place that corresponds at the Inspiratory Time. To change the time values the [Ti] key should be pressed one or twice, enabling the number of the high or low time respectively. With the key [×] of Selection sector it can be increase or decrease the value, accepting with [Enter]. PSV - Rise Time: During the period of high and low CPAP, the patient can have spontaneous ventilation with or without pressure support. As default there is 5 cm H2O of pressure support but it can be changed from 0 to 50 cm H2O. Sensitivity: Key to regulate the trigger sensitivity during the spontaneous breathings. For default, the sensitivity is for flow of 3 L/min.

Backup Ventilation Backup ventilation is a mode intended to guarantee ventilation in patients when there is a decrease in the breathing effort or episodes of apnea during spontaneous ventilation modes. The warning signal, when the apnea alarm is activated, is audible and visual, and repeats every ten seconds during five seconds. This signal is accompanied with a message in the screen and activation of the light of apnea alarm. This mode is of obligatory programming when some spontaneous ventilation form is selected, as being Pressure Support, SIMV in its two forms, MMV and PSV with VT Assured. In this way, the backup programming will offer security to the patient in case the ventilator does not detect signal of pressure or flow to begin an inspiratory phase. However, in SIMV it is possible to opt for the deactivation of the backup function.

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As the device does not recognize difference between effort reduction and apnea, generically this last term is used. For default the apnea time is established in 15 seconds, but it can be modified at 5, 10, 30 or 60 seconds (Menu key). The backup ventilation for ADULT and PEDIATRIC category is made by volume or pressure mode. In NEONATOLOGY it is made with pressure (PCV).

Common Controls to all Modes f: Regulation of the ventilator frequency. Disabled in PSV, CPAP, MMV and PSV+VT Assured. Vtr: Regulation of the inspiratory flow sensitivity. Ptr: Regulation of the inspiratory pressure sensitivity. FIO2: Regulation of the fraction of inspired oxygen in the gas mixture. PEEP/CPAP: To regulate a continuous positive pressure in the breathing circuit. Manual inspiration: To start an inspiration. Stand by: To suspend the operation of the ventilator without suppressing the set data. Nebulization: To begin a period of flow to the nebulizer. Alarm limits and related keys -High Inspiratory Pressure -Low Inspiratory Pressure -VT high/low -f max: High breathing frequency -Loss of PEEP: 2, 4, 6 cm H2O. -Apnea Time: 5, 10, 15, 30, 60 seconds. -Silence: To suppress the alarm sound up to 60 seconds. -Selection and Enter: Keys to increase or to lower a parameter and to accept a selected value. -Reset: To return some action in course. -Ctrl: To combine functions with other key.

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Alarms and Safety Mechanisms

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The device has an alarm system with simultaneous messages to alert conditions that, if they persist, they put or they can put in danger the patient's state and could require immediate attention. The safety mechanisms are referred to intrinsic functions of the device and comprise to assigned program limits of each ventilatory parameter and some automatic operative actions.

Alarms

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All the alarms have visual and audible signals, and are accompanied by a message on the screen indicating the name of the alarm activated, and the possible cause and some suggested solution. The alarms have activation priority and follow an order in accordance with that priority. This means that if there are two or more events taking place simultaneously, all the LED’s corresponding to those alarms is lit, but the message on the screen is that of the alarm with a higher hierarchy. In all cases, the High Inspiratory Pressure Alarm is considered the one with highest priority. Some alarms have programmable values (high and/or low limits of pressures, volumes, rate), other are automatically activated after an elapsed time. While the device remains functioning, all the alarm events are recorded in memory and they appear in the screen of Activated Alarms with date and hour in a maximum sequence of 50 lines. The signals of alarm are grouped in three categories: 1) High Priority 2) Medium Priority 3) Low Priority

High Priority Signals (urgency)

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They are those that require of an immediate action. They are characterized to be activated in instantaneous form. The alarms that are activated with signals of High Priority are the following ones:

High inspiratory pressure (Adjustable by the user)

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Definition: Maximum allowed airway pressure limit. Selection: In all the ventilatory modes. Ventilator action: 1) Immediately activated when the inspiratory pressure reaches the set limit. 2) Immediate opening of the expiratory valve with breathing circuit decompression to PEEP level. Signal type: Audible, visual and warn in the screen. Silence: It can be silenced temporarily. Setting limits: From 10 to 120 cm H2O Default value: According to patient category: ADL: 40 cm H2O PED: 30 cm H2O NEO: 25 cm H2O

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Value change: With the [Alarm Settings] key Screen message The audible alarm signal recovers automatically if the pressure returns to an inferior value to the limit. The panel light signal does not disappear until the [Reset] key is pressed.

Low inlet gas (Nonadjustable by the user) Definition: Warns an inappropriate pressure lowering of one or both feeding gases (oxygen or air). Ventilator action: It is activated immediately when the air or oxygen supply pressure is reduced below 2.7 bars. Simultaneously the gas with more pressure passes to replace the lacking gas. Signal type: Audible, visual and warn in the screen. Silence: It cannot be silenced. Screen message Automatic reposition if the pressure returns above the limit. The light signal does not disappear until the [Reset] key is pressed.

External power loss (Nonadjustable by the user) Definition: Failure in the electric power of the main line. It is activated when the current key of the device is in the ON position and the following events happen: 1) Power loss of the main line. 2) Unplugged of connection cable from mains, and 3) Burned entrance fuse. Ventilator action: Instantaneous commutation to internal battery source of energy. The indicative LED of the panel lights. Signal type: Audible, light and warn on the screen. Silence: It cannot be silenced. Screen message Automatic reposition if the electric power recovers. The light signal does not disappear until the power returns.

Low battery (Nonadjustable by the user) Definition: It is an indication that the utility time of operation with battery could be very brief or null. Ventilator action: There is not direct action. Signal type: 1) Light and warn in the screen. 2) Icon indicating charge level. Silence: It cannot be silenced. Screen message

Continuous pressure (Nonadjustable by the user) Definition: Maintenance of 5 cm H2O of pressure above PEEP/CPAP in the ventilatory breathing circuit for more than 15 seconds. Ventilator action: Decompression of the breathing circuit to the set baseline. Signal type: Light and warn in the screen. Silence: It cannot be silenced. Screen message

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Technical failure (Nonadjustable by the user) Definition: Important alteration (electronic circuit or software) or burnt fuse of the annex board. Ventilator action: The ventilator stops to work. The screen fades. Continuous light and audible signal is activated. Signal type: Audible and light. The left Technical Failure LED lit when the alteration comprises the electronic circuit or the software. The right LED lit when the annex board fuse burnt. No screen message. Silence: It cannot be silenced. Consequences: The alarm indicates to possible causes: 1) A serious alteration of the hardware or software; 2) Burnt fuse of the annex board. The device should not be used. Attention of specialized Service should be requested. WARNING When the Technical Failure alarm is activated, do not intent to use the ventilator again. It should be sent to an authorized service.

Medium Priority Signals (caution) They are activated with a time delay. In some the time is operator’s adjustable, in other the time is fixed. The alarms that are activated with signals of Medium Priority are the following ones:

Low inspiratory pressure (Adjustable by the user) Definition: Minimum allowed airway pressure limit. Selection: In all the modes. Ventilator action: It is activated when the ventilator inspiratory phase pressure stays more than 10 seconds below the set limit. If, after 30 seconds, no action is taken by the operator, the alarm status is changed to as a High Priority Signal. Signal type: Audible, light and warn in the screen. Silence: It can be temporarily silenced. Setting limits: From 3 to 99 cm H2O (from 0 in PCV). Default value: 5 cm H2O for all patient categories. Value change: With the [Alarm Settings] key. Screen message The audible alarm signal recovers automatically if the pressure returns to a superior value of the set limit. The light signal does not disappear until the [Reset] key is pressed.

VT high (Adjustable by the user) Definition: Maximum allowed limit of the tidal volume impelled by the ventilator. Selection: In all the modes. Ventilator action: It is activated when the tidal volume of successive breathings stays more than 10 seconds above the set limit. Signal type: Audible, light and warn in the screen. Silence: It can be silenced temporarily. Setting limits: From 0.010 L up to 3.0 L. Default value: According to the patient category: ADL: 0.600 L; PED: 0.300 L; NEO: 0.050 L

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Value Change: With the [Alarm Settings] key. The audible signal is suspended when the pressure recovers accepted limits. The light signal does not disappear until the [Reset] key is pressed. Screen message The audible signal of the alarm is suspended if the pressure returns to an inferior value to the limit. The light signal of the alarms sector does not disappear until the [Reset] key is pressed.

VT low (Adjustable by the user) Definition: Minimum allowed limit of the tidal volume impelled by the ventilator. Selection: In all the modes. Ventilator action: It is activated when the tidal volume of successive breathings stays more than 10 seconds below the set limit. If, after 30 seconds, no action is taken by the operator, the alarm status is changed to as a High Priority Signal. Signal type: Audible, light and warn in the screen. Silence: It can be silenced temporarily. Setting limits: From 0.001 L up to the low value of the VT high. Default value: According to the patient category: ADL: 0.200 L; PED: 0.100 L; NEO: 0.005 L Value change: With the [Alarm Settings] key. Screen message The audible signal of the alarm is suspended if the pressure returns to a superior value to the limit. The light signal does not disappear until the [Reset] key is pressed.

O2 concentration high (Adjustable by the user) Definition: Maximum allowed limit of the oxygen concentration supply by the ventilator. Selection: In all the modes. Ventilator Action: It is activated when the oxygen concentration of successive breathings stays more than 30 seconds above the set limit. Signal type: Audible and warn in the screen. Silence: It can be silenced temporarily. Setting limits: 25 a 110%. Lower: 18 a 95%. Default value: 60% Value change: With the [Alarm Settings] key. Screen message

O2 concentration low (Adjustable by the user) Definition: Minimum allowed limit of the oxygen concentration supply by the ventilator. Ventilator Action: It is activated when the oxygen concentration of successive breathings stays more than 30 seconds below the set limit. Signal type: Audible and warn in the screen. Silence: It can be silenced temporarily. Setting limits: 18 a 95%. Default value: 40% Value change: With the [Alarm Settings] key. Screen message

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Apnea (Adjustable by the user) Definition: It is a condition where the ventilator considers a breathing stop during spontaneous ventilation modes after an adjustable period of time. Selection: In Pressure Support, Continuous Positive Airway Pressure and Combined Modes (optional in SIMV). Ventilator action: Change to the selected backup mode at 5, 10, 15, 30, 60 seconds according to the set time. Signal type: Audible, light and warn in the screen. Silence: It can be silenced temporarily. Default value: 15 seconds in all the categories. Value change: Pressing the [Menu] key. Screen message The alarm resets automatically if the patient returns to spontaneous ventilation. The light signal does not disappear until the [Reset] key is pressed.

Fan Failure (Nonadjustable by the user) Definition: Detention of the fan’s operation with possibilities of electronic circuit overheating. Signal type: Audible, and warn in the screen. Silence: It cannot be silenced temporarily. Screen message Operator Action: Check the fan correct functioning looking for foreign materials obstructing the blades. If the failure persists, the ventilator should be replaced.

Low Priority Signals (warn) They are activated with a time delay, in some the time is adjustable for the operator, and in other the time is fixed. The alarms that are activated with Low Priority Signals are the following ones:

f max (Adjustable by the user) Definition: It regulates the spontaneous maximum breathing frequency limit. It is also activated if the breathing frequency is adjusted with a bigger value that the limit of the alarm. Selection: In all the modes. Ventilator action: The alarm is activated with light and audible signal after 20 seconds of having been surpassed the set limit. If, after one minute, no action is taken by the operator, the alarm status is changed to as a Medium Priority Signal. Signal type: Audible, light and I warn in the screen. Silence: It can be silenced temporarily. Default value: 30 bpm for all categories. Value change: With the [Alarm Settings] key. Screen message The alarm resets automatically if the frequency returns to an inferior value to the limit. The light signal does not disappear until the [Reset] key is pressed.

Low PEEP (Adjustable by the user) Definition: Descent of the base pressure below the set value during ventilation with expiratory positive pressure or continuous positive pressure. Selection: In all the modes. Ventilator action: Light and audible signal and message in the screen after 15

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m

seconds of persisting the alteration. If, after one minute, no action is taken by the operator, the alarm status is changed to as a Medium Priority Signal. Signal type: Audible, and warn in the screen. Silence: It can be silenced temporarily. Limits: 2, 4, 6 cm H2O below the PEEP limit. In OFF it is disabled. Default value: 4 cm H2O. Value change: With the [Alarm Settings] key or pressing Ctrl + PEEP keys. Screen message Automatic reset if the pressure returns above the limit. The light signal does not disappear until the [Reset] key is pressed.

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VE high (Adjustable by the user)

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Definition: Exhaled minute volume bigger that the selected in Mandatory Minute Ventilation mode (MMV). Ventilator action: Warn with light and audible signal with message in the screen after 10 seconds if the alteration persists. It generally indicates loss for the breathing circuit or disconnection. If, after one minute, no action is taken by the operator, the alarm status is changed to as a Medium Priority Signal. Signal type: Audible, light and warn in the screen. Silence: It can be silenced temporarily. Set limits: From 1 to 50 L/min. Value change: With the [Alarm Settings] key. Screen message

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VE low (Adjustable by the user)

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Definition: Exhaled minute volume smaller that the one selected in Mandatory Minute Ventilation mode (MMV). Ventilator action: Warns after 10 seconds. It generally indicates loss for the breathing circuit or disconnection. If, after one minute, no action is taken by the operator, the alarm status is changed to as a Medium Priority Signal. Signal type: Audible, light and warn in the screen. Silence: It can be silenced temporarily. Regulation limits: From 1.0 L/min. Value change: With the [Alarm Settings] key. Screen message

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Alarm Complements §

Silence 30/60 seconds It suspends the audible signal of some alarms. It does not suspend the sound of the power loss and technical alarms.

§

Reset It is a key with multiple functions, used alone or in combination with other keys. It reestablishes or aborts changes of not accepted values.

Safety Mechanisms The ventilator’s safety mechanisms comprise the devices that constitute it and the operative system that governs the microprocessor. Their function is to preserve the integrity of the procedure, making it safe and reliable.

Ventilator Components Safety valve: It is located at the beginning of the breathing circuit. It is factory preset. It is opened when the pressure within the patient’s circuit reaches, for any reason, 120 cm H2O. The gas enters into an internal gas collector and is expelled to the outside. Electronic circuit: When the microprocessors detect any failure in the electronic circuit, not only are the alarm for technical failure activated but also the ventilator enters into inoperative mode and all solenoid valves are deactivated. Inspiratory relief valve (antiasphyxia): Located at the beginning of the breathing circuit. It is opened when there is a power failure or an inoperative state, thus enabling the aspiration of ambient air. Operation gases exhaust: The operation gases that normally escape from some of the internal mechanisms are directed to a common collector from where they are expelled to the outside. Low supply pressure of the compressed air: The lack of pressure of the compressed air (command gas) is compensated by the compressed oxygen through a connecting valve. The corresponding alarm is triggered, through another device, by the lack of pressure. Low supply pressure of the compressed oxygen: The lack of pressure of the oxygen is compensated by the compressed air. The corresponding alarm is triggered, through another device, by the lack of pressure. Monitoring of the airway pressure: There are two pressure transducers located one at the beginning (proximal pressure) and the other at the end of the patient’s service circuit (distal pressure). The proximal transducer commands the pressure in the Pressure-Controlled (PCV) and Pressure Support (PSV) Modes, the limits of the maximum and minimum airway pressure, and the positive end expiratory pressure (PEEP). It also originates the values for the Peak, Plateau, Mean and Baseline Airway Pressure. The distal transducer is involved in the plotting of the pressure waveforms.

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Universal Voltage: The power source is self-regulated for alternate current from 100 to 240 volts. Automatic Zero Reset: The pressure transducers are zeroed every 15 minutes or when the operator activates this function ([Ctrl] + [Ptr-Vtr]). Line Purge: In order to avoid any obstruction of and/or humidity in the internal transducers, air is injected through the tubes connecting the expiratory pneumotachograph at reset.

Operative System The operative system, which regulates the functions of the microprocessor, is designed with algorithms that prevent or avoid the execution of any maneuver that may have unfavorable effects. Memory test: Every time the equipment is turned on, a test of the RAM and EPROM memories is run, thus ensuring the integrity of the operative system. PEEP and Flow Calibration: Every time the equipment is turned on, the expiratory valve is electronically calibrated to regulate the positive end expiratory pressure. There is also a calibration of the flows that go through the expiratory pneumotachograph. Parameter limits: Every parameter involved in the ventilation has minimum and maximum limits that cannot be exceeded. Values acceptance: All selected or changed values need to be accepted by pressing [Enter], within a maximum time of 5 seconds. Alarm limits: Each alarm has preset or programmed limits. When they are exceeded, in some cases the action is instantaneously suppressed (e.g.: maximum pressure limit) or in other cases, there is activation delay time (e.g. PEEP loss), depending on the alarm hierarchy. Alarm activation indicators: When an alarm is activated, there is not only a light and auditory signal but also the screen shows a message indicating the name of the activated alarm, the possible cause and suggestions for the solution of the problem. Watchdog: The watchdog is an independent system of surveillance of the function of the electronic circuit.

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References 1. Abraham E, Yoshihara G. Cardio-respiratory effects of pressure control ventilation in severe respiratory failure. Chest 1989; 96:1356. 2. Amato MB, Barbas CS, Bonaza J. Volume- Assured Pressure Support Ventilation: a new approach for reducing muscle work load during acute respiratory failure. Chest 1992; 102:1225. 3. Ashbaugh DG, Petty TL. Positive end-expiratory pressure: Physiology, indications and contraindications. J Torac Cardiovasc Surg 1973; 65:165. 4. Branson R.D., Hess D.R., Chatbrum R.L.: Respiratory care equipment. Philadelphia: J.B. Lippincot; 1995. 5. Brochard F; Rua F; et all. Inspiratory pressure support compensates for additional work of breathing caused by the endotracheal tube. Anesthesiology 1991; 75:739. 6. Brochard L, Pluskawa F, Lemaire F. Improved efficacy of sponteneous breathing with inspiratory pressure support. Am Rev respir Dis 1987; 136:411. 7. Cairo J.M., Pilbeam S.P.: Respiratory care equipment. St. Lous: Mosby; 1999. 8. Chatburn RL. A new system for understanding mechanical ventilators.Resp Care 1991;36:1123. 9. Chatburn RL. Classification of mechanical ventilators. Resp Care 1992;37:1009. 10. Downs JB, Klein EF, Desaultels E. Intermitent mandatory ventilation: a new approach to weaning patient from mechanical ventilation. Chest 1973; 64:331. 11. Goldsmith J.P., Karotkin E.H.: Assisted ventilation of the neonate. Philadelphia: W.B. Sauders; 1996. 12. Hewlett AM, Platt AS, Terry VC. Mandatory minute volume. Anaesthesia 1977; 32:163. 13. MacIntyre N, Nishimura M, Usada Y et al. The Nagoya conference on system designal and patient interactions during pressure support ventilation. Chest 1990; 97:1463. 14. Murphy DF, Dobb G, Effect of pressure support ventilation on sponteneous breathing during intermitent mechanical ventilation. Crit care Med 1987; 15:612. 15. Sanborn WG Microprocesor-based mechanical ventilation. Resp Care 1993;38:7. 16. Sassoon C. Mechanical ventilator designal and function: The trigger variable. Resp Care 1992; 37:1056. 17. Tharatt RS, Allen RP,Albertson TE. Pressure controlled inverse ratio ventilation in severe adult respiratory failure. Chest 1988; 94:755. 18. Thompson JD. Computerized control of mechanical ventilators: closing the loop. Resp Care 1987;32:440. 19. Tobin M.J.: Principles and practice of intensive care monitoring. New York: McGraw Hill; 1998. 20. Tobin M.J.: Principles and practice of mechanical ventilation. New York: McGraw Hill; 1994.

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CHAPTER II

MAINTENANCE INSTRUCTIONS

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Items to be checked during maintenance every 5000 hours of use:

2-Functional control.

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3- Control of alarms sound:

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1-External check-up, clean-up and disinfection of the device.

Press “Ctrl” + “Reset”

4-Functional inspection of keys. 5-Leds inspections:

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a-Go to Analog Input in Calibration Menu ( see chapter 4°) b-Press “Silence” key , and check all leds (except :Technical failure,

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battery and charging leds)

6-Check-up the sensors following chapter 4°. 7-Check up for software updates. 8-Removal of back cover and clean-up the fan and area.

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9-Inspection and clean-up porous metal filters and water trap. 10-Visual inspection of internal tubing:

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Look for water and oil traces

16-Replacement of sealing joint of cabinet. 17-Reemsambl the ventilator. 18-Complete recalibration. 19-Replacement of expiratory valve. 20-Update of records and documentation. 21-Final control.

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CHAPTER III

TROUBLE SHOOTING

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TROUBLE SHOUTING PROBLEM Device does not pass initial calibration

CORRECTIVE ACTION

POTENTIAL CAUSE 1. Leak in the patient’s circuit. 2. Gas supply closed. 3. Occlusion of pneumatic lines. 4. Expiratory valve control. 5. Hose of internal circuit is disconnected or clogged. 6. Pressure leak. 7. Internal electrical connections.

1. 2. 3. 4. 5.

6.

7. Low flow

1. Defective pressure regulators. 2. Occlusion of pneumatic lines or internal pneumatic leaks. 3. Leaks in the patient’s circuit. 4. Water in the Pneumotachograph system. 5. Altered flow sensors.

1.

2. 3. 4. 5.

High flow

1. Defective pressure regulators. 2. Poor flow calibration. 3. Altered pneumotachographs. 4. Altered flow sensors. 5. Extremely high electromagnetic interference (EMI).

1. 2. 3.

4. 5.

Check the patient’s circuit. Open the gas supply valve. Check inlet filters and supply hoses. Check the diaphragm of the expiratory valve. Verify if it is correctly connected. Check the equipment internal connections. Check the air-tightness of the pneumatic set with up to 100 cm of water. In order to do this, connect the supply gases to the equipment, and apply a pressure of 100 cm of water at the outlet of the internal pneumotachograph. If pressure drops sharply, then, there is a leak inside the pneumatic set. Review Safety Valve and Antisuffocation Valve. Check the cable of the proportional valves, and their connection. Check voltage in the CPU connectors. Check and recalibrate pressure of air and oxygen regulators at 2.8 kg/cm2. Check and recalibrate the regulator pressure at 10 PCI. Check for loose or kinked filters or hoses. Check the patient’s circuit. If there is water in the device, proceed as indicated below. Check the operation of flow sensors, and then calibrate them. Check and recalibrate pressure of air and oxygen regulators at 2.8 kg/cm2. Check to see if there is no water in the device and recalibrate the pneumotachograph and valves. Ensure there is no water in the device. Check the operation of flow sensors, and then calibrate machine. Check the operation of the flow sensors. Check for the presence of an electronic equipment nearby that may be emitting electromagnetic waves, and altering the normal operation of the equipment.

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TROUBLE SHOUTING PROBLEM Low Tidal Volume

High Tidal Volume

High Inspiratory Pressure

Low Inspiratory Pressure

High Minute Volume

Low Minute Volume

There is no PEEP

CORRECTIVE ACTION

POTENTIAL CAUSE 1. Incorrect initial calibration of the patient’s circuit. 2. Damaged expiratory valve or expiratory pneumotachograph. 3. Disconnection of the lower hose of the expiratory pneumotachograph. 4. Obstruction of P1. 5. Damaged flow sensors. 1. Incorrect initial calibration. 2. Damaged expiratory pneumotachograph. 3. Obstruction of P2. 4. Reversed connection of P1 and P2. 5. Damaged flow sensors.

1. Redo initial calibration of the circuit. 2. Check expiratory valve and pneumotachograph. 3. Check connections of the expiratory pneumotachograph. 4. Check permeability of P1. 5. Check flow sensors.

1. Occlusion of the patient’s circuit. 2. High volume. 3. High rise time. 4. High inspiratory flow. 5. Decalibrated flow sensor.

1. 2. 3.

1. Disconnection of the upper hose of the expiratory pneumotachograph. 2. Internal disconnection of the flow sensor. 3. Damaged flow sensor. 1. Disconnection of the upper hose of the pneumotachograph. 2. Obstruction of P2. 3. Reversed connection of P1 and P2. 4. Damaged flow sensors. 1. Obstruction of P1 or P2. 2. Damaged flow sensors. 3. Altered pneumotachographs. 1. Damaged expiratory valve. 2. Leaks in the patient’s circuit. 3. Defective PEEP electrovalve. 4. Water in the PEEP electrovalve.

1. 2. 3. 4. 5.

4. 5. 1. 2. 3.

Redo initial calibration. Check pneumotachograph. Check permeability of P2. Check if P1 and P2 are correctly connected (check they are not inverted). Check the operation of the flow sensors. Check the patient’s circuit. Check the volume. Regulate Rise Time according to the patient’s resistance. Complete calibration of the device. Check complete calibration of the device. Check connections of the expiratory pneumotachograph. Check connections of the internal pneumatic circuit. Check the flow sensor.

1. Check connections of the expiratory pneumotachograph. 2. Check permeability of P2. 3. Check if P1 and P2 are correctly connected (check they are not inverted). 4. Check flow sensors. 1. Check permeability of P1 and P2. 2. Check flow sensors. 3. Ensure there is no water in the device, and recalibrate the device completely. 1. Check expiratory valve. 2. Check the patient’s circuit. 3. Check operation of the PEEP electrovalves in the sensors board. 4. Check if water has entered into the pneumatic box. If water has entered into the valves, replace the PEEP electrovalve.

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TROUBLE SHOUTING PROBLEM High PEEP

Low PEEP

Nebulizer without flow

FiO2 different from % FIO2 measurement

POTENTIAL CAUSE 1. Diaphragm of the expiratory valve stuck. 2. Obstruction of the patient’s circuit. 3. Defective PEEP electrovalve. 1. Leaks in the patient’s circuit. 2. Damaged expiratory valve. 3. Leaks in the internal pneumatic circuit. 4. Defective PEEP electrovalve. 1. Inspiratory flow lower than 7 L/min. 2. Disconnection in the internal pneumatic circuit. 3. Obstruction in nebulizer. 4. Damaged solenoid valve. 1. Decalibrated air or oxygen proportional valves. 2. Decalibrated pressure regulators. 3. Decalibrated oxygen analyzer.

CORRECTIVE ACTION 1. Replace the diaphragm of the expiratory valve. 2. Check the patient’s circuit. 3. Check the operation of the electrovalve. 1. Check the patient’s circuit. 2. Check expiratory valve. 3. Check the internal pneumatic circuit. 4. Check the operation of the electrovalve. 1. Increase the inspiratory flow. 2. Check the internal pneumatic circuit. 3. Check permeability of the nebulizer capillary. 4. Check operation of the solenoid valve. 1. Recalibrate proportional valves, and then recalibrate the measurement parameters of the device. 2. Check the calibration of the pressure regulators. Then, recalibrate the device completely. 3. Calibrate oxygen analyzer. 1. Check fan and check connections. 2. Replace fan by one with the same features.

Blower failure

1. Back fan disconnected or blocked. 2. Damaged back fan.

Low battery charge

1. 2. 3. 4.

Screen does not work

1. Burnt screen. 2. Bad contact in display connections.

1. Charge the battery for 12 hours, and if it does not become charged, replace with new one. 2. Replace the battery with a new one. 3. Check the battery connections. 4. Check charge voltage (13 0.5 V). 1. Replace the display with a new one. 2. Check and clean the contacts of the different jacks of the display.

Emergency ventilation or technical failure

1. Failure of an electrical component. 2. Bad contact of an electronic component or cable. 3. Too much dirt inside the device. 4. Extremely high electromagnetic interference (EMI).

1. Check the condition of the electronic components of the sensors board, ancillary board and CPU board. 2. Check soldering of wires and electronic components. 3. Clean all the inside of the device, and clean the jacks. 4. Check for the presence of electrical devices nearby.

Low battery charge. Damaged battery. Battery disconnected. Electrical failure.

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TROUBLE SHOUTING PROBLEM Water in the device

1. Water has entered through the air or oxygen supply.

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1. Burnt LED’s. 2. Disconnected key board jack. 3.

1. Disassemble the device and check and replace all burnt LED’s. 2. Check the connection of the key board to the CPU, and clean contacts. 3.

1. Incorrect initial calibration. 2. Leak in the patient circuit 3. Extremely high electromagnetic interference (EMI). 4. Inadequate sensitivity. 5.

1. Redo initial calibration. 2. Check the patient circuit. 3. Check if there is a high emission electromagnetic equipment nearby that may be interfering with the device. 4. Set an adequate sensitivity.

1. Decalibrated device. 2. Decalibrated proportional valves. 3.

1. Recalibrate pneumotachographs, proportional valves and FO2. 2. Recalibrate proportional valves and FO2. 1. Check if there is a high emission electromagnetic device nearby.

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Not all LED’s of the keyboard are lit.

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Irregular baseline flow

Transitory failure in the reading of pressures, volumes with autocycling.

1. Open the device and clean all pneumatic components (2.8kg/cm2 pressure regulators, proportional valves, nonreturn valves, 10 PSI regulator, pneumotachograph, meshes of pneumotachograph) Then, recalibrate the device completely.

m

2.

Autocycling of device

CORRECTIVE ACTION

POTENTIAL CAUSE

1. Extremely high

electromagnetic interference (EMI).

2.

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CHAPTER IV

SENSOR VERIFICATION

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Sensor Inspection Access to the Calibration Menu When the device is off, press the “Reset” key, and turn it on while keeping the key pressed. The message “Enter Code” will be displayed on the screen. At that moment, press any key four times. A message will then be displayed warning that the code entered is incorrect. Press any key to continue. At that moment, the calibration menu is displayed on the screen. Choose the option “Analog Inputs” with the “selection” keys The readings of the sensors are displayed in this window, and it is also possible to manually open and close the air and oxygen proportional valves.

Opening and Closure of Proportional Valves Select the window “Analog inputs” in the Calibration menu, and then enter into the menu by pressing the “Enter” key. Analog Inputs Screen: Air Flow: Oxy Flow: Right press: Left Press: Exp Flow: Oxy Source: Air Source: Power Source: Oxy Cell:

0091 0080 0390 0441 0069 0930 0930 0881 0000

Air Val= OxyVal = SuffVal = PeepVal =

0 0 600 0

Serial No: 0333 31 008 REV:G1-2N-030410-1N Calibrated:10/04/03 By: HA

fan : 0 Load : No Source : Mains Fan : OK 61hs

In the lower left corner of the “Analog Inputs” window, there is an4-line column. Each line is identified. The numbers shown correspond to the opening value of the respective valve. When it is zero, the valve is closed. - With the “selection” keys

a valve may be chosen. A red bar will appear over the chosen

valve on the screen, then press “Enter” key.

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Sensor Inspection - The value for the opening of the chosen valve may be increased or decreased with selection keys This opening value may range between 0 (Closed Valve) and a maximum of 4095 (Valve completely opened). If press “ctrl” +“selection”

the values go up or dawn in tens.

- All valves (Opening value = 0) may be closed with the “Reset” key. The “AirVal” line corresponds to the air proportional valve. The “OxyVal” line corresponds to the oxygen proportional valve. The “SuffVal” line corresponds to the antisofocation valve The “PeepVal” line corresponds to the PEEP proportional valve.

Air and Oxygen Valves (AirVal and OxyValv) When the opening value is increased with a value ranging between 0 and 4095, we will notice that the valve remains closed while the opening value is lower than 900 units (approximately). When the opening exceeds this value, the valve begins to be opened progressively (air begins to flow through the inspiratory outlet) until the maximum value is reached (greater than 160 L/min), i.e., when the opening value reaches 4095 units. The valve can then be closed using the “Reset”.

Sensors Check In the upper left corner of the window, there is an 8-line column. Each lines shows the digitalized readings of the flow and pressure. These readings will vary depending on the flows or pressures being applied on the sensors. When there are no supply gases connected to the device, the readings given by these sensors are the ones shown in the following table: Table :1

The second column

Air Flow: Oxy Flow: Right press: Left Press: Exp Flow: Oxy Source: Air Source: Power Source: Oxy cell:

0091 0080 0390 0441 0069 0930 0930 0881 0000

0364 0320 1562 1767 0278 0900 3525 0000

shows a value equal to the first one

but multiplied by four (do not take this into account).

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Sensor Inspection Air Flow Sensor: 1) - Disconnect the supply gases from the device. - Check if the reading of the “Air Flow” is a stable value in correspondence with that indicated in Table 1. 2) - Connect the supply gases to the device. - Select the “AirVal”. - Open it progressively with “selection”

. When the air starts to flow through the inspiratory

outlet, the reading of the air flow begins to increase until the opening value of the valve reaches the maximum value (maximum flow). Check the maximum value reached in the air flow reading; it is usually greater than 800 units. 3) - Close valves with "Reset" Key.

Oxygen Flow Sensor: 1) - Disconnect the supply gases from the device. - Check if the reading of the “Oxi Flow” (Line 2) is a stable value in correspondence with that indicated in Table 1. 2) - Connect the supply gases to the device. - Select the “OxyVal”. - Open it progressively with “selection”

. When the air starts to flow through the inspiratory

outlet, the reading of the oxygen flow begins to increase until the opening value of the valve reaches the maximum value (maximum flow). Check the maximum value reached in the oxygen flow reading; it is usually greater than 800 units. 3) - Close valves with "Reset" key.

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Sensor Inspection Expiratory Flow Sensor (ExpFlow):

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1) - Disconnect the supply gases from the device.

- Check if the reading of the “Exp Flow” is a stable value in correspondence with that indicated

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in Table 1.

2) - Cover with a finger exerting pressure in port “P2”of the device and check if the expiratory flow reading decreases to zero.

3) - Cover with a finger exerting pressure in port “P1”of the device and check if the reading increases. With a pressure of 6 cmH2O in this port, the expiratory flow reading will be of 900

es

units approximately.

uid

4) - Close valves with "Reset" Key.

Power Source:

1) - Press “Neb” key to put the device in battery mode. 2) - Press “Stby” key to put the battery under charge.

Nebulizer:

all

-g

3) - Check if the reading off the “Power Source” is not under 750. 4)- Close valves with "Reset" key.

1)-Press “Ti” key.

2)-Check if there is flow in nebulizer outlet. 3)-Close valves with "Reset" key.

Purging: 1)-Press “I:E” key. 2)-Check if there is flow in P1 and P2 outlet. 3)-Close valves with "Reset" key.

36

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

Sensor Inspection Pneumotacograph: Fig.:1 Ventilator

Fl

Flow Analyzer

Patient outlet

AirVal and OxyVal: 1) -Connect the flow analyzer in the Patient outlet (Fig.:1). 2)-Open the air/Oxy valve until 160 L/min. 3)-Check if the reading of the first column Air Flow is below 1024. 4)- Close valves with "Reset" key. Fig.:2

Ventilator

Pressure analyzer Fl

Inspiratory outlet

Peep valve (Peepval): 1)-Connect the pressure analyzer in the inspiratory outlet (Fig.:2) . 2)-Select PeepVal . 2)-Open it progressively with “selection” 3)-Check the maximum value of the pressure must be between 40 and 70 cmH2O. 4)- Close valves with "Reset" key.

Inspiratory valve: 1)-Connect the pressure analyzer in the inspiratory outlet (Fig.:2). 2)-Open it with “fiO2” key. 3)-Check the maximum value of the pressure must be between 70 and 130 cmH2O. 4)- Close valves with "Reset" key.

37

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

Sensor Inspection Proportional valves: AirVal: 1)-Press the “Reset” key. At that moment, the Calibration Menu is displayed on the screen. 2)-Choose the option “Air Val” with the “selection” keys 3)-Put target value in 5 L/m and press the “fiO2” key. 4) - The valve must be open. 5)-Press the “Reset” key to finish and press one more time to go back to the calibration menu. OxyVal: Idem AirVal

38

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CHAPTER V

EQUIPMENT OPENING AND CLOSURE

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Operation 10

Description Removal of back cover: Open the ventilator by removing the eight screws located in the positions indicated in the figure.

Adjustment screw and flange - A.C. cable

Position of the device for the disconnection of the cables: - Lay the device down with the face downwards, and place it on foam rubber. - Lay the back cover down as indicated in the figure, and disconnect the cables.

Device

Back Cover

Foam Rubber

39

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator

uid

Fan

es

Battery Cables

.co

m

Operation Description Disconnect the following cables: 10 - Con.6, battery cable of the Ancillary Board. - Con.12, speaker cable of the CPU Board. - Con.5, fan cable of the Ancillary Board. - Con. 8, RS-232 cable of the CPU Board.

Speaker Cables

Battery

1

all

-g

Fan Cable

Speaker

RS-232 Cable

40

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Operation Description 20 Separation Back Cabinet – Front Cabinet: - Remove the screws indicated with arrows in Fig.:2-A-B. Fig.:2-B

Fig.:2-A

Rear View

Front View

- Disconnect the cables as indicated under operation 30:

Front Cabinet

Rear Cabinet

Fig.:2-C

41

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Operation 30

Description

Separation Front Cabinet – Back Cabinet, electrical part

Back Gabinet

To Con14 of CPU Board Proportional Valves Cables

Fig.:3-A

ON-OFF Cables

AC Cable To power source

Ground Cables

To Con 7 of Ancil Board

PNEUMATIC BOX

ANCIL BOARD Con.3 Con.5

CPU BOARD Proportional Valves Cables

Con.14

Front Gabinet

POWER SOUCE

AC Cable

Con.6 Con.7

ON-OFF Cables

42

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Description

Separation Front Cabinet – Back Cabinet, pneumatic part Fig.:4-A

Front Cabinet

0,7 Kg/cm2

Neumo inspiratory

air

salida

nebulizer

o2

F.scape

Pneumatic Box

entrada

Operation 40

P2 P1

Nebulizer

o2 (-) (+)

P1

aire

(-) (+)

Espiratory V.

Espiratory V.

P2

10PSI

O2

O2

AIR Gas Inlet

Back Gabinet

AIR

Antisofocation Val.

43

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Operation 40

Description Cabinets Separated

Fig.:4-B Front Cabinet

Cabinet sealing joint

Rear Cabinet

44

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Operation 50

Description

Separation Pneumatic Box - Front Cabinet, pneumatic part: - Disconnect the tubes indicated in Fig.:5-A Pneumatic Box

.co

es

10 psi Reg.

m

Fig.:5-A

outlet

air

uid

o2

inlet

nebulizer

P2 P1

Nebulizer

G.Exh.

Neumo Inspiratory

(-) (+)

P1

(-) (+)

P2

Expiratory V.

Expiratory V-

all

-g

Outlet Manifold

45

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Operation 50

Description

Separation Outlet Manifold – Box – Front Cabinet: -Remove the screws indicated in Fig.:5-B Fig.: 5-B Front Gabinet

Pneumatic Box

46

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Description

Separation Outlet Manifold – Box – Front Cabinet: -Disconnect tubes 1, 2, 3, and 4, and remove the outlet manifold, Fig.:5-C

Front Cabinet

F.scane

Reg.10 psi

Pneumatic Box

Neumo inspiratory

o2

air

salida

nebulizer entrada

Operation 50

P2 P1

(-) (+)

2

1

1

(-) (+)

3

2

V. Espiratory

4

3 4

Outlet Manifold

47

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Operation

Description

60

Disconnection: Pneumatic Box – Front Cabinet, electrical part: 1- Disconect cables J1 , J2 y S/N 2- Disconect power cable ancillary board – Pneumatic Box 3- Disconnect flat (ribbon) cables, CON 4 and CON 10, box, of the CPU board

Fig. 6-A

Front Gabinet CON 8

CON 9

CON 14 CON 12

CON 6

CON 5

CON 1

CPUBoard J1

CoaxialCables

CON 2

S/N J2

Ancil Board

CON 4

CON 4

CON 10

CON 7

Pneumatic Box

Power source

48

70

Operación

Date: 09/05/06

Review : 04

J2

J1

CON 9

S/N

Move the boards In this direction

CON 12

CON 5

CPU Board

Ffront Gabinet

CON 3

CON 8

1

CON 6

CON 5

Ancil Board

CON 7

To J2 in power source

CON 14

1- Desconect Con2 cables 2- Desconect Con1,Con3 and Con5 flat (ribbon)cables of CPU board 3- Remove the 4 screws indicated 4-Then, move the boards in the direction indicated by the arrows so as to remove them

How to Open and Close the Neumovent Graph Ventilator

CON 1 CON 2

Con3

TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Remove the screws indicated

2

Position 2 (Side shield)

Positiion 1 (Box Ground cable)

From Con 3 cable of Ancil board

Power Source

49

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CON 4

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Operation

Description

80

Removal of Shield

m

1-Remove the 5 screws indicated in Fig.:8-A. 2-Remove the shield, Fig.:8-B. Front Cabinet

-g

uid

es

.co

Fig.:8-A

Shield

all

Fig.:8-B

50

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Operation 90

Designation

Removal of Keyboard Board 1- Disconnect the cables indicated in Fig.:9-A. 2- Remove the Keyboard Board, by removing the 20 screws that attach it to the panel.

Fig.:9-A

Source Board – Inverter Board Cables

Inverter Board–DisplayCables

Fig. 9-B : Nut Keyboard board Filler

Screw Nut, do not remove Panel

51

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Operation 100

Description

Removal of Shield- Front Cabinet 1- Remove the washer screws and foam filler. 2- Do not remove the hexagonal fillers since they do not hold the panel. 3- Remove the nuts which hold the flanges, and finally remove the flanges and white head screws.

Fig.:10-A

Flange Flange

- The panel can be now removed. Proceed with extreme care since it is attached to the cabinet with silicone sealer.

52

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

How to Open and Close the Neumovent Graph Ventilator Operation 110

Description

Removal of the gas control set 1- Disconnect cables 1 and 2 from the connector indicated in Fig.:11-A. 2-Remove the screws indicated in Fig.:11-A.

Conector

1

2

B

A

Gas Control set

Screws Pneumotacograf o Security Valve

Proportional Valves screws

O2

Back Gabinet

AIR

Air and Oxigen Regulator

53

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CHAPTER VI

DETAIL OF ASSEMBLIES

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

ASSEMBLY DETAILS Name: Oxygen inlet

.co

m

Code:1782 A1V

-g

uid

es

6

all

1

No.

CODE

1 2 3 4 5 6

1782 M1V 1781 M1V 319 M2V 206 C1V 207 C0V 1199 M1T

5

4

5

2

DESCRIPTION IMP. GAS INLET, BODY WITH 6 HOLES IMP. GAS INLET, BODY 9/16 CONNECTOR POROUS METAL FILTER 2120 O´RING M4x0.7x8 SCREW

54

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

ASSEMBLY DETAILS Code:1781 A1V

Name: Air inlet

6

1 No.

CODE

1 2 3 4 5 6

1782 M1V 1781 M1V 659 M2V 206 C1V 207 C0V 1199 M1T

5

4

2

3

DESCRIPTION IMP. GAS INLET, BODY WITH 6 HOLES IMP. GAS INLET, BODY 3/4 CONNECTOR POROUS METAL FILTER 2120 O´RING M4x0.7x8 SCREW

55

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

ASSEMBLY DETAILS Code: 2200-A1V

Name: Expiratory valve

1

2

4

3

No.

CODE

1 2 3 4

2657 A1V 1111 G0V 2658 A1V

DESCRIPTION COMPLETE EXPIRATORY VALVE COVER PEEP VALVE DIAPHRAGM COMPLETE EXPIRATORY VALVE BODY M 3x6x120 mm CRYSTAL TUBE

56

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

ASSEMBLY DETAILS Code: 0554-A1V

2

2

Name: 2.8Kg/cm and 0.7 Kg/cm Regulator’s

13 12 11 9 10 8 14 7 6

5 4 3 2 1

57

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

ASSEMBLY DETAILS Code: 0554-A1V

No.

CODE

1 2 3 4 5 6 7 8 9 10 11 12 13 14

0480 M1T 0253 C0U 0560 C0A 0491 M1V 1326 M1 R 0511 G0V 1141 M1T 0477 M1V 0217 C0O 0475 M2V 0484 M1R 0562 C0T 0490 M2V 0476 M1V

2

2

Name: 2.8Kg/cm and 0.7 Kg/cm Regulator’s

DESCRIPTION ADJUSTING SCREW M 4x0,7 HEXAGONAL NUT WASHER REGULATOR COVER ADJUSTMENT SPRING REGULATOR DIAPHRAGM M 4x0.7x7 ROUND HEAD SCREW REGULATOR 1st STAGE SEAT 2020 O’RING CHOKE CELL SPRING AND REGULATOR M4x0.7x35 ALLEN SCREW REGULATOR BODY PIN

58

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Date: 09/05/06

ASSEMBLY DETAILS Name: Line nonreturn valve

all

-g

uid

es

.co

m

Code: 2460-A1V

1

No.

CODE

1 2 3 4 5

2138 M1V 2305 G1V 2182 M1R 211 C0V 2137 M1V

2

3

4

5

DESCRIPTION BODY CHOKE SPRING 2009 O’RING COVER

59

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Date: 09/05/06

ASSEMBLY DETAILS Code: 2294-A1V

Name: Pneumotacograph

5

1 2

N°

CÓDIGO

1 2 3 4 5

2781-M1V 2453-A1V 2772-M1V 2773-A1V 2493-A1V

4

3

DESIGNACIÓN Left cover Mesh holder Pneumotacograph body Right cover Safety valve

60

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Date: 09/05/06

ASSEMBLY DETAILS Code:2545-A1V

Name: Complete NV-Graph proportional valve

1

2

No.

CODE

1 2

2547 A1V 2548 A1V

DESCRIPTION SOLENOID SET MAIN PROPORTIONAL VALVE

61

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

ASSEMBLY DETAILS Code: 2493-A1V

1

Name: Safety valve

2

3

4

5

No.

CODE

1 2 3 4 5

2488 M1 V 2486 M1 V 2489 M1 V 2487 M1 V 0515-C0O

DESCRIPTION SAFETY VALVE, PRESS SAFETY VALVE, BODY SAFETY VALVE, SPRING SAFETY VALVE, CHOKE

O-ring 2-013

62

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CHAPTER VII

ELECTRONIC BOARDS: DETAIL

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Date: 09/05/06

ELECTRONICS DETAILS Designation: CPU-Board

all

-g

uid

es

.co

m

Code: 2410-A1V

Without components

Q:14,35 put it in the reverse position.

Optional Con3 : flat cable 20 conductors. of 70mm

63

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Date: 09/05/06

ELECTRONICS DETAILS Code: 2410-A1V Qty

Designation: CPU-Board Code

Placed

Obs.

1

3V 35mAh LITIO

Batery

BT1

1

BUZZER TYD12

BUZZER

1

STMM-110-02-G-D

Piezoeléctrico con osc.12V paso .3” diametro máx .65” CONECTOR

1

TCSD-10-D-09.00-01-F-N

CABLE

2 1

Jack:413990-2 Plug:413985-1 103309-1

M: CONECTOR 10 P/C

CON1

1

103309-2

M: CONECTOR 14 P/CI

CON4

1

103309-6

M: CONECTOR 26 P/CI

CON10

1

103308-8

M: CONECTOR 40 P/CI

CON5

1

26-61-4020

1

26-61-4100

2

26-61-4030

8

1µf x 50V

36

0,1µf x 50V

M: CONECTOR MOLEX 2 P/CI (opc. 26-65-4020) M: CONECTOR MOLEX 10 P/CI (opc. 26-65-4100) M: CONECTOR MOLEX 3 P/C (opc. 26-65-4030) Cap. Multicapa paso .2” (5 mm) radial Cap. montaje superficial Encap.1206

6

0,1µf x 50V

14

1nf x 50V

2

10nf x 50V

2

6,8pf

Capacitor SCP (5 mm) radial Siemens Cap. montaje superficial Encap.1206 Cap. montaje superficial Encap. 1206 Cap. mica plate

5

4,7µf x 16V

Cap. de tantalio

C:49;53;55;57;110

7

10µf x 16V

Cap. de tantalio

C:59;61;62;68;69;70;71

1

15pf

Cap. mica plate

C:60

1

22pf

Cap. mica plate

C:63

1

220pf

Cap. mica plate

C:64

1

2200µf x 16V

C:111

3

1N4148

Cap. Electrolítico paso .25” radial Diodo señal

1

LM385-1.2V

Diodo de referencia

D:2

5

1N4003

Diodo usos generales

D:3;4;5,8;10

11

RXE030

Polyswitch

1

8,2µHy

Choque axial paso .3”

F:6;7;8;9;10;11,13;14;15; 16;17 L:1

CON3

J1;J2

CON2 CON14 C:1;4;100;103;106;107;10 8;109; C:5;6;7;8;9;10;11;12;14; 15;16;17;18;19;20;22;23; 24;25;26;27;28;37;38;41; 43;44;45;46;47;50;51;52; 54;56;85 C:2;3;13;21;101;102 C:36;39;86;87;88;89;90;9 1;92;93;94;95;96;97 C:40;58 C:42;48

D:1;6;7

64

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

ELECTRONICS DETAILS Code: 2410-A1V Qty

Designation: CPU-Board Code

Placed

Obs.

4

BC337

Transistor

Q:1;10;15;28

18

BC327

Transistor

2

MPSA13

Transistor

Q.3;4;6;7;8;9;11;12;16;17; 18;19;20;24;25;26;27;29 Q:14;35

1

TIP32C

Transistor

Q:30

4

TIP31C

Transistor

Q:2;5,13; 21

1

10KW

Array de 10 pines

R:3

2

10KW

Array de 8 pines

R:4;110

3

1,5W 2W

Resistencia 1% metalfilm

R:43;47,55

2

10W 1W

Resistencia 1% metalfilm

R:70;79

7

47W 1W

Resistencia 1% metalfilm

R:82;83;84;85;87;88;89

2

910W 1% 1/8W

Resistencia 1% metalfilm

R:15;8

6

1KW 1% 1/8W

Resistencia 1% metalfilm

R:2, 10; 115;116;117;118

1

2,2KW 1% 1/8W

Resistencia 1% metalfilm

R:12

2

33KW 1/8W

Resistencia 1% metalfilm

R: 5;11

1

39KW 1/8W

Resistencia 1% metalfilm

R: 112

2

56KW 1% 1/8W

Resistencia 1% metalfilm

R:9;1

1

470W 1/8W

Resistencia carbón

R:86

1

180W 1/8W

Resistencia carbón

R:119

16

560W 1/8W

Resistencia carbón

1

1KW 1/8W

Resistencia carbón

R:50;51;52;53;54;56;57; 58;60;65;67;69;74;77;78; 80 R:73

2

2,2KW 1/8W

Resistencia carbón

R:36;46

11

4,7KW 1/8W

Resistencia carbón

3

8,2KW 1/8W

Resistencia carbón

R:33;44;66;75;81;90;91;9 6;97;98; 109 R:38;92;94

8

10KW 1/8W

Resistencia carbón

2

15KW 1/8W

Resistencia carbón

R:32;37;41;48;49;64;72;1 21 R:31;39

5

22KW 1/8W

Resistencia carbón

R:22,23,26,27,40

1

33KW 1/8W

Resistencia carbón

R: 113

5

100KW 1/8W

Resistencia carbón

R:6;7;13;14;45

1

220KW 1/8W

Resistencia carbón

R:42

4

470KW 1/8W

Resistencia carbón

R:21;24;25;28

1

2,2MW 1/8W

Resistencia carbón

R:18

1

SN74HC05PWT

Lógica CMOS

U:1

2

TC551001CF-70L

Ram Estatica

U2;U14

65

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

ELECTRONICS DETAILS Code: 2410-A1V Qty

Designation: CPU-Board Code

Placed

Obs.

1

AT27C040-12JC

Prom OTP 512Kb x 8 PLCC32 Cuadruple amplificador DIP14 Memoria EEPROM

3

OP400FY

2

25C320/P

1

S1D13503F00A100

1

AM188EM-40KC

Controlador de pantalla, U:8 montaje superficial U:9 Microcontrolador

1

DS1307

Reloj de tiempo real DIP8

U:10

1

MAX1202BCAP

ConversorA/D8 conversor

U:11

1

EPM7128SLC84-15

Lógicaprogramable PLCC84 U:12

1

MAX525BCAP

ConversorD/A4 conversor

1

74HC154D

1

ADM232LJR

2

ULN2003A

Lógica CMOS, montaje U:16 superficial Conversor RS232 a lógica, U:17 montaje U:18;19 Buffer, montaje superficial

1

74HC541D

1

74HC574D

1

10MHz

1

32768Hz

1

U:3 U:4;7;13 U:6;5

U:15

U:20

24MHz

Lógica CMOS, montaje superficial Lógica CMOS, montaje superficial Cristal controlador de pantalla Cristal de reloj de tiempo real Cristal microcontrolador

1

822473-3

zócalo PLCC32

U:3

1

822473-7

zócalo PLCC84

U:12

1

2621 M1 V

DISIPADOR EN "L"

1

2622 M1 V

DISIPADOR EN "U"

1

PLACA BASE

U:21 Y:1 Y:2 Y:3

66

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

ELECTRONICS DETAILS Code : 2109-A1 V

Designation: Ancillary Board

67

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TECHNICAL AND MAINTENANCE MANUAL Graph VENTILATOR

Date: 09/05/06

ELECTRONICS DETAILS Code:2109-A1V

Designation:Ancillary Board Obs.

Qty.

Placed

Resistencia 1% metalfilm

R2,R60

1

Resistencia 1% metalfilm

R3

3

Resistencia carbón

1

Resistencia metalfilm

2

Resistencia carbón

13

Resistencia carbón

2

Resistencia carbón

R10,R12

3

Resistencia carbón

R11,R13,R15

3

Resistencia carbón

R6,R22,R31

8

Resistencia carbón

2

Resistencia carbón

R17,R18,R20,R30, R33,R36,R40,R66 R23,R32

1

Resistencia carbón

R25

1

Resistencia metalfilm

R29

2

Resistencia cerámica

R34,R35

1

Resistencia carbón

3

Resistencia 1% metalfilm

R57,R58,R59

2

Resistencia 1% metalfilm

R61,R69

2

Resistencia carbón

R62,R63

1

Resistencia carbón

R64

1

Regulador 8V 1Amp

U1

1

Switching regulador

U2

1

Regulador

U3

1

Reg. positivo ajustable

U4

1

Reg. positivo

U5

2

Cuadruple amplificador oper.

2

Cab. Cilindrica (1493 C0T)

3

Tornillo M3x0.5x8 c.c.

2

Tornillo M3x0.5x12 c.c.

7

Tuerca M3x0,5

1

Terminal anillo

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es

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m

2

R14,R68 R5 R7,R9 R8,R16,R19,R21,R24, R26,R27,R28,R37,R38, R41,R65,R67

R39

U6,U7

16cm Cable plano 10 Cond. 9cm

Cable plano 2 Cond.

1

Con. plast.. HBR MINI AMP 2 vias

2

Term. MCH MINI CILIN. AMP

68

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ELECTRONICS DETAILS Code:1799-E2V rev7

Designation: Sensor Board, electric part. Differentials sensors pressure

TECME S.A. P/N 1799E2V Rev 6

Designation: Sensor Bard,pneumatic part.

69

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CHAPTER VIII

CALIBRATION

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Measurement, Inspection and Test Equipment 1-Flow analyzer (TSI Certifier) 2-Oximeter 3- Medical grade Air 4-Oxigen 5-Reusable adult respiratory circuit 6-O2 cell 2 7-5 Kg./cm Pressure regulator 8-100 cm. H2O Pressure regulator Remarks: - The EMI must be periodically calibrated by an official organization and the calibration must be recorded and filed. -The air used must be free of oil, humidity, and particles larger than 0.3 m

Procedure for Initial Calibration and Setup Neumovent Graph Ventilator Operación

Descripción

10

Access to the Calibration and Setup Menu: When the device is off, press the “Reset” key, and turn it on while keeping the key pressed. The next message will be displayed on the screen: Pasword: 1- If the changes to be made are to be saved in the memory, press the following sequence of keys: I : E – FREEZE – VOLUME - VERT The next message will be displayed on the screen: Correct Pasword PRESS ANY KEY You will get to MENU CALIBRATION by pressing any key

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Procedure for Initial Calibration and Setup Neumovent Graph Ventilator Operation

Description 2- If the changes in the calibration are not to be saved, press any key three times. The next message will be displayed on the screen: Incorrect Pasword PRESS ANY KEY You will get to MENU CALIBRATION by pressing any key

20

Calibration and Setup Menu: The calibration and setup menu displays a list in the following order:

Ajuste del reloj Presión Ambiente Flujo Aire Flujo Oxigeno Válvula Aire Válvula Oxigeno Sensores de Presión Válvula PEEP Comp. Neumo. Entradas Analógicas Opciones Iniciales Numero de Serie a-Select the desired option with the “Selection” key b-Press “enter” to enter into the selected calibration screen. Then, press “Reset”to return to initial menu.

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Procedure for Initial Calibration and Setup Neumovent Graph Ventilator Operation

Description

30

-To changes the date and hours values:

m

Clock Adjustment: a-Select the desired option with the “Selection” key

.co

b- Press “enter” to enter and modify the values with “Selection” key c-Press “enter” to exit.

-If the changes are ready

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Press “Menú” and the next message will be displayed on the screen: SAVE EXIT

Select the desired option with the “Selection” key

and press “Enter”.

uid

-If you select EXIT and the values was modified; the next message will be displayed on the screen: ¿Exit without save changes? Accept

[ Reset ]

Cancel

-g

[ Enter ]

Select the desired option

all

Then, press “Reset”to return to initial menu.

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Procedure for Initial Calibration and Setup Neumovent Graph Ventilator Operation

Description

40

Ambient Pressure Changes the values with “Selection”

key

Press “Menú” and the next message will be displayed on the screen: SAVE EXIT Select the desired option with the “Selection” key

and press “Enter”.

-If you select EXIT and the values was modified; the next message will be displayed on the screen: ¿Exit without save changes? [ Enter ]

Accept

[ Reset ]

Cancel

Select the desired option Then, press “Reset”to return to initial menu.

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Procedure for Initial Calibration and Setup Neumovent Graph Ventilator Operation

Description

50

Air Flow Air Flow Target

0 Lectura

0

Flow

0

Memory

0 Apertura

a- Connect the device outlet to a standard flowmeter Fig.:1-A (end of chapter ). b-Connect the inlets of the gas supply to a compressed air supply source c-Select the target value with “Selection”

key and press “Enter”

Open and close the valve with “Selection”

key

Low Fast d-When the target value is taked press “Enter”. e-Select a new target and repeat the operations a-b-c. f- Press “Menú” and the next message will be displayed on the screen: SAVE EXIT Select the desired option with the “Selection” key

and press “Enter”.

-If you select EXIT and the values was modified; the next message will be displayed on the screen: ¿Exit without save changes? [ Enter ]

Accept

[ Reset ]

Cancel

Select the desired option Then, press “Reset”to return to initial menu.

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Procedure for Initial Calibration and Setup Neumovent Graph Ventilator Operation

Description

60

Air Valve Air valve Target

0.1 Flujo

0.0

Apertura

0

Memoria

0

a-If the valve don’t have previous calibration the next message will be displayed on the screen: START SAVE EXIT b-If the valve have previous calibration then press “Menú”. c-Select START and press “Enter” to auto calibration begins d-Press “Menú” and the next message will be displayed on the screen: SAVE EXIT Select the desired option with the “Selection” key

and press “Enter”.

-If you select EXIT and the values was modified; the next message will be displayed on the screen: ¿Exit without save changes? [ Enter ]

Accept

[ Reset ]

Cancel

Select the desired option Then, press “Reset”to return to initial menu.

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Procedure for Initial Calibration and Setup Neumovent Graph Ventilator Operation

Description

70

Oxigen Valve Do the same operations than Air valve. 80

Pressure Sensors Presssure Sensors Derecho Izquierdo Aire Oxigeno

0 0 0 0

0 0 0 0

0 0 0 0

Cm H2O Cm H2O Kg./cm2 Kg./cm2

The screen will display a list of the calibration values saved in the memory which correspond to the pressures indicated in the following table:

(Control Sensor) (Graph Sensor) (Air Sensor) (Oxigen Sensor)

(zero p) 0 0 0 0

(calibration p.) 100 cmH2O 100 cmH2O 5 kg/cm2 (71 PSI) 5 kg/cm2 (71 PSI)

the values on the left column, which correspond to zero pressure Select the desired option with the “Selection” key value of the four sensors

and press “Enter” to save the zero

a-Maximum value for the control sensor (right) 1- Connect the supply pressures 2- Select the desired option with the “Selection”

key

3- Connect a 100 cmH2O pressure at the outlet to the patient. 4- Save the value with “Enter”.

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Procedure for Initial Calibration and Setup Neumovent Graph Ventilator Operation

Description b-Maximum value for the graph sensor (left) key

m

1- Select the desired option with the “Selection”

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2- Connect a 100 cmH2O pressure at the at the P1 and P2 inlets. simultaneously with a Y piece connection 3- Save the value with “Enter”. c-Maximum value for air and oxigen sensor

1- Select the desired option with the “Selection”

key

es

2- Connect an oxygen tube with a manometer at the gas inlet. Regulate a 5 kg/cm2 (or 71 PSI) pressure. 3- Save the value with “Enter”. d-Press “Menú” and the next message will be displayed on the screen: SAVE EXIT

uid

Select the desired option with the “Selection” key

and press “Enter”.

-If you select EXIT and the values was modified; the next message will be displayed on the screen:

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¿Exit without save changes? [ Enter ]

Accept

[ Reset ]

Cancel

Select the desired option

all

Then, press “Reset”to return to initial menu.

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Procedure for Initial Calibration and Setup Neumovent Graph Ventilator Operation

Description

90

PEEP Valve Press “Volume “ key

Vtr Ptr

Verify sensors reading Press “Menú” and the next message will be displayed on the screen: START SAVE EXIT Select SAVE option with the “Selection” key

and press “Enter”.

Then, press “Reset”to return to initial menu. 100

Comp. Neumo a-Place the expiratory valve and patient’s circuit.. b-Cap the patient’s circuit.Fig.:2(end of chapter) c- Press “Menú” and the next message will be displayed on the screen START SAVE EXIT Select INICIAR option with the “Selection” key

and press “Enter”.

When the auto-calibration is conclude : Press “Menú” and the next message will be displayed on the screen: START SAVE EXIT Select SAVE option with the “Selection” key

and press “Enter”.

Then, press “Reset”to return to initial menu. 110

Analog Inputs Check up the sensors following chapter 4°

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Procedure for Initial Calibration and Setup Neumovent Graph Ventilator Operation

Description

120

Initial Options Category Idiom

Adult Spanish

-Select the desired option with the “Selection” key -Press “Enter” to exit.

and press “Enter”.

Press “Menú” and the next message will be displayed on the screen: SAVE EXIT Select the desired option with the “Selection” key

and press “Enter”.

-If you select EXIT and the values was modified; the next message will be displayed on the screen: ¿Exit without save changes? [ Enter ]

Accept

[ Reset ]

Cancel

Select the desired option Then, press “Reset”to return to initial menu.

79

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Procedure for Initial Calibration and Setup Neumovent Graph Ventilator Connection for the calibration of Flows Fig.:1 Ventilator

Fl

Standard flowmeter

Patient outlet

Connection for of Comp.Neumo Fig.:2 Ventilator

Patient´s Circuit

Cap

80

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CHAPTER IX

FINAL CONTROL

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Final Control Neumovent Graph Ventilator Objective The purpose of this document is to provide the necessary information for the final control of the operation of the NEUMOVENT Graph ventilators.

m

Elements § Ventilator. § Adult or Pediatric Patient’s Circuit Steps

Operation

.co

§ Test Lung with a compliance of 50 and a resistance of 5.

Description

20

Perform initial calibration (instructions in the device)

30

Select the VCV mode (Volume Control Ventilation mode)

40

Program (initial parameters) Vt= 500 ml. FiO2=0.50 f= 15 (per minute) Peep=0 Ti= 1 sec. Sensit.= 3 l/min Inspirat. Pause: 0.50 sec. Square flow waveform Confirm the rest with + Volume Control: Reading of Vt expired = 500 ml. +/-85% (4.60 – 5.40) Reading of Plateau Pressure = 10 cm H2O +/- 2 cm H2O

60

Control of Flow Waveform: control the flow waveform on the screen.

Sensitivity Control: operation with initial parameters Check Flow Trigger – Program sensitivity at 3 liters/min. Check: a) Autocycling. b) Trigger by manipulation of the test lung. Check pressure trigger: Program: 1) Peep = 5 cm H2O 2) Sensitivity 0.5 – 1 – 1.5 cm H2O Check: a) Autocycling b) Trigger by manipulation of the test lung. Return Sensitivity = 3 liters/min. Flow Peep = 0 Peep Control: Adjust the maximum pressure alarm at 50 cm H2O Program 5 – 10 – 15 cm H2O. For each one of these values, check: Correct reading (+/- 1 cm H2O) in relation to the programmed value. Return to Peep = 0 Return to maximum pressure alarm = 40 cm H2O

all

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70

uid

50

es

10

Turn on the device.

80

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Final Control Neumovent Graph Ventilator Operation

Description

90

Fittings:

100

Alarms Maximum Pressure

-

Nebulizer: Check operation. Manual trigger: Check operation. O2 100%: Check operation.

Lower the alarm limit to the peak pressure level read. Check alarm activation Reset Return the alarm limit to 40 cm H2O Minimum Pressure Rise the minimum pressure alarm limit to the peak pressure level read. Check alarm activation Reset Return the alarm limit to 5 cm H2O High Vt With the initial parameters, lower the High Vt limit to 500 ml. Check alarm activation. Reset. Return the limit to 750 ml. Low Vt Rise the Low Vt alarm limit to 550 ml. Check alarm activation. Reset. Return the limit to 250 ml. Fmax Lower alarm limit to 15 per minute. Check alarm activation. Reset. Return alarm limit to 30 per minute. Gas supply Air Close the main supply valve. Check alarm activation. Open the supply valve again. Reset. Oxygen Follow the procedure indicated for air supply.

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Final Control Neumovent Graph Ventilator Operation 110

Description PCV (Pressure Control) Mode Select PCV Programming:

Check: 120

PCV = 10 ± 2 cm H2O Ti= 1.5 sec. Peep = 0 The rest is programmed with + Peak Pressure Reading = 10 ± 2 cm H2O Expired VT reading = 500 ml ± 8%

PSV Mode Select PSV a) Program Backup (Backup Ventilation). Apnea = 15 sec. SIMV = ON Confirm other backup parameters with + b) Program PSV. Pressure = 15 cm. H2O Peep = 0 ENTER Trigger the test lung. Check the mode operation (with the graph generated on the screen). Check Peak Pressure = 15 cm +/- 2 cm H2O Apnea Alarm Do not trigger the test lung. At 15 sec., the apnea alarm should become activated. The ventilator turns to backup ventilation. Trigger the test lung. Check if it returns to PSV ventilation.

130

SIMV VCV Mode Programming: f= 6 per minute. Inspiratory time = 1 sec. PSV 15 cm H2O The other parameters remain the same as for the initial programming. ENTER Trigger the test lung. Check the operation of the ventilatory mode.

140

SIMV PC Mode Programming: f= 6 per minute. Inspiratory time = 1 sec. PCV = 20 cm H2O

PSV = 15 cm H2O

. Trigger the test lung. Check the operation of the ventilatory mode.

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Final Control Neumovent Graph Ventilator Operation 150

Description MMV Mode Programming:

VE = 7 L / min. Min. VE Alarm = minimum value PSV = 10 cm H2O . Trigger the test lung at a low frequency to obtain a VE lower than that programmed. Ensure: a) Peak pressure should increase breath by breath. b) VT should increase breath by breath.

160

170

PSV + VT Assured mode Programming: Accept default parameters (CTRL + ENTER). Trigger the test lung. Control activation of the continuous flow phase. Check: VT expected = VT target Check operation of serial output.

180

Control the operation of the device installed with a circuit and test lung for 48 hrs.

84