Saadat Respina P1 User Manual

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Pooyandegan Rah Saadat Co.

Revision

Rev.

Date

16/8/13

Some warnings have been added based on failed items in the

16/12/21

standard test report (9503-B-1) and technical specifications

have been modified.

Some warnings and notes and also "Error code 17" (see

Alarms table) have been added. Section 7-3 has been

modified and "Base flow" value has been changed in

17/2/18

technical specifications. Pneumatic diagram has been

modified and the manual has been translated into English.

Some warnings have been added based on failed items in

the standard test report (9503-B-1) and technical

17/3/7

specifications have been modified. The manual has been

translated into English.

EMC declaration, CE sign, NB identification number and

EU rep information have been added to the manual and the

17/4/17

Technical Specifications have been modified. In addition,

the version 4 of the manual has been translated into English.

Some warnings and the Technical manual contents list have

been added, the device symbols, range of alarm limits and

the Technical specifications have been modified, the list of

17/8/29

accessories, troubleshooting table and alarms list have been

completed.

The version 5 of the manual has been translated into English.

User Manual

Code: O49-L01-V29

Description of Revision

Initial Release

2 pages.

Prepared by

Verified by

A. H.

N. Rahmati

Mehrnam

A. H.

N. Rahmati

Mehrnam

A. H.

N. Rahmati

Mehrnam

A. H.

N.Rahmati

Mehrnam

A. H.

N. Rahmati

Mehrnam

A. H.

N. Rahmati

Mehrnam

Verified by

H. AzizZadeh

Table of Contents

Summary of Contents for Saadat Respina P1

Page 1 Pooyandegan Rah Saadat Co. User Manual Code: O49-L01-V29 Revision Rev. Description of Revision Prepared by Verified by Verified by Date Initial Release A. H. 16/8/13 N. Rahmati H. AzizZadeh 2 pages. Mehrnam Some warnings have been added based on failed items in the A.
Page 2 A. H. 17/10/23 EMC declaration table has been modified. N. Rahmati H. AzizZadeh Mehrnam The alarm sound pressure range has been modified. A note N. Rahmati H. AzizZadeh 17/11/12 about Event log and a warning about oxygen alarms have been added. 100% O2 maneuver, Flow Trig and some points about nebulizer have been added.
Page 3 description of alarms, deleting High oxygen alarm test, editing ventilation modes, adding “Bi- level” mode, adding the limitation of setting parameters, editing leak compensation and NIV section, editing the description of monitoring parameters, updating the technical specification, updating the pneumatic diagram, editing trouble shooting and translating the document to English Updating technical specification, accessories list, section 7- A.
Page 4 RESPINA.P1 User Manual Pooyandegan Rah Saadat Co.
Page 5 POOYANDEGAN RAH SAADAT CO. Central Office: No. 4, East. 1st St, Ettehad Blvd., Damavand Ave., Tehran, Iran Post box: 1658916599 Tel: +98 21 77960719 Tel: +98 21 77962181 Fax: +98 21 77964239 Customer Services: Tel: +98 21 77798910 Tel: +98 21 73098000, +98 912 1977157...
Page 6 This manual provides the instructions necessary to operate ventilator system based on its intended use. It also describes all adjustable and measurable parameters by the system, defined maneuvers, alarms and briefly all capabilities of the Respina P1 ventilator. Observance of this manual is a prerequisite for proper operation and assures patient and operator safety.
Page 7: Table Of Contents
1-5 Device Labels and Symbols ......................13 1-6 Guarantee and responsibilities ...................... 15 1-7 Contents list of Technical Manual ....................16 2- Overview of Respina P1 Ventilator ......................17 2-1 Front View ............................17 2-2 User interface ..........................18 2-3 Accessories ............................. 18 2-4 Note ..............................
Page 8 5-7 Alarms ............................34 5-8 Config............................. 37 5-9 General Setup ..........................38 5-10 Graphic Settings ..........................39 5-11 Clinical Setup ..........................39 5-12 Technical settings ........................... 41 5-13 Maneuver ............................42 5-14 Shuting down the ventilator ......................46 Alarms ..............................48 6-1 Alarm Priority ..........................
Page 9: Introduction
1- Introduction Device description and intended use The Respina P1 ventilator system is intended to be used with adult and pediatric patients weighing more than 5 Kg in the ICU. This system is designed in such a way that can provide invasive and non-invasive mechanical ventilation for patients.
Page 10: Side Effects
 If there is no alternative ventilation method and equipment that can be used as a backup.  Connected the device to an inadequate electric mains power (e.g. without earth connection).  With gas supply which do not meet medical grade specifications. It is NOT possible to use the ventilator when any of the following events occurs: ...
Page 11 When the device is turned on, audible and visual alarms will be enabled for a few seconds to check the alarm system. Do not use the device if integrity of the alarm system is in doubt and contact the Customer Service department. Use only sterilized tracheal tube.
Page 12 The maximum time taken to increase the oxygen concentration in the delivered gas to the patient from 21% to 90% is 12 seconds (in the volumes 30, 150 and 300 ml). The device maintenance should always be accomplished in conformity with safety regulations.
Page 13: Device Labels And Symbols
Note: 1- The ventilator is equipped with a safety valve that functions mechanically to keep the pressure below 110 cmH2O. 2- The required time for oxygen concentration to reach from 21 to 90%, in volumes of 30, 150 and 300 ml, in the worst case, is less than 2 minutes. Device Labels and Symbols On key Alarm Silence...
Page 14 Refer to manual Sensor O2 Sensor location Device serial number SN: xxxxxx 2.4-6 bar (35 - 87 psi) O2 inlet port max. 180 L/min Air 2.4-6 bar (35 - 87 psi) Air inlet port max. 180 L/min AC –Input: 100 -240VAC input connector 1.0 - 0.5 A 50/60 Hz...
Page 15: Guarantee And Responsibilities
Parts of the device that have high temperature Authorized representative of Europe Warning! Refer to the device manual Device weight Lock and unlock the exhalation valve Battery location Indicates that the ventilator is On Alarm active indicator Indicates the ventilator running on the battery and the battery charge status Indicates the ventilator connection to the mains power and the battery charging...
Page 16: Contents List Of Technical Manual
Contents list of Technical Manual The Technical manual includes the following chapter headings. For more information about the device maintenance and servicing, please refer to the Technical manual.  About this manual  Theory of operation  Test and service ...
Page 17: 2- Overview Of Respina P1 Ventilator
 Then touch Save or push the knob to apply new setting. The ventilator is equipped with air and oxygen inlets that are connected to compressor or hospital main gas supply. Respina P1 ventilator is composed of the following parts (See figure 2-1).
Page 18: User Interface
Exhalation valve On/ off key Gas flow from the patient Battery cover Gas flow to the patient Oxygen sensor cover Exhalation valve- Air inlet Exhalation sensor interface flow sensor Nebulizer Filter Oxygen inlet Figure 2-1 Different parts of ventilator User interface The parts of the device that user or patient can interact with are: ...
Page 19 Complete Antistatic Hoses O2 (Hospital to ventilator)- P26468 Medsistem Optional list 1  Pediatric respiration set- Altech P26302 Trolley P26324 Holder of respiratory tubes P28129 Optional list2 Air compressor- Saadat F01451 Humidifier- Saadat F01492  Humidifier Chamber- Vadi P26311  Humidifier Chamber- Fisher & paykel P49079...
Page 20: Note
Pay attention to expiry date of the accessories and avoid using outdated accessories. If you see any damage to the packaging of the accessories, do not use them. The manufacturer approved exhalation filter and HME have a pressure drop lower than 2.9 cmH2O in flow of 30 l/min and dead space of less than 76 ml. Note During ventilation, an active screen will remain for 60 seconds after the user last interaction and then will revert back to the Main Screen.
Page 21: 3- Ventilator Preparation For Use
3- Ventilator preparation for use AC Mains Supply The ventilator operates on 100-240 VAC power supply and frequency of 50- 60 Hz. Use a grounded cable as the mains power cable. Battery The ventilator is equipped with an internal battery and can run on this battery up to 5 hours. When the ventilator runs on the battery, “AC Unplug”...
Page 22: Patient Breathing Circuit
For a proper hose connection, tighten the connection nuts with hand without using a wrench. Since the ventilator is a high-flow device, if it is connected to a hospital air or oxygen source, make sure that the source is suitable to supply the required flow of the device.
Page 23 Warning Breathing circuit filters, respiratory tubes (including water traps), humidifier chamber, HME and in specific condition, exhalation flow sensor and exhalation valve could be contaminated through lung secretions and expiratory gases. For more information about disinfection or sterilization of different parts, please refer to section 7-2 of this manual.
Page 24: 4- Operation
4- Operation Use of the Ventilator Warning The ventilator must be operated only by qualified clinicians. Note: Perform the system test before connecting the ventilator to the patient. Turn the ventilator on or off using On/Off key placed on the rear panel. Check that all cable and tubes are connected correctly and the ventilator is connected to an appropriate power source.
Page 25: 100% O2 Key
100% O2 Key Pressing 100% O2 key on the front panel (if the oxygen source is available with proper pressure) will deliver a mandatory or assisted breath (like applied pattern in Manual inspiration) depending on ventilation mode and time of key pressing and 100% oxygen will be delivered for 2 minutes in the current ventilation mode.
Page 26: Alarm Silence Key
Alarm Silence Key Press this key to silence audible alarms for 120 sec. Pressing the key again before end of this period will enable sound of all currently active alarms. If the alarm condition is not removed after 120 sec, the alarm will sound and visual alarm will also be activated.
Page 27: 5- The Ventilator Setting
5- The Ventilator Setting Warning Only trained users should change the ventilator setting. Turning on the Ventilator When the ventilator is turned on, self test page will appear. The device automatically checks different mechanical and electronic parts during this test. If there is a failure detect in any part, “NOT OK”...
Page 28 Figure 5-2 memory failure If test of all above items is carried out successfully, the patient option page of the device will appear. Figure 5-3 Self test Page...
Page 29: Patient Option
Gender Height Note: The Respina P1 ventilator is able to calculate Ideal Body Weight (IBW) automatically based on entered patient height. If calculated IBW value by the device is not approved by the clinician, you can enter IBW value manually.
Page 30: Calibration
Calibration Select this item to access calibration menu. For more information about this menu, please refer to section 7 of this manual. Settings After entering patient data, the device will load default settings automatically. Then user should select ventilation mode and other parameters settings and confirm the selected mode. After confirming the settings, the patient ventilation will start.
Page 31 Tidal volume delivered to patient during each inspiration Inspiration time PEEP Positive end expiratory pressure Pressure more than PEEP that applies to mandatory breaths in pressure modes control Pressure more than PEEP that applies to spontaneous breaths. support High pressure level in APRV mode high Low pressure level in APRV mode Time at high pressure level in APRV mode...
Page 32: Main Screen
the pattern of applied flow to the patient. Square or Decel. are selectable for this Flow Pat. parameter. If “Leak Compensation” is enabled, the ventilator will compensate leaks Leak Comp. automatically. Ability to use the device non-invasively (NIV) and using a mask. This feature is defined in P-SIMV and PSV modes.
Page 33: Monitoring
Figure 5-8 M Trend You can view stored parameters during 72 hours. The Respina P1 ventilator is able to display trend of three parameters at once. Clicking on label positioned beside each curve will open a menu in which you can select a parameter to be displayed in the trend.
Page 34: Alarms
Figure 5-9 Trend In each curve, the vertical axis represents the numerical value of the parameter and the horizontal axis of the time. it is possible to change time frame by clicking on the written time in the middle of horizontal axis area. These time frames are as follows 60 min, 6 h, 12 h, 24 h, 36 h and 72 h.
Page 35 Alarm limit Equation PEEP high PEEP monitoring PEEP low PEEP monitoring Rate high Rate monitoring Rate low Rate monitoring MV high monitoring MV low monitoring Vte high monitoring Vte low monitoring Figure 5-10 Alarms Menu Warning Incorrect setting of alarm limits (manually) could affect functionality of the alarm system.
Page 36 High 10-100 peak PEEP High 3-60 PEEP Low 2-59 or Off Leak 20-100 or Off Apnea Time 15-60 Vti Limit 20-3000 or Off The default values of alarm limits are listed below: Alarm limit Default Alarm limit Default ((Rate*VT)/1000 - MV Low MV High 2*(Rate*VT)/1000...
Page 37: Config
If New from Patient Setup menu is selected, the event log will be cleared and after IBW setting subsequent events will be stored. If Previous is selected from Setup menu, new events will be added to the current log. By clicking on each event, you can view current settings of time of alarm occurrence below the Event Log.
Page 38: General Setup
 General Setup  Graphic Settings  Clinical Setup  Technical Figure 5-12 Config menu General Setup You can set the below items in the General Setup menu (See the figure 5-8).  Alarm volume  Bed number  Touch sound ...
Page 39: 5-10 Graphic Settings
It should be noted that Back light, Touch Sound and Bed Number items are inactive. 5-10 Graphic Settings This page is currently inactive. 5-11 Clinical Setup The following items could be set in this menu:  Smart nebulizer  Humidification type ...
Page 40 The nebulizer will also be disabled in the below conditions and “Neb. Not Usable” alarm message will be displayed (to avoid deviations in flow delivery by the nebulizer): - If high pressure oxygen source is not available - If the oxygen pressure is out of the allowed range. When the nebulizer is enabled, flow and volume waveforms and parameters will be compensated.
Page 41: 5-12 Technical Settings
 O2 Sensor Select this item to set On/Off the oxygen sensor. Note: If you set the O2 sensor to off, “High Oxygen” and “Low Oxygen” alarms will be disabled and the measured value of O2 parameter will not be displayed. ...
Page 42: 5-13 Maneuver
5-13 Maneuver Select this item to set maneuver of the device. Maneuver options of the Respina P1 ventilator are: Insp. Hold, Exp. Hold, P0.1, NIF, Suction Support Figure 5-17 Maneuver  Expiratory Hold Press and hold this button to keep ventilation at the end of expiration phase of current respiratory cycle.
Page 43 Press and hold this button to keep ventilation at the end of inspiration phase of current respiratory cycle (Mandatory or Supported breaths). If the button is released before the end of inspiration phase, Inspiratory Hold will not be performed. The maximum duration of Inspiratory Hold maneuver is 20 sec. As soon as releasing the button, Inspiratory Hold procedure will terminate.
Page 44 the patient may terminate P0.1 maneuver, this maneuver will not enable Apnea alarm. If user intends not to switch to the apnea backup during the maneuver, he/she should disable the apnea backup. If user presses the STOP key during the maneuver, the maneuver terminates and ventilation will resume immediately.
Page 45  Suction Support The suction maneuver includes the below phases:  Premier 100% O2  Suction  Final 100% O2 After selecting and starting each phase, the next phase will be enabled. Each phase is carried out for maximum 2 minutes and then relevant button will be disabled and a progress bar is filled up.
Page 46: 5-14 Shuting Down The Ventilator
Note: During the suction phase, flow value will be zero and the below alarms will be disabled for 2 minutes: Low PEEP, Low MV, Low VTe, Low Rate, APNEA, Disconnection The message “Perform Suction and Reconnect within 120s” appears above the page during the suction phase.
Page 47 Warning Pay attention that turning off (hardware) the ventilator is not recommended in normal situation because it may cause problems with to save the latest data and settings.
Page 48: Alarms
Alarms Warning Always verify the audible and visual alarms when the ventilator is powered on. When the system is powered on, the indicators light up. If all indicators light up, it will show proper functioning of the indicators. Note: Alarm volume can be set by selecting General Setup from Config menu. It ranges from 1 to 7.
Page 49: Alarm Sound
User can not cancel alarm or delete the alarm message from the screen Message on the cyan until alarm condition is removed. 1 signal sounds Low/ background, indicator When the alarm cause is removed, “DO” every 30 Information flashes with the relevant message in the Alarm seconds.
Page 50: Alarms
Alarms High Priority Alarm Definition Ventilator reaction to alarm Alarm The maximum pressure has been exceeded from its limit during The inhalation terminates and High Inh. Pressure inhalation. expiration begins. The airway has been occluded partially. If current mode is one of VSV, PSV or APRV modes and apnea backup is No breath has been delivered in active, apnea backup ventilation starts...
Page 51 The oxygen inlet pressure is more High O2 Pressure Ventilation continues. than the specified level. If the Air source is available, The oxygen inlet pressure is lower ventilation continues with Air only. than the specified level. Low O2 Pressure The safety valve opens if the pressure This alarm will not be enabled if the of both Air and Oxygen sources drops oxygen concentration is set to 21%.
Page 52 Exhaled tidal volume has been below the limit set in three consecutive Low Vte Ventilation continues. respiratory cycles. PEEP pressure has exceeded high High PEEP PEEP alarm setting in two Ventilation continues. consecutive respiratory cycles. In PRVC-CMV, PRVC-SIMV and VSV modes (that pressure set by device), if in 3 consecutive respiratory cycle reaching to the maximum allowable pressure...
Page 53 Some parameters such as Vte that are measured by this sensor will be displayed blank. Ventilation continues. If flow trigger mode is active, the device will switch to a pressure Exhalation flow sensor is not placed trigger mode. In this condition you Exh Not Fitted correctly.
Page 54 The power supply alarms include: High Priority Alarm Definition Ventilator reaction to alarm Alarm Internal battery voltage is lower than Battery Low Ventilation continues. 20%. If the device is connected to the mains No Battery The internal battery is not available. power, ventilation continues.
Page 55 In certain situations, or in the presence of some alarms, a series of alarms are deactivated which are listed in the table below. Situation Deactivated alarm High PEEP Low PEEP High MV Low MV High Vte Until 60 seconds after the start of inspiration and Low Vte after 3 respiratory cycles High Rate...
Page 56: Alarms Test
Alarms test Alarm test setting Mode: Apnea time: 20 s Trigger Type: Flow High Rate: 100 b/min Rate: 10 b/min Low Rate: 2 b/min 500 ml High Ppeak: Pause: High MV: 50 l/min Oxygen: 21 % Low MV: 2 l/min 1.4 s High Vte: 1000 ml...
Page 57 Occlusion alarm test: Occlude the expiratory path completely during the exhalation phase. Verify that occlusion alarm is activated after two breaths. Disconnection alarm test: Disconnect the patient breathing circuit from the ventilator outlet port during the exhalation phase. Check that Disconnection alarm is activated after a while breath cycles.
Page 58: 7- Maintenance
7- Maintenance In this section maintenance procedure of the ventilator including calibration, cleaning, preventive maintenance and disposal of components and accessories will be described. Calibration Note: Use compressed air system of hospital to calibrate the ventilator. There is a calibration option in startup page of the ventilator. Selecting this option will load a window (See figure 7-1) in which you can select different types of calibration.
Page 59 Figure 7-2 O2 Sensor Calibration page  System Test The system test should always be performed before using the ventilator or after replacing the patient respiration set. This test is performed to inspect the patient breathing circuit. Any leakage in the patient tubing system could be calculated using this test.
Page 60: Cleaning, Disinfection And Sterilization
 EXH. Flow Sensor Calibration This test is used to calibrate exhalation flow sensor. It should be noted that the circuit wye is closed during this test. Press START button and wait until the calibration process is complete. Select SAVE button to store the calibration data. This test should be performed before using the device, after cleaning or replacing the exhalation flow sensor or if incorrect exhalation volume is measured by the sensor (e.g.
Page 61 Exterior surface Clean exterior surfaces by using a soft cloth damped with water and soap. Disinfect exterior surfaces of the device using isopropyl alcohol. Clean and disinfect the exterior surfaces of the ventilator after each patient or as required. Warning Do not sterilize the ventilator.
Page 62: Cleaning And Disinfecting
Exhalation Valve After each patient or as required, clean the exhalation valve by rinsing and drying with soap and water. And then disinfect or sterilize. Exhalation valve- flow sensor interface After each patient or as required, clean the exhalation valve by rinsing and drying with soap and water.
Page 63 Recommended cleaning, sterilization and disinfection methods of different parts of the ventilator are provided in the below table Ventilator part Single use Cleaning Disinfection Sterilization Display screen Using ethanol Exterior surfaces, trolley and tubes Using isopropyl holder alcohol Air compressor Hoses and the components Using water...
Page 64: Preventative Maintenance
Preventative Maintenance Follow below instructions to replace different parts of the ventilator. 7-4-1 Oxygen Sensor Warning Before using the oxygen sensor, check its expiry date on the package. Outdated oxygen sensor is not accurate and reliable. The sensor could be used for a specific period as specified on its package. Replace the oxygen sensor after this date or during sensor failure.
Page 65 7-4-2 Exhalation Flow Sensor If replacement of the exhalation flow sensor is required, use only recommended exhalation flow sensors by manufacturer (See section 2-3). The exhalation flow sensor should be replaced every 6 months or when the exhalation flow sensor failure message is displayed during exhalation flow sensor calibration.
Page 66 Remove the exhalation flow sensor. Turn the exhalation valve counterclockwise. Remove the exhalation valve, exhalation valve- flow sensor interface and the membrane. When reinstalling the exhalation valve, make sure that the membrane is placed in correct direction. After placing the membrane, check that round steel plate positioned at the back of the membrane is visible.
Page 67 7-4-4 Battery Replace internal battery of the ventilator every two years or as required. Use only manufacturer recommended batteries (see section 2-3). Take the following actions to replace the battery: Loosen the screw that attaches cover of the battery compartment to the device. Remove the battery and replace it with a correct one.
Page 68 Operation intervals Responsible person exhalation flow sensor or if the expiratory volume is incorrectly measured by the sensor Before using the ventilator System test calibration and after replacing the patient User breathing tube Air valve calibraion Annually Expert Oxygen valve calibration Annually Expert Exhalaion valve calibration...
Page 69 Operation intervals Responsible person replacement instructions According to manufacturer NIV mask replacement User instructions Nebulizer replacement After each patient User User: trained personnel of medical centers Expert: After-sales service expert or trained people by the manufacturer Warning In addition to above mentioned calibration and maintenance procedures that could be performed by the user, it is recommended that the device is calibrated once a year by trained service experts.
Page 70: 8- Ventilation
8- Ventilation Ventilation modes The Respina P1ventilator provides the following ventilation modes: VCV, V-SIMV, PCV, P-SIMV, PRVC-CMV, PRVC-SIMV, VSV, PSV, APRV  VCV (Volume Controlled Ventilation) During this mode the ventilator delivers the set tidal volume to the patient in inspiration phase.
Page 71 Figure 8-1- Flow versus time curve in VCV mode The operator encounters some limitations in setting high and low limits of parameters in a ventilation mode, these limitations result from other ventilation parameters setting. these limitations are defined to meet the following conditions: ...
Page 72 Dual control: Dual control is a feature in volume modes (VCV, V-SIMV) that allows the patient to receive more volume than the set value if needed, in case of activation. If the patient triggers to breathe during inhalation and causes a drop in pressure, the volume control is temporarily changed to pressure control.
Page 73 PEEP value is added to Pcontrol, thus the ventilator maintains the airway pressure on PEEP+Pcontrol. Rise time is a parameter that determines the speed to reach the control pressure (Pcontrol) and has three values, Fast, Med and Slow. In this mode as mode the patient could synchronize a mandatory breath with respiratory effort.
Page 74 Adjustable parameters in PCV mode are: Parameter Definition Percentage of delivered oxygen to the patient Rate Mandatory breaths per minute Inspiratory time PEEP Positive end expiratory pressure Inspiratory pressure above PEEP in mandatory breaths control Trigger The method of detecting the patient's respiratory effort (flow or pressure). F Trig/ P Trig Threshold of detecting patient respiratory effort based on flow or pressure Rise Time...
Page 75 Adjustable parameters in PRVC-CMV mode are: Parameter Definition Percentage of delivered oxygen to the patient Rate Mandatory breaths per minute Inspiratory time PEEP Positive end expiratory pressure Target tidal volume delivered per breath Trigger The method of detecting the patient's respiratory effort (flow or pressure). F Trig/ P Trig Threshold of detecting patient respiratory effort based on flow or pressure Rise Time...
Page 76 prevents further increase in pressure. If this happens in a few breathing cycles, the alarm for not delivering the user's adjusted volume will be activated (see the alarms chapter). The flow Pttern sets by the user. Two square and decelerating (Decel.) flow patterns are selectable in this ventilator.
Page 77  P-SIMV (Pressure Controlled Synchronized Intermittent Mandatory Ventilation) This mode is a combination of mandatory and spontaneous breaths. Mandatory breath is pressure controlled and spontaneous breath is pressure supported. Excessive increase of pressure or deliverd volume could cause terminating the inhalation. In this situation, applied Ti may shorter than set Ti (see the alarms chapter).
Page 78 F Trig/ P Trig Threshold of detecting patient respiratory effort based on flow or pressure Percentage of peak inspiratory flow in spontaneous breath necessary to % Esens terminate inhalation and initiate exhalation. Rise Time Time required for inspiratory pressure to rise to set pressure ...
Page 79  VSV (Volume Support Ventilation) This mode is a spontaneous breath mode and patient effort determines respiratory rate. In this mode the user sets tidal volume. When the patient makes an effort, the ventilator delivers pressure supported breath to achieve the set tidal volume. Low pressure limit is equal to PEEP + 3 cmH2O and high pressure limit is equal to Pmax –5 cmH2O (Pmax is high pressure limit).
Page 80 When the operator adjusts the parameters of a respiratory mode, he/ she is faced with limitations in setting the upper and lower limits of these parameters, which are due to the adjustment of other respiratory parameters. Note: During inhalation, if the airway pressure for any reason (such as the patient's cough) exceeds the value specified for it, the exhalation valve opens and prevents further increase in pressure.
Page 81 Thigh and Tlow determine the duration of exposure to each pressure levels. The device is in the inhalation phase during Thigh and in the exhalation phase duting Tlow. The minimum possible time for Thigh is one second and the maximum possible time for Tlow is two seconds.
Page 82 In the following conditions, The device is not able to detect expiratory flow peak: If the exhalation flow peak is less than 5 L/min If the exhalation flow sensor is damaged or disabled by the user Note: The Thigh time may be set by the user to a value greater than the apnea time, in this case it is recommended to disable the apnea mode if necessary.
Page 83 When apnea backup is on if the patient makes no breath effort once the set apnea time has passed, backup ventilation will be provided and apnea alarm will be activated. If apnea backup is off, apnea alarm will be activated and the ventilator will not switch to backup ventilation mode (in this condition if apnea backup is set on, backup ventilation will be provided).
Page 84: Limitations Of Setting Parameters
Limitations of setting parameters In adjusting the setting parameters in different modes, some respiratory parameters limit each other. These restrictions are divided into several categories: Dependence of Rate, Flow and Vti Dependence of Rate and Ti Dependence of Plow, Phigh, Psupport, Ppeak, PEEP and High pressure alarm limit that shown in the following table: Restrictions of parameters Ventilation mode...
Page 85: Non Invasive Ventilation (Niv)
The maximum leakage flow value is according to the below table. These limits are used in the measurement of leakage flow. Invasive 15 l/min 30 l/min pediatric 20 l/min 50 l/min adult It should be noted that added volume to inspiratory volume could be limited in the above conditions.
Page 86: Monitoring Data
3. The following parameters will not be displayed until 30 seconds after the start of ventilation and after 3 breathing cycles: MV, Vte, MV spont, Leak, Rate, Rate spont, O2 All monitored parameters of the Respina P1 ventilator are listed in below table: Parameter...
Page 87 Exhaled tidal volume. This parameter is calculated and updated in each breath. Inspired tidal volume. This parameter is calculated and updated in each breath. Volume of air expired in one minute including mandatory and spontaneous breaths. This parameter is calculated in 8 breaths but updated at each breath.
Page 88 milliseconds, this parameter is calculated. - If a patient is making respiratory effort during the measurement cycle especially pause time it may cause erroneous measurement of lung compliance. - Fault of pressure and flow sensors may result in erroneous measurement of this parameter. - The system leakage could result in invalid parameter value.
Page 89 P0.1/NIF Ratio of P0.1 to NIF This parameter indicates the work required of the patient to trigger the ventilator. The Respina P1 ventilator measures this parameter in all mandatory and supported breaths triggered by the patient except in APRV WOBimp ventilation mode.
Page 90: Respiratory Curves
Inspiration phase of spontaneous breaths is displayed in yellow and the exhalation phase is displayed in green. The Respina P1 ventilator displays two respiratory loops at the right side of the screen. These loops are: Flow-Volume, Pressure-Volume ...
Page 91 Default setting of time scale in all pressure-time, volume-time and flow-time curves is (0,12). The user can change default setting to one of above ranges. Changing the time scale of one curve makes the same change to the other curves. Flow, pressure and volume values may exceed the selected scale by some changes in parameters of the current ventilation mode.
Page 92: 9- Technical Specifications
9- Technical Specifications Technical Specifications Assisted Control Mandatory Ventilation Ventilation Synchronized Intermittent Mandatory Ventilation SIMV Modes Spontaneous Ventilation SPONT VCV, V–SIMV (With Dual control Volume–controlled breaths in the breath) Pressure–controlled breaths PCV, P–SIMV, PSV Breath Types Volume Targeted Pressure–controlled breaths (Pressure Regulated Volume Control) &...
Page 93 Pause (insp plateau) 0 – 75% of Inspiratory time Accuracy: ±0.02 sec Rise time Fast, Med, Slow Exhalation sensitivity 5 – 85 % of peak flow Accuracy: ±12% or ±(3 l/min +4% Actual reading) Oxygen (FiO2) 21 – 100 % Accuracy (Delivery): ±...
Page 94 MV (exhaled minute volume) 0 – 99 l/min Accuracy: ±15 % or ±(0.3 l/min) wig MV Spont (spontaneous exhaled minute volume) 0 – 99 l/min Accuracy: ±15 % or ±(0.3 l/min) wig Leak 0 – 100% Accuracy: ±12 % or ±(3% + 4% Actual reading) PF (peak inspiratory flow) 0 –...
Page 95 (The maximum negative pressure generated during -60 – 0 cmH2O inspiration against an occluded airway) Accuracy: ± (2 cmH20 + 4%) 0 – 100 % P0.1/NIF WOBimp (Work of breathing) 0 – 20 j/l Accuracy: ± 10% Actual reading 0 – 99.9 sec (Expiratory time constant) Gas Temp 0-100 °C...
Page 96 Active Exhalation valve (Pressure relief during Available in all modes inhalation) Duration: 1-480 min, Resolution:1 Nebulizer Accuracy: ±10 s Configuration Setting Humidification Type None, HME, Humidifier Compliance Comp On or Off; 100 to 240 VAC (47 – 63 Hz) AC input Battery Backup (with fully charged batteries) Up to 5 hours Clean oil-free and medical grade...
Page 97 Guidance and manufacturer's declaration – Ventilator Respina P1 emissions The Ventilator Respina P1 is intended for use in the electromagnetic environment specified below. The customer or the user of the Ventilator Respina P1, should assure that it is used in such an environment.
Page 98 Guidance and manufacturer's declaration – electromagnetic immunity The Ventilator Respina P1 is intended for use in the electromagnetic environment specified below. The customer or the user of the Ventilator Respina P1 should assure that it is used in such an environment.
Page 99 Guidance and manufacturer's declaration – electromagnetic immunity The Ventilator Respina P1 is intended for use in the electromagnetic environment specified below. The customer or the user of the Ventilator Respina P1should assures that it is used in such an environment.
Page 100 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment IMMUNITY Test Maximum Band Distance TEST frequency Service Modulation power (MHz) LEVEL (MHz) (V/m) Pulse 380- 390 TETRA 400 modulation 18 Hz GMRS 460, ±5 KHz 430- 470 FRS 460 deviation 1 KHz sine Pulse...
Page 101: 10-Pneumatic Diagram
10- Pneumatic Diagram Figure 10-1 Pneumatic diagram...
Page 102: 11-Troubleshooting
11- Troubleshooting Alarm Message Possible Cause Corrective Action The maximum pressure during the - Check the patient condition. inhalation exceeds the defined limit - Check the device settings. for the respiratory cycle. High Inh Pressure - Check the alarm limits. The airway has been occluded - Check the patient airway.
Page 103 Alarm Message Possible Cause Corrective Action - If Ftrig is used, ensure that exhalation flow sensor is faultless and calibrated. - Check the patient condition. - Check the device settings (especially ventilation mode and No breath has been delivered in set trigger value) mode (no patient triggered breath or Apnea...
Page 104 Alarm Message Possible Cause Corrective Action The air inlet pressure is lower than the specified level. - Check the air source. - If the alarm persists, contact the Low Air Pressure This alarm will not be enabled if the Customer Service department. oxygen concentration is set to 100%.
Page 105 Alarm Message Possible Cause Corrective Action The device is unplugged. - Plug in the device. AC Unplug Contact the Customer Service The battery failure Battery Defect department. - Ensure that a correct battery has been inserted in the device. The internal battery is not available. No Battery - If the alarm persists, contact the Customer Service department.
Page 106: 12-Attachments
12- Attachments This section of the manual provides a more complete explanation of some topics.
Page 107 Reached alarm In volume modes, if the airway pressure in three consecutive breaths approaches the level of the pressure alarm but does not pass, then a Plim Reached alarm is activated. Alarm activation and Pressure adjustment Pressure termination the time by the device alarm limit inhalation phase Pressure, flow and volume curves in VCV mode...

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