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Responsible person

intervals

Operation

exhalation flow sensor or if
the expiratory volume is
incorrectly measured by the
sensor

User

Before using the ventilator
and after replacing the patient
breathing tube

System test calibration

Expert

Annually

Air valve calibraion

Expert

Annually

Oxygen valve calibration

Expert

Annually

Exhalaion valve calibration

Expert

Annually

Periodic calibration

User

Annually or every 5000 hours
of ventilator operation (each
occurred earlier)

Air inlet filter check

User

Every 100 hours of ventilator
operation (4 days)

Water and Humidity Drain
Check (Air Filter Glass
Enclosure)

Expert

Annually or every 5000 hours
of ventilator operation (each
occurred earlier)

Oxygen filter check

Expert

After the expiration date or
sensor failure

Oxygen sensor replacement

Expert

Annually or as needed

Exhalation flow sensor
replacement

Expert

Every two years or during
battery failure

Battery replacement

Expert

In case of damage

Exhalation valve- flow sensor
interface replacement

Expert

After each patient or in case
of damage

Exhalation valve membrane
replacement

User

After each patient

Respiration set replacement

User

After each patient, every 24
hours or as needed

HME replcament

User

After each patient, every 24
hours or as needed

Exhalation filter replcament

Expert

In case of damage

Complete Antistatic Hoses
AIR (hospital Air to
compressor) replacement

Expert

In case of damage

Complete Antistatic Hoses
AIR (compressor to
ventilator) replace ment

Expert

In case of damage

Complete Antistatic Hoses O2
(Hospital to ventilator)
replacement

User

After each patient

Humidifier chamber
replacement

Expert

According to manufacturer

Humidifier temperature probe

Содержание Respina P1

Страница 1: ...H Mehrnam H AzizZadeh 3 17 3 7 Some warnings have been added based on failed items in the standard test report 9503 B 1 and technical specifications have been modified The manual has been translated i...

Страница 2: ...essories tables have been modified Finally the version 11 of the manual has been translated into English N Rahmati A H Mehrnam H AzizZadeh 12 18 12 24 A warning about humidifier and also NIV mask have...

Страница 3: ...ing flow pat To the setting parameters adding the description of Home key updating the list of the alarms updating the technical specification and translating the document to English N Rahmati A H Meh...

Страница 4: ...4 RESPINA P1 User Manual Pooyandegan Rah Saadat Co...

Страница 5: ...0719 Tel 98 21 77962181 Fax 98 21 77964239 Customer Services Tel 98 21 77798910 Tel 98 21 73098000 98 912 1977157 Fax 98 21 77960761 Legal responsible Trionara Technologies AB Polygonv gen 21 18766 T...

Страница 6: ...ent This manual is an essential part of and should always be kept close to the ventilator system so that it can be obtained conveniently when necessary Intended Audience This manual is provided for he...

Страница 7: ...Front View 17 2 2 User interface 18 2 3 Accessories 18 2 4 Note 20 2 5 Touch Screen 20 3 Ventilator preparation for use 21 3 1 AC Mains Supply 21 3 2 Battery 21 3 3 Air and Oxygen Supply 21 3 4 Patien...

Страница 8: ...rms 50 6 5 Alarms test 56 7 Maintenance 58 7 1 Calibration 58 7 2 Cleaning Disinfection and Sterilization 60 7 3 Cleaning and disinfecting 62 7 4 Preventative Maintenance 64 8 Ventilation 70 8 1 Venti...

Страница 9: ...ory effort of sensitive patient to flow or pressure Detecting Apnea Backup ventilation in case of Apnea occurrence Apnea Backup User selected oxygen concentration Numeric parameters display Respirator...

Страница 10: ...the patient in order to optimally adapt the ventilation settings to the patient s condition 1 3 Side effects The instructions for use do not discuss about risks that are obvious to users consequences...

Страница 11: ...vice If the ventilator is damaged and ventilation fails stop using the ventilator because it may lead to the patient death To avoid risk of electric shock the device must be connected to a mains suppl...

Страница 12: ...t to a curtain this could block cooling air thereby causing the equipment to overheat To prevent electric shock while servicing the ventilator ensure that it is disconnected from all power sources Do...

Страница 13: ...entration to reach from 21 to 90 in volumes of 30 150 and 300 ml in the worst case is less than 2 minutes 1 5 Device Labels and Symbols On key key Alarm Silence Manual Inspiration key Standby key O2 k...

Страница 14: ...inlet port AC Input 100 240VAC 1 0 0 5 A 50 60 Hz input connector AC Battery indicator Waste equipment is disposed of in compliance with environmental requirements Compliance with CE standard requirem...

Страница 15: ...r running on the battery and the battery charge status Indicates the ventilator connection to the mains power and the battery charging Lock Unlock key of touch screen 1 6 Guarantee and responsibilitie...

Страница 16: ...s 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 Test equipm...

Страница 17: ...ameter value by touching and options on the screen or turning the knob turn it clockwise to increase value and counter clockwise to decrease value Then touch Save or push the knob to apply new setting...

Страница 18: ...Flow sensor and exhalation valve Input filter Nebulizer Humidifier HME 2 3 Accessories Use only manufacturer recommended accessories These accessories are listed in the below table Oxygen sensor cover...

Страница 19: ...ilator FITT P26517 Complete Antistatic Hoses O2 Hospital to ventilator FITT P26468 Complete Antistatic Hoses O2 Hospital to ventilator Medsistem Optional list 1 P26302 Pediatric respiration set Altech...

Страница 20: ...er the user last interaction and then will revert back to the Main Screen To prevent accidental change and for more safety if any change is made in the setting and the change is not saved or accepted...

Страница 21: ...nplugged the LED will turn off The LED will turn red and flashing if there is no battery or battery failure 3 3 Air and Oxygen Supply The device required air and oxygen is supplied by compressor or ho...

Страница 22: ...4 Patient Breathing Circuit Warning Do not use antistatic or electrically conductive tubing Tubing containing oil is highly explosive Use only manufacturer approved breathing circuit or tubing To prev...

Страница 23: ...umidifier 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 o...

Страница 24: ...you can access the following menu with four options Figure 4 2 Standby menu Patient Setup select this option to stop ventilation and load Patient Setup menu This key is disable until the ventilator i...

Страница 25: ...maneuver cannot be enabled in the standby mode If mode setting parameters and other maneuvers are changed O2 100 maneuver will be disabled 4 4 Manual Key Press this key on the ventilator front panel...

Страница 26: ...able 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 If a new alarm occurs during this period the...

Страница 27: ...hown in red If even one part except parts which are related to the memory of the device detected as Fail FATAL ERROR wil be shown In this case after checking all parts the menu whould not closed until...

Страница 28: ...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...

Страница 29: ...ers will be set based on previously saved settings If New Patient is selected the following window will appear to enter data of new patient Figure 5 5 New Patient Data Input The following parameters c...

Страница 30: ...rm the selected mode After confirming the settings the patient ventilation will start Figure 5 6 the Ventilator Settings menu Select a mode from Modes menu and press Accept button After selecting mode...

Страница 31: ...Pcontrol in pressure breaths Available options for this parameter are Slow Med and Fast Rise Time Selecting the pattern of patient inspiratory effort in terms of flow or pressure Breath Trigger The p...

Страница 32: ...to this request by switching on the pressure control This feature can be selected in square flow pattern Dual control The exhalation phase continues until the expiratory flow reaches a certain percent...

Страница 33: ...e Volume Pressure 9 Basic parameter settings of current mode 10 Alarms of power supply 11 Alarm review key for quick access to the Event log menu and disabled alarms level 1 and 2 5 6 Monitoring The u...

Страница 34: ...ing on the vertical axis The parameters that could be trended are listed in below table Mechanics Advanced Basic Fundamental R insp Pplateau Vti R exp PEEP Vte C stat Auto PEEP MV C dyn Ti MV Spont WO...

Страница 35: ...e 2 Vte high monitoring Vte 0 5 Vte low Figure 5 10 Alarms Menu Warning Incorrect setting of alarm limits manually could affect functionality of the alarm system Alarm setting of different parameters...

Страница 36: ...be set to Off only in NIV ventilation If the user sets the alarm limit to Off this value changes to 0 1 when exiting non invasive breathing 5 The default of upper and lower lomits of Vte alarm and the...

Страница 37: ...log All events in the Event Log include the following data Settings Alarm event as well as setting and monitoring values of relevant parameter Adjusted high and low alarm limits using AutoSet key or...

Страница 38: ...2 Config menu 5 9 General Setup You can set the below items in the General Setup menu See the figure 5 8 Alarm volume Bed number Touch sound Back light Battery status Warning Alarm volume should be ad...

Страница 39: ...ebulizer operation can be specified in this section By activating the nebulizer from this menu the nebulizer activates for the time specified by the user and the related message is displayed on the sc...

Страница 40: ...the device continues the remaining time of drug nebulization Note Since 100 O2 is administered for drug nebulization the oxygen concentration of delivered gas to patient may exceed the user setting du...

Страница 41: ...e Low MV High MV and High Leak alarms will be disabled and measured value of following parameters will not be displayed Vte MV MV spont PFe Leak Rexp RCe 5 12 Technical settings Select Technical from...

Страница 42: ...ore intiating the maneuver the expiratory hold maneuver will not perform at that respiratory cycle Additionaly patient is not allowed to trigger the device during the maneuver is performed If the butt...

Страница 43: ...the button is pushed It is not possible to change the ventilation mode setting parameters and using the membrane keys during inspiratory hold maneuver P0 1 This parameter is used to determine patient...

Страница 44: ...the maneuver duration is selected by user and ranges from 4 to 20 sec the pressure drops resulted from the patient respiratory effort are monitored and the lowest pressure value is reported The patien...

Страница 45: ...r O2100 key the device delivers breaths with 100 oxygen for a maximum of 2 minutes At this time the user has 2 minutes to press the suction key and disconnect the device from the patient for suction I...

Страница 46: ...is carried out during the nebulization the nebulizer will stop working 2 Setting parameters or ventilation mode could not be changed during this maneuver 3 Other menus and membrane keys are inactive d...

Страница 47: ...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...

Страница 48: ...d ISO 80601 2 12 requirements Audible and visual alarms are classified based on priority as High Medium Low Information Remarks Audible alarm Visual alarm Alarm priority User can not cancel alarm or d...

Страница 49: ...respectively In all three levels new alarms have higher priority Among level 1 alarms Apnea High Pressure and Low MV have the highest priority irrespective of their occurrence time 6 2 Alarm sound Eac...

Страница 50: ...s activated during expiratory Occlusion Ventilation continues The breathing circuit is disconnected from the patient Disconnection Ventilation continues PEEP pressure has violated low PEEP alarm setti...

Страница 51: ...it 45 C High Gas Temperature Ventilation continues Error code 17 Ventilation continues Error code 2 Ventilation continues with the following settings Mode PCV Rate 15 Ti 1 PEEP 2 Pcontrol 20 Trigger P...

Страница 52: ...ilation continues PEEP pressure has exceeded high PEEP alarm setting in two consecutive respiratory cycles High PEEP Ventilation continues In PRVC CMV PRVC SIMV and VSV modes that pressure set by devi...

Страница 53: ...lation time Inverse Ratio The nebulizer is disabled When the nebulization condition is provided flow is higher than 11L min and pressure of the oxygen source is 1 2 bar the nebulizer will be activated...

Страница 54: ...ernal battery voltage is lower than 20 40 Battery Low Ventilation continues by using internal battery The device is unplugged AC Unplug Definition Technical messages Inspiratory Hold maneuver has been...

Страница 55: ...Leak Until 45 secods after Inh Exh hold and suction maneuvers Low PEEP Low MV Low Vte Low Rate Until 15 seconds after increasing PEEP value by the user Disconnection During suction maneuver Low PEEP...

Страница 56: ...d Change MV low alarm limit back to 2 l min Low O2 Pressure and Low Oxygen alarms test Change O2 to 100 and disconnect the oxygen supply Check that Low O2 Pressure alarm is activated immediately and L...

Страница 57: ...message are displayed on the screen Connect the power cable to the ventilator Verify that the battery icon and AC Unplug message are removed from the screen Battery low alarm test To test the interna...

Страница 58: ...bration is performed to ensure accuracy of the sensor Inaccuracy of the sensor will result in erroneous measurement and incorrect recognition Calibrate O2 sensor before using the ventilator and after...

Страница 59: ...t breathing circuit Any leakage in the patient tubing system could be calculated using this test In addition to the leakage this test will also measure total compliance of the patient tubing system Fi...

Страница 60: ...r e g when the difference between Vte and Vti values increases significantly It should be noted that leakage could be cause the reduction of Vte Figure 7 4 Exh Flow Sensor Calibration page 7 2 Cleanin...

Страница 61: ...humidifier according to manufacturer instructions For more information please refer to the humidifier manual Warning The humidifier could cause high resistance of the airway and pressure drop Check re...

Страница 62: ...tory filter and HME are disposable and must be replaced for each patient Replace faulty exhalation membrane Note that the exhalation membrane is disposable and must be replaced for each patient 7 3 Cl...

Страница 63: ...der Using isopropyl alcohol Air compressor Hoses and the components behind the ventilator Exhalation valve Using isopropyl alcohol Using autoclave at 121 C for 20 minutes Exhalation valve flow sensor...

Страница 64: ...or a specific period as specified on its package Replace the oxygen sensor after this date or during sensor failure Use recommended replacement oxygen sensors by manufacturer See section 2 3 Replace t...

Страница 65: ...s or when the exhalation flow sensor failure message is displayed during exhalation flow sensor calibration Take the following actions to replace this sensor Detach the exhalation flow sensor from exh...

Страница 66: ...ve 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 memb...

Страница 67: ...g Always perform the tests related to power and battery after the battery replacement 7 4 5 Ventilator preventive maintenance table The following table summarizes the replacement intervals of the vent...

Страница 68: ...date or sensor failure Oxygen sensor replacement Expert Annually or as needed Exhalation flow sensor replacement Expert Every two years or during battery failure Battery replacement Expert In case of...

Страница 69: ...h patient Nebulizer replacement 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...

Страница 70: ...rm be activated As the pressure approaches the pressure alarm active pressure the exhalation valve opens and prevents further increase in pressure If this happens in a few breathing cycles the alarm f...

Страница 71: ...Ti parameters are changed by the user Flow and Pause time will be displayed on the screen It should be noted that if Compliance Compensation and Leak Compensation are desabled the deliverd flow may b...

Страница 72: ...start of the inhalation phase in each respiratory cycle will always be with volume control due to the choice of volume mode Example If Ti 2 0 s and Vt 1200 ml are set the device applies 36 L min durin...

Страница 73: ...rve in PCV mode is shown in the above figure As you can see the pressure has a constant value equal to Pcontrol PEEP in the inspiratory phase that this value is set by the user When the operator adjus...

Страница 74: ...et tidal volume the pressure will be decreased in the next breath The pressure variations to achieve the setting tidal volume will not be more than 3 cmH2O per breath Low pressure limit is equal to PE...

Страница 75: ...hin Expectation window 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 ad...

Страница 76: ...opens and prevents further increase in pressure Adjustable parameters in V SIMV mode are Definition Parameter Percentage of delivered oxygen to the patient 2 O Mandatory breaths per minute Rate Targe...

Страница 77: ...urther increase in pressure The pressure curve in P SIMV mode is shown in the below figure The patient triggers a mandatory breath in synchronization with respiratory effort within Expectation window...

Страница 78: ...applied Ti may shorter than set Ti see the alarms chapter Note When changing the Rate and Ti parameters the values of Te and I E are displayed on the parameter setting menue Note During inhalation if...

Страница 79: ...patient s cough exceeds the value specified for it the exhalation valve opens and prevents further increase in pressure The below parameters could be set in this mode Definition Parameter Percentage...

Страница 80: ...in PEEP condition PEEP Psupport Figure 8 6 Pressure and flow curve in PSV mode Adjustable parameters in this mode are Definition Parameter Percentage of delivered oxygen to the patient 2 O Positive en...

Страница 81: ...ory flow peak Example In the following figure in the first cycle Auto Tlow off and Tlow 1 2 s are set It is observed that the exhalation lasts 1 2 s In the second cycle Auto Tlow is changed to 75 by t...

Страница 82: ...P Time at high PEEP level high T Time at low PEEP level low T Determines how long the device stays at the low pressure level exhalation low Auto T The method of detecting the patient s respiratory eff...

Страница 83: ...tions occurred during one of PSV VSV or APRV modes selecting another mode will result in disabling the apnea backup If the new mode is one of the PSV or VSV modes the apnea alarm will remain active un...

Страница 84: ...P Psupport 5 HPresAlarm P SIMV PRVC SIMV V SIMV PSV Plow 7 HPresAlarm APRV Plow 3 Phigh APRV PHigh 5 HPresAlarm APRV Warning Note that while changing the respiratory modes setting parameters may be li...

Страница 85: ...ted Note If expiratory flow sensor is faulty or inactive the leak compensation will not be enabled If the sensor is disabled or fails to function during the compensation the leak compensation will not...

Страница 86: ...parameters are displayed above the screen during ventilation To configure monitored parameters act in this way 1 Touch a monitored parameter that you want other parameter is displayed in its place 2 A...

Страница 87: ...minute This parameter is calculated in 8 breaths but updated at each breath Rate b min Number of spontaneous breaths in one minute This parameter is calculated in 8 breaths bat updated at each breath...

Страница 88: ...parameter is measured when the ventilator is in the following conditions Volume mode Square wave pattern Pause 200 ms If above conditions are not provided Rinsp parameter will not be measured even if...

Страница 89: ...negative airway pressure generated during 100 msec of inspiration occlusion This parameter is used to determine patient ablity to be released from mechanical ventilation A maneuver has been defined f...

Страница 90: ...spiratory curves are displayed in the middle of the screen These curves from top to bottom are Pressure time Flow time Volume time In the curve inspiration phase of mandatory breaths is displayed in r...

Страница 91: ...me changes in parameters of the current ventilation mode When the scale of a curve is changed the same change is made in corresponding loop If the numerical value of the curve exceeds the display wind...

Страница 92: ...tory Resistance 0 2 5 cmH2O s l Apnea Backup Settings On Rate Pcontrol Ti OFF Breath triggering Pressure triggering 2 20 cmH2O Flow triggering 2 20 l min Additional Setting Respiratory Rate Accuracy 1...

Страница 93: ...ompensation On or Off Graph Setting Waveforms flow pressure volume Loops P V F V Trend Data all parameters 72 hours Trend resolution 6 seconds Displayed Measurements 6 parameters Audio Settings Audio...

Страница 94: ...0 2 sec 0 1 99 9 sec I E calculated only 1 99 99 1 H L 1 599 299 1 Ti Ttot Accuracy 5 or 1 wig 1 99 9 Respiratory Mechanics Cstat static compliance lung stiffness Accuracy 10 or 4 ml cmH2O wig 0 250 m...

Страница 95: ...ximal slope of the airway pressure drop during the first 100 ms when the airway is occluded NIF The maximum negative pressure generated during inspiration against an occluded airway Suction This funct...

Страница 96: ...Internal speakers Visual alarm In the TFT display Indicator LED Types Technical Physiological Messages Priorities High Medium Low Environmental Data Operating temperature Battery operation 5 40 C Main...

Страница 97: ...e RF emissions CISPR 11 Group 1 The Ventilator Respina P1 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby e...

Страница 98: ...etition frequency Mains power quality should be that of a typical commercial or hospital environment Signal input output parts 1 kV 100 kHz repetition frequency Surge IEC 61000 4 5 Input a c power 0 5...

Страница 99: ...vironment Immunity test Port Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Input a c power 3 V 0 15 MHz 80 MHz 6 V in ISM bands between 0 15 MHz and 80 MHz 80 AM at...

Страница 100: ...A 850 LTE Band 5 Pulse modulation b 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth...

Страница 101: ...101 10 Pneumatic Diagram Figure 10 1 Pneumatic diagram...

Страница 102: ...patient condition Check the device settings Check the alarm limits Ensure that exhalation flow sensor is faultless and calibrated High Vte Exhaled tidal volume has exceeded high Vte alarm setting Chec...

Страница 103: ...oxygen concentration is too low compared with low alarm setting Ensure that the oxygen sensor is faultless and calibrated Check the oxygen source Check the inlet pressure oxygen source concentration...

Страница 104: ...connected securely Replace exhalation flow sensor and calibrate new sensor before use If the alarm persists contact the Customer Service department Exh Not Fitted The exhalation flow sensor is not in...

Страница 105: ...t the Customer Service department 100 O2 Not Usable High pressure oxygen source higher than 1 2 bar is not available Check the inlet oxygen source pressure Neb Not Usable Flow setting is lower than 11...

Страница 106: ...106 12 Attachments This section of the manual provides a more complete explanation of some topics...

Страница 107: ...m limit the device will prevent the pressure from increasing but the inhalation phase will continue However if for any reason the airway pressure exceeds the alarm limit the inhalation phase immediate...

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