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Breas Medical Vivo 45, User Manual

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Product Description

Vivo 45 User Manual

Doc.006149 En Y-2 

Symbols

This section describes symbols and markings that might appear on the
parts or packaging of the Vivo 45.

S

YMBOL

E

XPLANATION

Internal battery

Product number

Read user instructions.

Attention: 
Read the intended use in the manual.
Read the Safety chapter in the manual.
This product must not be exposed to open fire.

This product should be recycled.

Read “Disposal” on page 175 for information 
about recycling and disposal.

Degree of protection provided by enclosure, see 
page 184.

Manufacturer

Serial number

Date of Manufacture

Class II equipment; double insulation.

  Indication of applied parts (IEC 60601-1 Type BF, 

Isolated Applied Part)

REF

SN

Summary of Contents for Vivo 45

Page 1: ...Panel 27 3 3 The Side Panels 28 3 4 Equipment Designation 32 4 Preparing the Vivo 45 for Use 35 4 1 Checking the Vivo 45 before First Use 35 4 2 Placing the Vivo 45 36 4 3 Connecting the Vivo 45 to M...

Page 2: ...egular Maintenance Control 174 7 5 Service and Repair 174 7 6 Storage 174 7 7 Disposal 175 8 Technical Specifications 177 8 1 System Description 177 8 2 Data 179 8 3 Emission and Immunity Declaration...

Page 3: ...nnel In accordance with the operating conditions specified in this operating manual In original and unmodified shape and only with accessories spec ified or approved by Breas Medical AB Every other us...

Page 4: ...face For invasive use the patient interface may be a tracheostomy tube cuffed or uncuffed and for non invasive use it may be a mask mouthpiece or pillow interface See the patient interface s instructi...

Page 5: ...paces and home environments as well as during portable applications such as wheelchairs personal family vehi cles ground ambulances and civil aircraft excluding helicopters It is not intended for use...

Page 6: ...ent They may also operate the Ventilator system software applications for follow up on ventilators usage and for troubleshooting The Service Manual contains the information intended for the service pe...

Page 7: ...ocardial ischemia Severe bullous lung disease Risk of vomiting Pathologically low blood pressure especially if associated with intravascular volume depletion Cerebrospinal fluid leak recent cranial su...

Page 8: ...or per forming maintenance on the machine to ensure correct usage maxi mum performance and serviceability ICON EXPLANATION Warning Risk of death or serious personal injury Warning Risk of electric sho...

Page 9: ...En Y 2 1 7 Manufacturer Information Address Breas Medical AB F retagsv gen 1 SE 435 33 M lnlycke Sweden Web Address www breas com E mail address breas breas com Phone 46 31 868800 Order 46 31 868820 T...

Page 10: ...10 Introduction Vivo 45 User Manual Doc 006149 En Y 2...

Page 11: ...patient circuit When a patient is treated there must be a supervising person present during the treatment in order to take care of alarms and conditions that the patient cannot solve on their own To...

Page 12: ...and all of the parts and accessories used to connect to the patient before use Setting the alarm sound level below that of the ambient sound level can impede recognition of alarm conditions Clinical...

Page 13: ...04 F environment and with the cooling air intake vents blocked surface temperatures as high as 50 C 122 F can occur Before an unsafe temperature is reached the High Patient Air Temp alarm will occur I...

Page 14: ...nsid ered The Vivo 45 should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary the Vivo 45 should be observed to verify normal operation in that configura...

Page 15: ...rapy or injure the patient The delivered patient air can be as much as 4 C 7 F 7 higher than ambient temperature Caution should be exercised if the room tem perature is greater that 36 C 97 F If a roo...

Page 16: ...o 45 can potentially be exposed to fields from these RF emitters without the user s awareness If abnormal performance of the Vivo 45 is observed and the RF emitters cannot be identified and removed th...

Page 17: ...of static or electrically con ductive material Always make sure that the patient circuit and joined parts are undam aged and correctly connected in order to avoid unintentional leak age Patient connec...

Page 18: ...air tubing around the top of the bed It could twist around the patient s head or neck while sleeping Always follow the instructions of the mask manufacturer The Vivo 45 is equipped with a rebreathing...

Page 19: ...use of a high resistance bacterial filter on the output of the device may interfere with the operation of the patient disconnect function It may also interfere with the device trigger function The im...

Page 20: ...click in water chamber must be disconnected The use of a heated wire patient circuit decreases condensation in the patient circuit In case of invasive application the use of an appropriate external h...

Page 21: ...difier may require readjust ment of the Vivo 45 low pressure alarm Certain HMEs and HCHs are sufficient to provide humidification when the Vivo 45 is used invasively Check specific suppliers recom men...

Page 22: ...nce service and control and any applicable upgrades in accordance with Breas service instruc tions Vivo 45 shall only be repaired or modified in accordance with Breas service manuals technical bulleti...

Page 23: ...lator enclosure will increase the risk of fire Do not use a humidifier between the oxygen source and the ventila tor Ventilate the room adequately Do not smoke in a room where oxygen is being used Nak...

Page 24: ...d pressure must not exceed 15 l min and 100 kPa Supplemental oxygen is added before the volume measurement sen sor and thereby included in the measurements However the oxygen concentration still has i...

Page 25: ...25 Product Description Vivo 45 User Manual Doc 006149 En Y 2 3 Product Description 3 1 Main Components The Vivo 45 medical electric equipment contains the following compo nents 1 2 3 5 4 7 6...

Page 26: ...ation User Manual 006149 Clinician s Manual 006148 3 Circuit Single limb 15mm Deliver air to the patient 006712 disposable 4 Filter white fine Patient air inlet filtration 007103 5 Power cord EU 00352...

Page 27: ...ound indication 6 Mains Power source Mains 7 External DC Power source External DC 8 Click in battery Power source Click in battery 9 Internal battery Power source Internal battery NO USER BUTTONS FUNC...

Page 28: ...4 Air bypass unit Click in airway silencer for use without the click in humidifier If the click in humidifier is used it replaces the air bypass unit 5 Click in compart ment Compartment for either of...

Page 29: ...1 Side panel Cover 2 Memory card slot SD card Memory download 3 Alarm Alarm Sounds Output 4 Patient air inlet Air bypass unit in replaceable filters 5 Internal battery Compartment for the internal bat...

Page 30: ...m behind to dismount the filter side panel press the but ton above the panel 2 The panel is released 3 Remove the panel Reattaching the filter side panel 1 Lift the handle to access the release button...

Page 31: ...ompartment side panel press the button above the panel 2 The panel is released 3 Remove the panel 3 Reattaching the click in compartment side panel 1 Lift the handle to access the release button 1 2 T...

Page 32: ...or heated wire 2 Oxygen inlet port Connection for low pressure bleed in oxy gen source 3 CO2 interface port 4 SpO2 interface port 5 Remote start stop Audio pause and effort belt interface port 6 Remot...

Page 33: ...Attention Read the intended use in the manual Read the Safety chapter in the manual This product must not be exposed to open fire This product should be recycled Read Disposal on page 175 for informa...

Page 34: ...r of a licensed healthcare practitioner CE marking applies in accordance with the direc tive MDD 93 42 EEC as amended by 2007 47 EC CE marking applies in accordance with the direc tive MDD 93 42 EEC a...

Page 35: ...the chapter Safety Information on page 11 before setting up the Vivo 45 1 Check that all main com ponents and ordered acces sories have been delivered refer to the packing note or the invoice if avai...

Page 36: ...45 on a solid flat and clean surface The Vivo 45 should be placed lower than the patient in order to prevent the device from fall ing on the patient as well as preventing condensed water from reaching...

Page 37: ...t or out let Do not place the Vivo 45 on a soft surface that will prevent the air flow underneath the device Never cover the device Always position the Vivo 45 so the power supply lays on a surface wi...

Page 38: ...page 14 carefully to make sure all conditions are considered and met 1 Plug the power supply into the power inlet of the Vivo 45 2 Make sure a clicking sound is heard to ensure the power supply is com...

Page 39: ...by Breas Check that the cables are undamaged Check that the cables are properly connected Inspection of Placement The Vivo 45 shall be placed on solid flat surface below the patient level see Placing...

Page 40: ...this is not the case contact your service pro vider 8 Reconnect the power supply Check that the device switches to the mains supply and that an information message is shown on the screen together wit...

Page 41: ...pliance is used for correcting the volume of air delivered to the patient by subtracting the air retained in the patient circuit during pressur ization Starting the Pre use Test Manually 1 On the Othe...

Page 42: ...TEP ACTION 1 Start of pre use test 2 Connect the patient circuit 3 Make sure that nothing is blocking the patient end of the cir cuit 4 Wait while the Vivo 45 is checking the patient circuit resist an...

Page 43: ...On and Off Switch On and Enter Standby Mode Read the chapter Safety Information on page 11 before using the Vivo 45 1 If having access to mains power make sure the power sup ply is properly connected...

Page 44: ...e treatment is started 1 Press and hold the Start Stop button on the Vivo 45 2 Release the Start Stop button when the progress bar is filled Note You can also press the start button shortly and then p...

Page 45: ...knowledge the information message regarding reduced alarm functionality dur ing the ramp period 1 Open the second Setup page by pressing the Setup button twice 1 Select Stop Ramp using the Up and Down...

Page 46: ...To stop treatment and enter standby mode first press and hold the Start Stop button on the front panel 2 Release the Start Stop button when the progress bar is filled 3 Press Ok or the Audio Pause bu...

Page 47: ...the different sections defined above each navigation button The same navigation button can also be used to view additional information in some sections or it can be desig nated a temporary function wh...

Page 48: ...by a number above the ramp symbol Humidifier and or heated circuit connected The number in the drop symbol indicates the humid ity setting If the humidifier is connected but not activated the drop is...

Page 49: ...e the Vivo 45 menu has the following section layout High priority alarm event in history list Medium priority alarm event in history list SYMBOL DESCRIPTION Setup Others Main Alarm Monitor Setup 1 2 A...

Page 50: ...an 1 profile is used the active profile is displayed 3 Indication of battery status and connected sensors See Symbols Used in the Menu on page 48 for information about each icon 4 Ppeak max pressure d...

Page 51: ...ht be adjustable within ranges defined by the prescribing physician Adjustable parameters are indicated by green text If profiles with preset treatment settings have been created the profiles are sele...

Page 52: ...r Manual Doc 006149 En Y 2 The Alarm Section The Alarms section contains 3 pages The two first are for viewing alarm settings and the third is for viewing the alarm and message history Shift between t...

Page 53: ...or deactivates the circuit heating Device Memory The Device memory setting is used for transferring data to a memory card and for erasing the device data requires Clinical mode The monitoring section...

Page 54: ...ing on the ambient light Delayed the display is dimmed after 30 seconds or more depending on the mode and battery setup If any button is pressed or any alarm occurs the display light will return to no...

Page 55: ...ock On Off Home Language Selects the language for Home Mode Time and Date Time set time hours and minutes Time Format choose between 24 h or 12 h am pm format Date Format choose between yyyy mm dd dd...

Page 56: ...56 How to Use the Vivo 45 Vivo 45 User Manual Doc 006149 En Y 2 5 3 Monitored Values in the Vivo 45 Values monitored by the Vivo 45 can be found in The monitoring screen...

Page 57: ...ventilatory cycle inspiratory expiratory phase The Leakage displays the total leakage intentional and unintentional as calculated at expiratory pressure level The MVe displays the expired Minute Vol u...

Page 58: ...the FiO2 Sensor on page 87 The in TgV displays the percentage of breaths where the actual delivered Tidal Vol ume matches with the set Target Volume The Total Rate displays the actual total breath ra...

Page 59: ...on regarding the oxygen probe s range of peak wavelengths max optical power and usage please refer to the respec tive probe manual Environmental factors may influence the function or accuracy of the p...

Page 60: ...ys the duration of the pressure or volume increase measured from the start of inspiration until the set pressure or volume has been reached The EtCO2 displays the end tidal carbon dioxide measured on...

Page 61: ...not be available or have limited ranges when the Vivo 45 is in Home mode Inspiratory Pressure Insp Pressure ITEM DESCRIPTION Definition The Inspiratory Pressure setting is used to define the airway p...

Page 62: ...on 0 5 below 10 cmH2O 1 0 above 10 cmH2O Display ITEM DESCRIPTION Definition The Breath Rate setting defines the mini mum number of breaths the Vivo 45 will deliver as long as no inspiratory trigger e...

Page 63: ...Breath Rate settings is limited by the I E ratio 2 1 Setting min 0 3 s Setting max 5 s Adult 2 s Paediatric Setting resolution 0 1 s Display ITEM DESCRIPTION Definition The Backup Inspiratory Time se...

Page 64: ...the speed of the pressure increase from start of inspira tion to set inspiratory pressure A low setting will give a faster pressure increase and therefore a longer plateau at the set inspiratory press...

Page 65: ...ing flow is created in the patient circuit If the patient s effort reaches the set inspiratory trigger level an inspiration is initiated If the patient cannot trigger a breath the ventilator will deli...

Page 66: ...decrease of peak flow Setting max 9 90 decrease of peak flow Setting resolution 1 Setting 1 is the most sensitive and 9 is the least sensitive Display ITEM DESCRIPTION Definition The Minimum Inspirato...

Page 67: ...ing min 0 3 s Setting max 5 s Off Adult 2 s Off Paediatric Setting resolution 0 1 s Display ITEM DESCRIPTION Definition The Backup Rate setting defines the mini mum number of breaths the Vivo 45 will...

Page 68: ...hepatientinapressuremode To aim for the preset volume the Vivo 45 will adapt the Inspiratory Pressure between two adjustable pressure limits Min Pressure and Max Pressure When Target Volume is active...

Page 69: ...fines the upper pressure limit up to where the Vivo 45 can increase the pressure to reach the set Target Volume If Target Vol ume is not reached at Max Pressure the Vivo 45 will continue to ventilate...

Page 70: ...is above Target Volume at Min Pressure the Vivo 45 will continue to ventilate at this Min Pressure setting Setting min 4 cmH2O Setting max Max Pressure Setting resolution 0 5 below 10 cmH2O 1 0 above...

Page 71: ...e Ramp Time is only available in Clinical Mode Setting min Off Setting max 60 min Setting resolution 10 min ITEM DESCRIPTION Definition The Ramp Start Pressure defines the pres sure level delivered by...

Page 72: ...the Click in Humidifier on page 99 Setting min Off Setting max On ITEM DESCRIPTION Definition The Humidifier Setting defines the level of humidity of the air delivered to the patient See Using the Cli...

Page 73: ...ting ITEM DESCRIPTION Definition Circuit Heating allows the user to start or stop the heating of the circuit The Heated Circuit needs to be connected before the setting can be turned On See Using the...

Page 74: ...d for controlling the user access to the ventilator settings Clinical mode allows full access to the Vivo 45 treatment parameters for health care professionals Home mode is used to limit the access to...

Page 75: ...Ventilation with Tar get Volume CPAP Continuous Positive Airway Pressure PSV Pressure Support Ventilation In the PSV mode the patient s spontaneous breathing is assisted by the ventilator The patient...

Page 76: ...V mode the ventilation is controlled by the Vivo 45 This is done at the preset pressure breath rate inspiratory time and rise time set tings set by the operator The inspiration stops and an expiration...

Page 77: ...ume to the patient The delivered volume is compared to the set target volume on a breath by breath basis The delivered pressure for the next breath will be increased or decreased depending on the diff...

Page 78: ...s an overview of the available functions for each mode MODES PSV PSV TgV PCV PCV TgV PCV A PCV A TgV CPAP Functions Insp Pressure PEEP Breath Rate Insp Time Backup Insp Time Ramp Rise Time Insp Trigge...

Page 79: ...internal battery and show a message in the display window See the Vivo 45 Service Manual on how to perform service on the batteries How to test the Internal Battery The switchover to internal battery...

Page 80: ...iour of the Vivo 45 while Internal Battery or Click in Battery is Charging The battery icon will be animated filling in from bottom to top Charging Times Times are based on charging empty batteries Ho...

Page 81: ...to another Click in Battery The click in battery is intended as a power source during transportation or if the primary AC power source fails The click in battery can be replaced during treatment provi...

Page 82: ...de panel 3 Insert the click in battery Make sure the latch at the bottom of the click in compartment is engaged 4 Close the side panel Make sure there is a clicking sound to secure the side panel When...

Page 83: ...are based on new and fully charged batteries These ventilator settings affect the operating time significantly PARAMETER EXAMPLE ENVIRONMENTAL CONDITIONS Ambient temperature 20 C 68 F VENTILATOR SETT...

Page 84: ...rnal DC source connected the Vivo 45 will automatically switch over to the external DC source if the AC power supply fails The external DC voltage level is shown under Others Device Information in the...

Page 85: ...5 7 Using Accessories Connecting and Disconnecting the Cables Insert the cable in the appropriate port Make sure to insert the connector with the marking pointing upwards Pull the connector sleeve no...

Page 86: ...a nurse call system using the nurse call cable When connected the Vivo 45 alarms will also be forwarded to the nurse call system Connect the Vivo 45 to a Nurse Call System 1 Connect the nurse call cab...

Page 87: ...O2 measurements will be stored in the data memorywhichcanbedownloadedtoaPCandviewedinBreassoftware USAGE TIME Operating temperature 10 to 40 C 50 to 104 F Operating pressure 700 to 1250 mbar Expected...

Page 88: ...h 1 Place the Vivo 45 so the bot tom is accessible 2 Remove the hatch for FiO2 sensor 3 Insert the FiO2 sensor with the electrical contact side in 4 Reinstall the hatch 5 Calibrate the FiO2 sensor Whe...

Page 89: ...software Safety Information Information about safety warnings product description installation usage cleaning maintenance and technical specifications can be found in the user instruction for Remote A...

Page 90: ...Medical AB Do not apply tension to the CO2 sensor cable To keep secretions and moisture from pooling on the windows always position the CO2 sensor in a vertical position with the green LED pointing up...

Page 91: ...CO2 monitoring automatically compensates for changes in ambient barometric pressure The CO2 monitor shall fulfil the ISO 80601 2 55 standard Medical electrical equipment Particular requirements for th...

Page 92: ...port on the Vivo 45 according to the instruction Connecting and Disconnecting the Cables on page 85 A green LED indicates that the CO2 sensor is ready to use 2 Snap the CO2 sensor probe on top of the...

Page 93: ...heck shall be performed every year preferably when the Vivo 45 is sent for service 5 Make sure to position the CO2 sensor with the LED pointing upwards The CO2 sensor is not intended to be in contact...

Page 94: ...e 197 When connected the Vivo 45 will Display the monitored values and include them in trend views Store monitored values in the internal memory and include them The PtcCO2 values will also be include...

Page 95: ...itoring page Store the effort belt measurements in the internal memory The effort belt measurements will also be included in the data that can be downloaded and analysed with Breas PC software Automat...

Page 96: ...ction OK Communication box Green LED for each effort belt Vivo 45 Display White belts in the effort belt symbol Communication box connected but not belt Communication box Red LED for unconnected belt...

Page 97: ...and viewed in the Vivo 45 PC software When installed the Vivo 45 automatically detects the sensor also after powering off on and after power failure The effort belt communication box and the Remote S...

Page 98: ...example mounted on a wheelchair in a personal vehicle or carried by hand The protective cover protects the Vivo 45 from environmental impact such as shock water spill sunlight dust and dirt under norm...

Page 99: ...er setting on the Vivo 45 menu both in clinical and home mode If the water chamber is disconnected and reconnected after usage the Vivo 45 will remember the humidity setting used The click in humidifi...

Page 100: ...to the Vivo 45 Do not switch on the humidifier without a filled water chamber in order to avoid burn or damage to the humidifier s electronics if the Vivo 45 is equipped with click in battery remove...

Page 101: ...h the attached water chamber is placed lower than the patient and on a flat surface This is to prevent per sonal injury from accidental spillage or from excess water or conden sation flowing down the...

Page 102: ...er plate and water to cool Use only distilled or sterilised water or boiled chilled tap water in the humidifier water chamber This is to reduce mineral deposits and maximize the life of the water cham...

Page 103: ...agents or with the cleaning agents listed below The water chamber will withstand at least 20 of the above cleaning cycles without any degradation Always make sure the lid of the water chamber is total...

Page 104: ...er Instruction for the Patient Circuit Heated Wire with Cable Connector before using the patient circuit 1 Check the patient circuit including the electrical cable for damages 2 Connect the tube to th...

Page 105: ...a change in settings is made on the Vivo 45 Never leave a patient unattended during an alarm condition Setting alarm limits to extreme values could put the patient at risk Permitted distributed alarm...

Page 106: ...e The signal sequence is repeated with a 0 5 second pause and thereafter a 3 second pause Medium priority 3 signals with a lower frequency than the high prior ity alarm The signal sequence repeats aft...

Page 107: ...e Vivo 45 depending on the set audible alarm level To receive the visual part of an alarm and its priority the operator s posi tion should be within a distance of 4 metres 13 feet from the Vivo 45 and...

Page 108: ...spira tion Priority High Possible cause Mismatch between Insp pressure CPAP and alarm setting Coughing during inspiration Changes in airway resistance and or compli ance Setting min 5 cmH2O or Low Pre...

Page 109: ...r 15 0 5 seconds Priority High Possible cause Disconnection of patient circuit Mismatch between Inspiratory pressure CPAP and alarm setting Leakage from the mask or other components of the patient cir...

Page 110: ...given when the meas ured PEEP is 30 above the set value for more than 15 0 5 seconds Priority Medium Possible cause Too short expiratory time Changes in airway resistance and or compli ance Blocked le...

Page 111: ...Definition A Low PEEP Alarm will be given when the meas ured PEEP is 30 below the set value for more than 60 0 5 seconds Priority Medium Possible cause Excessive leakage Setting range On Off Ventilat...

Page 112: ...ired Tidal Volume alarm for 15 0 5 seconds Priority Medium Possible cause Mismatch between Expired Tidal Volume and alarm setting Pressure settings causing the Expired Tidal Volume to exceed the set a...

Page 113: ...e alarm for 15 0 5 seconds Priority High Possible cause Mismatch between Expired Tidal Volume and Alarm setting Changes in airway resistance and or compli ance Leakage around the mask or within one of...

Page 114: ...e exceeds the set limit for the High Expired Minute Volume alarm for 15 0 5 seconds Priority Medium Possible cause Mismatch between Breath Rate Tidal Volume settings and the alarm setting Increased Br...

Page 115: ...ds Priority High Possible cause Mismatch between Breath Rate and Tidal Vol ume settings and the alarm setting Changes in airway resistance and or compli ance Decreased Breath Rate Leakage around the m...

Page 116: ...ath Rate alarm limit for 15 0 5 seconds Priority Medium Possible cause Mismatch between the Breath Rate setting and the alarm setting Increased Breath Rate Too sensitive setting of the inspiratory tri...

Page 117: ...onds Priority High Possible cause Mismatch between the Breath Rate setting and the alarm setting The patient cannot trigger breaths because the inspiratory trigger setting is too high Decrease in the...

Page 118: ...f time This alarm is only used in assisted breath modes Priority High Possible cause Inspiratory Trigger is set too high Patient stopped breathing Patient decreases spontaneous breathing Circuit disco...

Page 119: ...atient interfaces To verify that patient disconnection can be detected including if the patient interface becomes accidentally detached from the patient it is advised to test the functionality of the...

Page 120: ...rm will be given when the measured leakage is lower than the expected leakage flow at the set pressure for more than 15 0 5 seconds Priority High Possible cause Obstructed or occluded leakage port Set...

Page 121: ...inspiratory breathing tube becomes blocked and remains blocked for 2 consecutive breaths Priority High Ventilator action With each breath cycle upon detection of an obstruction the Vivo 45 will reduce...

Page 122: ...will be given when the meas ured FiO2 exceeds the alarm limit for 30 0 5 seconds Priority Medium Possible cause Increased oxygen inflow Decreased minute ventilation Setting min 21 Setting max 100 Off...

Page 123: ...he meas ured FiO2 is below the alarm limit for 30 0 5 seconds Priority High Possible cause Decreased oxygen inlet Disconnection of oxygen inlet Increased minute ventilation High leakage Setting min Of...

Page 124: ...High SpO2 alarm will be given when the meas ured SpO2 exceeds the alarm limit for 30 seconds Priority Medium Possible cause Added O2 flow is too high Setting min 90 Setting max 100 Off Setting resolu...

Page 125: ...en the measured SpO2 is below the alarm limit for 30 seconds Priority High Possible cause Added O2 flow is too low Oxygen inlet is disconnected Delivered tidal volumes are too small Setting min Off 85...

Page 126: ...alarm limit for 30 seconds Priority High Possible cause Alarm limit is set too low Breath Rate too low Delivered Tidal Volume too low Excessive dead space between patient and leakage port Leak port oc...

Page 127: ...um Possible cause Alarm limit is set too high Ventilator disconnection Excessive leakage in the Patient circuit Inter face Partial obstruction of the airways Breath Rate too high Delivered Tidal Volum...

Page 128: ...en the measured inspired CO2 exceeds the alarm limit for 30 seconds Priority High Possible cause Alarm limit is set too low Excessive dead space between patient and leakage port Leakage port occluded...

Page 129: ...l be given when the measured pulse rate exceeds the alarm limit for 15 seconds Priority Medium Possible cause Insufficient ventilatory support FiO2 too low EPAP too high Setting min 20 bpm Setting max...

Page 130: ...when the measured pulse rate is below the alarm limit for 15 seconds Priority High Possible cause Bad positioning of the finger probe Insufficient ventilatory support FiO2 is low Setting min Off 20 bp...

Page 131: ...131 Alarms Vivo 45 User Manual Doc 006149 En Y 2...

Page 132: ...PtcCO2 monitor is outside its alarm limits Breath Rate needs adjustment Delivered Tidal Volume needs adjsutment Excessive dead space between patient and leakage port Leak port occluded Ventilator disc...

Page 133: ...when the last power source is below limits Priority High Ventilator action The Vivo 45 stops treatment and gives alarm for up to 2 minutes If power is restored within the alarm time the Vivo 45 will...

Page 134: ...when the patient air temperature exceeds 43 C 109 F Priority High Possible cause Blocked air inlets Blocked cooling air outlets Too high ambient temperature Ventilator action The Vivo 45 will continu...

Page 135: ...Temp ITEM DESCRIPTION Definition A Low Patient Air Temperature alarm will be given when the patient air temperature is below the preset limit 30 C 22 F Priority High Possible cause Too low ambient te...

Page 136: ...N Definition A Low Last Power Source alarm will be given when the last battery source internal battery or click in battery has 15 to 20 minutes of operating time left with current settings Priority Me...

Page 137: ...ion A Crit Low Last Power Source alarm will be given when the last battery source internal battery or click in battery has 5 minutes of operating time left with current settings Priority High Ventilat...

Page 138: ...finition A Mains Power Lost alarm will be given when the Vivo 45 switched from Mains to another power source due to Mains power is lost Priority Medium Ventilator action The Vivo 45 will continue trea...

Page 139: ...An SpO2 Sensor Failure Disconnection alarm will be given when an error signal or no signal from the SpO2 sensor has been detected for 2 seconds Check the SpO2 sensor Priority High Possible cause SpO2...

Page 140: ...alarm will be given when the SpO2 signal is not correct Check the SpO2 sensor Priority High Possible cause Probe is not correctly positioned Poor perfusion Nail varnish or pigment on finger Patient m...

Page 141: ...efinition A CO2 Sensor Failure Disconnection alarm will be given when communication between the Vivo 45and the CO2 sensor has been lost Check the CO2 sensor Priority High Possible cause CO2 Sensor dis...

Page 142: ...Error ITEM DESCRIPTION Definition A CO2 Accuracy Error alarm will be given when an accuracy error in the CO2 measure ment has occurred Perform a zeroing procedure of the CO2 sen sor Priority High Ven...

Page 143: ...ITEM DESCRIPTION Definition A Check CO2 Adapter alarm will be given when the airway adapter is not attached cor rectly to the CO2 sensor Check replace the airway adapter Priority High Ventilator acti...

Page 144: ...RIPTION Definition A CO2 Sensor Error alarm will be given when an error in the CO2 sensor has occurred Replace the CO2 sensor CO2 monitoring cannot be performed in this condition Priority High Ventila...

Page 145: ...on A FiO2 Sensor Failure Disconnection alarm will be given when no signal from the FiO2 sensor has been detected for 2 seconds Check the FiO2 sensor Priority High Possible cause FiO2 Sensor disconnect...

Page 146: ...Compensation Lost alarm will be given when the automatic ambi ent pressure compensation functionality is out of order Sea level is used as temporary ambient pres sure compensation If used at other al...

Page 147: ...ITEM DESCRIPTION Definition An Ambient Temperature Compensation Lost alarm will be given when the automatic ambient temperature compensation is out of order Priority Medium Ventilator action The Vivo...

Page 148: ...st ITEM DESCRIPTION Definition An Humidity Compensation Lost alarm will be given when the automatic humidity com pensation is out of order Priority Medium Ventilator action The Vivo 45 will continue t...

Page 149: ...2 LED Failure Alarm ITEM DESCRIPTION Definition A LED Failure alarm will be given when one or more LED indicators on the front panel are broken Priority Medium Ventilator action The Vivo 45 will conti...

Page 150: ...tion An alarm for Low Alarm Battery will be given if the alarm battery is not charged enough to have power for a Power Fail alarm for at least 2 minutes Priority Medium Ventilator action The Vivo 45 w...

Page 151: ...EM DESCRIPTION Definition An alarm for Alarm Battery Error will be given when unable to communicate with super capacitors providing backup power to the audible alarm signal Priority Medium Ventilator...

Page 152: ...tion An alarm for Internal Click In Battery Over heat in Discharge will be given when the internal or click in battery reaches 55 C 131 F The battery electronics by manufacture stops discharge at 60 C...

Page 153: ...arm ITEM DESCRIPTION Definition A Heated Circuit temp alarm will be given when the measured temperature of the heated wire is outside the tolerance Priority Medium Ventilator action The Vivo 45 will c...

Page 154: ...will be given if the humidifier heater plate temper ature exceeds 76 C 169 F for more than 2 seconds Priority Medium Ventilator action The Vivo 45 will turn off the click in humidi fier and then conti...

Page 155: ...ault alarm will be given if a fault in the humidifier electronics or tempera ture sensor is detected Priority Medium Ventilator action The Vivo 45 will turn off the humidifier and continue treatment w...

Page 156: ...t alarm will be given if a fault in the heated circuit electronics or tem perature sensor is detected Priority Medium Ventilator action The Vivo 45 will turn off the heated circuit and continue treatm...

Page 157: ...be given when the Vivo 45 has an internal func tion failure followed by an error code for the specific failure All Internal Function Failure alarm error codes are defined and explained in the Vivo 45...

Page 158: ...Definition The alarm is given in case of swivel boot tem perature sensor communication failure or sensor reporting temperatures out of range below 30 C or above 60 C Priority Medium Ventilator action...

Page 159: ...erial Communication Queue Full Alarm ITEM DESCRIPTION Definition This alarm is given if the serial communica tion buffer is full Priority High Ventilator action The Vivo 45 will continue treatment wit...

Page 160: ...when the Vivo 45 has an internal error followed by an error code for the specific failure All Internal Error alarm error codes are defined and explained in the Vivo 45 Service Manual Priority High Ve...

Page 161: ...9 En Y 2 Cooling Fan Error Alarm ITEM DESCRIPTION Definition The Cooling Fan Error alarm shall be given when the cooling fan runs too slow Priority High Ventilator action The Vivo 45 will continue tre...

Page 162: ...ock Failure Alarm ITEM DESCRIPTION Definition The alarm shall be given when the real time clock value is invalid Priority High Ventilator action The Vivo 45 will continue treatment with the same setti...

Page 163: ...Internal Temp High Alarm ITEM DESCRIPTION Definition The Internal High Temp alarm shall be given when the ventilator internal temperature is high Priority High Ventilator action The Vivo 45 will cont...

Page 164: ...nition The Humidifier Bypass Loose alarm shall be given when the air bypass humidifier is not inserted correctly Priority Medium Ventilator action The Vivo 45 will continue treatment with the same set...

Page 165: ...s below 1 Connect the Vivo 45 patient circuit to a test lung 2 Adjust the settings as follows 3 All alarm settings shall be set to Off if possible 4 Start the Vivo 45 5 Set the high pressure alarm to...

Page 166: ...evice and to your finger 14 2 Set the low SpO2 alarm to 85 14 3 Set the high SpO2 alarm to be 90 14 4 Start treatment and wait 30 s 14 5 High SpO2 alarm should be given 14 6 Stop treatment 14 7 Set th...

Page 167: ...use of the Vivo 45 High PEEP Alarm 1 Connect the Vivo 45 patient circuit to a test lung and a CPAP device 2 Set the CPAP device treatment pressure to 10 cmH2O 3 Adjust the Vivo 45 settings as follows...

Page 168: ...given 4 Stop treatment Test completed Low Vte Alarm 1 Start treatment and block the patient circuit completely to simulate an occlusion 2 Wait 15 seconds 3 The Low Vte Alarm will be given 4 Stop treat...

Page 169: ...aintenance service and control and any applicable upgrades in accordance with Breas service instructions Vivo 45 shall only be repaired or modified in accordance with Breas service manuals technical b...

Page 170: ...g splashing or pouring Use a moistened lint free cloth when cleaning Do not use an excessive amount of liquid when cleaning the Vivo 45 Do not autoclave the Vivo 45 1 Switch off the Vivo 45 and discon...

Page 171: ...e fault condition In case of contamination the internal air pathways of the Vivo 45 may be disinfected up to 10 times by a maximum 60 minute long validated ozone gas process CONDITION PARTS With bacte...

Page 172: ...where applicable For safety information read Usage of Patient Circuit on page 17 Appropriate personnel should determine the duration of use for the patient circuit based on accepted infection control...

Page 173: ...e frequently when used in high pollution or pollen rich environments 7 3 Change of Patient If the Vivo 45 is used in a clinic by several patients a low resistant bacte rial filter may be used between...

Page 174: ...epairs to the device 7 6 Storage Store the Vivo 45 in a dark room where the temperature range is within 20 to 60 C 4 to 140 F For instructions on how to charge the batteries after long time storage se...

Page 175: ...a radiator The time required for the device to cool from the maximum storage temperature of 60 C 140 F until it is ready for use in ambient temperature of 20 C 68 F is 30 min utes If stored in a cold...

Page 176: ...176 Cleaning and Maintenance Vivo 45 User Manual Doc 006149 En Y 2...

Page 177: ...chnical Specifications 8 1 System Description Pneumatic Diagram for the Vivo 45 NO DESCRIPTION 1 Vivo 45 2 Tube 3 Leakage port Patient interface connection 4 Patient NO DESCRIPTION 1 Air inlet with fi...

Page 178: ...Technical Specifications Vivo 45 User Manual Doc 006149 En Y 2 5 Flow sensor 6 Pressure sensors 7 Air bypass unit Humidifier 8 Patient air outlet 9 Low pressure bleed in oxygen connection NO DESCRIPT...

Page 179: ...cludes measurement uncertainty The accuracies have been tested with all allowed configurations Stated tolerances only disclose the maximum tolerance SETTING VALUE RANGE PERFORMANCE RESOLUTION Ventilat...

Page 180: ...to 5 s Adult 0 3 to 2 s Paediatric Tolerance 20 ms 5 of setting or 0 1 s 0 1 s Backup Inspiratory Time 0 3 to 5 s Adult 0 3 to 2 s Paediatric 0 1 s Rise Time 1 to 9 PSV PCV 1 Inspiratory Trigger 1 to...

Page 181: ...olerance 0 5 cmH2O or 5 whichever is greatest 0 5 below 10 cmH2O 1 0 above 10 cmH2O Audible alarm level 1 to 5 where 1 is the lowest volume setting and 5 is the highest volume setting 1 MONITORED VALU...

Page 182: ...ensor I E 1 10 to 10 1 0 1 unit for E 9 9 1 unit otherwise Insp Time 0 3 to 5 s 0 1 s Rise Time 0 1 to 5 s 10 or 0 1 s which ever is greatest EtCO2 0 to 25 0 to 15 0 3 vol 4 of reading 15 to 25 unspec...

Page 183: ...F Storage and transport temperature 20 to 60 C 4 to 140 F Ambient pressure range 700 to 1100 mbar corresponding to 4200 metres 13800 feet above sea level to 700 metres 2300 feet below sea level at nor...

Page 184: ...utes 2 5 minutes for each tilting direction PATIENT CIRCUIT LEAKAGE SPECIFICATION Recommended leakage 20 to 50 l min at 10 cmH2O leakage cir cuit Minimum leakage 12 l min at 4 cmH2O leakage circuit OX...

Page 185: ...single fault 6 cmH2O at 30 l min 6 cmH2O at 60 l min VIVO 45 DIMENSIONS SPECIFICATIONS W H D 216 159 152 mm Weight 2 4 kg Patient air outlet 22 mm male conical standard connector CO2 SENSOR SPECIFICAT...

Page 186: ...TION TECHNIQUE DESCRIPTION Pressure Low pass average time constant 16 ms Inspiration trigger Differential mass flow resolution 4 ms Expiration trigger Flow low pass filtering with level sensing SpO2 N...

Page 187: ...ndi tion The Vivo 45 will provide indication when the SpO2 value or pulse rate is potentially incorrect and generate an alarm condition to indicate when the SpO2 value update period has exceeded 30 se...

Page 188: ...that of a typical commer cial hospital and residential environment Surge IEC 61000 4 5 1 kV line to line Mains power quality should be that of a typical commer cial hospital and residential environmen...

Page 189: ...ncluding peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the Vivo 45 including cables specified by the manufacturer Otherwise degr...

Page 190: ...fied below The customer or the user of the Vivo 45 should assure that it is used in such an environment EMISSIONS TEST COMPLIAN CE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions CISPR 11 Group 1 Th...

Page 191: ...maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum outpu...

Page 192: ...ecom mended separation distance d in metres m can be estimated using the equation d I 2 H where I is the maximum current rating of the con ductor in amperes A according to the transmitter manufacturer...

Page 193: ...ctive Profile 2 Off Profile 3 Off PARAMETERS DELIVERY Inspiratory Pressure 15 cmH2O PEEP 5 cmH2O Breath Rate 12 bpm Inspiration Time 1 5 s Rise Time 3 Inspiratory Trigger 3 Expiratory Trigger 3 Maximu...

Page 194: ...Paediatric Low Vte Alarm 300 ml High MV Alarm Off Low MV Alarm Off High Breath Rate Alarm Off Low Breath Rate Alarm Off Apnea Alarm Off Disconnection Alarm On Rebreathing Alarm On Obstruction Alarm O...

Page 195: ...195 Technical Specifications Vivo 45 User Manual Doc 006149 En Y 2 Display light On Light Intensity 9 Alarm sound level 5 CO2 Unit mmHg Auto keypad lock Off Pre use Test On OTHERS DELIVERY...

Page 196: ...196 Technical Specifications Vivo 45 User Manual Doc 006149 En Y 2...

Page 197: ...IEC 60601 1 for medical equipment Furthermore all configurations must comply with the valid version of the system standard IEC 60601 1 1 Anybody who connects additional equipment to the signal input...

Page 198: ...ource for transpor tation 006265 Leakage Port Providing a leakage for clearing exhaled gases 004426 Memory card storage and transfer of set tings patient data and usage data 006705 Memory card reader...

Page 199: ...tal nurse call system NO 006365 NC 006364 10 k NO 006363 10 k NC 006362 Remote start stop Start and stop the Vivo 45 remotely Also pause audio remotely 006649 Mounting bracket Mount the Vivo 45 on a h...

Page 200: ...Y 2 SpO2 module Connection cable 006369 SpO2 sensor Finger Clip SpO2 sensor adult 006589 Paediatric 006590 SpO2 sensor Multisite SpO2 sensor 006591 Low pressure oxygen adapter 005032 12 24 V converter...

Page 201: ...Ventilator Adapter 006710 Cable Y adapter Mains AC and External DC to Ventilator 006711 Protective cover Shock protection 006067 EtCO2 sensor Measure CO2 in the patient air 006346 Airway adapter Conn...

Page 202: ...cts the Vivo 45 to a Radiometer PtcCO2 moni tor 006180 Effort belt communica tion box ConnectstheVivo 45toone or two effort belts 006182 Effort belt wireset Connects an effort belt to the communicatio...

Page 203: ...ts and consumables for the Vivo 45 COMPONENT FUNCTION PART NO Carry bag Storage for transportation 006014 Manual Product and usage informa tion User Manual 006149 Clinician s Manual 006148 Circuit Sin...

Page 204: ...washable Coarse inlet air filtration 5 pieces 007104 Cooling air filter Device air inlet filtration 5 pieces 007105 Air bypass unit Direct the air flow within the Vivo 45 007064 Side panels Grey 00706...

Page 205: ...Manual Doc 006149 En Y 2 Power cord Deliver power to the AC power supply EU 003520 Vivo 45 PC software Data monitoring software 0007067 USB cable Data cable PC and Vivo 45 USB to USB 005757 Polishing...

Page 206: ...206 Accessories and Parts Vivo 45 User Manual Doc 006149 En Y 2...

Page 207: ...the patient s settings Patient Settings Breas Vivo 45 Patient Date Clinic Set by Patient Circuit Pressure Inspiratory Trigger PEEP Expiratory Trigger Breath Rate Min Inspiratory Time Inspiratory Time...

Page 208: ...208 Patient Settings Vivo 45 User Manual Doc 006149 En Y 2...

Page 209: ...line with these requirements respiratory assistive devices may be used onboard an aircraft without further testing by the carrier provided they have been tested for Electromagnetic Compatibility EMC...

Page 210: ...210 FAA Compliance Vivo 45 User Manual Doc 006149 En Y 2...

Page 211: ...Fan Error 161 indication 105 internal error 160 Low Patient Air Temperature 135 Poor SpO2 signal 140 reset 107 Technical 133 Alarm Battery Error 151 Alarm Battery Error Alarm 151 Alarm section 52 Alar...

Page 212: ...9 Lost Mains Power 138 Low Alarm Battery 150 Low Breath Rate 117 Low EtCO2 127 Low Expired Minute Volume 115 Low Expired Tidal Volume 113 Low FiO2 123 Low Last Power Source 136 Low PEEP 111 Low Pressu...

Page 213: ...ange patient 173 Charge Click in battery 83 Charge batteries 80 Check before first use 35 Check FiO2 Adapter alarm 143 Cleaning 170 CO2 sensor 94 main unit 170 patient air filters 172 patient circuit...

Page 214: ...ing 70 Critical Last power source alarm 137 Critical Low Last Power Source alarm 137 D Data transfer between ventilator and PC 79 Database Integrity Fail Alarm 161 Date set 55 Date format 55 DC power...

Page 215: ...etting 66 Expired tidal volume Vte monitored value 57 External DC 84 F FAA 209 Filter bacterial 19 disposable 26 Filtering smoothing techniques specifications 186 Filters clean and replace 172 safety...

Page 216: ...erature alarm 134 High PEEP alarm 110 High Pressure alarm 108 High Pulse Rate alarm 129 High SpO2 alarm 124 High Vte alarm 112 HME 20 Home Adjust 74 Home Mode 74 overview 49 Humidification safety info...

Page 217: ...nternal Temp High Alarms 163 L Label 32 Language selecting for home mode 55 Last power source alarm 136 Leakage monitored value 57 Leakage circuit single limb pneumatic diagram 177 Leakage port connec...

Page 218: ...on 22 Max pressure setting 69 Maximum inspiratory time setting 67 Memory card slot position 29 Menu navigate 47 symbols 48 Min pressure setting 70 Minimum inspiratory time setting 66 Minute volume MV...

Page 219: ...4 Operating mode 74 Operator s position audible range 107 Others section 53 Oxygen safety information 23 Oxygen inlet position 32 specification 184 Oxygen saturation monitored value 59 P Paediatric ci...

Page 220: ...ms 108 Apnea 118 Disconnection 119 High Breath Rate 116 High EtCO2 126 High Expired Minute Volume 114 High Expired Tidal Volume 112 High FiO2 122 High PEEP 110 High Pressure 108 High Pulse Rate 129 Hi...

Page 221: ...n 76 Pressure Support Ventilation definition 75 Pressure Support Ventilation with Target Volume definition 76 Pressure unit 54 Pre use test perform 41 Priority power source 79 Product label 32 Profile...

Page 222: ...bel 32 Screen Alarm 52 home mode main screen overview 50 Monitor 53 Others 53 Section Alarm 52 Monitor 53 Others 53 Serial Communication Queue Full Alarm 159 Serial Communication Queue Full Alarms 159...

Page 223: ...supply 182 settings 179 sound level 184 SpO2 High SpO2 alarm 124 Low SpO2 alarm 125 monitored value 59 usage 97 SpO2 module using 97 SpO2 Sensor Failure Disconnection alarm 139 Spont rate monitored v...

Page 224: ...sation Lost 148 Internal Function Failure 157 LED Failure 149 Lost Mains Power 138 Low Alarm Battery 150 Low Last Power Source 136 Power Failure 133 SpO2 Sensor Failure Disconnection 139 Temperature a...

Page 225: ...149 En Y 2 patient circuit 17 V Ventilation mode 75 Vte tidal volume expired monitored value 57 W Warning icon 8 Water chamber detaching 101 filling 102 installing 100 open lid 103 Water trap 20 Weigh...

Page 226: ...226 Index Vivo 45 User Manual Doc 006149 En Y 2...

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