Vivo 65 User Manual Download Page 2

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2 Table of Contents

Vivo 65 users manual

Doc. 006088 En-US U-1b

Cleaning and Maintenance ......................................................................................... 165
7.1

Cleaning the Vivo 65 ..................................................................................... 166

7.2

Cleaning and Replacing the Patient Air Filters.............................................. 168

7.3

Change of Patient ......................................................................................... 169

7.4

Regular Maintenance Control ....................................................................... 170

7.5

Service and Repair ....................................................................................... 170

7.6

Storage.......................................................................................................... 170

7.7

Disposal ........................................................................................................ 171

Technical Specifications .............................................................................................. 172
8.1

System Description ....................................................................................... 172

8.2

Data Parameters ........................................................................................... 177

8.3

Emission and Immunity Declaration.............................................................. 192

8.4

Default Settings............................................................................................. 197

Accessories................................................................................................................. 201
9.1

Breas Accessories List.................................................................................. 201

Patient Settings ........................................................................................................... 207

FAA Compliance ......................................................................................................... 209

Index ........................................................................................................................... 212

Summary of Contents for 65

Page 1: ...de Panels 24 3 4 Equipment Designation and Safety Labels 27 4 Preparing the Vivo 65 for Use 30 4 1 Checking the Vivo 65 before First Use 30 4 2 Placing the Vivo 65 31 4 3 Connecting the Vivo 65 to AC Power 33 4 4 Connecting the Patient Circuit 34 4 5 Inspecting the Vivo 65 before Use 39 4 6 Performing the Pre use Test 40 5 How to Use the Vivo 65 41 5 1 Turning the Vivo 65 On and Off 41 5 2 Using t...

Page 2: ... 7 3 Change of Patient 169 7 4 Regular Maintenance Control 170 7 5 Service and Repair 170 7 6 Storage 170 7 7 Disposal 171 8 Technical Specifications 172 8 1 System Description 172 8 2 Data Parameters 177 8 3 Emission and Immunity Declaration 192 8 4 Default Settings 197 9 Accessories 201 9 1 Breas Accessories List 201 10 Patient Settings 207 11 FAA Compliance 209 12 Index 212 ...

Page 3: ...al personnel 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 use may lead to risk of personal injury CAUTION Read this operating manual thoroughly so that you completely under stand how the Vivo 65 is operated and maintained before operating the device to...

Page 4: ... VCV A Assisted Volume Controlled Ventilation VCV SIMV Volume Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation VCV MPV Volume Controlled Ventilation with MouthPiece Ventilation CPAP Continuous Positive Airway Pressure The Vivo 65 can be used with the following patient circuit configurations Dual limb circuit adult or pediatric connected to an integrated active exhalation...

Page 5: ...s It may be used for both invasive and non invasive ventilation The Vivo 65 is not intended to be used as a transport or critical care ventilator 1 4 Contraindications The use of the Vivo 65 is contraindicated for patients who need to be ventilated with oxygen concentrations FiO2 higher than achievable when combining inlet from a low pressure oxygen source at 15 l min with actual ventilator settin...

Page 6: ...l is intended for patients and other lay users operating the Vivo 65 Care providers clinical personnel physicians and others who require a working knowl edge of the Vivo 65 will find additional information on settings and functions in the Clinician s Manual ICON EXPLANATION Warning Risk of death and serious personal injury Caution Risk of minor or moderate injury Risk of equipment damage loss of d...

Page 7: ...have immediate access to an alternative means of ventilation which is ready for use to avoid patient death or serious injury Failure to have an alternate means of ventilation can result in serious injury or patient death if ventilator fails The Vivo 65 must be turned off and on at least every 90 days This is necessary in order for the Vivo 65 to perform a complete self test The self test automatic...

Page 8: ...erform the procedure Inspecting the Vivo 65 before Use on page 39 before use The Vivo 65 can be used for life supporting treatment provided an emergency equipment e g resuscitation bag is available and that one of the following configurations is used for surveillance of venti lator dependent patient breathing Dual limb patient circuit and insert with integrated exhalation valve The Vivo 65 s inter...

Page 9: ...ettings or components may require the readjustment of the alarm levels Setting the alarm sound level below that of the ambient sound level can impede recognition of alarm conditions Handle the Vivo 65 with care Do not use the Vivo 65 while in the carry bag Do not use the Vivo 65 with nitric oxide helium or helium mixtures The Remote Start Stop accessory is not to be used in Paediatric mode Ensure ...

Page 10: ...uirements of IEC 60601 1 The aspects of electromagnetic compatibility must be considered The Vivo 65 should not be used adjacent to or stacked with other equipment if adjacent or stacked use is necessary the Vivo 65 should be observed to verify normal operation in that configuration Mobile or transportable radio transmitters may interfere with the Vivo 65 Guidance for safe installation of the Vivo...

Page 11: ...n an ambient temperature warmer than 41 F 5 C MR Unsafe Do not use or store the Vivo 65 in a magnetic resonance MR envi ronment Use of the Vivo 65 in an MR environment may result in malfunction of the Vivo 65 and pose unacceptable risk to the patient medical staff or other persons Do not expose the Vivo 65 to rain or snowfall Do not use the Vivo 65 while positioned in a warm place such as direct s...

Page 12: ...ur bances Follow the instructions above and the guidance provided in Emission and Immunity Declaration on page 192 to mitigate the effects of electromagnetic disturbances The Vivo 65 any accessories and all replaced parts must be disposed of in accordance with the local environmental regulations regarding the disposal of used equipment and waste The performance of the Vivo 65 and treatment of the ...

Page 13: ...exhaust from the leakage ports or exhalation valve flushing exhaled gas from the circuit The Vivo 65 should be turned on and the function of the leakage port or exhalation valve should be checked before use Do not breathe in the connected patient circuit unless the Vivo 65 is turned on and operating properly Do not use patient hoses or tubes made of static or electrically con ductive material Alwa...

Page 14: ...hing of exhaled air The recom mended leakage is 20 to 50 l min at 10 cmH2O pressure Periodically check for moisture in the patient circuit When present remove the moisture Before attempting to dry the circuit disconnect it from the Vivo 65 to ensure no water flows back into the Vivo 65 When using the Vivo 65 invasively the low volume alarm and the low breath rate alarm must be carefully set to ens...

Page 15: ...ing that the leakage port or exhalation valve remains clear at all times Periodically check the patient circuit during therapy In general as pressure decreases the potential of rebreathing increases Lower pressures produce less flow through the leakage port which may not clear all CO2 from the circuit to prevent rebreathing To reduce the risk of rebreathing CO2 make sure that the leakage port or a...

Page 16: ...emperatures than intended A dirty fil ter may be caused by dust or animal hair in the home environment When operating the Vivo 65 make sure that the air inlet and filters are not obstructed or occluded The 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 T...

Page 17: ...If the condensation in the patient circuit is excessive the use of a heated humidifier may require the installation of a water trap in the circuit The water trap prevents any condensated water in the patient circuit from running into the patient airways and causing personal injury When adding or removing a HME Heat and Moisture Exchanger artificial nose or HCH Hygroscopic Condenser Humidifier alwa...

Page 18: ...d control pro cedures as well as any applicable upgrades in accordance with Breas service instructions The Vivo 65 shall only be repaired or modified in accordance with Breas service manuals technical bulletins and any special service instructions by service technicians authorized by Breas Medical AB Do not under any circumstances attempt to open service or repair the Vivo 65 yourself If you do so...

Page 19: ...s not operating Oxygen delivered into the patient tubing may accumulate within the machine enclosure Oxygen accumulated in the machine enclosure will increase the risk of fire Do not use a humidifier between the oxygen source and the ventila tor in order to humidify the oxygen flow Ventilate the room adequately Do not smoke in a room where oxygen is being used Naked light bulbs and other sources o...

Page 20: ...delivered air has influence on the volume measurement of the Vivo 65 This measurement is based on a normal oxygen concentration of 21 If the oxygen concentration is higher the monitored inspired volume will deviate from the actual volume as follows 40 oxygen concentration 2 5 deviation 60 oxygen concentration 5 deviation 80 oxygen concentration 7 5 deviation ...

Page 21: ...21 Product Description Vivo 65 users manual Doc 006088 En US U 1b 3 Product Description 3 1 Main Components The Vivo 65 system contains the following components 1 2 6 10 8 3 9 5 4 7 ...

Page 22: ...d gas volume and flow Adult or pediatric use Adult 005523 disposable Pediatric 005525 disposable 4 Single limb insert Connection for ventilator and single limb circuit with external exhalation valve connector 005521 5 Filter white Inlet air filtration 004910 6 Filter grey Inlet air filtration 004909 7 Cooling air inlet fil ter grey Inlet air filtration 006435 8 Power cord 005432 9 Click on battery...

Page 23: ...y 5 Internal battery Power source Internal battery 6 Alarm Alarm indication red or yellow 7 Audio pause Paused alarm sound indication 8 Sensor Ambient light sensor NO USER BUTTONS FUNCTION 9 Navigation Setting Navigation in current menu selec tion Define settings 10 Start Stop Start Stop ventilation treatment 11 Function Navigation Function according to display 12 Audio Pause Pause the alarm sound...

Page 24: ...hing can block the patient air inlet on the side of the Vivo 65 Read Placing the Vivo 65 on page 31 for more information 2 Cooling air inlet Inlet internal cooling cooling air filter 3 Nurse call Remote alarm Connection for nurse call 4 USB data connec tion port Data connection PC and the Vivo 65 The data connection port is only to be used by your care provider 3 4 5 10 11 12 13 14 15 16 1 2 6 8 7...

Page 25: ... Connection for FiO2 sensor 10 Standby button Power on and off 11 External DC inlet Connection for external DC power source 12 AC power inlet Connection for AC power source Attention Read the chapter Connecting the Vivo 65 to AC Power on page 33 13 Dual limb insert Changeable connection for dual limb circuit with inte grated exhalation valve Insert for Adult use Insert for Pediatric use 14 Dual li...

Page 26: ...ction for patient circuit 16 Oxygen inlet port Connection for low pressure bleed in oxygen source 17 Single limb insert Changeable connection for single limb circuit 18 Exhalation valve control pressure outlet Connection for external exha lation valve control pressure tube NO ITEM FUNCTION COLOR SYMBOL ...

Page 27: ... insert Click on battery connector Attention Make sure not to touch this con nector while simultaneously touching the patient Patient air inlet Attention Make sure that nothing can block the patient air inlet on the side of the Vivo 65 Read Placing the Vivo 65 on page 31 for more information Internal and Click on battery Attention Read the chapter Using Batter ies on page 89 Battery Product number...

Page 28: ...ngers and objects greater than 12 mm and protected from water spray less than 15 degrees from verti cal Class II equipment double insulation Body floating IEC 60601 1 Type BF Iso lated Applied Part Symbol only applicable in U S Caution U S Federal law restricts this device to sale by or on the order of a licensed health care practitioner Conforms to IEC 60601 1 2012 including ANSI AAMI ES60601 1 2...

Page 29: ...29 Product Description Vivo 65 users manual Doc 006088 En US U 1b Appears on box packaging Fragile This Side Up ...

Page 30: ...n page 7 before setting up the Vivo 65 1 Check that all main com ponents and ordered acces sories have been delivered Refer to the packing note or the invoice if available 2 Ensure that the equip ment is in good condition 3 If stored more than one month connect the Vivo 65 to the power supply to recharge the internal battery See Charging the Batteries on page 90 for further instructions 4 Check th...

Page 31: ...al Conditions on page 11 carefully to make sure all conditions are met and considered 1 Place the Vivo 65 on a solid flat surface The Vivo 65 should be placed lower than the patient in order to prevent the device from falling on the patient as well as preventing condensated water from reaching the patient 2 Make sure that nothing can block the patient air inlets on the side of the Vivo 65 ...

Page 32: ...rs manual Doc 006088 En US U 1b Do not place the Vivo 65 on a soft surface that will prevent the air flow underneath the device Never cover the device Always position the Vivo 65 so that it is easy to remove the power cord from the AC power inlet ...

Page 33: ...Electrical Safety on page 10 carefully to make sure all conditions are considered and met 1 Plug the power cord into the power inlet of the Vivo 65 2 Secure the power cord using the restraining clip 3 Connect the power cord to the power source To isolate the Vivo 65 from the supply mains remove the power cord from the AC power inlet ...

Page 34: ... leakage port Circuit with mouthpiece interface Connect Patient Circuit Insert The choice of insert makes it possible to connect the Vivo 65 to either a dual limb pediatric circuit a dual limb adult circuit or a single limb circuit The Vivo 65 automatically detects which insert has been installed Before Read the chapter Usage of Patient Circuit on page 13 carefully to make sure all conditions are ...

Page 35: ...ith inte grated exhalation valve Dual Single limb circuit with leakage port Leakage Circuit with mouthpiece interface Dual limb insert Pediatric Pediatric Dual limb circuit with inte grated exhalation valve Dual Single limb circuit with leakage port Leakage Circuit with mouthpiece interface Single limb insert optional Adult Pediatric Single limb circuit with active exhalation valve Exh valve Singl...

Page 36: ...fter changing the patient circuit type and or insert An incorrect combination of patient circuit type and insert will result in a Circuit Type Insert Mismatch alarm with medium alarm priority An incorrect combination of patient mode and insert will result in a Patient Mode Insert Mismatch alarm with medium alarm priority Do not remove the gasket that is placed inside the Vivo 65 s insert socket Re...

Page 37: ...o the lock sym bol on the ventilator 3 Make sure a click sound is heard when fastening the lockring This sound ensures that the insert is correctly attached Unlock and disconnect in reverse order 1 Connect one patient tube to the patient air outlet of the venti lator 2 Connect the other patient tube to the exhaled air inlet of the Vivo 65 3 Connect the other end of the patient circuit to an HME or...

Page 38: ...re Connect a Single Limb Circuit with Active Exhalation Valve 1 Connect the patient circuit to the patient air outlet of the venti lator 2 Connect the other end of the patient circuit to the leakage port or patient interface 1 Connect the patient circuit to the patient air outlet of the venti lator 2 Connect the control pressure tubing to the exhalation valve and to the exhalation valve control pr...

Page 39: ...5 to the power source 3 Turn on the Vivo 65 main power using the Standby button on the side panel 4 Ensure that the treatment settings and alarm settings are adjusted as prescribed and that the correct patient circuit type is selected 5 Perform a pre use test by following the instructions on the display 6 Press the Start Stop button on the front panel until the progress bar is filled 7 Check that ...

Page 40: ...ng the type and characteristics of the patient circuit that is connected to the Vivo 65 The resistance and com pliance of the patient circuit are measured and calculated This will be used to compensate for pressure and compliance deviations during treat ment The patient shall not be connected during the pre use test Always perform a new pre use test if the patient circuit configuration or insert h...

Page 41: ...On and Off Turn On and Enter Operating Mode Read the chapter Safety Information on page 7 before using the Vivo 65 1 Make sure the power source is connected and secured by the restraining clip 2 Turn on the Vivo 65 and enter Standby mode by pressing the Standby button on the side panel 3 To start treatment and enter operating mode first press and hold the Start Stop button on the front panel Relea...

Page 42: ...ess and hold the Start Stop button on the front panel 2 Release the Start Stop button on the front panel when the pro gress bar is filled 3 Press the Audio Pause button within 10 seconds Press the but ton firmly 4 When the Vivo 65 is not in an active treatment mode press the Standby button on the side panel to change the unit to a low power standby state ...

Page 43: ...n buttons on the panel in order to navigate the Vivo 65 menu The navigation buttons are used to view the different sections indicated above each one The same navigation button can also be used to view additional information in some sections or it can be designated a tempo rary function while an event window is active Use the up or down button to enter the menu list ...

Page 44: ... 65 users manual Doc 006088 En US U 1b Use the arrow buttons up and down to navigate up or down in a menu list or to select different parameters Use the arrow buttons left and right to alter parameters or enter and exit sub sections ...

Page 45: ...grated exhalation valve selected Dual Single limb circuit with leakage port selected Leak age Single limb circuit with active exhalation valve selected Exh valve MPV breath mode selected Circuit with mouthpiece interface shall be used SpO2 connected FiO2 connected CO2 connected Multiple pages Multiple content available High priority alarm event in history list Medium priority alarm event in histor...

Page 46: ...U 1b Overview Menu The Vivo 65 menu has the following section layout Setup Others Main Alarm Monitor Setup 1 2 Alarm Settings 1 2 Alarm Event History Device memory Patient Operating Time Device Settings Time and Date Device Information Page Sub menu Icon explanation ...

Page 47: ...ts and inspired expired tidal volume The red lines represent the low and high pressure alarms the low and high tidal volume alarms 2 Icon Alarm Message Information icons are presented here to give a quick overview of the Vivo 65 basic status See Symbols Used in the Menu on page 45 3 Screen Title and Context Area Screen title page number if more than one subpage exists in the section and time are d...

Page 48: ... The Setup Section In the Setup section treatment parameters can be altered See Functions and Parameters in the Vivo 65 on page 57 Home Adjust The Home Adjust function can be activated by the care provider When activated the care provider can unlock treatment parameters and define a limited setting range The patient and lay care giver can change these set tings within the limited range when the Vi...

Page 49: ...or more information The Alarm Event History screen displays all events that have been logged as well as alarms that have occurred Alarms are colored accord ing to priority and are maintained when the Vivo 65 is powered down The manufacturer configured state of physiological alarms may be retrieved by selecting Reset to basic settings on the Mode screen in Standby mode ...

Page 50: ...Patient Operating Time Shows the number of hours a patient has been using the Vivo 65 for breathing therapy Device Settings General settings for the Vivo 65 The monitoring screen contains a bargraph field that displays current Pressure PEEP and Ppeak pressure and volume alarm limits and inspired expired tidal volume The monitoring field displays all available values for the current treatment mode ...

Page 51: ... the lowest and 9 is the highest light intensity setting In cases where Display Light is set to Auto the Light Intensity setting will not be available Auto Keypad Lock On Off Time and Date Time set time hours and minutes Time Format choose between 24 h or 12 h am pm format Date set date year month and day Date Format choose between yyyy mm dd dd mm yyyy mm dd yyyy format Device Information Device ...

Page 52: ... screen The Ppeak displays the highest pressure that is recorded during the inspiratory phase The PEEP displays the pressure at the end of the expiratory phase The Pmean displays the calculated mean value of pressure during a complete ventilatory cycle inspiratory expiratory phase The Leakage displays the total leakage intentional and unintentional as calculated at expiratory pressure level ...

Page 53: ...n 1 and 30 litres The MVe displays the Expired Minute Vol ume calculated as Expired Tidal Volume multiplied with the Total Breath Rate This value is only displayed in the monitor ing field if the patient circuit type is Dual limb or Leakage circuit When the Vivo 65 is used non invasively the MVe can differ from the exhaled minute volume from the patient due to leaks around the mask The Vti display...

Page 54: ... When the Vivo 65 is used non invasively the Vte can differ from the exhaled tidal volume from the patient due to leaks around the mask The FiO2 displays the fraction of inspired oxygen as measured at the air outlet of the Vivo 65 An FiO2 sensor part no 006347 needs to be in place to measure and display this value see Using the Vivo 65 with the FiO2 Sensor on page 98 The in TgV displays the percen...

Page 55: ...ibrated to display functional oxygen saturation For data regarding the oxygen probe s range of peak wavelengths max optical power and usage please refer to the respective probe manual Environmental factors may influence the function or accuracy of the pulse oximeter such as ambient light physical movement diagnostic testing low perfusion electromagnetic interference dysfunctional haemoglobin prese...

Page 56: ... of inspiration to the start of expiration The Rise Time displays 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 the last portion of the exhaled volume that is passing through the CO2 sensor The InspCO2 displays the inspired carbon dioxide ...

Page 57: ... Definition The Inspiratory Pressure setting is used to define the airway pressure during the inspir atory phase In the PCV SIMV mode this setting defines the inspiratory pressure for the mandatory breaths controlled by the ventilator Modes PSV PSV TgV PCV PCV TgV PCV A PCV A TgV PCV SIMV PCV MPV Setting min 4 cmH2O Adult 4 cmH2O Pediatric Setting max 50 cmH2O Adult 35 cmH2O Pediatric Setting reso...

Page 58: ... the end of the expiratory phase Modes PSV PSV TgV PCV PCV TgV PCV A PCV A TgV PCV SIMV VCV VCV A VCV SIMV Setting min Off 2 cmH2O leakage circuit circuit with external integrated active exhalation valve single limb exhalation valve for Pediatric VCV Setting max 20 cmH2O Adult Paediatric Pressure 2 cmH2O or Min Pressure 2 cmH2O Setting resolution 0 5 below 10 cmH2O 1 0 above 10 cmH2O Display ...

Page 59: ...he Vivo 65 Vivo 65 users manual Doc 006088 En US U 1b PScalc ITEM DESCRIPTION Definition PScalc displays the pressure above the PEEP pressure applied to the patient in PCV PSV mode Modes PSV PCV PCV A PCV SIMV Display ...

Page 60: ...g as no inspiratory trigger effort from the patient is detected The cycles will be ventilator initiated breaths The combination of the Breath Rate and Inspiratory Time setting is limited by the I E ratio 2 1 Modes PCV PCV TgV PCV A PCV A TgV VCV VCV A PCV MPV VCV MPV Setting min 4 bpm Adult 6 bpm Pediatric 0 bpm MPV breath mode Setting max 40 bpm Adult 60 bpm Pediatric Setting resolution 1 bpm Dis...

Page 61: ...r controlled breaths The mandatory breaths can be either triggered by an inspiratory effort from the patient or ventilator initiated The SIMV Rate setting determines the SIMV cycle time The combination of the SIMV Rate and Inspiratory Time setting is limited by the I E ratio 2 1 Modes PCV SIMV VCV SIMV Setting min 4 bpm Adult 6 bpm Pediatric Setting max 40 bpm Adult 60 bpm Pediatric Setting resolu...

Page 62: ...xpiration In the PCV SIMV and VCV SIMV modes this setting is used for defining the inspira tion length of the mandatory breaths con trolled by the ventilator The combination of the Inspiratory Time and Breath Rate or SIMV Rate settings is limited by the I E ratio 2 1 to 1 99 Modes PCV PCV TgV PCV A PCV A TgV PCV SIMV PCV MPV VCV VCV A VCV SIMV VCV MPV Setting min 0 3 s Setting max 5 s Adult 2 s Pe...

Page 63: ...l Doc 006088 En US U 1b I Ecalc ITEM DESCRIPTION Definition The I Ecalc displays the calculated I E ratio based on the Breath Rate and Inspiratory Time settings Modes PCV PCV TgV PCV A PCV A TgV PCV SIMV PCV MPV VCV VCV A VCV SIMV VCV MPV Display ...

Page 64: ...atory Time setting defines the length of each inspiration delivered dur ing ventilator triggered backup ventilation initiated by the set Backup Rate The combination of the Backup Inspiratory Time and Backup Rate setting is limited by the I E ratio 2 1 Modes PSV PSV TgV Setting min 0 3 s Setting max 5 s Adult 2 s Pediatric Setting resolution 0 1 s Display ...

Page 65: ...If the High Pressure alarm or the High Tidal Volume alarm is active the Sigh function will be disabled Once the alarm condition has been resolved the Sigh function will con tinue operating Modes PSV PSV TgV PCV PCV TgV PCV A PCV A TgV VCV VCV A Setting min Sigh rate Off every 50 breaths Sigh 125 of actual set pressure or vol ume Setting max Sigh rate Every 250 breaths Sigh 200 of actual set pressu...

Page 66: ...tting will give a slow increase and therefore a shorter plateau In the VCV SIMV mode two different Rise Time settings are made one for mandatory ventilator controlled breaths and one for additional pressure support breaths trig gered by the patient Modes PSV PSV TgV PCV PCV TgV PCV A PCV A TgV PCV SIMV PCV MPV VCV VCV A VCV SIMV VCV MPV Setting min 1 PSV PCV PCV SIMV PCV MPV VCV SIMV 50 of the ins...

Page 67: ...fort reaches the set inspiratory trigger level an inspiration is initiated If the patient cannot trigger a breath the ventilator will deliver breaths according to the set Backup Rate Breath Rate or SIMV Rate The Assisted breath modes in PCV and VCV are turned off if the inspiratory trigger is set to Off Modes PSV PSV TgV PCV A PCV A TgV PCV SIMV PCV MPV VCV A VCV SIMV VCV MPV Setting min 1 Setting...

Page 68: ...nition The SIMV Support Pressure setting is used in the SIMV ventilation modes to define the inspiratory pressure for the pressure support breaths triggered by the patient Modes PCV SIMV VCV SIMV Setting min 4 cmH2O Setting max 50 cmH2O Adult 35 cmH2O Pediatric Setting resolution 0 5 below 10 cmH2O 1 0 above 10 cmH2O Display ...

Page 69: ...he ventilator will cycle from the inspiratory to the expiratory phase In PCV SIMV and VCV SIMV modes this setting is applicable to the pressure support breaths that are triggered by the patient Modes PSV PSV TgV PCV SIMV VCV SIMV Setting min 1 10 decrease of peak flow Setting max 9 90 decrease of peak flow Setting resolution 1 setting 1 cycles off early and 9 cycles off late Display ...

Page 70: ... Minimum Inspiratory Time setting defines a minimum length for each inspira tion If the Minimum Inspiratory Time is set to Off the length of the inspiration is dependent on the set Expiratory Trigger or the maximum inspiratory time Modes PSV PSV TgV Setting min Off 0 3 s Setting max 3 s Adult 2 s Pediatric Setting resolution 0 1 s Display ...

Page 71: ...aximum Inspiratory Time setting defines a maximum length for each inspira tion If the Maximum Inspiratory Time is set to Off the length of the inspiration is dependent on the set Expiratory Trigger and or minimum inspiratory time Modes PSV PSV TgV Setting min 0 3 s Setting max 3 s Off Adult 2 s Off Pediatric Setting resolution 0 1 s Display ...

Page 72: ...ver in case of prolonged apnea and as long as no inspiratory trigger effort from the patient has been detected The cycles will be ventilator initiated breaths The combination of the Backup Rate and Backup Inspiratory Time setting is limited by the I E ratio 2 1 Modes PSV PSV TgV Setting min 4 bpm Adult 6 bpm Pediatric Setting max 40 bpm Adult 60 bpm Pediatric Setting resolution 1 bpm Display ...

Page 73: ...t Volume is used with a patient cir cuit with an active exhalation valve leakage may be misinterpreted by the Vivo 65 as an increase of tidal volume This will lead to a decrease of the Inspiratory Pressure the Inspiratory Pressure will not be lower than the set Min Pressure This may result in hypoventilation as the true delivered tidal volume will decrease both as a result of the leakage and the d...

Page 74: ...pressure limit up to where the Vivo 65 can increase the pressure to reach the set Target Volume If Target Vol ume is not reached at Max Pressure the Vivo 65 will continue to ventilate at this Max Pressure setting Modes PSV TgV PCV TgV PCV A TgV Setting min Min Pressure Setting max 50 cmH2O or Max Pressure Adult 35 cmH2O or Max Pressure Pediatric Setting resolution 0 5 below 10 cmH2O 1 0 above 10 c...

Page 75: ...ure limit down to where the Vivo 65 can decrease the pressure to maintain the set Target Volume If the actual volume is above Target Volume at Min Pressure the Vivo 65 will continue to ventilate at this Min Pressure setting Modes PSV TgV PCV TgV PCV A TgV Setting min 4 cmH2O Setting max 50 cmH2O or Max Pressure Adult 35 cmH2O or Max Pressure Pediatric Setting resolution 0 5 below 10 cmH2O 1 0 abov...

Page 76: ... vol ume that will be delivered by the Vivo 65 for each breath In VCV SIMV mode this setting is applica ble to the mandatory breaths that are con trolled by the ventilator Modes VCV VCV A VCV SIMV VCV MPV Setting min 300 ml Adult 50 ml Pediatric Setting max 2000 ml Adult 300 ml Pediatric Setting resolution 10 below 500 ml 50 above 500 ml Display ...

Page 77: ...e flow will be delivered during inspi ration When a square wave pattern is applied the flow will be constant throughout the complete inspiratory cycle When a decelerating wave pattern is applied the flow will be higher at the start of the inspiratory cycle and decrease towards the end Modes VCV VCV A VCV SIMV VCV MPV Setting range Square Decelerating Display ...

Page 78: ...l Doc 006088 En US U 1b CPAP ITEM DESCRIPTION Definition The CPAP setting defines the pressure that will be applied to the airways Modes CPAP Setting min 4 cmH2O Setting max 20 cmH2O Setting resolution 0 5 below 10 cmH2O 1 0 above 10 cmH2O Display ...

Page 79: ... available in Standby mode Patient Mode The Vivo 65 can be operated in either Adult mode or Pediatric mode The Vivo 65 is intended for treatment of pediatric patients who weigh more than 11 lbs 5 kg In Pediatric mode some ventilator parameters for example Breath Rate Inspiratory Time and Tidal Volume have special setting limits The default settings and alarm limits of the Vivo 65 are preset when t...

Page 80: ...et Volume PCV A Assisted Pressure Controlled Ventilation PCV A TgV Assisted Pressure Controlled Ventilation with Tar get Volume PCV SIMV Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation PCV MPV Pressure Controlled Ventilation with MouthPiece Ventilation VCV Volume Controlled Ventilation VCV A Assisted Volume Controlled Ventilation VCV SIMV Volume Controlled Vent...

Page 81: ...nspiration time or 3 seconds The limit for the high pressure alarm is reached PSV TgV Pressure Support Ventilation with Target Vol ume The PSV TgV mode acts as the PSV mode but with an added regulation of the pressure Target volume is a feature that automatically adapts the pressure to make sure that the Vivo 65 delivers the desired set target vol ume to the patient The delivered volume is compare...

Page 82: ... com pared to the set target volume The delivered pressure for the next breath will be increased or decreased depending on the difference between the delivered volume and the set target volume Automatic pressure adjust ments will be made in between two adjustable limits min pressure and max pressure in order to deliver the optimal support to the patient PCV A TgV Assisted Pressure Controlled Venti...

Page 83: ...patient may trigger spontaneous breaths until the next SIMV cycle begins The ventilator will respond to the patient s inspiration efforts with additional pressure support breaths The inspiratory pressure of these support breaths is defined by the SIMV Support Pressure together with the settings for Rise Time and Expira tory Trigger The default value for SIMV Support Pressure is the Inspir atory pr...

Page 84: ...s controlled by the Vivo 65 This is done with the preset tidal volume breath rate inspiratory time and rise time settings set by the operator The inspiration stops and an expiration starts in two cases The inspiratory time expires The limit for the high pressure alarm is reached VCV A Assisted Volume Controlled Ventilation In the VCV A mode the ventilation is controlled by the Vivo 65 but the pati...

Page 85: ... cycle begins The ventilator will respond to the patient s inspiration efforts with additional pressure support breaths The inspiratory pressure of these support breaths is defined by the SIMV Support Pressure together with the settings for Rise Time and Expira tory Trigger The default value for SIMV Support Pressure is the Inspir atory pressure set in PCV or PSV VCV MPV Volume Controlled Ventilat...

Page 86: ...cuit is selected Sigh When the Sigh feature is enabled the Vivo 65 will deliver a Sigh breath as configured by the prescriber at a certain preset frequency A Sigh is a breath where an increased of the set pressure or volume is delivered to the patient In Volume modes the Vivo 65 can deliver a Sigh using 125 150 175 or 200 of the set Tidal Volume The Tidal Volume that will be used during the Sigh f...

Page 87: ...200 or 250 mandatory or assisted breaths In pressure modes during the sigh breath the high pressure alarm will automatically be set 10 cmH2O above set sigh pressure max 55 cmH2O In volume modes during the sigh breath the high pressure alarm will automatically be increased by the same percentage as the set sigh volume max 55 cmH2O ...

Page 88: ...esult in loss of data and or damaged equipment In order to view and present patient data correctly the Vivo 65 PC Soft ware must be installed on the PC Instructions on how to manage data in the Vivo 65 PC Software can be found in the software help The Vivo 65 can copy and transfer data to the memory card 1 Insert the memory card in the memory card slot on the side of the Vivo 65 Make sure the mem ...

Page 89: ...city and low self discharge Power Source Priority 1 AC power 2 External DC 3 Click on battery 4 Internal battery When a power source fails or is disconnected the Vivo 65 will switch to either the external DC if installed the click on battery if attached or the internal battery and show a message in the display window 4 Connect the memory card reader writer to a PC and insert the memory card See th...

Page 90: ...lly charged when con necting the Vivo 65 to the mains supply To ensure that the batteries are fully charged a maintaining charging cycle will be performed The batter ies are not charged when connecting the Vivo 65 to an external DC sup ply While charging the battery level will be animated The batteries are only charged if the internal temperatures are between 32 to 113 F 0 to 45 C High power consu...

Page 91: ...For example during transportation between one stationary power source to another Click on Battery The click on battery is intended as a power source during transportation or if the primary AC power source fails The click on battery can be replaced during treatment provided that the internal battery is charged SYMBOLS BATTERY STATUS Full Medium Empty Low Disconnected or malfunctioning Malfunctionin...

Page 92: ...ck on Battery 1 Use a thin stick to open the cover for the click on battery con nectors 2 Make sure the cover is com pletely opened 3 Hold the Vivo 65 as shown in the picture in order to target the click on battery holders marked with circles 4 Tilt the Vivo 65 into an upright position ...

Page 93: ...e screw to secure the click on battery by pressing it in and turn clockwise Remove the click on battery in reverse order Make sure the cover is closed after disconnecting the click on battery 1 Connect the click on battery charger to the click on battery 2 Connect the charger to the AC power supply To charge an empty click on bat tery using the click on battery charger takes about 3 hours ...

Page 94: ...ly charged batteries PARAMETER EXAMPLE 1 EXAMPLE 2 VENTILATOR SETTINGS Patient Mode Adult Paediatric Mode VCV PCV Tidal Volume 800 ml N A Inspiratory Pressure N A 30 cmH2O PEEP 5 cmH2O 5 cmH2O Breath Rate 20 bpm 30 bpm Insp Time 1 s 0 6 s I E Calculated 1 2 1 2 3 Insp Trigger Off Off Rise Time Off 4 Flow Pattern Square N A Display Light On On Light Intensity 5 5 LUNG CHARACTERISTICS Resistance 5 h...

Page 95: ...ce connected the Vivo 65 will automatically switch over to the external DC source if the mains power cord is removed or if the AC power supply fails The external DC voltage level is shown under Others Device Information in the menu Internal Battery 3 5 h 3 5 h Click on Battery 8 h 8 h Do not connect the Vivo 65 to a wheelchair unless the operating manual for the wheelchair permits this as this can...

Page 96: ...he switchover to external DC can be tested by connecting the external DC source and then disconnecting the AC power cord The Vivo 65 will automatically switch to external DC as power source Switchover is indi cated by power source LED and information message on the screen ...

Page 97: ...er to release the connector Using the Vivo 65 with a Nurse Call System The Vivo 65 can be connected to a nurse call system using the nurse call cable When connected the Vivo 65 alarms will also be forwarded to the nurse call system Connect the Vivo 65 to a Nurse Call System 1 Connect the nurse call cable on the left side panel of the Vivo 65 2 Test the connection by trigger ing an alarm on the Viv...

Page 98: ...iO2 sensor is not intended to be in contact with the patient s body The FiO2 sensor should be calibrated when first connected and then at least once a month How to connect the FiO2 Sensor FiO2 calibration can be performed by a clinician USAGE TIME Operating temperature 50 to 104 F 10 to 40 C Operating pressure 700 to 1250 mbar Response time 12 s Expected operating life 6 years in ambient air 1 yea...

Page 99: ... mon itor the Vivo 65 alarms remotely The Remote Alarm forwards alarms from the Vivo 65 When an alarm sounds the care provider or clinical personnel must attend to the patient quickly The FiO2 monitoring automatically compensates for changes in ambient barometric pressure Information about safety warnings product description installation usage cleaning maintenance and technical specifications can ...

Page 100: ... and trained medical personnel only The CO2 sensor is intended only as an adjunct in patient assessment It must be used in conjunction with other assessments of clinical signs and symptoms Masks deadspace patient s volumes and unintentional leakage may influence the CO2 measurements Disposable airway adapters shall not be reused Reuse of the single use adapter can cause cross infection Used airway...

Page 101: ...upwards If an intentional leakage port is used make sure that the CO2 sensor is placed between the patient interface and the leakage port If a patient interface with integrated leakage is used the monitored CO2 values may be influenced The CO2 sensor should be placed as close to the patient interface as possible However a HME Heat and Moisture Exchanger should be placed between the patient interfa...

Page 102: ...ion port on the Vivo 65 according to the instruction Connecting and Disconnecting the Cables on page 97 A green LED indicates that the CO2 sensor is ready to use 2 Snap the CO2 sensor probe on top of the airway adapter It will click into place when properly sealed 3 Perform a CO2 zeroing procedure 4 Connect the airway adapter to the patient circuit ...

Page 103: ...eci fied message is displayed Maintenance No periodical maintenance is required for the CO2 sensor 5 Make sure to position the CO2 sensor with the LED pointing upwards The CO2 sensor is not intended to be in contact with the patient body CO2 zeroing can be performed from the FiO2 CO2 Calibration page under the Others section LED STATUS DESCRIPTION Steady green light System OK Flashing green light ...

Page 104: ... measure functional oxygen saturation of arterial hemoglobin SpO2 and pulse rate The SpO2 sensor can be connected to the Vivo 65 in order to monitor and store SpO2 measurements The SpO2 measurements will be stored in the data memory which can be downloaded to a PC and viewed in the Vivo 65 PC software See the Vivo 65 service manual for how to perform the gas span check Do not under any circumstanc...

Page 105: ...e the Vivo 65 is operating for example mounted on a wheelchair in a personal vehicle or carried by hand Do not use the Vivo 65 in the protective cover while positioned in a warm place such as direct sunlight or close to a radiator Be careful when handling the trolley with the ventilator mounted in order to avoid any risk of the trolley falling The trolley can be tipped 10 and return to vertical po...

Page 106: ...e following functions NO COMPONENT FUNCTION 1 Transparent window for accessing front panel and buttons 2 Port for patient circuit cables O2 inlet standby button 3 Cooling air inlet 4 Patient air inlet 5 Straps for safe mounting 6 Cooling air outlet Do not cover the air inlets or outlets 1 2 5 6 3 4 ...

Page 107: ...larm Indication When an alarm condition arises the alarm is indicated in three ways The adjustable alarm settings should be re evaluated whenever a change in settings is made on the Vivo 65 Never leave a patient unattended during an alarm condition Setting alarm limits to extreme values could put the patient at risk The alarm settings are maintained during an extended power failure As soon as an a...

Page 108: ...the active alarm condition High priority 3 signals followed by 2 more The signal sequence is repeated with a one half 0 5 seconds pause and thereafter a three sec onds pause Medium priority 3 signals with a lower frequency than the high prior ity alarm The signal sequence repeats after a six seconds pause Information One signal with a low frequency The signal is repeated after a five seconds pause...

Page 109: ...l For receiving the visual part of an alarm and its priority the operator s position should be within a distance of 13 feet 4 meters from the Vivo 65 and within an angle of 30 to the normal of the Vivo 65 display The audible signal can be paused for 60 seconds by pressing the Audio Pause button The audible signal can be reactivated by press ing the Audio Pause button again If a new alarm condition...

Page 110: ...ra tion Priority High Possible cause Mismatch between Inspiratory Pressure CPAP and alarm setting Coughing during inspiration Changes in airway resistance and or compli ance Blocked exhalation valve or leakage port Setting min 5 cmH2O Setting max 55 cmH2O Setting resolution 0 5 below 10 cmH2O 1 0 above 10 cmH2O The High Pressure alarm setting is also visible with a red line in the pressure bar Ven...

Page 111: ... is activated In pressure modes during the sigh breath the high pressure alarm will automatically be set 10 cmH2O above set sigh pressure max 55 cmH2O for adult and pediatric In volume modes during the sigh breath the high pressure alarm will automatically be increased by the same percentage as the set sigh volume percentage max 55 cmH2O for adult and pediatric ITEM DESCRIPTION ...

Page 112: ... cause Disconnection of patient circuit Mismatch between Inspiratory Pressure CPAP and alarm setting Leakage from the mask or other components of the patient circuit Setting min 1 cmH2O Setting max 50 cmH2O Adult 35 cmH2O Pediatric Setting resolution 0 5 below 10 cmH2O 1 0 above 10 cmH2O The Low Pressure alarm setting is also visible with a red line in the pressure bar Ventilator action The Vivo 6...

Page 113: ... for more than 15 0 5 seconds Priority Medium Possible cause Malfunction of the exhalation valve Too short expiratory time Changes in airway resistance and or compli ance Blocked exhalation valve or leakage port Setting range On Off Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and ...

Page 114: ...PEEP is 30 below the set PEEP for more than 60 0 5 seconds Priority Medium Possible cause Malfunction of the exhalation valve Excessive leakage Setting range On Off Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message ...

Page 115: ...riority Medium Possible cause MismatchbetweenInspiredTidalVolumeand alarm setting Mismatch between selected and used patient circuit Pressure settings causing the Inspired Tidal Volume to exceed the set alarm level Leakage from the mask or other components of the patient circuit Setting min 300 ml Adult 50 ml Pediatric Setting max 2500 ml Off Adult 400 ml Off Pediatric Setting resolution 10 below ...

Page 116: ...r Leakage single limb circuit Priority Medium Possible cause Mismatch between Expired Tidal Volume and alarm setting Mismatch between selected and used patient circuit Pressure settings causing the Expired Tidal Volume to exceed the set alarm level Setting min 300 ml Adult 50 ml Pediatric Setting max 2500 ml Off Adult 400 ml Off Pediatric Setting resolution 10 below 600 ml 100 above 600 ml Ventila...

Page 117: ...rcuit type is set to Exhalation valve single limb circuit Priority High Possible cause MismatchbetweenInspiredTidalVolumeand Alarm setting Changes in airway resistance and or compli ance Obstructed or occluded patient circuit Setting min Off 100 ml Adult Off 10 ml Pediatric Setting max 1500 ml Adult 300 ml Pediatric Setting resolution 10 below 600 ml 100 above 600 ml Ventilator action The Vivo 65 ...

Page 118: ... single limb circuit Priority High Possible cause Mismatch between Expired Tidal Volume and Alarm setting Changes in airway resistance and or compli ance Obstructed or occluded patient circuit Leakage around the mask or within one of the components of the circuit Setting min Off 100 ml Adult Off 10 ml Pediatric Setting max 1500 ml Adult 300 ml Pediatric Setting resolution 10 below 600 ml 100 above...

Page 119: ...uit type is set to Exhalation valve single limb circuit Priority Medium Possible cause Mismatch between Breath Rate Inspired Tidal Volume settings and the alarm setting Increased Breath Rate Leakage around the mask or within one of the components of the circuit Setting min 1 0 l min Setting max 40 0 l min Off Adult 20 0 l min Off Pediatric Setting resolution 0 5 l min Ventilator action The Vivo 65...

Page 120: ...y used if the Vivo 65 s patient circuit type is set to Dual limb or Leakage single limb circuit Priority Medium Possible cause Mismatch between Breath Rate Tidal Volume settings and the alarm setting Increased Breath Rate Setting min 1 0 l min Setting max 40 0 l min Off Adult 20 0 l min Off Pediatric Setting resolution 0 5 l min Ventilator action The Vivo 65 will continue treatment with the same s...

Page 121: ...halation valve single limb circuit Priority High Possible cause Mismatch between Breath Rate and Inspired Tidal Volume settings and the alarm setting Changes in airway resistance and or compli ance Decreased Breath Rate Setting min Off 1 0 l min Adult Off 0 5 l min Pediatric Setting max 30 0 l min Adult 10 0 l min Pediatric Setting resolution 0 5 l min Adult 0 5 l min Pediatric Ventilator action T...

Page 122: ...uit 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 mask or within one of the components of the circuit Setting min Off 1 0 l min Adult Off 0 5 l min Pediatric Setting max 30 0 l min Adult 10 0 l min Pediatric Setting resolution 0 5 l min Adult 0 5 l m...

Page 123: ...rity Medium Possible cause Mismatch between the Breath Rate setting and the alarm setting Increased Breath Rate Too sensitive setting of the inspiratory trigger setting Setting min 10 bpm Setting max 70 bpm Off Adult 99 bpm Off Pediatric Setting resolution 1 bpm Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibl...

Page 124: ...reath Rate setting and the alarm setting The patient cannot trigger breaths because the inspiratory trigger setting is too high Decrease in the patient s spontaneous breath ing Circuit disconnection Setting min Off 4 bpm Adult Off 6 bpm Pediatric Setting max 30 bpm Adult 50 bpm Pediatric Setting resolution 1 bpm Ventilator action The Vivo 65 will continue treatment with the same settings Indicatio...

Page 125: ...igh Patient stopped breathing Patient decreases spontaneous breathing Circuit disconnection Setting min Off 5 s Off 15 s MPV breath mode Setting max 60 s 900 s MPV breath mode Setting resolution 5 s below 15 s 15 s above 15 s In MPV breath mode 15 s below 60 s 60 s above 60 s Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a t...

Page 126: ...binations of therapy settings circuit configurations and patient interfaces However the Low Pressure Alarm will also sound in the case of a disconnec tion when the alarm threshold is set at or above the PEEP pressure Priority High Possible cause Too high leakage in the patient circuit The patient has removed the mask Patient circuit is disconnected Setting range On Off Ventilator action The Vivo 6...

Page 127: ...n if the exhala tion valve is obstructed for more than 10 con secutive breaths Using MPV breath mode A Rebreathing alarm will be given if air returns into the Vivo 65 for more than 10 consecutive breaths Priority Medium Possible cause Incorrect patient circuit Obstructed or occluded patient circuit Patient exhales through mouthpiece Setting range On Off Ventilator action The Vivo 65 will continue ...

Page 128: ...ratory breathing tube can be detected with the Low Vte alarm Priority High Setting range High Low Off Ventilator action With each breath upon detection of an obstruction the Vivo 65 will reduce the air way pressure to the set PEEP Treatment will resume with the start of the next breath Indication The alarm is given audibly with a tone and vis ibly by the red alarm LED Indication of the alarm condi...

Page 129: ...s 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 Setting resolution 1 Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message ...

Page 130: ...or 30 0 5 seconds Priority High Possible cause Decreased oxygen inlet Disconnection of oxygen inlet Increased minute ventilation High leakage Setting min Off 21 Setting max 100 Setting resolution 1 Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 131: ...s ured SpO2 exceeds the alarm limit for 30 seconds Priority Medium Possible cause FiO2 is set too high Setting min 90 Setting max 100 Off Setting resolution 1 Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message ...

Page 132: ... limit for 30 seconds Priority High Possible cause FiO2 is set too low Oxygen inlet is disconnected Delivered tidal volumes are too small Setting min 85 Setting max 100 Setting resolution 1 Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 133: ...tCO2 is set too low Breath Rate is too low Delivered Tidal Volume is too low Excessive dead space between patient and exhalation valve leakage port Exhalation port valve is occluded Setting min 1 mmHg Setting max 74 mmHg Off Setting resolution 1 mmHg Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red...

Page 134: ...Ventilator disconnection Excessive leakage in the Patient circuit Inter face Partial obstruction of the airways Breath Rate too high Delivered Tidal Volume too high Self triggering of the ventilator Setting min Off 1 mmHg Setting max 74 mmHg Setting resolution 1 mmHg Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and v...

Page 135: ...30 seconds Priority High Possible cause High InspCO2 is set too low Excessive dead space between patient and exhalation valve leakage port Exhalation port valve occluded Setting min 1 mmHg Setting max 74 mmHg Off Setting resolution 1 mmHg Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED a...

Page 136: ...ds the alarm limit for 15 seconds Priority Medium Possible cause Insufficient ventilatory support FiO2 too low PEEP too high Setting min 20 bpm Setting max 250 bpm Off Setting resolution 5 bpm Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message ...

Page 137: ...larm limit for 15 seconds Priority High Possible cause Bad positioning of the finger probe Insufficient ventilatory support FiO2 is low Setting min Off 20 bpm Setting max 250 bpm Setting resolution 5 bpm Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 138: ...when the last power source is below limits Priority High Ventilator action The Vivo 65 stops treatment and gives alarm for at least 2 minutes and up to 10 minutes If power is restored within 2 to 10 minutes the Vivo 65 will automatically resume treat ment with current settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED ...

Page 139: ... alarm will be given when the patient air temperature exceeds 104 F 40 C Priority Medium Possible cause Blocked patient air inlet Blocked cooling air outlets Too high ambient temperature Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message ...

Page 140: ...re alarm will be given when the internal temperature is very high Priority High Possible cause Blocked cooling air inlet Blocked cooling air outlets Too high ambient temperature Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 141: ...will be given when the last battery source internal battery or click on battery has 15 minutes of operat ing time left with current settings Priority Medium Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message ...

Page 142: ...iven when the mains power is disconnected or lost Priority Medium Ventilator action The Vivo 65 will continue treatment with the same settings and switch to next available power source external DC click on battery or internal battery Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message ...

Page 143: ... alarm will be given when the last battery source internal battery or click on battery has at least 5 min utes of operating time left with current set tings Priority High Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 144: ... and the insert attached to the ven tilator Priority Medium Possible cause The Vivo 65 is set to one of the following incorrect combinations Patient circuit type Dual limb circuit Sin gle limb insert Patient circuit type Exhalation valve sin gle limb circuit Dual limb insert Ventilator action The Vivo 65 will continue the treatment with the same settings Indication The alarm is given audibly with ...

Page 145: ...ected patient mode setting and the insert attached to the ventilator Priority Medium Possible cause The Vivo 65 is set to one of the following incorrect combinations Adult mode Dual limb insert Pediatric Pediatric mode Dual limb insert Adult Ventilator action The Vivo 65 will continue the treatment with the same settings Indication The alarm is given audibly with a tone and visible by the yellow a...

Page 146: ...xhalation Valve Control Error alarm will be given when the Vivo 65 fails to control the internal external exhalation valve Priority High Possible cause Malfunction in the exhalation valve Internal error of the ventilator Indication The alarm is given audibly with a tone and visible by the red alarm LED and a display message ...

Page 147: ...ngs may be out of specified tolerances During this alarm alarms for Vte MVe Dis connection cannot be relied upon Other means of surveillance shall be used The Vivo 65 will automatically continue sen sor calibration attempts The alarm will reset when a successful calibration is made If the alarm persists contact your service provider The Vivo can still be used with single limb cir cuit Priority Hig...

Page 148: ... fails The Vte MVe readings on the display are not correct During this alarm alarms for high low Vte MVe Disconnection cannot be relied upon Other means of surveillance shall be used Contact your service provider The Vivo 65 can still be used with single limb circuit Priority High Indication The alarm is given audibly with a tone and visible by the red alarm LED and a display message ...

Page 149: ...hen a failure occurs with the patient interface or attached units Priority Medium Possible cause Failure in the Remote start stop unit Failure in the SpO2 sensor Failure in the CO2 sensor Internal failure in the Vivo 65 Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display mes...

Page 150: ...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 Sensor disconnected Failure in the SpO2 sensor Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 151: ...robe is not able to per form an adequate measurement due to low perfusion or artefacts Check the SpO2 sensor Priority High Possible cause Bad positioning or occlusion of the probe Low blood flow in finger Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 152: ...n alarm will be given when communication between the Vivo 65and the CO2 sensor has been lost Check the CO2 sensor Priority High Possible cause CO2 Sensor disconnected Failure in the CO2 sensor Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 153: ...or Accuracy Unspecified alarm will be given when an unspecified accuracy in the CO2 measurement has occurred Perform a zeroing procedure of the CO2 sen sor Priority High Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 154: ...pter 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 action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 155: ... 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 Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 156: ...m 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 disconnected Communication with the FiO2 sensor failed Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message ...

Page 157: ...he automatic ambi ent pressure compensation functionality is out of order Sea level is used as temporary ambient pres sure compensation If used at other altitude delivered and measured pressures may devi ate Priority Medium Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display...

Page 158: ...ature Compensation Lost alarm will be given when the automatic ambient temperature compensation is out of order Priority Medium Ventilator action The Vivo 65 will continue treatment with the same settings The accuracy of the volume measurement may be impaired Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message ...

Page 159: ...mpensation Lost alarm will be given when the automatic humidity com pensation is out of order Priority Medium Ventilator action The Vivo 65 will continue treatment with the same settings The accuracy of the volume measurement may be impaired Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message ...

Page 160: ...ED Failure alarm will be given when one or more LED indicators on the front panel is broken Priority Medium Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and vis ibly by the yellow alarm LED if possible and a display message ...

Page 161: ...Battery will be given as long as the alarm battery is not charged enough Keep the unit connected to mains until this alarm disappears Priority Medium Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and visibly by the yellow alarm LED and a display message ...

Page 162: ...TEM DESCRIPTION Definition Failure of the beeper control by the treatment processor Priority High Ventilator action The Vivo 65 will continue treatment with the same settings Indication The alarm is given audibly with a tone and vis ibly by the red alarm LED and a display mes sage ...

Page 163: ... Internal Function Failure alarm error codes are defined and explained in the Vivo 65 Service Manual Ventilator action The Vivo 65 will stop the treatment Indication The alarm is given audibly with a tone and visibly by the red alarm LED and a display message for at least 2 minutes depending on the type of alarm Ventilator reset In order to stop the alarm the ventilator must be turned off by press...

Page 164: ...ms 1 Start treatment and block the patient circuit completely to simulate an occlusion 2 Wait 15 seconds 3 The Low Vti or Low Vte Alarm will be given 4 Stop treatment Test completed Obstruction Alarm 1 Start treatment block the patient circuit completely to simulate an obstruction 2 Wait approximately 10 seconds 3 The Obstruction Alarm will be given If the expiratory path is blocked a Disconnectio...

Page 165: ...e service and control procedures as well as any applicable upgrades in accordance with Breas service instructions The Vivo 65 shall only be repaired or modified in accordance with Breas service manuals technical bulletins and any special ser vice instructions by service technicians that have been author ized after Breas Vivo 65 service training Do not under any circumstances attempt to service or ...

Page 166: ...y spraying splashing or pouring Use a moistened lint free cloth when cleaning Do not use an excessive amount of liquid when cleaning the Vivo 65 Do not autoclave the Vivo 65 1 Turn off the Vivo 65 and disconnect the power supply 2 Remove the patient circuit 3 Disconnect all electric cables 4 Clean the outside of the Vivo 65 using a lint free cloth and a mild soap solution If the Vivo 65 needs to b...

Page 167: ...ted in the filter cassette at the side of the ventilator Replace the filter at least once a year Wash the filter at least once a week 1 Wash the filter using warm water and a mild soap 2 Rinse thoroughly 3 Dry the filter by squeezing it out in a towel Do not wring the filter 4 Make sure the filter is com pletely dry before inserting ...

Page 168: ...lacing the Patient Air Filters Washable Filter grey Replace the washable filter at least once a year Wash the filter at least once a week 1 Wash the filter using warm water and a mild soap Appropriate personnel should determine the duration of use for the insert based on accepted infection control procedures The patient circuit should be cleaned and replaced in accordance with the manufac turer s ...

Page 169: ...nge of Patient If the Vivo 65 is used in a clinic by several patients a low resistant bacte rial filter may be used between the air outlet and the patient tube to pre vent patient cross contamination 1 Follow the instructions in Cleaning the Vivo 65 on page 166 steps 1 to 5 2 Replace the patient filters according to Cleaning and Replacing the Patient Air Filters on page 168 3 If a low resistant ba...

Page 170: ...after long time storage see Using Batteries on page 89 Do not use the device and contact your responsible care provider for an inspection of the device in the event of Unexpected patient symptoms during treatment Unexplainable or sudden pressure performance or sound changes during operation Suspected damage to the device including the occurrence of Inter nal Functional Failure alarms Suspected dam...

Page 171: ...Vivo 65 any accessories and all replaced parts must be disposed of and recycled in accordance with the local environmental regulations regarding the disposal of used equipment and waste Batteries used with the Vivo 65 shall be recycled in accordance with the local environmental regula tions ...

Page 172: ...Limb Circuit with Integrated Exhalation Valve Single Limb Circuit with Active Exhalation Valve NO DESCRIPTION 1 Vivo 65 2 Tubes 3 Insert with integrated exhalation valve 4 Patient interface connection 5 Patient NO DESCRIPTION 1 Vivo 65 2 Tube 3 Active Exhalation valve 4 Patient interface connection 5 Patient 1 2 5 4 3 1 2 5 4 3 ...

Page 173: ...nual Doc 006088 En US U 1b Single Limb Circuit with Leakage Port MPV Breath Mode NO DESCRIPTION 1 Vivo 65 2 Tube 3 Leakage port Patient interface connection 4 Patient NO DESCRIPTION 1 Vivo 65 2 Tube 3 Mouthpiece interface 4 Patient 1 2 4 3 1 2 4 3 ...

Page 174: ...t with filters 2 Inlet silencer 3 Blower 4 Outlet silencer 5 Restriction 6 Patient air outlet 7 Flow sensors 8 Pressure sensors 9 Zero valve 10 Exhaled air inlet outlet 11 Exhalation valve control pressure valve 12 Exhalation valve control pressure sensor 13 Exhalation valve 14 Low pressure bleed in oxygen connection 9 1 2 5 7 6 4 3 12 8 11 10 8 7 13 14 ...

Page 175: ...PTION 1 Air inlet with filters 2 Inlet silencer 3 Blower 4 Outlet silencer 5 Restriction 6 Patient air outlet 7 Flow sensor 8 Pressure sensors 9 Exhalation valve control pressure outlet 10 Exhalation valve control pressure valve 11 Exhalation valve control pressure sensor 12 Low pressure bleed in oxygen connection 9 1 2 5 7 6 4 3 11 8 10 12 ...

Page 176: ...e Control Modes The worst case Vivo 65 System is the dual limb patient circuit with HCH humidifier bacterial filter FiO2 sensor and CO2 sensor Volume Control Modes The worst case Vivo 65 System is the dual limb patient circuit with or without HCH humidifier bacterial filter FiO2 sensor and CO2 sensor ...

Page 177: ...V TgV PCV A PCV A TgV PCV SIMV PCV MPV VCV VCV A VCV SIMV VCV MPV CPAP Device modes Clinical Home Patient modes Adult Pediatric Inspiratory Pressure Pediatric 4 to 35 cmH2O Adult 4 to 50 cmH2O Tolerance 0 5 cmH2O or 5 whichever is greatest 0 5 below 10 cmH2O 1 0 above 10 cmH2O Note The stated toler ances are defined rela tive to the set value both with or without leakage ...

Page 178: ... 2 cmH2O Tolerance 0 5 cmH2O or 5 whichever is greatest 0 5 below 10 cmH2O 1 0 above 10 cmH2O Breath Rate 4 to 40 bpm breaths per minute Adult 6 to 60 bpm Pediatric 0 to 40 60 bpm MPV breath mode Tolerance 2 1 bpm SIMV Rate 4 to 40 bpm breaths per minute Adult 6 to 60 bpm Pediatric Tolerance 2 1 bpm Inspiratory Time 0 3 to 5 s Adult 0 3 to 2 s Pediatric Tolerance 0 1 s 0 1 s Backup Inspiratory Tim...

Page 179: ...MV VCV MPV 1 PSV PCV 10 VCV Inspiratory Trigger 1 to 9 PSV PCV VCV PCV SIMV VCV SIMV 1 to 9 Off PCV VCV 1 SIMV Support Pressure 4 to 50 cmH2O Adult 4 to 35 cmH2O Pediatric Tolerance 0 5 cmH2O or 5 whichever is greatest 0 5 below 10 cmH2O 1 0 above 10 cmH2O Expiratory Trigger 1 to 9 1 Min Inspira tion Time Off 0 3 to 3 s Adult Off 0 3 to 2 s Pediatric 0 1 s Max Inspira tion Time 0 3 to 3 s Off Adul...

Page 180: ...re Pediatric 4 cmH2O to 35 cmH2O or Max Pressure Adult 4 cmH2O to 50 cmH2O or Max Pressure 0 5 below 10 cmH2O 1 0 above 10 cmH2O Tidal Volume 300 to 2000 ml Adult 50 to 300 ml Pediatric Tolerance 12 ml or 10 10 ml below 500 ml 50 ml above 500 ml Flow Pattern Square Decelerating CPAP 4 to 20 cmH2O Tolerance 0 5 cmH2O or 5 whichever is greatest 0 5 below 10 cmH2O 1 0 above 10 cmH2O Audible alarm lev...

Page 181: ...10 or 10 ml bpm whichever is greatest MVe 0 to 99 9 l BTPS 10 or 10 ml bpm whichever is greatest Vti 0 to 9999 ml BTPS 10 ml or 10 which ever is greatest Vte 0 to 9999 ml BTPS 10 ml or 10 whichever is greatest FiO2 0 to 100 2 in TgV 0 to 100 1 Total Rate 0 to 99 bpm 1 bpm Spont Rate 0 to 99 bpm 1 bpm Spont 0 to 100 Not applicable SpO2 85 to 100 3 digits Data update period 1 s 4 beat average signal...

Page 182: ...N Auditory Alarm Signal Pressure 45 to 85 dB A 5 dB A Measured at 1 m High Pressure Alarm 5 to 55 cmH2O Resolution 0 5 below 10 cmH2O 1 0 above 10 cmH2O Red LED audible alarm and a warning message on the display Low Pressure Alarm Pediatric 1 to 35 cmH2O Adult 1 to 50 cmH2O Resolution 0 5 below 10 cmH2O 1 0 above 10 cmH2O Red LED audible alarm and a warning message on the display High PEEP Alarm O...

Page 183: ...0 to 2000 ml Adult Off 20 to 300 ml Pediat ric Resolution 10 below 600 ml 100 above 600 ml Red LED audible alarm and a warning message on the display Low Vte Alarm Off 100 to 2000 ml Adult Off 20 to 300 ml Pediatric Resolution 10 below 600 ml 100 above 600 ml Red LED audible alarm and a warning message on the display High MVi Alarm 1 0 to 40 0 l Off Adult 1 0 to 20 0 l Off Pediatric Resolution 0 5...

Page 184: ...Yellow LED audible alarm and a warning message on the display Low Breath Rate Alarm Off 4 to 30 bpm Adult Off 6 to 50 bpm Pediat ric Off 1 to 30 50 bpm MPV breath mode Resolution 1 bpm Red LED audible alarm and a warning message on the display Apnea Alarm Off 5 to 60 s Resolution 5 s below 15 s 15 s above 15 s In MPV breath mode Off 15 to 900 s Resolution 15 s below 60 s 60 s above 60 s Red LED au...

Page 185: ...larm 85 to 100 Resolution 1 Red LED audible alarm and a warning message on the display High EtCO2 Alarm 1 to 74 mmHg Off Resolution 1 mmHg Red LED audible alarm and a warning message on the display Low EtCO2 Alarm Off 1 to 74 mmHg Resolution 1 mmHg Yellow LED audible alarm and a warning message on the display High Inspired CO2 Alarm 1 to 74 mmHg Off Resolution 1 mmHg Red LED audible alarm and a wa...

Page 186: ... display Lost Mains Power Alarm Mains power fail or power cord disconnected Yellow LED audible alarm and a warning message on the display Critical Low Last Power Alarm The last battery source internal battery or click on battery has 5 minutes of operating time left Red LED audible alarm and a warning message on the display SpO2 CO2 Remote Start Stop Failure Alarm Failure in the Remote Start Stop u...

Page 187: ... during 2 seconds Red LED audible alarm and a warning message on the display Circuit Type Insert Mis match Alarm Incorrect combination of patient circuit type setting and attached insert Yellow LED audible alarm and a warning message on the display Patient Mode Insert Mis match Alarm Incorrect combination of patient mode setting and attached insert Yellow LED audible alarm and a warning message on...

Page 188: ...n data or humidity sensor failure Yellow LED audible alarm and a warning message on the display LED Failure Alarm One or more LED indica tors on the front panel are broken Yellow LED audible alarm and a warning message on the display Alarm for Low Alarm Battery Alarm battery voltage is below alarm limit Yellow LED audible alarm and a warning message on the display Alarm for Beeper Failure Failure ...

Page 189: ...Operating temperature range 41 to 104 F 5 to 40 C Storage and transport temperature 4 to 140 F 20 to 60 C Ambient pressure range 700 to 1100 mbar corresponding to 10000 feet 3000 meters above sea level to 2300 feet 700 meters below sea level at normal atmospheric pressure As seen in the graph above the Vivo 65 is unable to deliver set max pressure at a very low ambient pressure Humidity 10 to 95 n...

Page 190: ...on valve circuit resistance 0 to 20 cm H2O at 60 L min Pediatric 0 to 35 cm H2O at 120 L min Adult Exhalation valve circuit compliance 0 to 4 mL cm H20 OXYGEN INLET SPECIFICATION Oxygen inlet port Maximum flow 15 l min medical oxygen Oxygen coupling is type CPC MC1602 SOUND LEVEL SPECIFICATION Sound level at 10 cmH2O in CPAP mode Less than 30 dB A Measured at 1 m MISCELLANEOUS RESULT RANGE Maximum...

Page 191: ...n battery Patient air outlet 22 mm male 15 mm female conical standard connector CO2 SENSOR SPECIFICATIONS W H D 1 5 1 5 1 4 inch 38 37 34 mm Cable length 7 8 ft 2 4 m Weight 0 2 lb 75 g Warm up time 10 s Total system response time 1 s Interference from medi cal gases O2 0 1 relative CO2 per O2 calibrated at 21 O2 CO2 indicator 0 to 15 FUNCTION TECHNIQUE DESCRIPTION Pressure Low pass average time c...

Page 192: ... or pulse rate is potentially incorrect and generate an alarm condition to indicate when the SpO2 value update period has exceeded 30 seconds The Vivo 65 will provide EtCO2 and FiO2 values within its published accuracy specifications and generate an alarm condition upon high and low EtCO2 and FiO2 conditions Under the immunity test conditions of IEC 60601 1 2 4th Ed the fol lowing allowances are a...

Page 193: ...be that of a typi cal commercial hospital and residential environ ment Surge IEC 61000 4 5 1 kV line s to line s Mains power quality should be that of a typi cal commercial hospital and residential environ ment Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m Power frequency mag netic fields should be at levels characteristic of a typical location in a typ ical commercial hospi tal and...

Page 194: ...rnal antennas should be used no closer than 12 inches 30 cm to any part of the Vivo 65 including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result IMMUNITY TEST IEC 60601 TEST LEVEL RECOMMENDED SEPARATION DISTANCE Conducted RF IEC 61000 4 6 150 kHz to 80 MHz 3 Vrms ISM and amateur radio bands 6 Vrms d 0 35 P m at 150 kHz to 80 MHz Radiated...

Page 195: ...e in the electromagnetic environment specified below The customer or the user of the Vivo 65 should assure that it is used in such an environment EMISSIONS TEST COMPLIAN CE ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions CISPR 11 Group 1 The Vivo 65 use RF energy only for its inter nal function Therefore its RF emissions are very low and are not likely to cause any inter ference in nearby electr...

Page 196: ...at a 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 output power rating of the transmitter in watts W according to the transmitter manufacturer Notes At 80 MHz and 800 MHz the separation distance for the higher frequency range applies These guidelines m...

Page 197: ...in amperes A according to the transmitter manufacturer H is the Vivo 65 immunity compliance level to electromagnetic fields in the 50 60 Hz frequency span 30 A m 8 4 Default Settings RATED MAXIMUM CURRENT IN CONDUCTOR A SEPARATION DISTANCE M 50 60 Hz d I 2πH I 188 1 0 005 10 0 05 30 0 16 MODES AND FUNCTIONS SETTING Ventilation mode Pressure PCV A Breath Mode Assist Control Patient Mode Adult Profi...

Page 198: ...piration Time 1 5 s Sigh Off Sigh Rate 100 bpm Sigh 125 Target Volume Off Tidal Volume 400 ml Max Pressure 15 cmH2O Min Pressure 15 cmH2O Flow Pattern Square CPAP 10 cmH2O ALARMS DEFAULT VALUE High Pressure Alarm 25 cmH2O Adult 20 cmH2O Pediatric Low Pressure Alarm 10 cmH2O High PEEP Alarm Off Low PEEP Alarm Off High Vti Alarm 500 ml Adult 400 ml Pediatric High Vte Alarm 500 ml Adult 400 ml Pediat...

Page 199: ...Rate Alarm Off Apnea Alarm Off Disconnection Alarm On Rebreathing Alarm On High FiO2 Alarm Off Low FiO2 Alarm Off High SpO2 Alarm Off Low SpO2 Alarm 85 High EtCO2 Alarm 51 mmHg Low EtCO2 Alarm Off High InspCO2 Alarm Off High Pulse Rate Alarm Off Low Pulse Rate Alarm Off OTHERS DEFAULT VALUE Patient operating time 0 h Display light On Light Intensity 5 Alarm sound level 5 CO2 Unit mmHg Auto keypad ...

Page 200: ...200 Technical Specifications Vivo 65 users manual Doc 006088 En US U 1b Patient circuit type Dual limb circuit for integrated exhalation valve Pre use Test On OTHERS DEFAULT VALUE ...

Page 201: ...ccessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC standards e g IEC 60950 for data processing equipment and IEC 60601 1 for medical equipment Furthermore all configurations must comply with the valid version of the system standard IEC 60601 1 Anybody who connects additional equip ment to the signal input part or signal output part i...

Page 202: ...202 Accessories Vivo 65 users manual Doc 006088 En US U 1b 15 14 19 21 22 24 25 18 20 27 13 17 16 26 28 29 12 23 ...

Page 203: ...r inlet fil ter grey Inlet air filtration 004909 5 pcs 5 Cooling air inlet fil ter grey Inlet air filtration 006435 5 pcs 6 Dual limb insert Connection between venti lator and dual limb circuit with integrated exhalation valve for adult or pediatric use Adult 005523 disposable Pediatric 005525 disposable 7 Single limb insert Connection for ventilator and single limb circuit with external exhalatio...

Page 204: ...24 V DC 004899 12 Hygroscopic Con denser Humidifier HCH Humidifier 003974 13 Memory card Vivo 65 settings patient data and usage data 003619 14 Memory card reader writer Read write memory card 002185 15 USB cable Data cable PC and Vivo 65 USB to USB 004886 16 Remote alarm with cable Monitor Vivo 65 alarms remotely 10 m 006348 25 m 006349 17 Remote alarm cable 10 m 006359 25 m 006360 50 m 006361 NO...

Page 205: ...acket Mount the Vivo 65 on the trolley or a hospital rail sys tem 005122 23 Low resistant bac terial filter 303 Respirgard II Fil ter 004185 24 FiO2 sensor Measure O2 in the patient air 006347 25 T piece with plug Connect the FiO2 sensor to the patient circuit 005990 26 SpO2 module Connection cable 006369 27 SpO2 sensor Reusable SpO2 sensor adult 006374 pediatric 006373 28 SpO2 sensor Soft reusabl...

Page 206: ...adapter 005032 31 12 24 V converter 004901 32 Protective cover Shock protection 006344 33 CO2 sensor Measure CO2 in the patient air 006346 34 Airway adapter disposable Connects the CO2 sensor to the patient circuit 005263 25 pcs 35 Polishing cloth 005066 NO COMPONENT FUNCTION PART NO ...

Page 207: ...nt Settings Breas Vivo 65 Patient Date Clinic Set by Patient Circuit Pressure Inspiratory Trigger PEEP Expiratory Trigger Breath Rate Min Inspiratory Time Inspiratory Time Max Inspiratory Time Backup Rate Backup Inspiratory Time Target Volume Min Pressure Tidal Volume Max Pressure Flow Pattern CPAP SIMV Rate SIMV Support Pressure Notes PCV PSV VCV MPV CPAP ...

Page 208: ...208 Patient Settings Vivo 65 users manual Doc 006088 En US U 1b ...

Page 209: ...s In 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 in accord ance with the current version of RTCA DO 160 Section 21 Category M Breas Medical has successfully completed testing for the Vivo 65 System The Vivo 65 System complies with RTCA DO 160 Se...

Page 210: ...210 FAA Compliance Vivo 65 users manual Doc 006088 En US U 1b ...

Page 211: ...211 FAA Compliance Vivo 65 users manual Doc 006088 En US U 1b ...

Page 212: ...9 Technical 138 Alarm section 49 Alarm sound level 51 Alarm test 128 Obstruction Alarm 164 Alarm Event History 49 Alarms Ambient Pressure Compensation Lost 157 Ambient Temperature Compensation Lost 158 Apnea 125 Check CO2 Adapter 154 Circuit Type Insert Mismatch 144 CO2 Sensor Accuracy Unspecified 153 CO2 Sensor Error 155 CO2 Sensor Failure Disconnection 152 delivery settings 198 Disconnection 126...

Page 213: ...42 143 Low PEEP 114 Low Pressure 112 Low Pulse Rate 137 Low SpO2 132 Patient Mode Insert Mismatch 145 Physiological 110 Power Failure 138 Rebreathing 127 specifications 182 SpO2 Sensor Failure Disconnection 150 SpO2 Signal Inadequacy 151 SpO2 CO2 Remote Start Stop Failure 149 Ambient Pressure Compensation Lost alarm 157 Ambient Temperature Compensation Lost alarm 158 Apnea alarm 125 Artificial nos...

Page 214: ...nge patient 169 Charge Click on battery 93 Charge batteries 90 Check before first use Vivo 30 Check CO2 Adapter alarm 154 Circuit Resistance and Compliance Limits 190 Circuit Type Insert Mismatch alarm 144 Circuit Type Insert Mismatch alarm 144 Cleaning CO2 sensor 104 FiO2 sensor 99 insert 168 main unit 166 patient air filters 168 patient circuit 168 Cleaning and maintenance safety information 18 ...

Page 215: ... circuit single limb 38 FiO2 sensor to Vivo 98 insert to Vivo 34 leakage circuit single limb 38 nurse call 97 patient circuit 34 Vivo to AC power 33 Continuous Positive Airway Pressure definition 86 Contraindications Vivo 5 CPAP definition 86 setting 78 D Data transfer between Vivo and PC 88 transfer with memory card 88 Data Parameters 177 Date format 51 DC power Click on Battery LED 23 External D...

Page 216: ...afety label 27 EtCO2 High EtCO2 alarm 133 Low EtCO2 alarm 134 monitored value 56 surveillance life supporting treatment 8 Exhalation valve connect dual limb circuit 37 connect single limb circuit 38 Exhalation valve circuit single limb pneumatic diagram 172 Exhalation Valve Control Error alarm 146 Exhalation valve control pressure outlet position 26 Expiratory trigger setting 69 Expired minute vol...

Page 217: ...163 Function navigation buttons 23 G General user precautions 7 H Harmonized standards 197 HCH 14 17 Heat and moisture exchanger 14 17 High Breath Rate alarm 123 High EtCO2 alarm 133 High Expired Minute Volume alarm 120 High Expired Tidal Volume alarm 116 High FiO2 alarm 129 High InspCO2 alarm 135 High Inspired CO2 alarm 135 High Inspired Minute Volume alarm 119 High Inspired Tidal Volume alarm 11...

Page 218: ...arm 135 monitored value 56 Inspect cables 39 placement 39 Vivo before use 39 Inspiratory pressure 57 Inspiratory time monitored value 56 setting 62 Inspiratory trigger setting 67 Inspired carbon dioxide 56 Inspired minute volume MVi monitored value 53 Inspired tidal volume Vti monitored value 53 Integrated exhalation valve connect dual limb circuit 37 Internal battery 91 Internal Function Failure ...

Page 219: ... alarm 118 Low FiO2 alarm 130 Low Inspired Minute Volume alarm 121 Low Inspired Tidal Volume alarm 117 Low Last Power Source alarm 141 142 143 Low MVe alarm 122 Low MVi alarm 121 Low PEEP alarm 114 Low Pressure alarm 112 Low Pulse Rate alarm 137 Low SpO2 alarm 132 Low Vte alarm 118 Low Vti alarm 117 M Main components Vivo 21 Main screen 47 Main unit clean 166 Maintenance 170 safety information 18 ...

Page 220: ...e 52 MVe Minute volume expired 53 MVi Minute volume inspired 53 PEEP 52 Pmean 52 Ppeak 52 Pulse rate 55 Rise time 56 specifications 181 SpO2 55 Spont rate 55 Tidal volume expired Vte 54 Tidal volume inspired Vti 53 Total rate 54 Vte Tidal volume expired 54 Vti Tidal volume inspired 53 MVe Minute volume expired monitored value 53 MVi Minute volume inspired monitored value 53 N Navigate menu 43 Nurs...

Page 221: ... 203 main components 22 Patient change 169 Patient air outlet position 26 Patient air temperature alarm 139 Patient circuit 34 Adult 34 clean 168 configuration 34 insert 34 Pediatric 34 safety information 13 Patient circuit type 34 Patient mode 34 79 Patient Mode Insert Mismatch alarm 145 Patient Mode Insert Mismatch alarm 145 Patient operating time 50 Patient settings adjust 40 form 207 PC transf...

Page 222: ...spired Tidal Volume 115 High PEEP 113 High Pressure 110 High Pulse Rate 136 High SpO2 131 Low Breath Rate 124 Low EtCO2 134 Low Expired Minute Volume 122 Low Expired Tidal Volume 118 Low FiO2 130 Low Inspired Minute Volume 121 Low Inspired Tidal Volume 117 Low PEEP 114 Low Pressure 112 Low Pulse Rate 137 Low SpO2 132 Rebreathing 127 Placement inspect 39 Vivo 31 Pmean monitored value 52 Pneumatic d...

Page 223: ... Pressure Support Ventilation definition 80 Pressure Support Ventilation with Target Volume definition 81 Pre use test perform 40 Priority power source 89 Product description Vivo 21 Product label 27 Profiles delivery settings 197 Protective cover usage 105 PSV definition 80 PSV TgV definition 81 Pulse rate High Pulse Rate alarm 136 Low Pulse Rate alarm 137 monitored value 55 R Rebreathing alarm 1...

Page 224: ... 49 Main 47 Monitor 50 Others 50 Setup 48 Section Alarm 49 Monitor 50 Others 50 Setup 48 Serial number 51 Service 170 Setting 57 Backup inspiratory time 64 Backup rate 72 Breath rate 60 CPAP 78 Expiratory trigger 69 Flow pattern 77 Inspiratory time 62 Inspiratory trigger 67 Max pressure 74 Maximum inspiratory time 71 Min pressure 75 Minimum inspiratory time 70 PEEP 58 Rise time 66 Sigh 65 SIMV rat...

Page 225: ...1 dimensions 191 Environmental conditions 189 Filtering smoothing techniques 191 miscellaneous 190 monitored values 181 operating conditions 190 oxygen inlet 190 power supply 188 settings 177 sound level 190 SpO2 High SpO2 alarm 131 Low SpO2 alarm 132 monitored value 55 SpO2 sensor usage 104 SpO2 Sensor Failure Disconnection alarm 150 SpO2 sensor port position 25 SpO2 Signal Inadequacy alarm 151 S...

Page 226: ... Check CO2 Adapter 154 Circuit Type Insert Mismatch 144 CO2 Sensor Accuracy Unspecified 153 CO2 Sensor Error 155 CO2 Sensor Failure Disconnection 152 Critical Low Last Power Alarm 143 Exhalation Valve Control Error 146 FiO2 Failure Disconnection 156 High Patient Air Temperature 139 Humidity Compensation Lost 159 Internal Function Failure 163 LED Failure 160 Low Alarm Battery 161 162 Low Last Power...

Page 227: ...side effects Vivo 5 Unlock insert 37 Up down buttons 23 USB data connection port position 24 User interface navigate 43 symbols 45 User precautions electrical safety 10 environmental conditions 11 general 7 patient circuit 13 V VCV definition 84 VCV A definition 84 VCV SIMV definition 85 Ventilation mode 80 Volume Controlled Ventilation definition 84 Volume Controlled Ventilation with Synchronized...

Page 228: ...228 Index Vivo 65 users manual Doc 006088 En US U 1b W Warning icon 6 Water trap 17 Weight Vivo 191 ...

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