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Measurement Uncertainty

Parameter

Uncertainty

Pressure

± 0.75 % of reading or ± 0.1
cmH

Leakage (flow)

± 10 % or ± 0.1 sl/min

Tidal volume Vte

± 1.75 % or ± 0.20 sml

Minute volume MVe

± 2.5 % or 0.02 sl/min

Breath rate

± 2.5 % or ± 1 bpm

Inspiration time, Ti

± 0.02 s

I:E

± 2.5 %

NOTE

sl/min = standard liter per minute (calculated using STP conditions of 21 °C and
1013 mbar).

Filtering/Smoothing Techniques

Measurement

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

SpO

No data post-processing done by the
ventilator

9.7

Emission and Immunity Declaration

According to IEC 60601-1-2:2014.

The performance of all functions of the Vivo 3 is considered as essential performance
for the purpose of immunity testing.

Technical Specifications 123

Doc. 007232 Y-2

Vivo 3 Clinician

’

s Manual

Содержание Vivo 3

Страница 1: ...DOC 007232 EN EU Y 2 2019 09 03 Vivo 3 Clinician s Manual...

Страница 2: ......

Страница 3: ...2 2 Electricity Warnings and Precautions 19 2 2 1 Electromagnetic Compatibility and Electrostatic Discharge EMC and ESD 20 2 3 Environment Warnings and Precautions 20 2 3 1 Disposal 21 2 4 Patient Ci...

Страница 4: ...e Insp Time 55 4 2 7 Minimum Inspiratory Time Min Insp Time 55 4 2 8 Maximum Inspiratory Time Max Insp Time 56 4 2 9 Inspiratory Trigger Insp Trigger 56 4 2 10 Expiratory Trigger Exp Trigger 57 4 2 11...

Страница 5: ...rotective Cover 85 6 7 8 Using the Lightweight Mobility Bag 85 6 7 9 Using the Y Cable 86 6 7 10 Using the Vivo 3 with the Trolley 86 6 8 Transfer Data between the Vivo 3 and a PC 87 6 8 1 Log Data 88...

Страница 6: ...t Air Temperature 107 7 4 9 Flow Sensor Failure 107 7 4 10 Internal Function Failure 108 8 Cleaning and Maintenance 109 8 1 Cleaning the Vivo 3 109 8 1 1 Clean the Main Unit Externally 109 8 1 2 Air P...

Страница 7: ...and mobile RF communications equipment and the Vivo 3 127 9 7 4 Recommended separation distances between external power conductors and the Vivo 3 128 9 8 Delivery Settings 128 10 Accessories 130 10 1...

Страница 8: ......

Страница 9: ...that you completely understand how the Vivo 3 is operated and maintained before taking it into use to ensure correct usage maximum performance and serviceability Non professional caregivers e g famil...

Страница 10: ...entilatory support for the care of individuals who require long term sup port from mechanical ventilation for respiratory insufficiency or respiratory failure with or without obstructive sleep apnea T...

Страница 11: ...3 is intended to provide non invasive or invasive ventilation for patients weighing over 10 kg 22 lbs who require long term support or mechanical ventilation for respira tory insufficiency or respirat...

Страница 12: ...lay operators Training The lay operator shall be trained to basic knowledge of the Vivo 3 and in the specific operations they are assigned to perform The training shall be based on the user manual an...

Страница 13: ...brief interruptions in ventilation If a patient has any of the following conditions therapy with positive airway pressure may be contraindicated and the prescribing clinician shall decide if the bene...

Страница 14: ...Vivo 3 system The manual comprises detailed information of the settings and functions of the Vivo 3 to be handled by trained health care personnel only Patients and lay caregivers may read the user m...

Страница 15: ...tion Risk of equipment damage loss of data extra work or unexpected results Note Information that may be valuable but is not of critical importance tips Reference Reference to other manuals with addit...

Страница 16: ...not use the Vivo 3 in the event of Suspected damage to the device including the occurrence of Internal Functional Failure alarms Unexpected patient symptoms during treatment Unexplainable or sudden ch...

Страница 17: ...arm and the low breath rate alarm must be carefully set to ensure safe use Risk of Reduced Safety and Performance Accessories that have not been tested with the Vivo 3 might affect safety features and...

Страница 18: ...of the equipment and accessories Proper placement and positioning of the patient interface is critical to the consistent operation of this equipment Handle the Vivo 3 with care Make sure to place and...

Страница 19: ...e requirements of IEC 60601 1 WARNING Risk of Faulty Treatment Electromagnetic Interference may cause electrical equipment to malfunction The aspects of electromagnetic compatibility must be considere...

Страница 20: ...mize the build up of electrostatic charges Avoiding the use of radio emitting devices e g cellular or cordless telephones microwave ovens and high frequency surgery apparatus closer than 1 meter to th...

Страница 21: ...re outside the specifications Do not use the ventilator in an hyperbaric chamber as this would cause an ambi ent pressure outside the specifications Do not use the ventilator immediately after storage...

Страница 22: ...al Incompatible parts can result in degraded performance and change of pressure gradient If unapproved accessories are used Breas Medical has no responsibility for the safe and effective use of the Vi...

Страница 23: ...Suffocation If the patient is using a full face mask covering mouth and nose the mask must be equipped with a safety entrainment valve Risk of Constriction Entanglement with cables or tubing constric...

Страница 24: ...e at higher temperatures than intended When operating the Vivo 3 make sure that the air inlet and filters are not obstructed or occluded Risk of Insufficient Ventilation Insufficient ventilation may c...

Страница 25: ...rapeutic System Performance or Failure Invasive use of the attachable humidifier may cause reduced performance The attachable humidifier is not intended for invasive use Risk of Faulty Treatment If us...

Страница 26: ...Suffocation When the attachable humidifier is installed the Vivo 3 must be located below the patient and on a flat surface This is to prevent personal injury from accidental spill age or from excess...

Страница 27: ...g first remove the attachable water cham ber Water spillage may cause electric shocks Risk of Electric Shock Electrostatic discharge or contact with leakage current may cause an electric shock The att...

Страница 28: ...by unauthorized personnel If subjected to unauthorized operations Breas Medical is no longer responsible for the device s performance and safety and all warranties will become invalid The Vivo 3 must...

Страница 29: ...o 3 the oxygen flow must be turned off when the Vivo 3 is not operating Oxygen delivered into the patient tubing may accumulate within the machine enclosure Oxygen accumulated in the machine enclosure...

Страница 30: ...fier During Mobile Use WARNING Risk of Suffocation Do not use the attachable humidifier during mobile use Due to movements water spillage from the humidifier or condensed water may flow to the patient...

Страница 31: ...ON During mobile use protect the device with either of the Protective Cover accessory or the Lightweight Mobility Bag accessory Do not use the Vivo 3 while in a carry bag Safety Information 31 Doc 007...

Страница 32: ...pare parts see 10 Accessories page 130 3 1 Main Components Part Function Breas Part no Ventilator unit Main unit 229000 RRC PS90M AC DC Power supply Power supply adapter for the Vivo 3 006994 Mains po...

Страница 33: ...nual 007231 Clinician s manual 007232 Carry bag For transportation when not in use 007013 Patient circuit 15 mm Delivers air to the patient 006712 3 2 Ventilator Front This section describes the front...

Страница 34: ...or On Off 4 Navigation buttons Select pages according to the corre sponding label on the display The navigation buttons can tempo rarily be designated functions for replying to questions or requests f...

Страница 35: ...Patient air inlet Patient air inlet with filter holder 5 Air bypass module Directs the patient air flow Removed if the attachable humidi fier is used 6 USB port For data transfer to a PC 7 SD Card po...

Страница 36: ...list below 1 Mains power via Breas Mains power supply 2 External DC via Breas DC DC power supply adapter 3 Internal battery The power source is indicated by a symbol at the top of the display Power S...

Страница 37: ...State of Charge Icon High Charging Preparing the Battery for Storage If storing the Vivo 3 longer than 1 month make sure that the internal battery is about half charged before storing in order to mai...

Страница 38: ...with several pages Selecting the Section to Display 1 Press the navigation button for the requested function page The page is now displayed 2 For functions with several pages grouped together press t...

Страница 39: ...age The selected item is highlighted 2 To select another item on the list press the Up or Down arrow until it is highlighted Note that items with read only information cannot be selected Enter a Sub P...

Страница 40: ...mmand 1 To execute a command select it and press the right arrow button The command execution is started Additional actions related to the command might be requested in event windows 3 5 2 The Monitor...

Страница 41: ...Pages The setup pages contain settings related to the treatment WARNING Risk of Asphyxia or Personal Injury Using incorrect settings may cause personal injury or severe medical conditions such as hyp...

Страница 42: ...ngs and an alarm history list For information about the alarms and their possible settings see 7 Alarms page 90 3 5 5 The Others Pages The Others pages contain non clinical settings and information 3...

Страница 43: ...al user interface 3 5 5 3 Device Information Information Description Product name Battery Percentage Battery charge level Battery Time Left Estimated remaining usage time on battery power Firmware ver...

Страница 44: ...ivo 3 The time is used for logs and reports Date Sets the date for the Vivo 3 The date is used for logs and reports Time Format Select whether to use 12 hr clock or 24 hr clock Date Format Select the...

Страница 45: ...day Average Usage Hours The average number of hours per day the ventilator has been running in operating mode Only days where the ven tilator has been running in operating mode are part of the value...

Страница 46: ...rization Category M This category is defined for equipment and interconnected wiring located in areas where apertures are electro magneti cally significant and not directly in view of radio reciever s...

Страница 47: ...n the Vivo 3 Back Symbol Description Oxygen connection port Max 30 l min and 100 kPa Power connection port Use approved power supplies only USB port SD memory card port I O port for accessory box SpO2...

Страница 48: ...on hot surface Caution symbol read the Accessory s instructions for more information Keep away from rain Single patient use CE marking applies in accordance with directive MDD 93 42 EEC as amended by...

Страница 49: ...Symbol Description Effort belt port not used AC power port DC power port SP O2 SPO2 port Product Description 49 Doc 007232 Y 2 Vivo 3 Clinician s Manual...

Страница 50: ...ted 4 SpO2 connected 5 Humidifier activated 6 Heated circuit activated 7 Clock radio wake up activated 8 All alarms shut off 9 Powered by mains 10 Powered by external battery no icon powered by intern...

Страница 51: ...The patient controls the start of inspiration through the inspiratory trigger and the start of exhalation by the expiratory trigger The set pressure is used as a target pressure if the flow is decreas...

Страница 52: ...gger and the start of exhalation by the expiratory trigger The set pressure is used as a target pressure if the flow is decreased to the expiratory trigger level before the set pressure is reached the...

Страница 53: ...the following modes PCV A Assisted Pressure Controlled Ventilation See page 51 PSV Pressure Support Ventilation See page 51 S Spontaneous See page 52 S T Spontaneous Timed See page 52 T Timed See page...

Страница 54: ...value for EPAP is limited to the inspiratory pressure minus 2 cmH2O Default value 5 cmH2O Setting resolution Below 10 cmH2O 0 5 cmH2O Above 10 cmH2O 1 0 cmH2O Available in modes PCV A PSV S S T T 4 2...

Страница 55: ...es the length of each inspiration from start of inspira tion to cycling off to expiration Property Description Value range 0 3 s to 3 s The available range for Inspiratory Time might also be limited b...

Страница 56: ...S T 4 2 9 Inspiratory Trigger Insp Trigger The inspiratory trigger setting defines the patient s effort required to initiate a ventilator assisted breath When the patient starts a breath an increasing...

Страница 57: ...ion 1 Available in modes PSV S S T 4 2 11 Rise Time The Rise Time setting controls the speed of the pressure increase from start of inspira tion to set inspiratory pressure A low setting will give a f...

Страница 58: ...T T 4 2 13 Max Pressure The Max pressure setting is only used when Target Volume is activated Max pressure defines the upper pressure limit up to where the Vivo 3 can increase the pressure to reach t...

Страница 59: ...ue range 4 cmH2O to 20 cmH2O Default value Same as the value for IPAP Setting resolution Below 10 cmH2O 0 5 cmH2O Above 10 cmH2O 1 0 cmH2O Available in modes PCV A PSV S S T T 4 2 15 Ramp Up The ramp...

Страница 60: ...4 2 17 Ramp Pressure The ramp pressure setting is used for defining the start pressure when Ramp Up is used IPAP shall start 2 cmH2O above Ramp Pressure or 2 cmH2O above EPAP if Ramp Pressure is lower...

Страница 61: ...Precautions page 26 before activating the humidifier to make sure all conditions are met and considered Property Description Value range On Off Default value Off Available in modes All modes 4 2 19 H...

Страница 62: ...d circuit to make sure all conditions are met and considered Property Description Value range On Off Default value Off Available in modes All modes 4 2 21 Heated Circuit Level This setting defines the...

Страница 63: ...charge the internal battery 4 Check that the air inlet filters are installed 5 2 Placing the Vivo 3 WARNING Read the chapter 2 3 Environment Warnings and Precautions page 20 carefully to make sure all...

Страница 64: ...met CAUTION Mains isolation is provided by the approved AC DC and DC DC adapters The ven tilator must only be powered by the approved AC DC or DC DC adapter acces sory listed in 10 Accessories page 13...

Страница 65: ...e cord can be unplugged without difficulties 5 4 Connecting the Patient Circuit WARNING Read the chapter 2 4 Patient Circuit Warnings and Precautions page 22 Carefully to make sure all conditions are...

Страница 66: ...amages 2 Connect the ventilator cuff to the air outlet of the ventilator A click ing sound is heard when the latches are fitted correctly 3 If applicable perform a pre use test on the ventilator For s...

Страница 67: ...re than 5 seconds Check that the device switches to the internal battery and that the information mes sage Switched to Internal Battery is shown on the screen If not contact your supplier of the Vivo...

Страница 68: ...tment mode may have additional settings specific for the mode 4 Check that alarms can be received at the operator s position For detailed informa tion see 7 1 Operator s Position page 91 5 Make a copy...

Страница 69: ...and settings while the Home mode gives access only to a limited set of functions and settings Press and hold down the left and right arrow buttons simultaneously for 3 seconds to switch modes 6 3 Star...

Страница 70: ...w then red The audio pause LED lights yellow In about a second both LEDs are turned off If the function test beep absents take the Vivo 3 out of use and contact your supplier of the Vivo 3 e 6 4 Stop...

Страница 71: ...s in Standby mode 2 Press the On Off button When the message Do you want to turn off the ventilator is dis played confirm by pressing the Mute Alarm button within 6 sec onds Otherwise the Vivo 3 will...

Страница 72: ...High pressure alarm level 6 6 1 Treatment Values Monitored by the Vivo 3 Ppeak Ppeak Peak pressure is the highest pressure that is recorded during the latest inspira tory phase EPAP EPAP Expiratory Po...

Страница 73: ...s the patients pulse rate as measured by the SpO2 module This value is only displayed if the SpO2 module is connected Displayed ranges According to the manufacturer s specifications 6 6 2 Treatment Va...

Страница 74: ...o humidify the patient air It is intended for non invasive use only About the Attachable Humidifier The attachable humidifier is intended for non invasive use only The humidifier requires a connection...

Страница 75: ...e locking latch a and then pulling it out 2 Fill the humidifier with water 3 Insert the humidifier Detach the Humidifier from the Vivo 3 1 If any treatment is running stop it a 2 Push down the locking...

Страница 76: ...the water chamber with hot water Do not overfill the water chamber The water chamber has a capacity of 350 ml and the maximum filling level is indicated on the chamber After using the ventilator wait...

Страница 77: ...difier is correctly installed Activate the Humidifier 1 Press the Setup button twice The second setup page is now displayed with humidifier settings 2 Press the Up arrow button until the setting Humid...

Страница 78: ...mpty the humidifier of water 3 Insert the air path bypass unit Cleaning the Humidifier WARNING Risk of Burns If you remove and open the humidifier just after using the ventilator ensure that you don t...

Страница 79: ...ead section 2 7 Humidification and Heating Warnings and Precautions page 26 before using the Vivo 3 with the heated circuit NOTE The heated circuit requires connection to the Mains power supply to wor...

Страница 80: ...cuit symbol is lit on the display The setting for Heated Circuit Level is displayed 4 Press the Down arrow to select the Heated Circuit Level setting 5 Press the Left arrow button to decrease the heat...

Страница 81: ...urements The SpO2 measurements will be stored in the data memory which can be downloaded to a PC and viewed in the PC software Information about safety warnings product description installation usage...

Страница 82: ...meter such as ambient light physical movement diagnostic testing low perfusion electromagnetic interference dysfunctional haemoglobin presence of certain dyes and inappropriate positioning of the pul...

Страница 83: ...gen adapter to the oxygen port at the back of the Vivo 3 See 3 3 Ventilator Back page 35 for detailed information 3 If using a device for monitoring the oxygen saturation connect it according to the s...

Страница 84: ...lation usage cleaning maintenance and technical specifications can be found in the user instruction for Remote Alarm The Remote Alarm enables care providers and clinical personnel to monitor the Vivo...

Страница 85: ...gether with external power supply units The protective cover cannot be used together with the attachable humidifier When using the protective cover the air path bypass unit shall be installed in place...

Страница 86: ...ly page 64 When both power sour ces are available the mains will be used 6 7 10 Using the Vivo 3 with the Trolley This section describes how to use the Vivo 3 and a trolley with mounting bracket Mount...

Страница 87: ...9 kg 2 lbs 6 8 Transfer Data between the Vivo 3 and a PC WARNING Read the section 2 2 Electricity Warnings and Precautions page 19 CAUTION Do not eject the memory card or disconnect the USB cable whil...

Страница 88: ...the oldest data will be discarded 6 8 2 Transfer Data using a Memory Card The Vivo 3 has an SD memory card slot at the back of the device 1 Insert an SD card to the memory card slot 2 Open the Device...

Страница 89: ...lator and the power outlet The ventilator starts but the patient cir cuit doesn t deliver any air Ensure that both ends of the patient cir cuit are correctly connected Straighten the patient circuit o...

Страница 90: ...ote alarm unit provided by Breas Medical The nurse call cable provided by Breas Medical Alarm Function During Power Failure At power failure the following will happen 1 When the mains power is broken...

Страница 91: ...actions Find a better position for the operator Adjust the alarm sound level see 7 2 5 Adjust the Alarm Sound Level page 94 Add a remote alarm unit to the system see 10 Accessories page 130 7 2 Handle...

Страница 92: ...ical Alarms page 104 Display of Multiple Alarms If several alarms are active active high priority alarms have precedence over medium priority alarms All high priority alarm conditions must be resolved...

Страница 93: ...sig nal will be reactivated 7 2 3 Reset an Alarm To reset an alarm correct the cause of the alarm condition Once the cause is corrected the alarm disappears from the display WARNING If an alarm condit...

Страница 94: ...vigation button twice The second alarm page is now displayed 2 Press the Down or Up arrow but ton to select the Alarm Sound Level setting 3 Press the Left or Right arrow but tons to adjust the sound l...

Страница 95: ...ressure setting and alarm setting Coughing during inspiration Changes in airway resistance and or compliance Reset criteria A full breath is performed with maximum pressure below the alarm limit Venti...

Страница 96: ...er components of the patient circuit Reset criteria The pressure rises above the alarm limit Ventilator action The Vivo 3 will continue treatment according to the current settings Setting range 1 cmH2...

Страница 97: ...f Setting resolution 1 bpm 7 3 4 Low Breath Rate Alarm Property Description Alarm text Low Breath Rate Priority High Alarm condition A Low Breath Rate alarm will be given when the delivered total brea...

Страница 98: ...the current settings Setting range 1 l to 40 l Off Setting resolution 0 5 l 7 3 6 Low Minute Volume Alarm Property Description Alarm text Low MV Priority High Alarm condition A Low Minute Volume alarm...

Страница 99: ...e On Off 7 3 8 Apnea Alarm Property Description Alarm text Apnea Priority High Alarm condition An Apnea alarm will be given when no patient triggered breath is detected for the set period of time Poss...

Страница 100: ...g treat ment including items such as filters circuit connectors interface mask cannula etc Property Description Alarm text Disconnection Priority High Alarm condition A Disconnection alarm will be giv...

Страница 101: ...alue Ventilator action The Vivo 3 will continue treatment according to the current settings Setting range On Off 7 3 11 Low EPAP Alarm Property Description Alarm text Low EPAP Priority Medium Alarm co...

Страница 102: ...to 100 90 to 100 Off Setting resolution 1 This alarm requires a connected SpO2 sensor 7 3 13 Low SpO2 Alarm Property Description Alarm text Low SpO2 Priority High Definition A Low SpO2 alarm will be...

Страница 103: ...Off Setting resolution 5 bpm beats per minute This alarm requires a connected SpO2 sensor 7 3 15 Low Pulse Rate Alarm Property Description Alarm text Low Pulse Rate Priority High Alarm condition A lo...

Страница 104: ...the alarm LED and the audible signal only Priority High The display is turned off The Power Fail alarm is indicated by the alarm LED and the audible signal only Alarm condition The Power Fail alarm is...

Страница 105: ...tion The Vivo 3 will continue treatment according to the current settings 7 4 4 SpO2 Artifact This alarm requires a connected SpO2 sensor Property Description Alarm text Poor SpO2 Signal Priority Medi...

Страница 106: ...s Priority Medium Alarm condition This alarm will be given when the last battery source internal battery has 15 minutes of operating time left with current settings Ventilator action The Vivo 3 will c...

Страница 107: ...chable humidifier is used these will be turned off The ventilator stops treatment and gives alarm for up to 2 minutes Reset criteria The temperature goes below the limit again 7 4 9 Flow Sensor Failur...

Страница 108: ...n of the ventilator The error code that follows the alarm text indicates the kind of function failure Reset criteria Correct function is restored Ventilator action The ventilator will stop the treatme...

Страница 109: ...he Vivo 3 All replaced parts must be disposed of in accord ance with local environmental regulations regarding the disposal of used equipment and waste 8 1 Cleaning the Vivo 3 WARNING Risk of Electric...

Страница 110: ...t Circuit CAUTION The cleaning and replacement intervals should be established by the care provider based on the care provider s infection control procedures and the instructions from the patient circ...

Страница 111: ...Pull out the filter holder and remove the filters 3 If required by the interval or if visibly dirty wash the grey coarse filter 1 Wash the filter using warm water and a mild soap 2 Rinse thoroughly 3...

Страница 112: ...t has been used the airways of the Vivo 3 may need disinfection to prevent patient cross contamination See 8 1 2 Air Pathway Dis infection page 110 3 Replace the patient air inlet filters according to...

Страница 113: ...e tests are optional and not needed to ensure safe use of the Vivo 3 8 4 2 1 High Pressure Alarm 1 Connect the Vivo 3 patient circuit to a test lung and a CPAP device 2 Set High Pressure alarm to 10 c...

Страница 114: ...Volume Off IPAP 10 cmH2O EPAP 5 cmH2O Breath Rate 12 bpm 4 Start the treatment on the Vivo 3 device 5 Wait until the Low Breath Rate alarm is activated 6 Stop the treatment The test is completed 8 4...

Страница 115: ...MV Alarm limit below the monitored MVe 5 Wait approximately 15 seconds before the High MV alarm shall be given 6 Stop the treatment the test is completed 8 4 2 7 Low MV Alarm 1 Connect patient circui...

Страница 116: ...ss II ME Equipment External DC Power Supply Property Value External DC Supply 12 24 V isolated DC The approved DC DC supply listed in 10 Accessories page 130 must be used Internal Battery Property Val...

Страница 117: ...cessory box enclosure 42 C NC touch time 1 min Y cable box 42 C NC touch time 1 min Humidifier enclosure 46 C NC 55C SFC touch time 10 min Heated circuit 42 C NC 59C SFC touch time 10 min Extended Ope...

Страница 118: ...evel Ventilator ingress protection IP 22 Mechanical ingress protection protected from touch by fingers and objects greater than 12 5 mm Liquid ingress protection The device withstands dripping water e...

Страница 119: ...akage port Patient interface connection 4 Patient With Bypass Unit 1 2 3 4 5 Number Description 1 Air inlet Ambient room air intake 2 Blower 3 Sensors 4 Air bypass unit 5 Air outlet Breathing air to t...

Страница 120: ...Static sound pressure level 30 dB A 10 cmH2O 4 mm leak Measured at a distance of 1 meter according to standard Static sound pressure level stand by mode 22 dB A SPL Measured at a distance of 1 meter...

Страница 121: ...ressure cmH2O 10 bpm 15 bpm 20 bpm 4 0 3 1 0 0 5 1 2 0 7 1 6 8 0 3 1 0 0 5 1 2 0 7 1 6 12 0 3 1 0 0 5 1 2 0 7 1 6 16 0 3 1 0 0 5 1 2 0 7 1 6 20 0 3 1 0 0 5 1 2 0 7 1 6 Inlet Air Filter Specification S...

Страница 122: ...Parameter Tolerance Remark Pressure at patient end 0 5 cmH20 5 Steady state Ppeak 0 5 cmH20 10 Monitored in display EPAP 0 5 cmH20 10 Monitored in display Leakage 10 Monitored in display BTPS MVe 10ml...

Страница 123: ...Filtering Smoothing Techniques Measurement Description Pressure Low pass average time constant 16 ms Inspiration trigger Differential mass flow resolution 4 ms Expiration trigger Flow low pass filter...

Страница 124: ...has exceeded 30 seconds Under the immunity test conditions the following allowances are acceptable Temporary degradation of performance that does not adversely affect basic safety or essential perfor...

Страница 125: ...f a typical loca tion in a typical commercial hospital and residential environment Voltage dips short interrup tions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 0 5 cycle mu...

Страница 126: ...ctures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cord less telephones and land mobile radios amateur radio AM and FM radio broadcast and TV...

Страница 127: ...ustomer or the user of the Vivo 3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Vivo 3 as...

Страница 128: ...ted using the equation d I 2 H where I is the maximum current rating of the conductor in amperes A according to the transmit ter manufacturer H is the Vivo 3 immunity compliance level to electromagnet...

Страница 129: ...5 cmH2O CPAP 10 cmH2O Breath Rate 12 bpm Inspiration Time 1 5 sec Min Insp Time Off Max Insp Time Off Inspiratory Trigger Auto Expiratory Trigger Auto Rise Time Auto Max IPAP Set IPAP Min IPAP Set IPA...

Страница 130: ...EC 60601 1 Anybody who connects additional equipment to the signal input part or signal out put part is configuring a medical system and is therefore responsible for ensuring that the system complies...

Страница 131: ...ases Part No 007243 10 pieces Attachable humidifier Function Humidifies the patient air For non invasive use only Part No 006977 Air Bypass Unit Function Directs the patient air flow if the attachable...

Страница 132: ...acteristics Resistance 1 8 cmH2O 60 l m Deadspace 30 ml BFE Bacterial Filtration Efficiency 99 9 VFE Viral Filtration Efficiency 99 8 Part No 004185 10 2 Accessories RRC CAR70M DC DC Power Supply Func...

Страница 133: ...3 to the trolley Part No 006998 Accessory Box Function For connecting measure ment and communication accessories Nurse call cable or Remote alarm SpO2 sensor Might also be con nected directly to the V...

Страница 134: ...5 NC 006364 10 k NO 006363 10 k NC 006362 SpO2 module Function Connection interface Part No 006369 SpO2 sensor Function Finger Clip SpO2 sensor Part No Adult 006589 Paediatric 006590 SpO2 sensor Funct...

Страница 135: ...ion USB cable for transferring data between a PC and the Vivo 3 Part No 005757 Memory card Function Storage and transfer of set tings patient data and usage data Part No 006705 Memory card reader writ...

Страница 136: ......

Страница 137: ...Appendix Appendices 137 Doc 007232 Y 2 Vivo 3 Clinician s Manual Appendices...

Страница 138: ...ed for noting the patient s settings Patient Clinic Vivo SN Set by Date Treatment Settings Ventilation Mode IPAP EPAP CPAP Breath Rate Insp Time Min Insp Time Max Insp Time Insp Trigger Exp Trigger Ri...

Страница 139: ...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 Elec tromagnetic Compatibility...

Страница 140: ......

Страница 141: ...r failure disconnected 104 Alarm condition identifying 91 Alarm message 92 Alarm signal LED 92 Alarm sound pausing 93 Alarm tests 112 Alarm time 44 Alarm volume 44 Alarms 90 physiological 95 Ambient P...

Страница 142: ...idifier setting 61 Humidifier attachable using 74 Hypoventilation 97 I Icon Caution 14 Note 14 Reference 14 Warning 14 Inspiratory pressure 53 Inspiratory time 51 55 Inspiratory trigger 56 Interface b...

Страница 143: ...ations equipment 127 Rise time 51 S S T 52 Save memory data on card 43 SD card port 35 Settings 51 53 adjust 67 change 39 delivery 128 Setup pages 41 Sound level alarm 94 SpO2 sensor using 80 Start da...

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