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Technical Specifications

Vivo 40 clinician’s manual

Doc. 003886 En-Us A-1e

12.3 Compliance of Standards

S

TANDARD

S

PECIFICATION

IEC 60601-1 (1988)
A1 (1991)
A2 (1995)

Medical electrical equipment - Part 1: General
requirements for safety.

IEC 60601-1-2 (2001)

Medical electrical equipment - Part 1-2: Gen-
eral requirements for safety - Collateral stand-
ard: Electromagnetic compatibility -
requirements and tests.

IEC 60601-1-4 (2000)

Medical electrical equipment - Part 1-4: Gen-
eral requirements for safety - Collateral Stand-
ard: Programmable electrical medical systems.

IEC 60601-1-8 (2003)

Medical electrical equipment - Part 1-8: Gen-
eral requirements for safety - Collateral stand-
ard: Alarm systems - requirements, tests and
guidelines.

ISO 10651-6 (2004)

Lung ventilators for medical use - Particular
requirements for basic safety and essential
performance - Part 6: Home care ventilatory
support devices.

ISO 17510-1 (2002)

Sleep apnea breathing therapy - Part 1: Sleep
apnea breathing therapy devices.

ISO 8185 (2007)

Respiratory tract humidifiers for medical use -
Particular requirements for respiratory humid-
ification systems.

CAN/CSA-C22.2
No. 601.1-M90

Medical electrical equipement Part 1: General
requirements for safety.

CAN/CSA-C22.2
No. 601.1S1-94

Supplement no. 1-94 to CAN/CSA-C22.2
No. 601.1-M90--Medical electrical equipe-
ment Part 1: General requirements for safety
CSA 601.1 Amendment 2:1998

UL Std No. 60601-1, 1st Ed. Medical electrical equipement Part 1: General

requirements for safety.

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Содержание Vivo 40

Страница 1: ...24 3 4 The Vivo 40 s Back and Side Panels 25 3 5 Equipment Designation and Safety Label 26 4 Functions and Parameters of the Vivo 40 27 4 1 Ventilation Mode 27 4 2 Device Mode 27 4 3 Settings 27 4 4 T...

Страница 2: ...ion 66 8 2 Physiological Alarm 69 8 3 Technical Alarm 76 9 Complete Function Check 79 9 1 Pre use Check 79 9 2 Alarm Check 80 10 Cleaning the Vivo 40 and Replacement of Accessories 83 10 1 Cleaning th...

Страница 3: ...inal 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...

Страница 4: ...lowing the ventilator to more easily match each patient s needs The inspiratory pressure is set by the IPAP setting The end expiratory pressure is set by the EPAP setting In the CPAP mode Continuous P...

Страница 5: ...f the Vivo 40 for positive pressure therapy may be contraindicated on patients Incapable of maintaining life sustaining ventilation in the event of a brief circuit disconnection or loss of therapy Una...

Страница 6: ...ts signs of a sinus or middle ear infection 1 4 About this Manual Audience This manual is primarily intended for care providers clinical personnel physi cians and others who require a working knowledg...

Страница 7: ...ained in the table below ICON EXPLANATION Warning Risk of death and serious personal injury Caution Risk of minor or moderate injury Risk of equipment damage loss of data extra work or unexpected resu...

Страница 8: ...ment Vivo 40 must only be used for the intended treatment in accordance with this operating manual and with the instructions given by the responsible clinical personnel in accordance with the operatin...

Страница 9: ...tings or compo nents may require the readjustment of the alarm levels Handle the Vivo 40 with care Make sure to place and pack the device in a way that prevents unintentional start of the machine Due...

Страница 10: ...r data processing equipment and IEC 60601 1 for medical equipment Fur thermore all configurations shall comply with the valid version of the sys tem standard IEC 60601 1 1 Therefore everyone who conne...

Страница 11: ...95 Necessary measures should be taken in order to assure that field levels exceeding 10 V m are avoided since this may impair the safety and performance of the Vivo 40 Measures should include but not...

Страница 12: ...rically conductive material Always use a new mask tube and leakage port when the Vivo 40 is to be used by a new patient Patient connected parts and filter must be replaced regularly to ensure cor rect...

Страница 13: ...exhaled gases for longer than several min utes can in some circumstances lead to suffocation At low CPAP pressures the air flow through the ventilation holes in the mask or the leakage ports may be in...

Страница 14: ...the leakage ports remains clear at all times Periodically check the leakage ports during ther apy In general as pressure decreases the potential of rebreathing increases Lower pressures produce less f...

Страница 15: ...at the air inlet and filters are not obstructed or occluded If the Vivo 40 is used in a clinic by several patients a low resistance bacteria filter is recommended between the air outlet and the patien...

Страница 16: ...ull off the mask When using an external heated humidifier it should be located below the Vivo 40 and the patient to prevent injury from accidental spillage If the condensation in the patient circuit i...

Страница 17: ...rol and any applicable upgrades in accordance with Breas service instructions Vivo 40 shall only be repaired or modified in accordance with Breas service manuals technical bulletins and any special se...

Страница 18: ...wallowing of air while awake Air continually leaking from the mouth while sleeping Dryness of air passages or nose Ear pain runny nose or sinus discomfort Day time sleepiness Disorientation or memory...

Страница 19: ...adequately Do not smoke in a room where oxygen is being used Naked light bulbs and other sources of ignition must be kept a minimum of 6 feet 2 meters away from the oxygen cylinder or any part of the...

Страница 20: ...20 Product Description Vivo 40 clinician s manual Doc 003886 En Us A 1e 3 Product Description 3 1 Main Components The Vivo 40 system contains the following components 1 2 3 6 7 8 4 5...

Страница 21: ...g Storage for transportation 003519 2 User manual Product and usage information 003819 3 Patient tube 004465 4 Power cord 003522 5 Filter white disposa ble Inlet air filtration 003526 6 Filter grey wa...

Страница 22: ...cessories NO COMPONENT FUNCTION PART NO 9 HA 01 Humidifier Humidifies patient air 003530 10 Trach elbow Trach connection 004810 11 Hygroscopic Con denser Humidifier HCH Humidifier 003974 12 Leakage Ex...

Страница 23: ...o PC data cable Data cable PC and Vivo 40 RJ45 to D sub 003588 16 Vivo iCom data cable Data cable Vivo 40 and iCom RJ45 to D sub 003574 17 iCom PC data cable D sub Data cable iCom and PC D sub to D su...

Страница 24: ...tting Navigation in current menu selection Define settings NO LED FUNCTION 2 Trigger Patient breath trigger indication 3 4 Alarm red yellow Alarm indication 5 Audio pause Paused alarm sound indication...

Страница 25: ...ir outlet Air path out to the patient 4 Memory card slot Read and write memory card 5 HA 01 humidifier Patient air humidification 6 AC power inlet Connection for an external AC power source 7 On Off A...

Страница 26: ...ween the Vivo 40 and a PC on page 44 carefully 5 Class II electrical equipment double insulation 6 Body floating IEC 60601 1 Type BF Isolated Applied Part 7 Read the clinician s manual thoroughly befo...

Страница 27: ...ode should be activated before giving the Vivo 40 to the user The home mode hides treatment settings alarm limits and other selected information The clinical mode is used by the clinician to control a...

Страница 28: ...minimum and maxi mum length of each inspiration If the min and max inspiration time are set off the length of each inspiration is dependent on the set expiratory trigger Inspiration Time PCV only man...

Страница 29: ...unction is used for increasing the EPAP and IPAP pressure during a set time the IPAP pressure starts at 2 cmH2O above the ramp start pressure During CPAP mode the ramp function provides a pressure inc...

Страница 30: ...activated The ventilator tries to reach and maintain the set pressure until the expiration starts The inspiration stops and an exhalation starts in two cases The inspiration time expires The limit fo...

Страница 31: ...ration flow has dropped to the value set for expiratory trigger The limit for the high pressure alarm is reached The inspiration time is longer than the limit for maximal inspiration time or when insp...

Страница 32: ...manual Doc 003886 En Us A 1e 4 6 The Difference between PCV and PSV Mode The figure below shows the previous two examples superimposed to illustrate how the PCV and PSV modes differ PSV PCV Pressure c...

Страница 33: ...calculated volume and the set target volume Automatic pressure adjustments will be made in between two settable limits IPAPmin and IPAPmax in order to deliver the optimal sup port to the patient Targe...

Страница 34: ...nd Off on page 36 Enter standby mode by switching the Vivo 40 off again Some operations such as accessing the memory card and setting time and date are only available in standby mode 4 10 Low Leakage...

Страница 35: ...tient circuit to the Vivo 40 2 Connect the Vivo 40 to the AC power source 3 Switch on the Vivo 40 main power using the On Off switch on the side panel 4 Press the Start Stop button on the front panel...

Страница 36: ...ed on 2 Turn on the Vivo 40 by pressing the Start Stop button on the front panel for 2 seconds Press for 4 sec onds when using an external or inter nal battery A short sound signal is heard 1 Press th...

Страница 37: ...are used to select values in a section The plus and minus buttons are used to alter a value Use the four navigation buttons and the up down and buttons on the front panel to navigate the Vivo 40 menu...

Страница 38: ...ed in the Menu SYMBOL DESCRIPTION UNIT Battery level Alarm time active Hour Minute HA 01 humidifier active 1 to 9 Off Ramp active Minute Panel locked On Off Panel locked by the Breas Vivo PC software...

Страница 39: ...Memory Card standby only Time and Date standby only PCV Adjust Parameters Alarm Limits PSV Adjust Parameters Alarm Limits Active Target Volume Adjust Parameters Alarm Limits Home Inactive Target Volum...

Страница 40: ...Settings The menu list for Others in standby mode with HA 01 humidifier con nected The menu list for Others in operat ing mode Navigate to the section Others and select Wake up Alarm to reach the Wake...

Страница 41: ...Home Mode Navigate to the section Others and select Device Information to reach the Device Information page Navigate to the section Others and select Time and Date to reach the Time and Date page 1 N...

Страница 42: ...ode 4 In home mode navigate to the Main section and change the Device Mode setting back to Clinical if wanted When handing out the Vivo 40 to a patient the panel should always be locked The panel can...

Страница 43: ...display current pressure information about max and min pres sure mode estimated tidal volume leakage internal battery status HA 01 humidifier remaining ramp time total rate and the I E ratio In some s...

Страница 44: ...alarm history and alarm set tings in home mode Enter main screen and press down button for 3 seconds Read the chapter Electrical Safety on page 10 carefully to make sure all conditions are fulfilled...

Страница 45: ...Insert the memory card in the memory card slot on the side of the Vivo 40 Make sure the memory card is properly inserted 2 In clinical mode navigate to the Memory Card page under the Others section I...

Страница 46: ...With the Vivo PC data cable real time data can also be received and sent between the Vivo 40 and a PC 1 Connect the Vivo PC data cable to the Vivo 40 Make sure it is fitted correctly 2 Connect the ot...

Страница 47: ...A 1e 1 Connect the Vivo iCom data cable to the Vivo 40 Make sure it is fitted correctly 2 Connect the other end of the Vivo iCom data cable to the iCom 3 Connect the iCom PC data cable between the iC...

Страница 48: ...fter usage according to the instructions in the HA 01 Humidifier User manual the Vivo 40 will remember the humidity setting used Information about safety warnings product description installation usag...

Страница 49: ...also be used as a temporary power source for transpor tation between one stationary power source to another When running on battery the bat tery status is indicated by the fol lowing symbols Full Med...

Страница 50: ...l result in longer battery charging time Follow the instructions below to ensure that the battery capacity of the Vivo 40 is maximized during its lifetime Exercise the battery every 3 months by discha...

Страница 51: ...the external battery before connecting it to the Vivo 40 With an external battery connected the Vivo 40 will automatically switch over to the external battery source if the AC power cord is removed o...

Страница 52: ...ime Shows the total number of hours a patient have been using the Vivo 40 for breathing therapy 1 Connect the external DC cable to the Vivo 40 Make sure that it is fit ted correctly 2 Connect the othe...

Страница 53: ...on page 8 before setting up and using the Vivo 40 1 Check that all main compo nents and ordered accessories have been delivered refer to the packing note or the invoice if available 2 Ensure that the...

Страница 54: ...facing towards the patient The Vivo 40 should be placed lower than the patient in order to prevent the device from falling on the patient as well as preventing conden sated water to reach the patient...

Страница 55: ...55 Preparing the Vivo 40 for Use Vivo 40 clinician s manual Doc 003886 En Us A 1e 3 Connect the power cord to the AC power source...

Страница 56: ...tient Circuit on page 12 carefully to make sure all conditions are fulfilled and considered 1 Connect the patient tube to the air outlet 2 Connect the other end of the patient tube to the mask and the...

Страница 57: ...kage from the mask or leakage exhalation port should be at least 12 liter min at 4 cmH2O to prevent re breathing of exhaled air The recom mended mask leakage is 20 to 40 liter min at 10 cmH2O pressure...

Страница 58: ...ou must confirm all applicable settings for each of the PSV PCV or CPAP modes that are to be used by the patient See the table matrix in the follow ing section Always document the set values before th...

Страница 59: ...ration time 0 3 to 5 sec Min inspiration time Off 0 3 to 3 sec Max inspiration time 0 3 to 3 sec Off Rise time 1 to 9 Insp trigger PCV 1 to 9 Off Insp trigger PSV 1 to 9 Exp trigger 1 to 9 Target Volu...

Страница 60: ...entilator always starts in the mode and with the settings that were active when it was switched off Navigate to the section Mode and then to Ventilation Mode Use the and buttons to select the desired...

Страница 61: ...ieved the lines for these settings will flash Adjust the settings so that the flashing ceases For more information about how to use the menu please read the chapter Using the Menu on page 37 Study the...

Страница 62: ...te to the section Setup Setting range 0 3 to 5 seconds Navigate to the section Setup and press Setup one more time to reach the More Settings page Setting range 1 to 9 Navigate to the section Setup an...

Страница 63: ...one more time to reach the More Settings page Navigate to the section Mode and then to Target Volume Use the and buttons to select Active or Inactive Follow the on screen instructions and adjust the...

Страница 64: ...Navigate to the section Setup Ramp function On Off or Disabled where On and Off turns on and off the ramp function in operating mode With the ramp function Disabled it cannot be activated in operating...

Страница 65: ...A 1e Humidifier optional Setting range 1 to 9 where 9 is the maximum humidity Off Navigate to the section Others and select Humidity to reach the Humidity page In home mode the HA 01 humidifier can b...

Страница 66: ...for an overview of the position of the LEDs and the LCD display Alarm Indication When an alarm condition arises the alarm is indicated in three ways The adjustable alarm settings should be re evaluat...

Страница 67: ...as the high priority alarm or a constant signal depending on the kind of function failure The audible signal can be paused by pressing the Audio Pause button If the ventilator still registers the sam...

Страница 68: ...he Alarm History is maintained when the Vivo 40 is powered down The last set alarm settings are retrieved after power has been off Alarm History will display the 6 last alarms when the alarm occurred...

Страница 69: ...t for 15 seconds Possible cause Disconnection of patient circuit Setting is higher than IPAP IPAPmin Leakage from the mask or other components of the patient circuit Setting Parameter Low pressure Min...

Страница 70: ...onsecutive breaths Possible cause Only activated under exceptional conditions such as a strong cough during the ventilator s inspiration phase Setting Self adjusting Ventilator action The Vivo 40 will...

Страница 71: ...seconds 45 seconds after start up and after cancelling a high leakage alarm Possible cause Restrictions in airways Obstructed or occluded patient circuit Setting Parameter Low volume Min Max Resoluti...

Страница 72: ...rm limit for 15 seconds Possible cause Setting is higher than breath rate The patient doesn t trigger any breaths Decrease of the patient s spontaneous breath ing Setting Parameter Low breath rate Min...

Страница 73: ...s Possible cause The alarm for high breath rate is activated if the patient hyperventilates or if the ventilator starts to self trigger because of incorrect settings Setting Parameter High breath rate...

Страница 74: ...is lower than the expected leakage flow at set pressure Possible cause Incorrect patient circuit leakage Obstructed or occluded patient circuit Setting Self adjusting Ventilator action The Vivo 40 tri...

Страница 75: ...ceeds the expected leakage flow at set pressure during more than 15 seconds Possible cause Leakage in patient circuit The patient has removed the mask Setting Self adjusting Ventilator action The Vivo...

Страница 76: ...ds to be charged ITEM DESCRIPTION Definition A low internal battery warning will be given when the internal battery is the last power source and it falls below the voltage warning limit Under nor mal...

Страница 77: ...n the internal battery source has fallen lower than its voltage alarm limit Possible cause Discharged batteries Alarm limits Internal battery 14 0 75 V Ventilator action The Vivo 40 stops giving breat...

Страница 78: ...vo 40 has an internal function failure Ventilator action The Vivo 40 will continue or stop the treatment depending on the type and priority of the alarm Indication The alarm is given audibly with a to...

Страница 79: ...Remove and open HA 01 humidifier 2 Check that there is no visible damage 3 Check that the water container is clean Inspection of device Check that there is no visible damage Check that the surface is...

Страница 80: ...tor settings as follows Check the Low Leakage Alarm and High Leakage Alarm 5 Connect the patient circuit to a test lung 1 5 l and a leakage connector 6 Enter operating mode by starting the treatment 7...

Страница 81: ...e alarm shall be activated after 3 consecutive high pressure breaths Check the Low Pressure Alarm 16 Enter standby mode by stopping the treatment 17 Connect the patient circuit to a test lung 1 5 l an...

Страница 82: ...s follows 33 The low volume alarm shall occur within 20 seconds 34 Adjust the low volume alarm to 0 05 l 35 The alarm shall disappear in 30 seconds Check the Switching of Power Source to the Internal...

Страница 83: ...d of in accordance with local environmental regulations regarding the disposal of used equipment and waste 10 1 Cleaning the Vivo 40 Main Unit To avoid electrical shock disconnect the ACpower supply t...

Страница 84: ...humidifier attached In case a more thorough cleaning is needed detach the rear lid or the HA 01 humidifier 4 Disconnect all electric cables 5 Clean the outside of the Vivo 40 using a lint free cloth...

Страница 85: ...n case of damage replace the circuit If the parts need to be disinfected this can be done in a bath of disinfectant for instance Virkon or Gigasept Then rinse the parts well in clear water and dry the...

Страница 86: ...et and the patient tube to prevent patient cross contamination However if a HA 01 humidifier is connected to the Vivo 40 do not use any bacteria filter 1 Follow the instructions in Cleaning the Vivo 4...

Страница 87: ...any special serv ice instructions by service technicians that have been authorized after Breas Vivo 40 service training or have an equivalent techni cal knowledge on medical device Do not under any c...

Страница 88: ...e HA 01 humidifier if applicable before storage of the Vivo 40 11 4 Disposal The Vivo 40 any accessories and all replaced parts must be disposed of and recycled in accordance with the local environmen...

Страница 89: ...fications 12 1 System Description NO DESCRIPTION 1 Air inlet filter 2 Blower 3 Silencer box 4 Vivo 40 casing 5 Pressure regulating valve 6 Pressure sensor 7 Flow sensor 8 Ambient 9 Humidifier HA 01 10...

Страница 90: ...Pmin 2 cmH2O Tolerance 2 of the maxi mum value and 10 of the set value 0 5 below 10 cmH2O 1 0 above 10 cmH2O IPAP 4 to 40 cmH2O Tolerance 2 of the maxi mum value and 10 of the set value 0 5 below 10 c...

Страница 91: ...Max inspiration time 0 3 to 3 sec Off 0 1 sec Rise time 1 to 9 1 Inspiratory trig ger effort level 1 to 9 Off 1 Expiratory trig ger effort level 1 to 9 where 1 is the lowest effort and 9 is the highes...

Страница 92: ...level at 10 cmH2O Less than 30 dB A Measured at 1 m INDICATOR SPECIFICATION RESOLUTION Pressure 0 to 40 cmH2O 2 of full scale and 4 of actual reading Estimated tidal volume liter BTPS Body Tempera tu...

Страница 93: ...rning mes sage on the display Low leakage alarm Self adjusting Yellow LED audible alarm and a warning mes sage on the display High leakage alarm Self adjusting Red LED audible alarm and a warning mess...

Страница 94: ...to 100 F 5 to 38 C Storage and transport tem perature 4 to 140 F 20 to 60 C Ambient pressure range 600 to 1060 cmH2O corresponding to 4000 metres above sea level to 375 metres below sea level at norma...

Страница 95: ...for safety Collateral stand ard Alarm systems requirements tests and guidelines ISO 10651 6 2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Pa...

Страница 96: ...ON Class II IEC 60601 1 Class II Type BF Electrical equipment with dual isolation and body floating isolated applied part according to IEC 60601 1 Class IIb Classification according to the European Me...

Страница 97: ...sable Clinical On Home Off Humidifier Off Wake up Off PARAMETERS SETTING IPAP 10 cmH2O EPAP 4 cmH2O Target Volume 0 5 l IPAPmax 10 cmH2O CPAP 10 cmH2O Breath rate 10 BPM Inspiration time 1 5 sec Inspi...

Страница 98: ...essure 2 cmH2O High breath rate Off Low breath rate 8 Low volume 0 25 l OTHERS SETTING Time format 12 h AM PM Patient operating time 0 h Pressure unit cmH2O Wake up alarm sound 1 Sound level alarm 5 D...

Страница 99: ...NO Carry bag 003519 Users manual 003819 Clinician s manual 003886 Patient tube 004465 HA 01 humidifier 003530 Rear lid 003591 Filter grey washable 003563 5 pcs Filter white disposable 003564 5 pcs Le...

Страница 100: ...t and IEC 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC 60601 1 1 Everybody who connects additional equipment to the signa...

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