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Safety Information

Vivo 40 users manual

Doc. 003821 En-Uk E-1

2.2 Electrical Safety   

• Do not operate the Vivo 40 if it has a damaged power cord or casing.
• The Vivo 40 may not work properly if any part has been dropped, damaged

or submerged in water.

• To avoid electrical shock, disconnect the electrical supply to the Vivo 40

before cleaning. Do not immerse the Vivo 40 into any fluids.

• The operator shall not touch accessible contacts of connectors and the

patient simultaneously.

• When handling the HA 20 heating unit, always turn off the Vivo 40 and

disconnect the Vivo 40 from the mains supply. 

• Before detaching or attaching the HA 20 water chamber, always turn off

the Vivo 40.

• If an external battery is used, always disconnect it when the Vivo 40 is

switched off. Otherwise there is a risk that the battery will discharge.

• If the mains power source fails and the internal or the external battery acti-

vates, the HA 20 humidifier will be turned off automatically. It must be
activated again manually, if humidification during battery use is necessary.

•  The data connection port is only to be used by your care provider.

Содержание Vivo 30

Страница 1: ...ivo 40 s Front Panel 21 3 4 The Vivo 40 s Back and Side Panels 22 3 5 Equipment Designation and Safety Label 23 4 Functions and Parameters of the Vivo 40 25 4 1 Ventilation Mode 25 4 2 Settings 25 4 3...

Страница 2: ...of Accessories 55 8 1 Cleaning the Vivo 40 55 8 2 Cleaning and Replacing the Patient Air Filters 58 9 Maintenance 59 9 1 Regular Maintenance Control 59 9 2 Service and Repair 60 9 3 Storage 60 9 4 Dis...

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: ...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 Positive Airway Pressu...

Страница 5: ...tions are present Pathologically low blood pressure Severe cardiac arrhythmias Unstable angina pectoris Decompensated cardiac failure or hypotension particularly if associated with intravascular volum...

Страница 6: ...ceability Breas Medical AB reserves the right to make changes to the contents of this manual without any prior notification Care providers clinical personnel physicians and others who require a workin...

Страница 7: ...ce with the operating conditions specified in this operating manual in original and unmodified shape and only with accessories specified or approved by Breas Medical AB Do not use the Vivo 40 in the e...

Страница 8: ...he Vivo 40 with care Make sure to place and pack the device in a way that prevents unintentional start of the machine Due to the internal battery the Vivo 40 may start if the Start Stop button is pres...

Страница 9: ...atient simultaneously When handling the HA 20 heating unit always turn off the Vivo 40 and disconnect the Vivo 40 from the mains supply Before detaching or attaching the HA 20 water chamber always tur...

Страница 10: ...mited to normal precautions with regard to relative humidity and conductive char acteristics of clothing in order to minimize the build up of electrostatic charges avoiding the use of radio emitting d...

Страница 11: ...ent circuit unless the Vivo 40 is turned on and operating properly Do not use patient hoses or tubes made of static or electrically conductive material Patient connected parts and filter must be repla...

Страница 12: ...led gases for longer than several minutes can in some circumstances lead to suffocation At low CPAP pressures the air flow through the leakage ports may be inad equate to clear all exhaled gases Some...

Страница 13: ...eakage 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 flow t...

Страница 14: ...ially when changing patient Failure to replace or clean a dirty filter may cause the Vivo 40 to operate at higher temperatures than intended When operating the Vivo 40 make sure that the air inlet and...

Страница 15: ...ntal spillage or from excess water or condensation flowing down the patient tube and into the patient s mask Extra cautions should be taken for patients who are unable to guard their airways or cannot...

Страница 16: ...ctions by service technicians authorized by Breas Medical AB Do not under any circumstances attempt to service or repair the Vivo 40 yourself If you do so the manufacturer will no longer be responsibl...

Страница 17: ...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 2 metres away from the oxygen cylinder or any part of the patien...

Страница 18: ...18 Product Description Vivo 40 users manual Doc 003821 En Uk E 1 3 Product Description 3 1 Main Components The Vivo 40 system contains the following components 1 2 3 6 7 8 4 5...

Страница 19: ...e for transportation 003519 2 User manual Product and usage information 003821 3 Patient tube 004465 4 Power cord 003521 EU 003520 5 Filter white disposa ble Inlet air filtration 003526 6 Filter grey...

Страница 20: ...10 Trach elbow Trach connection 004810 11 Hygroscopic Con denser Humidifier HCH Humidifier 003974 12 Leakage Exhalation port Providing a leakage 004426 13 Battery cable 12 24 V DC 004258 14 EB 2 Batte...

Страница 21: ...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 22: ...o the patient 4 Memory card slot Read and write memory card 5 HA 20 humidifier Patient air humidification 6 Mains inlet Connection for an external mains power source 7 On Off Mains power on and off 8...

Страница 23: ...acture YYYY MM 5 Data connection port The data connection port is only to be used by your care provider 6 Caution The data connection port is only to be used by your care provider 7 Read user instruct...

Страница 24: ...al on page 60 for information about recycling and disposal 15 Manufacturer 16 Internal battery 17 Product number 18 Serial number 19 Date of manufacture YYYY MM 20 Caution Before using the internal ba...

Страница 25: ...O above the ramp start pressure During CPAP mode the ramp function provides a pressure increase from the ramp start pressure to the set CPAP pressure during a set time 4 3 Standby and Operating Mode S...

Страница 26: ...has sufficient leakage If the leakage measured is below the recommended level it will generate a Low Leakage Alarm The Vivo 40 will continue to deliver breaths during the alarm 4 5 Humidifier optiona...

Страница 27: ...ent circuit to the Vivo 40 2 Connect the Vivo 40 to the mains supply 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 Check...

Страница 28: ...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 the Sta...

Страница 29: ...The up and down buttons 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 n...

Страница 30: ...yout SYMBOL DESCRIPTION UNIT Battery level Alarm time active Hour Minute HA 20 humidifier active 1 to 9 Off Ramp active Minute Panel locked On Off Panel locked by the Breas Vivo PC software On Off Mai...

Страница 31: ...to display the current pres sure Further information about the alarm time HA 20 humidifier remaining ramp time and the panel lock is shown The menu list for Others in standby mode with HA 20 humidifi...

Страница 32: ...the display window Navigate to the section Others and select Device Settings to reach the Device Settings page Navigate to the section Others and select Device Information to reach the Device Informa...

Страница 33: ...ct description installation usage cleaning maintenance and technical specifications can be found in the Breas HA 20 Humidifier User manual Read the chapter Humidification on page 15 carefully to make...

Страница 34: ...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 35: ...esult 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 dischargi...

Страница 36: ...ltage is 12 V or 24 V Check the polarity of 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 batte...

Страница 37: ...2 battery pack is approximately 6 hours 1 Connect the external DC cable to the Vivo 40 Make sure that it is fit ted correctly 2 Connect the other end of the cable to the battery source Only use a Brea...

Страница 38: ...Time Shows the total number of hours the Vivo 40 have been operating Patient Operating Time Shows the total number of hours a patient have been using the Vivo 40 for breathing therapy The Vivo 40 rec...

Страница 39: ...page 7 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 eq...

Страница 40: ...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 2 Make...

Страница 41: ...Invasive Use 3 Connect the power cord to the mains supply Read the chapter Usage of Patient Circuit on page 11 carefully to make sure all conditions are fulfilled and considered 1 Connect the patient...

Страница 42: ...least 12 litre min at 4 cmH2O to prevent re breathing of exhaled air The recom mended mask leakage is 20 to 40 litre min at 10 cmH2O pressure This leakage may be achieved by integrated leakage in the...

Страница 43: ...en 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 40 Always check that the alarm...

Страница 44: ...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 same a...

Страница 45: ...h the low pressure alarm limit 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 Venti...

Страница 46: ...x in paediatric mode for 3 consecutive breaths Possible cause Only activated under exceptional conditions such as a strong cough during the ventilator s inspiration phase Ventilator action The Vivo 40...

Страница 47: ...ume alarm limit for 15 seconds 45 seconds after start up and after cancelling a high leakage alarm Possible cause Restrictions in airways Obstructed or occluded patient circuit Ventilator action The V...

Страница 48: ...the low breath rate alarm 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 Ventilator ac...

Страница 49: ...alarm limit for 15 seconds 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 Ventilat...

Страница 50: ...s lower than the expected leakage flow at set pressure Possible cause Incorrect patient circuit leakage Obstructed or occluded patient circuit Ventilator action The Vivo 40 tries to continue deliverin...

Страница 51: ...eeds the expected leakage flow at set pressure during more than 15 seconds Possible cause Leakage in patient circuit The patient has removed the mask Ventilator action The Vivo 40 tries to continue de...

Страница 52: ...ery needs 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 n...

Страница 53: ...iven when the internal battery source has fallen lower than its voltage alarm limit Possible cause Discharged batteries Ventilator action The Vivo 40 stops giving breaths and gives alarm for 2 minutes...

Страница 54: ...arm will be given when the Vivo 40 has an internal function failure Ventilator action The Vivo 40 will stop treatment Indication The alarm is given audibly with a tone and visible by a display message...

Страница 55: ...f in accordance with local environmental regulations regarding the disposal of used equipment and waste 8 1 Cleaning the Vivo 40 Main Unit To avoid electrical shock disconnect the mains supply to the...

Страница 56: ...20 humidifier to cool down for ten minutes Detach only the HA 20 water chamber In case a more thorough cleaning is needed detach the rear lid or the HA 20 heating unit 4 Disconnect all electric cables...

Страница 57: ...rcuit parts recommended by Breas Medical AB clean as fol lows 1 Place the dismantled parts in hot water containing mild detergent 2 Remove fouling with a brush 3 Rinse parts thoroughly under running h...

Страница 58: ...ter 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 Disposable Filter white Replace the filter at least every 4th week or mo...

Страница 59: ...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 circu...

Страница 60: ...20 humidifier if applicable before storage of the Vivo 40 9 4 Disposal The Vivo 40 any accessories and all replaced parts must be disposed of and recycled in accordance with the local environmental r...

Страница 61: ...tion PCV Pressure Control Ventilation CPAP Continuous Posi tive Airway Pressure Patient modes Adult Paediatric Target Volume Active Inactive Device modes Clinical Home EPAP 2 cmH2O to 20 cmH2O or IPAP...

Страница 62: ...e 2 of the maxi mum value and 10 of the set value 0 5 below 10 cmH2O 1 0 above 10 cmH2O CPAP 4 to 20 cmH2O Tolerance 2 of the maxi mum value and 10 of the set value 0 5 cmH2O Breath rate 4 to 40 breat...

Страница 63: ...alarm level 1 to 9 where 1 is the lowest and 9 is the highest volume setting 1 Maximum flow 200 litre min Maximum lim ited pressure during single fault condition PCV PSV 60 cmH2O Adult 35 cmH2O Paedi...

Страница 64: ...85 dB A 5 dB A Measured at 1 m Low pressure alarm 2 cmH2O to IPAP IPAPmin resolution 1 cmH2O Red LED audible alarm and a warning message on the display High pressure alarm Self adjusting Red LED audib...

Страница 65: ...20 0 0 5 V Int Batt 14 0 75 V Red LED audible alarm and a warning message on the display Internalfunction failure alarms Red or yellow LED audi ble alarm and a warning message on the display POWER SU...

Страница 66: ...re range 600 to 1060 mbar corresponding to 4000 metres above sea level to 375 metres below sea level at normal atmospheric pres sure Humidity 10 to 95 non condensing OPERATING CONDITIONS SPECIFICATION...

Страница 67: ...ESCRIPTION PART NO Carry bag 003519 Users manual 003821 Patient tube 004465 HA 20 Humidifier heating unit water chamber 2230 XX HA 20 water chamber 004861 Rear lid 003591 Filter grey washable 003563 5...

Страница 68: ...cal 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 signal input part or signal out...

Страница 69: ...nt Settings Patient Settings Breas Vivo 40 Patient Date Clinic Set by IPAP Max Inspiration Time IPAPmin Min Inspiration Time EPAP Inspiration Time Breath Rate Inspiration Trigger Rise Time Expiration...

Страница 70: ...70 Patient Settings Vivo 40 users manual Doc 003821 En Uk E 1...

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