Breas Vivo 2 User Manual
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Breas Vivo 2 User Manual

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Vivo 2 User's Manual
DOC. 007229 EN-EU Y-2
2019-09-03

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  • Page 1 Vivo 2 User’s Manual DOC. 007229 EN-EU Y-2 2019-09-03...

  • Page 3: Table Of Contents

    Table of Contents Introduction........................7 Manufacturer Information..................8 What is the Vivo 2? ..................... 8 1.2.1 Non Invasive Interfaces ..............9 1.2.2 Mobility and Usage Environment ............9 1.2.3 Continuous Operation................. 9 1.2.4 Service Life ..................9 Intended Use....................... 9 Intended Users....................
  • Page 4 4.2.7 Heated Circuit Level................49 Prepare the Vivo 2 for Use ....................50 Checking the Vivo 2 before First Use ............... 50 Placing the Vivo 2....................50 Connecting the Vivo 2 to Power Supply............51 Connecting the Patient Circuit ................52 5.4.1...
  • Page 5 High Patient Air Temp. (High Patient Air Temperature) ....89 7.4.7 Flow Sensor Failure ................90 7.4.8 Internal Function Failure ..............90 Cleaning and Maintenance ..................... 91 Cleaning the Vivo 2 ................... 91 8.1.1 Clean the Main Unit Externally ............91 8.1.2 Air Pathway Disinfection ..............92 8.1.3 Clean the Patient Circuit ..............
  • Page 6 Environmental Conditions................. 95 Pneumatic Diagram ..................97 Technical Data....................98 Accessories ........................101 10.1 Accessories/Consumables ................101 10.2 Accessories..................... 103 Appendices ......................... 107 Patient Settings Record ....................108 FAA Compliance......................109 6 Table of Contents Vivo 2 User’s Manual Doc. 007229 Y-2...

  • Page 7: Introduction

    CAUTION! Read this User’s manual thoroughly so that you completely understand how the Vivo 2 is operated and maintained before taking it into use, to ensure correct usage, maximum performance and serviceability. Non-professional caregivers (e.g. family members) should consult the medical equip- ment provider’s respiratory therapist if they have any questions about the function,...

  • Page 8: Manufacturer Information

    What is the Vivo 2? The Vivo 2 is a pressure ventilator capable of delivering non-invasive ventilatory sup- port for the care of individuals who require long-term support from mechanical ventila- tion for respiratory insufficiency or respiratory failure, with or without obstructive sleep apnea.

  • Page 9: Non Invasive Interfaces

    1.2.4 Service Life The expected service life of the Vivo 2 is 5 years or 20,000 hours. Intended Use Vivo 2 is intended to provide non-invasive ventilation for patients weighing over 10 kg (22 lbs) who require long-term support or mechanical ventilation for respiratory impair- ment, with or without obstructive sleep apnea.

  • Page 10: Lay Operators

    The User Manual contains the information intended for patients and lay operators. Training The lay operator shall be trained to basic knowledge of the Vivo 2 and in the specific operations they are assigned to perform. The training shall be based on the user manual and the responsible clinical personnel shall assess the level of training required for each lay operator.

  • Page 11: Contraindications

    Training and Certification Service personnel shall be trained on the Vivo 2 and certified by Breas for being allowed to perform any service, repairs or other operations on the Vivo 2. The training consists of reading the services manual in complete. After completed training the certification test may be performed.

  • Page 12: About This Manual

    Patients should report any unusual chest pain, severe headache or increased breathlessness. The following side effects may occur during the course of therapy with the Vivo 2, patients are advised to report any new or changing adverse effects to their physician: •...

  • Page 13: Safety Information

    Risk of Insufficient Ventilation Usage outside the specified operating conditions may cause reduced performance. The Vivo 2 must only be used in accordance with the operating conditions specified in this operating manual Risk of Faulty Treatment Do not use the Vivo 2 in the event of •...
  • Page 14 Modifying or using the ventilator with accessories that are not specified or approved by Breas may cause cardiac arrhythmia. The Vivo 2 must only be used in original and unmodified shape and only with acces- sories specified or approved by Breas Medical.

  • Page 15: Electricity - Warnings And Precautions

    High voltage contact may cause cardiac arrhythmia. • Do not operate the Vivo 2 if it has a damaged power cord, power supply or casing. • To avoid electrical shock, only clean the Vivo 2 according to instructions in this manual.

  • Page 16: Electromagnetic Compatibility And Electrostatic Discharge (Emc And Esd)

    Vivo 2. Please note some of these RF emitters may not be visible and the Vivo 2 can poten- tially be exposed to fields from these RF emitters without the user’s awareness. If abnormal performance of the Vivo 2 is observed, and the RF emitters cannot be identified and removed, the Vivo 2 may need to be reoriented or relocated.

  • Page 17: Environment - Warnings And Precautions

    Do not use or store the Vivo 2 in a magnetic resonance (MR) environment. Use of the Vivo 2 in an MR environment may result in malfunction of the Vivo 2 and pose unacceptable risk to the patient, medical staff or other persons.

  • Page 18: Disposal

    Do not expose the Vivo 2 to rain or snowfall. 2.3.1 Disposal The Vivo 2, any accessories and any replaced parts must be disposed of in accordance with the local environmental regulations regarding the disposal of used equipment and waste.
  • Page 19 • For active exhalation valve circuits: Check the function of the exhalation valve and that is not blocked or obstructed. • The Vivo 2 should be turned on and the function of the leakage port should be checked before use: The pressurized air from the Vivo 2 causes a continuous flow of air through the leakage port, enabling flushing of exhaled air.

  • Page 20: Filter Usage - Warnings And Precautions

    WARNING! Risk of Cross-Contamination Patient circuits might get contaminated by exhaled gases. To avoid cross-contamina- tion, always use a properly cleaned or a new patient circuit when the Vivo 2 is to be used by a new patient. NOTE For masks and accessories, always follow the manufacturer’s instructions.

  • Page 21: Humidification And Heating - Warnings And Precautions

    Risk of Insufficient Ventilation Insufficient ventilation may cause transient hypoxia. Do not use high resistance bacteria filter at the air outlet of the Vivo 2. High resist- ance bacteria filters placed between the air outlet and the patient interface may inter- fere with the operation of the patient disconnect function.
  • Page 22 Risk of Inflammation Incorrect connection of the ventilator may cause inflammation. The attachable humidifier is only enabled when the Vivo 2 is connected to the AC Power supply. Risk of Suffocation Installation of a water trap may be required if the condensation is extensive in the patient circuit when using a heated humidifier.

  • Page 23: Cleaning And Maintenance - Warning And Precautions

    Risk of Electric Shock Cleaning with excessive water or opening the device’s casing without certified training may cause electric shocks. The Vivo 2 should be regularly cleaned and maintained in accordance with this oper- ating manual. Risk of Electric Shock High voltage contact may cause cardiac arrhythmia.

  • Page 24: Oxygen Usage - Warning And Precautions

    The presence of oxygen can speed up combustion of inflammable materials. Risk of Fire When oxygen is used with the Vivo 2, the oxygen flow must be turned off when the Vivo 2 is not operating. Oxygen delivered into the patient tubing may accumulate within the machine enclosure.

  • Page 25: Mobile Use - Warning And Precautions

    • 60% oxygen concentration: -5% deviation • 80% oxygen concentration: -7.5% deviation Mobile Use — Warning and Precautions This section applies if using the Vivo 2 during transit, for example on a wheel chair or in a car. No Attachable Humidifier During Mobile Use...
  • Page 26 WARNING! Risk of Electric Chock If connecting the Vivo 2 to an external DC power source, always use the DC DC Power Supply accessory. Connecting directly to an external DC power source may compromise the electrical isolation and cause an electric shock.

  • Page 27: Product Description

    Product Description This section describes the main Vivo 2 medical electric equipment. For information about accessories and user replaceable spare parts., see .10 Accessories, page 101. Main Components Part Function Breas Part no. Ventilator unit Main unit. 228000 006994 Power supply adapter for the...

  • Page 28: Ventilator Front

    Clinician’s manual: 007230 Carry bag For transportation, when not 007013 in use. Patient circuit, 15 mm Delivers air to the patient 006712 Ventilator Front This section describes the front panel. 28 Product Description Vivo 2 User’s Manual Doc. 007229 Y-2...
  • Page 29 Audio pause button Pauses the alarm sound. Audio Pause LED Lights yellow when the alarm sound is paused. Alarm LED Flashes during active alarms. Product Description 29 Doc. 007229 Y-2 Vivo 2 User’s Manual...

  • Page 30: Ventilator Back

    Ventilator Back Item Description Power port Port for connecting the power sup- ply. See 5.3 Connecting the Vivo 2 to Power Supply, page 51 Oxygen port Connection for low pressure/bleed- in oxygen Patient air outlet Connection for patient circuit Patient air inlet...

  • Page 31: Power Management

    Power supply Y—cable is required. If a power source fails, the Vivo 2 will switch to the next source in priority and show a message on the display. If all available sources fail, the Power Failure alarm is given and the Vivo 2 shuts down.
  • Page 32 Press the navigation button for the requested function page. ⇒The page is now displayed. 2 For functions with several pages grouped together, press the naviga- tion button again to browse the pages. 32 Product Description Vivo 2 User’s Manual Doc. 007229 Y-2...
  • Page 33 3 Leave the sub page using the left arrow button Change a Setting Select the setting (indicated by an arrow to the right of the item text) using the Up or Down arrow button. Product Description 33 Doc. 007229 Y-2 Vivo 2 User’s Manual...

  • Page 34: The Monitor Page

    3.5.2 The Monitor Page The monitor page displays the treatment data. It consists of a bar graph illustrating the current pressure and text area displaying current monitored values in text. 34 Product Description Vivo 2 User’s Manual Doc. 007229 Y-2...

  • Page 35: The Alarm

    3. Set inspiration pressure level 4. High pressure alarm level For information about monitored values, see 6.5.1 Treatment Values Monitored by the Vivo 2, page 58. 3.5.3 The Alarm Pages The alarm pages contain alarm settings and an alarm history list.
  • Page 36 The available languages are listed with their native names accompanied by a flag representing a country where the lan- guage is spoken. Default value: English (The language selection menu is displayed when the Vivo 2 is started for the first time.) Pressure Unit Value range: • cmH •...
  • Page 37 • Usage log (containing at least 1 year data of non-clinical events, alarms and settings) 3.5.4.5 Clock Setting Description Time Sets the time for the Vivo 2. The time is used for logs and reports. Date Sets the date for the Vivo 2. The date is used for logs and reports.
  • Page 38 Patient Operating Time Total hours of usage Reset Patient Operating Reset the counter to 0. Time 3.5.4.9 About Setting / information Description Regulatory FCC Contains FCC Compliance statement Regulatory IC Contains IC Statment 38 Product Description Vivo 2 User’s Manual Doc. 007229 Y-2...

  • Page 39: Symbols On The Vivo 2

    Nemko certifikation mark (NRTL/SCC accredited) Degree of protection provided by enclosure. The Vivo 2 is rated IP22, which means it is protected from touch by fingers and objects greater than 12 mm, and pro- tected from water spray less than 15 degrees from vertical.
  • Page 40 Symbols on the Vivo 2 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/SpO 40 Product Description Vivo 2 User’s Manual...
  • Page 41 Additional Symbols on Parts and Accessories This section describes additional symbols for Vivo 2 detachable parts and accessories from Breas Medical. Each item, or its package, have the symbols that applies for the specific accessory. Symbol Description Caution, hot surface Caution symbol, read the Accessory’s instructions for more...
  • Page 42 Symbol Description Effort belt port (not used) AC power port DC power port port 42 Product Description Vivo 2 User’s Manual Doc. 007229 Y-2...

  • Page 43: Symbols On The Display

    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 Product Description 43 Doc. 007229 Y-2 Vivo 2 User’s Manual...

  • Page 44: Treatment Functions And Settings

    Vivo 2. Lay operators must only use the User Manual, not the Clinician’s Manual. Treatment Modes This section describes the ventilating modes of the Vivo 2. 4.1.1 PCV+A — Pressure Controlled Ventilation (Assisted) In PCV+A mode, the ventilation is controlled by set values for pressure, inspiratory time, and rise time.

  • Page 45: S - Spontaneous

    The inspiration starts by the interval set by the breath rate. The inspiration stops and the expiration starts by either of the following triggers: • The inspiration time expires. • The High Pressure Alarm limit is reached. Treatment Functions and Settings 45 Doc. 007229 Y-2 Vivo 2 User’s Manual...

  • Page 46: Cpap - Continuous Positive Airway Pressure

    4.1.6 CPAP — Continuous Positive Airway Pressure In CPAP mode the Vivo 2 is applying a continuous positive pressure to the airways. The flow will automatically be adjusted to maintain the set CPAP level. Treatment Settings This section describes settings and parameters that affects the ventilating function of the Vivo 2.

  • Page 47: Ramp Pressure

    Humidifier This setting defines whether a humidifier shall be used. By default, this setting can be modified in Clinical mode only, but the Vivo 2 may be configured to allow modification in home mode as well. Treatment Functions and Settings 47 Doc.

  • Page 48: Humidifier Level

    Humidifier Level This setting defines the level of humidification, if Humidifier is set to On. By default, this setting can be modified in Clinical mode only, but the Vivo 2 may be configured to allow modification in home mode as well.

  • Page 49: Heated Circuit Level

    Heated Circuit Level This setting defines the heating level, if Heated Circuit is set to On. By default, this setting can be modified in Clinical mode only, but the Vivo 2 may be configured to allow modification also in home mode.

  • Page 50: Prepare The Vivo 2 For Use

    Prepare the Vivo 2 for Use Checking the Vivo 2 before First Use Before using the Vivo 2, perform the following checks. Ensure that you have the equipment mentioned in 3.1 Main Components, page 27 2 Ensure that the equipment is in good condition.

  • Page 51: Connecting The Vivo 2 To Power Supply

    Vivo 2, such as a curtain etc. Connecting the Vivo 2 to Power Supply This chapter describes how to connect a Breas power supply. WARNING! Read the chapter 2.2 Electricity — Warnings and Precautions, page 15 carefully to make sure all conditions are considered and met.

  • Page 52: Connecting The Patient Circuit

    Read the chapter 2.4 Patient Circuit — Warnings and Precautions, page 18 Carefully to make sure all conditions are considered and met. The Vivo 2 is intended to be used with leakage circuits only. Recommended leak rate: 20 to 50 liters per minute at 10 cmH 52 Prepare the Vivo 2 for Use Vivo 2 User’s Manual...

  • Page 53: Connect The Heated Patient Circuit

    Power up the Vivo 2 This function check may be performed as a pre-use check or whenever the function of the Vivo 2 needs to be checked. Prepare the Vivo 2 for Use 53 Doc. 007229 Y-2 Vivo 2 User’s Manual...
  • Page 54 • The audio pause LED lights yellow. • In about a second, both LEDs are turned off. If the test fails, do not use the Vivo 2. Contact your supplier of the Vivo 2 for a technical check. 3 Perform a pre-use test (select Others —> Pre-use Test).

  • Page 55: How To Use The Vivo 2 55

    The therapy settings shall be based on a physician’s description. Changes to settings must be made by authorized clinical personnel only. Make sure that the Vivo 2 is in Standby mode. 2 Press and hold the On/Off button until the Starting Treatment progress bar is filled.

  • Page 56: Stop The Treatment

    Ramp Down time has been specified.) Switch Off the Vivo 2 Make sure that the treatment is stopped and the Vivo 2 is in Standby mode. 2 Press the On/Off button. ⇒When the message “Do you want to turn off the ventilator?” is dis-...

  • Page 57: Monitor Treatment

    Press the Monitor navigation button. ⇒The Monitor page is now displayed. The monitor page displays treatment data monitored by the Vivo 2. It consists of a bar graph illustrating the current pressure and text area displaying monitored values in text.

  • Page 58: Treatment Values Monitored By The Vivo 2

    2. Low pressure alarm level 3. Set inspiration pressure level 4. High pressure alarm level 6.5.1 Treatment Values Monitored by the Vivo 2 • Ppeak (Peak pressure) is the highest pressure that is recorded during the latest inspira- peak tory phase.

  • Page 59: Treatment Values Monitored By External Equipment

    For monitoring the patient air oxygen saturation, an external monitoring device shall be connected to the patient circuit. The device shall comply with ISO 80601-2-55 and have a high oxygen level alarm. Using Accessories This section describes how to use accessories provided by Breas Medical. 6.6.1 Using the Attachable Humidifier WARNING! Read the section 2.6 Humidification and Heating —...
  • Page 60 +15°C to +35°C. Humidity: RH from 15% to 95%. Gas leakage < 0.2 l/min at 50 cmH Max humidification > 13 mg/l, tested according to ISO 80601-2-74 output 60 How to Use the Vivo 2 Vivo 2 User’s Manual Doc. 007229 Y-2...
  • Page 61 2 Fill the humidifier with water. 3 Insert the humidifier. Detach the Humidifier from the Vivo 2 If any treatment is running, stop it. 2 Push down the locking latch (a) and then pull the humidifier out.
  • Page 62 3 If you will use the Vivo 2 without the humidifier, install the air bypass unit in place of the humidifier. Fill the Humidifier Duration of operation between humidifier refills Humidifier level (5): 12 hours. At lower settings, the duration will be longer.
  • Page 63 (a) and then pulling it out. 3 Make sure the humidifier is correctly filled and push it into the Vivo 2 so the locking latch is engaged. ⇒A click indicates that the humidifier is correctly installed.
  • Page 64 If you remove and open the humidifier just after using the ventilator, ensure that you don’t touch the heater inside the humidifier since it can be very hot. 64 How to Use the Vivo 2 Vivo 2 User’s Manual Doc. 007229 Y-2...

  • Page 65: Using The Heated Circuit

    Using the Heated Circuit WARNING! Read section 2.6 Humidification and Heating — Warnings and Precautions, page 21 before using the Vivo 2 with the heated circuit. NOTE The heated circuit requires connection to the Mains power supply to work. Information about safety, warnings, product description, installation, usage, cleaning, maintenance and technical specifications can be found in the user instruction for the heated circuit.

  • Page 66: Using The Spo Sensor

    The SpO module (consisting of a SpO sensor, an electronic unit) is intended to meas- ure functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. 66 How to Use the Vivo 2 Vivo 2 User’s Manual Doc. 007229 Y-2...
  • Page 67 The SpO module can be connected to the Vivo 2 (item 1 above) using the SpO adapter cable (007079) or to the accessory box (007000) in order to monitor and store measurements. The SpO measurements will be stored in the data memory which can be downloaded to a PC and viewed in the PC software.

  • Page 68: Using The Oxygen Supply Adapter

    CAUTION! • When using the Vivo 2 with the SpO2 sensor, the Vivo 2 displays functional oxygen saturation measured by the sensor. • The following information concerns the light emitted by the SpO2 – Peak Wavelength (red): 660 nm – Peak Wavelength (infrared): 905 nm –...

  • Page 69: Using The Remote Alarm Unit

    Connect the Oxygen supply Connect the oxygen adapter (article no. 005032) to the oxygen supply’s tube. 2 Connect the oxygen adapter to the oxygen port at the back of the Vivo 2. See 3.3 Ventilator Back , page 30 for detailed information.

  • Page 70: Using The Protective Cover

    3 Start the remote alarm unit. 4 Trigger an alarm on the Vivo 2 and check that it activates the remote alarm system. For detailed information about triggering alarms, see . 6.6.6 Using the Protective Cover The protective cover is intended for mobile use of the Vivo 2 in hospitals, institutions and home care environments.

  • Page 71: Using The Y-Cable

    6.6.8 Using the Y-Cable The Y-cable is used for connecting the Vivo 2 to both mains and external DC at the same time. see 5.3 Connecting the Vivo 2 to Power Supply, page 51. When both power sour- ces are available, the mains will be used.

  • Page 72: Basic Troubleshooting

    If the humidifier is incorrectly assembled, disassemble it and then assemble it correctly. If the air is dry despite using the humidi- fier, increase the level of humidification. 72 How to Use the Vivo 2 Vivo 2 User’s Manual Doc. 007229 Y-2...

  • Page 73: Alarms

    Handle Alarms 7.2.1 Identify an Alarm Condition If an alarm condition is detected, the Vivo 2 main unit and the remote alarm unit (if connected) will alarm without delay. The alarms will remain active until the alarm condi- tion is resolved.
  • Page 74 7.2.5 Adjust the Alarm Sound Level, page 76. Information Message Audio Signal Short signal every 5 seconds Alarm Sound Pressure Level The alarm sound pressure level is adjustable within 55–80 dBA. 74 Alarms Vivo 2 User’s Manual Doc. 007229 Y-2...

  • Page 75: Pause The Alarm Sound

    Audio Pause button. Pressing the button again reac- tivates the sound. If a new alarm condition occurs during the audio pause period, the audible sig- nal will be reactivated. Alarms 75 Doc. 007229 Y-2 Vivo 2 User’s Manual...

  • Page 76: 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 condition cannot be corrected, take the Vivo 2 out of use and contact your supplier of the Vivo 2 e. 7.2.4 View Historical Alarms To view historical alarms, press the Alarm button three times.
  • Page 77 5 When finished with the sound level adjustment, check that the alarm can be received at the operator’s position, see 7.1 Operator’s Position, page 73. Alarms 77 Doc. 007229 Y-2 Vivo 2 User’s Manual...

  • Page 78: Physiological Alarms

    A full breath is performed with maximum pressure below the alarm limit. Ventilator action The Vivo 2 will continue treatment according to the current settings. The actual breath is however terminated if the High Pressure alarm limit is reached. Setting range •...

  • Page 79: Low Pressure Alarm

    Alarm text Priority High Alarm condition A Low Pressure alarm will be given when the Vivo 2 pressure fails to reach the low pressure alarm limit for 15 seconds. Possible cause • Disconnection of patient circuit. • Mismatch between pressure setting and alarm setting.

  • Page 80: High Breath Rate Alarm

    • Too sensitive setting of the inspiratory trigger setting. Reset criteria The breath rate goes below the alarm limit. Ventilator action The Vivo 2 will continue treatment according to the current settings. Setting range • 10 bpm to 50 bpm •...

  • Page 81: High Minute Volume Alarm

    • Increased breath rate. Reset criteria The minute volume goes below the alarm limit. Ventilator action The Vivo 2 will continue treatment according to the current settings. Setting range • 1 l. to 40 l. • Off Setting resolution 0.5 l.

  • Page 82: Rebreathing Alarm

    Possible cause • Obstructed or occluded patient circuit. • Incorrect patient circuit. Reset criteria The leakage is back within limits. Ventilator action The Vivo 2 will continue treatment according to the current settings. Setting range • On • Off 7.3.8...

  • Page 83: Disconnection Alarm

    • Too high leakage in the patient circuit. • The patient has removed the mask. • Circuit disconnection. Reset criteria The leakage is back within limits. Ventilator action The Vivo 2 will continue treatment according to the current settings Setting range • On • Off Alarms 83 Doc.

  • Page 84: 7.3.10 High Epap Alarm

    • Changes in airway resistance and or compliance. Reset criteria EPAP has gone below the alarm limit (lower than 30% above the set value). Ventilator action The Vivo 2 will continue treatment according to the current settings. Setting range • On • Off 7.3.11...

  • Page 85: High Spo 2 Alarm

    Too high flow of bleed-in oxygen. Reset criteria The SpO value goes back below the alarm limit. Ventilator action The Vivo 2 will continue treatment according to the current settings. Setting range • 80 % to 100 % • 90 % to 100 % •...

  • Page 86: 7.3.14 High Pulse Rate Alarm

    • Bad positioning of the finger probe. Reset criteria The pulse rate goes back below the alarm limit. Ventilator action The Vivo 2 will continue treatment according to the current settings. Setting range 20 to 250 bpm (beats per minute)

  • Page 87: Technical Alarms

    External power supply connected to ventilator. Ventilator action The Vivo 2 stops the treatment, turns off the display and gives the Power Fail alarm for at least 2 minutes. If power is restored within the alarm time, the ventilator will automatically resume treatment with current settings.

  • Page 88: Spo 2 Artifact

    Reset criteria Normal communication with the sensor is reestablished. An information message remains until acknowledged by the user. Ventilator action The Vivo 2 will continue treatment according to the current settings. 7.4.4 Artifact This alarm requires a connected SpO sensor.

  • Page 89: Ambient Pressure Compensation Lost Alarm

    Ventilator action The Vivo 2 will continue treatment according to the current settings. Normal atmospheric pressure at sea level will be used as approximation for the temporary ambient pressure compen- sation.

  • Page 90: Flow Sensor Failure

    Correct data from the sensor is received again. An information message remains until acknowledged by the user. Ventilator action The Vivo 2 will continue treatment but with the following limitations: • Monitoring of leakage is disabled. • Volume measurements are disabled.

  • Page 91: Cleaning And Maintenance

    4 Clean the outside of the Vivo 2 using a lint free cloth moistened with a mild soap solution and / or ethanol 70%. 5 When the equipment is clean and dry, reconnect the patient circuit and any accesso- ries that was disconnected during the cleaning.

  • Page 92: Air Pathway Disinfection

    Clean and Replace Patient Air Inlet Filters The Vivo 2 patient air inlet filters are located inside a magnetic filter holder at the back of the ventilator. The table below describes the filters and their minimum maintenance intervals.
  • Page 93 • Replace: every 4th week or when assigning the Vivo 2 to a new patient. * If the Vivo 2 is used in an environment with high grades of pollen or pollutions, shorter intervals might be required. Turn off the Vivo 2 and place it on a clean dust free surface.

  • Page 94: Technical Specifications

    Class 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 101 must be used. 94 Technical Specifications Vivo 2 User’s Manual Doc. 007229 Y-2...

  • Page 95: Environmental Conditions

    Normal Operation +5°C to +40°C Temperature Precautions • Be careful not to position the Vivo 2 in an extra warm place, such as in direct sunlight or above a radiator. • Caution should be exercised if the room tem- perature is higher than 36°C (97°F).
  • Page 96 If stored in temperatures outside normal operation conditions, let the Vivo 2 acclimate before taking it to use. CAUTION! The Vivo 2 must not be stored in a warm place, such as direct sunlight or close to a radiator. When the ventilator is brought from...

  • Page 97: Pneumatic Diagram

    Leakage port / Patient interface connection Patient With Bypass Unit Number Description Air inlet (Ambient room air intake) Blower Sensors Air bypass unit Air outlet (Breathing air to the patient) Technical Specifications 97 Doc. 007229 Y-2 Vivo 2 User’s Manual...

  • Page 98: Technical Data

    Measured at a distance of 1 meter, according to standard. Maximum sound power level 48 dB (A) according to applicable standards. Measured at a distance of 1 meter, according to standard. 98 Technical Specifications Vivo 2 User’s Manual Doc. 007229 Y-2...
  • Page 99 BS EN 13274–7 NaCl at 16 cm/sec Air flow resist- 12.5 Pa typical at 82.5 l/min (100 cm ance (pressure 20 Pa max drop) flow 0.3 Pa max at 0.2 cm/sec Technical Specifications 99 Doc. 007229 Y-2 Vivo 2 User’s Manual...
  • Page 100 Ventilatory Breathing System Characteristics The ventilator is verified to maintain specified accuracies over these ranges. Property Value Resistance 0.4 to 1.7 cmH2O at 40 l/min Compliance Max 1.1 cmH2O 100 Technical Specifications Vivo 2 User’s Manual Doc. 007229 Y-2...

  • Page 101: Accessories

    Accessories The accessories described in this section, together with the medical electric equipment defined in chapter 3.1 Main Components, page 27, constitute the Vivo 2 medical electric system. CAUTION! Responsibility for System Accessory equipment connected to the analogue and digital interfaces must be certi- fied according to the respective IEC standards (e.g.
  • Page 102 Part No: 006977 Air Bypass Unit Function: Directs the patient air flow, if the attachable humidifier is not used. Part No: 006983 Filter Holder Function: Holder for air inlet filters Part No: 007598 102 Accessories Vivo 2 User’s Manual Doc. 007229 Y-2...

  • Page 103: Accessories

    Part No: 004185 10.2 Accessories RRC CAR70M DC/DC Power Supply Function: Power supply adapter for the Vivo 2 shall be used for connecting the Vivo 2 to an external DC source. Part No: 006995 Y Cable Function: Power supply cable, for connecting to both AC and DC power supply.
  • Page 104 Lightweight Mobility Bag Function: For mobile use of the Vivo 2 in hospital, institutions and home care environments. Part No: 007380 Trolley Function: Mobile ventilator use Part No: 007384 Mounting Bracket Function: Bracket to mount the Vivo 2 to the trolley...
  • Page 105 10 kΩ, NC: 006362 module Function: Connection interface Part No: 006369 sensor Function: Finger Clip SpO sensor Part No: Adult: 006589 Paediatric: 006590 sensor Function: Multisite SpO sensor Part No: 006591 Accessories 105 Doc. 007229 Y-2 Vivo 2 User’s Manual...
  • Page 106 Part No: 007079 PC Software Function: Support software for follow-up on patient treatment. USB Cable Function: USB cable for transferring data between a PC and the Vivo 2. Part No: 005757 Memory card Function: Storage and transfer of set- tings, patient data and usage data...

  • Page 107: Appendices

    Appendices Appendix: Appendices 107 Doc. 007229 Y-2 Vivo 2 User’s Manual...

  • Page 108: A Patient Settings Record

    Time: Time: Insp. Trigger: Exp. Trigger: Rise Time: Max Pressure: Target Pressure: Volume: Ramp Up: Ramp Down: Humidifier Humidifier: Level: Heated Heated Cir- Circuit: cuit Level: Notes 108 Appendix: A Patient Settings Record Vivo 2 User’s Manual Doc. 007229 Y-2...

  • Page 109: Bfaa Compliance

    Compatibility (EMC) in accordance with the current version of RTCA/ DO-160, Section 21, Category M. Breas Medical has successfully completed testing for the ventilator System. The ventila- tor System complies with RTCA/DO-160, Section 21, Category M and can be consid- ered FAA compliant.
  • Page 111 LED ............75 Filter Alarm sound usage ............20 pausing.............75 Filters Alarm time...........37 clean, replace..........92 Alarm volume ..........37 Firmware version .........36 Alarms ............73 Front panel ..........28 physiological..........78 Ambient Pressure Compensation Lost alarm............89 Heated circuit Index 111 Doc. 007229 Y-2 Vivo 2 User’s Manual...
  • Page 112 Save memory data on card ......37 Mobile use SD card port ..........30 safety............25 Settings ..........44, 46 Monitor treatment........57 change............33 Sound level, alarm ........76 sensor Note using ............66 Icon ............12 Start date............38 Stop the treatment........56 112 Index Vivo 2 User’s Manual Doc. 007229 Y-2...
  • Page 113 Treatment start............55 Treatment data ..........34 Treatment modes .........44 Undesirable side effects........11 Usage time ...........38 USB port............30 Using instructions ........55 Voltage supply ............94 Warning Icon ............12 Wheel chair safety............25 Y-cable ............71 Index 113 Doc. 007229 Y-2 Vivo 2 User’s Manual...

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