Breas VIVO 65 User Manual
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Breas VIVO 65 User Manual

Breas VIVO 65 User Manual

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U U S S E E R R M M A A N N U U A A L L
Vivo 65
User's
,
006150 M-1 EN-EU
ENGLISH (EU)
Breas Medical AB, Företagsvägen 1, SE-435 33 Mölnlycke, Sweden
Phone +46 31 86 88 00 Order +46 31 86 88 20 Technical Support +46 31 86 88 60
7 321820 061501
Fax +46 31 86 88 10 www.breas.com, Date: 2022-05-16 | 18320

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  • Page 1 Breas Medical AB, Företagsvägen 1, SE-435 33 Mölnlycke, Sweden Phone +46 31 86 88 00 Order +46 31 86 88 20 Technical Support +46 31 86 88 60 7 321820 061501 Fax +46 31 86 88 10 www.breas.com, Date: 2022-05-16 | 18320...

  • Page 3: Table Of Contents

    Connecting the Vivo 65 to AC power (Mains)........
  • Page 4 Functions and Parameters in the Vivo 65 ........
  • Page 5 Transferring Data between the Vivo 65 and a PC ....... .
  • Page 6 6.1.3 Audible Signal Presilence..........89 6.1.4 Alarm Reset .
  • Page 7 Cleaning the Vivo 65 ........
  • Page 8 Vivo 65 Essential Performance........

  • Page 9: Introduction

    Every other use may lead to risk of personal injury! CAUTION! Read this manual thoroughly so that you completely understand how the Vivo 65 is oper- ated and maintained before taking it into use, to ensure correct usage, maximum per- formance and serviceability.

  • Page 10: Multiple Use

    Intended Use The Vivo 65 (with or without the SpO2 and CO2 sensor) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical venti- lation. Specifically, the ventilator is applicable for paediatric through adult patients weighing more than 5 kg.

  • Page 11: Audience

    1.4.1 Audience This manual is intended for patients and other lay users operating the Vivo 65. • Care providers, clinical personnel, physicians and others who require a working knowledge of the Vivo 65 will find additional information on settings and func- tions in the Clinician’s Manual.

  • Page 12: Manufacturer Information

    Phone +46 31 868800, Order: +46 31 868820, Technical support: +46 31 868860 +46 31 868810 UK Sales and Support Information UK Responsible Person: Breas Medical Ltd Phone UK Head Office +44 (0)1789293460 Fax UK Head Office +44 (0)1789262470 General Enquiries and Ordering orders@nippyventilator.com...

  • Page 13: Safety Information

    Failure to have an alternative means of ventilation can result in serious injury or patient death if ventilator fails. The Vivo 65 must be turned off and on at least every 90 days. This is necessary in order for the Vivo 65 to perform a complete self-test. The self-test automatically tests the alarm sound and certain components.
  • Page 14 If you suspect that the device has been mistreated, perform a functional check before taking it to use. A basic functional check can be performed as described in 4.5 Inspecting the Vivo 65 before Use, page 39. A complete functional check can be performed by an authorized service technician.

  • Page 15: Electrical Safety

    Risk of Electric Shock High voltage contact may cause cardiac arrhythmia. • Do not operate the Vivo 65 if it has a damaged power cord, power supply or casing. • To avoid electrical shock, only clean the Vivo 65 according to instructions in this manual.
  • Page 16 Do not use or store the Vivo 65 in a magnetic resonance (MR) environment. Use of the Vivo 65 in an MR environment may result in malfunction of the Vivo 65 and pose unacceptable risk to the patient, medical staff or other persons.

  • Page 17: Usage Of Patient Circuit

    The ventilator should be turned on and the function of the leakage port or exhalation valve should be checked before use. Do not breathe in the connected patient circuit unless the Vivo 65 is turned on and oper- ating properly.
  • Page 18 Always follow the instructions of the mask manufacturer. The Vivo 65 is equipped with a rebreathing alarm. The alarm is not a substitute for oper- ator vigilance in ensuring that the leakage port or exhalation valve remains clear at all times.

  • Page 19: Usage Of Filters

    SpO module. WARNING! Always use a new patient circuit when the Vivo 65 is to be used by a new patient. NOTE The Vivo 65 and its packaging do not contain any natural rubber latex. Usage of Filters WARNING! Always use the ventilator with patient air inlet filters installed.

  • Page 20: Humidification

    WARNING! Humidification must only be used if this has been prescribed by your physician. The Vivo 65 therapy settings must always be prescribed by a physician or other licensed health care professional, and be carried out by authorized clinical personnel.

  • Page 21: Usage Of Oxygen

    WARNING! Risk of Fire When oxygen is used with the Vivo 65, the oxygen flow must be turned off when the Vivo 65 is not operating. Oxygen delivered into the patient tubing may accumulate within the machine enclosure. Oxygen accumulated in the machine enclosure increases the risk of fire.
  • Page 22 The oxygen concentration in the delivered air has influence on the volume measurement of the Vivo 65. This measurement is based on a normal oxygen concentration of 21%. If the oxygen concentration is higher, the monitored inspired volume will deviate from the actual volume as follows: •...

  • Page 23: Product Description

    Product Description Main Components The Vivo 65 system contains the following components (* = optional): Carry bag Function: Storage for transportation Part No: 006343 Manual Function: Product and usage information Part No User manual: 006150 Part No Clinician’s manual: 006151...
  • Page 24 Circuit: Dual Limb with Exhalation Valve Function: Deliver air to the patient. Part No: 007616 (disposable) Dual limb insert* Function: Insert for the dual limb patient circuit, enables integrated measurement of exhaled gas, volume and flow. Adult or paediatric use. Part No: Adult: 005523, Paediatric: 005525 Single limb insert* Function: Connection for ventilator and...
  • Page 25 Vivo 65 main unit The Vivo 65 and its packaging do not con- tain any natural rubber latex. Product Description User manual Doc. 006150 M-1...

  • Page 26: The Front Panel

    The Front Panel Item Function Trigger LED Patient triggered breath indication AC power Power source (Mains) LED External DC Power source: External DC Click-on battery Power source: Click-on battery Internal battery Power source: Internal battery Alarm LED Alarm indication (red or yellow) Audio pause Paused alarm sound indication Sensor...
  • Page 27 Item Function Function according to display Function/ Navigation Audio Pause Pause the alarm sound Information Show/Hide information Product Description User manual Doc. 006150 M-1...

  • Page 28: The Vivo 65'S Side Panels

    Patient air inlet Air path in, replaceable filters Make sure that nothing can block the patient air inlet on the side of the Vivo 65. Read 4.2 Placing the Vivo 65, page 32 for more information. Cooling air inlet Inlet internal cooling, cooling air...
  • Page 29 Function Colour/Symbol USB data con- Data connection (PC and the Vivo 65. The data nection port connection port is only to be used by your care provider) Memory card Ventilator Memory Data slot download Remote Start/ Connection for remote start/stop...

  • Page 30: Equipment Designation And Safety Labels

    At Patient air inlet: Make sure that nothing can block the patient air inlet on the side of the Vivo 65. Read 4.2 Placing the Vivo 65, page 32for more information At internal and click-on battery: Read the chapter 5.7 Using Batteries, page 71.
  • Page 31 Read 7.7 Disposal, page 128 for information about recycling and disposal. Degree of protection provided by enclosure The Vivo 65 is rated IP22, which means it is protected from touch by fingers and objects greater than 12 mm, and protected from water spray less than 15 degrees from vertical.
  • Page 32 Symbol Description CE marking Meets all requirements for CE marking according to relevant European health, safety and environmental protection legislation. Meets all requirements for UKCA marking according to applicable United Kingdom health, safety and environmental protection legislation. Manufacturer Product Description User manual Doc.

  • Page 33: Preparing The Vivo 65 For Use

    2 Ensure that the equipment is in good condition. 3 If stored more than one month, connect the Vivo 65 to the power supply to recharge the internal battery. (See 5.7.2 Charging the Batteries, page 71for further instructions.) 4 Check that the grey and white (optional use) air filters are installed.

  • Page 34: Placing The Vivo 65

    Read the chapter 2.3 Environmental Conditions, page 13 carefully to make sure all condi- tions are met and considered. Do not place the Vivo 65 on a soft surface that will prevent the air flow underneath the device. Never cover the device.

  • Page 35: Connecting The Vivo 65 To Ac Power (Mains)

    2 Secure the power cord using the restraining clip. 3 Connect the power cord to the AC power (Mains) supply. To isolate the Vivo 65 from the AC power (Mains) supply, remove the power cord from the AC power inlet. Preparing the Vivo 65 for Use User manual Doc.

  • Page 36: Connecting The Patient Circuit

    4.4.1 Connect Patient Circuit Insert The choice of insert makes it possible to connect the Vivo 65 to either a dual limb paediatric circuit, a dual limb adult circuit or a single limb circuit. The Vivo 65 automatically detects which insert has been installed. Before connecting an insert, make sure the configurations of...
  • Page 37 Single limb circuit with integrated exhalation insert Paediatric valve (Exh. valve) (optional for • Single limb circuit with leakage port (Leakage) leakage circuit and for MPV) • Circuit with mouthpiece interface Preparing the Vivo 65 for Use User manual Doc. 006150 M-1...
  • Page 38 Insert Mismatch alarm, with medium alarm priority. • Do not remove the gasket that is placed inside the Vivo 65’s insert socket. Remov- ing the gasket will result in a patient circuit leakage and a Disconnection alarm and/or Exhalation Valve Control Error alarm.
  • Page 39 3 Make sure a “click” sound is heard when fastening the lockring. This sound ensures that the insert is correctly attached. Unlock and disconnect in reverse order. Preparing the Vivo 65 for Use User manual Doc. 006150 M-1...

  • Page 40: Valve

    1 Connect one patient tube to the patient air outlet of the ventilator. 2 Connect the other patient tube to the exhaled air inlet of the Vivo 65. 3 Connect the other end of the patient circuit to an HME or patient interface. 4.4.3...

  • Page 41: Valve

    Check that the cables are properly connected. Inspection of Placement • The Vivo 65 shall be placed on solid flat surface below the patient level. (See 4.2 Placing the Vivo 65, page 32.) • Make sure that nothing can block the air inlet at the side.

  • Page 42: Perform The Pre-Use Test

    2. Connect the Vivo 65 to the AC power (Mains) supply. 3. Turn on the Vivo 65 main power using the Standby button on the side panel. 4. Ensure that the treatment settings and alarm settings are adjusted as prescribed, and that the correct patient circuit type is selected.
  • Page 43 Ensure that the delivered ventilation is closely monitored. Failure Due To Dual Limb Insert Calibration Indication: Dual: Fail 1 Check the patient circuit for leakage. 2 Replace the insert. Preparing the Vivo 65 for Use User manual Doc. 006150 M-1...

  • Page 44: How To Use The Vivo 65

    WARNING! Read the chapter 2 Safety Information, page 11 before using the Vivo 65. When the Vivo 65 is handed over to the patient, the physician in charge or hospital staff must instruct the patient in how the unit works.

  • Page 45: Stopping Treatment And Turning Off

    3 Press the Audio Pause button within 10 seconds. Press the button firmly. 4 When the Vivo 65 is not in an active treatment mode, press the Standby button on the side panel to change the unit to a low power standby state.

  • Page 46: Using The Menu

    The same navigation button can also be used to view additional information in some sec- tions, or it can be designated a temporary function while an event window is active. NOTE Use the up or down button to enter the menu list. How to Use the Vivo 65 User manual Doc. 006150 M-1...

  • Page 47: Symbols Used In The Menu

    Dual limb circuit for integrated exhalation valve selected (Dual). Single limb circuit with leakage port selected (Leakage) Exhalation valve Single limb circuit with active exhalation valve selected (Exh. valve) How to Use the Vivo 65 User manual Doc. 006150 M-1...
  • Page 48 Multiple pages Multiple content available High priority alarm High priority alarm event in history list Medium priority alarm Medium priority alarm event in history list How to Use the Vivo 65 User manual Doc. 006150 M-1...

  • Page 49: Menu Overview

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

  • Page 50: The Vivo 65 Display

    5.2.4 The Vivo 65 Display How to Use the Vivo 65 User manual Doc. 006150 M-1...
  • Page 51 The red lines represent the low and high pressure alarms, the low and high tidal volume alarms. 2. Icon/Alarm Message: Information icons are presented here to give a quick overview of the Vivo 65 basic sta- tus. (See 5.2.2 Symbols Used in the Menu, page 45.) 3. Screen, Title and Context Area: Screen title, page number (if more than one subpage exists in the section) and time are displayed.

  • Page 52: The Setup Section

    The Home Adjust function can be activated by the care provider. When activated, the care provider can unlock treatment parameters and define a limited setting range. The patient and lay care giver can change these settings within the limited range when the Vivo 65 is in Home mode.

  • Page 53: The Monitor Section

    The monitoring field displays all available values for the current treatment mode. (In most other screens, except for the curve and trend view, a small monitoring field is displayed with 8 values.) See 5.3 Monitored Values in the Vivo 65, page 53 for a description on the monitored values.
  • Page 54 Transferring Data with a Memory Card, page 69 for instructions on how to transfer memory data on a card and erase memory data. Patient Operating Time Shows the number of hours a patient has been using the Vivo 65 for breathing therapy. Device Settings General settings for the Vivo 65: •...

  • Page 55: Monitored Values In The Vivo 65

    • AC (On/Off) • External DC (V) • Serial Number Monitored Values in the Vivo 65 Values monitored by the ventilator can be found in: • The monitoring screen • Right hand side field in curve and trend screens •...

  • Page 56: Leakage

    Total Breath Rate. MVi is displayed when an MPV circuit or an active exhalation valve circuit is used. NOTE The Vivo 65 is suitable for treatment of patients that require a minute volume between 1 and 30 litres. 5.3.7...

  • Page 57: Total Rate

    5.3.19 Rise Time Rise Time displays the duration of the pressure or volume increase, measured from the start of inspiration until the set pressure or volume has been reached. How to Use the Vivo 65 User manual Doc. 006150 M-1...

  • Page 58: Etco 2

    The parameters used for controlling the breathing by the ventilator are described below. Depending on the setup for Home mode adjustment, parameters may not be available or have limited ranges when the Vivo 65 is in Home mode. 5.4.1 Parameters’ Availability in Different Modes This table offers an overview of the available parameters in each mode.

  • Page 59: Insp. Pressure

    The Backup Rate setting defines the minimum number of breaths the ventilator will deliver as long as no inspiratory trigger effort from the patient is detected. The cycles will be venti- lator-initiated breaths. How to Use the Vivo 65 User manual Doc. 006150 M-1...

  • Page 60: Simv Rate

    2 s (Paediatric mode) Default 1.5 s (Adult mode) 1 s (Paediatric mode) Resolution 0.1 s Tolerance ± (20 msec + 5%) or ± 0.1 s (whichever is smallest) How to Use the Vivo 65 User manual Doc. 006150 M-1...

  • Page 61: Backup Insp. Time (Backup Inspiratory Time)

    1 sigh every 100 breath Resolution — Tolerance Sigh % Sigh % sets the increased % of the set pressure (pressure mode) or volume (volume modes) is delivered to the patient. Default How to Use the Vivo 65 User manual Doc. 006150 M-1...

  • Page 62: Rise Time

    If the patient cannot trigger a breath, the ventilator will deliver breaths according to the set Backup Rate, Breath Rate or SIMV Rate. Off (Off only available in VCV and PCV modes. Off disables the Assist function) Default Resolution Tolerance — How to Use the Vivo 65 User manual Doc. 006150 M-1...

  • Page 63: Sup. Pressure (Simv Mode)

    Expiratory Trigger and/or minimum inspiratory time. 0.3 s 3 s (Adult mode) 2 s (Paediatric mode) Default Resolution 0.1 s Tolerance ± (20 msec + 5%) or ± 0.1 s (whichever is smallest) How to Use the Vivo 65 User manual Doc. 006150 M-1...

  • Page 64: Target Volume

    If Target Volume is used with a patient circuit with an active exhalation valve, leakage may be misinterpreted by the Vivo 65 as an increase of tidal volume. This will lead to a decrease of the Inspiratory Pressure (the Inspiratory Pressure will not be lower than the set Min Pressure).

  • Page 65: Tidal Volume

    5.4.19 Tidal Volume The Tidal Volume setting defines the volume that will be delivered by the Vivo 65 for each breath. In VCV-SIMV mode, this setting is applicable to the mandatory breaths that are controlled by the ventilator. 300 s (Adult mode)

  • Page 66: Patient Mode

    The ventilation and breath modes are used for controlling the ventilation treatment with the Vivo 65. The ventilation mode selected can be either Pressure, Volume or CPAP. It is used in combination with the Support, Assist/Control, SIMV or MPV breath mode.
  • Page 67 Inspiratory Trigger. This patient triggered breath will be delivered with the inspiratory time, rise time and pressure setting set by the operator. How to Use the Vivo 65 User manual Doc. 006150 M-1...
  • Page 68 See 5.4.16 Target Volume, page 62 for more information about Target Volume. PCV-SIMV – Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation In the PCV-SIMV mode, the Vivo 65 synchronizes mandatory pressure-controlled breaths with the patient’s breathing efforts. In this mode, the ventilator delivers mandatory pressure-controlled breaths with a preset breath frequency defined as the SIMV Rate.
  • Page 69 MPV breath mode shall not be used with ventilator dependent patients. VCV – Volume Controlled Ventilation In the VCV mode the ventilation is controlled by the Vivo 65. This is done with the preset tidal volume, breath rate, inspiratory time, and rise time settings set by the operator.
  • Page 70 VCV-SIMV – Volume Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation In the VCV-SIMV mode, the Vivo 65 synchronizes mandatory volume-controlled breaths with the patient’s breathing efforts. In this mode, the ventilator delivers mandatory volume-controlled breaths with a preset breath frequency defined as the SIMV Rate. The SIMV Rate setting determines the length of the SIMV cycle.

  • Page 71: Transferring Data Between The Vivo 65 And A Pc

    Read the chapter 2.2 Electrical Safety, page 13 carefully to make sure all conditions are con- sidered and met. CAUTION! Do not eject the memory card or disconnect the Vivo-PC data cable while the Vivo 65 is transferring data. Doing so may result in loss of data and/or damaged equipment. NOTE In order to view and present patient data correctly, the Vivo 65 PC Software must be installed on the PC.
  • Page 72 1 Insert the memory card in the memory card slot on the side of the Vivo 65. Make sure the memory card is properly inserted. 2 When the memory card is inserted, a pop-up window will appear on the Vivo 65’s display.

  • Page 73: Using Batteries

    Vivo 65 is maximized during its lifetime. The internal and click-on batteries in the Vivo 65 are of the Lithium-ion type, which is a high performance battery. It has long expected lifetime, low weight in relation to its capacity and low self discharge.

  • Page 74: Battery Icons

    To ensure that the batteries are fully charged, a maintaining charging cycle will be performed. The batteries are not charged when connecting the Vivo 65 to an external DC supply. While charging, the battery level will be animated. The batteries are only charged if the internal temperatures are between 0 to 45°C (32 to 113°F).

  • Page 75: Click-On Battery

    Connect the Click-on Battery 1 Use, for example, a small screwdriver to open the cover for the click-on battery connectors. 2 Make sure the cover is completely opened. How to Use the Vivo 65 User manual Doc. 006150 M-1...
  • Page 76 3 Hold the Vivo 65 as shown in the picture, in order to target the click-on battery holders (marked with circles). 4 Tilt the Vivo 65 into an upright position. 5 Once in position, a clicking sound should be heard.

  • Page 77: Battery Operating Time (Internal And Click-On)

    5.7.6 Battery Operating Time (Internal and Click-on) The operation time is dependent on the battery condition, its capacity, the ambient air tem- perature and the Vivo 65 pressure setting. These data are based on new and fully charged batteries. PARAMETER...

  • Page 78: Storing The Internal Battery And The Click-On Battery

    CAUTION! Only use a battery charger compliant to IEC 606011 if you are charging a battery that at the same time is connected to the ventilator. How to Use the Vivo 65 User manual Doc. 006150 M-1...
  • Page 79 See 9.2 Power Accessories, page 149 for part numbers and more information. With an external DC source connected, the Vivo 65 will automatically switch over to the external DC source if the AC power (Mains) cord is removed or if the AC power (Mains) supply fails.

  • Page 80: Using Accessories

    Using the Vivo 65 with a Nurse Call System The Vivo 65 can be connected to a nurse call system using the nurse call cable. When con- nected, the Vivo 65 alarms will also be forwarded to the nurse call system.

  • Page 81: Using The Vivo 65 With The Fio 2 Sensor

    1 Connect the nurse call cable on the left side panel of the Vivo 65. 2 Test the connection by triggering an alarm on the Vivo 65 and verify that the nurse call system activates. 5.8.3 Using the Vivo 65 with the FiO...
  • Page 82 T-piece and the Vivo 65. Disconnect the T-piece from the Vivo 65 and the patient circuit. Dismantle the plug from the T-piece. 2. Place the T-piece and the plug in hot water containing mild detergent.

  • Page 83: Using The Vivo 65 With The Remote Alarm

    Using the Vivo 65 with the CO Sensor The CO sensor can be connected to the patient breathing circuit and to a Vivo 65 in order to monitor and store CO measurements. The CO measurements will be stored in the Vivo 65 data memory which can be downloaded to a PC and viewed in the Vivo 65 PC software.
  • Page 84 Breas Medical reserves the right to make changes to this product without any prior notification. Do not use a damaged CO sensor or adapter.
  • Page 85 2 Snap the CO sensor probe on top of the airway adapter. It will click into place when properly sealed. 3 Perform a CO zeroing procedure. How to Use the Vivo 65 User manual Doc. 006150 M-1...
  • Page 86 Calibration” page under the “Others” section. LED Status Description Steady green light System OK Flashing green light Zeroing in progress Steady red light Sensor error Flashing red light Check adapter How to Use the Vivo 65 User manual Doc. 006150 M-1...

  • Page 87: Using The Vivo 65 With The Spo 2 Module

    Using the Vivo 65 with the SpO Module The SpO module can be connected to the Vivo 65 in order to monitor and store SpO measurements. The SpO measurements will be stored in the data memory which can be downloaded to a PC and viewed in the Vivo 65 PC software.

  • Page 88: Using The Vivo 65 With The Protective Cover

    Vivo 65 is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. Do not use the Vivo 65 in the protective cover while positioned in a warm place, such as direct sunlight or close to a radiator.
  • Page 89 Port for patient circuit, cables, O inlet, standby button Cooling air inlet Patient air inlet Straps for safe mounting Cooling air outlet CAUTION! * Do not cover the air inlets or outlets. How to Use the Vivo 65 User manual Doc. 006150 M-1...

  • Page 90: Alarms

    Never leave a patient unattended during an alarm condition. Setting alarm limits to extreme values could put the patient at risk. Permitted distributed alarm systems are Vivo 65 remote alarm with cable and Vivo 65 nurse call cables provided by Breas Medical only.

  • Page 91: Audible Signal Pause

    Audible signals • High priority: 3 signals followed by 2 more. The signal sequence is repeated with a 0.5 second pause and thereafter a 3 second pause. • Function failure: Same signal as the high priority alarm or a constant signal, depending on the kind of function failure.

  • Page 92: Alarm Reset

    1 Press and hold the Audio Pause button for about 3 seconds. ⇒A confirmation request is displayed. 2 Press OK to confirm. 6.1.4 Alarm Reset An alarm will automatically be reset once the cause of the alarm has been corrected. In the alarm descriptions, read the Possible cause information and perform corrective actions, if applicable.

  • Page 93: Physiological Alarms

    A full breath is performed with maximum pressure below the alarm limit. Ventilator action The Vivo 65 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 94: Low Pressure Alarm

    Priority High Alarm condition A Low Pressure alarm will be given when the Vivo 65 pressure fails to reach the low pressure alarm limit for 15 seconds. In MPV breath mode the alarm will be given when the pressure fails to reach the limit during inspiration.

  • Page 95: High Peep Alarm

    • Blocked exhalation valve. Reset criteria PEEP has gone below the alarm limit (lower than 30% above the set value). Ventilator action The Vivo 65 will continue treatment according to the current settings. Setting range • • 6.3.4 Low PEEP Alarm...

  • Page 96: High Vt I (High Inspired Tidal Volume Alarm)

    Inspired Tidal Volume exceeds the set limit for the High Inspired Tidal Volume alarm for 15 seconds. This alarm is only used if the Vivo 65’s patient circuit type is set to Exhalation valve (single limb) circuit or in MPV modes.

  • Page 97: High Vt E Alarm (High Expired Tidal Volume)

    A High Expired Tidal Volume alarm will be given when the monitored Expired Tidal Volume exceeds the alarm limit for 15 seconds. This alarm is only used if the Vivo 65’s patient circuit type is set to Dual limb or Leakage (single limb) circuit. Possible cause •...

  • Page 98: Low Vt I Alarm (Low Inspired Tidal Volume)

    Inspired Tidal Volume fails to reach the set limit for the Low Inspired Tidal Volume alarm for 15 seconds. This alarm is only used if the Vivo 65’s patient circuit type is set to Exhalation valve (single limb) circuit or in MPV modes.

  • Page 99: Low Vt E Alarm (Low Expired Tidal Volume)

    Expired Tidal Volume fails to reach the set limit for the Low Expired Tidal Volume alarm for 15 seconds. This alarm is only used if the Vivo 65’s patient circuit type is set to Dual limb or Leakage (single limb) circuit.

  • Page 100: High Mv

    A High Inspired Minute Volume alarm will be given when the monitored inspired minute volume exceeds the set limit for 15 seconds. This alarm is only used if the Vivo 65’s patient circuit type is set to Exhalation valve (single limb) circuit or in MPV modes. Possible cause •...

  • Page 101: High Mv E (High Expired Minute Volume Alarm)

    A High Expired Minute Volume alarm will be given when the monitored expired minute volume exceeds the alarm limit for 15 seconds. This alarm is only used if the Vivo 65’s patient circuit type is set to Dual limb or Leakage (single limb) circuit. Possible cause •...

  • Page 102: Low Mv I (Low Inspired Minute Volume Alarm)

    A Low Inspired Minute Volume alarm will be given when the monitored minute volume does not reach the alarm limit for 15 seconds. This alarm is only used if the Vivo 65’s patient circuit type is set to Exhalation valve (single limb) circuit. Possible cause •...

  • Page 103: Low Mv Alarm (Low Expired Minute Volume)

    A Low Expired Minute Volume alarm will be given when the monitored minute volume is below the alarm limit for more than 15 seconds. This alarm is only used if the Vivo 65’s patient circuit type is set to Dual limb or Leakage (single limb) circuit. Possible cause •...

  • Page 104: 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 65 will continue treatment according to the current settings. Setting range • 10 bpm to 70 bpm (Adult mode) •...

  • Page 105: Low Breath Rate Alarm

    Decrease in the patient’s spontaneous breathing. • Circuit disconnection. Reset criteria The breath rate goes above the alarm limit. Ventilator action The Vivo 65 will continue treatment according to the current settings. Setting range • Adult: 1 bpm to 30 bpm. •...

  • Page 106: Apnea Alarm

    • Inspiratory Trigger is set too high. Reset criteria Inspiratory effort detected by the Vivo 65. Ventilator action The Vivo 65 will continue treatment according to the current settings. Setting range • 5 to 60 s. (Non MPV mode) •...
  • Page 107 • The patient has removed the mask. • Circuit disconnection. Reset criteria The leakage is back within limits. Ventilator action The Vivo 65 will continue treatment according to the current settings Setting range • • Alarms User manual Doc. 006150 M-1...

  • Page 108: Rebreathing Alarm

    For active exhalation valve circuits: The control pressure evacuation outlet at the bottom the ventilator is obstructed. Reset criteria The leakage is back within limits. Ventilator action The Vivo 65 will continue treatment according to the current settings. Setting range • •...

  • Page 109: Obstruction Alarm

    6.3.18 Obstruction Alarm Property Description Obstruction Alarm text Priority High Alarm condition An Obstruction alarm will be given if the inspiratory breathing tube becomes blocked and remains blocked for 2 consecutive breaths. Note: An obstruction of the expiratory breathing tube can be detected with the Low Vt alarm.

  • Page 110: Low Fio

    Possible cause Too high flow of bleed-in oxygen. Reset criteria The SpO value goes back below the alarm limit. Ventilator action The Vivo 65 will continue treatment according to the current settings. Setting range • 90 % to 100 % •...

  • Page 111: Low Spo

    6.3.22 Low SpO Alarm Property Description Alarm text Low SpO2 Priority High Definition A Low SpO alarm will be given when the measured SpO below the alarm limit for 30 seconds. Possible cause • Too low flow of bleed-in oxygen. •...

  • Page 112: Low Etco

    6.3.24 Low EtCO Alarm Property Description Low EtCO2 Alarm text Priority Medium Alarm condition A Low EtCO alarm will be given when the measured EtCO below the alarm limit for 30 seconds. Possible cause • Alarm limit is set too high. •...

  • Page 113: 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 65 will continue treatment according to the current settings. Setting range 30 to 230 bpm (beats per minute) Setting resolution...

  • Page 114: Low Pulse Rate Alarm

    The power is restored Ventilator action The Vivo 65 stops treatment and gives alarm for at least 2 minutes. If power is restored within 10 minutes, the Vivo 65 will auto- matically resume treatment with current settings. Alarms User manual...

  • Page 115: High Patient Air Temp. (High Patient Air Temperature)

    • Blocked cooling air outlets. • Too high ambient temperature. Ventilator action The Vivo 65 will continue treatment. The ventilator stops treatment and gives alarm for up to 2 minutes. Reset criteria The temperature goes below the limit again. 6.4.3...

  • Page 116: Lost Mains Alarm

    Property Description Priority Medium Ventilator action The ventilator will continue treatment with the same settings. 6.4.5 Lost Mains Alarm Property Description Alarm text Lost Mains Power Alarm condition A Mains Power Lost alarm will be given when the ventilator switched from AC power (Mains) to another power source due to AC Power (Mains) is lost.

  • Page 117: Circuit Type/Insert Mismatch Alarm

    6.4.7 Circuit Type/Insert Mismatch Alarm Property Description Alarm text Circ/Insert Mismatch Alarm condition A Circuit Type/Insert Mismatch alarm will be given when the ventilator detects an incorrect combination of the selected patient circuit type setting and the insert attached to the ventilator.

  • Page 118: Exhalation Valve Control Error Alarm

    6.4.9 Exhalation Valve Control Error Alarm Property Description Exhalation Valve Control Error Alarm text Alarm condition An Exhalation Valve Control Error alarm will be given when the ventilator fails to control the internal /external exhalation valve. Priority High Possible cause •...

  • Page 119: Spo /Co /Remote Start/Stop Failure Alarm

    Property Description Alarm text Vte/MVe Sensor Error Alarm condition A Vte/MVe sensor error alarm occurs when the sensor for Vte/MVe measurement fails. The Vte/MVe readings on the display are not correct. Contact your service provider. The ventilator can still be used with single limb circuit.

  • Page 120: Signal)

    6.4.14 Signal Inadequacy Alarm (SpO Signal) Property Description Alarm text SPO2 Signal Alarm condition An SpO Signal Inadequacy alarm will be given when the SpO probe is not able to perform an adequate measurement, due to low perfusion or artefacts. Check the SpO sensor.

  • Page 121: Co 2 Sensor Error Alarm

    6.4.17 Sensor Error Alarm Property Description CO2 Sensor Error Alarm text Alarm condition A CO Sensor Error alarm will be given when an error in the sensor has occurred. Replace the CO sensor. CO monitoring cannot be performed in this condition. Priority High Ventilator action...

  • Page 122: Ambient Pressure Compensation Lost Alarm

    Ventilator action The Vivo 65 will continue treatment according to the current settings. Normal atmospheric pressure at sea level will be used as approximation for the temporary ambient pressure compensa- tion.

  • Page 123: Humidity Comp. Lost

    6.4.21 Humidity Comp. Lost (Humidity Compensation Lost Alarm) Property Description Alarm text Humidity Comp. Lost Alarm condition An Humidity Compensation Lost alarm will be given when the automatic humidity compensation is out of order. 50% relative humidity is used for temporary compensation. If the ventilator is used at other humidities, delivered and meas- ured pressure and flow may deviate.

  • Page 124: Alarm For Beeper Failure

    6.4.24 Alarm for Beeper Failure Property Description Alarm text Alarm Beeper Fail Alarm condition Failure of the beeper control by the treatment processor. Priority High Ventilator action The ventilator will continue treatment with the same settings. 6.4.25 Int. Function Failure (Internal Function Failure Alarm) Property Description Alarm text...
  • Page 125 3 The Low Vti or Low Vte Alarm will be given. 4 Stop treatment. Test completed. Obstruction Alarm 1 Start treatment; block the patient circuit completely to simulate an obstruction. 2 Wait approximately 10 seconds. 3 The Obstruction Alarm will be given. (If the expiratory path is blocked, a Disconnection Alarm may be triggered.) 4 Stop treatment.

  • Page 126: Cleaning And Maintenance

    2 Remove the patient circuit. 3 Disconnect all electric cables. 4 Clean the outside of the Vivo 65 using a lint-free cloth with a mild soap solution, and/or ethanol 70% for surface disinfection. 5 Reconnect the patient circuit. Make sure all parts are dry before the Vivo 65 is put into operation.

  • Page 127: Insert

    Cooling Air Inlet Filter The cooling air inlet filter is located in the filter cassette at the side of the ventilator. Replace the filter at least once a year. Wash the filter at least once a week. 1 Wash the filter using warm water and a mild soap.

  • Page 128: Cleaning And Replacing The Patient Air Filters

    CAUTION! Appropriate personnel should determine the duration of use for the patient circuit based on accepted infection control procedures. Cleaning and Replacing the Patient Air Filters The patient air filters are located in the filter cassette at the side of the ventilator. There are two types of filters: •...

  • Page 129: Change Of Patients

    1 Follow the instructions in 7.1 Cleaning the Vivo 65, page 124, steps 1 to 5. 2 Replace the patient filters according to 7.2 Cleaning and Replacing the Patient Air Filters, page 126.

  • Page 130: Storage

    Storage Store the Vivo 65 in a dark room, where the temperature range is within -20 to +60°C (-4 to +140°F). For instructions on how to charge the batteries after long time storage, see 5.7 Using Batteries, page 71.

  • Page 131: Technical Specifications

    Technical Specifications System Description 8.1.1 Dual Limb Circuit with Integrated Exhalation Valve DESCRIPTION Vivo 65 Tubes Insert with integrated exhalation valve Patient interface connection Patient Technical Specifications User manual Doc. 006150 M-1...

  • Page 132: Single Limb Circuit With Active Exhalation Valve

    8.1.2 Single Limb Circuit with Active Exhalation Valve DESCRIPTION Vivo 65 Tube Active Exhalation valve Patient interface connection Patient 8.1.3 Single Limb Circuit with Leakage Port DESCRIPTION Vivo 65 Tube Leakage port / Patient interface connection Patient Technical Specifications User manual...

  • Page 133: Mpv Breath Model

    8.1.4 MPV Breath Model DESCRIPTION Vivo 65 Tube Mouthpiece interface Patient Technical Specifications User manual Doc. 006150 M-1...

  • Page 134: Pneumatic Diagram For The Vivo 65 With Dual Limb

    8.1.5 Pneumatic Diagram for the Vivo 65 with Dual Limb Circuit DESCRIPTION Air inlet with filters Inlet silencer Blower Outlet silencer Restriction Patient air outlet Flow sensors Pressure sensors Zero valve Exhaled air inlet /outlet Exhalation valve control pressure valve...

  • Page 135: Pneumatic Diagram For The Vivo 65 With Single Limb

    Exhalation valve control pressure sensor Low pressure/bleed-in oxygen connection 8.1.7 Worst Case Accuracy Pressure Control Modes The worst case Vivo 65 System is the dual limb patient circuit with HCH humidifier, bacte- rial filter, FiO sensor and CO sensor. Technical Specifications User manual Doc.

  • Page 136: Data Parameters

    Volume Control Modes The worst case Vivo 65 System is the dual limb patient circuit with or without HCH humidifier, bacterial filter, FiO sensor and CO sensor. Data Parameters NOTE All stated tolerances includes measurement uncertainty. The accuracies have been tested with all allowed configurations.

  • Page 137: Alarms

    RANGE ACCURACY MONITORED VALUE % Spont 0 to 100%. Not applicable 70 to 100%. ±3 digits. Data update period 1 4-beat average signal processing. Pulse Rate 18 to 300 bpm. ±3 digits. Data update period 1 4-beat average signal processing. 1:99 to 10:1.
  • Page 138 (10000 feet) above sea level to ~700 metres (2300 feet) below sea level, at normal atmospheric pressure. As seen in the graph above, the Vivo 65 is unable to deliver set max pressure at a very low ambient pressure. Humidity 10% to 95%, non-condensing 8.2.4.3 Leakage Conditions...
  • Page 139 CIRCUIT RESISTANCE SPECIFICATION AND COMPLIANCE LIMITS Exhalation-valve circuit 0 to 20 cm H O at 60 l/min (Paediatric) resistance 0 to 35 cm H O at 120 l/min (Adult) Exhalation-valve circuit 0 to 4 ml/cm H compliance 8.2.4.5 Oxygen Inlet OXYGEN INLET SPECIFICATION Oxygen inlet port...
  • Page 140 8.2.4.8 Vivo 65 Dimensions DIMENSIONS SPECIFICATION W × H × D 348 × 120 × 264 mm (13.7 × 4.7 × 10.4 inch) with- out click-on battery 348 × 120 × 290 mm (13.7 × 4.7 × 11.4 inch) with...

  • Page 141: Emission And Immunity Declaration

    8.3.1 Vivo 65 Essential Performance The Vivo 65 will deliver ventilation at the patient-connection port within its published accu- racy specifications and within the alarm limits set by the operator, or generate an alarm con- dition for high pressure, low pressure, high PEEP, low inspired tidal volume, low expired...
  • Page 142 IEC 61000-4-8 in a typical commercial, hospi- tal and residential environment. Voltage dips, short 0% U , 0.5 cycle (multiple Vivo 65 runs on internal bat- interruptions and phase analysis); tery during voltage dips, short voltage variations 0% U , 1 cycle;...
  • Page 143 Immunity Test Compliance Level Electromagnetic Environ- ment - Guidance Conducted RF IEC 150 kHz to 80 MHz 3 Vrms d=0.35*√P m at 150 kHz to 61000-4-6 ISM and amateur radio bands; 80 MHz 6 Vrms Radiated RF IEC 10 V/m 80 MHz to 2.5 GHz d= 1.2*√P m at 80 MHz to 61000-4-3 800 MHz...

  • Page 144: Emission

    8.3.3 Guidance and Manufacturer's Declaration – Electromagnetic Emission The ventilator is intended for use in the electromagnetic environment specified below. The customer or the user of the ventilator should assure that it is used in such an environment. Emissions test Compliance Level Electromagnetic Environ- ment - Guidance...

  • Page 145: Recommended Separation Distances Between External Power

    For transmitters rated at a maximum output power not listed above, the recommended sepa- ration distance d in meters (m) can be estimated using the equation applicable to the fre- quency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 146 Default settings: parameters Inspiratory Pressure: 15 cmH PEEP: 5 cmH Breath Rate: 12 bpm SIMV Rate: 12 bpm Inspiration Time: 1.5 s Rise Time (ventilation mode: pressure): 3 Inspiratory Trigger: 3 SIMV Support Pressure: 15 cmH Expiratory Trigger: 3 Maximum Inspiratory Time: Off Minimum Inspiratory Time: Off Backup Rate: 12 bpm Backup Inspiration Time: 1.5 s...
  • Page 147 Default settings: alarms High Pressure Alarm: 25 cmH O (Adult), 20 cmH O (Paediatric) Low Pressure Alarm: 10 cmH High PEEP Alarm: Off Low PEEP Alarm: Off High Vt Alarm: 500 ml (Adult), 400 ml (Paediatric) High Vt Alarm: 500 ml (Adult), 400 ml (Paediatric) Low Vt Alarm: 300 ml (Adult), 100 ml (Paediatric) Low Vt...

  • Page 148: Accessories And Parts

    WARNING! Only use accessories recommended by Breas Medical AB. Breas Medical AB cannot guarantee the performance and safety for the use of other accessories with the Vivo 65. To reduce the likelihood of disconnection and to prevent adverse ventilator performance, use only accessories compatible with the Vivo 65.
  • Page 149 Circuit: Dual Limb with Exhalation Valve Function: Deliver air to the patient. Part No: 007616 (disposable) Circuit: Dual limb for integrated exhalation valve Function: Deliver air to the patient Adult, diameter 22 mm Paediatric, diameter 15 mm Part No: Adult: 005520 Paediatric: 005519 Circuit: Single limb with active exhalation valve Function: Deliver air to the patient...
  • Page 150 BFE (Bacterial Filtration Efficiency): 99.9% • VFE (Viral Filtration Efficiency): 99.8 % Part No: 004185 Low pressure oxygen adapter Function: Oxygen tube adapter with con- nector for the Vivo 65. Part No: 005032 Accessories and Parts User manual Doc. 006150 M-1...

  • Page 151: Power Accessories

    JP: 1,8 m:\005338\3,6 m:\007220 US: 1.8 m:\005432\3.6 m:\007219\ XPAC - External battery with charger Function: Extends usage time of sup- ported Breas products. Part No Cable for connection to device: 007804 Part No Charger with cable: Single: Charger with one battery...

  • Page 152: Monitoring Accessories

    Function: Convert 12 V DC, in a car for example, to stable 24 VDC. Part No: 004901 Monitoring Accessories Memory card Function: Vivo 65 settings, patient data and usage data Part No: 003619 Memory card reader/writer Function: Read/write memory card...
  • Page 153 Vivo 65 USB cable Function: Data cable: PC and Vivo 65 (USB to USB) Part No: 004886 Remote alarm with cable Function: Monitor Vivo 65 alarms remotely Part No: 10 m: 006348, 25 m: 006349 Remote alarm cable Function: Part No: 10 m: 006359, 25 m: 006360, 50...
  • Page 154 Remote start/stop Function: Start and stop the ventilator remotely. Also, pause audio remotely. Part No: 006342 sensor Function: Measure O in the patient air Part No: 006347 T-piece with plug Function: Connect the FiO sensor to the patient circuit Part No: 005120 module Function: Connection interface Part No: 006369...

  • Page 155: Ventilator Filters And Detachable Parts

    sensor Function: Multisite SpO sensor Part No: 006591 EtCO sensor Function: Measure CO in the airflow Part No: 006346 Airway adapter Function: Connects the EtCO sensor to the patient circuit Part No: 005263 (25 pcs) Ventilator Filters and Detachable Parts Patient air inlet filter (white) Function: Inlet air filtration Part No: 004910 (10 pcs)

  • Page 156: Other Accessories

    Other Accessories Manual Function: Product and usage information Part No User manual: 006150 Part No Clinician’s manual: 006151 Carry bag Function: Storage for transportation Part No: 006343 Trolley Function: Mobile use, transportation Part No: 007384 Accessories and Parts User manual Doc.
  • Page 157 Patient circuit arm Function: To support a patient circuit. Part No: 007917 Mounting bracket Function: Mount the Vivo 65 on the trol- ley or a hospital rail system Part No: 007916 Accessories and Parts User manual Doc. 006150 M-1...
  • Page 158 Universal rail clamp Function: Attach a humidifier to a trolley. This accessory is part of the trolley system. Part No: 007858 E-cylinder holder Function: Attach an E-cylinder to a trolley. This accessory is part of the trolley system. Part No: 005128 Accessories and Parts User manual Doc.
  • Page 159 IV-pole Function: Pole with hooks to hang IV fluid bags. Part No: 007859 MPV Arm Function: Hold an MPV circuit so Mouth- piece can be mounted close to the patient Part No: 006095 Protective cover Function: Shock protection Part No: 006344 Accessories and Parts User manual Doc.
  • Page 160 Polishing cloth Part No: 005066 Accessories and Parts User manual Doc. 006150 M-1...

  • Page 161: Patient Settings

    Patient Settings This section can be copied and used for noting the patient’s settings. Patient Settings - Vivo 65 Patient ....................Date ....................Clinic ....................Set by ....................Ventilation mode:................Patient Circuit Tidal Volume Pressure Inspiratory Trigger PEEP Expiratory Trigger...

  • Page 162: Faa Compliance

    Electromagnetic 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 ventilator System complies with RTCA/DO-160, Section 21, Category M and can be considered FAA compliant.

  • Page 163: Index

    Index Low pressure ..... . . 92 Low pulse rate ....112 Low SpO .
  • Page 164 Disconnection alarm....104 LED Failure alarm....121 Lost AC Power (Mains) alarm ..114 Low Alarm Battery alarm.
  • Page 165 Obstruction alarm ....107 Warning Operator’s position Icon........9 audible range .

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Vivo 55

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