Breas Vivo 45 LS User Manual
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Breas Vivo 45 LS User Manual

Breas Vivo 45 LS User Manual

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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
Fax +46 31 86 88 10 www.breas.com, Date: 2021-01-28
Vivo 45 LS
User's
,
ENGLISH (US)
7 321820 073016
U U S S E E R R M M A A N N U U A A L L
007301 EN-US K-1

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  • Page 1 User’s 007301 EN-US K-1 ENGLISH (US) 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 073016 Fax +46 31 86 88 10 www.breas.com, Date: 2021-01-28...

  • Page 3: Table Of Contents

    Checking the Vivo 45 LS before First Use ....... . .
  • Page 4 Connecting the Vivo 45 LS to Mains ....... . .47...
  • Page 5 Functions and Parameters in the Vivo 45 LS ....... . .
  • Page 6 5.7.10 Using the Vivo 45 LS with the Trolley ....107 Alarms ............... . 109 Alarm Function .
  • Page 7 Physiological Alarms ............. . .111 6.3.1 High Pressure Alarm .
  • Page 8 6.4.4 Low Last Power Source Alarm ......139 6.4.5 Crit. Low Last Power Source Alarm..... 139 6.4.6 Lost Mains Power Alarm.
  • Page 9 Vivo 45 LS Essential Performance ........
  • Page 10 Accessories and Parts............181 Air Delivery Accessories .

  • Page 11: Introduction

    U.S. Federal law restricts this device to sale by or on order of a physician. What is the Vivo 45 LS? The Vivo 45 LS is a pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation.
  • Page 12 CPAP – Continuous Positive Airway Pressure Compatible Patient Circuits The Vivo 45 LS can be used with a leakage circuit, an MPV circuit or a circuit with active exhalation valve. For leakage circuits: The patient circuit shall comply to ISO 17510. The leakage should be at least 12 l/min at 4 cmH O, to prevent rebreathing of exhaled air.

  • Page 13: Intended Use

    Data Log The Vivo 45 LS has an internal memory with a data log that holds the following data: • Running hours • Technical alarms • Settings • Asset data • Treatment hours • Treatment settings • Device serial number •...

  • Page 14: Contraindications

    The device is intended to be used in home, institution, hospitals and portable applica- tions such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or crit- ical care ventilator.

  • Page 15: 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 45 LS and in the spe- cific 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 16: About This Manual

    Training and Certification Service personnel shall be trained on the Vivo 45 LS and certified by Breas for being allowed to perform any service, repairs or other operations on the Vivo 45 LS. The training consists of reading the services manual in full.
  • Page 17 Icon Explanation Warning! Risk of death or personal injury. Warning! Risk of Cross-contamination. Warning! Risk of electric shock. Warning! Hot surface, risk of burns. Warning! Flammable material, risk of fire. Caution! Risk of equipment damage, loss of data, extra work, or unexpected results.

  • Page 18: Manufacturer Information

    Manufacturer Information Legal Manufacturer Postal Address Breas Medical AB Företagsvägen 1 SE-435 33 Mölnlycke Sweden Web Address www.breas.com Email address breas@breas.com Phone +46 31 868800, Order: +46 31 868820, Technical support: +46 31 868860 +46 31 868810 US Manufacturing Site Postal address Breas Medical Inc.

  • Page 19: Safety Information

    Risk of Reduced Safety and Performance Accessories that have not been tested with the Vivo 45 LS might affect safety fea- tures and performance negatively. Only use the Vivo 45 LS with accessories approved by Breas Medical.
  • Page 20 When a ventilator-dependent patient is treated outside a health care facility (e.g. in the home setting) there should always be a trained caregiver present to respond to alarms or conditions the patient is unable to solve on their own (e.g., troubleshooting alarm conditions and taking appropriate corrective action).
  • Page 21 Before starting treatment, always perform the procedure 4.5 Inspecting the Vivo 45 LS before Use , page 50. Risk of Unnoticed Critical Conditions •...

  • Page 22: Requirements For Life Supporting Treatment

    Modifying or using the ventilator with accessories that are not specified or approved by Breas may cause cardiac arrhythmia. The Vivo 45 LS must only be used in original and unmodified shape and only with accessories specified or approved by Breas Medical.

  • Page 23: Electrical Safety

    Risk of Electric Shock High voltage contact may cause cardiac arrhythmia. • Do not operate the Vivo 45 LS if it has a damaged power cord, power supply or casing. • To avoid electrical shock, only clean the Vivo 45 LS according to instructions in this manual.

  • Page 24: Environmental Conditions

    Caution should be exercised if the room temperature is greater that 36°C (97° Risk of Faulty Treatment If a room humidifier is used, place it at least 2 meters away from the Vivo 45 LS. Risk of faulty Treatment The performance of the Vivo 45 LS may deteriorate at altitudes or ambient tempera- tures outside the operation conditions specified in the chapter Technical Specifications.
  • Page 25 Do not use or store the Vivo 45 LS in a magnetic resonance (MR) environment. Use of the Vivo 45 LS in an MR environment may result in malfunction of the Vivo 45 LS and pose unacceptable risk to the patient, medical staff or other persons.

  • Page 26: Usage Of Patient Circuit

    • The Vivo 45 LS should be turned on and the function of the leakage port should be checked before use: The pressurized air from the Vivo 45 LS causes a continu- ous flow of air through the leakage port, enabling flushing of exhaled air.
  • Page 27 When present, remove the moisture. Before attempting to dry the circuit, disconnect it from the Vivo 45 LS to ensure no water flows back into the Vivo 45 LS. The frequency at which these checks must be performed will depend on the patient’s condition and the device used.
  • Page 28 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 45 LS is to be used by a new patient. NOTE For masks and accessories, always follow the manufacturer’s instructions.

  • Page 29: Usage Of Filters

    Risk of Insufficient Ventilation Insufficient ventilation may cause transient hypoxia. Do not use high resistance bacteria filter at the air outlet of the Vivo 45 LS. High resistance bacteria filters placed between the air outlet and the patient interface may interfere with the operation of the patient disconnect function.

  • Page 30: Cleaning And Maintenance

    Risk of Electric Shock Cleaning with excessive water or opening the device’s casing without certified train- ing may cause electric shocks. The Vivo 45 LS should be regularly cleaned and maintained in accordance with this operating manual. WARNING! Risk of Faulty Treatment Service and Maintenance of the Vivo 45 LS shall not be performed when the Vivo 45 LS is in use.

  • Page 31: Usage Of Oxygen

    The presence of oxygen can speed up combustion of inflammable materials. Risk of Fire When oxygen is used with the Vivo 45 LS, the oxygen flow must be turned off when the Vivo 45 LS is not operating. Oxygen delivered into the patient tubing may accu- mulate within the machine enclosure.
  • Page 32 WARNING! Do not use a humidifier between the oxygen source and the ventilator, in order to humidify the oxygen flow. If humidification is required, use an external humidifier after the patient air outlet. WARNING! Risk of Fire Ventilate the room adequately. Do not smoke in a room where oxygen is being used. Risk of Fire Naked light bulbs and other sources of ignition must be kept a minimum of 2 meters (6 feet) away from the oxygen cylinder or any part of the patient circuit.
  • Page 33 CAUTION! Supplemental oxygen is added before the volume measurement sensor and thereby included in the measurements. However, the oxygen concentration still has influence on the volume measurement of the delivered air. This measurement is based on a normal oxygen concentration of 21%. If the oxygen concentration is higher, the actual inspired volume will deviate from the monitored volume as follows: •...

  • Page 34: Product Description

    This section describes the components of the Vivo 45 LS medical electric equipment. NOTE • There might be local variations of the main components configuration. • The standard Vivo 45 LS and its packaging do not contain any natural rubber latex. Carry bag Function: Storage for transportation Part No: 006014...
  • Page 35 Power Supply Function: Deliver power to the ventilator Part No: 006396 Power cord Function: Deliver power to the AC power supply Part No: US: 009024 Vivo 45 LS Main Unit Main Unit Product Description User manual Doc. 007301 K-1...

  • Page 36: Front View

    Front View Item Function Sensor Ambient light sensor 2, 3 Alarm (red & yellow) LEDs Alarm indication: Red = High priority Yellow = Medium priority Audio pause LED Paused alarm sound indication Navigation /Setting buttons Navigate on the display /Define settings Mains LED Power source indication: Mains...

  • Page 37: Side Views

    Side Views Click-in compartment side Item Function Audio pause Pause the alarm sound Start/Stop Start/Stop ventilation treatment Patient air outlet Connection for patient circuit Air bypass unit Click-in airway/silencer. Click-in compartment Compartment for the click- in battery. Side panel Cover Carrying handle Handle for lifting the ventilator...
  • Page 38 Filter Side Item Function Side panel Cover Memory card slot (SD card) Memory download Alarm beeper Alarm Sounds Output Patient air inlet Air bypass unit in, replace- able filters Internal battery Compartment for the inter- nal battery sensor hatch Compartment for the optional FiO sensor Product Description...

  • Page 39: Detaching And Reattaching The Side Panels

    3.3.1 Detaching and Reattaching the Side Panels Detaching the Filter Side Panel 1 Lift the handle to access the release button (A). 2 Looking from behind, to dismount the filter side panel press the button above the panel (B). The panel is released.
  • Page 40 Detaching the Click-in Compartment Side Panel 1 Lift the handle to access the release button (A). 2 Press the button marked “1”. (B). ⇒The panel is released. 3 Remove the panel (C). Reattaching the Click-in Compartment Side Panel 1 Lift the handle to access the release button (A).

  • Page 41: Equipment Designation

    Equipment Designation 7 8 9 Description Colour Item/Symbol Not used Exhalation valve port Connection for low pressure/ bleed-in oxygen source interface port interface port Remote start/stop and Audio pause interface port Product Description User manual Doc. 007301 K-1...

  • Page 42: Additional Symbols

    USB data connection port Mains/External DC inlet 12-24V 3.4.1 Additional Symbols This section describes symbols and markings that might appear on the parts or packag- ing of the Vivo 45 LS. Symbol Description Internal battery Product number Read user instructions.
  • Page 43 Symbol Description Degree of protection provided by enclosure: IP22. See 8.2.5 Environ- mental Conditions, page 170 for detailed information. Manufacturer Serial number This product is a Medical Device. Date of Manufacture IEC protection Class II: Double insulated equipment. Indication of applied parts (IEC 60601-1 Type BF, Isolated Applied Part) (Symbol only applicable in U.S.) Caution: U.S.
  • Page 44 Symbol Description Single patient use Hot Surface. Do not touch. (Heating plate in click-in compartment.) MR Unsafe. The device should not enter a magnetic resonance (MR) environment, such as an MRI scanner room. Product Description User manual Doc. 007301 K-1...

  • Page 45: Preparing The Vivo 45 Ls For Use

    2 Ensure that the equipment is in good condition. 3 If stored more than 1 month, connect the Vivo 45 LS to the power supply to recharge the internal battery. 4 Check that the grey and white air filters are installed.
  • Page 46 Overnight, the Vivo 45 LS should be placed close enough to the patient’s bedside to allow movements during the sleep without pulling the Vivo 45 LS of its surface. 2 Make sure that nothing can block the patient air inlet.

  • Page 47: Connecting The Vivo 45 Ls To Mains

    CAUTION! • Do not place the Vivo 45 LS on a soft surface that will prevent the air flow under- neath the device. Never cover the device. • Always position the Vivo 45 LS so the power supply lays on a surface without strain to the power cord.

  • Page 48: Connecting The Patient Circuit

    3 Connect the power supply’s power cord to the mains supply. To isolate the Vivo 45 LS from the mains supply, disconnect the power supply. Connecting the Patient Circuit WARNING! Read 2.4 Usage of Patient Circuit, page 26 carefully to make sure all conditions are con- sidered and met.

  • Page 49: Connect A Leakage Patient Circuit

    4 Select the type of circuit. See . 4.4.3 Connect an MPV Circuit This kind of circuit shall be used in MPV mode only. Preparing the Vivo 45 LS for Use User manual Doc. 007301 K-1...

  • Page 50: Inspecting The Vivo 45 Ls Before Use

    Check that the cables are properly connected. Inspection of Placement • The Vivo 45 LS shall be placed on solid flat surface below the patient level (see 4.2 Placing the Vivo 45 LS, page 45). • Make sure that nothing can block the air inlet at the side.

  • Page 51: Adjusting The Vivo 45 Ls Patient Settings

    Adjusting the Vivo 45 LS Patient Settings WARNING! The configuration of the Vivo 45 LS therapy settings must always be prescribed by a licensed physician and carried out by an authorised health care professional. For detailed information about the treatment parameters of the Vivo 45 LS, see 5.5 Func- tions and Parameters in the Vivo 45 LS, page 76.

  • Page 52: Performing The Pre-Use Test

    The pre-use test is used for detecting the type and characteristics of the patient circuit that is connected to the Vivo 45 LS. The resistance and compliance of the patient circuit are measured and calculated. This will be used to compensate for pressure drop in the patient circuit and the compliance of the patient circuit.
  • Page 53 Connect the patient circuit. Make sure that nothing is blocking the patient end of the circuit. Wait while the Vivo 45 LS is checking the patient circuit resistance. If the resistance is not within the limits, the test will end without per- forming the following steps.

  • Page 54: How To Use The Vivo 45 Ls

    ⇒The Vivo 45 LS now starts up and enters standby mode. 3 Select Yes/No when asked to “Perform Pre-use Test”. (The Vivo 45 LS may be configured to not ask for pre-use test at start up. See 5.2.9 The Others Section , page 65.
  • Page 55 2 Release the Start/Stop button when the progress bar is filled. 3 Press “Ok” or the Audio Pause button to stop the treatment. To cancel the stopping process and continue the treatment, press “Cancel”. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 56: Using The Menu

    Use the up and down buttons to navigate up or down in a menu list, or to select differ- ent parameters. Use the left and right buttons to alter parameters, or enter and exit sub sections. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 57: Symbols Used In The Menu

    For detailed information about charge level indications, see 5.6.4 Battery Icons , page 92. Home Mode activated Connected to nurse call system Remote alarm unit connected Single limb circuit with leakage port selected (Leakage) How to Use the Vivo 45 LS User manual Doc. 007301 K-1...
  • Page 58 Multiple pages High priority alarm event in history list Medium priority alarm event in history list Size and colour of symbols may vary depending on displayed view. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 59: Menu Overview

    5.2.3 Menu Overview How to Use the Vivo 45 LS User manual Doc. 007301 K-1...
  • Page 60 In Home Mode, the Vivo 45 LS menu has the following section layout: Main Icon explanation Guided setup Setup Setup 1-2 Page Alarm Sub menu Alarm Settings 1-2 Alarm/Event History Monitor Others Device memory Patient Operating Time Compliance Data Device Settings...

  • Page 61: Display Overview

    The red lines represent the low and high pressure alarms, the low and high tidal volume alarms. 3. Icons/Alarm Message Information icons are presented here to give a quick overview of the Vivo 45 LS basic status (see 5.2.2 Symbols Used in the Menu, page 57). 4. Monitoring Field This field is designed to give a brief overview of the key monitor values.

  • Page 62: The Main Display, Home Mode

    57 for information about each icon. 6. Bar graph representing the tidal volume 7. PEEP value 8. Bar graph representing the current pressure 9. Red lines in the bar graphs represent alarm limits How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 63: The Setup Section, Home Mode

    The Setup Section, Home Mode In the Setup section, treatment parameters can be viewed. See 5.5 Functions and Parameters in the Vivo 45 LS, page 76. If Home Adjust is activated, some parameters might be adjustable within ranges defined by the prescribing physician. Adjustable parameters are indicated by green text.

  • Page 64: The Alarm Section

    The Alarms section contains 3 pages: The two first are for viewing alarm settings and the third is for viewing the alarm and message history. Shift between the pages by press- ing the Alarm button. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 65: The Monitor Section

    The monitoring page contains bar graphs for pressure and volume, and a field with measurement readings for the monitored values that are applicable for the treatment mode. See 5.3 Monitored Values in the Vivo 45 LS, page 66 for a description on the moni- tored values.

  • Page 66: Monitored Values In The Vivo 45 Ls

    • Serial Number Monitored Values in the Vivo 45 LS Values monitored by the Vivo 45 LS stored in the data log and displayed on the screen: 1. The monitoring screen: How to Use the Vivo 45 LS User manual...

  • Page 67: Ppeak

    PEEP displays the pressure at the end of the expiratory phase. 5.3.3 Pmean Pmean displays the calculated mean value of pressure during a complete ventilatory cycle (inspiratory + expiratory phase). How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 68: Leakage

    Target Volume (not calculated until 100 breaths are registered). 5.3.11 Total Rate The Total Rate displays the actual total breath rate independent of whether the breaths are patient- or ventilator-triggered breaths. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 69: Spont Rate

    I:E displays the ratio between the length of the inspiration and the length of the expiration. 5.3.17 Insp. Time Insp. Time displays the duration of the inspiratory cycle, measured from the start of inspiration to the start of expiration. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 70: Rise Time

    5.4.1 Standby and Operating Mode Standby mode is defined as the state of the Vivo 45 LS when it is powered on but with- out having treatment or pre-use test started. Operating mode is defined as the state of the Vivo 45 LS when the blower is operating and producing an air flow.

  • Page 71: Patient Mode

    In Pediatric mode, some ventilator parameters, for example Breath Rate, Inspiratory Time and Target Volume have special setting limits, in order to optimize the treatment for pediatric patients. The settings and alarm limits of the Vivo 45 LS are reset to default values when the patient mode is altered.
  • Page 72 See 5.5.17 Target Volume, page 86 for more information about Target Volume. 5.4.4.3 Pressure Controlled Ventilation (PCV) In the PCV mode the ventilation is controlled by the Vivo 45 LS. This is done at the preset pressure, breath rate, inspiratory time, and rise time settings set by the operator.
  • Page 73 Target volume is a feature that automatically adapts the pressure to make sure that the Vivo 45 LS delivers the desired set target volume to the patient. For every breath, the delivered volume is compared to the set target volume. The delivered pressure for the next breath will be increased or decreased depending on the difference between the delivered volume and the set target volume.
  • Page 74 Time and Expiratory Trigger. The default value for SIMV Support Pressure is the Inspiratory pressure in PCV. After a mandatory breath, Vivo 45 LS will always wait at least one second before a new mandatory breath can be initiated in the following SIMV cycle.
  • Page 75 5.4.4.9 VCV – Volume Controlled Ventilation In the VCV mode the ventilation is controlled by the Vivo 45 LS. This is done with the preset tidal volume, breath rate, inspiratory time, and rise time settings set by the operator. The inspiration stops and an expiration starts in two cases: •...

  • Page 76: Functions And Parameters In The Vivo 45 Ls

    MPV breath mode shall not be used with ventilator dependent patients. 5.4.4.13 CPAP – Continuous Positive Airway Pressure In CPAP mode the Vivo 45 LS is applying a continuous positive pressure to the airways. The flow will automatically be adjusted to maintain the set CPAP level.
  • Page 77 How to Use the Vivo 45 LS User manual Doc. 007301 K-1...
  • Page 78 How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 79: Insp. Pressure

    O and Min Pressure -2 cmH Setting 0.5 below 10 cmH O, 1.0 above 10 cmH resolution Default 5 cmH O (Adult mode) value 2 cmH O (Pediatric mode) How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 80: Breath Rate

    0 bpm (MPV modes) Setting max 30 bpm (Adult), 30 bpm (MPV), 60 bpm (Pediatric mode) Setting 1 bpm resolution Default 12 bpm (Adult mode) value 20 bpm (Pediatric mode) How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 81: Simv Rate

    Rate settings is limited by the I:E ratio 2:1. Setting min 0.3 s Setting max 5 s (Adult), 2 s (Pediatric) Setting 0.1 s resolution Default 1.5 s(Adult mode) value 1 s (Pediatric mode) How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 82: Backup Insp. Time (Backup Inspiratory Time)

    Default value NOTE In pressure modes (during the sigh breath), the high pressure alarm will automatically be set 10 cmH O above set sigh pressure (max 70 cmH How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 83: Sigh

    9 (PSV and PCV modes) 90% of the inspiration time (Min. 0.3 s) (VCV modes) Off (VCV modes) Setting 1 step(PSV and PCV modes) resolution 10% of the inspiration time (VCV modes) How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 84: Insp. Trigger (Inspiratory Trigger)

    Setting min PEEP +2 cmH Setting max Max Insp. Pressure Setting 0.5 below 10 cmH O, 1.0 above 10 cmH resolution Default 15 cmH value How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 85: Exp. Trigger (Expiratory Trigger)

    Expiratory Trigger. Modes PSV, PSV(TgV) Setting min 0.3 s Setting max 5 s (Adult mode) 2 s (Pediatric mode) Setting 0.1 s resolution Default value How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 86: Min Insp. Time (Minimum Inspiratory Time)

    Inspira- tory Pressure. This does not occur if a patient circuit with leakage port is used. How to Use the Vivo 45 LS User manual...

  • Page 87: Tidal Volume

    Definition The Tidal Volume setting defines the volume that will be delivered by the Vivo 45 LS for each breath when using volume control modes. In VCV-SIMV mode, this setting is applicable to the mandatory breaths that are controlled by the ventilator.

  • Page 88: Flow Pattern

    50 cmH Setting 0.5 below 10 cmH O, 1.0 above 10 cmH resolution Tolerance ±0.5 cmH O or ±5 %, whichever is the greatest. Default 15 cmH value How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 89: Min Pressure

    The internal and click-in batteries in the ventilator are of the Lithium-ion type, which is a high performance battery. It has long expected lifetime, low weight in relation to its How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 90: Power Source Priority

    • Information message “Switched to Internal Battery” is posted Click-in Battery Switchover Test Test Conditions • AC power connected • Click-in battery installed • Treatment is running 1 Disconnect the AC power cord. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 91: Charging The Batteries

    5.6.3 Charging the Batteries CAUTION! Do not charge the Vivo 45 LS while placed in the carry bag or other types of closed or non-ventilated spaces. The internal and click-in batteries are automatically charged when connecting the venti- lator to the mains supply. To ensure that the batteries are fully charged, a maintaining charging cycle will be performed.

  • Page 92: Battery Icons

    Information box displaying state of charge (alters with battery symbol above, when in standby mode) Information box displaying estimated remaining treatment time (alters with battery symbol above, when in treatment mode) How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 93: Internal Battery

    The click-in battery can be replaced during treatment, provided that the internal battery is charged. Connect the Click-in Battery 1 Release the side cover by pressing the button under the handle. 2 Open and remove the side panel. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 94: Battery Operating Time

    These data are based on new and fully charged batteries. Condition Value Environmental Conditions Ambient temperature 20°C (68°F) Ventilator settings Mode Pressure* 20 cmH PEEP 4 cmH Breath Rate* 20 bpm How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 95: Storing The Internal Battery And The Click-In

    5.6.9 External DC WARNING! Do not connect the Vivo 45 LS to a wheelchair unless the operating manual for the wheelchair permits this as this can affect the Vivo 45 LS performance and conse- quently result in patient death. The ventilator can be operated from: •...

  • Page 96: Using Accessories

    Using Accessories 5.7.1 Connecting and Disconnecting the Cables 1 Insert the cable in the appropriate port. 2 Make sure to insert the connector with the marking pointing upwards. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 97: Using The Ventilator With A Nurse Call

    FiO measurements. The FiO sen- sor measures the fraction of inspired oxygen in the air channel of the ventilator. The How to Use the Vivo 45 LS User manual Doc. 007301 K-1...
  • Page 98 5.7.3.1 Installing the FiO Sensor 1 Place the ventilator so the bottom is accessible. 2 Remove the hatch for FiO sensor. Use a torx TX10 screwdriver. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 99: Using The Ventilator With The Remote Alarm

    When installing a remote alarm system, check that it operates as intended before starting the treatment. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 100: Using The Ventilator With The Etco 2 Sensor

    5.7.5 Using the ventilator with the EtCO Sensor The EtCO sensor can be connected to the patient breathing circuit and to a Vivo 45 LS in order to monitor and store CO measurements. The CO measurements will be stored in the ventilator data memory which can be downloaded to a PC and viewed in the ventilator PC software.
  • Page 101 Incorrect CO zeroing will result in false gas readings. Replace the airway adapter if rain-out/condensation occurs inside the airway adapter. Only use airway adapters distributed by Breas Medical. Do not apply tension to the CO sensor cable. To keep secretions and moisture from pooling on the windows, always position the sensor in a vertical position with the green LED pointing upwards.
  • Page 102 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 45 LS User manual Doc. 007301 K-1...
  • Page 103 When installed, the ventilator automatically detects the sensor, also after powering off/ on or after power failure. WARNING! The CO sensor is not intended to be in contact with the patient body. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...
  • Page 104 Do not under any circumstances attempt to service or repair the CO sensor your- self. If you do so, the manufacturer will no longer be responsible for the perform- ance and safety of the CO sensor. How to Use the Vivo 45 LS User manual Doc. 007301 K-1...

  • Page 105: Using The Ventilator With The Ptcco 2 Cable

    Display the monitored values and include them in trend views. • Store monitored values in the internal memory. The PtcCO values will also be included in the data that can be downloaded and analysed with Breas PC software. • Repeat CO alarms from the external PtcCO monitor.

  • Page 106: Using The Ventilator With The Spo 2 Module

    (SpO ) and pulse rate. The SpO module can be connected to the Vivo 45 LS 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 Breas PC software.

  • Page 107: Using The Vivo 45 Ls With The Trolley

    The trolley shall only be used in indoor, hospital environment. The trol- ley system consists of a trolley base and a mounting bracket. This section describes how to use the Vivo 45 LS and a trolley with mounting bracket. How to Use the Vivo 45 LS User manual Doc.
  • Page 108 Mount and dismount the Vivo 45 LS as shown in the picture: The bottom plate is mounted to the trolley using two screws. Be careful when handling the trolley with the ventilator mounted, in order to avoid any risk of the trolley falling. The trolley can be tipped 10° and return to vertical position, when loaded in accordance with the weight specifications below.

  • Page 109: 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 45 LS remote alarm with cable and Vivo 45 LS nurse call cables provided by Breas Medical only.

  • Page 110: Audible Signal Pause

    Alarm text in display Displays the name of the active alarm condition. If several alarm conditions have been reached, the alarm descriptions are rolling in the display, displaying the alarms with high- est priority first. A “>>” symbol is indicating that more than 1 alarm is set. For detailed information about an alarm, press the info button at the lower left corner of the front.

  • Page 111: Alarm Reset

    6.1.3 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. WARNING! If an alarm condition cannot be corrected, discontinue use and refer the ventilator for service.

  • Page 112: High Pressure Alarm

    A full breath is performed with maximum pressure below the alarm limit. Ventilator action The Vivo 45 LS will continue treatment according to the current settings. The actual breath is however terminated if the High Pressure alarm limit is reached.

  • Page 113: Low Pressure Alarm

    Description Alarm text Low Pressure Priority High Alarm condition A Low Pressure alarm will be given when the Vivo 45 LS pressure fails to reach the low pressure alarm limit for 15 seconds. Possible cause • Disconnection of patient circuit.

  • Page 114: 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 45 LS will continue treatment according to the current settings. Setting range • • Alarms User manual...

  • Page 115: Low Peep Alarm

    Malfunction of the exhalation valve. Reset criteria PEEP has gone above the alarm limit (higher than 30% below the set value). Ventilator action The Vivo 45 LS will continue treatment according to the current settings. Setting range • • Alarms User manual Doc.

  • Page 116: High Vt I (High Inspired Tidal Volume Alarm)

    6.3.5 High Vt (High Inspired Tidal Volume Alarm) Property Description High Vti Alarm text Priority Medium Alarm Condition A High Inspired Tidal Volume alarm will be given when the monitored Inspired Tidal Volume exceeds the set limit for the High Inspired Tidal Volume alarm for 15 seconds. Possible cause •...

  • Page 117: Low Vti Alarm (Low Inspired Tidal Volume)

    6.3.6 Low Vti Alarm (Low Inspired Tidal Volume) Property Description Low Vti Alarm text Priority High Alarm Condition A Low Inspired Tidal Volume alarm will be given when the monitored Inspired Tidal Volume fails to reach the set limit for the Low Inspired Tidal Volume alarm for 15 seconds. Possible cause •...

  • Page 118: High Mv Alarm (High Inspired Minute Volume Alarm)

    6.3.7 High MV Alarm (High Inspired Minute Volume Alarm) Property Description High MVi Alarm text Priority Medium Alarm condition A High Inspired Minute Volume alarm will be given when the monitored inspired minute volume exceeds the set limit for 15 seconds. Possible cause •...

  • Page 119: Low Mv I (Low Inspired Minute Volume Alarm)

    6.3.8 Low MV (Low Inspired Minute Volume Alarm) Property Description Low MVi Alarm text Priority High Alarm condition A Low Inspired Minute Volume alarm will be given when the monitored minute volume does not reach the alarm limit for 15 seconds. Possible cause •...

  • Page 120: High Vt Alarm (High Expired Tidal Volume)

    6.3.9 High Vt Alarm (High Expired Tidal Volume) Property Description High Vte Alarm text Priority Medium Alarm condition A High Expired Tidal Volume alarm will be given when the monitored Expired Tidal Volume exceeds the alarm limit for 15 seconds. Possible cause •...

  • Page 121: Low Vt Volume) Alarm (Low Expirvolume)D Tidal Volumvolume))

    6.3.10 Low Vt Alarm (Low Expired Tidal Volume) Property Description Low Vte Alarm text Priority High Alarm Condition A Low Expired Tidal Volume alarm will be given when the monitored Expired Tidal Volume fails to reach the set limit for the Low Expired Tidal Volume alarm for 15 seconds. Possible cause •...

  • Page 122: High Mv E (High Expired Minute Volume Alarm)

    6.3.11 High MV (High Expired Minute Volume Alarm) Item Description High MVe Alarm text Priority Medium Alarm condition A High Expired Minute Volume alarm will be given when the monitored expired minute volume exceeds the alarm limit for 15 seconds. Possible cause •...

  • Page 123: Low Mv Alarm (Low Expired Minute Volume)

    6.3.12 Low MV Alarm (Low Expired Minute Volume) Property Description Low MVe Alarm text Priority High Alarm condition A Low Expired Minute Volume alarm will be given when the monitored minute volume is below the alarm limit for more than 15 seconds. Possible cause •...

  • Page 124: 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 45 LS will continue treatment according to the current settings. Setting range • 10 bpm to 70 bpm (Adult mode) •...

  • Page 125: Low Breath Rate Alarm

    • Circuit disconnection. Reset criteria The breath rate goes above the alarm limit. Ventilator action The Vivo 45 LS will continue treatment according to the current settings. Setting range • 4 bpm to 30 bpm (Adult mode, non-MPV modes) •...

  • Page 126: Apnea Alarm

    Inspiratory Trigger is set too high. Reset criteria Inspiratory effort detected by the Vivo 45 LS. Ventilator action The Vivo 45 LS will continue treatment according to the current settings. Setting range • 5 to 60 s. (Non MPV mode) •...
  • Page 127 • Circuit disconnection. • Pilot pressure tube disconnection Reset criteria The leakage is back within limits. Ventilator action The Vivo 45 LS will continue treatment according to the current settings Setting range • • Alarms User manual Doc. 007301 K-1...

  • Page 128: Rebreathing Alarm

    Disconnected pilot pressure line from rear of device or from the active exhalation valve. Reset criteria The leakage is back within limits. The bias flow is restored Ventilator action The Vivo 45 LS will continue treatment according to the current settings. Setting range • • Alarms User manual Doc.

  • Page 129: Obstruction Alarm

    6.3.18 Obstruction Alarm Property Description Alarm text Obstruction Priority High Alarm condition An Obstruction alarm will be given if the inspiratory breath- ing tube becomes blocked and remains blocked for 2 con- secutive breaths. Ventilator action With each breath cycle, upon detection of an obstruction the ventilator will reduce the airway pressure to the set PEEP.

  • Page 130: Low Fio

    Too high flow of bleed-in oxygen. Reset criteria The SpO value goes back below the alarm limit. Ventilator action The Vivo 45 LS will continue treatment according to the current settings. Setting range • 90 % to 100 % •...

  • Page 131: Low Spo

    This alarm requires a connected SpO sensor. 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 •...

  • Page 132: High Etco

    6.3.23 High EtCO Alarm Property Description Alarm text High EtCO2 Priority High Alarm condition A High EtCO alarm will be given when the measured EtCO exceeds the alarm limit for 30 seconds. Possible cause • Alarm limit is set too low. •...

  • Page 133: Low Etco

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

  • Page 134: High Inspco 2 Alarm

    6.3.25 High InspCO Alarm (High Inspired CO Property Description Alarm text High InspCO2 Priority High Alarm condition A High Inspired CO alarm will be given when the measured inspired CO exceeds the alarm limit for 30 seconds. Possible cause • Alarm limit is set too low.

  • Page 135: 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 45 LS will continue treatment according to the current settings. Setting range 30 to 230 bpm (beats per minute)

  • Page 136: Low Pulse Rate Alarm

    • Insufficient ventilatory support. Reset criteria The pulse rate goes back above the alarm limit. Ventilator action The Vivo 45 LS will continue treatment according to the current settings. Setting range 30 to 230 bpm (beats per minute) Setting resolution...

  • Page 137: Ptcco 2 Alarm

    6.3.28 PtcCO Alarm Property Description Alarm text PtcCO2 Outside Limits Priority High Alarm Condition A PtcCO alarm will be given when PtcCO is outside alarm limits. Check the PtcCO monitor. Possible cause • External PtcCO monitor is outside its alarm limits. •...

  • Page 138: Technical Alarms

    Reset criteria External power supply connected to ventilator. Ventilator action The Vivo 45 LS stops the treatment, 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 139: Low Patient Air Temp

    This alarm will be given when the last battery source (inter- nal battery) has 15 minutes of operating time left with cur- rent settings. Ventilator action The Vivo 45 LS will continue treatment according to the current settings. 6.4.5 Crit. Low Last Power Source Alarm...

  • Page 140: Lost Mains Power Alarm

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

  • Page 141: Spo2 Disconnected

    6.4.8 Disconnected (SpO Sensor Failure/Disconnection Alarm) Property Description Alarm text SPO2 Disconnected Alarm condition An SpO Sensor Failure/Disconnection alarm will be given when an error signal or no signal from the SpO sensor has been detected for 2 seconds. Check the SpO sensor.

  • Page 142: Poor Spo2 Signal

    6.4.10 Poor SpO Signal Property Description Alarm text Poor SPO2 Signal Alarm condition A Poor SpO signal alarm will be given when the SpO sig- nal is not correct. Check the SpO sensor. Priority High Possible cause Artifact or low perfusion reported by SpO electronics Ventilator action The ventilator will continue treatment with the same settings.

  • Page 143: Co 2 Accuracy Error Alarm

    6.4.12 Accuracy Error Alarm Property Description Alarm text CO2 Accuracy Error Alarm condition A CO Accuracy Error alarm will be given when an accuracy error in the CO measurement has occurred. Priority High Ventilator action The ventilator will continue treatment with the same settings. Reset OK message from sensor or sensor disconnected by user.

  • Page 144: Fio2 Disconnected

    Ventilator action The Vivo 45 LS will continue treatment according to the cur- rent settings. Normal atmospheric pressure at sea level will be used as approximation for the temporary ambient pressure compen- sation.

  • Page 145: Temperature Comp. Lost

    6.4.17 Temperature Comp. Lost (Ambient Temperature Compensation Lost Alarm) Property Description Alarm text Temperature Comp. Lost Alarm condition An Ambient Temperature Compensation Lost alarm will be given when the automatic ambient temperature compensa- tion is out of order. There is no communication with the air temperature sensor or the value is out of range (less than -30°C (-22°F) or more than 70°C (158°F).

  • Page 146: Led Failure Alarm

    6.4.19 LED Failure Alarm Property Description Alarm text LED Failure Alarm condition A LED Failure alarm will be given when one or more LED indicators on the front panel are broken. Priority Medium Ventilator action The ventilator will continue treatment with the same settings. Reset Power-on reset of ventilator (or repair).

  • Page 147: Internal/Click-In Battery Hot Alarm

    The ventilator will stop the treatment and shut down. Action to take Restart the Vivo 45 LS. If the alarm persists or reoccurs: Take a note of the error code and contact your supplier of the Vivo 45 LS . Alarms User manual Doc. 007301 K-1...

  • Page 148: Air Temp. Sensor Fail Alarm

    6.4.24 Air Temp. Sensor Fail Alarm Property Description Alarm text Air Temp Sensor Fail Alarm condition The alarm is given in case of swivel boot temperature sensor communication failure or sensor reporting temperatures out of range (below -30°C (-22°F) or above 60°C (140°F). Priority Medium Ventilator action...

  • Page 149: Cooling Fan Error Alarm

    6.4.27 Cooling Fan Error Alarm Property Description Alarm text Cooling Fan Error Alarm Condition The Cooling Fan Error alarm shall be given when the cooling fan runs too slow. Priority High Ventilator action The ventilator will continue treatment with the same settings. Reset When cooling fan speed is above 275 rpm.

  • Page 150: Bypass Loose Alarm

    The audio pause LED lights yellow. • In about a second, both LEDs are turned off. If the test fails, do not use the Vivo 45 LS. Contact your supplier of the Vivo 45 LS for a technical check. Alarms User manual Doc.

  • Page 151: Mandatory Alarm Tests

    6.5.2 Mandatory Alarm Tests This alarm test should be performed when changing patient, if the ventilator’s function needs to be checked for any other reason, or at least every 12 months. The alarm test should be included in the regular inspections during maintenance. To perform the alarm test, follow the instructions below: Alarm Test Preparation 1 Connect the ventilator patient circuit to a test lung.
  • Page 152 Related Alarm Test This alarm test applies if the EtCO accessory is used. 1 Connect the EtCO sensor with an attached airway adapter to the Vivo 45 LS. 2 Disconnect the airway adapter from the CO sensor. ⇒ The check CO adapter alarm shall be given.
  • Page 153 3 Connect the airway adapter to the CO sensor again. 6.5.2.5 SpO Related Alarm Tests These tests applies if the SpO accessory is used, 1 Connect SpO sensor to device and to your finger. 2 Set the low SpO alarm to 85%. 3 Set the high SpO alarm to be 90%.

  • Page 154: Optional Alarm Tests

    3 Start a timer and record the time for the following alarms to appear. • the Low last power source alarm shall be given after a run time of at least 1 hour and 40 minutes. The ventilator shall continue to run for at least 15 minutes more. •...
  • Page 155 4 Start treatment on both the ventilator and the CPAP device. 5 Wait approximately 15 seconds before the High PEEP alarm shall be given. 6 Stop treatment. Test completed. 6.5.3.2 Low Pressure and Disconnection Alarms 1 Start treatment and disconnect the patient circuit. 2 Wait 15 seconds.

  • Page 156: Cleaning And Maintenance

    The Vivo 45 LS should be subjected to maintenance, service and control and any applicable upgrades, in accordance with Breas service instructions. The Vivo 45 LS shall only be repaired or modified in accordance with Breas service manuals, technical bulletins, and any special service instructions, by service techni- cians that have been authorised after Breas Vivo 45 LS service training.

  • Page 157: Main Unit

    2 Remove the patient circuit. 3 Disconnect all electric cables. 4 Clean the outside of the Vivo 45 LS 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 ventilator is put into operation.

  • Page 158: Cleaning And Replacing The Filters

    Always use a new patient circuit when used by a new patient. Check the patient circuit regularly for damage. In case of damage, replace the circuit CAUTION! Appropriate personnel should determine the duration of use for the patient circuit based on accepted infection control procedures. Cleaning and Replacing the Filters Patient air filters NOTE...

  • Page 159: Washing A Coarse Filter

    Cooling Air Filter NOTE The filter shall be washed at least once a week and replaced every second year. See 7.2.1 Washing a coarse filter, page 159 for washing instructions. The cooling air inlet filter is located at the bottom left side of the ventilator. 1 Open the cooling air filter compartment by pulling at the top of the lid.

  • Page 160: Regular Maintenance

    Service and Repair The service and repair of the ventilator must only be carried out by authorised service personnel in accordance with Breas service instructions. Service inspections must always be carried out following any repairs to the device. Authorised service workshops can order the ventilator Service Manual that contains all technical documentation required for the maintenance and service of the ventilator.

  • Page 161: Disposal

    CAUTION! The ventilator must not be stored in a warm place, such as direct sunlight or close to a radiator. The time required for the device to cool from the maximum storage tem- perature of +60°C (+140°F) until it is ready for use in ambient temperature of +20° C (+68°F) is 30 minutes.

  • Page 162: Technical Specifications

    System Description Active Exhalation Valve Configuration This diagram provides an overview of the ventilator system when used with an active exhalation valve patient circuit. 1. Vivo 45 LS 2. Tube 3. Active Exhalation valve 4. Patient interface connection 5. Patient...

  • Page 163: Pneumatic Diagram For The Ventilator

    Data 8.2.1 Worst Case Accuracy Pressure Control Modes The worst case Vivo 45 LS configuration is the 15 mm patient circuit with HCH humidifier, bacterial filter and EtCO sensor. Volume control Modes The worst case Vivo 45 LS configuration is the 15mm circuit with or without HCH...
  • Page 164 Ventilation modes • PSV – Pressure Support Ventilation • PSV(TgV) – Pressure Support Ventilation with Target Volume • PCV – Pressure Controlled Ventilation • PCV(TgV) – Pressure Controlled Ventilation with Target Volume • PCV(A) – Assisted Pressure Controlled Ventilation • PCV(A+TgV) –...
  • Page 165 PEEP Range/Performance: 2 cmH O to 20 cmH O, IPAP -2 cmH O or Min IPAP -2 cmH Tolerance: ±0.5 cmH O or ±5%, whichever is greatest. Resolution: 0.5 below 10 cmH O, 1.0 above 10 cmH Breath Rate Range/Performance: 4 to 40 bpm (Adult), 6 to 60 bpm (Pediatric) Tolerance: ±2% Resolution: 1 bpm...
  • Page 166 Rise Time Range/Performance: 1 to 9 (PSV, PCV) Resolution: Inspiratory Trigger Range/Performance: 1 to 9 (PSV), 1 to 9, Off (PCV). Resolution: 1 SIMV Support Pressure Range/Performance: 4 to 50 cmH Tolerance: ±0.5 cmH O or ±5%, whichever is greatest. Resolution: 0.5 below 10 cmH O, 1.0 above 10 cmH Expiratory Trigger...
  • Page 167 Target Volume Range/Performance: Off, 300 to 2000 ml (Adult), Off, 50 to 500 ml (Pediatric). Tolerance: ±12 ml or ±10%, whichever is greatest. Resolution: 10 ml below 500 ml 50 ml above 500 ml Max Pressure Range/Performance: Min IPAP to 50 cmH Resolution: 0.5 below 10 cmH O, 1.0 above 10 cmH Min IPAP...

  • Page 168: Monitored Values Specifications

    8.2.3 Monitored Values Specifications This section describes the ranges and tolerances for monitored values on the Vivo 45 LS. All stated tolerances includes measurement uncertainty. The accuracies have been tested with all allowed configurations. Stated tolerances only disclose the maximum tolerance.
  • Page 169 Range/Performance: 0 to 9999 ml (BTPS*). Resolution: Exhalation valve circuit: ±15 ml or 10%, whichever is greatest. Leakage cir- cuit: ±15 ml or 15%, whichever is greatest Range/Performance: 0 to 9999 ml (BTPS*). Resolution: ±15 ml or 15%, whichever is greatest Range/Performance: 0 to 100%.

  • Page 170: Power Supply

    Range/Performance: 1:10 to 10:1. Resolution: ±0.1 unit for E < 9.9, ±1 unit otherwise. Insp. Time Range/Performance: 0.3 to 5 s. Resolution: ±0.1 s Rise Time Range/Performance: 0.1 to 5 s. Resolution: ±10% or ±0.1 s, whichever is greatest EtCO Range/Performance: 0 to 25%.

  • Page 171: Other

    Ambient pressure range: 700 to 1100 mbar, corresponding to ~4200 meters (13800 feet) above sea level to ~700 meters(2300 feet) below sea level, at normal atmospheric pressure. As seen in the graph above, the ventila- tor is unable to deliver set max pressure at a very low ambient pressure.

  • Page 172: Emission And Immunity Declaration

    Expiration trigger: Flow low pass filtering with level sensing : No data post-processing done by the ventilator Emission and Immunity Declaration The Vivo 45 LS does not have RF equipment or intended RF communications. Technical Specifications User manual Doc. 007301 K-1...

  • Page 173: Vivo 45 Ls Essential Performance

    The performance of all functions of the ventilator is considered as essential perform- ance for the purpose of immunity testing. 8.3.1 Vivo 45 LS Essential Performance The ventilator will deliver ventilation at the patient-connection port within its published accuracy specifications and within the alarm limits set by the operator, or generate an...
  • Page 174 Voltage dips, short 0% U , 0.5 cycle (multiple Vivo 45 LS runs on internal interruptions and phase analysis); battery during voltage dips, voltage variations 0% U , 1 cycle;...
  • Page 175 Immunity Test Compliance Level Electromagnetic Environ- ment - Guidance Conducted RF (150 kHz to 80 MHz) d=0.35*√P m at 150 kHz to IEC 61000-4-6 (inside ISM/ASR 80 MHz bands) 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 d= 2.3*√P m at 800 MHz to...

  • Page 176: Guidance And Manufacturer's Declaration - Electromagnetic

    a) Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromag- netic site survey should be considered.

  • Page 177: Frequencies Of Portable And Mobile Transmitters For Which The Recommended Separation Distance Is 30 Cm (12 Inches)

    8.3.4 Frequencies of portable and mobile transmitters for which the recommended separation distance is 30 cm (12 inches) Band (MHz) Service Immunity test level (V/m) 380 — 390 TETRA 400 430 — 470 GMRS 460, FRS 460 704 —787 LTE Band 13, 17 800 —...

  • Page 178: Delivery Settings

    Delivery Settings Delivery settings: modes and functions Ventilation Mode: Pressure Breath Mode: Support Patient Mode: Adult Device Mode: Clinical Home Adjust: Off Profile 1: Active Profile 2: Off Profile 3: Off Delivery Settings, Parameters Insp. Pressure: 15 cmH PEEP: 5 cmH Breath Rate: 12 bpm (Adult mode), 20 bpm (Pediatric mode) SIMV Rate: 12 bpm (Adult mode), 20 bpm (Pediatric mode) Inspiration Time: 1.5 s (Adult mode), 1 s (Pediatric mode)
  • Page 179 Delivery Settings, Alarms High Pressure Alarm: 25 cmH O (Adult) 20 cmH O (Pediatric) Low Pressure Alarm: 10 cmH High PEEP Alarm: Off Low PEEP Alarm: Off High Vt Alarm: 500 ml (Adult), 400 ml (Pediatric) High Vt Alarm: 500 ml (Adult), 400 ml (Pediatric) Low Vt Alarm: 300 ml (Adult), 100 ml (Pediatric) Low Vt...
  • Page 180 Other Patient operating time: 0 h Display light: On Light Intensity: 9 Alarm sound level: 5 Unit: mmHg Auto keypad lock: Off Pre-use Test: On Technical Specifications User manual Doc. 007301 K-1...

  • Page 181: Accessories And Parts

    IEC 60601-1-1. If in doubt, consult the technical service department or your local representative. The following Breas accessories are approved for the Vivo 45 LS.: Air Delivery Accessories Low pressure oxygen adapter Function: Oxygen tube adapter with connector for the Vivo 45 LS.
  • Page 182 Power cord Function: Deliver power to the AC power supply Part No: US: 009024 Click-in battery Function: Power source for transportation Part No: 006265 Click-in Battery Charger Function: External charger for click-in batteries, available with bank for 2 or 4 batteries) Part no: 07732 (2 batteries charger)

  • Page 183: Other Accessories

    Cable, external DC to Ventilator Adapter Function: Connect the ventilator to external DC Part No: 006710 Cable, Y-adapter, Mains AC and External DC to Ventilator Function: Connects the ventilator to both mains and external DC at the same time. If the Mains power source is avail- able, it will have precedence over the DC power source.
  • Page 184 Patient circuit arm Function: To support a patient circuit. Part No: 007917 Universal rail clamp Function: Attach a humidifier to a trolley. Part No: 007858 Accessories and Parts User manual Doc. 007301 K-1...
  • Page 185 E-cylinder holder Function: Attach an E-cylinder to a trolley. Part No: 005128 IV-pole Function: Pole with hooks to hang IV fluid bags. Part No: 007859 Accessories and Parts User manual Doc. 007301 K-1...
  • Page 186 Mounting bracket Function: Mount the ventilator to a stand / trolley / rail system. Part No: 006761 Protective cover Function: Shock protection Part No: 006067 Lightweight Mobility Bag Function: Mobile use Part No: 007555 Accessories and Parts User manual Doc. 007301 K-1...

  • Page 187: Monitoring Accessories

    Carry bag Function: Storage for transportation Part No: 006014 Monitoring Accessories USB cable Function: Data cable: PC to Vivo 45 LS (USB to USB) Part No: 005757 Memory card Function: Storage and transfer of set- tings, patient data and usage data...
  • Page 188 Remote alarm with cable Function: Monitor Vivo 45 LS alarms remotely Part No: 10 m: 006348, 25 m: 006349 Remote alarm cable Function: Part No: 10 m: 006359, 25 m: 006360, 50 m: 006361 Nurse call cable Function: Connect the ventilator to a...
  • Page 189 Remote start/stop Function: Start and stop the ventilator remotely. Also, pause audio remotely. Part No: 006649 sensor Function: Measure FiO to the patient. Part No: 006172 Masimo SpO cable Function: Connection interface Part No: 006369 Accessories and Parts User manual Doc.
  • Page 190 Masimo SpO sensor Function: Finger Clip SpO sensor Part No: Adult: 006589 Pediatric: 006590 sensor Function: Multisite SpO sensor Part No: 006591 EtCO sensor and airway adapter Function: Measure CO in the airflow Part No: 006346 Airway adapter, disposable Function: Connects the EtCO sensor to the patient circuit Part No: 005263 (25 pcs)

  • Page 191: Ventilator Filters And Detachable Parts

    PtcCO Cable, Sentec Function: Connects the ventilator to a Sentec PtcCO monitor. Part No: 006179 PtcCO Cable, Radiometer Function: Connects the ventilator to a Radiometer TCM5 PtcCO monitor. Part No: 008392 Ventilator Filters and Detachable Parts Patient air inlet filter, fine, white, disposable Function: Fine inlet air filtration.
  • Page 192 Patient air inlet filter, coarse, grey, disposable) Function: Coarse inlet air filtration Material: Bulpren S 28133 Filter diameter: 1080-1580 Microns Part No: 007104 (5pcs) Cooling air filter Function: Device air inlet filtration, 5 pieces Part No: 007105 Air bypass unit Function: Direct the air flow within the ventilator Part No: 007064...
  • Page 193 Side panels Function: Protect the internal ventila- tor components. Part No: Grey: 007065, Blue: 007066, Light blue: 007518 Accessories and Parts User manual Doc. 007301 K-1...

  • Page 194: Patient Settings

    Patient Settings This section can be copied and used for noting the patient’s settings. Patient Settings - Vivo 45 LS Patient ....................Date ....................Clinic ....................Set by ....................Ventilation mode:................Patient Circuit Insp. Pressure Inspiratory Trigger PEEP Expiratory Trigger...

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