Breas Vivo 45 User manual

D-2
007132 En
Service Manual

DOC. 007132 EN-EU D-2
2020-12-22
Service manual
Vivo 45/Nippy 4 Series

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Doc. 007132 D-2 Vivo 45/Nippy 4 Series
Table of Contents
1 Introduction........................................................................................................................ 7
1.1 Manufacturer Information.................................................................................... 7
1.2 About the Vivo 45 / Nippy 4 Series Ventilator ..................................................... 7
1.2.1 Function .............................................................................................. 7
1.2.2 Intended Use....................................................................................... 8
1.2.3 Design ................................................................................................. 8
1.2.4 Service Personnel’s Training Requirements ...................................... 8
1.3 About this Manual ............................................................................................... 8
1.3.1 Scope .................................................................................................. 8
1.3.2 Icons.................................................................................................... 9
1.4 Applicable Ventilators.......................................................................................... 9
2 Maintenance Instructions ................................................................................................ 10
2.1 Purpose............................................................................................................. 10
2.2 Service Software/Upgrade Tool ........................................................................ 10
2.3 Introduction ........................................................................................................11
2.3.1 Safety Precautions.............................................................................11
2.3.2 Service Schedule ...............................................................................11
2.3.3 Service Record ..................................................................................11
2.3.4 Inspection Equipment and Tools....................................................... 12
2.3.5 Replacement Parts ........................................................................... 12
2.4 Preparing for Inspection.................................................................................... 13
2.4.1 Initial Recording ................................................................................ 13
2.4.2 Checking Additional Services ........................................................... 13
2.4.3 Inspecting the Markings.................................................................... 13
2.4.4 Information from the Patient/User..................................................... 13
2.4.5 Validity of the Documentation ........................................................... 14
2.5 External Inspection ........................................................................................... 14
2.5.1 Visual Inspection for External Damage and Wear............................ 14
2.5.2 Checking the Power Connection ...................................................... 14
2.5.3 Inspecting the Patient Circuit ............................................................ 14
2.5.4 Inspecting the Ventilator Accessories............................................... 14
2.5.5 Changing/Washing the Patient Filters .............................................. 14
2.5.6 Changing the Cooling Air Inlet Filter ................................................. 14
2.5.7 Minimum Function Check ................................................................. 14
2.6 Internal Inspection............................................................................................. 15
2.6.1 Cleaning the Inside of the Ventilator ................................................. 15
2.6.2 Checking the Cables......................................................................... 15
2.6.3 Checking the Fastening of Components .......................................... 15
2.6.4 Checking the Power Adapter ............................................................ 15
2.6.5 Reassembling the Casing................................................................. 15
2.7 Power Failure Test ............................................................................................ 16

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2.7.1 Checking the Power Failure Alarm ................................................... 16
2.8 Complete Function Test .................................................................................... 16
2.9 CO2Sensor Gas Span Check........................................................................... 16
2.9.1 How to perform the CO2Gas Span Check ....................................... 17
2.10 Electrical Safety Precautions ............................................................................ 18
2.10.1 Preparations...................................................................................... 19
2.10.2 Insulation Check ............................................................................... 19
2.10.3 Leakage Currents Check .................................................................. 19
3 Parts Location ................................................................................................................. 21
3.1 View A ............................................................................................................... 21
3.2 View B ............................................................................................................... 21
3.3 View C ............................................................................................................... 22
3.4 View D ............................................................................................................... 23
3.5 View E ............................................................................................................... 24
3.6 View F ............................................................................................................... 25
3.7 Screw Kits ......................................................................................................... 26
3.7.1 MRT M3x6 FZB................................................................................. 26
3.7.2 M3x8 and MRT 3x10 FZB ................................................................. 27
3.7.3 M2.5x6 and Isolation Screw Grommets............................................ 27
3.8 Part List ............................................................................................................. 28
4 Functional Diagram ......................................................................................................... 32
5 Opening the Ventilator and Replacing the Main Components........................................ 34
5.1 Replace the Internal Battery ............................................................................. 34
5.2 Open and Close the Ventilator .......................................................................... 34
5.3 Replace the Cooling Air Filter ........................................................................... 37
5.4 Replace the Blower Assembly ......................................................................... 38
5.5 Replace the Cooling Fan .................................................................................. 43
5.6 Replace the Clock Battery ................................................................................ 47
5.7 Replace the PTU Board .................................................................................... 47
5.8 Replace the CPU Board.................................................................................... 48
5.8.1 Replace the Humidifier Sense Board ............................................... 48
5.9 Replace the Beeper .......................................................................................... 49
5.10 Replace the SD Board ...................................................................................... 51
5.11 Replace the Heated Wire Board ....................................................................... 51
5.12 Replace the Humidity Plate............................................................................... 52
5.13 Replace the FiO2Board .................................................................................... 52
5.14 Replace the Complete Contact Board .............................................................. 53
5.14.1 Replace the USB Board.................................................................... 54
5.15 Replace the Super Capacitors ......................................................................... 54
5.16 Replace the Button Board................................................................................. 55
5.17 Replace the Front Cover ................................................................................... 55

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5.18 Replace the LCD Display.................................................................................. 57
5.19 Replace the Top Cover ..................................................................................... 57
6 Upgrade and Calibration ................................................................................................. 59
6.1 Firmware Upgrade ............................................................................................ 59
6.2 Pressure and Flow Calibration.......................................................................... 59
7 Electronics....................................................................................................................... 60
7.1 Main Cabling Diagram of the Ventilator ............................................................ 60
7.2 Circuit Board Descriptions ................................................................................ 60
7.2.1 Main Board........................................................................................ 60
7.2.2 PTU (Pressure Transducer Unit) Board............................................ 64
7.3 Ventilator Switch-over Operating Conditions ................................................... 64
7.3.1 Mains DC Operation ......................................................................... 64
7.3.2 External DC Battery Operation ......................................................... 64
7.3.3 Click-In Battery Operation................................................................. 64
7.3.4 Internal Battery Operation................................................................. 64
7.4 Battery Charging .............................................................................................. 65
7.4.1 Mains Power Supply Operation ........................................................ 65
7.4.2 External Battery Operation ............................................................... 65
7.4.3 Click-In Battery Operation................................................................. 65
7.4.4 Internal Battery Operation................................................................ 65
7.5 Checking the Internal Battery............................................................................ 65
8 Fault Tracing.................................................................................................................... 67
8.1 Fault Tracing Table ........................................................................................... 67
8.2 Internal Error Codes.......................................................................................... 68
8.3 Function Failure Error Codes............................................................................ 69
8.3.1 Error Code Table ............................................................................... 69
9 Disposal........................................................................................................................... 74
9.1 Disposal Procedure........................................................................................... 74
9.2 Parts and Materials ........................................................................................... 76
9.3 Disposal ............................................................................................................ 90
10 Appendices...................................................................................................................... 92
10.1 Emission and Immunity Declaration ................................................................. 92
10.2 Returning Products to Breas............................................................................. 92
10.3 Service Record.................................................................................................. 92

1 Introduction
This chapter gives an overview of the ventilator and this service manual.
WARNING!
This product must be:
•Subjected to regular service, maintenance and control and any applicable upgrades,
in accordance with Breas service instructions.
•Repaired and/or modified in accordance with Breas service manuals, technical
bulletins, and any special service instructions, by service technicians that have
been authorised after the Breas ventilator service training.
Deviation from these service instructions may lead to risk of personal injury!
1.1 Manufacturer Information
Legal Manufacturer
Postal Address
Breas Medical AB
Företagsvägen 1
SE-435 33 Mölnlycke Sweden
Web Address
www.breas.com
Email address
[e-mail]
Phone
[phone], Order: [phone], Technical support: [phone]
Fax
[phone]
Local Representatives Information
www.breas.com/contact-us/
1.2 About the Vivo 45 / Nippy 4 Series Ventilator
1.2.1 Function
The Vivo 45/Nippy 4 series are ventilators delivering ventilatory support for patients
who require invasive or non-invasive mechanical ventilation. For detailed information
about functions, settings and modes, see the ventilator’s Clinician’s Manual.
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1.2.2 Intended Use
NOTE
For a detailed description on intended use, refer to the Clinician’s manual.
1.2.2.1 Intended Audience
This service manual is intended for service technicians who have medical/technical
training and who have a good knowledge of the construction and function of respira-
tory devices. Authorisation by Breas after service training is mandatory.
CAUTION!
Always contact your Breas representative if you have any questions or if training is
required.
1.2.3 Design
The ventilator is designed around a blower assembly that delivers air to the patient.
The main processor monitors, for example, sensors for pressure and flow, and controls
the blower to meet treatment settings and make breathing comfortable for the patient.
A number of various internal sensor readings are monitored to ensure that the ventilator
functions correctly. Some of them are checked at power up, some at treatment start and
some of them are monitored continuously.
1.2.4 Service Personnel’s Training Requirements
Service personnel working with the ventilator shall have medical/technical training and
a good knowledge of the construction and function of respiratory devices. Authorisa-
tion by Breas after service training is mandatory.
CAUTION!
Always contact your Breas representative if you have any questions or if training is
required.
1.3 About this Manual
1.3.1 Scope
This manual describes all the routine maintenance checks and the additional service
actions for the ventilator. The manual contains all the documentation that is required
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for the maintenance and the service of the ventilator, such as replacement parts lists,
exploded drawings, cabling diagrams, component location guides and more.
NOTE
The service manual is to be used in conjunction with the User Manual and Clinician’s
Manual for the Vivo to be serviced.
1.3.2 Icons
In this manual, icons are used to highlight specific information. The meaning of each
icon is explained in the table below.
Icon Explanation
Warning!
Risk of death or serious personal injury.
Caution!
Risk of minor or moderate injury or risk of equipment damage, loss of
data, extra work, or unexpected results.
Note
Information that may be valuable but is not of critical importance, tips.
1.4 Applicable Ventilators
This manual is applicable to the following ventilators:
•Vivo 45
•Vivo 45 LS
•Nippy 4
•Nippy 4+
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2 Maintenance Instructions
This chapter describes all the routine maintenance checks and additional service instruc-
tions for the ventilator.
WARNING!
This product must be:
•Subjected to regular service, maintenance and control and any applicable upgrades,
in accordance with Breas service instructions.
•Repaired and/or modified in accordance with Breas service manuals, technical
bulletins, and any special service instructions, by service technicians that have
been authorised after the Breas Vivo 45/Nippy 4 service training.
Deviation from these service instructions may lead to risk of personal injury!
NOTE
The patient and care provider should follow the checks that are described in the User
manual/Clinician’s manual.
2.1 Purpose
The ventilator is designed to give users many years of trouble-free breathing assistance,
provided that the preventive maintenance is carried out at the intervals specified in this
manual. Well-performed maintenance services will ensure the performance during its
lifetime.
It is also important that any peripheral equipment is checked at the same time as the
services are carried out
2.2 Service Software/Upgrade Tool
The Service Software/Upgrade Tool includes procedures for trained and authorized
technical personnel to perform complete function tests, which shall be performed every
second year. Also, this tool is used for calibrating units after repair in the field and
upgrading firmware in the ventilator.
Functions:
•Complete function check of the ventilator
•Automatic/manual calibration of flow sensors and pressure sensors
•Battery health
•Super Cap capacity status
•Upgrade Firmware
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2.3 Introduction
Before you start a maintenance service, read the safety precautions and make sure you
have a new service record and all the necessary equipment, tools, and replacement parts
at hand.
2.3.1 Safety Precautions
Follow the safety precautions below when working with the ventilator:
•Do not work on the ventilator with the casing removed and the power supply con-
nected, unless the instructions in this manual, or other special service instructions
sent out by Breas, clearly says so.
•Always use extreme caution when working with the ventilator connected to the
mains or any other power source and the casing removed.
•Do not use explosive gases and/or fluids near the ventilator.
•Make sure that all precautions to prevent electrostatic discharge (ESD) have been
taken. Follow all regulations regarding ESD.
NOTE
The Clinician’s Manual contains extended lists of safety precautions.
2.3.2 Service Schedule
Product Replace the Blower
Assembly
Replace the Battery
Vivo 45 When necessary. The expected lifetime
of the internal battery is 3 years.
Vivo 45
LS
20,000 hours When the Battery Health parameter is
below 80% (expected lifetime is
approximately 3 years).
Nippy 4 When necessary. The expected lifetime
of the internal battery is 3 years.
Nippy 4+ 20,000 hours When the Battery Health parameter is
below 80% (expected lifetime is
approximately 3 years).
2.3.3 Service Record
The Breas service record is found in Appendices below.
Copy the service record and use it for noting the service checks while performing serv-
ice every second year.
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2.3.4 Inspection Equipment and Tools
Before starting the service of the ventilator, make sure you have the following equip-
ment at hand:
•Test lung (for example Breas part no 001917)
•Ventilator tester (for example, Fluke VT Plus, Fluke VT305, Fluke VT650/900, IMT
Citrex H4/H5, IMT PF300
Or:
–Flow meter
–Pressure manometer
–Measuring instrument for tidal volume and minute volume/rate
•Torque screwdrivers:
–Torx TX3
–Torx TX10
•PH1 screwdriver
•Pliers
•ODU tool
•Service Software, available for download from Breas Extranet. Contact Breas techni-
cal support for more information. Test connector kit, Breas part no 004829 (connec-
tors and leakage ports used when testing).
•Vivo to PC communication cable, Breas part no 005757
2.3.5 Replacement Parts
The following replacement parts should be available when servicing the ventilator:
Item Part No Quantity
Air inlet filter, grey, washable 007104 5
Air inlet filter, white, disposable 007103 5
Cooling air filter 007105 1
If required:
Item Part No Quantity
Blower, complete 007271 1
Super capacitor/Clock battery 007260 2
Internal battery 007256 1
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2.4 Preparing for Inspection
2.4.1 Initial Recording
1Copy a new service record form (at the end of this manual).
2Note the model and serial number and any inventory number on the service record.
3Check any comments recorded on the previous service records.
4Document the current patient settings. A form is found in the User Manual.
2.4.2 Checking Additional Services
1Note the number of device operating hours on the service record.
NOTE
The operating hours are found at the “Device information”screen.
Access the “Device information”using the menu as described in the
Clinician’s manual.
2Check the schedule in the service record to see whether the alarm/clock battery, the
internal battery kit, or the complete blower assembly needs to be replaced.
2.4.3 Inspecting the Markings
Make sure that all markings on the ventilator’s information labels can be read:
•Model description, serial number
•Warning texts
•Any inventory marking
•Any other texts
For information about label placements, see the section on part location.
2.4.4 Information from the Patient/User
Check the following with the patient:
•Has the ventilator functioned without any problems? If not, what were they?
•How does the patient/care provider check the function of the ventilator? How
often?
•How often is the filter replaced?
•How many filters will be required until the next service?
•Other observations?
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2.4.5 Validity of the Documentation
1Check the validity of the User Manual enclosed with the ventilator (see Breas
extranet).
2Check if any modification or upgrading of the ventilator needs to be done at the
same time as the service (see Breas extranet).
2.5 External Inspection
2.5.1 Visual Inspection for External Damage and Wear
1Clean the outside of the ventilator using a mild soap solution.
2Check for any visible damage to the casing and the other components.
3Check that nothing has become loose.
4Check the oxygen low pressure/bleed-in inlet.
2.5.2 Checking the Power Connection
1. Check the plugs on the power cords, the two cords themselves, and the ventilator’s
power socket.
2. Check the click-in battery socket in the ventilator.
3. If used, check that the external DC power cord is not damaged.
2.5.3 Inspecting the Patient Circuit
Inspect the patient circuit and replace it if necessary.
2.5.4 Inspecting the Ventilator Accessories
Check any other accessories that are used with the ventilator.
2.5.5 Changing/Washing the Patient Filters
1Change the white air filter.
2If necessary, change the grey filter.
3Make sure the patient has enough filters to last until the next service.
2.5.6 Changing the Cooling Air Inlet Filter
Open the cooling air filter holder and replace the filter. For detailed information about
replacing filters, see the User Manual.
2.5.7 Minimum Function Check
1Connect the power cord.
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2Connect the patient circuit.
3Switch on the ventilator and make sure it operates normally.
2.6 Internal Inspection
WARNING!
Make sure to disconnect the power supply before opening the casing of the ventilator.
CAUTION!
Always perform an internal inspection after having opened the ventilator.
2.6.1 Cleaning the Inside of the Ventilator
1Open the casing. See the section on opening the ventilator for instructions.
2Remove any dirt or dust that has accumulated in the ventilator.
2.6.2 Checking the Cables
Inspect all the cables and their connectors. Make sure that the cables and the wires are
not pinched or kinked.
2.6.3 Checking the Fastening of Components
1Make sure that all the components, such as the pneumatic block, the circuit boards
and the connectors are securely fastened.
2Check that the blower assembly is placed correctly and that the vibration
dampening pad is properly in place.
3Check that the cooling fan is placed correctly.
4Make sure that all tubes are properly fastened and not pinched or kinked. Do not
forget the air inlet and outlet of the blower assembly.
2.6.4 Checking the Power Adapter
1Check that the power adapter is undamaged.
2.6.5 Reassembling the Casing
See the section on opening the ventilator and replacing parts for instructions.
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2.7 Power Failure Test
2.7.1 Checking the Power Failure Alarm
NOTE
The “Low Alarm Battery”alarm shall not be active prior to the test.
1Remove the internal battery as in 5.1 Replace the Internal Battery, page 34.
2Connect the ventilator to mains.
3Turn the ventilator on and start treatment.
4Disconnect mains power supply.
5Make sure that the ventilator gives the power failure alarm. The power failure alarm
is given with an audible signal and the red alarm LED flashing. The alarm shall be
given for, at least, two minutes. If the power fail alarm stops within two minutes,
change the super capacitors (see section 5.15 Replace the Super Capacitors , page 54).
6Reconnect the internal battery as in 5.1 Replace the Internal Battery, page 34.
2.8 Complete Function Test
To perform the complete function test you need the Service Software, which can be
downloaded from the Breas Extranet. Also, you will need the equipment listed in the
section on tools above.
Contact Breas technical support for more information.
2.9 CO2Sensor Gas Span Check
If a CO2sensor is used with the ventilator it shall be checked once a year to verify the
sensor readings.
To perform the CO2gas span check you need CO2calibration gas consisting of:
•5% CO2(carbon dioxide)
•21% O2(oxygen)
•74% N2(nitrogen)
You will also need a gas regulator.
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2.9.1 How to perform the CO2Gas Span Check
1Snap on a new airway adapter to
the CO2sensor probe.
2Perform a CO2zeroing procedure.
You will find the zeroing procedure under “FiO2/CO2 Calibration”in the
“Others”section
3Mount the gas regulator on the gas
bottle.
Be careful not to damage the thread
on the bottle.
Make sure that the pressure
indicator is not within the red mark.
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4Connect the CO2sensor to the
CO2 calibration gas as below. The
extra airway adapter mounted
behind the CO2sensor is to make
sure that no ambient air is present
during the check.
5Connect the CO2sensor to the ventilator.
For detailed information, see the Clinician’s Manual, the Using Accessories chapter.
6Change the ventilator device settings so that the CO2unit is set to percent (%).
Menu path:
Others > Device Settings > CO2 Unit
7Open the gas valve and adjust the flow so that the float of the rotameter lies above
the first line (or 0.5 l/min if other equipment is used) and let it flow for 30 seconds.
The gas bottle must be in an upright position when performing the gas span check.
8Check the “CO2 Momentary”reading on the ventilator.
Menu path:
Others > FIO2/CO2 Calibration
If the Momentary value is not between 4.5-5.5%:
•Be absolutely sure that the CO2 sensor is in ambient air and perform the CO2 zero-
ing procedure again.
•Check the expiration date of the gas bottle and that the pressure indicator is not
within the red mark.
•Make sure that you have attached an extra airway adapter behind the CO2 sensor
and that the output from the second adapter is unconnected out in ambient air.
•Check that the luer lock plug on the side of the gas regulator is tightly connected.
•Do not use a sensor that fails the gas span check.
2.10 Electrical Safety Precautions
Electrical safety measurements must be made in accordance with IEC 60601-1 3rd
edition.
Requirements
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