Service Manual
76 Pages
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Page 1
Service manual Vivo 45/Nippy 4 Series
DOC. 007132 EN-EU Y-2 2019-10-03
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 1.2.2 1.2.3 1.3
2
1.2.4 Service Personnel’s Training Requirements ... 9 About this Manual ... 9 1.3.1 Scope ... 9 1.3.2 Icons... 10
1.4 Applicable Ventilators... 10 Maintenance Instructions ...11 2.1 Purpose...11 2.2 Service Software/Upgrade Tool ...11 2.3 Introduction ... 12
2.4
2.5
2.3.1
Safety Precautions... 12
2.3.2 2.3.3
Service Schedule ... 12 Service Record ... 12
2.3.4 Inspection Equipment and Tools... 13 2.3.5 Replacement Parts ... 13 Preparing for Inspection... 14 2.4.1
Initial Recording ... 14
2.4.2
Checking Additional Services ... 14
2.4.3 Inspecting the Markings... 14 2.4.4 Information from the Patient/User... 14 2.4.5 Validity of the Documentation ... 15 External Inspection ... 15 2.5.1 Visual Inspection for External Damage and Wear... 15 2.5.2 2.5.3 2.5.4
2.6
2.7
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Function ... 7 Intended Use... 9 Design ... 9
Checking the Power Connection ... 15 Inspecting the Patient Circuit ... 15 Inspecting the Ventilator Accessories... 15
2.5.5 Changing/Washing the Patient Filters ... 15 2.5.6 Changing the Cooling Air Inlet Filter ... 15 2.5.7 Minimum Function Check ... 15 Internal Inspection... 16 2.6.1 Cleaning the Inside of the Ventilator ... 16 2.6.2 Checking the Cables... 16 2.6.3 Checking the Fastening of Components ... 16 2.6.4 Checking the Power Adapter ... 16 2.6.5 Reassembling the Casing... 16 Power Failure Test ... 17
Table of Contents 3 Vivo 45/Nippy 4 Series
2.8 2.9
2.7.1 Checking the Power Failure Alarm ... 17 Complete Function Test ... 17 CO2 Sensor Gas Span Check... 17 2.9.1
How to perform the CO2 Gas Span Check ... 18
2.10
3
Electrical Safety Precautions ... 19 2.10.1 Preparations... 20 2.10.2 Insulation Check ... 20 2.10.3 Leakage Currents Check ... 20 Parts Location ... 22 3.1 3.2 3.3 3.4
View A ... 22 View B ... 22 View C ... 23 View D ... 24
3.5 3.6 3.7
View E ... 25 View F ... 26 Screw Kits ... 27 3.7.1 MRT M3x6 FZB... 27 3.7.2 3.7.3
4 5
M3x8 and MRT 3x10 FZB ... 28 M2.5x6 and Isolation Screw Grommets... 28
3.8 Part List ... 29 Functional Diagram ... 33 Opening the Ventilator and Replacing the Main Components... 35 5.1 Replace the Internal Battery ... 35 5.2 Open and Close the Ventilator ... 35 5.3
Replace the Cooling Air Filter ... 37
5.4
Replace the Blower Assembly ... 38
5.5 5.6 5.7 5.8
Replace the Cooling Fan ... 42 Replace the Clock Battery ... 46 Replace the PTU Board ... 47 Replace the CPU Board... 47 5.8.1 Replace the Humidifier Sense Board ... 48
5.9 5.10 5.11
Replace the Beeper ... 48 Replace the SD Board ... 50 Replace the Heated Wire Board ... 51
5.12 5.13
Replace the Humidity Plate... 52 Replace the FiO2 Board ... 52
5.14
Replace the Complete Contact Board ... 53 5.14.1 Replace the USB Board... 54
5.15 5.16 5.17
Replace the Super Capacitors ... 54 Replace the Button Board... 54 Replace the Front Cover ... 55
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6
7
5.18 Replace the LCD Display... 56 5.19 Replace the Top Cover ... 57 Upgrade and Calibration ... 59 6.1 Firmware Upgrade ... 59 6.2 Pressure and Flow Calibration... 59 Electronics... 60 7.1 Main Cabling Diagram of the Ventilator ... 60 7.2
7.3
7.4
8
9
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Circuit Board Descriptions ... 60 7.2.1 Main Board... 60 7.2.2 PTU (Pressure Transducer Unit) Board... 64 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 Battery Charging ... 65 7.4.1 7.4.2
Mains Power Supply Operation ... 65 External Battery Operation ... 65
7.4.3 7.4.4
Click-In Battery Operation... 65 Internal Battery Operation... 65
7.5 Checking the Internal Battery... 65 Fault Tracing... 67 8.1 8.2
Fault Tracing Table ... 67 Internal Error Codes... 68
8.3
Function Failure Error Codes... 69 8.3.1 Error Code Table ... 69
Appendices... 74 9.1 Emission and Immunity Declaration ... 74 9.2 Returning Products to Breas... 74 9.3 Service Record... 74
Table of Contents 5 Vivo 45/Nippy 4 Series
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
Address Breas Medical AB Företagsvägen 1 SE-435 33 Mölnlycke Sweden Web Address www.breas.com E-mail address [email protected] Phone +46 31 868800, Order: +46 31 868820, Technical support: +46 31 868860 Fax +46 31 868810 Local Representatives Information www.breas.com/contact-us/
1.2
About the Vivo 45 / Nippy 4 Series Ventilator
1.2.1
Function The ventilation and breath modes are used for controlling the ventilation treatment with the ventilator. The following combinations of ventilation and breath modes can be selected for the ventilator:
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Introduction 7 Vivo 45/Nippy 4 Series Service manual
Vivo 45 • 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) - Pressure Controlled Ventilation (Assisted) • PCV(A+TgV) - Pressure Controlled Ventilation with Target Volume • CPAP – Continuous Positive Airway Pressure Vivo 45 LS • 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) - Pressure Controlled Ventilation (Assisted) • PCV(A+TgV) - Pressure Controlled Ventilation with Target Volume • PCV-SIMV - Pressure Support Ventilation with Synchronized Intermittent Mandatory Ventilation • PCV-MPV– Pressure Controlled Ventilation with Mouth-Piece Ventilation • CPAP – Continuous Positive Airway Pressure Nippy 4 • PSV - Pressure Support Ventilation • PSV(TgV) - Pressure Support Ventilation with Target Volume • PCV - Pressure Controlled Ventilation • CPAP – Continuous Positive Airway Pressure Nippy 4+ • 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-MPV - Mouthpiece - Pressure • VCV - Volume Control
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• VCV-MPV - Mouthpiece - Volume • CPAP – Continuous Positive Airway Pressure 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 respiratory devices. Authorisation by Breas after service training is mandatory. 1.2.3
Design The ventilator is designed around a blower assembly that delivers air to the patient. The main processor monitors sensors for pressure, flow etcetera 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. Authorisation by Breas after service training is mandatory. CAUTION! Always contact your Breas representative if you have any questions or if training is required.
1.3
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 for the maintenance and the service of the ventilator, such as replacement parts lists, exploded drawings, cabling diagrams, component location guides and more.
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Introduction 9 Vivo 45/Nippy 4 Series Service manual
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 instructions 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 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 analysis (cycle count) • Super Cap capacity status • Upgrade Firmware
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Maintenance Instructions 11 Vivo 45/Nippy 4 Series Service manual
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 connected, 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
Vivo 45 Vivo 45 LS
When necessary. The expected lifetime of the internal battery is 3 years. 20,000 hours
Nippy 4 Nippy 4+
2.3.3
Replace the Battery
When the Battery Health parameter is below 80% (expected lifetime is approximately 3 years). When necessary. The expected lifetime of the internal battery is 3 years.
20,000 hours
When the Battery Health parameter is below 80% (expected lifetime is approximately 3 years).
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 service 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 equipment 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 technical support for more information. Test connector kit, Breas part no 004829 (connectors 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
Item
Part No
Quantity
Blower, complete
007271
1
Super capacitor/Clock battery
007260
2
Internal battery
007256
1
If required:
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Maintenance Instructions 13 Vivo 45/Nippy 4 Series Service manual
2.4
Preparing for Inspection
2.4.1
Initial Recording
2.4.2
1
Copy a new service record (see 2.3.3 Service Record, page 12.)
2
Note the model and serial number and any inventory number on the service record.
3
Check any comments recorded on the previous service records.
4
Document the current patient settings.
Checking Additional Services 1
Note 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.
2
2.4.3
Check 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.
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 3.2 View B, page 22.
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 1
Check the validity of the User Manual enclosed with the ventilator.
2
Check if any modification or upgrading of the ventilator needs to be done at the same time as the service.
2.5
External Inspection
2.5.1
Visual Inspection for External Damage and Wear
2.5.2
1
Clean the outside of the ventilator using a mild soap solution.
2
Check for any visible damage to the casing and the other components.
3
Check that nothing has become loose.
4
Check the oxygen low pressure/bleed-in inlet.
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
2.5.6
Changing/Washing the Patient Filters 1
Change the white air filter.
2
If necessary, change the grey filter.
3
Make sure the patient has enough filters to last until the next service.
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
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Minimum Function Check 1
Connect the power cord.
2
Connect the patient circuit.
Maintenance Instructions 15 Vivo 45/Nippy 4 Series Service manual
3
2.6
Switch on the ventilator and make sure it operates normally.
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
2.6.2
Cleaning the Inside of the Ventilator 1
Open the casing. See 5 Opening the Ventilator and Replacing the Main Components, page 35 for instructions.
2
Remove any dirt or dust that has collected in the ventilator.
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
2.6.4
Checking the Fastening of Components 1
Make sure that all the components, such as the pneumatic block, the circuit boards and the connectors are securely fastened.
2
Check that the blower assembly is placed correctly and that the vibration dampening pad is properly in place.
3
Check that the cooling fan is placed correctly.
4
Make sure that all tubes are properly fastened and not pinched or kinked. Do not forget the air inlet and outlet of the blower assembly.
Checking the Power Adapter 1
2.6.5
Check that the power adapter is undamaged.
Reassembling the Casing See 5 Opening the Ventilator and Replacing the Main Components, page 35 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.
2.8
1
Remove the internal battery as in 5.1 Replace the Internal Battery, page 35.
2
Connect the ventilator to mains.
3
Turn the ventilator on and start treatment.
4
Disconnect mains power supply.
5
Make 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).
6
Reconnect the internal battery as in 5.1 Replace the Internal Battery, page 35.
Complete Function Test To perform the complete function test you need the Service Software, which can be downloaded from the Breas Extranet. Contact Breas technical support for more information.
2.9
CO2 Sensor Gas Span Check If a CO2 sensor is used with the ventilator it shall be checked once a year to verify the sensor readings. To perform the CO2 gas span check you need CO2 calibration gas consisting of: • 5% CO2 (carbon dioxide) • 21% O2 (oxygen) • 74% N2 (nitrogen) You will also need a gas regulator.
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Maintenance Instructions 17 Vivo 45/Nippy 4 Series Service manual
2.9.1
How to perform the CO2 Gas Span Check 1
Snap on a new airway adapter to the CO2 sensor probe.
2
Perform a CO2 zeroing procedure. You will find the zeroing procedure under “FiO2/CO2 Calibration” in the “Others” section
3
Mount 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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4
Connect the CO2 sensor to the CO2 calibration gas as below. The extra airway adapter mounted behind the CO2 sensor is to make sure that no ambient air is present during the check.
5
Connect the CO2 sensor to the ventilator. For detailed information, see the Clinician’s Manual, the Using Accessories chapter.
6
Change the ventilator device settings so that the CO2 unit is set to percent (%). Menu path: Others > Device Settings > CO2 Unit
7
Open 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.
8
Check 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 zeroing 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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Maintenance Instructions 19 Vivo 45/Nippy 4 Series Service manual
• Use an automatic electrical safety tester to make the measurements. • All tests must be performed in accordance with class II type BF (IEC 60601-1). 2.10.1
Preparations Supply Voltage Reading Note the power voltage reading. The voltage must be noted at each service check, as the currents measured are directly in relation to the supply voltage. This allows all measurements made on the same ventilator to be compared with measurements made on different occasions.
2.10.2
Insulation Check The insulation resistance is measured using a 500 V DC power supply. The most suitable method is to connect the plus lead to the two ventilator power socket pins, and the minus lead to the casing or the patient air connector. The measurements made during the delivery inspection can be used as reference values for measurements made during future services. If no reference values are available, the value for the insulation resistance should be ≥ 70 MW .
2.10.3
Leakage Currents Check NOTE The leakage current check is optional. The leakage current check is not necessary to ensure safe use of the Vivo. The leakage currents are measured at different parts of the ventilator using an RC circuit to earth. Make the measurements partly at normal case (NC) and at the single fault condition (SFC). Reverse the polarity of the power supply and note the highest value. Leakage currents to earth must not exceed the stated limit values.
2.10.3.1 Leakage Currents from the Casing The leakage current of the casing is measured at an unpainted point, for example, the head of a screw. Limit values: • NC <0.1 mA • SFC <0.5 mA Break neutral for SFC. 2.10.3.2 Patient Leakage Currents The patient leakage current is measured between the patient connector and earth.
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Limit values: • NC <0.1 mA • SFC <0.5 mA Break neutral for SFC. 2.10.3.3 Leakage Currents with Mains Power Supply at the Patient-connected Part This test must be done using an automatic electrical safety tester with this function. See the safety instructions for the tester. Limit value: SFC <5 mA 2.10.3.4 Leakage Currents with Mains Power Supply at the Patient-connected Part This test must be done using an automatic electrical safety tester with this function. See the safety instructions for the tester. Limit value: SFC <5 mA
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Maintenance Instructions 21 Vivo 45/Nippy 4 Series Service manual
3
Parts Location
3.1
View A
11-2
11-1 11-2 16/17
18-1 19
20 5 4
1-1
1-2
24
3.2
View B
12
14
10-1 10-2
+
22 Parts Location Vivo 45/Nippy 4 Series Service manual
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