Vivo 50 and 60 Service Manual Issue J-2

Table of Contents 1

Introduction ... 5 1.1

2

About the Vivo 50/60 Ventilator ... 5 1.1.1 Function... 5 1.1.2 Intended Use ... 6 1.1.3 Design ... 6 1.1.4 Service Personnel’s Training Requirements ... 6 1.2 About this Manual ... 6 1.2.1 Scope ... 6 1.2.2 Intended Audience... 6 1.2.3 Icons ... 7 Maintenance Instructions ... 8 2.1 2.2 2.3

2.4

2.5

2.6

2.7 2.8 2.9 2.10

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Purpose... 8 Service Schedule ... 9 Introduction ... 9 2.3.1 Safety Precautions ... 9 2.3.2 Service Record... 10 2.3.3 Inspection Equipment and Tools... 10 2.3.4 Replacement Parts ... 10 Preparing for Inspection ... 11 2.4.1 Initial Recording... 11 2.4.2 Checking additional services... 11 2.4.3 Inspecting the Markings ... 11 2.4.4 Information from the Patient/User... 11 2.4.5 Validity of the Documentation ... 11 External Inspection ... 12 2.5.1 Visual Inspection for External Damage and Wear... 12 2.5.2 Checking the Power Connection ... 12 2.5.3 Inspecting the Patient Circuit... 12 2.5.4 Inspecting the Ventilator Accessories... 12 2.5.5 Changing/Washing the Patient Filters ... 12 2.5.6 Minimum Function Check ... 12 Internal Inspection ... 12 2.6.1 Cleaning the Inside of the Ventilator... 12 2.6.2 Checking the Cables ... 13 2.6.3 Checking the Fastening of Components... 13 2.6.4 Checking the Power Supply... 13 2.6.5 Reassembling the Casing... 13 Power Failure Test... 13 2.7.1 Checking the Power Failure Alarm ... 13 Complete Function Test ... 13 CO2 Sensor Gas Span Check ... 14 2.9.1 How to perform the CO2 Gas Span Check ... 14 Electrical Safety Precautions ... 18

Table of Contents 1 Vivo 50/60 Service Manual

3

Parts Location ... 19 3.1 3.2

4

Parts Drawing 1 – Internal Battery, Filters... 19 Parts Drawing 2 – Bottom Casing, PSU Board, Cables, Screws ... 20 3.2.1 Vivo 50... 20 3.2.2 Vivo 60... 21 3.3 Parts Drawing 3 – Top Casing, CPU Board ... 22 3.4 Parts Drawing 4 - Pneumatic Block, PTU Board ... 23 3.4.1 Vivo 50... 23 3.4.2 Vivo 60... 24 3.5 Parts List for the Vivo 50/60 ... 25 Functional Diagram ... 28

5

4.1 Vivo 50 ... 28 4.2 Vivo 60 ... 30 4.3 Filtering/Smoothing Techniques ... 32 4.4 Vivo 50/60 Measuring and Display Devices ... 32 Opening the Vivo 50/60 and Replacing the Main Components ... 33

6

5.1 Replace the Internal Battery ... 33 5.2 Replace the Cooling Air Filter ... 34 5.3 Open and Close the Vivo 50/60 ... 35 5.4 Replace the Complete Blower Assembly ... 37 5.5 Replace the Vivo 50 Pneumatic Block and PTU Board ... 39 5.6 Replace the Vivo 50 Exhalation Valve Control Pressure Valve ... 40 5.7 Replace the Vivo 60 Pneumatic Block and PTU Board ... 42 5.8 Replace the Vivo 60 ZVU Board ... 44 5.9 Replace the Vivo 60 Exhalation Valve Control Pressure Valve ... 45 5.10 Replace the Cooling Fan... 47 5.11 Replace the PSU Board ... 49 5.12 Replace the Clock Battery ... 52 5.13 Replace the CPU Board... 52 5.14 Replace the Alarm Batteries ... 55 5.15 Replacing the LCD Display ... 55 Upgrade and Calibration ... 57

7

6.1 Firmware Upgrade ... 57 6.2 Pressure and Flow Calibration ... 57 Electronics ... 58 7.1 7.2

7.3

Main Cabling Diagram of the Vivo 50/60... 58 Circuit Board Descriptions ... 59 7.2.1 PSU (Power Supply Unit) Board... 59 7.2.2 CPU (Central Processor Unit) Board... 60 7.2.3 PTU (Pressure Transducer Unit) Board... 61 Test Points... 62 7.3.1 Test Point Locations ... 62

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7.4

8

Ventilator Switch-over Operating Conditions... 67 7.4.1 Mains Power Supply Operation ... 67 7.4.2 External Battery Operation ... 67 7.4.3 Click-On Battery Operation ... 67 7.4.4 Internal Battery Operation ... 67 7.5 Battery Charging ... 67 7.5.1 Mains Power Supply Operation ... 67 7.5.2 External Battery Operation ... 68 7.5.3 Click-On Battery Operation ... 68 7.5.4 Internal Battery Operation ... 68 7.6 Checking the Internal Battery... 68 Fault Tracing... 69 8.1 8.2

9

Fault Tracing Table ... 69 Function Failure Error Codes ... 70 8.2.1 Reading the Error Codes... 70 8.2.2 Error Code Table ... 70 Appendices ... 79 9.1

9.2 9.3

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Emission and Immunity Declaration... 79 9.1.1 Guidance and Manufacturer's Declaration – Electromagnetic Immunity ... 79 9.1.2 Guidance and Manufacturer's Declaration – Electromagnetic Emission ... 81 9.1.3 Recommended separation distances between portable and mobile RF communications equipment and the Vivo 50/60 ... 82 Service Record Vivo 50/60 ... 83 Returning Products to Breas... 85

Table of Contents 3 Vivo 50/60 Service Manual

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1

Introduction This chapter gives an overview of the Vivo 50/60 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 Vivo 50/60 service training.

Deviation from these service instructions may lead to risk of personal injury!

1.1

About the Vivo 50/60 Ventilator

1.1.1

Function

The Vivo 50/60 is a pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation. The Vivo 50/60 can be operated in 11 different 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) – Assisted Pressure Controlled Ventilation with Target volume

•

PCV-SIMV – Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation (Vivo 60 only)

•

VCV – Volume Controlled Ventilation

•

VCV(A) – Assisted Volume Controlled Ventilation

•

VCV-SIMV – Volume Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation (Vivo 60 only)

•

CPAP – Continuous Positive Airway Pressure

The Vivo 50 and Vivo 60 can be used with a leakage circuit or a circuit with external active exhalation valve. The Vivo 60 can be used with dual limb circuit connected to an integrated active exhalation valve, for internal measurement of expired volume, pressure and flow. The internal memory data of the Vivo 50/60 can be downloaded to a PC, printed out, and analysed via the Vivo 50/60 PC Software. For more information about the Vivo 50/60 PC Software, please contact your Breas representative.

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Introduction 5 Vivo 50/60 Service Manual

1.1.2

Intended Use

For a detailed description on intended use, refer to the Vivo 50 or Vivo 60 operating manual.

1.1.3

Design

The Vivo 50/60 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 Vivo 50/60 functions correctly. Some of them are checked at power up, some at treatment start and some of them are monitored continuously. 1.1.4

Service Personnel’s Training Requirements

Service personnel working with the Vivo 50/60 shall have medical/technical training and a good knowledge of the construction and function of respiratory devices. Authorisation by Breas after Vivo 50/60 service training is mandatory. Always contact your Breas representative if you have any questions or if training is required.

1.2

About this Manual

1.2.1

Scope

This manual describes all the routine maintenance checks and the additional service actions for the Vivo 50/60. 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. Breas Medical AB reserves the right to make changes to the products and/or the contents of this manual without any prior notice. The service manual is to be used in conjunction with the Vivo 50 and Vivo 60 operating manual.

1.2.2

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 Vivo 50/60 service training is mandatory. Always contact your Breas representative if you have any questions or if training is required. The service manual is not intended for clinical personnel or patients, who will find all the information they need in the Vivo 50 or Vivo 60 operating manual.

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1.2.3

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 and serious personal injury. Caution! Risk of minor or moderate injury. 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. Reference Reference to other manuals with additional information on a specific topic.

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Introduction 7 Vivo 50/60 Service Manual

2

Maintenance Instructions This chapter describes all the routine maintenance checks and additional service instructions for the Vivo 50/60. 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 authorized after Breas Vivo 50/60 service training.

Deviation from these service instructions may lead to risk of personal injury! The patient and care provider should follow the checks that are described in the Vivo 50 or Vivo 60 operating manual.

2.1

Purpose The Vivo 50/60 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.

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2.2

Service Schedule The maintenance service includes all the checks listed in the schedule below. A complete maintenance service (as described in this chapter) must be carried out at least every 12 months.

2.3

INTERVAL

SERVICE CHECK

CHAPTER

Every 12 months

Perform an external inspection Change the cooling air filter Perform a complete function test Perform the CO2 Gas Span Check (if a CO2 sensor is used with the Vivo 50/60)

2.5 5.2 2.8 2.9

Every 3 years

Change the internal battery Check the power failure alarm. Change the click-on battery (if used)

5.1 2.7

Every 5 years

Change the clock battery. Change the alarm batteries. Perform an internal inspection.

5.12 5.14 2.6

Every 20 000 hours of device operating time

Change the complete blower assembly. Perform an internal inspection.

5.4 2.6

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 Vivo 50/60: •

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.

The Vivo 50 and Vivo 60 operating manual contains extended lists of safety precautions.

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Maintenance Instructions 9 Vivo 50/60 Service Manual

2.3.2

Service Record

The Breas service record is found in chapter 9 “Appendices”. Copy the service record and use it for noting the service checks while performing the yearly service. 2.3.3

Inspection Equipment and Tools

Before starting the service of the Vivo 50/60, make sure you have the following equipment at hand: •

Test lung (for example Breas part no 001917)

•

Ventilator tester (Fluke VT Plus or IMT PF-300) Or: – – –

•

Torque screwdrivers: – – – –

2.3.4

Flow meter Pressure manometer Measuring instrument for tidal volume and minute volume/rate Torx TX 10 Torx TX 20 Phillips PH1 Socket 5.5 mm

•

Vivo to PC communication cable, Breas part no 004886

•

Vivo 50/60 Service Software (compatible with Fluke VT Plus and IMT PF-300), 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)

Replacement Parts

The following replacement parts should be available when servicing the ventilator: DESCRIPTION

PART NO.

Patient air inlet filter, grey, washable

004909 (5 pcs)

Patient air inlet filter, white, disposable

004910 (10 pcs)

Cooling air filter

004911 (5 pcs)

If required: Internal battery kit

004554

Click-on battery

004559

Alarm batteries, NiMH 4.8 V, 500 mAh (2 pcs) Clock battery, CR 2032

005058

Blower assembly kit

004558

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2.4

Preparing for Inspection

2.4.1

Initial Recording 1 Copy a new service record (see “Service Record Vivo 50/60” on page 83). 2 Identify the Vivo 50 or Vivo 60. 3 Note the model and serial number and any inventory number on the service record. 4 Check any comments recorded on the previous service records. 5 Document the current patient settings.

2.4.2

Checking additional services 1 Note the number of device operating hours on the service record.

The operating hours are found at the “Device information” screen. Access the “Device information” using the menu as described in the Vivo 50 or Vivo 60 operating manual. 2 Check the service schedule to see whether the alarm/clock batteries, the internal bat-

tery 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:

2.4.4

•

Model description, serial number

•

Warning texts

•

Any inventory marking

•

Any other texts

Information from the Patient/User

Check the following with the patient:

2.4.5

•

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?

Validity of the Documentation 1 Check the validity of the operating 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.

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Maintenance Instructions 11 Vivo 50/60 Service Manual

2.5

External Inspection

2.5.1

Visual Inspection for External Damage and Wear 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. 5 Remove and inspect the patient circuit insert (Vivo 60 only).

2.5.2

Checking the Power Connection 1 Check the plugs on the power cord, the cord itself, and the ventilator’s power socket. 2 Make sure that the restraining clip for the power cord is not damaged or missing. 3 Inspect the external battery cable, if used. 4 Check the external battery socket in the ventilator. 5 Check the click-on battery connector and make sure that the protection cover is not

damaged or missing. 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 1 Change the white air filter. 2 Change the grey filter, if necessary. 3 Make sure the patient has enough filters to last until the next service.

2.5.6

Minimum Function Check 1 Connect the power cord. 2 Connect the patient circuit. 3 Switch on the ventilator and make sure it operates normally.

2.6

Internal Inspection Make sure to disconnect the power supply before opening the casing of the ventilator. Always perform an internal inspection after having opened the Vivo 50/60.

2.6.1

Cleaning the Inside of the Ventilator 1 Open the casing. See “Opening the Vivo 50/60 and Replacing the Main Components”

on page 33 for instructions. 2 Remove any dirt or dust that has collected in the ventilator.

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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 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 pads are 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. 2.6.4

Checking the Power Supply 1 Make sure that the power connectors are undamaged and that they are securely in

place. 2 Check the cables to the CPU and PTU boards. 2.6.5

Reassembling the Casing

See “Opening the Vivo 50/60 and Replacing the Main Components” on page 33 for instructions.

2.7

Power Failure Test

2.7.1

Checking the Power Failure Alarm

The “Low Alarm Battery” alarm shall not be active prior to the test. 1 Remove the internal battery as in section 5.1. 2 Connect the Vivo 50/60 to mains. 3 Turn the Vivo 50/60 on and start treatment. 4 Disconnect mains power supply. 5 Make sure that the Vivo 50/60 gives the power failure alarm.

The power fail 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 alarm batteries (See section 5.14). 6 Reconnect the internal battery as in section 5.1.

2.8

Complete Function Test To perform the complete function test you need the Vivo 50/60 Service Software, which can be downloaded from the Breas extranet. Contact Breas technical support for more information.

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Maintenance Instructions 13 Vivo 50/60 Service Manual

2.9

CO2 Sensor Gas Span Check If a CO2 sensor is used with the Vivo 50/60 it shall be checked once a year to verify the sensor readings. To perform the CO2 gas span check you need a CO2 calibration gas; Breas part no 005341 or a similar gas consisting of: –

5% CO2 (carbon dioxide)

–

21% O2 (oxygen)

–

74% N2 (nitrogen)

You also need a gas regulator; Breas part no 005371 (fits to 005341). 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 find the zeroing procedure under “FiO2/CO2 Calibration” in the “Others” section.

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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.

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.

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Maintenance Instructions 15 Vivo 50/60 Service Manual

5 Connect the CO2 sensor to the

Vivo 50/60.

6 Change the Vivo 50/60 device set-

tings so that the CO2 unit is set to percent (%).

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 Vivo 50/60. You find the reading under “FiO2/CO2 Calibration” in the “Others” section. The CO2 Momentary value shall be between 4.5-5.5%.

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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.

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Maintenance Instructions 17 Vivo 50/60 Service Manual

2.10 Electrical Safety Precautions Electrical safety measurements must be made in accordance with IEC 601. Use an automatic electrical safety tester to make the measurements. All tests must be performed in accordance with class II type BF. Supply Voltage 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. Insulation 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 >20 MΩ . Leakage Currents The leakage current test is optional. The leakage current test is not necessary to ensure safe use of the Vivo 50/60. 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. 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. Patient Leakage Currents The patient leakage current is measured between the patient connector and earth. Limit values:

NC <0.1 mA SFC <0.5 mA

Break neutral for SFC. 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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Parts Location This chapter contains part-number lists and drawings of the parts for the ventilator.

3.1

Parts Drawing 1 – Internal Battery, Filters For definitions of the part numbers, refer to the parts list in section 3.5, "Parts List for the Vivo 50/60", on page 25.

2 1

4

3

5 17-1

24-3

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Parts Location 19 Vivo 50/60 Service Manual