SERVO-U-n Cleaning and Maintenance Manual Ver 01 June 2018

| TABLE OF CONTENTS |

Table of Contents

1 2 3 4

Introduction Patient unit and user interface Expiratory cassette O2 cell (maintenance)

5 Inspiratory channel (maintenance) 6 CO2 analyzer

7 Aerogen Pro nebulizer 8 Y sensor 9 NAVA system 10 Hardware accessories 11 Recommended intervals and disinfectants

SERVO-U/n Ventilator Systems, User's Manual Infologic 1.27

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4 7 10 14 17 22 24 27 29 30 31

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| 1 | Introduction |

1 Introduction Table of contents

1.1

Introduction 1.2 Maintenance 1.3 Safety guidelines 1.4 Symbols

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| Introduction | 1 |

1.1 Introduction As cleaning practices vary widely among health care institutions, it is not possible for Maquet to specify particular practices that will meet all needs, or to be responsible for the effectiveness of cleaning procedures carried out in the patient care setting. Maquet recommends methods that have been validated using the specified equipment and procedures outlined in this manual. Other methods may work but are not covered by the warranty unless Maquet has given written permission. Unless otherwise stated, the information in this User´s Manual is valid for all SERVO-U and SERVO-n ventilator systems.

1.2 Maintenance A preventive maintenance must be performed by authorized personnel at least once every year as long as the unit is not used more than normal. Normal operation during one year is estimated to correspond to approximately 5000 hours of operation.

1.3 Safety guidelines WARNING! Indicates critical information about a potential serious outcome to the patient or the user. CAUTION: Indicates instructions that must be followed in order to ensure the proper operation of the equipment. Important: Indicates information intended to help you operate the equipment or its connected devices easily and conveniently. Note: Indicates information requiring special attention. CAUTIONS: • All personnel should be aware of the risk of parts being infected when disassembling and cleaning the ventilator system. • The expiratory channel and expired gas from the exhaust port may be contaminated. • All disposable parts must be discarded according to hospital routines and in an environmentally safe way.

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| 1 | Introduction |

Important: • Follow your hospital‘s routines for handling infectious material when handling any part of the ventilator system. • If possible, cleaning should be performed immediately after use and always before steam autoclaving/disinfection. Blood or other residues should not be allowed to dry onto the devices. • Water quality affects cleaning/disinfection. Maquet recommends drinking water quality as the minimum quality level. • Maquet recommends the use of Servo Duo Guard bacterial filter or equivalent to reduce the transmission of bacteria from the patient via the expiratory cassette to the ambient air. This reduces the risk of infection spread and prolongs the life of the expiratory cassette due to reduced cleaning requirements.

Note: Single use (i.e. disposable) items shall not be reused. Cleaning of single use items can damage the item and compromise its intended use. Reuse of single use items increases the risk of spreading infections and compromises the durability of the item.

1.4 Symbols Hazardous waste The device contains parts which must not be disposed of with ordinary waste. Special waste This product contains electronic and electrical components. Discard disposable, replaced and left-over parts in accordance with appropriate industrial and environmental standards.

If a Servo Duo Guard bacterial filter (or equivalent) has been used only wiping off the ventilator and discarding filter is necessary. • The use of a washer-disinfector for cleaning/disinfection is recommended if bacterial filters are not used. • Steam autoclaving is normally not necessary for the expiratory cassette, as it is not an invasive instrument, but when applied, use validated processes only.

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| Patient unit and user interface | 2 |

2 Patient unit and user interface 1

2.1 Preparations Note: Cleaning should be done after each patient or according to hospital routines.

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Switch off the ventilator system using the on/off switch on the patient unit. Disconnect the ventilator system from the mains power and gas supply. Disconnect any optional equipment from the mains power and from the ventilator system. Discard disposable items according to hospital routines and environmental regulations. - Servo Duo Guard viral/bacterial filter - SERVO humidifier/HME

1.

Press the button on the expiratory cassette.

2.

Tilt the cassette upwards and remove.

Important: After removing the expiratory cassette, do not pour any fluid into the expiratory cassette compartment. Avoid contact with electrical connectors.

- disposable Y sensor - disposable patient tubing - disposable airway adapter - Edi catheters - Aerogen Solo nebulizer Remove the expiratory cassette.

2.1.1 Remove the expiratory cassette

2.2 Wiping and discarding Important: Do not use abrasive or sharp tools to clean the user interface. If a Servo Duo Guard bacterial filter (or equivalent) has been used only wiping off the ventilator and discarding filter is necessary.

Important: The expiratory cassette is a precision instrument and must be handled carefully.

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| 2 | Patient unit and user interface |

Cleaning should be done after each patient or according to hospital routines.

2.3 Assembling 2.3.1 Insert the expiratory cassette

1 2

Wipe all parts with cleaning wipes or a soft lint-free cloth moistened in soap & water or detergent-based disinfectant. Note: In case of more contaminated surfaces, use ethyl alcohol (70%) or isopropyl alcohol (70%). Avoid contact with electrical connectors. Refer to section Recommended intervals and disinfectants on page 31.

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• Hinge the expiratory cassette and press it firmly down into lock position. Important: Make sure that the cassette clicks into position. Check that it cannot be moved upwards and that the button on top of the cassette is completely ejected. • Note on a log sheet that a routine cleaning has been performed. Refer to hospital routines.

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| Patient unit and user interface | 2 |

2.3.2 Pre-use check After cleaning, always perform a pre-use check. Refer to the ventilator system User's Manual. If the pre-use check fails: • Carefully shake/tilt the cassette (5-7 times). • Run the cassette in a ventilator system with a test lung for 10 minutes.

2.4 Preventive maintenance 2.4.1 Check fan filters Regularly check that the fan filter looks clean (i.e. black). If dusty, remove (snap off/snap on) and rinse in water. Shake out, ensuring that the filter is free from excess water. Regularly check that the emergency air intake is not occluded.

• Re-do the pre-use check.

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| 3 | Expiratory cassette |

3 Expiratory cassette 3.1 Preparations • Remove the expiratory cassette Refer to section Remove the expiratory cassette on page 7.

3.2 Disinfection • Pre-disinfect according to hospital routines. Refer to section Recommended intervals and disinfectants on page 31.

• Wash the parts with water only in a washer-disinfector at a temperature of 85-95°C (185-203°F).

There are two disinfection procedures for the expiratory cassette and associated parts when no bacterial filter is used: • Washer-disinfector (ISO 15883-1)(recommended) • Disinfectant 3.2.1 Washer-disinfector If rinsing before disinfection is not included in the washer disinfector program: • Rinse the parts thoroughly in water (<35°C/95°F). • Let the water flow through the parts. Important: Immediate rinsing in water (<35°C/95°F) can remove particles and reduces the risk of crosscontamination between patients.

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• Place the expiratory cassette on its side with the electrical connector uppermost. Notes: • The water pressure in the washer-disinfector should not exceed 1.5 bar. • The maximum water flow should not exceed 10 l/min. • The water must have free passage through the cassette.

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3.2.2 Disinfectant

Rinse after disinfection Important: Follow the disinfectant manufacturer's recommendation and instructions regarding rinsing.

Let the parts soak in disinfectant. Refer to section Recommended intervals and disinfectants on page 31.

Mineral deposits from disinfectant on the expiratory cassette affect the function. It is important to rinse the expiratory cassette thoroughly. Residues from chemicals can affect the patient, cause leakage and extra stress on the material.

Important: Follow the disinfectant manufacturer’s recommendations and instructions, otherwise the cassette may be damaged or not disinfected properly.

Rinse the parts thoroughly in water to remove all traces of disinfectant. Let the water flow through the parts. Carefully shake and tilt the cassette, turn upside down and repeat at least 5-7 times.

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| 3 | Expiratory cassette |

3.3 Drying alternatives

3.3.1 Recommended position in a drying cabinet

Important: The expiratory cassette must be dried before use (if not dry, the expiratory cassette may not pass the preuse check). Always shake/tilt the cassette carefully (5-7 times). There are several drying alternatives for the expiratory cassette: • Drying cabinet 1 hour in maximum 70°C (158°F); if available, connect a 22 mm air hose to the expiratory cassette for extra drying effect, or

3.3.2 Recommended position in room air

• Drying the cassette in room air 12-24 hours, depending on surrounding conditions.

If the pre-use check is not passed after drying then: Run the cassette in a ventilator system with a test lung for 10 minutes, or Dry the cassette in room air (if no drying cabinet is available) 12-24 hours, depending on surrounding conditions. Notes: Never dry the cassette by applying high-pressure air as the internal tubing may be damaged. Drying may not be necessary if the washer-disinfector has a drying phase.

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| Expiratory cassette | 3 |

3.4 Steam autoclaving Note: Steam autoclaving procedures are not recommended. Steam autoclaving will reduce the lifetime of the expiratory cassette and is not recommend as a cleaning method.

3.4.4 Drying after steam autoclaving Refer to section Drying alternatives on page 12.

3.5 Assembling Refer to section Assembling on page 8.

Steam autoclaving is normally not necessary for the expiratory cassette, as it is not an invasive instrument, but when applied, use validated processes only. Refer to section Recommended intervals and disinfectants on page 31. 3.4.1 Cleaning • Clean before steam autoclaving. Refer to section Washer-disinfector on page 10. 3.4.2 Rinse • Rinse the parts thoroughly in water (<35°C/95°F). • Let the water flow through the parts.

3.4.3 Drying before steam autoclaving Before placing the expiratory cassette in a steam autoclave, make sure that no water remains inside the cassette. Refer to section Drying alternatives on page 12.

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| 4 | O2 cell (maintenance) |

4 O 2 cell (maintenance) 4.1 Preventive maintenance Regularly check the cell status in quick menu SYSTEM STATUS/O2 cell. The O2 cell should be exchanged if <10% estimated remaining capacity is indicated.

Refer to the ventilator system User's manuals for O2 cell adjustment.

4.2 Preparations WARNING! The sealed unit of the O2 cell

contains a caustic liquid which may cause severe burns to the skin and eyes. In case of contact, immediately wash the affected area continuously with water for at least 15 minutes and seek medical attention, especially if the eyes are affected. Important: • Make sure the O2 cell is for the intended

• Turn the inspiratory channel lock one quarter of a turn to release. • Lift off the inspiratory channel cover. WARNING! The inspiratory channel cover shall be kept in place once maintenance has been performed. Otherwise the gas modules can be affected and deliver the wrong flow.

ventilator model.

• Replacement of the O2 cell and filter and extended cleaning must only be performed by trained personnel.

• Unpack the O2 cell at least 15 minutes

before replacement. Turn the ventilator system off using the on/off switch on the patient unit.

• Disconnect the ventilator system from the power and gas supply.

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| O2 cell (maintenance) | 4 |

4.2.1 Remove O2 cell and/or bacterial filter

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• Lower the locking catch.

• Disconnect the O2 cell connector. • Lift and discard the O2 cell with the rubber seal to special waste and/or remove and discard the bacterial filter to hazardous waste.

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| 4 | O2 cell (maintenance) |

4.3 Assembling 4.3.1 Insert the O2 cell

• Ensure that the new rubber seal is intact, then firmly put in a new bacterial filter.

• Put the inspiratory channel cover in position. • Tighten the inspiratory channel lock. • Perform a pre-use check. Refer to the ventilator system User's Manual.

• Connect the O2 cell connector. • Put the O2 cell in position. • Close the locking catch.

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| Inspiratory channel (maintenance) | 5 |

5 Inspiratory channel (maintenance) 5.1 Preventive maintenance

If an O2 sensor is installed:

Important: It is recommended that a regular cleaning and an extended cleaning of the inspiratory channel should be performed before carrying out preventive maintenance.

5.2 Preparations • Remove the inspiratory channel cover. Refer to chapter O2 cell (maintenance),

• Disconnect the O2 sensor and carefully unlock the latches.

section Preparations on page 14. • Remove O cell/sensor. 2

If an O2 cell is installed:

• Lift the O2 sensor out of position. • Lower the locking catch.

• Disconnect the O2 cell connector and lift out the O2 cell.

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| 5 | Inspiratory channel (maintenance) |

5.2.1 Remove inspiratory channel and tube • Remove the inspiratory channel.

5.3 Disinfection Important: It is recommended that cleaning of the inspiratory channel should be performed during preventive maintenance. The cleaning must be done by trained personnel only. • Pre-disinfect according to hospital routines. Refer to section Recommended intervals and disinfectants on page 31. 5.3.1 Rinse before disinfection

• Press the latches and lift the inspiratory channel upwards. Disconnect the connector muffs. • Disconnect the tube and remove the bacterial filter. Discard the filter to hazardous waste.

If rinsing before disinfection is not included in the washer disinfector program: • Rinse the parts thoroughly in water (<35°C/95°F). • Let the water flow through the parts. Important: Immediate rinsing in water (<35°C/95°F) can remove particles and reduces the risk of cross-contamination between patients.

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5.3.2 Washer-disinfector

5.4 Assembling 5.4.1 Insert inspiratory channel and tube

• Place the inspiratory channel so that the water flows through it. • Clean the inspiratory channel and tube the same way as the expiratory cassette. Refer to section Disinfection on page 10.

• Put a new bacterial filter in position and connect the filter to the tube.

• Put the connector muffs in position.

• Press the latches and insert the inspiratory channel.

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| 5 | Inspiratory channel (maintenance) |

Important: • There should always be clearance between the connector muffs and gas modules.

If an O2 sensor is installed:

• Make sure the latches are locked in position.

5.4.2 Insert O2 cell/O2 sensor If an O2 cell is installed:

• Put the O2 sensor in position.

2x

• Connect the O2 cell connector and put the O2 cell in position.

• Close the locking catch.

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• Connect the O2 sensor (two "clicks" are heard).

• Connect the O2 sensor connector.

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| Inspiratory channel (maintenance) | 5 |

• Re-assemble the inspiratory channel cover according to instructions given in section Assembling on page 16. • Note on a log sheet that an extended cleaning of the inspiratory channel has been performed. • Perform a pre-use check. Refer to the ventilator system User's Manual.

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