SERVO-U and SERVO-n Cleaning and Maintenance User Manual Rev 03 Sept 2022

| TABLE OF CONTENTS |

TABLE OF CONTENTS

1 Introduction 2 Routine cleaning 3 Maintenance

SERVO-U/SERVO-n Ventilator System, User´s Manual Infologic 1.12.1.1

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| TABLE OF CONTENTS |

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SERVO-U/SERVO-n Ventilator System, User´s Manual Infologic 1.12.1.1

| Introduction | 1 |

1 Introduction Table of contents

1.1 1.2 1.3 1.4

SERVO-U/SERVO-n Ventilator System, User´s Manual

Introduction Safety guidelines Symbols General information

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1.1 Introduction Unless otherwise stated, the information in this User´s Manual is valid for all SERVO-U and SERVO-n ventilator systems. Here you will find the information needed to clean and maintain the ventilator system safely. The manual is divided into three sections: • Introduction (mandatory information) • Routine cleaning • Maintenance

1.2 Safety guidelines WARNING! Indicates critical information about a potential serious outcome to the patient or the user.

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.

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Important: Indicates information intended to help you operate the equipment or its connected devices easily and conveniently.

Note: Indicates information requiring special attention.

1.3 Symbols Hazardous waste The device contains parts which must not be disposed of with ordinary waste.

1.4 General information 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.

SERVO-U/SERVO-n Ventilator System, User´s Manual

| Introduction | 1 |

• The inspiratory channel may be contaminated if the safety valve is opened when the patient is coughing.

• 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 room air. This reduces the risk of infection spread and prolongs the life of the expiratory cassette due to reduced cleaning requirements.

• The expiratory channel and expired gas from the exhaust port may be contaminated.

• The use of a washer-disinfector for cleaning/disinfection is recommended if bacterial filters are not used.

• All disposable parts must be discarded according to hospital routines and in an environmentally safe way.

• Steam autoclaving is normally not necessary for the expiratory cassette, as it is not an invasive instrument, but when applied, use validated processes only.

Important: • Follow your hospital‘s routines for handling infectious material when handling any part of the ventilator system.

Notes: • 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.

CAUTIONS: • All personnel should be aware of the risk of parts being infected when disassembling and cleaning 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 quality water as the minimum quality level.

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| 1 | Introduction |

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2 Routine cleaning Table of contents

2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13

SERVO-U/SERVO-n Ventilator System, User´s Manual

Cleaning/disinfection procedures - a summary | Preparations and dismantling | Wiping and discarding | Disinfection procedures | Steam autoclaving procedures (not | recommended) Assembling | User interface and patient unit cleaning | Aeroneb nebulizer cleaning | Y sensor cleaning | NAVA system cleaning | CO2 analyzer cleaning | Humidifier cleaning | Hardware accessories cleaning |

10 11 12 14 18 19 20 20 23 25 26 27 28

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2.1 Cleaning/disinfection procedures - a summary

2.1.2 Disinfection when no bacterial filter is used

A summary of the procedures for cleaning, disinfection and steam autoclaving is given here. Details for each step are given in the following sections.

Dismantle

Wipe off/discard

2.1.1 Cleaning when bacterial filter is used

Rinse D1

D2

Dismantle

Wipe off/discard

WasherDisinfector

Disinfectant

Rinse

Assemble

Wipe off and discard filter. Refer to section Wiping and discarding on page 12.

Dry

Assemble

There are two disinfection procedures for the expiratory cassette and associated parts, D1 and D2. In D1 (recommended) a Washer-Disinfector (ISO 15883-1) is used, and in D2 a disinfectant is used.

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2.1.3 Steam autoclave (NOT recommended)

2.2 Preparations and dismantling Dismantle

Dismantle

Wipe off/discard

Wipe off/discard Rinse

Rinse D1

D2

Dry WasherDisinfector

Disinfectant

Autoclave Rinse

Dry Dry

Assemble

Assemble

Steam autoclaving will reduce the lifetime of the expiratory cassette and is not recommend as a cleaning method. 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 Number of cycles in steam autoclave on page 18.

SERVO-U/SERVO-n Ventilator System, User´s Manual

2.2.1 Preparations • 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.

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2.2.2 Remove the expiratory cassette

2.3 Wiping and discarding

1

Dismantle

Wipe off/discard

2

Rinse D1

D2

WasherDisinfector

Disinfectant

Rinse

1. 2.

Press the button on the expiratory cassette.

Dry

Tilt the cassette upwards and remove. Assemble

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

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• Wipe the ventilator system and all removable parts with cleaning wipes or a soft lint-free cloth moistened in soap & water or detergent-based disinfectant.

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.

• User interface and patient unit cleaning. Refer to section User interface and patient unit cleaning on page 20.

Regularly check that the emergency air intake is not occluded.

Note: In case of more contaminated surfaces, use cleaning wipes, ethyl alcohol (70%) or isopropyl alcohol (70%). Avoid contact with electrical connectors.

CAUTION: Do not immerse battery, CO2, Edi or Y sensor modules in any fluid.

This is all the cleaning that is required when a Servo Duo Guard filter (or equivalent) is used. Cleaning wipes • 3M Respirator cleaning wipes 2.3.1 Rinse before disinfection

Dismantle

• Discard disposable items: - Servo Duo Guard viral/bacterial filter - SERVO humidifier/HME

Wipe off/discard

- disposable Y sensor - disposable patient tubing

Rinse D1

D2

- disposable airway adapter - Edi catheters

WasherDisinfector

Disinfectant

- Aeroneb Solo nebulizer Rinse

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.

SERVO-U/SERVO-n Ventilator System, User´s Manual

Dry Assemble

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2.4 Disinfection procedures Dismantle

Wipe off/discard Rinse D1

D2

WasherDisinfector

Disinfectant

Rinse

If rinsing before disinfection is not included in the washer disinfector program: • Rinse the parts thoroughly in water (<35°C/95°F).

Dry Assemble

• 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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Important: • The expiratory cassette is a precision instrument and must be handled carefully. • After disinfection procedure, all parts must be dried before use. If the expiratory cassette is not dry it may not pass the pre-use check.

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2.4.1 Washer-Disinfector (D1)

• 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. • Wash the parts with water only in a washer-disinfector at a temperature of 85-95°C (185-203°F). The following cleaning agent can be used: - neodisher® MediClean forte

• The maximum water flow should not exceed 10 l/min. • The water must have free passage through the cassette. The expiratory cassette will last at least 200 cycles.

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2.4.2 Disinfectant (D2)

2.4.3 Rinse after disinfection (D2)

Let the parts soak in disinfectant such as: • Alcohol (ethyl or isopropyl alcohol 70%) • Aniosyme DD1 • Anioxyde 1000 • Cidex OPA • Gigazyme Plus • Salvanios pH7 Important: Follow the disinfectant manufacturer’s recommendations and instructions, otherwise the cassette may be damaged or not disinfected properly.

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• 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. Important: 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.

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2.4.4 Drying alternatives

Recommended position in a drying cabinet

Dismantle

Wipe off/discard Rinse D1

D2

WasherDisinfector

Disinfectant

Rinse

Recommended position in room air

Dry Assemble

The expiratory cassette must be dried before use (if not dry, the expiratory cassette may not pass the pre-use 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

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.

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

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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.

2.5 Steam autoclaving procedures (not recommended) A steam autoclave may be used to sterilize the expiratory cassette but it is normally not necessary, as the expiratory cassette is not an invasive instrument. Steam autoclaving will reduce the lifetime of the expiratory cassette and is not recommend as a cleaning method.

2.5.3 Steam Autoclave • Instrument parts should be steam autoclaved in a validated process, at a temperature of 134°C (273°F) for 3 minutes. • Rubber parts should be steam autoclaved in a validated process, at a temperature of 121°C (250°F) for 15-20 minutes.

2.5.4 Number of cycles in steam autoclave The expiratory cassette will last at least: • 100 autoclaving cycles with 3 minutes sterilization time at 134ºC (273ºF). • 30 autoclaving cycles with 18 minutes sterilization time at 134ºC (273ºF).

2.5.5 Drying after steam autoclaving 2.5.1 Rinse • Rinse the parts thoroughly in water (<35°C/95°F).

Refer to section Drying alternatives on page 17.

• Let the water flow through the parts.

2.5.2 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 17.

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2.6 Assembling

• Hinge the expiratory cassette and press it firmly down into lock position.

Dismantle

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.

Wipe off/discard

Rinse

WasherDisinfector

Disinfectant

• Note on a log sheet that a routine cleaning has been performed. Refer to hospital routines.

Rinse

2.6.2 PRE-USE CHECK Dry

After cleaning, always perform a pre-use check. Refer to the ventilator system User's Manual.

Assemble

2.6.1 Re-inserting the expiratory cassette

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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. • Re-do the pre-use check.

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2.7 User interface and patient unit cleaning 2.7.1 Wiping and discarding Cleaning should be done after each patient or according to hospital routines.

2.8 Aeroneb nebulizer cleaning Important: Do not use abrasive or sharp tools to clean the nebulizer unit.

Note: The Solo nebulizer unit is intended for single patient use only, do not re-use, clean or sterilize. Cleaning should be done after each patient or according to hospital routines. Perform a function test of the Aeroneb Pro nebulizer after the cleaning. Refer to the ventilator system User's Manual.

Preparation

Wipe off/discard

Wipe all parts with cleaning wipes or a soft lint-free cloth moistened in soap & water or detergent-based disinfectant.

Rinse

Refer to section Cleaning wipes on page 13. In case of more contaminated surfaces, use cleaning wipes, ethyl alcohol (70%) or isopropyl alcohol (70%). Avoid contact with electrical connectors. Important: Do not use abrasive or sharp tools to clean the user interface. WasherDisinfector

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Disinfectant

Autoclave

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Only the Aeroneb Pro nebulizer unit, T piece and neonate adapters can be autoclaved.

2.8.3 Disinfection procedure Cleaning

2.8.1 Preparation Disconnect the nebulizer unit from the control cable, and remove the nebulizer unit, T piece and adapters from the patient circuit or mask.

• Ensure there is no medication remaining in the nebulizer. • Disassemble the nebulizer unit and adapters into individual components. • Remove the filler cap from nebulizer unit.

2.8.2 Wiping and discarding

• Clean all parts with warm water and mild liquid detergent. • Rinse all parts in sterile water. • Shake excess water from parts and allow parts to air dry. • Assemble the nebulizer. Refer to the ventilator system User's Manual.

• Wipe the control cable with a damp cloth. Do not autoclave. • Check for exposed wiring, damaged connectors, or other defects and replace if any are visible. Note: In case of more contaminated surfaces, use ethyl alcohol (70%).

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