Getinge servonu_operman_6880314_r06_v2dot1_170223-en-non_us n Ventilator Systems Cleaning and Maintenance User's Manual

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User's Manual

SERVO-U/n Ventilator Systems

Cleaning and Maintenance

| TABLE OF CONTENTS |

1 2 3 4 5 6 7 8 9 10 11

4|Introduction

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

| Introduction |

| 1

1 Introduction Table of contents

5|Introduction1.1

5|Maintenance1.2

5|Safety guidelines1.3

6|Symbols1.4

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

| 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.

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

| Introduction |

| 1

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.

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.

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 wasteThe 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.

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

2 Patient unit and user interface

2.1 Preparations

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

• 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

- 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

Important: The expiratory cassette is a

precision instrument and must be handled carefully.

| Patient unit and user interface |

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.

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.

2 |

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

| Patient unit and user interface |

| 2

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

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.

2.3 Assembling

2.3.1 Insert the expiratory cassette

• 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.

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

| 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.

• Re-do the pre-use check.

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.

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

| Expiratory cassette |

| 3

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.

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 cross-contamination between patients.

• Wash the parts with water only in a

washer-disinfector at a temperature of 85-95°C (185-203°F).

• 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.

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

| Expiratory cassette |

3 |

3.2.2 Disinfectant

• Let the parts soak in disinfectant.

Refer to section Recommended intervals and disinfectants on page 31.

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

Rinse after disinfection

Important:

• Follow the disinfectant manufacturer's

recommendation and instructions regarding rinsing.

• 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.

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

• 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.

| Expiratory cassette |

| 3

3.3 Drying alternatives

Important: 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

• Drying the cassette in room air 12-24 hours,

depending on surrounding conditions.

3.3.1 Recommended position in a drying cabinet

3.3.2 Recommended position in room air

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.

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

| 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.

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.

3.4.4 Drying after steam autoclaving

Refer to section Drying alternatives on page 12.

3.5 Assembling

Refer to section Assembling on page 8.

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.

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

| O2 cell (maintenance) |

| 4

4O2 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

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.

• 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.

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

4.2.1 Remove O2 cell and/or bacterial filter

• Lower the locking catch.

cell (maintenance) |

| O

• 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.

4 |

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

| O2 cell (maintenance) |

| 4

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.

• Connect the O2 cell connector.

• Put the O2 cell in position.

• Close the locking catch.

• 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.

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

5 Inspiratory channel (maintenance)

If an O2 sensor is installed:

5.1 Preventive maintenance

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

| Inspiratory channel (maintenance) |

5 |

• Remove the inspiratory channel cover.

Refer to chapter O2 cell (maintenance), section Preparations on page 14.

• Remove O2 cell/sensor.

If an O2 cell is installed:

• Lower the locking catch.

• Disconnect the O2 sensor and carefully

unlock the latches.

• Lift the O2 sensor out of position.

• Disconnect the O2 cell connector and lift

out the O2 cell.

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

| Inspiratory channel (maintenance) |

| 5

5.2.1 Remove inspiratory channel and tube

• Remove the inspiratory channel.

• 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.

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

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.

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

| Inspiratory channel (maintenance) |

5 |

5.3.2 Washer-disinfector

• 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.

5.4 Assembling

5.4.1 Insert inspiratory channel and tube

• Put a new bacterial filter in position and

connect the filter to the tube.

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

• Put the connector muffs in position.

• Press the latches and insert the inspiratory

channel.

| Inspiratory channel (maintenance) |

| 5

Important:

• There should always be clearance

between the connector muffs and gas modules.

• Make sure the latches are locked in

position.

5.4.2 Insert O2 cell/O2 sensor

If an O2 cell is installed:

If an O

sensor is installed:

• Put the O2 sensor in position.

• Connect the O2 cell connector and put the

O2 cell in position.

• Close the locking catch.

• Connect the O2 sensor (two "clicks" are

heard).

• Connect the O2 sensor connector.

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

• 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.

| Inspiratory channel (maintenance) |

5 |

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

| CO2 analyzer |

| 6

6CO2 analyzer

6.1 Preparation

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

Important: Do not immerse the CO2 module or the CO2 sensor in fluid.

Disconnect the CO2 sensor and airway adapter from the patient circuit and the ventilator system.

6.2 Wipe and discard

6.2.1 CO2 sensor

• Wipe the CO2 sensor with a soft cloth

moistened in disinfectant (Cidex OPA or isopropyl alcohol 70%).

6.2.2 Airway adapter

Note: Discard the disposable airway

adapter. The disposable airway adapter is for single patient use only.

• Pre-disinfect according to hospital routines.

Refer to section Recommended intervals and disinfectants on page 31.

The reusable airway adapter can be disinfected or steam autoclaved.

• Rinse the adapter thoroughly in water

(<35°C/95°F).

• Let the adapter soak in Cidex OPA solution.

• Rinse the adapter thoroughly in distilled

water.

• Before reusing the adapter, the windows

must be dry and wiped off.

• After cleaning, wipe the CO2 sensor with a

water-dampened clean cloth.

• The CO2 sensor windows must be dried

after cleaning.

Important: Follow the disinfectant manufacturer's recommendations and instructions.

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

6.3 Steam autoclaving

6.3.1 Airway adapter

• The adult adapter can be autoclaved in a

validated process.

• The adapters can be sterilized using EtO

(ethylene oxide) gas method.

• After sterilization procedure the adapters

must be dried before use.

Refer to section Recommended intervals and disinfectants on page 31.

| CO

analyzer |

6 |

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

| Aerogen Pro nebulizer |

| 7

7 Aerogen Pro nebulizer

7.1 Preparation

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

Note: The Aerogen 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.

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

7.2 Wiping and discarding

7.3 Disinfection

7.3.1 Cleaning

• 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.

• 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%).

7.3.2 Washer-disinfector

Two different washing cycles are validated for the Aerogen Pro nebulizer:

• Liquid alkaline cleaner (diluted as per

manufacturer instruction) and mains water.

Load the components in the

washer-disinfector.

- Pre-rinse the components for 3 minutes.

- Clean the components with liquid alkaline

cleaner at 55 °C (131 °F) for 10 minutes.

- Rinse for 1 minute.

- Rinse using thermal disinfection cycle at

93 °C (199.4 °F) for 10 minutes.

• Mains water and without the use of a

detergent.

Load the components in the

washer-disinfector.

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

| Aerogen Pro nebulizer |

7 |

- Wash components for 10 minutes at 91 °C (195.8 °F).

- Drain the machine for 40 seconds.

- Rinse at 90 °C (194 °F) for 1 minute.

- Drain the machine for 40 seconds.

- Rinse at 90 °C (194 °F) for 1 minute.

- Drain the machine for 40 seconds.

- Dry at 90 °C (194 °F) for 15 minutes.

7.3.3 Disinfectant

• Immerse the parts in appropriate

disinfecting agent.

Refer to section Recommended intervals and disinfectants on page 31.

Important: Follow the disinfectant manufacturer’s recommendations and instructions.

7.4 Steam autoclaving

• Disassemble the nebulizer unit and adapters

into individual components.

• Remove the filler cap from the nebulizer

unit.

• Clean all parts with warm water and mild

liquid detergent. Rinse thoroughly and air dry.

• Check for cracks or damage and replace if

any defects are visible.

• Place the disassembled components into

appropriate sterilization wrapping.

Note: Do not reassemble parts prior to steam autoclaving

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

Refer to section Recommended intervals and disinfectants on page 31.

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

| Aerogen Pro nebulizer |

| 7

Note: Sterilization using the long autoclave cycle may cause some areas of the nebulizer to become discolored. This does not affect the performance of the nebulizer unit.

To sterilize with hydrogen peroxide gas plasma, place wrapped parts in a STERRAD® System, and use the long cycle.

Note: Users should refer to the product labelling for the STERRAD® 100S Sterilization System for specific instructions regarding its proper operation.

7.5 Assembling

Assemble the nebulizer. Perform a function test of the Aerogen Pro nebulizer after the cleaning.

Refer to the ventilator system User's Manual.

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

8 Y sensor

| Y sensor |

8 |

8.1 Preparation

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

Important: Do not immerse the Y sensor module in fluid.

• Disconnect the Y sensor from the patient

circuit.

8.2 Wipe and discard

CAUTION: The disposable Y sensor is intended for single patient use only, do not re-use, clean or sterilize.

• Discard the pressure line. The pressure line

is for single patient use only.

• Wipe all parts with a soft lint-free cloth

moistened in soap and water or detergent-based disinfectant.

8.3 Disinfection

• Pre-disinfect according to hospital routines.

Refer to section Recommended intervals and disinfectants on page 31.

8.3.1 Washer-Disinfector

Place the Y sensor in a washing basket.

• Wash the parts with water only in a

washer-disinfector at a disinfection temperature of maximum 90°C (194°F).

Important: Do not clean the flow sensor with compressed air or a hard water jet, since the sensor wires can be destroyed.

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

Refer to section Recommended intervals and disinfectants on page 31.

| Y sensor |

| 8

8.3.2 Cleaning

• Clean the Y sensor with warm water and

mild liquid detergent.

• Rinse the Y sensor in water.

• Shake excess water from Y sensor and

allow to air dry.

8.3.3 Disinfectant

• Immerse the parts in appropriate

disinfecting agent.

Refer to section Recommended intervals and disinfectants on page 31.

Important: Follow the disinfectant manufacturer’s recommendations and instructions.

8.4 Steam autoclaving

• Clean the Y sensor with warm water and

mild liquid detergent. Rinse thoroughly and air dry.

• Check for cracks or damage and replace if

any defects are visible.

Refer to section Recommended intervals and disinfectants on page 31.

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

9 NAVA system

9.1 Preparation

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

Disconnect the Edi module from the ventilator system and remove Edi cable and Edi catheter.

9.2 Wiping and discarding

Discard the Edi catheter. The Edi catheter is for single patient use only.

| NAVA system |

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 cleaning wipes, ethyl alcohol (70%) or isopropyl alcohol (70%). Avoid contact with electrical connectors.

9 |

Note: The Edi catheter must not be

disposed of with ordinary waste.

Important: Do not immerse the Edi module or the cable in fluid.

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

| Hardware accessories |

| 10

10 Hardware accessories

Hardware accessories are:

• Mobile cart

• Handle

• Humidifier holder

• Support arm 178

• Water bag/IV pole

• Drawer

• Gas cylinder restrainer kit

• Pendant/bed holder

• Shelf base

• Y piece holder

• User interface holder

• Cable holder for handle

Refer to section Recommended intervals and disinfectants on page 31.

10.1 Patient circuits

Note: Discard the disposable patient circuits. The disposable patient circuits are for single patient use only.

Refer to the cleaning routines in the operating manual for the patient circuit.

10.2 Humidifier

Fisher & Paykel Humidifier MR850/MR810

Refer to the cleaning routines in the operating manual for the Fisher & Paykel Humidifier.

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

| Recommended intervals and disinfectants |

11 Recommended intervals and disinfectants

Patient unit and user interface

Surface cleaning

Expiratory cassette

Pre-disinfectant

Disinfectant

cycles Cleaning agent

washer-disinfector Steam autoclave

Number of cycles in steam autoclave

• 3M Respirator Cleaning Wipes

• Clorox Bleach Germicidal Wipes (may cause discoloration)

• Super Sani-Cloth Germicidal Wipes (may cause discoloration)

• Virkon S

• Accel TB (Virox 5)

• In case of more contaminated surfaces, use ethyl alcohol (70%) or isopropyl

alcohol (70%) together with lint free cleaning wipes.

• Aniosyme DD1

• Gigazyme Plus

• Salvanios pH7

Follow the disinfectant manufacturer's recommendation and instructions.

• Alcohol (ethyl or isopropyl alcohol 70%)

• Anioxyde 1000

• Cidex OPA

• Actanios HLD (prion decontamination agent), may cause discoloration

Follow the disinfectant manufacturer's recommendation and instructions. at least 100 cyclesNumber of immersion

• neodisher® MediClean forte

• Getinge MIS Detergent

at least 200 cycles.Number of cycles in

• 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.

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).

11 |

O2 cell

Replace the O2 cell when it is requested by the ventilator system.O2 cell

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

| Recommended intervals and disinfectants |

| 11

Inspiratory channel

Pre-disinfectant

• Aniosyme DD1

• Gigazyme Plus

• Salvanios pH7

Follow the disinfectant manufacturer's recommendation and instructions.

Disinfectant

• Alcohol (ethyl or isopropyl alcohol 70%)

• Anioxyde 1000

• Cidex OPA

• Actanios HLD (prion decontamination agent), may cause discoloration

Follow the disinfectant manufacturer's recommendation and instructions. at least 10 cyclesNumber of immersion

cycles Cleaning agent

• neodisher® MediClean forte

• Getinge MIS Detergent

at least 20 cycles.Number of cycles in

washer-disinfector Number of cycles in

steam autoclave

CO2 analyzer

Disinfectant

The inspiratory channel will last at least 10 autoclaving cycles with 3 minutes sterilization time at 134ºC (273ºF).

• Cidex OPA

• Isopropyl (70 %)

Follow the disinfectant manufacturer's recommendation and instructions. neodisher® MediClean forteCleaning agent

Steam autoclave (adapter)

Instrument parts should be steam autoclaved in a validated process, at a temperature of 134°C (273°F) for 3 minutes.

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

Aerogen Pro nebulizer

Pre-disinfectant

Disinfectant

steam autoclave Steam autoclave

| Recommended intervals and disinfectants |

• Hexanios G+R

Follow the disinfectant manufacturer's recommendation and instructions.

• Isopropyl alcohol (70 %)

• CIDEX

• NU-CIDEX

• Cidex OPA

at least 26 cyclesNumber of cycles in

Steam autoclaving can be performed using the following three methods:

• Autoclave wrapped parts using steam autoclaving pre-vacuum cycle, a

minimum of 134°C (270°F - 275°F) for 3.5 minutes with drying cycle (134°C wrapped cycle).

• Autoclave wrapped parts using steam autoclaving pre-vacuum cycle, a

minimum of 121°C (250°F) for 20 minutes with drying cycle (121°C wrapped cycle).

• Autoclave wrapped parts using steam autoclaving pre-vacuum cycle, a

minimum of 134°C (270°F - 275°F) for 20 minutes with drying cycle (sometimes referred to as a “Prion cycle”).

Note: This cycle may cause some areas of the nebulizer to become discolored. This does not affect the performance of the nebulizer.

11 |

Y sensor

Surface cleaning

Pre-disinfectant

Disinfectant

washer-disinfector

Steam autoclave

Number of cycles in steam autoclave

• 3M Respirator Cleaning Wipes

• Super Sani-Cloth Germicidal Wipes

• Virkon S

• Accel TB (Virox 5)

• In case of more contaminated surfaces, use ethyl alcohol (70%) or isopropyl

alcohol (70%) together with lint free cleaning wipes.

• Aniosyme DD1

• Gigazyme Plus

• Salvanios pH7

Follow the disinfectant manufacturer's recommendation and instructions.

• Alcohol (ethyl or isopropyl alcohol 70%)

• Cidex OPA

Follow the disinfectant manufacturer's recommendation and instructions. at least 20 cycles.Number of cycles in

neodisher® MediClean forteCleaning agent Instrument parts should be steam autoclaved in a validated process, at a

temperature of 134°C (273°F) for 3 minutes. The Y sensor will last at least 20 autoclaving cycles with 3 minutes sterilization

time at 134ºC (273ºF).

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

| Recommended intervals and disinfectants |

| 11

NAVA system

Surface cleaning

Wipe the surface with a soft cloth moistened in soap and water or in disinfectant.

In case of more contaminated surfaces, use ethyl alcohol (70%) or isopropyl alcohol (70%) together with lint free cleaning wipes.

Accessories

Surface cleaning

Wipe the surface with a soft cloth moistened in soap and water or in disinfectant.

In case of more contaminated surfaces, use ethyl alcohol (70%) or isopropyl alcohol (70%) together with lint free cleaning wipes.

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

Manufacturer: Maquet Critical Care AB Röntgenvägen 2 171 54 Solna, Sweden Phone: +46 (0) 10 335 73 00 www.maquet.com

For local contact:

Please visit our website www.maquet.com

Getinge Group is a leading global provider of innovative solutions for operating rooms, intensive-care units, hospital wards, sterilization departments, elderly care and for life science companies and institutions. With a genuine passion for life we build quality and safety into every system. Our unique value proposition mirrors the continuum of care, enhancing efficiency throughout the clinical pathway. Based on our first-hand experience and close partnerships, we are able to exceed expectations from customers – improving the every-day life for people, today and tomorrow.

• Order No. 68 80 314 • User's Manual • Printed in Sweden • 170223 • Rev: 06 English •

Getinge servonu_operman_6880314_r06_v2dot1_170223-en-non_us n Ventilator Systems Cleaning and Maintenance User's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

TABLE OF CONTENTS

1 Introduction Table of contents

1.1 Introduction

1.2 Maintenance

1.3 Safety guidelines

1.4 Symbols

2 Patient unit and user interface

2.1 Preparations

2.1.1 Remove the expiratory cassette

2.2 Wiping and discarding

2.3 Assembling

2.3.1 Insert the expiratory cassette

2.3.2 Pre-use check

2.4 Preventive maintenance

2.4.1 Check fan filters

3 Expiratory cassette

3.1 Preparations

3.2 Disinfection

3.2.1 Washer-disinfector

3.2.2 Disinfectant

3.3 Drying alternatives

3.3.1 Recommended position in a drying cabinet

3.3.2 Recommended position in room air

3.4 Steam autoclaving

3.4.1 Cleaning

3.4.4 Drying after steam autoclaving

3.5 Assembling

3.4.2 Rinse

3.4.3 Drying before steam autoclaving

4O2 cell (maintenance)

4.1 Preventive maintenance

4.2 Preparations

4.2.1 Remove O2 cell and/or bacterial filter

4.3 Assembling

4.3.1 Insert the O2 cell

5 Inspiratory channel (maintenance)

5.1 Preventive maintenance

5.2 Preparations

5.2.1 Remove inspiratory channel and tube

5.3 Disinfection

5.3.1 Rinse before disinfection

5.3.2 Washer-disinfector

5.4 Assembling

5.4.1 Insert inspiratory channel and tube

5.4.2 Insert O2 cell/O2 sensor

6CO2 analyzer

6.1 Preparation

6.2 Wipe and discard

6.2.1 CO2 sensor

6.2.2 Airway adapter

6.3 Steam autoclaving

6.3.1 Airway adapter

7 Aerogen Pro nebulizer

7.1 Preparation

7.2 Wiping and discarding

7.3 Disinfection

7.3.1 Cleaning

7.3.2 Washer-disinfector

7.3.3 Disinfectant

7.4 Steam autoclaving

7.5 Assembling

8 Y sensor

8.1 Preparation

8.2 Wipe and discard

8.3 Disinfection

8.3.1 Washer-Disinfector

8.3.2 Cleaning

8.3.3 Disinfectant

8.4 Steam autoclaving

9 NAVA system

9.1 Preparation

9.2 Wiping and discarding

10 Hardware accessories

10.1 Patient circuits

10.2 Humidifier

11 Recommended intervals and disinfectants