Maquet Servo User Manual

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User's Manual

SERVO-air Ventilator System v2.1

| TABLE OF CONTENTS |

1 2 3 4 5 6 7 8 9 10

109|Alarm handling 123|Service & Settings 131|Technical data 159|Index

SERVO-airVentilator System v2.1, User's Manual Infologic 1.39

| TABLE OF CONTENTS |

SERVO-airVentilator System v2.1, User's Manual

Infologic 1.39

1 Introduction Table of contents

| Introduction |

6|Device description1.1

8|Safety guidelines1.2 14|Version and configurations1.3

1 |

SERVO-airVentilator System v2.1, User's Manual

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1.1 Device description

1.1.1 Device components

The ventilator system consists of:

1. a user interface for setting ventilation modes, displaying data and indicating alarms

2. a patient unit for mixing gases and controlling gas delivery

3. a patient circuit for delivering and exchanging gases

1.1.2 Intended use

The SERVO-air ventilator system is:

• intended for respiratory support, monitoring

and treatment of pediatric and adult patients

• to be used only by healthcare providers

• to be used only in professional healthcare

facilities and for transport within these facilities

SERVO-airVentilator System v2.1, User's Manual

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1.1.3 User's Manual

This manual summarizes the functions and safety features of the ventilator system. It is not all-inclusive and should not be seen as a substitute for training.

1.1.4 Cleaning & Maintenance

Please refer to the SERVO-air Cleaning and Maintenance User's Manual.

1.1.5 Servicing Guidelines

CAUTIONS:

• Regular service: The ventilator system

must be serviced at regular intervals by Maquet authorized personnel who have received specialized training.

• Complete service records: All service

performed on the ventilator system must be recorded in a service log in accordance with hospital procedures and local and national regulations.

1.1.6 Disclaimers

Non-professional servicing:

Maquet has no responsibility for the safe operation of the ventilator system if installation, service or repairs are performed by persons other than Maquet authorized personnel.

• Service contract: It is strongly

recommended that all service on the ventilator system should be performed as part of a service contract with Maquet.

Note: If the ventilator system is to be a part of another system it requires an evaluation of the requirements of the IEC 60601-1 standard.

SERVO-airVentilator System v2.1, User's Manual

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1.2 Safety guidelines

Follow these safety guidelines. Additional warnings appear in context throughout this document.

Information is highlighted with Warning, Caution, Important or Note, where:

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 as help to operate the equipment or its connected devices easily and conveniently.

Note: Indicates information requiring special attention.

1.2.1 General

WARNINGS!

• The ventilator system may be operated

only by authorized personnel who are properly trained in its use. It must be operated according to the instructions in this User´s Manual.

• After unpacking, perform a routine

cleaning and a pre-use check.

• Always perform a pre-use check before

connecting the ventilator system to a patient.

• Secure all tubing and cables to avoid the

risk of unwanted movement of the equipment.

• If any of the following occurs, discontinue

use of the ventilator system and contact a service technician:

- unfamiliar pop-up windows on the

screen

- unfamiliar sounds

- any unfamiliar or unexplained event

- alarms that cannot be resolved

• Make sure that a resuscitator is readily

available.

• The air inlet must not be occluded.

• Positive pressure ventilation can be

associated with the following adverse events: barotrauma, hypoventilation, hyperventilation or circulatory impairment.

• Ventilation must be started manually

when a patient is connected to the ventilator system.

• Keep the ventilator system upright during

use.

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• Do not cover the ventilator system in any

way, since the functioning of the equipment may be adversely affected.

• Do not modify or remove any original

parts.

• The ventilator system must not be used

during radiotherapy, since this may cause system malfunction.

• The ventilator system must not be used

in a hyperbaric chamber.

• The ventilator system must be kept away

from magnetic resonance imaging (MRI) equipment.

• The ventilator system must not be used

with helium or any gas mixture containing helium.

• When the ventilator system is used with

MCare Remote Services, use only network equipment that is safe and complies with the relevant electrical and EMC standards such as IEC 60950.

Note:The network cable is excluded

from this requirement.

• Only accessories, supplies, and auxiliary

equipment recommended by Maquet should be used with the ventilator system. Use of any other accessories, spare parts or auxiliary equipment may cause degraded system performance and safety.

• Use only the Maquet approved active

humidifiers. Use of non-approved active humidifiers may result in higher gas temperatures and increase resistance in filters.

• During humidification, carefully monitor

the airway pressure. Increased airway pressure could result from a clogged

filter. Replace the filter if the expiratory resistance increases or according to the instructions for the filter, whichever comes first.

• Service, repair and installation may only

be performed by Maquet authorized personnel.

• The ambient sound needs to be taken

into consideration when setting the alarm sound level.

• Always disconnect the patient from the

ventilator system when performing operations that involve risk for the patient, such as replacing the O2 cell, dismantling etc.

CAUTIONS:

• Never leave the patient unattended when

connected to the ventilator system.

• Before use, make sure the system

version displayed under SYSTEM STATUS/General corresponds to the system version described in the User's Manual.

• Maquet has no responsibility for the safe

operation of the ventilator system if the requirements specified in Intended use on page 6 are not followed.

• When lifting or moving the ventilator

system or parts of the system, follow established ergonomic guidelines, ask for assistance, and take appropriate safety precautions. The weight is specified on the ventilator system.

• The air inlet filter must be in place when

the system is running.

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• The expiratory channel and expired gas

from the exhaust port may be contaminated.

• If a scavenging system (i.e. gas

evacuation) is connected to the ventilator system, it must conform to ISO 80601-2-13 guidelines for subatmospheric pressure and induced flow.

• During operation any water traps must

be checked regularly and if necessary emptied.

• All technical documentation is available

for use by Maquet authorized personnel.

• When using the MCare Remote Services

function, instal the network cable so that there is no risk of anyone tripping over it.

• The ventilator system must not be used

with any anaesthetic agent.

Important:

• Portable and mobile radio frequency (RF)

communications equipment can affect medical electrical equipment.

• The ventilator system must be installed

and put into service according to the EMC declaration.

• Securely attach all cables, etc, to

minimize the risk of unintentional disconnection.

• While the ventilator system is in use, the

wheels of the mobile cart must be locked and the mobile cart must be in a horizontal position.

• When the ventilator system is connected

to a patient:

- Do not lift or disconnect the expiratory

cassette.

- Continuously monitor the settings and

measurements displayed on the screen.

• Always use a heat and moisture

exchanger (HME) or an active humidifier to prevent dehydration of lung tissue.

• If a heated patient circuit is not used in

the system, a water trap must be used on the expiratory tube to avoid condensation in the system when an active humidifier is used. During operation the water traps must be checked regularly and if necessary emptied.

• Check that the cooling fan intakes are

not covered. Do not place the ventilator system on soft surfaces.

• The air inlet filters must be checked

regularly and replaced if necessary.

• Use an inspiratory filter when ventilating

a highly infectious patient.

• All excess fluids must be disposed of

according to hospital routines.

• The emergency air intake must not be

blocked.

• Do not disconnect the expiratory

cassette while the ventilator system is in operation; if necessary, disconnect the cassette while in STANDBY.

SERVO-airVentilator System v2.1, User's Manual

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Notes:

• Do not simultaneously touch the patient

and any accessible connector contacts.

• Do not solely rely on the use of an

external monitor to determine the status of the patient and the ventilator system.

• Make sure that the ventilator system is

firmly mounted on the mobile cart.

• Make sure that cables and patient circuit

is not obstructed or squeezed due to improper mounting.

• Extra care should be taken when

handling tubes, connectors and other components of the patient circuit. The use of a support arm to relieve the patient from the weight of the tubing system is recommended.

• Contact a Maquet representative

regarding decommissioning of the equipment.

• Turn off the active humidifier during

nebulization.

• Expiratory filter connection is mandatory

during nebulization.

• A water trap is recommended if a single

heated patient circuit is used.

• Thermoshell, expiratory cassette must

be used when using heated expiratory tubing or Expiratory heater Servo Duo Guard.

1.2.2 Power supply

WARNINGS!

• The power cord must be connected only

to an AC mains power outlet with protective earth to avoid the risk of electric shock.

• The power supply cord must be plugged

directly into the mains power outlet without the use of any multiple socket outlets. If a multiple socket outlet is used together with other products, total leakage current might be exceeded in the event of a fault in the protective earth.

CAUTIONS:

• Do NOT use antistatic or electrically

conductive tubing with this system.

• Avoid contact with external electrical

connector pins.

SERVO-airVentilator System v2.1, User's Manual

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Important: In case of total loss of power during ventilation, an alarm will sound for 2 minutes. When power is restored, the ventilator system will start in the same state and with the same settings as before the power loss.

Note: When the system is connected to an external power supply, all connected battery modules are being recharged. This does not affect ventilation.

Battery

WARNINGS!

• Do not use sharp tools when extracting

the batteries.

• To guarantee reliable battery backup,

make sure a battery is in place in slot 2 at all times during ventilation.

• Dispose of batteries according to local

regulations and not with ordinary waste.

CAUTION:

The battery modules must be charged before first use.

Do not expose the batteries to water, fire or excessive heat.

Do not crush, disassemble, puncture or short circuit the connector terminals.

One battery can be added to an available slot during operation.

Hold onto the battery strap when inserting a battery in the ventilator system.

Important:

• If a battery status message is displayed

on the screen, always go to SYSTEM STATUS/Batteries for detailed information.

• Check battery in SYST EM

STATUS/Batteries window to ensure safe battery operation. Always charge the battery before use.

• Always replace batteries when the

ventilator system provides notification of imminent expiration or of diminished operating capacity.

• When not in use, the ventilator system

should always be connected to the mains power to ensure fully charged batteries.

Refer to section Battery status on page 23.

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1.2.3 Fire hazard

WARNINGS!

• Keep all sources of ignition away from

the ventilator system and the oxygen hoses.

• Do not use a ventilator system with worn

or frayed gas supply hoses or hoses that have been contaminated by combustible materials such as grease or oil.

• Oxygen-enriched gas is extremely

flammable: if a burning odor is detected, disconnect the oxygen supply and mains power and remove the batteries.

• Make sure that both the mains power

outlet and the power supply connector are accessible.

1.2.4 Gases

1.2.5 Auxiliary equipment

CAUTION:

Measurements of numerical values that have been processed by auxiliary equipment:

• may be inaccurate if equipment not

authorized by Maquet is used

• should be disregarded if they conflict

with information on the ventilator screen

• must not be used as a substitute for

therapeutic or diagnostic decisions.

Accessories, supplies, and auxiliary equipment used with the ventilator system must be recommended by Maquet.

WARNING! The ventilator system must not be used with helium or any gas mixture containing helium.

Refer to section Ventilator system on page 134.

SERVO-airVentilator System v2.1, User's Manual

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1.3 Version and configurations

This manual applies to version 2.1 of the SERVO-air ventilator system.

1.3.1 Configurations

The ventilator system can be used in both invasive and non invasive ventilation. The configurations includes adult and pediatric. Refer to section System on page 132.

1.3.2 Available modes and functions

Patient categoryModes/Functions

SIMV

• (PC) + PS

• (PRVC) + PS

• (VC) + PS

AdultPediatric

XXPC

OOPRVC

XXVC

OOBi-Vent/APRV

XXPS/CPAP OOVS OOAutomode

X O

OONIV PC OONIV PS

XXNebulizer OOAlarm output connection

O = option— = not applicableX = standard

SERVO-airVentilator System v2.1, User's Manual

2 System Overview Table of contents

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SERVO-airVentilator System v2.1, User's Manual

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2.1 Ventilator

The ventilator consists of a user interface and a patient unit.

Air is supplied from ambient air by an internal turbine and O2 may be supplied by a medical pipeline system or by gas cylinder.

2.1.1 Mounting on mobile cart

• Lock the wheels.

• Release the locking clamp on the mobile

cart.

• Stand directly in front of the mobile cart

when mounting the ventilator system.

• Tilt the ventilator system to fit the two front

clamps in position on the mobile cart.

• Press down the rear end of the ventilator to

fit the rear clamp in position.

• Lock the ventilator system to the mobile

cart with the locking clamp.

• Ensure that the patient unit is firmly fixed

to the mobile cart via the clamps and locking clamp.

SERVO-airVentilator System v2.1, User's Manual

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1. Patient unit

2. User interface

3. Expiratory inlet

4. Inspiratory outlet

5. Emergency air intake

6. Air inlet

7. Battery compartment

8. Patient circuit

9. AC mains power

10. O2 supply

11. Wheel lock

Note: Lock the wheels whenever the ventilator system is standing still.

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2.2 Patient unit

6 8 9 10

14 13 12 11

1. On/Off switch

The switch must be pulled downwards before it can be switched.

2. Expiratory outlet

3. Power indicators

4. RS-232 connectors

5. Equipotentiality terminal.

6. AC mains power source connector with

fuse

7. Alarm output connection

8. External +12V DC inlet

9. Fuse for external DC power

10. Ethernet connection

11. Battery compartments

12. USB ports

13. Gas inlet for O

14. Gas inlet for air including air inlet filter

15. Inspiratory outlet

16. Emergency air intake

17. Nebulizer connector

18. Expiratory inlet

19. Cooling fan with filter (on both sides)

20. Expiratory cassette

21. Expiratory inlet with moisture trap

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Important: No other external devices than

a USB memory stick may be connected to the USB ports. Only one memory stick can be used at the same time.

2.2.1 Symbols on patient unit

DescriptionSymbol

CE label—indicates compliance with the requirements of the Medical Device Directive 93/42/EEC

CSA label—Indicates compliance with Canadian and US standards

UDI Label - Unique Device Identification. Refer to section UDI label on page 156.

ONLY

In USA, Federal law restricts this device to sale by or on the order of a physician.

Type B—indicates classification according to IEC 60601-1

Type BF applied part — indicates classification according to IEC 60601-1

Potential equalization terminal Note: The potential equalization

terminal is designed for the connection of a potential equalization conductor according to DIN 42 801 and IEC 60601-1. The function of the potential equalization terminal is to equalize potentials between the ventilator system and other medical devices that can be touched simultaneously. The potential equalization terminal must not be used for a protective earth connection.

SERVO-airVentilator System v2.1, User's Manual

12V

Nebulizer connector

RS-232/Serial port - connector for data communication

Ingress protection, IP21

Fuse (specification) External 12V DC input

Battery

Expiratory gas flow from the patient

Inpiratory gas flow to patient

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DescriptionSymbol

Mains power On/Off Mains connected, batteries charging Gas exhaust port—exhaust gas flow

from ventilator system Network connection

USB connection

Alarm output connection

Special waste

Note: This product contains electronic and electrical components. Discard disposable, replaced and left-over parts in accordance with appropriate industrial and environmental standards.

Caution

Consult instructions for use

DescriptionSymbol

MR Unsafe - keep away from magnetic resonance imaging (MRI) equipment.

Consult accompanying documentation

Locked

Unlocked

Serial number

Order number

Weight of patient unit with user interface and ventilator including its safe working load.

Use of ON/OFF switch The switch must be pulled

downwards before it can be switched.

Manufacturer The symbol is accompanied by

manufacturer address and manufacturing date.

SERVO-airVentilator System v2.1, User's Manual

2.2.2 Gas flow through the patient unit

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1. Air inlet with air inlet filter.

2. Turbine module for ambient air.

3. The check valve prevents the gas to flow

backwards.

4. Gas inlet for O2.

5. The gas module for O2 regulates the O

gas flow.

6. The flow meter measures the gas flow.

7. The pressure of the gas delivered to the

patient is measured by the inspiratory pressure transducer. The transducer is protected by a bacterial filter.

3 1

12 13

10. The expiratory inlet in the expiratory cassette contains a moisture trap.

11. The ultrasonic transducers in the expiratory cassette measure the outgoing gas flow.

12. The expiratory pressure transducer in the expiratory cassette measures the pressure in the patient circuit. The transducer is protected by a bacterial filter.

13. The expiratory valve in the expiratory cassette regulates the pressure in the patient circuit.

14. Exhaust port.

8. The O2 cell measures the oxygen concentration. The O2 cell is protected by a bacterial/viral filter.

9. The inspiratory channel delivers gas to the patient circuit inspiratory tubing and contains a safety valve.

SERVO-airVentilator System v2.1, User's Manual

Note: The expiratory cassette can be exchanged between different ventilator systems. Always perform a pre-use check after exchanging an expiratory cassette.

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2.3 Batteries

2.3.1 Charging battery modules

Important: The battery modules are

delivered in shipping-mode and must be charged before use.

To charge the battery modules, insert the battery modules in the ventilator system. The ventilator must be connected to mains. The battery modules are charged automatically.

The batteries can also be charged with the External battery charger, SERVO-air.

2.3.2 Handling battery modules

The battery compartment is divided into two slots, 1 and 2.

The ventilator system uses the battery in slot 1 first. Make sure that the battery in slot 2 is in place as a backup at all times during ventilation.

Refer to section Battery on page 12.

• Remove the battery from the ventilator

system.

To insert a battery module:

• Hold onto the battery strap when inserting

a battery in the ventilator system. When inserting a battery module in slot 1, check that the battery strap for the battery in slot 2 is not folded into the battery compartment.

• Ensure that the battery is fully inserted so

that the release button returns to a completely closed position.

The battery module in slot 1 may be exchanged during ventilation.

To remove a battery module:

• Press the release button to the left and pull

the battery strap.

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2.3.3 Battery status

Important:

• If Replace battery is displayed, the

battery is unreliable, regardless of the operating time displayed under Batteries. In this situation, replace the battery even when the STATUS window indicates that significant operating time remains.

• At least one battery module must always

be installed.

Detailed information about batteries is accessed via SYSTEM STATUS/Batteries. There is also an indication in the status bar showing the power supply currently being used by the ventilator system.

If the ventilator system is running on battery power, the active battery in the battery symbol turns yellow and the mains power symbol disappears. The estimated remaining battery time in minutes is always displayed, regardless of the power supply in use.

The following information is displayed under Batteries in SYSTEM STATUS for each connected battery module:

• BATTERY CAPACITY – usable backup time

in minutes An estimated backup time is shown in Standby. This estimate may differ from the actual usable backup time during running. Usable backup time depends on set mode and selected ventilation settings.

Note: The presented usable backup time is the sum of the estimated operation time displayed for each battery module minus 20 minutes.

• Slot number

• Serial number

• Remaining operation time in minutes for

each battery

• Notification – may be displayed close to the

remaining operation time in minutes.

• Remaining battery life

The battery symbol also functions as a shortcut to the window otherwise accessed via SYSTEM STATUS/Batteries.

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2.4 Patient circuit

Notes:

• Turn off the active humidifier during

nebulization.

• Expiratory filter connection is mandatory

during nebulization.

• A water trap is recommended if a single

heated patient circuit is used.

• Thermoshell, expiratory cassette must

be used when using heated expiratory tubing or Expiratory heater Servo Duo Guard.

• To ensure that the inspiratory gas

temperature is below 43°C the patient circuit inspiratory tube must be at least

1.2 m to let the gas cool down.

Refer to System Flow Chart, SERVO-air for information regarding patient circuit configurations to be used with the ventilator system.

SERVO-airVentilator System v2.1, User's Manual

15 - 22 mm Ø patient circuit, reusable

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1. Inspiratory patient tube

2. Y piece

3. Heat and moisture exchanger (HME)

4. Angled adapter for endotracheal tube

5. Aerogen Pro

6. Expiratory patient tube

7. Expiratory filter

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22 mm Ø patient circuit, dual heat disposable

1. Inspiratory patient tube

2. Water autofill

3. Humidification chamber

4. Active humidifier

5. Cuff with temperature port

6. Y piece

7. Angled adapter for endotracheal tube

8. Aerogen Solo

9. Expiratory patient tube

10. Expiratory filter

11. Expiratory heater Servo Duo Guard

12. Thermoshell, expiratory cassette

SERVO-airVentilator System v2.1, User's Manual

10 mm Ø patient circuit, single heat reusable

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1. Inspiratory patient tube

2. Water autofill

3. Humidification chamber

4. Active humidifier

5. Cuff with temperature port

6. Y piece

7. Angled adapter for endotracheal tube

8. Pressure line connection port

9. Aerogen Pro

10. Expiratory patient tube

11. Water trap

12. Expiratory filter

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10 mm Ø patient circuit, dual heat disposable

1. Inspiratory patient tube

2. Water autofill

3. Humidification chamber

4. Active humidifier

5. Cuff with temperature port

6. Extension tube for incubator use

7. Angled Y piece

8. Pressure line connection port

9. Angled adapter for endotracheal tube

10. Y piece

11. Aerogen Solo

12. Expiratory patient tube

13. Expiratory filter

14. Expiratory heater Servo Duo Guard

15. Thermoshell, expiratory cassette

SERVO-airVentilator System v2.1, User's Manual

2.5 User interface

2.5.1 User interface adjustment

2. Loudspeaker1. Alarm indicator

2.5.2 Interactive areas

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The user interface can be adjusted into different positions.

The user interface is completely touch based and is divided into the following areas:

1. Status bar

2. Quick menu/extended menu

3. Display area

4. Direct access bar/media bar

5. Numerical values

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Important:

• Do not use sharp tools on the screen.

• Fluid on the screen can disturb touch

functionality.

2.5.3 Navigating

To navigate the user interface, adjust settings and get support:

• Tap (the touchpad changes color when the

navigating is registered).

• Tap and hold

• Scroll vertically or horizontally

• Drag and drop

2.5.4 User support

The user is supported by the following:

• Alarm management

• Safety scales

• Dynamic images

• Information texts

• Pre-use check instructions

• Shortcuts

• Prompts

Note:

The following colors are used for settings:

• Red — not recommended

• Yellow — use with caution

• Green — normal

Alarm management

1. Alarm list

2. Number of active alarms

3. Alarm management checklist

4. Alarm history Refer to chapter Alarm handling on page 109.

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Safety scales

1 3

1. Slide bar

2. Increase/decrease setting

3. Full settings range

4. Accept

5. Cancel

Refer to section Safety scales on page 41.

Dynamic images

Information texts

1. Information text is available.

2. Indication that more information is available by scrolling vertically in the middle of the information window.

Shortcuts

Some frequently used functions can be accessed via a shortcut. There are shortcuts to the following windows:

• Alarm limits

• Patient data

• Battery status

• Leakage compensation deactivation

• Circuit compensation deactivation

• Nebulization

The dynamic image illustrates the effects of the changes made to selected ventilation settings.

SERVO-airVentilator System v2.1, User's Manual

Refer to section Symbols on user interface on page 32.

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Prompts

Prompts indicate that input is required.

2.5.5 Symbols on user interface

DescriptionSymbol

Extended menu show/extended menu hide

Start ventilation

Stop ventilation/Standby

Do not push the user interface as the ventilator system may tip over.

Alarm limits/Alarm limits shortcut

Audio pause

Audio paused

Audio off

Audio pause - all alarms, active and inactive are pre-silenced.

Alarm on

Alarm off

Check alarms

Alarm sound level

Alarm history

Message

Number of messages

Adult/patient data shortcut

Pediatric/patient data shortcut

AC mains power Missing battery

Unknown battery (not a Maquet battery)

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DescriptionSymbol

Charging battery

Total battery capacity, active battery

xx min

and battery status shortcut External 12V DC power

DescriptionSymbol

Screen layout

Disconnect Service & Settings Biomed

Backup on

Backup off

Circuit compensation on

Circuit compensation off/Circuit

Service

Remote services

Exit

compensation deactivation shortcut Invasive ventilation adult

Nebulization period/Nebulization shortcut

Continuous nebulization/Nebulization

Invasive ventilation pediatric

Non invasive ventilation adult

100

O2 BOOST

shortcut O2 boost locked to 100 %

Pneumatic trigger, pressure/flow

Non invasive ventilation pediatric

Organize

Two overlay loops

Reference loop

Panel locked

Panel unlocked

Loop grid on

Progress

Loop grid off

Full settings range

Compensation

Normal settings range

Configuration

Maneuvers

Recorder Recording waveforms 30 seconds

Media

Modes Patient data

System status

Trends & logs

Views

SERVO-airVentilator System v2.1, User's Manual

Recording waveforms in progress

Camera for taking screenshots

Value not within range Uncertain value Test failed (red)

Test not performed (yellow)

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DescriptionSymbol

Test passed (green)

Decrease

Increase

Information text Cancel (red)

Close (green) Switch between main/backup modes

Additional values & settings hide/Additional values & settings show

Additional information hide/Additional information show

2.5.6 Symbols on accessories and

packaging

DescriptionSymbol

CE label—indicates compliance with the requirements of the Medical Device Directive 93/42/EEC

Order number Number to identify the production

batch

QTY

Quantity Outer diameter in mm Inner diameter in mm

Indicates the inner diameter of the endotracheal tube

Circumference/lengthFr/cm Use by date

Do not re-use. Single use only.

ONLY

Do not use if packaging is damaged

Consult accompanying documentation

Keep away from sunlight

Manufacturer The symbol is accompanied by

manufacturer address and manufacturing date.

Manufacturing date

In USA, Federal law restricts this device to sale by or on the order of a physician.

Recyclable material. Recycling must be performed in accordance with appropriate industrial and environmental standards.

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DescriptionSymbol

Special waste to be disposed of in accordance with appropriate

DescriptionSymbol

The support arm must be folded

during transport. industrial and environmental standards

Gas cylinder

Locked

Defibrillation proof Type CF applied part - indicates classification according to IEC 60601-1

Type BF applied part — indicates classification according to IEC 60601-1

Type B—indicates classification according to IEC 60601-1

Humidity limitation

+55oC

Temperature limitation

-10

Fragile — handle with care

Unlocked

Consult instructions for use

Keep away from water

This way up — indicates correct upright position of the transport package

Atmospheric pressure limitation

Do not expose to heat or fire.

Do not expose to mechanical force.

Do not dismantle, open or shred.

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2.6 Transport

2.6.1 Before intrahospital transport

Before transporting the ventilator system with or without a patient connected, follow facility guidelines and:

• Be sure that the patient unit is securely

attached and locked.

• Be sure that all accessories such as battery

modules, gas cylinder, and humidifier are securely attached and locked.

• Be sure that the gas cylinders are

connected and have sufficient gas.

• Be sure that the straps are firmly wrapped

across the center of the gas cylinders so that the cylinders do not move during transport.

• Be sure that the battery in slot 2 is fully

charged.

• Inspect the resuscitator.

• Inspect the mobile cart for damage.

• Be sure that the support arm is folded

before transport.

2.6.2 During intrahospital transport

While transporting the ventilator system with or without a patient connected, follow facility guidelines and:

• Use the handles on the patient unit.

• Transport the bed and the ventilator system

slowly, and watch the patient connection carefully to see that no pulling or other movement occurs.

• If triggering problems occur during

intrahospital transport because of extreme vibrations, Pressure Control mode is recommended or to set the trigger so that it is less sensitive.

• Be careful not to tip the mobile cart when

crossing an obstacle like a threshold.

• On arrival, connect the ventilator system to

mains power and lock the brakes.

CAUTION: Do not load the ventilator equipment asymmetrically on the ventilator system to avoid instability.

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3 Operation overview Table of contents

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3.1 Workflow summary

• Turn on the ventilator system, prepare the

patient circuit to be used and perform a pre-use check.

• Select patient category.

• Select invasive or non invasive ventilation.

• Set the ventilation mode.

• Check, and if necessary, adjust the alarm

limits.

• Enter data for the new patient, including

height, weight, and gender (optional).

• Start ventilation and connect the ventilator

system to the patient.

• Adjust alarm limits if necessary.

Stop ventilation when desired.

3.2 Pre-use check

The pre-use check contains a number of tests that the ventilator system automatically performs. Refer to section Pre-use check tests on page 140.

Each test starts automatically when the previous test is completed.

To ensure correct system functionality, optimal performance and patient safety, a pre-use check must be performed.

WARNINGS!

• Always perform a pre-use check before

connecting the ventilator system to a patient.

• Do not connect the ventilator system to

a patient while a malfunction persists.

Important:

• When the pre-use check is completed,

all sources of alarm signals and alarm conditions have been verified and the alarm system operates correctly.

• The volume of the patient circuit used

during pre-use check should be the same as during ventilation. If the patient circuit is changed after the pre-use check is completed, perform a new pre-use check or a patient circuit test.

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3.2.1 Start pre-use check

• Connect the ventilator system to a mains

power outlet.

• Connect the ventilator system to O2 gas

supply.

• Turn the ventilator system on.

Refer to section Patient unit on page 18.

• Ta p PRE-USE CHECK in STANDBY.

• Tap Ye s in the PRE-USE CHECK window

to start, and follow on-screen instructions.

3.2.2 Complete pre-use check

A symbol and a color marking appear on screen for each pre-use check test, as appropriate: Passed, Failed and Not performed.

• Tap OK to confirm or tap Redo test to

restart a pre-use check test.

The ventilator system returns to STANDBY when the pre-use check is completed.

3.3 Patient circuit test

In Standby, the patient circuit test may be performed separately from the pre-use check.

CAUTION: The patient circuit test must be performed with a complete patient circuit, including all accessories (e.g. active humidifier filled with water, filter and nebulizer), that is to be used with the patient.

The patient circuit test measures resistance and compliance in the patient circuit. If the patient circuit is changed and no new patient circuit test is performed, the ventilator will compensate incorrectly based on the measurements of the previous patient circuit. If the correct circuit is not tested, the following risks may arise:

• In volume-based modes, the volume

delivered to the patient will be incorrect.

• In pressure-based modes, the volume

measured will be incorrect.

Notes:

• The status of the two latest pre-use

checks and patient circuit tests is displayed under SYSTEM STATUS/General.

• The status of the latest pre-use check

and patient circuit test is also displayed in STANDBY.

SERVO-airVentilator System v2.1, User's Manual

Tap PATIENT CIRCUIT TEST and follow on-screen instructions.

The result from the patient circuit test is displayed in PATIENT CIRCUIT TEST in

STANDBY. Detailed result are displayed in the SYSTEM STATUS/General window.

Important: The patient circuit test does not replace the pre-use check.

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3.4 Select patient category

• Tap patient category in STANDBY. All

available patient categories appear.

• Select the appropriate patient category.

The patient data shortcut in the status bar changes accordingly.

Important: Always check the alarm settings after changing the patient category.

Notes:

• Changing the patient category affects

the following settings:

- default values for alarm limits

- allowed ranges for alarm limits

- default values for ventilatory settings

- allowed ranges for ventilatory settings

- pressure and flow regulation

- scaling

3.4.1 Change patient category

To change the patient category during ventilation:

• Tap the patient data shortcut in the status

bar or tap PATIENT DATA in the quick menu.

• Select the appropriate patient category.

• Follow on-screen instructions.

3.5 Select ventilation type

• Select invasive or non invasive ventilation

in STANDBY.

Note: The default values may have been changed by a previous user.

• The default values may have been

changed by a previous user.

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3.6 Set ventilation mode

• Tap MODES in STANDBY to open the

MODES window.

• Select mode.

Note: Tap and hold the tile to access more information about the selected mode.

• When a ventilation mode has been selected,

all parameters can be set in the mode settings window.

• Tap a parameter to adjust its value.

• Tap Accept to confirm, or Cancel to cancel

the settings.

3.6.1 Settings

Important: If one or several settings in the

mode settings window are highlighted in yellow, this indicates that it/they should be considered for adjustment, as the values entered there may have been carried over from the previous mode.

3.6.2 Safety scales

1 3

1. Slide the bar to the right or left to increase or decrease the settings. The bar displays the safety scale, that is the range that is safe to use for most patients.

2. Tap to incrementally increase or decrease the setting. Tap and hold to rapidly increase or decrease the setting.

3. Tap on full settings range to extend the safety scale setting range.

4. Confirm the setting by tapping Accept.

5. Exit settings without changing by tapping cancel.

Refer to section Ventilatory settings on page 142.

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3.7 Set alarm limits

• Tap ALARM LIMITS in the quick menu.

• The limits are set in the alarm limit bars in

the ALARM LIMITS window.

• Tap the upper or lower value in the selected

alarm limit bar.

• A scale appears, tap plus or minus or slide

the bar to set the value.

Confirm each setting by tapping Accept. Tap Autoset all alarms, if desired, to get alarm

limit proposals for the following modes:

-VC

-PC

-PRVC

Important: Before accepting Autoset all alarms values, make sure they are

appropriate for the patient. If not, enter settings manually.

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To activate the new alarm limits tap Accept.

Note: Autoset all alarms is not available in supported or NIV modes or in STANDBY because the ventilator system requires patient values in order to propose alarm limits.

3.7.1 Set alarm sound level

The ambient sound needs to be taken into consideration when setting the alarm sound level.

• Tap ALARM LIMITS in the quick menu.

• Tap alarm sound level.

3.8 Enter patient data

• Tap the patient data shortcut in the status

bar or tap PATIENT DATA in the quick menu.

• Tap in the selected input field to open a

keyboard or keypad.

• Tap Accept to confirm new data.

• Enter/edit the following data:

- Patient category

- Name

- Date of birth / ID

- Gender

- Height

- Weight

Note: If gender, height and weight have been entered, predicted body weight will be automatically displayed.

• Tap the sound level bar to set appropriate

alarm sound level.

• Tap Accept.

Refer to section Predicted body weight (PBW) on page 91.

• Tap Done when entry is complete.

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3.9 Start ventilation

Tap START VENTILATION in STANDBY or START in the quick menu to start ventilation.

WARNING! Ventilation must be started manually when a patient is connected to the ventilator system.

3.10 Stop ventilation

To disconnect and stop ventilation:

• Physically disconnect the patient from the

ventilator system.

• Tap STANDBY in the quick menu.

• Tap and hold STOP VENTILATION to stop

ventilation.

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4 Displaying and saving data Table of contents

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4.1 Views

The ventilator system offers different views to suit different needs. They are accessed via the quick menu during ventilation.

4.1.1 Basic view

Note: All non invasive ventilation modes

start in the BASIC view.

It is possible to adjust the layout by tapping either SCREEN LAYOUT in the extended menu or VIEWS/Screen layout in the quick menu.

This makes it possible to show or hide the volume waveform.

Refer to section Adapting the waveform display on page 49.

It is also possible to adjust the scaling, sweep speed, appearance of the waveforms and user interface brightness in the SCREEN LAYOUT window.

The view consists of:

• two or three waveforms – pressure and flow

waveforms are always present, together with the volume waveform, if desired

• a single column of numerical values

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4.1.2 Advanced view

The view consists of:

• two to three waveforms – pressure and flow

waveforms are always present, together with the volume waveform, if desired

• two columns of numerical values

Note: All invasive ventilation modes start in the ADVANCED view.

It is possible to adjust the layout by tapping either SCREEN LAYOUT in the extended menu or VIEWS/Screen layout in the quick menu.

Refer to section Adapting the waveform display on page 49.

4.1.3 Loops view

This view provides a graphical representation of the relationship between pressure-flow, pressure-volume and volume-flow.

The view consists of:

• up to three loops – pressure-flow,

pressure-volume and volume-flow

• two to three waveforms – pressure and flow

waveforms are always present, together with the volume waveform, if desired

• two columns of numerical values

Note: The LOOPS view is not available in non invasive modes.

SERVO-airVentilator System v2.1, User's Manual

It is possible to adjust the layout by tapping either SCREEN LAYOUT in the extended menu or VIEWS/Screen layout in the quick menu.

It is also possible to adjust the scaling, sweep speed, appearance of the waveforms and user interface brightness in the SCREEN LAYOUT window.

Refer to section Adapting the waveform display on page 49.

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In addition, all loops can be shown or hidden. The maximum number of loops displayed is three, in which case no more than three waveforms may be displayed. The loops may also be displayed with or without a loop grid by tapping Loop grid.

To store a reference loop or see two overlaid loops simultaneously:

1. Tap the reference loop symbol. A reference loop will then be displayed together with a time stamp.

2. Tap the two overlay loops symbol to display the two previous loops.

4.1.4 Family view

4.1.5 Distance view

The view is designed for optimal readability from a distance. Information displayed includes numerical values and waveforms.

There are six large tiles displaying:

• five enlarged numerical values

• the pressure and flow waveforms

The screen layout cannot be adjusted.

The view has a neutral background image and may be used during family visits to hide the standard user interface.

Displayed information is minimized to:

• one column of numerical values

• the direct access bar

• alarms and messages in the status bar

• a dynamic representation (moving bubbles)

showing that ventilation is in progress.

The screen layout cannot be adjusted.

Tap anywhere on the screen for rapid access to the most recently used view.

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4.2 Displaying waveforms

The ventilator system can display a minimum of two waveforms and a maximum of three, depending on the view selected.

Pressure and flow waveforms are always mandatory except in the FAMILY view.

The waveforms displayed on the user interface are:

• pressure – (yellow)

• flow – (green)

• volume – depending on view selected and

layout adjustments (blue)

4.2.1 Adapting the waveform display

It is possible to adapt the waveform display via the scaling function.

• Tap and hold a displayed waveform.

• In the window that opens, adjust the scaling

function manually or use Auto to scale automatically.

• To close the window, tap anywhere on the

screen other than the opened window.

Alternatively:

• Adjust the layout by tapping either SCREEN

LAYOUT in the extended menu orVIEWS/Screen layout in the quick menu.

• Tap the tile shown in the figure directly to

the left of each waveform name.

It is also possible to show or hide non-mandatory waveforms in the SCREEN LAYOUT window.

The sweep speed can be adjusted by tapping Sweep speed and selecting either of three speeds.

In addition, there is a choice under Appearance between filled and unfilled waveforms.

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4.3 Displaying numerical values

During ventilation, numerical values (measured or calculated) are displayed on the right side of the screen.

• Alarm limits (if applicable) are displayed in

small digits for each numerical value.

• Values that are off the scale are replaced

by three asterisks.

• Values that are uncertain are indicated by

a single asterisk.

Depending on the view, either one or two columns of numerical values are displayed.

To access additional values, tap the arrow at the right edge of the screen to display all numerical values.

4.4 Trends and logs

4.4.1 Trends

Trend values are stored every 60 seconds and retained for a maximum of 72 hours. Stored events and system changes are also displayed here.

To view trends:

• In the extended menu, tap TRENDS &

LOGS /TRENDS.

• To adjust the time resolution, tap the

number of hours displayed.

• The time valid for the cursor position is

displayed. If events have been stored, their number is displayed in the circle shown in the figure and an explanation appears to the left of this circle.

• If a recording is saved at a time

corresponding to the cursor position, a recorder is displayed. To view the recording, tap this recorder.

• Tap Organize trends to place the trends in

the desired order by dragging and dropping the different trended values presented.

Refer to section Trends on page 147.

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4.4.2 Logs

To view the event log:

• In the extended menu, tap TRENDS &

LOGS /LOGS.

• Scroll among all the events listed.

• The LOGS window offers a search function.

Tap the text field to open the keyboard and enter a search word. To display only log items that contain the search word entered, tap Filter. Tap again to deactivate the filter.

• Use the backspace arrow to delete the

search word.

Each event includes the event time and date. The event log is cleared when a new patient is admitted.

4.5 Saving and exporting data

Data can be saved in a number of ways:

• as screenshots

• as recordings

• as files for export including event log, trends

and both the above.

The screenshots and recordings are stored under MEDIA.

Data can later be exported to a USB memory stick.

4.5.1 Saving screenshots

To save a screenshot, tap the camera in the status bar.

Refer to section Event log on page 148.

SERVO-airVentilator System v2.1, User's Manual

The screenshot will be stamped with the date and time it was taken and saved under the Saved screens tab in the MEDIA window.

There is space for 40 screenshots under this tab. When the space is full, the next screenshot taken will erase the oldest one.

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4.5.2 Viewing saved screens

To view screenshots, tap MEDIA in Saved screens. Choose the relevant screenshot

displayed at the bottom of the window. If there are more than ten screens saved, scroll to the right to find more.

4.5.3 Recording waveforms

To make a recording, tap the recorder (not available in Standby) in the status bar.

A 30 second long recording will be made starting 15 seconds before, and lasting until 15 seconds after the time the recording was initiated. A blue progress bar will be displayed under the recorder while the recording is being made.

4.5.4 Viewing recordings

To view recordings, tap TRENDS & LOGS/MEDIA /Recordings in the extended

menu. Choose the relevant recording displayed at the bottom of the window. If more than ten recordings have been saved, scroll to the right to find more.

The cursor (pale green) is positioned on the dotted line indicating the middle point of the recording. It is activated by moving it or by pressing the arrows to the right of the recorder seen above the dotted line. The values at the cursor position are displayed in digits to the right of the waveform name in the recording window.

When viewing a recording, it is also possible to view the settings by tapping Settings at the bottom left of the window. This will open a list of the actual parameter settings in use at the time the recording was initiated.

The recording will be stamped with the date and time that it was initiated and will be saved under the Recordings tab in the MEDIA window. All settings applying at the time the recording is initiated will also be saved.

There is space for 40 recordings under this tab. When the space is full, the next recording made will erase the oldest one.

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4.5.5 Exporting and deleting data

To export or delete screenshots or recordings, tap TRENDS & LOGS/MEDIA /Export & Delete in the extended menu.

Alternatively, tap the Export & delete tab.

Both screenshots and recordings can be selected for export or deletion.

The additional choice of exporting files that include other material is also given at the bottom right of this window. To use this function, tap Export files.

4.6 Ventilator configuration

The ventilator system will always start up with the stored configuration settings.

To view the stored configuration settings, tap CONFIGURATION in the extended menu:

The following configurations can be viewed:

• Alarms

• General

• Units

• Startup configuration

The alarms configuration can be viewed for each of the patient categories. The other configurations do not vary with patient category.

Note: No editing can be done under CONFIGURATION.

Refer to chapter Service & Settings on page 123.

The following data will be exported to a USB memory stick:

• Event log

• Trends

• Saved screens & recordings

Important: Only one USB memory stick may be connected to the USB ports at the same time.

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4.7 System status

To view the current status of the ventilator system:

• Tap SYSTEM STATUS in the quick menu

in Standby.

• Tap SYSTEM STATUS in the extended

menu during ventilation.

The SYSTEM STATUS window that opens contains:

1. Installed options

2. General

3. Batteries

4. Expiratory cassette

5. Pre-use check

6. O2 cell

7. Patient circuit

8. Turbine

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5 Ventilation modes Table of contents

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5.1 Introduction

5.1.1 Safety guidelines

Not all safety guidelines apply to all modes.

WARNINGS!

• Autotriggering should be avoided. Do not

set the trigger level too low.

• The following warning apply to non

invasive ventilation (NIV) modes only:

- Avoid high inspiratory pressure as it

may lead to gastric overdistension and risk of aspiration. It may also cause excessive leakage.

Be sure to set alarm limits as appropriate for each mode, especially those for:

- expired minute volume

- apnea time

- airway pressure

Important:

• To protect the patient’s lungs from

excessive pressure it is important to set the upper pressure limit to a suitable value.

• It is important to avoid leakage so as to

ensure the proper functioning of modes such as:

-PRVC

-VS

- Automode PRVC ⇄ VS

- SIMV (PRVC) + PS

• The circuit compensation function should

be used – it is important to make sure that the compressible volume of the patient circuit is not changed after the pre-use check/patient circuit test has been performed (e.g. filling an active humidifier with water or connecting a filter after the test has been performed).

Note:

The ventilator system is delivered preset with the following configuration options:

• Ventilatory settings are based on either

minute volume or tidal volume.

• Ventilatory settings are based on either

I:E ratio or inspiration time.

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5.2 Pressure Control (PC)

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Pressure Control (PC):

• delivers a constant pressure over a preset

inspiratory time and at a preset respiratory rate

• delivers the inspiration with a decelerating

flow

• changes in lung or thorax resistance or

compliance will affect the volume delivered

1234

567

The following parameters are set:

1. Oxygen concentration (%)

2. PEEP (cmH2O)

3. Respiratory rate (b/min)

4. PC above PEEP (cmH2O)

The delivered volume is dependent on the pressure above PEEP, lung compliance and resistance in the patient circuit and airways. This means that the tidal volume can vary.

The flow during inspiration is decelerating. The patient can trigger extra breaths. As the delivered tidal volume can vary, it is very important to set alarm limits for the minute volume to adequate levels.

PC ventilation is often preferred when there is leakage in the patient circuit, e.g. due to an uncuffed endotracheal tube, or in situations where the maximum airway pressure must be controlled.

If a patient tries to exhale during inspiration, pressure increases. When it increases 3 cmH2O above the set inspiratory pressure level, the active expiratory valve opens and regulates the pressure down to the set inspiratory pressure level. If the pressure increases to the set upper pressure limit, e.g. if the patient is coughing, the expiratory valve opens and the ventilator system switches to expiration.

5. I:E ratio or Inspiration time (s)

6. Inspiratory rise time (% or s)

7. Trigger

Refer to section Settings on page 41.

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5.2.1 Pressure Control in detail

The circles in the figure indicate patient triggering.

• PC ensures that the preset inspiratory

pressure level is constant throughout inspiration. Breaths are delivered in accordance with the preset respiratory rate, inspiration time and inspiratory pressure level, resulting in a decelerating flow.

• The preset pressure level is controlled by

the ventilator system. The resulting volume depends on the set pressure level, the inspiration time and the mechanical properties of the patient's lungs during each breath.

• Inspiration starts in accordance with the

preset respiratory rate or when the patient triggers.

Expiration starts:

• After the termination of the preset

inspiration time.

• If the upper pressure limit is exceeded.

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5.3 Pressure Regulated Volume Control (PRVC)

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Pressure Regulated Volume Control (PRVC):

• combines the advantages of Volume

Control and Pressure Control by delivering a preset tidal volume with a decelerating inspiratory flow at a preset respiratory rate

• maintains the lowest possible constant

pressure throughout inspiration

• the inspiratory pressure of a breath will

never exceed 5 cmH2O below the upper pressure limit

The ventilator system can be configured so that either tidal volume or minute volume is set.

1234

567

The flow during inspiration is decelerating. The patient can trigger extra breaths.

5 cmH2O

The first breath is a volume controlled test breath with the pause time set to 10 %. The measured pause pressure of this breath is then used as the pressure level for the following breath.

Following the initial breath, the ventilator system calculates and continuously regulates the pressure needed to deliver the preset tidal volume.

An alarm is activated if the set target volume cannot be delivered due to the fact that the pressure required to deliver it is higher than 5 cmH2O below the set upper pressure limit.

The following parameters are set:

1. Oxygen concentration (%)

2. PEEP (cmH2O)

3. Respiratory rate (b/min)

4. Tidal volume (ml) or minute volume (l/min)

5. I:E ratio or Inspiration time (s)

6. Inspiratory rise time (% or s)

7. Trigger

Refer to section Settings on page 41.

The ventilator system delivers a preset tidal volume. The pressure is automatically regulated to deliver this volume but limited to 5 cmH2O below the set upper pressure limit.

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Refer to section Leakage compensation on page 94.

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5.3.1 PRVC in detail

The circles in the figure indicate patient triggering.

• PRVC ensures a set target minute

ventilation to the patient. The target volume is based on settings for tidal volume, respiratory rate and inspiration time.

• The inspiratory pressure level is constant

during each breath, but automatically adapts in small increments on a breath-by-breath basis to match the mechanical properties of the patient's lungs, thus ensuring delivery of the target volume.

• Inspiration starts in accordance with the

preset respiratory rate or when the patient triggers.

Expiration starts:

• After the termination of the preset

inspiration time.

• If the upper pressure limit is exceeded.

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5.4 Volume Control (VC)

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Volume Control (VC):

• delivers a preset tidal or minute volume over

a preset inspiratory time and at a preset respiratory rate, regardless of changes in lung or thorax resistance or compliance

• maintains a constant flow with varying peak

pressure

The ventilator system can be configured so that either tidal volume or minute volume is set.

1234

5 6 7 8

The airway pressure is dependent on the tidal volume, the inspiration time and the resistance and compliance of the respiratory system. The set tidal volume will always be delivered. An increase in resistance and decrease in compliance will lead to an increased airway pressure. The delivered pressure can vary, so in order to protect the patient's lungs from excessive pressure, it is very important to set the upper pressure limit to a suitable value.

Patients may trigger extra breaths if they can overcome the set trigger level.

Flow adaptation

Patient inspiratory efforts can also result in a higher inspiratory flow and tidal volume than were preset. This is because the ventilator system enables the patient to modify both flow rate and timing.

The following parameters are set:

1. Oxygen concentration (%)

2. PEEP (cmH2O)

3. Respiratory rate (b/min)

4. Tidal volume (ml) or minute volume (l/min)

5. I:E ratio or Inspiration time (s)

6. Pause time (% or s)

7. Inspiratory rise time (% or s)

8. Trigger

Refer to section Settings on page 41.

SERVO-airVentilator System v2.1, User's Manual

Thus, if the patient demands a higher flow than the calculated constant flow, the system will sense any sudden pressure drop of > 3 cmH2O and temporarily enables PS to deliver a higher flow adapted to patient demand.

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5.4.1 Volume Control in detail

The circles in the figure indicate patient triggering.

• VC ensures a preset tidal volume during a

preset inspiratory time at a preset respiratory rate.

• The inspiratory flow is constant or linearly

decelerating and depends on the ventilatory settings.

• Inspiration starts in accordance with the

preset respiratory rate or when the patient triggers.

• If the patient makes an inspiratory effort

during the inspiratory period, when flow adaption is enabled and flow pattern is 100%, the ventilator system will switch to PS to satisfy the patient´s flow demand, as shown in the second breath in the figure.

Expiration starts:

• When the preset tidal volume is delivered

and after the preset pause time.

• When the flow returns to the set value after

the preset tidal volume is delivered and after the preset pause time (flow adaptation). The patient is however always guaranteed an expiration time corresponding to at least 20 % of the total breath.

• If the upper pressure limit is exceeded.

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5.5 Bi-Vent/APRV

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Bi-Vent:

• is a time-cycled, pressure-limited mode that

allows spontaneous breathing throughout the entire ventilatory cycle

• has two time-cycled pressure levels and

switches between these two levels. The patient can breathe spontaneously at both these levels and it is possible to give Pressure Support at both levels.

Airway Pressure Release Ventilation (APRV):

• is a time-cycled, pressure-limited mode that

allows spontaneous breathing throughout the entire ventilatory cycle

• alternates between two levels of positive

airway pressure, with the main time on the high level and a brief expiratory release to facilitate ventilation

• differs from Bi-Vent in that it uses an inverse

I:E ratio

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5 6 7

9 10

The following parameters are set:

1. Oxygen concentration (%)

2. Pressure at the lower pressure level (PEEP)

3. Pressure at the higher pressure level (Phigh) (cmH2O)

4. Time at the higher pressure level (Thigh) (s)

5. Time at the lower pressure level (TPEEP) (s)

6. PS above Phigh (cmH2O)

7. PS above PEEP (cmH2O)

8. End inspiration (%)

9. Inspiratory rise time (s)

10. Trigger

Refer to section Settings on page 41.

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5.5.1 Bi-Vent/APRV in detail

The circles in the figure indicate patient triggering.

1. Bi-Vent/APRV cycle = Thigh + TPEEP

2. PEEP

3. Phigh

4. PS above PEEP

5. PS above Phigh

Each Bi-Vent/APRV cycle is regarded as autonomous and therefore most of the measured values are updated every cycle, i.e. minute volume, respiratory rate, mean pressure and end expiratory pressure. Associated alarms are also handled for every cycle.

Bi-Vent/APRV allows for spontaneous breathing/PS ventilation at two different pressure levels. These basic levels are individually set, as well as the time in seconds at each level. The ventilator system always tries to synchronize with the patient's breathing. The main difference between Bi-Vent and APRV is the inverse I:E ratio in APRV.

Since Bi-Vent/APRV is basically a controlled

At extreme settings, the update of measured values and alarms will show a mandatory frequency dependence even in the face of preserved spontaneous breathing.

As a result of switching between two different pressure levels, the tidal volumes may vary significantly between different breaths. This may also be the case for etCO2 (end tidal CO2) concentration.

mode of ventilation, apnea alarm and backup ventilation are not available. It is also very important to set the lower and upper alarm limit for expired minute volume.

SERVO-airVentilator System v2.1, User's Manual

5.6 Pressure Support (PS)/CPAP

Pressure Support (PS)/CPAP:

• is initiated by the patient, who controls the

respiratory rate and tidal volume

• delivers ventilator support using the preset

pressure level and with a decelerating flow

• provides backup (PC) ventilation in case of

apnea

Continuous Positive Airway Pressure (CPAP):

• is initiated by the patient and works exactly

like PS except that the Pressure Support level is set to zero

• maintains positive pressure in the airways

at all times

• is effectively a spontaneous breathing mode

with continuous positive pressure to keep the airways open

PS is thus a patient-initiated breathing mode in which the ventilator system supports the patient with a set constant pressure.

The ventilator system provides this constant preset pressure when activated by patient effort. The patient determines the frequency and duration of the breaths, which have a decelerating flow pattern. Duration of inspiration can be adjusted with the help of the End inspiration setting.

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5 6

8 9 10

The following parameters are set:

1. Oxygen concentration (%)

2. PEEP (cmH2O)

3. PS above PEEP (cmH2O) (PS level)

4. End inspiration (%)

5. Inspiratory rise time (s)

6. Trigger

7. Apnea time (s)

8. Backup respiratory rate (b/min)

9. Backup PC above PEEP (cmH2O)

10. Backup I:E or Ti (s)

Refer to section Settings on page 41.

The higher the preset inspiratory pressure level from the ventilator system, the more gas flows into the patient. As the patient becomes more active, the PS level may be gradually reduced.

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CPAP may be seen as a special case of PS in which the inspiratory pressure level is set to zero and is used when the patient is breathing spontaneously.

SERVO-airVentilator System v2.1, User's Manual

Always set the apnea time that is appropriate to the individual patient situation. If the apnea alarm limit is reached, the ventilator system will automatically switch to backup ventilation (PC).

The alarm should alert staff to take action by either returning to a supported mode or changing to a controlled mode of ventilation.

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It is also very important to set the lower and upper alarm limits for expired minute volume.

The inspiratory rise time should be set to a comfortable value for the patient. In PS, the inspiratory rise time should normally be increased.

The End inspiration setting is important to patient comfort and ventilator synchronization with the patient. If the patient's expiratory resistance is high, the End inspiration setting should be raised to guarantee enough time for expiration.

It is important to monitor how this affects the tidal volume.

SERVO-airVentilator System v2.1, User's Manual

5.6.1 PS/CPAP in detail

The circles in the figure indicate patient triggering.

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• PS ensures that a preset inspiratory

pressure level is constantly maintained in response to patient effort.

• The preset pressure level is controlled by

the ventilator system, while the patient determines the respiratory rate and inspiration time.

• Inspiration starts when the patient triggers

a breath and gas flows into the lungs at a constant pressure. Since the pressure provided by the ventilator system is constant, the flow will decrease until the level set for End inspiration is reached.

• For CPAP, inspiration starts upon patient

effort.

Expiration starts:

• When the inspiratory flow decreases below

a preset fraction of the peak inspiratory flow (End inspiration)

• If the upper pressure limit is exceeded

• If the maximum time for inspiration is

exceeded Refer to section Functions in ventilation modes on page 146.

• If the flow drops to a range between 25 %

of peak flow and the lower limit for End inspiration, and remains within the range for a period longer than 50% of the time elapsing between inspiration start and the point when the range was entered.

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5.7 Volume Support (VS)

Volume Support (VS):

• is initiated by the patient, who controls the

respiratory rate

• delivers ventilator support with a variable

peak pressure and decelerating flow to guarantee the preset tidal volume

• the inspiratory pressure of a breath will

never exceed 5 cmH pressure limit

• provides backup (PRVC) ventilation in case

of apnea

A patient-adapted constant inspiratory support is supplied when activated by patient effort. The resulting volume is continuously monitored and the constant inspiratory pressure automatically adjusts to the required level. The patient determines the frequency and duration of the breaths which have a decelerating flow pattern.

O below the upper

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The following parameters are set:

1. Oxygen concentration (%)

2. PEEP (cmH2O)

3. Tidal volume (ml)

4. End inspiration (%)

5. Inspiratory rise time (s)

6. Trigger

7. Apnea time (s)

8. Backup respiratory rate (b/min)

9. Backup tidal volume (ml)

10. Backup I:E or Ti (s)

Refer to section Settings on page 41.

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If patient activity increases, the inspiratory support will decrease provided that the set tidal volume is maintained. If the patient breathes below the set tidal volume, the inspiratory support will increase.

5 cmH2O

The initial breath provides support with 5 cmH2O. Following this breath, the ventilator system calculates and continuously regulates the pressure needed to deliver the preset tidal volume.

An alarm is activated if the set target volume cannot be delivered due to the fact that the pressure required to deliver it is higher than 5 cmH2O below the set upper pressure limit.

In this mode it is also important to set the apnea time that is appropriate to the individual patient's situation. If this time is reached, the ventilator system will automatically switch to backup ventilation.

Refer to section Leakage compensation on page 94.

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5.7.1 Volume Support in detail

The circles in the figure indicate patient triggering.

• VS ensures delivery of a set target tidal

volume following patient effort by providing inspiratory pressure support that is adapted to the patient.

• The inspiratory pressure level is constant

during each breath, but alters in small increments, on a breath-by-breath basis, to match the patient´s breathing ability and the mechanical properties of the lungs.

• Inspiration starts when the patient triggers.

Expiration starts:

• When the inspiratory flow decreases below

a preset fraction of the peak inspiratory flow (End inspiration)

• If the upper pressure limit is exceeded

• If the maximum time for inspiration is

exceeded Refer to section Functions in ventilation modes on page 146.

• If the flow drops to a range between 25 %

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5.8 Automode

In Automode, the ventilator system shifts automatically between controlled and supported ventilation, allowing better patient-ventilator interaction. When the patient is making a breathing effort, the ventilator system immediately switches to a supported mode of ventilation. If the patient is not making any breathing effort, the ventilator system will return to the controlled mode and deliver controlled breaths.

The parameters for each Automode combination are adjusted in the settings window and are basically the same as those for the relevant controlled or supported mode. Refer to section Settings on page 41.

Automode PC ⇄ PS:

• is an interactive mode automatically

switching between the controlled mode PC and supported mode PS based on patient triggering

• delivers controlled breaths in the absence

of patient breathing effort, switching to supported breaths when a breathing effort is detected

• serves as an aid to starting the weaning

period

• adapts to the patient’s breathing capacity

Automode PRVC ⇄ VS:

• is an interactive mode automatically

switching between the controlled mode PRVC and supported mode VS based on patient triggering

• delivers controlled breaths in the absence

of patient breathing effort, switching to supported breaths when a breathing effort is detected

• serves as an aid to starting the weaning

period

• adapts to the patient’s breathing capacity

In this combination, the first supported breath delivered to the patient has the same pressure level as the preceding PRVC breath.

Automode VC ⇄ VS:

• is an interactive mode automatically

switching between the controlled mode VC and supported mode VS based on patient triggering

• delivers controlled breaths in the absence

of patient breathing effort, switching to supported breaths when a breathing effort is detected

• serves as an aid to starting the weaning

period

• adapts to the patient’s breathing capacity

In this combination, the ventilator system uses the plateau pressure in the VC breath as a reference pressure for the first VS breath.

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5.8.1 Automode in detail

1. The ventilator system starts in PC, PRVC or VC mode. If the patient triggers a breath, the ventilator system will turn to the relevant supported mode to encourage the patient's respiratory drive.

2. If the patient is breathing adequately:

In VS, the ventilator system adjusts the

inspiratory pressure level on a breath-by-breath basis to ensure delivery of the preset target volume.

b. In PS, the ventilator system ensures

that the preset inspiratory pressure level is maintained throughout inspiration.

3. The ventilator system initially adapts with an increasing apnea time.This means that for the spontaneously triggering patient, the apnea time increases successively until the level set in the settings window for the maximal apnea time parameter is reached after 10 consecutive spontaneously triggered breaths. Refer to section Settings on page 41.

4. Exceeding the maximal apnea time setting without a sufficient patient effort will cause the following:

In VS, a PRVC or VC breath will be

delivered according to the selected Automode functionality.

b. In PS, a PC breath will be delivered.

5. The rings in the figures indicate patient triggering.

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PC ⇄ PS

12b3 4b

PRVC ⇄ VS

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12a 4a

In the Automode PRVC ⇄ VS combination, the first supported breath delivered to the patient has the same pressure level as the preceding PRVC breath.

VC ⇄ VS

12a 4a

In the Automode VC ⇄ VS combination, the ventilator system uses the plateau pressure in the VC breath as a reference pressure for the first VS breath.

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5.9 SIMV

SIMV stands for Synchronized Intermittent Mandatory Ventilation. In SIMV modes, mandatory controlled ventilation breaths are delivered with a preset SIMV rate. The patient can breathe spontaneously with PS between the mandatory breaths.

The parameters for each SIMV combination are adjusted in the settings window and are basically the same as those for the relevant controlled or supported mode. Refer to section Settings on page 41.

SIMV (PC) + PS:

• delivers mandatory controlled breaths using

a preset respiratory rate and a preset pressure

• delivers inspiratory support (PS) during

spontaneous breaths taken between the mandatory breaths

SIMV (PRVC) + PS:

• delivers mandatory controlled breaths using

a preset respiratory rate and a preset volume

• delivers inspiratory support (PS) during

spontaneous breaths taken between the mandatory breaths

SIMV (VC) + PS:

• delivers mandatory controlled breaths using

a preset respiratory rate and a preset volume

• delivers inspiratory support (PS) during

spontaneous breaths taken between the mandatory breaths

In SIMV modes, the mandatory breath is defined by the basic settings.

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Settings

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SIMV (VC)+ PSSIMV (PRVC)+PSSIMV (PC) + PS

——XPC above PEEP

5 |

volume

Breath cycle time

——Pause time

Only when the ventilator system is configured for setting the I:E ratio.

XX—Tidal volume /Minute

XXXSIMV rate

XXXI:E ratio / Inspiration time

XXXInsp. rise time

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Note: In the minute volume configuration, the tidal volume is determined by dividing the minute volume by the SIMV rate.

The breath cycle time is the length of the mandatory breath in seconds and is the same as the duration of an SIMV period.

In SIMV, the very first breath is always a mandatory one.

If the patient triggers a breath during the SIMV period, the breath delivered is a mandatory one. If the patient fails to trigger a breath within the first 90 % of the SIMV period, a mandatory breath is delivered.

Note: If the ventilator system is configured for setting the inspiration time, an I:E ratio of 1:2 will be used to estimate the breath cycle time.

5.9.1 SIMV in detail

• This combination of controlled and

supported ventilation allows for preset mandatory breaths that are synchronized with the patient's breathing.

• If there is no trigger attempt within a time

window equal to 90 % of the set breath cycle time, a mandatory breath is delivered (the breath cycle time is the total time for one mandatory breath).

• The mandatory breath is defined by the

basic settings (mode of ventilation, breath cycle time, respiratory pattern and volumes/pressures).

• The spontaneous/supported breaths are

defined by the setting for PS.

The spontaneous/Pressure Support breaths are defined by setting the level for Pressure Support above PEEP (PS above PEEP).

SERVO-airVentilator System v2.1, User's Manual

5.9.2 SIMV (PC) + PS

The circles in the figure indicate patient triggering.

5.9.3 SIMV (PRVC) + PS

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90%

5 |

The circles in the figure indicate patient triggering.

5.9.4 SIMV (VC) + PS

The circles in the figure indicate patient triggering.

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90%

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5.10 Non Invasive Ventilation (NIV)

5.10.1 Safety guidelines

WARNINGS!

• Avoid high inspiratory pressure as it may

lead to gastric overdistension and risk of aspiration. It may also cause excessive leakage.

• The dead space will increase in NIV when

using a mask or helmet.

• NIV is not intended to be used on

intubated or tracheotomized patients.

• In non invasive ventilation, the measured

expired volume may be different from the actual volume exhaled by the patient due to leakage around the mask.

• If nasal prongs are used, make sure that

they are applied so that air can flow freely through both prongs.

CAUTIONS:

• It is not recommended to use a nebulizer

during NIV as the nebulized drug might come in contact with the patient's eyes in case of leakage.

• Mask/prongs leakage might affect

nebulizer efficiency.

Important:

• The mask/prongs must be properly

applied in order to minimize leakage.

• When selecting the mask/prongs, it is

essential to consider such things as proper size and accurate adaptation to the patient.

• CO2 rebreathing will increase during NIV

and use of a face mask/prongs.

5.10.2 Introduction

NIV refers to ventilation when the patient is not intubated or tracheotomized. It involves the use of a patient interface such as:

• nasal mask

• nasal prongs

• face mask

• total face mask

• endotracheal tube positioned above the

vocal cords

• NIV helmet

In NIV, the ventilator system adapts to variations in leakage to maintain the required pressure and PEEP level. Excessive leakage will result in a high priority alarm. Ventilation will resume automatically if the leakage decreases. It can also be started manually by tapping Resume ventilation in the LEAKAGE DETECTED window that opens to inform about leakage.

Note: In NIV, flow and volume curves and the following measured values are compensated for leakage: VTi, VTe, MVi, MVe.

Refer to chapter Alarm handling on page 109.

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In all NIV modes, there is an automatic detection of patient connection and disconnection – the NIV disconnection functionality. This ensures that ventilation starts in a comfortable manner when the patient interface is applied to the patient's face. It ensures that ventilation stops when the interface is removed, avoiding high air flows and alarms.

It is possible to configure the NIV disconnection functionality. The setting made here will ensure a constant disconnection flow while ventilation is paused (at a high flow or a low flow setting). It is also possible to disable the NIV disconnection functionality, which may result in high air flows and alarms.

Refer to chapter Service & Settings on page 123.

5.10.3 Using a NIV helmet

WARNING!

The helmet application shall not be used with volume controlled modes.

The helmet application must only be used with pressure supported ventilation in NIV.

Important:

• When using NIV PS, the filling of the

helmet must be initiated by tapping

START VENTILATION or Resume ventilation on the screen. This must also

be done after disconnection.

• To secure a proper patient triggering

function, the PEEP level should never be set below 3 cmH2O. When helmets with a safety valve are used, it is recommended to set a PEEP level of at least 5 cmH2O.

• Alarms related to volume are not reliable.

To avoid nuisance alarms the alarm limits must be properly set.

• It is essential to set pressure alarms

adequately.

It is possible to use a helmet for non invasive ventilation of patients between 10 and 250 kg. Only use the adult patient category when using a helmet.

For instructions for the helmet application, refer to the manufacturer's instructions for use.

There are a few points to remember in order to use a helmet safely:

• Do not rely on flow and volume parameters.

• The volume in the helmet may cause delays

in signals and patient triggering.

• Make sure that the helmet used eliminates

CO2 re-breathing.

• High pressure levels may affect the patient's

ears and the flow may affect the patient's eyes.

• Patients may perceive the helmet

application as noisy. A Servo Duo Guard filter used on the inspiratory side will reduce the noise level. The noise level may vary between different helmets.

• Do not use humidified ventilation gas as this

will cause condensation on the helmet walls.

• Do not use nebulizers.

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5.11 NIV Pressure Control (NIV PC)

NIV Pressure Control (NIV PC):

• delivers a constant pressure over a preset

inspiratory time and at a preset respiratory rate

• delivers the inspiration with a decelerating

flow

• changes in lung or thorax resistance or

compliance will affect the volume delivered

• is leakage compensated

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The following parameters are set:

1. Oxygen concentration (%)

2. PEEP (cmH2O)

Differences compared with invasive PC:

• When START VENTILATION is tapped, a

waiting position dialog is displayed. All patient related alarms are turned off for 2 minutes. In this position, ventilation will start if the ventilator system detects patient activity.

• The trigger cannot be manually set in NIV.

• Detection of pressure below PEEP or

expiratory volume decrease will start a new breath.

3. Respiratory rate (b/min)

4. PC above PEEP (cmH2O)

5. I:E ratio or Inspiration time (s)

6. Inspiratory rise time (% or s) Refer to section Settings on page 41.

SERVO-airVentilator System v2.1, User's Manual

5.12 NIV Pressure Support (NIV PS)

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NIV Pressure Support (NIV PS):

• is initiated by the patient, who controls the

respiratory rate and tidal volume

• delivers ventilator support using the preset

pressure level and with a decelerating flow

• has a fixed trigger

• provides backup (PC) ventilation in case of

apnea

• is leakage compensated

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Differences compared with invasive PS:

• When START VENTILATION is tapped, a

waiting position dialog is displayed. All patient related alarms are turned off for 2 minutes. In this position, ventilation will start if the ventilator system detects patient activity.

• The ventilator system will not lock in backup

ventilation. There is no limit on the number of times the ventilator system can switch between supported mode and backup.

• The trigger cannot be manually set in NIV.

The following parameters are set:

1. Oxygen concentration (%)

2. PEEP (cmH2O)

3. PS above PEEP (cmH2O) (PS level)

4. End inspiration (%)

5. Inspiratory rise time (% or s)

6. Apnea time (s)

7. Backup respiratory rate (b/min)

8. Backup PC above PEEP (cmH2O)

9. Backup I:E or Ti (s)

Refer to section Settings on page 41.

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SERVO-airVentilator System v2.1, User's Manual

6 Ventilatory settings and functions Table of contents

| Ventilatory settings and functions |

98|Apnea management6.15 101|Nebulization6.16 107|Adjust the O2 cell6.17

6 |

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6.1 O2 concentration

The O2 concentration delivered to the patient is set in the mode settings window and is monitored by the ventilator system with upper and lower alarm limits. Refer to section Alarm limits on page 145.

The alarm is delayed 40 seconds after changing the O2 concentration.

6.2 Tidal volume/Minute volume

Depending on the ventilator configuration, the inspiratory volume can be set as either:

• tidal volume or

• minute volume

Whichever of these is set, the other will be displayed in the lower right information area of the mode settings window.

6.3 Pressure level

PC above PEEP is the set inspiratory pressure level for each mandatory breath in:

• PC

• SIMV (PC) + PS

• Automode PC ⇄ PS

• backup ventilation in PS

PS above PEEP is the set inspiratory pressure support level for triggered breaths in:

• PS

• all SIMV modes

• Automode PC ⇄ PS

• Bi-Vent

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6.4 I:E ratio/Inspiration time

The setting of ventilatory settings can be configured in two different ways, based on:

• I:E ratio or

• inspiration time, in seconds, to better meet

the requirements for pediatric care.

6.4.1 I:E ratio

The I:E ratio expresses the relation between the inspiration phase and the expiration phase. Spontaneous breathing has an I:E ratio of around 1:1.5.

Note that increasing the inspiration time may raise mean airway pressure and improve oxygenation but may also cause hyperinflation. Reversed I:E ratios (e.g. 1.5:1 or 2:1) will further lengthen inspiratory time and shorten expiration, which may be helpful if the lungs are very stiff, but requires low respiratory rates to avoid gas trapping.

1 2

1:2

1. Inspiration

2. Expiration An inverse I:E ratio is also used in

Bi-Vent/APRV mode. Refer to section Bi-Vent/APRV on page 63.

A prolonged expiration time (e.g. 1:3) may be used for weaning and in case of obstructive lung disease, but a short inspiration time may also lower the tidal volume and lead to inadequate ventilation.

SERVO-airVentilator System v2.1, User's Manual

When the ventilator system is configured for setting of I:E, the unit for pause time and inspiratory rise time automatically switches to percent. The corresponding inspiration time for each I:E is displayed in the lower right information area of the mode settings window.

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6.4.2 Inspiration time

The setting makes it possible to set the inspiration time (Ti) to a fixed time in seconds.

With this configuration, the unit for inspiratory rise time and pause time automatically switches to seconds. The corresponding I:E ratio for each inspiration time setting is displayed in the lower right information area of the mode settings window.

As the inspiration time is explicitly set, a change in the respiratory rate, for example, will affect the I:E ratio. As a safety precaution, there will therefore be an indication when the resulting I:E ratio passes 1:1 in either direction.

Note: When the inspiration time is directly set, the breath cycle time parameter is not displayed when an SIMV mode is selected, since there is no need to set it.

6.5 End inspiration

End inspiration:

• is the point at which inspiration changes to

expiration in supported ventilation

• if set too low, inspiration will be longer,

which may cause pulmonary hyperinflation and increased work of breathing

• if set too high, inspiration will be shorter,

which may mean that the patient receives insufficient tidal volume

100%

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6.6 Inspiratory rise time

The inspiratory rise time (Tinsp.rise):

• is the time taken to reach peak inspiratory

flow or pressure at the start of each breath

• is expressed in seconds or as a percentage

of the respiratory cycle time depending on how the ventilator is configured

0.10

An increased inspiratory rise time will affect the rate of flow/pressure increase and can be evaluated by the shape of the flow and pressure waveforms.

Inspiratory rise time set in seconds is applicable in:

• PS

• VS

• Bi-Vent/APRV

Note: When the ventilator system is configured for setting of inspiration time rather than I:E ratio, the unit for inspiratory rise time automatically switches to seconds for all ventilation modes.

In supported modes, the inspiratory rise time should normally be increased from the default setting to enhance patient comfort.

Inspiratory rise time set as a percentage is applicable in:

• VC

• PC

• PRVC

• all SIMV modes

• all Automode modes

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6.7 Trigger

6.7.1 Pneumatic trigger

WARNING! If the flow trigger level is very

low (too far to the left on the scale), an autotriggering condition may be reached. This condition can also be reached if there is leakage in the patient circuit, e.g. if an uncuffed endotracheal tube is used. Triggering will then be initiated by the ventilator system and not by the patient. This should always be avoided by increasing the patient effort required to trigger the ventilator system, moving further to the right on the scale.

The ventilator system has a pneumatic trigger (flow or pressure based) functionality.

The pneumatic trigger setting:

• determines the level of patient effort needed

to trigger the ventilator to inspiration

• may be set as either flow or pressure

triggering, where flow triggering allows the patient to breathe with less effort

• should generally be set so that it requires

minimal patient effort without causing autotriggering

During expiration, the ventilator system continuously delivers a gas flow (bias flow), which is measured in the expiratory channel.

0.40

1. Flow

2. Less effort

3. Trigger setting

4. Pressure

5. More effort

When triggering is based on flow, to the left on the scale, the ventilator system senses deviations in the bias flow delivered during expiration. These deviations are caused by the inspiratory efforts of the patient.

Refer to section Ventilatory settings on page 142.

SERVO-airVentilator System v2.1, User's Manual

The further to the left on the scale, the less effort the patient has to make. At the far left of the scale, there is a risk of autotriggering, and the scale and value are therefore marked in red. The trigger setting is marked with a ring in the dynamic image.

When triggering is based on pressure, to the right on the scale, the ventilator system senses deviations in the pressure below PEEP created by the patient. The pressure below PEEP required to initiate a breath is displayed when the setting is made.

The further to the right on the scale, the greater the patient effort required to trigger.

The trigger scale has different colors based on the setting. Green indicates a normal setting for pneumatic triggering. Red indicates that the setting is not recommended, e.g. when the risk of autotriggering may increase. Yellow is used as a warning color.

| Ventilatory settings and functions |

Patient triggering (flow or pressure) is indicated by a symbol in the status bar.

The pressure or flow curve will also be highlighted in white depending on which type of trigger is used.

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6.8 Apnea time

Apnea time is the time without a patient breathing effort that the ventilator system will allow to elapse in supported ventilation before the No patient effort alarm is activated and the ventilator system switches to the backup mode.

Refer to section Apnea management on page 98.

6.8.1 Maximal apnea time

The maximal apnea time:

• is the maximum time without a patient

breathing effort that the ventilator will allow to elapse in supported ventilation before switching to controlled ventilation.

In Automode, the apnea time becomes longer as spontaneous breathing becomes more regular. It is therefore set, in Automode only, as Max. apnea time.

6.9 SIMV breath cycle time

The SIMV breath cycle time:

• is the duration of the total respiratory cycle

of the mandatory breath in SIMV (inspiration + pause + expiration)

• only applies if the inspiratory time is set

using the I:E ratio

• together with a spontaneous period, makes

up one full SIMV cycle

The breath cycle time is sometimes referred to as an SIMV period.

Note: The breath cycle time parameter is not displayed when an SIMV mode is selected and inspiration time is configured.

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6.10 Predicted body weight (PBW)

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Notes:

• For adult patients outside the height

range 130-200 cm, PBW is the same as the patient weight (BW).

• For pediatric patients, PBW is the same

as the patient weight (BW).

In mechanical ventilation, predicted body weight can be used to help reduce the risk that differences in body weight will affect the estimated ventilation needs of different patients.

The ventilator monitors the ratio of tidal volume to PBW (VT/PBW) in ml/kg.

In the adult patient category PBW is calculated according to the Devine Formula and requires that height and gender are entered.

The tidal volume setting will, when tapped, present a calculated value for VT/PBW if the necessary patient data has been entered under PATIENT DATA. The value will also be presented in the numerical values and trended under TRENDS & LOGS/TRENDS

6.11 Maneuvers

The following four functions can be accessed under MANEUVERS (only available during ventilation) in the quick menu.

1. Manual breath

2. Static measurements

3. Nebulization

4. O2 boost level

6.11.1 Manual breath

When MANUAL BREATH is tapped, the ventilator system will initiate a new breath cycle according to the current ventilator settings.

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6.11.2 Static measurements

The inspiratory and expiratory hold can be used to perform certain measurements:

• PEEPtot: set PEEP + intrinsic PEEP

• Cstatic: static compliance, a measure of the

elastic properties of the respiratory system. A decrease in compliance implies stiffer lungs.

• E: elastance, has different compliances and

resistances in the lungs and an increase in elastance implies stiffer lungs.

• Ri: inspiratory resistance

• Re: expiratory resistance

• Tc: time constant, calculated as Cstatic x Re.

Some lung units have decreased compliance, and some have increased resistance, or both. Differences in Re and Cstatic affect the speed at which the lung units are filled and emptied. An expiration time of three time constants is recommended to avoid auto PEEP.

• Pplat: pressure during end inspiratory pause

Inspiratory hold

This function is activated by pressing INSPIRATORY HOLD for a maximum of 30 seconds. The inspiratory and expiratory valves close after inspiration. This function can provide an exact measurement of the end inspiratory lung pressure. It can be used to pause ventilation during X-ray or to determine the plateau pressure (Pplat), or, together with the expiratory hold, to calculate static compliance.

Expiratory hold

Expiratory and inspiratory valves are closed after the expiration phase is completed for as long as EXPIRATORY HOLD is pressed, but only up to a maximum of 30 seconds. Expiratory hold provides an exact measurement of the end expiratory pause pressure. It can be used to determine total PEEP and, together with inspiratory hold, static compliance (Cstatic). The dynamic pressure is displayed on the PEEP numerical value.

6.11.3 Nebulization

Refer to section Nebulization on page 101.

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6.11.4 O2 boost level

1. O2 boost level

2. O2 boost function

3. O2 concentration setting (O2 conc.)

By tapping O2 BOOST LEVEL, it is possible to change the desired level for the O2 boost function. It is possible to lock the O2 boost level to 100 %. It is also possible to set it to 0 %, in which case the O2 boost function will no longer be active and will be replaced by three asterisks.

6.11.5 O2 boost function

To use the O2 boost function, tap and hold O boost at the bottom left corner of the screen.

When tapped, O2 boost delivers the oxygen setting displayed here for a period of 1 minute. The O2 boost function can be interrupted by tapping the red cancel symbol in the O2 boost timer window anytime during the 1 minute interval.

The value entered under O2 boost (%) level specifies the number of percentage units that will be added to the value set for the O

concentration. For example: if the current O2 concentration is 40 % and the O2 boost level is 30 %, the O2 boost function will, when tapped, deliver 70 % O2.

The O2 boost function figure displayed will change accordingly. Since the minimum O

concentration is 21 %, the O2 boost (%) level scale goes from 0 to 79 %.

Refer to section Ventilatory settings on page 142 and to to section Edit Temporary O

increase (%) on page 127.

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6.12 Compensation functions

6.12.1 Leakage compensation

Leakage compensation is automatic for all patient categories in non invasive modes.

The function is designed to help maintain PEEP throughout the breath and is activated by default.

Leakage compensation may also affect important ventilatory parameters, such as patient triggering and the termination of inspiration.

Leakage is measured and presented in percent.

6.12.2 Circuit compensation

Part of the volume of each inspiration will not reach the patient because of gas compression in the ventilator and expansion of the tubing. All components in the patient circuit affect such losses.

When circuit compensation is activated, the delivered and measured volume and flow values are automatically compensated for these losses, as indicated by the symbols on the affected values.

The patient circuit test must be passed in order to activate circuit compensation.

To deactivate or reactivate, tap COMPENSATION in the extended menu/CIRCUIT COMPENSATION. Follow on-screen instructions.

Important: When monitoring VT/PBW, circuit compensation must be activated.

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6.13 Disconnection/Suction

Important: If a closed-suction system is used, DISCONNECTION/SUCTION, as well as the inspiratory and expiratory hold functions, should not be used.

Tap DISCONNECTION/SUCTION in the quick menu during ventilation to open the DISCONNECTION/SUCTION window.

The window always opens in Preparation.

DISCONNECTION/SUCTION enables automatic inhibition of the ventilator system during a tracheal suction procedure or when briefly pausing ventilation in invasive modes. The ventilator system is prevented from cycling without activating alarms.

Refer to section Ventilatory settings on page 142 and to to section Edit Temporary O increase (%) on page 127.

6.13.1 Suctioning procedures

Open suctioning

Important:

• Alarms are turned off during the Patient

disconnected phase for a maximum of

60 seconds. If the patient has not been reconnected within 60 seconds, alarms are activated.

• The minimum PEEP level during

disconnection is 3 cmH2O. The ventilator system will adjust to the minimum level if the PEEP level is below 3 cmH2O in order to detect disconnection of the patient.

For open suctioning procedures, there are three phases following Preparation:

• Pre-oxygenation

• Patient disconnected

• Post-oxygenation

Notes:

• DISCONNECTION/SUCTION is not

available in NIV modes or when Manual breath is activated.

• During the Patient disconnected phase

of a suctioning procedure, the nebulizer is temporarily paused.

• When only one gas is connected, an

elevated oxygen level cannot be set during the preparation phase. In this case, the post-oxygenation phase will be skipped.

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Adjust the O2 concentration, if desired, then tap Accept.

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Note: Tapping Cancel will close the DISCONNECTION/SUCTION window.

• Pre-oxygenation

Pre-oxygenation of the patient begins automatically after Accept is tapped during preparation.

The Patient circuit disconnected alarm is turned off. The maximum duration of the pre-oxygenation phase is 120 seconds. After this, the system automatically returns to ventilation using the previous oxygen setting. The same thing happens if Cancel is tapped.

• Patient disconnected

The system automatically enters the Patient disconnected phase when the patient is disconnected during the pre-oxygenation phase.

During the Patient disconnected phase, the following alarms are turned off for up to 60 seconds:

- apnea

- minute volume

- respiratory rate

- PEEP When the patient is reconnected, the

system automatically enters the post-oxygenation phase and then resumes ventilation. It is also possible to restart ventilation manually by tapping START VENTILATION.

• Post-oxygenation

After reconnection, the ventilator system will deliver the same oxygen concentration as in the pre-oxygenation phase for 60 seconds.

After 60 seconds the system automatically returns to ventilation using the previous oxygen concentration setting.

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Closed suctioning

When using a closed-suction system, DISCONNECTION/SUCTION should not be used. The O2 boost function should be used instead for oxygenation purposes. Consider pre-silencing the alarms before suctioning.

Use one of the pressure-based modes listed here. Adjust settings to levels suitable for the patient and follow hospital guidelines for closed suctioning.

• PC

• PS

• Bi-Vent/APRV

• SIMV (PC) + PS

6.14 Previous mode

When MODES is tapped in the quick menu during operation, the current mode tile is always highlighted and the previous mode tile is marked PREVIOUS, together with the date and time it was used.

Note: If the previous mode was non invasive and the current mode is invasive, or vice versa, it is necessary to go to Standby and choose the relevant ventilation type to find the previous mode.

To recall the previous ventilation mode used:

• Tap the tile marked with an arrow in the

MODES window.

• A dialog will open asking Do you want to

keep the previous settings for the mode?

• Tap one of the two choices Yes or No as

appropriate.

- If Yes is tapped, the mode settings

window will open with the previous settings intact.

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Important: If one or several settings in the mode settings window are highlighted in yellow, this indicates that it/they should be considered for adjustment, as the values entered there may have been carried over from the previous mode.

- If No is tapped, the mode settings

window will open with default settings, which may then be adjusted.

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Notes:

• The previous mode function is not

available:

- after a pre-use check

- after changing the patient category

- after admitting a new patient

- after using the same ventilation mode

for more than 24 hours

- after restarting the system.

• When the previous mode function is

activated during backup ventilation, the ventilator system returns to the mode that was active before the supported mode was initiated.

• A recall of previous settings is only

possible after a change of ventilation mode.

6.15 Apnea management

6.15.1 Apnea time

The relevant backup mode is highlighted in white in the heading on the screen and the alarm No patient effort is displayed.

If the patient triggers a breath, the ventilator system automatically switches back to supported ventilation and the No patient effort alarm disappears.

Apnea time is available in all supported modes and in all SIMV modes. Set the apnea time that is appropriate for each patient in the mode settings window.

Note: In SIMV modes, there is no backup ventilation and the apnea time only controls the No patient effort alarm. The apnea time is therefore set in the ALARM LIMITS window.

Refer to chapter Alarm handling on page 109 and to section Alarm limits on page 145.

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6.15.2 Backup ventilation

For invasive modes, backup ventilation entails a switch in case of apnea:

• from VS to PRVC

• from PS/CPAP to PC.

For non invasive modes, the switch is from NIV PS to NIV PC.

When the relevant backup mode is activated while ventilating in a supported mode, the name of the mode is highlighted in white in the mode heading and the backup parameters in the direct access bar are shown as active.

The following parameters are set under the backup mode heading in the mode settings window:

• PC above PEEP (cmH2O) for PS backup.

The minimum backup pressure level is 5 cmH2O.

• Tidal volume (ml) for VS backup.

• Respiratory rate (b/min)

• I:E or Ti (s) (depending on configuration)

Backup ventilation trends

The number of switches to backup ventilation per minute is trended under TRENDS & LOGS/TRENDS.

The percentage time spent in backup ventilation per minute is also trended.

No consistent patient effort

This alarm occurs in invasive ventilation only.

If the patient fulfils the criteria for the No consistent patient effort alarm, the ventilator system will lock in backup ventilation.

A dialog Backup ventilation active - review

ventilation settings or continue in supported mode. is displayed on the screen. A choice

must be made or this dialog will remain open and the ventilator system will remain in backup ventilation.

Tap Review ventilation settings in the dialog window to return to the mode settings window.

Refer to section Settings on page 41.

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• Tap Cancel to close the mode settings

window without changes being applied. Ventilation will continue as before, i.e. in backup ventilation.

• Tap Accept to accept the settings and

continue in the supported mode with a reset apnea time.

Alternatively, tap Continue in supported mode in the dialog window to return to the supported mode. The apnea time will be reset.

Refer to chapter Alarm handling on page 109 and to section Alarm limits on page 145.

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6.15.3 Deactivating backup ventilation

It is possible to deactivate backup ventilation for invasive PS/CPAP and VS. If backup ventilation is deactivated, the No patient effort alarm will be activated at the end of the apnea time but no backup ventilation will start.

To allow deactivation of backup ventilation:

• Tap SERVICE & SETTINGS in the extended

menu in STANDBY.

• Tap BIOMED and enter the code, then tap

CONFIGURATION/STARTUP CONFIGURATION/Deactivation of backup function.

• Change from Not allowed to Allowed.

If this choice is made, Deactivate backup ventilation is displayed at the top right of the mode settings window during ventilation.

To deactivate backup ventilation:

• Tap Deactivate backup ventilation in the

mode settings window.

• A confirmation dialog Do you really want to

deactivate backup ventilation? is displayed. Confirm by pressing Yes.

• Tap Accept in the mode settings window.

• Backup ventilation off is displayed after the

mode name in the heading when ventilation then begins.

The backup function is automatically re-activated if:

• a change is made to a controlled mode of

ventilation

• the ventilator system is switched to Standby

• the system is turned off.

100

Note: Backup ventilation remains inactive if a change of mode is made between PS/CPAP and VS.

SERVO-airVentilator System v2.1, User's Manual

Maquet Servo User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

TABLE OF CONTENTS

1 Introduction Table of contents

1.1 Device description

1.1.1 Device components

1.1.2 Intended use

1.1.3 User's Manual

1.1.4 Cleaning & Maintenance

1.1.5 Servicing Guidelines

1.1.6 Disclaimers

1.2 Safety guidelines

1.2.1 General

1.2.2 Power supply

1.2.3 Fire hazard

1.2.4 Gases

1.2.5 Auxiliary equipment

1.3 Version and configurations

1.3.1 Configurations

1.3.2 Available modes and functions

2 System Overview Table of contents

2.1 Ventilator

2.1.1 Mounting on mobile cart

2.2 Patient unit

2.2.1 Symbols on patient unit

2.2.2 Gas flow through the patient unit

2.3 Batteries

2.3.1 Charging battery modules

2.3.2 Handling battery modules

2.3.3 Battery status

2.4 Patient circuit

2.5 User interface

2.5.1 User interface adjustment

2.5.2 Interactive areas

2.5.3 Navigating

2.5.4 User support

2.5.5 Symbols on user interface

2.6 Transport

2.6.1 Before intrahospital transport

2.6.2 During intrahospital transport

3 Operation overview Table of contents

3.1 Workflow summary

3.2 Pre-use check

3.2.1 Start pre-use check

3.2.2 Complete pre-use check

3.3 Patient circuit test

3.4 Select patient category

3.4.1 Change patient category

3.5 Select ventilation type

3.6 Set ventilation mode

3.6.1 Settings

3.6.2 Safety scales

3.7 Set alarm limits

3.7.1 Set alarm sound level

3.8 Enter patient data

3.9 Start ventilation

3.10 Stop ventilation

4 Displaying and saving data Table of contents

4.1 Views

4.1.1 Basic view

4.1.2 Advanced view

4.1.3 Loops view

4.1.4 Family view

4.1.5 Distance view

4.2 Displaying waveforms

4.2.1 Adapting the waveform display

4.3 Displaying numerical values

4.4 Trends and logs

4.4.1 Trends

4.4.2 Logs

4.5 Saving and exporting data

4.5.1 Saving screenshots

4.5.2 Viewing saved screens

4.5.3 Recording waveforms

4.5.4 Viewing recordings

4.5.5 Exporting and deleting data

4.6 Ventilator configuration

4.7 System status