Maquet Servo-i User Manual

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User´s Manual

SERVO-i VENTILATOR SYSTEM V7.0

| TABLE OF CONTENTS |

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SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual Infologic 1.73

| TABLE OF CONTENTS |

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

Infologic 1.73

1 INTRODUCTION

TABLE OF CONTENTS

| Introduction |

6|Device description1.1

9|Warning, Caution, Important and Note1.2 14|Version and Configurations1.3

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SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

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1.1 DEVICE DESCRIPTION

This section provides general information about the SERVO-i Ventilator System along with guidelines for appropriate use.

1.1.1 DEVICE DIAGRAM

SVX-128a

1.1.2 DEVICE COMPONENTS

1.1.3 INTENDED USE

The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or respiratory insufficiency.

NAVA

The added indications for use of the NAVA or NIV NAVA software are that the electrical signal from the brain to the diaphragm is intact, and that there is no contraindication for insertion/exchange of nasogastric tube.

1.1.4 INTENDED USER

The SERVO-i Ventilator System should be used only by those who:

are professional healthcare providers, and

have received training in the use of this system, and

have experience with ventilation treatment.

The SERVO-i Ventilator System consists of the following components:

1. User Interface—for setting ventilation modes, displaying patient data, and indicating alarms

2. Patient Unit—for mixing gases

3. Patient Breathing System—for delivering and exchanging gases

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1.1.5 INTENDED USE ENVIRONMENT

The SERVO-i Ventilator System should be used only:

in hospitals

in facilities whose primary purpose is to provide healthcare

during transport of a patient within hospitals or healthcare facilities

during MR examinations of patients if the conditions in the SERVO-i MR Environment declaration (order no. 66 71 670) are met and an agreement with MAQUET is signed.

1.1.6 CLEANING AND MAINTENANCE

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

1.1.7 SERVICING GUIDELINES

CAUTIONS:

Regular Service: The SERVO-i 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 SERVO-i Ventilator System must be recorded in a service log in accordance with hospital procedures and local and national regulations.

Service Contract: We strongly

recommend that all service on the SERVO-i Ventilator System should be performed as part of a service contract with MAQUET.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

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1.1.8 DISCLAIMERS

Improper Use Environment MAQUET has no responsibility for the safe operation of SERVO-i Ventilator System if the Intended Use Environment requirements specified in this document are not followed.

Nonprofessional Servicing MAQUET has no responsibility for the safe operation of the SERVO-i Ventilator System if installation, service or repairs are performed by persons other than MAQUET authorized personnel.

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1.2 WARNING, CAUTION,

IMPORTANT AND NOTE

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

Note: Indicates information requiring special attention.

1.2.1 GENERAL

This manual summarizes the functions and safety features of the SERVO-i Ventilator System. It is not all-inclusive and should not be construed as a substitute for training.

WARNINGS!

Always perform a Pre-use check before connecting the ventilator to a patient.

If any of the following occurs, discontinue use of the ventilator and contact a service technician:

- Unfamiliar pop-up windows on the screen

- Unresolvable alarms

- Unfamiliar sounds

- Any unfamiliar or unexplained event

Keep the ventilator upright during use.

Make sure that ventilation is started when a patient is connected to the ventilator. When the ventilator is in Standby, a flashing message, Patient not ventilated, is displayed as a reminder directly above the word Standby.

When the ventilator is connected to a patient:

- Do not lift or disconnect the expiratory cassette.

- Continuously monitor the settings and measurements displayed on the screen.

- Make sure a resuscitator is readily available.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

The SERVO-i Ventilator System must be operated only by authorized personnel who are well trained in its use. It must be operated according to the instructions in this User´s Manual.

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Do not modify or remove any original parts.

Do not cover the ventilator in any way, since the functioning of the equipment may be adversely affected.

When the ventilator is used for MCare Remote Service, use only network equipment that is safe and in compliance with the relevant electrical and EMC standards such as IEC-60950.

Note: The network cable is excluded

from this requirement.

Always disconnect the network cable before starting ventilation when the ventilator is used for MCare Remote Service.

Positive pressure ventilation can be associated with the following adverse events: barotrauma, hypoventilation, hyperventilation or circulatory impairment.

The SERVO-i Ventilator System should not be used in MR environments unless the requirements described in the SERVO-i MR Environment Declaration (order no. 66 71 670) are met and an agreement with MAQUET is signed.

The SERVO-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.

The SERVO-i Ventilator System must not be used in a hyperbaric chamber unless it is equipped for hyperbaric oxygenation.

The SERVO-i Ventilator System must not be used with helium without the Heliox option.

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.

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 at earth fault.

CAUTIONS:

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

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

Refer to the Installation instructions to assemble the system or options to obtain a proper mechanical assembly.

Service, repair and installation must be performed by MAQUET authorized personnel only.

When lifting or moving the ventilator system or parts of the system, follow established ergonomic guidelines, ask for assistance, and take appropriate safety precautions.

Before use, make sure the system version displayed under Status corresponds to the system version described in the User´s Manual.

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Extra care should be taken when handling tubes, connectors and other parts of the patient circuit. The use of a support arm to relieve the patient from the weight of the tubing system is recommended.

When using the MCare Remote Service function, install the network cable so that there is no risk of anyone tripping over it.

Do not leave the patient unattended when connected to the ventilator.

MAQUET has no responsibility for the safe operation of the SERVO-i Ventilator System if the Intended Use requirements specified in this document are not followed.

Contact a MAQUET representative regarding decommissioning of the equipment.

Disconnect the mains power cable from the outlet to isolate the ventilator from mains power.

Do not touch accessible connector contacts and the patient simultaneously.

Important:

Always use a heat and moisture exchanger (HME) or equipment to prevent dehydration of lung tissue.

While the SERVO-i Ventilator System is in use, the wheels of the carrier shall be locked and the carrier shall be in a horizontal position.

Securely attach all cables, etc, to minimize the risk of unintentional disconnection.

Extra care should be taken when handling the gas trolley, as it may tip over.

All excess fluids must be disposed according to hospital routines.

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1.2.2 POWER SUPPLY

WARNINGS!

The power cord must be connected only to a properly grounded AC electrical outlet to avoid the risk of electrical shock.

To guarantee reliable battery backup, two fully charged battery modules must be installed at all times.

CAUTIONS:

Do NOT use antistatic or electrically conductive tubing with this system.

Avoid contact with external electrical connector pins.

Unused module compartments should always contain an empty module to protect the electrical connector pins from spillage and dust.

1.2.3 FIRE HAZARD

WARNINGS!

Keep the system and its gas hoses clear of all ignition sources.

Do not use the system with worn or frayed hoses or hoses that have been contaminated by combustible materials such as grease or oil.

Oxygen-enriched gas is extremely flammable: if you detect a burning odor, disconnect the oxygen supply, mains power and remove the batteries.

Make sure that both the mains power outlet and the power supply connector are accessible.

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1.2.4 GASES

CAUTION: The system is not intended to

be used with any anesthetic agent.

Important:

Supplied gases shall meet the requirements for medical grade gases according to applicable standards.

Maximum levels:

Air

H2O < 7 g/m

Oil < 0.5 mg/m

Chlorine: must not be detectable

Oxygen

H2O < 20 mg/m Oil < 0.3 mg/m

Note: For devices with serial numbers below 70000 that are updated to version

7.0, the maximum inlet gas pressure will be reduced (see the Technical data chapter on page 222).

1.2.5 AUXILIARY EQUIPMENT

CAUTIONS:

Accessories, supplies, and auxiliary equipment used with the ventilator should:

- be recommended by MAQUET

- meet EN/IEC 60601-1standards

- meet IEC standards as a whole system

If a scavenging system (i.e. gas evacuation) is connected to the ventilator, it must conform to ISO8835-3 guidelines for subatmospheric pressure and

induced flow.

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

- may be inaccurate if equipment not authorized by MAQUET is used

- should be discounted if they conflict with information on the ventilator screen

- must not substitute for therapeutic or diagnostic decisions

Note: Applied parts, i.e. equipment making physical contact with the patient, comprise nebulizer patient unit and cable, Y Sensor, CO2 sensor, Edi Catheter and cable and the Ventilator Breathing System described in System Flow Chart, Ventilation, Patient Connection, part no. 66 92 522.

1. If the compressed air is generated by a liquid ring compressor there is a potential risk of chlorine in the supplied air.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

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1.3 VERSION AND CONFIGURATIONS

This manual applies to version 7.0 of the SERVO-i Ventilator System, which can be delivered in three configurations: SERVO-i Infant; SERVO-i Adult and SERVO-i Universal.

1.3.1 CONFIGURATIONS

The weight ranges served by each configuration of the SERVO-i Ventilator System.

The SERVO-i Ventilator System can be used in both invasive and non invasive ventilation.

Configuration

ventilation

Universal

NIV = Non Invasive Ventilation

Adult

Weight range

Non invasive ventilationInvasive

Infant

NIV NAVA InfantNIV PC + PS

NIV Nasal CPAP

0.5 kg – 10 kg0.5 kg – 30 kg3 kg – 30 kgNot Applicable0.5 kg – 30 kgSERVO-i Infant

Not ApplicableNot ApplicableNot Applicable10 kg – 250 kg10 kg – 250 kgSERVO-i Adult

0.5 kg – 10 kg0.5 kg – 30 kg3 kg – 30 kg10 kg – 250 kg0.5 kg – 250 kgSERVO-i

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

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1.3.2 CONFIGURATION LABELS

NAVA readySERVO-i Universal

NAVASERVO-i Adult

SERVO-i Infant

1.3.3 AVAILABLE OPTIONS

The SERVO-i Ventilator System Configurations - lists the available functions and indicates if included or optional with each configuration

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Infant

Standard Configuration

OptionsAdult

Not applicableUniversal

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

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NIV NAVA

NAVA

Nasal CPAP

Non Invasive Ventilation (NIV)

Y Sensor Measuring

CO2 Analyzer

Nebulizer

Heliox

Stress Index

Open Lung Tool

(OLT)

Automode

Bi-Vent

VS (Volume Support)

PRVC (incl. SIMV (PRVC) + PS)

VC (incl. SIMV (VC) + PS)

PC (incl. SIMV (PC) + PS)

PS/CPAP

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

2 SYSTEM OVERVIEW

TABLE OF CONTENTS

2.2 symbols

| System Overview |

18|Ventilator2.1 19|User Interface - Connections, labels and

22|Navigating the User Interface2.3 28|Patient Unit - Connections, labels and symbols2.4 34|Transport and storage2.5

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2.1 VENTILATOR

The User Interface is used to control ventilator settings. Settings may be adjusted using touchpads on the screen or a rotary dial.

Breathing parameters are continuously measured and controlled. A difference between the actual measured value of a parameter and the preset or calculated value results in the adjustment of gas delivery to achieve the target value.

The system has two gas modules, one for air and one for O2. Gases may be supplied by a medical pipeline system, a compressor, or by gas tanks.

Ensure that the ventilator is in its locked position on the cart or holder used, to prevent unintentional movements.

CAUTION: Lock the wheels if the ventilator is not to be used for transportation.

1. Air and O2 supply

2. Power cable

3. User Interface

4. Patient Unit

5. Expiratory inlet

6. Servo Duo Guard, viral/bacterial filter

7. Inspiratory outlet

8. Patient circuit

9. Module compartment

10. Emergency air intake

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

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2.2 USER INTERFACE - CONNECTIONS, LABELS AND SYMBOLS

The User Interface includes:

a screen with active touchpads

fixed keys

rotary dials

2.2.1 USER INTERFACE DIAGRAM

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2.2.2 USER INTERFACE COMPONENTS

Refer to the User Interface Diagram for the location of the following numbered components:

1. Current Patient category

2. Current mode of ventilation

3. Automode On/Off (option)

4. Admit patient/Entered patient data and admission date

5. Nebulizer On/Off (option)

6. System status parameters

7. Fixed keys

8. Main Rotary Dial—used to select a menu touchpad or parameter box, to adjust values, and to confirm settings

9. Special Function Keys—used to start special ventilatory functions

10. Direct Access Knobs—used for immediate adjustment of breathing parameters

11. AC Power indicator (green)

12. Standby indicator (yellow)—when the ventilator is in Standby, a flashing message, Patient not ventilated, is displayed on the screen directly above the word Standby.

13. Start/Standby key

14. On/Off switch (rear side)

15. Slot for Ventilation Record Card (front view)

16. Luminescence detector—for automatically adjusting screen brightness

17. Text messages, including patient triggering symbols

18. Alarm messages

19. Waveform area—for monitoring two to four individually scaled parameters, including a volume/pressure loop and a flow/volume loop

20. Measured values and alarm limits display (customizable)

21. Additional settings

22. Additional measured values

23. Loudspeaker

24. Cable reel for the control cable

25. Slot for Ventilation Record Card (side/rear view)

26. Locking lever for rotation

27. Locking screw for alternative cart mounting

28. Holder for positioning on the Mobile Cart

29. Control cable (2.9 m long)

30. Service connector

31. On/Off switch

32. Locking lever for tilting

33. Model number

34. Serial number

35. Manufacturing information

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

2.2.3 USER INTERFACE SYMBOLS

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12 V

DescriptionSymbol

Audio Pause - silence or confirm an alarm. Note: This symbol may be different depending on User interface version.

Audio off

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

Alarm on

Alarm off

Attention—consult documentation Note: This symbol may be different

depending on User Interface version

Do not push the User Interface as the ventilator may tip over.

Start ventilation/Standby—yellow indicates Standby

Power indicator—green indicates AC power connected

Battery—indicates ventilator is using battery power, with estimated minutes remaining

12 V - indicates that external 12V DC is connected.

ON/OFF switch

Trigger indication—appears in the message/alarm field when the patient triggers a breath

Indicates that the system is compensated for Heliox.

Infant patient category

DescriptionSymbol

Volume Control with decelerating flow

Note: The patient unit symbols are described later in this chapter.

Adult patient category

Volume Control with flow adaptation

Volume Control without flow adaptation

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2.3 NAVIGATING THE USER INTERFACE

The following subsections provide general procedures for working with the user interface. More detailed procedures for specific tasks are found in later chapters and in the Appendix.

2.3.1 TOUCH SCREEN

To adjust ventilator settings:

1. Open the desired window by pressing one of the touchpads on the screen or one of the fixed keys.

2. Activate the desired touchpad by pressing it. The touchpad is now highlighted in white with a blue frame and it is possible to set a new value.

3. Turn the Main Rotary Dial to the desired value.

4. Confirm the settings by pressing the parameter touchpad or by pressing the Main Rotary Dial.

5. The touchpad turns grey again indicating that the new setting has been entered.

6. Press Accept to activate the new settings, or Cancel to start over.

Important: Different ways of interacting with the screen will affect its lifetime. Never use any sharp or pointed objects, such as ballpoint pens, on the screen.

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2.3.2 MAIN ROTARY DIAL

SVX-6021_XX

To use an alternative method for adjusting ventilator settings once the desired menu is activated:

1. Turn the Main Rotary Dial until the desired menu touchpad is marked with a blue frame.

4. Confirm the setting by pressing the Main Rotary Dial. The parameter touchpad turns grey again indicating that a new setting has been entered.

5. Touch Accept to activate your settings, or Cancel to start over.

Note: When the defined safety limits for a given parameter have been reached, the Main Rotary Dial becomes inoperative for 2 seconds to indicate that a limit has been reached.

2. Press the Main Rotary Dial to confirm. The menu touchpad is highlighted in white with a blue frame, indicating that a new value can be entered.

3. Turn the Main Rotary Dial to the desired value or line.

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2.3.3 FIXED KEYS

There are two groups of fixed keys on the user interface screen:

The keys in group 1 activate user interface functions such as Save and access various screens such as Menu.

The keys in group 2 start special ventilatory functions

Important: The special ventilatory functions require continuous supervision.

2.3.4 DIRECT ACCESS KNOBS

Using Direct Access Knobs

To adjust a breathing parameter directly:

1. Turn the Direct Access Knob corresponding to the parameter you wish to change until the desired value is displayed on the screen.

WARNING! When you adjust a breathing parameter using a Direct Access Knob, the parameter will change immediately starting with the next breath; no additional confirmation is required.

The four dials along the bottom of the User Interface screen are the Direct Access Knobs. They permit direct control of four breathing parameters, which are automatically selected depending on ventilation mode.

The Main Rotary Dial and Direct Access Knobs become inoperative for 2 seconds when the user reaches a defined safety limit for the parameter being adjusted.

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Direct Access Knobs - Safety

The four Direct Access Knob parameters are displayed at the bottom of the screen with color-coded bars that indicate whether the parameter values are within generally-recognized safety limits.

Note: When the defined safety limits for a given parameter have been reached, the Direct Access Knob becomes inoperative for 2 seconds to indicate that a safety limit has been reached.

The figure above shows the following components.

1. A Direct Access Knob

2. A yellow bar indicating the corresponding parameter value is outside safety limits; a text message is displayed accompanied by an audible signal.

3. A red bar indicating the corresponding parameter value is significantly outside safety limits; a text message is displayed accompanied by an audible signal.

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2.3.5 MENU KEY

To access the user interface windows:

1. Press the fixed key Menu. Touchpads leading to the user interface windows appear.

2. If the touchpad shows a sheet icon, press the touchpad to open a user interface window, OR

3. If the touchpad shows an arrow icon, press the touchpad to display the submenu.

Press any of the following touchpads.

4. Alarm

5. Review

6. Options

7. Compensate

8. Copy (to Ventilation Record Card)

9. Biomed

10. Panel lock

11. Change patient category (option)

For more information see Appendix • User interface on page 253.

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2.3.6 STATUS TOUCHPAD

The Status touchpad indicates the power supply currently being used by the ventilator (AC power, battery power, or external 12V DC power). If the ventilator is running on battery power, the estimated remaining battery time in minutes is shown.

To access the status window:

1. Press the Status touchpad.

Touchpads leading to status windows appear.

Press any of the following touchpads.

2. General

3. O2 cell / O2 Sensor

4. Expiratory cassette

5. Batteries

6. Modules - CO2 module (if fitted), Y Sensor measuring (if fitted), Edi module (if fitted)

7. Installed Options

8. Pre-use check

9. Patient Circuit

CAUTION: When using an external 12V DC supply, battery modules must be installed to ensure proper operation.

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2.4 PATIENT UNIT - CONNECTIONS, LABELS AND SYMBOLS

The patient unit consists of the following components:

gas supplies and their connectors

power supplies and their connectors

connectors for accessories

2.4.1 PATIENT UNIT DIAGRAM

0123

12V

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

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2.4.2 PATIENT UNIT COMPONENTS

Refer to the Patient Unit Diagram for the location of the following numbered components:

21. Cover, inspiratory channel

1. Handle

2. Gas inlet for air

3. Gas inlet for O

4. Air / Luft

5. O

6. Model number

22. Expiratory inlet

23. Battery lock

24. Module compartment

25. Nebulizer connector

26. Inspiratory outlet

27. Emergency air intake

7. Serial number

8. Manufacturing information

9. Equipotentiality terminal

10. Label

11. AC power supply connector with fuse

12. Cooling fan with filter

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13. Alarm output connection

14. RS-232 connector

15. External +12V DC inlet

16. Fuse for external DC power supply

17. Optional connector

18. User interface connector

19. RS-232 connector

20. Expiratory outlet

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2.4.3 PATIENT UNIT SYMBOLS

&  86

E 01

ExplanationSymbol

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

CSA label—Indicates compliance with Canadian and US standards

PCT label - indicates compliance with Russian standards

Class I equipment, Type B—indicates classification according to IEC 60601-1/EN 60601-1

Equipotentiality terminal Note: The equipotentiality terminal

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

Nebulizer Connector

12V

ExplanationSymbol

External 12V DC input Note: This symbol may be different

depending on Patient Unit version.

Expiratory label—gas flow from patient.

Inspiratory label—gas flow to patient.

Gas exhaust port label—exhaust gas flow from ventilator

Note: This port should not be connected to a spirometer because the volume through the exhaust port is not equal to the expired volume from the patient.

Alarm output connection—external alarm output communication

Special waste. This product

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

Caution

RS 232 / Serial port—connector for data communication.

Note: This symbol may be different depending on Patient Unit version.

User Interface connector Note: This symbol may be different

depending on Patient Unit version.

Optional connector / Expansion Note: This symbol may be different

depending on Patient Unit version.

10A Fuse for external DC power supply.

Consult Instructions for use

Batteries

Weight - Patient unit and User interface.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

2.4.4 PATIENT UNIT GAS FLOW DIAGRAM

| System Overview |

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SVS-0099_EN

3 4

to Patient

from Patient

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2.4.5 GAS FLOW THROUGH THE PATIENT UNIT

Refer to the Patient Unit gas flow diagram for the location of the following numbered components:

1. Gas inlet for O

2. Gas inlet for air

3. The gas flow is regulated by the gas modules for Air and O2.

4. The gases are mixed in the inspiratory mixing section.

5. The Oxygen concentration can be measured with an O2 cell or O2 sensor.

An O2 cell is shown here. The O2 cell is protected by a bacteria filter.

6. The pressure of the mixed gas delivered to the patient is measured by the Inspiratory pressure transducer. The transducer is protected by a bacterial filter.

7. The inspiratory channel delivers the mixed gas to the patient systems inspiratory tubing. The inspiratory channel also contains a safety valve.

8. The patient breathing systems expiratory tubing is connected to the expiratory inlet. The inlet also contains a moisture trap.

9. The gas flow through the expiratory channel is measured by ultrasonic transducers.

10. The expiratory pressure is measured by the expiratory pressure transducer (located inside the ventilator). The transducer is protected by a bacterial filter inside the expiratory cassette.

11. The pressure (PEEP) in the patient system is regulated by the expiratory valve.

12. Gas from the patient system leaves the ventilator via the expiratory outlet. The outlet contains a non-return valve.

Note: The expiratory cassette can be exchanged between different SERVO-s and SERVO-i Ventilator Systems. Always perform a Pre-use check after exchanging an expiratory cassette.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

2.4.6 SYMBOLS ON ACCESSORIES AND PACKAGING

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QTY

ExplanationSymbol

Order number

Number to identify the production batch

Quantity

Outer diameter in millimeters

Inner diameter in millimeters

Circumference/lengthFr/cm

Use by date

Do not re-use. Single use only.

Do not use if packaging is damaged

Attention—consult documentation

Keep away from sunlight

Method of sterilization using irradiation

Manufacturer

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

Manufacturing date

Phthalates

-10

PHT

ExplanationSymbol

Humidity limitation

+55oC

Temperature limitation

Phthalate free

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

Output

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

Type B—indicates classification according to IEC 60601-1/EN 60601-1

Fragile - handle with care

Keep away from water

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

Atmospheric pressure limitation

Do not expose the battery to heat or fire.

sale by or on the order of a physician.

ONLY

Recycling. Worn-out batteries must

be recycled or disposed of properly in accordance with appropriate industrial and environmental standards.

Federal law restricts this device to

Hazardous waste

(infectious)

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

Hazardous waste (infectious) The device contains parts which must not be disposed of with ordinary waste.

Indicates the inner diameter of the endotracheal tube.

Do not expose the battery to mechanical force.

Do not dismantle, open or shred the battery.

The support arm must be folded during transport.

Consult Instructions for use

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2.5 TRANSPORT AND STORAGE

2.5.1 BEFORE INTRAHOSPITAL TRANSPORT

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

Be sure the patient unit and the user interface are securely attached and locked.

Be sure all accessories such as modules, gas cylinders, and humidifier are securely attached and locked.

Be sure the gas cylinders are connected and have sufficient gas.

Be sure the batteries are fully charged.

Important: At least two batteries should be connected during transport.

Inspect the resuscitator.

Inspect the Mobile Cart for damage.

Be sure 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 support arm is folded before transport.

2.5.2 DURING INTRAHOSPITAL

TRANSPORT

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

Use the handles on the Mobile Cart.

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

When moving the Support Arm or changing position, watch the patient connection carefully to see that no pulling or other movement occurs.

Be careful not to tip the Mobile Cart when crossing an obstacle like a doorstep.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

2.5.3 STORAGE

When the SERVO-i Ventilator System is in storage, keep the ventilator connected to mains power to maintain full charge in the batteries.

Do not dispose of battery modules and O cells with ordinary waste.

Be sure the system is not exposed to temperatures below +10oC or above +40oC.

Be sure the system is not exposed to a relative humidity above 95%.

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SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

3 POWER SUPPLY

TABLE OF CONTENTS

| Power supply |

38|Introduction3.1 38|Viewing battery status3.2 40|Alarms and safety3.3

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3.1 INTRODUCTION

The SERVO-i Ventilator System is equipped with an AC power supply with automatic range selection. The ventilator will automatically operate correctly using 100-120V AC or 220 - 240V AC outlets.

See chapter Technical data on page 221.

The ventilator is equipped with at least two battery modules which automatically supply 12V DC power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure.

Note: Batteries can be added to available slots during operation.

The ventilator also comes equipped with an inlet for an external 12V DC power supply. This power supply activates automatically in case of an AC power failure, and ventilator settings and stored data remain intact.

3.2 VIEWING BATTERY STATUS

When operating from batteries, the estimated remaining battery time in minutes is displayed in the upper right corner of the screen on the Status touch pad.

WARNING! If the remaining battery time on the Status touchpad is displayed in red, the battery modules have very little operational time left and battery modules must be replaced. If possible, connect the ventilator to AC power.

Note: The total usable backup time is the sum of the estimated operation time displayed for each battery module minus 10 minutes.

CAUTION: When using external 12V DC, at least two installed battery modules are required to ensure proper operation.

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

Alarms and Messages

See Alarms and Safety later in this chapter.

When the ventilator is turned off with the on/off switch, batteries continue to charge.

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Detailed battery status information is available via the Battery Status Window:

1. Press the Status touchpad at the top-right of the user interface to display the Status Window.

SVX-9033

2. Press the Batteries touchpad to display the Battery Status Window.

The following information is displayed for each mounted battery module:

Slot number

Serial number

Charge indicator, where 0 boxes filled = < 10% relative charge

1 box filled = 10-25% relative charge

2 boxes filled = 26-50% relative charge

3 boxes filled = 51-75% relative charge

4 boxes filled = 76-100% relative charge,

Remaining operating time in minutes

Activity Instruction—an instruction may be displayed next to the remaining operating time in minutes:

ResponseActivity Instruction

Expires soon

Replace battery

Order a new battery module.

The battery no longer reliable; replace it immediately.

SVX-9032

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

Note: If the Replace battery is displayed, the battery has become unreliable, regardless of the operating time displayed in the Battery Status Window. In this situation, replace the battery even when the status window indicates significant operating time remains.

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3.3 ALARMS AND SAFETY

The status of the battery modules is continuously monitored by the ventilator. If the status is unsatisfactory, four types of messages may be displayed at the top of the user interface:

Technical Error Message

High Priority Alarm Message

Medium Priority Alarm Message

Text Message

3.3.1 WARNINGS

WARNINGS!

If a battery status message is displayed on the user interface, check the battery status as soon as possible. If no action is taken, the ventilator may eventually shut down.

To guarantee reliable battery backup, two fully charged battery modules must be installed at all times.

Always replace batteries when the ventilator software notifies you of imminent expiration or of diminished operating capacity.

Do not disconnect and store battery modules over long periods of time because this will degrade their capacity. If used battery modules need to be stored for short periods of time (up to one week), then store them fully charged in a cool (15-20°C or 59-68°F), dry environment.

Batteries that have been stored or disconnected should be recharged before use.

Dispose of batteries according to local regulations and not with ordinary waste.

After a new battery module is installed, display the Battery Status Window to ensure safe battery operation.

When delivered, the battery modules may not be fully charged. Check the status of the batteries via the user interface and, if necessary, charge the battery before use by connecting the ventilator to the power supply.

Always recharge discharged batteries.

When not in use, the ventilator should always be connected to the power supply to ensure fully charged batteries.

When the ventilator is running on batteries, the Servo Ultra Nebulizer is disabled to reduce power consumption.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

3.3.2 STATUS MESSAGES

Check battery status (Text Message)

Nebulizer cannot be run on one battery (Text

message)

Battery mode! Nebulizer switched off (Medium Priority Alarm)

Battery operation (Medium Priority Alarm)

Low battery voltage (High Priority Alarm)

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ExplanationMessage (message type)

Power failure.Technical error no. 1 - 6, 29, 10001 (technical error)

There is a problem with the battery modules. One or more battery modules must be replaced.

When using an Aeroneb module installed by MAQUET and any Aeroneb nebulizer unit, nebulization cannot be maintained with less than two batteries installed.

Ventilator is running on batteries and the Servo Ultra Nebulizer has been disabled to reduce the power consumption.

AC power is off line due to a power failure or disconnection.

Less than 10 minutes left of battery operation.Limited battery capacity (High Priority Alarm)

Less than 3 minutes left of battery operation.No battery capacity (High Priority Alarm)

Battery voltage too low. Cannot guarantee continued ventilator operation.

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3.3.3 AC POWER FAILURE

In the event of an AC power failure or disconnection, the ventilator switches to battery operation and activates medium priority alarms, see Table above in Status Messages for details.

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SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

4 OPERATION OVERVIEW

TABLE OF CONTENTS

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4.1 WORKFLOW SUMMARY

The following summary procedure provides an overview of the operation of the SERVO-i Ventilator System.

1. Turn on the ventilator and perform a Pre-use check. When the ventilator is in Standby, a flashing message, Patient not ventilated, is displayed on the screen directly above the word Standby.

2. Select patient category (option).

3. Enter data for the new patient, including height and weight.

4. Select type of ventilation (option).

5. Set the ventilation mode.

6. Check, and if necessary, adjust the alarm profile.

7. Connect ventilator to patient and start ventilation.

8. During ventilation you can:

use the Additional Settings and Alarm profile touchpads to review and adjust settings

use suction support

adjust the O2 cell (not when O2 sensor is used)

9. Disconnect the patient.

The following sections describe each of the above steps in more detail.

4.2 PRE-USE CHECK

The Pre-use check includes tests and measurements of:

internal technical functionality

gas supply

internal leakage

pressure transducers

safety valve

O2 cell / O2 sensor

flow transducers

battery modules

patient circuit leakage

patient circuit compliance

patient circuit resistance

WARNINGS!

Always perform a Pre-use check before connecting the ventilator to a patient.

The volume of the patient circuit used during Pre-use check should be the same as, and must never be higher than, during ventilation e.g. the active humidifier must be filled before Pre-use check.

The separate Patient Circuit Test that can be performed in Standby does not replace the Pre-use check.

If any malfunctions are detected during the start-up procedure, see chapter System messages for more information.

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WARNINGS!

Do not connect the ventilator to a patient while a malfunction persists.

Do not disconnect the expiratory cassette while the ventilator is in operation; if necessary, disconnect the cassette while in Standby.

Important:

If you change the breathing circuit after completion of the Pre-use check, perform a new Pre-use check or a patient circuit test.

When the Pre-use check is completed, all possible sources of alarm signals have been verified and the alarm system operates correctly.

4.2.1 PRE-USE CHECK WITH HeO

The Pre-use check can be performed with HeO2 instead of air if desired (only if Heliox option is installed).

Always perform the Pre-use check on a warm expiratory cassette when HeO2 is used. In order for the expiratory cassette to get warm enough, the system must be in the power-on state for 15-30 minutes.

1. Follow the normal Pre-use check procedure.

2. The HeO2 icon (1) indicates that the ventilator is adjusted for Heliox use.

SVX-9042

Note: If the identified gas mixture is not approved for use with the SERVO-i Ventilator System (e.g. pure helium or Heliox 70:30), then the Gas supply test and O cell/sensor test are not passed and the Pre-use check will fail. The message

Unapproved gas mixture identified. Check gas supply is displayed.

Note: For optimum Oxygen calibration the HeO2 gas used should contain 21% Oxygen.

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4.2.2 START-UP

1. Connect power and gas supplies: Power: AC outlet

Gas: Air and O

CAUTION: Ensure that the cable to the User Interface is never disconnected while the SERVO-i Ventilator System is powered on.

2. Turn the ventilator on.

3. Start the Pre-use check by pressing Yes.

4.2.3 INTERNAL LEAKAGE TEST

Connect the test tube between the inspiratory outlet and the expiratory inlet.

Important: Use only the MAQUET test tube.

4.2.4 BATTERY SWITCH TEST

The Pre-use check tests the ventilator’s ability to switch between AC and battery power when AC power is lost and restored:

When the on-screen instruction appears, disconnect the ventilator from AC power.

When the on-screen instruction appears, reconnect the ventilator to AC power.

4. Follow the on-screen instructions.

5. After pressing the touchpad Pre-use

check the message Do you want to start a pre-use check? is displayed - confirm

by pressing Yes.

Note: This test will not be performed if there is less than 10 minutes of battery operation available.

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4.2.5 PATIENT CIRCUIT TEST/Y SENSOR

TEST

The test measures the compliance and resistance of the patient breathing system.

The patient circuit resistance is automatically measured to determine if the ventilator maintains the specified accuracy with the connected breathing circuit.

1. Connect the complete breathing system

to be used on the patient. If an active humidifier is used, it must be filled with water.

2. Block the end of the complete breathing system and follow the on-screen instructions. The circuit compliance and resistance are automatically measured. Go to Compensate for Circuit compliance (see page 48).

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3. Unblock the end of the complete breathing system and follow the on-screen instructions.

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Important: When blocking the end of the complete breathing system, make sure there is no leakage. Leakage will affect the circuit compliance compensation calculation.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

The test will be repeated if a Y sensor is connected. Follow the on-screen instructions.

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4.2.6 COMPENSATE FOR CIRCUIT COMPLIANCE

When the Compensate for circuit compliance? dialog appears on the screen,

do one of the following:

To add the compensation, press Yes

(recommended),

- To refuse the compensation, press No.

Important: If the patient circuit is changed, a Patient Circuit Test must be performed.

4.2.7 TEST ALARM OUTPUT CONNECTION (OPTION)

If the Alarm Output Connection option is installed, a dialog for the external alarm system test appears on the screen.

Do one of the following:

To perform the test, press Yes and follow

the on-screen instructions.

- To cancel the test, press No.

Note: Circuit compliance compensation is not available in NIV modes (option).

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

4.2.8 COMPLETE THE PRE-USE CHECK

A message appears on screen for each Pre-use check test, as appropriate: Cancelled, Failed, Not Completed, Passed or Running.

Press OK to confirm and to have the Pre-use check tests logged. The ventilator now switches to Standby.

Notes:

After the Pre-use check is completed (or skipped), you will be prompted to keep or discard old patient-related data.

By accessing the Status menu, the results of the two latest Pre-use checks are displayed under General.

The status of the Patient Circuit test is displayed under Status/ Patient Circuit.

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4.2.9 PRE-USE CHECK TESTS

Internal test

Audio test and other internal tests (memory and safety-related hardware).

Remedy if test failsDescriptionTest

Make sure the patient unit front cover and the user interface rear cover are correctly mounted.

Barometer test

Gas supply test

Internal leakage test

Pressure transducer test

Safety valve test

cell / sensor test

Checks the barometric pressure measured by the internal barometer.

Checks that the gas supply pressures (air/HeO

and O2) measured by the

internal gas supply pressure transducers are within the specified range. The test checks the presence of different gas types.

Checks for internal leakage, with test tube connected, using the inspiratory and expiratory pressure transducers.

Allowed leakage: 10 ml/min at 80 cmH

Calibrates and checks the inspiratory and expiratory pressure transducers.

Checks and if necessary adjusts the opening pressure for the safety valve to 117 ± 3 cmH

Calibrates and checks the O sensor at 21% O

and 100% O

cell /

Checks if the O2cell is worn out. Because different gas mixtures are

required for this test, it will not be performed if one gas is missing.

Check the barometric pressure value in the Status Window.

Check that the gas supply pressure (air/HeO

and O2) is within the specified

range, and that the gas used is approved for the SERVO-i Ventilator System. See page 222 for specification.

If message Leakage or Excessive leakage appears:

check that the test tube is correctly connected,

check all connections for the expiratory cassette and inspiratory channel,

make sure the expiratory cassette and the inspiratory channel are clean and dry, OR

contact a service technician.

If the Internal leakage test passed (see above):

check/replace inspiratory or expiratory pressure transducer

check that there is no excess water in the expiratory cassette

Check the inspiratory section:

check that the safety valve membrane is correctly seated in the inspiratory pipe

check that the inspiratory pipe is correctly mounted in inspiratory section

check that the safety valve closes properly when the Pre-use check is started (distinct clicking sound from the valve)

Check that the connected gas supply pressure (air and O

) is within the

specified range. Replace the O2 cell. Replace gas modules (air and/or O2).

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

Flow transducer test

Battery switch test

Patient circuit test

Checks the inspiratory flow transducers. Calibrates and checks the expiratory flow transducer.

If battery modules are installed, tests switching to battery power when AC power is lost and back to AC power when it is restored.

Checks the patient circuit leakage, compliance and resistance, with patient tubing connected, using the inspiratory and expiratory pressure transducers.

Allowed leakage: 80 ml/min at 50 cmH

Will allow the system to calculate a compensation for circuit compliance (if the leakage requirements are met).

Checks the patient circuit resistance, with patient tubing connected, using the inspiratory and expiratory pressure transducers.

For ranges and accuracies, see chapter Technical data on page 224.

| Operation overview |

Remedy if test failsDescriptionTest

Check that the connected gas supply pressure (air and O

) is within the

specified range. Check that the cassette is correctly

seated in the cassette compartment.

Check that the total remaining time for the connected battery modules are at least 10 minutes. If not, replace the discharged battery with a fully charged battery and repeat the test.

If the internal leakage test has passed, the leakage is located in the patient circuit. Check for leakage or replace the patient circuit.

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Y Sensor test

Alarm state test

Alarm output connection

Checks the pressure and flow measurement of the Y Sensor.

are active during the Pre-use check

Checks that the alarm activation functions correctly.

Check Y Module and Y Sensor. If the problem persists, change the Y Module/Sensor.

Refer to service technician.Checks that no Technical error alarms

Check that the cable is connected to the external system.

Refer to service technician.

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4.3 PATIENT CIRCUIT TEST

In Standby, the Patient circuit test may be performed separately from the Pre-use check. This is useful, for example, when changes are made to the circuit or additional accessories are connected. The test evaluates circuit leakage and measures circuit compliance and resistance.

SVX-9042

Press the Patient circuit test touchpad and follow the on-screen instructions.

Follow the instructions in section Patient circuit test/Y Sensor test.

The results from the Patient circuit test is displayed in the Status>Patient circuit window.

Note: Considerable leakage may occur around the endotracheal tube if it is uncuffed. The combination of small tidal volumes, leakage around the tube, and activated compliance compensation may trigger the Low Expiratory Minute Volume alarm due to a very low expiratory flow passing from the patient through the expiratory channel. By observing the difference between the Vti and Vte values presented on the user interface, a leakage can be detected and its extent easily controlled. The first time an unacceptably large leakage occurs around the tube, correct this problem to avoid triggering the Low Expiratory Minute Volume alarm. If the leakage persists, either adjust the alarm limit down to its lowest level (10 ml) or permanently silence the alarm (see page 179)—if this step is clinically appropriate. Finally, if the leakage still has not been remedied, deactivate the compliance compensation to avoid triggering the alarm. If the compliance compensation is deactivated while in Pressure Control, Pressure Support, or SIMV (Pressure Control) ventilation modes, then no further settings need to be adjusted. However, in volume-related modes, the set volumes must be adjusted.

WARNINGS!

A Pre-use check must always be done before connecting the ventilator to a patient.

The Patient circuit test does not replace the Pre-use check.

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4.4 SELECT PATIENT CATEGORY (OPTION).

SVX-9042

Press Adult or Infant.

Note:

Changing the patient category affects the following settings:

default values for alarm limits

allowed ranges for alarm limits

default values for breathing parameters

allowed ranges for breathing parameters

pressure and flow regulation

scaling

4.4.1 CHANGE THE PATIENT CATEGORY (OPTION)

To change the patient category during ventilation:

1. Press the Menu fixed key.

2. Press the Change patient category touchpad.

3. Press Yes to confirm OR,

4. Press No to cancel.

PROCEDURE DIAGRAM: CHANGE THE PATIENT CATEGORY DURING VENTILATION

The factory default values for the Adult and Infant patient categories may have been

changed by a previous user.

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

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4.5 ENTER THE PATIENT DATA

1. Press the Admit patient touchpad.

2. Activate touchpads by turning and pressing the Main Rotary Dial or by pressing the appropriate touchpads.

Enter/edit the following characteristics:

3. Patient name

4. Identity number

5. Date of birth

6. Date of admission

7. Body height

8. Body weight

9. Press, for example, Name to enter the patient’s name.

10. Press Close keyboard when entry is complete.

11. When the ID touchpad is pressed, a keypad appears in the window.

12. Press Accept to confirm new data or Cancel to cancel new data.

PROCEDURE DIAGRAM: ENTER PATIENT DATA

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a_XX

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Important:

Adult weights are in kilograms.

Infant weights are in grams.

Copy patient data before you enter a new name or ID, otherwise all data corresponding to the previous patient will be lost.

The calculation of tidal and minute volume is based on entered body weight. If you omit this data, default values will be used for ventilation. An automatic calculation of Tidal Volume (based on body weight and immediately executed) will be performed only if the system is configured for Tidal Volume based on

body weight.

4.6 SELECT THE TYPE OF VENTILATION (OPTIONS)

Press Invasive ventilation or NIV (Non invasive ventilation).

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

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4.7 SET VENTILATION MODE

To set ventilation mode and parameters:

1. Press the Mode touchpad.

2. Press the arrow at the active Mode pad. Available ventilation modes appear.

3. Press the touchpad for desired mode of ventilation.

4. If Automode is selected and the patient is triggering the ventilator, a green indicator mark will appear.

Note: Automode is not available in NIV.

5. When a ventilation mode has been selected, all related parameters can be set in the same window. Calculations are also displayed in this window.

6. Values are adjusted by turning the Main Rotary Dial.

7. Confirm each setting by pressing the parameter touchpad or pressing the Main Rotary Dial.

8. To activate all settings in the window press Accept, or to cancel the settings press Cancel.

PROCEDURE DIAGRAM: SET VENTILATION MODE

SVX-6032a_XX

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4.8 SET ALARM LIMITS

To set alarm limits:

1. Press the Alarm Profile fixed key.

2. Press the touchpad corresponding to the alarm limit you want to adjust or press the Alarm sound level touchpad.

3. Turn the Main Rotary Dial to adjust values.

4. Confirm each setting by pressing the parameter touchpad or Main Rotary Dial.

5. Press Autoset, if desired, to get a proposal for alarm limits in VC, PC, and PRVC modes.

Important: Before accepting Autoset values, make sure they are appropriate for the patient. If not, enter settings manually.

6. Press Accept to activate the new alarm limits.

Notes:

Autoset is not possible in Standby because the ventilator requires patient values in order to propose alarm limits.

Autoset is not available in supported or NIV (optional) modes.

Current alarm limits are displayed during ventilation in smaller figures to the right of the parameter display.

The Main Rotary Dial becomes inoperative for 2 seconds when a defined safety limit for the alarm limit being adjusted is reached. After this, it will be operable again.

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4.9 START VENTILATION

The Start/Standby key is used to start and stop both invasive and non invasive ventilation. It is also possible in Standby to start ventilation by pressing the Start ventilation touchpad on the screen.

WARNING! Make sure that ventilation is started when a patient is connected to the ventilator. When the ventilator is in Standby, a flashing message, Patient not ventilated, is displayed as a reminder directly above the word Standby.

4.9.1 START INVASIVE VENTILATION

4.9.2 START NIV (NON INVASIVE

VENTILATION) (OPTION)

    

69;    B( 1

1. When the Start/Standby key is pressed and the SERVO-i Ventilator System is configured for NIV, a waiting position dialog is shown.

1. When the system is configured for invasive ventilation press the Start/Standby key (1) to start ventilation, or press the Start ventilation touchpad on the screen.

Note: All patient-related alarms are turned off for 120 seconds.

2. Press the Start ventilation touchpad.

Note: Ventilation starts automatically upon patient effort.

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4.10 ADDITIONAL SETTINGS

WINDOW

To adjust breathing parameters during ventilation, press the Additional settings touchpad to open the Additional Settings Window.

1. The Additional settings touchpad is in the lower left corner of the screen.

2. Values derived from settings such as inspiration time in seconds and calculated inspiratory flow are displayed.

3. A white bar indicates that the selected setting is within generally recognized safety limits.

4. A yellow (advisory) bar indicates that the selected setting is beyond generally recognized safety limits (this warning is accompanied by an audio signal and text message).

5. A red (warning) bar indicates that the selected setting is significantly beyond generally recognized safety limits (this warning is accompanied by an audio signal and text message).

6. Turning and pressing the Main Rotary Dial allows you to select settings and adjust values.

7. The waveforms and measured values are displayed. Thus, the effects of the adjustments made can be checked immediately.

8. The Close touchpad closes the Additional Settings Window.

Note: The trigger sensitivity bar has different colors based on the setting. A green bar indicates a normal setting for flow triggering. The risk of self-triggering increases when the bar is red. A white bar indicates that pressure triggering is required.

THE ADDITIONAL SETTINGS WINDOW

Note: New settings are effective from

the first breath after adjustment (when the touchpad is deactivated).

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4.11 SUCTIONING

4.11.1 SUCTION SUPPORT

The Suction Support function makes it possible to automatically inhibit the ventilator from cycling during a tracheal suction procedure without activating alarms.

Suction Support includes:

pre-oxygenation/preparation phase

disconnect phase

post-oxygenation phase

WARNINGS!

Suction Support is not intended to be used together with closed-suction systems.

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

Notes:

Suction Support is not available in NIV mode or when the O2 Breaths function is activated.

During the disconnect phase in Suction Support, 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.

Important: Alarms are turned off during the disconnect phase for a maximum of 60 seconds. If the patient has not been reconnected within 60 seconds, alarms are activated.

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PRE-OXYGENATION/PREPARATION PHASE

SVX-9000 XX

To enter the pre-oxygenation/preparation phase:

1. Press the Quick access fixed key.

2. Press the Suction Support touchpad.

3. Set the desired pre-oxygenation value by turning the Main Rotary Dial and press Accept.

Note: The Cancel touchpad will close the Suction Support program.

The Check tubing alarm is turned off: the maximum duration of the pre-oxygenation/preparation phase is 120 seconds. After 120 seconds, the system automatically returns to ventilation using the previous oxygen setting.

DISCONNECT PHASE

The system automatically enters the disconnect phase when the patient is disconnected during the pre-oxygenation/preparation phase.

During the disconnect phase the following alarms are turned off for up to 60 seconds:

Apnea

Minute volume

Respiratory rate

EtCO

PEEP

When the patient is reconnected, the system automatically enters the post-oxygenation phase and restarts ventilation.

It is also possible to restart ventilation manually by pressing the Start ventilation touchpad.

POST-OXYGENATION PHASE

After reconnection, the ventilator will deliver the same oxygen concentration as in the preparation phase for 60 seconds.

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

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4.11.2 CLOSED-SUCTION SYSTEMS

If a closed-suction system is used, the Suction Support, Insp. hold and Exp. hold functions should not be used. Pressure-based modes (such as Pressure Control, Pressure Support, Bi-Vent, SIMV (PC) + PS, or NAVA) should be used. Settings should be adjusted to levels suitable for the patient. Hospital guidelines for suctioning should be followed.

4.12 RE-ADJUST THE OXYGEN CELL

Note: This does not apply if the SERVO-i

Ventilator System has an O2 sensor fitted.

If the ventilator has been in continuous use for an extended period, the measured O concentration may drop due to normal degradation of the oxygen cell. In order to avoid nuisance alarms in this situation, it is possible to temporarily adjust the O2 cell during ventilation.

When the O2 cell adaptation function is activated, the oxygen cell is re-adjusted so that the current measured O2 concentration is equal to the O2 concentration set by the user. This temporary adjustment will be valid until the ventilator is switched off.

Important: Before using the SERVO-i Ventilator System, always perform a Pre-use check to make sure the O2 cell is properly calibrated.

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4.13 DISCONNECT THE PATIENT

To disconnect and stop ventilation:

1. Physically disconnect the patient from the ventilator.

2. Press the Start/Standby key.

3. Press Yes to stop ventilation.

4. Turn the ventilator off using the On/Off switch behind the User Interface.

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SVX-6089a_XX

To re-adjust the O2 cell:

1. Press the Menu fixed key.

2. Press the Biomed touchpad.

3. Press the O2 cell adaptation touchpad.

4. Press the Yes touchpad to perform the O cell adaptation.

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SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

5 MONITOR AND RECORD

TABLE OF CONTENTS

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5.1 MEASURED VALUES DISPLAY

During ventilation, measured or calculated values of breathing parameters are displayed. This section describes the display, gives the procedure for displaying additional pages of measured and calculated values, and lists all viewable values.

5.1.1 DESCRIPTION

8.5

6.5

6.2

8.5

6.5

5.1.2 DISPLAY ADDITIONAL PAGES

SVX.5092_EN

To view more values:

1. Press the Additional values touchpad in the lower right corner of the screen.

2. View desired values.

3. Press the Additional values touchpad again to view the next page of values.

Breathing parameter values are displayed on the right side of the screen.

1. Alarm limits are displayed in small digits.

2. An up or down arrow indicates whether the upper or lower alarm limit has been exceeded.

If a high priority alarm limit is exceeded, the box turns red.

If a medium priority alarm limit is exceeded, the box turns yellow.

3. Off-scale values are indicated by ***.

4. It is possible to change which values are displayed in the measured value boxes. (See Configuration chapter)

Notes:

In NIV mode there is only one page of additional values.

In Nasal CPAP mode no additional values are available.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

5.1.3 VALUES LIST

Values in boldface are shown on the first page by default.

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Ppeak

Pmean

PEEP

tot

I:E

Ti/Ttot

MVe

MVe sp / MVe

VTi

VTe

etCO

VTCO

Maximum inspiratory pressure

Pressure during end-inspiratory pausePplat

Mean airway pressure

Positive end expiratory pressure

Set PEEP + Intrinsic PEEPPEEP

Continuous Positive Airway Pressure (Nasal CPAP only)CPAP

Respiratory Rate

Measured oxygen concentration in vol.%

Inspiration timeTi

Time constantTc

Inspiration to expiration ratio (during controlled ventilation)

Duty cycle or ratio of inspiration time to total breathing cycle time (during spontaneous breathing and Bi-Vent).

Expiratory Minute Volume

Inspiratory Minute VolumeMVi

Spontaneous expiratory minute volume (Bi-Vent)MVe sp

The relation between spontaneous expired minute volume and total expired minute volume (Bi-Vent).

Leakage % (NIV)Leakage

Inspiratory Tidal Volume

Expiratory Tidal Volume

End expiratory flow

End tidal carbon dioxide concentration (CO

Analyzer - option)

Volume of expired CO2 per minute (CO2 Analyzer - option)

CO2 tidal elimination (CO2 Analyzer - option)

Dynamic characteristicsCdyn

Stress IndexSI

Static compliance, respiratory systemCstatic

ElastanceE

Inspiratory resistanceRi

Expiratory resistanceRe

Work of breathing, ventilatorWOB v

Work of breathing, patientWOB p

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Indicator for respiratory driveP0.1

Shallow Breathing IndexSBI

5.2 WAVEFORM DISPLAY

The following color-coded waveforms are shown on the user interface screen by default:

pressure time

flow time

volume time

If the optional Edi module and CO2 Analyzer are connected, the following color-coded waveforms are shown:

pressure time

flow time

Edi time

CO2 concentration time

5.2.1 DESCRIPTION

The default waveform display has the following characteristics:

The value of a measured parameter vs. time is displayed.

The displayed parameter and the scale are indicated on the y-axis.

The pressure vs. time display is dark yellow.

The flow vs. time display is green.

The volume vs. time display is light blue.

The Edi signal vs. time display is light green.

The CO2 concentration vs. time display is light yellow.

This section describes the waveform display, and the procedures for hiding/displaying the volume, Edi and CO2 waveforms and for adjusting the sweep speed and scale of the waveforms.

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5.2.2 SHOW AND HIDE

Notes:

The pressure waveform and the flow waveform are always displayed. The volume, Edi and CO2 waveforms may be hidden. Thus, 2, 3, or 4 waveforms may be displayed.

When you hide a waveform, the remaining waveforms are expanded to use all available screen space.

SVX-6029a_XX

To show or hide the volume, Edi or the CO

waveform display:

1. Press the Quick access fixed key.

2. Press the Waveform configuration touchpad.

3. Press the touchpad corresponding to the waveform you wish to show or hide.

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5.2.3 ADJUST SCALE/SWEEP SPEED

To set the sweep speed and amplitude for displayed waveforms:

1. Press the Quick access fixed key.

2. Press the Waveform Scales touchpad.

3. Press the touchpad corresponding to the waveform whose scale you wish to change or select a sweep speed (5, 10 or 20 mm/s).

4. To adjust the scale of a waveform, turn the Main Rotary Dial to the desired value or use auto scale (press Auto).

Important: MAQUET does not recommend using auto scale in Bi-Vent mode, when patient breathing is spontaneous on both levels.

SVX-6008a_XX

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5.3 SHOW LOOPS

The Loops function provides a graphical representation of the relationship between flow-volume and pressure-volume.

To activate the Loops function:

1. Press the Quick access fixed key.

2. Press the Loops touchpad

3. Press

[reference loop] to store a

reference loop.

4. Press [overlay loops] to see the two previous loops simultaneously.

5. To close the window, press Close.

SVX-6004a_XX

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5.4 SHOW TRENDS

Trend values are stored every 60 seconds and retained as far back as 24 hours. Stored events and system changes are shown as event stamps.

8. If a recording is saved at a time corresponding to the cursor position, a recording button is shown. To view the recording, press the button.

5.5 SHOW EVENT LOG

To show trends:

1. Press the Trends fixed key.

2. Use the up and down arrows to scroll between the different trend channels.

3. To quit the Trends Window press Close.

4. To adjust the time resolution press the Hours touchpad and turn the Main Rotary Dial.

5. Activate the Cursor. Move it back and forth on the time axis using the Main Rotary Dial or touch screen.

6. Time valid for the cursor position. For event stamps, an explanation appears.

7. Logged event stamps.

To view the Event Log:

1. Press the Menu fixed key.

2. Press the Review touchpad.

3. Press the Event log touchpad to view all logged events.

4. Use the arrows to scroll.

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5.6 SAVE DATA

Waveforms and settings may be saved in the following ways:

A 20-second recording may be taken for immediate on-screen analysis.

Screen data or patient data may be written to an Ventilation Record Card (option) for later analysis (patient data file is readable by Microsoft Excel).

5.6.1 RECORD WAVEFORMS

1. Press the Save fixed key.

To save one recording of the current waveform along with breathing parameter values:

A total of 20 seconds of data will be recorded: 10 seconds before the Save key was pressed and 10 seconds after the Save key was pressed.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

Note: If Save is pressed again, the previous recording will be erased. Using Admit patient also erases the previous recording.

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5.6.2 VIEW RECORDED WAVEFORMS.

SVX-5093a_XX

To view the data in a recorded waveform:

1. Press the Menu fixed key.

2. Press the Review touchpad.

3. Press the Recorded waveform touchpad.

4. Vertical gray lines indicate the time when the Save key was pressed.

5. Press the Settings touchpad to open the list of parameter settings in use at the time the Save key was activated.

6. Press the Cursor touchpad to activate the cursor. Move the cursor using the Main Rotary Dial.

7. View measured/calculated values next to the vertical gray lines.

8. Press Close to quit the Recorded Waveform Window.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

5.6.3 VENTILATION RECORD CARD (OPTION)

The Ventilation Record Card (VRC) can be used in Standby or during ventilation. The following data can be saved for analysis:

screen data

patient data

Important: Always handle the VRC and its contents in accordance with regulations and hospital routines.

Please refer to the Ventilation Record Card User's Manual.

Copy Screen Data to a Ventilation Record Card

To make a copy of the screen, the Save key must be configured. It is possible to copy multiple data sets to the same Ventilation Record Card.

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SVX-9007_XX

1. Press the Menu fixed key.

2. Press the Copy touchpad.

3. Press the Copy screen touchpad.

4. Insert the VCR and press OK to continue.

5. Press the Save fixed key.

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SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

A copy of the screen is stored on the VRC.

Notes:

To make another screen copy, press the Save key again.

When the VRC is removed or the ventilator is restarted, the Save key is automatically reconfigured to save a recording.

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Copy Patient Data to a Ventilation Record Card

The following patient data may be copied to a VRC:

Event log

Trends

Recordings

Open Lung Tool® data

Neuro Ventilatory Tool data

Included in all data files are:

Patient name and ID

Ventilator serial number

Pre-use check status.

To copy patient data to a VRC:

1. Press the Menu fixed key.

2. Press the Copy touchpad.

3. Press the Copy data touchpad.

4. Insert the VRC.

5. Press the Copy data touchpad.

Remove the VRC when copying is complete.

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6 VENTILATION, MODES AND FUNCTIONS

TABLE OF CONTENTS

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6.1 INTRODUCTION

The SERVO-i Ventilator System can operate in several different modes. This chapter describes the modes, their settings, and associated safety information.

It also summarizes special ventilatory functions, backup ventilation, and breathing parameters.

See the Technical data chapter for default values and allowed ranges for the breathing parameters.

Note:

The SERVO-i Ventilator System is delivered preset with the following configuration options:

Breathing parameters are based on either Minute Volume or Tidal Volume.

Breathing parameters are based on either I:E Ratio or Inspiration Time.

6.1.1 WARNINGS

The following warnings apply to Non Invasive Ventilation (NIV) only:

- Avoid high inspiratory pressure as it may lead to gastric overdistention and risk of aspiration. It may also cause excessive leakage.

- Use of the Nebulizer is not recommended.

- We recommend ventilator-independent monitoring for Nasal CPAP.

Ensure that PRVC, SIMV (PRVC) and VS function properly (especially for small patients):

- Avoid leakage (e.g. due to an uncuffed endotracheal tube).

- If compliance compensation is used, 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 after the test has been made).

Note: Not all warnings apply to all modes.

WARNINGS!

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

- Minute Volume Alarm

- Apnea time

Self-triggering should be avoided. Do not set the trigger sensitivity too high.

To protect the patient’s lungs from excessive pressure it is important to set the upper pressure limit to a suitable value.

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6.1.2 APPLICATION

The SERVO-i Ventilator System also contains tools to assist the user in application of lung protective methodologies.

6.1.3 SCOPE - VENTILATORY NEEDS

When required, all ventilation is provided for mandatorily. When the patient is able to initiate a breath, the ventilator supports and monitors the patient´s breathing capability and controls ventilation only if required.

The ventilator can be used for:

1. controlled ventilation

2. supported ventilation, or

3. spontaneous breathing/CPAP

It also allows for combined ventilatory control or support. Spontaneous breathing efforts are sensed during controlled ventilation, e.g. Volume Control. Mandatory ventilation can be used during supported/spontaneous breathing, e.g. the enhanced SIMV functionality.

The Automode functionality continuously adapts to the patient´s breathing capability.

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6.2 IMPORTANT DEFINITIONS

The graphic display of pressure, flow and volume is visualized in waveforms. Modes of ventilation directly affect flow, pressure and volume patterns.

6.2.1 VOLUME CONTROL

xy z

FLOW-TIME WAVEFORM

7. Peak inspiratory flow

8. Zero flow phase

9. Peak expiratory flow

10. Slope decelerating expiratory limb

11. End expiratory flow

VOLUME-TIME WAVEFORM

12. Start of inspiration

13. The slope represents current delivery of inspiratory tidal volume

14. End inspiration

15. The slope represents current patient delivery of expiratory tidal volume

16. End expiration

I:E

X. Inspiration time

Y. Pause time

Z. Expiration time

PRESSURE-TIME WAVEFORM

1. Start of Inspiration

2. Peak inspiratory pressure

3. Early inspiratory pause pressure

4. End inspiratory pause pressure

5. Early expiratory pressure

6. End expiratory pressure

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6.2.2 PRESSURE CONTROL

I:E

X. Inspiration time

Z. Expiration time

PRESSURE-TIME WAVEFORM

VOLUME-TIME WAVEFORM

8. Start of inspiration

9. End inspiration

10. End expiration

1. Start of Inspiration

2. Peak inspiratory pressure

3. End expiratory pressure

FLOW-TIME WAVEFORM

4. Peak inspiratory flow

5. End inspiratory flow

6. Peak expiratory flow

7. End expiratory flow

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6.3 SETTINGS

6.3.1 TRIGGER FUNCTIONALITY

Trigger sensitivity determines the level of patient effort needed to trigger the ventilator to inspiration.

Trigger sensitivity can be set as flow triggering (settings above zero) or pressure triggering (settings below zero). Normally flow triggering is preferable as this enables the patient to breathe with less effort.

The sensitivity is set as high as possible without self-triggering. This ensures that triggering is patient initiated and avoids auto-cycling by the ventilator.

Important: In NIV it is not possible to set trigger sensitivity.

Trigg. Pressure Trigg. Flow

-20 10

WHITE GREEN RED

WARNINGS!

WARNING! The trigger sensitivity bar

has different colors based on the setting. A green bar indicates a normal setting for flow triggering. The risk of self-triggering increases when the bar is red. A white bar indicates pressure triggering.

WARNING! If the trigger sensitivity is set too high, a self triggering (auto-triggering) condition may be reached. This condition can also be reached if there is leakage in the breathing system, e.g. if an uncuffed endotracheal tube is used. Triggering will then be initiated by the system and not by the patient. This should always be avoided by decreasing the trigger sensitivity.

During expiration, the ventilator continuously delivers a gas flow (bias flow), which is measured in the expiratory channel. For details of the bias flow, see Technical data on page 226.

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At a trigger sensitivity level above zero (0), The ventilator senses deviations in the bias flow delivered during expiration. These deviations are caused by the inspiratory efforts of the patient. The further to the right on the scale, the more sensitive is the trigger function.

At a trigger sensitivity level below zero (0), the ventilator senses deviations in the pressure below PEEP created by the patient. The pressure below PEEP required to initiate a breath is shown when the setting is made. The further to the left on the scale, the more effort is required to trigger.

6.3.2 INSPIRATORY RISE TIME

100 %

Time to peak inspiratory flow or pressure at the start of each breath as a percentage of the respiratory cycle time or in seconds. Increased rise time will affect the rate of flow/pressure increase and can be evaluated by the shape of the flow and pressure waveforms.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

Inspiratory rise time (%) is applicable in Pressure Control, Volume Control, PRVC, SIMV-Volume Control, SIMV-Pressure Control, SIMV-PRVC. Setting can be in the range 0-20% of the respiratory cycle time.

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Inspiratory rise time set in seconds is applicable in Pressure Support, Volume Support and Bi-Vent. For adults the range is 0-0.4 seconds and for infants the range is 0-0.2 seconds.

Note: When the ventilator is configured for setting of Inspiration time, the unit for Inspiratory rise time then automatically switches to seconds for all ventilation modes.

Normally in supported modes the Inspiratory rise time should be increased from the default setting and to give more comfort to the patient.

6.3.3 TRIGGER TIMEOUT

Trigger Timeout is the maximum allowed apnea time in Automode before controlled ventilation is activated.

Initially the ventilator adapts with a dynamic Trigger Timeout limit. This means that for the spontaneously triggering patient the timeout increases successively during the first ten breaths.

For Automode trigger timeout setting ranges, see section 230 on page 230.

6.3.4 PEEP

PEEP

SVX-646_EN

A Positive End Expiratory Pressure is maintained in the alveoli and may prevent the collapse of the airways.

For Positive End Expiratory Pressure setting ranges, see section 230 on page 231

6.3.5 I:E RATIO / INSPIRATION TIME

The setting of breathing parameters in SERVO-i Ventilator System can be configured in two different ways, based on:

I:E ratio (independent of changes of e.g. the breathing frequency) or,

Inspiration time in seconds (independent of changes of e.g. the breathing frequency), to better meet the requirements for infant care.

When the ventilator is configured for setting of Inspiration time, the unit for Pause time and Insp. rise time then automatically switches to seconds. The resulting I:E ratio for each setting is shown in the upper right information area of the ventilation mode window.

As the inspiration time is explicitly set, a change of for example the Respiratory Rate will affect the I:E ratio. As a safety precaution, it will therefore be indicated when the resulting I:E ratio passes 1:1 in either direction.

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Note: The touchpad Breath cycle time is

not shown when an SIMV mode is selected, since there is no need to set Breath cycle time when Inspiration time is directly set.

6.3.6 INSPIRATORY CYCLE-OFF

SVX-205_XX

Inspiratory Cycle-off is the point at which inspiration changes to expiration in spontaneous and supported modes of ventilation. A decrease of the inspiratory flow to a preset level causes the ventilator to switch to expiration. This preset level is measured as a percentage of the maximum flow during inspiration.

For inspiratory cycle off setting ranges, see section 230 on page 230.

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6.3.7 BREATH CYCLE TIME

This is the length of the breath i.e. the total cycle time of the mandatory breath in SIMV (inspiration, pause plus expiration).

Note: The touchpad Breath cycle time is not shown when an SIMV mode is selected and inspiration time is configured. Refer to heading I:E ratio / Inspiration times.

6.3.9 CONTROLLED / SUPPORTED

PRESSURE LEVEL

PC (Pressure Control level) above PEEP is the set inspiratory pressure level for each mandatory breath in Pressure Control and SIMV (PC) + PS, and also for backup ventilation in Pressure Support and NAVA.

PS (Pressure Support level) above PEEP is the set inspiratory pressure support level for triggered breaths in Pressure Support, SIMV modes and Bi-Vent.

6.3.10 O2 CONCENTRATION

The setting range for the gas mixer is 21% O to 100% O2. The alarm limits are automatically set at approximately 5% O2 above or below the set concentration value. The alarm is delayed 40 seconds after changing the O

concentration setting. There is also an absolute minimum alarm limit of 18% O2 which is independent of operating settings.

6.3.8 VOLUME SETTING

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

Minute Volume or,

Tidal Volume

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

6.3.11 RESPIRATORY RATE / SIMV RATE

Respiratory rate is the number of controlled mandatory breaths per minute in controlled modes excluding SIMV. The respiratory rate is also used for calculation of tidal volume if the ventilator is configured for Minute volume setting. SIMV rate is the number of controlled mandatory breaths in SIMV modes.

6.3.12 PREVIOUS MODE

1. Time when previous mode was inactivated.

2. Name of the previous mode.

3. Press the touchpad Show previous mode to recall the previous accepted ventilation mode.

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4. Activate the previous used ventilation mode settings by pressing the Accept touchpad.

Notes:

The previous mode function is not available after a Pre-use check, changing of patient category, admitting a new patient, use of the same ventilation mode for more than 24 hours or after restarting the system.

When Previous Mode is activated during Backup ventilation, the ventilator returns to the mode that was active before Support mode was initiated.

A recall of previous settings is only possible after a change of ventilation mode.

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6.4 VOLUME CONTROL

6.4.1 FUNCTIONAL DESCRIPTION VOLUME CONTROL

In the flow/volume oriented modes a controlled flow is used to maintain the set inspiratory Tidal Volume.

Volume Controlled ventilation ensures that the patient receives a certain pre-set Minute/Tidal Volume.

The SERVO-i Ventilator System can be configured to set Tidal Volume or Minute Volume. The following parameters are set:

1. Tidal Volume (ml) or the Minute Volume (l/min)

2. Respiratory Rate (b/min)

3. PEEP (cmH2O)

4. Oxygen concentration (%)

5. I:E ratio / Insp. time

6. Pause time (%/s)

7. Inspiratory rise time (%/s)

8. Trigg. Flow / Trigg. Pressure

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

6.4.2 FLOW ADAPTATION

It is possible for the patient to trigger extra breaths if they can overcome the pre-set trigger sensitivity. It is also possible for the patient, by their own inspiratory efforts, to receive a higher inspiratory flow and Tidal Volume during an inspiration than pre-set. The flow during inspiration is constant. The patient can trigger extra breaths.

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Volume Controlled ventilation has, by tradition, delivered each breath with a constant flow and constant inspiratory and expiratory times, according to the settings. The SERVO-i Ventilator System gives the possibility to the patient to modify both flow rate and timing. So, if a pressure drop of 3 cmH

O is detected

during inspiration, the ventilator cycles to Pressure Support with a resulting increase in inspiratory flow. When the flow decreases to the calculated target level this flow will be maintained until the set Tidal Volume is delivered.

The illustrated waveform show some practical consequences of this enhanced functionality.

the top waveform shows the trace for a normal Volume Controlled breath

the second waveform shows a situation when inspiration is prematurely interrupted as the set tidal volume has been delivered

the third waveform shows a situation where the patient maintains a flow rate higher than the calculated target value. The set Tidal Volume has been delivered when calculated target flow is reached and the inspiration is prematurely interrupted

the bottom waveform, shows a situation where the increased flow rate is maintained into the expiratory period. The patient will receive a higher tidal volume than set due to a higher flow/volume demand than calculated.

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6.4.3 VOLUME CONTROL IN DETAIL

SVX-9002_XX

1. Volume Control assures a preset tidal volume with constant flow during a preset inspiratory time at a preset frequency.

2. The inspiratory flow is constant and depends on User Interface setting.

3. Inspiration starts according to the preset frequency or when the patient triggers.

4. If the patient makes an inspiratory effort during the inspiratory period, the ventilator will switch to Pressure Support to satisfy the patient´s flow demand.

1 2

Expiration starts:

a. When the preset tidal volume is delivered

and after the preset pause time.

b. When the flow returns to the set value after

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

c. If the upper pressure limit is exceeded.

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6.4.4 VOLUME CONTROL WITH

ALTERNATIVE FLOW PATTERNS

When the Volume Control with alternative flow patterns is enabled in the start-up

configuration, new touchpads for setting of alternative flow patterns are available in Volume Control, Automode VC <--> VS and SIMV (VC)+PS.

1 3

To ventilate with Volume Control with flow adaptation:

Press the Volume Control with flow adaptation touchpad.

Press Accept.

Volume Control without flow adaptation

The ventilator delivers volume strictly according to the settings.

To ventilate with Volume Control without flow adaptation:

Press the Volume control without flow adaptation touchpad.

Press Accept.

Note: Set trigger sensitivity at an adequate level. A patient who needs more ventilation may increase the breathing frequency instead of increasing the flow during inspiration.

1. Volume control with flow adaptation

2. Volume control without flow adaptation

3. Volume control with decelerating flow

4. Flow pattern

See section User Interface Symbols on page 21.

Volume Control with flow adaptation

The ventilator interacts with the patient and delivers the extra volume requested regardless of the settings. See section Flow adaptation on page 88.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

Volume Control with decelerating flow

The ventilator delivers a decelerating flow according to Flow pattern settings.

To ventilate with decelerating flow:

Press the Volume control with decelerating flow touchpad.

Press the Flow pattern touchpad and set the flow pattern with the Main Rotary Dial. The flow pattern can be set so that the end inspiratory flow is 75 %, 50 % (default), 25 % or 0 % of the peak flow.

Press Accept.

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FLOW-TIME WAVEFORM

xy z

X. Inspiration time

Y. Pause time

Z. Expiration time

1. Peak inspiratory flow

2. End inspiratory flow

3. Zero flow phase

4. Peak expiratory flow

5. Slope decelerating expiratory limb

6. End expiratory flow

STRESS INDEX

Stress index can not be calculated during Volume control with decelerating flow. It can only be calculated at a constant flow.

Notes:

Flow adaptation is not enabled in Volume Control with decelerating flow. Set trigger

sensitivity at an adequate level. A patient who needs more ventilation may increase the breathing frequency instead of increasing the flow during inspiration.

The default setting of Pause time is 0 s.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

6.5 PRESSURE CONTROL

6.5.1 FUNCTIONAL DESCRIPTION

PRESSURE CONTROL

The Pressure Controlled mode is a controlled breathing mode.

Breaths are delivered mandatorily at a preset pressure level, causing a decelerating flow pattern.

The following parameters are set:

1. PC (Pressure Control level) above PEEP (cmH2O)

2. Respiratory Rate (b/min)

3. PEEP (cmH2O)

4. Oxygen concentration (%)

5. I:E ratio / Insp. time

6. Inspiratory rise time (%/s)

7. Trigg. Flow / Trigg. Pressure

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The delivered volume is dependent upon the pressure above PEEP, lung compliance and resistance in the patient tube system and airways. This means that the Tidal Volume can vary. Pressure Controlled mode is preferred when there is leakage in the breathing system e.g. due to uncuffed endotracheal tube or in situations when the maximum airway pressure must be controlled. The flow during inspiration is decelerating. The patient can trigger extra breaths. If the patient tries to exhale during the inspiration, the expiratory valve will allow exhalation as long as the pressure is more than 3 cmH2O above the set pressure level. As the delivered tidal volume can vary it is very important to set alarm limits for Minute Volume to adequate levels.

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6.5.2 PRESSURE CONTROL IN DETAIL

SVX-9003_XX

1. Pressure Control assures that the preset inspiratory pressure level is kept constant during the entire inspiration. Breaths are delivered according to the preset frequency, inspiration time and inspiratory pressure level resulting in a decelerating flow.

2. The preset pressure level is controlled by the ventilator. The resulting volume depends on the set pressure level, inspiration time and the patient´s lung mechanical properties during each breath with a decelerating flow.

3. Inspiration starts according to the preset frequency or when the patient triggers.

2 3

Expiration starts:

a. After the termination of preset inspiration

time.

b. If the upper pressure limit is exceeded.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

ACTIVE EXPIRATORY VALVE

SVX-9008_XX

If a patient tries to exhale during the inspiration, pressure increases. When it increases 3 cmH2O above the set inspiratory pressure level, the expiratory valve opens and regulates the pressure down to the set inspiratory pressure level.

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Upper pressure Limit

SVX-9009_EN

If the pressure increases to the set upper pressure limit e.g. the patient is coughing, the expiratory valve opens and the ventilator switches to expiration.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

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6.6 PRESSURE REGULATED VOLUME CONTROL

6.6.1 FUNCTIONAL DESCRIPTION PRVC

The Pressure Regulated Volume Control (PRVC) mode is a controlled breathing mode.

Breaths are delivered mandatorily to assure preset volumes, with a constant inspiratory pressure continuously adapting to the patient´s condition. The flow pattern is decelerating.

The ventilator delivers a pre-set Tidal Volume. The pressure is automatically regulated to deliver the pre-set volume but limited to 5 cmH2O below the set upper pressure limit.

The SERVO-i Ventilator System can be configured to set Tidal Volume or Minute Volume. The following parameters are set:

1. Tidal Volume (ml) or Minute Volume (l/min)

2. Respiratory Rate (b/min)

3. PEEP (cmH2O)

4. Oxygen concentration (%)

5. I:E ratio / Insp. time

6. Inspiratory rise time (%/s)

7. Trigg. Flow / Trigg. Pressure

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

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

6.6.2 PRVC IN DETAIL

| Ventilation, modes and functions |

6 |

SVX-9006_XX

1. PRVC assures a set target minute ventilation to the patient. The target volume is based upon settings for Tidal Volume, frequency and inspiration time.

2. The inspiratory pressure level is constant during each breath, but automatically adapts in small increments breath-by-breath to match the patient´s lung mechanical properties for target volume delivery.

3. Inspiration starts according to a preset frequency or when the patient triggers.

Expiration starts:

a. After the termination of preset inspiration

time

b. If the upper pressure limit is exceeded.

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

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The first breath of a start sequence is a volume-controlled test breath with Pause time set to 10%. The measured pause pressure of this breath is then used as the pressure level for the following breath. An alarm is activated if the pressure level required to achieve the set target volume cannot be delivered due to a lower setting of the Upper pressure limit (- 5 cmH2O).

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

6.7 VOLUME SUPPORT

6.7.1 FUNCTIONAL DESCRIPTION VOLUME

SUPPORT

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 frequency and duration of the breaths which show a decelerating flow pattern.

The Volume Support mode is a patient initiated breathing mode, where the patient will be given support in proportion to their inspiratory effort and the target Tidal Volume.

| Ventilation, modes and functions |

8. Resp.Rate (b/min) in backup ventilation.

9. I:E / Ti (s) in backup ventilation (depending on configuration).

If the patient’s activity increases the inspiratory pressure support will decrease provided the set Tidal Volume is maintained. If the patient breathes below the set Tidal Volume the inspiratory pressure support will increase.

6 |

The following parameters are set:

1. Tidal Volume (ml)

2. PEEP (cmH2O)

3. Oxygen concentration (%)

4. Inspiratory rise time (s)

5. Trigg. Flow / Trigg. Pressure

6. Inspiratory Cycle off (%)

7. Tidal Volume (ml)

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SVX-657_EN

The start breath is given with 10 cmH2O support. From that breath the ventilator calculates and continuously regulates the pressure needed to deliver the pre-set Tidal Volume.

During the next 3 breaths of the start up sequence the maximum pressure increase is 20 cmH2O for each breath. After the start up sequence the pressure increases or decreases in steps of maximum 3 cmH2O.

If the delivered Tidal Volume decreases below the set Tidal Volume the pressure support level is increased in steps of maximum 3 cmH2O until preset Tidal Volume is delivered. If the pressure support level causes a larger Tidal Volume than preset, the support pressure is lowered in steps of maximum 3 cmH2O until the preset Tidal Volume is delivered.

For maximum inspiration time, see section Functions in ventilation modes on page 235.

An alarm is activated if the pressure level required to achieve the set target volume cannot be delivered due to a lower setting of the upper pressure limit - 5 cmH2O.

In this mode it is also important to set the apnea time appropriate to the individual patient situation. If this time is reached then the ventilator will automatically switch to backup ventilation. In all spontaneous modes it is important to set the Minute Volume alarm.

100

SERVO-i VENTILATOR SYSTEM V7.0, User´s Manual

Maquet Servo-i User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

TABLE OF CONTENTS

1 INTRODUCTION

1.1 DEVICE DESCRIPTION

1.1.1 DEVICE DIAGRAM

1.1.2 DEVICE COMPONENTS

1.1.3 INTENDED USE

1.1.4 INTENDED USER

1.1.5 INTENDED USE ENVIRONMENT

1.1.6 CLEANING AND MAINTENANCE

1.1.7 SERVICING GUIDELINES

1.1.8 DISCLAIMERS

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 CONFIGURATION LABELS

1.3.3 AVAILABLE OPTIONS

2 SYSTEM OVERVIEW

2.1 VENTILATOR

2.2 USER INTERFACE - CONNECTIONS, LABELS AND SYMBOLS

2.2.1 USER INTERFACE DIAGRAM

2.2.2 USER INTERFACE COMPONENTS

2.2.3 USER INTERFACE SYMBOLS

2.3 NAVIGATING THE USER INTERFACE

2.3.1 TOUCH SCREEN

2.3.2 MAIN ROTARY DIAL

2.3.3 FIXED KEYS

2.3.4 DIRECT ACCESS KNOBS

2.3.5 MENU KEY

2.3.6 STATUS TOUCHPAD

2.4 PATIENT UNIT - CONNECTIONS, LABELS AND SYMBOLS

2.4.1 PATIENT UNIT DIAGRAM

2.4.2 PATIENT UNIT COMPONENTS

2.4.3 PATIENT UNIT SYMBOLS

2.4.4 PATIENT UNIT GAS FLOW DIAGRAM

2.4.5 GAS FLOW THROUGH THE PATIENT UNIT

2.4.6 SYMBOLS ON ACCESSORIES AND PACKAGING

2.5 TRANSPORT AND STORAGE

2.5.1 BEFORE INTRAHOSPITAL TRANSPORT

2.5.3 STORAGE

3 POWER SUPPLY

3.1 INTRODUCTION

3.2 VIEWING BATTERY STATUS

3.3 ALARMS AND SAFETY

3.3.1 WARNINGS

3.3.2 STATUS MESSAGES

3.3.3 AC POWER FAILURE

4 OPERATION OVERVIEW

4.1 WORKFLOW SUMMARY

4.2 PRE-USE CHECK

4.2.2 START-UP

4.2.3 INTERNAL LEAKAGE TEST

4.2.4 BATTERY SWITCH TEST

4.2.6 COMPENSATE FOR CIRCUIT COMPLIANCE

4.2.7 TEST ALARM OUTPUT CONNECTION (OPTION)

4.2.8 COMPLETE THE PRE-USE CHECK

4.2.9 PRE-USE CHECK TESTS

4.3 PATIENT CIRCUIT TEST

4.4 SELECT PATIENT CATEGORY (OPTION).

4.4.1 CHANGE THE PATIENT CATEGORY (OPTION)

4.5 ENTER THE PATIENT DATA

4.6 SELECT THE TYPE OF VENTILATION (OPTIONS)

4.7 SET VENTILATION MODE

4.8 SET ALARM LIMITS

4.9 START VENTILATION

4.9.1 START INVASIVE VENTILATION

4.11 SUCTIONING

4.11.1 SUCTION SUPPORT

4.11.2 CLOSED-SUCTION SYSTEMS

4.12 RE-ADJUST THE OXYGEN CELL

4.13 DISCONNECT THE PATIENT

5 MONITOR AND RECORD

5.1 MEASURED VALUES DISPLAY