Maquet SERVO-i User manual V3.1

User’s manual (US Version)

VENTILATOR SYSTEM SERVO-i V3.1

Contents

1 Before use ...............................................................3

2 Ventilation..............................................................15

3 Patient safety.........................................................71

4 Device description.................................................81

5 Set-ups and preparations....................................119

6 Pre-use check .....................................................145

7 Operating your Servo-i ........................................157

8 Routine cleaning..................................................191

9 Maintenance........................................................211

10 Troubleshooting.................................................225

11 Technical data ...................................................241

12 Abbreviations and definitions ............................255

13 Appendix: User Interface...................................259

14 Index..................................................................273

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1. Before use

Contents

Brief device description . . . . . . . . . . . . . . . . . . . . . 4

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Intended user . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Warnings, Cautions and Important in this manual. 4

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Support material related to the Servo-i system . . . 7

General warnings . . . . . . . . . . . . . . . . . . . . . . . . . . 9

General cautions . . . . . . . . . . . . . . . . . . . . . . . . . 10

Context-related warnings. . . . . . . . . . . . . . . . . . . 12

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Before use

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Welcome as a user of the Servo-i Ventilator system! We hope that you will be very satisfied with your new system. For the latest information about it, call your local MAQUET representative. Before use, please read the general information below.

Brief device description

User Interface

Patient Patient breathing system

SVX-128_EN

The Servo-i Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.

The ventilator delivers controlled or supported breaths to the patient, with either constant flow or constant pressure, using a set oxygen concentration. The entire Servo-i system includes a wide range of optional accessories, e.g. Mobile Cart, breathing systems, compressors, Battery modules, humidifiers and equipment for nebulization, CO

measurement and Y-piece

2

measurement.

Unit

Intended use

The Servo-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.

Note: The Servo-i Ventilator System is not intended to be used with any anesthetic agents.

professional health care providers who have sufficient experience in ventilator treatment.

Intended population

The Servo-i Ventilator System can be delivered in three configurations:

• Servo-i Infant range 0,5 - 30kg

NIV (PC+PS) Infant range 3 - 30kg NIV Nasal CPAP range 0.5 - 10kg

• Servo-i Adult range 10 - 250kg

• Servo-i Universal range 0.5 - 250kg

NIV (PC+PS) Infant range 3 - 30kg NIV Nasal CPAP range 0.5 - 10kg

Note: Servo-i Universal covers both Basic and Extended edition.

Intended Use Environment

The SERVO-i ventilator system should be used:

• in hospitals

• in facilities whose primary purpose is to provide health care

• for in-hospital transport

• for interhospital transport if the conditions stated in the Servo-i Interhospital Transport declaration are fulfilled and an agreement with MAQUET is signed.

• during MR examinations of patients if the conditions in the Servo-i MR Environment declaration are met and an agreement with Maquet signed.

Warnings, Cautions and Important in this manual

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.

Intended user

Servo-i is a ventilator system with advanced functionality. It may be used only by

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

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Before use

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Symbols

User Interface

Audio off Silence alarm or confirm

alarm.

Alarm off .

Audio pause Silence alarm or

confirm alarm.

Reserved for future use.

Save To save a recording or to copy screen.

Attention Consult accompanying documents.

Standby/Start ventilation Set standby mode or start ventilation.

Yellow lamp indicating Standby mode.

Patient Unit

CE label The device complies with

the requirements of the Medical Device Directive 93/42/EEC.

CSA label The device complies with the Canadian standards.

C US

Class I equipment, Type B The device classification according to according to IEC 60601-1/EN 6060-1.

Equipotentiality terminal

Nebulizer

connector for nebulizer.

RS 232 / Serial port

connector for data communication Note: The symbol has two different

labels depending on panel version.

Mains indicator Green lamp indicating mains

connected.

Battery Symbol indicating battery power supply.The estimated remaining time with current power consumption is indicated in minutes.

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

The NIV symbol appears in the Mode pad field during Non Invasive Ventilation.

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ON/OFF switch

NIV symbol

User Interface connector / Panel Note: The symbol has two different

labels depending on panel version.

Optional connector / Expansion

connector for optional equipment. Note: The symbol has two different labels depending on panel version.

10A

fuse for external DC power supply.

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12V DC / Ext. bat 12V

external +12V DC inlet. Note: The symbol has two different labels depending on panel version.

Caution: When external +12 V DC is used, at least one installed Battery module is required to ensure proper operation.

Expiratory label

Gas flow from patient.

Inspiratory label

Gas flow to patient.

Gas exhaust port label

Exhaust gas flow from ventilator. Note: Should not be connected to a

spirometer, as the volume through the exhaust port is not equal to the expired volume from the patient.

Single use

Special waste

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

Recycling

Worn-out batteries must be recycled or disposed of properly in accordance with appropriate industrial and environmental standards.

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

Alarm output connection

option

External alarm output communication.

In this manual

Adult Information valid for the Adult

configuration

Infant Information valid for the Infant configuration

Universal (Basic and Extended editions) Information valid for the

Universal configuration.

Options

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Support material related to the Servo-i system

Wall cleaning diagram

Configuration Card

User‘s manual

This concept comprises components intended to cover the needs of a clinical user. It is divided into different components according to use to facilitate accessibility of information. If you have any comments or suggestions regarding this information material, please let us know.

This User´s manual covers functionality and use but should not be regarded as all inclusive within the very complex field of ventilatory treatment. Clinical judgements or settings are therefore not described in this manual. Authorized, medically competent health care providers with good knowledge of Servo-i Ventilator System have the responsibility to determine the clinical judgement and settings based on the needs of the patient.

Read the User´s manual carefully before use and follow the instructions.

SVX-129_EN

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This User´s manual

The information in this User´s manual is valid for Servo-i Ventilator System 3.1 unless stated otherwise.

Here you will find the information needed to use the Servo-i system safely.

It is divided into five main sections:

• Before use (mandatory information)

•Description

• Operation

• Maintenance

• Miscellaneous

Recommended use

The main document, for every-day use.

Text shown on the User Interface is presented in these instructions in a special typeface.

Brief instructions

Overviews and step-by-step instructions for the set-ups. These instructions you will find in the drawer above the ventilator, when positioned on the Mobile Cart.

Recommended use These documents are intended to be used as

a guide for the experienced user.

Wall diagram

Overviews and step-by-step instructions for cleaning, to be posted on a wall.

Recommended use Checklist for the experienced user.

Ventilator - Information material

Caution: The Servo-i Ventilator System may

have different software versions. Before use, make sure the software version shown on the screen under the Status / General menu corresponds to the version number on the User´s manual. Refer to page 259.

Trademark

Trademark ™ is written only when a product/ method name appears for the first time in this manual.

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Warnings, cautions and important

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General warnings

• 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.

• After unpacking, perform a Routine cleaning and a Pre-use check.

• To provide adequate patient safety, set the alarm limits to relevant values.

• To avoid electrical shock hazard, connect the power cord to a mains outlet equipped with a protective ground.

• Should any unfamiliar events occur, such as irrelevant pop-up windows on the screen, unfamiliar sounds, alarms from the Patient Unit or technical high priority alarms, the ventilator should immediately be checked and, if applicable, replaced.

• Only accessories and auxiliary equipment that meet current IEC standards (e.g. IEC 60601-1-1) may be connected to the Servo-i Ventilator System. If external equipment such as computers, monitors, humidifiers or printers are connected, the total system must comply with IEC 606011-1.

• The ventilator must only be used in an upright position.

• When a Servo Ultra Nebulizer is used, always consult the drug manufacturer regarding the appropriateness of ultrasonic nebulization for certain medication.

• All personnel should be aware of the risk of parts being infected when disassembling and cleaning the ventilator.

• Service mode may only be used when no patient is connected to the ventilator.

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

• The Servo-i Ventilator System is verified against and complies with IEC 60601-1-2 regarding electromagnetic compatibility. It is the responsibility of the user to take necessary measures to ensure that the clinical environment is compatible with the limits specified in IEC 60601-1-2. Exceeding of these limits may impair the performance and safety of the system. Such measures should include, but are not limited to:

– Normal precautions with regard to

relative humidity and conductive characteristics of clothing in order to minimize the build-up of electrostatic charges.

– Avoiding the use of radio-emitting

devices, such as cellular phones and high-frequency apparatus in close proximity to the system.

• The SERVO-i Ventilator System may only be used during MR examinations if the conditions in the MR Environment Declaration are met and an agreement with Maquet is signed. Disregard of these conditions may cause deactivation of the system functions and may result in permanent damage to the SERVO-i Ventilator System.

• The Servo-i Ventilator System is not intended to be used with any anesthetic agent. To avoid risk of fire, flammable agents such as ether and cyclopropane must not under any circumstances be used with this device.

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Warnings, cautions and important

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• To avoid fire hazard, keep all sources of ignition away from the Servo-i Ventilator System and oxygen hoses. Do not use oxygen hoses that are worn, frayed, or contaminated by combustible materials such as grease or oils. Textiles, oils, and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen. Immediately disconnect the ventilator from the oxygen supply, facility power, and backup sources if there is a smell of burning.

General cautions

• As a general rule always avoid contact with external electrical connector pins. It is recommended to have the module compartment filled up with empty modules to protect from spillage and dust.

• Federal law in the USA restricts this device to sale by or on the order of a physician (or a properly licensed practitioner).

• The Servo-i Ventilator System must be serviced at regular intervals by specially trained personnel. The intervals are stated in the chapter Regular maintenance. Any maintenance must be noted in a log book for that purpose in accordance with national regulations.

• MAQUET has no responsibility for the safe operation of the equipment if service or repair is done by a non-professional or by persons who are not employed by or authorized by MAQUET. We recommend that service is done as part of a service contract with MAQUET.

• MAQUET has no responsibility for the safe operation of the equipment if the equipment is used for anything other than its intended use, as specified in this User´s manual.

• A resuscitator should always be readily accessible for extra safety.

• When connected to a patient, the system must never be left unattended.

• The nebulizer module is inoperative when the ventilator is running on batteries, to reduce the power consumption.

• The Expiratory cassette must not be lifted up when the ventilator is in operation. This may, however, be done when in Standby mode.

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

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

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

• Antistatic or electrically conductive breathing tubing should not be used with this lung ventilator system.

• Any scavenging system (Gas evac) connected must comply to ISO8835-3 with regard to subatmospheric pressure and induced flow. Otherwise ventilator functions and patient safety may be degraded.

• It is not recommended to use the Servo Evac 180 in the Nasal CPAP mode.

• Values measured at the signal outputs of the Servo-i Ventilator System and which have been processed in auxiliary equipment must not be used as a substitute for therapeutic or diagnostic decisions. Such decisions can be made only by staff with medical expertise, according to established and accepted practice. If auxiliary equipment that has not been delivered by MAQUET with the system is used, MAQUET denies all responsibility for the accuracy of signal processing.

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Warnings, cautions and important

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• If there should be any deviation between information shown on the User Interface of the ventilator and that shown by the auxiliary equipment, the ventilator parameters shown on the User Interface shall be considered the primary source for information. When combining the Servo-i Ventilator System with accessories and auxiliary equipment other than those recommended by MAQUET, it is the responsibility of the user to ensure the integrity of system performance and safety. In order to maintain electrical system safety, i.e. such that compliance with IEC 60601-1-1 is fulfilled, only accessories and auxiliary equipment that meet current IEC standards (e.g. IEC 60601-1, IEC 950) may be connected to signal inputs and outputs of the Servo-i Ventilator System.

• Only original parts from MAQUET must be used in the system.

• Only accessories, supplies or auxiliary equipment recommended by MAQUET should be used with the ventilator system (“Products and accessories” catalog and “Spare parts list”). Use of any other accessories, spare parts or auxiliary equipment may cause degraded system performance and safety.

• The displayed information about set and corresponding measured parameters, shall continously be compared by the operator.

Important:

• This symbol on the unit means Attention, consult accompanying documents.

Note: The are two versions of this symbol depending on System version.

• The gases supplied must be free from water, oil, particles and other contaminants:

Air ........ H

O < 7 g/m

2

............. Oil < 0.5 mg/m

............. Chlorine: Must not be detectable

Oxygen H2O < 20 mg/m

3

• The environmental declaration is part of the service manual.

• The Servo-i Ventilator system does not contain any latex.

• Data on pressures can be given in cmH where: 1 kPa ~ 10 cmH 100 kPa = 1bar ~1atm ~1kgf/cm

O

2

(kp/cm2)

100 kPa ~15 psi.

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

• Do not expose the Expiratory cassette compartment to excessive amounts of fluid, e.g. during cleaning and disinfection, as this may influence ventilator functionality.

• Do not use sharp tools on the screen.

• It is recommended that at least two batteries always is used in the ventilator for backup.

• It is recommended that at least two batteries are used for ventilation during transport.

2

1

O,

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

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Warnings, cautions and important

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• Documentation for Servo-i Ventilator System consists of:

–User´s manual – Brief instructions – Wall diagram – Installation instructions – Service manual – Products and accessories, catalog – Spare parts list

Context-related warnings

Note: General warnings are not listed here

even though they are repeated inside the manual.

Note: Context-related Cautions and "Important" are not listed here, but are written in the relevant context inside the manual.

Operation

• Always disconnect the ventilator if any operation which may involve risk for the patient will be done, e.g. replacement of O

cell, dismantling etc. (page 211,

2

page 225).

• 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 (page 23). This is also important during transport as the movement of the body and the breathing system may lead to false triggering.

• When you turn a Direct Access Knob, ventilation will change accordingly from the next breath without additional confirmation (For further information see page 166).

• If any malfunctions are detected during the start-up procedure, please refer to Chapter, Troubleshooting (page 225).

• If a malfunction persists, the ventilator may not be connected to the patient.

• A Pre-use check must always be done before connecting the ventilator to a patient (page 145).

• To protect the patient against high airway pressures, the upper pressure limit must always be set to the relevant value so as to provide adequate patient safety (page

165). Caution: If airway pressure rises 6 cmH

above the set upper pressure limit the safety valve opens. The safety valve also opens if system pressure exceeds 117 cmH

O.

2

• To provide adequate patient safety, always set the alarm limits at relevant values (page 165).

O

2

± 7

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Warnings, cautions and important

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Nebulization

• Servo Humidifier/HME must be disconnected during nebulization otherwise the humidifier may be blocked (page 128).

• The heated humidifier must be switched off during nebulization. Otherwise the particle size may be affected (page 128).

• During nebulization a filter must be connected to the expiratory inlet of the ventilator. Always carefully monitor the airway pressure during nebulization. Increased airway pressure could be caused by a clogged filter. The filter should be replaced if the expiratory resistance increases or every 24 hours when the nebulizer is being used.

• When a Servo Ultra Nebulizer is used, always consult the drug manufacturer regarding the appropriateness of ultrasonic nebulization for certain medications (page 128, 187).

• The nebulizer must not be used without buffer liquid (sterile water). Otherwise the ultrasonic generator crystal may break (page 129, 187).

• To avoid explosion hazards, flammable agents such as ether and cyclopropane must not be used with this device. Only agents which comply with the requirements on non-flammable agents in the IEC standard “Particular requirements for electrical safety of anaesthetic machines” are suitable.

• For adult/pediatric patients, never fill the medication cup with more than 10 ml (page 129).

• For neonatal patients, never fill the medication cup with more than 4 ml (page 129).

• If the patient unit of the nebulizer is tilted, the drug can flow into the patient´s lungs or the ventilator.

• The nebulizer must not be left unattended when connected to a patient.

• Continuously check that the buffer liquid level is between MIN. and MAX. during nebulization (page 187).

• During nebulization: Continuously check that moisture is generated in the medication cup (page 187).

• When the ventilator is running on batteries the nebulizer module is inoperative, to reduce the power consumption (page 187).

• For information about the stand alone Aeroneb Professional Nebulizer System, refer to separate manual.

Cleaning

• All personnel should be aware of the risk of parts being infected when disassembling and cleaning the ventilator (page 191).

• After removing the Expiratory cassette, do not pour any fluid into the Expiratory cassette compartment (page 196).

Replacement of O2 cell

The sealed unit of the O2 cell, contains a caustic liquid which may cause severe burns to the skin and eyes. In case of contact, immediately flush continuously with water for at least 15 minutes and seek medical attention especially if the eyes are affected (page 214)

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Notes

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2. Ventilation

Contents

Modes of ventilation. . . . . . . . . . . . . . . . . . . . . . . 16

Important definitions . . . . . . . . . . . . . . . . . . . . . . 21

Trigger sensitivity . . . . . . . . . . . . . . . . . . . . . . . . . 23

Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Special functions . . . . . . . . . . . . . . . . . . . . . . . . . 29

Controlled ventilation - PRVC . . . . . . . . . . . . . . . 32

Controlled ventilation - Volume Control . . . . . . . . 35

Controlled ventilation - Pressure Control . . . . . . . 38

Supported ventilation - Volume Support . . . . . . . 40

Supported ventilation - Pressure Support . . . . . . 43

Spontaneous/CPAP . . . . . . . . . . . . . . . . . . . . . . . 46

Automode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

SIMV. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Bi-Vent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Non Invasive Ventilation (NIV) . . . . . . . . . . . . . . 61

NIV - Pressure Control . . . . . . . . . . . . . . . . . . . . . 62

NIV - Pressure Support . . . . . . . . . . . . . . . . . . . . 63

NIV - Nasal CPAP. . . . . . . . . . . . . . . . . . . . . . . . . 64

Open Lung Tool . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Ventilatory parameters, overview . . . . . . . . . . . . . 66

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Modes of ventilation

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Ventilatory management

The Servo-i Ventilator System is designed for safe and effective treatment. It can be set for continuous adaptation to the patient´s prevailing condition or for manually controlled operations. The servo systems for pressure, flow and timing operate in all modes of ventilation (set time in control modes and patient-related timing in support modes).

Important:

• To show all available installed ventilation modes, please refer to "Setting ventilation mode" on page 164 in this manual.

• In all pressure controlled modes, it is important to set alarm limits to adequate levels.

• For information about default values and parameter settings refer to page 249.

Application

The Servo-i ventilator system also contains tools to assist the user in application of lung recruitment methodologies.

Scope - ventilatory needs

The ventilator can be used for true:

1. controlled ventilation

2. supported ventilation, or

3. spontaneous breathing/CPAP 4-7. 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.

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

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.

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Modes of ventilation

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Implementation

Ventilation can be managed and administered with a focus on:

A. pressure and volume B. pressure C. flow/volume.

Extra flow and extra breaths

In flow/volume- oriented modes of ventilation, additional on-demand flow can be triggered during inspiration. Additional breaths can always be triggered between the ordinary breaths if the set trigger criteria are met.

Timing

In controlled ventilation modes, timing is related to preset values. In supported ventilation modes, timing is related to patient triggering and Inspiratory cycle-off setting.

Pressure and volume in focus

In the pressure- and flow- oriented modes, a constant inspiratory Tidal Volume is maintained. The inspiratory pressure level is constant during each breath. (PRVC, Volume Support.)

Pressure in focus

In the pressure-oriented modes, a constant preset pressure level is maintained during inspiration. (Pressure Control, Pressure Support)

Flow/volume in focus

In the flow/volume oriented modes a constant inspiratory volume is maintained. The inspiratory flow is constant during each breath (Volume Control).

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Modes of ventilation

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Basic functionality - An overview

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1.(PRVC) Pressure Regulated Volume Control

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.

2. Volume Control

Breaths are delivered mandatorily with a constant flow to assure preset volumes.

3. 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.

4. Spontaneous breathing (CPAP)

When sufficient inspiratory volumes are achieved, spontaneous breathing without ventilator support is allowed for in Volume Support.

5. Pressure Control

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

6. Pressure Support

Inspiration is supported by a constant preset pressure when activated by patient effort. The patient determines frequency and duration of the breaths, which show a decelerating flow pattern. Inspiratory breath duration can be influenced by adjusting the Inspiratory cycle-off criteria.

7. Spontaneous breathing/CPAP

True spontaneous breathing (CPAP) occurs when the inspiratory pressure level is set to zero in Pressure Support.

8. Nasal CPAP

Spontaneous breathing on a set pressure level.

Modes of ventilation

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Modes of ventilation

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Combined modes - An overview

Automode

The ventilator continuously adapts to the patient's breathing capability and allows the patient to better interact with the ventilator. The ventilator automatically shifts between controlled ventilation, supported ventilation and spontaneous ventilation. Each controlled ventilation mode has a corresponding support mode.

Volume Control <----> Volume Support PRVC <----> Volume Support Pressure Control <----> Pressure Support

When the patient is making a breathing effort, the ventilator immediately switches to a support mode of ventilation. If the patient is not making any breathing effort, the ventilator will return to the controlled mode and deliver controlled breaths.

Synchronized intermittent Mandatory ventilation (SIMV)

The ventilator provides mandatory breaths which are synchronized with the patient´s spontaneous efforts at a preset rate. The mandatory breaths can be Volume Control, Pressure Control or PRVC breaths.

Bi-Vent

Bi-Vent is pressure controlled breathing, giving the patient the opportunity of unrestricted spontaneous breathing. Two pressure levels are set together with the individually set duration of each level. Spontaneous efforts can be assisted by pressure support.

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Important definitions

2

x

V

ServoS-0046_XX

z

y

I:E

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

Volume Control

Pressure-Time waveform. Points and regions of interest

X. Inspiration time Y. Pause time Z. Expiration time

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

2

4

3

1

12

5

7

8

14

13

6

t

11

t

10

9

15

16

t

Flow-Time waveform. Points and regions of interest

X. Inspiration time Y. Pause time Z: Expiration time

7. Peak inspiratory flow

8. Zero flow phase

9. Peak expiratory flow

10. Slope decelerating expiratory limb

11. End expiratory flow

Volume-Time waveform. Points and regions of interest

X. Inspiration time Y. Pause time Z. Expiration time

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

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Important definitions

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P

V

ServoS-0047_XX

X

Z

I:E

Pressure Control

Pressure-Time waveform. Points and regions of interest

X. Inspiration time Z. Expiration time

1. Start of Inspiration

2. Peak inspiratory pressure

3. End expiratory pressure

2

1

4

5

6

9

8

3

t

7

t

10

t

Volume-Time waveform. Points and regions of interest

X. Inspiration time Z.: Expiration time

8. Start of inspiration

9. End inspiration

10. End expiration

Flow-Time waveform. Points and regions of interest

X. Inspiration time Z. Expiration time

4. Peak inspiratory flow

5. End inspiratory flow

6. Peak expiratory flow

7. End expiratory flow

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Trigger functionality

Trigg. Flow

5

Trigg. Pressure

-2

T rig g e r s e n s itiv it y

2

SVX-638_EN

This determines the level of patient effort to trigger the ventilator to inspiration.

Trigger sensitivity can be set in flow triggering (Trigg. Flow) or pressure triggering (Trigg. Pressure). Normally flow triggering is preferable as this enables the patient to breath with less effort.

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

Pressure triggering can be set in the range

-20 to 0 cmH level, white area on the bar).

O (in reference to set PEEP

2

When the trigger sensitivity is set above 0 (green and red area on the bar), flow triggering is set, i.e. the amount of the bias flow that the patient has to inhale to trigg a new breath. The sensitivity can be set from 100% of the bias flow (left), to 0% of the bias flow (right). For information about the different colors of the bar refer to page 167.

Important: In

NIV it is not possible to set

trigger sensitivity.

The ventilator continuously delivers a gas flow during expiration, which is measured in the expiratory channel.

1. Inspiration.

Bias flow during expiration.

2. Bias flow Infant 0.5 l/min. Bias flow: Adult 2 l/min.

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Trigger sensitivity

2

Weak patient effort

Trigg. Flow

5

SVX-141_EN

1. At a Trigger sensitivity level above zero

(0), the ventilator senses deviations in the bias flow caused by inspiratory efforts of the patient. The more to the right on the scale, the more sensitive is the trigger function.

2. Weak inspiratory effort.

3. Very weak inspiratory effort. For further information see page 167.

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.

Stronger patient effort

Trigg. Pressure

-2

SVX-142_EN

1. At a Trigger sensitivity level below zero (0), the ventilator senses negative pressures created by the patient. Required preset negative pressure to initiate a breath is shown numerically. The more to the left on the scale, the more effort is required to trigger.

2. Stronger patient effort.

For further information see page 167.

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

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Settings

2

Inspiratory rise time

Insp rise time

P

0

100 %

0

SVX-644_EN

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.

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.

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.

t

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. The range of Inspiratory cycle-off is 1 - 70%.

Note: In NIV the range is 10-70%.

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

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Settings

2

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). This is set in seconds within the range:

Infants: 0,5 -15 seconds in half second steps. Adults: 1-15 seconds in one second steps. Note: The soft key 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.

Trigger timeout

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

Automode: Volume Control PRVC Pressure Control The settings are within the ranges:

• Infant: 3-15 seconds

• Adult: 7-12 seconds

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.

<--->Volume Support <--->Volume Support <--->Pressure Support

PEEP

SVX-646_EN

Positive End Expiratory Pressure (PEEP) can be set in the range of 0 - 50 cmH Positive End Expiratory Pressure is maintained in the alveoli and may prevent the collapse of the airways.

Note: In NIV the range is 2-20 cmH

O. A

2

O.

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Settings

2

I:E ratio / Inspiration time

The setting of breathing parameters in Servo-i 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.

Note: The soft key 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.

Note: The configuration is done by a service technician with a service card.

Volume setting

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

– Minute Volume or, – Tidal Volume

Note: The configuration is done by a service technician with a service card.

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 Apnea back-up in Pressure Support.

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

O2 concentration

The setting range for the gas mixer is 21% O2 to 100% O automatically set at approximately 6% O2 above or below the set concentration value. There is also an absolute minimum alarm limit of 18% O operating settings.

. The alarm limits are

2

which is independent of

2

Respiratory rate / SIMV frequency

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.

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Settings

2

Previous ventilation mode

1. Time when previous mode was inactivated.

2. Press the pad Show previous mode to recall the previous accepted ventilation mode.

3. Activate the previous used ventilation mode settings by pressing the Accept pad.

Note:

• The previous ventilation 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 startup (cold start) of the system.

• In backup ventilation, the ventilator shows

the settings for the supported mode when previous mode is activated.

• A recall of previous settings is only

possible after a change of ventilation mode.

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Special functions

2

Fixed keys

1. Start breath

2. O

breaths

2

3. Expiratory hold

4. Inspiratory hold can all be chosen by manually pressing the

respective fixed key.

Start breath

The ventilator will initiate a new breath cycle according to the current ventilator settings.

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Special functions

2

O2 breaths

This function allows 100% oxygen to be given for 1 minute. After this time the oxygen concentration will return to the pre-set value. The oxygen breaths can be interrupted by repressing the O the 1 minute interval.

breaths fixed key during

2

Expiratory hold

Expiratory and inspiratory valves are closed after the expiration phase is completed, for as long as the fixed key is depressed, up to a maximum of 30 seconds. Expiratory hold provides an exact measurement of the end expiratory pause pressure. It can be used for static compliance measuring and to determine the total PEEP. The dynamic pressure is shown on the PEEP numerical value.

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Special functions

2

Inspiratory hold

Inspiratory hold is activated by manually pressing the fixed key. The maximum time is 30 seconds. The inspiratory and expiratory valves close after inspiration. This function can provide an exact measurement of the end inspiratory lung pressure. It can be used during x-ray or to determine Plateau pressure, or static compliance calculation.

Back-up ventilation

Pressure support/

CPAP

Apnea

Volume support

SVX-647_EN

Back-up ventilation is available in all support modes (not applicable in Automode and NIV Pressure Support mode).

The Back-up function switches Volume Support to Volume Control, Pressure Support and CPAP to Pressure Control. During Back-up ventilation default settings are used for I:E ratio, Respiratory Rate, and Inspiratory rise time. Apnea alarm can be set in infant mode (5-45 seconds) and in adult mode (15-45 seconds). The Back-up pressure level is adjustable, minimum settable value is 5 cmH

Note: Back-up not applicable in NIV Nasal CPAP.

O.

2

Pressure control

Volume control

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Controlled ventilation - PRVC

2

Functional description PRVC

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

Servo-i Ventilator 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 (cmH

4. Oxygen concentration (%)

5. I:E ratio / Insp. time

6. Inspiratory rise time (%/s)

7. Trigg. Flow / Trigg. Pressure

O)

2

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

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

O below the set upper

2

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PRVC in detail

Controlled ventilation - PRVC

2

1

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-bybreath 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.

2

3

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Controlled ventilation - PRVC

2

SVX-697_EN

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 cmH

2

O).

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Controlled ventilation - Volume Control

Functional description Volume Control

2

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

Servo-i Ventilator 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 (cmH

4. Oxygen concentration (%)

5. I:E ratio / Insp. time

6. Pause time (%/s)

7. Inspiratory rise time (%/s)

8. Trigg. Flow / Trigg. Pressure

O)

2

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.

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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Controlled ventilation - Volume Control

2

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 gives the possibility to the patient to modify both flow rate and timing. So, if a pressure drop of 3 cmH during inspiration, the ventilator cycles to

O is detected

2

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.

SVX-652_EN

The waveform illustrations above 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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Controlled ventilation - Volume Control

Volume Control in detail

2

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.

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.

1 2

3

4

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Controlled ventilation - Pressure Control

2

Functional description Pressure Control

The Pressure Controlled mode is a controlled breathing mode.

The following parameters are set:

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

O)

2

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 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 cmH As the delivered tidal volume can vary it is very important to set alarm limits for Minute Volume to adequate levels.

O above the set pressure level.

2

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Controlled ventilation - Pressure Control

Pressure Control in detail

2

1

SVX-9003_XX

1. Pressure Control assures that the preset inspiratory pressure level is maintained constantly 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.

Expiration starts:

a. After the termination of preset

inspiration time.

b. If the upper pressure limit is

exceeded.

2 3

Active expiratory valve

SVX-9008_XX

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

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.

t

O above the set inspiratory

2

t

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Supported ventilation - Volume Support

2

Functional description Volume Support

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.

The following parameters are set:

1. Tidal Volume (ml)

2. PEEP (cmH

3. Oxygen concentration (%)

4. Inspiratory rise time (s)

5. Trigg. Flow / Trigg. Pressure

6. Inspiratory Cycle-off (%)

O)

2

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.

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SVX-657_EN

Supported ventilation - Volume Support

2

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 remaining 3 breaths of the start up sequence the maximum pressure increase is 20 cmH sequence the pressure increases or decreases in steps of maximum 3 cmH

O for each breath. After the start up

2

O.

2

If the delivered Tidal Volume decreases below the set Tidal Volume the pressure support level is increased in steps of maximum 3 cmH is delivered. If the pressure support level

O until preset Tidal Volume

2

causes a larger Tidal Volume than preset, the support pressure is lowered in steps of maximum 3 cmH Volume is delivered.

O until the preset Tidal

2

The maximum time for inspiration is:

• Infant 1.5 seconds

• Adult 2.5 seconds

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 cmH

2

O).

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 Back-up mode providing controlled ventilation. In all spontaneous modes it is important to set the Minute Volume alarm.

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Supported ventilation - Volume Support

2

Volume Support in detail

1

SVX-9005_XX

1. Volume Support assures a set target Tidal Volume upon patient effort by an adapted inspiratory pressure support.

2. The inspiratory pressure level is constant during each breath, but alters in small increments, breath-by-breath, to match the patient´s breathing ability and lung mechanical properties.

3. Inspiration with Volume Support starts: When the patient triggers.

Expiration starts:

a. When the inspiratory flow decreases

below a preset fraction of the inspiratory peak flow (Inspiratory cycle-off)

b. If the upper pressure limit is

exceeded.

c. Maximum time for inspiration is

exceeded.

2

3

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Supported ventilation - Pressure Support

Functional description Pressure Support

Pressure Support is a patient initiated breathing mode in which the ventilator supports the patient with a set constant pressure.

2

The following parameters are set:

1. PS (Pressure Support level) above PEEP (cmH

O)

2

2. PEEP (cmH

3. Oxygen concentration (%)

4. Inspiratory rise time (s)

5. Trigg. Flow / Trigg. Pressure

6. Inspiratory Cycle-off (%)

7. PC (pressure control level) above PEEP (cmH

2

O).

O)

2

During Pressure Supported ventilation the patient regulates the respiratory rate and the Tidal Volume with support from the ventilator. The higher the pre-set inspiratory pressure level from the ventilator the more gas flows into the patient. As the patient becomes more active the pressure support level may be gradually reduced. It is important to set the Inspiratory rise time to a comfortable value for the patient. In Pressure Support the Inspiratory rise time should normally be increased.

It is also very important to set lower and upper alarm limit for expired Minute Volume.

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Supported ventilation - Pressure Support

2

SVX-661_XX

Inspiratory Cycle-off is important for the patient’s comfort and ventilator synchronization with the patient. Inspiratory Cycle-off is the point when inspiration switches to expiration. E.g. for a patient with expiratory resistance the inspiratory Cycleoff should be set to a high value to guarantee enough time for expiration.

Note: It is important to monitor the corresponding Tidal Volume levels.

Inspiration: when the patient triggers a breath, gas flows into the lungs at a constant pressure. Since the pressure provided by the ventilator is constant, the flow will decrease until the Inspiratory Cycle-off is reached.

Expiration starts when:

– The inspiratory flow decreases to the

pre-set Inspiratory Cycle-off level. – If the upper pressure limit is exceeded. – If the flow drops to a flow range between

25% of the peak flow and lower limit for

Inspiratory Cycle-off fraction level and

the spent time within this range exceeds

50% of the time spent in between the

start of the inspiration and entering this

range.

The maximum time for inspiration is:

• Infant 1.5 seconds

• Adult 2.5 seconds

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Supported ventilation - Pressure Support

Pressure Support in detail

1 2 3

SVX-9004_XX

1. Pressure Support assures that a preset inspiratory pressure level is constantly maintained upon patient effort.

2. The preset pressure level is controlled by the ventilator, while the patient determines frequency and inspiration time.

3. Inspiration starts when the patient triggers.

2

Expiration starts:

a. When the inspiratory flow decreases

below a preset fraction of the inspiratory peak flow (Inspiratory cycle-off)

b. If the upper pressure limit is

exceeded.

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Spontaneous/CPAP

2

Functional description Spontaneous breathing/CPAP

The mode Continuous Positive Airway Pressure is used when the patient is breathing spontaneously.

The following parameters are set:

1. PS (Pressure Support level) above PEEP (cmH

O)

2

O).

O)

2

2. PEEP (cmH

3. Oxygen concentration (%)

4. Inspiratory rise time (s)

5. Trigg. Flow / Trigg. Pressure

6. Inspiratory Cycle-off (%)

7. PC (pressure control level) above PEEP (cmH

2

A continuous positive pressure is maintained in the airways. Properly set this may prevent collapse of airways. Inspiration starts upon patient effort. Expiration starts as for Pressure Support above. Always set the Apnea time appropriate to the individual patient situation. If the apnea alarm limit is reached the ventilator will automatically switch back to a Back-up mode.

The alarm should alert staff to take action, either to go back to supported mode or change to a controlled mode of ventilation.

It is also very important to set lower and upper alarm limit for expired Minute Volume

The maximum time for inspiration is:

• Infant 1.5 seconds

• Adult 2.5 seconds.

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Spontaneous breathing/CPAP in detail

– True spontaneous breathing will occur:

a. In Volume Support when the target

volume is maintained without support (automatically regulated by the ventilator)

b. In Pressure Support when the

inspiratory pressure level is set to zero

c. In Automode when either of the above

defined conditions is met.

– Inspiration starts upon patient effort.

Expiration starts:

a. When the inspiratory flow decreases

below a preset fraction of the inspiratory peak flow (Inspiratory cycle-off)

b. If the upper pressure limit is

exceeded.

Spontaneous/CPAP

2

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Automode

2

Automode Functional description

SVX-602_EN

Automode is a ventilator functionality where the ventilator adapts to the patient's varying breathing capacity and automatically shifts between a control mode and a support mode using a fixed combination of ventilation modes. There are three different combinations, depending on the modes installed:

• Volume Control<----> Volume Support

• PRVC <----> Volume Support

• Pressure Control <----> Pressure Support.

Note: Automode is not possible in NIV.

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Automode

2

Volume Control<->Volume Support

The ventilator uses the plateau pressure in the Volume Controlled breath as a reference pressure for the first Volume Supported breath.

PRVC <-> Volume Support

Pressure Control<->Pressure Support

In this combination of Automode - Pressure Control and Pressure Support - the Direct Access Knob will regulate the PC above PEEP (Pressure Control level).

The first supported breath delivered to the patient has the same pressure level as the preceding PRVC breath.

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Automode

2

Automode in detail

1. The ventilator starts in control mode and operates according to the Volume Control, PRVC or Pressure Control mode. If the patient triggers a breath, the ventilator will turn to support mode, to encourage the patient's respiratory drive.

2. If the patient is breathing adequately: a. In Volume Support the ventilator

adjusts the inspiratory pressure level breath-by-breath to assure the preset target volume.

b. In Pressure Support the ventilator

assures that the preset inspiratory pressure level is maintained constantly during the entire inspiration.

3. Exceeding the default or manually set

trigger timeout limit without a sufficient patient effort will cause:

a. In Volume Support; a PRVC or Volume

controlled breath will be delivered according to the selected automode functionality.

b. In Pressure Support; a Pressure

controlled breath will be delivered.

4. The ventilator initially adapts with a

dynamic trigger timeout limit. This means that for the spontaneously triggering patient, the trigger timeout limit increases successively until the set trigger timeout limit is reached.

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PRVC - Volume Support

1

SVX-165_EN

2a

3a

Volume Control - Volume Support

Automode

4

2

1

SVX-222_EN

2a

3a

Pressure Control - Pressure Support

1

SVX-167_EN

3b2b

4

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SIMV

2

Functional description SIMV

SIMV is a combination mode where the patient receives mandatory breaths synchronized with his breathing efforts and according to the selected SIMV mode. The patient can breath spontaneously with Pressure Support in between the mandatory breaths.

There are three different SIMV modes, depending on the modes installed:

• SIMV (PRVC) + Pressure Support

• SIMV (Volume Control) + Pressure Support

• SIMV (Pressure Control) + Pressure

Support

The mandatory breath

SIMV

(PRVC)+P

S

1

X

2

X

SIMV

(PC) + PS

X

2

X

PC above PEEP

Tidal volume / Minute volume

SIMV rate

Breath cycle time

SIMV

(VC)+ PS

XX

1

X

2

X

The Breath cycle time is the length of the mandatory breath in seconds.

For example: A SIMV rate of 6, a breath cycle time of 3 seconds with an I:E ratio of 1:2 means that the inspiration will take 1 second and the expiration 2 seconds.

SIMV Cycle

10 sec

373

SIMV Period

SVX-9010_EN

Spon. Period

SIMV Period

During the SIMV period, the first triggered breath will be a mandatory breath. If the patient has not triggered a breath within the first 90% of the Breath Cycle time a mandatory breath will be delivered.

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

The spontaneous/pressure supported breaths are defined by setting the Pressure support level above PEEP.

I:E ratio / Inspiration time

Insp. rise time

Pause time

1

Only when the ventilator is configured for

XXX

2

X

Minute volume setting.

2

Only when the ventilator is configured for

I:E ratio setting. The Mandatory breath is defined by the basic

settings (as shown in the table above): Minute Volume/Tidal Volume (depending on configuration), PC above PEEP, I:E ratio/ Inspiration time (depending on configuration), Pause time, Inspiratory rise time and Breath cycle time.

Note: In the Minute Volume configuration the Tidal Volume is determined by Minute Volume divided by SIMV rate.

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SIMV (PRVC) + Pressure Support

The following parameters are set:

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

2. SIMV rate (b/min)

SIMV

2

3. PEEP (cmH

4. Oxygen concentration (%)

5. I:E ratio / Insp. time

6. Inspiratory rise time (%/s)

7. Breath cycle time (s)

Note: The soft key Breath cycle time is not shown when an SIMV mode is selected and inspiration time is configured. Refer to page 27.

8. Trigg. Flow / Trigg. Pressure

9. Inspiratory Cycle-off (%)

10. PS (Pressure Support level) above PEEP (cmH

2

O)

2

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s

SIMV

2

SIMV (PRVC) + Pressure Support

P

SIMV Breath cycle

3

time

Spont. period

4

SIMV

Breath cycle

time

2

V

SVX-9027_EN

1

SIMV - in detail

1. This combined control and pressure support/spontaneous function allows for preset mandatory breaths synchronized with the patient's breathing.

2. If there is no trigger attempt within a time window equal to 90% of the set Breath cycle time, a mandatory breath is delivered. (The Breath cycle time is the total time for one mandatory breath.)

3. The mandatory breath is defined by the basic settings (mode of ventilation, breath cycle time, respiratory pattern and volumes/pressures).

4. The spontaneous/pressure supported breaths are defined by the setting for Pressure Support.

90%

time

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SIMV (Volume Control) + Pressure Support

The following parameters are set:

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

2. SIMV rate (b/min)

SIMV

2

3. PEEP (cmH

4. Oxygen concentration (%)

5. I:E ratio / Insp. time

6. Pause time (%/s)

7. Inspiratory rise time (%/s)

8. Breath cycle time (s)

Note: The soft key Breath cycle time is not shown when an SIMV mode is selected and inspiration time is configured. Refer to page 27.

9. Trigg. Flow / Trigg. Pressure

10. Inspiratory Cycle-off (%)

11. PS (Pressure support) above PEEP (cmH

2

O)

2

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s

SIMV

2

SIMV (Volume Control) + Pressure Support

P

SIMV

Breath cycle time Spont. period

3

4

SIMV

Breath cycle time

2

V

SVX-9011_EN

1

SIMV - in detail

1. This combined control and pressure support/spontaneous function allows for preset mandatory breaths synchronized with the patient's breathing.

2. If there is no trigger attempt within a time window equal to 90% of the set Breath cycle time, a mandatory breath is delivered. (The Breath cycle time is the total time for one mandatory breath.)

3. The mandatory breath is defined by the basic settings (mode of ventilation, breath cycle time, respiratory pattern and volumes/pressures).

4. The spontaneous/pressure supported breaths are defined by the setting for Pressure Support.

90%

time

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SIMV (Pressure Control) + Pressure Support

The following parameters are set:

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

O)

2

2. SIMV rate (b/min)

SIMV

2

3. PEEP (cmH2O)

4. Oxygen concentration (%)

5. I:E ratio / Insp. time

6. Inspiratory rise time (%/s)

7. Breath cycle time (s) Note: The soft key Breath cycle time is

not shown when an SIMV mode is selected and inspiration time is configured. Refer to page 27.

8. Trigg. Flow / Trigg. Pressure

9. Inspiratory Cycle-off (%)

10. PS (Pressure Support level) above PEEP (cmH

O)

2

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s

SIMV

2

SIMV (Pressure Control) + Pressure Support

P

SIMV Breath cycle

3

time

Spont. period

4

SIMV

Breath cycle

2

time

V

SVX-9027_EN

1

SIMV - in detail

1. This combined control and pressure support/spontaneous function allows for preset mandatory breaths synchronized with the patient's breathing.

2. If there is no trigger attempt within a time window equal to 90% of the set Breath cycle time, a mandatory breath is delivered. (The Breath cycle time is the total time for one mandatory breath.)

3. The mandatory breath is defined by the basic settings (mode of ventilation, breath cycle time, respiratory pattern and volumes/pressures).

4. The spontaneous/pressure supported breaths are defined by the setting for Pressure Support.

90%

time

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Bi-Vent Functional description

Bi-Vent

2

Bi-Vent is pressure controlled breathing that allows the patient the opportunity of unrestricted spontaneous breathing. Two pressure levels are set together with the individually set duration of each level. Spontaneous breathing efforts can be. assisted by pressure support

The following parameters are set:

1. Pressure high (P

pressure level (cmH

) for the higher

High

O)

2

2. PEEP for the lower pressure level O)

(cmH

2

3. Oxygen concentration (%)

4. Time at the higher pressure (T

High

) level

(s)

5. Time at the lower pressure (T

PEEP

) level

(s)

6. Inspiratory rise time (s)

7. Trigg. Flow / Trigg. Pressure

8. Inspiratory Cycle-off (%)

9. Pressure Support level above P O)

(cmH

2

High

In the Bi-Vent mode the ventilator uses two shifting pressure levels, with the patient being able to breath spontaneously on both these levels.

Since Bi-Vent is basically a controlled mode of ventilation, apnea alarm and back-up ventilation are not available. It is also very important to set lower and upper alarm limit for expired Minute Volume.

Every Bi-Vent cycle is regarded as autonomous and therefore most of the measured values are updated every Bi-Vent cycle, i.e. minute volumes, respiratory rate, mean pressure and end expiratory pressure. In accordance to this, associated alarms are also handled for every Bi-Vent cycle.

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

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

It is not recommended to use Auto scale in Bi-Vent mode, when patient is breathing spontaneous on both levels.

2

10. Pressure Support level above PEEP O)

(cmH

2

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Bi-Vent

2

Bi-Vent in detail

1

5

3

SVX-184_XX

This function allows for spontaneous breathing / pressure supported ventilation at two different pressure levels. These basic levels are individually set, as well as the time in seconds at each level.The ventilator always tries to synchronize with the patient´s breathing.

1. Bi-Vent cycle; T

High

+ T

PEEP

2. PEEP

3. P

High

4. The pressure support level is set

individually: PS above PEEP

5. PS above P

High

2

4

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Non Invasive Ventilation (NIV)

2

Non Invasive Ventilation

This chapter refers to when the Servo-i is used during Non Invasive Ventilation (NIV). NIV refers to ventilation, where the patient is not intubated or tracheotomized. It is achieved using a nasal mask / prongs, face mask / prongs or full-face mask / prongs.

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

WARNINGS!

• Avoid high inspiratory pressure as it may

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

• The dead space will increase when use of

a mask / prongs.

• NIV is not intended to be used on

intubated patients.

•CO

measurement will be affected by

2

mask / prongs leakage.

Cautions:

Read more about NIV

Intended population page 4 Ventilation modes (NIV): pages 62, 63 Alarm settings: page 73 Preparation: page 160

• Mask / prongs leakage might affect the

nebulizer efficiency.

• It is not recommended to use the nebulizer

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

Important:

• The mask / prongs must be applied in

order to avoid leakage.

• Selection of the mask / prongs must take

into consideration proper size and an accurate adaptation to the patient.

•CO

rebreathing will increase during NIV

2

and use of a face mask / prongs.

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NIV - Pressure Control

2

Functional description Pressure Control

The Pressure Controlled (NIV) mode is a controlled breathing mode.

SVX-9013_XX

The following parameters are set:

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

O)

2

2. Respiratory Rate (b/min)

3. PEEP (cmH

4. Oxygen concentration (%)

O)

2

Differences from invasive Pressure control mode:

• When the Standby key is pressed a

waiting position dialog is shown. All patient related alarms are turned off during 120 seconds. Press the Start ventilation pad to start the ventilation.

• During NIV the ventilator automatically adapts to the variation of leakage in order to maintain the required pressure and PEEP level. If the leakage is excessive, the ventilator will issue a high priority alarm, deliver a continuous flow and pause breath cycling. Ventilation will resume automatically if the leakage decreases. Ventilation can also be started manually by pressing the Start ventilation pad in the excessive leakage dialog.

• Trigger sensitivity cannot be set in NIV.

Read more about NIV

Intended population page 4 NIV general information: page 61 Ventilation modes (NIV): page 63 Alarm settings: page 73 Preparation: page 160

5. I:E ratio / Insp. time

6. Inspiratory rise time (%/s)

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NIV - Pressure Support

2

Functional description Pressure Support

Pressure Support (NIV) is a patient initiated breathing mode in which the ventilator supports the patient with a set constant pressure.

SVX-9014_XX

The following parameters are set:

1. PS (Pressure Support level) above PEEP (cmH

O)

2

2. PEEP (cmH

3. Oxygen concentration (%)

4. Inspiratory rise time (s)

5. Inspiratory Cycle-off (%)

6. NIV rate (b/min)

7. Backup Ti (s)

O)

2

Differences from invasive Pressure support mode:

• When the Standby key is pressed a

waiting position dialog is shown. All patient related alarms are turned off during 120 seconds. Press the Start ventilation pad to start the ventilation.

• During NIV the ventilator automatically adapts to the variation of leakage in order to maintain the required pressure and PEEP level. If the leakage is excessive, the ventilator will issue a high priority alarm, deliver a continuous flow and pause breath cycling. Ventilation will resume automatically if the leakage decreases. Ventilation can also be started manually by pressing the Start ventilation pad in the excessive leakage dialog.

• During Pressure support the system ensures a minimum Back-up Rate and maintains the set Inspiratory pressure and PEEP level. The Back-up Rate is activated when the spontaneous breathing rate is lower then the Back-up Rate, but the ventilator does not activate a Backup ventilation mode as in Invasive Pressure Support.

• Trigger sensitivity cannot be set in NIV.

Read more about NIV

Intended population page 4 NIV general information: page 61 Ventilation modes (NIV): page 62 Alarm settings: page 73 Preparation: page 160

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NIV - Nasal CPAP

2

Functional description Nasal CPAP

The mode Nasal Continuous Positive Airway Pressure is used when the patient is breathing spontaneously.

SVX-9057

The following parameters are set:

1. CPAP (cmH

2. Oxygen concentration (%)

O)

2

Differences from invasive CPAP

• When the Standby key is pressed a

waiting position dialog is shown. All patient related alarms are turned off during 120 seconds. Press the Start ventilation pad to start the ventilation.

• Trigger and cycle-off is automatically adapted to the leakage and cannot be set in Nasal CPAP.

• There is no backup ventilation available in Nasal CPAP.

• The apnea alarm can be turned off in Nasal CPAP

The following functions are not available during Nasal CPAP ventilation:

•Volume curve

• Loops

• Open Lung Tool

• Additional values

• Additional settings

• Inspiratory hold

• Expiratory hold

•CO

Analyzer.

2

SVX-9061

64

WARNING! Patient effort and artifacts affecting patient flow or pressure such as heart beats, movement of patient tubings, intermittent leakage may not always be correctly detected or discriminated. This may affect the accuracy of alarms and measured parameters, therefore, we advise that a ventilator-independent means of monitoring the patient should be in place.

Read more about NIV

Intended population page 4 NIV general information: page 61 Ventilation modes (NIV): page 62 Alarm settings: page 73

Preparation: page 160

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Open Lung Tool

Clinical performance

The Open Lung Tool is a tool for graphically visualizing measured and calculated values for easier interpretation of already available ventilation data. Three simultaneous graphical trends are presented with a fixed set of parameters as a function of a number of collected breaths. The User Interface features an adjustable cursor which helps illustrate the opening and closing airway pressures. This alternative presentation may be used for immediate visualization of the effect of altered settings.

Note: When the Y Sensor Measuring function is active, then the values recorded in the Open Lung Tool are based on values measured at the Y-piece. Note that when this function is disabled or enabled, then the compliance in the patient circuit may cause the values in the Open Lung Tool to change.

Read more about NIV

Ventilation modes page 61 Preparation page 160

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s

The alarm window

3

Current alarms window

This window can be displayed if more than one alarm is active.

1. Press the bell (s) in the alarm message pad.

2. All alarms are shown in a window. This is dynamic and will be updated if more alarms occur while the window is open. The alarms are listed by priority and 10 alarm messages are displayed at the most.

3. Press the History pad.

4. The last 16 alarm-dependent events are listed chronologically. The most recent event is at the bottom.

Note: For viewing more than the latest 10 alarms, use the Event log to view all logged alarms (refer to page 270).

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Alarms - Visual / audible

3

Visual

1. A text message explaining the cause of the alarm flashes in the alarm message area. The alarm with highest priority is displayed first.

2. The corresponding measured value or set value box flashes and an arrow points at the exceeded limit.

A red background color indicates a high priority alarm. A yellow background indicates a medium or low priority alarm.

A high priority alarm which has been active but for which the condition has returned to normal is latched and requires manual resetting. (Latched alarms: The alarm text remains even though the alarm condition ceases.)

Note: NIV alarm Leakage out of range is not latched.

Audible

An active alarm is indicated by a distinct, but soft alarm signal. The sound level can be adjusted, e.g. lowered during the night time. (Set sound level is indicated in the Alarm profile window.)

Technical errors may also be indicated by a signal similar to that a medium priority alarm, generated by a sounding device in the Patient Unit.

Two bells in the alarm message area indicate that more than one alarm is activated.

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Audio off (Silence / Pre-silence of alarm)

3

General

All alarms except for No battery capacity and technical error alarms can be silenced (Audio pause) for two minutes. New alarms can be activated during this period. In Standby, only the following alarms are applicable:

– No battery capacity (when Battery

module is connected)

– Limited battery capacity (when Battery

module is connected)

– Battery operation (when Battery module

is connected)

– Technical error – Touch screen or knob press time

exceeded – Internal temperature: High – Exp. cassette exchanged – Technical error in Expiratory cassette

Audio off (Silence of alarms)

At any time while the ventilator is operating (either Invasive or Non Invasive Ventilation modes), alarms can be placed into a state of audio off (silence alarms).

Non Invasive Ventilation

When Non Invasive Ventilation is chosen, the following alarms can be placed into a state of audio off (silenced alarms):

– Minute volume – Respiratory rate – PEEP

– End tidal CO – CPAP ( Nasal CPAP)

By pressing the corresponding bell symbol in the alarm profile window the button changes to a crossed bell to indicate Audio Off. It is also possible to configure these alarms individually to be set to the Audio Off state by default.

Note: When an alarm is silenced (Audio off) in the NIV mode, a symbol will appear on the screen, next to the corresponding measured value, saying Audio Off (a bell with negation cross). The Audio Off symbol will remain on the screen until the user reactivates the alarms or returns to the standby mode. If the user then enters Invasive ventilation and after that returns to NIV, the audible alarms will be reset to their default states.

(CO2 Analyzer)

2

Audio off of non-latching alarms

For a very limited number of alarms a single alarm condition can be silenced (Audio off) during the remaining time of the continuing alarm condition when the message Audio off? is shown. These alarms, such as Battery operation and Low Air/O will be re-activated the next time the alarm condition occurs.

supply pressure,

2

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Audio pause (Silence / Pre-silence alarm)

3

Audio pause/Prolong pre-silence period/Clear latched alarm

SVX-5098_EN

1. Press the Audio pause (Silence/Presilence alarm) key briefly, for less than two seconds:

• Active alarms are silenced (Audio

pause) for 2 minutes.

• If already silenced, the silent period is

prolonged for two minutes.

• Latched alarms disappear (latched

alarms: the alarm text remains even though the alarm condition ceases).

An alarm silence (Audio pause) symbol and the remaining time are then displayed in the message area.

Pre-silence alarm (Audio pause))

SVX-5099_EN

1. If you press the Audio pause (Silence/ Pre-silence alarm) key for more than two seconds:

•The active alarms are silenced (Audio

pause), i.e. a two minute period is started.

•All other alarms are silenced (Audio

pause) for 2 minutes, except those which cannot be silenced.

–Latched alarms disappear from the

alarm message area.

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s

Built-in safety precautions

3

For patient safety your Servo-i Ventilator System also has a range of built-in safety precautions.

Apnea alarm

The apnea alarm is applicable in all supported/spontaneous modes.

Note: When using the knob to adjust a value, the defined safety limits may be unintentionally reached or exceeded. In this case, the knob will become inoperable for 2 seconds to make you aware that the safety limit has been passed. (Note that this is only valid for Servo-i Infant and Servo-i Universal System versions).

Backup ventilation

In case of exceeded apnea in Volume Support or Pressure Support, a safety backup mode is activated with default breathing frequency and set / default values.

High pressures

The safety valve opens if the pressure in the inspiratory channel is too high.

Caution: If airway pressure rises 6 cmH above the set upper pressure limit the safety

valve opens. The safety valve also opens if system pressure exceeds 117

± 7 cmH

O

2

O.

2

NIV rate

During Pressure support (NIV) the system ensures a minimum Back-up Rate and maintains the set Inspiratory pressure and PEEP level. The Back-up Rate is activated when the spontaneous breathing rate is lower then the Back-up Rate.

No gas supply

If the air and O2 pressure is too low the safety valve and the expiratory valve will open. An alarm will be activated simultaneously.

Parameters and alarm limits

The system has default values for parameters and alarm limits. These are valid until you adjust them before/after connection to a patient. You can also enter new default values or use the values previously applied.

Standby position

All settings will be saved when the ventilator is set in standby position. The ventilator can thus be prepared and the CO warmed up for admission in advance.

transducer

2

Gas supply O2/Air

If the O2 or air supply pressure is too low the flow from the missing gas is automatically compensated for. The patient will get preset volumes and pressure with O alarm will be activated.

/air and an

2

Mains failure and battery

In case of a mains failure, the ventilator will automatically switch over to battery operation. The switch is indicated by a medium priority alarm. The remaining battery capacity is displayed in the status menu on top of the screen. In case of a mains failure and no Battery module has been inserted or connected, a high priority alarm is activated. The inspiratory and expiratory valves are opened to allow for breathing through the ventilator. All settings are saved until the ventilator is powered again.

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Maquet SERVO-i User manual V3.1

Specifications and Main Features

Frequently Asked Questions

User Manual