Maquet Servo-i User manual V3.1 (2023)

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

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, CO2 measurement and Y-piece measurement.

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.

Intended user

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

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.

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

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.

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.

ON/OFF switch

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

NIV symbol

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

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.

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.

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.

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

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.

Support material related to the Servo-i system

Wall cleaning diagram

Configuration Card

User‘s manual

SVX-129_EN

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.

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.

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 60601- 1-1.

•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.

•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.

•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 ........ H2O < 7 g/m3

............. Oil < 0.5 mg/m3

............. Chlorine: Must not be detectable1 Oxygen H2O < 20 mg/m3

•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 cmH2O, where:

1 kPa ~ 10 cmH2O

100 kPa = 1bar ~1atm ~1kgf/cm2 (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.

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

•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

O2 cell, dismantling etc. (page 211, 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 cmH2O above the set upper pressure limit the safety valve opens. The safety valve also opens if system pressure exceeds 117 ± 7 cmH2O.

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

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)

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.

Implementation

Ventilation can be managed and administered with a focus on:

A.pressure and volume

B.pressure

C.flow/volume.

Pressure and volume in focus

In the pressure- and floworiented 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).

Extra flow and extra breaths

In flow/volumeoriented 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.

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

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

2.Peak inspiratory pressure

3.Early inspiratory pause pressure

4.End inspiratory pause pressure

5.Early expiratory pressure

6.End expiratory pressure

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

Trigger functionality

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.

Weak patient effort

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.

Inspiratory rise time

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.

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

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%.

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

PEEP

Positive End Expiratory Pressure (PEEP) can be set in the range of 0 - 50 cmH2O. A 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 cmH2O.

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% O2. The alarm limits are automatically set at approximately 6% O2 above or below the set concentration value. There is also an absolute minimum alarm limit of 18% O2 which is independent of operating settings.

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.

Fixed keys

1.Start breath

2.O2 breaths

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.

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 O2 breaths fixed key during the 1 minute interval.

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.

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

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 cmH2O.

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

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 (cmH2O)

4.Oxygen concentration (%)

5.I:E ratio / Insp. time

6.Inspiratory rise time (%/s)

7.Trigg. Flow / Trigg. Pressure

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

Functional description Volume Control

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 (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.

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.

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.

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 (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

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.

Active expiratory valve

t

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.

Upper pressure

Limit

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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.

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 (cmH2O)

3.Oxygen concentration (%)

4.Inspiratory rise time (s)

5.Trigg. Flow / Trigg. Pressure

6.Inspiratory Cycle-off (%)

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 remaining 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.

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 cmH2O).

Functional description Pressure Support

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

The following parameters are set:

1.PS (Pressure Support level) above PEEP (cmH2O)

2.PEEP (cmH2O)

3.Oxygen concentration (%)

4.Inspiratory rise time (s)

5.Trigg. Flow / Trigg. Pressure

6.Inspiratory Cycle-off (%)

7.PC (pressure control level) above PEEP (cmH2O).

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.

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 (cmH2O)

2.PEEP (cmH2O)

3.Oxygen concentration (%)

4.Inspiratory rise time (s)

5.Trigg. Flow / Trigg. Pressure

6.Inspiratory Cycle-off (%)

7.PC (pressure control level) above PEEP (cmH2O).

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.