Maquet Servo-i User Manual

User´s Manual

SERVO-i VENTILATOR SYSTEM V7.0

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

| TABLE OF CONTENTS |

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

Infologic 1.73

1 INTRODUCTION

TABLE OF CONTENTS

| Introduction |

6|Device description1.1

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

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

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1.1 DEVICE DESCRIPTION

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

1.1.1 DEVICE DIAGRAM

SVX-128a

1.1.2 DEVICE COMPONENTS

1.1.3 INTENDED USE

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

NAVA

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

1.1.4 INTENDED USER

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

are professional healthcare providers, and

have received training in the use of this system, and

have experience with ventilation treatment.

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

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

2. Patient Unit—for mixing gases

3. Patient Breathing System—for delivering and exchanging gases

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1.1.5 INTENDED USE ENVIRONMENT

The SERVO-i Ventilator System should be used only:

in hospitals

in facilities whose primary purpose is to provide healthcare

during transport of a patient within hospitals or healthcare facilities

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

1.1.6 CLEANING AND MAINTENANCE

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

1.1.7 SERVICING GUIDELINES

CAUTIONS:

Regular Service: The SERVO-i Ventilator

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

Complete Service Records: All service

performed on the SERVO-i Ventilator System must be recorded in a service log in accordance with hospital procedures and local and national regulations.

Service Contract: We strongly

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

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1.1.8 DISCLAIMERS

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

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

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1.2 WARNING, CAUTION,

IMPORTANT AND NOTE

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

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

WARNING! Indicates critical information about a potential serious outcome to the patient or the user.

CAUTION: Indicates instructions that must be followed in order to ensure the proper operation of the equipment.

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

Note: Indicates information requiring special attention.

1.2.1 GENERAL

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

WARNINGS!

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

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

- Unfamiliar pop-up windows on the screen

- Unresolvable alarms

- Unfamiliar sounds

- Any unfamiliar or unexplained event

Keep the ventilator upright during use.

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

When the ventilator is connected to a patient:

- Do not lift or disconnect the expiratory cassette.

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

- Make sure a resuscitator is readily available.

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

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

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Do not modify or remove any original parts.

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

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

Note: The network cable is excluded

from this requirement.

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

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

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

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

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

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

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

The power supply cord must be plugged directly into the mains power outlet without the use of any multiple socket outlets. If a multiple socket outlet is used together with other products, total leakage current might be exceeded at earth fault.

CAUTIONS:

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

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

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

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

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

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

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

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

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

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

Contact a MAQUET representative regarding decommissioning of the equipment.

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

Do not touch accessible connector contacts and the patient simultaneously.

Important:

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

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

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

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

All excess fluids must be disposed according to hospital routines.

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1.2.2 POWER SUPPLY

WARNINGS!

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

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

CAUTIONS:

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

Avoid contact with external electrical connector pins.

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

1.2.3 FIRE HAZARD

WARNINGS!

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

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

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

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

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1.2.4 GASES

CAUTION: The system is not intended to

be used with any anesthetic agent.

Important:

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

Maximum levels:

Air

H2O < 7 g/m

Oil < 0.5 mg/m

Chlorine: must not be detectable

Oxygen

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

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

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

1.2.5 AUXILIARY EQUIPMENT

CAUTIONS:

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

- be recommended by MAQUET

- meet EN/IEC 60601-1standards

- meet IEC standards as a whole system

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

induced flow.

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

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

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

- must not substitute for therapeutic or diagnostic decisions

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

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

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

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1.3 VERSION AND CONFIGURATIONS

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

1.3.1 CONFIGURATIONS

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

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

Configuration

ventilation

Universal

NIV = Non Invasive Ventilation

Adult

Weight range

Non invasive ventilationInvasive

Infant

NIV NAVA InfantNIV PC + PS

NIV Nasal CPAP

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

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

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

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1.3.2 CONFIGURATION LABELS

NAVA readySERVO-i Universal

NAVASERVO-i Adult

SERVO-i Infant

1.3.3 AVAILABLE OPTIONS

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

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Infant

Standard Configuration

OptionsAdult

Not applicableUniversal

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NIV NAVA

NAVA

Nasal CPAP

Non Invasive Ventilation (NIV)

Y Sensor Measuring

CO2 Analyzer

Nebulizer

Heliox

Stress Index

Open Lung Tool

(OLT)

Automode

Bi-Vent

VS (Volume Support)

PRVC (incl. SIMV (PRVC) + PS)

VC (incl. SIMV (VC) + PS)

PC (incl. SIMV (PC) + PS)

PS/CPAP

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

2 SYSTEM OVERVIEW

TABLE OF CONTENTS

2.2 symbols

| System Overview |

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

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

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2.1 VENTILATOR

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

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

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

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

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

1. Air and O2 supply

2. Power cable

3. User Interface

4. Patient Unit

5. Expiratory inlet

6. Servo Duo Guard, viral/bacterial filter

7. Inspiratory outlet

8. Patient circuit

9. Module compartment

10. Emergency air intake

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

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2.2 USER INTERFACE - CONNECTIONS, LABELS AND SYMBOLS

The User Interface includes:

a screen with active touchpads

fixed keys

rotary dials

2.2.1 USER INTERFACE DIAGRAM

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2.2.2 USER INTERFACE COMPONENTS

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

1. Current Patient category

2. Current mode of ventilation

3. Automode On/Off (option)

4. Admit patient/Entered patient data and admission date

5. Nebulizer On/Off (option)

6. System status parameters

7. Fixed keys

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

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

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

11. AC Power indicator (green)

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

13. Start/Standby key

14. On/Off switch (rear side)

15. Slot for Ventilation Record Card (front view)

16. Luminescence detector—for automatically adjusting screen brightness

17. Text messages, including patient triggering symbols

18. Alarm messages

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

20. Measured values and alarm limits display (customizable)

21. Additional settings

22. Additional measured values

23. Loudspeaker

24. Cable reel for the control cable

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

26. Locking lever for rotation

27. Locking screw for alternative cart mounting

28. Holder for positioning on the Mobile Cart

29. Control cable (2.9 m long)

30. Service connector

31. On/Off switch

32. Locking lever for tilting

33. Model number

34. Serial number

35. Manufacturing information

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

2.2.3 USER INTERFACE SYMBOLS

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12 V

DescriptionSymbol

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

Audio off

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

Alarm on

Alarm off

Attention—consult documentation Note: This symbol may be different

depending on User Interface version

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

Start ventilation/Standby—yellow indicates Standby

Power indicator—green indicates AC power connected

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

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

ON/OFF switch

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

Indicates that the system is compensated for Heliox.

Infant patient category

DescriptionSymbol

Volume Control with decelerating flow

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

Adult patient category

Volume Control with flow adaptation

Volume Control without flow adaptation

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2.3 NAVIGATING THE USER INTERFACE

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

2.3.1 TOUCH SCREEN

To adjust ventilator settings:

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

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

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

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

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

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

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

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2.3.2 MAIN ROTARY DIAL

SVX-6021_XX

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

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

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

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

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

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

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

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2.3.3 FIXED KEYS

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

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

The keys in group 2 start special ventilatory functions

Important: The special ventilatory functions require continuous supervision.

2.3.4 DIRECT ACCESS KNOBS

Using Direct Access Knobs

To adjust a breathing parameter directly:

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

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

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

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

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Direct Access Knobs - Safety

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

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

The figure above shows the following components.

1. A Direct Access Knob

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

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

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2.3.5 MENU KEY

To access the user interface windows:

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

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

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

Press any of the following touchpads.

4. Alarm

5. Review

6. Options

7. Compensate

8. Copy (to Ventilation Record Card)

9. Biomed

10. Panel lock

11. Change patient category (option)

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

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2.3.6 STATUS TOUCHPAD

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

To access the status window:

1. Press the Status touchpad.

Touchpads leading to status windows appear.

Press any of the following touchpads.

2. General

3. O2 cell / O2 Sensor

4. Expiratory cassette

5. Batteries

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

7. Installed Options

8. Pre-use check

9. Patient Circuit

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

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2.4 PATIENT UNIT - CONNECTIONS, LABELS AND SYMBOLS

The patient unit consists of the following components:

gas supplies and their connectors

power supplies and their connectors

connectors for accessories

2.4.1 PATIENT UNIT DIAGRAM

0123

12V

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

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2.4.2 PATIENT UNIT COMPONENTS

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

21. Cover, inspiratory channel

1. Handle

2. Gas inlet for air

3. Gas inlet for O

4. Air / Luft

5. O

6. Model number

22. Expiratory inlet

23. Battery lock

24. Module compartment

25. Nebulizer connector

26. Inspiratory outlet

27. Emergency air intake

7. Serial number

8. Manufacturing information

9. Equipotentiality terminal

10. Label

11. AC power supply connector with fuse

12. Cooling fan with filter

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13. Alarm output connection

14. RS-232 connector

15. External +12V DC inlet

16. Fuse for external DC power supply

17. Optional connector

18. User interface connector

19. RS-232 connector

20. Expiratory outlet

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2.4.3 PATIENT UNIT SYMBOLS

&  86

E 01

ExplanationSymbol

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

CSA label—Indicates compliance with Canadian and US standards

PCT label - indicates compliance with Russian standards

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

Equipotentiality terminal Note: The equipotentiality terminal

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

Nebulizer Connector

12V

ExplanationSymbol

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

depending on Patient Unit version.

Expiratory label—gas flow from patient.

Inspiratory label—gas flow to patient.

Gas exhaust port label—exhaust gas flow from ventilator

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

Alarm output connection—external alarm output communication

Special waste. This product

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

Caution

RS 232 / Serial port—connector for data communication.

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

User Interface connector Note: This symbol may be different

depending on Patient Unit version.

Optional connector / Expansion Note: This symbol may be different

depending on Patient Unit version.

10A Fuse for external DC power supply.

Consult Instructions for use

Batteries

Weight - Patient unit and User interface.

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

+ 243 hidden pages

Maquet Servo-i User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

TABLE OF CONTENTS

1 INTRODUCTION

1.1 DEVICE DESCRIPTION

1.1.1 DEVICE DIAGRAM

1.1.2 DEVICE COMPONENTS

1.1.3 INTENDED USE

1.1.4 INTENDED USER

1.1.5 INTENDED USE ENVIRONMENT

1.1.6 CLEANING AND MAINTENANCE

1.1.7 SERVICING GUIDELINES

1.1.8 DISCLAIMERS

1.2.1 GENERAL

1.2.2 POWER SUPPLY

1.2.3 FIRE HAZARD

1.2.4 GASES

1.2.5 AUXILIARY EQUIPMENT

1.3 VERSION AND CONFIGURATIONS

1.3.1 CONFIGURATIONS

1.3.2 CONFIGURATION LABELS

1.3.3 AVAILABLE OPTIONS

2 SYSTEM OVERVIEW

2.1 VENTILATOR

2.2 USER INTERFACE - CONNECTIONS, LABELS AND SYMBOLS

2.2.1 USER INTERFACE DIAGRAM

2.2.2 USER INTERFACE COMPONENTS

2.2.3 USER INTERFACE SYMBOLS

2.3 NAVIGATING THE USER INTERFACE

2.3.1 TOUCH SCREEN

2.3.2 MAIN ROTARY DIAL

2.3.3 FIXED KEYS

2.3.4 DIRECT ACCESS KNOBS

2.3.5 MENU KEY

2.3.6 STATUS TOUCHPAD

2.4 PATIENT UNIT - CONNECTIONS, LABELS AND SYMBOLS

2.4.1 PATIENT UNIT DIAGRAM

2.4.2 PATIENT UNIT COMPONENTS

2.4.3 PATIENT UNIT SYMBOLS