MAQUET FLOW-i User Manual

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User's Manual

FLOW-i 4.2

Anesthesia System

| Table of contents |

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

5|Introduction

9|Important 17|System overview 47|Startup and system checkout 65|System functionality

FLOW-i 4.2, User's Manual Infologic 1.67

| Table of contents |

FLOW-i 4.2, User's Manual

Infologic 1.67

1 Introduction Table of contents

| Introduction |

6|Indications for use1.1

6|Intended use1.2

7|Using this manual1.3

1 |

FLOW-i 4.2, User's Manual

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1.1 Indications for use

The indication for FLOW-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation anesthesia administration.

1.2 Intended use

The system is intended for use in administrating anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.

The system is intended for use by healthcare professionals, trained in the administration of anesthesia.

The system is intended for use on neonate to adult patient populations.

The system is intended for use in hospital environments, except the MRI environment.

When not in operation, the system is designed for in-hospital transport.

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1.3 Using this manual

This manual is divided into the following chapters:

• Chapters 1 and 2: Important information

before use, along with a basic introduction to the system and User's Manual.

• Chapter 3: Overview of the functional parts

of the system.

• Chapters 4 through 11: Understanding and

working with the system.

• Chapter 12: Routine cleaning and

maintenance procedures.

• Chapter 13: The technical specification of

the system.

• Chapter 14: EMC Declaration

• Chapter 15: Terminology and definitions

• Chapter 16: Certificates

• Chapter 17: Index

Important information is highlighted with Warning or Caution, 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.

• Chapter 18: Log sheets

References made to optional accessories within the FLOW-i User's Manual are accompanied by the text 'option' in brackets.

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FLOW-i 4.2, User's Manual

2 Important Table of contents

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2.1 General information

• The following applies throughout this User's

Manual:

- 'FLOW-i', 'anesthesia system' and

'system' represent FLOW-i anesthesia system version 4.2.

• This manual applies to the FLOW-i

anesthesia system models C20, C30 and C40, and optional equipment that can be fitted onto these.

• Only authorized personnel who are well

trained in its use should operate the anesthesia system. It must be operated according to the instructions in this User's Manual.

• Gas volumes, flows and leakages

associated with the breathing system are stated in the technical specifications and adhere to BTPS reference conditions. (Body temperature, ambient pressure, Saturated).

• All gas concentration readings are normally

referenced to dry gas conditions, ambient room temperature and atmospheric pressure (ATPD).

• The condition for measured inlet gas

pressures and flows is STPD (Standard Temperature and Pressure Dry); 20° C, standard pressure at 101.3 kPa and 0 % relative humidity (dry).

• All data on pressures are given in either

cmH2O or bar, where 1 cmH2O = 1 hPa = 1 mbar 1 bar = 15 psi = 1 atm = 1 kgf/cm2 (kp/cm2)

• The anesthesia system is not made with

natural latex.

• Applied parts, i.e. equipment making

physical contact with the patient, comprise gases (including agents) and the patient mask.

• If the mains power supply is interrupted,

the internal battery will provide temporary power to the system (approx. 90 minutes when fully charged).

• The fresh gas/gas supply outlets are not

affected by switch to battery power.

• Malfunction of the central gas supply can

potentially cause one or several of the devices connected to the system to stop their operation simultaneously.

• When the system is in use, a backup gas

supply shall always be available.

• If the central gas supply is interrupted, the

backup gas cylinders O2/N2O or O2/Air (option) will provide gas to the system.

• In case of automatic ventilation failure,

switch to manual ventilation. In case of manual ventilation failure, switch to emergency ventilation.

• In case of a total power (mains power and

battery) or other electronic failures, the built-in emergency ventilation system can be used.

• The system maintains its performance when

tilted up to two degrees.

• In case of a complete system failure,

immediate access to alternative means of ventilation, e.g. a manually powered resuscitator, must be ensured to avoid possible patient injury.

• MAQUET takes full responsibility for

compliance of the CE mark requirements for the MAQUET CO2 cartridge produced by Molecular Products Ltd (MPL). MAQUET takes full responsibility for the supply of the instructions for use in accordance with the legislation relevant for the intended use for this product.

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WARNING! To avoid the risk of electric

shock, this equipment must only be connected to a supply mains with protective earth.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

2.2 Connection

• A full System checkout procedure must be

performed at least once a day.

• The system must never be left unattended

while connected to a patient.

• Electronic accessories and auxiliary

equipment other than the vaporizers must not be connected or disconnected during operation or when the system is plugged into a mains power outlet. Such connection or disconnection may interfere with the functioning of the system.

• Supplied gases shall meet the requirements

for medical grade gases according to applicable standards.

• The backup gas supply should only be

turned ON (valves open) when the backup gas supply is in use, or during System checkout.

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2.3 Operation

• The system shall always be used in

combination with other vital signs monitoring devices and/or professional human judgements of patient condition.

• To protect the patient from high airway

pressure, an upper pressure limit must always be set. See Chapter 10 for details.

• To protect the patient, an alarm limit must

always be set for low expired minute volume. See Chapter 10 for details.

• Only anesthetic agents recommended by

MAQUET are suitable for use.

• Anesthetic agent bottles without keying may

not be used with the system, nor is it allowed to tamper with the keying of anesthetic agent bottles.

• Ensure that the operating room is properly

ventilated.

• The system is not intended for use during

interhospital transportation.

• The system is not intended for use in an MR

environment.

• Antistatic or electrically conductive

breathing tubes should not be used. If such breathing tubes are used in combination with high frequency electric surgery equipment, burns may occur.

• To allow for mains power disconnection,

make sure that the power cable connected to the mains power supply remains visible and fully accessible during patient treatment and not obstructed in any way by ME (Medical Electrical) equipment.

• If the integrity of the protective earth

conductor or the protective earthing system in the installation is in doubt, unplug the mains power cable and use battery power.

• The equipotentiality terminal is designed for

the connection of a potential equalization conductor according to DIN 42 801 and 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.

• The anesthesia system has been designed

and tested to comply with requirements specified in electromagnetic compatibility standard IEC 60601-1-2. It is the responsibility of the user to take necessary measures to ensure that the EMC environment in which the workstation will be used is compatible with the requirements of IEC 60601-1-2 and that the installation is carried out according to the EMC information. See Chapter 16 for details on EMC environments. If limits are exceeded, the accuracy and safety of the system may be impaired. Proactive measures include, but are not limited to, avoiding the use of portable and mobile radio-emitting devices, such as cellular phones and high frequency apparatus, in the proximity of the system.

• Full performance is reached after a 15

minute warm-up. In case of an emergency, the system can be used immediately.

• FLOW-i shall be connected to a

centre-tapped single phase supply circuit when connected to a 240 Vac (L1-L2-N-GND) supply in the United States.

• The breathing system can handle negative

pressures down to -200 cmH2O, but is not designed to withstand pressures below that.

• The operator must not touch the patient

and any of the following parts simultaneously:

Accessible contacts of connectors-

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- Contacts of fuse holders that are accessible during replacement of the fuse.

- Contacts of lamp holders that are accessible after removal of the lamp.

- Parts inside access covers that can be opened without the use of a tool, e.g. patient cassette lid connector.

WARNINGS!

• In case of system failure, the lack of

immediate access to appropriate alternative means of ventilation can result in patient injury.

• Gas inlets and outlets shall not be

covered or in any other way be obstructed.

• FLOW-i is not designed to be resistant

to direct exposure to high ionizing radiation. Such exposure may result in memory erasure and/or interruption of ventilation.

2.4 Installation and service

• Installation, service and maintenance of the

system must be performed by personnel trained and authorized by MAQUET.

• Instructions for installation, service and

maintenance, i.e. a service manual, is available for personnel trained and authorized by MAQUET.

• Only original spare parts from MAQUET

must be used in the system.

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2.5 Accessories and auxiliary equipment

• External equipment intended for connection

to signal input, signal output or other connectors shall comply with relevant IEC standards (e.g. IEC 60950 for IT equipment and the IEC 60601 series for medical electrical equipment). In addition, all such combinations – systems – shall comply with the standard IEC 60601-1 'Safety requirements for medical electrical systems'. Equipment not complying with IEC 60601-1 shall be kept outside the patient environment, as defined in the standard.

• Any person who connects external

equipment to signal input, signal output or other connectors has formed a system and is therefore responsible for ensuring that the whole system complies with the requirements of IEC 60601-1. If in doubt, contact a qualified medical technician or your local representative.

• For optional equipment and accessories,

refer to the user documentation supplied by the manufacturer.

• Use of an anesthesia gas scavenging

system is compulsory and must comply with ISO 7396-2 (wall connection) and ISO 80601-2-13 (tubings).

• Values measured at the signal outputs of

the anesthesia system, 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, and according to established and accepted practice.

• If there should be any deviation between

information shown on the system and that shown by auxiliary equipment, the parameters shown on the system shall be considered the primary source of information.

• When electrical equipment is connected to

the auxiliary power outlet or communications interface, a medical electrical system (ME system) is effectively created, potentially reducing the level of safety. This could result in previously unidentified risks to patient, users or third parties. It is the responsibility of the user to ensure that the connected equipment is compatible with the requirements of IEC 60601-1.

• Connecting auxiliary equipment to the

auxiliary power outlet can potentially increase leakage currents to values above the allowable limits.

• External monitors or similar devices

connected to the VGA port of the system, must be powered via a medical grade isolation transformer. No other use is allowed.

• The responsible organization should

identify, analyze, evaluate and control these risks.

• Subsequent changes to the medical

electrical system could introduce new risks and require additional analysis.

• Changes to the medical electrical system

include configuration changes, connection of additional items, disconnection of items, update or upgrade of connected equipment.

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• The use of O2 and Air gas outlets may,

depending on central gas supply pressure and ventilation settings, affect ventilation performance.

• Reprocessing parts labelled 'Single-use'

will degrade biocompatibility and cleanliness.

WARNINGS!

• The use of other accessories,

transducers and cables other than those specified by MAQUET may result in increased emissions or decreased immunity (EMC) of the system.

• No other electrical equipment other than

those described in this user's manual may be placed on, or in the immediate vicinity of the system.

• The patient monitor power connector

must only be used for patient monitors or equipment mounted on the top shelf.

CAUTIONS:

• Only MAQUET recommended

accessories, supplies and auxiliary equipment must be connected to or used in conjunction with the system. Use of other unvalidated accessories, supplies and auxiliary equipment may impair the performance and safety of the system.

• To prevent the system from tilting, follow

the restrictions for patient monitors and auxiliary equipment specified in Chapter 15, page 268. Maximum torque on the side rails by the table is 20 Nm.

• Equipment placed on shafts or rails must

not restrict opening of the Emergency Ventilation cover.

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FLOW-i 4.2, User's Manual

3 System overview Table of contents

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The anesthesia system is designed to enable the operator to work with the basic parts of the system in the most suitable way for each procedure. As the system is mounted on wheels, and the control panel is mounted on a rotatable arm, it can be easily moved into an ergonomically-suitable position.

There are a number of different system models available. For more information on the different models, see page 40.

3.1 System parts

The system comprises the following basic parts:

220-240V~ 400 VA

T 1.6 A

250 V

T 4 A 250 V

5. Emergency ventilation system1. Control panel

2. Patient monitor (option) 6. Vaporizer unit

7.3. Additional arm 'A' (option) and/or

Breathing system

Gas backup holder 'B' (option)

4. External connections

1. C30 can only be equipped with the additional arm or the extra backup gas holder.

FLOW-i 4.2, User's Manual

3.2 Control panel

01-01 13 00

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312

The control panel includes:

1. Screen with active touch pads

2. Rotary knob

3. Membrane buttons

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3.2.1 Areas of the screen

11 12 13

5 2 1

4 3

The screen is divided up into a number of different areas:

1. Ventilation direct access settings

2. Gas direct access settings

3. Activate additional settings/gas settings window

4. Fresh gas mix rotameter

9. Tab area:

- Short trends

- Loops

- Volume Reflector Indicator

- Gas supply pressure

5. APL valve value

6. Gas measurement area

7. Ventilation measurement area

8. Waveform area

10. Current alarm and status area

11. Alarm functions

12. Timer

13. Mode indicator

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The touch screen and rotary knob allow the operator to control the primary functions of the anesthesia system, where the patient's condition is monitored through measured values and waveform displays.

Measured values and waveforms are displayed on the screen in the following color groups:

Color for measured values and waveforms

YellowPressure GreenFlow BlueVolume

Light grayCO WhiteO BlueN2O GrayMAC PurpleIsoflurane BlueDesflurane YellowSevoflurane

Messages are displayed in the Alarm message area or System message area. The following color scheme is adopted:

Color for alarms and system messages

High priority alarms

Medium priority alarms

Low priority alarms

Technical alarms, i.e. alarms with the prefix TEXXX, where XXX is an integer.

System messages

Black text on red background

Black text on yellow background

Black text on blue background

Black text on red, yellow or blue background, dependent on priority (high/medium/low)

White text on black background

A detailed description of alarms and patient safety is found in Chapter 10.

The colors for O2 and N2O in the above table may vary due to country-specific standards.

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3.2.2 Navigating the screen

There are several ways of navigating the screen and setting values.

Using the touch screen

1. Press the required touch pad. The touch pad becomes active, which is indicated by a blue highlight.

2. Turn the rotary knob to the required value.

3. Press the touch pad to confirm setting.

An activated touch pad is only active for 20 seconds. The system will prompt the user to enter a value when 10 seconds have passed. If no value is entered and confirmed within the following 10 seconds, the touch pad setting returns to its previous setting and is deactivated.

Using the rotary knob

1. Turn the Rotary knob to move between the touch pads on the screen. The selected touch pad is indicated by a blue

frame.

2. On required touch pad, press the rotary knob to activate the touch pad. This will highlight the touch pad in blue.

3. Turn the Rotary knob to the required value.

4. Press the Rotary knob to confirm setting.

FLOW-i 4.2, User's Manual

Active screen

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Pressing any of the areas labelled with a number in the illustration, displays a window according to the table below.

7. Mode indicator area

9. Tab area (displayed window depends on selected tab)

Dialog/window producedScreen area

Multiple windows, see Chapter 51. Gas settings/ Ventilation settings Patient category, see Chapter 5, page 75.2. MAC value Alarm profile window, see Chapter 10, page 187.3. Gas measurement area Alarm profile window, see Chapter 10, page 187.4. Ventilation measurement area Patient category, see Chapter 5, page 75.5. Patient category symbol Alarm profile window, see Chapter 10, page 187.6. Alarm functions Ventilation mode selection, see Chapter 5, page

87. Waveforms and scales, see Chapter 9, page 163.8. Waveform area

- Waveforms and scales, see Chapter 9, page 163.

- Screen layout, see Chapter 9, page 163.

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3.2.3 Touch pad settings

A range bar is located at the bottom of all ventilation and gas touch pads, where a numeric value can be specified by the user. If the entered value deviates too far from the norm given the current ventilation mode and other parameter settings, the bar will change color according to the table below.

DescriptionTouch pad setting

A black range bar indicates normal

0 120

cmH20

0 120

cmH20

0 120

cmH20

parameter setting.

A yellow range bar indicates that the parameter setting is high (or low, depending on the parameter).

A red range bar indicates that the parameter setting is very high (or very low, depending on the parameter).

3.2.4 Membrane buttons

The change in color of the range bar is accompanied by a system message that remains displayed on the screen until the trigger condition is relieved.

1. Audio pause

2. Alarm profile

3. Start case

4. End case

5. Save screen

6. Trends

7. Start/Stop timer

8. Reset timer

9. Home

10. Screen layout

11. Menu

See Chapter 9 for more information.

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3.3 Patient monitor (option)

The system can be connected to a selection of different patient monitors. For full details, contact your local MAQUET representative.

The patient monitor must comply with IEC 60601-1 ed. 3.

During mains power failure, the backup battery in the anesthesia system will not power the patient monitor.

3.3.1 Panel interchangeability

If desired, the placement of the control panel and the patient monitor can be switched so that the patient monitor is placed on the display arm. This procedure shall only be performed by a service technician trained and authorized by MAQUET. Contact your local MAQUET supplier for more information.

3.4 Breathing system

The breathing system comprises the following:

1. Patient cassette

2. O2 flush

3. MAN/AUTO ventilation switch

4. APL valve

5. Volume reflector

6. AGS (Anesthetic Gas Scavenging) flow indicator

7. Patient tubing

8. Manual breathing bag with tubing

9. Y-piece

10. AFGO - Additional Fresh Gas Outlet (option)

11. Water trap and sampling line

12. CO2absorber

13. Auxiliary O2 and suction module (option)

FLOW-i 4.2, User's Manual

MAQUET recommends that a bacterial/viral filter is always connected to the expiratory connection on the patient cassette. This will minimize the risk of cross-contamination.

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3.5 Vaporizer unit

The vaporizer unit holds one to two vaporizers, where vaporizers can be selected for the following agents:

• Isoflurane

• Sevoflurane

• Desflurane

3.6 Emergency ventilation system

10 8

mbar / cmH2O

6 4 2

I/min

Emergency ventilation

I/min

In case of a total power (i.e. mains power and battery) or system failure, this system will allow the patient to be manually ventilated. The emergency ventilation system comprises:

1. Activation switch

2. O2 gas supply and flowmeter, graded up to 10 l/min.

3. Mechanical APL

8 6 4 2

I/min

Not for use with AFGO

APL

mbar / cmH2O

APL

1 3

WARNING! If the emergency ventilation system is activated while the anesthesia system is in operation, the anesthesia system will be shutdown.

FLOW-i 4.2, User's Manual

3.7 External connections

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Air

N2O

The following external connections exist on the system:

1. Power supply and fuses

2. Gas connections

3. Input/Output ports

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3.7.1 Power supply and fuses

4 5

1. Auxiliary power outlets fuse 2A (option)

2. Auxiliary power outlets (option)

3. Auxiliary power outlets fuse 1A (option)

4. Auxiliary power outlets fuse 1A (option)

5. Patient monitor fuse (option)

6. Isolation transformer fuse (option)

7. Mains power inlet fuses

8. Lift fuses (C30 model only)

9. Mains power inlet

10. Equipotential terminal (earth)

The patient monitor outlet and the auxiliary power outlets do not have a battery backup.

Auxiliary power supply outlet connections vary depending on country specific standards.

In addition to the individual fuses, the maximum current delivered through the system is regulated by a shared fuse.

In case of mains power failure, a battery backup will power the system for a limited time.

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WARNING!

Restrictions apply to the use of auxiliary power outlets:

• Outlets must not be used to power life

support equipment unless the life support equipment itself is equipped with battery backup.

• A multiple socket extension cord must

not be connected to any of the outlets.

CAUTION: The auxiliary power outlets shall only be used for supplying power to equipment intended to form part of the medical electric system.

For more details on the power supply and status, see Chapter 10, page 203.

3.7.2 Gas connections

FLOW-i 4.2, User's Manual

1. O2 outlet (option)

2. O2 inlet

3. Air outlet (option)

4. Air inlet

5. N2O inlet

6. AGS outlet (country-specific connections)

7. Gas cylinder inlets for O2, Air and N2O (option)

If equipment with high gas consumption are connected to the gas outlets, the central gas supply pressure should be above 3 bar (300 kPa, 44 PSI). Make sure that the central gas supply is sufficient for the extra equipment.

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The intended use for the Auxiliary O2 outlet is to provide oxygen for patient therapy.

The intended use for the Auxiliary AIR outlet is to provide drive gas for small ejector driven suction devices.

Maximum allowed air flow from each of the O

and Air outlets is 60 l/min.

The central N2O gas supply (wall supply) is connected to the system via a pressure regulator attached to the N2O gas inlet.

3.7.3 Input/Output ports

2 3 4

1. RS232 serial data communication ports

2. Control panel connection

3. VGA connector

4. USB port

5. Network connection

6. Cable restrainer

The intended use of the USB port is only for USB memory flash drives. Restricted items include, but are not limited to, external hard drives, USB hubs and any equipment using the USB port primarily as a power source.

Clinical situations that require high gas consumption might affect the supply gas pressure.

If the gas supply is low, i.e. close to 2.5 bar (250 kPa, 36 PSI), the system's ability to deliver gas according to all possible settings might be compromised by additional gas hoses and connections.

FLOW-i 4.2, User's Manual

The network connection (LAN) port is for service use, and should only be used by personnel trained and authorized by MAQUET.

External cables connected to the I/O ports must be secured using cable restrainers where available.

CAUTION: The operator must not touch any of the input/output ports, e.g. RS232, VGA connector and USB port, and the patient simultaneously.

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3.8 Explanation of symbols

3.8.1 Labels

The following symbols are shown on the system:

DescriptionSymbol

CE label. The device complies with the requirements of the

0123

C US

European Council Directive 93/42/EEC (i.e. the Medical Device Directive).

CSA label—Indicates compliance with Canadian and US standards

Manufacturer

Manufacturing date

2012

UDI Label - Unique Device Identification. See technical specifications, page 290.

Class 1 equipment, Type B. The device classification according to IEC 60601-1.

Federal law restricts this device

to sale by or on the order of a physician.

ONL

IP classification: IPX1, drip proof

IPX1

LOT

DescriptionSymbol

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

White drawing on a blue background. Consulting accompanying documentation is a mandatory action.

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

Use by date

Black cross over an orange background. Broken CO absorber canisters may cause skin irritation.

Use no oil. Applicable to parts marked with this symbol.

Serial number

Batch code

Article number

Do not use if packaging is damaged

Black border, black exclamation mark over a yellow background. Indicates critical information about a potentially serious outcome to the patient or the user.

Special waste to be disposed of in accordance with appropriate industrial and environmental standards.

Caution must be taken when moving the system up or down a slope. Refer to Transport conditions, page 38.

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365 kg

DescriptionSymbol

Medical device maximum weight (C20 with three drawers). C30 and C40 are lighter, see technical specifications, page

266. Red circle with a single red line

over a black drawing. Pushing prohibited

Red circle with a single red line over a black drawing. Stepping prohibited

Red circle with a single red line over a black drawing. Sitting prohibited

Lift button, 10% lift dutycycle, for more information see Chapter

7, page 146.

Manual (MAN) ventilation

Autoclavable

DescriptionSymbol

CO2 absorber connected and locked in position

CO2 absorber bypassed

CO2 absorber unlocked, vaporizer unlocked, patient cassette unlocked, wheel brake unlocked

Wheel brake locked

Labelled part may be disinfected using a steam autoclave

Use centre of floating ball as reference when reading from the Auxiliary O

flow scale

Inspiratory connection to the patient cassette

FLOW-i 4.2, User's Manual

Automatic (AUTO) ventilation

Manual breathing bag connection

Y-piece connection for System checkout

Equipotentiality terminal.

Mains power On Off button

Insp.

Expiratory connection to the patient cassette

Exp.

O2 flow meter/suction equipment

O2 flush

02 +

Anesthesia Gas Scavenging

AGS

Home touch pad symbol, see Chapter 9, page 162

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Emergency ventilation

Not for use with AFGO

N O

2 . 5 - 6.5 k Pa x 10 0 ( 3 6 - 94 p s i )

DescriptionSymbol

Timer touch pad symbol, see Chapter 9, page 162

Emergency ventilation

Not for use with AFGO. Emergency O

flow is always

delivered through the patient cassette.

N2O inlet pressure range: 250-650 kPa/2.5-6.5 bar/36-94 PSI

AFGO Max 120 mbar/cmH2O

Reading lamp

Cylinder gas inlet

DescriptionSymbol

Data communication input/output ports

Fuse

Control panel connection

VGA connection

USB connection

RS232

Backup gas system pressure increase/decrease

RS232 serial port

Gas supply inlet

Gas supply outlet

Network connection

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3.8.2 Screen-displayed symbols

The following symbols are shown on the screen:

DescriptionSymbol

Standby mode

Active alarm

Multiple active alarms

Audio pause, pre-mute alarm, mute active alarm or remove resolved alarms.

Audio off

Alarm off

Power indicator - indicates AC power connected

Infant

60 58

2:00

88 min

DescriptionSymbol

Overlay loops

Numerical trends selected

Graphical trends selected

Activates a cursor in the trends display window, and allows for use of the rotary knob to scroll through values.

Checkbox - can be selected to mark an option or to choose a feature for display on the screen

Gas analyzer has no information to display

Audio pause—silence or confirm an alarm

Power indicator - indicates battery operation, along with estimated time remaining

FLOW-i 4.2, User's Manual

Adult

Ventilation mode indicator

Manual ventilation selected

Automatic ventilation selected

Reference loop

Timer activated

02:35:10

Date and time

08-19 16 04

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3.9 Ergonomical positioning

• The C20 and C30 systems are on wheels

and can be rotated 360°.

• The C40 system is mounted onto a ceiling

pendant and can be moved and rotated as allowed by the pendant solution.

• The control panel can be tilted up and down

15° and rotated 220° (without moving the display arm).

• The display arm can be rotated 170°.

• The height of the C30 working surface can

be set anywhere between approx. 30 in. and 40 in.

3.9.1 Using the brake

Once a suitable position has been found, the wheels should be locked into position.

1 2

1. Push the brake down to lock the wheel.

2. Push the brake up to unlock the wheel.

CAUTION: Be careful when moving the display arm to avoid damaging equipment placed on the writing table or top shelf.

FLOW-i 4.2, User's Manual

3.9.2 Working position

The flexibility of the system allows the operator many alternative working positions:

Examples of working positions

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3.10 Storage and transportation

3.10.1 Before transport

• If the system is to be moved to another

room or transported a longer distance, ensure mounted accessories are securely attached to the system.

• The C40 system is intended for transport

inside the operation room only when undocked from the ceiling pendant. Transportation to other locations requires the use of a suitable cart or trolley according to hospital routines.

CAUTION: Make sure extra equipment and accessories, e.g. support arm and additional table, are folded close to the system during transport to minimize the risk of tipping. The display arm should be positioned as shown in the illustration.

3.10.2 During transport

• Move the system using the handles on the

main unit and not those on the control panel or patient monitor. This will reduce the risk of tipping and/or system damage.

• If the optional extra table is installed, make

sure it is folded into a vertical position.

• Be careful when moving the system down

a slope.

FLOW-i 4.2, User's Manual

3.10.3 Storage

• During storage keep the system connected

to the mains power supply so that the batteries maintain a full charge.

• If the system is disconnected from a power

source, ensure the batteries are fully charged before storage to avoid deterioration of battery performance.

• When the system is disconnected from a

mains power supply, a fully charged battery can be stored in the FLOW-i system for up to six weeks at temperatures between +5°C (+40°F) and +40°C (+105°F). At temperatures between +50°C (+125°F) and 60°C (+140°F) storage time is one week. If these limits are exceeded, battery performance can no longer can be guaranteed.

• MAQUET recommends that the vaporizers

are emptied before long term storage (>30 days).

• For fire safety purposes, the system

requires functional batteries for system Startup.

• Ensure the system is not exposed to

temperatures below -25oC (-13oF) or above +60oC (140oF).

• For information on CO2 absorber storage,

see Chapter 7, page 128.

• Ensure the system is not exposed to a

relative humidity above 95%.

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FLOW-i 4.2, User's Manual

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3.11 System models

The anesthesia system is available in different models:

• C20

• C30

• C40

The following table shows the standard equipment for these different models (main components):

C40C30C20

• Working surface/writing table

• Reading lamp

• Two drawers, one lockable

• Battery for approx. 90 minutes

support (fully charged)

• Vertical shafts for optional

horizontal rails

• Four wheels with individual

locking brake

• Height adjustable

• Working surface/writing table

• Reading lamp

• One lockable drawer

• Battery for approx. 90 minutes

support (fully charged)

• Vertical shafts for optional

horizontal rails

• Four wheels with individual

locking brake

• Ceiling pendant

• Working surface/writing table

• Reading lamp

• One lockable drawer

• Battery for approx. 90 minutes

support (fully charged)

• Vertical shafts for optional

horizontal rails

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3.12 Optional equipment

Not all listed optional equipment may be available in your country, contact your local MAQUET representative for more information.

3.12.1 Vaporizer holder

The vaporizer holder provides easy access to an additional vaporizer during surgical procedures.

The vaporizer holder may only be installed or moved by a service technician trained and authorized by Maquet.

FLOW-i 4.2, User's Manual

Attaching a vaporizer

Slide the vaporizer into the slot until the front locks into place (A).

To remove the vaporizer, lift up the front and gently pull outwards.

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3.12.2 Universal bracket for C20

The universal bracket for C20 is intended for use with the FLOW-i C20 model only. It provides additional space for mounting accessory equipment.

3.12.3 Manual breathing bag support arm

The support arm provides a static and secure support for the manual breathing bag and associated tubings.

The support arm shall only be used to secure the manual breathing bag and associated tubings.

The universal bracket is permanently attached to the core unit, and shall only be removed by a service technician trained and authorized by MAQUET.

Maximum dimensions of mounted equipment is approximately 430x340x180 mm (WxHxD).

Always ensure mounted equipment is properly secured before starting a patient case.

Connection

The support arm is fastened to the vertical railing on the core unit by turning the fastening knob (A).

FLOW-i 4.2, User's Manual

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3.12.4 EVAC Restrictor

The EVAC restrictor acts to reduce the pressure difference between high vacuum evacuation systems and the FLOW-i AGS outlet. This ensures proper gas evacuation without adverse side effects.

The EVAC restrictor may only be installed by a service technician trained and authorized by Maquet.

AGS hose assemblies connected to the system shall comply with ISO 80601-2-13.

If equipped with alternate connector systems, the connectors shall comply with DISS: CGA-V5:2008 (WAGD), SS 875 24 30:2004 (UTS).

Restrictor unit

3.12.5 Cable support arm

To organize and manage cables connecting the patient to the patient monitor, a cable support arm can be attached to any of the system's four vertical shafts.

The arm can be bent and angled to provide the most suitable cable arrangement. Ensure that the emergency ventilation hatch is not obscured by the cable support arm.

The apropriate evacuation flow is achieved by turning the adjusting knob (A), so that the evacuation floater in the AGS flow meter hovers above the dashed area. This ensures sufficient evacuation flow.

FLOW-i 4.2, User's Manual

The cable support arm is to be used for electrical cables only. It shall not be used for patient tubings or any other equipment.

The maximum load is 1.1 lbs.

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3.12.6 Top shelf

The top shelf is attached to the display column. Various types of equipment, e.g. parameter box and patient monitor, can be used in combination with the shelf.

20”

CAUTIONS:

• The maximum load of the top shelf is 20

kg. Applies to all system models.

• The size and placement of equipment

mounted on the top shelf must be constrained to the following dimensions:

- Height: 20 in.

- Width: 14 in.

- Depth: 18 in.

• Ensure that equipment mounted on the

top shelf is properly fastened.

• Be aware of equipment mounted on the

top shelf when moving the display arm.

The top shelf, along with any associated equipment, shall be assembled by a hospital technician.

FLOW-i 4.2, User's Manual

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3.12.7 Vaporizer slot cover

The vaporizer slot cover is intended to protect the gas and electrical connections inside the vaporizer slot when no vaporizer is connected.

1 2

Slide the cover at a slight angle into the vacant vaporizer slot until it locks into place..

3.12.8 Backup gas system

The backup gas rack and backup gas cylinder holder are described in Chapter 10, page 204.

FLOW-i 4.2, User's Manual

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FLOW-i 4.2, User's Manual

4 Startup and system checkout Table of contents

| Startup and system checkout |

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4.1 System startup

• Start the system by means of the Power

button found directly above the Emergency ventilation system.

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4.2 System checkout

01-01 13 00

1 2

A prompt to start the System checkout procedure is automatically displayed at system startup:

1. Bypass the System checkout

2. Start the System checkout

To ensure correct system functionality, optimal performance and patient safety, the System checkout procedure must be performed as follows:

• Once a day, or before connecting the first

patient within a running 24 hour period.

• After replacing the patient cassette.

• After the system has been transported.

If the system needs to be used immediately, i.e. during an emergency, values and results from the last successful System checkout remain in effect.

Press the Start touch pad in the System checkout window to begin the procedure.

The System checkout can also be initiated via the Menu membrane button during Standby, see Chapter 9, page 166.

The procedure includes the following main areas:

• Preparations

• Checks requiring user interaction

• Automatic checks

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4.2.1 Preparations

01-01 13 00

The first part of the System checkout procedure ensures that the system is correctly prepared for use.

6 7 8 9

An in-depth description of the different steps is presented in the table on page 52.

Check the components listed on the screen and press the 'Continue' touch pad located in the bottom right of the screen when finished.

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If an external Patient Gas Analyzer is used (not the one in FLOW-i), the sampling has to be switched off in order not to remove gas from the system. The Leakage check may otherwise fail.

If the system has backup cylinders installed, an extra check point appears on the screen. Make sure these cylinders are open for the duration of the System checkout.

If only the O

backup gas cylinder is used, the

Air and/or N2O backup gas cylinder pressure check can be disabled in Service and Settings – Startup configuration, see Chapter 9, page

178.

If any of the connected vaporizers contain <5% of the total agent volume, the automatic vaporizer test will not be initiated for that vaporizer. A prompt window appears. Pressing 'bypass test' will exclude that vaporizer from the check. Pressing 'redo test' will repeat the test.

4.2.2 Gas sampling leakage

The 'sampling leakage alarm' responds to amounts of leakage sufficient to interfere with the gas sampling precision.

If the alarm is activated, perform any or all of the following actions before contacting Maquet service:

• Check the sampling line connections

• Check the patient tubing connections

• Replace the patient cassette

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Additional descriptionPreparatory steps

Step 1

Check that the breathing circuit is correctly mounted and connected to the test plug (A).

Step 2

Check the water trap and sampling line.

Discard/empty any water present in the water trap.

Step 3

Check that the absorber is correctly mounted and unsaturated. Also check that the switch is in the 'locked' position.

FLOW-i 4.2, User's Manual

Step 4

Check that the vaporizer(s) contains sufficient agent.

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Additional descriptionPreparatory steps

max

Step 5

Check that the Anesthesia Gas Scavenging (AGS) flow indicator is above the dashed area.

CAUTION: Ensure that the AGS is correctly connected. Running the system with a poor AGS connection may result in anesthetic agent being emitted into the operation environment.

Step 6

Check that the central gas supplies are connected.

min

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Step 7 (only if backup cylinders are installed)

Check that the Backup cylinders are opened. Close the cylinders after completing System checkout.

The system checkout will not initiate if the system is not connected to the central gas supply.

WARNING! If the backup gas supply pressure is higher than the central gas supply pressure, the backup cylinder gas will be used during the System checkout. Make a note of the backup cylinder pressure presented on the Control Panel screen during the System checkout.

Additional descriptionPreparatory steps

Step 8

Check that the manual resuscitator is readily available and is working correctly.

Step 9

Check for adequate suction pressure in the suction unit and that the auxiliary O

flow is functioning

properly, refer to Chapter 7, page 129, for instructions.

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4.2.3 Checks requiring user interaction

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The second part of the System checkout procedure requires the user to perform a few actions before proceeding to the next step:

A. Manually test the O2 flush:

• Press the 'Start check' touch pad.

• Fully depress the O2 flush button for

approx. 3 seconds. If the test is successful, 'Passed' appears on the panel screen. Continue to the next step (B). Otherwise repeat the test.

FLOW-i 4.2, User's Manual

B. Inspect the function of the inspiratory and

expiratory unidirectional valves (some systems may be fitted with a patient cassette lid that needs to be opened to see the valves):

• If necessary, open the patient cassette

lid.

• Press 'Start check' and ensure that the

unidirectional valves are moving up and down.

• Confirm by pressing 'Yes' on the panel

screen prompt.

• If necessary, close the patient cassette

lid and press 'Continue' or simply press 'Continue' to move on to the next step.

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4.2.4 Automatic checks

01-01 13 00

The third part of the System checkout procedure contains a number of tests that the system automatically performs. These are as follows:

• Internal tests

• Barometer

• Gas supply pressure

• Pressure transducers

• Safety valve

• Vaporizer inlet/outlet valve

• Flow transducer

• AUTO ventilation leakage

• MAN ventilation leakage

• Gas analyzer

• Battery

• Vaporizer 1

• Vaporizer 2

• Technical alarms

Components listed on the screen are individually tested. 'Passed' (in green text) or 'Failed' (in red text) is displayed after each test depending on the outcome. 'Running' indicates the test currently being performed.

If the gas analyzer test fails, the vaporizer tests will not be performed. A dialog box will appear to inform the user of this.

The automatic check procedure ends when all tests are performed. This procedure can at any time be bypassed by pressing the Bypass touch pad located in the lower left area of the panel screen (1).

The current leakage for manual and automatic ventilation is displayed separately in ml/min. A maximum leakage of up to 150 ml/min is allowed for each of the ventilation modes. The leakage tests are performed using a pressure of 50 cmH2O and 30 cmH2O for AUTO and MAN ventilation mode respectively.

Some automatic tests can be repeated after the automatic test sequence has finished; a prompt to check the relevant part and redo check appears on the screen.

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If only the O2 backup gas cylinder is used, the Air and/or N

O backup gas cylinder pressure

check can be disabled in Service and Settings – Startup configuration, see Chapter 9, page

178.

Circuit compliance compensation is calculated during the leakage tests and presented with the test results.

If N2O central gas supply pressure is connected while the N2O function is deactivated, the system checkout will fail.

WARNING! If the System checkout is unsuccessful, the system must not be connected to the patient until the malfunction is corrected. If the malfunction cannot be corrected by the operator, the system must be turned Off, taken out of operation and serviced by personnel trained and authorized by MAQUET.

4.2.5 Finalization

01-01 13 00

1 2 3

Once all checks are completed, a summary is displayed on the screen. Press the Standby touch pad located at the bottom right of the screen to enter Standby mode.

Checks can be repeated by pressing any of the touch pad buttons located in the bottom left area of the panel screen:

FLOW-i 4.2, User's Manual

1. Redo System checkout

2. Redo leakage check

3. Redo vaporizer check

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These checks can also be initiated in Standby mode via the Menu membrane button.

The results of each test in the System checkout procedure can also be viewed by pressing the 'Results' touch pad in the Standby mode main screen, or by accessing the System checkout sub-menu via the Menu membrane button.

CAUTION: Close the backup cylinders after completing the System checkout to avoid unintentional use or leakage of the backup gas.

4.2.6 Bypassing System checkout

In emergencies, the System checkout can be bypassed at any stage of the procedure. This, however, is not recommended.

With an emergency startup situation, Manual ventilation and fresh gas dosage are ready for use within 15 seconds. Monitored parameters have full accuracy after a maximum of 15 minutes. However, pressure, flow and volume displays will be 90-95% accurate after approx. two minutes.

If the system is still warm, full accuracy is obtained much more quickly.

If the System checkout is bypassed, the default system value (without patient tubing) for circuit compliance compensation will be used.

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4.3 Leakage check

Performs a Leakage check of the manual and automatic breathing circuits. It shall be performed after each change of tubings, breathing bags or filters.

01-01 13 00

1 3

2 4

Leakage check preparatory phase contains four steps, equivalent to steps 1, 2, 3 and 6 performed during the Full system check, see section 4.2.1.

The automatic check sequence includes automatic and manual breathing circuit leakage checks.

01-01 13 00

1 2 3

A summary of the results is displayed after the automatic check. Press the Standby touch pad to enter Standby mode or press any of the touch pads marked 1-3 to repeat any of the checks.

The circuit compliance compensation is re-calculated during the Leakage check and the log is updated with the new measured values for leakage.

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4.4 Vaporizer check

Performs a leakage check of the manual and automatic breathing circuits and a check of vaporizer functionality. It shall be performed after a vaporizer has been connected to the system.

The first part is identical to the Leakage check and is made to ensure that no agents leak out into the operating room during Run mode.

01-01 13 00

1 2 3

The automatic check sequence includes vaporizer checks in addition to the automatic and manual breathing circuit leakage checks.

A summary of the Leakage check and the Vaporizer check results is displayed after the automatic check. Press the Standby touch pad to enter Standby mode or press any of the touch pads marked 1-3 to repeat any of the checks.

Vaporizer check preparatory phase contains six steps, equivalent to steps 1 to 6 performed during the Full system check, see section

4.2.1.

When the vaporizer is connected and active, the Agent concentration touch pad displays the name of the agent, and the agent concentration is by default set to OFF.

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4.5 Understanding results

01-01 13 00

In Standby mode, the central area of the screen displays the result of performed system checks, along with date, time and outcome. The symbol (1) can be either green, yellow or red, depending on the current status of system checkouts. A detailed view is obtained by pressing 'View results' (2). A full system checkout, leakage check or vaporizer check is initiated by pressing the corresponding touch pad (3).

Patient cases should not be started if only Leakage or Vaporizer checks have been performed since system startup or during the last 24 hours period.

Press the 'Results' touch pad to display a window describing the system checkout results in more detail.

Symbol color codes correspond to the following:

Passed. A patient case can be started.

FLOW-i 4.2, User's Manual

More than 24 hours since a successful full system checkout was performed. Perform a System checkout.

Not performed. A patient case can be started, but this is not recommended. Perform a System checkout.

Red symbolYellow symbolGreen symbol

Failed. One or several checks failed during the System checkout/Leakage check/Vaporizer check. Make appropriate adjustments and redo check.

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4.6 Standby mode

01-01 13 00

The Standby screen provides a summary of the System status, the current gas/ventilation settings and the selected ventilation mode. If a vaporizer is connected and selected, the name of the agent is presented on the screen.

Listed below are examples of functions that can be performed in Standby mode either by pressing the active touch pads, or by accessing the menu using the Menu button.

If the System checkout was bypassed, or if the System checkout failed, a corresponding system message will be displayed in the message area.

When a patient case is started using AUTO ventilation or a switch is made during Run mode to AUTO ventilation, the preset gas and ventilation settings are activated.

• The gas and ventilation settings can be

preset before starting a patient case.

• Define patient settings.

• Any or all system checks can be started;

System checkout, Leakage test and Vaporizer test.

• The Service and settings menu can be

accessed.

• A patient case can be started.

• Alarm limits can be preset before starting

a patient case.

• Test results of the latest performed checks

can be reviewed by pressing the results touch pad.

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4.7 Start case

Once a successful system checkout has been performed, the system is ready to start a patient case. Customize the case by defining patient category, ventilation mode, ventilation mode settings, and alarm limits. Press the 'start case' membrane button to start the case. See Chapter 9, page 157, for more information.

Patient category selection is described in Chapter 5, page 75.

Ventilation mode selection and parameter settings are described in Chapter 5.

Alarm limit settings are described in Chapter 9, page 187.

WARNING! Ensure that all alarm limits and ventilator settings are appropriately set before connecting the system to the patient.

4.7.1 Compliance compensation

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

When compliance compensation is calculated, the delivered and measured volume and flow values are automatically compensated for these losses. The leakage test must be passed in order for the system to calculate correct compliance compensation. If the leakage test is not passed, the default system value (without patient tubing) for circuit compliance compensation will be used.

The compliance compensation calculations are made based on the current set-up of the system, and are subject to changes to the breathing system volume.

FLOW-i 4.2, User's Manual

These calculations become obsolete when, for example, patient tubings are changed (e.g. from adult to infant), or if additional equipment is installed which increases the breathing system volume.

Update the system by performing a new leakage check to ensure correct delivery of gas flow.

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4.8 Emergency ventilation

4.8.1 Manual check of Emergency

ventilation system

To test its operation, perform the following:

1. Activate the Emergency ventilation system

using the activation switch for emergency ventilation.

2. Set the O2 flow to 10 l/min - the current

flow is indicated on the flowmeter when the center of the ball is aligned with the printed scale.

3. Check at various APL settings that the

test lung can be ventilated using the Manual breathing bag.

mbar / cmH2O

6 4 2

I/min

APL

If the emergency ventilation is activated, either during a patient case or when testing the system, the emergency ventilation APL valve must be set to minimum before resuming normal ventilation (AUTO or MAN) or starting a new patient case.

CAUTIONS:

• The emergency flow is always delivered

via the patient cassette outlet and thus the patient tubings must always be connected to patient cassette outlets when emergency ventilation is used.

• Staff working with the system should

practise regularly using the emergency ventilation system.

I/min

Not for use with AFGO

1 3

FLOW-i 4.2, User's Manual

5 System functionality Table of contents

| System functionality |

66|FLOW-i Anesthesia system5.1 74|Patient settings5.2 79|Fresh gas flow settings5.3

5 |

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5.1 FLOW-i Anesthesia system

The FLOW-i is a software controlled circle system for anesthesia. It features several components distinguishing it from other anesthesia systems; gas modules regulating fresh gas flow, the volume reflector and the injector based vaporizer.

The volume reflector replaces the 'bag in bottle' used in many traditional systems. It has a fixed volume of 1.2 liters and no moving parts. Gas flow is regulated by the reflector gas module. This facilitates precise control of gas flow and pressure during automatic ventilation.

The Vaporizer works with an electronic based injector technology capable of operating at low tidal volumes. This allows for fresh gas to be led directly through the vaporizer chamber and be mixed with the anesthetic agent. Changes made in agent concentrations will therefore be instantaneous. The vaporizer technology also enables high agent concentrations at high fresh gas flows, i.e. up to 20 l/min.

5.1.1 Tidal volume delivery

The tidal volume delivered to the patient comes from two sources: the fresh gas flow and exhaled gas in the volume reflector pushed back towards the patient by the reflector gas module. Refer to page 72 for a schematic view.

When the part of the tidal volume delivered from the volume reflector exceeds one litre, gas from the reflector gas module may pass through the volume reflector and add oxygen to the breathing system. This will trigger the 'Leakage' alarm.

In these situations, the oxygen concentration will increase and the agent concentration will decrease. However, ventilation will always be maintained.

The situation can be corrected by increasing the fresh gas flow.

Carefully monitor displayed gas measurements when using low fresh gas flow settings and high tidal volumes.

FLOW-i 4.2, User's Manual

5.1.2 Low flow anesthesia

The use of oxygen as the drive gas in the volume reflector diminishes the risk for hypoxia should a leakage occur during low, or minimal flow anesthesia. However, should a leakage occur (the source of which is either known of unknown), then the volume reflector always ensures ventilation (it will never collapse like a bellows).

A leakage moves the borderline between exhaled gas and oxygen towards the breathing circuit, see illustration below. During a leakage the volume reflector adds oxygen to the breathing circuit. The leakage is obvious to the anesthetist as there is a simultaneous slow increase of oxygen concentration and a slow decrease of agent concentration at the y-piece. A leakage alarm will also be activated.

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The illustration shows the relative positioning of oxygen to exhaled gas during three different situations; Inhalation (A), Exhalation (B) and Leakage (C).

1. Exhaled gas

2. Oxygen from the reflector module

3. Oxygen/exhaled gas border

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5.1.3 Safety functions in FLOW-i to avoid potential hypoxia

To prevent the oxygen concentration in the breathing circuit from becoming too low and potentially causing hypoxia, the system has two features; O2Guard and the Safety Flush.

O2Guard

During a patient case, exhaled gas from the volume reflector and fresh gas from the system are mixed in the breathing circuit. This results in an oxygen concentration in the breathing circuit that is lower than the set oxygen concentration.

During low flow anesthesia the oxygen concentration in the total inspiratory flow may decrease over time. This may result in a situation whereby the inspiratory oxygen concentration becomes so low that the patient experiences hypoxia.

Safety flush

If the inspiratory oxygen concentration falls even lower, possibly due to gas delivery malfunction, then the system performs a safety flush replacing the entire breathing circuit volume with gas containing a high oxygen concentration. In addition, the fresh gas flow and O2 concentration are increased to predefined values. These actions are accompanied by a dialog window informing of the changes.

If the system detects an inspiratory oxygen concentration below a certain level (see image below), it will initiate several actions to mitigate the situation. The gas mix is set to Air/O2, the fresh gas flow and oxygen concentration are both adjusted. A dialog window appears informing of the alterations. These changes remain in effect until new settings are made.

The trigger level is always lower than the relevant alarm, 'FiO2: low, thus avoiding interference.

FLOW-i 4.2, User's Manual

Inspiratory oxygen concentration and alarm limits

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21%

5 |

The illustration opposite shows how the settings for the 'FiO2: Low' alarm affect the activation thresholds for O2Guard and the Safety Flush. At lower alarm settings, the respective thresholds for O2Guard and Safety Flush decrease accordingly to avoid interference between the functions. At higher alarm settings, these thresholds remain at

20.5% and 17.5% for O2Guard and the Safety Flush respectively.

Each shaded area corresponds to a system action that is dependant on the current inspiratory oxygen concentration (Y-axis), and current alarm limit settings (X-axis). A vertical line can be drawn from the X-axis (21% in the illustration), representing the current alarm level setting. In this case, as long as the inspiratory oxygen level remains above 21%, no O2-alarm is triggered.

However, if at an alarm setting of 21%, the inspiratory oxygen falls below 21%, the 'FiO2: Low'-alarm is triggered. If the inspiratory oxygen decreases even further, then O2Guard is activated at 20,5%, and the Safety Flush at 16,5% respectively.

The O2Guard and Safety Flush are only activated after the trigger requirements have been met for more than 20 consecutive seconds.

17.5

13.5

18% 99%

Inspiratory oxygen concentration i listed on the Y-axis, and inspiratory oxygen alarm level on the X-axis.

1. Normal operation (no alarm)

2. Activation of the low inspiratory oxygen alarm

3. Activation of O2Guard

4. Activation of the Safety Flush

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5.1.4 Manual ventilation

The fresh gas flow is constant during both inspiration and expiration when manual breathing mode is selected.

Inspiration

Expired gas is, together with new fresh gas from the gas modules, re-administered to the patient by compression of the manual breathing bag. This resulting pressure build-up also serves to evacuate gas through the APL valve when the set APL pressure is reached.

Direction of gas flow is indicated by the arrows.

1. Air gas module

2. O2 gas module

3. N2O gas module

4. Vaporizer

5. One-way valve

6. CO2 absorber

7. Flow transducer

8. Volume reflector

9. Manual breathing bag

10. APL valve

11. Gas evacuation

FLOW-i 4.2, User's Manual

Expiration

Exhaled gas enters the volume reflector. Fresh gas is added to the circle system from the gas modules.

Due to the counter pressure in the inspiratory channel caused by flow from the patient, fresh gas delivered during the expiration phase will fill the CO2 absorber. It will be returned to the inspiratory channel during the next inspiration.

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5 |

Direction of gas flow is indicated by the arrows.

1. Air gas module

2. O2 gas module

3. N2O gas module

4. Vaporizer

5. CO2 absorber

6. One-way valve

7. Flow transducer

8. Volume reflector

9. Manual breathing bag

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5.1.5 Automatic ventilation

The fresh gas delivery is designed to be cost effective with regards to agent consumption. The fresh gas flow is thus limited to the set minute volume, i.e. the delivered fresh gas can never exceed the set minute volume.

A larger proportion of the fresh gas is added during the inspiration phase, also contributing to minimizing agent consumption. The set fresh gas flow is the mean of fresh gas flow delivered during a full breathing cycle.

Inspiration

In automatic (controlled) ventilation, reflector gas is used to mechanically push the exhaled gas mixture in the volume reflector, back into the circle system. The mixture passes through the CO2 absorber, washing the gas free of CO2, before re-administration to the patient.

The gas mixture from the volume reflector, along with new fresh gas, form the patient's tidal volume. This ensures precise delivery of the tidal volume irrespective of changes in the fresh gas flow.

Direction of gas flow is indicated by the arrows.

1. Air gas module

2. O2 gas module

3. N2O gas module

4. Vaporizer

5. One-way valve

6. CO2 absorber

7. Flow transducer

8. Volume reflector

9. Reflector gas module

FLOW-i 4.2, User's Manual

Expiration

Exhaled gas enters the volume reflector. Reflector gas is pushed back and evacuated through the PEEP valve.

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910

5 |

Direction of gas flow is indicated by the arrows.

1. Air gas module

2. O2 gas module

3. N2O gas module

4. Vaporizer

5. CO2 absorber

6. One-way valve

7. Flow transducer

8. Volume reflector

9. PEEP valve

10. Gas evacuation

FLOW-i 4.2, User's Manual

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| 5

5.2 Patient settings

01-01 13 00

Press 'Patient settings' in standby, or press the patient category symbol in the upper left corner to open the patient settings menu.

3 4

Press each data field and use the rotary knob to set and confirm the patient data value.

The patient data (1-5) is used to determine allowable ventilatory setting ranges, relative MAC

and recommended ventilatory values.

age

To estimate PBW, all fields need to be filled in. The PBW, together with the patient category, is then used to define the recommended values for ventilation (7) displayed on the right.

The 'Use recommended values' touch pad (8) may be used to apply these recommended values.

1. Category

2. Age

3. Weight

4. Height

5. Gender

6. Predicted body weight

7. Recommended values

8. Use recommended values

FLOW-i 4.2, User's Manual

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5.2.1 Patient category

The selected patient category is either 'Infant' or 'Adult'. This determines the allowable setting ranges for ventilatory parameters and patient data.

Recommended ventilatory parameters outside the allowed patient category range are always highlighted in yellow.

If the patient category is changed in standby, all entered patient data except age is removed. Patient age has the default setting. Recommended ventilation parameters are also removed.

If the patient category is changed during running mode, entered patient data is generally conserved but patient details outside the allowed patient category range are automatically changed to the closest allowable value.

If patient data is changed while the system is in AUTO running mode, it will not be possible to select and use the resulting 'recommended values'.

Changing the patient category affects the following:

• Alarm ranges and defaults

• Circuit compliance compensation

• Parameter setting ranges

• Step values, i.e. differences in increments

when increasing/decreasing parameter values

• Automatic changes in parameter settings

when the current value is outside the patient category parameter range

If there is no circuit compliance compensation data available after the patient category has been changed, the default value will be used until a full check, or leakage check, has been performed.

CAUTION: Alarm limits and ventilation settings may change after having selected a different patient category. Re-check the set alarm limits after the patient category has been changed.

Changing the patient category can also be done by using options available under the Menu membrane button, see Chapter 9, page

165.

FLOW-i 4.2, User's Manual

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| 5

5.2.2 Patient Age

This field is never blank. If no information is entered, the default value will be used.

Select 'Age' in the patient settings menu and use the rotary knob to adjust the value.

DefaultRangeCategory

11 - 15 yearsInfant 405 - 120 yearsAdult

Patient category age default values can be changed in Service and Settings, see Chapter 9 page 178.

Patient age is used to estimate the relative MAC for the current patient, see page 145.

5.2.3 Weight

Used for calculating PBW and recommended ventilatory values according to the description on page 74.

5.2.6 Predicted body weight

If all patient details have been filled in, PBW will be displayed. In some cases, it will be the same as the actual body weight, while in others the PBW may be either higher or lower than actual body weight.

The PBW estimate is based on various formulae depending on patient gender, height and weight, as shown in the tables.

Gender - male

Weight < 30 kg

Weight > 30 kg

Height < 130 cm

Actual body weight used for PBW

PBW based on a limited version of the formula used by Devine et al,

1974.

Height > 130 cm

PBW based on a combination of actual body weight and the formula used by Devine et al,

1974.

PBW estimate based on the formula used by Devine et al,

1974.

5.2.4 Height

Used for calculating PBW and recommended ventilatory values according to the description on page 74.

5.2.5 Gender

Used for calculating PBW and recommended ventilatory values according to the description on page 74.

FLOW-i 4.2, User's Manual

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5 |

Gender female

Weight < 30 kg

Weight > 30 kg

Height < 135 cm

Actual body weight used for PBW

PBW based on a limited version of the formula used by Devine et al,

1974.

Height > 135 cm

PBW based on a combination of actual body weight and the formula used by Devine et al,

1974.

PBW estimate based on the formula used by Devine et al,

1974.

The PBW value displayed here forms the basis for all values for ventilatory parameters recommended in this window.

The estimated PBW may be displayed alongside the patient category symbol in the top left corner depending on the setting in the Screen layout window. See section Screen layout on page 163.

When PBW is shown, the figure is used as the basis of an estimated parameter, set VT/PBW, displayed among estimated parameters in the ventilation mode window and in the additional ventilation settings for the following ventilation modes:

• Volume Control (VC)

• Pressure Regulated Volume Control (PRVC)

• SIMV (VC) + PS

It also forms the basis of a measured value, expired VT/PBW, found on the selected page of Measured values when the system is running. See section Ventilation measurements on page 104.

FLOW-i 4.2, User's Manual

This measured value is also trended, see section Page information on page 161.

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5.2.7 Recommended values

The values recommended here for Tidal volume, Resp. rate and Minute volume are based on the patient category selected and the patient data entered.

Values that are out of range for the patient category are highlighted in yellow.

5.2.8 Use recommended values

When the patient data fields have been completed, the suggested ventilatory parameters are presented.

The 'Use recommended values' touch pad may then be either automatically checked or empty depending on settings made in Service & Settings/Startup configuration/Ventilation & gas. See section Startup configuration on page 174.

If the recommended ventilatory values are satisfactory, either press 'Accept' if the touch pad is pre-checked,or check it and then press 'Accept'. The direct settings at the bottom right of the control panel are then updated accordingly.

This can be done when the system is in standby. When it is running, it can only be done if using manual ventilation (MAN) but NOT when using automatic ventilation (AUTO). See section MAN/AUTO ventilation switch on page 84. This restriction also applies if the Volume setting in Service & Settings/Startup configuration/Ventilation & gas is set to Minute Volume. See section Startup configuration on page 174.

FLOW-i 4.2, User's Manual

5.3 Fresh gas flow settings

01-01 13 00

312

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5 |

1 2 3 4

The fresh gas supply is set using the following touch buttons:

1. Gas mix

2. Fresh gas flow

3. O2 concentration

4. Agent concentration

FLOW-i 4.2, User's Manual

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| 5

5.3.1 Selection of gas mixture

01-01 13 00

312

There are two settings:

• O2/Air (oxygen/air)

• O2/N2O (oxygen/nitrous oxide).

5.3.2 Setting fresh gas flow

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312

Total fresh gas flow in liters/minute.

The minimum O2 flow is 200 ml/min. The electronic gas mixer will automatically adjust the fresh gas flow settings to match this if necessary.

01-01 13 00

312

Additionally, the fresh gas flow can be shown using the rotameter, configurable via the Screen layout membrane button. It is a graphic representation of the individual flow rates for each gas.

FLOW-i 4.2, User's Manual

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5.3.3 Setting O2 concentration

01-01 13 00

312

Percentage oxygen set in the fresh gas mixture. The range of the fresh gas concentration is 28-100% for O2/N2O and 21-100% for O2/Air.

The O2 flow can never be less than 200 ml/min for any patient category. The current O

concentration in the gas mix is automatically adjusted to match this requirement if the fresh gas flow is decreased sufficiently. In addition, the O2 concentration touch pad is highlighted to inform of this adjustment, and a system message is displayed for as long as the limitation is active: 'O2 lower limit reached'. Confirming the new fresh gas flow will also confirm the new O2 concentration.

5.3.4 Setting anesthesia agent

concentration

01-01 13 00

312

Sets the anesthesia agent concentration for the selected vaporizer.

The name of the selected vaporizer agent is shown on the touch pad.

The agent concentration can have four states:

DescriptionState

No agent

OFF

0 %

0.3 - 5 % (ISO)

0.3 - 8 % (SEV)

1.0 - 18 % (DES)

No connected vaporizer in the selected slot

Vaporizer ready to be disconnected

Pressurized and active vaporizer

Selected vaporizer/ agent concentration range

FLOW-i 4.2, User's Manual

Agent concentration values on the screen are grayed out when the vaporizer lid is open.

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5.3.5 Selecting active vaporizer

Selecting an active vaporizer is necessary if:

• The vaporizer is connected into the

non-selected slot.

• There is a need to change the active

vaporizer when there are two vaporizers connected to the system.

1. Press the vaporizer touch button on the

screen.

01-01 13 00

312

2. The Select vaporizer window appears. It

displays the connected vaporizer´s current liquid level (1) and vaporizer type (2).

FLOW-i 4.2, User's Manual

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5 |

3. To select a vaporizer, press the required

vaporizer type and confirm by pressing Accept. This activates the vaporizer. The agent name is shown on the Vaporizer setting touch pad.

If the new vaporizer contains another agent, the suggested agent concentration displayed on the control panel is based on the equivalent MAC value of the previous agent.

When a second vaporizer is activated, the other vaporizer is automatically de-activated; the agent concentration is set to OFF, the vaporizer is depressurized, flushed and unlocked.

It is possible to manually set the agent concentration to OFF, and the vaporizer to standby, using the Agent concentration touch pad, see page 141 for details.

5.4 Ventilation settings

The system can be run using manual (MAN) or automatic (AUTO) ventilation. Ventilation modes available for automatic ventilation include the following:

• Pressure Control (PC)

• Volume Control (VC)

• Pressure Support (PS)

Manual ventilation modes include manual ventilation using the circle system and manual ventilation using an external breathing system connected to the AFGO outlet (option).

The system also allows for the patient category (Infant or Adult) to be specified, affecting parameter setting limits and step values.

FLOW-i 4.2, User's Manual

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| 5

5.4.1 MAN/AUTO ventilation switch

Sets the status of the ventilator:

• Manual ventilation (MAN)

• Automatic ventilation (AUTO)

Using manual ventilation

Manual ventilation is performed using the manual breathing bag to administer breaths, and the APL valve to regulate the pressure limit. For details on the APL valve, see page

122.

The set value of the APL valve is displayed at the bottom-left of the screen:

01-01 13 00

312

FLOW-i 4.2, User's Manual

Using automatic ventilation

Automatic ventilation is performed using the built-in ventilator, where the ventilation mode initially selected will depend on the system's startup configuration, see Chapter 9.

For a detailed description of each automatic ventilation mode, see Chapter 11.

The required ventilation settings can be pre-set before switching to automatic ventilation. The ability to pre-set these values is also true when switching back to manual ventilation.

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FLOW-i 4.2, User's Manual

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| 5

5.4.2 Parameter settings

01-01 13 00

312

The ventilation parameter settings are controlled using the following touch pads on the screen:

1. Ventilation mode selection

2. PEEP

3. Respiratory rate

4. PC above PEEP/Tidal volume

PC above PEEP will be replaced with Tidal/Minute volume in the Volume Control ventilation mode.

2 3

Due to interdependencies between parameter settings, certain setting combinations are not possible, particularly settings relating to breathing cycle phases (Ti, Tinsp rise, Tpause and RR) in combination with Tidal volume (VC) and Pressure over PEEP (PC, PS). These parameters cannot be set so that the subsequent gas flow exceeds the system’s performance, e.g. high tidal volumes with a short Ti.

FLOW-i 4.2, User's Manual

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5 |

5.4.3 Selection of automatic ventilation

mode

01-01 13 00

312

Pressing the ventilation mode text (e.g. Volume control) on the control panel, displays the following window:

01-01 13 00

If AFGO is installed on the system then manual and AFGO ventilation appear as selectable options to the left of this window. These options can be preset in preparation for switching to manual breathing mode using the MAN/AUTO switch, see Chapter 7, page 151.

312

Available ventilation modes appear and can be selected. Manual ventilation modes are grayed out.

FLOW-i 4.2, User's Manual

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| 5

When selecting the required ventilation mode, the set ventilation mode parameter window appears:

01-01 13 00

312

Adjust the ventilation settings as desired and press 'Accept'. This will activate (or preset if current mode is AFGO or MAN) the chosen automatic ventilation mode.

The following pages describe each ventilation mode parameter window individually.

Direct access ventilation settings are always accessible at the bottom right of the control panel.

Additional settings can be viewed anytime by pressing the triangular 'Additional settings' touchpad located above the direct settings area. The additional settings window always corresponds to the current ventilation mode.

01-01 13 00

312

Refer to page 95 for a description of direct access settings.

Refer to page 99 for a description of additional settings.

FLOW-i 4.2, User's Manual

Pressure Control

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Additional settings windowVentilation mode parameter window

2 3

1. PEEP

2. Respiratory Rate

3. PC above PEEP

4. I:E or Ti (inspiration time)

5. T insp. rise

6. Trigger

7. Estimated parameters

1. I:E or Ti (inspiration time)

2. T insp. rise

3. Trigger

4. Estimated parameters

FLOW-i 4.2, User's Manual

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| 5

Volume Control

Additional settings windowVentilation mode parameter window

1. PEEP

2. Respiratory Rate

3. Tidal/Minute volume

4. I:E or Ti (inspiration time)

5. T pause

6. T insp. rise

7. Trigger

8. Estimated parameters

1. Trigger

2. I:E or Ti (inspiration time)

3. T pause

4. T insp. rise

5. Estimated parameters

FLOW-i 4.2, User's Manual

PRVC

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5 |

Additional settings windowVentilation mode parameter window

2 3

1. PEEP

2. Respiratory Rate

3. Tidal/Minute volume

4. I:E or Ti (inspiration time)

5. T insp. rise

6. Trigger

7. Estimated parameters

1. Trigger

2. I:E or Ti (inspiration time)

3. T insp. rise

4. Estimated parameters

FLOW-i 4.2, User's Manual

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| 5

Pressure Support

Additional settings windowVentilation mode parameter window

1. PEEP

2. PS above PEEP

3. T insp. rise

4. Trigger

5. Insp. cycle off

6. Estimated parameters

1. PS above PEEP

2. PC above PEEP

3. Trigger

4. Insp. cycle off

5. T insp. rise

6. Estimated parameters

FLOW-i 4.2, User's Manual

SIMV (PC) + PS

| System functionality |

Additional settings windowVentilation mode parameter window

5 |

1. PEEP

2. SIMV rate

3. PC above PEEP

4. I:E or Ti (inspiration time)

5. T insp. rise

6. Breath cycle time

7. Trigger

8. Insp. cycle off

9. PS above PEEP

10. Estimated parameters

1. PS above PEEP

2. Trigger

3. Insp. cycle off

4. I:E or Ti (inspiration time)

5. T insp. rise

6. Breath cycle time

7. Estimated parameters

FLOW-i 4.2, User's Manual

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| 5

SIMV (VC) + PS

Additional settings windowVentilation mode parameter window

6 7

1. PEEP

2. SIMV rate

3. Tidal/Minute volume

4. I:E or Ti (inspiration time)

5. T pause

6. T insp. rise

7. Breath cycle time

8. Trigger

9. Insp. cycle off

10. PS above PEEP

11. Estimated parameters

1. PS above PEEP

2. Trigger

3. Insp. cycle off

4. I:E or Ti (inspiration time)

5. T pause

6. T insp. rise

7. Breath cycle time

8. Estimated parameters

FLOW-i 4.2, User's Manual

5.4.4 Setting direct access parameters

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312

The following direct access parameters can be set for the selected ventilation mode:

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5 |

Ventilation mode

+ PS

Tidal/Minute volume

PC above PEEP

PS above PEEP

Respiratory Rate

Backup RR

PEEPSIMV rate

XXXPC XXXVC XXXPRVC XXX XXXSIMV (PC)

XXXSIMV (VC)

2. In PS backup ventilation, the direct access parameter toggles between 'PS above PEEP' and 'PC above PEEP' depending on if pressure support or backup ventilation is the current active mode.

FLOW-i 4.2, User's Manual

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| 5

Tidal/Minute volume

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312

Sets the tidal/minute volume.

Different setting intervals apply for adult and infant patient categories, see table below.

Patient Category

Tidal Volume

Minute Volume

0.5 - 60 l/min100 - 2000 mlAdult

0.3 - 20 l/min20 - 350 mlInfant

Either tidal (MTi) or minute (MV) volume can be used and is selected as part of the system configuration, see Chapter 9.

Pressure control above PEEP

01-01 13 00

312

Sets the pressure level above PEEP. When the set inspiration pressure above PEEP is reached, the system generates a pressure plateau until the start of the expiration phase.

Different setting intervals apply for adult and infant patient categories, see table below.

PC above PEEPPatient category

0 - 120 cmH2OAdult 0 - 80 cmH

OInfant

FLOW-i 4.2, User's Manual

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Pressure support above PEEP

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312

PS above PEEP is the set inspiratory pressure support level for triggered breaths in pressure support. Same restrictions apply as for 'PC above PEEP'.

Respiratory rate

01-01 13 00

Backup respiratory rate

01-01 13 00

312

Sets the frequency of pressure controlled administered breaths, i.e. backup rate, should the patient not initiate a breathing attempt. The time-out period, after which a breath is administered, is 60 seconds divided by 'backup respiratory rate'.

The system allows a backup breathing frequency within the range of 2 to 60 breaths/minute and OFF.

312

Sets the frequency of administered breaths.

The system allows a breathing frequency within the range of 4 to 100 breaths/minute.

FLOW-i 4.2, User's Manual

Setting the backup respiratory rate to OFF will deactivate this parameter when running PS backup ventilation.

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SIMV rate

01-01 13 00

312

Rate of controlled mandatory breaths (b/min). Active only in SIMV modes.

PEEP

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312

Sets the Positive End Expiratory Pressure.

The system allows PEEP settings within the range 0 to 50 cmH2O.

FLOW-i 4.2, User's Manual

5.4.5 Setting additional parameters

The following additional parameters can be set for the selected ventilation mode:

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5 |

Ventilation mode

+ PS

T pauseI:E/TiTrigger

T insp. rise

PC above PEEP

XXXPC XXXXVC XXXPRVC

PS above PEEP

Insp. cycle off

Breath cycle time

XXXXPS

XXXXXXSIMV (PC)

XXXXXXXSIMV (VC)

FLOW-i 4.2, User's Manual

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| 5

Setting inspiration time

The following parameters can be set to control inspiration time:

• I:E/Ti

• T pause

• T insp. rise

I:E/Ti

Sets the ratio between the inspiratory and expiratory time for each breath.

Either I:E or Ti can be used and is selected as part of the system configuration. See Chapter 9, page 178, for more information.

If I:E is set to 1:4, the fresh gas flow is limited to the highest allowed flow for this setting, and may result in the delivered fresh gas flow being less than the set fresh gas flow.

ventilation. A decrease of the inspiratory flow to a preset level causes the system to switch to expiration. This preset level is measured as a percentage of the maximum flow during inspiration.

The range is 1 - 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.

See Chapter 11, page 227, for more background on breath cycle time.

T pause

Sets the inspiratory pause time as a percentage of the breath cycle time. During the pause, the inspiratory flow is closed.

The range is 0 to 30%.

T insp. rise

Sets the time to full inspiratory flow or pressure at the start of each breath, as a percentage of the breath cycle time.

The range is 0 to 20%.

Insp. cycle off

Inspiratory Cycle-off is the point at which inspiration changes to expiration in spontaneous and supported modes of

100

FLOW-i 4.2, User's Manual

MAQUET FLOW-i User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of contents

1 Introduction Table of contents

1.1 Indications for use

1.2 Intended use

1.3 Using this manual

2 Important Table of contents

2.1 General information

2.2 Connection

2.3 Operation

2.4 Installation and service

2.5 Accessories and auxiliary equipment

3 System overview Table of contents

3.1 System parts

3.2 Control panel

3.2.1 Areas of the screen

3.2.2 Navigating the screen

3.2.3 Touch pad settings

3.2.4 Membrane buttons

3.3 Patient monitor (option)

3.3.1 Panel interchangeability

3.4 Breathing system

3.5 Vaporizer unit

3.6 Emergency ventilation system

3.7 External connections

3.7.1 Power supply and fuses

3.7.2 Gas connections

3.7.3 Input/Output ports

3.8 Explanation of symbols

3.8.1 Labels

3.8.2 Screen-displayed symbols

3.9 Ergonomical positioning

3.9.1 Using the brake

3.9.2 Working position

3.10 Storage and transportation

3.10.1 Before transport

3.10.2 During transport

3.10.3 Storage

3.11 System models

3.12 Optional equipment

3.12.1 Vaporizer holder

3.12.2 Universal bracket for C20

3.12.3 Manual breathing bag support arm

3.12.4 EVAC Restrictor

3.12.5 Cable support arm

3.12.6 Top shelf

3.12.7 Vaporizer slot cover

3.12.8 Backup gas system

4 Startup and system checkout Table of contents

4.1 System startup

4.2 System checkout

4.2.1 Preparations

4.2.2 Gas sampling leakage

4.2.3 Checks requiring user interaction

4.2.4 Automatic checks

4.2.5 Finalization

4.2.6 Bypassing System checkout

4.3 Leakage check

4.4 Vaporizer check

4.5 Understanding results

4.6 Standby mode

4.7 Start case

4.7.1 Compliance compensation

4.8 Emergency ventilation

5 System functionality Table of contents

5.1 FLOW-i Anesthesia system

5.1.1 Tidal volume delivery

5.1.2 Low flow anesthesia

5.1.3 Safety functions in FLOW-i to avoid potential hypoxia

5.1.4 Manual ventilation

5.1.5 Automatic ventilation

5.2 Patient settings

5.2.1 Patient category

5.2.2 Patient Age

5.2.3 Weight

5.2.6 Predicted body weight

5.2.4 Height