MAQUET FLOW-i User Manual

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

| Introduction |

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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.

FLOW-i 4.2, User's Manual

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FLOW-i 4.2, User's Manual

2 Important Table of contents

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FLOW-i 4.2, User's Manual

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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.

FLOW-i 4.2, User's Manual

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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

+ 287 hidden pages

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