Flow-c v4.8 Users Manual Rev 01

| Table of contents |

Table of contents

1 Introduction 2 System overview 3 Operation overview 4 Displaying and saving data 5 System functionality 6 Alarms and patient safety 7 Service & Settings 8 Optional functions 9 Optional hardware and accessories 10 Technical specifications 11 Terms and definitions

Flow-c v4.8, User's Manual Infologic 1.56

| 5 | 17 | 39 | 65 | 87 | 109 | 129 | 135 | 169 | 177 | 207

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| Table of contents |

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Flow-c v4.8, User's Manual Infologic 1.56

| Introduction | 1 |

1 Introduction Table of contents

1.1 1.2 1.3 1.4

Flow-c v4.8, User's Manual

Intended use Safety guidelines Ergonomical positioning Available modes and functions

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6 6 12 15

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| 1 | Introduction |

1.1 Intended use

1.2 Safety guidelines

The Flow-c anesthesia system is intended for use in administering 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.

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

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

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

The system is intended for use on neonate to adult patient populations. The system is intended for use in hospital environments, except MRI environments. When not in operation, the system is designed for in-hospital transport.

The safety signal words Warning and Caution have the following meanings:

CAUTION: Indicates instructions that must be followed in order to ensure the proper operation of the equipment. The following applies throughout this User's Manual: ‘Flow-c’, ‘anesthesia system’ and ‘system’ represent Flow-c version 4.8. This manual applies to the Flow-c anesthesia system base unit, that is, the system not including optional functions and equipment, which are described separately. References made to optional functions and equipment within this User's Manual are generally accompanied by the word option in brackets. See also section Available modes and functions on page 15. For information on optional functionality and optional hardware and accessories/equipment, see section Optional functions on page 135 and section Optional hardware and accessories on page 169.

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Flow-c v4.8, User's Manual

| Introduction | 1 |

1.2.1 General information WARNING! To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

WARNING! Do not modify this equipment without authorization of the manufacturer. • 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. •

WARNING! 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.

• Do not use flammable anesthetic agents close to the anesthesia system. • 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 will provide gas to the system.

Flow-c v4.8, User's Manual

• In case of automatic ventilation failure, switch to manual ventilation. In case of manual ventilation failure, switch to emergency ventilation (if available) or use alternative means of ventilation, e.g. a manually powered resuscitator. • In case of a total power (mains power and battery) or other electronic failures, the built-in emergency ventilation system can be used if available. If not available, use alternative means of ventilation, e.g. a manually powered resuscitator. • The manufacturer takes full responsibility for compliance of the CE mark requirements for the CO2 cartridge produced by Molecular Products Ltd (MPL) in countries where these requirements apply. The manufacturer also takes full responsibility for supplying the instructions for use in accordance with the legislation relevant to the intended use of this product. • 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 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 2 2 1 bar = 15 psi = 1 atm = 1 kgf/cm (kp/cm ) • The anesthesia system is not made with natural latex. 7

| 1 | Introduction |

• Applied parts, i.e. equipment making physical contact with the patient, comprise gases (including agents) and the patient mask. • The system maintains its performance when tilted up to two degrees. 1.2.2 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. 1.2.3 Operation WARNINGS! • In case of system failure, the lack of immediate access to appropriate alternative means of ventilation can result in patient injury. • Air intake shall not be covered nor in any other way be obstructed.

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• The anesthesia system 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. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Flow-c Anesthesia System including its specified cables. Otherwise degradation of this equipment could result. • To protect the patient from high airway pressure, an upper pressure limit must always be set. For details, see chapter Alarms and patient safety on page 109. • In order to prevent unexpected oxygen delivery from the volume reflector during electrosurgical procedures in the patient's airways, ensure high fresh gas flows (exceeding inspired Minute volume). • Never perform electrosurgical procedures in the patient's airways if the Oxygen Only option is installed and Air supply is disabled.

CAUTION: HF surgery equipment shall not be connected to the mains power outlet. • 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.

Flow-c v4.8, User's Manual

| Introduction | 1 |

For details, see chapter Alarms and patient safety on page 109. • To protect the patient, an alarm limit must always be set for low expired minute volume. For details, see chapter Alarms and patient safety on page 109. • Only anesthetic agents recommended by the manufacturer 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 transfers between hospitals. • The system must be kept away from magnetic resonance imaging (MRI) equipment. • 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 Flow-c v4.8, User's Manual

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 60601-1-2:2014. 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 60601-1-2:2014 and that the installation is carried out according to the EMC information in the separate document, Electromagnetic Compatibility, Flow-c Anesthesia System. If limits are exceeded, the accuracy and safety of the system may be impaired. • Full performance is reached after a 10 minute warm-up. In case of an emergency, the system can be used immediately. • 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 - 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. • Administration of pharmaceuticals, such as salbutamol, propelled by norflurane (1,1,1,2 tetrafluoroethane) may interfere with the gas analyzer and result in deactivation of the vaporizer. 9

| 1 | Introduction |

1.2.4 Installation and service • Installation, service and maintenance of the system must be performed by personnel trained and authorized by the manufacturer. • Instructions for installation, service and maintenance, i.e. a service manual, is available for personnel trained and authorized by the manufacturer. • Only original spare parts from the manufacturer must be used in the system. 1.2.5 Accessories and auxiliary equipment WARNINGS! • 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. • Only accessories, supplies and auxiliary equipment recommended by the manufacturer 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.

CAUTIONS: • To prevent the system from tilting, follow the restrictions for patient monitors and auxiliary equipment specified on page 181. • Equipment placed on shafts or rails must not restrict opening of the Emergency Ventilation cover. • 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 10

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. • Use of an anesthetic gas scavenging system (AGSS) 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 responsible organization to ensure that the connected equipment is compatible with the requirements of IEC 60601-1. The responsible organization should identify, analyze, evaluate and control these risks. Flow-c v4.8, User's Manual

| Introduction | 1 |

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. If in doubt, contact a qualified medical technician or your local representative. • 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. • Reprocessing parts labelled 'Single-use' will degrade biocompatibility and cleanliness.

1.2.6 Electromagnetic Compatibility

• For optional equipment and accessories, refer to the user documentation supplied by the manufacturer of the equipment/accessory.

• Gas measurement accuracy (for Isoflurane, Desflurane, Sevoflurane, CO2, N2O, O2) and generation of gas measurement associated clinical alarms or generation of a technical alarm

• The ventilation performance may be affected by the use of the Auxiliary O2 and Air powered suction (venturi), depending on Central Gas Supply pressure and ventilation settings.

Flow-c v4.8, User's Manual

The anesthesia system must be installed and put into service according to Electromagnetic Compatibility, Flow-c Anesthesia System. In order to ensure that the Flow-c Anesthesia System, during electromagnetic disturbances, will fulfil its Essential Performance (IEC 60601-1), as listed here: • Oxygen flow under all conditions except the failure of the oxygen supply or generation of a clinical and/or technical alarm • Delivery of a non-hypoxic gas mixture to the patient or generation of a clinical and/or technical alarm • Non-delivery of excessive concentrations of a volatile anesthetic agent or generation of a clinical alarm • Airway pressure monitoring and associated clinical alarms (Ppeak, PEEP)

• Delivery of ventilation at the patient connection port within the alarm limits set by the operator or generation of a clinical or technical alarm

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| 1 | Introduction |

The following performance has been monitored during electromagnetic immunity tests: • Delivered volume • Monitoring of: - Oxygen concentration - CO2 concentration - N2O, Isoflurane, Desflurane and Sevoflurane concentration - Airway pressure - Expired volume - Internal electrical power source - Mains power status - Gas supply

1.3 Ergonomical positioning CAUTION: Be careful when moving the display arm to avoid damaging equipment placed on the writing table or top shelf. • The system is equipped with wheels and can be rotated 360°. • 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°.

• Ability to generate alarms No degradation or failure of the essential performance has been observed during these tests. No other effects on the anesthesia system have been observed during the electromagnetic immunity tests.

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Flow-c v4.8, User's Manual

| Introduction | 1 |

1.3.1 Using the foot brake

1.3.2 Before transport

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

If the system is to be moved to another room or transported a longer distance, ensure mounted accessories are securely attached to the system.

• To lock the wheels, push down the right-hand side of the foot brake (A). • To unlock the wheels, push down the left-hand side of the foot brake (B).

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

1

Display arm

2

Equipment arm

3

Direction of transportation

1.3.3 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-c v4.8, User's Manual

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| 1 | Introduction |

1.3.4 Storage • Ensure that the system is not exposed to conditions other than those specified in section Environment on page 183. • 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. For operating and non-operating conditions applying to batteries, see section Environment on page 183. • For fire safety purposes, the system requires functional batteries for system Startup. • The manufacturer recommends that the vaporizers are emptied before long term storage (>30 days). • For information on CO2 absorber storage, see page 25.

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Flow-c v4.8, User's Manual

| Introduction | 1 |

1.4 Available modes and functions The optional functions, hardwares and accessories of the Flow-c Anesthesia System are shown in the table below. Please note that these functions can be referred to and described in the User's Manual without mentioning that they are optional. Information about what software options that are installed on the system is available in the system's Service & Settings, see section Options on page 131. Make a note in the column Installed options to show which optional functions that are installed on the system. Function/hardware/accessory

Flow-c

Volume Control (VC)

X

Pressure Control (PC)

O

Pressure Regulated Volume Control (PRVC)

O

Pressure Support (PS)

O

SIMV • (PC) + PS • (VC) + PS

O O

Low VT ventilation

O

High performance ventilation

O

HLM mode (CPB mode)

O

Inspiratory and expiratory hold

O

Agent usage

O

Predicted body weight (PBW)

O

Auxiliary Fresh Gas Outlet (AFGO)

O

Pause function

X

Backup gas supply

O

Vacuum ejector pump – Venturi

O

Reusable CO2 absorber

O

N2O delivery

O

Oxygen 93

O

Emergency ventilation

O

Suction unit

O

Flow-c v4.8, User's Manual

Installed options

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| 1 | Introduction |

Function/hardware/accessory Oxygen Only

1

Flow-c

Installed options

O

Auxiliary power outlets

O

X = standard

O = option

1. Not available in EU

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Flow-c v4.8, User's Manual

| System overview | 2 |

2 System overview Table of contents

2.1 2.2 2.3 2.4 2.5 2.6 2.7

Flow-c v4.8, User's Manual

System parts Control panel Breathing system Gas analyzer External connections User interfaces Explanation of symbols

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18 19 20 28 31 33 34

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| 2 | System overview |

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.

2.1 System parts The system comprises the following basic parts:

Ref. no.

Description

1

Control panel

2

External connections

3

Tower shelf with auxiliary systems

4

Emergency ventilation system

5

Vaporizer unit

6

Breathing system

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Flow-c v4.8, User's Manual

| System overview | 2 |

2.2 Control panel

01-01

13 00

1 2 3

3

2

1

The control panel includes: 1. 2. 3.

Touchscreen Rotary knob Membrane buttons

For more detailed information about the control panel and its use, see chapter Displaying and saving data on page 65.

Flow-c v4.8, User's Manual

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| 2 | System overview |

2.2.1 Patient monitor

The breathing system comprises the following:

The system can be connected to a selection of different patient monitors. For full details, contact a local representative of the anesthesia system manufacturer. During mains power failure, the backup battery in the anesthesia system will not power the patient monitor. 2.2.2 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 the anesthesia system manufacturer. Contact your local supplier for more information.

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2.3 Breathing system The breathing system is the inspiratory and expiratory pathways through which gas flows at respiratory pressures between the fresh-gas inlet, the patient connection port and the exhaust valve or port.

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Ref. no.

Description

1

Patient cassette

2

O2 flush

3

MAN/AUTO ventilation switch

4

Auxiliary O2

5

APL valve

6

Suction unit

7

Volume reflector

8

AGSS (anesthetic gas scavenging system) flow indicator

9

Manual breathing bag with tubing

10

AFGO (additional fresh gas outlet)

11

Patient tubing

12

Y-piece

13

Water trap and sampling line

14

CO2 absorber

15

Suction outlet and suction filter

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| System overview | 2 |

The manufacturer recommends that the bacterial/viral Servo Duo Guard filter is always connected to the expiratory port on the patient cassette. This will minimize the risk of cross-contamination. 2.3.1 Patient cassette The patient cassette acts as the hub of the gas flow in the machine. The patient cassette contains the expiratory flowmeter, and the inspiratory and expiratory unidirectional valves.

2.3.2 O2 flush The O2 flush is used to manually supply the breathing system with an additional gas flow from the O2 gas supply. This gas supply will not go through the vaporizer. For details, see section Fresh gas flow on page 188. Using the O2 flush Press and hold in the O2 flush button (O2+). The flow will continue as long as the button is depressed.

The patient cassette is connected to the following parts: • Fresh gas inlet • Volume reflector • Manual breathing bag • CO2 absorber • Pressure transducers • Gas evacuation • Patient tubing • Gas sampling return

Flow-c v4.8, User's Manual

If the O2 flush is used during AUTO mode ventilation, the excess pressure is released via the expiratory valve. Set PEEP is maintained throughout the flush procedure.

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