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User's Manual Flow-i 4.8 Anesthesia System
| Table of contents |
Table of contents
1 Introduction 2 System overview 3 Startup and system checkout 4 System functionality 5 AGC (Option) 6 Recruitment Maneuvers 7 Breathing system 8 AFGO (Additional Fresh Gas Outlet, Option) 9 Membrane buttons 10 Alarms and patient safety 11 Ventilation modes 12 System shutdown 13 Technical specifications 14 Definitions 15 Index
Flow-i 4.8, User's Manual Infologic 1.156
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| Table of contents |
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Flow-i 4.8, User's Manual Infologic 1.156
| Introduction | 1 |
1 Introduction Table of contents
1.1 1.2 1.3
Flow-i 4.8, User's Manual
Intended use Safety guidelines Available modes and functions
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6 6 13
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1.1 Intended use
1.2 Safety guidelines
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.
Important information is highlighted with Warning or Caution, where:
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.
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.
The system is intended for use in hospital environments, except MRI environments. When not in operation, the system is designed for in-hospital transport.
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Flow-i 4.8, User's Manual
| Introduction | 1 |
1.2.1 General information • The following applies throughout this User's Manual: - The terms 'Flow-i', 'anesthesia system' and 'system' refer to the Flow-i anesthesia system version 4.8. • This manual applies to the C20, C30 and C40 anesthesia system models, and optional functions and equipment that can be installed on them. 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 13. • 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. • Do not use Flammable Anesthetic Agents close to the anesthesia system. • 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 ) Flow-i 4.8, User's Manual
• 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 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. • The system maintains its performance when tilted up to two degrees. • 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. 7
| 1 | Introduction |
• For devices with serial numbers below 20 000, a higher supply pressure is allowed. For more information, see chapter Technical specifications.
WARNING! To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
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.
WARNING! Do not modify this equipment without authorization of the manufacturer.
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.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
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Flow-i 4.8, User's Manual
| Introduction | 1 |
1.2.3 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, an alarm limit must always be set for low expired minute volume. For details, see chapter Alarms and patient safety on page 193. • 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 interhospital transportation. • 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 Flow-i 4.8, User's Manual
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 60601-1-2:2014. 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-i 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 anesthesia system 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 - Contacts of fuse holders that are accessible during replacement of the fuse. - Contacts of lamp holders that are accessible after removal of the lamp. 9
| 1 | Introduction |
- 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.
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. • 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-i 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 193. • 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). 10
• 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.
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 • 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. • For optional equipment and accessories, refer to the user documentation supplied by the manufacturer.
Flow-i 4.8, User's Manual
| Introduction | 1 |
• 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. 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. Flow-i 4.8, User's Manual
• 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 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! • 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 247. 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. 11
| 1 | Introduction |
1.2.6 Electromagnetic Compatibility The anesthesia system must be installed and put into service according to Electromagnetic Compatibility, Flow-i Anesthesia System. In order to ensure that the Flow-i 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
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
• Delivery of a non-hypoxic gas mixture to the patient or generation of a clinical and/or technical alarm
• Ability to generate alarms
• Non-delivery of excessive concentrations of a volatile anesthetic agent or generation of a clinical alarm
No degradation or failure of the essential performance has been observed during these tests.
• Airway pressure monitoring and associated clinical alarms (Ppeak, PEEP) • Gas measurement accuracy (for Isoflurane, Desflurane, Sevoflurane, CO2, N2O, O2) and generation of gas measurement associated clinical alarms or generation of a technical alarm
No other effects on the anesthesia system have been observed during the electromagnetic immunity tests.
• 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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Flow-i 4.8, User's Manual
| Introduction | 1 |
1.3 Available modes and functions Modes/Functions VC
X
PC
X
PRVC
O
PS
O
SIMV • (PC) + PS • (VC) + PS
O O
HLM mode (CPB mode)
X
High performance ventilation
X
Low VT ventilation
X
PBW
X
Inspiratory and expiratory hold function
X
Pause function
X
Agent and gas usage
X
N2O delivery
X
Double vaporizer station
X
Automatic Gas Control (AGC)
O
Recruitment maneuvers
O
Auxiliary Fresh Gas Outlet (AFGO)
O
Oxygen 93
O
Oxygen Only
1
O
X = standard
O = option
1. Not available in EU Flow-i 4.8, User's Manual
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| 1 | Introduction |
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Flow-i 4.8, 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 2.8 2.9 2.10 2.11
Flow-i 4.8, User's Manual
System parts Control panel Breathing system Vaporizer unit Emergency ventilation system External connections Explanation of symbols Ergonomical positioning Storage and transportation System models Optional equipment
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16 17 23 24 24 25 29 33 34 36 37
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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. There are a number of different system models available. For more information on the different models, see page 36.
2.1 System parts The system comprises the following basic parts:
A 2
1
B 3
4
5
220-240V~ 400 VA
6
7
1. 2. 3. 4.
Control panel Patient monitor (option) Additional arm 'A' (option) and/or 2 Gas backup holder 'B' (option) External connections
5. 6. 7.
T 1.6 A 250 V
T4A 250 V
Emergency ventilation system Vaporizer unit Breathing system
2. C30 can only be equipped with the additional arm or the backup gas holder.
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Flow-i 4.8, 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.
Screen with active touch pads Rotary knob Membrane buttons
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| 2 | System overview |
2.2.1 Areas of the screen
11
12
13
10
9 8 7
6
5
4
3
2
1
The screen is divided up into a number of different areas: 1. 2. 3. 4. 5. 6. 7. 8.
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Ventilation direct access settings Gas direct access settings Activate additional settings/gas settings window Fresh gas mix rotameter APL valve value Gas measurement area Ventilation measurement area Waveform area
9.
Tab area: - Waveforms - Loops - Short trends - Volume reflector indicator - Manometer - Gas pressure - Recruitment This is an option. For details, refer to chapter Recruitment Maneuvers on page 131. 10. Current alarm and status area 11. Alarm functions 12. Timer 13. Mode indicator
Flow-i 4.8, User's Manual
| System overview | 2 |
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
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
Black text on red background
Medium priority alarms Black text on yellow background Low priority alarms
Black text on blue background
Pressure
Yellow
Flow
Green
Volume
Blue
CO2
Light gray
Technical alarms, i.e. Black text on red, alarms with the prefix yellow or blue TEXXX, where XXX is an background, dependent integer. on priority (high/medium/low)
O2
White
System messages
N2O
Blue
MAC and MAC Brain
Gray
Isoflurane
Purple
Desflurane
Blue
Sevoflurane
Yellow
White text on black background
A detailed description of alarms and patient safety is found in chapter Alarms and patient safety.
The colors for O2 and N2O in the above table may vary due to country-specific standards. In addition, not all gases listed above may be available in all countries.
Flow-i 4.8, User's Manual
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| 2 | System overview |
2.2.2 Navigating the screen There are several ways of navigating the screen and setting values. Using the touch screen 1.
2. 3.
Press the required direct access touch pad. The touch pad becomes active, which is indicated by a blue highlight. Turn the rotary knob to the required value, which then begins to flash. Press the touch pad to confirm setting. If the setting is not confirmed within 15 seconds, a dialog window opens to prompt the user to confirm or reject the setting.
An activated direct access touch pad is only active for 10 seconds. If no value is entered within 10 seconds, the touch pad is deactivated. Touch pads other than direct access touch pads, such as those in separate windows where settings need to be accepted or cancelled as a whole, are also activated and changed using the touch screen or rotary knob but do not display the flashing or dialog described above.
Using the rotary knob 1.
2.
3. 4.
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Turn the rotary knob to move between the direct access touch pads on the screen. The selected touch pad is indicated by a blue frame. Press the rotary knob to activate the selected touch pad. This will highlight the touch pad in blue. Turn the rotary knob to the required value, which then begins to flash. Press the rotary knob to confirm setting. If the setting is not confirmed within 15 seconds, a dialog window opens to prompt the user to confirm or reject the setting.
Flow-i 4.8, User's Manual
| System overview | 2 |
Active screen
5
6
7
8
9
4
3 2
1
Pressing any of the areas labelled with a number in the illustration, displays a window according to the table below. Screen area
Dialog/window produced
1.
Gas settings/ Ventilation settings
Multiple windows, see pages 75 and 80.
2.
MAC value
Patient category, see page 71.
3.
Gas measurement area
Alarm profile window, see page 197.
4.
Ventilation measurement area
Alarm profile window, see page 197.
5.
Patient category symbol
Patient category, see page 71.
6.
Alarm functions
Alarm profile window, see page 197.
7.
Mode indicator area
Ventilation mode selection, see page 83.
8.
Waveform area
Waveforms and scales, see page 183.
9.
Tab area (displayed window depends on selected tab)
- Waveforms and scales, see page 183. - Screen layout, see page 182.
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