SERVO-U Ventilator System Users Manual Ver 4.0 Rev 03 April 2019

| TABLE OF CONTENTS |

TABLE OF CONTENTS

1 Introduction 2 System Overview 3 Operation overview 4 Displaying and saving data 5 Ventilation modes and therapies 6 Ventilatory settings and functions 7 Alarm handling 8 Service & Settings 9 Technical data 10 Index

SERVO-U Ventilator System v4.0, User's Manual Infologic 1.93

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| TABLE OF CONTENTS |

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SERVO-U Ventilator System v4.0, User's Manual Infologic 1.93

| Introduction | 1 |

1 Introduction Table of contents

1.1 1.2 1.3

SERVO-U Ventilator System v4.0, User's Manual

Device description Safety guidelines Version and Configurations

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6 8 15

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| 1 | Introduction |

1.1 Device description

1.1.2 Intended use

1.1.1 Device components

The SERVO-U Ventilator System is: • intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients

The ventilator system consists of: 1. a user interface for setting ventilation modes and therapies, displaying data and indicating alarms 2.

a patient unit for mixing gases and controlling gas delivery

3.

a patient circuit for delivering and exchanging gases

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• to be used only in professional healthcare facilities and for transport within these facilities For NAVA and Edi monitoring, it is in addition intended: • to provide monitoring of the patient's breathing drive • to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active

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• to be used only by healthcare providers

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• for use on all patients with no contraindication for insertion/exchange of a nasogastric tube

SERVO-U Ventilator System v4.0, User's Manual

| Introduction | 1 |

1.1.3 User's Manual

1.1.6 Disclaimers

This manual summarizes the functions and safety features of the ventilator system. It is not all-inclusive and should not be seen as a substitute for training.

Non-professional servicing: The manufacturer has no responsibility for the safe operation of the ventilator system if installation, service or repairs are performed by persons other than those authorized by the manufacturer.

1.1.4 Cleaning & Maintenance Please refer to the SERVO-U/n Cleaning and Maintenance User's Manual. 1.1.5 Servicing Guidelines CAUTIONS: • Regular Service: The ventilator system must be serviced at regular intervals by personnel who have received authorization and specialized training by the manufacturer. • Complete service records: All service performed on the ventilator system must be recorded in a service log in accordance with hospital procedures and local and national regulations. Service Contract: It is strongly recommended that all service on the ventilator system should be performed as part of a service contract with the manufacturer. Note: Modifications of the ventilator system during the actual service life require an evaluation of the requirements of the IEC 60601-1 standard.

SERVO-U Ventilator System v4.0, User's Manual

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| 1 | Introduction |

1.2 Safety guidelines Follow these safety guidelines. Additional warnings appear in context throughout this document. Information is highlighted with Warning, Caution, Important or Note, where: WARNING! Indicates critical information about a potential serious outcome to the patient or the user.

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

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

Note: Indicates information requiring special attention.

1.2.1 General WARNINGS! • The ventilator system may be operated only by authorized personnel who are properly trained in its use. It must be operated according to the instructions in this User´s Manual. • After unpacking, perform a routine cleaning and a pre-use check. • Always perform a pre-use check before connecting the ventilator system to a patient. • Secure all tubing and cables to avoid the risk of unwanted movement of the equipment. • If any of the following occurs, discontinue use of the ventilator system and contact a service technician: - unfamiliar pop-up windows on the screen - unfamiliar sounds - any unfamiliar or unexplained event - alarms that cannot be resolved • Make sure that a resuscitator is readily available. • Positive pressure ventilation can be associated with the following adverse events: barotrauma, hypoventilation, hyperventilation or circulatory impairment. • Ventilation must be started manually when a patient is connected to the ventilator system. • Keep the patient unit upright during use. • Do not cover the ventilator system in any way, since the functioning of the equipment may be adversely affected.

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SERVO-U Ventilator System v4.0, User's Manual

| Introduction | 1 |

• Do not modify or remove any original parts. • The ventilator system must not be used during radiotherapy, since this may cause system malfunction. • The ventilator system must not be used in a hyperbaric chamber. • The ventilator system must be kept away from magnetic resonance imaging (MRI) equipment. • When the ventilator system is used with MCare Remote Services, use only network equipment that is safe and complies with the relevant electrical and EMC standards such as IEC 60950. Note: The network cable is excluded from this requirement. • Only accessories, supplies, and auxiliary equipment recommended by the manufacturer should be used with the ventilator system. Use of any other accessories, spare parts or auxiliary equipment may cause degraded system performance and safety. • Use only active humidifiers approved by the manufacturer of the ventilator system. Use of non-approved active humidifiers may result in higher gas temperatures, increase resistance in filters and degrade ventilation performance. • During humidification, carefully monitor the airway pressure. Increased airway pressure could result from a clogged filter. Replace the filter if the expiratory resistance increases or according to the instructions for the filter, whichever comes first.

SERVO-U Ventilator System v4.0, User's Manual

• Service, repair and installation must only be performed by personnel authorized by the manufacturer. • 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 SERVO-U Ventilator System including cables specified by the manufacturer. Otherwise degradation of the performance of this equipment could result.

CAUTIONS: • Never leave the patient unattended when connected to the ventilator system. • Before use, make sure the system version displayed under SYSTEM STATUS/General corresponds to the system version described in the User's Manual. • The manufacturer has no responsibility for the safe operation of the ventilator system if the requirements specified in Intended use on page 6 are not followed. • When lifting or moving the ventilator system or parts of the system, follow established ergonomic guidelines, ask for assistance, and take appropriate safety precautions. The weight is specified on the ventilator system. • The expiratory channel and expired gas from the exhaust port may be contaminated.

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| 1 | Introduction |

• If a scavenging system (i.e. gas evacuation) is connected to the ventilator system, it must conform to ISO 80601-2-13 guidelines for subatmospheric pressure and induced flow. • During operation any water traps must be checked regularly and if necessary emptied. • All technical documentation is available for use by personnel authorized by the manufacturer. • When using the MCare Remote Services function, instal the network cable so that there is no risk of anyone tripping over it.

Important: • The ventilator system must be installed and put into service according to the EMC declaration. • Securely attach all cables, etc, to minimize the risk of unintentional disconnection. • While the ventilator system is in use, the wheels of the mobile cart must be locked and the mobile cart must be in a horizontal position. • When the ventilator system is connected to a patient: - Do not lift or disconnect the expiratory cassette. - Continuously monitor the settings and measurements displayed on the screen. • Always use a heat and moisture exchanger (HME) or an active humidifier to prevent dehydration of lung tissue. • If a heated patient circuit is not used in the system, a water trap must be used on the expiratory tube to avoid condensation in the system when an active humidifier is used. During operation the water traps must be checked regularly and if necessary emptied. • Use an inspiratory filter when ventilating a highly infectious patient. • All excess fluids must be disposed of according to hospital routines.

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SERVO-U Ventilator System v4.0, User's Manual

| Introduction | 1 |

Notes: • In USA, Federal law restricts this device to sale by or on the order of a physician. • Do not simultaneously touch the patient and any accessible connector contacts. • Do not solely rely on the use of an external monitor to determine the status of the patient and the ventilator system. • Extra care should be taken when handling tubes, connectors and other components of the patient circuit. The use of a support arm to relieve the patient from the weight of the tubing system is recommended. • Contact a representative of the manufacturer regarding decommissioning of the equipment.

1.2.2 Power supply WARNINGS! • The power cord must be connected only to an AC mains power outlet with protective earth to avoid the risk of electric shock. • The power supply cord must be plugged directly into the mains power outlet without the use of any multiple socket outlets. If a multiple socket outlet is used together with other products, total leakage current might be exceeded in the event of a fault in the protective earth.

CAUTIONS: • Do NOT use antistatic or electrically conductive tubing with this system. • Avoid contact with external electrical connector pins. • Unused module compartments should always contain a dummy module to protect the electrical connector pins from spillage and dust.

Important: In case of total loss of power during ventilation, an alarm will sound for 2 minutes. When power is restored, the ventilator system will start in the same state and with the same settings as before the power loss.

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Notes: • When the system is connected to an external power supply, all connected battery modules are being recharged. This does not affect ventilation. • Batteries can be added to available slots during operation.

Battery WARNINGS! • To guarantee reliable battery backup, two fully charged battery modules must be connected at all times. • Dispose of batteries according to local regulations and not with ordinary waste.

Important: • If a battery status message is displayed on the screen, go to SYSTEM STATUS/Batteries for detailed information. If no action is taken, the battery operation time may be unreliable. • Always replace batteries when the ventilator system provides notification of imminent expiration or of diminished operating capacity. • Do not disconnect and store battery modules over long periods of time because this will degrade their capacity. If battery modules need to be stored for short periods of time (up to one week), then store them fully charged. • Check battery in SYSTEM STATUS/Batteries window to ensure safe battery operation. Always charge the battery before use. • When not in use, the ventilator system should always be connected to the mains power to ensure fully charged batteries.

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SERVO-U Ventilator System v4.0, User's Manual

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1.2.3 Fire hazard

1.2.5 Auxiliary equipment

WARNINGS! • Keep all sources of ignition away from the ventilator system and the oxygen hoses.

CAUTION: Measurements of numerical values provided by the ventilator system that have been processed by auxiliary equipment: • may be inaccurate if equipment not authorized by the manufacturer is used • should be disregarded if they conflict with information on the ventilator screen • must not be used as a substitute for therapeutic or diagnostic decisions.

• Do not use a ventilator system with worn or frayed gas supply hoses or hoses that have been contaminated by combustible materials such as grease or oil. • Oxygen-enriched gas is extremely flammable: if a burning odor is detected, disconnect the oxygen supply and mains power and remove the batteries. • Make sure that both the mains power outlet and the power supply connector are accessible.

1.2.4 Gases

Note: Accessories, supplies, and auxiliary equipment used with the ventilator system should: • be recommended by the manufacturer • meet IEC 60601-1 standards • meet IEC standards as a whole system

WARNING! The ventilator system must not be used with helium or any gas mixture containing helium. Refer to section Ventilator system on page 185.

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| 1 | Introduction |

1.2.6 Electromagnetic Compatibility General Important: The ventilator system must be installed and put into service according to Electromagnetic Compatibility, SERVO-U Ventilator System. In order to ensure that the SERVO-U Ventilator System, during electromagnetic disturbances, will deliver ventilation at the patient connection port within the alarm limits set by the user, or generate an alarm condition, the following essential performance (IEC 60601-1) has been monitored during electromagnetic immunity tests: • Delivered volume • Monitoring of: - Oxygen concentration - Airway pressure - Expired volume - Electrical supply failure - Internal electrical power source - Gas supply - Gas failure cross flow • Ability to generate alarms No degradation or failure of the essential performance has been observed during these tests. No other effects on the ventilator system have been observed during the electromagnetic immunity tests.

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SERVO-U Ventilator System v4.0, User's Manual

| Introduction | 1 |

1.3 Version and Configurations This manual applies to version 4.0 of the SERVO-U Ventilator System. The ventilator system has a number of patient categories and ventilation modes available, both for invasive and non invasive ventilation. The standard configuration includes adult and pediatric patient category, while the neonatal patient category is an option. 1.3.1 Available modes and functions Modes/Functions

Patient category Neonatal

Pediatric

Adult

PC

X

X

X

PRVC

X

X

X

VC

-

X

X

Bi-Vent/APRV

X

X

X

PS/CPAP

X

X

X

VS

X

X

X

NAVA *

X

X

X

Automode • PC ⇄ PS • PRVC ⇄ VS • VC ⇄ VS

O O -

O O O

O O O

SIMV • (PC) + PS • (PRVC) + PS • (VC) + PS

X X -

X X X

X X X

NIV PC

O

O

O

NIV PS

-

O

O

NIV NAVA *

O

O

O

Nasal CPAP

O

O

-

High Flow therapy

O

O

O

Y sensor *

O

O

-

CO2 analyzer *

O

O

O

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| 1 | Introduction |

Modes/Functions

Patient category Neonatal

Pediatric

Adult

O -

O O

O O

-

-

O

Transpulmonary pressure

-

O

O

SERVO COMPASS

O

O

O

Nebulizer

X

X

X

Alarm output connection

O

O

O

Open Lung Tool • Trends • Automatic Recruitment Maneuver (Auto RM) • Automatic Stepwise Recruitment Maneuver (Auto SRM)

* excluding module

X = standard

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- = not applicable

O = option

SERVO-U Ventilator System v4.0, User's Manual

| System Overview | 2 |

2 System Overview Table of contents

2.1 2.2 2.3 2.4 2.5 2.6

SERVO-U Ventilator System v4.0, User's Manual

Ventilator Patient unit Patient circuit configurations User interface Symbols on accessories and packaging Transport

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18 20 25 29 36 37

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| 2 | System Overview |

2.1 Ventilator The ventilator consists of a user interface and a patient unit. Air and O2 may be supplied by a medical pipeline system, a compressor, or by gas cylinders. Ensure that the patient unit is firmly fixed to the mobile cart via the clamps and locking clamp.

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SERVO-U Ventilator System v4.0, User's Manual

| System Overview | 2 |

1

3 2

4 5

8

6 7

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10 1.

User interface

2.

Patient unit

3.

Expiratory inlet

4.

Inspiratory outlet

5.

Emergency air intake

6.

Patient circuit

7.

Module compartment

8.

User interface control cable

9.

Air and O2 supply

WARNING! For safety reasons, ensure that the user interface control cable is securely fastened by tightening the locking nuts on the connectors properly.

CAUTIONS: • The emergency air intake must not be blocked or covered. • Lock the wheels if the ventilator system is not to be used during transportation.

10. Wheel lock

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| 2 | System Overview |

2.2 Patient unit

1 2 3 4

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14 15

17 18

20

5

21

6 7 8

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9 11 12

10

24 23

25 26

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SERVO-U Ventilator System v4.0, User's Manual

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1.

Expiratory outlet

2.

AC mains power LED, blue

3.

Power on LED, green

4.

On/Off switch The switch must be pulled downwards before it can be switched.

5.

RS-232 connectors

6.

Fuse for external DC power

7.

External +12V DC inlet

8.

User interface control cable connector

9.

AC mains power source connector with fuse

27. Serial number label

2.2.1 Handling modules Insert a module into the patient unit. Ensure that the module is fully inserted so that the release button returns to a completely closed position.

10. Potential equalization terminal 11. Alarm output connection 12. Cooling fan with filter 13. Lock for inspiratory channel cover 14. Gas inlet for air 15. Gas inlet for O2 16. Inspiratory channel cover 17. Inspiratory outlet 18. Emergency air intake 19. Module compartment

To remove a module: • Pull the lever slightly and press the release button while continuing to pull the lever until the module is released from the ventilator system. • Remove the module from the ventilator system.

20. Expiratory inlet 21. Nebulizer connector 22. Module release levers 23. Expiratory cassette 24. Expiratory inlet with moisture trap 25. Fuse, power label - Fuse label - AC mains power voltage - Potential equilization terminal information 26. Gases and gas inlet pressure label - Air - O2 - Allowed gas inlet pressures SERVO-U Ventilator System v4.0, User's Manual

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