SERVO-i Ventilator System V8.0 Users Manual Rev 06

| TABLE OF CONTENTS |

TABLE OF CONTENTS

1 Introduction 2 System Overview 3 Power supply 4 Operation overview 5 Monitor and record 6 Ventilation, modes and functions 7 NAVA 8 Alarms 9 Optional Accessories 10 System messages 11 Technical data 12 Definitions 13 Appendix • User interface 14 Index

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| TABLE OF CONTENTS |

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| Introduction | 1 |

1 Introduction Table of contents

1.1 1.2 1.3

SERVO-i VENTILATOR SYSTEM V8.0, User's Manual

Device description Warning, Caution, Important and Note Version and Configurations

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6 8 14

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1.1 Device description

1.1.3 Intended Use

This section provides general information about the SERVO-i Ventilator System along with guidelines for appropriate use.

The SERVO-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants, and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.

1.1.1 Device Diagram

1

2

3

SVX-128a

The added indications for use of the NAVA option is when the electrical signal from the brain to the diaphragm is intact; NAVA will improve synchrony between the ventilator and patients with no contraindication for insertion/exchange of a Naso-Gastric tube. The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen).

1.1.2 Device Components The SERVO-i Ventilator System consists of the following components: 1. User Interface-for setting ventilation modes, displaying patient data, and indicating alarms 2.

Patient Unit-for mixing gases

3.

Patient Breathing System-for delivering and exchanging gases

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The SERVO-i Ventilator, with MR environment option, is classified as MR Conditional for 1T, 1.5T and 3T MR scanners. This means that it is safe to use in the MR environment if the conditions in the MR Environment Declaration for SERVO-i are met.

SERVO-i VENTILATOR SYSTEM V8.0, User's Manual

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1.1.4 Cleaning and Maintenance

1.1.6 Disclaimers

Please refer to the SERVO-i/s Cleaning and Maintenance User's Manual.

• Improper Use Environment The manufacturer has no responsibility for the safe operation of SERVO-i Ventilator System if the Intended Use requirements specified in this document are not followed.

1.1.5 Servicing Guidelines CAUTIONS: • Regular Service: The SERVO-i Ventilator System must be serviced at regular intervals by personnel who have received authorization and specialized training by the manufacturer.

• Nonprofessional Servicing The manufacturer has no responsibility for the safe operation of the SERVO-i Ventilator System if installation, service or repairs are performed by persons other than those authorized by the manufacturer.

• Complete Service Records: All service performed on the SERVO-i Ventilator System must be recorded in a service log in accordance with hospital procedures and local and national regulations. • Service Contract: We strongly recommend that all service on the SERVO-i Ventilator System should be performed as part of a service contract with the manufacturer.

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1.2 Warning, Caution, Important and Note 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.

1.2.1 General This manual summarizes the functions and safety features of the SERVO-i Ventilator System. It is not all-inclusive and should not be construed as a substitute for training. WARNINGS! • Always perform a Pre-use check before connecting the ventilator to a patient. • If any of the following occurs, discontinue use of the ventilator and contact a service technician: - Unfamiliar pop-up windows on the screen - Unresolvable alarms - Unfamiliar sounds - Any unfamiliar or unexplained event

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

Note: Indicates information requiring special attention.

• Keep the ventilator upright during use. • Make sure that ventilation is started when a patient is connected to the ventilator. When the ventilator is in Standby, a flashing message, Patient not ventilated, is displayed as a reminder directly above the word Standby. • When the ventilator is connected to a patient: - Do not lift or disconnect the expiratory cassette. - Continuously monitor the settings and measurements displayed on the screen. - Make sure a resuscitator is readily available. • The SERVO-i Ventilator System must be operated only by authorized personnel who are well trained in its use. It must be operated according to the instructions in this User´s Manual.

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• Do not modify or remove any original parts. • Do not cover the ventilator in any way, since the functioning of the equipment may be adversely affected. • When the ventilator is used for MCare Remote Service, use only network equipment that is safe and in compliance with the relevant electrical and EMC standards such as IEC-60950. Note: The network cable is excluded from this requirement. • Always disconnect the network cable before starting ventilation when the ventilator is used for MCare Remote Service. • Positive pressure ventilation can be associated with the following adverse events: barotrauma, hypoventilation, hyperventilation or circulatory impairment. • The SERVO-i Ventilator System should not be used in MR environments unless the requirements described in the SERVO-i MR Environment Declaration (order no. 66 71 670) are met and an agreement with the manufacturer is signed. • The SERVO-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction. • The SERVO-i Ventilator System must not be used in a hyperbaric chamber unless it is equipped for hyperbaric oxygenation. • The SERVO-i Ventilator System must not be used with helium without the Heliox option.

SERVO-i VENTILATOR SYSTEM V8.0, User's Manual

• 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. • 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 at earth fault. • 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-i Ventilator System including cables specified by the manufacturer. Otherwise degradation of this equipment could result.

CAUTIONS: • In USA, Federal law restricts this device to sale by or on the order of a physician. • The expiratory channel and expired gas from the exhaust port may be contaminated. • Refer to the Installation instructions to assemble the system or options to obtain a proper mechanical assembly. • Service, repair and installation must only be performed by personnel authorized by the manufacturer.

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• When lifting or moving the ventilator system or parts of the system, follow established ergonomic guidelines, ask for assistance, and take appropriate safety precautions. • Before use, make sure the system version displayed under Status corresponds to the system version described in the User´s Manual. • Extra care should be taken when handling tubes, connectors and other parts of the patient circuit. The use of a support arm to relieve the patient from the weight of the tubing system is recommended. • When using the MCare Remote Service function, install the network cable so that there is no risk of anyone tripping over it.

Important: • Always use a heat and moisture exchanger (HME) or equipment to prevent dehydration of lung tissue. • While the SERVO-i Ventilator System is in use, the wheels of the carrier shall be locked and the carrier shall be in a horizontal position. • Securely attach all cables, etc, to minimize the risk of unintentional disconnection. • Extra care should be taken when handling the gas trolley, as it may tip over. • All excess fluids must be disposed according to hospital routines.

• Do not leave the patient unattended when connected to the ventilator. • The manufacturer has no responsibility for the safe operation of the SERVO-i Ventilator System if the Intended Use requirements specified in this document are not followed. • Contact a representative of the manufacturer regarding decommissioning of the equipment. • Disconnect the mains power cable from the outlet to isolate the ventilator from mains power. • Do not touch accessible connector contacts and the patient simultaneously.

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1.2.2 Power Supply

1.2.3 Fire Hazard

WARNINGS! • The power cord must be connected only to a properly grounded AC electrical outlet to avoid the risk of electrical shock.

WARNINGS! • Keep the system and its gas hoses clear of all ignition sources.

• To guarantee reliable battery backup, at least two fully charged battery modules must be installed at all times.

CAUTIONS: • Do NOT use antistatic or electrically conductive tubing with this system. • Avoid contact with external electrical connector pins.

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

• Unused module compartments should always contain an empty module to protect the electrical connector pins from spillage and dust.

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1.2.4 Gases

1.2.5 Auxiliary Equipment

CAUTION: The system is not intended to be used with any anesthetic agent.

CAUTIONS: • Accessories, supplies, and auxiliary equipment used with the ventilator should: - be recommended by the manufacturer

Important: • Supplied gases shall meet the requirements for medical grade gases according to applicable standards. Maximum levels: Air 3 • H2O < 7 g/m • Oil < 0.5 mg/m

3

• Chlorine: must not be detectable

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Oxygen 3 • H2O < 20 mg/m 3 • Oil < 0.3 mg/m

Note: For devices with serial numbers below 70000 that are updated to version 7.0, the maximum inlet gas pressure will be reduced (see the Technical data chapter on page 216).

- meet IEC 60601-1 standards - meet IEC standards as a whole system • If a scavenging system (i.e. gas evacuation) is connected to the ventilator, it must conform to ISO8835-3 guidelines for subatmospheric pressure and induced flow. • Measurements of parameter values 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 substitute for therapeutic or diagnostic decisions

Note: Applied parts, i.e. equipment making physical contact with the patient, comprise nebulizer patient unit and cable, Y Sensor, CO2 sensor, Edi Catheter and cable and the Ventilator Breathing System described in System Flow Chart, Ventilation, Patient Connection, part no. 66 92 522.

1. If the compressed air is generated by a liquid ring compressor there is a potential risk of chlorine in the supplied air.

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1.2.6 Electromagnetic Compatibility Important: The ventilator system must be installed and put into service according to Electromagnetic Compatibility, SERVO-i Ventilator System. In order to ensure that the SERVO-i Ventilator System, during electromagnetic disturbances, will deliver ventilation at the 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 • 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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1.3 Version and Configurations This manual applies to version 8.0 of the SERVO-i Ventilator System, which can be delivered in three configurations: SERVO-i Infant; SERVO-i Adult and SERVO-i Universal.

1.3.1 Configurations The weight ranges served by each configuration of the SERVO-i Ventilator System. The SERVO-i Ventilator System can be used in both invasive and non invasive ventilation. Configuration

Weight range Invasive ventilation

Non invasive ventilation Adult

NIV PC + PS Infant

NIV NAVA Infant NIV Nasal CPAP

SERVO-i Infant 0.5 kg – 30 kg

Not Applicable

3 kg – 30 kg

0.5 kg – 30 kg

0.5 kg – 10 kg

SERVO-i Adult

10 kg – 250 kg

10 kg – 250 kg

Not Applicable

Not Applicable

Not Applicable

SERVO-i Universal

0.5 kg – 250 kg 10 kg – 250 kg

3 kg – 30 kg

0.5 kg – 30 kg

0.5 kg – 10 kg

NIV = Non Invasive Ventilation

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1.3.2 Configuration labels SERVO-i Universal

NAVA ready

SERVO-i Adult

NAVA

SERVO-i Infant

1.3.3 Available options The SERVO-i Ventilator System Configurations - lists the available functions and indicates if included or optional with each configuration Infant

Standard Configuration

Adult

Options

Universal

Not applicable

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NIV NAVA

Bi-Vent/APRV

NAVA

VS (Volume Support)

Nasal CPAP

PRVC (incl. SIMV (PRVC) + PS)

Non Invasive Ventilation (NIV) Y Sensor Measuring CO2 Analyzer

VC (incl. SIMV (VC) + PS) PC (incl. SIMV (PC) + PS) PS/CPAP

Nebulizer Heliox Stress Index ®

Open Lung Tool (OLT) ®

Automode

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SERVO-i VENTILATOR SYSTEM V8.0, User's Manual

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2 System Overview Table of contents

2.1 2.2 2.3 2.4 2.5

SERVO-i VENTILATOR SYSTEM V8.0, User's Manual

Ventilator | User Interface - Connections, labels and | symbols Navigating the User Interface | Patient Unit - Connections, labels and symbols | Transport and storage |

18 19 22 28 35

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2.1 Ventilator The User Interface is used to control ventilator settings. Settings may be adjusted using touchpads on the screen or a rotary dial.

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Breathing parameters are continuously measured and controlled. A difference between the actual measured value of a parameter and the preset or calculated value results in the adjustment of gas delivery to achieve the target value.

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The system has two gas modules, one for air and one for O2. Gases may be supplied by a medical pipeline system, a compressor, or by gas tanks.

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Ensure that the ventilator is in its locked position on the cart or holder used, to prevent unintentional movements. CAUTION: Lock the wheels if the ventilator is not to be used for transportation. 1.

Air and O2 supply

2.

Power cable

3.

User Interface

4.

Patient Unit

5.

Expiratory inlet

6.

Servo Duo Guard, viral/bacterial filter

7.

Inspiratory outlet

8.

Patient circuit

9.

Module compartment

10. Emergency air intake

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2.2 User Interface - Connections, labels and symbols The User Interface includes: • a screen with active touchpads • fixed keys • rotary dials 2.2.1 User Interface Diagram

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2.2.2 User Interface Components Refer to the User Interface Diagram for the location of the following numbered components: 1.

Current Patient category

2.

Current mode of ventilation

20. Measured values and alarm limits display (customizable)

3.

Automode On/Off (option)

21. Additional settings

4.

Admit patient/Entered patient data and admission date

22. Additional measured values

5.

Nebulizer On/Off (option)

24. Cable reel for the control cable

6.

System status parameters

7.

Fixed keys

25. Slot for Ventilation Record Card (side/rear view)

8.

Main Rotary Dial-used to select a menu touchpad or parameter box, to adjust values, and to confirm settings

26. Locking lever for rotation

Special Function Keys-used to start special ventilatory functions

28. Holder for positioning on the Mobile Cart

9.

10. Direct Access Knobs-used for immediate adjustment of breathing parameters 11. AC Power indicator (green) 12. Standby indicator (yellow)-when the ventilator is in Standby, a flashing message, Patient not ventilated, is displayed on the screen directly above the word Standby.

23. Loudspeaker

27. Locking screw for alternative cart mounting 29. Control cable (2.9 m long) 30. Service connector 31. On/Off switch 32. Locking lever for tilting 33. Model number 34. Serial number 35. Manufacturing information

13. Start/Standby key 14. On/Off switch (rear side) 15. Slot for Ventilation Record Card (front view) 16. Luminescence detector-for automatically adjusting screen brightness 17. Text messages, including patient triggering symbols 18. Alarm messages 19. Waveform area-for monitoring two to four individually scaled parameters, including a volume/pressure loop and a flow/volume loop 20

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2.2.3 User Interface Symbols Symbol

Description

Audio Pause - silence or confirm an alarm. Note: This symbol may be different depending on User interface version. Audio off

Symbol

Description

Volume Control with decelerating flow

Note: The patient unit symbols are described later in this chapter.

Audio Pause - all alarms, active and inactive, are pre-silenced. Alarm on Alarm off Attention consult documentation Note: This symbol may be different depending on User Interface version Do not push the User Interface as the ventilator may tip over. Start ventilation/Standby-yellow indicates Standby Power indicator-green indicates AC power connected Battery-indicates ventilator is using battery power, with estimated minutes remaining 12 V

12 V - indicates that external 12V DC is connected. ON/OFF switch Trigger indication-appears in the message/alarm field when the patient triggers a breath Indicates that the system is compensated for Heliox. Infant patient category

Adult patient category

Volume Control with flow adaptation Volume Control without flow adaptation SERVO-i VENTILATOR SYSTEM V8.0, User's Manual

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