SERVO-air Users Manual v2.2 Rev 03

| TABLE OF CONTENTS |

TABLE OF CONTENTS

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

SERVO-air Ventilator System v2.2, User's Manual Infologic 1.48

| 5 | 17 | 39 | 47 | 57 | 85 | 111 | 125 | 133 | 161

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| TABLE OF CONTENTS |

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SERVO-air Ventilator System v2.2, User's Manual Infologic 1.48

| Introduction | 1 |

1 Introduction Table of contents

1.1 1.2 1.3

SERVO-air Ventilator System v2.2, User's Manual

Device description Safety guidelines Version and configurations

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6 8 15

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1.1 Device description

1.1.2 Intended use

1.1.1 Device components

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

The ventilator system consists of: 1. a user interface for setting ventilation modes, 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

• to be used only by healthcare providers • to be used only in professional healthcare facilities and for transport within these facilities

1

2

6

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SERVO-air Ventilator System v2.2, User's Manual

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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-air 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: If the ventilator system is to be a part of another system it requires an evaluation of the requirements of the IEC 60601-1 standard.

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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. • The air inlet must not be occluded. • 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 ventilator system upright during use.

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SERVO-air Ventilator System v2.2, User's Manual

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• Do not cover the ventilator system in any way, since the functioning of the equipment may be adversely affected. • 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. • The ventilator system must not be used with helium or any gas mixture containing helium. • 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 and increase resistance in filters. • During humidification, carefully monitor the airway pressure. Increased airway pressure could result from a clogged

SERVO-air Ventilator System v2.2, User's Manual

filter. Replace the filter if the expiratory resistance increases or according to the instructions for the filter, whichever comes first. • Service, repair and installation must only be performed by personnel authorized by the manufacturer. • The ambient sound needs to be taken into consideration when setting the alarm sound level. • Always disconnect the patient from the ventilator system when performing operations that involve risk for the patient, such as replacing the O2 cell, dismantling etc. • 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-air Ventilator System including cables specified by the manufacturer. Otherwise degradation 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.

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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. The weight is specified on the ventilator system. • The air inlet filter must be in place when the system is running. • The expiratory channel and expired gas from the exhaust port may be contaminated. • 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 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. • Check that the cooling fan intakes are not covered. Do not place the ventilator system on soft surfaces. • The air inlet filters must be checked regularly and replaced if necessary.

• When using the MCare Remote Services function, instal the network cable so that there is no risk of anyone tripping over it.

• Use an inspiratory filter when ventilating a highly infectious patient.

• The ventilator system must not be used with any anaesthetic agent.

• The emergency air intake must not be blocked.

Important: • Securely attach all cables, etc, to minimize the risk of unintentional disconnection.

• All excess fluids must be disposed of according to hospital routines.

• Do not disconnect the expiratory cassette while the ventilator system is in operation; if necessary, disconnect the cassette while in STANDBY.

• 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. 10

SERVO-air Ventilator System v2.2, User's Manual

| Introduction | 1 |

Notes: • 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. • Make sure that the ventilator system is firmly mounted on the mobile cart. • Make sure that cables and patient circuit is not obstructed or squeezed due to improper mounting. • 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.

• Expiratory filter connection is mandatory during nebulization. • A water trap is recommended if a single heated patient circuit is used. • Thermoshell, expiratory cassette must be used when using heated expiratory tubing or Expiratory heater Servo Duo Guard.

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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.

CAUTION: The battery modules must be charged before first use.

Note: When the system is connected to an external power supply, all connected battery modules are being recharged. This does not affect ventilation.

One battery can be added to an available slot during operation.

Battery

Important: • If a battery status message is displayed on the screen, always go to SYSTEM STATUS/Batteries for detailed information.

WARNINGS! • Do not use sharp tools when extracting the batteries. • To guarantee reliable battery backup, make sure a battery is in place in slot 2 at all times during ventilation. • Dispose of batteries according to local regulations and not with ordinary waste.

Do not expose the batteries to water, fire or excessive heat. Do not crush, disassemble, puncture or short circuit the connector terminals.

Hold onto the battery strap when inserting a battery in the ventilator system.

• Check battery in SYSTEM STATUS/Batteries window to ensure safe battery operation. Always charge the battery before use. • Always replace batteries when the ventilator system provides notification of imminent expiration or of diminished operating capacity. • When not in use, the ventilator system should always be connected to the mains power to ensure fully charged batteries. Refer to section Battery status on page 25.

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SERVO-air Ventilator System v2.2, 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 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.

Accessories, supplies, and auxiliary equipment used with the ventilator system must be recommended by the manufacturer

1.2.4 Gases WARNING! The ventilator system must not be used with helium or any gas mixture containing helium. Refer to section Ventilator system on page 136.

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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-air Ventilator System. In order to ensure that the SERVO-air 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 - Internal electrical power source - Mains power status - Gas supply - Gas temperature • 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-air Ventilator System v2.2, User's Manual

| Introduction | 1 |

1.3 Version and configurations This manual applies to version 2.2 of the SERVO-air Ventilator System.

1.3.1 Configurations The ventilator system can be used in both invasive and non invasive ventilation. The configurations includes adult and pediatric. Refer to section System on page 134. 1.3.2 Available modes and functions Modes/Functions

Patient category Pediatric

Adult

PC

X

X

PRVC

O

O

VC

X

X

Bi-Vent/APRV

O

O

PS/CPAP

X

X

VS

O

O

Automode

O

O

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

X O X

X O X

NIV PC

O

O

NIV PS

O

O

Nebulizer

X

X

Alarm output connection

O

O

X = standard

SERVO-air Ventilator System v2.2, User's Manual

- = not applicable

O = option

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SERVO-air Ventilator System v2.2, User's Manual

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2 System Overview Table of contents

2.1 2.2 2.3 2.4 2.5 2.6

SERVO-air Ventilator System v2.2, User's Manual

Ventilator Patient unit Batteries Patient circuit User interface Transport

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18 20 24 26 31 37

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2.1 Ventilator The ventilator consists of a user interface and a patient unit. Air is supplied from ambient air by an internal turbine and O2 may be supplied by a medical pipeline system or by gas cylinder. 2.1.1 Mounting on mobile cart • Lock the wheels. • Release the locking clamp on the mobile cart. • Stand directly in front of the mobile cart when mounting the ventilator system. • Tilt the ventilator system to fit the two front clamps in position on the mobile cart. • Press down the rear end of the ventilator to fit the rear clamp in position. • Lock the ventilator system to the mobile cart with the locking clamp. • Ensure that the patient unit is firmly fixed to the mobile cart via the clamps and locking clamp.

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2 3 4

1

6 7 8

5

9 10

11

1.

Patient unit

2.

User interface

3.

Expiratory inlet

4.

Inspiratory outlet

5.

Emergency air intake

6.

Air inlet

7.

Battery compartment

8.

Patient circuit

9.

AC mains power

Note: Lock the wheels whenever the ventilator system is standing still.

10. O2 supply 11. Wheel lock

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2.2 Patient unit

1 2 3 4 5

14 13 12 11 6 7 8 9

15 18

16

10

17 21

20

19 1.

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

2.

Expiratory outlet

3.

Power indicators

4.

RS-232 connectors

5.

Equipotentiality terminal.

6.

AC mains power source connector with fuse

7.

Alarm output connection

8.

External +12V DC inlet

9.

Fuse for external DC power

11. Battery compartments 12. USB ports 13. Gas inlet for O2 14. Gas inlet for air including air inlet filter 15. Inspiratory outlet 16. Emergency air intake 17. Nebulizer connector 18. Expiratory inlet 19. Cooling fan with filter (on both sides) 20. Expiratory cassette 21. Expiratory inlet with moisture trap

10. Ethernet connection 20

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Important: No other external devices than a USB memory stick may be connected to the USB ports. Only one memory stick can be used at the same time.

2.2.1 Symbols on patient unit Symbol

Description

CE label-indicates compliance with the requirements of the Medical Device Directive 93/42/EEC CSA label-Indicates compliance with Canadian and US standards UDI Label - Unique Device Identification. Refer to section UDI label on page 159.

Rx ONLY

In USA, Federal law restricts this device to sale by or on the order of a physician. Type B-indicates classification according to IEC 60601-1 Type BF applied part - indicates classification according to IEC 60601-1 Potential equalization terminal Note: The potential equalization terminal is designed for the connection of a potential equalization conductor according to DIN 42 801 and IEC 60601-1. The function of the potential equalization terminal is to equalize potentials between the ventilator system and other medical devices that can be touched simultaneously. The potential equalization terminal must not be used for a protective earth connection. Nebulizer connector RS-232/Serial port - connector for data communication Ingress protection, IP21 Fuse (specification)

- +

External 12V DC input

12V

- +

Battery Expiratory gas flow from the patient Inpiratory gas flow to patient

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