Datex-Ohmeda Centiva-5 User manual

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Page 1

Centiva/5

User’s Reference Manual

Software Revision 2.n

Page 2

User Responsibility

CAUTION

This Product will perform in conformity with the description thereof contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should repair or replacement become necessary, Datex-Ohmeda recommends that a telephonic or written request for service advice be made to the nearest Datex-Ohmeda Field Service Support center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Datex-Ohmeda and by Datex-Ohmeda trained personnel. The Product must not be altered. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than Datex-Ohmeda.

U.S. Federal laws restrict this device to sale by or on the order of a licensed medical practitioner. Outside the U.S.A. check local laws for any restriction that may apply.

Datex-Ohmeda products have unit serial numbers with coded logic which indicates a product group, the year of manufacture and a sequential unit number for identification.

AAA B 12345

This alpha character indicates the year of product manufacture and when the serial number was assigned. 1 = 2001, 2 = 2002 etc.

URM Centiva/5, CM-920041, rev. 2.22  TIM GmbH

Page 3

Table of Contents

1 Introduction

2 Safety

3 General description

4 Concept of operation

1.1 How to use this manual 1-2

1.2 Symbols used in this manual or on the equipment 1-3

1.3 Abbreviations used in this manual or on the equipment 1-5

2.1 Safety 2-2

3.1 General description 3-2

3.1.1 Intended use 3-2

3.1.2 Principle of operation 3-2

3.1.3 Ventilation modes 3-3

3.1.4 Additional function 3-4

3.2 Supply 3-5

3.2.1 Electrical supply 3-5

3.2.2 Gas supply 3-5

3.3 Positioning 3-6

3.4 Main components 3-7

3.5 System controls 3-8

3.5.1 Front side 3-8

3.5.2 Rear side 3-9

4.1 Concept of operation 4-2

4.1.1 Screen content 4-3

4.1.2 Soft keys 4-5

4.1.3 I : E Ratio soft key 4-6

URM Centiva/5, CM-920041, rev. 2.22

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Page 4

Table of Contents

4 Concept of operation

continued

5 Preparation

4.1.4 Timing parameters 4-7

4.1.5 Graphics 4-8

4.1.9 Changing a parameter 4-13

4.1.10 Menu button 4-14

4.1.11 Selecting a menu topic 4-15

4.1.12 Activating a menu function 4-16

5.1 Electrical supply 5-2

5.1.1 Mains supply 5-2

5.1.2 Back-up battery supply 5-4

5.2 Gas supply 5-5

5.2.1 Dual gas supply 5-5

5.2.2 Single gas supply 5-6

5.3 Set up of expiration valve 5-7

5.4 Breathing gas conditioning 5-8

5.5 Breathing circuit 5-9

5.5.1 Connection with HME 5-9

5.5.2 Connection with active humidifier 5-10

5.6 Placing the device 5-12

5.6.1 Control panel 5-12

5.6.2 Entire system 5-14

5.7 Turn ON and OFF 5-15

5.8 Self test 5-16

5.8.1 Power-up test 5-16

5.8.2 System test 5-17

5.8.3 In-operation test 5-18

5.9 Select the type of patient 5-19

5.10 System test menu 5-20

5.11 Starting the ventilator 5-22

4.1.6 Numerical patient data 4-9

4.1.7 Status information 4-10

4.1.8 ComWheel 4-12

4.1.13 Submenus 4-17

4.1.14 Open a submenu 4-19

4.1.15 Change a parameter in a submenu 4-20

4.1.16 Alarm silence 4-22

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Table of Contents

6 Operation

7 Cleaning and Sterilization

6.1 Adjust ventilation modes 6-2

6.1.1 Select a ventilation mode 6-2

6.1.2 Default ventilation values 6-3

6.1.3 Changing ventilation modes 6-4

6.2 Adjust ventilation parameters 6-6

6.2.1 VCV 6-6

6.2.3 Bi-Level 6-12

6.2.4 Bi-Level/PSV 6-14

6.2.5 CPAP/PSV 6-17

6.2.5 CPAP/Apnea 6-19

6.3 Additional functions 6-21

6.3.1 Standby 6-22

6.3.2 ASR (Automatic Suction routine) 6-24

6.3.5 Alarm AUTOSET 6-38

6.3.6 ARC (Airway Resistance Compensation) 6-41

6.3.9 NIV (Non Invasive Ventilation) 6-51

6.3.10 APD (Automatic Patient Detection) 6-53

6.3.11 OCV (Online O2 sensor Calibration) 6-54

6.3.12 Short cuts 6-55

7.1 General advice 7-2

7.2 Disassembly 7-3

7.2.1 Used with HME 7-3

7.2.2 Used with active humidifier 7-4

7.3 Expiration valve 7-5

7.3.1 Removing expiration valve assembly 7-5

7.3.2 Disassemble expiration valve assembly 7-7

7.4 Clean and sterilize 7-8

7.4.1 Housing and control panel 7-8

7.5 Reassembly 7-9

6.2.2 SIMV-VC 6-9

6.3.3 Parameter menu 6-32

6.3.7 NEB (Nebulizer drug delivery) 6-44

6.3.8 System test 6-50

7.4.2 Expiration valve 7-8

7.5.1 Reassemble expiration valve assembly 7-9

7.5.2 Reinsertion of expiration valve assembly 7-10

URM Centiva/5, CM-920041, rev. 2.22,

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Table of Contents

8 Alarms and messages

9 Maintenance

10 Technical data

11 Parts list

8.1 Alarm modality 8-2

8.2 Alarm messages 8-4

8.3 Other messages 8-8

9.1 General 9-2

9.2 Oxygen sensor calibration 9-3

9.2.1 Start calibration 9-3

9.2.2 Stop calibration 9-4

9.3 Expiration valve 9-5

9.3.1 Remove valve assembly 9-5

9.3.2 Replace components 9-7

9.3.3 Reassembly 9-8

9.4 Additional maintenance 9-10

9.4.1 Every twelve (12) months 9-10

9.4.2 Every twenty four (24) months 9-10

10.1 General 10-2

10.2 Supplies 10-3

10.3 Ventilator characteristics 10-4

10.4 Controls and ranges 10-8

10.6 Measurement functions 10-9

10.7 Monitoring functions 10-10

10.8 Control panel 10-13

11.1 Spare parts 11-2

11.2 Accessories 11-2

8.3.1 Messages during power up 8-8

8.3.2 Messages during system test 8-11

8.3.3 Messages during O2 calibration 8-19

8.3.4 Messages during operation 8-20

9.3.4 Reinsertion of expiration valve assembly 9-9

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URM Centiva/5, CM-920041, rev. 2.22

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1 Introduction

In this section

1.1 How to use this manual 1-2

1.2 Symbols used in this manual or on the equipment 1-3

1.3 Abbreviations used in this manual or on the equipment 1-5

URM Centiva/5, CM-920041, rev. 2.22

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1 Introduction

1.1 How to use this manual

This manual describes the operation of the

The Centiva/5 ICU ventilator may be used together with additional accessories, such as trolleys, compressors etc. These accessories come with a separate operation manual.

Use this manual together with the manuals for optional accessories.

Centiva/5 ICU ventilator Release 2.2n.

1-2

URM Centiva/5, CM-920041, rev. 2.22

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1.2 Symbols used in this manual or on the equipment

Warnings and Cautions tell you about dangerous conditions that can occur if you do not follow all instructions in this manual.

WARNING

CAUTION

Warnings indicate a condition that can cause injury to the operator or the patient.

Cautions indicate a condition that can cause damage to the equipment. Read and follow all warnings and cautions.

Alarm silence touch key

Menu touch key

Left turn ComWheel to decrease value

Right turn ComWheel to increase value

Rotate ComWheel to change value

Push ComWheel to confirm selection (ENTER)

1 Introduction

URM Centiva/5, CM-920041, rev. 2.22

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1 Introduction

On (power)

Off (power)

10101

xxx

Earth ground

Protective earth ground

Equipotential

Type B equipment

Input (Expiratory port)

Output (Inspiratory port)

Attention, refer to product instructions, EN/IEC 60601-1

Serial data transfer connection

Systems with this mark comply with the European Council Directive (93/42/EEC) for Medical Devices when they are used as specified in their Operation and Maintenance Manuals. The “xxxx” is the certification number of the Notified Body used by the manufacturer’s Quality Systems.

Nebulizer gas supply

DC external power supply

1-4

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1 Introduction

1.3 Abbreviations used in this manual or on the equipment

Vent. mode

VCV

SIMV - VC

Bi-Level

PSV

CPAP

CPAP/PSV

CPAP/Apnea

APD ARC ASR NEB

NIV

OCV

Endot.tube

Trach.tube

max

limit

insp

peak

min

PEEP

Rate

I:E

Ramp

PS ramp

Time window

I-Flow

Trigg.

Byflow

PS endflow

Flow

Ventilation mode Volume constant Controlled Ventilation Synchronized Intermittent Controlled Ventilation- volume constant Bi Level pressure controlled ventilation Pressure Support Ventilation Continuous positive airway pressure CPAP with pressure support ventilation CPAP with apnea Bi-Level back up ventilation

Automatic patient detection Airway resistance compensation Automatic suction routine Nebulizer Non Invasive Ventilation Online oxygen calibration during ventilation Endotracheal tube Tracheal tube

Safety pressure setting Pressure limit setting Inspiratory pressure setting Pressure Support pressure setting Highest airway pressure, measured within last breath Lowest airway pressure, measured within last breath Positive End Expiratory Pressure setting Airway pressure in general

Breaths per minute Inspiratory to Expiratory time ratio Ramp time between lower and upper Bi-level Ramp time between PEEP level and PS pressure level Trigger time window

Time in general

Tidal volume setting Tidal volume, measured Minute volume, measured Inspiratory flow setting Trigger flow required to trigger an assisted breath Bias flow End-of-flow criteria for PS pressure support Flow in general

URM Centiva/5, CM-920041, rev. 2.22

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1 Introduction

Fi-O2

O2-I

or AC or DC

Rev. x.nn

40 … 80 PSI

AIR 40 … 80 PSI

24V/3A DC

Serial Port

Inspiratory O2 concentration setting Inspiratory O2 concentration, measured

On (power), line supply

Off (power), line supply

Alternating current Direct current

Ref

Stock number

Serial number Software revision number

O2 gas supply input with a pressure range of 40 … 80 PSI AIR gas supply input with a pressure range of 40 … 80 PSI

DC supply input with 24 V and a maximum current of 3 A Connection for serial data transfer

1-6

URM Centiva/5, CM-920041, rev. 2.22

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2 Safety

In this section

2.1 Safety 2-2

URM Centiva/5, CM-920041, rev. 2.22

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Page 14

2 Safety

2.1 Safety

Reference

Safe Operation

Classification

Safety standards

This manual describes the operation of the

To ensure safe operation of the Centiva/5 use the system only as intended. Operators need to be familiar with this Operation Manual prior to operating the system. Only trained operators are allowed to use this system. Always ensure compliance with the requirements of this Operation manual and with the local governmental or other authority’s requirements for operating ICU ventilators.

The Centiva/5 is a device of group IIb, according to the directive 93/42/EEC, Annex IX, Rule 9 for medical products.

Classification according to EN 60601-1 for electro medical devices

EVICE OF PROTECTION CLASS I, with internal power supply. Protection

D against electrical hazard is performed by grounded operation.

EVICE TYPE B, according to safety grade for electrical hazard

ONTINUOUS OPERATION according to described operation modes.

The Centiva/5 is designed with respect to the following safety standards:

- EN 60601-1, Medical electrical equipment, General conditions

- EN 794-1, Special requirements for lung ventilators

- EN 475, Specification for warning, advice and information in anesthesia and critical care

- EN 60601-1-4, software controlled medical devices

- EN 60601-1-2, electro magnetic compatibility

URM Centiva/5, CM-920041, rev. 2.22

Release 2.2n.

2-2

URM Centiva/5, CM-920041, rev. 2.22

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2 Safety

Safety features

Patient Safety

The following safety features are built into the Centiva/5 to warn the operator in case of risk to the patient.

Device alarms

Control of Control for

Gas supply O2 supply fail, AIR supply fail

Disconnection Disconnection of patient and breathing

O2 concentration O2 concentration

Electrical energy Line supply fail, battery supply fail

Device’s control system Watchdog alarm

Patient alarms

Control of Control for

High pressure High pressure alarm

Minute volume Upper and lower minute volume alarm

Rate Upper and lower rate alarm

Airway pressure Pressure sustained

The Centiva/5 shall be operated by or on the order of a physician. The Centiva/5 shall only be operated by qualified medical personal, to ensure adequate intervention in case of a device malfunction.

Constant surveillance of a patient connected to an ICU ventilator by trained personal is required.

Ensure alarm limits are set according to the patient’s situation and ensure alarms are activated whenever a patient is connected to the system.

Use only breathing circuits and accessories approved by the manufacturer of either the Centiva/5 or the accessory.

system

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2 Safety

Patient Safety (cont.)

WARNING

Residual risk

Always perform the Centiva/5’s system test before using the ventilator.

Never perform a system test when a patient is connected to the Centiva/5.

This system test is designed to test all safety relevant features and components prior to the start of ventilation.

In case of emergency the system test may be bypassed. The system will recognize this status as “No test” and displays this status in the screen to remind the operator to perform the system test at their earliest convenience.

If the system test is not performed, the system does not know the correct breathing circuit’s specifications necessary for optimized compliance and resistance compensation. In this case the ventilator may not work with the specified accuracy and tolerances.

To reduce the risk of a device malfunction, redundant systems are integrated into the Centiva/5.

High and medium risk functions are designed to provide an alternate system in case of a first failure.

Low risk functions are tested with the power-up test each time the unit is powered up prior to operation.

The system provides for an adjustable pressure limiter in the VCV and SIMV –VC modes. In the VCV or SIMV-VC modes the P

O in Pediatric and 30 cmH2O in Adult mode.

cmH

The system has an additional second level safety pressure function,

, that is active in all modes. The P

max

Pediatric and 40 cmH

O in the Adult mode, when in the VCV or SIMV-VC

modes. The Pmax default is set to 18 cmH

defaults to 30cmH2O in

max

O in Pediatric and 21 cmH2O

in the Adult mode, when in Bi-Level, CPAP/PSV or CPAP/Apnea modes.

defaults to 20

limit

2-4

URM Centiva/5, CM-920041, rev. 2.22

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2 Safety

Risk of electrical hazard

Fire hazard

Risk of electromagnetic

interference

The Centiva/5 is designed to be operated only in electrical environments according to VDE 0107 or EN 60601-1.

Prior to cleaning, repair or maintenance always disconnect the system from the electrical supply. Prior to reconnecting the system to the electrical supply ensure the housing is dry.

Prior to connecting the device to an electrical supply check your local supply voltage to match the operation voltage of the device, which is marked on the serial plate on the rear side of the device.

Store the system only according to the given specifications for temperature and humidity.

Operate the system only according to the given specifications for temperature and humidity. In case system’s temperature is lower or higher than specified, allow the system to stabilize for one hour before operation.

Do not use materials such as Ammonia, Phenol or Acetone to clean this device.

Do not use the Centiva/5 when there is doubt in the proper function of the electrical earth ground in the installation environment

Do not use the Centiva/5 in the presence of flammable anesthetics.

Devices radiating electromagnetic fields in a strength beyond the requirements of EN 60601-1-2 can influence the safe operation of the Centiva/5 and can cause risk to the patient.

Devices radiating high frequency fields and installed near the system can influence the safe operation of the Centiva/5 and can cause risk to a patient.

Do not use cellular phones (mobile phones) within 10 meters of the Centiva/5. Otherwise this may result in a possible influence on the safe operation of the device and can cause risk to a patient.

Do not use the Centiva/5 in the presence of nuclear magnet resonance devices (NMR, MRI).

URM Centiva/5, CM-920041, rev. 2.22

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2 Safety

Accessories

Monitoring

Service and maintenance

The Centiva/5 has a wide range of accessories available.

Use only accessories that are listed in the Centiva/5 accessories list.

Prior to connecting a network or any other data management transfer system to the serial output of the Centiva/5 verify that these devices are in compliance with EN 60950 standard for data transfer safety, or EN 60601-1 medical electrical equipment.

The person connecting other systems (electrical or other) to Centiva/5 is responsible that the entire system meets the requirements of EN 60601-1.

The Centiva/5 is equipped with monitoring features that will help to monitor and control the patient’s ventilation situation and to detect changes in the ventilation parameters.

Changes in the ventilation parameters can be caused by:

• changes in the patient’s status

• changes in the settings

failure in operation

•

• device malfunction

• changes in the electrical supply

changes in gas supply

•

A resuscitator for manual ventilation shall be present to maintain ventilation in case of a device malfunction.

The Centiva/5 shall be checked at least every twelve months for safety and proper function.

Only authorized service personal shall perform repair, service and maintenance to the device.

The maintenance intervals and procedures are documented in section 9, ”Maintenance”.

2-6

URM Centiva/5, CM-920041, rev. 2.22

Page 19

2 Safety

Responsibility of the

manufacturer

Manufactured by

Manufactured for

The manufacturer is not responsible for any function change, damage or injury to patient or operator that is caused by misuse or by disregard of the safety advices mentioned in this manual.

The user or owner is responsible for the function of the system if the device is serviced, maintained or repaired by unauthorized personnel.

The user or owner is responsible for the function of the system if the device is misused or not used according to the instructions in this Operation manual .

Salvia Lifetec GmbH & Co KG Niederhöchstädter Strasse 62 61476 Kronberg Germany

Datex-Ohmeda Inc. Ohmeda Drive P.O. Box 7550 Madison, WI 53707-7550 USA Phone. +1 608 221 1551 Fax: +1 608 223 2476

0123

URM Centiva/5, CM-920041, rev. 2.22

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2 Safety

Notes

2-8

URM Centiva/5, CM-920041, rev. 2.22

Page 21

3 General description

In this section

3.1 General description 3-2

3.1.1 Intended use 3-2

3.1.2 Principle of operation 3-2

3.1.3 Ventilation modes 3-3

3.1.4 Additional function 3-4

3.2 Supply 3-5

3.2.1 Electrical supply 3-5

3.2.2 Gas supply 3-5

3.3 Positioning 3-6

3.4 Main components 3-7

3.5 System controls 3-8

3.5.1 Front side 3-8

3.5.2 Rear side 3-9

URM Centiva/5, CM-920041, rev. 2.22

3-1

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3 General description

3.1 General description

3.1.1 Intended use

3.1.2 Principle of operation

Centiva /5 is a critical care ventilator used for intensive care ventilation of humans.

This ventilator is intended to be used for adult patients and children age 1 year + or bodyweight greater than or equal to 5 kg.

This ventilator is designed to maintain and support existing and returning patient’s spontaneous breathing.

Centiva/5 is a time controlled, volume constant, pressure cycled, software controlled system.

The expiration valve is electromechanically controlled with a locking system to provide proper seating of the PEEP valve assembly.

The system uses a flow trigger and allows patient’s free breathing over a built-in free breathing valve.

The system provides for a permanent Byflow in the breathing circuit and allows patient’s spontaneous breathing in all modes.

3-2

URM Centiva/5, CM-920041, rev. 2.22

Page 23

3 General description

3.1.3 Ventilation modes

VCV (Volume Controlled Ventilation)

Controlled volume constant ventilation with the ability of patient’s spontaneous breathing between the mandatory breaths. Additional capabilities are:

- PLV - Pressure Limited Ventilation

- IRV - Inverse Ratio Ventilation

SIMV - VC (Synchronized Intermittent Mandatory Ventilation – Volume Constant) Synchronized volume constant ventilation with the ability of patient’s spontaneous breathing in between the mandatory breaths. Additional capabilities are:

- PLV - Pressure Limited Ventilation

- IRV - Inverse Ratio Ventilation

- PSV - Pressure Support Ventilation

Bi-Level (Bi-Level) Synchronized pressure controlled ventilation combined with patient’s free spontaneous breathing during the entire breathing cycle. Additional capabilities are:

- IRV - Inverse Ratio Ventilation

- PSV - Pressure Support Ventilation on lower Bi-Level pressure level

CPAP/PSV (Continuous Positive Airway Pressure/ Pressure Support Ventilation) Spontaneous breathing with environmental pressure or positive airway pressure. Additional capabilities are:

- PSV - Pressure Support Ventilation on CPAP pressure level

CPAP/Apnea (Continuous Positive Airway Pressure / Apnea back-up) Spontaneous breathing with environmental pressure or positive airway pressure with PSV - Pressure Support Ventilation on CPAP pressure level Additional capabilities are:

- Bi-Level back up ventilation mode with pre-adjusted settings if patient activates the apnea alarm.

For more details refer to section 6 “operation”.

URM Centiva/5, CM-920041, rev. 2.22

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3 General description

3.1.4. Additional functions

APD (Automatic Patient Detection)

Function that provides automatic detection of a patient being connected to the ventilator in all ventilation modes.

ARC (Airway Resistance Compensation) Function that provides adjustable inspiratory and expiratory compensation of the tube’s resistance in all spontaneous breathing modes to ease patient’s spontaneous breathing.

ASR (Automatic Suction Routine) Function that provides an automatic procedure for bronchial suction preparation with a pre-oxygenation phase, a pressure free opening of the y-piece and a post-oxygenation with automatic return to previous settings in all ventilation modes.

NEB (Nebulizer drug delivery) Function that provides drug delivery in all ventilation modes to the patient via the breathing circuit by means of a so called “jet nebulizer”.

NIV (Non-Invasive Ventilation) Function that provides leakage compensation in all ventilation modes to allow ventilation of leaking systems such as nasal or face mask , larynx mask or uncuffed tubes.

OCV (Online O2 sensor Calibration during Ventilation) Function that allows O2 sensor calibration during ventilation.

3-4

URM Centiva/5, CM-920041, rev. 2.22

Page 25

3.2 Supply

3 General description

3.2.1 Electrical supply

3.2.2 Gas supply

Special notice

3.3 Positioning

The Centiva/5 can be configured to be supplied with electrical power from a line supply voltage of 230 V or 115 V AC.

The Centiva/5 can be supplied by a 24 V DC external battery pack (option) for e.g. inner clinical transportation purposes.

As a back-up supply Centiva/5 is provided with an internal battery that supports operation for a minimum of 30 minutes (battery fully charged).

The Centiva/5 is designed to be supplied with O2 and AIR. Single gas operation with either AIR or O2 can be selected .

Ensure clean and dry medical gas supply sources.

Special notice

URM Centiva/5, CM-920041, rev. 2.22

The Centiva/5 is design to be positioned on

The control panel of Centiva/5 is tiltable and detachable. The control panel can be mounted up to a 3 meter distance from the main engine (remote control).

Ensure the Centiva/5 is securely mounted.

a trolley or cart (option)

•

• a rail mount (option)

• a ceiling pendulum (option)

3-5

Page 26

3 General description

3.4 Main Components

Main engine

Control panel

Expiration valve

The Centiva/5 is a system that can be separated into three (3) user accessible components

• The main engine

• The control panel

The expiration valve

•

These three assemblies can be separated by the user without using any tools.

3-6

URM Centiva/5, CM-920041, rev. 2.22

Page 27

3.5 System controls

3 General description

3.5.1 Front side

Screen

Soft keys

Paw cmH2O

Flow L/min

-20

-40

Fi02

Bi-Level

40 20

Rate

1/min

Tube : E 7.5 50%

I:E

Ramp

1:2

0.2

sec

P-Insp

cmH2O

Centiva/5

MV-E

Vt-E

Ppeak

Pmin

O2-I

Rate

PEEP

cmH2O

dult

5.2

350

3 21 18

cmH2O

1/min

Liter

Alarm lights

Silencer

25 18

Menu key

ComWheel

Stopper

Exp. port

Nebulizer

URM Centiva/5, CM-920041, rev. 2.22

Insp. port

ON/OFF

3-7

Page 28

3 General description

3.5.2 Rear side

Serial plate

C inl

Com p

24V/ 3A DC

Gro

und

Caution. U.S. Federal laws restrict this device to sale by o r on the order of a l icensed medical practitioner.Outside the U.S.A. check local laws for any restriction that may apply.

Line switch

Lin

nle

O2 AIR

280 .. . 600 kPa or 40 ... 80 PSI

3-8

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Page 29

4 Concept of operation

In this section

4.1 Concept of operation 4-2

4.1.1 Screen content 4-3

4.1.2 Soft keys 4-5

4.1.3 I : E Ratio soft key 4-6

4.1.4 Timing parameter 4-7

4.1.5 Graphics 4-8

4.1.6 Numerical patient data 4-9

4.1.7 Status information 4-10

4.1.8 ComWheel 4-12

4.1.9 Changing a parameter 4-13

4.1.10 Menu button 4-14

4.1.11 Selecting a menu topic 4-15

4.1.12 Activating a menu function 4-16

4.1.13 Submenus 4-17

4.1.14 Open a submenu 4-19

4.1.15 Change a parameter in a submenu 4-20

4.1.16 Alarm silence 4-22

URM Centiva/5, CM-920041, rev. 2.22

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4 Concept of operation

4.1 Concept of operation

The Centiva/5 is a menu operated and software controlled system.

All information for control is provided by the Display.

All controls are located on the front panel, except the On-Off button on the lower front right and the line supply switch on the rear.

The principle for all controls is based on the S A C system.

Select

Adjust

Confirm

There are two ways to select a parameter to change, either by soft keys or by menu.

The adjustment is always made by turning the ComWheel clockwise for up and counterclockwise for down.

Confirmation of the adjusted value for the selected parameter is made by pushing the ComWheel.

Screen

Soft keys

Paw cmH2O

Flow L/min

Fi02

Bi-Level

40 20

-20

-40

Rate

1/min

Tube : E 7.5 50%

I:E

Ramp

1:2

0.2

sec

P-Insp

cmH2O

Centiva/5

MV-E

Vt-E

Ppeak

Pmin

O2-I

Rate

PEEP

cmH2O

dult

5.2

350

3 21 18

cmH2O

Liter

cmH2O

1/min

25 18

Menu key

ComWheel

4-2

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4 Concept of operation

Softkeys for ventilation parameter settings

4.1.1 Screen content

Soft key parameters

Graphics

Numerical data

The Centiva/5 display shows all information on a color LCD screen. The screen is divided into four different areas.

Area # 1.

This area shows the ventilation parameter settings aligned with the specific soft key. For details refer to soft keys.

Area # 4

Graphical patient data

and alarm messages

Status information

Area # 2

Area # 1

Area # 2

This area shows the measured patient data in graphical format as well as alarm messages.

Area # 3

This area shows the

Area # 4

Graphical patient data

and alarm messages

Softkeys for ventilation parameter settings

Area # 4

Status information

Area # 2

Area # 1

Status information

measured patient data in numeric format.

Area # 2

Graphical patient data

and alarm messages

Softkeys for ventilation parameter settings

Area # 1

Area # 3

numerical

patient

data

Area # 3

numerical

patient

data

Area # 3

numerical

patient

data

URM Centiva/5, CM-920041, rev. 2.22

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4 Concept of operation

Status information

Area # 4.

Area # 4

Status information

This area shows the status information for the ventilator.

Area # 2

Graphical patient data

and alarm messages

Area # 3

numerical

patient

data

Softkeys for ventilation parameter settings

Area # 1

4-4

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4 Concept of operation

cmH2O

1/Min

L/Min

cmH2O

1/Min

cmH2O

Sec.

1/Min

cmH2O

1/Min

cmH2O

Sec.

N-val

c-val

Val

cmH2O

Sec.

cmH2O

4.1.2 Soft keys

Soft keys in VCV

Soft keys in SIMV - VC

Soft keys in Bi-Level

Soft keys in CPAP/PSV

Soft keys in CPAP/Apnea

By using the soft keys the operator selects a parameter to change. Depending on the current ventilation mode the soft keys are related to different parameters. Immediately above the soft key the parameter is displayed in the screen showing the value and units of measure.

Fi O2

Rate

I : E

1:2.0

110

Plimit

PEEP

OFF

Fi O2

Plimit

I : E

1:2.0

Rate

110

PEEP

OFF

Fi O2

P-Insp

I : E

1:2.0

Rate

Ramp

0.20

PEEP

OFF

Fi O2

Rate

I : E

1:2.0

Ramp

0.20

Ramp

0.20

P-Insp

PEEP

OFF

PEEP

OFF

I-Flow

6.6

URM Centiva/5, CM-920041, rev. 2.22

The soft key shows parameter (type) and value

Type

(Val) with blue characters on yellow background.

Activating a soft key will change the background

unit

color from yellow to blue and the character from blue to yellow. When changing the parameter with the ComWheel, the current parameter is displayed as a small character on top to remind the operator

type

of the value (c-val) while making the new parameter change (N- val). After confirming the changed value the soft key returns to blue character on yellow background.

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4 Concept of operation

2.0:1

1:2.0

I : E

2.0:1

I : E

9.9:1

3:1.0

I : E

4.1.3 I : E ratio soft key

Inverse I:E ratio

Inverse I:E ratio in SIMV-VC mode

APRV I:E ratio in Bi-Level mode

Note

For standard I : E ratio settings from 1:1 to 1:9.9 the I : E ratio soft key‘s characters and background colors are identical to the other soft keys.

When changing the I : E ratio in all ventilation modes to inverse values (I>E) (range 1:1 to 4:1) the user will be notified by a change of the background color from blue to red and the character color from yellow to white. After confirming the changed value the soft key returns to blue character on yellow background.

Changing the soft key parameter rate in the SIMVVC mode causes a change of the I:E ratio accordingly to keep the ventilation pattern similar. When this change in I : E ratio leads to inverse values (I>E) the user will be notified by a change of the background color from blue to white and the character color from yellow to red. After confirming the changed value the soft key returns to blue character on yellow background.

Only in Bi-Level mode Centiva/5 offers extreme inverse I:E ratio values to simulate APRV (airway pressure release ventilation).

When changing the I : E ratio in Bi-Level mode beyond the inverse I:E ratio level to extreme inverse I:E ratio values (range 4:1 to 9.9:1) the user will be notified by a change of the background color from red to brown. After confirming the changed value the soft key returns to blue character on yellow background.

When changing the ventilation mode from Bi-Level to any other mode, APRV I:E ratios will not transfer automatically, but the user will be notified to correct the I:E ratio accordingly by a message “I :E > 4:1 !”.

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4 Concept of operation

cmH2O

1/Min

L/Min

cmH2O

4.1.4 Timing parameter

The Centiva/5’s timing parameter in all ventilation modes are:

- ventilation rate (rate)

- inspiration to expiration time ratio (I:E)

Fi O2

Plimit

I : E

1:2.0

Rate

110

PEEP

Off

Changing the I-Flow setting in the ventilation modes VCV and SIMV-VC has an impact on the timing, too. In this case the inspiratory pause will be affected by this parameter.

All timing parameters are relative parameters and do not directly set absolute times. During changing the setting of one of the timing parameters Centiva/5 will display the absolute time information on the screen in the format:

I=xx s, P=yy %, E= zz s

„I“ is inspiration time (T

„P“ is inspiratory pause in % of inspiration time (T

„E“ is expiration time (T

) in seconds

insp

) in seconds.

exsp.

pause

/ T

insp

)

After confirming made changes to one of the timing parameters this absolute time message in the screen disappears automatically.

I-Flow

6.6

URM Centiva/5, CM-920041, rev. 2.22

I= 2.0 s, P= 30%, E=3.0 s

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4 Concept of operation

4.1.5 Graphics

The Centiva/5 displays two graphical waveforms on the screen:

- current airway pressure versus time

- current airway flow versus time

The upper waveform shows the airway pressure and contains markers for the pressure settings, such as PEEP, Pinsp or Plimit.

The lower waveform shows the airway flow.

The display will automatically change to scale to maximize readability of the waveform.

The graphic waveform data is real time and both waveforms are synchronized on the same time base.

Paw cmH2O

40 20

Flow L/min

-20

-40

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4 Concept of operation

Val

cmH2O

4.1.6 Numerical patient data

The Centiva/5 displays measured patient data in a numeric format.

The expiratory minute volume is measured over a period of 60 secs or 10 breaths.

The expiratory tidal volume is measured during each breath.

The maximum (Peak) airway pressure is measured during each breath.

The minimum (Min) airway pressure is measured during each breath.

The inspiratory O2 concentration is measured at the inspiratory port.

The total patient breath rate is measured over a period of 60secs or 10 breaths and represents spontaneous plus mechanical breaths.

The format of this numeric data field shows the parameter (Para) with the measured value (Val) and the unit of measure (unit).

If alarm limits for this particular parameter are available, the upper limit (UL) and the lower limit (LL) are displayed in the same data field.

MV-E

3.0

TV-E

361

Ppeak

Pmin

O2-I

Rate

Para

cmH2O

12.0

2.5

Liter

26 18

1/min

UL LL

Unit

URM Centiva/5, CM-920041, rev. 2.22

4-9

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4 Concept of operation

Tube: E 7.5 40%

Battery: 28 min

Adult

No Test

4.1.7 Status information

Vent. mode

NEB

ARC

Battery

Patient type

System Test

The Centiva/5 shows status information in the top portion of the display. The following describes the status information in order from left to right appearing on the screen.

The selected ventilation mode is displayed: “VCV”, “SIMV-VC”, “Bi-Level”, “CPAP/PSV”, “CPAP/Apnea”.

When nebulization is activated, an icon is displayed during operation in nebulization mode

When Airway Resistance Compensation is activated, status information is displayed giving the selected tube (E=endotracheal, T= tracheal), size of tube (e.g. 7.5 mm) and level of compensation (e.g. 40%). If ARC is not turned ON this status information field is not present.

When the system is supplied by the internal back-up battery the remaining operation time on battery is displayed. Whenever the internal battery is being charged, the same status information appears. If the system is supplied by line (main) supply and the battery is fully charged this status information field is not present.

Status information about the selected patient type is displayed with either ”Adult” or “Pedia” (pediatric).

When the System test is not performed and the ventilator is started by bypassing the system test, the “No Test” is displayed. If the system test was performed prior to the start of the ventilation this status information field is not present.

Bi-Level

4-10

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4 Concept of operation

Switch off device ? Yes: Enter, No: any button

Only O2

Single gas supply

ASR

Shut down

External DC supply

If the operator has confirmed single gas operation during the system test, this status information field displays “Only AIR” for single gas supply with AIR or “Only O2” for single gas supply with O2. If dual gas supply with O2 and AIR is confirmed this status information field is not present.

When the Automatic Suction Routine is activated the status information field reports the different phases of the ASR procedure:

If ASR is not turned ON this status information field is not present.

When the “System Open?” message is displayed on the screen and the ON-OFF button is activated for longer than 3 seconds, the shut down status information appears. This shut down information indicates that pushing the “<Enter>” button (ComWheel), powers down the Centiva/5 or by pressing any other button the system remains in the normal operation mode. This status information field overwrites all other status information fields and covers the entire status information area on the screen

When an external DC supply (e.g. battery pack) takes over the mains supply, an icon is displayed to indicate the power supply by external battery.

- “Pre oxygen” for the pre-oxygenation phase,

- “Suction” for the suction phase,

- “Post oxygen” for the post oxygenation phase.

Pre oxygen

URM Centiva/5, CM-920041, rev. 2.22

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4 Concept of operation

4.1.8 ComWheel

Special notice

The ComWheel is turned to change the selected parameter values .

Turing clockwise increases the value or moves up the cursor in a menu.

Turning counterclockwise decreases the value or moves down the cursor in a menu.

Pushing the ComWheel confirms a selection.

Confirming a selection returns the soft key background color from blue to yellow or changes the highlighted area in a menu. The changed parameter will only become valid when the ComWheel is pushed for confirmation.

When a screen message asks for “<Enter>”, the system asks the operator to push the ComWheel to confirm an action.

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4 Concept of operation

4.1.9 Changing a parameter

The following shows how a parameter change is made.

This is the parameter field before we start.

Select the FiO2 soft key.

Notice the color change.

Turn the ComWheel clockwise to increase the value to 50%.

Notice the value change.

The current value is shown on the top and the new value in the middle.

Confirm the selection by pushing the ComWheel.

This is the parameter field after the change.

FiO2

URM Centiva/5, CM-920041, rev. 2.22

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4 Concept of operation

A R C

Exit

4.1.10 Menu button

To select additional functions or infrequently used parameters push the menu button.

Within the Centiva/5’s screen the main menu will open. It is here that most functions are directly accessible.

Submenus can be opened for detailed parameter settings.

Stand-by A S R

ON Parameter menu Alarm limits Alarm AUTOSET Vent. modes

Nebulizer

System test

4-14

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4 Concept of operation

4.1.11 Selecting a menu topic

To select a specific menu topic turn the ComWheel to select the menu option and push the ComWheel to confirm the selection.

Turning the ComWheel clockwise will move the cursor up the menu.

Turing the ComWheel counterclockwise will move the cursor down in the menu.

Pushing the ComWheel will confirm the selection

URM Centiva/5, CM-920041, rev. 2.22

4-15

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4 Concept of operation

A R C

Exit

A R C

Exit

4.1.12 Activating a menu function

The following shows how to activate a menu selection.

Open the main menu by pushing the menu button.

The main menu will appear in the screen.

Rotate the ComWheel to select the Alarm AUTOSET function.

The selected function will be highlighted in the menu.

Confirm the selection by pushing the ComWheel.

The function “Alarm AUTOSET” is activated and the menu closes automatically.

Stand-by A S R Parameter menu Alarm limits Alarm AUTOSET Vent. modes

Nebulizer

System test

Stand-by A S R Parameter menu Alarm limit s

Alarm AUTOSET

Vent. modes

Nebulizer

System test

ON ON

4-16

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4 Concept of operation

A R C

Exit

A R C

Exit

Buzzer

PS endflow

Rate min

Rate max

Apn.del.

4.1.13 Submenus

Parameter menu

Alarm limits

The following selections in the main menu open the submenus :

• Parameter menu

• Alarm limits

Ventilation modes (Vent. Modes)

•

• Airway Resistance Compensation (ARC)

These submenus open upon selecting the topic in the main menu.

Stand-by A S R

Parameter menu

Alarm limits Alarm AUTOSET Vent. modes

Nebulizer

System test

ON ON

I-flow PS ramp Trigg. ByFlow Time window

Previous menu

10.0 L/m

0.20 s

3.0 L/m

100%

Exit

60% 25%

Stand-by A S R Parameter menu

Alarm limits

Alarm AUTOSET Vent. modes

Nebulizer

System test

ON ON

MV max MV min Leakage Pmax

Previous menu

1.7 L

0.5 L 25%

40cmH2O

20 Sec

40/Min

8/Min

Exit

URM Centiva/5, CM-920041, rev. 2.22

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4 Concept of operation

A R C

Exit

A R C

Exit

CPAP/Apnea

CPAP/PSV

VCV

Vent. modes

A R C

Stand-by A S R Parameter menu Alarm limits Alarm AUTOSET

Vent. modes

Nebulizer

System test

Stand-by A S R Parameter menu Alarm limits Alarm AUTOSET Vent. modes

Nebulizer

System test

ON ON

SIMV - VC Bi-Level

Previous menu

Exit

Endot.tube Trach.tube Diameter 7.5 Compensat. 75 % Previous menu

OFF OFF

Exit

4-18

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4 Concept of operation

A R C

Exit

CPAP/Apnea

CPAP/PSV

VCV

4.1.14 Open a submenu

Push the Menu button to open the main menu,

Select the “Vent. modes” by opening the main menu and rotating the ComWheel to the “Vent. Modes” selection.

Confirm this selection by pushing the ComWheel which opens the “Vent. Modes” submenu.

The “Vent. modes” submenu allows you to select the appropriate ventilation mode by rotating the ComWheel and confirming the selection by pushing the ComWheel.

Stand-by A S R Parameter menu Alarm limits Alarm AUTOSET

Vent. modes

Nebulizer

System test

SIMV - VC Bi-Level

Previous menu

ON ON

Exit

URM Centiva/5, CM-920041, rev. 2.22

4-19

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4 Concept of operation

A R C

Exit

A R C

Exit

4.1.15 Change a

parameter in a sub menu

The following shows how to change the parameter “MV max” in the alarm limit submenu.

Open the main menu by pushing the menu button.

The main menu will appear in the screen.

Stand-by A S R Parameter menu Alarm limits Alarm AUTOSET Vent. modes

Nebulizer

System test

Select the “Alarm limits” by rotating the ComWheel.

The selected function will be highlighted in the menu.

Stand-by A S R Paramet er menu

Alarm limits

Alarm AUTOSET

Vent. m odes

Nebulizer

System test

Confirm the selection by pushing the ComWheel. The “Alarm limits” sub menu will open.

ON ON

4-20

URM Centiva/5, CM-920041, rev. 2.22

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4 Concept of operation

Rate min

Rate max

Apn.del.

Rate min

Rate max

Apn.del.

Rate min

Rate max

Apn.del.

1.7 L

The “Alarm limits” submenu opens.

Select the “MV max” by rotating the ComWheel.

MV max MV min Leakage

40cmH2O

Pmax

20 Sec

40/Min

Previous menu

Exit

1.7 L

0.5 L 25%

8/Min

The selected function will be highlighted in the menu.

Confirming the selection highlights the value in the “MV max” setting.

The selected parameter value is highlighted.

MV max

MV min Leakage Pmax

Previous menu

MV max

MV min 0.5 L Leakage Pmax

Previous menu

1.7 L

0.5 L 25%

40cmH2O

20 Sec

40/Min

8/Min

Exit

25%

40cmH2O

20 Sec 40/Min

8/Min

Exit

URM Centiva/5, CM-920041, rev. 2.22

4-21

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4 Concept of operation

Rate min

Rate max

Apn.del.

2.5 L

Rate min

Rate max

Apn.del.

4.1.16 Alarm silence

Rotating the ComWheel adjusts the new value.

The MV max is changed to 2.5 L.

Confirming the selection activates the new value for the alarm limit MV max.

Selecting the “Previous menu” selection returns you to the main menu. Confirming the “exit” function will close the menu window or if left open for 30 secs the menu will automatically close.

MV max

MV min 0.5 L Leakage Pmax

Previous menu

MV max MV min Leakage Pmax

Previous menu

25%

40cmH2O

20 Sec

40/Min

8/Min

Exit

2.5 L

0.5 L 25%

40cmH2O

20 Sec

40/Min

8/Min

Exit

Pushing the alarm silence button during a high priority alarm silences the audible alarm for two (2) minutes. A clock in the screen starts displaying the remaining alarm silence time. When an alarm becomes inactive , the alarm message stays on the screen, but changes color from red to yellow and the audible alarm turns OFF. This is to remind the operator that an alarm situation had occurred . Pushing the alarm silence button again will remove the yellow alarm message from the screen.

4-22

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Page 51

5 Preparation

In this section

5.1 Electrical supply 5-2

5.1.1 Mains supply 5-2

5.1.2 Back-up battery supply 5-4

5.2 Gas supply 5-5

5.2.1 Dual gas supply 5-5

5.2.2 Single gas supply 5-6

5.3 Set up of expiration valve 5-7

5.4 Breathing gas conditioning 5-8

5.5 Breathing circuit 5-9

5.5.1 Connection with HME 5-9

5.5.2 Connection with active humidifier 5-10

5.6 Placing the device 5-12

5.6.1 Control panel 5-12

5.6.2 Entire system 5-14

5.7 Turn ON and OFF 5-15

5.8 Self test 5-16

5.8.1 Power-up test 5-16

5.8.2 System test 5-17

5.8.3 In-operation test 5-18

5.9 Select the type of patient 5-20

5.11 Starting the ventilator 5-22

URM Centiva/5, CM-920041, rev. 2.22

5-1

Page 52

5 Preparation

5.1 Electrical supply

5.1.1 Mains Supply

The Centiva/5 is designed to operate from electrical supplies:

• Mains supply

• External battery.

The system will treat all of these supply sources as a main supply.

Verify your local mains supply voltage matches the rated device’s voltage on the serial plate (rear side).

Connect the power cord to the mains inlet on the rear of the device.

24V/3A DC

Serial plate

Caution. U.S. Federal laws restrict this device to sale by or on the order of a licensed medical practitioner.Outside the U.S.A. check local laws for any restriction that may apply.

Lin

wit

Line

O2 AIR

280 ... 600 kPa or 40 ... 80 PSI

Connect the power cord to the wall outlet.

Switch ON the mains switch.

Verify the ON-OFF button on the front is lit.

5-2

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5 Preparation

External battery

Place the external battery (option) below the Centiva/5 housing and lock the battery housing to the Centiva/5 housing .

Caution. U.S. Federal laws restrict this device to sale by or on the order of a l icensed medical practi tioner .Outsid e the U.S.A . chec k local laws for any restriction that may apply.

inle

24V/3A DC

O2 AIR

280 ... 600 kPa or 40 ... 80 PSI

Out: 24V/

3 A DC

In: 27,5V/ 0,25 A DC

3,15 A T

Locking

Connect the DC supply power cord from the external battery pack to the blue inlet and verify proper locking of the connector.

Special Notice

Verify the ON-OFF button on the front is lit.

Verify the external battery is fully charged prior to usage. When fully charged the battery’s charging indicator is lit permanently in green.

When powered by the external battery pack, Centiva/5 displays an battery icon in the top left of the screen

For more details to the external battery refer to the operation manual of this accessory.

URM Centiva/5, CM-920041, rev. 2.22

5-3

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5 Preparation

5.1.2 Back-up battery supply

Special notice

WARNING

The Centiva/5 is equipped with an internal back-up battery supply that provides at least 30 minutes of operation upon loss of electrical main supply.

This back-up supply will automatically switch on whenever the main supply is lost and will maintain uninterrupted operation of the Centiva/5.

When operating on the back-up battery, the system will display a message in the operation screen (no line supply).

At the same time the battery status in the status line of the screen will display the remaining operation time on battery.

When operating on back-up battery the system reduces power consumption to save energy for extended battery life by turning off the expiration valve heating system and by reducing the screen brightness.

Upon restoring line (main) supply the system automatically switches back to the line supply and changes the message in the screen (no line supply) from red to yellow.

Upon restoring line (main) supply the system automatically starts recharging the internal battery.

Whenever the Centiva/5 is supplied by any main supply (line, 24 VDC or external battery) and the system is turned ON, the internal back-up battery is recharged. The recharging process is indicated by the battery status displayed in the status line of the screen (with the timer counting up ). The re-charger is not active when the system is turned OFF.

Battery 28 min

Do not use the internal back-up battery as a main supply.

When turning the Centiva/5 ON without line (main) supply, the system powers up on the back-up battery to allow opening of the system test menu only, (e.g. to release the expiration valve for cleaning purpose). Without line (main) supply the Centiva/5 will not go into a ventilation mode. After having passed the power-up test and the system test, the back-up battery function is activated and will perform uninterrupted operation upon loss of line (main) supply.

5-4

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Page 55

5.2 Gas supply

5 Preparation

5.2.1 Dual gas supply

The Centiva/5 is equipped with an electronic O2/AIR mixer to provide a wide range of inspiratory oxygen concentrations. This requires the supply of both O2 and AIR gases. The gas supply range for both gases ranges from 40 to 80 PSI. The Centiva/5 is protected against overpressure up to 140 PSI. The Centiva/5 provides high peak flow capability for optimized pressure support ventilation. This capability requires a flow of 120 l/min per gas.

Verify your gas supply pressure matches the pressure range mentioned above.

24V/3A DC

Connect the O2 gas supply hose to the O2 gas inlet on the rear of the device. Connect the O2 gas supply hose to the wall outlet and check the connection for leaks.

Connect the AIR gas supply hose to the AIR gas inlet on the rear of the device. Connect the AIR gas supply hose to the wall outlet and check the connection for leaks.

Caution. U.S. Federal laws restrict this device to sale by or on the order of a licensed medical practitioner.Outside the U.S.A. check local laws for any restriction that may apply.

O2 gas

O2 AIR

280 ... 600 kPa or 40 ... 80 PSI

nle

WARNING

URM Centiva/5, CM-920041, rev. 2.22

Use only gas supply hoses in compliance with the local standards. Incorrect connecting of O2 and AIR supply can result in risk to the patient.

Only supply the system with dry and clean gases to prevent water, oil or particles to enter the system. Dirt, water or oil can damage the system and may result in risk to the patient.

5-5

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5 Preparation

OnlyAIR

Only O2

5.2.2 Single gas supply

Special notice

The Centiva/5 needs at least 40 PSI from the gas supply for proper operation. If this pressure level is not sufficient from one gas source the system automatically switches to the gas supply which has sufficient pressure and displays an alarm message on the screen.

The Centiva/5 can operate with a single gas supply without alarms. When the system recognizes the single gas supply during the system test it prompts a message on the screen and asks for single gas operation.

In the event of a single gas supply (e.g. AIR) the following screen will appear during system test.

Restoring the O2 supply at this time in the system test removes the message automatically and the system test proceeds. Confirming the single gas operation for AIRsupply by pushing the ComWheel to <Enter> will cause the system test to proceed , but all tests that use O2 will be skipped .

After the system test is completed and ventilation has started, the system will change the default setting for FiO2 according to the selected single gas operation to avoid nuisance alarms. In the single gas AIR operation the FiO2 default is 21 %. In the single gas O2 operation the FiO2 default is 100%.

The single gas operation is displayed in the status line with "Only Air" when lacking O2 supply or “Only O2” when lacking AIR supply.

Restoring the missing gas during operation allows the unit to operate in the dual gas supply mode . The system will still display the selected single gas supply mode until a new system test is performed with both gases available.

System test Rev. x.nn

No O2 gas supply Check O2 gas supply or for single gas AIR-supply press <Enter>

Centiva/5

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Page 57

5.3 Set up of expiration valve

The Centiva/5’s expiration valve is removable from the device for easy cleaning. Upon re-insertion it will lock in automatically for safe operation.

The valve assembly consists of three components:

Special notice

• the valve block

• the PEEP membrane

•

Verify the PEEP membrane assembly is inserted in the valve block with the note “TOP” facing you.

Verify the membrane plate (stainless steel) is positioned on top of the membrane assembly.

The expiratory valve assembly should slide easily into the mating slot on the side of the ventilator

The expiration valve assembly should be inserted smoothly . If you feel a high resistance when inserting the assembly do not force it in but check for proper assembly of the expiration valve.

5 Preparation

assembly

the membrane plate

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5 Preparation

5.4 Breathing gas conditioning

An intubated patient’s physiological function for heating and humidifying the breathing gases is bypassed while on a ventilator. Therefore, it is necessary to care for this missing function by using either a passive heat and moisture exchanger (HME) or an active heated humidifier.

The use of high efficient humidification and heating with low flow resistance is preferred.

CAUTION

Do not use active and passive humidification at the same time in the same breathing circuit !

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Page 59

5.5 Breathing circuit

Insp. line

WARNING

5.5.1 Connection with HME

5 Preparation

The Centiva/5 ventilator can be used with all approved breathing circuits and components, noted in the Centiva/5 accessories list.

In pediatric ventilation, in general (tidal volumes less than 300 ml), the use of pediatric breathing circuits is preferred.

To avoid restriction of the ventilator’s performance, use of breathing circuits with low resistance and a flow optimized y-piece is preferred.

During the system test, compliance, resistance and leakage rate of the breathing circuit is measured and displayed.

Do not use antistatic or conductive tubes or breathing circuits. Risk of electrical hazard to the patient !

Use of a support arm (option) to hold up the breathing circuit between the device and patient is recommended.

Connect inspiratory tube to the right, front 22 mm connector (inspiratory output).

Connect expiratory tube to the left, front 22 mm connector (expiratory input).

Connect y-piece to open end of inspiratory and expiratory tube

Connect HME to the y-piece and connect patient to the HME.

Check for proper seating of all connections.

Bi-Level / ASB

Paw mbar

20 Flow L/min

-20

-40

Fi02

Rate

1/min

Tube : E 7. 5 50%

I:E

1:2

Ramp

0.2

Centiva/5

dult

MV-E

4.2

Liter

Vt-E

350

Ppeak

cmH2O

Pmin

cmH2O

O2-I

Rate

P-Insp

sec

1/min

PEEP

P-ASB

cmH2O

URM Centiva/5, CM-920041, rev. 2.22

HME

Exp. line

5-9

Page 60

5 Preparation

5.5.2 Connection with active humidifier

Adjust the humidifier rail of the cart according to the height requirement of the active humidifier so that between the upper level of the humidifier and the lowest part of the drawer or

Bi-Level / ASB

Paw mbar

20 Flow L/min

-20

-40

Fi02

Rate

1/min

Tube : E 7.5 50%

I:E

1:2

Ramp

P-Insp

0.2

sec

cmH2O

plate of the cart is a minimum of 15 cm.

Release the screw in front of the rail mount to change the position of the rail and tighten it, when the correct position is found.

Place the active humidifier onto the rail and properly fix it there.

Fill humidifier chamber or use a

Bi-Level / ASB

Tube : E 7.5 50%

pre-filled humidifier chamber according to manufacturer’s advice.

Paw mbar

20 Flow L/min

-20

-40

Fi02

Rate

I:E

Ramp

P-Insp

1:2

0.2

1/min

sec

cmH2O

Connect humidifier electrical supply according to manufacturer’s advice.

Turn ON humidifier and verify proper function.

PEEP

cmH2O

PEEP

cmH2O

Centiva/5

dult

MV-E

4.2

Vt-E

350

Ppeak

Pmin

O2-I

Rate

P-ASB

Centiva/5

dult

MV-E

4.2

Vt-E

350

Ppeak

Pmin

O2-I

Rate

P-ASB

cmH2O

Liter

cmH2O

25 18

1/min

cmH2O

Liter

cmH2O

25 18

1/min

5-10

URM Centiva/5, CM-920041, rev. 2.22

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5 Preparation

Connect an inspiratory tube from the right, front 22 mm connector of the Centiva/5 to the inlet of the humidifier chamber.

Connect the inspiratory tube from to the outlet of the humidifier chamber to the y-piece.

Connect an expiratory tube from the left, front 22 mm connector of the Centiva/5 and to a water trap.

Connect another expiratory tube from the water trap to the y-piece.

Water trap

Bi-Level / ASB

Paw mbar

20 Flow L/min

-20

-40

Fi02

Rate

1/min

Tube : E 7.5 50%

I:E

1:2

CAUTION

When using active humidifiers do not use HMEs between y-piece and patient at the same time. This may result in increased breathing resistance and risk to the patient .

Special notice

Active humidifiers in general increase the resistance of the breathing system. Care should be taken to keep the resistance as low as possible.

Ramp

Centiva/5

dult

MV-E

4.2

Liter

Vt-E

350

Ppeak

cmH2O

Pmin

cmH2O

O2-I

Rate

1/min

P-Insp

PEEP

0.2

sec

P-ASB

cmH2O

URM Centiva/5, CM-920041, rev. 2.22

5-11

Page 62

5 Preparation

5.6 Placing the device

5.6.1 Control panel

For better visibility and easy handling the Centiva/5 control panel can be adjusted to optimize the viewing angle.

To adjust the viewing angle, the upper part of the control panel can be moved forward or backward.

The control panel can be detached from the main engine and mounted a distance of up to 3 meters away from the main engine.

Ramp

0.2

Centiva/5

Adult

MV-E

4.2

Liter

Vt-E

350

Ppeak

cmH2O

Pmin

cmH2O

O2-I

Rate

1/min

P-Insp

PEEP

P-ASB

sec

cmH2O

Bi-Level / ASB

Paw mbar

20 Flow L/min

-20

-40

Fi02

Rate

1/min

Tube : E 7. 5 50%

I:E

1:2

For this application use the optional extension cable and mounting accessories.

Positioning of control panel

• At the main engine with adjustable viewing angle

• At a wall rail mount (optional) with adjustable viewing angle

At a bed mount (optional) with adjustable viewing angle

•

5-12

URM Centiva/5, CM-920041, rev. 2.22

Page 63

5 Preparation

To mount the Centiva/5 control panel away from the Centiva/5 main engine , follow the instructions below.

Place the selected mounting bracket to the desired position.

Turn OFF the Centiva/5.

Move control panel to a full angled position.

Press both stainless steel buttons of the bracket mount together to release the locking mechanism.

Move the control panel carefully to the front and up.

Disconnect the control panel from the main engine.

Place the control panel onto the selected bracket.

Connect control panel and control panel bracket and secure proper seated connector.

Press both stainless steel buttons of the bracket mount together to release the locking mechanism. Insert the bracket and release the two buttons to activate the locking mechanism.

Reconnect the control panel and main engine using the extension cable.

Turn ON the Centiva/5 and check for proper function by passing the “power-up” test.

WARNING

Do not disconnect the control panel during operation. This may result in risk to the patient.

URM Centiva/5, CM-920041, rev. 2.22

5-13

Page 64

5 Preparation

ous

5.6.2 Entire system

CAUTION

Placement of the entire unit or main engine:

• On the trolley (optional)

• On other flat surfaces

On a wall rail mount (optional)

•

• On an ICU cabinet

When placing the ventilator on the optional trolley ensure that the feet match with the trolley’s receptacles.

Ensure the locking mechanism locks in, when the device is properly placed.

To release the device pull the metal knob of locking mechanism forward and remove the device.

Hous

Bi-Level / ASB

Tube : E 7 . 5 50%

Paw mbar

20 Flow L/min

-20

-40

Fi02

Rate

I:E

Ramp

1:2

1/min

Centiva/5

dult

MV-E

4.2

Liter

Vt-E

350

Ppeak

cmH2O

Pmin

cmH2O

O2-I

Rate

P-Insp

0.2

sec

1/min

PEEP

P-ASB

cmH2O

Always ensure proper seating of the system and activated locking mechanism, when applicable.

5-14

URM Centiva/5, CM-920041, rev. 2.22

Page 65

5.7 Turn ON and OFF

5 Preparation

Turn ON

Turn OFF

The Centiva/5’s ON-OFF button is located on the lower right side of the ventilator engine .

When supplied with line (mains) power (line switch on the rear should always be turned ON) the ON-OFF button is illuminated by a green light and the unit turns ON when the ON-OFF button is pressed.

If no mains supply is present, or the mains switch is off, the ON-OFF button is not illuminated. Pressing the ON-OFF button with no mains supply activates the internal back-up battery to allow for service activities, such as removing the expiratory valve assembly . For safety reasons the Centiva/5 will not go into normal operation when the main supply is missing.

Bi-Level

Paw cmH2O

20 Flow L/min

-20

-40

Fi02

Rate

1/min

Tube : E 7.5 50%

I:E

Ramp

1:2

0.2

Centiva/5

dult

MV-E

5.2

Liter

Vt-E

350

Ppeak

cmH2O

Pmin

cmH2O

O2-I

Rate

P-Insp

sec

1/min

PEEP

cmH2O

The Centiva/5 can only be turned OFF when the patient is not being ventilated and is disconnected (Status: System open ?).

In the non-ventilating “System open ?” mode, or in any other non-ventilating mode, press and hold the ONOFF button for approximately 3 secs.

Turn OFF device? Yes= Enter , No= any button

Centiva /5

System test Rev. 2.1n

System test OK. To start ventilation <Enter> Compliance 2.3 ml/cmH2O

Resistance 0.8 cmH2O/L/s Leakage 15 ml/min

Adult Pediatric

A message appears asking the user to either turn off the system by confirming with the enter key (ComWheel) or returning to the current status by pressing any other key.

ON/OFF

URM Centiva/5, CM-920041, rev. 2.22

5-15

Page 66

5 Preparation

Start system test <Enter>

5.8 Self test

5.8.1 Power-up test

The Centiva/5 software includes self tests that determine if the operating software is functioning properly and if the electronic and pneumatic circuits are functional. The self tests include:

• Power-up test

• System test

In-operation test

•

The power-up test starts automatically when the system is turned ON. The following screen is displayed:

System test Rev. x.nn

Test active, wait for 5 secs

Centiva/5

Message box

The power-up test takes at least 5 secs. The test time counts down on the screen.

During the power-up test, the ventilator checks the proper function of all essential electronic components. If a malfunction is identified during this power up test, the corresponding message appears in the message box area. For details of error messages refer to section 8 “Alarms and messages”.

After having passed the

System test Rev. x.nn

Complete system set up, seal y-piece

Centiva/5

power-up test, the Centiva/5 prompts with a short audible sound and moves to the “Start

Adult Pediatric

system test” screen:

Connect the breathing circuit to the system and seal the Y-piece by placing the open end onto the sealer on the exp. valve assembly.

Bi-Level

Tube : E 7.5 50%

Paw cmH2O

20 Flow L/min

-20

-40

Fi02

Rate

I:E

Ramp

1:2

0.2

1/min

Centiva/5

dult

MV-E

5.2

Liter

Vt-E

350

Ppeak

cmH2O

Pmin

cmH2O

O2-I

Rate

1/min

P-Insp

PEEP

sec

cmH2O

5-16

Stopper

URM Centiva/5, CM-920041, rev. 2.22

Page 67

5 Preparation

System test

5.8.2 System test

Push the ComWheel to confirm the <Enter> command.

This starts the system test.

This system test takes at least 40 secs. The test time counts down on the screen.

During the system test, the system will check the proper function of all pneumatic and electronic components together with the function of the attached breathing circuit . If any malfunction is identified during this system test, the corresponding message appears in the message box area. For details of error messages refer to section 8 “Alarms and messages”.

After having passed the system test, the system prompts the user to open the Y-piece which allows the testing of inspiratory resistance.

Disconnect the Y-piece from the sealer.

The system will recognize that the Y-piece is open automatically and will proceed with the system test.

Test active, wait for 35

System test Rev. x.nn

Open Y-piece

Centiva/5

Message

Adult

Centiva/5

Adult

URM Centiva/5, CM-920041, rev. 2.22

5-17

Page 68

5 Preparation

5.8.3 In-operation test

CAUTION

After measuring the inspiratory resistance, the Centiva/5 displays the following screen:

The compliance and leakage values represent the entire breathing circuit and ventilator. This value is used for the internal compliance compensation.

The resistance value represents the inspiratory resistance of the breathing circuit and ventilator to the y-piece. This value is used for the internal resistance compensation .

The nebulizer flow value represents the measured nebulizer flow of the connected nebulizer. Incase no nebulizer was connected during system, the last measured nebulizer flow is displayed with a note added (last value).

In case the expiration flow sensor was readjusted during system test the according message “Exp. flow sensor data re-adjusted” is displayed.

Values for compliance, resistance and leakage depend upon the breathing circuit used.

Values for nebulizer flow depend upon the nebulizer used (if applicable)

For details to the nebulizer test refer to section 6. 3.10. “Nebulizer”.

Filters and HMEs may significantly increase the resistance values.

System test Rev. x.nn

System test OK. To start ventilation <Enter> Compliance 2.3 ml/mbar

Resistance 0.8 mbar/L/s Leakage 15 ml/min Nebulizer flow 7,0 l/min

Exp. flow sensor data re-adjusted

Centiva /5

Adult

Do not perform the system test with a filter or HME on the breathing circuit. Inappropriate pressure and flow compensation may result.

Other breathing circuit designs, such as co-axial systems, may increase the measured resistance values.

Always use breathing circuits with low inspiratory resistance.

During operation the Centiva/5 continuously checks all safety relevant functions and parameters. If a malfunction is identified, the system will display alarms or messages on the screen. For details of error messages refer to section 8 “ Alarms and messages”.

5-18

URM Centiva/5, CM-920041, rev. 2.22

Page 69

5.9 Select the type of patient

System test

The Centiva/5 allows for the pre-adjustment of ventilator settings and alarm limits according to two different types of patients:

CAUTION

• Adult

• Pediatric

Prior to the system tests the user can select the desired patient type on the screen by pressing either of the soft keys below the patient types.

Activating the new patient type changes the color of the button in the screen from gray to yellow to prompt the change.

This pre-selection is important to establish default settings in the different ventilation modes. For details see section 6.1.2 “Default ventilation values”.

The selected patient type is displayed during system test in the screen’s lower left corner and during operation within the status information area.

The default settings provide a minimum ventilation for the selected patient type, while the patient is connected and prepared. After preparation and proper connection the settings must be adjusted according to the patient’s needs.

Centiva/5

System test OK. To start ventilation Compliance 2.3 ml/cmH2O

Resistance 0.8 cmH2O/L/s Leakage 15 ml/min

Adult

Pediatric

5 Preparation

URM Centiva/5, CM-920041, rev. 2.22

5-19

Page 70

5 Preparation

System Test

Bypass system

Unlock expiration

Calibrate O2

5.10 System test menu

Bypass system test

After having successfully passed the power-up and/or the system tests the system test menu can be activated by pressing the menu button.

The system test menu appears and allows for

Centiva/5

the selection of certain service functions. Selecting “Exit” closes the system test menu

Complete system set up, seal YStart system test by pressing

without any activity.

Adult

Service functions available in the system test menu are:

• Bypass system test

• Unlock expiration valve

• Calibrate O2 sensor

The required system test is bypassed with this function.

Bypass system test

Unlock expiration valve

Calibrate O2 sensor

Exit

5-20

WARNING

CAUTION

Use the system test bypass only in case of emergency.

In this situation the system uses the compliance and resistance data from the last system test for all internal compensations. If the current breathing circuit differs significantly to the past circuit, differences in ventilation parameters due to changes in the compensation process are possible. This may result in risk to the patient.

Starting the ventilator without having performed the system test will result in a status display “no test” to remind the user that the system was started without a system test and to perform the system test as soon as possible.

URM Centiva/5, CM-920041, rev. 2.22

Page 71

5 Preparation

Unlock expiration valve

O2 sensor calibration

This function releases the expiration valve assembly.

Releasing the expiration valve is necessary for cleaning purposes only.

After inserting the expiration valve it will automatically lock in place and the system performs a powerup test.

Releasing the expiratory valve will work with internal backup battery power. Locking only works with line (mains) power supply.

System test Rev. x.nn

Expiration valve unlocked Ready to be removed from device

This function starts an automatic O details refer to section 9 “Maintenance”.

Bypass system test

Unlock expiration valve

Calibra t e O2 se ns or

Exit

Centiva/5

sensor calibration procedure. For

URM Centiva/5, CM-920041, rev. 2.22

5-21

Page 72

5 Preparation

5.11 Starting the ventilator

After having passed the system test the Centiva/5 will go to normal operation when the <Enter> button (ComWheel) is pressed.

Push the ComWheel to start ventilation.

The Centiva/5 defaults to the ventilation mode ”Bi-Level“ with the ventilator settings and alarm limits set according to the selected patient type.

Centiva /5

System test Rev. x.nn

System test OK. To start ventilation <Enter> Compliance 2.3 ml/mbar

Resistance 0.8 mbar/L/s Leakage 15 ml/min

Nebulizer flow 7,0 l/min

Adult

5-22

URM Centiva/5, CM-920041, rev. 2.22

Page 73

6 Operation

In this section

6.1 Adjust ventilation modes 6-2

6.1.1 Select a ventilation mode 6-2

6.1.2 Default ventilation values 6-3

6.1.3 Changing ventilation modes 6-4

6.2 Adjust ventilation parameters 6-6

6.2.1 VCV 6-6

6.2.2 SIMV-VC 6-9

6.2.3 Bi-Level 6-12

6.2.4 Bi-Level/PSV 6-14

6.2.5 CPAP/PSV 6-17

6.2.5 CPAP/Apnea 6-19

6.3 Additional functions 6-21

6.3.1 Standby 6-22

6.3.2 ASR (Automatic Suction routine) 6-24

6.3.3 Parameter menu 6-27

6.3.4 Alarm lim its 6-32

6.3.5 Alarm AUTOSET 6-38

6.3.6 ARC (Airway Resistance Compensation) 6-41

6.3.7 NEB (Nebulizer drug delivery) 6-44

6.3.8 System test 6-50

6.3.9 NIV (Non Invasive Ventilation) 6-51

6.3.10 APD (Automatic Patient Detection) 6-53

6.3.11 OCV (Online O2 sensor Calibration) 6-54

6.3.12 Short cuts 6-55

URM Centiva/5, CM-920041, rev. 2.22

6-1

Page 74

6 Operation

A R C

Exit

CPAP/Apnea

CPAP/PSV

VCV

6.1 Adjust ventilation modes

6.1.1 Select a ventilation mode

The Centiva/5 uses the “Bi-Level” as the default mode.

The system uses default settings according to the selected patient type to provide a minimum level of ventilation performance.

To change the default ventilation mode to another mode open the main menu with the menu button.

Using the ComWheel select “Vent. Modes” to access the ventilation modes menu.

The “Vent. Modes” topic is highlighted.

Stand-by A S R Parameter menu Alarm limits Alarm AUTOSET

Vent. modes

Nebulizer

System test

Confirm the selection by pushing the ComWheel.

ON ON

6-2

The ventilation modes menu appears.

SIMV - VC Bi-Level

Make your selection with the ComWheel for the desired ventilation mode and confirm the selection by pushing the ComWheel.

Previous menu

Exit

Adjust the ventilation parameter settings to the patient’s needs and set the alarm limits accordingly.

URM Centiva/5, CM-920041, rev. 2.22

Page 75

6 Operation

6.1.2 Default ventilation values

Pediatric

When starting the Centiva/5 the system will provide default ventilator settings to enable easy preparation of the patient.

These settings are designed for the selected patient range to maintain a minimum ventilation performance . The default ventilation mode is “Bi-Level”.

Parameter VCV SIMV-VC Bi-Level CPAP/PSV

FiO2 50 % 50 %

Rate 16 /min 16 /min

I : E 1 : 2 1 : 2

Vt 100 ml 100 ml

Ramp - -

Pinsp - -

50 %

16 /min

1 : 2

0.2 sec

7 cmH

Plimit 20 cmH2O 20 cmH2O - -

PEEP Off Off

I-Flow 10 l/min 10 l/min

PS - 3 cmH2O

Off

3 cmH

50 %

Off

3 cmH

Adult

URM Centiva/5, CM-920041, rev. 2.22

Parameter VCV SIMV-VC Bi-Level CPAP/PSV

FiO2 50 % 50 %

Rate 10 /min 10 /min

50 %

10 /min

50 %

I : E 1 : 2 1 : 2 1 : 2 -

Vt 500 ml 500 ml

Ramp - -

Pinsp - -

Plimit 30 cmH2O 30 cmH2O

PEEP Off Off

I-Flow 30 l/min 30 l/min

PS - 5 cmH2O

0.2 sec

10 cmH

Off

5 cmH

Off

5 cmH

6-3

Page 76

6 Operation

CPAP/Apnea

CPAP/PSV

VCV

CPAP/Apnea

CPAP/PSV

VCV

6.1.3 Changing ventilation modes

CAUTION

When changing from an active ventilation mode to another mode, the Centiva/5 will transfer the settings for identical parameters (e.g. FiO2) to the new mode.

For those non-transferable parameters algorithm are used to calculate settings for the new ventilation mode based on measured data. These algorithm are based on a calculation taking into account that the lung’s compliance and resistance will not change significantly when changing the mode.

Example:

Change from Bi-Level mode

to VCV (or SIMV-VC) mode:

FiO2 50 % - 50% Rate 10 /min - 10 /min I : E 1 : 2 - 1 : 2 Ramp 0.2 sec - N/a Pinsp 10 cmH2O - N/a Vt N/a 350 ml ( C ) 330 ml PEEP 3 cmH2O - 3 cmH2O

In Bi-Level the patient’s lung compliance is calculated and tidal volume setting for the VCV or SIMV-VC mode is calculated according to Vt set = P

insp

x C.

In case compliance calculation is not leading to stable data, the system uses the lowest value for that mode.

The data used is stored in the Centiva/5 as long as the system is not turned OFF. That provides automatic access to this data when ventilation is restarted after standby. Whenever the system is turned OFF and is turned ON again, the default settings are used.

SIMV - VC

Bi-Level

SIMV - VC

Previous menu

Exit

Bi-Level

Previous menu

Exit

Bi-Level VCV Parameter

Settings Measured Settings

Ensure all parameter settings and alarm limits are set according to the patient’s situation.

6-4

URM Centiva/5, CM-920041, rev. 2.22

Page 77

6 Operation

CPAP/Apnea

CPAP/PSV

VCV

CPAP/Apnea

CPAP/PSV

VCV

Example:

Change from VCV (or SIMV-VC) mode

to Bi-Level mode:

VCV Bi-Level Parameter

Settings Measured Settings FiO2 50 % - 50% Rate 10 /min - 10 /min I : E 1 : 2 - 1 : 2 Ramp N/a - Default Pinsp N/a ( C ) 10 cmH2O Vt 350 ml - N/a PEEP 3 cmH2O - 3 cmH2O

In VCV or SIMV-VC the patient’s lung compliance is calculated and inspiratory pressure setting for the Bi-Level mode is calculated according to P

= Vt / C.

insp

In case compliance calculation is not leading to stable data, the system uses the lowest values for that mode.

SIMV - VC

Bi-Level

Previous menu

Exit

SIMV - VC

Bi-Level

Previous menu

Exit

URM Centiva/5, CM-920041, rev. 2.22

6-5

Page 78

6 Operation

Spontaneous breathing

6.2 Adjust ventilation parameter

6.2.1 VCV

Volume Controlled Ventilation.

This mandatory ventilation mode provides a constant minute volume to a patient, that has limited spontaneous breathing capabilities.

Paw

P max

P limit

PEEP

Insp. Pause

T insp T exp

60/rate

Flow

I-Flow

6-6

The desired minute volume is determined by the set tidal volume (Vt) and the set rate (rate).

The pressure and flow waveforms are influenced by the timing for inspiratory and expiratory times (I:E) and by the inspiratory flow (I-Flow).

The system automatically provides an inspiratory pause depending on timing and flow. The higher the I-Flow the longer the plateau time.

Although this is a mandatory mode, the system allows patient’s spontaneous breathing during the expiration time and therefore, allows the patient to increase the total minute volume beyond the set mandatory.

URM Centiva/5, CM-920041, rev. 2.22

Page 79

cmH2O

1/Min

L/Min

Buzzer

PS endflow

Leakage compensation

CAUTION

6 Operation

Use the soft keys to adjust the ventilation settings, described above according to the patient’s needs

Fi O2

Rate

I : E

1:2.0

110

Plimit

PEEP

OFF

Additional adjustments for

• Byflow

can be set in the parameter menu.

I-flow PS ramp Trigg.

ByFlow

Time window

Previous menu

10.0 L/m

Exit

A leak can occur when ventilating patients. To compensate for such leakage, the Centiva/5 is equipped with an automatic leakage compensation.

This leakage compensation is always active and compensates for temporary as well as permanent leaks.

The compensation covers a maximum leak of up to 50% of the desired tidal volume.

For more details refer to section “NIV” in this chapter.

Always set the leakage alarm at an appropriate level to ensure immediate notification in the event a leak were to occur.

I-Flow

6.6

0.20 s

3.0 L/m

60% 25%

100%

URM Centiva/5, CM-920041, rev. 2.22

6-7

Page 80

6 Operation

Paw

Volume not delivered

Pressure limited

ventilation

Changes in a patient’s lung compliance or resistance can alter the peak pressure at given settings.

When in the VCV mode, the P Pressure Limited Ventilation (PLV).

setting provides the ability to perform

limit

P max

P limit

PEEP

Pressure limited

When P set P

is reached the flow is decelerated to limit the pressure to the

limit

level. A low priority message “Plimit reached” will appear on the

limit

screen.

When pressure limitation causes a tidal volume of less than 80% of the set tidal volume to be delivered an alarm will indicate this with the “Vt not delivered” message.

Beyond the “P for additional safety. The P

(default). When the P

limit

” level there is a second pressure safety barrier “P

limit

is autom atically set to 10 cmH2O over the

max

level is reached all inspiratory flow is

max

stopped and the over pressure release valve is activated, reducing the pressure to the PEEP level.

The P

safety pressure level can be adjusted manually in the alarm

max

limits menu.

“

max

6-8

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6 Operation

Flow

Short

Long

Ramp

Trigg. window

Spontaneous bre athing

with ASB pressure support

P ASB

without pressure support

6.2.2 SIMV-VC

Mandatory parameters

Synchronized Intermittent Mandatory Ventilation – Volume Constant

This synchronized mandatory ventilation mode provides a constant mandatory minute volume and supports spontaneous breathing with pressure support ventilation (PSV) for patients with limited spontaneous breathing capability or to intentionally reduce the mandatory support.

Paw

P max

P limit

Spontaneous breathing

Ramp

PEEP

T insp T exp

60/rate

I-Flow

The desired mandatory minute volume is determined by the set tidal volume (Vt) and the set rate (rate).

The pressure and flow waveforms are influenced by the timing for inspiratory and expiratory times (I:E) and by the inspiratory flow (I-Flow).

The system automatically provides an inspiratory pause depending on timing and flow. The higher the I-Flow the longer the pause (plateau) time.

URM Centiva/5, CM-920041, rev. 2.22

6-9

Page 82

6 Operation

cmH2O

1/Min

cmH2O

Buzzer

PS endflow

Trigger parameters

PSV parameter

Settings

To synchronize the mandatory ventilation with the spontaneous breathing activity of the patient, the Centiva/5 uses a flow trigger that detects the patient’s inspiratory effort. The sensitivity of the flow trigger (Trigg.) can be adjusted to match the patient’s needs. The lower the flow value the more sensitive the system reacts. Self triggering can occur at low trigger flow settings.

The detected flow trigger needs to occur within the trigger time window (time window) to start a synchronized mandatory breath.

Pressure support ventilation is a pressure support (PS) function that will increase the tidal volume or decrease the work of breathing)of a spontaneous breathing patient. When a pressure supported breath is initiated the ventilator delivers the required flow to increase the pressure to the set PS pressure above the PEEP level. The pressure support breath ends when the flow to the patient decreases to the set PS end flow measured in % of the peak PSV flow. 25% is the default setting.

The rise time between the PEEP level and the PS pressure level can be modified by the PS- ramp time (ramp). The shorter the ramp time the higher the initial PS flow.

The Centiva/5 allows spontaneous breathing on the PEEP pressure level if the PSV function is turned off (PS set to 0 cmH

O).

Use the soft keys to adjust the ventilation settings according to the patient’s needs.

6-10

Fi O2

Rate

I : E

1:2.0

Additional adjustments for

• Inspiratory flow (I-Flow)

PS ramp time (PS ramp)

•

• Trigger flow sensitivity (Trigg)

• Byflow (Byflow)

Trigger time window (time window)

•

• PS end flow (PS endflow)

can be set in the parameter menu.

PEEP

OFF

I-flow PS ramp Trigg. ByFlow Time window

Previous menu

110

Plimit

URM Centiva/5, CM-920041, rev. 2.22

Exit

10.0 L/m

0.20 s

3.0 L/m

3.0 L/m 60% 25%

100%

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6 Operation

Paw

Volume not delivered

Leakage compensation

CAUTION

ARC

Pressure limited

ventilation

A leak can occur when ventilating patients. To compensate for such leakage, the Centiva/5 is equipped with an automatic leakage compensation.

This leakage compensation is always active and compensates for temporary as well as permanent leaks.

The compensation covers a maximum leak of up to 50% of the desired tidal volume.

For more details refer to section “NIV” in this chapter.

Always set the leakage alarm at an appropriate level to ensure immediate notification in the event a leak were to occur.

The Airway Resistance Compensation (ARC) can be activated in the SIMV-VC mode .

ARC compensates for the inspiratory and expiratory resistance of the patient’s artificial airway.

For more details refer to section “ARC” in this chapter.

In the SIMV-VC mode the Plimit setting also allows for Pressure Limited Ventilation (PLV).

URM Centiva/5, CM-920041, rev. 2.22

P max

P limit

PEEP

Pressure limited

This mode is identical with the PLV mode in VCV mode.

For more details refer to the section ”PLV” in the “VCV” section in this chapter.

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6 Operation

Without spontaneous breathing

ramp time

P insp

6.2.3 Bi-Level

Without spontaneous breathing

Bi – Level

This synchronized, time controlled, pressure cycled ventilation mode provides a CPAP with two pressure levels. The change between these two pressure levels provides a mandatory minute volume to patients with limited spontaneous breathing capability.

P max

Paw

short ramp

long ramp

PEEP

T insp

T exp

60/rate

Flow

6-12

The desired minute volume is determined by the set pressure difference between the upper and lower CPAP level (Pinsp) and the set rate (rate) and is dependent on the patient’s lung compliance and resistance.

The pressure and flow waveform is influenced by the timing for the inspiratory and expiratory times (I:E) and the ramp time (ramp) between the lower und upper pressure level.

The base pressure level is adjusted with the positive end expiratory pressure (PEEP) setting.

Although this is a mandatory mode, the system allows spontaneous breathing during the inspiration and expiration period which allows the patient to increase their total minute volume beyond the set mandatory minute volume.

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Page 85

cmH2O

Buzzer

PS endflow

Leakage compensation

CAUTION

Use the soft keys to adjust the ventilation settings, described above according to the patient’s needs.

Fi O2

Additional adjustments for

• Byflow (Byflow)

can be set in the parameter menu.

Rate

1/Min

I : E

1:2.0

Ramp

0.20

Sec.

P-Insp

PEEP

OFF

I-flow

PS ramp Trigg. ByFlow Time window

Previous menu

Exit

A leak can occur when ventilating patients. To compensate for such leakage, the Centiva/5 is equipped with an automatic leakage compensation.

This leakage compensation is always active and compensates for temporary as well as permanent leaks.

For more details refer to section “NIV” in this chapter.

Always set the leakage alarm at an appropriate level to ensure immediate notification in the event a leak were to occur.

6 Operation

cmH2O

10.0 L/m

0.20 s

3.0 L/m

3.0 L/m 60% 25%

100%

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6 Operation

t t

with spontaneous

6.2.4 Bi-Level

With spontaneous breathing

Mandatory parameters

Bi – Level

This synchronized, time controlled, pressure cycled ventilation mode provides a CPAP with two pressure levels. The change between the two pressure levels provides a mandatory minute volume and supports spontaneous breathing activities with PSV for patients with limited spontaneous breathing capability or to intentionally reduce the mandatory support.

Paw

P max

PEEP

P insp

P S

Spontaneous breathing without pressure support

60/rate

time window

Spontaneous breathing with pressure support

Flow

The mandatory parameters are identical to the previous section “Bi-Level without spontaneous breathing”.

The pressure and flow waveform is influenced by the timing for the inspiratory and expiratory times (I:E) and the ramp time (ramp) between the lower und upper pressure level.

The base pressure level is adjusted with the positive end expiratory pressure (PEEP) setting.

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6 Operation

cmH2O

Sec.

1/Min

cmH2O

Buzzer

PS endflow

Trigger parameters

PSV parameter

Settings

To synchronize the mandatory ventilation with the spontaneous breathing activity of the patient, the Centiva/5 uses a flow trigger to detect the patient’s inspiratory effort. The sensitivity of the flow trigger (Trigg.) can be adjusted to match the patient’s needs. The lower the flow trigger value the more sensitive the system becomes. Auto-triggering can occur at low trigger flow settings.

The detected flow trigger needs to match with the trigger time expectation window (time window) to start a synchronized mandatory breath.

Pressure support ventilation is a pressure support (PS) function that will increase the tidal volume or decrease the work of breathing of a spontaneous breathing patient. When a pressure supported breath is initiated the ventilator delivers the required flow to increase the pressure to the set PS pressure above the PEEP level. The pressure support breath ends when the flow to the patient decreases to the set PS end flow measured in % of the peak PSV flow. 25% is the default setting.

The rise time between the PEEP level and the PS pressure level can be modified by the PS- ramp time (ramp). The shorter the ramp time the higher the initial PS flow.

The Centiva/5 allows spontaneous breathing on the PEEP pressure level if the PSV function is turned off (PS set to 0 cmH

O).

Use the soft keys to adjust the ventilation settings, described above, according to the patient’s needs.

Fi O2

Rate

I : E

1:2.0

0.20

Ramp

P-Insp

cmH2O

PEEP

OFF

Additional adjustments for

• PS ramp time (PS ramp)

• Trigger flow sensitivity (Trigg)

Byflow (Byflow)

•

• Trigger time window (time window)

• PS end flow (PS endflow)

can be set in the parameter menu.

I-flow

PS ramp Trigg. ByFlow Time window

Previous menu

10.0 L/m

0.20 s

3.0 L/m

3.0 L/m 60% 25%

100%

Exit

URM Centiva/5, CM-920041, rev. 2.22

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6 Operation

Leakage compensation

CAUTION

ARC

A leak can occur when ventilating patients. To compensate for such leakage, the Centiva/5 is equipped with an automatic leakage compensation.

This leakage compensation is always active and compensates for temporary as well as permanent leaks.

For more details refer to section “NIV” in this chapter.

Always set the leakage alarm at an appropriate level to ensure immediate notification in the event a leak were to occur.

The Airway Resistance Compensation (ARC) can be activated in the Bi-Level mode .

ARC compensates for the inspiratory and expiratory resistance of the patients artificial airway.

For more details refer to section “ARC” in this chapter.

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6 Operation

P ASB

ASB endflow

6.2.5 CPAP/PSV

Trigger parameters

Continuous Positive Airway Pressure / Pressure Support Ventilation

This ventilation mode provides a set continuous positive airway pressure for a spontaneous breathing patient, with or without a set pressure support level. This mode requires a patient’s stable spontaneous breathing activity.

Paw

short ramp

long ramp

P ASB

PEEP

ramp time

Flow

25 %

The base pressure level is adjusted with the positive end expiratory pressure (PEEP) setting.

To detect the inspiration effort of a patient’s spontaneous breathing activity the Centiva/5 uses a flow trigger. The sensitivity of the flow trigger (Trigg.) can be adjusted to match the patient’s needs. The lower the flow trigger value the more sensitive the system becomes . Autotriggering can occur at low trigger flow settings.

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6 Operation

cmH2O

Sec.

cmH2O

Buzzer

PS endflow

PSV parameter

Settings

ARC

The rise time between the PEEP level and the PS pressure level can be modified by the PS- ramp time (ramp). The shorter the ramp time the higher the initial PS flow.

The Centiva/5 allows spontaneous breathing on the PEEP pressure level if the PSV function is turned off (PS set to 0 cmH

O).

Use the soft keys to adjust the ventilation settings, described above according to the patient’s needs.

Fi O2

Additional adjustments for

• Trigger flow sensitivity (Trigg)

• Byflow (Byflow)

PS end flow (PS endflow)

•

can be set in the parameter menu.

Ramp

0.20

PEEP

OFF

I-flow PS ramp

Trigg. ByFlow

Time window

Previous menu

10.0 L/m

Exit

The Airway Resistance Compensation (ARC) can be activated in the CPAP/PSV mode.

ARC compensates for the inspiratory and expiratory resistance of the patient’s artificial airway.

For more details refer to section “ARC” in this chapter

0.20 s

3.0 L/m

60%

25%

100%

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6 Operation

cmH2O

Sec.

cmH2O

1/Min

cmH2O

Buzzer

PS endflow

6.2.6 CPAP/Apnea

Setting CPAP/PSV

Continuous Positive Airway Pressure with APNEA mandatory back-up

ventilation.

In case the patient experiences an apneic episode while in this mode this ventilator will provide a back-up mode of ventilation using the

• Bi – Level.

This synchronized, time controlled, pressure cycled ventilation mode provides a CPAP with two pressure levels. This change between the two pressure levels provides a mandatory minute volume and supports spontaneous breathing activities with PSV for patients with limited spontaneous breathing capability. For more details refer to the mode “Bi-Level” in this section.

When starting this mode “CPAP/PSV” is activated with the corresponding soft keys highlighted.

Use the soft keys to adjust the ventilation settings, described above according to the patient’s needs.

URM Centiva/5, CM-920041, rev. 2.22

Fi O2

Rate

I : E

1:2.0

0.20

Ramp

Additional adjustments for

• Trigger flow sensitivity (Trigg)

Byflow (Byflow)

•

• PS end flow (PS endflow)

can be set in the parameter menu.

P-Insp

PEEP

OFF

I-flow PS ramp

Trigg. ByFlow

Time window

Previous menu

Exit

10.0 L/m

0.20 s

3.0 L/m

60%

25%

100%

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6 Operation

cmH2O

Sec.

1/Min

cmH2O

Buzzer

PS endflow

Setting the Back-up

ventilation mode

When Apnea is detected, the system switches automatically to the ventilation mode “Bi-Level”. The settings of this mode are displayed , but the soft keys are grayed to indicate that the settings can be set but are not active until the back up ventilation mode is activated.

Fi O2

Rate

I : E

1:2.0

0.20

Ramp

P-Insp

PEEP

OFF

Additional adjustments for

• PS ramp time (PS ramp)

Trigger flow sensitivity (Trigg)

•

• Byflow (Byflow)

• Trigger time window (Time window)

I-flow

PS ramp Trigg. ByFlow Time window

10.0 L/m

• PS end flow (PS endflow)

can be set in the parameter menu.

Previous menu

Exit

If the patient’s spontaneous breathing activity resumes the ventilator remains in the ventilation mode “Bi-Level”. The system does not automatically return to the ventilation mode “CPAP/PSV”.

To switch back to the initial mode requires the operator to re-select this ventilation mode from the ventilation menu.

0.20 s

3.0 L/m

3.0 L/m 60% 25%

100%

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Page 93

6.3 Additional functions

A R C

Exit

The Centiva/5 ventilator offers additional functions to support the operation of the ventilator and to allow fine-tuning for particular needs.

The following functions are available in the main menu:

These functions will be described in detail in the order they appear in the main menu.

The Centiva/5 provides other additional functions that are permanently activated.

• Stand-by

ASR (Automatic Suction Routine)

•

• Parameter menu

• Alarm limits

Alarm AUTOSET

•

• ARC (Airway Resistance Compensation)

• Nebulizer

• System test

NIV (Non-Invasive Ventilation)

•

6 Operation

Stand-by A S R Parameter menu Alarm limits Alarm AUTOSET Vent. modes

Nebulizer

System test

ON ON

URM Centiva/5, CM-920041, rev. 2.22

• APD (Automatic Patient Detection)

These functions are described in this chapter.

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6 Operation

A R C

Exit

A R C

Exit

6.3.1 Stand-by

Special notice

The standby function allows for the temporary interruption of the Centiva/5 ventilator without alarming. All patient related settings are saved and available upon reconnecting the patient to the ventilator.

To activate the standby function the user must disconnect the patient from the system and wait for the “System open?” message on the screen.

Open the main menu by pushing the menu button.

Select the function “Stand-by ON” by rotating the ComWheel.

This function is only accessible when a patient is disconnected from the ventilator.

Stand-by A S R Parameter menu Alarm limits Alarm AUTOSET Vent. modes

Nebulizer

System test

Push the ComWheel to confirm the selection.

Notice the change in the menu from “Standby ON” to “Stand-by OFF”.

The status line in the screen indicates the “Standby” mode is active.

Ventilation is stopped and all alarms are silenced.

All ventilation settings are stored.

Stand-by

A S R Paramet er menu Alarm limits

Alarm AUTOSET

Vent. m odes

Close the main menu either with “Exit” or the menu

Nebulizer

System test

will close automatically after 30 secs.

ON ON

OFF

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6 Operation

To turn OFF the stand-by mode and to return to the former ventilation mode reconnect the patient to the Centiva/5.

When the reconnection is detected by the APD function, the stand-by function automatically is turned off and the Centiva/5 proceeds with ventilating the patient with the stored parameters .

The Automatic Patient Detection (APD) has a delay of 15 secs after turning ON the stand-by mode before becoming active to reduce false triggering of the APD function.

To manually turn OFF the stand-by mode and ventilate using current settings :

• open the main menu with the menu button

• select the “Stand-by OFF” with the ComWheel

• confirm the selection

close the menu with “Exit”.

•

URM Centiva/5, CM-920041, rev. 2.22

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6 Operation

A R C

Exit

6.3.2 ASR (Automatic Suction Routine)

To perform bronchial suction the user needs access to the patient’s tube.

Using a breathing circuit with a bronchial suction access port the user can perform this therapy while in the ventilation mode .

To gain access to the tube on most breathing circuits the patient needs to be disconnected from the ventilator.

The Centiva/5 offers an Automatic Suction Routine (ASR) that provides the following sequence:

• Pre-suction oxygenation phase for up to 2 minutes

• Stand-by suction phase for up to 2 minutes with silenced alarms

• Post-suction oxygenation phase for up to 2 minutes.

ASR can be activated in all ventilation modes via the main menu.

To activate the ASR functions open the main menu by pushing the menu button.

Select the function “ASR ON” by rotating the ComWheel.

Stand-by

A S R

Parameter menu Alarm limits Alarm AUTOSET Vent. modes

Nebulizer

System test

Confirm the selection by pushing the ComWheel.

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6 Operation

A R C

OFF

Exit

Pre-Oxygenation phase

Suction phase

Notice the change in the menu from “ASR ON” to “ASR OFF”.

The first phase of ASR starts immediately.

The status line in the screen shows “Pre-Ox 1:59” to indicate the start of the pre-oxygenation phase and to show the remaining time in this phase.

The soft key for the FiO2 setting changes from the previous setting to 100 Vol %. The soft key color changes from yellow to red to indicate that this is a temporary change during the ASR procedure.

This FiO2 setting for the pre-oxygenation of 100 Vol % can be adjusted to any desired FiO2 by the user.

Stand-by A S R Parame t er menu Alarm limits Alarm AUTOSET Vent. m odes

Nebulizer

System test

After 2 minutes the pre-oxygenation phase ends and the suction phase starts. The status line in the screen shows “Suct 1:59” to indicate the start of the suction phase and to show the remaining time in this phase.

The ventilator is stopped and the pressure is relieved to zero to allow hygienic opening of the patient’s tube connection.

The screen shows the message “System open?”.

All alarms are silenced, but the Centiva/5 gives a short audible signal to indicate the start of the suction phase. This audible signal is repeated every 5 secs to remind the operator ventilation is not active.

Within 15 secs the patient needs to be disconnected from the ventilator. If the APD does not recognize a patient disconnect within this 15 second window the suction phase will be terminated and the ventilator will go to the post-oxygenation phase.

If after 2 minutes the APD does not recognizes a reconnection of the patient the Centiva/5 starts the Apnea Alarm.

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6 Operation

Post-Oxygenation phase

WARNING

The status line in the screen shows “Post-Ox 1:59” to indicate the start of the post-oxygenation phase and to show the remaining time in this phase.

The ventilator starts back in the set mode with the previous ventilation pattern and settings. PEEP pressure will build up again. All alarms are activated .

The soft key for FiO2 setting is still set to the value of the pre-oxygenation phase. The color of the soft key is still red to indicate this temporary change by the ASR procedure.

This FiO2 default setting for the post-oxygenation of 100 Vol % can be adjusted to any desired FiO2 by the user.

At the end of the 2 minute post-oxygenation phase the FiO2 setting returns automatically to the setting prior to the start of the ASR procedure. The ASR procedure turns off automatically.

Ensure sufficient patient oxygenation if the FiO2 pre and post suction concentration is changed from 100 Vol % to any other value.

ASR can be activated by a short cut. For more details refer to section “short cuts” in this chapter.

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6 Operation

A R C

Exit

Buzzer

PS endflow

6.3.3 Parameter menu

Frequently used settings for the different ventilation modes are accessible via the soft keys on the screen. Centiva/5 offers additional setting options. To keep the interface easy to use these other settings are accessible in the parameter menu.

The parameter menu provides access to certain settings depending on the current ventilation mode. For details refer to the “Adjust ventilation parameters” in this section.

To access the parameter menu open the main menu by pushing the menu button.

Select the function “Parameter menu” by rotating the ComWheel.

Stand-by A S R

Parameter menu

Alarm limits Alarm AUTOSET Vent. modes

Nebulizer

System test

Confirm the selection by pushing the ComWheel.

The parameter menu is accessible.

ON ON

URM Centiva/5, CM-920041, rev. 2.22

Close the parameter menu and main menu either with “Exit” or let the menu close automatically after 30 secs.

I-flow PS ramp Trigg. ByFlow Time window

10.0 L/m

0.20 s

3.0 L/m

Previous menu

Exit

60% 25%

100%

6-27

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6 Operation

Buzzer

PS endflow

Buzzer

PS endflow

Buzzer

PS endflow

Buzzer

PS endflow

I-flow

PS ramp

Trigg.

Byflow

Available in the ventilation mode SIMV-VC.

This allows the setting of the inspiratory flow in the range of 2 to 99.9 L/min, depending on the timing settings of the mode.

This setting is identical to the I-flow soft key setting in the ventilation mode “VCV”.

Available in the ventilation modes: SIMV-VC, Bi-Level, CPAP/PSV and CPAP/Apnea.

This setting adjusts the rate the pressure increases from the PEEP pressure to the PS pressure in the range of 0.1 to 0.5 secs. This setting is similar to the Bi-Level ramp soft key setting.

The default setting is 0.2 secs.

Available in the following ventilation modes: SIMVVC, Bi-Level, CPAP/PSV and CPAP/Apnea.

This allows the setting of the flow trigger in the range of 0.5 to 20 L/min. The flow trigger value is the amount of flow the patient needs to remove from the breathing circuit by their inspiratory effort to trigger the ventilator.

The default setting is 3.0 L/min.

Available in the ventilation modes: VCV, SIMV-VC, Bi-Level, CPAP/PSV and CPAP/Apnea.

The setting of the Byflow is from 3.0 to 30 L/min. The Byflow permanently flows through the breathing circuit providing a “flow reservoir” for a spontaneous breathing patient. Increasing the Byflow increases the flow reservoir, but also increases the pressure drop within the breathing circuit. The default setting is 3.0 L/min.

I-flow

PS ramp Trigg. ByFlow Time window

I-flow

PS ramp

Trigg. ByFlow Time window

I-flow PS ramp

Trigg.

ByFlow Time window

I-flow PS ramp Trigg.

ByFlow

Time window

10.0 L/m

0.20 s

3.0 L/m

Previous menu

Exit

10.0 L/m

0.20 s

3.0 L/m

Previous menu

Exit

10.0 L/m

0.20 s

3.0 L/m

Previous menu

Exit

10.0 L/m

0.20 s

3.0 L/m

Previous menu

Exit

60% 25%

100%

60% 25%

100%

60% 25%

100%

60% 25%

100%

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URM Centiva/5, CM-920041, rev. 2.22

Datex-Ohmeda Centiva-5 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual