Centiva 5 Users Reference Manual Sw Rev 2.n

User Responsibility

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.

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.

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

Table of Contents

1 Introduction

1.1 How to use this manual 1.2 Symbols used in this manual or on the equipment 1.3 Abbreviations used in this manual or on the equipment

1-2 1-3 1-5

2.1 Safety

2-2

3 General description

3.1 General description 3.1.1 Intended use 3.1.2 Principle of operation 3.1.3 Ventilation modes 3.1.4 Additional function 3.2 Supply 3.2.1 Electrical supply 3.2.2 Gas supply 3.3 Positioning 3.4 Main components 3.5 System controls 3.5.1 Front side 3.5.2 Rear side

3-2 3-2 3-2 3-3 3-4 3-5 3-5 3-5 3-6 3-7 3-8 3-8 3-9

4 Concept of operation

4.1 Concept of operation 4.1.1 Screen content 4.1.2 Soft keys 4.1.3 I : E Ratio soft key

4-2 4-3 4-5 4-6

2 Safety

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

0-1

Table of Contents

4 Concept of operation continued

5 Preparation

0-2

4.1.4 Timing parameters 4.1.5 Graphics 4.1.6 Numerical patient data 4.1.7 Status information 4.1.8 ComWheel 4.1.9 Changing a parameter 4.1.10 Menu button 4.1.11 Selecting a menu topic 4.1.12 Activating a menu function 4.1.13 Submenus 4.1.14 Open a submenu 4.1.15 Change a parameter in a submenu 4.1.16 Alarm silence 5.1 Electrical supply 5.1.1 Mains supply 5.1.2 Back-up battery supply 5.2 Gas supply 5.2.1 Dual gas supply 5.2.2 Single gas supply 5.3 Set up of expiration valve 5.4 Breathing gas conditioning 5.5 Breathing circuit 5.5.1 Connection with HME 5.5.2 Connection with active humidifier 5.6 Placing the device 5.6.1 Control panel 5.6.2 Entire system 5.7 Turn ON and OFF 5.8 Self test 5.8.1 Power-up test 5.8.2 System test 5.8.3 In-operation test 5.9 Select the type of patient 5.10 System test menu 5.11 Starting the ventilator

4-7 4-8 4-9 4-10 4-12 4-13 4-14 4-15 4-16 4-17 4-19 4-20 4-22 5-2 5-2 5-4 5-5 5-5 5-6 5-7 5-8 5-9 5-9 5-10 5-12 5-12 5-14 5-15 5-16 5-16 5-17 5-18 5-19 5-20 5-22

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

Table of Contents

6 Operation

6.1 Adjust ventilation modes 6.1.1 Select a ventilation mode 6.1.2 Default ventilation values 6.1.3 Changing ventilation modes 6.2 Adjust ventilation parameters 6.2.1 VCV 6.2.2 SIMV-VC 6.2.3 Bi-Level 6.2.4 Bi-Level/PSV 6.2.5 CPAP/PSV 6.2.5 CPAP/Apnea 6.3 Additional functions 6.3.1 Standby 6.3.2 ASR (Automatic Suction routine) 6.3.3 Parameter menu 6.3.5 Alarm AUTOSET 6.3.6 ARC (Airway Resistance Compensation) 6.3.7 NEB (Nebulizer drug delivery) 6.3.8 System test 6.3.9 NIV (Non Invasive Ventilation) 6.3.10 APD (Automatic Patient Detection) 6.3.11 OCV (Online O2 sensor Calibration) 6.3.12 Short cuts

6-2 6-2 6-3 6-4 6-6 6-6 6-9 6-12 6-14 6-17 6-19 6-21 6-22 6-24 6-32 6-38 6-41 6-44 6-50 6-51 6-53 6-54 6-55

7 Cleaning and Sterilization

7.1 General advice 7.2 Disassembly 7.2.1 Used with HME 7.2.2 Used with active humidifier 7.3 Expiration valve 7.3.1 Removing expiration valve assembly 7.3.2 Disassemble expiration valve assembly 7.4 Clean and sterilize 7.4.1 Housing and control panel 7.4.2 Expiration valve 7.5 Reassembly 7.5.1 Reassemble expiration valve assembly 7.5.2 Reinsertion of expiration valve assembly

7-2 7-3 7-3 7-4 7-5 7-5 7-7 7-8 7-8 7-8 7-9 7-9 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

0-4

8.1 Alarm modality 8.2 Alarm messages 8.3 Other messages 8.3.1 Messages during power up 8.3.2 Messages during system test 8.3.3 Messages during O2 calibration 8.3.4 Messages during operation

8-2 8-4 8-8 8-8 8-11 8-19 8-20

9.1 General 9.2 Oxygen sensor calibration 9.2.1 Start calibration 9.2.2 Stop calibration 9.3 Expiration valve 9.3.1 Remove valve assembly 9.3.2 Replace components 9.3.3 Reassembly 9.3.4 Reinsertion of expiration valve assembly 9.4 Additional maintenance 9.4.1 Every twelve (12) months 9.4.2 Every twenty four (24) months

9-2 9-3 9-3 9-4 9-5 9-5 9-7 9-8 9-9 9-10 9-10 9-10

10.1 General 10.2 Supplies 10.3 Ventilator characteristics 10.4 Controls and ranges 10.6 Measurement functions 10.7 Monitoring functions 10.8 Control panel

10-2 10-3 10-4 10-8 10-9 10-10 10-13

11.1 Spare parts 11.2 Accessories

11-2 11-2

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

1 Introduction

In this section

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

1.1 How to use this manual 1.2 Symbols used in this manual or on the equipment 1.3 Abbreviations used in this manual or on the equipment

1-2 1-3 1-5

1-1

1 Introduction

1.1 How to use this manual This manual describes the operation of the Centiva/5 ICU ventilator Release 2.2n. 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.

1-2

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

1 Introduction

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

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

CAUTION

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)

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

1-3

1 Introduction

On (power) Off (power) Earth ground Protective earth ground Equipotential Type B equipment Input (Expiratory port) Output (Inspiratory port) Attention, refer to product instructions, EN/IEC 60601-1

10101

Serial data transfer connection

xxxx

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

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

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

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

Pmax Plimit Pinsp PS Ppeak Pmin PPEEP Paw

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

Rate I:E Ramp PS ramp Time window t

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

Vt TV MV I-Flow Trigg. Byflow PS endflow Flow

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 I O or AC or DC Ref SN Rev. x.nn

1-6

Inspiratory O2 concentration setting Inspiratory O2 concentration, measured On (power), line supply Off (power), line supply Alternating current Direct current Stock number Serial number Software revision number

O2 40 … 80 PSI AIR 40 … 80 PSI

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

24V/3A DC Serial Port

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

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

2 Safety

In this section

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

2.1 Safety

2-2

2-1

2 Safety

2.1 Safety Reference

This manual describes the operation of the URM Centiva/5, CM-920041, rev. 2.22 Release 2.2n.

Safe Operation

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.

Classification

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 DEVICE OF PROTECTION CLASS I, with internal power supply. Protection against electrical hazard is performed by grounded operation. DEVICE TYPE B, according to safety grade for electrical hazard CONTINUOUS OPERATION according to described operation modes.

Safety standards

2-2

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

2 Safety

Safety features

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

Patient Safety

Control of

Control for

Gas supply

O2 supply fail, AIR supply fail

Disconnection

Disconnection of patient and breathing system

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.

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

2-3

2 Safety

Patient Safety (cont.) WARNING

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.

Residual risk

2-4

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 Plimit defaults to 20 cmH2O in Pediatric and 30 cmH2O in Adult mode. The system has an additional second level safety pressure function, Pmax, that is active in all modes. The Pmax defaults to 30cmH2O in Pediatric and 40 cmH2O in the Adult mode, when in the VCV or SIMV-VC modes. The Pmax default is set to 18 cmH2O in Pediatric and 21 cmH2O in the Adult mode, when in Bi-Level, CPAP/PSV or CPAP/Apnea modes.

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

2 Safety

Risk of electrical hazard

Fire hazard Risk of electromagnetic interference

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

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).

2-5

2 Safety

Accessories

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.

Monitoring

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.

Service and maintenance

2-6

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”.

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

2 Safety

Responsibility of the manufacturer

Manufactured by

Manufactured for

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

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

0123

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

2-7

3 General description

In this section

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

3.1 General description 3.1.1 Intended use 3.1.2 Principle of operation 3.1.3 Ventilation modes 3.1.4 Additional function 3.2 Supply 3.2.1 Electrical supply 3.2.2 Gas supply 3.3 Positioning 3.4 Main components 3.5 System controls 3.5.1 Front side 3.5.2 Rear side

3-2 3-2 3-2 3-3 3-4 3-5 3-5 3-5 3-6 3-7 3-8 3-8 3-9

3-1