Evita 4 and Evita Instructions for Use Sw 4.n 2nd editon Sept 2010

Working with these Instructions for Use Header line – the title... of the main chapter The title of the specific sub-section is printed underneath the main header – to help you find your way quickly from subject to subject.

Calibrating

Page body... the Instructions for Use in combined text/illustrations. The information is expressed in the form of practical actions, giving the user direct hands-on experience in learning how to use the machine.

The last calibration/zeroing values remain stored until the next calibration/zero calibration, even when the machine is switched off. Calibration of the pressure sensors for measuring the airway pressure is automatic. The flow sensor and O2 sensor are automatically calibrated once per day. Manual calibration of the flow sensor can be performed at any time, even during ventilation. Manual calibration of the O2 sensor can be performed at any time, even during ventilation. The applied O2 concentration is not affected by calibration. The calibration of the CO2 sensor can be checked during ventilation.

Start calibration: z Press »Calibration« key. Display (example):

z Touch the »O2« screen key. The LED in the screen key changes colour to yellow.

Message in the help line at the bottom of the screen: »O2-calibration« After calibration is complete, the yellow LED in the screen key goes out.

134

Right-hand column – the illustrations... provide the visual reference for the text and make it easier to locate the various parts of the equipment. Elements mentioned in the text are highlighted. Unnecessary details are avoided. Screen displays prompt the user to proceed and confirm correct actions.

Calibrating the O2 sensor – Before operation, during the device check. – After replacing the O2 sensor (wait for the 15 minute warmup time of the O2 sensor). – If the measured value and set value deviate from each other by more than 2 Vol%. The O2 sensor can be calibrated during ventilation.

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

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Instructions for Use Evita 4 / Evita 4 edition SW 4.n

site_109

Left-hand column – the text... provides explanations and instructs the user step-by-step in the practical use of the product, with short, clear instructions in easy-to-follow sequence. z Bullet points indicate the steps to be followed, 1 Where several steps are described, the numbers refer to the illustration. Numbering starts from 1 again on each new page, – Dashes indicate lists of data, options or objects.

Operation

Trademarks Registered trademarks – AutoFlow® Trademarks used under licence – BIPAP*

Definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the equipment or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation. Abbreviations and Symbols Please refer to "Abbreviations" on page 193 and "Symbols" on page 195 for explanations.

*

Licensed trademark

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

3

Evita 4 edition The Evita 4 edition is identical to the Evita 4. Both devices have identical components, options and functionalities. This refers to all electrical, electronic and pneumatic components as well as to the trolley, the installed software and the available options. The terms "Evita 4" and "Evita 4 edition" are used synonymously in these Instructions for Use.

What's new in Evita 4 software 4.n* Specification of the humidifier used – »Active humidifier« or – »HME/Filter« (artificial nose) – for more accurate measurement of the volume parameters

Apnoea ventilation On/Off – can be selected as starting configuration

Extended range of settings for the alarm time »TApnoea « – from 5 to 60 seconds (formerly 15 to 60 seconds)

Frequency can be reduced to 0 – for BIPAP and SIMV, for weaning without transitions

Ventilation mode BIPAPAssist – for pressure-controlled assisted ventilation

Patient mode »prev. patient« can be selected – to adopt the settings, including alarms, which were effective before switching off the equipment

Additional weaning parameters available as software version 4.n plus upgrade in addition to the parameter occlusion pressure P 0.1 Evita 4 4.n also determines the parameters – RSB Rapid Shallow Breathing index and – NIF Negative Inspiratory Force index

External flow source available as software version 4.n plus upgrade – The amount of external flow is calculated by Evita 4 4.n (e. g. for additional tracheal gas insufflation) and adjusts the volume monitoring tolerances in order to avoid inadvertent alarms

Extended use of loop presentations available as software version 4.n plus upgrade – Loops can be zoomed and frozen – Loops can be displayed permanently in the upper part of the screen

Evita Remote (Remote Pad) optionally available – Remote control pad for parallel remote operation of function keys on Evita 4

NIV optionally available – Application mode to support non-invasive ventilation therapies

Nurse call optionally available – Connection for transmitting alarm signals to a central hospital alarm station

Leakage compensation On/Off – for activation and deactivation of the automatic leakage compensation function

Extended logbook entries – Evita 4 4.n identifies alarms which are active but not displayed with an asterisk

Monitoring of tube blockages – new alarm message »Tube blocked !!!«

*

4

Please refer to page 200 onwards for new features in software versions 2.n and 3.n

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

Contents

Contents Trademarks... 3 Definitions... 3

Troubleshooting... 141

For Your Safety and that of Your Patients... 7

Dismantling... 150 Disinfecting/Cleaning... 153 Care list for the Evita 4 intensive care ventilator... 155 Assembling... 156 Before Reusing on Patient... 157 Maintenance... 157 Clean Covering Grid for Heating Patient Part... 159 Disposal... 159

General WARNINGS and CAUTIONS...10 Intended Medical Application... 13 Operating Concept... 17 Structure of the Control Unit... 18 The Power Switch...19 On-Screen Controls...20 Screen Pages... 23 Control Unit Location... 29 Preparation... 31 Information on Preparation...32 Preparing the EvitaMobil Trolley... 32 Positioning the Control Unit... 33 Fitting the Device Components...35 Using HME, Bacterial Filters and Hose Systems... 38 Ventilating Adults and Children...39 Ventilating Infants...41 Connecting to Supplies... 43 Connecting Evita Remote (optional)...45 Connecting the Nurse Call (optional)...47 Before Using for the First Time...49 Device Check... 51 Transportation within the hospital... 58 Switching piped gas supply to cylinder supply...58 No Instrument Tray (optional)... 59

Cleaning, Disinfection, and Sterilisation... 149

What is what... 161 Technical Data... 167 Description... 177 Ventilation Modes... 178 Weaning Parameters... 189 Insp. O2 Concentration During Medication Nebulisation . . 192 Abbreviations... 193 Symbols... 195 Bibliography... 196 Parts List... 197 What was new in Evita 4 software 2.n... 200 What was new in Evita 4 software 3.n... 201 Index... 202

Operation... 61 Starting up... 62 Patient Mode...63 Starting Ventilation... 64 Setting Ventilation Modes...65 ILV... 79 Apnoea Ventilation... 86 Setting Alarm Limits...87 In the Event of an Alarm... 88 Displaying Curves and Measured Values... 90 Displaying Measured Values...91 Trends... 92 Loops...93 Logbook... 95 Screen Freeze...96 Special Functions...97 Switching off monitor functions...106 Selecting Standby Mode... 108 Calibrating... 109 Configuration...123 Sound... 124 Screen...125 Ventilation... 128 System Defaults...138

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

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Instructions for Use Evita 4 / Evita 4 edition SW 4.n

For Your Safety and that of Your Patients

For Your Safety and that of Your Patients Strictly follow these Instructions for Use... 8 Maintenance... 8 Accessories... 8 Not for use in areas of explosion hazard... 8 Safe connection with other electrical equipment... 8 Safe networking of computers... 8 Patient safety... 9 Patient monitoring... 9 Functional safety... 9 General WARNINGS and CAUTIONS... 10 Note on EMC/ESD risk for the device function... 10 Appropriate ventilation monitoring... 11 Back-up ventilation with an independent manual ventilation device... 11

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

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For Your Safety and that of Your Patients

Strictly follow these Instructions for Use

Accessories

WARNING Strictly follow these Instructions for Use. Any use of the product requires full understanding and strict observation of all portions of these instructions. The device is only to be used for the purpose specified under "Intended Use" from page 13 and in conjunction with appropriate patient monitoring (see page 9). Observe all WARNING and CAUTION statements throughout this manual and all statements on device labels.

WARNING Only the accessories indicated on the list of accessories for Evita 90 38 780 (1st edition or higher) have been tested and approved to be used with the device. Accordingly it is strongly recommended that only these accessories be used in conjunction with the specific device. Otherwise the correct functioning of the device may be compromised.

Maintenance WARNING The device must be inspected and serviced regularly by trained service personnel. Repair of the device may also only be carried out by trained service personnel. Dräger recommends that a service contract be obtained with DrägerService and that all repairs also be carried out by them. Dräger recommends that only authentic Dräger repair parts be used for maintenance. Otherwise the correct functioning of the device may be compromised. See chapter "Maintenance".

8

Not for use in areas of explosion hazard WARNING This apparatus is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur. Safe connection with other electrical equipment WARNING Electrical connections to equipment which is not listed in these Instructions for Use should only be made following consultation with the respective manufacturers. Safe networking of computers When networking with electrical devices, the operator is responsible for ensuring that the resulting system meets the requirements set forth by the following standards: – EN 60601-1 (IEC 60601-1) Medical electrical equipment Part 1: General requirements for safety – EN 60601-1-1 (IEC 60601-1-1) Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems – EN 60601-1-2 (IEC 60601-1-2) Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility; Requirements and tests – EN 60601-1-4 (IEC 60601-1-4) Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems Follow associated installation and operating instructions.

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

For Your Safety and that of Your Patients

Patient safety The design of the equipment, the accompanying literature, and the labelling on the equipment take into consideration that the purchase and use of the equipment are restricted to trained professionals, and that certain inherent characteristics of the equipment are known to the trained operator. Instructions, warnings, and caution statements are limited, therefore, largely to the specifics of the Dräger design. This publication excludes references to various hazards which are obvious to a medical professional and operator of this equipment, to the consequences of product misuse, and to potentially adverse effects in patients with abnormal conditions. Product modification or misuse can be dangerous. Patient monitoring The operators of the system must recognise their responsibility for choosing appropriate safety monitoring that supplies adequate information on equipment performance and patient condition. Patient safety may be achieved through a wide variety of different means ranging from electronic surveillance of equipment performance and patient condition to simple, direct observation of clinical signs. The responsibility for the selection of the best level of patient monitoring lies solely with the equipment operator. Functional safety The essential performance consists in controlled and monitored patient ventilation with user-defined settings for the monitoring functions – minimum breathing gas flow, – maximum airway pressure, – minimum and maximum oxygen concentration in the breathing gas, or, if a set limit is exceeded, by an appropriate alarm. The device is equipped with basic safety features to reduce the possibility of patient injury while the cause of an alarm is remedied.

Dräger Medical GmbH

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

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For Your Safety and that of Your Patients

General WARNINGS and CAUTIONS The following WARNINGS and CAUTIONS apply to general operation of the device. WARNINGS and CAUTIONS specific to subsystems or particular features appear with those topics in later sections of the manual. WARNING Use the device under the supervision of qualified medical personnel only to ensure that any malfunction is remedied without delay. WARNING This equipment must not be used with flammable gases or anaesthetic agents. Danger of fire! WARNING Do not use the device in hyperbaric chambers! Device operation may be affected, thus placing the patient at risk. WARNING The equipment must not be used for nuclear resonance tomography (MRT, NMR, NMI)! This may impair correct functioning of the equipment and endanger the patient.

Note on EMC/ESD risk for the device function General information on electromagnetic compatibility (EMC) pursuant to international EMC standard IEC 60601-1-2 Electromedical devices are subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information included in the technical documentation which is available from DrägerService on request. Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING Connector pins with an ESD warning sign should not be touched and no connections should be made between these connectors without implementing ESD protective measures. Such precautionary procedures may include antistatic clothing and shoes, the touch of a ground stud before and during connecting the pins or the use of electrically isolating and antistatic gloves. All staff involved in the above shall receive instruction in these ESD precautionary procedures.

WARNING Do not place any liquid container (e. g. infusion container) above or on top of the Evita 4. Any liquid getting into the device could prevent Evita 4 from working properly or damage it, and endanger the patient. WARNING Medications and other substances based on inflammable solvents, such as alcohol, must not be used in the patient system. Adequate ventilation must be ensured when using inflammable substances for disinfection. Flammable vapours may ignite during calibration of the flow sensor and destroy the sensor. Fire hazard! NOTE The risk of a software error endangering the patient can be minimized as follows: A software development process is applied that conforms with the state-of-the-art technology and international standards for medical products.

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Instructions for Use Evita 4 / Evita 4 edition SW 4.n

For Your Safety and that of Your Patients

Appropriate ventilation monitoring The built-in monitoring facilities of Evita 4 ensure appropriate monitoring of ventilation therapy and therefore detect any undesirable changes in the following ventilation parameters: – Airway pressure, Paw – Expiratory minute volume, MV – Inspiratory O2 concentration, FiO2 – Inspiratory breathing gas temperature, T – Expiratory CO2 concentration, etCO2 (optional) – Inspiratory breathing volume, VTi – Apnoea time – Tachypnoea monitoring Changes in these parameters may be caused by: – Acute changes in the patient's condition – Incorrect settings and faulty handling – Equipment malfunctions – Failure of power and gas supplies If a fault occurs in this equipment, separate measuring instruments should be used.

Back-up ventilation with an independent manual ventilation device If a fault is detected in Evita 4 so that its life-support functions are no longer assured, ventilation using an independent ventilation device must be started without delay – if necessary with PEEP and/or increased inspiratory O2 concentration (e. g. with manual breathing bag MR 100)

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

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Instructions for Use Evita 4 / Evita 4 edition SW 4.n

Intended Medical Application

Intended Medical Application Scope of Application... 14 With the following ventilation modes... 14 Supplements... 14 Diagnostic functions... 15 Monitoring... 15 DC power supply unit (optional)... 15 Evita 4 Link (optional)... 15 MEDIBUS... 15 Automatic gas switch-over... 15 Areas of use... 15

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

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Intended Medical Application

Scope of Application Evita 4 – long-term ventilator for intensive care. For adults, children and neonates. For premature babies with the "NeoFlow" option.

With the following ventilation modes IPPV (Intermittent Positive Pressure Ventilation) Volume-controlled ventilation with fixed mandatory minute volume. With the options: – CPPV (Continuous Positive Pressure Ventilation) Controlled ventilation with continuous positive airway pressure – PLV (Pressure Limited Ventilation) Pressure limited constant-volume ventilation – AutoFlow® for automatic regulation of "Insp. Flow" and "Pinsp" – IRV (Inversed Ratio Ventilation) Ventilation with inversed inspiration/expiration ratio. SIMV (Synchronized Intermittent Mandatory Ventilation) Combines mechanical (volume-controlled) ventilation with spontaneous breathing. With the options: – PLV (Pressure Limited Ventilation) Pressure limited constant-volume ventilation – AutoFlow® for automatic regulation of "Insp. Flow" and "Pinsp". MMV (Mandatory Minute Volume Ventilation) Spontaneous breathing with automatic adjustment of mandatory ventilation to the patient's minute volume requirement. With the options: – PLV (Pressure Limited Ventilation) Pressure limited constant-volume ventilation – AutoFlow® for automatic regulation of "Insp. Flow" and "Pinsp".

BIPAP (Biphasic Positive Airway Pressure) Pressure-controlled ventilation combined with free spontaneous breathing during the complete breathing cycle and adjustable pressure assist on CPAP level. BIPAPAssist (Biphasic Positive Airway Pressure Assisted) Pressure-controlled assisted ventilation. APRV (Airway Pressure Release Ventilation) Spontaneous breathing on two pressure levels with long time ranges – independently adjustable. PPS (Proportional Pressure Support) (optional) For differentiated proportional support of spontaneous breathing with pathological compliance and/or resistance. ILV (Independent Lung Ventilation) Separate, differentiated, synchronised ventilation with two Evita units, independently ventilating each lung.

Supplements Automatic Tube Compensation ATC (optional) Can be used for all ventilation modes. Compensates the tube resistance. Apnoea ventilation For switching over automatically to volume-controlled mandatory ventilation, if breathing stops. If apnoea occurs, Evita 4 emits an alarm after the preset alarm « and starts volume-controlled ventilation. period »TApnoea NIV mask ventilation (optional) Non-invasive ventilation For ventilation with a nasal or facial mask to support noninvasive ventilation of patients with spontaneous breathing. Choice available between mask ventilation and ventilation of intubated patients.

SB (Spontaneous Breathing) Spontaneous breathing at ambient pressure. CPAP (Continuous Positive Airway Pressure) Spontaneous breathing with positive airway pressure. ASB (Assisted Spontaneous Breathing) Pressure-assisted spontaneous breathing.

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Instructions for Use Evita 4 / Evita 4 edition SW 4.n

Intended Medical Application

Diagnostic functions Intrinsic PEEP measurement For determining intrinsic PEEP when air trapping occurs. Occlusion pressure measurement For evaluating breathing drive during spontaneous breathing. Negative Inspiratory Force NIF (optional) For measuring the patient's maximum inspiratory effort following expiration.

Monitoring Airway pressure Paw Expiratory minute volume MV Inspiratory tidal volume VTi Inspiratory O2 concentration FiO2 Inspiratory breathing gas temperature T Apnoea time Tachypnoea Expiratory CO2 concentration etCO2 (optional)

DC power supply unit (optional) Integrated DC power supply unit, supplying Evita 4 with power from two DC sources: – Two internal 12 V lead-gel batteries in the DC power supply unit and – optionally via additional external 12 V or 24 V lead-gel batteries.

MEDIBUS Software protocol for the transfer of data between Evita 4 and an external medical or non-medical device (e. g. patient monitors or computers for data management systems) via an RS 232 port, see "MEDIBUS for Dräger Intensive Care Devices" (90 28 329). WARNING All transferred data are for information only and should not be used as basis for diagnostic or therapeutic decisions. Danger to the patient cannot be excluded. To protect the patient and the user against electrical hazards, it is essential that all systems consisting of medical devices as well as other electrical devices which are not restricted to computers, printers etc., are only assembled by trained personnel. The system must meet the requirements of the IEC/EN 60601-1-1 and IEC/EN 60601-1-2 standards.

Automatic gas switch-over In the event of a gas failure, the unit automatically changes over to the other gas supply available.

Areas of use In the intensive care ward or in the recovery room and with the optional DC power supply unit when transporting ventilated patients within the hospital.

For uninterrupted operation following failure of the mains power supply, by automatically switching over to the external or internal battery. For supplying power from the internal batteries or additionally from external batteries during in-house transport.

Evita 4 Link (optional) Interface card For output of measured values, status messages and alarm messages to on-line equipment for monitoring, documentation or processing.

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

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Instructions for Use Evita 4 / Evita 4 edition SW 4.n

Operating Concept

Operating Concept Structure of the Control Unit... 18 The Power Switch... 19 On-Screen Controls... 20 Screen Keys for Selecting Functions without Confirmation... 20 Screen Keys for Function Selection, Adjustment and Confirmation... 21 Screen Knobs for Setting Parameters... 22 Screen Pages... 23 Standard Page... 24 Screen Page »Mode settings«... 24 »Alarm limits« Screen Page... 26 »Values measured« Screen Page... 27 Display Logbook... 27 »Special procedure« Screen Page... 28 »Calibration« Screen Page... 28 »Configuration« Screen Page... 29 Control Unit Location... 29

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

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Operating Concept

Structure of the Control Unit The main components of the control unit are the screen, a set of fixed function, keys and the central rotary dial-knob. The function keys are used to call up the screen pages appropriate to the application.

Evita 4

Evita 4

214

NOTE Do not cover the black plastic frame around the screen and do not place any objects in the frame. The touch-sensitive screen keys and knobs will no longer function correctly.

001

In addition to curves, measured values and status displays, the screen contains, in a separate field, touch-sensitive keys and touch-sensitive rotary knobs for parameter setting. The touch-sensitive screen keys and the screen knobs are used in a similar way to ordinary keys and knobs: Touching with the fingertip is equivalent to pressing a key or taking hold of a knob. The display always contains only the screen keys and screen knobs required for function selection and/or adjustment. Settings and confirmations are made by turning and pressing the central, rotary knob.

The keys for routine functions are placed to the right and left on the outside of the front panel. Frequently used function keys are placed on the right, e. g. the key » « for selecting the standard page or the »Alarm Reset« key for resetting or confirming messages.

Evita 4

002

Less frequently used function keys are placed on the left-hand side of the front panel, e. g. the key » « for switching the medication nebuliser on/off, or the »O2 Suction« key for bronchial suctioning.

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Instructions for Use Evita 4 / Evita 4 edition SW 4.n

Operating Concept

The Power Switch

004

003

for switching the device on/off. The power switch is located on the back panel and has a pivoting cover to protect against being inadvertently switched off.

Instructions for Use Evita 4 / Evita 4 edition SW 4.n

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Operating Concept

On-Screen Controls The lower half of the screen contains touch-sensitive coloured screen keys and screen knobs.

IPPV Assist

Touching these controls with the fingertip is equivalent to pressing key or taking hold of a knob. The colour displays the status of the "control" and "LEDs":

60

green

0 -10

= usable

40

white

= not usable

yellow

= adjust/confirm

21

black

= effective function/display

2

4

.500

21

Ppeak

33 > 50

Pplat

27

1.7

VT

8

MV

5.3 _ 4.0

t [s]

21

Tinsp

f

7.0

Basic settings

IPPV

Extra settings

BIPAP SIMV

60

5

Flow

PEEP

ASB

005

O2 [%]

6

1 2 3

FiO2

20

0

Screen Keys for Selecting Functions without Confirmation e. g. for paging through the system on-screen for changing the menu for switching over displays.

A m

Paw [mbar]

IPPV Assist 60

A m

Paw [mbar]

40

21

Ppeak

33 > 50

Pplat

27

MV

5.3 _ 7.0 4.0

20 0 -10

0 MV

2

4

6 f

11:06 total 1.5 spon 0.0

8

t [s]

11:06 total 1.5 spon 0.0

1 2 3

FiO2

Zoom in

Table

Zoom out

Trends

40

20

20

10

Loops

0 12:03 11:03

12:03

Logbook

006

0 11:03

Example: z Press the »Table« key = select display. The key goes black to show that the function is active.

Table

007

Table

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Instructions for Use Evita 4 / Evita 4 edition SW 4.n