Evita XL and Evita XL Neo Instructions for Use Sw 7.0n 2nd edition Sept 2010

Working with these Instructions for Use The title of the main chapter in the header line helps with orientation and navigation.

Typografic conventions

The instructions for the user combine text and illustrations, providing a comprehensive overview of the system. The information is presented as sequential steps of action, allowing the user to learn directly how to use the device.

Any text shown on the screen and any labeling on the device are printed in bold and italics, for example, PEEP, Air or Apnoea ventilation.

The text provides explanations and instructs the user step-by-step in the practical use of the product, with short, clear instructions in easy-tofollow sequence. 1

Consecutive numbers indicate steps of action, with the numbering restarting with “1” for each new sequence of actions.

z Bullet points indicate individual actions or different options for action. –

The “greater than” symbol > indicates the navigation path in a dialog window, for example, System Setup > Therapy > Alarm Limits. In this example, System Setup represents the dialog window title, Therapy represents a horizontal tab and Alarm Limits a vertical tab. These Instructions for Use apply to Evita XL and Evita XL Neo as well as to Evita 4 and Evita 2 dura with the Evita XL option. In the existing Instructions for Use, only the term "Evita XL" is used.

Dashes indicate the listing of data, options or objects.

(A) Letters in parentheses refer to elements in the relevant illustration.

The illustrations show the relationship between the text and the device. Elements mentioned in the text are highlighted. Unnecessary details are omitted. Schematic renderings of screen images guide the user and allow to reconfirm actions performed. The actual screen images differ in look or in configuation. A Letters denote elements referred to in the text.

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Instructions for Use Evita XL SW 7.0n

Trademarks

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Evita XL® AutoFlow®

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SmartCare®

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are trademarks owned by Dräger. BIPAP*) *

Trademark Used Under Licence

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 medical device or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

Abbreviations and Symbols Please refer to the sections "Abbreviations" on page 24 and "Symbols" on page 28 for explanations.

Instructions for Use Evita XL SW 7.0n

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Instructions for Use Evita XL SW 7.0n

Contents

Contents For Your Safety and that of Your Patients . .

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General WARNINGS and CAUTIONS... 10 Application... 13 Intended Use... 14 Environment of Use... 14 Scope of Delivery and Available Options... 14 System Overview... 19 Control Panel... 20 Front Connections... 21 Back Panel... 22 Evita XL Mobil trolley... 23 Abbreviations... 24 Symbols... 28 Operating Concept... 31 Control Panel... 32 Buttons with a Fixed Function... 32 Screen... 33 Preparation... 39 Safety Information for Preparation... 40 Safety Information for the Trolley... 40 Preparation of the Evita XL Mobil Trolley... 41 Preparation of the EvitaMobil Trolley... 45 Positioning the Control Panel... 47 Preparation of Evita XL for Ventilation... 48 Connecting Evita Remote... 58 Connecting Nurse Call... 60 Transportation within the hospital / Moving Evita XL with the trolley... 62 Starting Up... 63 Switching on Evita XL... 64 Entering the Humidification Type... 65 Checking Readiness for Operation... 66 Selecting Tube or Mask (NIV) Application Mode... 71

Operation...

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Selecting the Patient... 75 Starting Ventilation... 76 Setting Ventilation... 77 ILV... 84 NIV – Non-Invasive Ventilation... 87 Medication nebulization... 91 Pre- and Postoxygenation for Bronchial Suctioning... 96 Manual Inspiration... 98 Expiratory Hold... 98 Diagnostics... 99 Low Flow PV-Loop... 101 O2 Therapy... 104 Standby Mode... 106 Mains Power Supply / DC Power Supply... 108 Evita Link... 115 Alarms... 119 On-Screen Alarm Messages... 120 Displaying Alarm Information... 121 Silencing Audible Alarms... 122 Power Failure Alarm... 122 Setting Alarm Limits... 123 Measured Values, Graphics, and Trends . . 125 Displaying Graphics... 126 Displaying Measured Values... 130 Monitoring... 133 Information on Sensor Calibration... 134 Flow Sensor Calibration... 135 External Flow Compensation... 136 Neonatal Flow Sensor Calibration... 137 O2 Sensor Calibration... 138 Checking CO2 Sensor... 139 Switching Monitoring Functions Off or On... 147 NeoFlow Monitoring... 150 Configuration... 151 Information on Configuration... 152 System-Specific Settings... 152 Therapy-Specific Start-Up Settings... 159

Instructions for Use Evita XL SW 7.0n

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Contents

Problem Solving... 165 Alarm – Cause – Remedy... 166 Cleaning, Disinfection, and Sterilization . . . 183 Safety Information for Reprocessing... 184 Disassembling Components and Reprocessing... 184 Reprocessing Procedure... 190 Reprocessing List for Evita XL... 192 Re-assembly of Parts... 194 Before Reusing on Patient... 195

References... 281 Special ASCII Characters Used... 284 Parts List... 286 Index... 291

Maintenance... 197 Maintenance Intervals... 198 Filters... 199 Disposal... 201 Safety Information... 202 Disposal of batteries... 202 Disposal of O2 sensor... 202 Disposal of a neonatal flow sensor... 202 Disposal of the medical device... 203 Technical Data... 205 Environmental Conditions... 206 Settings... 206 APRV Airway Pressure Release Ventilation. . . 208 ATC Automatic Tube Compensation... 208 PPS Proportional Pressure Support... 209 O2 Therapy... 210 Power Characteristics... 210 Display of Measured Values... 212 Computed Value Displays... 216 Monitoring... 217 Operating Data... 219 Device Outputs... 223 DC Power Pack... 225 LUST Protocol... 226 EMC Declaration... 232 Principle of Operation... 237 Ventilation Modes... 238 Additional Settings... 253 Measurements... 260 Alarm – Detection/Description... 270 Screen Configurations... 276 6

Instructions for Use Evita XL SW 7.0n

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 Networking... 9 Patient safety... 9 Patient monitoring... 9 Functional Safety... 10 General WARNINGS and CAUTIONS... 10 Note on EMC/ESD risk for the device function... 11 Sterile Accessories... 11 Ventilation Monitoring... 12 Back-up ventilation with an independent manual ventilation device... 12

Instructions for Use Evita XL SW 7.0n

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For Your Safety and that of Your Patients

Strictly follow these Instructions for Use

Accessories

WARNING Any use of the medical device requires full understanding and strict observation of all portions of these Instructions for Use. The medical device is only to be used for the purpose specified under "Intended Use" on page 14 and in conjunction with appropriate patient monitoring (see page 9). Strictly observe all WARNING and CAUTION statements throughout these Instructions for Use and all statements on medical device labels.

WARNING Only the accessories indicated on the list of accessories 9038780 (1st edition or higher) have been tested and approved to be used with the medical device. Accordingly it is strongly recommended that only these accessories be used in conjunction with the specific medical device. Otherwise the correct functioning of the medical device may be compromised.

Not for use in areas of explosion hazard Maintenance WARNING The medical device must be inspected and serviced regularly by properly trained service personnel. Repair of the medical device may also only be carried out by properly 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 medical device may be compromised. See chapter "Maintenance".

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WARNING This medical device 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 CAUTION Danger to the patient Electrical connections to equipment which is not listed in these Instructions for Use should only be made following consultation with the respective manufacturers.

Instructions for Use Evita XL SW 7.0n

For Your Safety and that of Your Patients

Networking

Patient safety

Device combinations approved by Dräger (see Instructions for Use of the individual devices or units) meet the requirements set forth by the following standards:

The design of the medical device, the accompanying literature, and the labeling on the medical device take into consideration that the purchase and use of the medical device are restricted to trained professionals, and that certain inherent characteristics of the medical device 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 medical device, to the consequences of medical device misuse, and to potentially adverse effects in patients with abnormal conditions. Medical device modification or misuse can be dangerous.

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IEC 60601-1 (EN 60601-1) Medical electrical equipment Part 1: General requirements for safety

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IEC 60601-1-1 (EN 60601-1-1) Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems

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IEC 60601-1-2 (EN 60601-1-2) Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility; Requirements and tests

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IEC 60601-1-4 (EN 60601-1-4) Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems

If Dräger devices or units are connected to other Dräger devices or third-party devices and the resulting combination is not approved by Dräger, the correct functioning of the devices may be compromised. The operator is responsible for ensuring that the resulting system meets the requirements set forth by the above standards. Strictly follow Assembly Instructions and Instructions for Use for each networked device.

CAUTION Danger to the patient. Individual measured values and monitoring parameters should not be used as the sole basis for therapeutic decisions.

Patient monitoring The operators of the medical device are responsible for choosing appropriate safety monitoring that supplies adequate information on medical device performance and patient condition. Patient safety may be achieved through a wide variety of means ranging from electronic surveillance of medical device 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 medical device operator.

Instructions for Use Evita XL SW 7.0n

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For Your Safety and that of Your Patients

Functional Safety The essential performance consists in controlled and monitored patient ventilation with user-defined settings for the monitoring functions –

minimum breathing gas flow,

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maximum airway pressure,

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minimum and maximum O2 concentration in the breathing gas,

or, if a set limit is exceeded, by an appropriate alarm. The medical device is equipped with basic safety features to reduce the possibility of patient injury while the cause of an alarm is remedied.

General WARNINGS and CAUTIONS The following WARNINGS and CAUTIONS apply to general operation of the medical device. WARNINGS and CAUTIONS specific to subsystems or particular features appear with those topics in later sections of these Instructions for Use or in the Instructions for Use of any product being used with this device. WARNING Evita XL must only be used under the supervision of qualified medical personnel in order to provide immediate corrective action in the case of a malfunction. WARNING Do not use the device in conjunction with flammable gases or anesthetics - fire hazard! WARNING Do not use Evita XL in hyperbaric chambers. Device malfunction may result, with the risk of patient injury.

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WARNING Do not use in conjunction with magnetic resonance imaging (MRI)! Device malfunction may result, with the risk of patient injury. WARNING Using high frequency electrosurgery equipment, defibrillators, or short-wave treatment equipment in the vicinity of the device may interfere with its operation and pose a risk of patient injury. WARNING Never use flammable medications (e.g. on the basis of isopropyl alcohol) or other substances based on flammable solvents in the breathing system. Always provide adequate ventilation when using flammable substances for disinfection. Flammable vapors may otherwise ignite when calibrating the flow sensor and destroy the flow sensor in the process. Fire hazard!

Instructions for Use Evita XL SW 7.0n

For Your Safety and that of Your Patients

WARNING Do not place any container with liquids (e.g., infusion bottle) above or on top of Evita XL. Any liquid getting into the device could prevent Evita XL from working properly or damage it and endanger the patient. WARNING When using Evita XL in combination with other products and when using Evita XL during transportation within the hospital the person responsible for operating the device must ensure that all equipment is adequately secured in accordance with the relevant basic requirements of Directive 93/42/EEC. CAUTION The touch active area of the screen has a sensitive surface. Damage to the surface will lead to malfunctions when using the touch active operating elements. Do not operate the touch active area of the screen with sharp objects. Do not damage the screen surface of Evita XL when cleaning or during transportation within the hospital. NOTE The risk of endangering the patient by software errors is minimized as follows: A software development process is applied that conforms with the state-of-the-art technology and international standards for medical devices.

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 provided on page 232. Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING Connector pins with an electrostatic discharge (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.

Sterile Accessories CAUTION Do not use sterile-packaged accessories if the packaging has been opened, is damaged or there are other signs of non-sterility. Disposable articles may not be reprocessed and resterilized. Reuse, processing or sterilization can lead to a failure of the medical devices and cause injuries to patient.

Instructions for Use Evita XL SW 7.0n

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For Your Safety and that of Your Patients

Ventilation Monitoring The monitoring integrated in Evita XL monitors the following parameters: –

Airway pressure, PAW

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Expiratory minute volume, MV

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Inspiratory tidal volume, VTi

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Inspiratory O2 concentration, FiO2

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Inspiratory breathing gas temperature, T

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End-expiratory CO2 concentration, etCO2

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Apnea time, TApnoea

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Respiratory rate, fspn

Changes in these parameters may be caused by: –

acute changes in the patient’s condition

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incorrect settings and user error

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device fault conditions

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failure of power and gas supplies

In case of malfunction of any of the built-in monitoring, a substitute must be provided in order to maintain an adequate level of monitoring. During O2 Therapy, the monitoring functions of Evita XL are restricted.

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

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Instructions for Use Evita XL SW 7.0n

Application

Application Intended Use... 14 Environment of Use... 14 Scope of Delivery and Available Options. . . 14 Evita XL without options... 14 Options... 16 Monitoring in accordance with the options used... 18

Instructions for Use Evita XL SW 7.0n

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Application

Intended Use Evita XL – Long-term ventilator for intensive care. For adults, children, and neonates with a minimum body weight of 3 kg (6.6 lbs). For premature infants with a minimum body weight of 0.5 kg (1.1 lbs) with the NeoFlow option.

Evita XL Neo* – Long-term ventilator for intensive care. For children, neonates, and premature infants with a minimum body weight of 0.5 kg (1.1 lbs). For adults with the Adult option. *

In some countries only available under the name Evita XL.

Environment of Use In the intensive care ward or in the recovery room.

During transportation of ventilated patients within the hospital.

Scope of Delivery and Available Options

Evita XL without options

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PLV (Pressure Limited Ventilation) Pressure limited constant-volume ventilation

Evita XL for the Adult and Pediatric patient categories

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AutoFlow® for automatic setting of inspiratory flow and Pinsp

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IRV (Inversed Ratio Ventilation) Ventilation with inversed inspiration/expiration ratio

Evita XL Neo for the Neonatal and Pediatric patient categories Evita XL and Evita XL Neo can be supplemented with options, see page 16. IPPV ventilation mode

SIMV ventilation mode

Intermittent Positive Pressure Ventilation

Synchronized Intermittent Mandatory Ventilation

Volume-controlled ventilation with fixed mandatory minute volume.

Combines mechanical (volume-controlled) ventilation with spontaneous breathing.

With the functions:

With the functions:

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CPPV (Continuous Positive Pressure Ventilation) Controlled ventilation with continuous positive airway pressure

PLV (Pressure Limited Ventilation) Pressure limited constant-volume ventilation

Instructions for Use Evita XL SW 7.0n

Application

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AutoFlow® for automatic setting of inspiratory flow and Pinsp

If apnea occurs, Evita XL sounds an alarm after the preset alarm period (TApnoea ) and starts apnea ventilation.

SB (Spontaneous Breathing)

O2 Therapy

Spontaneous breathing at ambient pressure

Continuous flow application with adjustable O2 concentration and flow for the O2 Therapy function for patients with independent breathing and using oxygen masks.

BIPAP* ventilation mode Biphasic Positive Airway Pressure Pressure-controlled ventilation combined with free spontaneous breathing during the complete breathing cycle and adjustable pressure support on CPAP level.

DC power pack** Integrated DC power pack supplying Evita XL with power from two internal 12 V lead-acid gel batteries for a maximum of 10 minutes.

Continuous Positive Airway Pressure

For uninterrupted operation in case of mains power failure, Evita XL automatically switches over to the internal batteries.

Spontaneous breathing with positive airway pressure.

MEDIBUS

CPAP ventilation mode

ASB ventilation mode Assisted Spontaneous Breathing Pressure-supported spontaneous breathing.

Software protocol for the transfer of data between Evita XL and an external medical or non-medical device (e.g., patient monitors or computers for data management systems) via an RS 232 interface, see "MEDIBUS for Dräger Intensive Care Devices" (9028329).

ILV ventilation mode Independent Lung Ventilation Differential, synchronized ventilation with two Evita devices, independently ventilating each lung. Apnoea ventilation additional setting If apnea occurs while Apnea Ventilation is activated, the system automatically switches over to mandatory ventilation. In the Adult and Pediatric patient categories, the device switches over to volume-controlled ventilation.

Automatic gas switch-over In the event of a gas failure, Evita XL automatically switches over to the other gas supply available. Other features –

Standard display of waveforms, measured values, and PV-Loop

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Three waveforms can be displayed on-screen at the same time

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PV-Loop

Evita XL offers limited configurability.

In the Neonatal patient category, the device switches over to pressure-controlled ventilation. **

*

Trademark Used Under Licence

Instructions for Use Evita XL SW 7.0n

Optional on Evita 4 and Evita 2 dura with the Evita XL option

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Application

Options Evita XL displays the options available in the device, see "Displaying available options" on page 158. PPS* (Proportional Pressure Support) Differential proportional support of spontaneous breathing in cases of pathological compliance and/or resistance.

XL Ventilation Plus Additional ventilation modes: –

APRV (Airway Pressure Release Ventilation) Spontaneous breathing on two independentlyadjustable pressure levels with long time ranges.

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MMV (Mandatory Minute (Volume) Ventilation) Spontaneous breathing with automatic adjustment of mandatory ventilation to the patient's minute volume requirement. With the functions: – PLV (Pressure Limited Ventilation) Pressure limited constant-volume ventilation. – AutoFlow® for automatic setting of inspiratory flow and Pinsp

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BIPAP Assist (Biphasic Positive Airway Pressure Assisted) Pressure-controlled, assisted ventilation

NIV – Non-Invasive Ventilation Patients with spontaneous breathing are supported with non-invasive ventilation therapies using a nasal or face mask. Choice between mask ventilation and ventilation of intubated patients. NIV Plus In addition to NIV: – Evita XL detects the patient’s inspiration and switches automatically from Standby Plus mode to non-invasive ventilation – When the mask is removed, patient flow is reduced until the mask is put back on – Extended leakage compensation

XL Monitoring Plus Additional loops, trends, and diagnostic functions –

Intrinsic PEEP measurement Determination of Intrinsic PEEP and measuring trapped volume (air trapping)

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Occlusion pressure measurement Evaluation of patient’s breathing drive during spontaneous breathing

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Negative Inspiratory Force NIF Measurement of the patient's maximum inspiratory effort following expiration

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RSB Rapid Shallow Breathing

LPP** (Lung Protection Package) – –

Recruitment Trends Low Flow PV-Loop

Adult Standard on Evita XL Addition of Adult patient category to Evita XL Neo

XL Configuration Plus ATC (Automatic Tube Compensation) Compensation of tube resistance Can be used with all ventilation modes. * **

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Not available for the US market Not available on Evita XL Neo

Additional configuration possibilities for: – Measured values – Buttons in the main menu bar – Screen configurations – Customized values and settings

Instructions for Use Evita XL SW 7.0n

Application

SmartCare / PS*

External battery for DC power pack

Knowledge-based system for clinical guidelines.

Extension of integrated DC power pack with external 12 V or 24 V lead-acid gel batteries.

For the use of SmartCare / PS the following options are additionally required: – CapnoPlus – ATC – XL Monitoring Plus – XL Configuration Plus NeoFlow Standard on Evita XL Neo Neonatal mode with basic flow Extends the range of uses of Evita XL to include long-term ventilation of premature infants through addition of the Neo. patient category. In the Paed. and Neo. patient categories, a proximal neonatal flow sensor is used for flow monitoring.

For uninterrupted operation for max. 2 hours in case of mains supply failure For supplying power during transportation within the hospital Quiet Power Failure Alarm** Evita XL can be equipped with a quiet version of the power failure alarm for use in particularly quiet clinical environments. Quiet loudspeaker Evita XL can be equipped with a quiet version of the alarm enunciator for use in particularly quiet clinical environments. Remote Pad

NurseCall – –

Nurse call for connection to central hospital alarm system Connection option for Remote Pad

CapnoPlus

Remote control of routine functions Insp. term. PIF Adjustable criterion for the termination of ASB breaths

Proximal CO2 measurement Evita Link Interface card Output of measured values, status messages and alarm messages to connected equipment for monitoring, documentation, or further processing.

** *

Not available on Evita XL Neo

Instructions for Use Evita XL SW 7.0n

Not available for USA, Canada, Japan, China, Taiwan, Korea, and Brazil

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Application

Monitoring in accordance with the options used –

Airway pressure, PAW

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Expiratory minute volume, MV

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Inspiratory tidal volume, VTi

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Inspiratory O2 concentration, FiO2

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Inspiratory breathing gas temperature, T

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Apnea time, TApnoea

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Respiratory rate, fspn

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End-expiratory CO2 concentration, etCO2

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Instructions for Use Evita XL SW 7.0n

System Overview

System Overview Control Panel... 20 Front Connections... 21 Back Panel... 22 Evita XL Mobil trolley... 23 Abbreviations... 24 Symbols... 28

Instructions for Use Evita XL SW 7.0n

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System Overview

Control Panel

I

A B C D E F G

MT-0071-2008

H

A

Audio paused 2 min. or Alarm Silence key for suppressing the alarm tone for two minutes

B

Alarm Limits key for setting alarm limits

C

Ventilator Settings key for setting ventilation mode and ventilation parameters

I

Touch-sensitive screen

D Unassigned key for future functions E

Sensor Parameter key for calibrating sensors and for switching monitoring on or off

F

System Setup key for configuring device functions

G

Start/Standby key for switching between operation and standby mode

1 2 3

H Rotary knob for selecting and confirming settings 20

Instructions for Use Evita XL SW 7.0n