Evita V500 Instructions for Use sw 2.n Edition 9 April 2016

Typographical conventions 1

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

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

Dashes indicate the listing of data, options, or objects.

(A) Letters in parentheses refer to elements in the related illustration. A Letters in illustrations denote elements referred to in the text. Any text shown on the screen and any labeling on the device are printed in bold and italics, for example, PEEP, Air or Alarms. The "greater than" symbol > indicates the navigation path in a dialog window, for example, System setup > Ventilation > Modes. In this example, System setup represents the dialog window title, Ventilation represents a horizontally aligned tab, and Modes a vertically aligned tab.

Screen images Schematic renderings of screen images are used, which may differ in appearance or in configuration from the actual screen images.

Product name used In these instructions for use, the designation Evita V500 is used for Evita Infinity V500.

Use of terms Dräger uses the term "Accessory" not only for accessories in the sense of IEC 60601-1, but also for consumable parts, removable parts, and attached parts.

Trademarks Trademark AutoFlow Infinity

®

®

Trademark owner

Trademark

Trademark owner

Dräger

MEDIBUS.X®

Dräger

Sekusept

®

QuickSet®

Actichlor®

ATC®

Oxycide®

SmartCare®

Klorsept

Ecolab USA

®

Medentech

Acute Care SystemTM

BruTab 6S

Medical CockpitTM

Descogen®

DrägerService® MEDIBUS™

2

Dispatch

Ecolab

®

® ®

Dismozon

Brulin Antiseptica Clorox BODE Chemie

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

Trademark

Trademark owner

Virkon®

DuPont

Perform® Mikrozid

Schülke & Mayr

®

Buraton® acryl-des® BIPAP1) 1)

Licensed trademark

Safety information 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.

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

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Definition of the target groups For this medical device users, service personnel, and experts are defined as target groups.

Service personnel

These target groups have been instructed in the use of the medical device and have the necessary knowledge to use, install, reprocess, maintain or repair the medical device.

Service personnel are persons who are responsible for the maintenance of the medical device towards the operating organization.

Dräger emphasizes that the medical device must be used, installed, reprocessed, maintained or repaired exclusively by defined target groups.

Service personnel are persons who may install, reprocess, or maintain the medical device.

Experts Experts are persons who may carry out repair or complex maintenance work on the medical device.

Users Users are persons who may use the medical device in accordance with its intended use.

Abbreviations and symbols For explanations refer to sections "Abbreviations" and "Symbols" in chapter "System overview".

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Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

Contents

Contents Typographical conventions... Trademarks... Safety information definitions... Definition of the target groups... Abbreviations and symbols...

2 2 3 4 4

For your safety and that of your patients. . .

7

General safety information... 8 Product-specific safety information... 12 Application... 17 Intended use... 18 Indications for use and contraindications... 18 Environment of use... 18 System overview... 19 Infinity Acute Care System – Workstation Critical Care... Evita V500 ventilation unit... Trolley 2-90 cm... GS500 gas supply unit... Range of functions... Abbreviations... Symbols...

20 21 23 24 25 27 33

Operating concept... 37 Operating concept for Infinity C500... 38 Operating concept for Evita V500... 38 Assembly and preparation... 43 Safety information for assembly and preparation... 44 Preparing the trolley... 44 Preparing the Medical Cockpit... 48 Preparing the ventilation unit... 53 Intrahospital transport... 66 Getting started... 67 Safety information on getting started... 68 Switching on Evita V500 and Infinity C500... 68 Selecting a patient... 69 Selecting the breathing circuit and the breathing gas humidifier... 72

Checking readiness for operation... 74 Selecting the Tube or NIV application mode . 83 Transfer of ventilation settings... 84 Selecting the therapy type... 85 Starting the therapy... 86 Displaying the status of accessories... 87 Operation...

89

Setting ventilation... 91 NIV – Non-invasive ventilation... 99 Displaying curves and measured values... 102 Help... 106 Maneuvers... 107 Medication nebulization... 111 Measurement maneuver Low Flow PV Loop... 119 Diagnostics – measurement maneuver... 123 GS500 gas supply unit... 126 O2 therapy... 127 Standby mode... 130 Ending operation... 132 Storing Evita V500... 133 Mains power supply / DC power supply... 134 Intrahospital patient transport... 137 Alarms... 139 Overview... 140 Display of alarms... 140 Displaying information on alarms... 142 Alarm history... 143 Setting alarm limits... 144 Setting the volume of the alarm tone... 146 Suppressing the alarm tone... 147 Position of the user to the alarm system... 147 Failure of the acoustic alarm... 148 Trends and data... 149 Overview... 150 Displaying trends... 150 Displaying data... 154 Displaying the logbook... 155 Data export... 156

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

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Contents

Monitoring... 157

Technical data... 277

Information on monitoring... 158 Flow monitoring... 159 O2 monitoring... 164 CO2 monitoring... 165

Ambient conditions... 278 Set values... 279 Performance characteristics... 283 Displayed measured values... 286 Displayed calculated values... 291 Monitoring... 292 Operating data... 296 Device ports... 301 Automatic alarm limits... 302 Essential performance characteristics... 305 Connections to IT networks... 306 Open-source software... 307

Configuration... 173 Information on configuration... 174 Configuring the screen display... 174 Configuring alarm settings... 183 Configuring ventilation settings... 186 Importing and exporting configurations... 195 Installing applications... 197 System status... 198 System settings... 200 Service dialog... 203 Alarm – Cause – Remedy... 205 Reprocessing... 243 Disassembly... 244 Information on reprocessing... 248 Classifications for reprocessing... 250 Reprocessing list... 251 Reprocessing procedure... 253 After reprocessing... 259 Maintenance... 263 Overview... 264 Inspection... 265 Preventive maintenance... 266 Repair... 266 Replacing the ambient air filter... 267 Replacing the diaphragm of the expiratory valve... 267 Replacing the expiratory valve... 268 Preventive maintenance on the GS500 gas supply unit... 268 Battery maintenance... 270

Principles of operation... 309 Description of the ventilation modes... 310 Additional settings for ventilation... 332 Special functions... 345 Description of the therapy types... 353 Automatic leakage compensation... 354 Flow reduction Anti Air Shower... 355 Measurements... 356 Battery concept... 359 Pneumatic functional description... 363 Main menu bar structure... 366 Factory-set screen views... 371 List of references... 372 Index... 375 Password for Evita V500 SW 2.n... 381 Information on the password... 381

Disposal... 273 Safety information on disposal... 274 Disposal of packaging material... 274 Disposal of batteries... 275 Disposal of flow sensor and neonatal flow sensor... 275 Disposal of medical devices... 275 6

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

For your safety and that of your patients

For your safety and that of your patients General safety information...

8

Strictly follow these instructions for use... 8 Maintenance... 8 Safety checks... 8 Accessories... 8 Not for use in areas of explosion hazard... 9 Safe connection to other electrical equipment... 9 Connected devices... 9 Device combinations... 9 Connection to IT network... 10 Patient safety... 10 Patient monitoring... 10 Information on electromagnetic compatibility . . 11 Disposable articles... 11 Sterile accessories... 11 Installing accessories... 11 Storing the instructions for use... 11 Training... 12 Product-specific safety information... 12 Monitoring ventilation... 14 Back-up ventilation with an independent manual ventilation device... 14 Handling Infinity ID components... 15

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

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For your safety and that of your patients

General safety information The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these instructions for use or in the instructions for use of another product being used with this device.

Strictly follow these instructions for use WARNING Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under "Intended use" on page 18 and in conjunction with appropriate patient monitoring (see page 10). Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

Maintenance WARNING The medical device must be inspected and serviced regularly by service personnel. Repairs or complex maintenance work carried out on the medical device must be performed by experts. Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. Dräger recommends that only genuine Dräger parts are used for maintenance. If the above are not complied with, the correct functioning of the medical device may be compromised. Observe chapter "Maintenance".

Safety checks The medical device must be subject to regular safety checks. See chapter "Maintenance".

Accessories WARNING Only the accessories indicated on the list of accessories 9039085 (2nd edition or later) have been tested and approved for use with the medical device. Therefore, it is strongly recommended that only these accessories are used in conjunction with the medical device. Otherwise, the correct functioning of the medical device may be compromised.

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Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

For your safety and that of your patients

Not for use in areas of explosion hazard

Device combinations

WARNING This medical device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur.

This device can be operated in combination with other Dräger devices or with devices from other manufacturers. Observe the accompanying documents of the individual devices.

Safe connection to other electrical equipment WARNING Risk of patient injury Electrical connections to equipment not listed in these instructions for use or these assembly instructions must only be made when approved by each respective manufacturer.

Connected devices WARNING Risk of electric shock and of device malfunction Any connected devices or device combinations not complying with the requirements mentioned in these instructions for use may compromise the correct functioning of the medical device. Before operating the medical device, strictly comply with the instructions for use of all connected devices or device combinations.

If a device combination is not approved by Dräger, the safety and the functional state of the individual devices may be compromised. The operating organization must ensure that the device combination complies with the applicable editions of the relevant standards for medical devices. Device combinations approved by Dräger meet the requirements of the following standards: – IEC˽60601-1, 3rd˽edition (general requirements for safety, device combinations, software-controlled functions) – IEC˽60601-1-2 (electromagnetic compatibility) – IEC˽60601-1-8 (alarm systems) Or: – IEC˽60601-1, 2nd˽edition (general requirements for safety) – IEC˽60601-1-1 (device combinations) – IEC˽60601-1-2 (electromagnetic compatibility) – IEC˽60601-1-4 (software-controlled functions) – IEC˽60601-1-8 (alarm systems)

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

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For your safety and that of your patients

Connection to IT network The connection of the medical device to a network or later changes in the network can result in previously unidentified risks for patients, users and third parties. These risks must be identified and controlled before putting the medical device into operation. Relevant changes to the network include: – Configuration changes – Adding or removing additional equipment – Update or upgrade of connected devices Risks Overloading of the medical device as a result of very high network traffic (e.g., due to "denial of service" attacks) could lead to deactivation of the interfaces. The service functionality would not then be available until the medical device has been restarted. In rare cases, a warm boot may take place and may occur repeatedly.

CAUTION Risk of patient injury Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.

Patient monitoring The user of the medical device is responsible for choosing suitable monitoring that provides appropriate information about medical device performance and the patient's condition. Patient safety may be achieved by 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 selecting the best level of patient monitoring lies solely with the user of the medical device.

Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. These instructions for use do not contain references to various hazards which are obvious to users or references to the consequences of medical device misuse, or to potentially adverse effects in patients with different underlying diseases. Medical device modification or misuse can be dangerous.

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Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

For your safety and that of your patients

Information on electromagnetic compatibility General information on electromagnetic compatibility (EMC) according 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 in the separate instructions for use "Workstation Critical Care and Workstation Neonatal Care". Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING Do not connect connectors with an ESD warning symbol and do not touch the pins of such connectors without implementing ESD protective measures. Such protective measures may include antistatic clothing and shoes, touching a ground stud before and during connection of the pins, or using electrically insulating and antistatic gloves. All relevant personnel must be instructed in these ESD protective measures. WARNING Do not use portable and mobile HF communications equipment, e.g., mobile phones, in the vicinity of the medical device. Maintain separation distances; see EMC information in the separate instructions for use, "Workstation Critical Care and Workstation Neonatal Care".

Disposable articles WARNING Risk of patient injury as a result of failure of the accessories Disposable articles were developed, tested and manufactured for single use only. Reuse, reprocessing or sterilization can lead to a failure of the accessories and cause injuries to the patient. Do not reuse, reprocess, or sterilize disposable articles.

Sterile accessories CAUTION Do not use sterile-packaged accessories if the packaging has been opened, is damaged, or if there are other signs of non-sterility.

Installing accessories CAUTION Install accessories to the basic device in accordance with the instructions for use of the basic device. Make sure that there is a safe connection to the basic device system. Strictly observe instructions for use and assembly instructions.

Storing the instructions for use CAUTION The instructions for use must be kept in an accessible location for users.

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

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For your safety and that of your patients

Training Training for users is available from the Dräger organization responsible, see www.draeger.com.

Product-specific safety information WARNING This medical device is intended to be used only by trained users. WARNING Risk of fire The flow sensor can ignite medications or other substances based on highly flammable substances. – Do not nebulize medications or other substances that are easily flammable or spray them into the device. – Do not use substances containing alcohol. – Do not allow flammable or explosive substances to enter the breathing system or the breathing circuit. WARNING Risk of fire

WARNING Do not use the medical device in hyperbaric chambers! This may impair correct functioning of the medical device and endanger the patient. WARNING Correct functioning of the medical device may be impaired by operation of high-frequency electrosurgery units, defibrillators or shortwave therapy equipment and endanger the patient. WARNING Risk of malfunction Unauthorized modifications to the medical device lead to malfunctions. This medical device must not be modified unless authorized by the manufacturer.

Do not use the medical device in conjunction with flammable gases or flammable solutions that can mix with air, oxygen or nitrous oxide, or other sources of ignition since the medical device could ignite. Do not allow the medical device to come into contact with sources of ignition.

WARNING Risk of electric shock Live components are located under the cover. Do not open the housing of the medical device.

WARNING Do not use the medical device during magnetic resonance imaging (MRI, NMR, NMI)! This may impair correct functioning of the medical device and endanger the patient.

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Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

For your safety and that of your patients

WARNING Risk of fire Do not use the medical device in oxygenenriched rooms since the medical device could ignite. Medical device malfunctions can increase the O2 concentration in the ambient air. The medical device is only suitable for use in rooms with sufficient ventilation. WARNING Do not obstruct the gas inlet for the safety valve. Otherwise, spontaneous breathing via the emergency breathing valve is not possible in the event of a device failure. WARNING With neonates, the administration of increased O2 concentrations can lead to retinopathy of prematurity. Use additional monitoring, e.g., external SpO2. WARNING Risk of fire The use of unapproved O2 pressure reducers can lead to excess pressure which can cause a fire. When supplying the ventilator with oxygen from a compressed gas cylinder, only use pressure reducers compliant with ISO 10524. Slowly open the pressure reducer manually. Do not use tools.

WARNING Risk of unnoticed change in inspiratory O2 concentration If an additional flow is delivered by an external flow source, the actual O2 concentration delivered may deviate from the displayed values. Use additional monitoring, e.g., external SpO2 monitoring, if necessary. WARNING Risk of patient injury If leakages are present, e.g., with non-invasive ventilation, the actual tidal volume may deviate from the measured values for VTe and VTi. Activate leakage compensation and monitor the measured value for VT. Minimize or remedy all leakages. WARNING Risk of failure of flow measurement Deposits that were not removed during reprocessing can damage the measuring wires in the flow sensor or cause a fire. – Before inserting the flow sensor check for visible damage, soiling, and particles. Repeat this check regularly. – Replace flow sensors when damaged, soiled, or not particlefree. CAUTION Keep away from sources of heat such as direct sunlight, heat radiators or spotlights! Otherwise the medical device may become too hot.

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

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For your safety and that of your patients

CAUTION Do not obstruct or close off the vents on the medical device. Air must be able to enter freely. Otherwise the medical device may become too hot. An alarm is triggered if the medical device overheats during operation. CAUTION Positive-pressure ventilation can lead to negative effects, such as barotrauma or strain on the circulatory system. CAUTION Risk of patient injury An additional flow delivered by an external flow source can affect the measured values for airway pressure and flow.

Monitoring ventilation The following parameters are monitored by the built-in monitoring facilities of Evita V500: – Airway pressure – Expiratory minute volume – Inspiratory tidal volume – Respiratory rate – Apnea alarm time – Inspiratory O2 concentration – End-expiratory CO2 concentration Changes in these parameters may be caused by: – Acute changes in the patient's condition – Incorrect settings and faulty handling – Device malfunctions – Failure of power and gas supplies If a fault occurs in this equipment, separate measuring instruments must be used. During O2 therapy, the monitoring functions of the medical device are restricted. See chapter "O2 therapy" on page 127.

CAUTION Risk of malfunction The touch screen has a sensitive surface. Damage to the surface may cause the touchsensitive controls not to work properly. Do not operate the screen with sharp objects.

Back-up ventilation with an independent manual ventilation device WARNING If a fault is detected in the medical device, its life-support functions may no longer be assured. Ventilation of the patient using an independent ventilation device must be started without delay, if necessary with PEEP and/or an increased inspiratory O2 concentration (e.g., with a manual resuscitator).

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Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

For your safety and that of your patients

Handling Infinity ID components Through ownership or purchase of this medical device equipped with RFID technology, you have only acquired the right to use the medical device and RFID technology in conjunction with products approved by Dräger and in strict compliance with these instructions for use. No intellectual property rights or any rights to the use of the medical device or RFID technology are hereby granted, either explicitly or implicitly, which are contrary to the above-mentioned conditions. WARNING Risk of patient injury

The RFID system of this medical device complies with Part 15 of the FCC regulations, and its operation is subject to the following conditions: 1

This medical device does not cause any dangerous interference.

2

The medical device is not liable to damage caused by the reception of interference, including interference causing undesired operating conditions.

Dräger hereby declares that the RFID system in the ventilation unit is in compliance with the basic requirements and the other pertinent regulations of Directive 1999/5/EC.

Although Evita V500 does not exceed the applicable limiting values for electromagnetic fields, radiation can interfere with the functioning of pacemakers. Wearers of pacemakers must keep a distance of at least 25 cm (10 in) between the pacemaker and Evita V500. Emission of high-frequency energy This medical device is equipped with an RFID (Radio Frequency Identification) system to enable wireless communication with Infinity ID accessories. Any changes or modifications to the RFID system may only be carried out by experts. Otherwise this may compromise patient safety. This medical device has been designed and manufactured to comply with emission limit values for high-frequency energy. These limiting values are incorporated in international safety standards such as IEC 60601-1-2 (EN 60601-1-2) which have been defined by regulation authorities, such as the Federal Communications Commission (FCC Rules), Industry Canada (Radio Standards Specifications) and the European Telecommunications Standards Institute (ETSI standards).

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

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Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

Application

Application Intended use... 18 Indications for use and contraindications . . 18 Environment of use... 18

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

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Application

Intended use The Evita V500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of adults, pediatric patients and neonates. Evita V500 provides mandatory ventilation modes and ventilation modes for

supporting spontaneous breathing and also airway monitoring. The Evita V500 ventilation unit is used with Dräger Infinity C Series Medical Cockpits. The Evita V500 ventilation unit is intended for use in different medical care areas.

Indications for use and contraindications Indications The Evita V500 ventilation unit is used in combination with Dräger Infinity C Series Medical Cockpits. Evita V500 is used for treating patients who require temporary or longer term respiratory support for different medical reasons.

It is the responsibility of the user to select the appropriate respiratory mode for the underlying disease of the patient. For all ventilator settings, the user needs to consider the respiratory status and the general state of health of the patient in order to optimally adapt the ventilation settings to the patient's condition. Any changes to the patient's state need to be monitored continuously.

Contraindications There are no additional contraindications apart from the contraindications contained in chapter "For your safety and that of your patients".

Environment of use Evita V500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

–

In rooms without sufficient ventilation

Do not operate the device with helium or helium mixtures.

Do not use the device in the following environments: – In hyperbaric chambers – For magnetic resonance imaging (MRI, NMR, NMI) – In conjunction with flammable gases or flammable solutions that can mix with air, oxygen or nitrous oxide – In areas of explosion hazard – In areas with combustible or explosive substances 18

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

System overview

System overview Infinity Acute Care System – Workstation Critical Care... 20 How to use the Workstation Critical Care... 20 Evita V500 ventilation unit... 21 Front panel... Back panel... Left side view... Right side view...

21 22 22 23

Trolley 2-90 cm... 23 GS500 gas supply unit... 24 Back panel... 24 Range of functions... 25 Ventilation functions of Evita V500... 25 Monitoring... 26 Power supply... 26 Gas supply... 26 Data transfer... 26 Medication nebulizer... 26 Attaching accessories... 26 Abbreviations... 27 Symbols... 33

Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n

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System overview

Infinity Acute Care System – Workstation Critical Care How to use the Workstation Critical Care The Workstation Critical Care can consist of the following units: – Infinity C500 (Medical Cockpit) – Evita V500 (ventilation unit) – Trolley 2-90 cm (trolley) – GS500 (gas supply unit) – PS500 (power supply unit) – Transport Supply Unit (transport supply unit)

A

Before using the Workstation Critical Care, carefully read the following instructions for use: – Instructions for use for "Workstation Critical Care and Workstation Neonatal Care" – Instructions for use for "Infinity Medical Cockpits" – Instructions for use for "Evita Infinity V500" – Instructions for use for "Transport Supply Unit"

B

The Workstation Critical Care may include additional accessories, see separate list of accessories.

C D

001

E A Infinity C500 – Control and display unit (Medical Cockpit). Strictly follow the instructions for use for "Infinity Medical Cockpits". B Evita V500 – Ventilation unit C GS500 – Gas supply unit D PS500 – Power supply unit E Trolley 2-90 cm – Trolley

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Instructions for use Infinity Acute Care System – Evita Infinity V500 SW 2.n