Primus Infinity Empowered Instructions for Use Sw 4.5n

Typographical conventions 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. –

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

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, e.g. PEEP, Air, or Alarm Settings. The "greater than" symbol > indicates the navigation path in a dialog window, e.g. System Setup > Ventilation > Basic Settings. In this example,

System Setup represents the dialog window title, Ventilation represents a horizontally aligned tab, and Basic Settings a vertically aligned tab.

Screen reproductions The reproductions of screen content in the instructions for use can differ from the content actually shown on the screen.

Product name In these Instructions for Use, Primus IE, the abbreviated form of the device name, is used instead of the long form Primus Infinity Empowered.

Trademarks Registered trademarks –

DrägerService®

–

Drägersorb®

–

D-Vapor®

–

Infinity®

–

Spirolog®

–

SpiroLife®

–

Vapor®

–

WaterLock®

is a registered trademark of Chemische Fabrik DR. WEIGERT GmbH & Co. KG. Pending trademark applications VacuSmartTM is a pending trademark application of Dräger.

are registered trademarks of Dräger. –

Durasensor®

–

OxiMax®

are registered trademarks of Nellcor. – 2

Neodisher® Medizym Instructions for Use Primus Infinity Empowered SW 4.5n

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.

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

Service personnel

These target groups must have received instruction in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product.

Service personnel are persons who are responsible for the maintenance of the product.

The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target groups.

Service personnel must be trained in the maintenance of medical devices and install, reprocess, and maintain the product.

Experts

Users

Experts are persons who perform repair or complex maintenance work on the product.

Users are persons who use the product in accordance with its intended use.

Experts must have the necessary knowledge and experience with complex maintenance work on the product.

Abbreviations and symbols For explanations refer to sections Abbreviations and Symbols see page 29.

Instructions for Use Primus Infinity Empowered SW 4.5n

3

This page intentionally left blank

4

Instructions for Use Primus Infinity Empowered SW 4.5n

Contents

Contents For Your Safety and that of your Patients . .

7

General safety information... 8 Product-specific safety information... 11 Application... 15 Intended use... 16 Overview... 19 Components... 20 Ancillary functions... 28 Abbreviations... 29 Symbols... 31 Operating concept... 35 Screen ergonomics... 36 Keys with permanent functions (hard keys) . . . 37 Keys with variable functions (soft keys)... 38 Selecting and setting... 38 Color concept... 41 System LED indicators... 42 General information about Infinity ID functions... 43 Menu Structure Overview... 45 Assembly... 51 Before first use... 52 Information about transport within the clinic . . . 53 Accessory Weight Limits... 54 Primus Infinity Empowered as a wall/ceiling device (optional)... 55 Connecting the gas supply... 58 Connecting the anesthetic gas scavenging system AGS... 60 Connecting the endotracheal aspiration system (optional)... 61 Connecting the patient system... 62 Connecting the flexible arm for the manual breathing bag (optional)... 66 Park holder for vaporizer units (optional)... 67 Connecting the electrical connections... 68 Getting started... 71 Device check... 72 Instructions for Use Primus Infinity Empowered SW 4.5n

Self test... Emergency start...

81 86

Operation...

89

Starting Operation... 90 Setting fresh-gas concentrations... 93 Setting the Vapor... 95 Ventilation... 96 Using non-rebreathing systems... 112 Changing patients... 113 Alarms... 119 Alarm displays... 120 Alarm priorities and alarm signals... 121 Suppressing alarms... 122 Limit-based alarms activated in respective ventilation modes... 124 Enabling/disabling CO2 alarms... 125 HLM mode... 126 Enabling/disabling SpO2 alarms (optional) . . . 128 Displaying and setting alarm limits... 129 Monitoring... 133 Selecting the standard screen... 134 Monitoring mode... 135 Screen layout... 135 Displayed parameters... 136 Gas measurement... 138 Using the volumeter function... 141 Econometer (optional)... 142 Loops (optional)... 142 Mini trends (optional)... 143 Selecting the data screen... 145 Selecting the trend screen... 145 Selecting the logbook... 147 Using the timer function... 148 SpO2 measurement (optional)... 149 Configuration... 153 Configuring the default settings... 154 Basic settings and audible signals... 155 Parameters... 156 Interfaces/logbook... 157 5

Contents

Screen layout... 158 Setting alarm limits... 159 Ventilator and gas delivery... 161 System information... 164 Configuration during operation... 166 Setting the patient's age and weight during operation... 169 Fault – Cause – Remedy... 171 Power failure... 172 Gas failure... 173 Ventilator failure... 174 Fresh gas delivery failure... 175 Ventilator and fresh gas delivery failure... 175 Gas measurement failure... 176 Screen error... 176 User interface failure... 176 System failure... 177 Alarm messages... 178 Cleaning, Disinfection and Sterilization... 197 Disassembly... 198 Reprocessing Procedure... 205 Reprocessing List... 208 Assembly... 210 Maintenance... 217 Overview... 218 Inspection... 218 Preventive maintenance... 219 Repair... 222 Emptying or replacing the water trap... 222 Replacing the O2 sensor... 223 Disposal... 225 Disposal of the Medical Device... 226 Disposal of Non-Rechargeable Batteries... 226 Technical Data... 227 Technical Data... 228 EMC Declaration... 247 Index... 251

6

Instructions for Use Primus Infinity Empowered SW 4.5n

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 Accessories... 8 Not for use in areas of explosion hazard... 8 Connected devices... 9 Safe connection with other electrical equipment... 9 Safe networking of computers... 9 Patient safety... 9 Patient monitoring... 9 Information on Electromagnetic Compatibility... 10 Sterile accessories... 10 Installing accessories... 10 Only one copy of the Instructions for Use available... 11 Training... 11 Emission of Radio Frequency Energy... 11 Product-specific safety information... 11 Functional safety... 13

Instructions for Use Primus Infinity Empowered SW 4.5n

7

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 medical 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 16 and in conjunction with appropriate patient monitoring (see page 17). 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 professionals who possess the required qualifications due to their training and their experience. Repair of the medical device must also be performed by trained personnel with additional product-specific DrägerService training. Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. Dräger further recommends that only authentic Dräger repair parts are used for maintenance. If the above are not complied with, the correct functioning of the medical device may be compromised. See chapter "Maintenance".

Accessories WARNING Only the accessories indicated on the list of accessories 90 39 430 (1st edition or higher) 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.

Not for use in areas of explosion hazard WARNING This medical device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur. 8

Instructions for Use Primus Infinity Empowered SW 4.5n

For Your Safety and that of your Patients

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 any combination of devices, refer to and strictly comply with the Instructions for Use for all connected devices and device combinations.

–

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 Assembly Instructions and Instructions for Use.

Patient safety Safe connection with other electrical equipment WARNING Risk of electric shock Electrical connections to equipment not listed in these Instructions for Use must only be made when approved by each respective manufacturer.

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

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 professionals, and that certain inherent characteristics of the medical device are known to the user. 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 professionals who operate this medical device as well as references to the consequences of medical device misuse, and to potentially adverse effects in patients with different underlying diseases. Medical device modification or misuse can be dangerous. 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 patient´s condition.

Instructions for Use Primus Infinity Empowered SW 4.5n

9

For Your Safety and that of your Patients

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 selection the best level of patient monitoring lies solely with the user of the medical device.

Information on Electromagnetic Compatibility General information on electromagnetic compatibility (EMC) according to international EMC standard IEC60601-1-2: Medical electrical equipment is 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 247.

WARNING Risk of electric shock Connecting devices to the auxiliary outlets of the anesthesia machine can cause an increase in leakage current beyond permissible values if the protective conductor of a device fails. Check the leakage current when connecting devices to the auxiliary outlets. If connecting a device (or devices) increases the leakage current to a value which exceeds the permissible value, do not use the auxiliary outlets of the anesthesia machine: use a separate wall socket. The system must meet the requirements for medical electrical equipment in accordance to IEC/EN 60601-1-1 and IEC/EN 60601-1-2.

Portable and mobile RF communications equipment can affect medical electrical equipment.

Sterile accessories

WARNING

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 must not be reprocessed and resterilized. Reuse, reprocessing, or resterilization can lead to a failure of the medical device and cause injury to the patient.

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.

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 Assembly Instructions and Instructions for Use.

10

Instructions for Use Primus Infinity Empowered SW 4.5n

For Your Safety and that of your Patients

Only one copy of the Instructions for Use available CAUTION The medical devices are not available individually. Only one copy of the Instructions for Use is included in the clinical package and must therefore be kept in a location accessible for users.

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

Emission of Radio Frequency Energy For wireless communication with Infinity ID accessories, this medical device is equipped with an RFID (Radio Frequency Identification) system.

Any changes or modifications to the RFID system must be implemented by properly trained service personnel; otherwise patient safety may be negatively affected. This medical device was developed and produced in such a manner that the emission limits for radio frequency (RF) energy will not be exceeded. These limits are part of international safety standards, such as IEC 60601-1-2 (EN 60601-1-2), and have been defined by regulatory bodies such as the Federal Communications Commission (FCC Rules), Industry Canada (Radio Standards Specifications) and the European Telecommunications Standards Institute (ETSI Standards). The RFID system of this medical device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Product-specific safety information WARNING Risk due to barely audible alarms

WARNING Risk due to a noisy environment

The user must remain within the hearing range of the acoustic alarm signal. This permits quick recognition and handling of the alarm.

When operating in a noisy environment, the volume of the alarm signals must be adjusted to suit.

Adjust the volume of the alarm signal to the distance from the medical device.

Instructions for Use Primus Infinity Empowered SW 4.5n

Always set the volume of the alarm signal sufficiently high.

11

For Your Safety and that of your Patients

WARNING Risk of use error

CAUTION Risk of patient injury

Various potentially dangerous situations may occur which demand the attention of trained personnel.

An incorrect diagnosis or misinterpretation of measured values, or other parameters, may endanger the patient.

The workstation may only be used under the permanent supervision of qualified medical personnel so that assistance can be provided immediately in the event of any malfunctions.

Do not base therapy decisions on individual measured values or monitoring parameters only.

WARNING Risk of fire In order to prevent a fire hazard, explosive anesthetics, such as ether or cyclopropane, must not be used. WARNING Risk of device failure and/or danger to patient Magnetic fields may negatively influence the proper function of the anesthesia machine, thus endangering the patient. Primus IE must not be used with magnetic resonance imaging (MRT, NMR, NMI)! WARNING Risk of explosion, fire If an oxygen leak is suspected within or near the anesthesia machine, do not initiate operation. Disconnect all oxygen supplies and contact a trained service technician. WARNING Risk of fire

WARNING Risk of patient injury If ventilation of the patient is no longer assured due to an obvious fault in the equipment, the patient must immediately be ventilated with a separate emergency ventilator. Always keep a manual ventilator at hand. WARNING Risk of burns Conductive breathing hoses or face masks may cause burns during HF surgery. Do not use these types of hoses and masks in combination with HF surgery. CAUTION Risk of mechanical failure The shock and vibrations caused by transportation may lead to a mechanical failure. The application of a wall or ceiling mount is designated for buildings. Do not use the anesthesia machine for mobile facilities such as ambulances, helicopters or ships.

To prevent a fire hazard, drugs or other substances based on inflammable solvents, such as alcohol, must not be introduced into the patient system. Adequate ventilation must be ensured if highly inflammable substances are used for disinfection. 12

Instructions for Use Primus Infinity Empowered SW 4.5n

For Your Safety and that of your Patients

CAUTION Risk of physical injury To avoid physical injury, e.g. pinching, pay special attention to edges, moving parts and corners when working with drawers, the ventilator module, doors, the writing tray and/or swivel arms for mounted devices, as well as other accessories, such as gas cylinders, vaporizer units, CLIC absorbers and CLIC adapters. CAUTION Risk of device failure Compressed gas supply (central supply or cylinder): To avoid damaging the device(s) attached to a gas supply, use only medical gases. Pay particular attention to national and international standards regulating the use of medical gases.

Functional safety The essential performance features comprise: –

Delivery of medical gases enriched with anesthetic agents in adjustable concentrations and amounts

–

Patient ventilation with parameters and modes set by the user

–

Monitoring functions and alarm functions with settings selected by the user: –

minimum minute volume

–

maximum airway pressure

–

minimum and maximum O2 and anesthetic gas concentration in the breathing gas

The medical device is equipped with basic safety features to reduce the likelihood of patient injury until the cause of an alarm is remedied.

Instructions for Use Primus Infinity Empowered SW 4.5n

13

This page intentionally left blank

14

Instructions for Use Primus Infinity Empowered SW 4.5n

Application

Application Intended use... 16 Utilization... 16 Ventilation modes... 16 The following measured values are displayed... 16 The following parameters can be displayed as mini trends... 17 The following parameters are displayed as curves... 17 The following are displayed as bar graphs... 17 Monitoring... 17

Instructions for Use Primus Infinity Empowered SW 4.5n

15

Application

Intended use WARNING Risk of device failure and/ or danger to patient If the intended use of this anesthesia machine is not adhered to, it may fail and/or the patient may be endangered.

–

Spontaneous breathing (Spont.)

–

Pressure-assisted spontaneous breathing in Press. Support CPAP (optional)

–

Volume AF (Volume Mode AutoFlow) (optional). With activation of: Synchronization, Press. Support (Pressure support) (optional)

Use the anesthesia machine only as specified in the intended use of these Instructions for Use. Primus Infinity Empowered – Anesthesia Workstation for adults, children, and neonates with automatic and manual ventilation, as well as spontaneous breathing with or without pressure support.

The following measured values are displayed –

Peak pressure PEAK, mean pressure PMEAN, plateau pressure PLAT, and PEEP

–

Expiratory minute volume MV, difference between insp. and exp. minute volume MVLEAK,

–

patient compliance CPAT,

Utilization –

Inhalation anesthesia in rebreathing systems

–

Inhalation anesthesia in semi-closed to virtually closed systems with "low flow" and "minimal flow" techniques (for minimal gas and anesthetic agent consumption)

–

Inhalation anesthesia in non-rebreathing systems, with a separate fresh-gas outlet for connecting, e.g. a Bain system or Magill system, with a fresh-gas flow of 0.2 to 18 L/min (optional).

tidal volume VT, breathing rate freq. –

Inspiratory and expiratory concentration of O2, N2O, anesthetic gas, and CO2

–

ΔO2: difference between insp. and exp. O2 concentration

Optional:

Ventilation modes –

–

Functional oxygen saturation (SpO2) and pulse rate

Volume-controlled ventilation in Volume Mode. With activation of: Synchronization, Press. Support (Pressure support) (optional)

–

Pressure-controlled ventilation in Pressure Mode. With activation of: Synchronization, Press. Support (Pressure support) (optional)

– 16

Manual ventilation (Man.) Instructions for Use Primus Infinity Empowered SW 4.5n

Application

The following parameters can be displayed as mini trends* –

CO2 minute volume MV*CO2

–

O2 Uptake

–

PEEP, patient compliance CPAT

The following parameters are displayed as curves

Monitoring by means of adjustable alarm limits which can automatically be adapted to the momentary ventilation situation. With monitoring for –

Airway pressure PAW

–

Expiratory minute volume MV

–

Apnea

–

Inspiratory and expiratory anesthetic gas concentration

–

Airway pressure PAW

–

Inspiratory and expiratory flow

–

–

Inspiratory and expiratory concentration of O2, CO2, and anesthetic gas

Detection of anesthetic gas mixtures (simultaneous detection of up to two anesthetic agents)

–

Inspiratory O2 and N2O concentrations

Optional:

–

Inspiratory and expiratory CO2 concentrations

–

Plethysmogram

–

Special alarm response in HLM mode

–

PAW-V loops and V-Flow loops

–

Automatic agent alarm activation for multiples of MAC (xMAC)

The following are displayed as bar graphs –

Inspiratory, expiratory, and leakage tidal volume

–

Volumeter

–

Pressure

–

Econometer for indicating fresh-gas utilization (optional)

Optional: –

Oxygen saturation

–

Pulse rate

Trends showing the measured values over time and a logbook are also available.

*

optional

Instructions for Use Primus Infinity Empowered SW 4.5n

17

This page intentionally left blank

18

Instructions for Use Primus Infinity Empowered SW 4.5n

Overview

Overview Components... 20 Front... 20 Rear... 21 Gas inlets... 22 Screen with user interface... 23 Interface panel... 24 Flexible arm for manual breathing bag (optional)... 25 Auxiliary flowmeter and mechanical pressure gauge (optional)... 26 Gas flow diagram... 27 Ancillary functions... 28 Infinity ID wireless accessory detection system... 28 MEDIBUS/MEDIBUS.X Protocol... 28 Abbreviations... 29 List of abbreviations used in the software and on the device... 29 List of general abbreviations... 30 Units... 31 Symbols... 31

Instructions for Use Primus Infinity Empowered SW 4.5n

19

Overview

Components Front

V

A B C

U T S R Q

D E F G H I J

P

K L M N

001

O A B C D E F G H I J K 20

Lighting control (dimmer) Top shelf (for external monitors) Screen with user interface Rotary knob System power switch O2 emergency delivery Safety O2 O2 flush button O2+ Writing table Breathing system Release button for ventilator module Disposable absorber Drägersorb CLIC (or reusable absorber)

L M N O P Q R S T U V

Drawer Central brake Footrest Castors Endotracheal aspiration system (optional) Water trap with sample line connection Auxiliary oxygen flowmeter (optional) Mechanical pressure gauge (optional) Vapor units with Interlock system External fresh-gas outlet (optional) Auxiliary AC socket (for Desflurane vaporizer)

Instructions for Use Primus Infinity Empowered SW 4.5n