Primus Infinity Empowered Instructions for Use sw 4.5n Edition 4 Feb 2015

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. –

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.

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, e.g., PEEP, Air, or Alarm Settings.

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

The greater than symbol > is used in menu sequences. The main menu is indicated first, then the menu option for selection, and if applicable further submenus, e. g. System Setup > Ventilation > Basic Settings.

Trademarks Trademark

Trademark owner

DrägerService

Neodisher®

Dr. Weigert

Drägersorb®

Medizym

Trademark

Trademark owner ®

D-Vapor® Infinity® Spirolog®

Dräger

SpiroLife® Vapor® VacuSmart® WaterLock® Durasensor® OxiMax 2

™

Nellcor Covidien 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.

Instructions for use Primus Infinity Empowered SW 4.5n

3

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 Explanations are listed in chapter "Overview" in the sections "Abbreviations" and "Symbols".

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Instructions for use Primus Infinity Empowered SW 4.5n

Contents

Contents For your safety and that of your patients. . .

7

Getting started...

73

General safety information... 8 Product-specific safety information... 12

Device check... Self test... Emergency start...

74 84 89

Operation...

91

Application... 15 Intended use... 16 Indications and contraindications... 18 Further information on application... 18 Overview... 19 Components... Additional functions... Abbreviations... Symbols...

20 28 30 33

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 LED indicators of the device... 43 General information about Infinity ID functions... 44 Menu structure overview... 46 Assembly and preparation... 51 Before first use... 52 Information about transport within the clinic . . . 53 Accessory weight limits... 55 Primus Infinity Empowered as a wall/ceiling device (optional)... 57 Connecting the gas supply... 59 Connecting the anesthetic gas scavenging system AGS... 61 Connecting the endotracheal aspiration system (optional)... 62 Connecting the patient system... 63 Connecting the flexible arm for the breathing bag (optional)... 69 Park holder for vaporizer units (optional)... 69 Connecting the electrical connections... 70

Instructions for use Primus Infinity Empowered SW 4.5n

Operation... 92 Setting fresh-gas concentrations... 95 Setting the Vapor... 98 Ventilation... 99 Using non-rebreathing systems... 119 Changing patients... 121 Alarms... 127 Alarm displays... 128 Alarm priorities and alarm signals... 129 Suppressing alarms... 130 Limit-based alarms activated in respective ventilation modes... 132 Enabling/disabling CO2 alarms... 134 HLM mode... 135 Enabling/disabling SpO2 alarms (optional) . . . 136 Displaying and setting alarm limits... 137 Monitoring... 141 Selecting the standard screen... 142 Monitoring mode... 143 Screen layout... 143 Displayed parameters... 144 Gas measurement... 147 Using the volumeter function... 151 Econometer (optional)... 152 Loops (optional)... 153 Mini trends (optional)... 154 Selecting the data screen... 156 Selecting the trend screen... 157 Selecting the logbook... 159 Using the timer function... 160 SpO2 measurement (optional)... 160

5

Contents

Configuration... 165

Technical data... 247

Configuring the default settings... 166 Basic settings and audible signals... 167 Parameters... 168 Interfaces/logbook... 169 Screen layout... 170 Setting alarm limits... 171 Ventilator and gas delivery... 175 System information... 178 Configuration during operation... 180 Setting the patient's age and weight during operation... 183

Technical data... 248 EMC declaration... 271 Device combinations... 276 Connections to IT networks... 276 Index... 279

Remedying faults... 185 Power failure... 186 Gas failure... 187 Ventilator failure... 189 Fresh gas delivery failure... 190 Ventilator and fresh gas delivery failure... 191 Gas measurement failure... 192 Screen error... 192 User interface failure... 192 System failure... 193 Alarm – Cause – Remedy... 194 Cleaning, disinfection and sterilization... 215 Disassembly... 216 Reprocessing procedure... 224 Reprocessing list... 227 Assembly... 229 Before using on patients on again... 236 Maintenance... 237 Overview... 238 Inspection... 239 Preventive maintenance... 240 Repair... 242 Emptying or replacing the water trap... 243 Replacing the O2 sensor... 244 Disposal... 245 Disposing of the medical device... 246 Disposal of non-rechargeable batteries... 246

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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... 9 Connection with other electrical equipment . . . 9 Patient safety... 10 Patient monitoring... 10 Information on electromagnetic compatibility . . 10 Sterile accessories... 11 Storing the instructions for use... 11 Training... 11 Emission of Radio Frequency Energy... 11 Product-specific safety information... 12 Functional safety... 14

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 Risk of incorrect operation and of incorrect use 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 the information 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 Risk of medical device failure and of patient injury The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device must be performed by experts. If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Maintenance". Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. For maintenance Dräger recommends the use of authentic Dräger repair parts.

Accessories WARNING Risk due to incompatible accessories Dräger has tested only the compatibility of accessories listed in the current list of accessories. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure. Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories.

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Instructions for use Primus Infinity Empowered SW 4.5n

For your safety and that of your patients

NOTE Strictly observe the instructions for use of all accessories such as:

Connection with other electrical equipment

– – – – – – – – – – – –

WARNING Risk of electric shock or device malfunction

Water traps Flow sensors CLIC adapter CLIC absorber Soda lime Breathing hoses Masks Filters Endotracheal suction Vaporizer Manual resuscitator AGSS terminal unit

Not for use in areas of explosion hazard WARNING Risk of explosion and fire The medical device is not approved for use in areas where oxygen concentrations greater than 25 Vol%, or combustible or explosive gas mixtures are likely to occur.

Instructions for use Primus Infinity Empowered SW 4.5n

Any connected devices or device combinations not complying with the requirements mentioned in these instructions for use can compromise the correct functioning of the medical device and lead to an electric shock. – 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. – Before operating the medical device, strictly comply with the instructions for use of all connected devices or device combinations. For further information, see "Device combinations" on page 276.

9

For your safety and that of your patients

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. The instructions for use do not contain any information on the following points:

Information on electromagnetic compatibility General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2: 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 (see page 271).

–

Risks that are obvious to users

Portable and mobile radio frequency communication equipment can affect medical electrical equipment.

–

Consequences of obvious improper use of the medical device

WARNING Risk of electric shock

–

Potentially negative effects on patients with different underlying diseases

Do not connect connectors with an ESD warning symbol and do not touch their pins without implementing ESD protective measures. Such protective measures can include antistatic clothing and shoes, touching a potential equalization pin before and during connection of the pins, or using electrically insulating and antistatic gloves.

Medical device modification or misuse can be dangerous.

Patient monitoring The user of the medical device is responsible for choosing a suitable patient monitoring system that provides appropriate information on medical device performance and patient condition.

All users concerned must be instructed in these ESD protective measures.

Patient safety can be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to direct observation of clinical signs. The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.

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Instructions for use Primus Infinity Empowered SW 4.5n

For your safety and that of your patients

Storing the instructions for use

WARNING Risk of electric shock Connecting equipment to the auxiliary outlets on the anesthesia machine may result in increased leakage current. If the protective conductor on one of these devices fails, the leakage current may exceed the permissible values. 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 fulfill the requirements for medical electrical equipment in accordance with the relevant standards, see "Technical data", page 270.

Sterile accessories CAUTION Risk of medical device failure and of patient injury Do not use sterile-packaged accessories if the packaging has been opened, is damaged, or if 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.

Instructions for use Primus Infinity Empowered SW 4.5n

CAUTION Risk of incorrect use Instructions for use must be kept accessible to the user.

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 limit values are incorporated in 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 in this medical device complies with Part 15 of the FCC regulations and its operation is subject to the following 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.

11

For your safety and that of your patients

Product-specific safety information WARNING Risk of malfunctions

WARNING Risk of fire

Unapproved modifications to the medical device can cause malfunctions.

In order to prevent a fire hazard, explosive anesthetics, such as ether or cyclopropane, must not be used.

No modifications must be made to this medical device without the permission of Dräger. Dräger does not accept responsibility for modifications to the device made without the permission of Dräger. WARNING Risk due to barely audible alarms The user must remain within the hearing range of the acoustic alarm signal. This permits quick recognition and handling of the alarm. Adjust the volume of the alarm signal to the distance from the medical device. WARNING Risk due to a noisy environment When operating in a noisy environment, the volume of the alarm signals must be adjusted to suit. Always set the volume of the alarm signal sufficiently high. WARNING Risk of use error Various potentially dangerous situations may occur which demand the attention of trained personnel. 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.

12

WARNING Risk of device failure and/ or danger to patient Magnetic fields may negatively influence the proper function of the medical device, thus endangering the patient or user. The medical device must not be used in the vicinity of magnetic resonance imagers (MRI, 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 To prevent fire hazards, drugs or other substances based on inflammable solvents, such as alcohol, must not be introduced into the medical device, particularly into the breathing circuit and the breathing system. Adequate ventilation must be ensured if highly inflammable substances are used for disinfection.

Instructions for use Primus Infinity Empowered SW 4.5n

For your safety and that of your patients

CAUTION Risk of patient injury

CAUTION Risk of crushing

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

Movable parts and attached parts can lead to crushing injuries. Pay special attention to edges, movable parts, and corners when working with the following parts:

Do not base therapy decisions on individual measured values or monitoring parameters only. WARNING Risk of patient injury If ventilation of the patient is no longer ensured due to an obvious fault in the equipment, the patient must immediately be ventilated with a manual resuscitator. Always keep an emergency manual breathing bag at hand. WARNING Risk of burns Conductive breathing hoses or face masks may cause burns during HF surgery.

– – – – – –

Drawers Ventilator module Doors Writing table Swivel arms for mounted devices Accessories such as gas cylinders, vaporizers, 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.

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.

Instructions for use Primus Infinity Empowered SW 4.5n

13

For your safety and that of your patients

Functional safety The essential performance consists in: –

Supplying the anesthesia workstation with O2 If the O2 supply (central supply or gas cylinder) fails, an alarm is issued.

–

Supply of the patient with adequately oxygenated breathing gas If the breathing gas contains insufficient levels of O2, an alarm is issued.

–

Patients are not supplied with excessively high anesthetic gas concentrations If excessively high anesthetic gas concentrations are delivered, an alarm is issued.

–

Monitoring the airway pressure and the expiratory minute volume Alarms are issued depending on the set alarm limits.

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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 Indications and contraindications... 18 Indications... 18 Contraindications... 18 Further information on application... 18 Environment of use... 18

Instructions for use Primus Infinity Empowered SW 4.5n

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Application

Intended use Optional activation of: Synchronization, Press. Support (Pressure support) (optional)

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. 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.

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).

Optional: –

–

Manual ventilation (Man.)

–

Spontaneous breathing (Spont.)

–

Pressure-supported spontaneous breathing Press. Support CPAP (optional)

–

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

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, tidal volume VT, breathing rate freq.

–

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

–

∆O2: Difference between inspiratory and expiratory O2 concentration

Operation without nitrous oxide: The device may only be operated with O2 and air.

Optional:

Ventilation modes –

–

Functional oxygen saturation (SpO2) and pulse rate

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

–

16

Pressure-controlled ventilation in Pressure Mode

Instructions for use Primus Infinity Empowered SW 4.5n

Application

The following parameters can be displayed as mini trends* –

Minute volume CO2 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 behavior 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 tidal volume, expiratory tidal volume, 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

Application

Indications and contraindications

Indications

Contraindications

Primus Infinity Empowered is intended for inhalational anesthesia and/or patient ventilation in accordance with its intended use during surgical or diagnostic procedures.

For patients with suspected malignant hyperthermia: Do not use any volatile anesthetic agents or Primus Infinity Empowered with residual concentrations of these gases above 5 ppm. Do not perform long term low-flow anesthesia on patients with ketoacidosis or patients under the influence of alcohol. Otherwise, there is a risk of acetone accumulation in the patient.

Further information on application

Environment of use Primus is designed for use in areas in which therapeutic or diagnostic procedures can be performed. WARNING Risk of explosion and fire

Do not use Primus in the following environments: –

Outside buildings

–

On intensive care units

–

During patient transport

–

In vehicles, airplanes, or helicopters

The medical device is not approved for use in areas where oxygen concentrations greater than 25 Vol%, or combustible or explosive gas mixtures are likely to occur. WARNING Risk of device failure and/ or danger to patient Magnetic fields may negatively influence the proper function of the medical device, thus endangering the patient or user. The medical device must not be used in the vicinity of magnetic resonance imagers (MRI, NMR, NMI).

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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 breathing bag (optional)... 25 Auxiliary flowmeter and mechanical pressure gauge (optional)... 26 Gas flow diagram... 27 Additional functions... 28 Infinity ID wireless accessory detection system... 28 MEDIBUS/MEDIBUS.X Protocol... 28 Abbreviations... 30 List of abbreviations used in the software and on the device... 30 List of general abbreviations... 32 Units... 32 Symbols... 33

Instructions for use Primus Infinity Empowered SW 4.5n

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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 Button for O2 flush 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 flow tube (optional) Mechanical pressure gauge (optional) Vapor units with Interlock system Ext. fresh-gas outlet (optional) Auxiliary power outlet (for desflurane vaporizer)

Instructions for use Primus Infinity Empowered SW 4.5n