Zeus Infinity Empowered Instructions for Use Sw 2.n Edition 1 Feb 2015

Typographical conventions 1

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

l

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.

>

The "greater than" symbol indicates the navigation path in a dialog window. Bold italic text is used to identify labeling on the device and text displayed on the screen.

Screen reproductions The illustrations of products and screen contents may, depending on configuration and equipment, differ from the actual products.

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. The product "Zeus Infinity Empowered" is also referred to as "Zeus IE".

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Instructions for use Zeus Infinity Empowered SW 2.n

Trademarks Trademark

Trademark owner

AutoFlow®

Trademark

Trademark owner

Nellcor®

Zeus®

Covidian

Nellcor OxiMax

Drägersorb® 800 Plus

IVDock™

® Free

Drägersorb

Trident™

Forta®

Dräger Fill™

SpiroLife®

®

Dräger

Dräger

DrägerService®

Bispectral Index™

Aspect Medical Systems Inc.

VacuSmart®

Saf-T-Fill™

Baxter

Infinity®

Incidin Extra N®

Quik Fil®

Abbott Laboratories

®

Masimo

Masimo SET®

BIS™

Buraton 10F

®

Gigasept FF

®

Ecolab Schülke & Mayr

Masimo Corporation

Signal Extraction Technology (SET)®

Definition WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

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.

Instructions for use Zeus Infinity Empowered SW 2.n

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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 sections "Abbreviations" and "Symbols".

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Instructions for use Zeus Infinity Empowered SW 2.n

Contents

Contents Trademarks...

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For your safety and that of your patients. . .

9

General safety information... 10 Product-specific safety information... 15 Application... 19 Intended use... 20 Data exchange, ports... 22 Overview... 23 Components... Abbreviations... Symbols... Product labels...

24 33 38 40

Operating concept... 41 Screen... 42 Screen layout... 44 Using the touch screen... 47 Color concept... 48 Overview of the menu structure... 49 Assembly and preparation... 57 Before initial use... 58 Zeus IE as a ceiling device... 59 Establishing the mains power supply... 60 Establishing the gas supply... 63 Connecting anesthetic gas receiving system (AGS)... 65 Replacing or filling the CO2 absorber... 66 Connecting hoses... 69 Preparing optional patient monitoring... 72 Connecting IV system... 73 DIVA metering modules for anesthetic agents... 74 DIVA metering module with Dräger Fill filling system... 77 DIVA metering module with safety filling device... 80 Quik Fil sevoflurane safety filling system... 84 Filling system for desflurane... 87

Instructions for use Zeus Infinity Empowered SW 2.n

Startup...

89

Device check... 90 Switching on Zeus IE... 94 Checklist... 95 Self test... 96 Automatic self test (Auto self test)... 99 Pretest... 100 Displaying the test results... 101 Displaying the test results during operation . . 104 Startup in emergencies... 105 Operation... 107 Start settings... 108 Changing patient data... 112 Integrated SmartPilot View (optional)... 114 Gas delivery... 115 Ventilation... 122 Web access (optional)... 138 IV system – IVenus... 140 End of operation... 156 Alarms... 159 Alarm behaviour at power on... 160 Display alarms... 160 Alarm info... 161 Alarm log... 161 Alarm limits... 162 Suspending alarms... 166 Alarm recorder (optional with hemodynamic and Infinity network)... 167 All limits... 168 Autoset limits... 172 Suppressing the alarm tone... 177 Set ranges of the patient monitoring alarm limits... 179 Trends and diagnosis windows... 184 Monitoring... 187 Overview of the monitoring... 188 Device monitoring... 189 Patient monitoring... 197

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Contents

Fault – Cause – Remedy... 249

Technical data... 395

Failure behavior... 250 Power outage... 250 Gas failure... 251 Ventilator failure... 252 Anesthetic gas delivery failure (DIVA failure) . . 252 Mixer and DIVA failure... 252 Rotary safety knob Anesth. Ventilator Off for ventilation... 253 In the event of partial system failures... 253 In the event of device failure... 254 Failure behavior DPS... 255 Messages Zeus IE... 255 Metering module faults... 317

General information... 396 Identification... 397 Classification... 397 Latex-free... 398 Penetration values of IBF filter... 398 Screen... 398 Power supply... 399 Ambient conditions... 400 Alarm tone sequence IEC... 400 Central gas supply... 401 Gas delivery, control mode FG ctrl... 404 Gas delivery, control mode Auto control... 404 Ventilation... 405 Breathing system... 407 Fresh-gas outlet for non-rebreathing system (optional)... 408 Airway resistances... 408 Measuring system... 409 O2-, CO2 and anesthetic gas measurement . . 411 Anesthetic gas measurement (infrared spectroscopy)... 412 Anesthetic gas metering modules... 413 Data communication... 413 General safety standards for anesthesia workstations... 414 Modules for patient monitoring... 416 Hemodynamic modules... 416 Trident Pod (NMT)... 417 BISx pod... 418 Monitoring specifications... 418 ECG... 418 Non-invasive blood pressure measurement (NIBP)... 420 Invasive blood pressure (IBP)... 422 Wedge measurement... 422 Cardiac output (C.O.)... 423 Pulse oximetry (SpO2)... 423 Temperature... 426 Neuromuscular Transmission Monitoring NMT... 426 Anesthesia depth monitoring BIS... 428 Essential performance... 429 EMC Declaration... 430 Device combinations... 435 Connections to IT networks... 436

Configuration... 321 Configuration information... 322 System setup... 323 Configuring the screen... 329 Configuring basic settings... 335 Other functions of the system... 353 Service functions... 356 Cleaning, disinfection, and sterilization... 357 Disassembly... 358 Dismantling components... 360 Reprocessing methods... 367 Reprocessing list... 371 Care instructions for monitoring accessories . . 376 Assembly... 378 Maintenance... 383 Overview... 384 Inspection... 385 Preventive maintenance... 387 Repair... 389 Disposal... 391 Disposal of the medical device... 392 Disposing of accessories... 392 Disposal of non-rechargeable batteries... 393

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Instructions for use Zeus Infinity Empowered SW 2.n

Contents

Description... 439 Gas flow diagram... 440 Gas control loops... 441 Ventilation... 446 Ventilation modes... 446 Appendix... 451 Index... 455

Instructions for use Zeus Infinity Empowered SW 2.n

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Instructions for use Zeus Infinity Empowered SW 2.n

For your safety and that of your patients

For your safety and that of your patients General safety information... 10 Strictly follow these instructions for use... 10 Maintenance... 10 Safety checks... 10 Metrological checks*... 10 Accessories... 11 Connected devices... 11 Not for use in areas of explosion hazard... 12 Safe connection with other electrical equipment... 12 Patient safety... 12 Patient monitoring... 12 Information on electromagnetic compatibility . . 13 Sterile accessories... 13 Installing accessories... 14 Storing the instructions for use... 14 Training... 14 Product-specific safety information... 15

Instructions for use Zeus Infinity Empowered 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.

Maintenance WARNING Risk of medical device failure and 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.

Strictly follow these instructions for use WARNING Risk of incorrect operation and of incorrect use

If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Maintenance".

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 20 and in conjunction with appropriate patient monitoring (see page 12).

Dräger recommends DrägerService for a service contract and for repairs. Dräger also recommends using original Dräger parts for maintenance.

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.

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

Metrological checks* The medical device must undergo regular metrological checks. See chapter "Maintenance".

*

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Only applies in the Federal Republic of Germany

Instructions for use Zeus Infinity Empowered SW 2.n

For your safety and that of your patients

Accessories

Connected devices

WARNING Risk due to incompatible accessories

WARNING Risk of electric shock and device malfunction

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.

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. Before using the medical device, refer to and strictly comply with the instructions for use of all connected devices and device combinations.

Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories. WARNING Risk of operating errors and incorrect use Strictly observe the instructions for use of all accessory parts, e.g.: – Water traps – Flow sensors – CLIC adapter – CLIC absorber – Soda lime – Breathing hoses – Masks – Filter – Endotracheal suction – Vaporizer – Manual resuscitator – AGSS terminal unit

Instructions for use Zeus Infinity Empowered SW 2.n

WARNING Risk of device malfunction The medical device may be operated in combination with other Dräger devices or with devices from third party manufacturers. If a device combination is not approved by Dräger, the safety and the functionality 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. – Strictly observe assembly instructions and instructions for use for each networked device.

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For your safety and that of your patients

Not for use in areas of explosion hazard

Patient monitoring

WARNING Risk of explosion and fire

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.

This medical device is neither approved nor certified for use in areas where oxygen concentrations greater than 25 Vol.% or combustible or explosive gas mixtures are likely to occur.

Safe connection with other electrical equipment

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.

CAUTION Risk of patient injury Connections to electrical devices not listed in these instructions for use may only be made when approved by each respective device manufacturer.

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 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: –

Dangers that are obvious to the user

–

Consequences of obvious improper use of the medical device

–

Possible negative impacts on patients with various underlying diseases

Medical device modification or misuse can be dangerous. 12

Instructions for use Zeus Infinity Empowered SW 2.n

For your safety and that of your patients

Information on electromagnetic compatibility

WARNING Risk of electric shock

General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2:

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

The connection of devices to auxiliary power sockets can lead to an increased leakage current. If the protective ground of one of these devices fails, the leakage current may rise above the permissible values. – Only connect with the approval of the respective device manufacturer. – Have the leakage current checked by service personnel. – If the permissible value is exceeded, use a mains power socket on a wall instead of the auxiliary power socket of the device.

WARNING Risk of electric shock

Sterile accessories

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 provided EMC information (see page 430).

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 equilization pin before and during connection of the pins, or using electrically insulating and antistatic gloves. All relevant users must be instructed in these ESD protective measures.

CAUTION Risk of medical device failure and patient injury Do not use accessories in sterile packaging if the packaging has been opened, damaged, or if there are other signs that the accessories are not sterile. Reuse, reprocessing, and sterilization of disposable products is not permitted.

WARNING Risk of device failure Electromagnetic fields can compromise proper operation of the device. Electromagnetic fields are generated by, e.g., radio frequency communication equipment such as: – Mobile phones – Radio frequency electrosurgical equipment – Defibrillators – Shortwave therapy equipment Use radio frequency equipment only with a sufficient safety clearance of at least 20 cm (7.9 in).

Instructions for use Zeus Infinity Empowered SW 2.n

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For your safety and that of your patients

Installing accessories CAUTION Risk of device failure Install the accessory on the basic device in accordance with the instructions of the basic device. Check for secure connection to the basic device. Strictly observe the instructions for use and assembly instructions.

Storing the instructions for use CAUTION Risk of operating errors 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.

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Instructions for use Zeus Infinity Empowered SW 2.n

For your safety and that of your patients

Product-specific safety information WARNING Risk of misinterpretation

WARNING Risk of not hearing the alarm tone

Misdiagnosis or misinterpretation of the measured values or other parameters may endanger the patient.

Dräger recommends the user to remain in the vicinity of the anesthesia machine, i.e. within a distance of up to 4 meters (12 ft). This facilitates fast recognition and response in the event of an alarm.

Do not make therapeutic decisions based solely on individual measured values and monitoring parameters. Therapeutic decisions must be made solely by the user. WARNING Risk of malfunction Unallowed modifications to the medical device lead to malfunctions. This medical device may not be modified without permission from Dräger. WARNING Risk of malfunction Device failure or user errors may compromise the correct functioning of the device. The medical device does not react automatically to certain changes in the patient condition, operating errors, or failure of components.

WARNING Risk of insufficient ventilation Device failure or operating errors can lead to ventilation failure. – To ensure immediate remedial action in case of device failure, the device may only be operated under permanent supervision of users. – The general safety standards for anesthesia systems require that a manual resuscitator be kept at the ready for emergency ventilation.

WARNING Risk of burns Do not use humidifiers or heated hoses!

Continuously monitor the medical device so that corrective measures can be initiated immediately. WARNING Risk of device failures The device may fail if the power supply is interrupted. Always connect the device on an uninterruptible power supply.

Instructions for use Zeus Infinity Empowered SW 2.n

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For your safety and that of your patients

WARNING Risk of fire

WARNING Risk of burns

The flow sensor may ignite medications or other substances that are easily flammable. – 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. – Do not use cyclopropane or ether.

Conductive breathing hoses or face masks may cause burns during HF surgery.

WARNING Risk due to flow measurement failure Deposits which are not removed during reprocessing may damage the measuring wires in the flow sensor or cause 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. WARNING Risk of strangulation Make connection to the patient carefully. WARNING Zeus IE must not be used with magnetic resonance imaging (MRI, NMR, NMI). Device operation may be affected, thus placing the patient at risk. WARNING Device contamination possible Only operate Zeus IE with airway filters.

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Do not use this type of hose and mask combined with HF surgery. WARNING Risk of patient injury When using near-patient filters do not scavenge at the patient end! In the event of stenosis or increased filter resistance the patient may be injured by vacuum. WARNING Risk of equipment malfunction Only have network functions configured by authorized, trained personnel. Errors in configuration can impair operation of the device and the network. WARNING Risk of patient injury The following operating states are prohibited when the patient is connected: – Standby – Self test – Leak test – Leakage assistant – Pretest – Service mode No monitoring is possible in these operating states. During the test, pressures and concentrations may occur in the system which are hazardous to the patient!

Instructions for use Zeus Infinity Empowered SW 2.n

For your safety and that of your patients

CAUTION Risk of crushing

CAUTION Risk of tipping over during transport

Movable device parts or attached components may cause crushing due to clamping. Pay special attention to edges, movable parts, and corners when working with the following components: – Column cover – Breathing system cover – Drawers – Extensible writing tray – Swivel arms for mounted devices – Accessories such as gas cylinders, vaporizers, CLIC absorber, and CLIC adapter

The medical device may tip over if handled incorrectly. Observe the following points when transporting medical devices: – The medical device may only be moved by people who have the physical ability to do so. – To improve the maneuverability, transport the device with 2 persons. – When transporting over inclines, around corners, or over thresholds (e.g., through doors or in elevators), make sure that the medical device does not bump against anything. – Clear the writing tray and fold it down completely or slide it into the device. – Do not pull the medical device over hoses, cables, or other obstacles lying on the floor. – Do not activate the brake while the medical device is being moved. – Use only the handles provided to push or pull the device.

CAUTION Risk of crushing If the writing tray is not correctly locked in place, objects can fall down or fingers and breathing hoses, for example, can be pinched. Make sure that the writing tray is correctly locked when folding down or sliding into the device.

CAUTION Health risk Operate Zeus IE with connected anesthetic gas scavenging system (AGSS) only. CAUTION Do not use silicone spray! Silicone spray may cause breathing system valves to stick. CAUTION Do not use DIVA metering modules which have been dropped or damaged. Any damage may result in faulty metering.

Instructions for use Zeus Infinity Empowered SW 2.n

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For your safety and that of your patients

CAUTION Risk of tipping over When transporting the device and all the hinged arms are swung inward to the center of the device and locked, make sure that the slope of the floor does not exceed ±10°. If the transport position is not maintained, the maximum slope of the floor is reduced to ±5°. NOTE Do not cover or close off the vents on the device. Make sure there is an adequate supply of air. Otherwise, the device may overheat. NOTE Risk of injury Handle the DIVA metering module with care and prevent it from tilting and falling down. NOTE Operate in sufficiently ventilated rooms or the CO2 measurement may otherwise be impaired. NOTE The ambient conditions specified in the Technical Data must be observed during operation and storage of the device. NOTE There may be a restriction of ambient conditions owing to mounted accessories or specifications issued by the anesthetic agent manufacturer. NOTE In a closed system, foreign gases can accumulate in the breathing gas with longer surgery times, e.g., by decomposition of the breathing gas. Increased concentrations of foreign gases can be prevented by regularly flushing the breathing system.

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Instructions for use Zeus Infinity Empowered SW 2.n

Application

Application Intended use... 20 Application... 20 Ventilation modes... 20 Device monitoring... 20 Patient monitoring (optional)... 21 Monitoring... 21 Gas supply... 22 Gas disposal... 22 Breathing system... 22 Data exchange, ports... 22

Instructions for use Zeus Infinity Empowered SW 2.n

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Application

Intended use Zeus IE enables all forms of general anesthesia (inhalation anesthesia, balanced anesthesia and total intravenous anesthesia) and regional anesthesia, as well as the monitoring of regional anesthesia.

Ventilation modes

Anesthesia is conducted with automatic ventilation, manual ventilation or spontaneous breathing with an oxygen ratio of at least 25 %, using a mixture of Air (medical compressed air) or nitrous oxide with pure oxygen and additional delivery of volatile anesthetic agents and/or intravenous drugs.

Volume-controlled ventilation with decelerating inspiratory flow Volume Control AutoFlow; synchronization of Sync.(VC) and Pressure Support breaths if required.

Application The Anesthesia workstation system Zeus IE is designed for use in medical rooms, operating rooms and induction and recovery rooms. Applications range from adults to pediatric patients and neonates. Ventilation is accomplished on the patient through a laryngeal mask, a mask, or an endotracheal tube. The breathing system can be used either with partial rebreathing (low flow or minimal flow) or with complete rebreathing (closed system). Non-rebreathing system with external fresh-gas outlet, for manual ventilation for connection to Bain or Magill system for example (optional). Zeus IE is equipped with modules for drug metering, for patient and device monitoring and for ventilation.

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Volume-controlled ventilation at constant inspiration flow Volume Control

Pressure-controlled ventilation Pressure Control; synchronization of Sync.(PC) and Pressure Support breaths if required. Pressure-supported ventilation at constant positive airway pressure Pressure Support Manual ventilation/spontaneous breathing with and without CPAP MAN/SPON

Device monitoring The following are displayed as measured values: – – – – – – – – – – –

Airway pressure PIP Airway pressure Plat Airway pressure PEEP Airway pressure Mean Minute volume MV Tidal volume VT Respiratory rate RR CO2, inspiratory and expiratory O2, inspiratory and expiratory N2O, inspiratory and expiratory Anesthetic agent concentration, inspiratory and expiratory

Instructions for use Zeus Infinity Empowered SW 2.n