Zeus Infinity Empowered Instructions for Use Sw 1.n Edition 2 Sept 2010

Working with these Instructions for Use The title of the main chapter in the header line helps to orient and navigate quickly. The Instructions for Use in a combination of text and pictures provide the user with a comprehensive overview of the system. The information is presented as action steps which the user can implement directly on the device. The text gives explanations and guides the user unambiguously with brief instructions in an ergonomic sequence to the benefits of the product. 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 parentheses refer to elements in the related illustration.

The illustrations establish the relationship between text and device. Elements mentioned in the text are highlighted; unimportant details are dispensed with. Schematic screen displays guide the user and confirm the action steps. Schematic renderings of screen images are used, which may differ in appearance or in configuration from the actual screen images. A Letters identify elements referred to in the text.

Typographical Conventions Any text appearing on the screen and any labeling on the device are printed in bold and italics, for example, PEEP, or MixGas settings. The "greater than" symbol > indicates the navigation path in a dialog window, for example, Screen setup > Screen layout > General. In this example, Screen setup represents the dialog window title, Screen layout represents a horizontally aligned tab, and General a vertically aligned tab. These Instructions for Use apply to the Zeus Infinity Empowered In these Instructions for Use, only the term "Zeus IE" is used.

Trademarks – – – – – – – – 2

AutoFlow® Drägersorb® 800 Plus Drägersorb® Free Forta® SpiroLife® VacuSmart® Zeus® Infinity®

are registered trademarksof Dräger. – – –

IVDock™ Trident™ Dräger Fill™

are protected trademarks of Dräger. –

BIS™

Instructions for Use Zeus Infinity Empowered SW 1.n

–

Bispectral Index ™

are protected trademarks of Aspect Medical Systems Inc. –

Quik Fil®

is a registered trademark of Abbott Laboratories. –

Masimo®

–

Masimo SET®

–

Signal Extraction Technology (SET)®

are registered trademarks of Masimo Corporation. –

Nellcor®

–

Nellcor OxiMax

registered trademarks of Covidian. Saf-T-Fill™ is a protected trademark of Baxter.

Definition

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 of the medical device.

Abbreviations and Symbols Explanations can be found in the chapters "Abbreviations" on page 27 and "Symbols" on page 32.

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Contents

Contents For Your Safety and that of Your Patients . .

7

Application... 15

Self test... 81 Automatic self test (Auto self test)... 84 Pretest... 84 Displaying the test results... 85 Displaying the test results during operation . . 88 Starting in emergencies... 89

System overview... 19

Operation...

Components... 20 Abbreviations... 27 Symbols... 32

Start settings... 92 Changing patient data... 94 Gas delivery... 97 Ventilation... 102 Web access (optional)... 115 IV system – IVenus... 116 End of operation... 130

General Safety Information... 10 Delivery form and processing to make it ready for use... 13

Operating concept... 35 Screen... 36 Screen layout... 37 Using the touch screen... 39 Color concept... 40 Overview of the menu structure... 41 Preparation... 49 Before initial use... 50 Zeus IE as ceiling unit... 51 Establishing electrical connections... 51 Establishing the gas supply... 53 Connecting anesthetic gas receiving system (AGS)... 54 Replacing or filling the CO2 absorber... 55 Connecting hoses... 57 Preparing optional patient monitoring... 60 Connecting IV system... 61 DIVA metering modules for anesthetic agents... 62 DIVA metering module with Dräger Fill filling system... 65 DIVA metering module with safety filling device... 67 Sevoflurane safety filling system Quik Fil... 71 Filling system for desflurane... 73

91

Alarms... 133 Alarm behaviour at power on... 134 Display alarms... 134 Alarm info... 135 Alarm log... 135 Alarm limits... 136 Suspending alarms... 139 Alarm recorder (optional with hemodynamic and Infinity network)... 140 All limits... 141 Autoset limits... 145 Suppressing the alarm tone... 148 Set ranges of the patient monitoring alarm limits... 150 Trends and diagnosis windows... 154 Monitoring... 157 Overview of the monitoring... 158 Device monitoring... 159 Patient monitoring... 165 Fault - Cause - Remedy... 213

Device check... 76 Switching on Zeus IE... 79 Checklist... 80

Failure behavior... 214 Power outage... 214 Gas supply failure... 215 Ventilator failure... 215 Anesthetic gas delivery failure (DIVA failure) . 216

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Startup... 75

Contents

Mixer and DIVA failure... 216 Rotary safety knob Anaesth. Ventilator Emerg. Off for ventilation... 216 In the event of partial system failures... 217 In the event of device failure... 218 Failure behavior DPS... 218 Messages Zeus IE... 218 Metering module faults... 274 Configuration... 279 Configuration information... 280 System setup... 281 Configuring the screen... 287 Configuring basic settings... 291 Other functions of the system... 306 Service functions... 308 Cleaning, disinfection, and sterilization... 309 Safety information on reprocessing... 310 Hygiene precautions... 310 Care instructions for monitoring accessories . . 315 Dismantling components... 317 Care list... 323 Assembly... 325 Maintenance... 329 Overview... 330 Inspection... 331 Maintenance... 332 Repair... 334 Disposal... 335

Gas delivery, control mode Auto control... 346 Ventilation... 347 Breathing system... 349 Fresh-gas outlet for non-rebreathing system (optional)... 349 Airway resistances... 350 Measuring system... 350 O2-, CO2 and anesthetic gas measurement . . 352 Anesthetic gas measurement (infrared spectroscopy)... 353 Anesthetic gas metering modules... 354 Data communication... 354 Relevant standards... 355 Modules for patient monitoring... 356 Hemodynamic modules... 356 Trident Pod (NMT)... 357 BISx pod... 358 Monitoring specifications... 359 ECG... 359 Non-invasive blood pressure measurement (NIBP)... 360 Invasive blood pressure (IBP)... 362 Wedge measurement... 363 Cardiac output (C.O.)... 363 Pulse oximetry (SpO2)... 363 Temperature... 366 Neuromuscular Transmission Monitoring NMT... 366 Anesthesia depth monitoring BIS... 368 EMC declaration... 369 Description... 373

Safety Information... 336 Disposing of batteries... 336 Disposing of disposable articles... 336 Disposal of the Medical Device... 337

Gas flow diagram... 374 Gas control loops... 375 Ventilation... 380 Ventilation modes... 380 Appendix... 385

Technical Data... 339

Index... 389

Identification... 340 Classification... 340 Latex-free... 341 Penetration values of IBF filter... 341 Screen... 341 Power supply... 341 Ambient conditions... 342 Central gas supply... 343 Gas delivery, control mode FG ctrl... 345 6

Instructions for Use Zeus Infinity Empowered SW 1.n

For Your Safety and that of Your Patients

For Your Safety and that of Your Patients Strictly follow these Instructions for Use... 8 Maintenance... 8 Safety inspections... 8 Metrological controls*... 8 Accessories... 8 Connected devices... 8 Not for use in areas of explosion hazard... 9 Safe connection with other electrical equipment... 9 Networking... 9 Patient safety... 9 Patient monitoring... 9 Essential performance... 10 General Safety Information... 10 Note on the EMC/ESD hazard to device function... 10 Sterile-packaged accessories... 12 Alternative monitoring... 13 Delivery form and processing to make it ready for use... 13

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For Your Safety and that of Your Patients

Strictly follow these Instructions for Use

Metrological controls*

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 9). Strictly observe all WARNING and CAUTION statements throughout these Instructions for Use and all statements on medical device labels.

Subject the medical device to regular metrological controls in accordance with the German Medical Devices Operator Ordinance (MPBetreibV) (see "Inspection" on page 331).

Maintenance WARNING The medical device must be inspected and serviced regularly by trained personnel. Repair of the medical device may also only be carried out by trained personnel. Dräger recommends that a service contract be obtained with DrägerService and that all repairs also be carried out by them. Dräger recommends that only authentic Dräger repair parts be used for maintenance and that the Remote Service be used. Otherwise, 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 52 018 (1st edition or later) have been tested and approved for use with the medical device. Therefore, it is strongly recommended that the medical device is only used in conjunction with the corresponding accessories. Otherwise, the correct functioning of the medical device may be compromised.

Connected devices WARNING Any connected devices or device combinations not complying with the requirements mentioned in these Instructions for Use may compromise the proper functioning of the medical device. Before starting the medical device, read the respective documentation and the Instructions for Use for all connected devices or device combinations.

Safety inspections* Subject the medical device to regular safety inspections in accordance with the German Medical Devices Operator Ordinance (MPBetreibV) (see "Inspection" on page 331).

*

8

Only applies in the Federal Republic of Germany

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For Your Safety and that of Your Patients

Not for use in areas of explosion hazard WARNING The medical device is not approved for use in areas of explosion hazard.

Safe connection with other electrical equipment CAUTION Risk of patient injury Electrical connections to equipment not listed in these Instructions for Use may only be made after consultation with each respective manufacturer.

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

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

–

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

–

–

IEC 60601-1-2 (EN 60601-1-2) Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility; Requirements and tests IEC 60601-1-4 (EN 60601-1-4) Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems

If Dräger devices or units are connected to other Dräger devices or third-party devices and the resulting combination is not approved by Dräger, Instructions for Use Zeus Infinity Empowered SW 1.n

the correct functioning of the devices may be compromised. The owner is responsible for ensuring that the resulting system meets the requirements of the above-mentioned standards. Strictly observe the Assembly Instructions and Instructions for Use for each networked 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 trained professionals, and that certain inherent characteristics of the medical device are known to the trained user. Instructions for use 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 a medical professional who operates this medical device nor references to the consequences of medical device misuse, and to potentially adverse effects in patients with different underlying diseases. Modification or misuse of the medical device 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 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. 9

For Your Safety and that of Your Patients

The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.

Essential performance The essential performance consists of –

controlled and monitored patient ventilation

–

and anesthetic agent delivery

with user-defined settings for the monitoring functions:

–

minimum breathing gas flow

–

maximum airway pressure

–

minimum and maximum O2 concentration in the breathing gas,

–

minimum and maximum anesthetic agent concentration in the breathing gas

or –

if a set limit is exceeded, by an appropriate alarm.

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

General 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. WARNING Only use the Zeus IE anesthesia workstation with constant supervision by qualified medical personnel in order to intervene immediately in the event of a malfunction.

Note on the EMC/ESD hazard to device function General information on the electromagnetic compatibility EMC/ESD declaration according to the international EMC standard IEC 60601-1-2:

installed and put into operation in accordance with the EMC information provided in the technical documentation, see page 369. Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING Pins of connectors carrying an ESD warning symbol (electrostatic discharge) must not be touched or connections made between these connectors without ESD protective measures being applied. 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 should be instructed in these ESD protective measures.

Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be

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For Your Safety and that of Your Patients

WARNING Danger of electric shock to user and patient. Connection of devices to the auxiliary sockets of the anesthesia device can cause an increase in the patient discharge current beyond the permissible value if the protective conductor of a device fails. Therefore, check the entire discharge current when connecting. When the permissible values for the entire discharge current are exceeded, devices must not be connected to the auxiliary sockets of the anesthesia device, but to a separate wall socket. The system must meet the requirements for medical electrical equipment according to the IEC/EN 60601-1-1 and IEC/EN 60601-1-2 standards. WARNING Risk of burns. Do not use humidifiers or heated hoses! WARNING Fire hazard. Drugs or other substances based on combustible solvents such as alcohol must not be introduced to the patient system. WARNING Risk of strangulation.

Portable and mobile HF communication equipment can influence medical devices! Only device combinations released according to Medical Devices Directive 93/42/EEC may be used. WARNING Device contamination possible. Only operate Zeus IE with airway filters. WARNING Risk of burns when using HF surgery equipment. Do not use antistatic or conductive breathing hoses. 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.

Make connection to the patient carefully. WARNING Fire hazard. Do not use any explosive anesthetic agents such as ether or cyclopropane. WARNING Zeus IE must not be used with magnetic resonance imaging (MRT, NMR, NMI)! Device operation may be affected, thus placing the patient at risk. Instructions for Use Zeus Infinity Empowered SW 1.n

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For Your Safety and that of Your Patients

WARNING Risk of patient injury

NOTE Risk of injury.

The following operating states are prohibited when the patient is connected: – Standby – Self test – Leak test – Leakage assistant – Pretest – Service mode.

Handle the DIVA metering module with care and prevent it from tilting and falling down.

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! CAUTION Health risk. Operate Zeus IE with connected anesthetic gas scavenging system (AGSS) only. CAUTION Do not use silicone spray! Silicone spray can cause breathing system valves to stick. CAUTION Do not use DIVA metering modules which have been dropped or damaged. Any damage can result in faulty metering. 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, ensure that the slope of the floor does not exceed ±10°. If the transport position is not observed, the maximum slope of the floor is reduced to ±5°.

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.

Sterile-packaged accessories CAUTION Do not use sterile-packaged accessories if the packaging has been opened, is damaged or there are other signs of non-sterility. Single-use articles must not be reprocessed and resterilized. Reuse, reprocessing, or sterilization may lead to failure of the medical devices and injury to the patient.

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. 12

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For Your Safety and that of Your Patients

Alternative monitoring In the event of a failure of individual monitoring functions, appropriate alternative monitoring must be provided. Patient monitoring (ECG, SpO2, etc.) must be used according to the customary recommendations in the particular country.

CAUTION Risk of patient injury Individual measuring and trend values may be evaluated only in the context of other measuring and metering parameters. Otherwise, artefacts and erroneous measuring and trend values for an individual parameter could lead to a false diagnosis when assessing the patient.

Delivery form and processing to make it ready for use Before the first use, the Zeus IE anesthesia workstation system must be equipped with the accessories required for operation as well as other devices required for use, e.g., patient monitoring. The required connections must be established with the supply lines (power supply, Air, N2O, O2, anesthetic gas scavenging system). Charge the internal battery for at least 10 hours before the first startup. Before every use, Zeus IE must be equipped according to the specifications in the Instructions for Use. Zeus IE goes through an internal self test after each power-on. The self test must be performed once a day as well as after servicing and when replacing parts. Perform a leak test before a patient change when replacing the breathing hoses. Before operation, at least the measurement displays of the following parameters have to be configured on the screen in accordance with the requirements of national standards (see IEC 60601-2-13): – FiO2 – etCO2 – inVA – MV – Airway pressure

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Application

Application Intended Use... 16 Application... 16 Ventilation modes... 16 Device monitoring... 16 Patient monitoring (optional)... 17 Monitoring... 17 Gas supply... 17 Gas disposal... 17 Data exchange, interfaces... 18 Breathing system... 18

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Application

Intended Use

Ventilation modes

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.

Volume-controlled ventilation at constant inspiration flow Volume Control

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 nitrousoxide with pure oxygen and additional delivery of volatile anesthetic agents and/or intravenous drugs.

Volume-controlled ventilation at decelerating inspiration flow Volume Control AutoFlow, synchronization of ventilation breaths Sync.(VC) and Pressure Support if required. Pressure-controlled ventilation Pressure Control, synchronization of ventilation breaths Sync.(PC) and Pressure Support if required. Pressure-supported ventilation at constant positive airway pressure Pressure Support

Application

Manual ventilation/spontaneous breathing with and without CPAP MAN/SPON

The Anesthesia Workstation System Zeus IE is designed for use in medical rooms, operating rooms and induction and recovery rooms.

Device monitoring

Applications range from adults to pediatric patients and neonates. Ventilation is performed on the patient using 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.

The following are indicated 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

The following are represented as curves: – – – – –

Airway pressure Paw Inspiratory and expiratory flow or volume curves Capnogram Oxigram PV FV Loops

Additionally there are chronological trends of measured values (trends) as well as a log book available. 16

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Application

Patient monitoring (optional) The following are indicated as measured values: – – – – – – – – – –

Heart rate ECG HR/PLS ST segment ST segm. Oxygen saturation SpO2 Non-invasive blood pressure NIBP Invasive blood pressure IBP Cardiac output C.O./ Calculat. Temperature Temp Degree of muscle relaxation: Single, TOF, PTC Depth of hypnosis BIS Wedge pressure PWP

Patient monitoring* – – – – – – – – –

Heart rate HR ST segment ST Oxygen saturation SpO2 Non-invasive blood pressure NIBP Invasive blood pressure IBP Temperature T1, T2 Relaxometry measurement TOF Depth of hypnosis measurement BIS Arrhythmia detection (optional)

Applicable inhalation anesthetic agents – – –

Isoflurane Sevoflurane Desflurane

The following are represented as curves: – – – –

Electrocardiogram ECG (up to 3 curves) Plethysmogram SpO2 Invasive blood pressure IBP (up to 10 curves) Electroencephalogram EEG

Additionally there are chronological trends of measured values (trends) as well as a log book available.

Monitoring The monitoring of the patient is ensured by adjustable alarm limits. Device monitoring – – – – – – – –

Airway pressure Paw Expiratory minute volume MVe Apnea Tidal volume, inspiratory VTi Inspiratory anesthesia gas concentration Recognition of anesthesia gas mixtures Inspiratory O2 and N2O concentrations FiO2, inN2O Inspiratory and expiratory CO2 concentrations inCO2, etCO2

Applicable intravenous drugs All suitable medications permitted for anesthesia and for metering with syringe pumps (optional). Applicable gas mixtures for the carrier gas – –

Gas supply The plug formats of the Zeus IE anesthesia workstation are selectable and comply with the customary formats in the particular country. Zeus IE has connections for O2, Air or N2O backup gas cylinders, which must be equipped with pressure reducers and pressure sensors.

Gas disposal The anesthetic gas receiving system (AGS) must be used as a required accessory. The AGS is connected to an appropriately marked connecting nozzle on Zeus IE.

*

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O2/Air O2/N2O

depending on the options installed

17

Application

Data exchange, interfaces For data communication there are two serial ports, COM1 and COM2, using the Dräger MEDIBUS data protocol. USB interfaces for e.g., import/export of device setups An Infinity network connection in conjunction with patient monitoring (optional). Two network interfaces for remote diagnosis, printers and web applications, e.g., WebView (optional).

Breathing system Interfaces to the patient are the 22 mm ∅-sockets on the breathing system for the connection of EN 12342-compliant breathing hoses. For breathing systems without rebreathing, e.g., Bain system, an external fresh-gas outlet is available (optional).

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System overview

System overview Components... 20 Front... 20 Breathing system view... 21 Connection for oxygen therapy... 21 Connection field for patient monitoring and IV system (optional)... 21 Rear with doors open... 23 Connections to the gas supply block... 24 Connections to the back of the device Zeus IE... 25 Connections to the back of the screen... 25 Connections, power supply and additional sockets... 26 DIVA metering modules... 26 Abbreviations... 27 Symbols... 32

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System overview

Components

Front

A P O N M L K J I H

B C D E

001

F G

A Control panel – screen

K External fresh-gas outlet, optional

B Transport handles

L O2 flow meter for regional anesthesia

C Pull-out writing table

M Self-test adapter

D DIVA metering modules, 2 pieces

N Breathing system with APL valve

E Unlock buttons for DIVA metering modules

O Bracket with infusion apparatus stand

F Central brake

P IV system (IVenus) consisting of: IVDock (basis) and up to 4 syringe pumps Module DPS (Dynamic Pressure System), optional

G Drawer H Endotracheal suction system I

Disposable absorber Drägersorb CLIC (or reusable absorber)

J

Output from O2 flow meter

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