Infinity Acute Care System Models C700, C500 and M540 Instructions for Use SW VG2 June 2012

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

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

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Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

Trademarks –

Acute Care SystemTM

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OxiMaxTM

–

Babylog®

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SatSecondsTM

–

DrägerService®

–

Evita®

are trademarks of Nellcor Puritan Bennett, LLC, a Covidien company

–

Hemo4®

–

–

Hemo2®

–

Infinity®

is a registered trademark of ViewSonic Corporation in the U.S. and other countries.

–

Innovian®

–

MCableTM

–

Medical Cockpit®

–

MegaCareTM

–

MPod®

–

PatientWatchTM

–

TruST®

–

MonoLead®

–

Perseus A500

are trademarks of Dräger. –

Masimo®

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Masimo® SET® (Signal Extraction Technology)

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Masimo® rainbow® SET®

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PVI®

–

SET®

–

SpCO®

–

SpHb®

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SpMet®

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SpOCTM

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Pulse CO-Oximeter TM

–

M-LNCS TM

ViewSonic®

–

Edwards Vigilance®

–

Edwards Vigileo®

are trademarks of Edwards Lifesciences, LLC. –

ComplianceTM

is a trademark of Cardinal Health, Inc. –

Dismozun®pur

is a trademark of BODE Chemie GmbH. –

Sporox II®

is a trademark of Sultan Healthcare, Inc. –

SERVO-i®

is a trademark of Maquet, Inc.

are trademarks of the Masimo corporation. –

NellcorTM

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

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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.

Abbreviations and symbols For explanations, refer to the sections ""Abbreviations" on page 27" and "Device symbols" on page 25".

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Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

Contents

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

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General safety information... 14 Application... 17 Intended use – Infinity Acute Care System – Monitoring Applications... 18 System overview... 19 Overview... 20 Infinity Medical Cockpit (Cockpit)... 20 Infinity PS250 Comm Hub (PS250) power supply... 21 Infinity P2500 power supply (P2500)... 21 Infinity M540 patient monitor (M540)... 22 Infinity M500 docking station (M500)... 22 Additional hardware... 23 Device symbols... 25 Abbreviations... 27 Operating concept... 33 Overview... 34 The IACS components... 35 M540 and Cockpit communication... 36 Communicating with the Infinity network... 38 Remote control and remote view... 40 Communication management... 42 Loss of power... 44 Locked options... 44 Secondary display... 45 Export protocol... 45 User interface... 46 Header bar... 47 Monitoring area... 48 Supported banners... 51 Main menu bar and quick access toolbar... 53 Filtering the parameter content... 55 Auto and manual display modes... 55 Auto view setup toolbar... 56 Customizing the display... 56 Parameter priority... 60 Views... 61 Profiles... 62 Standby mode... 63

Privacy mode...

64

Assembly and preparation...

65

Assembly overview... 66 Docking/undocking the M540... 67 Locking/unlocking the M540... 68 Connecting the system cables... 69 Mounting the Infinity MCable – Masimo SET/Masimo rainbow SET/ Nellcor OxiMax . . 71 Getting started...

73

Overview... 74 Turning the IACS on/off... 74 Viewing demographic data... 75 Admitting a patient... 76 Discharging a patient... 77 Patient categories... 78 Alarms...

81

Overview of alarms... 83 Alarm priorities... 84 Alarm processing... 84 Activating or deactivating alarm validation . . . 86 Visual alarm signals... 87 Acoustic alarm signals... 89 Testing visual and acoustic alarm signals... 90 Viewing current alarm messages... 91 Special alarm behavior... 91 Pre-silencing alarms... 93 Pausing acoustic alarm signals... 94 Activating or deactivating acoustic alarm signals... 95 Pausing alarm monitoring temporarily... 95 Activating or deactivating alarm monitoring . . 96 Configuring the alarm settings for a patient. . . 97 Configuring the alarm setup for an individual parameter... 98 Configuring the alarm setup for multiple parameters... 100 Configuring the arrhythmia alarm setup... 102 Alarm setup for ST... 104 Auto setting all alarm limits... 106 Alarm history and stored events... 107 Viewing the alarm history... 108

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

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Contents

Viewing a snapshot of a single event... 109 Remote alarm control... 110 External device disconnection alarm... 111 The Code button... 111 Alarm ranges and defaults... 112 Calculations... 121 Overview... 122 Accessing the calculation functions... 123 Viewing the calculation results... 125 Lab data... 126 Calculation equations... 127 Drug calculations... 131 Accessing the drug calculation functions... 131 Customized drug list... 132 Drug calculator equations... 134 Trends/data dialog windows... 137 Overview... 138 Trending behavior... 138 Trend graphs... 140 Interacting with the trend graphs pages... 142 Recruitment page... 145 Interacting with the Recruitment page... 146 Trend table... 148 Interacting with the trend table... 150 Mini-trends... 152 Data review pages... 153 Reports tab... 155 ECG, arrhythmia, and ST segment... 157 Overview of ECG and heart rate monitoring . . 159 ECG precautions... 160 Connecting the 3-, 5-, 6-lead wire sets for ECG monitoring... 160 Connecting the lead wire set for 12-lead monitoring... 161 Connecting the lead wires for neonatal monitoring... 162 Patient preparation for ECG monitoring... 163 ECG display... 164 ECG colors... 166 Electrode placement... 167 12-lead monitoring... 170 Accessing the ECG functions... 170 ECG parameter setup functions... 171 Monitoring paced patients... 174 6

Pacemaker precautions... 175 Optimizing pacer processing... 177 Arrhythmia monitoring overview... 177 Selecting arrhythmia leads... 178 Arrhythmia modes... 178 Arrhythmia display... 180 Accessing the arrhythmia functions... 181 Arrhythmia parameter setup functions... 182 Monitoring ST overview... 182 Standard ST monitoring... 183 TruST 12-lead monitoring... 183 12-lead ST monitoring... 183 Connecting lead wire sets for ST monitoring. . 184 ST display... 184 Reviewing ST complexes... 185 ST measuring points... 187 ST reference... 188 ST alarm settings... 189 Accessing the ST settings... 189 ST setup functions... 190 Learning/relearning QRS pattern... 192 Impedance respiration (RRi)... 193 Overview of respiration monitoring... 194 Respiration precautions... 194 Connecting the 3-, 5-, 6-lead wire sets for respiration monitoring... 195 Connecting the lead wire set for 12-lead monitoring... 196 Connecting the lead wires for neonatal monitoring... 197 Patient preparation for respiration monitoring . 197 Respiration display... 199 Adjusting the detection threshold and activating the respiration marker... 200 Respiration measuring modes... 200 Accessing the respiration settings... 201 Respiration parameter setup functions... 201 SpO2 and Pulse CO-Ox monitoring with Masimo SET MCables... 203 Overview of SpO2 and Pulse CO-Ox monitoring... 204 SpO2 and Pulse CO-Ox precautions... 206 Connecting the Masimo SET MCable... 208 Connecting the Masimo rainbow SET MCable... 209 Patient preparation... 210

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

Contents

SpO2 and Pulse CO-Ox display... 211 Reviewing the SpO2 and Pulse CO-Ox parameters... 214 Accessing the SpO2 settings... 215 SpO2 parameter setup functions... 216 Masimo rainbow SET Pulse CO-Ox parameter setup functions... 218 Password-protected Masimo rainbow SET setup functions... 221 SpO2 and pulse rate with Nellcor OxiMax MCable... 223 Overview of SpO2 monitoring... 224 SpO2 precautions... 225 Connecting the Nellcor OxiMax MCable... 226 Patient preparation for SpO2 monitoring... 227 SpO2 display... 228 Accessing the SpO2 settings... 229 SpO2 parameter setup functions... 229 Temperature... 231 Overview of temperature monitoring... 232 Connecting the temperature sensors... 232 Temperature display... 235 Accessing the temperature settings... 236 Temperature parameter setup functions... 236 Non-invasive blood pressure (NIBP)... 237 Overview of non-invasive blood pressure monitoring... 238 Non-invasive blood pressure precautions... 239 Connecting the non-invasive blood pressure hose and cuff... 240 Patient preparation for non-invasive blood pressure monitoring... 241 Non-invasive blood pressure display... 242 Non-invasive blood pressure measurement modes... 243 Venous stasis... 246 Accessing the non-invasive blood pressure settings... 246 Non-invasive blood pressure parameter setup functions... 247 Invasive blood pressure (IBP)... 249 Overview of invasive blood pressure monitoring... 250

IBP precautions... 252 Connecting the Hemo4 pod and Hemo2 pod . 253 Connecting the MPod – QuadHemo... 254 Connecting the Dual Hemo MCable... 255 Patient preparation for invasive blood pressure monitoring... 256 Invasive blood pressure display... 256 Labeling invasive blood pressure channels. . . 258 Standard labels... 259 Pressure label conflicts... 260 Zeroing an invasive blood pressure transducer... 260 Pulmonary wedge pressure... 263 Starting wedge measurements from the pods . 264 Accessing the invasive blood pressure settings... 266 Invasive blood pressure parameter setup functions... 267 Cardiac output (C.O.)... 269 Overview of cardiac output monitoring... 270 C.O. Precautions... 270 Connecting the cardiac output hardware... 271 Patient preparation for cardiac output monitoring... 273 Cardiac output display... 274 Cardiac output computation constant... 275 Cardiac output measuring modes... 277 Saving the cardiac output value... 280 Reviewing the cardiac output averages... 281 Accessing the cardiac output settings... 282 Cardiac output parameter setup functions . . . 282 Carbon dioxide concentrations (CO2)... 285 Overview of CO2 monitoring... 286 CO2 precautions... 287 Connecting the sensor... 288 Patient preparation for CO2 monitoring... 289 CO2 display... 290 Accessing the CO2 settings... 293 CO2 parameter setup functions... 293 External device – continuous cardiac output (CCO)... 295 Overview of CCO monitoring... 296 CCO precautions... 298 CCO/SvO2 Display... 299

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

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Contents

Viewing the CCO/SvO2 parameters... 299 Accessing the CCO/SvO2 settings... 300 SvO2 parameter setup functions... 300 External device – ventilation / anesthesia . . 301 Overview of ventilation monitoring... 302 Ventilator precautions... 308 Ventilator display... 309 Loops... 309 Viewing all ventilation parameters... 310 Accessing the ventilator settings... 310 Ventilator Paw setup functions... 311 Ventilator parameter setup functions... 312 CO2 parameter setup functions... 313 Overview of anesthesia monitoring... 313 Perseus A500 precautions... 316 Perseus A500 display... 316 System configuration... 317 Overview... 318 Screen setup... 318 Screen setup – general settings... 319 Screen setup – auto view functions... 320 Configuring parameters for display... 322 Screen setup – configuring views... 325 Screen setup – configuring function keys... 326 Screen setup – the View editor... 328 Configuring the alarm setup... 330 Configuring the recording and report settings . 335 Biomed setup... 338 Biomed IT setup... 346 Profile setup... 351 Saving profiles... 352 Configuring profiles... 354 Transferring profiles... 356 Reports/recordings... 359 Overview... 360 R50N recorder... 360 Timed recordings... 361 Continuous recordings... 363 Requesting recordings... 363 Available reports... 364 Printing reports... 364 Configuring a case summary report... 368

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IT applications (options)... 369 Overview... 370 Configuring IT tabs... 370 Accessing an IT tab... 371 Supported IT applications... 372 Problem solving... 373 Overview... 374 Device communication messages... 374 ECG... 376 ST... 379 ARR... 380 Respiration (RRi)... 382 SpO2... 385 NIBP... 390 Temperature... 393 IBP... 394 Cardiac Output (C.O.)... 398 CO2... 401 Recording status messages... 405 Cleaning and disinfection... 407 Overview of general precautions... 408 Approved agents... 408 Cockpit components... 409 Maintenance... 411 Overview... 412 Maintenance of the IACS components... 412 Safety inspections... 414 Disposal... 417 Technical data... 419 Overview... 420 Infinity PS250 Comm Hub... 420 Infinity P2500... 422 Infinity MCable – Nurse Call... 423 Infinity R50N... 424 Secondary display... 425 Electromagnetic compatibility... 425 Index... 429

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

For your safety and that of your patients

For your safety and that of your patients Strictly follow these instructions for use... 10 Training... 10 Maintenance... 10 Safety checks... 10 Accessories... 11 Installing accessories... 11 Sterile accessories... 11 Restrictions for use... 11 Connected devices... 11 Safe connection with other electrical equipment... 11 Electrical safety... 12 Networking and connection to other devices . . 12 Connection to hospital network... 13 Patient safety... 13 Patient monitoring... 13 General safety information... 14 Not for use in areas of explosion hazard... 14 Site of operation... 15 Defibrillator precautions... 15 Electrosurgery... 16 Virus protection... 16

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

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For your safety and that of your patients

Strictly follow these instructions for use

Maintenance

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" and in conjunction with appropriate patient monitoring. 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.

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 productspecific 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.

Training

If the above are not complied with, the correct functioning of the medical device may be compromised. See chapter "Maintenance."

Training for users is available from the responsible Dräger organization. See www.draeger.com for more information.

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

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Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

For your safety and that of your patients

Accessories

Restrictions for use

WARNING Only the accessories indicated in the Infinity Acute Care System – Monitoring Accessories instructions for use (latest edition) have been tested and approved for use with the medical device.

CAUTION Device for use in health care facilities only and exclusively by persons with specific training and experience in its use.

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.

Connected devices

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.

Sterile accessories 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.

CAUTION Federal (U.S.) law restricts this device to sale by or on the order of a physician. 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.

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

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

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For your safety and that of your patients

WARNING The leakage current increases when multiple medical devices are connected to a patient. Make sure that the electrical isolation of each device is suitable for the intended application. Connect only equipment that is set up and tested according to IEC standards to the analog and digital signal inputs and outputs. Connect only passive USB devices to the IACS (Infinity Acute Care System) Cockpit. To protect the patient from possible injury due to electrical shock, peripheral devices should only be connected to a monitor within the same room. The installer or service provider should verify that the leakage current of the interconnected system meets the electrical safety requirements of IEC 60601-1 and IEC 60601-1-1.

Electrical safety WARNING Because of the danger of electric shock, never remove the cover of a device while it is in use or plugged into a power socket. CAUTION Connect the PS250 (Infinity PS250 Comm Hub) or the P2500 with an attached power cord only to hospital-grade electrical power sockets to make sure that it is properly grounded. CAUTION To avoid injuring the patient, do not touch any connector or mounting screw on the device when you are touching the patient. Do not allow the conductive parts of electrodes and cables to contact other conductive parts or ground, either.

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Networking and connection to other devices When combining Dräger devices with other electrical devices, the owner must ensure that the resulting system meets 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 CAUTION Combinations of Dräger devices and third-party devices that are not approved by Dräger may adversely affect operation of those devices and may put the patient at greater risk of injury. CAUTION The medical device must only be used with software tested and approved by Dräger. Any modifications of the operating system settings can impair operating safety. Responsibility for any such modifications lies with the owner. Strictly follow the assembly instructions and instructions for use for each connected device.

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

For your safety and that of your patients

Connection to hospital network

Patient monitoring

Many medical devices manufactured by Dräger use networks to transmit patient data in real-time and to notify clinical users of alarm conditions. Hospitals should refer to IEC 80000-1 before attempting to connect such medical devices to their IT networks. The technical documentation that IEC 80000-1 requires manufacturers such as Dräger to make available in support of such network connections can be requested. Contact your Dräger representative for that information or to facilitate negotiation of an IEC 80000-1 Responsibility Agreement for additional support from Dräger.

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

Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to trained professionals, and that certain inherent characteristics of the medical device are known to a trained 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 a professional who operates 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.

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

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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. WARNING Follow local regulations for safe disposal of batteries. To prevent fire or explosion, never dispose of batteries in fire. WARNING Follow local regulations for safe disposal of batteries. To prevent fire or explosion, never dispose of batteries in fire. WARNING To avoid electric shock, inspect all cables before use. Never use cables that appear cracked, worn, or damaged in any way (doing so may compromise performance or put the patient at risk).

WARNING Do not cover the device with blankets or bed sheets. To prevent burns to the patient, avoid direct contact between external surfaces and the patient. CAUTION To avoid injuring the patient, disconnect all sensors that will not be used during transport, before moving the patient.

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CAUTION Read all cleaning instructions (for example, originating from the disinfectant manufacturer and the hospital) carefully before cleaning the device. Refer to the chapter entitled "Cleaning and disinfection" on page 407 for device-specific cleaning instructions. Moisture may damage the circuits, compromise critical performance and present a safety risk. WARNING Dräger recommends using the Infinity Acute Care System or the M540 (if on wireless transport) for primary diagnosis and the (ICS) Infinity CentralStation for patient viewing only. For countries subject to the EU directive 2002/96/EC This device is subject to EU Directive 2002/96/EC (WEEE). In order to comply with its registration according to this directive, this device may not be disposed of at municipal collection points for waste electrical and electronic equipment. Dräger has authorized a company to collect and dispose of this device. To initiate collection or for further information, visit Dräger on the Internet at www.draeger.com. Use the Search function with the keyword "WEEE" to find the relevant information. If access to Dräger's website is not possible, contact the local Dräger organization.

Not for use in areas of explosion hazard WARNING When placing the device, make sure that adequate airflow exists. To prevent overheating, position the device with at least 5 cm (2 in) of space all around.

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

For your safety and that of your patients

Information on electromagnetic compatibility General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2: WARNING Do not connect connectors with an ESD warning symbol and do not touch the pins of such connectors without implementing ESD protective measures. Such protective measures may include antistatic clothing and shoes, touching a ground stud before and during connection of the pins, or using electrically insulating and antistatic gloves. All relevant personnel must be instructed in these ESD protective measures.

Site of operation Only use devices (monitor, MPod, MCable, and accessories) in areas that meet the environmental requirements outlined in the technical data section. WARNING To avoid interfering with device operation, do not operate devices (monitor, MPod, MCable, and accessories) within 10 m (33 feet) of equipment that emits microwave or other high-frequency emissions.

WARNING Make sure that the device is properly mounted and secured to prevent injury. Make sure the requirements for maximum load and slope of floor are met. Consult the documentation of the mounting manufacturer for detailed information.

WARNING To minimize the risk of patient strangulation, carefully position and secure sensor cables. Also position the sensor cables to minimize inductive loops. CAUTION To prevent overheating, do not place the device in direct sunlight or near radiant heaters. CAUTION After extended exposure in a cold environment, acclimate the device carefully so that condensation does not form on the electronic parts and damage the device. CAUTION To avoid damaging the touch-sensitive screen, do not allow sharp instruments to touch the front panel of the devices. CAUTION To avoid short-circuiting and otherwise damaging the device, Dräger recommends that no fluids come in contact with the IACS devices when they are connected to a power socket. If fluids are accidentally spilled on the equipment, remove the affected device from service as soon as possible and have technical personnel verify that patient safety is not compromised.

Defibrillator precautions The IACS and the peripheral devices are protected against high-frequency interference from defibrillators and electrosurgical units and against 50-Hz and 60-Hz power line interference. CAUTION To prevent burns and electric shock due to rerouting of electrical current through electrodes, do not position the defibrillator pads near any electrodes or sensors.

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

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For your safety and that of your patients

CAUTION Only defibrillate across the chest. CAUTION Using ECG electrodes and cables specified by Dräger protects the device from damage during defibrillation and reduces noise and other interference on the ECG waveform.

WARNING To reduce the hazard of burns during electrosurgery, keep the sensor or transducer (ECG, pressure, SpO2) and their associated cables away from the surgical site, the ESU return electrode, and earth ground. NOTE Cover internally placed reusable temperature sensors with temperature probe sheaths.

Electrosurgery Observe the following precautions during electrosurgery to reduce electrosurgical unit (ESU) interference and improve operator and patient safety. WARNING For better performance and to reduce the hazard of burns during surgery, always use accessories designed for ESU environments. Do not use skin temperature sensors.

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Virus protection CAUTION The IACS does not have virus protection software and relies therefore on the firewall of your institution to prevent access to infected files. While setting up IT applications to access web sites, evaluate each web site with regard to possible virus infection.

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

Application

Application Intended use – Infinity Acute Care System – Monitoring Applications... 18 Indications for use... 18

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

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Application

Intended use – Infinity Acute Care System – Monitoring Applications The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained healthcare professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The IACS and any connected optional hardware are not intended for use in the following hospital environments: –

Hyperbaric chambers

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Environments containing MRI equipment

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Indications for use The M540 monitors the following parameters: –

Heart rate

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Arrhythmia (adult and pediatric patients only)

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12-lead ECG monitoring

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12-lead ECG monitoring including TruST (adult and pediatric patients only)

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ST segment analysis (adult and pediatric patients only)

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12-lead ST segment analysis (adult and pediatric patients only)

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Apnea

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Respiration rate

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Invasive blood pressure

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Non-invasive blood pressure

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Temperature

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Cardiac output (adult and pediatric patients only)

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Arterial oxygen saturation – SpO2

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Pulse rate

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Perfusion index – PI

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Total hemoglobin – SpHb, (adult and pediatric patients only)

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Total oxygen content – SpOC, (adult and pediatric patients only)

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Carboxyhemoglobin saturation – SpCO

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Methemoglobin saturation – SpMet

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Pleth variability index – PVI

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Mainstream etCO2

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

System overview

System overview Overview... 20 Infinity Medical Cockpit (Cockpit)... 20 Infinity PS250 Comm Hub (PS250) power supply... 21 Infinity P2500 power supply (P2500)... 21 Infinity M540 patient monitor (M540)... 22 Infinity M500 docking station (M500)... 22 M500 front panel... 22 M500 back panel... 23 Additional hardware... 23 Device symbols... 25 Abbreviations... 27

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2

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System overview

Overview These instructions for use describe the Cockpit (Medical Cockpit), the primary display and user interface of the Infinity Acute Care System – Monitoring Applications – M540 Patient Monitor (IACS). Specifically, these instructions for use describe the setup tasks and features available on the Cockpit. For detailed information on the M540 patient monitor, refer to the instructions for use Infinity Acute Care System – Infinity M540.

–

Undocking the M540 – refers to removing the M540 from the M500 for patient transport.

The following diagram shows the basic components of the IACS. In addition, you can connect various hardware to expand the viewing and monitoring capabilities (see "Additional hardware" on page 23).

Some terms used in these instructions for use: Cockpit – refers to the Infinity C700 Medical Cockpit or the Infinity C500 Medical Cockpit

–

M540 – refers to the Infinity M540 transport component and patient connection point of the IACS.

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M500 – refers to the Infinity M500 Docking Station that secures the M540, provides communication between the M540 and the Cockpit, and charges the battery in the M540.

A

B

D C 001

–

–

PS250 – refers to the Infinity PS250 Comm Hub

A C500 / C700

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P2500 – refers to the Infinity P2500 Communications Hub

B PS250 or P2500

–

Docking the M540 – refers to placing the M540 on the M500.

D M540

C M500

Infinity Medical Cockpit (Cockpit) The Cockpit is the primary display and user interface for the IACS and is available in the following sizes: –

C500 – 43 cm (17 in) wide screen

–

C700 – 50 cm (20.1 in) wide screen

For detailed description regarding the front and back panel of the Cockpit, refer to the instructions for use Infinity Acute Care System – Infinity Medical Cockpit. 20

Instructions for Use Infinity Acute Care System – Monitoring Applications VG2