Infinity Central Station Software VG1 and Infinity M300 Instructions for Use Edition 1 Nov 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, Printer setup.

The “greater than” symbol > indicates the navigation path in a dialog window. In the example System setup > General settings, System setup represents the dialog window title (which is often accessed by selecting a button), and General settings represents a horizontally aligned tab within the selected window.

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

Trademarks –

Infinity®

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Masimo®

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Pick and Go®

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Masimo SET®

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TruST®

are registered trademarks of Masimo Corporation.

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ACE (Arrhythmia Classification Expert)

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NellcorTM

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DrägerService®

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OxiMaxTM

®

are registered trademarks of Dräger.

2

are trademarks of Covidien.

Instructions for use Infinity CentralStation SW VG1 and M300

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 equipment or other property. NOTE A NOTE provides additional information intended to avoid inconveniences during operation.

Abbreviations and symbols Refer to "Device symbols" on page 32, and to "Abbreviations" on page 34 for explanations.

Product compatibility information Contact DrägerService for product compatibility information.

Instructions for use Infinity CentralStation SW VG1 and M300

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Instructions for use Infinity CentralStation SW VG1 and M300

For your safety and that of your patients

For your safety and that of your patients Strictly follow these instructions for use... Unauthorized changes to hardware or software... Maintenance... ICS CPU precautions... KVMA (keyboard, video, mouse, audio) extender precautions... Sterile accessories... Installing accessories... Electrical safety... Safe connection with other electrical equipment... Connected devices... Networking and connection to other devices . . Connection to hospital network... Restriction of distribution... Patient safety...

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General safety information...

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6 6 7 7 7 7 7 8 8 8 8 9 9

Information on electromagnetic compatibility . . 10 Site of operation... 10 Not for use in areas of explosion hazard... 11 Defibrillator precautions... 11 Virus protection... 11

Instructions for use Infinity CentralStation SW VG1 and M300

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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.

Unauthorized changes to hardware or software

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

WARNING Any changes or modifications to the device hardware or software must be performed exclusively by service technicians authorized by Dräger. Any unauthorized change can decrease patient safety, can void the user’s authority to operate the equipment, and will void the warranty.

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Instructions for use Infinity CentralStation SW VG1 and M300

For your safety and that of your patients

ICS CPU precautions

Installing accessories

Observe the following precautions for the ICS CPU.

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.

WARNING The Infinity CentralStation CPU and its display(s) must always remain on and the external speakers always connected to avoid loss of audible alarms. Never press any of the On/Off buttons to turn the CPU or the display(s) off. Contact your technical personnel for assistance in properly shutting down the ICS.

KVMA (keyboard, video, mouse, audio) extender precautions Observe the following precautions for KVMA extenders. WARNING In the event the hospital decides to install or relocate the Infinity CentralStation CPU from a Dräger approved centralized setup to a noncentralized location, the user must perform a risk assessment according to DIN EN 80001-1. In such a configuration, malfunction of the external speakers could result in the loss of audible alarming for the user. To mitigate this risk, be sure to perform regular functional checks on the system and all peripherals, including KVMA extenders.

Strictly observe assembly instructions and instructions for use.

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 power cord of the power supply only to hospital-grade electrical outlets 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.

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.

Instructions for use Infinity CentralStation SW VG1 and M300

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For your safety and that of your patients

Safe connection with other electrical equipment WARNING 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. 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. Only equipment that is set up and tested according to IEC standards should be connected to the analog and digital signal inputs and outputs.

Connected devices WARNING Risk of electric shock and of device malfunction Any connected devices or device combinations not complying with the requirements mentioned in these Instructions for Use may compromise the correct functioning of the medical device. Before operating any combination of devices, refer to and strictly comply with the Instructions for Use for all connected devices and device combinations.

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:

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–

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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.

Connection to hospital network 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 EN IEC 80001-1 before attempting to connect such medical devices to their IT networks. The technical documentation that EN IEC 80001-1 requires manufacturers such as Dräger to make available in support of such network connections can be requested. Contact your Dräger repre-

Instructions for use Infinity CentralStation SW VG1 and M300

For your safety and that of your patients

sentative for that information or to facilitate negotiation of an EN IEC 80001-1 Responsibility Agreement for additional support from Dräger.

Restriction of distribution Federal Law (U.S.) restricts this device to sale by or on the order of a physician.

ING 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.

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 WARN-

CAUTION Risk of patient injury Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.

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.

CAUTION To avoid injuring the patient, disconnect all sensors that will not be used during transport, before moving the patient. 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" for device-specific cleaning instructions. Moisture may damage the circuits, compromise critical performance and present a safety risk.

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).

Instructions for use Infinity CentralStation SW VG1 and M300

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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: Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided on page 316. Portable and mobile RF communications equipment can affect medical electrical equipment. 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.

WARNING To avoid interfering with device operation, do not operate devices (monitors, MPods, MCables, and accessories) within 10 m (33 feet) of equipment that emits microwave or other high-frequency emissions. WARNING Ensure that the device is properly mounted and secured to prevent injury. 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. WARNING When placing the M300, make sure adequate airflow exists. Do not cover the device with blankets. CAUTION To prevent overheating, do not place the device in direct sunlight or near radiant heaters.

Site of operation Only use devices (monitors, MPods, MCables, and accessories) in areas that meet the environmental requirements outlined in the Technical Data chapter.

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.

WARNING Do not operate the device in the following areas: magnetic resonance imaging (MRI) environments, aircraft, ambulance, home, or hyperbaric chambers.

CAUTION To avoid damaging the touch-sensitive screen, do not allow sharp instruments to touch the front panel of the devices.

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Instructions for use Infinity CentralStation SW VG1 and M300

For your safety and that of your patients

CAUTION To avoid short-circuiting and otherwise damaging the device, Dräger recommends that no fluids come in contact with the ICS 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.

Virus protection CAUTION The Infinity CentralStation (ICS) 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.

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

Defibrillator precautions The M300 and Bedside Charger are protected against high-frequency interference from defibrillators 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. 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.

Instructions for use Infinity CentralStation SW VG1 and M300

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Instructions for use Infinity CentralStation SW VG1 and M300

Contents

Contents Trademarks... Safety information definitions... Abbreviations and symbols... Product compatibility information...

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For your safety and that of your patients. . .

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Strictly follow these instructions for use . . . 6 Unauthorized changes to hardware or software... 6 Maintenance... 6 ICS CPU precautions... 7 KVMA (keyboard, video, mouse, audio) extender precautions... 7 Sterile accessories... 7 Installing accessories... 7 Electrical safety... 7 Safe connection with other electrical equipment... 8 Connected devices... 8 Networking and connection to other devices... 8 Connection to hospital network... 8 Restriction of distribution... 9 Patient safety... 9 General safety information... 9 Information on electromagnetic compatibility... 10 Site of operation... 10 Not for use in areas of explosion hazard . . 11 Defibrillator precautions... 11 Virus protection... 11 Indications/Intended use... 19 Infinity CentralStation with Infinity M300 Indications/Intended use... 20 Contraindication... 20 System overview... 21 Overview of the ICS system... Overview of the ICS... Display panel of the ICS... Display connectors... Central processing unit front and back cover of the ICS...

22 22 23 24 25

Overview of the M300... Front panel of the M300... Battery status LED of the M300... Back panel of the M300... Overview of the bedside charger... Avoiding charger and adapter damage . . . Overview of the central charger... Device symbols... Abbreviations...

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Operating concept...

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Overview of ICS operating concept... ICS... M300... Infinity patient monitors... ICS components... Overview of M300 operating concept... M300 power... Remote display... Communication between an M300 and the ICS... Communicating with the Infinity network... Local ICS... Remote ICS... M300... Communication management... ICS user interface – overview... ICS user interface – Main screen... ICS menu bar... ICS parameter box allocation... ICS waveforms... ICS user interface – split screen mode... ICS user interface – BedView... ICS header bar in split screen mode... BedView parameter boxes... BedView parameter box content... Configuring the ICS Main screen – views... Display mode... Supported banners... Supported symbols... Electronic patient data transfer... Transferring patient data... Remote view and remote control... Local monitoring units...

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Instructions for use Infinity CentralStation SW VG1 and M300

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Contents

Remote monitoring units... Remote export of Full disclosure data and Events data... ICS online help... The online help window... Standby mode... Standby/ Discharge page... Activating standby mode... Patient confidentiality... M300 user interface... M300 header bar... M300 keypad... M300 waveforms...

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Charging the M300 battery... 81 Overview... 82 Battery status LED... 82 Using the bedside charger... 83 Getting started... 87 Overview of monitoring a patient... Turning the ICS and display on/off... Telemetry/Parameters dialog window (BedView)... The Layout/ Parameters page... The Demographics page... Admitting a patient... Admitting under special circumstances . . . Discharging a patient... Discharging an M300 patient... Patient categories... Selecting a different patient category...

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Alarms... 99 Overview of alarms... 100 Alarm priorities... 101 High-priority alarm conditions... 101 Medium-priority alarm conditions... 101 Low-priority alarm conditions... 101 Alarm processing... 101 ICS alarm processing... 101 Latching and non-latching alarm behavior . 102 Activating or deactivating alarm validation... 103 Alarm validation times for the M300... 103 Alarm signals... 104 M300 visual alarm signals... 104 Visual alarm signal colors on the M300 . . . 105 14

Visual alarm indicators on the M300... 105 Visual alarm indicators on the ICS... 106 Audio pause and Alarm pause buttons . . . 107 ICS and M300 acoustic alarm signals... 109 Adjusting the ICS volume for acoustic alarm signals... 109 Adjusting the M300 volume for acoustic alarm signals... 110 Pausing audio alarms on the ICS Main screen... 111 Pausing audio alarms for the bedside monitors... 112 Pausing audio alarms for the M300... 113 Pausing audio alarms for the M300 from a remote network device... 113 Pausing alarms for the M300... 114 Pausing alarms for the M300 from a remote network device... 114 Configuring the alarm settings of the patient. . 115 Alarm settings for bedside monitors... 115 Activating/deactivating alarms... 115 Upper and lower alarm limits... 115 Archive function... 115 Alarm setup for multiple parameters... 116 Configuring alarm settings for multiple parameters... 117 Alarm setup for arrhythmia parameters... 118 Auto setting all alarm limits... 120 Special conditions for alarm event recordings... 120 Special conditions for alarm event storage 120 Alarm groups... 121 The surveillance feature... 121 Visual surveillance alarm signals... 122 Audible surveillance alarm signals... 123 M300 alarm ranges and defaults... 124 Parameter ranges and defaults... 124 Arrhythmia parameter ranges and defaults... 125 Trends/Data dialog windows... 127 Overview... 128 Accessing the Trends/Data dialog window . . . 128 Selecting a patient... 128 Trends... 131 Trending behavior... 131 Representation of special conditions... 132 Trends graph... 133

Instructions for use Infinity CentralStation SW VG1 and M300

Contents

The Trends graph page... 133 Navigator timeline... 134 Accessing the Trends graph page... 136 Trends graph page functions... 136 Configuring the Trends graph page... 136 The Trends graph setup page... 136 Trend scales... 137 Auto scale... 137 Trends table... 138 The Trends table page... 138 Event handling... 138 Accessing the Trends table page... 140 Trends table page functions... 140 Configuring the Trends table page... 140 Navigating through the Trends table... 141 Setting up a trends report... 141 Full disclosure... 143 The Full disclosure page... 144 Accessing the Full disclosure page... 144 Full disclosure page functions... 146 Viewing Full disclosure history... 146 Locking a Full disclosure record... 146 Reviewing Full disclosure data... 146 Exporting waveforms... 147 Special conditions for Full disclosure and Events... 147 The Full disclosure Setup page... 149 Selecting the waveform display order... 149 Setting the pacer mark on or off... 151 Generating Full disclosure reports... 152 ECG Calipers tool... 152 The Calipers page... 153 Accessing the Calipers page... 155 Interval measurement calculation... 155 Caliper measurements... 156 Calipers > Review page... 156 Calipers page functions (measure)... 157 Taking interval measurements... 157 Printing an ECG Calipers report... 157 Saving references... 158 Calipers page functions (Review)... 158 Reviewing interval measurements... 158 Deleting interval measurements... 158 Events... 159 The Events page... 159 Accessing the Events page... 162 Events page functions... 162 Reviewing events... 162

Viewing parameter values... 162 Annotating events... 163 Reclassifying events... 164 Event classes... 165 Deleting an event or event class... 165 Special conditions for events... 165 Generating event reports... 166 Exporting events from the Events page . . . 166 ECG, arrhythmia, and ST segment monitoring with M300... 167 Overview of ECG monitoring... 168 ECG signal processing and display... 168 Supported parameters... 168 ECG precautions... 169 Starting ECG monitoring on a patient... 169 Connecting the 3-, 5-, 6-lead wire sets to the M300... 170 Patient preparation for ECG monitoring... 171 ECG display... 172 ECG parameter box in a viewport of the ICS Main screen... 172 ECG parameter box in the ICS BedView . . 172 ECG parameter box on the M300... 172 ECG electrode colors... 174 Electrode placement... 174 Accessing the ECG setup page... 176 ECG parameter setup functions... 177 Monitoring paced patients... 178 Pacemaker precautions... 178 Pacer Fusion mode... 179 Device interference with pacemaker monitoring... 179 Overview of arrhythmia monitoring... 180 Selecting arrhythmia leads... 180 Arrhythmia modes... 181 Arrhythmia display... 182 Arrhythmia parameter box on an ICS BedView... 182 Accessing the Arrhythmia setup page... 183 Arrhythmia parameter setup function... 183 Overview of ST monitoring... 184 Connecting lead wire sets for ST monitoring. . 184 Standard ST monitoring... 185 12-lead TruST monitoring... 186 ST display... 187 ST parameter box on an ICS BedView . . . 187 ST complex pages... 188

Instructions for use Infinity CentralStation SW VG1 and M300

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Contents

Viewing all ST complexes... 188 Zooming in on an ST complex... 189 ST measuring and ISO points... 190 Adjusting ST measuring and ISO points. . . 190 ST reference... 190 Saving ST reference... 190 Accessing the ST setup page... 191 ST parameter setup functions... 191 Learning/relearning QRS pattern... 192 SpO2 and pulse rate monitoring with Masimo and M300... 193 Overview of SpO2 monitoring with Masimo . . . 194 Supported parameters... 194 SpO2 precautions... 195 Starting SpO2 monitoring on a patient... 196 Connecting the SpO2 cable to the M300... 196 Patient preparation for SpO2 monitoring... 197 Applying the sensor... 197 Turning SpO2 monitoring on... 198 SpO2 display... 198 SpO2 parameter box in the ICS BedView . . 198 SpO2 parameter box on an M300... 199 Accessing the SpO2 page... 200 SpO2 parameter setup functions... 200 SpO2 and pulse rate monitoring with Nellcor and M300... 201 Overview of SpO2 monitoring with Nellcor... 202 Supported parameters... 202 SpO2 precautions... 203 Starting SpO2 monitoring on a patient... 204 Connecting the SpO2 cable to the M300... 204 Patient preparation for SpO2 monitoring... 205 Applying the sensor... 205 Turning SpO2 monitoring on/off... 206 SpO2 display... 206 SpO2 parameter box on an ICS BedView. . 207 SpO2 parameter box on an M300... 207 Accessing the SpO2 setup page... 208 SpO2 parameter setup functions... 208 Recordings/reports... 209 Overview... 210 R50N recorder... 211 Recorder setup... 211 Initiating manual recordings... 212 16

Processing of strip recordings... 212 Requesting a remote recording... 212 Setting up a recording... 212 Manual (timed) recordings... 212 Canceling a recording... 216 Actions that affect recordings... 217 Laser printers... 218 Print screen... 218 Reports... 219 Simultaneous ECG report... 220 Full disclosure strip report... 220 Full disclosure 1-hour report... 220 Full disclosure 24-hour report... 220 Events strip reports... 220 Shift report... 221 Setting-up a trend report... 226 Selected strip report... 226 Selected events report... 227 ECG caliper report... 227 Requesting recordings and reports... 230 System configuration... 235 Overview... 236 System setup... 236 The General settings page... 236 System setup > General settings page... 237 The Alarms page... 238 System setup – Alarms page... 238 The Recorders/ Reports page... 239 System setup – Recorders/ Reports page . . . 240 The Layouts page... 242 System setup > Layouts page... 242 The Biomed page... 243 System setup > Biomed page... 243 Telemetry setup defaults... 253 Telemetry default setup (System setup) . . 253 Telemetry setup (for each M300 device) . . 253 The General settings page... 254 General settings setup page... 254 The Alarms page (telemetry)... 255 Alarms > Limits page... 255 Changing alarm limits settings... 256 Alarms > Arrhythmia page... 257 The Layout/ Parameters page... 259 The Find device page... 266 The Device setup page... 266

Instructions for use Infinity CentralStation SW VG1 and M300

Contents

Problem solving... 269

Technical specifications... 301

Overview of problem solving... 270 ICS – parameter alarm messages... 270 ICS – banner messages... 271 ICS – status messages... 273 ICS – data transfer messages... 274 ICS – printer status messages... 275 ICS – recording status messages... 276 M300 – arrhythmia alarm messages... 278 M300 – ECG alarm messages... 279 M300 – ST alarm messages... 281 M300 – SpO2 alarm messages... 283 M300 messages... 285 External device messages... 286

Infinity CentralStation... 302 Touch screen display... 304 Uninterruptible power supply... 305 Infinity R50N... 307 Infinity M300... 308 Infinity M300 bedside charger (MS18620) . . . 313 Infinity M300 bedside charger (MS29558) . . . 314 Infinity M300 central charger (MS25699)... 315 Electromagnetic compatibility... 316

Maintenance... 287 Overview... 288 Recommended maintenance intervals... 289 Safety inspections... 290 Scope of safety inspection for the ICS and M300... 290 Cleaning the ICS CPU filter kit... 290 Cleaning and disinfection... 291 Overview of cleaning and disinfecting the ICS system and accessories... 292 Cleaning and disinfecting precautions... 292 Approved cleaning agents... 293 Cleaning the ICS display and CPU... 293 Cleaning and disinfecting the M300... 294 M300 precautions... 294 Cleaning the M300 connectors... 294 Cleaning the non-disposable pouch... 295 Cleaning the central charger and bedside charger... 295 Cleaning and disinfecting patient cables... 296 Patient cable precaution... 296 Reusable SpO2 sensor... 296 Cleaning and disinfecting reusable ECG lead wires... 297 Disposal... 299 Disposal of the medical device... 300 ICS display and CPU, M300, bedside charger, central charger, and power supply . . . 300

List of accessories... 321 Infinity CentralStation accessories overview . . 322 Displays... 322 CPU mount package... 322 M300 accessories overview... 323 Sterile accessories... 323 General M300 accessories... 324 System components... 324 ECG monitoring – reusable leadsets... 325 ECG monitoring – single-patient use leadsets 326 ECG monitoring – MonoLead... 327 ECG monitoring – Telemetry... 329 ECG cable... 329 Telemetry lead wire sets (3-lead)... 329 Telemetry lead wire sets (5-lead)... 329 Telemetry lead wire sets (6-lead)... 329 Pulse Oximetry (SpO2) monitoring with Masimo... 330 Masimo SpO2 cables... 330 Masimo LNCS disposable sensors... 330 Masimo LNCS reusable sensors... 331 Masimo LNOP disposable sensors... 331 Masimo LNOP reusable sensors... 331 Pulse Oximetry (SpO2) monitoring with Nellcor... 332 Nellcor SpO2 cables... 332 Nellcor disposable sensors... 332 Nellcor reusable sensors... 332 Dräger disposable sensors... 333 Dräger reusable sensors... 333 Index... 335

Instructions for use Infinity CentralStation SW VG1 and M300

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Instructions for use Infinity CentralStation SW VG1 and M300

Indications/Intended use

Indications/Intended use Infinity CentralStation with Infinity M300 Indications/Intended use... 20 Contraindication... 20

Instructions for use Infinity CentralStation SW VG1 and M300

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Indications/Intended use

Infinity CentralStation with Infinity M300 Indications/Intended use The Infinity CentralStation (ICS) is intended for use by trained healthcare professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation. Infinity CentralStation with Rest ECG is intended for the production and interpretation of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12Lead ECG monitoring enabled. The Infinity M300 is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network. The Infinity M300 with TruST is intended for 12Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for realtime assessment of ST segment changes.

Contraindication The Infinity M300 is not compatible for use in an MRI magnetic field.

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Instructions for use Infinity CentralStation SW VG1 and M300