Infinity M540 Patient Monitor SW VG2 Ed1 Instructions for Use Dec 2013

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. –

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

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 Menu. The "greater than" symbol > indicates the navigation path in a dialog window, for example, Menu > Patient setup > Admit date. In this example, Menu represents the function key, Patient setup represents a horizontal tab, and Admit date a menu selection.

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Instructions for use Infinity Acute Care System – Infinity M540 VG2

Trademarks –

Acute Care SystemTM

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Durasensor®

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DrägerService®

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Nellcor®

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Infinity®

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OxiMax®

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Hemo4®

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OxiCliq®

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Hemo2®

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OxiBandTM

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Innovian®

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SoftCare®

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MCable®

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SatSeconds®

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Medical CockpitTM

are trademarks of Covidien.

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MPod®

–

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MonoLead®

is a trademark of Cardinal Health, Inc.

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TruST®

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are trademarks of Dräger.

ComplianceTM Dismozun®pur

is a trademark of BODE Chemie GmbH.

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Masimo®

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Sporox II®

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Masimo SET® (Signal Extraction Technology)

is a trademark of Sultan Healthcare, Inc.

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Masimo Rainbow® SET

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PVI®

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SET®

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SpCO®

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SpHb®

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SpMet®

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SpOCTM

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Pulse CO-Oximeter TM

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M-LNCS TM

are trademarks of Masimo corporation.

Instructions for use Infinity Acute Care System – Infinity M540 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.

Definition of target groups For this product, users, service personnel, and experts are defined as target groups. These target groups must have received instruction in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product. The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target groups. Users Users are persons who use the product in accordance with its intended use.

Service personnel Service personnel are persons who are responsible for the maintenance of the product. Service personnel must be trained in the maintenance of medical devices and install, reprocess, and maintain the product. Experts Experts are persons who perform repair or complex maintenance work on the product. Experts must have the necessary knowledge and experience with complex maintenance work on the product.

Abbreviations and symbols For explanations, refer to the sections "Abbreviations" on page 32 and "Device symbols" on page 30.

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Instructions for use Infinity Acute Care System – Infinity M540 VG2

For your safety and that of your patients

For your safety and that of your patients Strictly follow these instructions for use... Storing the instructions for use... Training... Maintenance... Safety checks... The medical device must be subject to regular safety inspections. See chapter "Maintenance"... Accessories... Installing accessories... Sterile accessories... Restrictions for use... Restriction of distribution... Connected devices... Safe connection with other electrical equipment... Networking and connection to other devices . . Connection to hospital network... Patient safety... Patient monitoring...

6 6 6 6 7

General safety information...

9

7 7 7 7 7 7 7 7 8 8 8 9

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

Instructions for use Infinity Acute Care System – Infinity M540 VG2

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For your safety and that of your patients

Strictly follow these instructions for use

Training

NOTE The Infinity Acute Care System provides the following additional instructions for use:

Training for users is available from the responsible Dräger organization, see www.draeger.com.

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Infinity Acute Care System – Monitoring applications (describes the Cockpit user interface of the IACS)

Maintenance

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Infinity Acute Care System – Medical Cockpit (describes the hardware of the Cockpit)

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Infinity Acute Care System – Monitoring accessories (describes all of the IACS accessories).

Please refer to these additional instructions for use for device-specific information. WARNING Risk of incorrect operation and of incorrect use. Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under ’Application’ 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 Risk of medical device failure and of patient injury. The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device must be performed by experts. If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Maintenance". Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. For maintenance Dräger recommends the use of authentic Dräger repair parts. WARNING Any changes or modifications to the device hardware or software have to be exclusively done by service technicians authorized by Dräger. Any non-authorized change can decrease patient safety, could void the user's authority to operate the equipment and will void the warranty.

Storing the instructions for use WARNING Risk of incorrect use Instructions for use must be kept accessible for the user.

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Instructions for use Infinity Acute Care System – Infinity M540 VG2

For your safety and that of your patients

Safety checks

Restrictions for use

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

CAUTION Device for use in health care environments only and exclusively by persons as defined in the target groups (see "Maintenance" on page 6).

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

Installing accessories CAUTION Risk of device failure 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. Strictly observe instructions for use and assembly instructions.

Sterile accessories CAUTION Risk of medical device failure and of patient injury. Do not use sterile-packaged accessories if the packaging has been opened, is damaged or if there are other signs of non-sterility. Single-use accessories must not be reused, reprocessed, or resterilized.

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

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 can compromise the correct functioning of the medical device and lead to electric shock. Before operating the medical device, strictly comply with the instructions for use of 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 the assembly instructions must only be made when approved by each respective manufacturer.

Instructions for use Infinity Acute Care System – Infinity M540 VG2

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For your safety and that of your patients

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.

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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 IEC 80001-1 before attempting to connect such medical devices to their IT networks. IEC 80001-1 requires manufacturers such as Dräger to make technical documentation in support of such network connections available upon request. Contact your Dräger representative.

Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. These instructions for use do not contain any information on the following points: –

Risks that are obvious to users

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Consequences of obvious improper use of the medical device

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Potentially negative effects on 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 – Infinity M540 VG2

For your safety and that of your patients

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

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

General safety information The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these instructions for use or in the instructions for use of another product being used with this medical device. 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. 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 289 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 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.

Instructions for use Infinity Acute Care System – Infinity M540 VG2

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For your safety and that of your patients

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.

WARNING

WARNING Risk of fire

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

The medical device is not approved for use in areas where combustible or explosive gas mixtures are likely to occur.

Site of operation

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.

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 331. Portable and mobile radio frequency communications equipment can affect medical electrical equipment.

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.

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Instructions for use Infinity Acute Care System – Infinity M540 VG2

For your safety and that of your patients

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 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.

Electrosurgery 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 M540 and the peripheral devices are protected against high-frequency interference from defibrillators and electrosurgical units and against 50- 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.

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. WARNING To reduce the hazard of burns during electrosurgery, keep the sensor of transducer (ECG, pressure) 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.

Instructions for use Infinity Acute Care System – Infinity M540 VG2

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Instructions for use Infinity Acute Care System – Infinity M540 VG2

Contents

Contents Screen images... Definition of target groups...

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For your safety and that of your patients. . .

5

Strictly follow these instructions for use . . . 6 Storing the instructions for use... 6 Training... 6 Maintenance... 6 Safety checks... 7 The medical device must be subject to regular safety inspections. See chapter "Maintenance"... 7 Accessories... 7 Installing accessories... 7 Sterile accessories... 7 Restrictions for use... 7 Restriction of distribution... 7 Connected devices... 7 Safe connection with other electrical equipment... 7 Networking and connection to other devices... 8 Connection to hospital network... 8 Patient safety... 8 Patient monitoring... 9 General safety information... 9 Not for use in areas of explosion hazard . . 10 Information on electromagnetic compatibility... 10 Site of operation... 10 Defibrillator precautions... 11 Electrosurgery... 11 Contents... 13 Application... 19 Intended use... 20 Indications for use... 21 Overview... 23 Overview of Infinity M540... 24 M540 front panel... 25 M540 back panel... 26 M540 side panel... 26 M500 docking station... 27

M500 front panel... M500 back panel... M540 docked in the M500... Additional hardware... Device symbols... Wireless symbols... Abbreviations...

27 27 28 28 30 31 32

Operating concept...

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Overview... M540 in standalone / wireless mode... Configuration changes while on wireless transport... Bed label setting... Network status symbol... M540 in an IACS configuration... Communicating with the Infinity network... ICS (Infinity CentralStation) communication . . Audio pause feature... Network communication interruptions... Remote view and remote control... Function keys... Default function key assignments... Alternate function key assignments... Monitoring area... Header bar... Parameter boxes... Waveforms... Dialog windows... Adjusting the display... Calibrating the touch screen... Battery power... Battery charging times... Battery operating times... Low battery conditions... Power-saving mode... Views... Selecting a view... Profiles... Settings included in a profile... Alarm profile settings... CO2 profile settings... Heart rate and arrhythmia profile settings . ST profile settings...

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Instructions for use Infinity Acute Care System – Infinity M540 VG2

37 38 38 39 39 40 41 41 42 44 44 45 45 45 46 46 47 48 48 49 49 49 49 50 50 50 51 52 52 53 54 55 13

Contents

Respiration (RRi) profile settings... 55 SpO2 (Masimo) profile settings... 56 Pulse CO-Ox (Masimo) profile settings . . . 57 SpO2 (Nellcor) profile settings... 57 Non-invasive blood pressure profile settings... 58 Temp profile settings... 58 Invasive blood pressure profile settings . . . 59 Monitor settings... 60 Settings not included in a profile... 61 Saving a profile... 62 Profile behavior in an IACS configuration... 62 Profile behavior in a standalone configuration . 63 Profile adoption... 64 Different profile configurations... 64 Use-case scenario... 65 Standby mode... 66 Privacy mode... 66 Recordings/reports... 67 Timed, continuous, and stored recordings . 67 Rest ECG reports... 68 Assembly and preparation... 69 Overview... Commercially available M500 mounting solutions... Docking/undocking the M540... M500 front view with M540 docked... M500 side view (M540 undocked)... Locking/unlocking the M540... Connecting the system cables in an IACS configuration... Connecting the system cable in an M540 stand-alone configuration... Mounting the Infinity MCable – Masimo SET and Masimo rainbow SET/Nellcor OxiMax...

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Getting started... 77 Overview of monitoring a patient... Turning the M540 on/off... Admitting a patient... Admitting a patient using ’Get HIS’... Discharging a patient... Patient categories... Selecting a new patient category...

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Alarms...

83

Overview of alarms... 84 Alarm priorities... 84 High-priority alarm conditions... 84 Medium-priority alarm conditions... 84 Low-priority alarm conditions... 84 Alarm processing... 85 Latching and non-latching alarm behavior. 85 Multiple alarm conditions... 85 Activating or deactivating alarm validation . . . 86 Visual alarm signals... 87 Alarm bar... 88 Acoustic alarm signals... 89 Adjusting the alarm tone... 90 Testing visual and acoustic alarm signals... 90 Special alarm behavior... 91 Arrhythmia/ventricular fibrillation alarms . . 91 SpO2 desaturation alarm feature... 91 NIBP/SpO2 interlock alarm feature... 91 Zeroing invasive blood pressures... 92 Privacy mode... 92 Standby mode... 93 OR mode... 93 Cardiac bypass mode... 93 French NFC mode... 93 Pre-silencing alarms... 94 Central audio pause feature... 94 Initiating a pre-silence period... 95 Pausing acoustic alarm signals (audio pause) 96 Pausing alarms at the M540... 96 Central audio pause feature... 97 Pausing alarm monitoring temporarily... 98 Activating or deactivating alarm monitoring. . . 99 Configuring a patient’s alarm settings... 100 Setting the upper and lower alarm limits . . 100 Using the Auto set function... 101 Activating/deactivating alarms... 102 Archive function... 102 Event recall... 103 Viewing stored events... 104 Viewing a snapshot of a single event... 105 Configuring the SpO2 alarm priority... 106 Configuring the alarm priority for the Masimo sensor off message... 106 Configuring the alarm condition for the Nellcor check sensor message... 106 Alarm management setup (passwordprotected)... 107

Instructions for use Infinity Acute Care System – Infinity M540 VG2

Contents

The Code function key... 107 Alarm groups... 107 Alarm ranges and defaults... 108 Arrhythmia ranges and defaults... 114 ECG, arrhythmia, and ST segment... 117 Overview of ECG and heart rate monitoring. . . 119 ECG signal processing and display... 119 Supported parameters... 119 ECG precautions... 120 Connecting the 3-, 5-, 6-lead wire sets for ECG monitoring... 121 Connecting the lead wire sets for 12-lead ECG monitoring... 122 Connecting the lead wires for neonatal ECG monitoring... 123 Patient preparation for ECG monitoring... 124 Electrosurgery... 124 ECG display... 125 ECG parameter box... 125 ECG waveforms... 125 ECG electrode colors... 126 Electrode placement... 126 Standard configuration, three electrodes (IEC/AHA)... 126 Standard configuration, five electrodes (IEC/AHA)... 127 Pacer configuration, five electrodes (IEC/AHA)... 127 Standard configuration, six electrodes (IEC/AHA)... 128 12-Lead configuration, ten electrodes for 12-lead Rest ECG monitoring (AHA)... 128 12-Lead configuration, ten electrodes for 12-Lead Rest ECG monitoring (IEC)... 129 12-lead monitoring... 129 Accessing the ECG dialog window... 130 ECG parameter setup functions... 130 Monitoring paced patients... 134 Pacemaker precautions... 135 Pacer fusion mode... 135 Device interference with pacemaker monitoring... 136 Optimizing pacer processing... 137 Arrhythmia monitoring overview... 137 Selecting arrhythmia leads... 138 Arrhythmia modes... 139 Arrhythmia display... 141

Arrhythmia basic parameter box... 141 Accessing the arrhythmia dialog window... 142 Arrhythmia parameter setup functions... 142 Monitoring ST overview... 143 Standard ST monitoring... 143 TruST 12-lead monitoring... 144 12-Lead ST monitoring... 144 Connecting lead wire sets for ST monitoring. . 145 ST display... 145 ST complex dialog windows... 146 Zooming in on a single ST complex... 146 ST measuring points... 147 Adjusting ST measuring points... 147 ST reference... 147 Saving ST reference... 147 Accessing the ST dialog window... 148 ST setup functions... 148 Learning/relearning QRS pattern... 150 Manual relearning... 150 Impedance respiration (RRi)... 151 Overview of respiration monitoring... 152 Supported parameters... 152 RRi precautions... 152 Connecting the 3-, 5-, 6-lead wire sets for respiration monitoring... 153 Connecting the lead wire sets for 12-lead respiration monitoring... 154 Connecting the lead wires for neonatal respiration monitoring... 155 Patient preparation for respiration monitoring . 156 Respiration display... 158 Respiration parameter box... 158 Respiration markers... 158 Respiration measuring modes... 159 Accessing the respiration dialog window... 159 Respiration parameter setup functions... 160 SpO2 and Pulse CO-Ox monitoring with Masimo SET MCable... 163 Overview of SpO2 monitoring... 164 Supported parameters... 164 SpO2 and Pulse CO-Ox precautions... 166 Connecting the Masimo SET MCable... 168 Connecting the Masimo rainbow SET MCable... 169 Patient preparation... 170 Applying the sensor... 170

Instructions for use Infinity Acute Care System – Infinity M540 VG2

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Contents

SpO2 and Pulse CO-Ox display... 171 Accessing the SpO2 dialog window... 173 SpO2 parameter setup functions... 174 Accessing the Pulse CO-Ox dialog window . . . 177 Pulse CO-Ox parameter setup functions... 177 Password-protected Masimo rainbow SET setup functions... 180 SpO2 and pulse rate monitoring with Nellcor OxiMax MCable... 181 Overview of SpO2 monitoring... 182 Supported parameters... 182 SpO2 precautions... 183 Connecting the Nellcor OxiMax MCable... 184 Patient preparation for SpO2 monitoring... 185 Applying the sensor... 185 SpO2 display... 186 Accessing the SpO2 dialog window... 187 SpO2 parameter setup functions... 188 Temperature... 191 Overview of temperature monitoring... 192 Supported parameters... 192 Connecting the temperature sensors... 192 Connecting the temperature sensors to the M540... 193 Connecting the temperature sensors to the hemodynamic pods... 194 Temperature display... 195 Temperature parameter box... 195 Accessing the temperature dialog window... 196 Temperature parameter setup functions... 196 Non-invasive blood pressure (NIBP)... 197 Overview of non-invasive blood pressure monitoring... 198 Supported parameters... 198 Non-invasive blood pressure precautions... 199 Connecting the non-invasive blood pressure hose and cuff... 200 Patient preparation for non-invasive blood pressure monitoring... 201 Applying the non-invasive blood pressure cuff... 201 Non-invasive blood pressure display... 202 Non-invasive blood pressure measurement modes... 203 16

Single measurement mode... 203 Interval measurements mode... 203 Continuous measurements... 204 Venous stasis... 205 Activating or deactivating venous stasis . . 206 Accessing the non-invasive blood pressure dialog window... 206 Non-invasive blood pressure parameter setup functions... 207 Invasive blood pressure (IBP)... 209 Overview of invasive blood pressure monitoring... 210 Supported parameters... 210 Invasive blood pressure pods... 210 Invasive blood pressure precautions... 212 Connecting the Hemo4 and Hemo2 pods... 213 Connecting the MPod – QuadHemo... 214 Connecting the Dual Hemo MCable... 215 Preventing fluid ingress... 215 Patient preparation for invasive blood pressure monitoring... 216 Invasive blood pressure display... 216 Invasive blood pressure parameter box. . . 216 Labeling Invasive blood pressure channels . . 217 Standard pressure labels... 218 Pressure label conflicts... 219 Pod-M540 label conflicts... 219 Zeroing an invasive blood pressure transducer... 219 Zeroing a specific transducer... 219 Zeroing all pressure transducers... 220 Pulmonary wedge pressure... 221 Accessing the invasive blood pressure dialog window... 221 Invasive blood pressure parameter setup functions... 222 Cardiac Output (C.O.)... 223 Overview of cardiac output monitoring... 224 Cardiac output measurement method... 224 Supported parameters... 224 Cardiac output precautions... 224 Connecting the cardiac output hardware... 225 Patient preparation for cardiac output monitoring... 227

Instructions for use Infinity Acute Care System – Infinity M540 VG2

Contents

Carbon Dioxide Concentrations (CO2)... 229

Maintenance... 283

Overview of CO2 monitoring... 230 Supported parameters... 230 CO2 precautions... 230 Connecting the CO2 sensor... 232 Patient preparation for CO2 monitoring... 233 CO2 display... 234 CO2 parameter box... 234 CO2 waveform (capnogram)... 234 Troubleshooting... 234 Accessing the CO2 dialog window... 236 CO2 parameter setup functions... 236

Overview... 284 Definition of maintenance concepts... 285 Inspection... 285 Visual inspection... 285 Inspection / safety checks... 286 Scope of inspection/safety checks for the M540... 286 Metrological checks... 286 Preventive maintenance... 287

System configuration... 239 System configuration overview... 240 Configuring general settings... 241 Configuring the patient settings... 242 Configuring the system settings... 243 Accessing the system information... 243 Accessing the Alarm setup dialog window . 244 Accessing the configurable SpO2 alarm features... 247 Viewing the system information... 248 Configuring the biomed settings... 250 Configuring units of measure... 252 Configuring the M500 setup... 253 Configuring the wireless network setup . . . 254 Configuring the screen setup... 256 Configuring alarm settings... 257 Options... 258 Temporary options... 258 Problem solving... 259 Overview... 260 Device communication messages / general device messages... 260 M540 battery messages... 262 ECG... 263 ST... 264 Arrhythmia... 266 Respiration (RRi)... 267 SpO2... 269 Non-invasive blood pressure... 274 Cardiac output... 276 Temperature... 277 Invasive blood pressure... 278 CO2... 280

Cleaning and disinfection... 289 Overview of cleaning and disinfecting the M540 and its accessories... 290 Cleaning and disinfecting precautions... 290 Approved cleaning agents... 291 Cleaning and disinfecting the M540, M500, and power supply... 292 M540, M500, and power supply precaution... 292 Cleaning and disinfecting an MCable and MPod... 293 MCable precautions... 293 Cleaning and disinfecting patient cables... 294 Patient cable precautions... 294 Cleaning and disinfecting reusable ECG lead wires... 294 Cleaning and disinfecting temperature sensors and cables... 295 Temperature probe and cable precautions... 295 Cleaning non-invasive blood pressure cuffs . . 296 Non-invasive blood pressure precaution . . 296 Cleaning and disinfecting invasive blood pressure transducers and hemodynamic pods... 296 Transducers... 296 Cleaning and disinfecting mainstream CO2 sensors and airway adapters... 297 Mainstream sensors and airway adapters precaution... 297 Disposal... 299 EU Directive 2002/96/EC (WEEE)... 300 M540, M500 and instructions for use... 300

Instructions for use Infinity Acute Care System – Infinity M540 VG2

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Contents

Technical data... 301 Overview... 302 Infinity M540... 303 Infinity M500... 306 Power supply (PS50)... 307 Infinity MCable – Mainstream CO2... 308 Infinity MCable – Masimo SET and Infinity MCable – Masimo rainbow SET... 309 Infinity MCable – Nellcor OxiMax... 310 Infinity Hemo2 and Hemo4 pods... 311 Infinity MPod – Quad Hemo... 312 Infinity MCable – Dual Hemo... 313 Infinity MCable – Analog/Sync... 314 Infinity MCable – Nurse call... 316 Parameter monitoring specifications... 317 ECG... 317 ECG/Arrhythmia/ST supplemental information required by ANSI/AAMI EC13:2002 and IEC 60601-2-27:2005... 318 Arrhythmia (ARR)... 319 ST segment analysis... 319 Respiration (RRi)... 320 Invasive blood pressure (IBP)... 320 Non-invasive blood pressure (NIBP)... 321 Cardiac Output (C.O.)... 323 Pulse Oximetry (SpO2) Infinity MCable – Masimo SET and Infinity MCable – Masimo rainbow SET... 324 Pulse oximetry (SpO2) Infinity MCable – Nellcor OxiMax... 327 Carbon dioxide concentrations (CO2)... 329 Temperature... 330 Electromagnetic compatibility... 331 General notes... 331

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Instructions for use Infinity Acute Care System – Infinity M540 VG2

Application

Application Intended use... 20 Indications for use... 21

Instructions for use Infinity Acute Care System – Infinity M540 VG2

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Application

Intended use The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient information obtained from connected hardware in environments where patient care is provided by trained health care professionals.The M540 is intended to monitor one patient at a time. The M540 is also intended for patient transport inside the hospital or outside the hospital in a land ambulance. For land ambulance transport, the battery-operated M540 patient monitor supports ECG, SpO2, Temperature, and Mainstream etCO2. Tests were performed in accordance with the following standards: EN1789, EMC (IEC 60601-1-2). EMC and environmental requirements may vary from country to country according to local regulatory standards and directives.

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This device is not approved for land ambulance use in the United States and Canada. The M540 and any connected hardware are not intended for use in the following hospital environments: –

Hyperbaric chambers

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Environments containing MRI equipment

NOTE The Dräger wireless 802.11 b/g radio card complies with part 15 of the FCC rules. Operation is subject to the following two conditions: –

This device may not cause harmful interference.

–

This device must accept any interference received, including interference that may cause undesired operation.

Instructions for use Infinity Acute Care System – Infinity M540 VG2