Philips Medical Systems North America WLANBV3 WLAN Module IEEE 802.11 a/b/g/n User Manual 865221 english
Philips Medical Systems North America Co. WLAN Module IEEE 802.11 a/b/g/n 865221 english
Contents
- 1. User manual
- 2. user_manual mp2 english
- 3. user manual 865221 english
user manual 865221 english
In stru ctio ns fo r Use IntelliVue Cableless Measurements CL SpO2 Pod – CL NBP Pod – CL Respiration Pod Rel ease D.00 Patient Monitori ng 1 Table of Contents 1 Introduction and Basic Operation Safety Information Security Information Introducing the IntelliVue Cableless Measurements 2 IntelliVue CL SpO2 Pod General Operation of the SpO2 Pod Connection with Host Systems Monitoring SpO2 Alarms Local Attended Monitoring SpO2 Default Settings Integrated Battery Handling Accessories Maintenance and Troubleshooting 3 IntelliVue CL NBP Pod General Operation of the NBP Pod Connection with Host Systems Monitoring NBP Alarms Local Attended Monitoring NBP Default Settings Integrated Battery Handling Accessories Maintenance and Troubleshooting 4 IntelliVue CL Respiration Pod General Operation of the Respiration Pod Connection with Host Systems Monitoring Respiration Technical Alarms (INOPs) Respiration Default Settings Integrated Battery Handling Accessories Maintenance and Troubleshooting 5 Cableless Measurement Auxiliary Devices IntelliVue CL Transmitter and IntelliVue CL Hotspot IntelliVue CL Transmitter Base Station 10 13 13 20 28 34 43 49 50 52 53 55 55 62 69 77 86 91 92 93 97 99 99 100 104 108 109 110 111 112 113 113 117 IntelliVue CL Charging Station Maintenance and Troubleshooting 118 119 6 Care and Cleaning 121 General Points Cleaning and Disinfecting the IntelliVue Cableless Measurement Devices Disposing of the IntelliVue Cableless Measurement Devices 7 Specifications Indications for Use Compatible Medical Devices Symbols Manufacturer's Information Regulatory and Safety Specifications EMC and Radio Regulatory Compliance Safety and Performance Tests Electromagnetic Compatibility (EMC) Accessories Compliant with EMC Standards Electrosurgery Interference/Defibrillation IntelliVue CL SpO2 Pod Specifications IntelliVue CL NBP Pod Specifications IntelliVue CL Respiration Pod Specifications Alarm Specifications for CL NBP, CL SpO2 and CL Resp Pod Telemetry Device Battery Runtime Specifications IntelliVue CL Transmitter Specifications IntelliVue CL Transmitter Base Station Specifications IntelliVue CL Hotspot Specifications Index 121 122 123 125 125 127 127 129 129 130 132 132 133 133 133 135 138 140 141 141 143 144 147 1 Introduction and Basic Operation These Instructions for Use are for clinical professionals using the IntelliVue Cableless Measurements and their specified compatible accessories. IntelliVue Cableless Measurements refers to the IntelliVue Cableless Measurements product family consisting of the IntelliVue CL SpO2 Pod (865215), IntelliVue CL NBP Pod (865216) and IntelliVue CL Respiration Pod (865218) with their accessories. Also included are the auxiliary devices: the IntelliVue CL Charging Station (865220), IntelliVue CL Transmitter (865221), IntelliVue CL Transmitter Base Station (865237) and IntelliVue CL Hotspot (865222). The IntelliVue Cableless Measurements are used for monitoring and recording arterial oxygen saturation, pulse rate, noninvasive blood pressure and respiration rate of adult and pediatric patients. Familiarize yourself with all instructions including warnings and cautions, and attend one of the training courses, before starting to make measurements with patients. Read and keep the Instructions for Use that come with any accessories, as these contain important information about care and cleaning that is not repeated here. When using the IntelliVue Cableless Measurements with an IntelliVue Patient Monitor, an Avalon Fetal Monitor, a telemetry system or IntelliVue GuardianSoftware, refer to and adhere to all warnings in the Instructions for Use of the respective device or software. This guide may contain descriptions of functionality and features that are not implemented in the equipment currently shipped to Japan and/or of products that are not currently sold in Japan due to limitations and restrictions under the applicable local laws and regulations in Japan. Please contact your local sales representative and/or Philips Customer Support for details. In these Instructions for Use: • A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient. • A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury. Display refers to the physical display of the Cableless Measurement Device. Screen refers to everything you see on the IntelliVue Cableless Measurement's display, such as measurement values, patient data and so forth. IntelliVue CL Transmitter/WLAN functionality may not be available in all countries. 1 Introduction and Basic Operation Safety Information Use Environment WARNING • If a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are not transmitted to the patient monitor or the Information Center. Keep the patient monitor with the patient during transport. • Always make sure that the applied pod is assigned to the correct patient. Electrical Hazards WARNING • Electrical shock hazard: Do not open the device housing. Refer all servicing to qualified service personnel. • Always use the supplied power cord with the grounded mains plug to connect the charging station to a grounded AC mains socket. Never adapt the mains plug from the charging station to fit an ungrounded AC mains socket. • Do not use AC mains extension cords or multiple portable socket outlets. If a multiple portable socket outlet without an approved isolation transformer is used, the interruption of its protective grounding may result in enclosure leakage currents equal to the sum of the individual ground leakage currents, so exceeding allowable limits. • Do not connect any devices that are not supported as part of a system. Radiofrequency Interference WARNING • Short Range Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP on the NBP or SpO2 Pods, or a cl NBP Disconnect, cl SpO₂ Disconnect or cl Resp Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the Configuration Guide for details. Battery Handling WARNING • Do not crush or puncture - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally. • Do not incinerate the devices or expose them to temperatures above 60°C (140°F). 1 Introduction and Basic Operation Accessories WARNING • Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard, in particular with regard to cross-contamination. • Philips’ approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance and cause a potential hazard. • Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the IntelliVue Cableless Measurement Devices. Maintenance WARNING • Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. • Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. • If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient, contact your service personnel. Care, Cleaning and Disposal WARNING • If you spill liquid on the equipment, or if the equipment is accidentally immersed in liquid, contact your service personnel or Philips service engineer. Do not operate the equipment before it has been tested and approved for further use. • Do not use flammable agents for disinfecting the equipment in an oxygen-enriched environment, as this might lead to sudden ignition of vapors, resulting in injury to the patient or staff. • To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the IntelliVue Cableless Measurement Devices appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories, where not otherwise specified, follow local regulations regarding disposal of hospital waste. 1 Introduction and Basic Operation Security Information Protecting Personal Information Protecting personal health information is a primary component of a security strategy. Each facility using the devices must provide the protective means necessary to safeguard personal information consistent with country laws and regulations, and consistent with the facility’s policies for managing this information. Protection can only be realized if you implement a comprehensive, multi-layered strategy (including policies, processes, and technologies) to protect information and systems from external and internal threats. As per their intended use, the devices operate in the patient vicinity and contain personal and sensitive patient data. They also include controls to allow you to adapt the devices to the patient's care model. To ensure the patient's safety and protect their personal health information you need a security concept that includes: • Physical security access measures - access to the devices must be limited to authorized users. It is essential that you consider physical security measures to ensure that unauthorized users cannot gain access. • Operational security measures - for example, ensuring that devices are powered off after monitoring in order to remove patient data from the device. • Procedural security measures - for example, assigning only staff with a specific role the right to use the devices. In addition, any security concept must consider the requirements of local country laws and regulations. Always consider data security aspects of the network topology and configuration when connecting devices to shared networks. Your medical facility is responsible for the security of the network, where sensitive patient data from the monitor may be transferred. When a device is returned for repair, disposed of, or removed from your medical facility for other reasons, always ensure that all patient data is removed from the device by powering it off. NOTE Log files generated by the devices are used for system troubleshooting and do not contain protected health data. About HIPAA Rules If applicable, your facility’s security strategy should include the standards set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), introduced by the United States Department of Health and Human Services. You should consider both the security and the privacy rules and the HITECH Act when designing policies and procedures. For more information, please visit: http://www.hhs.gov/ocr/privacy/ About the EU Directives If applicable, your facility’s security strategy should include the practices set forth in the Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data (Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995). In addition, your facility should also take into account any additional applicable regulation or statutory requirement. Philips Product Security Policy Statement Additional security and privacy information can be found on the Philips product security web site at: http://www.usa.philips.com/healthcare/about/customer-support/product-security 1 Introduction and Basic Operation Manufacturer Disclosure Statement for Medical Device Security – MDS2 You can view the Manufacturer Disclosure Statements for Medical Device Security (MDS2) for specific devices at: http://www.usa.philips.com/healthcare/about/customer-support/product-security 1 Introduction and Basic Operation Introducing the IntelliVue Cableless Measurements The IntelliVue Cableless Measurement Devices provide measurement values and communicate them to other system components using a wireless short range radio (SRR) interface. Introduction IntelliVue CL SpO2 Pod IntelliVue CL NBP Pod The IntelliVue CL SpO2 Pod is a battery powered, cableless Pulse Oximetry measuring device. The IntelliVue CL NBP Pod is a battery powered, cableless, noninvasive blood pressure (NBP) measuring device. IntelliVue CL Respiration Pod The IntelliVue CL Respiration Pod is a battery powered, cableless device for measuring respiration rate and, optionally, pulse. It also provides basic information about patient posture and activity. 10 1 Introduction and Basic Operation Basic Operation IntelliVue CL SpO2 Pod and IntelliVue CL NBP Pod The IntelliVue CL SpO2 Pod and the IntelliVue CL NBP Pod can be used together with IntelliVue Patient Monitors MP5/MP5SC/MP5T, MP2/X2, IntelliVue Telemetry System Transceivers TRx4841A/ TRx4851A, MX40 wearable patient monitors, Avalon Fetal Monitors, and IntelliVue GuardianSoftware. Both devices have an LC display and three keys for basic operation: Integrated monochrome LC display Hardkeys Measurement identifier IntelliVue CL Respiration Pod The IntelliVue CL Respiration Pod can be used together with IntelliVue Patient Monitors MP5/MP5SC/ MP5T, MP2/X2, or IntelliVue GuardianSoftware. The device has one multi-color LED for status display and one hardkey for basic operation, e.g. to start a measurement. Multi-color LED Measurement identifier Hardkey Indication for built-in RFID tag 11 1 Introduction and Basic Operation 12 2 IntelliVue CL SpO2 Pod The IntelliVue CL SpO2 Pod is a wrist-worn device; you need a Mobile CL SpO2 Cradle to hold the sensor connector in place and a wristband to fix the cradle to a patient's arm. Specialized single-patient SpO2 sensors are available for use with the IntelliVue CL SpO2 Pod. For details regarding the complete set of single-patient supplies, cradle, wristband and sensors, refer to “IntelliVue CL SpO2 Pod Accessories” on page 52. General Operation of the SpO2 Pod The following sections describe operation on the SpO2 Pod itself. For operation from a patient monitor, see “Controls Available with a Patient Monitor” on page 25. For operation from an Information Center via a telemetry system, see “Controls Available with a Telemetry Device” on page 26. For operation with IntelliVue GuardianSoftware, see “Controls Available with GuardianSoftware” on page 27. The SpO2 Pod has three hardkeys for basic operation and a set of configurable SmartKeys which appear on the screen. These are used to activate and navigate through the on-screen menus and to select individual items. The typical operator's position is such that everything on the device's display can be read clearly and easily. Switching the Device On The first time an SpO2 Pod is used, or after the device has been powered off for storage, place it on the IntelliVue CL Charging Station. This will automatically switch the device on. If the SpO2 Pod has only been switched off temporarily (see “Switching the Device Off” on page 17), press any hardkey to turn the device on again. When an SpO2 Pod is not operated, it will automatically switch off the screen lighting after a short time. A little later the low-activity screen will be displayed. 13 2 IntelliVue CL SpO2 Pod Screen Layout There are three variations of the Main Screen layout depending on the Alarm status and the general activity level. Standard Layout When assigned to a monitor, telemetry device or a patient in GuardianSoftware: Connection status indicator Indicator that alarming capability has been transferred to the host (to the monitor or, for the telemetry device, to the Information Center). No patient alarms will be announced on the Cableless Measurement Device. Battery indicator Measurement values Measurement-related symbols (see the “Monitoring SpO2” section for details) Patient identification When not assigned to a monitor or telemetry device: Connection status indicator Battery indicator Measurement values Measurement-related symbols (see the “Monitoring SpO2” section for details). The Alarms Off symbols indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host. Cableless Measurement Device equipment label Alarm Layout If an alarm occurs the full alarm message appears at the top of the screen. After the alarm message has been silenced the alarm indicator is shown as a symbol on the right side of the screen. 14 Full length alarm message Alarm indicator 2 IntelliVue CL SpO2 Pod Low-Activity Screen If the Cableless Measurement Device has not been operated for a while, the screen lighting will switch itself off and a little later the screen will switch to a pre-configured "low-activity" screen. When a Cableless Measurement Device Cannot be Activated If you cannot activate a device by pressing a key, place it on the IntelliVue CL Charging Station. The device becomes active. Check the battery status. If necessary, leave the device on the charger until the battery is fully charged. Using the Hardkeys The IntelliVue Cableless Measurement Devices have three hardkeys: ◄, , ►. Use ◄ and ► to navigate through SmartKeys and menus and to select items or to silence alarms. The three hardkeys also have an additional function when the key is held down for a couple of seconds: ◄ opens the Add To screen to assign a device (or to unassign it when it is already assigned) opens the SmartKeys menu ► returns to the Main Screen. If already on the Main Screen, it locks the keys and a lock symbol appears on the screen above the battery symbol. If keys are already locked, it unlocks the keys and the lock symbol disappears Using the SmartKeys A SmartKey is a graphical key which appears on the screen and gives you fast access to functions. SmartKeys Menu Press the hardkey (without any screen element highlighted) to get to the SmartKeys menu. Use the ◄ and ► hardkeys to move along the row of SmartKeys. The highlighted SmartKey is displayed in full above the row of SmartKeys. When you use the ◄ or ► hardkey at the end of the row, an Exit screen appears and then with further presses you move on to the next page of SmartKeys. To leave the SmartKeys menu you can use the Exit screen or press the ► hardkey for a couple of seconds to return to the Main Screen. When the required SmartKey is highlighted, press the key to activate the corresponding function. To get to the next page of the SmartKeys menu, highlight the rightmost SmartKey then press the ► key. 15 2 IntelliVue CL SpO2 Pod List of Available SmartKeys SmartKey Text Labels Main Setup start an SpO2 measurement set the SpO2 mode Add/Remove device enter Battery menu enter Profiles menu change Screen put device in standby mode (or power off when pressed for more than two seconds) enter Patient menu enters the Alarms menu to access: Alarm Messages, Alarm Limits, Alarms On/ Off/Pause, Alarm Volume. Change alarm volume Change pulse tone volume 16 2 IntelliVue CL SpO2 Pod Using the Main Setup Menu In addition to the hardkeys and SmartKeys for the most needed functions, the Main Setup menu gets you to all settings that can be adjusted for the respective device. Select the Main Setup SmartKey to get to the Main Setup menu. Main Setup SpO₂ Pulse Alarms Patient Equipment User Interface Standby Profiles Operating Modes Date, Time Battery Revisions Switching the Device Off To put the device in standby mode, select the Standby SmartKey, then Confirm. If you keep Standby pressed for more than two seconds, you can choose between Standby or Power Off. • Standby • Power Off means that the device is switched off completely and can only be switched on again by putting it on a charger. Use this option when the device is not used for a longer time or prepared for storage or shipping. means that the display is switched off and the measurements are disabled. Use this option if your device is not used temporarily. Press any hardkey to turn the device on again. Auto Standby and Auto Power Off The device can be configured to automatically go into standby mode after a configurable time span of inactivity. When in standby mode, the device can be automatically powered off after a configurable time span. See the IntelliVue Cableless Measurements Configuration Guide for details on how to configure these settings. Operating Modes Your device has four operating modes. Some are passcode protected. • Monitoring Mode: This is the normal, every day working mode that you use for making measurements. You can change elements such as measurement modes, patient category and so forth. When you remove the patient from the device, these elements return to their default values. Changes can be stored permanently only in Configuration Mode. You may see items, such as some menu options, that are visible but 'grayed out' so that you can neither select nor change them. These are present for your information only and can be changed only in Configuration Mode. • Demonstration Mode: Passcode protected, this is for demonstration purposes only. You must not change into Demonstration Mode during monitoring. • Configuration Mode: Passcode protected, this mode is for personnel trained in configuration tasks. These tasks are described in the Configuration Guide. During installation the Cableless Measurement Device is configured for use in your environment. This configuration defines the default settings you work with when you switch on. 17 2 IntelliVue CL SpO2 Pod • Service Mode: Passcode protected, this is for trained service personnel. When you switch the device on, it starts up in monitoring mode. To change to a different mode: Use the Main Setup SmartKey to get to the Main Setup menu. Select Operating Modes and choose the mode you require. Using the Patient Menu The Patient menu allows you to see patient demographics information and to remove a patient from a device. Patient Demographic information is only displayed if the Cableless Measurement Device is assigned to a patient monitor or GuardianSoftware. Patient Category is the only item of patient data which can be changed at the Cableless Measurement Device, but only when the device is not assigned to a patient monitor or telemetry device. Displaying the Patient Menu To display the Patient menu, • select the Patient SmartKey, or • select the Main Setup SmartKey followed by Patient. Stop Using a Device for a Patient To remove a patient from the Cableless Measurement Device, • in the Patient menu select Free Device. All patient data is cleared, settings are reset to the defaults and the device is removed from the monitor or telemetry device. NOTE Depending on your configuration, when the device is put on the charger, patient data will also be cleared and the device will be free for another patient. Using the Device for a New Patient To use a device for a new patient, • in the Patient menu, select New Patient. If the device was not free, the existing data will be deleted and the profile set to the default. Using Profiles A profile is a set of measurement and general settings which have been customized for a particular purpose. The Cableless Measurement Devices can have four different profiles configured to your requirements. The default profile is marked with a symbol. To select a different profile, Select the Profiles SmartKey or the Main Setup SmartKey followed by Profiles. Select the required profile from the list. Selecting New Patient or Free Device will always reset the profile to the default. 18 2 IntelliVue CL SpO2 Pod Setting the Date and Time If the Cableless Measurement Device is assigned to a patient monitor, telemetry device or GuardianSoftware, the date and time will be taken from the host. If this is not the case, you can set the date and time on the Cableless Measurement Device, Select the Main Setup SmartKey and then Date, Time. Enter the data for date and time one after another. Select Store Date, Time. If the time has not been set, --:-- will display on the device. Battery Status The IntelliVue CL SpO2 Pods show their battery status on their display both in operating and charging condition. The battery status indicator is located in the lower right corner of the screen during operation and in the middle of the screen during charging. Battery Status Menu Select the Battery SmartKey or Main Setup followed by Battery using the ◄ and ► keys, then press the key to open the Battery menu. The Battery menu provides the following information: full-charge and remaining capacity, voltage, current and temperature. 19 2 IntelliVue CL SpO2 Pod Connection with Host Systems The following sections describe how the IntelliVue Cableless Measurement Devices work together with host systems (Patient Monitors, Fetal Monitors, Telemetry Devices / Information Center or GuardianSoftware). IntelliVue Cableless Measurements Use Models With these patient-worn measurement devices you can measure and transmit a patient's vitals regularly or on an intermittent data collection basis. There are four typical use models: With a Patient Monitor The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T, MP2 or X2 patient monitor (with an SRR interface). They can communicate their measurement values via short range radio to the monitor. The monitor may be assigned to a patient sector at the IntelliVue Information Center (IIC). When assigned to the Information Center, certain actions can be performed at both the patient monitor and the Information Center. See the table “Controls Available with a Patient Monitor” on page 25. In situations where patients are becoming more mobile (for example, in step-down/intermediate care units) the lightweight Cableless Measurement Devices allow increased mobility within the short range radio range, without giving up vital signs monitoring. When assigned to a patient monitor, the Cableless Measurement Device can be selected for use in patient transport at the patient monitor (for details see the Patient Monitor Instructions for Use). In this case, the Cableless Measurement Device will perform local attended monitoring. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See “Alarms” on page 34 for details. A telemetry device can be assigned to a patient monitor equipped with short range radio at the same time as any Cableless Measurement Devices are also assigned to this monitor. When assigned to a patient monitor, the admitted patient name is displayed on the SpO2 Pod. If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be displayed at the monitor: cl SpO₂ Disconnect. A No Host Monitoring INOP will be displayed on the SpO2 Pod, and an INOP tone will sound. In this case, visual and audible alarms are still available at the SpO2 Pod, but it is not possible to change the alarm settings. With a Fetal Monitor In combination with an Avalon CL Transducer System, the IntelliVue CL SpO2 Pod can be used together with an Avalon FM 20-50 Fetal Monitor. The SpO2 Pods are assigned to the fetal monitor by docking them at the Avalon CL Base Station. For information about Avalon Fetal Monitors, the Avalon CL Transducer System and the Avalon CL Base Station, please refer to the Avalon Fetal Monitor Instructions for Use. With a Telemetry Device The Cableless Measurement Devices can be assigned to a patient with the telemetry device TRx4841A/ TRx4851A or an MX40 wearable patient monitor. They can communicate their measurement values via short range radio to the telemetry device which communicates them to an IntelliVue Information Center to provide a consolidated set of patient values. Some of the measurement tasks can be performed remotely from the Information Center. See the table “Controls Available with a Telemetry Device” on page 26. If the patient name is available at the Information Center, it will be also displayed on the SpO2 Pod. 20 2 IntelliVue CL SpO2 Pod When a Cableless Measurement Device is assigned to a telemetry device, it is not possible for the telemetry device to be wirelessly assigned or directly connected to a patient monitor. If the connection between the telemetry device and the Cableless Measurement Device is lost, an INOP will be displayed at the Information Center: cl SpO₂ Disconnect. A No System Monitor. INOP will be displayed on the SpO2 Pod, and an INOP tone will sound. With IntelliVue GuardianSoftware The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware. GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter, Hotspot or MP5 from the Cableless Measurement Devices. Using the collected data, it provides trending, review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application provides basic assessment guidance, helping you to recognize the early signs of deterioration in your patients. GuardianSoftware is not intended for monitoring in combination with Cableless Measurement Devices. Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table “Controls Available with GuardianSoftware” on page 27. GuardianSoftware also manages the patient data. If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the connection symbol will be displayed gray at GuardianSoftware. A No System INOP will be displayed on the SpO2 Pod (no alarm sound). If a patient name is available at GuardianSoftware, it will be also displayed on the Pod. Any update of patient data will be synchronized between the Pods and GuardianSoftware. The only patient management action available directly at the Pod is Free Device. Selecting Free Device removes the current patient from the Pod and resets the Pod to the default profile. The Pod is unassigned. Device Compatibility The IntelliVue CL SpO2 Pods require the following software levels in the associated equipment: • IntelliVue Patient Monitor - Release H.0 or above • Avalon Fetal Monitor in combination with an Avalon CL Transducer System - Release J.3 or above • IntelliVue Information Center - Release M or above • Philips Patient Information Center iX - Release A or above • Telemetry device TRx4841A/TRx4851A - Revision D.00.22 or above • MX40 wearable patient monitor - Revision A.0 or above • IntelliVue GuardianSoftware - Revision A.0 or above Availability of Patient Alarms When the IntelliVue CL SpO2 Pod is used alone, without an assignment to a monitor or telemetry device, no patient alarms will be generated. When the IntelliVue CL SpO2 Pod is assigned to a patient monitor or telemetry device and a short range radio connection exists, alarms may be announced at the patient monitor or the Information Center. • When assigned to a patient monitor / fetal monitor: Alarm messages will be displayed and audible alarm indicators sounded at the monitor in the same way and under the same conditions as for its own measurements. See the Instructions for Use of the patient monitor for details. If a Cableless Measurement Device that is assigned to a patient monitor is selected for use in patient transport at the patient monitor, the Cableless Measurement Device will perform local attended monitoring. See the Instructions for Use of the patient monitor for details on how to do this. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text 21 2 IntelliVue CL SpO2 Pod appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See “Alarms” on page 34 for details. • When assigned to a telemetry device: Measurement values sent via the telemetry device to the IntelliVue Information Center can generate alarms at the Information Center when the values meet the criteria set there for alarms. The alarms will be announced in the same way as measurements from other sources. See the Instructions for Use of the Information Center for details. • When assigned to GuardianSoftware: Measurement values sent via transmitter, hotspot or MP5 to IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue GuardianSoftware is a data management system, no alarms are announced. The IntelliVue Cableless Measurement Devices will also not generate physiological alarms when connected to IntelliVue GuardianSoftware. See the Instructions for Use of GuardianSoftware. Assigning an IntelliVue Cableless Measurement Device to a Host When an IntelliVue CL SpO2 Pod is used with a host system (patient monitor, telemetry device or GuardianSoftware), the Pod must be assigned to that host system. The assignment can be done at the CL SpO2 Pod itself or at the host system (patient monitor or GuardianSoftware). WARNING Always make sure that the applied CL SpO2 Pod is assigned to the correct patient. WARNING Short Range Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP on the SpO2 Pod, or a cl SpO₂ Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the Configuration Guide for details. Assignment at the Measurement Device To make an assignment, select: • the Add/Remove SmartKey • hold the ◄ key pressed. , or This opens the Add To menu which lists the available patient monitors and telemetry devices within the SRR range. In order to save power, the list is only visible for a short time; the menu is automatically closed after 40 seconds. Telemetry device: A telemetry device must be put into assignment mode by pressing the key on the telemetry device before it can appear in the list. Pressing the key starts an SRR channel search to find the clearest channel available. During the search all 4 LEDs will blink once per second. The search will 22 2 IntelliVue CL SpO2 Pod take approximately 20-25 seconds. Once a channel is identified, the first LED will light up and blink once per second to indicate that the telemetry device is ready for assignment. Add To Mon 1 Mon 2 Tele 33 Tele 44 Select a patient monitor or telemetry system using the ◄ and ► keys. If you select a patient monitor, the measurement selection key on that monitor will change to show the type of measurement device. Activate the assignment by pressing the key twice on the measurement device. The Cableless Measurement Device is assigned to the selected patient monitor or telemetry device. A telemetry device plays the assignment tone when the assignment is successful. A patient monitor issues an assignment prompt message. If the internal measurement in the patient monitor is active (the measurement selection key has a yellow frame), you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign. To do this: Select the measurement selection key on the monitor. A prompt message appears with the Confirm and Cancel keys. Select Confirm to deactivate the internal measurement. When the Cableless Measurement Device is assigned, the symbol appears on its display indicating that alarming capability has been transferred to the host (to the monitor or, for the telemetry device, to the Information Center). No patient alarms will be announced on the Cableless Measurement Device. To unassign the measurement device from the monitor or telemetry system, select the Add/Remove SmartKey, then select Remove From. After confirmation the SRR connection is disconnected. Assignment at the Patient Monitor Assignment at the Patient Monitor Prepare the Cableless Measurement Device for assignment by activating the Add/Remove SmartKey. At the patient monitor, Select the Measurement Selection key. Select the Add cl Msmt pop-up key. This opens the Add cl Measurement window, which shows the available Cableless Measurement Devices: Select the device which you want to assign to the patient in the monitor. The monitor displays the assignment prompt message. If the internal measurement in the patient monitor is active, you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign. When the Cableless Measurement Device is assigned, the alarms from the device will be sent to the patient monitor. symbol appears on its display indicating that 23 2 IntelliVue CL SpO2 Pod An assigned Cableless Measurement Device can be removed in the Measurement Selection window. For more details see the Instructions for Use for your patient monitor. Assignment with an RFID Reader and Tagged Cableless Devices You can directly assign all cableless devices that have RFID tags with a Philips HS1-R RFID/barcode reader. The SpO2 Pod used must have an IntelliVue ProxiTag RFID tag adhesively attached. Hold the cableless device close to the reader. Depending on its configuration, the reader beeps, vibrates or indicates via the LEDs when it has read the tag. Press any hardkey on the cableless device. The Cableless Measurement Device is now added to the monitor. If the corresponding internal measurement in the patient monitor is active, you will be asked to confirm that it should be deactivated in favor of the Cableless Measurement Device by selecting Replace. If a Cableless Measurement of the same type is already assigned to the monitor, you will be asked to confirm that it should be removed by selecting Replace. Assignment at the Fetal Monitor The first time an IntelliVue Cableless Measurement Device is used with an Avalon Fetal Monitor, or after a device has been powered off for storage, place it on the Avalon CL Base Station. This will automatically switch the device on. The device is assigned automatically to the Fetal Monitor working with the CL Base Station. NOTE When you place a Cableless Measurement Device onto an Avalon CL Base Station to assign it to an Avalon Fetal Monitor, the Cableless Measurement Device is automatically unassigned from the previous patient. Special Conditions when Working with Fetal Monitors The following special conditions apply when CL SpO2 Pods are operating with an Avalon Fetal Monitor as a host: 24 • The SpO2 Pods are intended to measure the maternal SpO2 and Pulse. The patient category is always Adult. • The Pulse measurement is always On. The Pulse: On/Off setting is not available. • Physiological alarms are only available at the Avalon Fetal Monitor, not at the Cableless Measurement Devices. Local attended monitoring is not available: Use for Transp. is not supported. (Local attended monitoring is used for displaying alarms locally at the Cableless Measurement Devices during patient transport, when the patient is attended by a caregiver). • Alarm-related operations (e.g. switching alarms on and off, setting the high and low alarm limits) are not available when Alarm Mode is set to INOP only in the Avalon Fetal Monitor. See the Avalon Fetal Monitor Instructions for Use and Avalon Fetal Monitor Configuration Guide for further information. 2 IntelliVue CL SpO2 Pod • You can use the Remove operation at the host to remove Cableless Measurement Devices, as described in the Avalon Fetal Monitor Instructions for Use. • Averaging Time is not configurable. • Smart Alarm Delay is not supported. • Pulse tone from the CL SpO2 Pod is not supported at the Avalon Fetal Monitor. • Perfusion • Perfusion Change Indicator is not supported. • It is not possible to change the label, it is always SpO₂. • Continuous mode only. The functions for starting a measurement, selecting the measurement mode and setting the repetition time are not supported. • Configuration of Aging Time (for Aging Numerics) is not possible. • Pleth wave is not available. is always Off and cannot be changed to On. Assignment with GuardianSoftware To assign a Cableless Measurement Device to a patient in GuardianSoftware: Select the patient on the Chalkboard. Take the Cableless Measurement Device from the charger. On the Equipment List tab, select the Cableless Measurement Device on the Available Equipment list, highlighted in green on top of the list. The device on top of the list is always the one with the most recent user interaction (taken off the charger, put on the charger, or key pressed). Click Use for Patient to assign the device to the patient. Controls Available with a Patient Monitor The controls available when working with the Cableless Measurement Device and a patient monitor are described in the table below. Action At the Cableless Measurement Device At the Patient Monitor At the IIC Start SpO2 Yes Yes No Change SpO2 Mode Yes Yes No Select SpO2 Repetition Time Yes Yes No Assign SpO2 Pod Yes Yes No Remove SpO2 Pod Yes Yes No Change Alarm Limits Yes* Yes No Place Device in Standby Yes Yes Yes Alarm Silence Yes Yes Yes Alarm Off/Pause Yes Yes Yes * except when SRR connection to host is lost 25 2 IntelliVue CL SpO2 Pod WARNING If a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are not transmitted to the patient monitor or the Information Center. The measurements are available on the Cableless Measurement Device only. If this occurs, the No Host Monitoring message is displayed on the measurement device. The measurement device will also sound the INOP tone. Controls Available with a Telemetry Device The controls available when working with the Cableless Measurement Device and a TRx4841/TRx4851A Transceiver or MX40 wearable patient monitor with a short range radio adapter (SRRA) are described in the table below. Action At the Cableless Measurement Device At the IIC Start SpO2 Yes Yes Change SpO2 Mode Yes Yes Select SpO2 Repetition Time Yes No Assign SpO2 Pod Yes No Remove SpO2 Pod Yes Yes Change Alarm Limits No Yes Place Device in Standby No No Alarm Silence No Yes Alarm Off/Pause No Yes NOTE When you unplug the ECG cable from the telemetry device and plug it into the monitor associated with the same patient, the ECG source will automatically be from the monitor. The SpO2 measurement devices assigned to the telemetry device will continue to source data to the telemetry device and the Information Center. You may need to change screens on the patient monitor to see the measurements. NOTE The SpO2 measurement sourced from the telemetry device (label: SpO2T) has priority over the IntelliVue CL SpO2 measurement. The SpO2T measurement is sent to the Information Center as long as it is available and the IntelliVue CL SpO2 measurement is available on the measurement device only. 26 2 IntelliVue CL SpO2 Pod Controls Available with GuardianSoftware The controls available when working with the Cableless Measurement Device and GuardianSoftware are described in the table below. Action At the Cableless Measurement Device At GuardianSoftware Start SpO2 Yes Yes Change Mode Yes Yes Select SpO2 Repetition Time Yes Yes Assign SpO2 Pod Yes Yes Remove SpO2 Pod Yes Yes Place Device in Standby No No Technical Alarm Silence No Yes Alarm Off/Pause No No Trending The IntelliVue Cableless Measurement Devices provide data for trending of parameters. The trended data are only available via a host system. For details on trends see the Instructions for Use of your host system. When the connection to the host is lost during measurement, the IntelliVue Cableless Measurement Devices are able to collect data in a local memory. These data can be uploaded to GuardianSoftware, but not to other host systems, when a connection is established at a later stage. 27 2 IntelliVue CL SpO2 Pod Monitoring SpO2 Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier artifact suppression technology (FAST). A sensor is used that transmits light of two different wavelengths through the tissue of the patient. The measurement principle of pulse oximetry is based on the specific absorption characteristics of oxyhemoglobin and deoxyhemoglobin and the pulsating arteriolar vascular bed at the measurement site. It provides four measurements: • Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation). • Pleth waveform - auto-scaled visual indication of patient's pulse which is not directly proportional to the pulse volume (only on patient monitor, GuardianSoftware or Information Center, if assigned). • Pulse rate (derived from pleth wave) - detected pulsations per minute. • Perfusion indicator - numerical value for the pulsatile portion of the measured signal caused by arterial pulsation (only on patient monitor, if assigned). NOTE No alarms are generated for SpO2 and Pulse when measuring SpO2 with the SpO2 Pod not assigned to a patient monitor or telemetry device. The SpO2 measurement is suitable for use in the presence of electrosurgery and during the discharge of a cardiac defibrillator according to IEC 80601-2-30. SpO2 Sensors Specialized SpO2 Sensors are available for use with the IntelliVue CL SpO2 Pod. See the “IntelliVue CL SpO2 Pod Accessories” section for details. Familiarize yourself with the Instructions for Use supplied with your sensor before using it. In particular, check that the sensor being used is appropriate for your patient category and application site. Additional Information The following documents contain additional information, depending on which accessories you are using: • Mobile CL Single-Patient SpO2 Sensor Instructions for Use • Mobile CL Reusable SpO2 Sensor1 Instructions for Use • Mobile CL SpO2 Wristband Instructions for Use 28 may not be available in all geographies 2 IntelliVue CL SpO2 Pod Connecting SpO2 Sensors Connect the sensor to the single patient Mobile CL SpO2 Cradle (if not already connected). Insert the SpO2 Pod into the Mobile CL SpO2 Cradle. The correct orientation is indicated by a matching blue dot inside the cradle. CAUTION Make sure that the contacts of the SpO2 Pod and the sensor are dry and free of residues. Secure the cradle on the patient's arm using the wristband. a. Feed the free end of the wristband through the slot in the cradle, starting from the underside of the cradle. b. Slide the wristband onto the patient's arm and pull the free end until the wristband fits snugly. c. Close the wristband using the Velcro patch on the free end of the band. 29 2 IntelliVue CL SpO2 Pod Removing the Pod from the Cradle To remove the SpO2 Pod from the cradle, pull on the Pod at the opening in the cradle, while holding the cradle in place on the patient's arm. Applying the Sensor Choose a finger of the patient that matches the sensor dimension in a way that the sensor optical components are properly aligned and the sensor is neither too loose nor applies too much pressure to the finger. For small pediatric patients consider the thumb. Remove colored nail polish from the application site. Apply the sensor to the patient. The application site should match the sensor size so that the sensor can neither fall off, nor apply excessive pressure. See the sections below for details on applying the different sensors. Check that the light emitter and the photodetector are directly opposite each other. All light from the emitter must pass through the patient's tissue. WARNING Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxemia and tissue malnutrition. Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and lacerations, periodically inspect the sensor application site and change the application site regularly. Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulation and lead to inaccurate measurements. Ambient Temperature: At elevated ambient temperatures be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41°C on the skin if the initial skin temperature does not exceed 35°C. Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff or an intravascular venous infusion line. 30 2 IntelliVue CL SpO2 Pod Measuring SpO2 During measurement, ensure that the application site: – – has a pulsatile flow, ideally with a perfusion indicator value above 1.0 or, if the perfusion indicator is not available, with signal quality indicator of at least medium. has not changed in its thickness (for example, due to edema), causing an improper fit of the sensor. WARNING • If not specified otherwise in the SpO2 sensor's instructions for use, the following applies: – For fully conscious pediatric or adult patients, who have a normal function of perfusion and sensory perception at the measurement site: – To ensure skin quality and correct optical alignment of the sensor, inspect the application site when the measurement results are suspicious or when the patient complains about pressure at the application site, but at least every 24 hours. Correct the sensor alignment if necessary. Move the sensor to another site, if the skin quality changes. For all other patients: Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. Correct the sensor alignment if necessary. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. • Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements. • Inaccurate measurements may result when the application site for the sensor is deeply pigmented or deeply colored, for example, with nail polish, artificial nails, dye or pigmented cream. • Interference can be caused by: – High levels of ambient light (including IR warmers) or strobe lights or flashing lights (such as fire alarm lamps). (Hint: cover application site with opaque material.) – Another SpO2 sensor in close proximity (e.g. when more than one SpO2 measurement is performed on the same patient). Always cover both sensors with opaque material to reduce crossinterference. – Electromagnetic interference, especially at perfusion indicator values below 1.0 or signal quality indicator below medium. – Excessive patient movement and vibration. Selecting Measurement Modes There are three different modes available for making SpO2 measurements: • Continuous mode - SpO2 is measured continuously until the measurement is switched off. • Manual mode - a single SpO2 measurement is made when the Start SpO₂ SmartKey or the Start SpO₂ menu item is selected. One set of values is then displayed with the time the measurement was made. • Automatic mode - a series of measurements is made with an interval between them. The interval is selected using the Repeat Time SmartKey or the Repeat menu item. The measurement starts automatically when automatic mode is selected. The values measured in manual mode or automatic mode will be displayed for a configurable time span. After that the values are regarded as invalid and are no longer displayed. Battery power usage will be appreciably higher when measuring in continuous mode, in comparison to manual or automatic mode, resulting in a reduced battery runtime. 31 2 IntelliVue CL SpO2 Pod Starting and Stopping Measurements Use the setup menu or SmartKeys to start measurements manually: Action to be Performed SpO2 menu Start manual measurement Start SpO₂ SmartKeys Start When manual measurements are made, there will be no continuous SpO2 monitoring or alarming. The manual measurement value reflects a momentary status. The numerics from SpO2 measurements made in manual mode will remain for a time on the main screen. They are annotated with the time that the measurement was made to distinguish them from continuously measured values. Understanding SpO2 Numerics and Symbols SpO2 numeric Pulse rate numeric Symbol indicating pulse rate Measurement mode - indicates here that Auto mode is active and shows the time to the next measurement. Alarms Off symbol for Pulse Timestamp Alarms Off symbol for SpO2 Note: The Alarms Off symbols indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host. SpO2 Signal Quality Indicator The SpO2 numeric is displayed together with a signal quality indicator (if configured and enough space is available) which gives an indication of the reliability of the displayed values. The level to which the triangle is filled shows the quality of the signal; the indicator below shows a medium signal quality, the signal quality is at a maximum when the triangle is completely filled. 32 SpO2 Quality Indicator 2 IntelliVue CL SpO2 Pod Assessing a Suspicious SpO2 Reading Traditionally, pulse rate from SpO2 was compared with heart rate from ECG to confirm the validity of the SpO2 reading. With newer algorithms, such as FAST-SpO2, this is no longer a valid criteria because the correct calculation of SpO2 is not directly linked to the correct detection of each pulse. When pulse rate is very low, or strong arrhythmia is present, the SpO2 pulse rate may differ from the heart rate calculated from ECG but this does not indicate an inaccurate SpO2 value. If you doubt the measured SpO2, use the signal quality indicator (if available) or, when used with a patient monitor, the pleth wave and perfusion indicator on the monitor to assess the signal quality. WARNING With pulse oximetry, sensor movement, ambient light (especially strobe lights or flashing lights) or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might occur when the sensor is dangling. Changing the Averaging Time Depending on the monitor configuration, you may be able to change the averaging time for the SpO2 values. The averaging time represents the approximate time period used for the calculation. The exact averaging time also depends on the signal conditions. The longer the averaging time, the longer the time needed until the SpO2 values reflect the physiological event. The same averaging is applied to all numerical values: SpO2, pulse rate and perfusion (only available at the patient monitor). Fast averaging is useful for situations where an extremely fast measurement is required or few artifacts are expected. Use slow averaging where you expect the number of artifacts to be relatively high. In the SpO₂ menu, select Average. Select the required averaging time from the list. Perfusion Numeric (only available on the Patient Monitor) The perfusion numeric (Perf) gives a value for the pulsatile portion of the measured signal caused by the pulsating arterial blood flow. You can also use the perfusion numeric as a quality indicator for the SpO2 measurement. Above 1 is optimal, between 0.3-1 is acceptable. Below 0.3 is marginal; reposition the sensor or find a better site. 33 2 IntelliVue CL SpO2 Pod Alarms The IntelliVue Cableless Measurements have two different types of alarm: patient alarms and technical alarms (INOPs). Patient Alarms Patient Alarms are high priority alarms (such as a potentially life threatening situation), also called red alarms, or medium priority alarms, also called yellow alarms. Technical Alarms (INOPs) Technical alarms, also known as INOPs, indicate that the measuring device cannot measure reliably. If an INOP interrupts monitoring, there will be a question mark in place of the measurement numeric. An INOP tone sounds at the Cableless Measurement Device only when there is no SRR connection to a host. Exception: the Battery empty INOP tone sounds also with SRR connection. Most INOPs are low priority, however there are a small number of INOPs which, due to their severity, are medium or high priority. Alarm Delays There is a delay between a physiological event at the measurement site and the corresponding alarm indication at the Cableless Measurement Device. This delay has two components: • The general measurement delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing. • The time between the displayed numerical values crossing an alarm limit and the alarm indication on the device is the system alarm delay. The system alarm delay is the processing time the system needs for any alarm on the Cableless Measurement Device to be indicated after the measurement has triggered the alarm. This delay depends on the Cableless Measurement Device and the connected host system. See the performance specifications in the chapter “IntelliVue CL SpO2 Pod Specifications” on page 133 for the system alarm delay specification of the Cableless Measurement Device. The alarm delay configured for a specific measurement is normally a fixed time. Multiple Alarms If more than one alarm is active, the alarm messages are shown in the alarm status area in succession. An arrow symbol next to the alarm message informs you that more than one message is active. The Cableless Measurement Device sounds an audible indicator for the highest priority alarm. If more than one alarm condition is active in the same measurement, the Cableless Measurement Device announces the most severe. NOTE If you want to use local attended monitoring, make sure to have all Cableless Measurement Devices upgraded to at least Rev. B.02. Visual Alarm Indicators WARNING 34 • No patient alarms are available on the Cableless Measurement Devices when assigned to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware. • Visual patient alarm indicators are disabled on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware. 2 IntelliVue CL SpO2 Pod Alarm Message Alarm messages are displayed in black on a light gray background in the alarm status area at the top of the screen indicating the source of the alarm and coded according to their severity. If more than one measurement is in an alarm condition, the message changes every few seconds, and has an arrow ( ) at the side. The asterisk symbols (*) beside the alarm message match the alarm priority: *** for red alarms, ** for yellow alarms. Standard INOPs do not have a symbol, red and yellow INOPs have exclamation marks beside the alarm message: !!! for red INOPs and !! for yellow INOPs. An alarm message that appears is automatically highlighted. Use the key to silence the message. A Silence message is displayed at the bottom of the screen and highlighted. Press again to confirm the acknowledgment of the alarm. After the confirmation, any ongoing alarm message is displayed in the icon tray of the screen. Alarm States Depending on the alarm state of your Cableless Measurement Device, the following icons may be displayed on the device: Icon Description No local alarming on Cableless Measurement Device. The device is connected to a host monitor or telemetry device and has no visual or audible patient alarm indicators. The device will only display INOP messages. Alarms are switched off. Alarm volume is set to 0. Audible Alarm Indicators Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching). Cableless Measurements Devices alone (without host, e.g. a patient monitor) are not suitable for unattended monitoring due to their limited alarm volume. WARNING • Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. • No patient alarms are available on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or to GuardianSoftware. • When connected to a host monitor or GuardianSoftware, no alarm tones are available on the Cableless Measurement Devices (unless they are selected for use in patient transport at the monitor they are assigned to). 35 2 IntelliVue CL SpO2 Pod Silencing an Alarm To silence an alarm, select the alarm message and press the key. This will silence the alarm tone and clear the alarm message. If the condition which caused the alarm is still present, the alarm indicator will be displayed in the icon tray of the screen. Full length alarm message Alarm indicator When using a Cableless Measurement Pod with an IntelliVue Information Center iX Release A, make sure to remove the pod at the telemetry device and only when in SRR range of the telemetry device. Otherwise you will get a technical alarm (cl SpO₂ Disconnect) that can not be silenced at the telemetry device. You will then have to reboot the telemetry device to remove the message. Displaying a List of Current Alarms To display a list of the currently active alarms, Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms. Select Alarm Messages. Setting the Volume of the Alarm Tone To set the volume for the Alarm tone, Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms. Select AlarmVol and select a volume setting. The maximum is 10 and the minimum depends on your configuration. If the volume of the Alarm tone is set to zero, the following symbol is displayed on the right icon tray of the Cableless Measurement Device screen: NOTE No Alarm tone will sound at the device as long as it is within the SRR range. Minimum Volume for No Host Monitoring INOP If your device is connected to a host monitor, and the connection is interrupted, the INOP message No Host Monitoring will appear within 30 seconds, accompanied by an INOP tone. To help ensure that this INOP, and any other active alarm, is not overlooked, the INOP and alarm tones may be configured to have a minimum volume. In this case, INOP and alarm tones will sound even if the device alarm volume is set to zero. 36 2 IntelliVue CL SpO2 Pod Alarm Reminder If Reminder is configured on your device, you will get an audible reminder of alarm conditions that remain active after you have silenced the alarm. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). Alarm Reminder is not available for standard, light blue INOPs but for yellow and red INOPs. In Configuration Mode, you can set the interval between silencing the alarm and sounding the reminder tone to one, two, or three minutes. Pausing or Switching Off Alarms If you want to temporarily prevent alarms from sounding, for example while you are moving a patient, you can pause alarms. Depending on your device configuration, alarms are paused for one, two, or three minutes, or infinitely. Infinite alarm pause is equivalent to switching the alarms off. To view the alarm pause setting chosen for your unit, In the SmartKeys Menu select Main Setup, Alarms, then OffDurat. Check the setting. This setting can only be changed in Configuration Mode. To Pause or Switch Off Alarms Select the key in the SmartKeys Menu followed by Alarms. Press the hardkey to switch to Paused. If your device is configured to infinite pause time, selecting this option switches alarms off. Restarting Paused Alarms To manually switch on alarm indication again after a pause, select the key again. Alarm indication starts again automatically after the pause period expires. If the device is configured to stay paused infinitely, you must select again to restart alarm indication. 37 2 IntelliVue CL SpO2 Pod Alarm Limits The alarm limits you set determine the conditions that trigger yellow and red limit alarms. For SpO2, where the value ranges from 100 to 0, setting the high alarm limit to 100 switches the high alarm off. In these cases, the alarms off symbol is not displayed. WARNING Be aware that the devices in your care area may each have different alarm settings, to suit different patients. Always check that the alarm settings are appropriate for your patient before you start monitoring. Adjusting the Alarm Limits Select the Alarms SmartKey followed by Alarm Limits (or select Main Setup followed by SpO₂): Select High Lim then choose the high alarm limit. Select Low Lim then choose the low alarm limit. WARNING High oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration do NOT set the high alarm limit to 100%, which is equivalent to switching the high alarm off. Adjusting the Desat Limit Alarm The Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in oxygen saturation. In the SpO₂ menu, select DesatLim. Adjust the limit. Setting Up Tone Modulation Only when the Cableless Measurement Device is not connected to a host: If tone modulation is on, the pulse tone pitch lowers when the SpO2 level drops. Select Main Setup followed by User Interface. In this menu, select Tone Modulation to switch between Yes (for on) and No (for off). NOTE If the SpO2 level drops below 52%, two short tones will be issued rather than one long tone. Latching Alarms The alarm latching setting for your device defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the device after the alarm condition ends. The indication lasts until you acknowledge the alarm. 38 2 IntelliVue CL SpO2 Pod Viewing the Alarm Latching Settings To see the alarm latching setting for your device, In the Main Setup menu, select Alarms. Here you can see the Visual Latching and Audible Latching settings. This setting can only be changed in Configuration Mode. You should be aware of the settings chosen for your unit. There are three possible choices each for visual and audible latching, red only, red and yellow, and off. These choices can be combined to give the following settings: Visual Latching Audible Latching Red&Yellow Red&Yellow Red&Yellow Red Only Red&Yellow Off Red Only Red Only Red Only Off Off Off Alarm Latching Behavior Red & Yellow Measurement Alarms Non-latching alarms Visual and audible latching Visual latching, audible non-latching Alarm has not been acknowledged. Alarm condition still present. Alarm tone on. Alarm message. Alarm tone on. Alarm message. Alarm condition All audible and visual alarm no longer present. indicators automatically stop. Alarm tone on. Alarm message. Alarm message. Audible alarm indicators automatically stop. Alarm has been acknowledged. Alarm condition still present. All audible and visual alarm indicators automatically stop. All audible and visual alarm indicators automatically stop. All audible and visual alarm indicators automatically stop. Alarm condition Audible and visual alarm no longer present. indicators automatically stop. Audible and visual alarm indicators automatically stop. Audible and visual alarm indicators automatically stop. Alarm tone on. Alarm message. All INOPs are non-latching. Testing Alarms When you switch the CL SpO2 Pod on, a selftest is started. You must check that the backlight switches on, and that you hear a single tone. This indicates that the alarm indicators are functioning correctly. For further testing of individual measurement alarms, perform the measurement on yourself or use a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed. Alarm Behavior at Power On If the device is switched off (Standby), all alarm settings are maintained. If the device is switched off completely (Power Off), or the battery is completely empty, resulting in complete power loss, all alarm settings will be lost unless they were actively saved by storing the active profile before the device was switched off. See “Switching the Device Off” on page 17 and “Using Profiles” on page 18 for details. When the device is switched back on from either state, it will start in Profile A and you may have to switch to the desired profile which contains your alarm settings. After any of these situations, you should check that the alarm settings are appropriate for your patient and monitoring situation, and if necessary, select the correct profile and patient category. 39 2 IntelliVue CL SpO2 Pod Reference List of Patient Alarms Alarm Message, Indication Source Condition *** Brady (Pulse) SpO2 The heart rate from the Pulse signal has fallen below the bradycardia limit. *** Desat SpO2 The SpO2 value has fallen below the desaturation alarm limit. ** Pulse High SpO2 The pulse rate has exceeded the high alarm limit. ** Pulse Low SpO2 The pulse rate has dropped below the low alarm limit. **High SpO2 The arterial oxygen saturation has exceeded the high alarm limit. ** Low SpO2 The arterial oxygen saturation has dropped below the low alarm limit. *** Tachy (Pulse) SpO2 The Pulse Rate from the Pleth signal has exceeded the tachycardia limit Reference List of all INOPs INOP Message, Indication Source What to do Batt Incompatible Battery Battery cannot be used with this Cableless Measurement Device. Replace battery with one that has been approved for use with this Cableless Measurement Device. Contact your service personnel. Batt Malfunction Battery Malfunction of the battery system detected (charger circuit or battery). Contact your service personnel. Battery Empty Battery The remaining monitoring time is below 30 minutes. Charge battery. Battery Low Battery The remaining monitoring time is below 2 hours. Check Batt Temp Battery The temperature of the battery is critically high. Check that Cableless Measurement Device is not covered and not exposed to a heat source. If INOP persists, remove Cableless Measurement Device from patient and contact your service personnel. Check Battery Battery The maximum number of charge/discharge cycles of the battery will be reached in less than 50 cycles. Contact your service personnel to replace the battery. Check Charger I/F Battery Overvoltage or undervoltage detected at the charger interface. Clean contacts of charger interface at Cableless Measurement Device and charging station. If the INOP persists, contact your service personnel. INOP tone INOP tone INOP tone INOP tone INOP tone INOP tone INOP tone 40 2 IntelliVue CL SpO2 Pod INOP Message, Indication Source cl SpO₂ Chk Sett Cableless Measurement If this INOP appears and an INOP tone sounds, check the Device Cableless Measurement Device and patient settings before you resume making measurements. If the settings are unexpected, there may be a problem with the Cableless Measurement Device software. Contact your service personnel. INOP tone What to do If this INOP is acknowledged at the Cableless Measurement Device, it is cleared. If it is silenced remotely, only the tone is cleared. cl SpO₂ Disconnect Cableless Measurement The SpO2 Pod has lost the SRR connection to the telemetry device or the patient monitor. Device No Host Monitoring Cableless Measurement There is a problem with the communication to the assigned Device patient monitor or telemetry device and monitoring is currently not possible (no patient alarms or information). Check the connection. Contact your service personnel. No System Cableless Measurement There is a problem with the communication to the assigned Device IntelliVue GuardianSoftware and monitoring is currently not possible (no patient alarms or information). Check the connection. Contact your service personnel. Remove From Pat Cableless Measurement Displayed on the Cableless Measurement Device. The Device temperature of the battery is too high. Remove the Cableless Measurement Device from the patient and contact service personnel. Service Battery Battery Maximum number of charge/discharge cycles for battery exceeded. Charging of the battery is inhibited. Contact your service personnel to replace battery. Equip Malf SpO2 The SpO2 Pod is faulty. Contact your service personnel. Erratic SpO2 Check the sensor placement. Try another adapter cable and sensor. If the INOP persists, contact your service personnel. Extd.Update SpO2 The update time for displayed values is extended due to an NBP measurement on the same limb or an excessively noisy signal. Interference SpO2 There is too much interference, caused by a high level of ambient light and/or electrical interference. Cover the sensor to minimize ambient light. If the INOP persists, make sure that the sensor cable is not damaged or positioned too close to power cables. Low Perf SpO2 Accuracy may be compromised due to very low perfusion. Stimulate circulation at sensor site. If INOP persists, change the measurement site. NeoPatient? SpO2 The patient monitor the SpO2 Pod is assigned to is in neonatal mode. The INOP will remain active until the monitor is changed to adult or pediatric mode. only at the host INOP tone INOP tone INOP tone Numeric is replaced by -?INOP tone Numeric is replaced by -?INOP tone Numeric is replaced by -?- Numeric is replaced by -?INOP tone Numeric is replaced by -?- Numeric is replaced by -?INOP tone 41 2 IntelliVue CL SpO2 Pod INOP Message, Indication Source What to do No Pulse SpO2 Check the perfusion at the measurement site. If necessary, stimulate circulation or change the measurement site. If the INOP is due to an NBP measurement on the same limb, wait until the NBP measurement is finished. No Sensor SpO2 Make sure the SpO2 sensor is connected. If the INOP persists, try another sensor. If you acknowledge this INOP, the measurement will be switched off. NoisySignal SpO2 Excessive patient movement or electrical interference is causing irregular pulse patterns. Try to reduce patient movement or to relieve the cable strain on the sensor. Poor Signal SpO2 The signal quality of the SpO2 measurement is poor. The accuracy may be compromised. Pulse? SpO2 The detectable pulsations of the SpO2 signal are outside the specified pulse rate range. Searching SpO2 The patient signal is analyzed, but no valid numerics are available yet. Sensor Malf SpO2 The SpO2 sensor is faulty. Try another sensor. If the INOP persists, contact your service personnel. Sensor Off SpO2 The algorithm has determined that a sensor is connected, but not properly applied to the patient. The ability of the algorithm to detect this condition depends on the used sensor type. Unkn.Sensor SpO2 The connected SpO2 sensor is not supported by this measurement hardware. Upgrade SpO2 SpO2 in upgrade mode, no patient monitoring possible. Numeric is replaced by -?INOP tone Numeric is replaced by -?INOP tone Numeric is replaced by -?INOP tone Numeric is replaced by -?INOP tone Numeric is unavailable Numeric is replaced by -?INOP tone Numeric is replaced by -?INOP tone Numeric is replaced by -?INOP tone Numeric is replaced by -?- 42 2 IntelliVue CL SpO2 Pod Local Attended Monitoring When working with an IntelliVue MP5, MP5SC, MP5T Patient Monitor with software revision J.2 or higher as a host, or with an IntelliVue X2 Multi-Measurement Module with software revision K.2 or higher, the IntelliVue CL SpO2 and NBP Pods can be used for local attended monitoring. This is for situations where you want to have alarm indications at the CL Pods when they are out of reach of the patient monitor (disconnected). The patient monitor setting to switch CL Measurement Alarms on and off (cl Alarms On/ Off) is used to enable and disable this functionality. As a default, the CL Measurement Alarms are on. Local Attended Monitoring Enabled By default, the patient monitor is set to receive alarms from the CL Pods (can only be changed in configuration mode). This scenario is used for patients who require uninterrupted monitoring. The various alarms from the CL Pods are indicated at the patient monitor if they are enabled at the monitor. When the CL Pod is disconnected from the patient monitor and the caregiver has activated the transport mode at the monitor, physiological alarms are indicated locally at the CL Pod. A cl SpO₂ Disconnect INOP is shown at the monitor if the SRR connection is lost and the transport mode has not been activated. CL Pod connected to a patient monitor and CL Measurement Alarms On (Standard Use Model): SRR connection At the CL Pod: Indication of technical alarms only At the monitor: Indication of physiological and technical alarms from CL Pods CL Pod disconnected from patient monitor and CL Measurement Alarms On, Local Attended Monitoring: No SRR connection At the CL Pod: Indication of technical and physiological alarms At the monitor: No indication of physiological alarms from CL Pods. No indication of technical alarms after disconnection. 43 2 IntelliVue CL SpO2 Pod Local Attended Monitoring Disabled The patient monitor is set to cl Alarms Off (this can only be done in configuration mode). This scenario is used if the patients do not require permanent monitoring and are mobile, but vital signs are taken from time to time. All alarms from the CL Pods are switched off at the monitor. If the SRR connection is lost, no cl SpO₂ Disconnect INOP is shown at the monitor in this scenario. CL Pod connected to a patient monitor and CL Measurement Alarms Off: SRR connection At the CL Pod: Indication of technical alarms only At the monitor: No indication of physiological alarms from CL Pods. Indication of technical alarms from CL Pods. CL Pod disconnected from patient monitor and CL Measurement Alarms Off: No SRR connection At the CL Pod: Indication of technical alarms only 44 At the monitor: No indication of physiological and technical alarms from CL Pods. 2 IntelliVue CL SpO2 Pod Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms On Standard Use Model Local Attended Monitoring -> Caregiver activates 'Use for transport' Patient mobile 10 kg 20 Single-Patient Cradles pre-assembled 989803165921 Mobile CL 20 single patient SpO2 Sensors for 20 Single-Patient Mobile CL DSpO2-1A Sensors use on pediatric and adult patients >10 kg 9898031659311 Mobile CL reusable SpO2 Sensor and Cradles for use on pediatric and adult patients > 15 kg 1 Reusable Mobile CL RSpO2-1A Sensor 20 Single-Patient Cradles with pre-attached Wristbands 989803165951 Mobile CL 20 SpO2 Cradles (single patient) 20 Single-Patient Cradles with pre-attached Wristbands 989803165961 Mobile CL 50 SpO2 Wristbands (single patient) 50 Single-Patient Wristbands 989803168861 Mobile CL SpO2 Battery Kit 1 Battery 1 disassembly tool 1 front housing 52 May not be available in all geographies Contents 2 IntelliVue CL SpO2 Pod Maintenance and Troubleshooting WARNING Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards. Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier. Inspecting the Equipment and Accessories You should perform a visual inspection before every use, and in accordance with your hospital's policy. With the device switched off: Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are not cracked or broken, that everything is present, that there are no spilled liquids and that there are no signs of abuse. Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use them. WARNING If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient, contact your service personnel. Maintenance Task and Test Schedule All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for Philipsqualified service professionals only. Ensure that these tasks are carried out as indicated by the device's maintenance schedule, or as specified by local laws. Contact a Philips-qualified service provider if your device needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it. Troubleshooting If a device will not switch on when you press a key, place it onto a charger slot on the charging station. If you suspect a problem with an individual measurement device, read the Instructions for Use and double check that you have set up the measurement correctly. Check also that the measurement has not been switched off at the patient monitor that the device is assigned to. If you suspect an intermittent, system-wide problem call your service personnel. 53 2 IntelliVue CL SpO2 Pod 54 3 IntelliVue CL NBP Pod To measure NBP, you need Philips standard cuffs, a Mobile CL NBP Cradle and a pouch and extension air hose, or a Mobile CL NBP Cradle and Mobile CL Cuffs. When using Mobile CL Cuffs, the cradle is used to attach the Pod to the cuffs and to allow easy removal of the Pod. Standard Philips cuffs and specialized single-patient and reusable NBP cuffs are available for use with the IntelliVue CL NBP Pod. For details regarding the cuffs and single-patient cradle, refer to “IntelliVue CL NBP Pod Accessories” on page 94. General Operation of the NBP Pod The following sections describe operation on the NBP Pod itself. For operation from a patient monitor, see “Controls Available with a Patient Monitor” on page 67. For operation from an Information Center via a telemetry system, see “Controls Available with a Telemetry Device” on page 68. For operation with IntelliVue GuardianSoftware, see “Controls Available with GuardianSoftware” on page 68. The NBP Pods have three hardkeys for basic operation and a set of configurable SmartKeys which appear on the screen. These are used to activate and navigate through the on-screen menus and to select individual items. The typical operator's position is such that everything on the device's display can be read clearly and easily. Switching the Devices On The first time an NBP Pod is used, or after the device has been powered off for storage, place it on the IntelliVue CL Charging Station. This will automatically switch the device on. If the NBP Pod has only been switched off temporarily (see “Switching the Device Off” on page 17), press any hardkey to turn the device on again. When an NBP Pod is not operated, it will automatically switch off the screen lighting after a short time. A little later the low-activity screen will be displayed. 55 3 IntelliVue CL NBP Pod Screen Layout There are three variations of the Main Screen layout depending on the Alarm status and the general activity level. Standard Layout When assigned to a monitor, telemetry device or a patient in GuardianSoftware: Connection status indicator Indicator that alarming capability has been transferred to the host (to the monitor or, for the telemetry device, to the Information Center). No patient alarms will be announced on the Cableless Measurement Device. Battery indicator Measurement values Measurement-related symbols (see the “Monitoring NBP” section for details) Patient identification When not assigned to a monitor or telemetry device: Connection status indicator Battery indicator Measurement values Measurement-related symbols (see the “Monitoring NBP” section for details). The Alarms Off symbols indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host. Cableless Measurement Device equipment label Alarm Layout If an alarm occurs the full alarm message appears at the top of the screen. After the alarm message has been silenced the alarm indicator is shown as a symbol on the right side of the screen. 56 Full length alarm message Alarm indicator 3 IntelliVue CL NBP Pod Low-Activity Screen If the Cableless Measurement Device has not been operated for a while, the screen lighting will switch itself off and a little later the screen will switch to a pre-configured "low-activity" screen. When a Cableless Measurement Device Cannot be Activated If you cannot activate a device by pressing a key, place it on the IntelliVue CL Charging Station. The device becomes active. Check the battery status. If necessary, leave the device on the charger until the battery is fully charged. Using the Hardkeys The IntelliVue Cableless Measurement Devices have three hardkeys: ◄, , ►. Use ◄ and ► to navigate through SmartKeys and menus and to select items or to silence alarms. The three hardkeys also have an additional function when the key is held down for a couple of seconds: ◄ opens the Add To screen to assign a device (or to unassign it when it is already assigned) opens the SmartKeys menu ► returns to the Main Screen. If already on the Main Screen, it locks the keys and a lock symbol appears on the screen above the battery symbol. If keys are already locked, it unlocks the keys and the lock symbol disappears Using the SmartKeys A SmartKey is a graphical key which appears on the screen and gives you fast access to functions. SmartKeys Menu Press the hardkey (without any screen element highlighted) to get to the SmartKeys menu. Use the ◄ and ► hardkeys to move along the row of SmartKeys. The highlighted SmartKey is displayed in full above the row of SmartKeys. When you use the ◄ or ► hardkey at the end of the row, an Exit screen appears and then with further presses you move on to the next page of SmartKeys. To leave the SmartKeys menu you can use the Exit screen or press the ► hardkey for a couple of seconds to return to the Main Screen. When the required SmartKey is highlighted, press the key to activate the corresponding function. To get to the next page of the SmartKeys menu, highlight the rightmost SmartKey then press the ► key. 57 3 IntelliVue CL NBP Pod List of Available SmartKeys SmartKey Text Labels Main Setup - start/stop manual NBP measurement - start auto series - start measurement sequence - stop current automatic measurement within series stop any NBP measurement and measurement series start NBP STAT measurement start venipuncture (inflate cuff to subdiastolic pressure) set the NBP repetition time Add/Remove device enter Battery menu change Screen enter Profiles menu put the device in standby mode (or power off when pressed for more than two seconds) enter Patient menu enters the Alarms menu to access: Alarm Messages, Alarm Limits, Alarms On/ Off/Pause, Alarm Volume. change alarm volume change pulse tone volume access NBP mode selection and setup, with direct start/stop function 58 3 IntelliVue CL NBP Pod Using the Main Setup Menu In addition to the hardkeys and SmartKeys for the most needed functions, the Main Setup menu gets you to all settings that can be adjusted for the respective device. Select the Main Setup SmartKey to get to the Main Setup menu. Main Setup NBP Alarms Patient Equipment User Interface Standby Profiles Operating Modes Date, Time Battery Revisions Switching the Device Off To put the device in standby mode, select the Standby SmartKey, then Confirm. If you keep Standby pressed for more than two seconds, you can choose between Standby or Power Off. • Standby • Power Off means that the device is switched off completely and can only be switched on again by putting it on a charger. Use this option when the device is not used for a longer time or prepared for storage or shipping. means that the display is switched off and the measurements are disabled. Use this option if your device is not used temporarily. Press any hardkey to turn the device on again. Auto Standby and Auto Power Off The device can be configured to automatically go into standby mode after a configurable time span of inactivity. When in standby mode, the device can be automatically powered off after a configurable time span. See the IntelliVue Cableless Measurements Configuration Guide for details on how to configure these settings. Operating Modes Your device has four operating modes. Some are passcode protected. • Monitoring Mode: This is the normal, every day working mode that you use for making measurements. You can change elements such as measurement modes, patient category and so forth. When you remove the patient from the device, these elements return to their default values. Changes can be stored permanently only in Configuration Mode. You may see items, such as some menu options, that are visible but 'grayed out' so that you can neither select nor change them. These are present for your information only and can be changed only in Configuration Mode. • Demonstration Mode: Passcode protected, this is for demonstration purposes only. You must not change into Demonstration Mode during monitoring. • Configuration Mode: Passcode protected, this mode is for personnel trained in configuration tasks. These tasks are described in the Configuration Guide. During installation the Cableless Measurement Device is configured for use in your environment. This configuration defines the default settings you work with when you switch on. • Service Mode: Passcode protected, this is for trained service personnel. 59 3 IntelliVue CL NBP Pod When you switch the device on, it starts up in monitoring mode. To change to a different mode: Use the Main Setup SmartKey to get to the Main Setup menu. Select Operating Modes and choose the mode you require. Standby Mode The IntelliVue Cableless Measurement Devices do not have standby mode. However, when connected to a monitor that is in standby mode, the IntelliVue Cableless Measurement Device will show a standby screen. Using the Patient Menu The Patient menu allows you to see patient demographics information and to remove a patient from a device. Patient Demographic information is only displayed if the Cableless Measurement Device is assigned to a patient monitor or GuardianSoftware. Patient Category is the only item of patient data which can be changed at the Cableless Measurement Device, but only when the device is not assigned to a patient monitor or telemetry device. Displaying the Patient Menu To display the Patient menu, • select the Patient SmartKey, or • select the Main Setup SmartKey followed by Patient. Stop Using a Device for a Patient To remove a patient from the Cableless Measurement Device, • in the Patient menu select Free Device. All patient data is cleared, settings are reset to the defaults and the device is removed from the monitor or telemetry device. NOTE Depending on your configuration, when the device is put on the charger, patient data will also be cleared and the device will be free for another patient. Using the Device for a New Patient To use a device for a new patient, • in the Patient menu, select New Patient. If the device was not free, the existing data will be deleted and the profile set to the default. Using Profiles A profile is a set of measurement and general settings which have been customized for a particular purpose. The Cableless Measurement Devices can have four different profiles configured to your requirements. The default profile is marked with a symbol. To select a different profile, Select the Profiles SmartKey or the Main Setup SmartKey followed by Profiles. Select the required profile from the list. Selecting New Patient or Free Device will always reset the profile to the default. 60 3 IntelliVue CL NBP Pod Setting the Date and Time If the Cableless Measurement Device is assigned to a patient monitor, telemetry device or GuardianSoftware, the date and time will be taken from the host. If this is not the case, you can set the date and time on the Cableless Measurement Device, Select the Main Setup SmartKey and then Date, Time. Enter the data for date and time one after another. Select Store Date, Time. If the time has not been set, --:-- will display on the device. Battery Status The IntelliVue CL NBP Pods show their battery status on their display both in operating and charging condition. The battery status indicator is located in the lower right corner of the screen during operation and in the middle of the screen during charging. Battery Status Menu Select the Battery SmartKey or Main Setup followed by Battery using the ◄ and ► keys, then press the key to open the Battery menu. The Battery menu provides the following information: full-charge and remaining capacity, voltage, current and temperature. 61 3 IntelliVue CL NBP Pod Connection with Host Systems The following sections describe how the IntelliVue Cableless Measurement Devices work together with host systems (Patient Monitors, Fetal Monitors, Telemetry Devices / Information Center or GuardianSoftware). IntelliVue Cableless Measurements Use Models With these patient-worn measurement devices you can measure and transmit a patient's vitals regularly or on an intermittent data collection basis. There are four typical use models: With a Patient Monitor The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T, MP2 or X2 patient monitor (with an SRR interface). They can communicate their measurement values via short range radio to the monitor. The monitor may be assigned to a patient sector at the IntelliVue Information Center (IIC). When assigned to the Information Center, certain actions can be performed at both the patient monitor and the Information Center. See the table “Controls Available with a Patient Monitor” on page 67. In situations where patients are becoming more mobile (for example, in step-down/intermediate care units) the lightweight Cableless Measurement Devices allow increased mobility within the short range radio range, without giving up vital signs monitoring. When assigned to a patient monitor, the Cableless Measurement Device can be selected for use in patient transport at the patient monitor (for details see the Patient Monitor Instructions for Use). In this case, the Cableless Measurement Device will perform local attended monitoring. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See “Alarms” on page 34 for details. A telemetry device can be assigned to a patient monitor equipped with short range radio at the same time as any Cableless Measurement Devices are also assigned to this monitor. When assigned to a patient monitor, the admitted patient name is displayed on the NBP Pod. If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be displayed at the monitor: cl NBP Disconnect. A No Host Monitoring INOP will be displayed on the NBP Pod, and an INOP tone will sound. In this case, visual and audible alarms are still available at the NBP Pod, but it is not possible to change the alarm settings. With a Fetal Monitor In combination with an Avalon CL Transducer System, the IntelliVue CL NBP Pod can be used together with an Avalon FM 20-50 Fetal Monitor. The NBP Pods are assigned to the fetal monitor by docking them at the Avalon CL Base Station. For information about Avalon Fetal Monitors, the Avalon CL Transducer System and the Avalon CL Base Station, please refer to the Avalon Fetal Monitor Instructions for Use. With a Telemetry Device The Cableless Measurement Devices can be assigned to a patient with the telemetry device TRx4841A/ TRx4851A or an MX40 wearable patient monitor. They can communicate their measurement values via short range radio to the telemetry device which communicates them to an IntelliVue Information Center to provide a consolidated set of patient values. Some of the measurement tasks can be performed remotely from the Information Center. See the table “Controls Available with a Telemetry Device” on page 68. If the patient name is available at the Information Center, it will be also displayed on the NBP Pod. 62 3 IntelliVue CL NBP Pod When a Cableless Measurement Device is assigned to a telemetry device, it is not possible for the telemetry device to be wirelessly assigned or directly connected to a patient monitor. If the connection between the telemetry device and the Cableless Measurement Device is lost, an INOP will be displayed at the Information Center: cl NBP Disconnect. A No System Monitor. INOP will be displayed on the NBP Pod, and an INOP tone will sound. With IntelliVue GuardianSoftware The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware. GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter, Hotspot or MP5 from the Cableless Measurement Devices. Using the collected data, it provides trending, review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application provides basic assessment guidance, helping you to recognize the early signs of deterioration in your patients. GuardianSoftware is not intended for monitoring in combination with Cableless Measurement Devices. Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table “Controls Available with GuardianSoftware” on page 68. GuardianSoftware also manages the patient data. If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the connection symbol will be displayed gray at GuardianSoftware. A No System INOP will be displayed on the NBP Pod (no alarm sound). If a patient name is available at GuardianSoftware, it will be also displayed on the Pod. Any update of patient data will be synchronized between the Pods and GuardianSoftware. The only patient management action available directly at the Pod is Free Device. Selecting Free Device removes the current patient from the Pod and resets the Pod to the default profile. The Pod is unassigned. Device Compatibility The IntelliVue CL NBP Pods require the following software levels in the associated equipment: • IntelliVue Patient Monitor - Release H.0 or above • Avalon Fetal Monitor in combination with an Avalon CL Transducer System - Release J.3 or above • IntelliVue Information Center - Release M or above • Philips Patient Information Center iX - Release A or above • Telemetry device TRx4841A/TRx4851A - Revision D.00.22 or above • MX40 wearable patient monitor - Revision A.0 or above • IntelliVue GuardianSoftware - Revision A.0 or above Availability of Patient Alarms When the IntelliVue CL NBP Pod is used alone, without an assignment to a monitor or telemetry device no patient alarms will be generated. When the IntelliVue CL NBP Pod is assigned to a patient monitor or telemetry device and a short range radio connection exists, alarms may be announced at the patient monitor or the Information Center. • When assigned to a patient monitor / fetal monitor: Alarm messages will be displayed and audible alarm indicators sounded at the monitor in the same way and under the same conditions as for its own measurements. See the Instructions for Use of the patient monitor for details. If a Cableless Measurement Device that is assigned to a patient monitor is selected for use in patient transport at the patient monitor, the Cableless Measurement Device will perform local attended monitoring. See the Instructions for Use of the patient monitor for details on how to do this. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See “Alarms” on page 34 for details. 63 3 IntelliVue CL NBP Pod • When assigned to a telemetry device: Measurement values sent via the telemetry device to the IntelliVue Information Center can generate alarms at the Information Center when the values meet the criteria set there for alarms. The alarms will be announced in the same way as measurements from other sources. See the Instructions for Use of the Information Center for details. • When assigned to GuardianSoftware: Measurement values sent via transmitter, hotspot or MP5 to IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue GuardianSoftware is a data management system, no alarms are announced. The IntelliVue Cableless Measurement Devices will also not generate physiological alarms when connected to IntelliVue GuardianSoftware. See the Instructions for Use of GuardianSoftware. Assigning an IntelliVue Cableless Measurement Device to a Host When an IntelliVue CL NBP Pod is used with a host system (patient monitor, telemetry device or GuardianSoftware), the Cableless Measurement Device must be assigned to that host system. The assignment can be done at the CL NBP Pod itself or at the host system (patient monitor or GuardianSoftware). WARNING Always make sure that the applied CL NBP Pod is assigned to the correct patient. WARNING Short Range Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP on the NBP Pod, or a cl NBP Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the Configuration Guide for details. Assignment at the Measurement Device To make an assignment, select: • the Add/Remove SmartKey • hold the ◄ key pressed. , or This opens the Add To menu which lists the available patient monitors and telemetry devices within the SRR range. In order to save power, the list is only visible for a short time; the menu is automatically closed after 40 seconds. Telemetry device: A telemetry device must be put into assignment mode by pressing the key on the telemetry device before it can appear in the list. Pressing the key starts an SRR channel search to find the clearest channel available. During the search all 4 LEDs will blink once per second. The search will 64 3 IntelliVue CL NBP Pod take approximately 20-25 seconds. Once a channel is identified, the first LED will light up and blink once per second to indicate that the telemetry device is ready for assignment. Add To Mon 1 Mon 2 Tele 33 Tele 44 Select a patient monitor or telemetry system using the ◄ and ► keys. If you select a patient monitor, the measurement selection key on that monitor will change to show the type of measurement device. Activate the assignment by pressing the key twice on the measurement device. The Cableless Measurement Device is assigned to the selected patient monitor or telemetry device. A telemetry device plays the assignment tone when the assignment is successful. A patient monitor issues an assignment prompt message. If the internal measurement in the patient monitor is active (the measurement selection key has a yellow frame), you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign. To do this: Select the measurement selection key on the monitor. A prompt message appears with the Confirm and Cancel keys. Select Confirm to deactivate the internal measurement. When the Cableless Measurement Device is assigned, the symbol appears on its display indicating that alarming capability has been transferred to the host (to the monitor or, for the telemetry device, to the Information Center). No patient alarms will be announced on the Cableless Measurement Device. To unassign the measurement device from the monitor or telemetry system, select the Add/Remove SmartKey, then select Remove From. After confirmation the SRR connection is disconnected. Assignment at the Patient Monitor Assignment at the Patient Monitor Prepare the Cableless Measurement Device for assignment by activating the Add/Remove SmartKey. At the patient monitor, Select the Measurement Selection key. Select the Add cl Msmt pop-up key. This opens the Add cl Measurement window, which shows the available Cableless Measurement Devices: Select the device which you want to assign to the patient in the monitor. The monitor displays the assignment prompt message. If the internal measurement in the patient monitor is active, you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign. When the Cableless Measurement Device is assigned, the alarms from the device will be sent to the patient monitor. symbol appears on its display indicating that 65 3 IntelliVue CL NBP Pod An assigned Cableless Measurement Device can be removed in the Measurement Selection window. For more details see the Instructions for Use for your patient monitor. Assignment with an RFID Reader and Tagged Cableless Devices You can directly assign all cableless devices that have RFID tags with a Philips HS1-R RFID/barcode reader. The Respiration Pod has a built-in RFID tag. The NBP Pod used must have an IntelliVue ProxiTag RFID tag adhesively attached. Hold the cableless device close to the reader. Depending on its configuration, the reader beeps, vibrates or indicates via the LEDs when it has read the tag. Press any hardkey on the cableless device. The Cableless Measurement Device is now added to the monitor. If the corresponding internal measurement in the patient monitor is active, you will be asked to confirm that it should be deactivated in favor of the Cableless Measurement Device by selecting Replace. If a Cableless Measurement of the same type is already assigned to the monitor, you will be asked to confirm that it should be removed by selecting Replace. Assignment at the Fetal Monitor The first time an IntelliVue Cableless Measurement Device is used with an Avalon Fetal Monitor, or after a device has been powered off for storage, place it on the Avalon CL Base Station. This will automatically switch the device on. The device is assigned automatically to the Fetal Monitor working with the CL Base Station. NOTE When you place a Cableless Measurement Device onto an Avalon CL Base Station to assign it to an Avalon Fetal Monitor, the Cableless Measurement Device is automatically unassigned from the previous patient. Special Conditions when Working with Fetal Monitors The following special conditions apply when CL NBP Pods are operating with an Avalon Fetal Monitor as a host: 66 • The CL NBP Pods are intended to measure the maternal NBP and Pulse. The patient category is always Adult. • The Pulse measurement is always On. The Pulse: On/Off setting is not available. • Physiological alarms are only available at the Avalon Fetal Monitor, not at the Cableless Measurement Devices. Local attended monitoring is not available: Use for Transp. is not supported. (Local attended monitoring is used for displaying alarms locally at the Cableless Measurement Devices during patient transport, when the patient is attended by a caregiver). • Alarm-related operations (e.g. switching alarms on and off, setting the high and low alarm limits) are not available when Alarm Mode is set to INOP only in the Avalon Fetal Monitor. See the Avalon Fetal Monitor Instructions for Use and Avalon Fetal Monitor Configuration Guide for further information. 3 IntelliVue CL NBP Pod • You can use the Remove operation at the host to remove Cableless Measurement Devices, as described in the Avalon Fetal Monitor Instructions for Use. • STAT mode is not supported. • Accelerated Measurement mode is not supported. Assignment with GuardianSoftware To assign a Cableless Measurement Device to a patient in GuardianSoftware: Select the patient on the Chalkboard. Take the Cableless Measurement Device from the charger. On the Equipment List tab, select the Cableless Measurement Device on the Available Equipment list, highlighted in green on top of the list. The device on top of the list is always the one with the most recent user interaction (taken off the charger, put on the charger, or key pressed). Click Use for Patient to assign the device to the patient. Controls Available with a Patient Monitor The controls available when working with the Cableless Measurement Device and a patient monitor are described in the table below. Action At the Cableless Measurement Device At the Patient Monitor At the IIC Start/Stop/Stat NBP Yes Yes Yes Change NBP Mode Yes Yes No Change NBP Repetition Time Yes Yes No Change Alarm Limits Yes* Yes No Assign NBP Pod Yes Yes No Remove NBP Pod Yes Yes No Place Device in Standby Yes Yes Yes Alarm Silence No Yes Yes Alarm Off/Pause No Yes Yes * except when SRR connection to host is lost WARNING If a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are not transmitted to the patient monitor or the Information Center. The measurements are available on the Cableless Measurement Device only. If this occurs, the No Host Monitoring message is displayed on the measurement device. The measurement device will also sound the INOP tone. 67 3 IntelliVue CL NBP Pod Controls Available with a Telemetry Device The controls available when working with the Cableless Measurement Device and a TRx4841/TRx4851A Transceiver or MX40 wearable patient monitor with a short range radio adapter (SRRA) are described in the table below. Action At the Cableless Measurement Device At the IIC Start/Stop/Stat NBP Yes No Change NBP Mode Yes No Change NBP Repetition Time Yes No Change Alarm Limits No Yes Assign NBP Pod Yes No Remove NBP Pod Yes Yes Place Device in Standby No No Alarm Silence No Yes Alarm Off/Pause No Yes NOTE When you unplug the ECG cable from the telemetry device and plug it into the monitor associated with the same patient, the ECG source will automatically be from the monitor. The NBP measurement devices assigned to the telemetry device will continue to source data to the telemetry device and the Information Center. You may need to change screens on the patient monitor to see the measurements. Controls Available with GuardianSoftware The controls available when working with the Cableless Measurement Device and GuardianSoftware are described in the table below. Action At the Cableless Measurement Device At GuardianSoftware Start/Stop/Stat NBP Yes Yes Change NBP Mode Yes Yes Change NBP Repetition Time Yes Yes Assign NBP Pod Yes Yes Remove NBP Pod Yes Yes Place Device in Standby No No Alarm Silence No Yes Alarm Off/Pause No No Trending The IntelliVue Cableless Measurement Devices provide data for trending of parameters. The trended data are only available via a host system. For details on trends see the Instructions for Use of your host system. When the connection to the host is lost during measurement, the IntelliVue Cableless Measurement Devices are able to collect data in a local memory. These data can be uploaded to GuardianSoftware, but not to other host systems, when a connection is established at a later stage. 68 3 IntelliVue CL NBP Pod Monitoring NBP The IntelliVue CL NBP Pod uses the oscillometric method for measuring NBP. The blood pressure measurements determined with this device were clinically validated according to ISO 81060-2 in relation to mean error and standard deviation, when compared to auscultatory measurements (depending on the configuration) in a representative patient population. The fifth Korotkoff sound was used to determine the diastolic pressure for adult/adolescent subjects and the 4th for pediatric subjects. The accuracy of the mean arterial pressure (MAP) was validated using the approximation: MAPref = (SYSref + 2*DIAref) / 3 with SYSref and DIAref being the blood pressure measured by the auscultatory method. The NBP measurement is suitable for use in the presence of electrosurgery and during the discharge of a cardiac defibrillator according to IEC 80601-2-30. Introducing the Oscillometric NBP Measurement Oscillometric devices measure the amplitude of pressure changes (oscillations) in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish. Studies show that, especially in critical cases (arrhythmia, vasoconstriction, hypertension, shock), oscillometric devices are more accurate and consistent than devices using other noninvasive measuring techniques. WARNING Patient Category: Do not use the IntelliVue CL NBP Pod on neonatal patients. The initial inflation pressure and overpressure safety limits are too high for neonatal patients and could cause fractures and bruises. Intravenous infusion: Do not use the NBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation. Skin Damage: Do not measure NBP in cases of sickle-cell disease or any condition where skin damage has occurred or is expected. Existing Wounds: Do not apply the cuff over a wound as this can cause further injury. Mastectomy: Avoid applying the cuff on the side of the mastectomy, as the pressure increases the risk of lymphedema. For patients with a bilateral mastectomy, use clinical judgement to decide whether the benefit of the measurement outweighs the risk. Unattended Measurement: Use clinical judgement to decide whether to perform frequent unattended blood pressure measurements. Too frequent measurements can cause blood flow interference potentially resulting in injury to the patient. In cases of severe blood clotting disorders frequent measurements increase the risk of hematoma in the limb fitted with the cuff. Temporary Loss of Function: The pressurization of the cuff can temporarily cause loss of function of monitoring equipment used simultaneously on the same limb. CAUTION If you spill liquid onto the equipment or accessories, particularly if there is a chance that it can get inside the tubing or the measurement device, contact your service personnel. 69 3 IntelliVue CL NBP Pod Measurement Limitations NBP readings can be affected by the position of the patient, their physiological condition, the measurement site, and physical exercise. Thus a physician must determine the clinical significance of the NBP information. Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 300 bpm, or if the patient is on a heart-lung machine. The measurement may be inaccurate or impossible: • with excessive and continuous patient movement such as shivering or convulsions • if a regular arterial pressure pulse is hard to detect with cardiac arrhythmias • with rapid blood pressure changes • with severe shock or hypothermia that reduces blood flow to the peripheries • with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery • on an edematous extremity. Accelerated Measurement When the accelerated measurement is used the minimum number of oscillations per deflation step is 1, instead of the 2 in the standard measurement. This allows a faster measurement result but requires that the patient keeps the limb in question still. The accelerated measurement is recommended for use when very few or no artifacts are expected, for example with sedated patients. You can see whether the accelerated measurement is in use by looking in the patient monitor's Setup NBP menu. The Accelerated Msmt setting shows whether the accelerated measurement is Off, on for Manual measurements or on for All measurements. You can see this setting in Monitoring Mode but it can only be changed in Configuration Mode. When the accelerated measurement is in use, no pulse rate is derived from NBP. Measurement Modes There are three modes for measuring NBP: • Manual • Auto • Sequence - up to four measurement cycles which will run consecutively, with number of measurements and interval between them configurable for each cycle. - measurement on demand. - continually repeated measurements (between one minute and 24 hours adjustable interval). Auto and Sequence modes must be set up, before a measurement series can be started. See “Enabling Automatic Mode and Setting Repetition Time” on page 74 and “Enabling Sequence Mode and Setting Up The Sequence” on page 75. Additionally, you have the possibility to start an immediate, one-time measurement series at any time: • STAT - rapid series of measurements over a five minute period. Use only on supervised patients. After a STAT measurement series, the monitor returns to the previous mode. If an Auto or Sequence measurement series was running before the STAT measurement, it will continue to run afterwards. Reference Method The measurement reference method is always Auscultatory (manual cuff). For further information, see the Application Note supplied on the documentation DVD. 70 3 IntelliVue CL NBP Pod Preparing to Measure NBP with Standard Cuffs Apply the carrying pouch to the patient. Apply the cuff to the patient's upper arm at the same level as the heart. If the cuff is not at heart level, you must use the measurement correction formula to correct the measurement. Make sure that you are using a Philips-approved correct sized cuff and that the bladder inside the cover is not folded or twisted. A wrong cuff size, and a folded or twisted bladder, can cause inaccurate measurements. The width of the cuff should be in the range from 37% to 47% of the limb circumference. Do not wrap the cuff too tightly around the limb. It may cause discoloration, and ischemia of the extremities. Connect the extension air hose to the cuff. 71 3 IntelliVue CL NBP Pod Connect the extension air hose to the cradle. Hold the flat part of the connector vertically when plugging it into the inlet, then twist it clockwise to lock into place. Avoid compression or restriction of pressure tubes. Air must pass unrestrictedly through the tubing. WARNING Kinked or otherwise restricted tubing can lead to a continuous cuff pressure, causing blood flow interference and potentially resulting in injury to the patient. Place the NBP Pod into the cradle. Put the NBP Pod into the carrying pouch. Make sure to pinch the velcro enclosures firmly together around the extension hose exiting from the pouch. CAUTION Make sure that the air vent, located next to the air tubing connector on the NBP Pod, is not covered during operation. If air cannot enter the air vent, the pump may be damaged. 72 3 IntelliVue CL NBP Pod WARNING Inspect the application site of the cuff regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth and sensitivity. If the skin quality changes, or if the extremity circulation is being affected, move the cuff to another site or stop the blood pressure measurements immediately. Check more frequently when making automatic or stat measurements. Attaching the Pod Directly to a Mobile CL Cuff As an alternative to using a carrying pouch, you can attach the NBP Pod directly to the cuff. In this case you do not need the extension hose. Attach the cradle to the NBP cuff. Plug the air tubing into the cradle. Apply the cuff to the patient's upper arm. Apply the cuff so that the cradle is located at the outside of the arm. The bladder of the cuff is then automatically over the artery. Insert the NBP Pod into the cradle. Additional Information The following documents contain additional information, depending on which accessories you are using: • Mobile CL Reusable NBP Cuffs Instructions for Use • Mobile CL Single-Patient NBP Cuffs Instructions for Use • Mobile CL NBP Cradle Instructions for Use • Mobile CL Extension Air Hose Instructions for Use Recommendations For Measurements Used in Diagnosis of Hypertension To make a measurement for use in the diagnosis of hypertension, follow the steps below: Ensure the patient is comfortably seated, with their legs uncrossed, feet flat on the floor and back and arm supported. Ask the patient to relax and not talk before and during the measurement. If possible, wait 5 minutes before making the first measurement. 73 3 IntelliVue CL NBP Pod Starting and Stopping Measurements Use the setup menu or SmartKeys to start and stop measurements. Action to be Performed NBP Setup menu Start manual measurement Start/Stop SmartKeys Start Auto series Start/Stop Start measurement sequence Start STAT measurement Start NBP Stat Start NBP STAT Stop Manual measurements Start/Stop Start/Stop Stop current Auto/sequence measurement Start/Stop Start/Stop Stop current STAT measurement and end STAT mode Start/Stop Start/Stop Stop All Stop Auto, Manual or STAT measurement, end STAT mode AND Auto/Sequence series Stop All Depending on the configuration of the NBP Auto/Sequence series, measurements are automatically started within 3 seconds (Automatic Start set to Fast) or 3 minutes (Automatic Start set to Slow) after the NBP Pod has been inserted into the cradle. With Automatic Start set to Off, the Auto/Sequence series have to be started manually. No pulse can be derived from the NBP measurement in Accelerated and STAT mode. If accelerated measurement mode is configured for manual or manual and Auto/Sequence measurements, make sure that the patient is not moving during the measurements. CAUTION Use clinical judgment to decide whether to perform repeated series of STAT measurements because of the risk of purpura, ischemia and neuropathy in the limb with the cuff. Enabling Automatic Mode and Setting Repetition Time 74 In the NBP menu, select Mode and select Auto from the pop-up menu. For an automatic measurement, select Repeat and set the time interval between two measurements. 3 IntelliVue CL NBP Pod Enabling Sequence Mode and Setting Up The Sequence In the NBP menu, select Mode and select Sequence from the pop-up menu. Select Setup Sequence to open the Setup Sequence menu. Up to four measurement phases can be setup which will run consecutively. For each phase you can set the number of measurements and the interval between them. If you want to run less than four phases in a sequence, you can set the number of measurements for one or more phases to Off. Select each phase in turn (A, B, C and D) and select the number of measurements and the time interval between the measurements. To have measurements continue after the sequence, set the number of measurements for your last phase to Cont and this phase will run indefinitely. CAUTION Be aware that, if none of the phases are set to Cont, NBP monitoring will end after the last measurement of the last phase. When the NBP measurement mode is set to Sequence, the repetition time for Auto mode cannot be changed. Announcement Tone: Depending on the configuration of the NBP Pod, a tone before each measurement announces the next measurement. Please inform the patient to stop moving, and especially stop moving the arm with the cuff, when the tone sounds and the cuff inflates in order to allow a fast and accurate measurement. Understanding the NBP Numerics and Symbols Systolic/Diastolic pressure Mean pressure Pulse rate Pulse rate indicator Measurement mode (see below) Alarms Off symbol for Pulse (Pulse from NBP does not have alarm capability, therefore it cannot be switched on) Timestamp Alarms Off symbol for NBP Note: The Alarms Off symbols indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host. Measurement modes with a series of measurements can be indicated with two different symbols: indicates that a series is running and shows the relative time to the next measurement. indicates that auto or sequence mode is selected but the measurement series has not yet started. An S in front of the symbol indicates Sequence mode and an A, B, C or D indicates which phase of the sequence is currently running. 75 3 IntelliVue CL NBP Pod During Measurements The cuff pressure is displayed instead of the timestamp. Correcting the Measurement if Limb is not at Heart Level To correct the measurement if the limb is not at heart level, to the displayed value Add 0.75 mmHg (0.10 kPa) for each centimeter higher or Deduct 0.75 mmHg (0.10 kPa) for each centimeter lower or Add 1.9 mmHg (0.25 kPa) for each inch higher. Deduct 1.9 mmHg (0.25 kPa) for each inch lower. When Unexpected Values are Measured When values measured are higher or lower than expected, check the following potential causes: Possible Cause Solution The patient was talking or moving before or during Allow the patient to rest quietly, then try again after the measurement. three to five minutes. The incorrect cuff size was used or the cuff was not Check the cuff size, level, and position then repeat at heart level the measurement. Measurement limitations have not been taken into account. Check the list in “Measurement Limitations” on page 70. Switching Pulse from NBP On/Off In the process of making the NBP measurement, a pulse value can be derived and displayed. The pulse value is displayed together with the time the measurement was made. After one hour the value becomes invalid. There are no alarms associated with pulse from NBP. When the accelerated measurement is in use, no pulse value can be derived. To switch the display of the pulse value on or off: • In the NBP menu select Pulse. Assisting Venous Puncture You can use the NBP cuff to cause subdiastolic pressure. The cuff deflates automatically after a set time (adult/pediatric 170 seconds) if you do not deflate it. In the NBP menu select Veni Puncture, or select the Veni Puncture SmartKey. Puncture vein and draw blood sample. Reselect Veni Puncture to deflate the cuff. During measurement, the NBP display shows the inflation pressure of the cuff and the remaining time in venous puncture mode. Calibrating NBP NBP is not user-calibrated. NBP pressure transducers must be verified and calibrated, if necessary, at least once every two years by a qualified service professional. See the Service Guide for details. 76 3 IntelliVue CL NBP Pod Alarms The IntelliVue Cableless Measurements have two different types of alarm: patient alarms and technical alarms (INOPs). Patient Alarms Patient Alarms are high priority alarms (such as a potentially life threatening situation), also called red alarms, or medium priority alarms, also called yellow alarms. Technical Alarms (INOPs) Technical alarms, also known as INOPs, indicate that the measuring device cannot measure reliably. If an INOP interrupts monitoring, there will be a question mark in place of the measurement numeric. An INOP tone sounds at the Cableless Measurement Device only when there is no SRR connection to a host. Exception: the Battery empty INOP tone sounds also with SRR connection. Most INOPs are low priority, however there are a small number of INOPs which, due to their severity, are medium or high priority. Alarm Delays There is a delay between a physiological event at the measurement site and the corresponding alarm indication at the Cableless Measurement Device. This delay has two components: • The general measurement delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing. • The time between the displayed numerical values crossing an alarm limit and the alarm indication on the device is the system alarm delay. The system alarm delay is the processing time the system needs for any alarm on the Cableless Measurement Device to be indicated after the measurement has triggered the alarm. This delay depends on the Cableless Measurement Device and the connected host system. See the performance specifications in the chapter “IntelliVue CL NBP Pod Specifications” on page 135 for the system alarm delay specification of the Cableless Measurement Device. The alarm delay configured for a specific measurement is normally a fixed time. Multiple Alarms If more than one alarm is active, the alarm messages are shown in the alarm status area in succession. An arrow symbol next to the alarm message informs you that more than one message is active. The Cableless Measurement Device sounds an audible indicator for the highest priority alarm. If more than one alarm condition is active in the same measurement, the Cableless Measurement Device announces the most severe. NOTE If you want to use local attended monitoring, make sure to have all Cableless Measurement Devices upgraded to at least Rev. B.02. Visual Alarm Indicators WARNING • No patient alarms are available on the Cableless Measurement Devices when assigned to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware. • Visual patient alarm indicators are disabled on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware. 77 3 IntelliVue CL NBP Pod Alarm Message Alarm messages are displayed in black on a light gray background in the alarm status area at the top of the screen indicating the source of the alarm and coded according to their severity. If more than one measurement is in an alarm condition, the message changes every few seconds, and has an arrow ( ) at the side. The asterisk symbols (*) beside the alarm message match the alarm priority: *** for red alarms, ** for yellow alarms. Standard INOPs do not have a symbol, red and yellow INOPs have exclamation marks beside the alarm message: !!! for red INOPs and !! for yellow INOPs. An alarm message that appears is automatically highlighted. Use the key to silence the message. A Silence message is displayed at the bottom of the screen and highlighted. Press again to confirm the acknowledgment of the alarm. After the confirmation, any ongoing alarm message is displayed in the icon tray of the screen. Alarm States Depending on the alarm state of your Cableless Measurement Device, the following icons may be displayed on the device: Icon Description No local alarming on Cableless Measurement Device. The device is connected to a host monitor or telemetry device and has no visual or audible patient alarm indicators. The device will only display INOP messages. Alarms are switched off. Alarm volume is set to 0. Audible Alarm Indicators Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching). Cableless Measurements Devices alone (without host, e.g. a patient monitor) are not suitable for unattended monitoring due to their limited alarm volume. WARNING 78 • Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. • No patient alarms are available on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or to GuardianSoftware. • When connected to a host monitor or GuardianSoftware, no alarm tones are available on the Cableless Measurement Devices (unless they are selected for use in patient transport at the monitor they are assigned to). 3 IntelliVue CL NBP Pod Silencing an Alarm To silence an alarm, press the key. This will silence the alarm tone and clear the alarm message. If the condition which caused the alarm is still present, the alarm indicator will be displayed on the right hand side of the screen. Full length alarm message Alarm indicator When using a Cableless Measurement Pod with an IntelliVue Information Center iX Release A, make sure to remove the pod at the telemetry device and only when in SRR range of the telemetry device. Otherwise you will get a technical alarm (cl NBP Disconnect) that can not be silenced at the telemetry device. You will then have to reboot the telemetry device to remove the message. Displaying a List of Current Alarms To display a list of the currently active alarms, Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms. Select Alarm Messages. Setting the Volume of the Alarm Tone To set the volume for the Alarm tone, Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms. Select AlarmVol and select a volume setting. The maximum is 10 and the minimum depends on your configuration. If the volume of the Alarm tone is set to zero, the following symbol is displayed on the right icon tray of the Cableless Measurement Device screen: Minimum Volume for No Host Monitoring INOP If your device is connected to a host monitor, and the connection is interrupted, the INOP message No Host Monitoring will appear within 30 seconds, accompanied by an INOP tone. To help ensure that this INOP, and any other active alarm, is not overlooked, the INOP and alarm tones may be configured to have a minimum volume. In this case, INOP and alarm tones will sound even if the device alarm volume is set to zero. Alarm Reminder If Reminder is configured on your device, you will get an audible reminder of alarm conditions that remain active after you have silenced the alarm. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). Alarm Reminder is not available for standard, light blue INOPs but for yellow and red INOPs. In Configuration Mode, you can set the interval between silencing the alarm and sounding the reminder tone to one, two, or three minutes. 79 3 IntelliVue CL NBP Pod Pausing or Switching Off Alarms If you want to temporarily prevent alarms from sounding, for example while you are moving a patient, you can pause alarms. Depending on your device configuration, alarms are paused for one, two, or three minutes, or infinitely. Infinite alarm pause is equivalent to switching the alarms off. To view the alarm pause setting chosen for your unit, In the SmartKeys Menu select Main Setup, Alarms, then OffDurat. Check the setting. This setting can only be changed in Configuration Mode. To Pause or Switch Off Alarms Select the key in the SmartKeys Menu followed by Alarms. Press the hardkey to switch to Paused. If your device is configured to infinite pause time, selecting this option switches alarms off. Restarting Paused Alarms To manually switch on alarm indication again after a pause, select the key again. Alarm indication starts again automatically after the pause period expires. If the device is configured to stay paused infinitely, you must select again to restart alarm indication. Choosing the NBP Alarm Source You can monitor for alarm conditions in systolic, diastolic and mean pressure, either singly or in parallel. Only one alarm is given, with the priority of mean, systolic, diastolic. In the NBP menu, select Al. from and choose from: Menu Option Displayed as Pressure value monitored Sys. Sys. systolic Dia. Dia. diastolic Mean Mean mean Sys & Dia S&D systolic and diastolic in parallel Dia & Mean D&M diastolic and mean in parallel Sys & Mean S&M systolic and mean in parallel Sys&Dia&Mean S&D&M all three pressures in parallel If Mean is not selected as alarm source (Sys., Dia., or Sys & Dia selected), but the monitor can only derive a mean value, mean alarms will nevertheless be announced using the most recent mean alarm limits. Check that the mean alarm limits are appropriate for the patient, even when not using mean as the alarm source. When no value can be derived an NBP Measure Failed INOP will be displayed. 80 3 IntelliVue CL NBP Pod Alarm Limits The alarm limits you set determine the conditions that trigger limit alarms. WARNING Be aware that the devices in your care area may each have different alarm settings, to suit different patients. Always check that the alarm settings are appropriate for your patient before you start monitoring. Adjusting the Alarm Limits Select the Alarms SmartKey followed by Alarm Limits (or select Main Setup followed by NBP). Depending on your alarm source: a. Select Sys.High, Dia.High and/or MeanHigh then choose the high alarm limit. b. Select Sys. Low, Dia. Low and/or Mean Low then choose the low alarm limit. Latching Alarms The alarm latching setting for your device defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the device after the alarm condition ends. The indication lasts until you acknowledge the alarm. Viewing the Alarm Latching Settings To see the alarm latching setting for your device, In the Main Setup menu, select Alarms. Here you can see the Visual Latching and Audible Latching settings. This setting can only be changed in Configuration Mode. You should be aware of the settings chosen for your unit. There are three possible choices each for visual and audible latching, red only, red and yellow, and off. These choices can be combined to give the following settings: Visual Latching Audible Latching Red&Yellow Red&Yellow Red&Yellow Red Only Red&Yellow Off Red Only Red Only Red Only Off Off Off Alarm Latching Behavior As NBP is an aperiodic parameter, "Alarm condition no longer present" means either that for a measurement in alarm the alarm limits are changed in such a way that the value is now within the limits, or that a new measurement is done with a value within the limits. 81 3 IntelliVue CL NBP Pod Red & Yellow Measurement Alarms Non-latching alarms Visual and audible latching Visual latching, audible non-latching Alarm has not been acknowledged. Alarm condition still present. Alarm tone on. Alarm message. Alarm tone on. Alarm message. Alarm condition All audible and visual alarm no longer present. indicators automatically stop. Alarm tone on. Alarm message. Alarm message. Audible alarm indicators automatically stop. Alarm has been acknowledged. Alarm condition still present. All audible and visual alarm indicators automatically stop. All audible and visual alarm indicators automatically stop. All audible and visual alarm indicators automatically stop. Alarm condition Audible and visual alarm no longer present. indicators automatically stop. Audible and visual alarm indicators automatically stop. Audible and visual alarm indicators automatically stop. Alarm tone on. Alarm message. All INOPs are non-latching. NBP specific INOPs generated by the CL Pod are latching. Testing Alarms When you switch the CL NBP Pod on, a selftest is started. You must check that the backlight switches on, and that you hear a single tone. This indicates that the alarm indicators are functioning correctly. For further testing of individual measurement alarms, perform the measurement on yourself or use a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed. Alarm Behavior at Power On If the device is switched off (Standby), all alarm settings are maintained. If the device is switched off completely (Power Off), or the battery is completely empty, resulting in complete power loss, all alarm settings will be lost unless they were actively saved by storing the active profile before the device was switched off. See “Switching the Device Off” on page 17 and “Using Profiles” on page 18 for details. When the device is switched back on from either state, it will start in Profile A and you may have to switch to the desired profile which contains your alarm settings. After any of these situations, you should check that the alarm settings are appropriate for your patient and monitoring situation, and if necessary, select the correct Profile and patient category. Reference List of Patient Alarms Alarm Message, Indication Source Condition ** NBPs High NBP The measured NBP value is above the high alarm limit. s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit. NBP The measured NBP value is below the low alarm limit. s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit. ** NBPd High ** NBPm High ** NBPs Low ** NBPd Low ** NBPm Low Reference List of all INOPs 82 3 IntelliVue CL NBP Pod INOP Message, Indication Source What to do Batt Incompatible Battery Battery cannot be used with this Cableless Measurement Device. Replace battery with one that has been approved for use with this Cableless Measurement Device. Contact your service personnel. Batt Malfunction Battery Malfunction of the battery system detected (charger circuit or battery). Contact your service personnel. Battery Empty Battery The remaining monitoring time is below 30 minutes. Charge battery. Battery Low Battery The remaining monitoring time is below 2 hours. Check Batt Temp Battery The temperature of the battery is critically high. Check that Cableless Measurement Device is not covered and not exposed to a heat source. If INOP persists, remove Cableless Measurement Device from patient and contact your service personnel. Check Battery Battery The maximum number of charge/discharge cycles of the battery will be reached in less than 50 cycles. Contact your service personnel to replace the battery. Check Charger I/F Battery Overvoltage or undervoltage detected at the charger interface. Clean contacts of charger interface at Cableless Measurement Device and charging station. If the INOP persists, contact your service personnel. cl NBP ChkSettings Cableless Measurement If this INOP appears and an INOP tone sounds, check the Device Cableless Measurement Device and patient settings before you resume making measurements. If the settings are unexpected, there may be a problem with the Cableless Measurement Device software. Contact your service personnel. INOP tone INOP tone INOP tone INOP tone INOP tone INOP tone INOP tone INOP tone If this INOP is acknowledged at the Cableless Measurement Device, it is cleared. If it is silenced remotely, only the tone is cleared. cl NBP Disconnect only at the host Cableless Measurement The NBP Pod has lost the SRR connection to the telemetry Device device or the patient monitor. Cuff Not Deflated NBP Numeric is replaced by -?INOP tone During this INOP, alarms cannot be paused or switched off. The NBP cuff pressure has exceeded 15 mmHg (2 kPa) for more than 3 minutes. Remove the cuff from the patient. Make sure that the tubing is not kinked or twisted and that the correct patient category is selected. Try repeating the measurement. You can acknowledge the INOP, but the INOP message remains visible until the next NBP measurement is started or the Stop All SmartKey is selected. 83 3 IntelliVue CL NBP Pod INOP Message, Indication Source What to do NBP Check Cuff NBP Check if cuff is connected to the NBP Pod and cuff is applied to the patient; check tubing and cuff for leakage. Numeric is replaced by -?INOP tone Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. This INOP arises when the maximum time for inflation is exceeded or when there is a significant change in inflation time between two successive measurements in auto and sequence mode. NBP Cuff Overpress NBP The NBP cuff pressure exceeds the overpressure safety limits. Remove the cuff from the patient. Make sure that the tubing is not kinked or twisted and that the correct patient category is selected. Try restarting the measurement. You can acknowledge this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. NBP Equip Malf NBP Remove the NBP Pod and cuff from the patient. The NBP hardware is faulty. Contact your service personnel. You can acknowledge this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. NBP Interrupted NBP Check the tubing and cuff for leakages or kinks. Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. This INOP arises when the measurement needed longer than the maximum time for deflation or the total measurement. NBP Measure Failed NBP Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected. Check the condition and suitability of the patient for NBP monitoring. Use another cuff to continue measuring. NBP Neo Patient? NBP The patient monitor that the NBP pod is assigned to is in neonatal mode or a neonatal cuff has been detected. The monitor must be in adult or pediatric mode. No Cradle NBP The NBP Pod is not in the cradle. You can silence this INOP, but the INOP message remains visible until the NBP Pod is inserted into the cradle and the next measurement is started or the Stop All SmartKey is selected. Numeric is replaced by -?INOP tone During this INOP, alarms cannot be paused or switched off. Numeric is replaced by -?INOP tone Numeric is replaced by -?INOP tone Numeric is replaced by -?INOP tone Numeric is replaced by -?INOP tone Numeric is replaced by -?INOP tone If INOP appears with the NBP Pod inserted into the cradle, remove and replace the cradle. 84 3 IntelliVue CL NBP Pod INOP Message, Indication Source No Host Monitoring Cableless Measurement There is a problem with the communication to the assigned Device patient monitor and monitoring is currently not possible (no patient alarms or information). Check the connection. Contact your service personnel. No System Cableless Measurement There is a problem with the communication to the network Device and central monitoring is currently not possible. Check the connection. Remove From Pat Cableless Measurement Displayed on the Cableless Measurement Device. The Device temperature of the battery is too high. Remove the Cableless Measurement Device from the patient and contact service personnel. Service Battery Battery INOP tone INOP tone INOP tone What to do Maximum number of charge/discharge cycles for battery exceeded. Charging of the battery is inhibited. Contact your service personnel to replace battery. 85 3 IntelliVue CL NBP Pod Local Attended Monitoring When working with an IntelliVue MP5, MP5SC, MP5T Patient Monitor with software revision J.2 or higher as a host, or with an IntelliVue X2 Multi-Measurement Module with software revision K.2 or higher, the IntelliVue CL SpO2 and NBP Pods can be used for local attended monitoring. This is for situations where you want to have alarm indications at the CL Pods when they are out of reach of the patient monitor (disconnected). The patient monitor setting to switch CL Measurement Alarms on and off (cl Alarms On/ Off) is used to enable and disable this functionality. As a default, the CL Measurement Alarms are on. Local Attended Monitoring Enabled By default, the patient monitor is set to receive alarms from the CL Pods (can only be changed in configuration mode). This scenario is used for patients who require uninterrupted monitoring. The various alarms from the CL Pods are indicated at the patient monitor if they are enabled at the monitor. When the CL Pod is disconnected from the patient monitor and the caregiver has activated the transport mode at the monitor, physiological alarms are indicated locally at the CL Pod. A cl NBP Disconnect INOP is shown at the monitor if the SRR connection is lost and the transport mode has not been activated. CL Pod connected to a patient monitor and CL Measurement Alarms On (Standard Use Model): SRR connection At the CL Pod: Indication of technical alarms only At the monitor: Indication of physiological and technical alarms from CL Pods CL Pod disconnected from patient monitor and CL Measurement Alarms On, Local Attended Monitoring: No SRR connection At the CL Pod: Indication of technical and physiological alarms 86 At the monitor: No indication of physiological alarms from CL Pods. No indication of technical alarms after disconnection. 3 IntelliVue CL NBP Pod Local Attended Monitoring Disabled The patient monitor is set to cl Alarms Off (this can only be done in configuration mode). This scenario is used if the patients do not require permanent monitoring and are mobile, but vital signs are taken from time to time. All alarms from the CL Pods are switched off at the monitor. If the SRR connection is lost, no cl NBP Disconnect INOP is shown at the monitor in this scenario. CL Pod connected to a patient monitor and CL Measurement Alarms Off: SRR connection At the CL Pod: Indication of technical alarms only At the monitor: No indication of physiological alarms from CL Pods. Indication of technical alarms from CL Pods. CL Pod disconnected from patient monitor and CL Measurement Alarms Off: No SRR connection At the CL Pod: Indication of technical alarms only At the monitor: No indication of physiological and technical alarms from CL Pods. 87 3 IntelliVue CL NBP Pod Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms On Standard Use Model Local Attended Monitoring -> Caregiver activates 'Use for transport' Patient mobile 60 bpm and normal adult cuff Maximum 180 seconds ±(3 mmHg or 2% whichever is greater) @ 10 to 40°C STAT and Accelerated Mode: Typical 30 seconds @ >60 bpm and normal adult cuff Maximum 180 seconds STAT Mode Cycle Time 5 minutes Initial Cuff Inflation Pressure Adult: 165 ±15 mmHg Pediatric: 130 ±15 mmHg Venipuncture Pressure Range Adult: 20 to 120 mmHg in steps of 5 mmHg Pediatric: 20 to 80 mmHg in steps of 5 mmHg Venipuncture Pressure Accuracy ±10 mmHg Cuff size detection INOP, if neonatal cuff size is detected 1Approval pending 137 7 Specifications IntelliVue CL Respiration Pod Specifications Complies with ISO 80601-2-61:2011 / EN ISO 80601-2-61:2011. Physical Specifications Size (W x H x D) 45 mm x 14 mm x 65 mm ±5% (1.7 in x 0.5 in x 2.5 in ±5%) (without accessories) Weight 35 g ±10% (1.2 oz ±10%) Robustness Survives shock, random vibration and bump according to IEC TR 60721-4-7 Class 7M3 as well as a 1 m drop Ingress Protection IP67 according to IEC 60529 Environmental Specifications Operating Temperature Range 0 to 40°C (32 to 104°F) Operating Humidity Range ≤95% RH @ 40°C (104°F), no condensation Operating Altitude Range -500 to 3000 m Storage/Transportation Temperature Range -20 to 60°C (-4 to 140°F) Storage/Transportation Humidity Range ≤90% RH @ 60°C (140°F), no condensation Storage/Transportation Altitude Range -500 to 4600 m Storage/Transportation Ambient Pressure 1075 hPa to 570 hPa (-500 m to 4600 m / -1650 ft to 15000 ft) (Altitude Range) Performance Specifications Battery Integrated rechargeable Li-Ion battery with battery gauge and cycle counter Runtime (fully charged battery) Minimum 12 hours in frequent measurement mode with posture and activity detection Typically 18 hours in frequent measurement mode with posture and activity detection Minimum 1.5 days @ 4 measurements per hour without posture and activity detection Typical 3 days @ 4 measurements per hour without posture and activity detection Minimum 1 day @ 4 measurements per hour with posture and activity detection Typical 2 days @ 4 measurements per hour with posture and activity detection Charging Time max 2.5 hours Short Range Radio Specifications Type built in interface with integrated antenna Technology IEEE 802.15.4 Frequency band 2.4 GHz ISM (2.400 - 2.483 GHz) MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1 Modulation DSSS (O-QPSK) 138 7 Specifications Performance Specifications Bandwidth 5 MHz Effective radiated power (ERP) max. 2 dBm (1.6 mW) Real Time Clock Accuracy better than 5 seconds per day (typically) as long as device is in power state "Device on". Automatically synchronized with assigned host system. Respiration Measurement Range 5 to 60 rpm Accuracy ±1 rpm Resolution 1 rpm Pulse Measurement Range Adult: 30 to 220 bpm For rapid, irregular heart rates: 30 to 110 bpm Pediatric: 30 to 220 bpm Accuracy ±3% or ±1 bpm (whichever is greater) Resolution 1 bpm Posture Information 14 patient postures (supine, prone, upright, reclined, forward, lying on left side, lying on right side, lying (unspecific), sitting, standing, rolling (in bed), walking, wheelchair (self), upside down) Activity Information 10 levels from 1 (very low activity) to 10 (very high activity); level 0: no signal Approval pending Attachment Specifications Size (W X H) 196 mm x 64 mm (7.7 in x 2.5 in) Environmental Specifications Operating temperature range 0 to 40°C (32 to 104°F) Storage / Transportation Temperature Range Storage: 12 to 35°C (54 to 95°F) Transportation: -20 to 60°C (-4 to 140°F) Storage / Transportation Humidity Range Storage: 18% RH to 78% RH Transportation: ≤ 90% RH @ 60°C (140°F); no condensation Storage / Transportation Ambient Pressure (Altitude Range) 1075 hPa to 570 hPa (-500 m to 4600 m / -1650 ft to 15000 ft) 139 7 Specifications Alarm Specifications for CL NBP, CL SpO2 and CL Resp Pod When the CL Respiration Pod is used alone, without an assignment to a host, no physiological alarms will be generated. When the CL SpO2 Pod or CL NBP Pod are used for local attended monitoring, the following specifications apply: Alarm Signal System Alarm Delay less than 4 seconds The system alarm delay is the processing time the system needs for any alarm to be indicated on the device, after the measurement has triggered the alarm. Delay for alarm availability on the network less than 5 seconds This is the time needed after alarm indication on the device until the alarm signal is available on the network, to the monitor or to other systems. Sound Pressure Range min. 0 dB(A) max. 30-65 dB(A) SpO2 Alarm Specifications Range Adjustment SpO2 Adult: 50 to 100% Pedi: 30 to 100% 1% steps Desat Adult: 50 to Low alarm limit Pedi: 30 to Low alarm limit 1% steps Pulse 30 to 300 bpm Adult: 1 bpm steps (30 to 40 bpm) 5 bpm steps (40 to 300 bpm) Pedi: 1 bpm steps (30 to 50 bpm) 5 bpm steps (50 to 300 bpm) Tachycardia Difference to high limit 0 to 50 bpm 5 bpm steps Clamping at 150 to 300 bpm 5 bpm steps Bradycardia Difference to low limit 0 to 50 bpm 5 bpm steps Clamping at 30 to 100 bpm 5 bpm steps SpO2 Alarm Specifications (cont.) Standard Delay SpO2 high and low limit alarms 0 to 30 seconds (adjustable in 1 second steps) + system alarm delay Desat 0 to 30 seconds (adjustable in 1 second steps) + system alarm delay Pulse 10 seconds + system alarm delay Tachycardia 10 seconds + system alarm delay Bradycardia 10 seconds + system alarm delay 140 7 Specifications NBP Alarm Specifications Range Adjustment Systolic Adult: 30 to 270 mmHg (4 to 36 kPa) 10 to 30 mmHg: 2 mmHg (0.5 kPa) >30 mmHg: 5 mmHg (1 kPa) Pedi: 30 to 180 mmHg (4 to 24 kPa) Diastolic Adult: 10 to 245 mmHg (1.5 to 32 kPa) Pedi: 10 to 150 mmHg (1.5 to 20 kPa) Mean Adult: 20 to 255 mmHg (2.5 to 34 kPa) Pedi: 20 to 160 mmHg (2.5 to 21 kPa) When the Cableless Measurement Devices are assigned to a monitor or telemetry device, alarms may be announced at the host monitor (for the telemetry device, at the Information Center). See the respective Instructions for Use for detailed alarm specifications. Alarm delay times are as specified in the Instructions for Use of your patient monitor or IntelliVue Information Center plus 4 seconds. NOTE If the SRR connection between the Cableless Measurement Device and the patient monitor or telemetry device is interrupted, the patient monitor or telemetry device will issue an INOP within 5 seconds. Telemetry Device Battery Runtime Specifications Operating Mode Battery Runtime ECG Only Telemetry Device with CL SpO2/NBP Pod connected 20 hours Telemetry Device is host to CL SpO2/NBP Pod ECG/SpO2 (continuous) Telemetry Device with internal SpO2 running in continuous mode and CL SpO2/NBP Pod connected 8 hours Telemetry Device is host to CL SpO2/NBP Pod IntelliVue CL Transmitter Specifications Physical Specifications Size (W x H x D) 55 mm x 27 mm x 122 mm ±5% (2.2 in x 1.0 in x 4.8 in ±5%) (without cradle) Weight 154 g ±10% (5.4 oz ±10%) (without cradle) Robustness Provides essential performance during exposure to random vibration according to IEC TR 60721-4-7 Class 7M1 Survives shock, random vibration and bump according to IEC TR 60721-4-7 Class 7M3 as well as a 1 m drop Ingress Protection IP32 according to IEC 60529 (protected against ingress of water when the water is dripping vertically and the CL Transmitter is tilted up to 15° and protected against contact with or ingress of objects larger than 2.5 mm) 141 7 Specifications Environmental Specifications Operating Temperature Range 0 to 40°C (32 to 104°F) 0 to 35°C (32 to 95°F) when charging the battery with an active WLAN connection Operating Humidity Range ≤95% RH @ 40°C (104°F) no condensation Operating Altitude Range -500 to 3000 m Storage / Transportation Temperature Range -20 to 60°C (-4 to 140°F) Storage / Transportation Humidity Range ≤90% RH @ 60°C (140°F) (non-condensing) Storage / Transportation Altitude Range -500 to 4600 m Performance Specifications Display Specifications Type monochrome (4 grey scales), passive LCD (STN), positive/transflective Viewing Area 25.6 mm x 19.2 mm Dot Size 0.2 mm x 0.2 mm Resolution 128 x 96 pixel Backlight white LED Battery Integrated rechargeable Li-Ion battery with battery gauge and cycle counter Runtime (fully charged battery) Typical 8 hours Charging Time (WLAN and SRR not active) Maximum 2.5 hours Electronic Article Surveillance (EAS) EAS tag inside the housing Short Range Radio Specifications Type built in interface with integrated antenna Technology IEEE 802.15.4 Frequency Band 2.4 GHz ISM (2.400 - 2.483 GHz) MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1 Modulation DSSS (O-QPSK) Bandwidth 5 MHz Effective Radiated Power (ERP) max. 0 dBm (1 mW) WLAN Specifications Type Internal wireless adapter Technology IEEE 802.11a/b/g/n 142 7 Specifications Performance Specifications Frequency Band USA: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.725 - 5.825 GHz Europe: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.47 - 5.725 GHz Japan: 2.400 - 2.483 GHz, 5.150 - 5.250 GHz, 5.25 - 5.35 GHz, 5.470 5.725 GHz China: 2.400 - 2.483 GHz, 5.725 - 5.85 GHz Modulation Technique 802.11b/g DSSS (DBPSK, DQPSK, CCK) OFDM (BPSK, QPSK, 16-QAM, 64-QAM) 802.11a OFDM (BPSK, QPSK, 16-QAM, 64-QAM) Effective Radiated Power (ERP) 2.400 - 2.483 GHz: max. 18 dBm (63 mW) 5.150 - 5.725 GHz: max. 19 dBm (79 mW) 5.745 - 5.825 GHz: max. 14 dBm (25 mW) Realtime Clock Accuracy less than 5 seconds per day (typically) as long as device is in power state "Device on" or "Standby". Automatically synchronized with assigned patient monitor/ telemetry device. Approval pending IntelliVue CL Transmitter Base Station Specifications Physical Specifications Size (W x H x D) 75 mm x 45 mm x 173 mm ±5% (3.0 in x 1.8 in x 6.8 in ±5%) Weight 236 g ±10% (8.3 oz ±10%) Robustness Operating within specification during exposure to random vibration according to IEC TR 60721-4-7 Class 7M1 Survives shock and 0.05 m free fall according to IEC TR 60721-4-7 Class 7M1 Ingress Protection IP21 according to IEC 60529 (protection against ingress of water when the water is dripping vertically) Environmental Specifications Operating Temperature Range 0 to 40°C (32 to 104°F) Operating Humidity Range ≤95% RH @ 40°C (104°F) Operating Altitude Range -500 to 3000 m -500 to 2000 m when powered from external power supply 865222 #E90 Storage/Transportation Temperature Range -20 to 60°C (-4 to 140°F) Storage/Transportation Humidity Range ≤90% RH @ 60°C (140°F) no condensation Storage/Transportation Altitude Range -500 to 4600 m 143 7 Specifications Performance Specifications Charging Interface (output) Power output (PoE powered) 5 V ±10% Power output (USB powered) USB input voltage - 180 mV (@ 500 mA) Communication USB 2.0 full speed USB Interface Standard USB 2.0 full speed Device Port Power Input 4.5 V - 5.5 V (8 W) power requirement for service and upgrade of connected Cableless Measurement Devices 2.5 W Connector USB series “Standard-B” receptacle Network Standards IEEE 802.3 100-Base-T, IEEE 802.3af (PoE Class 3) Connector RJ45 (8 pin) External AC/DC 5V requirements (connection to USB) Output voltage 5 V +/-5% Power output min. 8 W Isolation double according to IEC 60950-1 Class II Classification Limited Power Source according to IEC 60950-1 External AC/DC 48V requirements (connection to RJ45) Output Voltage 48 V +/-10% Power output min. 8 W Compliancy IEEE 802.3af (PoE Class 3) Isolation double according to IEC 60950-1 Class II Classification Limited Power Source according to IEC 60950-1 Connector RJ45 (Data-in), RJ45 (Data&Power Out) IntelliVue CL Hotspot Specifications Physical Specifications Size (W x H x D) 75 mm x 53 mm x 177 mm ±5% (3.0 in x 2.1 in x 7.0 in ±5%) Weight 367 g ±10% (12.9 oz ±10%) Robustness Provides essential performance during exposure to random vibration according to IEC TR 60721-4-7 Class 7M1 Survives shock and 0.05 m free fall according to IEC TR 60721-4-7 Class 7M1 Environmental Specifications Operating Temperature Range 0 to 40°C (32 to 104°F) Operating Humidity Range ≤95%RH @ 40°C (104°F) no condensation 144 7 Specifications Environmental Specifications Operating Altitude Range -500 to 3000 m -500 to 2000 m when powered from external power supply 865222 #E90 Storage / Transportation Temperature Range -20 to 60°C (-4 to 140°F) Storage / Transportation Humidity Range ≤90% RH @ 60°C (140°F) (non-condensing) Storage / Transportation Altitude Range -500 to 4600 m Performance Specifications Display Specifications Type monochrome (4 gray scales), passive LCD (STN), positive/transflective Viewing Area 25.6 mm x 19.2 mm Dot Size 0.2 mm x 0.2 mm Resolution 128 x 96 pixel Backlight white LED Short Range Radio Specifications Type built in interface with integrated antenna Technology IEEE 802.15.4 Frequency Band 2.4 GHz ISM (2.400 - 2.483 GHz) MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1 Modulation DSSS (O-QPSK) Bandwidth 5 MHz Effective Radiated Power (ERP) max. 0 dBm (1 mW) WLAN Specifications Type Internal wireless adapter Technology IEEE 802.11a/b/g/n Frequency Band USA: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.725 - 5.825 GHz Europe: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.47 - 5.725 GHz Japan: 2.400 - 2.483 GHz, 5.150 - 5.250 GHz, 5.25 - 5.35 GHz, 5.470 5.725 GHz China: 2.400 - 2.483 GHz, 5.725 - 5.85 GHz Modulation Technique 802.11b/g DSSS (DBPSK, DQPSK, CCK) OFDM (BPSK, QPSK, 16-QAM, 64-QAM) 802.11a OFDM (BPSK, QPSK, 16-QAM, 64-QAM) Effective Radiated Power (ERP) 2.400 - 2.483 GHz: max. 18 dBm (63 mW) 5.150 - 5.725 GHz: max. 19 dBm (79 mW) 5.745 - 5.825 GHz: max. 14 dBm (25 mW) 145 7 Specifications Performance Specifications Realtime Clock Accuracy less than 5 seconds per day (typically) as long as device is in power state "Standby" or "Device off". Automatically synchronized with assigned patient monitor/telemetry device. USB Interface Standard USB 2.0 full speed Device Port Power Input 4.5 V - 5.5 V (3 W) power requirement for service and upgrade of connected Cableless Measurement devices 2.5 W Connector USB series “Standard-B” receptacle LAN Network Standards IEEE 802.3 100-Base-T, IEEE 802.3af (PoE Class 3) Connector RJ45 (8 pin) External AC/DC 5V requirements (connection to USB) Output voltage 5 V +/-5% Power output min. 3 W Isolation double according to IEC 60950-1 Class II Classification Limited Power Source according to IEC 60950-1 External AC/DC 48V requirements (connection to RJ45) Output Voltage 48 V +/-10% Power output min. 3 W Compliancy IEEE 802.3af (PoE Class 3) Isolation double according to IEC 60950-1 Class II Classification Limited Power Source according to IEC 60950-1 Connector RJ45 (Data-in), RJ45 (Data&Power Out) 1Approval 146 pending 1 activity 107 alarms off symbol 32, 75 ambient light 31 assignment 22 at the measurement device 22 at the patient monitor 23 assignment mode 22 auto power off 17 automatic mode 74 automatic mode SpO2 31 averaging time 33 changing 33 electrosurgery 69 electrosurgery interference/ defibrillation 133 elevated ambient temperatures 30 EMC 130 directive compliance 131 radio regulatory compliance 130 Index intravenous infusion 69 local attended monitoring 43 loose sensor 30 low-activity screen 15 FCC and industry canada radio compliance 130 fetal monitors (NBP) 66 fetal monitors (SpO2) 24 free device 18, 107 main setup menu 17, 59 maintenance task and test schedule 53 manual mode SpO2 31 monitoring mode 17 MR imaging 125 battery 50 care 50 lifetime management 51 power indicators 118 status menu 19 status on the cableless device 19 hardkeys 15 NBP 94 accessories 94 default settings 91 numerics 75 specifications 135 new patient 18 adding 18 no host monitoring 22, 25, 64, 67 care and cleaning 121 caution, definition 5 charging 118 cleaning and disinfecting 122 compatibility (NBP) 63 compatibility (SpO2) 21 configuration mode 17 connection status symbol 22 continuous mode SpO2 31 date and time 19 default profile 18 demonstration mode 17 device compatibility (NBP) 63 device compatibility (SpO2) 21 disinfecting 122 disinfecting agents 122 disposing of the IntelliVue Cableless Measurement Device 123 electromagnetic compatibility (EMC) 132 infection control 121 ingress protection (NBP Pod) 135 ingress protection (SpO2 Pod) 133 injected dyes 31 INOP 14, 56 layout 14 NBP 82 Resp 108 SpO2 40 tone 36 inspecting the equipment and accessories 53 IntelliVue CL hotspot specifications 144 IntelliVue CL NBP Pod 94 accessories 94 specifications 135 IntelliVue CL Respiration Pod 99 IntelliVue CL SpO2 Pod 52 accessories 52 specifications 133 IntelliVue CL Transmitter 116 accessories 116 specifications 141 IntelliVue CL transmitter and IntelliVue CL hotspot 113 IntelliVue CL transmitter base station 117 specifications 143 intended use 125 interference 22, 31 operating modes 17 oscillometric NBP measurement 69 oxygen saturation 28 patient category 18 patient demographics 18 patient menu 18 patient movement 31 perfusion indicator 28, 31 perfusion numeric 33 pleth waveform 28 posture 107 posture detection 107 profiles 18 pulsatile flow 31 pulse oximetry 28 pulse rate 28 pulse rate numeric 32, 75 147 R R&TTE directive compliance 131 radiofrequency radiation exposure information 132 removing a patient from the device 18 removing the pod from the cradle 30 repetition time 74 respiration measurement 104 Respiration sensor 104 safety and performance tests 132 safety specifications 129 screen layout 14 sensor (Resp) 105 applying 105 sensor (SpO2) 30 applying 30 sequence mode 75 service mode 17 setup sequence 75 short range radio 22 short range radio (SRR) 10 signal quality indicator 32 skin damage 69, 105 smartkeys 15 SpO2 52 accessories 52 default settings 49 numerics 32 sensors 28 signal quality indicator 32 specifications 133 SpO2 accessories 52 SpO2 numerics 32 SpO2 Sensors 29 Connecting 29 SpO2 specifications 133 standby mode 60 starting and stopping measurements (NBP) 74 suspicious SpO2 reading 33 symbols 127 technical alarms (INOPs, NBP) 82 technical alarms (INOPs, Resp) 108 technical alarms (INOPs, SpO2)) 40 telemetry device 20 telemetry device battery runtime specifications 141 test schedule 53 148 timestamp 75 timestamp SpO2 32 transceiver 26 transmitter base station specifications 143 troubleshooting 53 use models 20 venipuncture 76 venous pulsation 30 visual inspection 53 warning 5 Part Number 453564657401 Published in Germany 02/2017 *453564657401*
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