Philips Medical Systems North America CLNBPBV2 2.4 GHz Transceiver User Manual

Philips Medical Systems North America Co. 2.4 GHz Transceiver

User Manual

Instructions for Use IntelliVue Cableless MeasurementsCL SpO2 Pod – CL NBP Pod – CL Respiration PodRelease D.00Patient Monitoring
31Table of Contents1Introduction and Basic Operation 5Safety Information 6Security Information 8Introducing the IntelliVue Cableless Measurements 102IntelliVue CL SpO2 Pod 13General Operation of the SpO2 Pod 13Connection with Host Systems 20Monitoring SpO2 28Alarms 34Local Attended Monitoring 43SpO2 Default Settings 49Integrated Battery Handling 50Accessories 52Maintenance and Troubleshooting 533IntelliVue CL NBP Pod 55General Operation of the NBP Pod 55Connection with Host Systems 62Monitoring NBP 69Alarms 77Local Attended Monitoring 86NBP Default Settings 91Integrated Battery Handling 92Accessories 93Maintenance and Troubleshooting 974IntelliVue CL Respiration Pod 99General Operation of the Respiration Pod 99Connection with Host Systems 100Monitoring Respiration 104Technical Alarms (INOPs) 108Respiration Default Settings 109Integrated Battery Handling 110Accessories 111Maintenance and Troubleshooting 1125Cableless Measurement Auxiliary Devices 113IntelliVue CL Transmitter and IntelliVue CL Hotspot 113IntelliVue CL Transmitter Base Station 117
4IntelliVue CL Charging Station 118Maintenance and Troubleshooting 1196Care and Cleaning 121General Points 121Cleaning and Disinfecting the IntelliVue Cableless Measurement Devices 122Disposing of the IntelliVue Cableless Measurement Devices 1237Specifications 125Indications for Use 125Compatible Medical Devices 127Symbols 127Manufacturer's Information 129Regulatory and Safety Specifications 129EMC and Radio Regulatory Compliance 130Safety and Performance Tests 132Electromagnetic Compatibility (EMC) 132Accessories Compliant with EMC Standards 133Electrosurgery Interference/Defibrillation 133IntelliVue CL SpO2 Pod Specifications 133IntelliVue CL NBP Pod Specifications 135IntelliVue CL Respiration Pod Specifications 138Alarm Specifications for CL NBP, CL SpO2 and CL Resp Pod 140Telemetry Device Battery Runtime Specifications 141IntelliVue CL Transmitter Specifications 141IntelliVue CL Transmitter Base Station Specifications 143IntelliVue CL Hotspot Specifications 144Index 147
151Introduction and Basic OperationThese 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 Operation6Safety InformationUse EnvironmentWARNING• 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 HazardsWARNING•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 InterferenceWARNING• 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 HandlingWARNING• 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 Operation7AccessoriesWARNING•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.MaintenanceWARNING•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 DisposalWARNING• 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 Operation8Security InformationProtecting Personal InformationProtecting 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.NOTELog files generated by the devices are used for system troubleshooting and do not contain protected health data.About HIPAA RulesIf 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 DirectivesIf 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 StatementAdditional 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 Operation9Manufacturer Disclosure Statement for Medical Device Security – MDS2You 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 Operation10Introducing the IntelliVue Cableless MeasurementsThe IntelliVue Cableless Measurement Devices provide measurement values and communicate them to other system components using a wireless short range radio (SRR) interface.IntroductionIntelliVue CL SpO2 PodThe IntelliVue CL SpO2 Pod is a battery powered, cableless Pulse Oximetry measuring device.IntelliVue CL NBP PodThe IntelliVue CL NBP Pod is a battery powered, cableless, noninvasive blood pressure (NBP) measuring device.IntelliVue CL Respiration PodThe 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.
1 Introduction and Basic Operation11Basic OperationIntelliVue CL SpO2 Pod and IntelliVue CL NBP PodThe 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:IntelliVue CL Respiration PodThe 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.1Integrated monochrome LC display2Hardkeys3Measurement identifier1Multi-color LED2Measurement identifier3Hardkey4Indication for built-in RFID tag
1 Introduction and Basic Operation12
2132IntelliVue CL SpO2 PodThe 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 PodThe 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 OnThe 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.
2 IntelliVue CL SpO2 Pod14Screen LayoutThere are three variations of the Main Screen layout depending on the Alarm status and the general activity level.Standard LayoutAlarm LayoutIf 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.When assigned to a monitor, telemetry device or a patient in GuardianSoftware:1Connection status indicator2Indicator 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.3Battery indicator4Measurement values5Measurement-related symbols (see the “Monitoring SpO2” section for details)6Patient identificationWhen not assigned to a monitor or telemetry device:1Connection status indicator2Battery indicator3Measurement values4Measurement-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.5Cableless Measurement Device equipment label1Full length alarm message2Alarm indicator
2 IntelliVue CL SpO2 Pod15Low-Activity ScreenIf 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 ActivatedIf 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 HardkeysThe 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:Using the SmartKeysA SmartKey is a graphical key which appears on the screen and gives you fast access to functions.SmartKeys MenuPress 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.◄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
2 IntelliVue CL SpO2 Pod16List of Available SmartKeysSmartKey Text LabelsMain Setupstart an SpO2 measurementset the SpO2 modeAdd/Remove deviceenter Battery menuenter Profiles menuchange Screenput device in standby mode (or power off when pressed for more than two seconds)enter Patient menuenters the Alarms menu to access: Alarm Messages, Alarm Limits, Alarms On/Off/Pause, Alarm Volume.Change alarm volumeChange pulse tone volume
2 IntelliVue CL SpO2 Pod17Using the Main Setup MenuIn 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.Switching the Device OffTo 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 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.•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.Auto Standby and Auto Power OffThe 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 ModesYour 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.Main SetupSpO₂PulseAlarmsPatientEquipmentUser InterfaceStandbyProfilesOperating ModesDate, TimeBatteryRevisions
2 IntelliVue CL SpO2 Pod18•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:1Use the Main Setup SmartKey to get to the Main Setup menu.2Select Operating Modes and choose the mode you require.Using the Patient MenuThe 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 MenuTo display the Patient menu,• select the Patient SmartKey, or• select the Main Setup SmartKey followed by Patient.Stop Using a Device for a PatientTo 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.NOTEDepending 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 PatientTo 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 ProfilesA 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,1Select the Profiles SmartKey or the Main Setup SmartKey followed by Profiles.2Select the required profile from the list.Selecting New Patient or Free Device will always reset the profile to the default.
2 IntelliVue CL SpO2 Pod19Setting the Date and TimeIf 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,1Select the Main Setup SmartKey and then Date, Time.2Enter the data for date and time one after another.3Select Store Date, Time.If the time has not been set, --:-- will display on the device.Battery StatusThe 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 MenuSelect 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.
2 IntelliVue CL SpO2 Pod20Connection with Host SystemsThe 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 ModelsWith 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 MonitorThe 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 MonitorIn 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 DeviceThe 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.
2 IntelliVue CL SpO2 Pod21When 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 GuardianSoftwareThe 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 CompatibilityThe 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 aboveAvailability of Patient AlarmsWhen 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
2 IntelliVue CL SpO2 Pod22appears 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 HostWhen 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).WARNINGAlways make sure that the applied CL SpO2 Pod is assigned to the correct patient.WARNINGShort 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 DeviceTo make an assignment, select:•the Add/Remove SmartKey , or• hold the ◄key pressed.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
2 IntelliVue CL SpO2 Pod23take 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.1Select 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.2Activate 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:1Select the measurement selection key on the monitor.A prompt message appears with the Confirm and Cancel keys.2Select 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 MonitorAssignment at the Patient MonitorPrepare the Cableless Measurement Device for assignment by activating the Add/Remove SmartKey.At the patient monitor,1Select the Measurement Selection key.2Select the Add cl Msmt pop-up key.This opens the Add cl Measurement window, which shows the available Cableless Measurement Devices:3Select the device which you want to assign to the patient in the monitor.4The 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 symbol appears on its display indicating that alarms from the device will be sent to the patient monitor.Add ToMon 1Mon 2Tele 33Tele 44
2 IntelliVue CL SpO2 Pod24An 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 DevicesYou 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.1Hold 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.2Press 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 MonitorThe 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.NOTEWhen 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 MonitorsThe following special conditions apply when CL SpO2 Pods are operating with an Avalon Fetal Monitor as a host:•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 Pod25• 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 is always Off and cannot be changed to On.• 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.Assignment with GuardianSoftwareTo assign a Cableless Measurement Device to a patient in GuardianSoftware:1Select the patient on the Chalkboard.2Take the Cableless Measurement Device from the charger.3On 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).4Click Use for Patient to assign the device to the patient.Controls Available with a Patient MonitorThe controls available when working with the Cableless Measurement Device and a patient monitor are described in the table below.* except when SRR connection to host is lostAction At the Cableless Measurement DeviceAt the Patient MonitorAt the IICStart SpO2Yes Yes NoChange SpO2 Mode Yes Yes NoSelect SpO2 Repetition Time Yes Yes NoAssign SpO2 Pod Yes Yes NoRemove SpO2 Pod Yes Yes NoChange Alarm Limits Yes* Yes NoPlace Device in Standby Yes Yes YesAlarm Silence Yes Yes YesAlarm Off/Pause Yes Yes Yes
2 IntelliVue CL SpO2 Pod26WARNINGIf 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 DeviceThe 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.NOTEWhen 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.NOTEThe 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.Action At the Cableless Measurement DeviceAt the IICStart SpO2Yes YesChange SpO2 Mode Yes YesSelect SpO2 Repetition Time Yes NoAssign SpO2 Pod Yes NoRemove SpO2 Pod Yes YesChange Alarm Limits No YesPlace Device in Standby No NoAlarm Silence No YesAlarm Off/Pause No Yes
2 IntelliVue CL SpO2 Pod27Controls Available with GuardianSoftwareThe controls available when working with the Cableless Measurement Device and GuardianSoftware are described in the table below.TrendingThe 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.Action At the Cableless Measurement DeviceAt GuardianSoftwareStart SpO2Yes Yes Change Mode Yes YesSelect SpO2 Repetition Time Yes YesAssign SpO2 Pod Yes YesRemove SpO2 Pod Yes YesPlace Device in Standby No NoTechnical Alarm Silence No YesAlarm Off/Pause No No
2 IntelliVue CL SpO2 Pod28Monitoring SpO2Philips 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).NOTENo 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 SensorsSpecialized 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 InformationThe 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 Use1 may not be available in all geographies
2 IntelliVue CL SpO2 Pod29Connecting SpO2 Sensors1Connect the sensor to the single patient Mobile CL SpO2 Cradle (if not already connected).2Insert the SpO2 Pod into the Mobile CL SpO2 Cradle. The correct orientation is indicated by a matching blue dot inside the cradle.CAUTIONMake sure that the contacts of the SpO2 Pod and the sensor are dry and free of residues.3Secure 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.
2 IntelliVue CL SpO2 Pod30Removing the Pod from the CradleTo 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 Sensor1Choose 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.2Remove colored nail polish from the application site.3Apply 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.4Check that the light emitter and the photodetector are directly opposite each other. All light from the emitter must pass through the patient's tissue.WARNINGProper 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.
2 IntelliVue CL SpO2 Pod31Measuring SpO2During 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 cross-interference.– Electromagnetic interference, especially at perfusion indicator values below 1.0 or signal quality indicator below medium.– Excessive patient movement and vibration.Selecting Measurement ModesThere 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.
2 IntelliVue CL SpO2 Pod32Starting and Stopping MeasurementsUse the setup menu or SmartKeys to start measurements manually: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 SymbolsSpO2 Signal Quality IndicatorThe 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.Action to be Performed SpO2 menu SmartKeysStart manual measurement Start SpO₂Start1SpO2 numeric2Pulse rate numeric3Symbol indicating pulse rate4Measurement mode - indicates here that Auto mode is active and shows the time to the next measurement.5Alarms Off symbol for Pulse6Timestamp7Alarms Off symbol for SpO2Note: The Alarms Off symbols indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host.1SpO2 Quality Indicator
2 IntelliVue CL SpO2 Pod33Assessing a Suspicious SpO2 ReadingTraditionally, 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.WARNINGWith 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 TimeDepending 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.1In the SpO₂ menu, select Average.2Select 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.
2 IntelliVue CL SpO2 Pod34AlarmsThe IntelliVue Cableless Measurements have two different types of alarm: patient alarms and technical alarms (INOPs).Patient AlarmsPatient 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 DelaysThere 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 AlarmsIf 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.NOTEIf you want to use local attended monitoring, make sure to have all Cableless Measurement Devices upgraded to at least Rev. B.02.Visual Alarm IndicatorsWARNING• 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 Pod35Alarm MessageAlarm 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 StatesDepending on the alarm state of your Cableless Measurement Device, the following icons may be displayed on the device:Audible Alarm IndicatorsAudible 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).Icon DescriptionNo 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.
2 IntelliVue CL SpO2 Pod36Silencing an AlarmTo 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.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 AlarmsTo display a list of the currently active alarms,1Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms.2Select Alarm Messages.Setting the Volume of the Alarm ToneTo set the volume for the Alarm tone,1Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms.2Select 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: NOTENo Alarm tone will sound at the device as long as it is within the SRR range.Minimum Volume for No Host Monitoring INOPIf 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.1Full length alarm message2Alarm indicator
2 IntelliVue CL SpO2 Pod37Alarm ReminderIf 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 AlarmsIf 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,1In the SmartKeys Menu select Main Setup, Alarms, then OffDurat.2Check the setting.This setting can only be changed in Configuration Mode.To Pause or Switch Off AlarmsSelect 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 AlarmsTo 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.
2 IntelliVue CL SpO2 Pod38Alarm LimitsThe 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.WARNINGBe 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 Limits1Select the Alarms SmartKey followed by Alarm Limits (or select Main Setup followed by SpO₂):2Select High Lim then choose the high alarm limit.3Select Low Lim then choose the low alarm limit.WARNINGHigh 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 AlarmThe Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in oxygen saturation.1In the SpO₂ menu, select DesatLim.2Adjust the limit.Setting Up Tone ModulationOnly 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).NOTEIf the SpO2 level drops below 52%, two short tones will be issued rather than one long tone.Latching AlarmsThe 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.
2 IntelliVue CL SpO2 Pod39Viewing the Alarm Latching SettingsTo see the alarm latching setting for your device,1In the Main Setup menu, select Alarms.2Here 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:Alarm Latching BehaviorAll INOPs are non-latching.Testing AlarmsWhen 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 OnIf 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.Visual Latching Audible LatchingRed&Yellow Red&YellowRed&Yellow Red OnlyRed&Yellow OffRed Only Red OnlyRed Only OffOff OffRed & Yellow Measurement AlarmsNon-latching alarms Visual and audible latching Visual latching, audible non-latchingAlarm has not been acknowledged.Alarm condition still present.Alarm tone on. Alarm message. Alarm tone on. Alarm message.Alarm tone on. Alarm message.Alarm condition no longer present.All audible and visual alarm 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 no longer present.Audible and visual alarm indicators automatically stop.Audible and visual alarm indicators automatically stop.Audible and visual alarm indicators automatically stop.
2 IntelliVue CL SpO2 Pod40Reference List of Patient AlarmsReference List of all INOPsAlarm Message, Indication Source Condition*** Brady (Pulse) SpO2The heart rate from the Pulse signal has fallen below the bradycardia limit.*** Desat SpO2The SpO2 value has fallen below the desaturation alarm limit.** Pulse High SpO2The pulse rate has exceeded the high alarm limit.** Pulse Low SpO2The pulse rate has dropped below the low alarm limit.** <SpO₂ Label> High SpO2The arterial oxygen saturation has exceeded the high alarm limit.** <SpO₂ Label> Low SpO2The arterial oxygen saturation has dropped below the low alarm limit.*** Tachy (Pulse) SpO2The Pulse Rate from the Pleth signal has exceeded the tachycardia limitINOP Message, Indication Source What to doBatt IncompatibleINOP toneBattery 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 MalfunctionINOP toneBattery Malfunction of the battery system detected (charger circuit or battery). Contact your service personnel.Battery EmptyINOP toneBattery The remaining monitoring time is below 30 minutes. Charge battery.Battery LowINOP toneBattery The remaining monitoring time is below 2 hours.Check Batt TempINOP toneBattery 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 BatteryINOP toneBattery 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/FINOP toneBattery 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.
2 IntelliVue CL SpO2 Pod41cl SpO₂ Chk SettINOP toneCableless Measurement DeviceIf this INOP appears and an INOP tone sounds, check the 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.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 Disconnectonly at the hostCableless Measurement DeviceThe SpO2 Pod has lost the SRR connection to the telemetry device or the patient monitor.No Host MonitoringINOP toneCableless Measurement DeviceThere is a problem with the communication to the assigned 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 DeviceThere is a problem with the communication to the assigned IntelliVue GuardianSoftware and monitoring is currently not possible (no patient alarms or information). Check the connection. Contact your service personnel.Remove From PatINOP toneCableless Measurement DeviceDisplayed on the Cableless Measurement Device. The temperature of the battery is too high. Remove the Cableless Measurement Device from the patient and contact service personnel.Service BatteryINOP toneBattery Maximum number of charge/discharge cycles for battery exceeded. Charging of the battery is inhibited. Contact your service personnel to replace battery.<SpO₂ Label> Equip MalfNumeric is replaced by -?-INOP toneSpO2The SpO2 Pod is faulty. Contact your service personnel.<SpO₂ Label> ErraticNumeric is replaced by -?-INOP toneSpO2Check the sensor placement. Try another adapter cable and sensor. If the INOP persists, contact your service personnel.<SpO₂ Label> Extd.UpdateNumeric is replaced by -?-SpO2The update time for displayed values is extended due to an NBP measurement on the same limb or an excessively noisy signal.<SpO₂ Label>InterferenceNumeric is replaced by -?-INOP toneSpO2There 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.<SpO₂ Label> Low PerfNumeric is replaced by -?-SpO2Accuracy may be compromised due to very low perfusion. Stimulate circulation at sensor site. If INOP persists, change the measurement site.<SpO₂ Label> NeoPatient?Numeric is replaced by -?-INOP toneSpO2The 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.INOP Message, Indication Source What to do
2 IntelliVue CL SpO2 Pod42<SpO₂ Label> No PulseNumeric is replaced by -?-INOP toneSpO2Check 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.<SpO₂ Label> No SensorNumeric is replaced by -?-INOP toneSpO2Make sure the SpO2 sensor is connected. If the INOP persists, try another sensor. If you acknowledge this INOP, the measurement will be switched off.<SpO₂ Label> NoisySignalNumeric is replaced by -?-INOP toneSpO2Excessive patient movement or electrical interference is causing irregular pulse patterns. Try to reduce patient movement or to relieve the cable strain on the sensor.<SpO₂ Label> Poor Signal SpO2The signal quality of the SpO2 measurement is poor. The accuracy may be compromised.<SpO₂ Label> Pulse?Numeric is replaced by -?-INOP toneSpO2The detectable pulsations of the SpO2 signal are outside the specified pulse rate range.<SpO₂ Label> SearchingNumeric is unavailableSpO2The patient signal is analyzed, but no valid numerics are available yet.<SpO₂ Label> Sensor MalfNumeric is replaced by -?-INOP toneSpO2The SpO2 sensor is faulty. Try another sensor. If the INOP persists, contact your service personnel.<SpO₂ Label> Sensor OffNumeric is replaced by -?-INOP toneSpO2The 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.<SpO₂ Label> Unkn.SensorNumeric is replaced by -?-INOP toneSpO2The connected SpO2 sensor is not supported by this measurement hardware.<SpO₂ Label> UpgradeNumeric is replaced by -?-SpO2SpO2 in upgrade mode, no patient monitoring possible.INOP Message, Indication Source What to do
2 IntelliVue CL SpO2 Pod43Local Attended MonitoringWhen 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 EnabledBy 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):CL Pod disconnected from patient monitor and CL Measurement Alarms On, Local Attended Monitoring:SRR connectionAt the CL Pod:Indication of technical alarms onlyAt the monitor:Indication of physiological and technical alarms from CL PodsNo SRR connectionAt the CL Pod:Indication of technical and physiological alarmsAt the monitor:No indication of physiological alarms from CL Pods. No indication of technical alarms after disconnection.
2 IntelliVue CL SpO2 Pod44Local Attended Monitoring DisabledThe 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:CL Pod disconnected from patient monitor and CL Measurement Alarms Off:SRR connectionAt the CL Pod:Indication of technical alarms onlyAt the monitor:No indication of physiological alarms from CL Pods. Indication of technical alarms from CL Pods.No SRR connectionAt the CL Pod:Indication of technical alarms onlyAt the monitor:No indication of physiological and technical alarms from CL Pods.
2 IntelliVue CL SpO2 Pod45Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms On12Standard Use Model Local Attended Monitoring->Caregiver activates 'Use for transport'<-Caregiver activates 'Use with monitor'SRR connection no SRR connectionAction / Event Situation Alarm Availabilityat CL PodAlarm Availabilityat Patient MonitorStandard Use Model:normal operation,no special actionCL Pod connected to the patient monitor (1)Technical alarms(own)No physiological alarmsNo Local Alarming icon is displayed:Technical alarms (own + from Pod)Physiological alarms(own + from Pod)
2 IntelliVue CL SpO2 Pod46Activation of Local Attended Monitoring:Caregiver activates Local Attended Monitoring and disconnects CL Pod temporarily by setting Use for Transp. in the Patient Monitor's Equipment windowPatient is in transport without connection to the host system, caregiver attends the patient (2)Technical alarms(own)Physiological alarms(own)Technical alarms(own)Physiological alarms(own)No alarms from CL PodDeactivation of Local Attended Monitoring:Caregiver deactivates Local Attended Monitoring and reconnects CL Pod to a patient monitor by setting Use with Monitor in the patient monitor's Equipment windowPatient returns from transport.Back to the standard use model (1)Technical alarms (own)No physiological alarmsNo Local Alarming icon is displayed:Technical alarms (own + from Pod)Physiological alarms(own + from Pod)Special Case:Connection lost while in Standard Use ModelAction / Event Situation Alarm Availabilityat CL PodAlarm Availabilityat Patient MonitorAlternative Use Model:CL Pod temporarily disconnected from a monitor due to unintentional loss of connection (e.g. out of range), Local Attended Monitoring has not been activated by the caregiverNo Host Monitoring INOP at CL Podcl SpO₂ Disconnect INOP at patient monitorLocal Attended Monitoring is automatically activated (2)Technical alarms(own)Physiological alarms(own)Technical alarms(own)Physiological alarms(own)No alarms from CL Pod
2 IntelliVue CL SpO2 Pod47Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms Off34Patient within Range Patient Mobile->Patient mobile<-Patient backSRR connection no SRR connectionAction / Event Situation Alarm Availabilityat CL PodAlarm Availabilityat Patient MonitorConnected, but no CL Alarms (CL Measurement Alarms Off):normal operation,no special actionCL Pod connected to the patient monitor (3)Technical alarms(own)No physiological alarmsNo Local Alarming icon is displayed:Technical alarms (own + from Pod)Physiological alarms(own)
2 IntelliVue CL SpO2 Pod48Patient is leaving the vicinity of the monitor:no special actionPatient is mobile without connection to the host system (4)Technical alarms (own)No physiological alarmsAlarms Off icon is displayed in front of each numeric:Technical alarms (own)Physiological alarms(own)No alarms from CL PodPatient returns to the vicinity of the monitor:no special actionPatient returns.Back to connected status (3)Technical alarms (own)No physiological alarmsNo Local Alarming icon is displayed:Technical alarms (own + from Pod)Physiological alarms(own + from Pod)
2 IntelliVue CL SpO2 Pod49SpO2 Default SettingsThese are the most important default settings of your IntelliVue CL SpO2 Pod as they are delivered from the factory. For a comprehensive list and explanation of default settings, see the Configuration Guide supplied with your devices. The default settings can be permanently changed in Configuration Mode. When the Pod is assigned to a patient monitor, the settings defined at the patient monitor will overwrite the settings defined at the Pod.SpO2 Settings Factory DefaultsAdult Pedi NeoMode Continuous Continuous ContinuousRepeat Time 15 min 15 min 15 minAlarms On On OnPulse Volume 111ToneMod. Yes Yes YesPerfusion OnOnOnAverage 10 sec 10 sec 10 secNBP Alarm Suppr. OnOnOnAging Time 10 min 10 min 10 minColor Cyan (light blue) Cyan (light blue) Cyan (light blue)Average in Mon. No No NoSignal Quality OnOnOnLabel SpO₂SpO₂SpO₂SpO2 Alarm Default SettingsSetting Adult Pedi NeoDesatLim 80 80 80Low Lim 90 90 85High Lim 100 100 95Desat Delay 20 sec 20 sec 20 secHigh Alarm Delay 10 sec 10 sec 10 secLow Alarm Delay 10 sec 10 sec 10 secPulse Settings Factory DefaultsAdult Pedi NeoPulse OnOnOnAlarms On On OnHigh Lim 120 160 200Low Lim 50 75 100Δ Brady 202020Brady Clamp 40 40 50
2 IntelliVue CL SpO2 Pod50Integrated Battery HandlingOnly qualified and authorized service personnel (biomedical engineers or technicians) should change batteries.Battery CareBattery care begins when you receive a new IntelliVue Cableless Measurement Device with built-in battery and continues throughout the life of the device. The table below lists battery care activities and when they should be performed.Handling PrecautionsLithium ion batteries store a large amount of energy in a small package. Use caution when handling the IntelliVue Cableless Measurement Devices with built-in battery; misuse or abuse could cause bodily injury and/or property damage.• Handle with care.• Do not expose the device to liquids.• Do not attempt to disassemble the device.• Do not put device in autoclave.• Damaged devices should not be used anymore.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).Δ Tachy 202020Tachy Clamp 200 220 240Pulse Settings Factory DefaultsAdult Pedi NeoActivity When to performPerform a visual inspection Before using the IntelliVue Cableless Measurement DeviceCharge the battery Upon receipt, after use, or if a low battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible.Store the device in a state of charge in the range of 40-50% and power off the device completely.When not in use for an extended period of time, or when the device is shipped.
2 IntelliVue CL SpO2 Pod51StorageIf unused IntelliVue Cableless Measurement Devices are stored for an extended period of time:• they should be powered off for storage• they should be stored in a cool place, ideally between 15°C and 25°C (60°F and 77°F)• the state of charge should be between 40 and 50%• they should be recharged every six monthsStoring in a cool place slows the aging process of the batteries. They should be fully charged prior to use. Do not store the device at a temperature outside the range of -20°C (-4°F) to 60°C(140°F).Do not store cableless devices in direct sunlight.NOTEStoring the devices at temperatures above 40°C (104°F) for extended periods of time could significantly reduce the battery's life expectancy.Battery Lifetime ManagementThe lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 4 years or 400 complete charge-discharge cycles, whichever comes first. In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. We therefore strongly recommend that lithium ion batteries be replaced after 4 years or 400 complete charge-discharge cycles.To see the date of manufacture and the number of charge-discharge cycles:1Select the Battery Smartkey or Main Setup followed by Battery.2Press the  hardkey to view the battery details.The date of manufacture and the number of charge-discharge cycles are listed with other battery data on the screen. Use the ◄ hardkey to scroll through the list.The age of a lithium ion battery begins at the date of manufacture.
2 IntelliVue CL SpO2 Pod52AccessoriesYou can order parts and accessories from Philips supplies at www.medical.philips.com or consult your local Philips representative for details. Also consult the accessories' Instructions for Use, if available.WARNINGReuse: 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.Accessories Compliant with EMC StandardsAll accessories listed in the accessories sections comply, in combination with the IntelliVue Cableless Measurements, with the requirements of IEC 60601-1-2.IntelliVue CL SpO2 Pod AccessoriesAll listed sensors operate without risk of exceeding 41°C on the skin, if the initial skin temperature does not exceed 35°C.Make sure that you use only the accessories that are specified for use with this device, otherwise patient injury can result.1 May not be available in all geographiesPart Number Description Contents989803165941 Mobile CL 20 single patient SpO2 Sensors and Cradles for use on pediatric and adult patients >10 kg20 Single-Patient Mobile CL DSpO2-1A Sensors20 Single-Patient Wristbands20 Single-Patient Cradlespre-assembled989803165921 Mobile CL 20 single patient SpO2 Sensors for use on pediatric and adult patients >10 kg20 Single-Patient Mobile CL DSpO2-1A Sensors9898031659311Mobile CL reusable SpO2 Sensor and Cradles for use on pediatric and adult patients > 15 kg1 Reusable Mobile CL RSpO2-1A Sensor20 Single-Patient Cradles with pre-attached Wristbands989803165951 Mobile CL 20 SpO2 Cradles (single patient) 20 Single-Patient Cradles with pre-attached Wristbands989803165961 Mobile CL 50 SpO2 Wristbands (single patient)50 Single-Patient Wristbands989803168861 Mobile CL SpO2 Battery Kit 1 Battery1 disassembly tool1 front housing
2 IntelliVue CL SpO2 Pod53Maintenance and TroubleshootingWARNINGSchedule: 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 AccessoriesYou should perform a visual inspection before every use, and in accordance with your hospital's policy. With the device switched off:1Examine 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.2Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use them.WARNINGIf 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 ScheduleAll 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 Philips-qualified 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.TroubleshootingIf 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.
2 IntelliVue CL SpO2 Pod54
3553IntelliVue CL NBP PodTo 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 PodThe 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 OnThe 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.
3 IntelliVue CL NBP Pod56Screen LayoutThere are three variations of the Main Screen layout depending on the Alarm status and the general activity level.Standard LayoutAlarm LayoutIf 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.When assigned to a monitor, telemetry device or a patient in GuardianSoftware:1Connection status indicator2Indicator 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.3Battery indicator4Measurement values5Measurement-related symbols (see the “Monitoring NBP” section for details)6Patient identificationWhen not assigned to a monitor or telemetry device:1Connection status indicator2Battery indicator3Measurement values4Measurement-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.5Cableless Measurement Device equipment label1Full length alarm message2Alarm indicator
3 IntelliVue CL NBP Pod57Low-Activity ScreenIf 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 ActivatedIf 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 HardkeysThe 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:Using the SmartKeysA SmartKey is a graphical key which appears on the screen and gives you fast access to functions.SmartKeys MenuPress 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.◄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
3 IntelliVue CL NBP Pod58List of Available SmartKeysSmartKey Text LabelsMain Setup- start/stop manual NBP measurement- start auto series- start measurement sequence- stop current automatic measurement within seriesstop any NBP measurement and measurement seriesstart NBP STAT measurementstart venipuncture (inflate cuff to subdiastolic pressure)set the NBP repetition timeAdd/Remove deviceenter Battery menuchange Screenenter Profiles menuput the device in standby mode (or power off when pressed for more than two seconds)enter Patient menuenters the Alarms menu to access: Alarm Messages, Alarm Limits, Alarms On/Off/Pause, Alarm Volume.change alarm volumechange pulse tone volumeaccess NBP mode selection and setup, with direct start/stop function
3 IntelliVue CL NBP Pod59Using the Main Setup MenuIn 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.Switching the Device OffTo 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 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.•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.Auto Standby and Auto Power OffThe 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 ModesYour 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.Main SetupNBPAlarmsPatientEquipmentUser InterfaceStandbyProfilesOperating ModesDate, TimeBatteryRevisions
3 IntelliVue CL NBP Pod60When you switch the device on, it starts up in monitoring mode. To change to a different mode:1Use the Main Setup SmartKey to get to the Main Setup menu.2Select Operating Modes and choose the mode you require.Standby ModeThe 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 MenuThe 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 MenuTo display the Patient menu,• select the Patient SmartKey, or• select the Main Setup SmartKey followed by Patient.Stop Using a Device for a PatientTo 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.NOTEDepending 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 PatientTo 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 ProfilesA 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,1Select the Profiles SmartKey or the Main Setup SmartKey followed by Profiles.2Select the required profile from the list.Selecting New Patient or Free Device will always reset the profile to the default.
3 IntelliVue CL NBP Pod61Setting the Date and TimeIf 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,1Select the Main Setup SmartKey and then Date, Time.2Enter the data for date and time one after another.3Select Store Date, Time.If the time has not been set, --:-- will display on the device.Battery StatusThe 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 MenuSelect 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.
3 IntelliVue CL NBP Pod62Connection with Host SystemsThe 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 ModelsWith 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 MonitorThe 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 MonitorIn 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 DeviceThe 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.
3 IntelliVue CL NBP Pod63When 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 GuardianSoftwareThe 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 CompatibilityThe 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 aboveAvailability of Patient AlarmsWhen 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.
3 IntelliVue CL NBP Pod64•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 HostWhen 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).WARNINGAlways make sure that the applied CL NBP Pod is assigned to the correct patient.WARNINGShort 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 DeviceTo make an assignment, select:•the Add/Remove SmartKey , or• hold the ◄key pressed.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
3 IntelliVue CL NBP Pod65take 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.1Select 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.2Activate 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:1Select the measurement selection key on the monitor.A prompt message appears with the Confirm and Cancel keys.2Select 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 MonitorAssignment at the Patient MonitorPrepare the Cableless Measurement Device for assignment by activating the Add/Remove SmartKey.At the patient monitor,1Select the Measurement Selection key.2Select the Add cl Msmt pop-up key.This opens the Add cl Measurement window, which shows the available Cableless Measurement Devices:3Select the device which you want to assign to the patient in the monitor.4The 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 symbol appears on its display indicating that alarms from the device will be sent to the patient monitor.Add ToMon 1Mon 2Tele 33Tele 44
3 IntelliVue CL NBP Pod66An 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 DevicesYou 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.1Hold 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.2Press 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 MonitorThe 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.NOTEWhen 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 MonitorsThe following special conditions apply when CL NBP Pods are operating with an Avalon Fetal Monitor as a host:• 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 Pod67• 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 GuardianSoftwareTo assign a Cableless Measurement Device to a patient in GuardianSoftware:1Select the patient on the Chalkboard.2Take the Cableless Measurement Device from the charger.3On 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).4Click Use for Patient to assign the device to the patient.Controls Available with a Patient MonitorThe controls available when working with the Cableless Measurement Device and a patient monitor are described in the table below.* except when SRR connection to host is lostWARNINGIf 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.Action At the Cableless Measurement DeviceAt the Patient MonitorAt the IICStart/Stop/Stat NBP Yes Yes YesChange NBP Mode Yes Yes NoChange NBP Repetition Time Yes Yes NoChange Alarm Limits Yes* Yes NoAssign NBP Pod Yes Yes NoRemove NBP Pod Yes Yes NoPlace Device in Standby Yes Yes YesAlarm Silence No Yes YesAlarm Off/Pause No Yes Yes
3 IntelliVue CL NBP Pod68Controls Available with a Telemetry DeviceThe 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.NOTEWhen 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 GuardianSoftwareThe controls available when working with the Cableless Measurement Device and GuardianSoftware are described in the table below.TrendingThe 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.Action At the Cableless Measurement DeviceAt the IICStart/Stop/Stat NBP Yes NoChange NBP Mode Yes NoChange NBP Repetition Time Yes NoChange Alarm Limits No YesAssign NBP Pod Yes NoRemove NBP Pod Yes YesPlace Device in Standby No NoAlarm Silence No YesAlarm Off/Pause No YesAction At the Cableless Measurement DeviceAt GuardianSoftwareStart/Stop/Stat NBP Yes YesChange NBP Mode Yes YesChange NBP Repetition Time Yes YesAssign NBP Pod Yes YesRemove NBP Pod Yes YesPlace Device in Standby No NoAlarm Silence No YesAlarm Off/Pause No No
3 IntelliVue CL NBP Pod69Monitoring NBPThe 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 MeasurementOscillometric 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.WARNINGPatient 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.CAUTIONIf 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.
3 IntelliVue CL NBP Pod70Measurement LimitationsNBP 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 MeasurementWhen 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 ModesThere are three modes for measuring NBP:•Manual - measurement on demand.•Auto - continually repeated measurements (between one minute and 24 hours adjustable interval).•Sequence - up to four measurement cycles which will run consecutively, with number of measurements and interval between them configurable for each cycle.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 MethodThe measurement reference method is always Auscultatory (manual cuff). For further information, see the Application Note supplied on the documentation DVD.
3 IntelliVue CL NBP Pod71Preparing to Measure NBP with Standard Cuffs1Apply the carrying pouch to the patient.2Apply 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.3Connect the extension air hose to the cuff.
3 IntelliVue CL NBP Pod724Connect 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.WARNINGKinked or otherwise restricted tubing can lead to a continuous cuff pressure, causing blood flow interference and potentially resulting in injury to the patient.5Place the NBP Pod into the cradle.6Put the NBP Pod into the carrying pouch.Make sure to pinch the velcro enclosures firmly together around the extension hose exiting from the pouch.CAUTIONMake 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.
3 IntelliVue CL NBP Pod73WARNINGInspect 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 CuffAs 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.1Attach the cradle to the NBP cuff.2Plug the air tubing into the cradle.3Apply 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.4Insert the NBP Pod into the cradle.Additional InformationThe 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 UseRecommendations For Measurements Used in Diagnosis of HypertensionTo make a measurement for use in the diagnosis of hypertension, follow the steps below:1Ensure the patient is comfortably seated, with their legs uncrossed, feet flat on the floor and back and arm supported.2Ask the patient to relax and not talk before and during the measurement.3If possible, wait 5 minutes before making the first measurement.
3 IntelliVue CL NBP Pod74Starting and Stopping MeasurementsUse the setup menu or SmartKeys to start and stop measurements.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.CAUTIONUse 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 Time1In the NBP menu, select Mode and select Auto from the pop-up menu.2For an automatic measurement, select Repeat and set the time interval between two measurements.Action to be Performed NBP Setup menu SmartKeysStart manual measurementStart Auto seriesStart measurement sequenceStart/StopStart/StopStart STAT measurement Start NBP StatStart NBP STATStop Manual measurements Start/StopStart/StopStop current Auto/sequence measurement Start/StopStart/StopStop current STAT measurement and end STAT modeStart/StopStart/StopStop Auto, Manual or STAT measurement, end STAT mode AND Auto/Sequence seriesStop AllStop All
3 IntelliVue CL NBP Pod75Enabling Sequence Mode and Setting Up The Sequence1In the NBP menu, select Mode and select Sequence from the pop-up menu.2Select 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.3Select each phase in turn (A, B, C and D) and select the number of measurements and the time interval between the measurements.4To have measurements continue after the sequence, set the number of measurements for your last phase to Cont and this phase will run indefinitely.CAUTIONBe 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 SymbolsNote: 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: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.1Systolic/Diastolic pressure2Mean pressure3Pulse rate4Pulse rate indicator5Measurement mode (see below)6Alarms Off symbol for Pulse (Pulse from NBP does not have alarm capability, therefore it cannot be switched on)7Timestamp8Alarms Off symbol for NBPindicates 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.
3 IntelliVue CL NBP Pod76During MeasurementsThe cuff pressure is displayed instead of the timestamp.Correcting the Measurement if Limb is not at Heart LevelTo correct the measurement if the limb is not at heart level, to the displayed valueWhen Unexpected Values are MeasuredWhen values measured are higher or lower than expected, check the following potential causes:Switching Pulse from NBP On/OffIn 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 PunctureYou 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.1In the NBP menu select Veni Puncture, or select the Veni Puncture SmartKey.2Puncture vein and draw blood sample.3Reselect 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 NBPNBP 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.Add 0.75 mmHg (0.10 kPa) for each centimeter higher orDeduct 0.75 mmHg (0.10 kPa) for each centimeter lower orAdd 1.9 mmHg (0.25 kPa) for each inch higher. Deduct 1.9 mmHg (0.25 kPa) for each inch lower.Possible Cause SolutionThe patient was talking or moving before or during the measurement.Allow the patient to rest quietly, then try again after three to five minutes.The incorrect cuff size was used or the cuff was not at heart levelCheck the cuff size, level, and position then repeat the measurement.Measurement limitations have not been taken into account.Check the list in “Measurement Limitations” on page 70.
3 IntelliVue CL NBP Pod77AlarmsThe IntelliVue Cableless Measurements have two different types of alarm: patient alarms and technical alarms (INOPs).Patient AlarmsPatient 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 DelaysThere 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 AlarmsIf 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.NOTEIf you want to use local attended monitoring, make sure to have all Cableless Measurement Devices upgraded to at least Rev. B.02.Visual Alarm IndicatorsWARNING• 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.
3 IntelliVue CL NBP Pod78Alarm MessageAlarm 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 StatesDepending on the alarm state of your Cableless Measurement Device, the following icons may be displayed on the device:Audible Alarm IndicatorsAudible 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).Icon DescriptionNo 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.
3 IntelliVue CL NBP Pod79Silencing an AlarmTo 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.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 AlarmsTo display a list of the currently active alarms,1Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms.2Select Alarm Messages.Setting the Volume of the Alarm ToneTo set the volume for the Alarm tone,1Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms.2Select 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 INOPIf 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 ReminderIf 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.1Full length alarm message2Alarm indicator
3 IntelliVue CL NBP Pod80Pausing or Switching Off AlarmsIf 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,1In the SmartKeys Menu select Main Setup, Alarms, then OffDurat.2Check the setting.This setting can only be changed in Configuration Mode.To Pause or Switch Off AlarmsSelect 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 AlarmsTo 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 SourceYou 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: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.Menu Option Displayed as Pressure value monitoredSys. Sys. systolicDia. Dia. diastolicMean Mean meanSys & Dia S & D systolic and diastolic in parallelDia & Mean D & M diastolic and mean in parallelSys & Mean S & M systolic and mean in parallelSys&Dia&Mean S&D&M all three pressures in parallel
3 IntelliVue CL NBP Pod81Alarm LimitsThe alarm limits you set determine the conditions that trigger limit alarms.WARNINGBe 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 Limits1Select the Alarms SmartKey followed by Alarm Limits (or select Main Setup followed by NBP).2Depending 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 AlarmsThe 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 SettingsTo see the alarm latching setting for your device,1In the Main Setup menu, select Alarms.2Here 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:Alarm Latching BehaviorAs 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.Visual Latching Audible LatchingRed&Yellow Red&YellowRed&Yellow Red OnlyRed&Yellow OffRed Only Red OnlyRed Only OffOff Off
3 IntelliVue CL NBP Pod82All INOPs are non-latching. NBP specific INOPs generated by the CL Pod are latching.Testing AlarmsWhen 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 OnIf 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 AlarmsReference List of all INOPsRed & Yellow Measurement AlarmsNon-latching alarms Visual and audible latching Visual latching, audible non-latchingAlarm has not been acknowledged.Alarm condition still present.Alarm tone on. Alarm message. Alarm tone on. Alarm message.Alarm tone on. Alarm message.Alarm condition no longer present.All audible and visual alarm 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 no longer present.Audible and visual alarm indicators automatically stop.Audible and visual alarm indicators automatically stop.Audible and visual alarm indicators automatically stop.Alarm Message, Indication Source Condition** NBPs High** NBPd High** NBPm HighNBP 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.** NBPs Low** NBPd Low** NBPm LowNBP 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.
3 IntelliVue CL NBP Pod83INOP Message, Indication Source What to doBatt IncompatibleINOP toneBattery 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 MalfunctionINOP toneBattery Malfunction of the battery system detected (charger circuit or battery). Contact your service personnel.Battery EmptyINOP toneBattery The remaining monitoring time is below 30 minutes. Charge battery.Battery LowINOP toneBattery The remaining monitoring time is below 2 hours.Check Batt TempINOP toneBattery 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 BatteryINOP toneBattery 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/FINOP toneBattery 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 ChkSettingsINOP toneCableless Measurement DeviceIf this INOP appears and an INOP tone sounds, check the 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.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 Disconnectonly at the hostCableless Measurement DeviceThe NBP Pod has lost the SRR connection to the telemetry device or the patient monitor.Cuff Not DeflatedNumeric is replaced by -?-INOP toneDuring this INOP, alarms cannot be paused or switched off.NBP 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.
3 IntelliVue CL NBP Pod84NBP Check CuffNumeric is replaced by -?-INOP toneNBP Check if cuff is connected to the NBP Pod and cuff is applied to the patient; check tubing and cuff for leakage.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 OverpressNumeric is replaced by -?-INOP toneDuring this INOP, alarms cannot be paused or switched off.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 MalfNumeric is replaced by -?-INOP toneNBP 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 InterruptedNumeric is replaced by -?-INOP toneNBP 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 FailedNumeric is replaced by -?-INOP toneNBP 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?Numeric is replaced by -?-INOP toneNBP 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 CradleNumeric is replaced by -?-INOP toneNBP 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.If INOP appears with the NBP Pod inserted into the cradle, remove and replace the cradle.INOP Message, Indication Source What to do
3 IntelliVue CL NBP Pod85No Host MonitoringINOP toneCableless Measurement DeviceThere is a problem with the communication to the assigned patient monitor and monitoring is currently not possible (no patient alarms or information). Check the connection. Contact your service personnel.No System Cableless Measurement DeviceThere is a problem with the communication to the network and central monitoring is currently not possible. Check the connection.Remove From PatINOP toneCableless Measurement DeviceDisplayed on the Cableless Measurement Device. The temperature of the battery is too high. Remove the Cableless Measurement Device from the patient and contact service personnel.Service BatteryINOP toneBattery Maximum number of charge/discharge cycles for battery exceeded. Charging of the battery is inhibited. Contact your service personnel to replace battery.INOP Message, Indication Source What to do
3 IntelliVue CL NBP Pod86Local Attended MonitoringWhen 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 EnabledBy 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):CL Pod disconnected from patient monitor and CL Measurement Alarms On, Local Attended Monitoring:SRR connectionAt the CL Pod: Indication of technical alarms onlyAt the monitor:Indication of physiological and technical alarms from CL PodsNo SRR connectionAt the CL Pod:Indication of technical and physiological alarmsAt the monitor:No indication of physiological alarms from CL Pods. No indication of technical alarms after disconnection.
3 IntelliVue CL NBP Pod87Local Attended Monitoring DisabledThe 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:CL Pod disconnected from patient monitor and CL Measurement Alarms Off:SRR connectionAt the CL Pod: Indication of technical alarms onlyAt the monitor:No indication of physiological alarms from CL Pods. Indication of technical alarms from CL Pods.No SRR connectionAt the CL Pod:Indication of technical alarms onlyAt the monitor:No indication of physiological and technical alarms from CL Pods.
3 IntelliVue CL NBP Pod88Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms On12Standard Use Model Local Attended Monitoring->Caregiver activates 'Use for transport'<-Caregiver activates 'Use with monitor'SRR connection no SRR connectionAction / Event Situation Alarm Availabilityat CL PodAlarm Availabilityat Patient MonitorStandard Use Model:normal operation,no special actionCL Pod connected to the patient monitor (1)Technical alarms (own)No physiological alarmsNo Local Alarming icon is displayed:Technical alarms (own + from Pod)Physiological alarms(own + from Pod)
3 IntelliVue CL NBP Pod89Activation of Local Attended Monitoring:Caregiver activates Local Attended Monitoring and disconnects CL Pod temporarily by setting Use for Transp. in the Patient Monitor's Equipment windowPatient is in transport without connection to the host system, caregiver attends the patient (2)Technical alarms (own)Physiological alarms(own)Technical alarms (own)Physiological alarms(own)No alarms from CL PodDeactivation of Local Attended Monitoring:Caregiver deactivates Local Attended Monitoring and reconnects CL Pod to a patient monitor by setting Use with Monitor in the patient monitor's Equipment windowPatient returns from transport. Back to the standard use model (1)Technical alarms (own)No physiological alarmsNo Local Alarming icon is displayed:Technical alarms (own + from Pod)Physiological alarms(own + from Pod)Special Case:Connection lost while in Standard Use ModelAction / Event Situation Alarm Availabilityat CL PodAlarm Availabilityat Patient MonitorAlternative Use Model:CL Pod temporarily disconnected from a monitor due to unintentional loss of connection (e.g. out of range), Local Attended Monitoring has not been activated by the caregiverNo Host Monitoring INOP at CL Podcl NBP Disconnect INOP at patient monitorLocal Attended Monitoring is automatically activated (2)Technical alarms(own)Physiological alarms(own)Technical alarms(own)Physiological alarms(own)No alarms from CL Pod
3 IntelliVue CL NBP Pod90Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms Off34Patient within Range Patient Mobile->Patient mobile<-Patient backSRR connection no SRR connectionAction / Event Situation Alarm Availabilityat CL PodAlarm Availabilityat Patient MonitorConnected, but no CL Alarms (CL Measurement Alarms Off):normal operation,no special actionCL Pod connected to the patient monitor (3)Technical alarms(own)No physiological alarmsNo Local Alarming icon is displayed:Technical alarms (own + from Pod)Physiological alarms(own)
3 IntelliVue CL NBP Pod91NBP Default SettingsThese are the most important default settings of your IntelliVue CL NBP Pod as they are delivered from the factory. For a comprehensive list and explanation of default settings, see the Configuration Guide supplied with your devices. The default settings can be permanently changed in Configuration Mode. When the Pod is assigned to a patient monitor, the settings defined at the patient monitor will overwrite the settings defined at the Pod.Patient is leaving the vicinity of the monitor:no special actionPatient is mobile without connection to the host system (4)Technical alarms (own)No physiological alarmsAlarms Off icon is displayed in front of each numeric:Technical alarms (own)Physiological alarms(own)No alarms from CL PodPatient returns to the vicinity of the monitor:no special actionPatient returns.Back to connected status (3)Technical alarms (own)No physiological alarmsNo Local Alarming icon is displayed:Technical alarms (own + from Pod)Physiological alarms(own + from Pod)NBP SettingsAdult PediMode Auto AutoAl. from Sys. Sys.Sys.High 160 120Dia.High 90 70MeanHigh 110 90Sys. Low 90 70Dia. Low 50 40Mean Low 60 50Alarms On OnNBP On OnRepeat Time 10 min 10 minPulse On OnUnit mmHg mmHgDone Tone Off OffStart Time Synchronized SynchronizedVP Pressure 60 mmHg 40 mmHgReference Auscultatory Auscultatory
3 IntelliVue CL NBP Pod92Integrated Battery HandlingOnly qualified and authorized service personnel (biomedical engineers or technicians) should change batteries.Battery CareBattery care begins when you receive a new IntelliVue Cableless Measurement Device with built-in battery and continues throughout the life of the device. The table below lists battery care activities and when they should be performed.Handling PrecautionsLithium ion batteries store a large amount of energy in a small package. Use caution when handling the IntelliVue Cableless Measurement Devices with built-in battery; misuse or abuse could cause bodily injury and/or property damage.• Handle with care.• Do not expose the device to liquids.• Do not attempt to disassemble the device.• Do not put device in autoclave.• Damaged devices should not be used anymore.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).Aging Time 10 min 10 minColor Red RedAnnouncementTone Off OffAutomatic Start Off OffAccelerated Msmt Off OffNBP SettingsAdult PediActivity When to performPerform a visual inspection Before using the IntelliVue Cableless Measurement DeviceCharge the battery Upon receipt, after use, or if a low battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible.Store the device in a state of charge in the range of 40-50% and power off the device completely.When not in use for an extended period of time, or when the device is shipped.
3 IntelliVue CL NBP Pod93StorageIf unused IntelliVue Cableless Measurement Devices are stored for an extended period of time:• they should be powered off for storage• they should be stored in a cool place, ideally between 15°C and 25°C (60°F and 77°F)• the state of charge should be between 40 and 50%• they should be recharged every six monthsStoring in a cool place slows the aging process of the batteries. They should be fully charged prior to use. Do not store the device at a temperature outside the range of -20°C (-4°F) to 60°C(140°F).Do not store cableless devices in direct sunlight.NOTEStoring the devices at temperatures above 40°C (104°F) for extended periods of time could significantly reduce the battery's life expectancy.Battery Lifetime ManagementThe lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 4 years or 400 complete charge-discharge cycles, whichever comes first. In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. We therefore strongly recommend that lithium ion batteries be replaced after 4 years or 400 complete charge-discharge cycles.To see the date of manufacture and the number of charge-discharge cycles:1Select the Battery Smartkey or Main Setup followed by Battery.2Press the  hardkey to view the battery details.The date of manufacture and the number of charge-discharge cycles are listed with other battery data on the screen. Use the ◄ hardkey to scroll through the list.The age of a lithium ion battery begins at the date of manufacture.AccessoriesYou can order parts and accessories from Philips supplies at www.medical.philips.com or consult your local Philips representative for details. Also consult the accessories' Instructions for Use, if available.WARNINGReuse: 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.Accessories Compliant with EMC StandardsAll accessories listed in the accessories sections comply, in combination with the IntelliVue Cableless Measurements, with the requirements of IEC 60601-1-2.
3 IntelliVue CL NBP Pod94IntelliVue CL NBP Pod AccessoriesMobile CL Cuffs and AccessoriesComfort Care Reusable CuffsPart Number Description Limb Circumference RangeContents989803163171 Mobile CL Reusable Small Adult Cuff21 - 27 cm 1 cuff989803163191 Mobile CL Reusable Adult Cuff 26.0 - 34.5 cm 1 cuff989803163211 Mobile CL Reusable Large Adult Cuff33.5 - 45.0 cm 1 cuff989803163181 Mobile CL Single-Patient Small Adult Cuff21 - 27 cm 20 cuffs989803163201 Mobile CL Single-Patient Adult Cuff26.0 - 34.5 cm 20 cuffs989803163221 Mobile CL Single-Patient Large Adult Cuff33.5 - 45.0 cm 20 cuffs989803163251 Mobile CL NBP Cradle Kit - 20 cradles989803163131 Mobile CL Extension Air Hose, 1.0 m- 1 extension air hose989803187431 Mobile CL Air Hose - Bayonet Connector- 1 adapter air hose989803163261 Mobile CL NBP Battery Kit - 1 Battery1 disassembly tool1 front housing989803137831 Telemetry Pouch with window - 50 pouches989803140371 Telemetry Pouch with window - 4 boxes of 50 pouches989803101971(9300-0768-050)White Telemetry Pouch with Snaps; box of 50- 50 pouches989803101981(9300-0768-200)White Telemetry Pouch with Snaps; 4 boxes of 50- 4 boxes of 50 pouchesPart Number Description Limb Circumference RangeM1571A Infant cuff 10.0 - 15.0 cmM1572A Pediatric cuff 14.0 - 21.5 cmM1573A Small adult cuff 20.5 - 28.0 cmM1573XL Small adult cuff, XL 20.5 - 28.0 cmM1574A Adult cuff 27.0 - 35.0 cmM1574XL Adult cuff, XL 27.0 - 35.0 cmM1575A Large adult cuff 34.0 - 43.0 cmM1575XL Large adult cuff, XL 34.0 - 43.0 cm
3 IntelliVue CL NBP Pod95Easy Care Reusable CuffsMulti Care CuffsM1576A Thigh cuff 42.0 - 54.0 cmM1577A Kit of small cuffs (M1571A to M1574A)M1578A Kit of large cuffs (M1573A to M1576A)M1579A Kit of all cuffs (M1571A to M1576A)Part Number Description Limb Circumference RangePart Number Description Limb Circumference RangeM4552B Infant cuff 10.0 - 15.0 cmM4552B5 Pack of 5 M4552B cuffsM4553B Pediatric cuff 14.0 - 21.5 cmM4553B5 Pack of 5 M4553B cuffsM4554B Small adult cuff 20.5 - 28.5 cmM4554B5 Pack of 5 M4554B cuffsM4555B Adult cuff 27.5 - 36.0 cmM4555B5 Pack of 5 M4555B cuffsM4556B Adult cuff, XL 27.5 - 36.0 cmM4556B5 Pack of 5 M4556B cuffsM4557B Large adult cuff 35.0 - 45.0 cmM4557B5 Pack of 5 M4557B cuffsM4558B Large adult cuff, XL 35.0 - 45.0 cmM4558B5 Pack of 5 M4558B cuffsM4559B Thigh cuff 44.0 - 56.0 cmM4559B5 Pack of 5 M4559B cuffs864288 Assortment pack of one small adult, one adult, one large adult and one thigh cuff864289 Assortment pack of one infant, one pediatric, one small adult and one adult cuff864290 Assortment pack of one infant, one pediatric, one small adult, one adult, one large adult and one thigh cuff864291 Assortment pack of one small adult, one adult, one adult XL, one large adult, one large adult XL and one thigh cuffPart Number Description Limb Circumference Range989803183311 Infant cuff 10.0 - 15.0 cm989803183321 Pediatric cuff 14.0 - 21.5 cm989803183331 Small adult cuff 20.5 - 28.0 cm989803183341 Adult cuff 27.0 - 35.0 cm989803183351 Adult cuff, XL 27.0 - 35.0 cm
3 IntelliVue CL NBP Pod96Single Patient, Gentle Care CuffsSingle Care CuffsValue Care Cuffs989803183361 Large adult cuff 34.0 - 43.0 cm989803183371 Thigh cuff 42.0 - 54.0 cmPart Number Description Limb Circumference RangePart Number Description Limb Circumference RangeM4572B Infant cuff 10.0 - 15.0 cmM4573B Pediatric cuff 14.0 - 21.5 cmM4574B Small adult cuff 20.5 - 28.5 cmM4575B Adult cuff 27.5 - 36.0 cmM4576B Adult cuff, XL 27.5 - 36.0 cmM4577B Large adult cuff 35.0 - 45.0 cmM4578B Large adult cuff, XL 35.0 - 45.0 cmM4579B Thigh cuff 44.0 - 56.0 cmPart Number Description Limb Circumference Range989803182281 Pediatric cuff 14.0 - 21.5 cm989803182291 Small adult cuff 20.5 - 28.5 cm989803182301 Adult cuff 27.5 - 36.0 cm989803182311 Adult cuff, XL 27.5 - 36.0 cm989803182321 Large adult cuff 35.0 - 45.0 cmPart Number Description Limb Circumference Range989803160811 Infant cuff 10.0 - 15.0 cm989803160821 Pediatric cuff 14.0 - 21.5 cm989803160831 Small adult cuff 20.5 - 28.5 cm989803160841 Adult cuff 27.0 - 35.0 cm989803160851 Adult cuff, XL 27.0 - 35.0 cm989803160861 Large adult cuff 34.0 - 43.0 cm
3 IntelliVue CL NBP Pod97Maintenance and TroubleshootingWARNINGSchedule: 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 AccessoriesYou should perform a visual inspection before every use, and in accordance with your hospital's policy. With the device switched off:1Examine 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.2Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use them.WARNINGIf 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 ScheduleAll 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 Philips-qualified 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.TroubleshootingIf 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.
3 IntelliVue CL NBP Pod98
4994IntelliVue CL Respiration PodFor respiration measurement, attach the Cableless Respiration Pod to the patient's left costal arch using the Mobile CL Respiration Pod Attachment. As an option, the Respiration Pod also provides pulse measurement. The CL Respiration Pod also provides information about patient posture (positions like supine, prone, upright,...) and activity (e.g. very high or very low activity).For details regarding the adhesive attachment (Mobile CL Respiration Pod Attachment), refer to “IntelliVue CL Respiration Pod Accessories” on page 111.General Operation of the Respiration PodThe IntelliVue CL Respiration Pod does not have a display and is generally operated via the host system (e.g. patient monitor). The Pod reports the measured values and status information to the host system via SRR.The IntelliVue CL Respiration Pod has a multi-color LED and a single operation key to display states and allow some basic operation locally.Putting the Pod into OperationThe first time a CL Respiration Pod is used, place it on the IntelliVue CL Charging Station. This will automatically switch the device on, and the device will become visible to the host (patient monitor or GuardianSoftware).Checking the Battery StatusPress the key once to check the battery status:If the LED is blinking, this means that the Pod is currently not assigned to a host.Status LED Battery OK greenBattery low yellowBattery empty redBattery or system malfunction cyan
4 IntelliVue CL Respiration Pod100Recharging the PodTo recharge the pod, place it on the charging station. During loading, the pod's LED shows the status:Power OffTo power off the IntelliVue CL Respiration Pod, take the device from the charging station, then press and hold the key on the pod for five seconds until the LED blinks red. Release the key and press it again to confirm power off. The LED will switch to solid red and fade out. To switch it back on, you must place the device on a charging station. Use this option when the device is not used for a longer time or prepared for storage or shipping.Connection with Host SystemsThe following sections describe how the IntelliVue Cableless Measurement Devices work together with host systems (Patient Monitors or GuardianSoftware).IntelliVue Cableless Measurements Use ModelsWith these patient-worn measurement devices you can measure and transmit a patient's vitals regularly or on an intermittent data collection basis. There are two typical use models:With a Patient MonitorThe 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 102.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.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.If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be displayed at the monitor: cl Resp Disconnect.With IntelliVue GuardianSoftwareThe 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 103. 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.Status LED Battery full (≥90%) greenBattery loading yellowBattery malfunction cyan
4 IntelliVue CL Respiration Pod101Device CompatibilityThe IntelliVue CL Respiration Pod requires the following software levels in the associated equipment:• Patient Monitor - Release J.2 or above• IntelliVue GuardianSoftware - Revision B.0 or aboveThe IntelliVue CL Respiration Pod Pediatric Mode requires the following software levels in the associated equipment:• Patient Monitor - Release M.0 or above• IntelliVue GuardianSoftware - Revision D.0 or aboveAvailability of Patient AlarmsWhen the IntelliVue CL Respiration Pod is assigned to a host and a short range radio connection exists, alarms will be announced at the host device.•When assigned to a patient monitor: Alarm messages will be displayed and audible alarm indicators sounded at the patient 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.•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 derived. 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 HostWhen an IntelliVue CL Respiration Pod is used with a host system (patient monitor or GuardianSoftware), the Pod must be assigned to that host system.The assignment must be done at the host system.WARNINGAlways make sure that the applied CL Respiration Pod is assigned to the correct patient.WARNINGShort 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 cl Resp Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the Configuration Guide for details.
4 IntelliVue CL Respiration Pod102Assignment at the Patient MonitorManual AssignmentPrepare the Pod for assignment by pressing the hardkey once (LED shows battery and assignment status).At the patient monitor,1Open the Add cl Measurement window, e.g. by using the measurement selection key followed by the Add cl Msmt pop-up key.The available Cableless Measurement Devices are shown in the window.2Select the device which you want to assign to the patient on the monitor.3The monitor displays the assignment prompt message.When the Cableless Measurement Device is assigned, the LED changes from blinking to solid.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 DevicesYou 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.1Hold 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.2Press any hardkey on the cableless device.The Cableless Measurement Device is now added to the monitor.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 with GuardianSoftwareTo assign a Cableless Measurement Device to a patient in GuardianSoftware:1Select the patient on the Chalkboard.2Take the Cableless Measurement Device from the charger.3On 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).4Click Use for Patient to assign the device to the patient.Controls Available with a Patient MonitorThe controls available when working with the Cableless Measurement Device and a patient monitor are described in the table below.Action At the Cableless Measurement DeviceAt the Patient MonitorAt the IICStart Resp/Pulse Measurement Yes Yes NoChange Measurement Mode No Yes NoChange Repetition Time No Yes NoChange Alarm Limits No Yes NoAssign Respiration Pod No Yes No
4 IntelliVue CL Respiration Pod103WARNINGIf 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.Controls Available with GuardianSoftwareThe controls available when working with the Cableless Measurement Device and GuardianSoftware are described in the table below.TrendingThe 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.Remove Respiration Pod Yes Yes NoDynamic Repetition Mode On/Off No Yes NoPosture On/Off No Yes NoActivity On/Off No Yes NoAlarm Silence No Yes YesAlarm Off/Pause No Yes YesAction At the Cableless Measurement DeviceAt the Patient MonitorAt the IICAction At the Cableless Measurement DeviceAt GuardianSoftwareStart Resp/Pulse Measurement Yes YesChange Measurement Mode No YesChange Repetition Time No YesChange Alarm Limits No YesAssign Respiration Pod No YesRemove Respiration Pod Yes YesDynamic Repetition Mode On/Off No YesPosture On/Off No YesActivity On/Off No YesTechnical Alarm Silence No Yes
4 IntelliVue CL Respiration Pod104Monitoring RespirationThe CL Respiration Pod derives the respiration and pulse signal from the chest and abdomen movements measured with a built-in acceleration sensor. The CL Respiration Pod gets attached with a Mobile CL Respiration Pod Attachment to the left costal arch on the patient's chest.When configured, the CL Respiration Pod provides information on the basic patient posture and patient activity. Various postures such as supine, upright and lying on left/right side are detected and updated after a posture change has occurred and posture is stable again. The activity is determined once per second, and an average activity level between 0 and 10 is reported once per minute to the connected host system. The activity status information provides only an approximate indication of the actual patient activity.WARNINGThe CL Respiration Pod is not an apnea monitor and does not provide apnea alarming.Excessive patient movement can interfere with the measured signal. This may result in inaccurate measurements.The CL Respiration Pod does not provide continuous measurement. When configured in frequent mode, the fastest update rate for pulse is 8 sec.If the patient has a condition where the respiration rate approaches the upper limit of the measurement range (60 rpm), use other means of respiration rate measurement.Do not use the CL Respiration Pod in an environment where continuous monitoring is needed, such as intensive care units or operating rooms, because life-critical events might be missed due to the intermittent mode of measurement.Do not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm. Use under these conditions has not been clinically validated.Measurement ModesThere are three different modes available for performing respiration/pulse measurements: Manual Mode, Automatic Mode and Frequent Mode. The mode can only be set on the host system:•Manual Mode - a single respiration and pulse measurement is performed when a measurement is started at the host or when the key on the Respiration Pod is pressed (key must be pressed twice if the LED is off).•Automatic Mode - respiration and pulse measurements are performed with an interval between them. The interval is selected at the host. The first measurement starts immediately after entering the automatic measurement mode. If configured: When the respiration rate rises above or falls below the defined alarm limits, the measurement mode changes temporarily to frequent mode. The automatic mode will resume if the respiration rate readings are valid for at least 1 minute and no respiration rate reading within the last minute violates the respiration rate alarm.•Frequent Mode - respiration and pulse measurement is active all the time. The respiration rate is updated with every new detected breath. The shortest update interval for the pulse rate is 8 seconds.If Dynamic Repetition is enabled (this is setting available in Configuration mode, see IntelliVue Patient Monitor Configuration Guide for details), and the respiration rate violates the high or low respiration rate limit, the measurement switches automatically to Frequent mode. As soon as the respiration rate values are within the limits again, and the values are valid for at least 1 minute, Dynamic Repetition switches back to Automatic mode.
4 IntelliVue CL Respiration Pod105Assigning the PodTake the pod from the charging station. The multi-color LED blinks if the pod is not assigned to a host system.When working with a patient monitor:Go to the patient monitor you want to use and select Add cl Msmt. The LED on the pod changes from blinking to solid.When working with GuardianSoftware:In GuardianSoftware:1Select the patient on the Chalkboard.2On the Equipment List tab, select the Cableless Measurement Device on the Available Equipment list.The LED on the Respiration pod blinks.3Click Use for Patient to assign the pod to the patient.Attaching the Pod to the Patient1Put the pod front side up onto the adhesive attachment according to the positioning markers.2Remove the protective cover from the strap with the adhesive patch.3Fold the straps over the front of the pod, beginning with the strap that has no adhesive patch.
4 IntelliVue CL Respiration Pod1064Fold the second strap over the pod and make sure that the pod is securely and tightly enclosed by the straps.The arrow symbols on the upper strap must be in line with the end of the lower strap:5Remove the protective cover from the back of the adhesive attachment.6Place the pod on the patient's skin in the region of the left costal arch, with the operation key facing upwards. Press down the adhesive attachment all around the pod.CAUTIONThe patient's skin should be dry, clean and free of excessive hair.Make sure that the CL Respiration Pod is attached the right way round, with the operation key facing upwards. Otherwise, the posture detection will not provide correct readings.
4 IntelliVue CL Respiration Pod107WARNINGDo not use an adhesive attachment on a patient with a history of skin irritation, allergies or hypersensitivity to adhesives. Do not use on patients with lesions, infections or skin inflammations.To avoid skin irritations and lacerations, periodically inspect the sensor application site and change the application site regularly. After use, clean the patient's skin to remove residual adhesive.Always make sure that the attached pod is assigned to the correct patient. For this purpose, it may be helpful to put the equipment label on the pod (for example by using a stick-on label) and to write the patient name on the adhesive attachment.Do not reuse an adhesive attachment on another patient due to risk of cross-infection.Measuring RespirationIf the LED is on, press the key once to start a measurement. If the LED is off, press the key twice. Alternatively, start the measurement from the host system.If the measurement has been started directly at the pod, the LED blinks white while the measurement is in progress.When the measurement has finished successfully: The LED changes to solid white.If a measurement fails: The LED blinks white quickly.For a description of the way the measurement results are displayed on the host (Monitor or GuardianSoftware), see the Instructions for Use of the product used as a host.Unassigning the Respiration PodTo unassign the CL Respiration Pod from a host:Put the pod on the IntelliVue CL Charging Stationor:Keep the key pressed for 2 seconds, until the LED is blinking yellow. Press the key once more to confirm. LED changes to solid yellow and fades out (CL Respiration Pod unassigned).Posture and Activity InformationThe CL Respiration Pod can also provide information on basic patient posture (body positions). The patient's position is determined and the corresponding information is displayed at the host:•Supine•Prone•Lying Left (lying on left side)•Lying Right (lying on right side)•Lying (unspecific)•Upright•Reclined•Forward•Upside Down•Sitting•Standing
4 IntelliVue CL Respiration Pod108•Rolling (in bed; example: patient is agitated)•Walking•Wheelchair (unassisted)Additionally, the activity level is displayed at the host as a numerical value that ranges in normal operation between level 1 (very low activity) and level 10 (very high activity). Activity level 0 indicates that no physiological signal can be detected (for example when the device has fallen off and is lying on the ground).NOTEThe information on basic patient posture and activity is not intended for monitoring or diagnostic purposes. The basic patient posture and activity information is only for reference, showing clinical personnel the approximate posture and activity status of the patient. The activity level does not provide information on a specific activity pattern (e.g. if a patient is walking, or if a patient is rolling over in bed). The activity information is also not intended to recognize abnormal body movements caused by specific diseases, like Parkinson’s disease, or other neurological conditions.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 on the host monitor.The IntelliVue CL Respiration Pod does not provide any INOP displays or sounds locally at the device itself. INOPs will be announced visually and audibly at the host monitor.Some INOPs have a severity indication: !! for a medium severity INOP and !!! for a high severity INOP.Reference List of all INOPsINOP Message, Indication Source What to doCan't Analyze cmRR Resp Unable to analyze respiration signalCan't AnalyzePulse Resp Unable to analyze pulse signalcl Resp Batt EmptyINOP toneBattery The remaining monitoring time is below 30 minutes. Charge battery.cl Resp Batt IncmpINOP toneBattery Battery cannot be used with this Cableless Measurement Device. Contact your service personnel.cl Resp Batt LowINOP toneBattery The remaining monitoring time is below 2 hours.cl Resp Batt MalfINOP toneBattery Malfunction of the battery system detected (charger circuit or battery). Contact your service personnel.cl Resp Batt TempINOP toneBattery The temperature of the battery is critically high. Remove Cableless Measurement Device from patient and contact your service personnel.cl Resp Check BattINOP toneBattery The maximum number of charge/discharge cycles of the battery will be reached in less than 50 cycles. Contact your service personnel.cl Resp Chk SettINOP toneResp If this INOP appears, check the Cableless Measurement Device and patient settings before you resume taking measurements. If the settings are unexpected, there may be a problem with the Cableless Measurement Device software. Contact your service personnel.
4 IntelliVue CL Respiration Pod109Respiration Default SettingsThese are the most important default settings of your IntelliVue CL Respiration Pod as they are delivered from the factory. For a comprehensive list and explanation of default settings, see the Configuration Guide supplied with your devices. The default settings can be permanently changed in the Support Tool Configuration Editor.cl Resp Disconnect Resp The Respiration Pod has lost the SRR connection to the host.cl Resp RemoveINOP toneResp The temperature of the battery is too high. Take the Cableless Measurement Device away from the patient and contact service personnel.cl Resp Serv BattINOP toneBattery Maximum number of charge/discharge cycles for battery exceeded. Charging of the battery is inhibited. Contact your service personnel.clResp License Req Resp Unlicensed exchange device. Contact your service personnel. cmResp NeoPatient?Numeric is replaced by -?-INOP toneResp The patient monitor the Respiration Pod is assigned to is in neonatal mode. The INOP will remain active until the monitor is changed to adult mode.cmResp No Signal Resp No active signal can be detected.cmRespCan'tAnalyze Resp Unable to analyze respiration and pulse signalcmRespPediPatient?Numeric is replaced by -?-INOP toneResp The patient monitor the Respiration Pod is assigned to is in pediatric mode. The INOP will remain active until the monitor is changed to adult mode.INOP Message, Indication Source What to doRespiration Settings Factory DefaultsMode AutoRepeat Time 15 mincmResp OnPulse OnDyn. Repetition EnabledPosture OffActivity OffAging Time 10 minColor Yellow
4 IntelliVue CL Respiration Pod110Integrated Battery HandlingBattery CareThe IntelliVue CL Respiration Pod has a built-in battery that is not exchangeable. Battery care begins when you receive a new pod and continues throughout the life of the pod. The table below lists battery care activities and when they should be performed.Handling PrecautionsLithium ion batteries store a large amount of energy in a small package. Use caution when handling the IntelliVue Cableless Measurement Devices with built-in battery; misuse or abuse could cause bodily injury and/or property damage.• Handle with care.• Do not expose the device to liquids.• Do not attempt to disassemble the device.• Do not put device in autoclave.• Damaged devices should not be used anymore.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).StorageIf unused IntelliVue Cableless Measurement Devices are stored for an extended period of time:• they should be powered off for storage• they should be stored in a cool place, ideally between 15°C and 25°C (60°F and 77°F)• the state of charge should be between 40-50%• they should be recharged every six monthsStoring in a cool place slows the aging process of the batteries. They should be fully charged prior to use. Do not store the device at a temperature outside the range of -20°C (-4°F) to 60°C (140°F).Do not store cableless devices in direct sunlight.NOTEStoring the devices at temperatures above 40°C (104°F) for extended periods of time could significantly reduce the battery's life expectancy.Activity When to performCharge the battery Upon receipt, after use, or if a low battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible.Store the device in a state of charge in the range of 40-50% and power off the device completely.When not in use for an extended period of time.
4 IntelliVue CL Respiration Pod111Battery Lifetime ManagementThe lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 4 years or 400 complete charge-discharge cycles, whichever comes first. In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. The batteries of the IntelliVue CL Respiration Pod cannot be exchanged, so the device itself must be replaced after 4 years or 400 complete charge-discharge cycles.AccessoriesYou can order parts and accessories from Philips supplies at www.medical.philips.com or consult your local Philips representative for details. Also consult the accessories' Instructions for Use, if available.WARNINGReuse: 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.IntelliVue CL Respiration Pod AccessoriesPart Number Description Contents989803179541 Mobile CL Respiration Pod Attachment 50 attachments
4 IntelliVue CL Respiration Pod112Maintenance and TroubleshootingWARNINGSchedule: 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 AccessoriesYou should perform a visual inspection before every use, and in accordance with your hospital's policy: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.WARNINGIf 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 ScheduleAll 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 Philips-qualified 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.TroubleshootingIf the status LED does not light up when you press a key, place the device 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.
51135Cableless Measurement Auxiliary DevicesIntelliVue CL Transmitter and IntelliVue CL HotspotThe IntelliVue CL Transmitter and the IntelliVue CL Hotspot are auxiliary network devices that convert the SRR radio technology from the IntelliVue CL SpO2 Pod, the IntelliVue CL NBP Pod and the IntelliVue CL Respiration Pod into WLAN or LAN technology. This allows data from the measurement devices to be transmitted to a PC for use with IntelliVue GuardianSoftware.The IntelliVue CL Transmitter is a mobile device which can be worn by the patient or by an attending caregiver. It transmits vital signs data to IntelliVue GuardianSoftware while the patient is moving around. The display on the CL Transmitter shows only technical data that may be useful for troubleshooting system problems.The IntelliVue CL Hotspot serves as an access point in a fixed location, to provide communication to IntelliVue GuardianSoftware for any CL Pods currently in its transmission area. The CL Hotspots will normally be located in areas where mobile patients regularly pass by or spend time. When the patient comes into the transmission area, any available measurement results will be automatically communicated to GuardianSoftware.The IntelliVue CL Transmitter is battery-powered while the IntelliVue CL Hotspot is powered by an external power supply or PoE (Power over Ethernet).IntelliVue CL Transmitter IntelliVue CL Hotspot
5 Cableless Measurement Auxiliary Devices114WARNINGThe IntelliVue CL Hotspot may not be used in the patient vicinity.Screen LayoutThe CL Transmitter and CL Hotspots have the same hardkeys and display as the CL SpO2 and NBP Pods.However, there is no user interaction required during normal operation.This is the standard screen of a CL Transmitter or CL Hotspot:The network status symbols show one of the following states:CL Transmitter Integrated Battery HandlingBattery CareBattery care begins when you receive a new IntelliVue Cableless Measurement Device with built-in battery and continues throughout the life of the device. The table below lists battery care activities and when they should be performed.Screen of a CL Transmitter / CL Hotspot:1Equipment label2Number of GuardianSoftware Servers connected3Network status symbols (LAN and WLAN)4Connection status5Number of Cableless Measurement Devices connected6Battery gaugeState LAN symbol WLAN symboloff - (no symbol displayed) - (no symbol displayed)not connectedno IP addressno Guardian server connectednormally connectedActivity When to performPerform a visual inspection Before using the IntelliVue Cableless Measurement DeviceCharge the battery Upon receipt, after use, or if a low battery state is indicated. To optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible.Store the device in a state of charge in the range of 40-50% and power off the device completely.When not in use for an extended period of time, or when the device is shipped.
5 Cableless Measurement Auxiliary Devices115Handling PrecautionsLithium ion batteries store a large amount of energy in a small package. Use caution when handling the IntelliVue Cableless Measurement Devices with built-in battery; misuse or abuse could cause bodily injury and/or property damage.• Handle with care.• Do not expose the device to liquids.• Do not attempt to disassemble the device.• Do not put device in autoclave.• Damaged devices should not be used anymore.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).StorageIf unused IntelliVue Cableless Measurement Devices are stored for an extended period of time:• they should be powered off for storage• they should be stored in a cool place, ideally between 15°C and 25°C (60°F and 77°F)• the state of charge should be between 40 and 50%• they should be recharged every six monthsStoring in a cool place slows the aging process of the batteries. They should be fully charged prior to use. Do not store the device at a temperature outside the range of -20°C (-4°F) to 60°C(140°F).Do not store cableless devices in direct sunlight.NOTEStoring the devices at temperatures above 40°C (104°F) for extended periods of time could significantly reduce the battery's life expectancy.Battery Lifetime ManagementThe lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly cared for, the useful life is approximately 4 years or 400 complete charge-discharge cycles, whichever comes first. In addition, experience indicates that the incidence of failure may increase with battery service life due to the accumulated stresses of daily use. We therefore strongly recommend that lithium ion batteries be replaced after 4 years or 400 complete charge-discharge cycles.To see the date of manufacture and the number of charge-discharge cycles:1Select the Battery Smartkey or Main Setup followed by Battery.2Press the  hardkey to view the battery details.The date of manufacture and the number of charge-discharge cycles are listed with other battery data on the screen. Use the ◄ hardkey to scroll through the list.The age of a lithium ion battery begins at the date of manufacture.
5 Cableless Measurement Auxiliary Devices116AccessoriesYou can order parts and accessories from Philips supplies at www.medical.philips.com or consult your local Philips representative for details. Also consult the accessories' Instructions for Use, if available.WARNINGReuse: 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.IntelliVue CL Transmitter AccessoriesOrder Number Description Contents989803168881 Mobile CL 20 Transmitter Cradle Kit 20 Single-Patient cradles and straps989803168871 Mobile CL Transmitter Battery Kit 1 Battery1 disassembly tool1 front housing
5 Cableless Measurement Auxiliary Devices117IntelliVue CL Transmitter Base Station(shown here with the transmitter inserted)The IntelliVue CL Transmitter Base Station is used with the IntelliVue CL Transmitter. When the patient is in their room, the Transmitter can be inserted into the Base Station where it is powered and recharged and also remains connected to the WLAN to communicate vital signs data.WARNING• The IntelliVue CL Transmitter Base Station may not be used in the patient vicinity.• Ensure that the CL Transmitter Base Station does not come into close contact with implanted pacemakers, to avoid magnetic interference affecting the mode of the pacemaker.•Electrical shock hazard: Do not open the device housing. Refer all servicing to qualified service personnel.CAUTIONThe CL Transmitter Base Station generates a magnetic field. Do not store magnetic media (such as identity cards or credit cards with magnetic strips or magnetic tapes/disks) near to the Base Station, as the data may be damaged.
5 Cableless Measurement Auxiliary Devices118IntelliVue CL Charging StationThis section contains some general information about charging IntelliVue Cableless Measurement Devices. For detailed information about the IntelliVue CL Charging Station, please see the separate IntelliVue CL Charging Station Instructions for Use.Charging IntelliVue Cableless Measurement DevicesAll IntelliVue Cableless Measurement Devices and Auxiliary Devices except the CL Hotspot are battery powered and need to be recharged using the IntelliVue CL Charging Station. The batteries are built in and can only be exchanged by trained service personnel, with the exception of the IntelliVue CL Respiration Pod, where the whole device needs to be exchanged.To charge a battery, place the device onto a charger slot on the charging station. The NBP Pod and Transmitter should always be placed on one of the slots in the upper row. The battery power indicators will supply information about the charge status.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.Battery Power IndicatorsThere are various indications which help you keep track of the battery power status:• LEDs on the charging station slots• battery status information on the charging station's display, the NBP/SpO2 Pod's display and the Respiration Pod's LED• INOP messages• battery symbol on the patient monitor's screen (when assigned to a patient monitor)• battery symbol in GuardianSoftware (when assigned to a patient in GuardianSoftware)The indicators always show the remaining capacity in relation to the battery's actual maximum capacity, which may lessen as the battery ages. You can see the actual capacity in the Battery menu.
5 Cableless Measurement Auxiliary Devices119Maintenance and TroubleshootingWARNINGSchedule: 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 AccessoriesYou should perform a visual inspection before every use, and in accordance with your hospital's policy. With the device switched off:1Examine 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.2Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use them.WARNINGIf 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 ScheduleAll 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 Philips-qualified 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.TroubleshootingIf 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.
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61216Care and CleaningUse only the Philips-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods.Philips makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Consult your hospital’s Infection Control Officer or Epidemiologist. For comprehensive details on cleaning agents and their efficacy refer to "Guideline for Disinfection and Sterilization in Healthcare Facilities" issued by the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, Atlanta, Georgia, 2008. See also any local policies that apply within your hospital, and country.General PointsKeep your IntelliVue Cableless Measurement Devices and accessories free of dust and dirt. After cleaning and disinfection, check the equipment carefully. Do not use if you see signs of deterioration or damage. If you need to return any equipment to Philips, decontaminate it first.Observe the following general precautions:• Always dilute according to the manufacturer’s instructions or use lowest possible concentration.• Do not allow liquid to enter the case.• Do not immerse any part of the equipment or any accessories in liquid if it is not explicitly allowed and described in the respective accessory Instructions for Use.• Do not pour liquid onto the charging station.• Never use abrasive material (such as steel wool or silver polish).WARNINGIf you spill liquid on the charging station or accessories, or if any device or accessory 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 cableless measurement devices in an oxygen-enriched environment, as this might lead to sudden ignition of vapors, resulting in injury to the patient or staff.
6 Care and Cleaning122Cleaning and Disinfecting the IntelliVue Cableless Measurement DevicesThe following instructions apply to the IntelliVue CL SpO2 Pod, the IntelliVue CL Respiration Pod, the IntelliVue CL NBP Pod, the corresponding single patient Mobile CL Cradles and the auxiliary devices: IntelliVue CL Charging Station, IntelliVue CL Transmitter, IntelliVue CL Transmitter Base Station and IntelliVue CL Hotspot.Clean with a lint-free cloth, moistened with warm water (40°C/104°F maximum) and soap, a diluted non-caustic detergent, tenside, ammonia- or alcohol-based cleaning agent. Do not use strong solvents such as acetone or trichloroethylene.CAUTIONSolutions: Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may result.Hospital policy: Disinfect the product as determined by your hospital’s policy only using the cleaning agents specified below, to avoid long term damage to the cableless device.Drying devices: Do not use heat sources, such as ovens or hairdryers, to dry the devices. Do not put the devices in a microwave.No sterilizing: Do not put the devices in an autoclave, they are not sterilizable.Rinse the Pods in water, paying special attention to the contact area to remove all residues. Wipe them dry with a clean cloth and then leave them to dry completely.Do not allow any liquid to enter the charging station case and avoid pouring it on the charging station while cleaning.The wristbands used with the Mobile CL SpO2 Cradles are single-patient items and cannot be cleaned or disinfected.Refer to the accessory Instructions for Use for cleaning and disinfection information for SpO2 sensors.Recommended Disinfection AgentsWe recommend that you use one of the following disinfectants:Product Name Product Type Manufacturer DilutionIsopropanol liquid - 80%Sodium Hypochlorite, bleach liquid - 1%Hydrogen Peroxide liquid - 3%
6 Care and Cleaning123Refer to the accessory Instructions for Use for cleaning and disinfection information for SpO2 sensors and NBP cuffs.Disposing of the IntelliVue Cableless Measurement DevicesWARNINGTo 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 them 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.You will find detailed disposal information on the following webpage:www.healthcare.philips.com/main/about/Sustainability/Recycling/pm.wpdThe Recycling Passports located there contain information on the material content of the equipment, including potentially dangerous materials which must be removed before recycling (for example, batteries and parts containing mercury or magnesium).Do not dispose of waste electrical and electronic equipment as unsorted municipal waste. Collect it separately, so that it can be safely and properly reused, treated, recycled, or recovered.For information in disposal of accessories, refer to the accessory Instructions for Use.Bacillol® AF liquid, spray BODE Chemie GmbH According to manufacturer's instructionsDismozon® plus liquid BODE Chemie GmbHMeliseptol®liquid, spray B. Braun Melsungen AGIncidin® Foam liquid Ecolab Inc.Oxivir® Tb Cleaner Disinfectant liquid, spray Diversey Inc.Super Sani-Cloth®Germicidal Disposable Wipeswipes PDI Inc.Sani-Cloth® PlusGermicidal Disposable Wipeswipes PDI Inc.Mikrozid® Sensitive Wipes wipes Schülke & Mayr GmbHMikrozid® PAA Wipes wipes Schülke & Mayr GmbHDescogen® Liquid rfu liquid Antiseptica Dr. Hans-Joachim Molitor GmbHLysoformin liquid Lysoform Dr. Hans Rosemann GmbHDescosept PUR liquid Dr. Schumacher GmbHProduct Name Product Type Manufacturer Dilution
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71257SpecificationsThe specifications in this section apply to the:• IntelliVue CL SpO2 Pod• IntelliVue CL NBP Pod• IntelliVue CL Respiration Pod• IntelliVue CL Charging Station• IntelliVue CL Transmitter• IntelliVue CL Transmitter Base Station• IntelliVue CL HotspotThe IntelliVue Cableless Measurement Devices might not meet the performance specification listed in this chapter, if stored or operated outside the specified environmental conditions.WARNINGThe IntelliVue Cableless Measurement Devices are not intended for use in an MRI environment or in an oxygen-enriched environment (e.g. hyperbaric chambers). During MR imaging, remove all IntelliVue Cableless Measurement Devices and sensors from the patient. Induced currents could cause burns.Indications for UseIntelliVue CL SpO2 Pod:The IntelliVue CL SpO2 Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters SpO2 and pulse rate wirelessly.The intended use of the IntelliVue CL SpO2 Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring and recording of, and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients.The IntelliVue CL SpO2 Pod is also intended for local attended monitoring of, and to generate alarms for, arterial oxygen saturation and pulse rate of adult and pediatric patients. Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the IntelliVue CL SpO2 Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room.The IntelliVue CL SpO2 Pod is also intended for acquisition of arterial oxygen saturation and pulse rate data of adult and pediatric patients for a clinical information management system.The IntelliVue CL SpO2 Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device.
7 Specifications126IntelliVue CL NBP Pod:The IntelliVue CL NBP Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters noninvasive blood pressure and pulse rate wirelessly.The intended use of the IntelliVue CL NBP Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring and recording of, and to generate alarms for, systolic, diastolic, and mean pressure and pulse rate of adult and pediatric patients.The IntelliVue CL NBP Pod is also intended for local attended monitoring of, and to generate alarms for, systolic, diastolic, and mean pressure, and to measure pulse rate of adult and pediatric patients. Local attended monitoring refers to situations where clinical staff is close to the patient such that acoustic alarming of the IntelliVue CL NBP Pod will be noticed. Example: In-hospital transport of a patient by hospital staff to a procedure room.The IntelliVue CL NBP Pod is also intended for acquisition of systolic, diastolic, and mean pressure and pulse rate data of adult and pediatric patients for a clinical information management system.The IntelliVue CL NBP Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device.IntelliVue CL Respiration Pod:The IntelliVue CL Respiration Pod is indicated for use by health care professionals whenever there is a need for intermittent or spot-check acquisition and monitoring of physiological patient parameters respiration rate and pulse rate wirelessly in specific hospital areas. The IntelliVue CL Respiration Pod is mainly indicated for use in general medical and surgery wards and in waiting areas of emergency rooms. It is not indicated for use in hospital areas in which continuous patient monitoring is needed, such as intensive care units or operating rooms.The intended use of the IntelliVue CL Respiration Pod when used together with a patient monitor is for intermittent or spot-check monitoring and recording of, and to generate alarms for, respiration rate and pulse rate of adult and pediatric patients.The IntelliVue CL Respiration Pod is also intended for acquisition of respiration rate and pulse rate data of adult and pediatric patients for a clinical information management system.The IntelliVue CL Respiration Pod is intended for use by health care professionals. It is not intended for home use. It is not a therapeutic device.The IntelliVue CL Respiration Pod is not intended for use on patients with extremely high values for respiration rate (above 60 rpm).The IntelliVue CL Respiration Pod is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias, e.g. very fast atrial fibrillation or ventricular tachycardia (rapid irregular pulse rate). For monitoring of these patients, a device for continuous ECG monitoring is necessary. The IntelliVue CL Respiration Pod is not a substitute for an ECG monitor.WARNINGDo not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm. Use under these conditions has not been clinically validated.Rx only: US Federal Law restricts these devices to sale by or on the order of a physician.
7 Specifications127Compatible Medical Devices• IntelliVue Patient Monitors MP5/MP5SC/MP5T, MP2 or X2• IntelliVue Telemetry System Transceivers TRx4841A/TRx4851A and MX40 wearable patient monitors1• Avalon Fetal Monitors1• Clinical information management system: IntelliVue GuardianSoftware1 not compatible with the CL Respiration PodCompatible Medical Devices supporting local attended monitoring together with CL SpO2 and NBP Pods:• IntelliVue Patient Monitors MP5/MP5SC/MP5TSymbolsThese symbols can appear on the IntelliVue Cableless Measurement Devices.SymbolsCaution is necessary when operating the device.Operating instructions should be considered when operating the device.Follow instructions for use.Protective earth Equipotential groundingAlternating current Connector has special protection against electric shocks and is defibrillator proofError LED Built-in wireless network (WLAN)USB interface Non-ionizing radiation symbolNBP identifier SpO2 identifierAlways use separate collection for waste electrical and electronic equipment (WEEE)Indicates manufacturing dateIndicates location of the date of manufacture and/or name and address of manufacturerIndicates location of serial numberIndicates location of catalog number Indicates location of service number
7 Specifications128Followed by two alphanumeric characters, indicates ingress protection gradeChina RoHSDo not reuse LAN connection indicator for connection to a wired networkResp identifier Not made with natural rubber latexMass in kilogram (kg) RCM compliance markEAC mark CSA US markFCC ID Federal Communications Commission: FCC ID xxxxCMIIT ID Chinese Radio marking: CMIIT ID (China Ministry of Industry and Information Technology)CE marking accompanied by the Notified Body number 0123SymbolsIC-ID (Industry Canada ID)One IC-ID labeling for each built in radio: OBR, SRRJapanese Radio marking: Radio mark + [R]-symbol + IDTaiwan Radio Label (NCC Logo) + ID Korea radio mark: KC logo, KCC ID number, and Conformity assessment information
7 Specifications129Manufacturer's InformationYou can write to Philips at this addressPhilips Medizin Systeme Boeblingen GmbHHewlett-Packard-Str. 271034 BoeblingenGermanyAustralia Sponsor:Philips Electronics Australia Ltd 65 Epping Road,North Ryde, NSW Australia 2113Visit our website at: www.healthcare.philips.com.© Copyright 2017. Koninklijke Philips N.V. All Rights Reserved.Regulatory and Safety SpecificationsGeneral Conditions for Cableless MeasurementsThe IntelliVue Cableless Measurements are compliant with IEC 60601-1 Ed. 3. However, they can still be used with IntelliVue Patient Monitors MP5/MP5SC/MP5T, MP2/X2, Avalon Fetal Monitors, IntelliVue Telemetry System Transceivers TRx4841A/TRx4851A, MX40 wearable patient monitors, that are compliant with IEC 60601-1 Ed. 2.IntelliVue CL SpO2 Pod, CL NBP Pod and CL Respiration Pod:0123IntelliVue CL Charging Station and CL Transmitter:The IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, CL Charging Station, and CL Transmitter comply with the Medical Device Directive 93/42/EEC. In addition, the IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, CL Charging Station and CL Transmitter comply with:IEC 60601-1:2005 + Cor.1:2006 + Cor.2:2007+ A1:2012; EN 60601-1:2006+ AC:2010+ A1:2013; ANSI/AAMI ES60601-1:2005/(R)2012; CAN/CSA C22.2 No. 60601-1-14The possibility of hazards arising from software errors was minimized in compliance with:ISO 14971:2007; EN ISO 14971:2012, IEC 60601-1-4:1996 + A1:1999; EN 60601-1-4:1996 + A1:1999; IEC 60601-1-6:2010 / EN 60601-1-6:2010; IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+AC:2010; IEC 60601-2-49:2011 / EN 60601-2-49:2001 (NBP Pod and SpO2 Pod only).Classification (according to IEC 60601-1):IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod: Internally powered equipment, Type CF, Continuous OperationIntelliVue CL Transmitter: Internally powered equipment, Continuous OperationIntelliVue CL Charging Station: Class I equipment, Continuous OperationIntelliVue CL Transmitter Base Station and CL Hotspot:
7 Specifications130The IntelliVue CL Transmitter Base Station and CL Hotspot comply with the Low Voltage Directive 2014/35/EC.In addition, these devices comply with:IEC 60950-1:2005; EN 60950-1:2006+A11:2009 +A1:2010 +A12:2011 +A2:2013.EMC and Radio Regulatory ComplianceFCC and Industry Canada Radio ComplianceIntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, CL Charging Station, CL TransmitterThis ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB-001 du Canada.IntelliVue CL Transmitter Base StationThis Class B digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe B est conforme à la norme NMB-003 du Canada.IntelliVue CL HotspotThis Class A digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe A est conforme à la norme NMB-003 du Canada.These devices comply with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) these devices may not cause harmful interference, and (2) these devices must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radiofrequency interference and void your authority to operate this equipment. Usage of license-exempt local area network (LE-LAN) in Canada:IntelliVue CL Transmitter and CL HotspotThe maximum antenna gain permitted (for devices in the bands 5250-5350 MHz and 5470-5725 MHz) complies with the e.i.r.p. limits as stated in RSS-210.The maximum antenna gain permitted (for devices in the 5725-5825 MHz band) complies with the e.i.r.p. limits specified for point-to-point operation, as stated in RSS-210.The device for the band 5150-5250 MHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems.CAUTIONHigh power radars are allocated as primary users (meaning they have priority) of the bands 5250-5350 MHz and 5650-5850 MHz and these radars could cause interference and/or damage to LE-LAN devices.Japanese Radio Law and Japanese Telecommunications Business Law ComplianceIntelliVue CL Respiration Pod and CL Hotspot
7 Specifications131R&TTE Directive ComplianceIntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, and CL Charging StationIntelliVue CL Transmitter, and CL Hotspot Philips Medizin Systeme Boeblingen GmbH hereby declares that these products are in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC (Radio and Telecommunications Terminal Equipment Directive).The IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, CL Charging Station, CL Transmitter, and CL Hotspot incorporate a SRR module, which is Class 1 radio equipment.The IntelliVue CL Transmitter and CL Hotspot incorporate additionally the IntelliVue 802.11 Adapter, which is Class 2 radio equipment. The products are intended to be connected to the Publicly Available Interfaces (PAI) and used throughout the EEA. Individual countries may apply restrictions on putting this device into service or placing on the market.To obtain a copy of the original Declaration of Conformity, please contact Philips at the address as stated in the “Manufacturer's Information”.WARNING• The IntelliVue CL Charging Station is Class A professional equipment. This equipment is not intended for use in domestic establishments or connection to the public mains network. In domestic establishments or when connected to the public mains network, this equipment may cause radio interference or may disrupt the operation of nearby equipment.• The IntelliVue CL Hotspot is a Class A product. In a domestic environment this product may cause radio interference, in which case the user may be required to take adequate measures.• This equipment generates, uses and radiates radiofrequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications.• The device, equipped with a wireless network interface, intentionally receives RF electromagnetic energy for the purpose of its operation. Therefore, other equipment may cause interference, even if that other equipment complies with CISPR emission requirements.EMC Directive ComplianceIntelliVue CL Transmitter Base Station and CL Hotspot The IntelliVue CL Transmitter Base Station and CL Hotspot comply with the EMC Directive 2014/30/EC.In addition these devices comply with:ETSI EN 301 489-1:V1.9.2, ETSI EN 301 489-17:V2.2.1CISPR 22:2008 / EN55022:2010/AC 2011 and CISPR 24:2010 / EN55024:2010
7 Specifications132Radiofrequency Radiation Exposure InformationIntelliVue CL TransmitterFor body worn operation, this device has been tested and meets FCC RF exposure guidelines when used in the standard configuration with the rear side towards the body, without a gap. Alternatively, it can be used with any accessory that positions the front side of the device a minimum of 10 mm from the body. The accessory itself must not contain any metal parts. Use of other accessories may not ensure compliance with FCC RF exposure guidelines.Nevertheless it is strongly recommended to operate the CL Transmitter with the rear side towards the body to achieve best possible radio performance.Safety and Performance TestsYou must follow and apply any national regulations on the qualification of the testing personnel and suitable measuring and testing facilities. Required safety and performance tests, and what to do if the Cableless Measurements do not meet these specifications, are described in the IntelliVue Cableless Measurements Service Guide.Electromagnetic Compatibility (EMC)Take special precautions regarding electromagnetic compatibility (EMC) when using the IntelliVue Cableless Measurements. Operate the IntelliVue Cableless Measurements according to the EMC information provided in these Instructions for Use and in the IntelliVue Cableless Measurements Service Guide. Portable and mobile radiofrequency (RF) communications equipment can affect the IntelliVue Cableless Measurements.WARNINGFor paced patients: The radiated SRR power of the IntelliVue SpO2, NBP and Respiration Cableless Measurement Devices, the CL transmitter, and other sources of radiofrequency energy, when used in very close proximity of a pacemaker, might be sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring paced patients.In order to minimize the possibility of interference, avoid positioning and wearing the Cableless Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer for information on the RF susceptibility of their products.WARNINGFor paced patients: The radiated WLAN power of the IntelliVue CL Transmitter, and other sources of radiofrequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring any paced patients.In order to minimize the possibility of interference, position the IntelliVue CL Transmitter, when body worn, as far away from the pacemaker as possible. Consult the pacemaker manufacturer for information on the RF susceptibility of their products.
7 Specifications133Accessories Compliant with EMC StandardsAll IntelliVue CL SpO2 Pod, CL NBP Pod and CL Respiration Pod accessories comply, in combination with the IntelliVue Cableless Measurement Devices, with the requirements of IEC 60601-1-2:2001 + A1 2004; EN 60601-1-2:2001 + A1 2006 or IEC 60601-1-2:2007; EN 60601-1-2:2007.WARNINGUsing accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the IntelliVue Cableless Measurement Devices.Electrosurgery Interference/DefibrillationThe IntelliVue CL SpO2 Pod, CL NBP Pod and CL Respiration Pod including all accessories are suitable for use in the presence of electrosurgery and during the discharge of a cardiac defibrillator.Measurement accuracy may be temporarily decreased or measurement may be interrupted while performing electrosurgery or defibrillation. The equipment returns to the previous operating mode within 10 seconds without loss of any stored data. This does not affect patient or equipment safety. Do not expose the equipment to X-ray or strong magnetic fields (MRI).IntelliVue CL SpO2 Pod SpecificationsComplies with ISO 80601-2-61:2011 / EN ISO 80601-2-61:2011.Measurement Validation: The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, Physical SpecificationsSize (W x H x D) 54 mm x 27 mm x 65 mm ±5% (2.1 in x 1.1 in x 2.6 in ±5%)(without cradle and sensor)Weight 82 g ±10% (2.8 oz ±10%)Robustness Provides essential performance during exposure to random vibration according to IEC TR 60721-4-7 Class 7M1Survives shock, random vibration and bump according to IEC TR 60721-4-7 Class 7M3 as well as a 1 m dropIngress Protection IP34 according to IEC 60529 (protection against ingress of water when water drips, falls or splashes from any direction, and protection against contact with or ingress of objects larger than 2.5 mm)Environmental SpecificationsOperating 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 mStorage/Transportation Temperature Range-20 to 60°C (-4 to 140°F)Storage/Transportation Humidity Range ≤90% RH @ 60°C (140°F)no condensationStorage/Transportation Altitude Range -500 to 4600 m
7 Specifications134only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements.Display Update Period: Typical: 2 seconds, Maximum: 30 seconds. Maximum with NBP INOP suppression on: 60 seconds.Performance SpecificationsSpO2Measurement Range 0 to 100%AccuracyThe specified accuracy is the root-mean-square (RMS) difference between the measured values and the reference valuesMobile CL DSpO2-1A single patient sensor:3% (70 to 100%)Mobile CL RSpO2-1A reusable sensor (may not be available in all geographies):3% (70 to 100%)Resolution 1%Pulse Oximeter Calibration Range 70% to 100%PulseMeasurement Range 30 to 300 bpmAccuracy ±2% or 1 bpm, whichever is greaterResolution 1 bpmSensorsLED Power Dissipation Temperature rise at sensor skin interface in compliance with ISO 9919Optical Output Power ≤15 mWWavelength RangeInformation about the wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed)500 to 1000 nmFor further information on accessory specifications, refer to the accessory Instructions for Use.Display SpecificationsType monochrome (4 gray scales), passive LCD (STN), positive/transflectiveViewing Area 25.6 mm x 19.2 mmDot Size 0.2 mm x 0.2 mmResolution 128 x 96 pixelBacklight white LEDSounds Hardkey operation toneAssignment toneAlarm tonePulse tone with and without tone modulationBattery Integrated rechargeable Li-Ion battery with battery gauge and cycle counter
7 Specifications1351Approval pendingIntelliVue CL NBP Pod SpecificationsComplies with IEC 80601-2-30:2010 + A1:2013/EN 80601-2-30:2010.Measurement ValidationClinical investigation according ISO 81060-2:2013 with the auscultatory reference method– the 5th Korotkoff sound (K5) was used in adult / adolescent subjects and the 4th Korotkoff sound (K4) was used in pediatric subjects to determine the diastolic reference pressures– the approximation MAP = (2*DIA + SYS) / 3 was used to calculate reference MAP (mean arterial pressure) values from the systolic and diastolic reference pressures.NOTEThe effectiveness of this sphygmomanometer has been established in pregnant, including pre-eclamptic patients.Runtime (fully charged battery) Continuous measurement:Typically 24 hoursMinimum 12 hours in continuous modeIntermittent measurement:Typically 60 hours with repetition interval of 2 minutesTypically 3 days with repetition interval of 5 minutesCharging Time max 2.5 hoursShort Range Radio SpecificationsType built in interface with integrated antennaTechnology IEEE 802.15.4Frequency band 2.4 GHz ISM (2.400 - 2.483 GHz)MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1Modulation DSSS (O-QPSK)Bandwidth 5 MHzEffective radiated power (ERP) max. 0 dBm (1 mW)Electronic Article Surveillance (EAS) EAS tag inside the housingReal Time Clock Accuracy better than 5 seconds per day (typically) as long as device is in power state "Device on" or "Standby". Automatically synchronized with assigned host system.Performance SpecificationsPhysical SpecificationsSize (W x H x D) 66 mm x 138 mm x 31 mm ±5% (2.6 in x 5.4 in x 1.2 in ±5%)(without cradle and cuff)Weight 234 g ±10% (8.3 oz ±10%)(without cradle and cuff)
7 Specifications136The monitor may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges.Robustness Provides essential performance during exposure to random vibration according to IEC TR 60721-4-7 Class 7M1Survives shock, random vibration and bump according to IEC TR 60721-4-7 Class 7M3 as well as a 1 m dropIngress Protection IP32 according to IEC 60529 (protected against ingress of water when the water is dripping vertically and the CL NBP Pod is tilted up to 15° and protected against contact with or ingress of objects larger than 2.5 mm)Physical SpecificationsEnvironmental SpecificationsOperating Temperature Range 0 to 40°C (32 to 104°F)Operating Humidity Range ≤95% RH @ 40°C (104°F) (non-condensing)Operating Altitude Range -500 to 3000 mStorage/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 mIntelliVue CL NBP Pod Performance SpecificationsDisplay SpecificationsType monochrome (4 gray scales), passive LCD (STN), positive/transflectiveViewing Area 25.6 mm x 19.2 mmDot Size 0.2 mm x 0.2 mmResolution 128 x 96 pixelBacklight white LEDSounds Hardkey operation toneAssignment toneNBP Announcement toneNBP done toneAlarm toneBattery Integrated rechargeable Li-Ion battery with battery gauge and cycle counterRuntime (fully charged battery) Minimum 12 hours @ 4 measurements per hourTypical 4 days @ 2 measurements per hourTypical 5 days @ 1 measurement every 2 hoursCharging Time Maximum 2.5 hoursShort Range Radio SpecificationsType built in interface with integrated antennaTechnology IEEE 802.15.4Frequency band 2.4 GHz ISM (2.400 - 2.483 GHz)MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1
7 Specifications1371Approval pendingModulation DSSS (O-QPSK)Bandwidth 5 MHzEffective radiated power (ERP) max. 0 dBm (1 mW)Electronic Article Surveillance (EAS) EAS tag inside the housingReal Time Clock Accuracy better than 5 seconds per day (typically) as long as device is in power state "Device on" or "Standby". Automatically synchronized with assigned host system.Measurement Ranges Adult:Systolic: 30 to 270 mmHg (4.0 to 36.0 kPa)Mean: 20 to 255 mmHg (2.5 to 34.0 kPa)Diastolic: 10 to 245 mmHg (1.5 to 32.0 kPa)Pediatric:Systolic: 30 to 180 mmHg (4.0 to 24.0 kPa)Mean: 20 to 160 mmHg (2.5 to 21.0 kPa)Diastolic: 10 to 150 mmHg (1.5 to 20.0 kPa)Rated Range of Cuff Pressure max. 300 mmHg (40.0 kPa)Pressure Transducer Accuracy (0 to 300 mmHg)±3 mmHg @ 15 to 25°C±(3 mmHg or 2% whichever is greater) @ 10 to 40°CBlood Pressure Measurement Accuracy8 mmHg standard deviation±5 mmHg mean errorPulse Rate Measurement Range 40 to 300 bpmPulse Rate Measurement Accuracy 40 - 100 bpm: ±5 bpm101 - 200 bpm: ±5% of reading201 - 300 bpm: ±10% of reading(average over NBP measurement cycle)Measurement Time Auto/manual/sequence mode:Typical 40 seconds @ >60 bpm and normal adult cuffMaximum 180 secondsSTAT and Accelerated Mode:Typical 30 seconds @ >60 bpm and normal adult cuffMaximum 180 secondsSTAT Mode Cycle Time 5 minutesInitial Cuff Inflation Pressure Adult: 165 ±15 mmHgPediatric: 130 ±15 mmHgVenipuncture Pressure Range Adult: 20 to 120 mmHg in steps of 5 mmHgPediatric: 20 to 80 mmHg in steps of 5 mmHgVenipuncture Pressure Accuracy ±10 mmHgCuff size detection INOP, if neonatal cuff size is detectedIntelliVue CL NBP Pod Performance Specifications
7 Specifications138IntelliVue CL Respiration Pod SpecificationsComplies with ISO 80601-2-61:2011 / EN ISO 80601-2-61:2011.Physical SpecificationsSize (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 dropIngress Protection IP67 according to IEC 60529Environmental SpecificationsOperating Temperature Range 0 to 40°C (32 to 104°F)Operating Humidity Range ≤95% RH @ 40°C (104°F), no condensationOperating Altitude Range -500 to 3000 mStorage/Transportation Temperature Range-20 to 60°C (-4 to 140°F)Storage/Transportation Humidity Range ≤90% RH @ 60°C (140°F), no condensationStorage/Transportation Altitude Range -500 to 4600 mStorage/Transportation Ambient Pressure (Altitude Range)1075 hPa to 570 hPa (-500 m to 4600 m / -1650 ft to 15000 ft)Performance SpecificationsBattery Integrated rechargeable Li-Ion battery with battery gauge and cycle counterRuntime (fully charged battery) Minimum 12 hours in frequent measurement mode with posture and activity detectionTypically 18 hours in frequent measurement mode with posture and activity detectionMinimum 1.5 days @ 4 measurements per hour without posture and activity detectionTypical 3 days @ 4 measurements per hour without posture and activity detectionMinimum 1 day @ 4 measurements per hour with posture and activity detectionTypical 2 days @ 4 measurements per hour with posture and activity detectionCharging Time max 2.5 hoursShort Range Radio SpecificationsType built in interface with integrated antennaTechnology IEEE 802.15.4Frequency band 2.4 GHz ISM (2.400 - 2.483 GHz)MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1Modulation DSSS (O-QPSK)
7 Specifications1391Approval pendingBandwidth 5 MHzEffective 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.RespirationMeasurement Range 5 to 60 rpmAccuracy ±1 rpmResolution 1 rpmPulseMeasurement Range Adult: 30 to 220 bpmFor rapid, irregular heart rates: 30 to 110 bpmPediatric: 30 to 220 bpmAccuracy ±3% or ±1 bpm (whichever is greater)Resolution 1 bpmPosture 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 signalPerformance SpecificationsAttachment SpecificationsSize (W X H) 196 mm x 64 mm (7.7 in x 2.5 in)Environmental SpecificationsOperating temperature range 0 to 40°C (32 to 104°F)Storage / Transportation Temperature RangeStorage: 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% RHTransportation: ≤ 90% RH @ 60°C (140°F); no condensationStorage / Transportation Ambient Pressure (Altitude Range)1075 hPa to 570 hPa (-500 m to 4600 m / -1650 ft to 15000 ft)
7 Specifications140Alarm Specifications for CL NBP, CL SpO2 and CL Resp PodWhen 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 SignalSystem Alarm DelayThe 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.less than 4 secondsDelay for alarm availability on the networkThis 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.less than 5 secondsSound Pressure Range min. 0 dB(A)max. 30-65 dB(A)SpO2 Alarm Specifications Range AdjustmentSpO2Adult: 50 to 100%Pedi: 30 to 100%1% stepsDesat Adult: 50 to Low alarm limitPedi: 30 to Low alarm limit1% stepsPulse 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 stepsClamping at 150 to 300 bpm 5 bpm stepsBradycardia Difference to low limit 0 to 50 bpm 5 bpm stepsClamping at 30 to 100 bpm 5 bpm stepsSpO2 Alarm Specifications (cont.) Standard DelaySpO2 high and low limit alarms 0 to 30 seconds (adjustable in 1 second steps) + system alarm delayDesat 0 to 30 seconds (adjustable in 1 second steps) + system alarm delayPulse 10 seconds + system alarm delayTachycardia 10 seconds + system alarm delayBradycardia 10 seconds + system alarm delay
7 Specifications141When 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.NOTEIf 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 SpecificationsIntelliVue CL Transmitter SpecificationsNBP Alarm Specifications Range AdjustmentSystolic Adult: 30 to 270 mmHg (4 to 36 kPa) 10 to 30 mmHg: 2 mmHg (0.5 kPa)>30mmHg: 5mmHg (1kPa)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)Operating Mode Battery RuntimeECG Only Telemetry Device with CL SpO2/NBP Pod connectedTelemetry Device is host to CL SpO2/NBP Pod20 hoursECG/SpO2 (continuous) Telemetry Device with internal SpO2 running in continuous mode and CL SpO2/NBP Pod connectedTelemetry Device is host to CL SpO2/NBP Pod8 hoursPhysical SpecificationsSize (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 7M1Survives shock, random vibration and bump according to IEC TR 60721-4-7 Class 7M3 as well as a 1 m dropIngress 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)
7 Specifications142Environmental SpecificationsOperating 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 connectionOperating Humidity Range ≤95% RH @ 40°C (104°F)no condensationOperating Altitude Range -500 to 3000 mStorage / 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 mPerformance SpecificationsDisplay SpecificationsType monochrome (4 grey scales), passive LCD (STN), positive/transflectiveViewing Area 25.6 mm x 19.2 mmDot Size 0.2 mm x 0.2 mmResolution 128 x 96 pixelBacklight white LEDBattery Integrated rechargeable Li-Ion battery with battery gauge and cycle counterRuntime (fully charged battery) Typical 8 hoursCharging Time (WLAN and SRR not active)Maximum 2.5 hoursElectronic Article Surveillance (EAS) EAS tag inside the housingShort Range Radio SpecificationsType built in interface with integrated antennaTechnology IEEE 802.15.4Frequency Band 2.4 GHz ISM (2.400 - 2.483 GHz)MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1Modulation DSSS (O-QPSK)Bandwidth 5 MHzEffective Radiated Power (ERP) max. 0 dBm (1 mW)WLAN SpecificationsType Internal wireless adapterTechnology IEEE 802.11a/b/g/n
7 Specifications1431Approval pendingIntelliVue CL Transmitter Base Station SpecificationsFrequency Band USA: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.725 - 5.825 GHzEurope: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.47 - 5.725 GHzJapan: 2.400 - 2.483 GHz, 5.150 - 5.250 GHz, 5.25 - 5.35 GHz, 5.470 - 5.725 GHzChina: 2.400 - 2.483 GHz, 5.725 - 5.85 GHzModulation Technique 802.11b/gDSSS (DBPSK, DQPSK, CCK)OFDM (BPSK, QPSK, 16-QAM, 64-QAM)802.11aOFDM (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.Performance SpecificationsPhysical SpecificationsSize (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 7M1Survives shock and 0.05 m free fall according to IEC TR 60721-4-7 Class 7M1Ingress Protection IP21 according to IEC 60529 (protection against ingress of water when the water is dripping vertically)Environmental SpecificationsOperating 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 #E90Storage/Transportation Temperature Range-20 to 60°C (-4 to 140°F)Storage/Transportation Humidity Range ≤90% RH @ 60°C (140°F)no condensationStorage/Transportation Altitude Range -500 to 4600 m
7 Specifications144IntelliVue CL Hotspot SpecificationsPerformance SpecificationsCharging 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 speedUSB InterfaceStandard USB 2.0 full speed Device PortPower Input 4.5 V - 5.5 V (8 W)power requirement for service and upgrade of connected Cableless Measurement Devices 2.5 WConnector USB series “Standard-B” receptacleNetworkStandards 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 WIsolation double according to IEC 60950-1 Class IIClassification Limited Power Source according to IEC 60950-1External AC/DC 48V requirements (connection to RJ45)Output Voltage 48 V +/-10%Power output min. 8 WCompliancy IEEE 802.3af (PoE Class 3)Isolation double according to IEC 60950-1 Class IIClassification Limited Power Source according to IEC 60950-1Connector RJ45 (Data-in), RJ45 (Data&Power Out)Physical SpecificationsSize (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 7M1Survives shock and 0.05 m free fall according to IEC TR 60721-4-7 Class 7M1Environmental SpecificationsOperating Temperature Range 0 to 40°C (32 to 104°F)Operating Humidity Range ≤95%RH @ 40°C (104°F)no condensation
7 Specifications145Operating Altitude Range -500 to 3000 m-500 to 2000 m when powered from external power supply 865222 #E90Storage / 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 mEnvironmental SpecificationsPerformance SpecificationsDisplay SpecificationsType monochrome (4 gray scales), passive LCD (STN), positive/transflectiveViewing Area 25.6 mm x 19.2 mmDot Size 0.2 mm x 0.2 mmResolution 128 x 96 pixelBacklight white LEDShort Range Radio SpecificationsType built in interface with integrated antennaTechnology IEEE 802.15.4Frequency Band 2.4 GHz ISM (2.400 - 2.483 GHz)MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)1Modulation DSSS (O-QPSK)Bandwidth 5 MHzEffective Radiated Power (ERP) max. 0 dBm (1 mW)WLAN SpecificationsType Internal wireless adapterTechnology IEEE 802.11a/b/g/nFrequency Band USA: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.725 - 5.825 GHzEurope: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.47 - 5.725 GHzJapan: 2.400 - 2.483 GHz, 5.150 - 5.250 GHz, 5.25 - 5.35 GHz, 5.470 - 5.725 GHzChina: 2.400 - 2.483 GHz, 5.725 - 5.85 GHzModulation Technique 802.11b/gDSSS (DBPSK, DQPSK, CCK)OFDM (BPSK, QPSK, 16-QAM, 64-QAM)802.11aOFDM (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)
7 Specifications1461Approval pendingRealtime 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 InterfaceStandard USB 2.0 full speed Device PortPower Input 4.5 V - 5.5 V (3 W)power requirement for service and upgrade of connected Cableless Measurement devices 2.5 WConnector USB series “Standard-B” receptacleLAN NetworkStandards 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 WIsolation double according to IEC 60950-1 Class IIClassification Limited Power Source according to IEC 60950-1External AC/DC 48V requirements (connection to RJ45)Output Voltage 48 V +/-10%Power output min. 3 WCompliancy IEEE 802.3af (PoE Class 3)Isolation double according to IEC 60950-1 Class IIClassification Limited Power Source according to IEC 60950-1Connector RJ45 (Data-in), RJ45 (Data&Power Out)Performance Specifications
1471IndexAactivity 107alarms off symbol 32, 75ambient light 31assignment 22at the measurement device 22at the patient monitor 23assignment mode 22auto power off 17automatic mode 74automatic mode SpO2 31averaging time 33changing 33Bbattery 50care 50lifetime management 51power indicators 118status menu 19status on the cableless device 19Ccare and cleaning 121caution, definition 5charging 118cleaning and disinfecting 122compatibility (NBP) 63compatibility (SpO2) 21configuration mode 17connection status symbol 22continuous mode SpO2 31Ddate and time 19default profile 18demonstration mode 17device compatibility (NBP) 63device compatibility (SpO2) 21disinfecting 122disinfecting agents 122disposing of the IntelliVue Cableless Measurement Device 123Eelectromagnetic compatibility (EMC) 132electrosurgery 69electrosurgery interference/defibrillation 133elevated ambient temperatures 30EMC 130directive compliance 131radio regulatory compliance 130FFCC and industry canada radio compliance 130fetal monitors (NBP) 66fetal monitors (SpO2) 24free device 18, 107Hhardkeys 15Iinfection control 121ingress protection (NBP Pod) 135ingress protection (SpO2 Pod) 133injected dyes 31INOP 14, 56layout 14NBP 82Resp 108SpO2 40tone 36inspecting the equipment and accessories 53IntelliVue CL hotspot specifications 144IntelliVue CL NBP Pod 94accessories 94specifications 135IntelliVue CL Respiration Pod 99IntelliVue CL SpO2 Pod 52accessories 52specifications 133IntelliVue CL Transmitter 116accessories 116specifications 141IntelliVue CL transmitter and IntelliVue CL hotspot 113IntelliVue CL transmitter base station 117specifications 143intended use 125interference 22, 31intravenous infusion 69Llocal attended monitoring 43loose sensor 30low-activity screen 15Mmain setup menu 17, 59maintenance task and test schedule 53manual mode SpO2 31monitoring mode 17MR imaging 125NNBP 94accessories 94default settings 91numerics 75specifications 135new patient 18adding 18no host monitoring 22, 25, 64, 67Ooperating modes 17oscillometric NBP measurement 69oxygen saturation 28Ppatient category 18patient demographics 18patient menu 18patient movement 31perfusion indicator 28, 31perfusion numeric 33pleth waveform 28posture 107posture detection 107profiles 18pulsatile flow 31pulse oximetry 28pulse rate 28pulse rate numeric 32, 75
148RR&TTE directive compliance 131radiofrequency radiation exposure information 132removing a patient from the device 18removing the pod from the cradle 30repetition time 74respiration measurement 104Respiration sensor 104Ssafety and performance tests 132safety specifications 129screen layout 14sensor (Resp) 105applying 105sensor (SpO2) 30applying 30sequence mode 75service mode 17setup sequence 75short range radio 22short range radio (SRR) 10signal quality indicator 32skin damage 69, 105smartkeys 15SpO2 52accessories 52default settings 49numerics 32sensors 28signal quality indicator 32specifications 133SpO2 accessories 52SpO2 numerics 32SpO2 Sensors 29Connecting 29SpO2 specifications 133standby mode 60starting and stopping measurements (NBP) 74suspicious SpO2 reading 33symbols 127Ttechnical alarms (INOPs, NBP) 82technical alarms (INOPs, Resp) 108technical alarms (INOPs, SpO2)) 40telemetry device 20telemetry device battery runtime specifications 141test schedule 53timestamp 75timestamp SpO2 32transceiver 26transmitter base station specifications 143troubleshooting 53Uuse models 20Vvenipuncture 76venous pulsation 30visual inspection 53Wwarning 5
Part Number 453564657401Published in Germany 02/2017*453564657401*

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