Philips Medical Systems North America CLNBPBV1 Intellivue CL NBP Pod User Manual ait fm manual en 2010 09 06

Philips Medical Systems North America Co. Intellivue CL NBP Pod ait fm manual en 2010 09 06

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CLNBPBV1 User Manual

User Manual

DraftInstructions for UseIntelliVue Cableless MeasurementsIntelliVue CL SpO2 Pod and CL NBP PodRelease A.0Patient Monitoring

Part Number 453564199661Printed in Germany 07/10*453564199661*

31Table of Contents1Introduction and Basic Operation 7Introducing the IntelliVue Cableless Measurements 8Operating and Navigating 11Operating Modes 15Using the Patient Menu 16Using Profiles 17Setting the Date and Time 17Charging IntelliVue Cableless Measurement Devices 172Monitoring with the IntelliVue Cableless Measurements 19IntelliVue Cableless Measurements Use Models 19Assigning an IntelliVue Cableless Measurement Device to a Patient Monitor or Telemetry Device 20Controls Available with a Patient Monitor 22Controls Available With a Telemetry Device 233Monitoring SpO2 25SpO2 Sensors 25Connecting SpO2 Sensors 26Applying the Sensor 27Measuring SpO2 28Selecting Measurement Modes 28Understanding SpO2 Numerics and Symbols 29Assessing a Suspicious SpO2 Reading 30Changing the Averaging Time 30Understanding SpO2 Alarms 30Perfusion Numeric (only available on the Patient Monitor) 314Monitoring NBP 33Introducing the Oscillometric NBP Measurement 33Preparing to Measure NBP 35Starting and Stopping Measurements 36Enabling Automatic Mode and Setting Repetition Time 37Enabling Sequence Mode and Setting Up The Sequence 37Understanding the NBP Numerics and Symbols 38Correcting the Measurement if Limb is not at Heart Level 38Switching Pulse from NBP On/Off 38Assisting Venous Puncture 39Calibrating NBP 39

45Technical Alarms (INOPs) 41Display of INOPs 41Acknowledging an INOP 41Displaying a List of Current INOPs 41Setting the Volume of the INOP Tone 42Reference List of all INOPs 426Care and Cleaning 47General Points 47Cleaning and Disinfecting the IntelliVue Cableless Measurements 487Maintenance and Troubleshooting 51Inspecting the Equipment and Accessories 51Maintenance Task and Test Schedule 51Troubleshooting 52Disposing of the IntelliVue Cableless Measurement Devices 528Integrated Battery Handling 53Battery Care 53Handling Precautions 53Storage 54Battery Lifetime Management 549Accessories 55IntelliVue CL SpO2 Pod Accessories 55IntelliVue CL NBP Pod Accessories 56Miscellaneous Accessories 5710 Specifications 59Intended Use 59Manufacturer's Information 59Symbols 60Installation Safety Information 61Safety Specifications 61EMC And Radio Regulatory Compliance 61IntelliVue CL SpO2 Pod Specifications 63IntelliVue CL NBP Pod Specifications 65Alarm Specifications 68Telemetry Device Battery Runtime Specifications 69IntelliVue CL Charging Station Specifications 69IntelliVue CL Transmitter Base Station Specifications 70Safety and Performance Tests 72Electromagnetic Compatibility (EMC) Specifications 72Accessories Compliant with EMC Standards 72Electrosurgery Interference/Defibrillation 72

171Introduction and BasicOperationThese Instructions for Use are for clinical professionals using the IntelliVue Cableless Measurements and their respective accessories together with IntelliVue Patient Monitors MP5/MP5T, MP2 or X2 or with the IntelliVue Telemetry System Transceiver TRx4841A/TRx4851A for monitoring and recording arterial oxygen saturation, pulse rate and non-invasive blood pressure of adult and pediatric patients. This section gives you an overview of the cableless measurements and how they are used. The remaining sections tell you how to perform individual measurements, and how to care for and maintain the equipment.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 or the telemetry system, refer to and adhere to all warnings in the Instructions for use of the respective device.In this guide:•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.IntelliVue Cableless Measurements refers to the IntelliVue Cableless Measurements product family consisting of the IntelliVue CL SpO2 Pod and IntelliVue CL NBP Pod with their accessories and auxiliary devices such as the IntelliVue CL Charging Station. Display refers to the physical display of the CL device. Screen refers to everything you see on the IntelliVue CL measurement's display, such as measurement values, patient data and so forth.

1 Introduction and Basic Operation8Introducing the IntelliVue Cableless MeasurementsThe IntelliVue Cableless Measurements family consists of the following components and their respective accessories:The cableless measurement devices provide measurement values on the built-in display and communicate them to other system components using a wireless short range radio (SRR) interface. They can also be controlled via SRR from an assigned patient monitor or an IntelliVue Information Center via a telemetry device. They have an LCD display and three keys for basic operation e.g. to assign the device to a patient.IntelliVue CL SpO2 Pod IntelliVue CL NBP PodIntelliVue CL Charging Station

1 Introduction and Basic Operation9IntelliVue CL SpO2 PodThe IntelliVue CL SpO2 Pod is a battery powered, cableless Pulse Oximetry measuring device. It 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 the Accessories chapter.IntelliVue CL NBP PodThe IntelliVue CL NBP Pod is a battery powered, cableless, non-invasive blood pressure (NBP) measuring device.To measure NBP, you need a Mobile CL NBP Cradle and Mobile CL Cuffs. The cradle is used to attach the Pod to the cuffs and to allow easy removal of the Pod.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 the Accessories chapter.IntelliVue CL Charging StationThe IntelliVue CL Charging Station is used to charge the IntelliVue CL SpO2 Pod and the IntelliVue CL NBP Pod. It contains nine charger slots for IntelliVue Cableless measurement devices. Depending on its size a measurement device may occupy one or two charger slots at a time.As soon as a device is placed onto a charger slot, the device will switch on and the charging cycle begins automatically.

1 Introduction and Basic Operation10If the ambient temperature is high, the built-in fan will switch on automatically to cool the charging station.WARNINGEnsure that the charging station does not come into close contact with implanted pacemakers, to avoid magnetic interference affecting the mode of the pacemaker.CAUTIONThe charging 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 charging station, as the data may be damaged.Availability of Patient AlarmsWhen the Cableless Measurement Devices are used alone, without an assignment to a monitor or telemetry device, no patient alarms will be generated.When the Cableless Measurement Devices are assigned to a monitor or telemetry device, alarms may be announced at the host device. •When assigned to a 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.•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.

1 Introduction and Basic Operation11Measurement Device Main Parts and KeysAll IntelliVue Cableless Measurement devices have an integrated monochrome LCD display and 3 keys.Operating and NavigatingThe following sections describe operation on the IntelliVue Cableless Measurement device itself. For operation from a patient monitor, see “Controls Available with a Patient Monitor” on page 22 and for operation from an Information Center via a telemetry system, see “Controls Available With a Telemetry Device” on page 23.The IntelliVue CL Cableless Measurement devices have three hard keys for basic operation and a set of configurable SmartKeys which appear on the screen. These are used to navigate through the screen elements and activate the on-screen menus for the individual items.Switching the Devices On and OffThe first time an IntelliVue Cableless Measurement Device is used, or after a device has been powered off for storage, place it on the IntelliVue CL Charging Station. This will automatically switch the device on. For Power Off details, see the IntelliVue Cableless Measurements Service Guide.To switch off a device manually, select the Main Setup SmartKey, then select Device Off, then Confirm. Press any key to turn the device on again.When an IntelliVue Cableless Measurement Device 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.Screen LayoutThere are three variations of the Main Screen layout depending on the INOP status and the general activity level.1Integrated monochrome LCD display2Hard keys: ◄, 9, ►3Measurement identifier

1 Introduction and Basic Operation12Standard LayoutINOP LayoutIf an INOP occurs the full INOP message appears at the top of the screen. After the INOP message has been acknowledged the INOP indicator is shown as an icon on the right side of the screen.When assigned to a monitor or telemetry device: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 measurement chapters for details)6Patient identification (from a monitor or telemetry device)When not assigned to a monitor or telemetry device:1Connection status indicator2Battery indicator3Measurement values4Measurement-related symbols (see the measurement chapters for details) The Alarms Off symbols indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host.5Patient identification (from a monitor or telemetry device)1Full length INOP message2INOP indicator

1 Introduction and Basic Operation13Low-Activity ScreenIf the 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, the battery in the device may have been empty for an extended period of time. In this case, activate the device by placing it on the IntelliVue CL Charging Station and leave it there until the battery is fully charged.Using the Hard KeysThe IntelliVue CL Cableless Measurement devices have three hardkeys: ◄, 9, ►.In the Main Screen, use ◄ and ► to highlight screen elements (e.g. numeric, battery symbol) and then 9to select that element and activate the corresponding menu.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.Smart Keys MenuPress the 9 hardkey (without any screen element highlighted) to get to the SmartKeys menu.◄opens the Add To screen to assign a device9opens 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.

1 Introduction and Basic Operation14Use 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 9 key to activate the corresponding function.To get to the next page of the SmartKeys menu, highlight the rightmost SmartKey then press the ► key.List of Available SmartKeysSmartKey Text LabelsMain Setup- start/stop manual NBP measurement- start auto series- 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 timestart an SpO2 measurementset the SpO2 repetition timeAdd/Remove deviceenter Battery menu

1 Introduction and Basic Operation15Using the Main Setup MenuIn addition to the hard keys 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.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.change Screenenter Profiles menuswitch device offenter Patient menuSmartKey Text LabelsMain SetupSpO₂INOPsPatientEquipmentUser InterfaceDevice OffProfilesOperating ModesDate, TimeBatteryRevisions

1 Introduction and Basic Operation18• battery status information on both the device's and the charging station's display• INOP messages• battery icon on the patient monitor's screen (when assigned to a patient monitor)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.Charging Station LEDsThe nine charger slot LEDs show the battery status of the device in their slot, and are switched off if no device is inserted.If an IntelliVue Cableless Measurement Device is put on a charging station slot, the corresponding LED will flash yellow until the device and its current state have been identified. Then a beep is issued and the LED reflects the device's battery status as described in the table below.The AC Power / Error LED is• green when the Charging Station is connected to AC power• cyan during startup or to indicate a general Charging Station errorBattery Status on the Charging Station DisplayThe IntelliVue CL Charging Station display provides a quick overview of all the connected devices and their battery status. The screen is arranged in the same layout as the charger slots.Battery Status on the Cableless DeviceAll IntelliVue Cableless Measurement Devices 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 symbol using the ◄ and ► keys, then press the 9 key to open the Battery menu. The Battery menu provides the following information: full-charge and remaining capacity, voltage, current and temperature.Status LEDno device on charger slot offdevice put on charger slot flashing yellowdevice not properly recognized, error cyandevice recognized, battery charging yellowdevice recognized, battery full (≥90%) green

2192Monitoring with the IntelliVueCableless MeasurementsIntelliVue 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 SpO2 and the NBP Pods can be used together with an MP5/MP5T, MP2 or X2 patient monitor (with a 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 22.In situations where patients are becoming more mobile (for example, in step-down/intermediate care units) the lightweight, cableless SpO2 and NBP Pods allow increased mobility within the short range radio range, without giving up vital signs monitoring.When assigned to a patient monitor, the admitted patient name is displayed on the Pod.A telemetry device can be assigned to a patient monitor equipped with short range radio at the same time as any SpO2 and NBP Pods are also assigned to this monitor.If the connection between the monitor and the NBP Pod or SpO2 Pod is lost, an INOP will be displayed at the monitor: cl SpO₂ Disconnect or cl NBP Disconnect. A No System Monitor. INOP will be displayed on the Pod.With a Telemetry DeviceThe SpO2 and the NBP Pods can be assigned to a patient with the telemetry device TRx4841A/TRx4851A. 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 23.If the patient name is available at the Information Center, it will be also displayed on the Pod.

2 Monitoring with the IntelliVue Cableless Measurements20When 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 NBP Pod or SpO2 Pod is lost, an INOP will be displayed at the Information Center: cl SpO₂ Disconnect or cl NBP Disconnect. A No System Monitor. INOP will be displayed on the Pod.Device CompatibilityThe Cableless Measurement Devices require the following software levels in the associated equipment:• Patient Monitor - Release H.0 or above• Information Center - Release M or above• Telemetry device TRx4841A/TRx4851A - Revision D.XXAssigning an IntelliVue Cableless Measurement Device to a Patient Monitor or Telemetry DeviceWhen an IntelliVue Cableless Measurement Device is used with a patient monitor or telemetry device, the Cableless Measurement Device must be assigned to that monitor/telemetry device.The assignment can be done at the Cableless Measurement Device itself (this is the only way for a telemetry device) or at the patient monitor.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 DECT 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 Cableless Measurement Device or a cl NBP Disconnect or 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 Assignment SmartKey , or• the connection status symbol (or if the device is not assigned), or•hold the ◄key pressed.If the device was not assigned, 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.

2 Monitoring with the IntelliVue Cableless Measurements21A telemetry device must be put into assignment mode by pressing the 9 key on the telemetry device before it can appear in the list. Pressing the 9 key starts an SRR channel search to find the clearest channel available. During the search all 4 LEDs flash once per second. The search will take approximately 20-25 seconds. Once a channel is identified, the first LED will light up and blink once per second to indicate that the telemetry device is ready for assignment. 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 9 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 is yellow), 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.If the device was assigned, this opens a menu for the patient monitor or telemetry system. To unassign the measurement device from that monitor or telemetry system, select Remove From. After confirmation the SRR connection is disconnected.Assignment at the Patient MonitorThe cableless measurement device must be prepared for assignment by activating the Add/Remove SmartKey. At the patient monitor, 1Open the Add Cableless window, e.g. using the measurement selection key followed by the Add Cbleless pop-up key.The available cableless measurement devices are shown in the window2Select the device which you want to assign to the patient in the monitor.3The 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. Add ToMon 1Mon 2Tele 33Tele 44

2 Monitoring with the IntelliVue Cableless Measurements22When 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.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. Controls Available with a Patient MonitorThe controls available when the Cableless Measurement Device is assigned to a patient monitor are described in the table below.Action At Cableless Measurement DeviceAt Patient MonitorAt IICSpO2Start 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 No Yes NoPlace Device in Standby No Yes YesAlarm Silence No Yes YesAlarm Off/Pause No Yes YesNBPStart/Stop/Stat NBP Yes Yes YesChange NBP Mode Yes Yes NoChange NBP Repetition Time Yes Yes NoChange Alarm Limits No Yes NoAssign NBP Pod Yes Yes NoRemove NBP Pod Yes Yes NoPlace Device in Standby No Yes YesAlarms Silence No Yes YesAlarm Off/Pause No Yes Yes

2 Monitoring with the IntelliVue Cableless Measurements23WARNINGIf a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are available on the Cableless Measurement Device only. They are not transmitted to the patient monitor or the Information Center. If this occurs, the No Host Monitoring message is displayed on the measurement device. The measurement device will also sound the INOP tone. No alarms will be available for the measurements when the devices are out of range, as alarms are only available on the patient monitor.Keep the patient monitor with the patient during transport.Controls Available With a Telemetry DeviceThe controls available when the Cableless Measurement Device is assigned to a TRx4841/TRx4851A Transceiver with a short range radio adapter (SRRA) are described in the table below. Action At the Cableless Measurement DeviceAt the IICSpO2Start 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 YesNBPStart/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 NoAlarms Silence No YesAlarm Off/Pause No Yes

2 Monitoring with the IntelliVue Cableless Measurements24NOTEWhen 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 and/or 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.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.

3253Monitoring 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 - visual indication of patient's pulse (only on patient monitor 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 host. SpO2 SensorsSpecialized SpO2 Sensors are available for use with the IntelliVue CL SpO2 Pod. See “Accessories” on page 55 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

3 Monitoring SpO226Connecting 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.

3 Monitoring SpO227Removing the Pod from the CradleTo remove the SpO2 Pod from the cradle, 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. For large adults the little finger might be suitable.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.WARNINGLoose Sensor: 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 at least every four hours.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.pull on the Pod at the opening in the cradle, while holding the cradle in place on the patient's arm.

3 Monitoring SpO228Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff or an intravascular venous infusion line.Measuring 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• 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 numeric 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:

3 Monitoring SpO229•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 one hour. After that the values are regarded as invalid and are no longer displayed.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.1SpO2 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

3 Monitoring SpO230Assessing 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 Index (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.Understanding SpO2 AlarmsIf you are using the SpO2 pod with an assigned patient monitor, you will see SpO2 alarms and pulse rate alarms (if configured) on the monitor.There is a delay between a physiological event at the measurement site and the corresponding alarm at the host system. This delay has two components:• The general system 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 and the configured averaging time. The longer the averaging time configured, the longer the time needed until the numerical values reflect the physiological event.

3 Monitoring SpO231• The time between the displayed numerical values crossing an alarm limit and the alarm indication on the monitor. This delay depends on the host system.Refer to the Instructions for Use of the monitor for information about the SpO2 and pulse rate alarms.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.

$4334Monitoring NBPThe IntelliVue CL NBP Pod uses the oscillometric method for measuring NBP. The blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10:2002/(R)2008 + A1:2003/(R)2008) 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.The accuracy of the mean arterial pressure (MAP) was validated by comparative laboratory testing to the M3000A Multi-Measurement Server using an NBP simulator and a patient signal database. The accuracy of the MAP of the M3000A was validated in a clinical evaluation using the intra-arterial reference method. The NBP measurement is suitable for use in the presence of electrosurgery and during the discharge of a cardiac defibrillator according to IEC 60601-2-30:1999/EN 60601-2-30:2000.A physician must determine the clinical significance of the NBP information.Introducing the Oscillometric NBP MeasurementOscillometric devices measure the amplitude of pressure changes 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.$