Philips Medical Systems North America WLANBV2 WLAN Module IEEE 802.11 a/b/g/n User Manual IntelliVue CL

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User Manual IntelliVue CL

Instructions for Use

IntelliVue Cableless

Measurements

CL SpO2 Pod – CL NBP Pod –

CL Respiration Pod

Release B.02

Patient Monitoring

1Table of Contents

1Introduction and Basic Operation 5

Introducing the IntelliVue Cableless Measurements 6

2IntelliVue CL SpO2 Pod 9

General Operation of the SpO2 Pod 9

Connection with Host Systems 16

Monitoring SpO2 22

Alarms 28

SpO2 Default Settings 38

Integrated Battery Handling 39

Accessories 41

Maintenance and Troubleshooting 42

3IntelliVue CL NBP Pod 43

General Operation of the NBP Pod 43

Connection with Host Systems 50

Monitoring NBP 56

Alarms 63

NBP Default Settings 72

Integrated Battery Handling 73

Accessories 74

Maintenance and Troubleshooting 78

4IntelliVue CL Respiration Pod 79

General Operation of the Respiration Pod 79

Connection with Host Systems 80

Monitoring Respiration 84

Technical Alarms (INOPs) 88

Respiration Default Settings 89

Integrated Battery Handling 89

Accessories 91

Maintenance and Troubleshooting 91

5Cableless Measurement Auxiliary Devices 93

IntelliVue CL Transmitter and IntelliVue CL Hotspot 93

IntelliVue CL Transmitter Base Station 97

IntelliVue CL Charging Station 97

Maintenance and Troubleshooting 99

6Care and Cleaning 101

General Points 101

Cleaning and Disinfecting the IntelliVue Cableless Measurement Devices 102

Disposing of the IntelliVue Cableless Measurement Devices 103

7Specifications 105

Indications for Use 105

Compatible Medical Devices 107

Manufacturer's Information 107

Symbols 108

Safety Specifications 109

EMC and Radio Regulatory Compliance 110

Safety and Performance Tests 112

Electromagnetic Compatibility (EMC) 112

Accessories Compliant with EMC Standards 113

Electrosurgery Interference/Defibrillation 113

IntelliVue CL SpO2 Pod Specifications 113

IntelliVue CL NBP Pod Specifications 115

IntelliVue CL Respiration Pod Specifications 118

Alarm Specifications 119

Telemetry Device Battery Runtime Specifications 121

IntelliVue CL Transmitter Specifications 121

IntelliVue CL Transmitter Base Station Specifications 123

IntelliVue CL Hotspot Specifications 124

Index 127

1Introduction and Basic

Operation

These Instructions for Use are for clinical professionals using the IntelliVue Cableless Measurements

and their respective accessories for monitoring and recording arterial oxygen saturation, pulse rate,

non-invasive blood pressure and respiration rate of adult 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, a telemetry

system or IntelliVue GuardianSoftware, refer to and adhere to all warnings in the Instructions for Use

of the respective device or software.

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.

IntelliVue Cableless Measurements refers to the IntelliVue Cableless Measurements product family

consisting of the IntelliVue CL SpO2 Pod, IntelliVue CL NBP Pod and IntelliVue CL Respiration Pod

with their accessories. Also included are the auxiliary devices: the IntelliVue CL Charging Station,

IntelliVue CL Transmitter, IntelliVue CL Transmitter Base station and IntelliVue CL Hotspot.

Display refers to the physical display of the Cableless Measurement Device. Screen refers to

everything you see on the IntelliVue Cableless Measurement's display, such as measurement values,

patient data and so forth.

IntelliVue CL Transmitter/WLAN functionality may not be available in all countries.

1 Introduction and Basic Operation

Introducing the IntelliVue Cableless Measurements

The IntelliVue Cableless Measurement Devices provide measurement values and communicate them

to other system components using a wireless short range radio (SRR) interface.

The IntelliVue CL SpO2 Pod and the IntelliVue CL NBP Pod can be used together with IntelliVue

Patient Monitors MP5/MP5SC/MP5T, MP2/X2, IntelliVue Telemetry System Transceivers

TRx4841A/TRx4851A, MX40 wearable patient monitors, and IntelliVue GuardianSoftware. Both

devices have an LCD display and three keys for basic operation:

IntelliVue CL SpO2 Pod

The IntelliVue CL SpO2 Pod is a battery

powered, cableless Pulse Oximetry measuring

device.

IntelliVue CL NBP Pod

The IntelliVue CL NBP Pod is a battery

powered, cableless, non-invasive blood pressure

(NBP) measuring device.

1Integrated monochrome LCD display

2Hardkeys

3Measurement identifier

1 Introduction and Basic Operation

IntelliVue CL Respiration Pod

The IntelliVue CL Respiration Pod is a battery powered, cableless respiration rate measuring device

which can be used together with IntelliVue Patient Monitors MP5/MP5SC/MP5T, 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.

1Multi-color LED

2Hardkey

1 Introduction and Basic Operation

2IntelliVue CL SpO2 Pod

The IntelliVue CL SpO2 Pod is a wrist-worn device; you need a Mobile CL SpO2 Cradle to hold the

sensor connector in place and a wristband to fix the cradle to a patient's arm.

Specialized single-patient SpO2 sensors are available for use with the IntelliVue CL SpO2 Pod. For

details regarding the complete set of single-patient supplies, cradle, wristband and sensors, refer to

“IntelliVue CL SpO2 Pod Accessories” on page 41.

General Operation of the SpO2 Pod

The following sections describe operation on the SpO2 Pod itself. For operation from a patient

monitor, see “Controls Available with a Patient Monitor” on page 20. For operation from an

Information Center via a telemetry system, see “Controls Available with a Telemetry Device” on

page 21. For operation with IntelliVue GuardianSoftware, see “Controls Available with

GuardianSoftware” on page 21.

The SpO2 Pod has three hardkeys for basic operation and a set of configurable SmartKeys which

appear on the screen. These are used to activate and navigate through the on-screen menus and to

select individual items. The typical operator's position is such that everything on the device's display

can be read clearly and easily.

Switching the Device On

The first time an SpO2 Pod is used, or after the device has been powered off for storage, place it on

the IntelliVue CL Charging Station. This will automatically switch the device on.

If the SpO2 Pod has only been switched off temporarily (see “Switching the Device Off” on page 13),

press any hardkey to turn the device on again.

2 IntelliVue CL SpO2 Pod

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.

Screen Layout

There are three variations of the Main Screen layout depending on the Alarm status and the general

activity level.

Standard Layout

When assigned to a monitor, telemetry device or a patient in GuardianSoftware:

1Connection status indicator

2Indicator 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 indicator

4Measurement values

5Measurement-related symbols (see the measurement

chapters for details)

6Patient identification

When not assigned to a monitor or telemetry device:

1Connection status indicator

2Battery indicator

3Measurement values

4Measurement-related symbols (see the Monitoring

chapter 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 label

2 IntelliVue CL SpO2 Pod

Alarm Layout

If an alarm occurs the full alarm message appears at the top of the screen. After the alarm message has

been silenced the alarm indicator is shown as a symbol on the right side of the screen.

Low-Activity Screen

If the Cableless Measurement Device has not been operated for a while, the screen lighting will switch

itself off and a little later the screen will switch to a pre-configured "low-activity" screen.

When a Cableless Measurement Device Cannot be Activated

If you cannot activate a device by pressing a key, place it on the IntelliVue CL Charging Station. The

device becomes active. Check the battery status. If necessary, leave the device on the charger until the

battery is fully charged.

Using the Hardkeys

The IntelliVue Cableless Measurement Devices have three hardkeys: ◄, , ►.

Use ◄ and ► to navigate through SmartKeys and menus and to select items or to silence alarms.

The three hardkeys also have an additional function when the key is held down for a couple of

seconds:

1Full length alarm message

2Alarm indicator

◄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 Pod

Using the SmartKeys

A SmartKey is a graphical key which appears on the screen and gives you fast access to functions.

SmartKeys Menu

Press the  hardkey (without any screen element highlighted) to get to the SmartKeys menu.

Use the ◄ and ► hardkeys to move along the row of SmartKeys. The highlighted SmartKey is

displayed in full above the row of SmartKeys. When you use the ◄ or ► hardkey at the end of the

row, an Exit screen appears and then with further presses you move on to the next page of SmartKeys.

To leave the SmartKeys menu you can use the Exit screen or press the ► hardkey for a couple of

seconds to return to the Main Screen.

When the required SmartKey is highlighted, press the  key to activate the corresponding function.

To get to the next page of the SmartKeys menu, highlight the rightmost SmartKey then press the ►

key.

List of Available SmartKeys

SmartKey Text Labels

Main Setup

start an SpO2 measurement

set the SpO2 repetition time

Add/Remove device

enter Battery menu

change Screen

enter Profiles menu

switch device off (or power off when pressed for more than two seconds)

enter Patient menu

2 IntelliVue CL SpO2 Pod

Using the Main Setup Menu

In addition to the hardkeys and SmartKeys for the most needed functions, the Main Setup menu gets

you to all settings that can be adjusted for the respective device. Select the Main Setup SmartKey to get

to the Main Setup menu.

Switching the Device Off

To switch off a device manually, select the Device Off SmartKey, then Confirm.

If you keep Device Off pressed for more than two seconds, you can choose between Device Off or

Power Off.

•Device Off 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.

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.

enters the Alarms menu to access: Alarm Messages, Alarm Limits, Alarms

On/Off/Pause, Alarm Volume.

Change alarm volume

Change pulse tone volume

SmartKey Text Labels

Main Setup

SpO₂

Pulse

Alarms

Patient

Equipment

User Interface

Device Off

Profiles

Operating Modes

Date, Time

Battery

Revisions

2 IntelliVue CL SpO2 Pod

Operating Modes

Your device has four operating modes. Some are passcode protected.

•Monitoring Mode: This is the normal, every day working mode that you use for making

measurements. You can change elements such as measurement modes, patient category and so

forth. When you remove the patient from the device, these elements return to their default values.

Changes can be stored permanently only in Configuration Mode. You may see items, such as some

menu options, that are visible but 'grayed out' so that you can neither select nor change them.

These are present for your information only and can be changed only in Configuration Mode.

•Demonstration Mode: Passcode protected, this is for demonstration purposes only. You must

not change into Demonstration Mode during monitoring.

•Configuration Mode: Passcode protected, this mode is for personnel trained in configuration

tasks. These tasks are described in the Configuration Guide. During installation the Cableless

Measurement Device is configured for use in your environment. This configuration defines the

default settings you work with when you switch on.

•Service Mode: Passcode protected, this is for trained service personnel.

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.

Standby Mode

The IntelliVue Cableless Measurement Devices do not have standby mode. However, when connected

to a monitor that is in standby mode, the IntelliVue Cableless Measurement Device will show a

standby screen.

Using the Patient Menu

The Patient menu allows you to see patient demographics information and to remove a patient from a

device. Patient Demographic information is only displayed if the Cableless Measurement Device is

assigned to a patient monitor or GuardianSoftware. Patient Category is the only item of patient data

which can be changed at the Cableless Measurement Device, but only when the device is not assigned

to a patient monitor or telemetry device.

Displaying the Patient Menu

To display the Patient menu,

• select the Patient SmartKey, or

• select the Main Setup SmartKey followed by Patient.

Stop Using a Device for a Patient

To remove a patient from the Cableless Measurement Device,

•in the Patient menu select Free Device.

All patient data is cleared, settings are reset to the defaults and the device is removed from the monitor

or telemetry device.

2 IntelliVue CL SpO2 Pod

NOTE

Depending on your configuration, when the device is put on the charger, patient data will also be

cleared and the device will be free for another patient.

Using the Device for a New Patient

To use a device for a new patient,

•in the Patient menu, select New Patient.

If the device was not free, the existing data will be deleted and the profile set to the default.

Using Profiles

A profile is a set of measurement and general settings which have been customized for a particular

purpose. The Cableless Measurement Devices can have four different profiles configured to your

requirements. The default profile is marked with a symbol. To select a different profile,

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.

Setting the Date and Time

If the Cableless Measurement Device is assigned to a patient monitor, telemetry device or

GuardianSoftware, the date and time will be taken from the host. If this is not the case, you can set the

date and time on the Cableless Measurement Device,

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 Status

The IntelliVue CL SpO2 Pods show their battery status on their display both in operating and charging

condition. The battery status indicator is located in the lower right corner of the screen during

operation and in the middle of the screen during charging.

Battery Status Menu

Select the Battery SmartKey or Main Setup followed by Battery using the ◄ and ► keys, then press

the  key to open the Battery menu. The Battery menu provides the following information: full-

charge and remaining capacity, voltage, current and temperature.

2 IntelliVue CL SpO2 Pod

Connection with Host Systems

The following sections describe how the IntelliVue Cableless Measurement Devices work together

with host systems (Patient Monitors, Telemetry Devices / Information Center or GuardianSoftware).

IntelliVue Cableless Measurements Use Models

With these patient-worn measurement devices you can measure and transmit a patient's vitals regularly

or on an intermittent data collection basis. There are three typical use models:

With a Patient Monitor

The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T,

MP2 or X2 patient monitor (with an SRR interface). They can communicate their measurement values

via short range radio to the monitor. The monitor may be assigned to a patient sector at the IntelliVue

Information Center (IIC). When assigned to the Information Center, certain actions can be performed

at both the patient monitor and the Information Center. See the table “Controls Available with a

Patient Monitor” on page 20.

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 28 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 Telemetry Device

The Cableless Measurement Devices can be assigned to a patient with the telemetry device

TRx4841A/TRx4851A or an MX40 wearable patient monitor. They can communicate their

measurement values via short range radio to the telemetry device which communicates them to an

IntelliVue Information Center to provide a consolidated set of patient values.

Some of the measurement tasks can be performed remotely from the Information Center. See the

table “Controls Available with a Telemetry Device” on page 21.

If the patient name is available at the Information Center, it will be also displayed on the SpO2 Pod.

When a Cableless Measurement Device is assigned to a telemetry device, it is not possible for the

telemetry device to be wirelessly assigned or directly connected to a patient monitor.

2 IntelliVue CL SpO2 Pod

If the connection between the telemetry device and the Cableless Measurement Device is lost, an

INOP will be displayed at the Information Center: cl SpO₂ Disconnect. A No System Monitor.

INOP will be displayed on the SpO2 Pod, and an INOP tone will sound.

With IntelliVue GuardianSoftware

The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware.

GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter or

Hotspot 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 21. GuardianSoftware also manages the patient

data.

If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the

connection symbol will be displayed gray at GuardianSoftware. A No System INOP will be displayed

on the SpO2 Pod (no alarm sound).

If a patient name is available at GuardianSoftware, it will be also displayed on the Pod. Any update of

patient data will be synchronized between the Pods and GuardianSoftware. The only patient

management action available directly at the Pod is Free Device. Selecting Free Device removes the

current patient from the Pod and resets the Pod to the default profile. The Pod is unassigned.

Device Compatibility

The IntelliVue CL SpO2 Pods require the following software levels in the associated equipment:

• Patient Monitor - Release H.0 or above

• Information Center - Release M or above

• Telemetry device TRx4841A/TRx4851A - Revision D.00.22 or above

• MX40 wearable patient monitor - Revision A.0 or above

• IntelliVue GuardianSoftware - Revision A.0 or above

Availability of Patient Alarms

When the IntelliVue CL SpO2 Pod is used alone, without an assignment to a monitor or telemetry

device, no patient alarms will be generated.

When the IntelliVue CL SpO2 Pod is assigned to a patient monitor or telemetry device and a short

range radio connection exists, alarms may be announced at the patient monitor or the Information

Center.

•When assigned to a patient monitor: 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.

If a Cableless Measurement Device that is assigned to a 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 Pod

appears in the alarm status area at the top of the screen indicating the source of the alarm and an

alarm tone is issued. See “Alarms” on page 28 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 transmitters or hotspots to

IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue

GuardianSoftware is a data management system, no alarms are announced. The IntelliVue

Cableless Measurement Devices will also not generate physiological alarms when connected to

IntelliVue GuardianSoftware. See the Instructions for Use of GuardianSoftware.

Assigning an IntelliVue Cableless Measurement Device to a Host

When an IntelliVue CL SpO2 Pod is used with a host system (patient monitor, telemetry device or

GuardianSoftware), the Pod must be assigned to that host system.

The assignment can be done at the CL SpO2 Pod itself or at the host system (patient monitor or

GuardianSoftware).

WARNING

Always make sure that the applied CL SpO2 Pod is assigned to the correct patient.

WARNING

Short Range Radio connections are subject to interruption due to interference from other radio

sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and

cordless phones. Depending on the strength and duration of the interference, the interruption may

occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for

other reasons, is indicated with a No Host Monitoring INOP on the SpO2 Pod, or a cl SpO₂

Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the

Configuration Guide for details.

Assignment at the Measurement Device

To make an assignment, select:

•the

Add/Remove SmartKey , 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

2 IntelliVue CL SpO2 Pod

search to find the clearest channel available. During the search all 4 LEDs will blink 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  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 Monitor

Prepare the Pod 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 Cableless window, which shows the available Cableless Measurement

Devices:

Add To

Mon 1

Mon 2

Tele 33

Tele 44

2 IntelliVue CL SpO2 Pod

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.

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 GuardianSoftware

To 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 Monitor

The controls available when the Cableless Measurement Device is assigned to a patient monitor are

described in the table below.

* except when SRR connection to host is lost

WARNING

If a patient being monitored by Cableless Measurement Devices moves out of range of the patient

monitor, the measurements are not transmitted to the patient monitor or the Information Center. The

measurements are available on the Cableless Measurement Device only. If this occurs, the No Host

Action At the Cableless

Measurement

Device

At the Patient

Monitor

At the IIC

Start SpO2Yes Yes No

Change SpO2 Mode Yes Yes No

Select SpO2 Repetition Time Yes Yes No

Assign SpO2 Pod Yes Yes No

Remove SpO2 Pod Yes Yes No

Change Alarm Limits Yes* Yes No

Place Device in Standby No Yes Yes

Alarm Silence Yes Yes Yes

Alarm Off/Pause Yes Yes Yes

2 IntelliVue CL SpO2 Pod

Monitoring message is displayed on the measurement device. The measurement device will also sound

the INOP tone.

Controls Available with a Telemetry Device

The controls available when the Cableless Measurement Device is assigned to a TRx4841/TRx4851A

Transceiver or MX40 wearable patient monitor with a short range radio adapter (SRRA) are described

in the table below.

NOTE

When you unplug the ECG cable from the telemetry device and plug it into the monitor associated

with the same patient, the ECG source will automatically be from the monitor. The SpO2

measurement devices assigned to the telemetry device will continue to source data to the telemetry

device and the Information Center. You may need to change screens on the patient monitor to see the

measurements.

NOTE

The SpO2 measurement sourced from the telemetry device (label: SpO2T) has priority over the

IntelliVue CL SpO2 measurement. The SpO2T measurement is sent to the Information Center as long

as it is available and the IntelliVue CL SpO2 measurement is available on the measurement device only.

Controls Available with GuardianSoftware

The controls available when the Cableless Measurement Device is assigned to GuardianSoftware are

described in the table below.

Action At the Cableless

Measurement Device

At the IIC

Start SpO2Yes Yes

Change SpO2 Mode Yes Yes

Select SpO2 Repetition Time Yes No

Assign SpO2 Pod Yes No

Remove SpO2 Pod Yes Yes

Change Alarm Limits No Yes

Place Device in Standby No No

Alarm Silence No Yes

Alarm Off/Pause No Yes

Action At the Cableless

Measurement Device

At GuardianSoftware

Start SpO2Yes Yes

Change Mode Yes Yes

Select SpO2 Repetition Time Yes Yes

Assign SpO2 Pod Yes Yes

2 IntelliVue CL SpO2 Pod

Trending

The IntelliVue Cableless Measurement Devices provide data for trending of parameters. The trended

data are only available via a host system. For details on trends see the Instructions for Use of your host

system.

When the connection to the host is lost during measurement, the IntelliVue Cableless Measurement

Devices are able to collect data in a local memory. These data can be uploaded to GuardianSoftware,

but not to other host systems, when a connection is established at a later stage.

Monitoring SpO2

Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier artifact

suppression technology (FAST). A sensor is used that transmits light of two different wavelengths

through the tissue of the patient. The measurement principle of pulse oximetry is based on the specific

absorption characteristics of oxyhemoglobin and deoxyhemoglobin and the pulsating arteriolar

vascular bed at the measurement site. It provides four measurements:

• Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to

the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation).

• Pleth waveform - auto-scaled visual indication of patient's pulse which is not directly proportional

to the pulse volume (only on patient monitor, GuardianSoftware or Information Center, if

assigned).

• Pulse rate (derived from pleth wave) - detected pulsations per minute.

• Perfusion indicator - numerical value for the pulsatile portion of the measured signal caused by

arterial pulsation (only on patient monitor, if assigned).

NOTE

No alarms are generated for SpO2 and Pulse when measuring SpO2 with the SpO2 Pod not assigned to

a patient monitor or telemetry device.

SpO2 Sensors

Specialized SpO2 Sensors are available for use with the IntelliVue CL SpO2 Pod. See the “Accessories”

chapter 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.

Remove SpO2 Pod Yes Yes

Place Device in Standby No No

Technical Alarm Silence No Yes

Alarm Off/Pause No No

Action At the Cableless

Measurement Device

At GuardianSoftware

2 IntelliVue CL SpO2 Pod

Additional Information

The following documents contain additional information, depending on which accessories you are

using:

• Mobile CL Single-Patient SpO2 Sensor Instructions for Use

• Mobile CL Reusable SpO2 Sensor1 Instructions for Use

• Mobile CL SpO2 Wristband Instructions for Use

1 may not be available in all geographies

Connecting SpO2 Sensors

1Connect 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.

CAUTION

Make 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 Pod

Removing the Pod from the Cradle

To remove the SpO2 Pod from the cradle, pull on the Pod at the opening in the cradle, while holding

the cradle in place on the patient's arm.

Applying the Sensor

1Choose 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.

WARNING

Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it

is too tight, for example because the application site is too large or becomes too large due to edema,

excessive pressure may be applied. This can result in venous congestion distal from the application site,

leading to interstitial edema, hypoxemia and tissue malnutrition. Skin irritations or lacerations may

occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and

lacerations, periodically inspect the sensor application site and change the application site regularly.

Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may

severely obstruct circulation and lead to inaccurate measurements.

Ambient Temperature: At elevated ambient temperatures be careful with measurement sites that are

not well perfused, because this can cause severe burns after prolonged application. All listed sensors

operate without risk of exceeding 41°C on the skin if the initial skin temperature does not exceed

35°C.

Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff

or an intravascular venous infusion line.

2 IntelliVue CL SpO2 Pod

Measuring SpO2

During measurement, ensure that the application site:

– has a pulsatile flow, ideally with a perfusion indicator value above 1.0 or, if the perfusion

indicator is not available, with signal quality indicator of at least medium.

– has not changed in its thickness (for example, due to edema), causing an improper fit of the

sensor.

WARNING

• 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.

2 IntelliVue CL SpO2 Pod

Selecting Measurement Modes

There are three different modes available for making SpO2 measurements:

•Continuous mode - SpO2 is measured continuously until the measurement is switched off.

•Manual mode - a single SpO2 measurement is made when the Start SpO₂ SmartKey or the Start

SpO₂ menu item is selected. One set of values is then displayed with the time the measurement was

made.

•Automatic mode - a series of measurements is made with an interval between them. The interval

is selected using the Repeat Time SmartKey or the Repeat menu item. The measurement starts

automatically when automatic mode is selected.

The values measured in manual mode or automatic mode will be displayed for a configurable time

span. After that the values are regarded as invalid and are no longer displayed. Battery power usage will

be appreciably higher when measuring in continuous mode, in comparison to manual or automatic

mode, resulting in a reduced battery runtime.

Starting and Stopping Measurements

Use 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.

Action to be Performed SpO2 menu SmartKeys

Start manual measurement Start SpO₂

Start

2 IntelliVue CL SpO2 Pod

Understanding SpO2 Numerics and Symbols

SpO2 Signal Quality Indicator

The SpO2 numeric is displayed together with a signal quality indicator (if configured and enough space

is available) which gives an indication of the reliability of the displayed values.

The level to which the triangle is filled shows the quality of the signal; the indicator below shows a

medium signal quality, the signal quality is at a maximum when the triangle is completely filled.

Assessing a Suspicious SpO2 Reading

Traditionally, pulse rate from SpO2 was compared with heart rate from ECG to confirm the validity of

the SpO2 reading. With newer algorithms, such as FAST-SpO2, this is no longer a valid criteria because

the correct calculation of SpO2 is not directly linked to the correct detection of each pulse.

When pulse rate is very low, or strong arrhythmia is present, the SpO2 pulse rate may differ from the

heart rate calculated from ECG but this does not indicate an inaccurate SpO2 value.

If you doubt the measured SpO2, use the signal quality indicator (if available) or, when used with a

patient monitor, the pleth wave and perfusion indicator on the monitor to assess the signal quality.

WARNING

With pulse oximetry, sensor movement, ambient light (especially strobe lights or flashing lights) or

electromagnetic interference can give unexpected intermittent readings when the sensor is not

1SpO2 numeric

2Pulse rate numeric

3Symbol indicating pulse rate

4Measurement mode - indicates here that Auto

mode is active and shows the time to the next

measurement.

5Alarms Off symbol for Pulse

6Timestamp

7Alarms Off symbol for SpO2

Note: The Alarms Off symbols indicate that no physiological alarms are available from the

Cableless Measurement Devices when not assigned to a host.

1SpO2 Quality Indicator

2 IntelliVue CL SpO2 Pod

attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might

occur when the sensor is dangling.

Changing the Averaging Time

Depending on the monitor configuration, you may be able to change the averaging time for the SpO2

values.

The averaging time represents the approximate time period used for the calculation. The exact

averaging time also depends on the signal conditions. The longer the averaging time, the longer the

time needed until the SpO2 values reflect the physiological event. The same averaging is applied to all

numerical values: SpO2, pulse rate and Perfusion 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 Alarms

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.

• The time between the displayed numerical values crossing an alarm limit and the alarm indication

on the device. This delay depends on the Cableless Measurement Device or connected host

system.

Refer to the Alarms chapter 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.

Alarms

The IntelliVue Cableless Measurements have two different types of alarm: patient alarms and INOPs.

Patient Alarms

Patient Alarms are high priority alarms (such as a potentially life threatening situation), also called red

alarms, or medium priority alarms, also called yellow alarms.

Technical Alarms (INOPs)

Technical alarms, also known as INOPs, indicate that the measuring device cannot measure reliably. If

an INOP interrupts monitoring, there will be a question mark in place of the measurement numeric.

2 IntelliVue CL SpO2 Pod

An INOP tone sounds at the Cableless Measurement Device only when there is no SRR connection to

a host.

Most INOPs are low priority, however there are a small number of INOPs which, due to their severity,

are medium or high priority.

Alarm Delays

There is a delay between a physiological event at the measurement site and the corresponding alarm

indication at the Cableless Measurement Device. This delay has two components:

• The general measurement delay time is the time between the occurrence of the physiological event

and when this event is represented by the displayed numerical values. This delay depends on the

algorithmic processing.

• The time between the displayed numerical values crossing an alarm limit and the alarm indication

on the device is the system alarm delay. The system alarm delay is the processing time the system

needs for any alarm on the Cableless Measurement Device to be indicated after the measurement

has triggered the alarm. See the performance specifications in the Specifications chapter for the

system alarm delay specification.

The alarm delay configured for a specific measurement is normally a fixed time.

Multiple Alarms

If more than one alarm is active, the alarm messages are shown in the alarm status area in succession.

An arrow symbol next to the alarm message informs you that more than one message is active.

The Cableless Measurement Device sounds an audible indicator for the highest priority alarm. If more

than one alarm condition is active in the same measurement, the Cableless Measurement Device

announces the most severe.

NOTE

If you want to use local attended monitoring, make sure to have all Cableless Measurement Devices

upgraded to Rev. B.02.

Visual Alarm Indicators

WARNING

• No patient alarms are available on the CL 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 CL device when connected to a host monitor

(unless they are selected for use in patient transport at the monitor they are assigned to) or

GuardianSoftware.

Alarm Message

Alarm messages are displayed in black on a light gray background in the alarm status area at the top of

the screen indicating the source of the alarm and coded according to their severity. If more than one

measurement is in an alarm condition, the message changes every few seconds, and has an arrow ( )

at the side. The asterisk symbols (*) beside the alarm message match the alarm priority: *** for red

alarms, ** for yellow alarms. Standard INOPs do not have a symbol, red and yellow INOPs have

exclamation marks beside the alarm message: !!! for red INOPs and !! for yellow INOPs.

2 IntelliVue CL SpO2 Pod

An alarm message that appears is automatically highlighted. Use the  key to silence the message. A

Silence message is displayed at the bottom of the screen and highlighted. Press  again to confirm the

acknowledgment of the alarm. After the confirmation, any ongoing alarm message is displayed in the

icon tray of the screen.

Alarm States

Depending on the alarm state of your Cableless Measurement Device, the following icons may be

displayed on the device:

Audible Alarm Indicators

Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or

pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching).

Cableless Measurements Devices alone (without host, e.g. a patient monitor) are not suitable for

unattended monitoring due to their limited alarm volume.

WARNING

• Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm

volume to a low level or off during patient monitoring may result in patient danger. Remember

that the most reliable method of patient monitoring combines close personal surveillance with

correct operation of monitoring equipment.

• No patient alarms are available on the Cableless Measurement Device 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 Device (unless they are selected for use in patient transport at the monitor

they are assigned to).

Icon Description

No local alarming on Cableless Measurement Device. The

device is connected to a host monitor or telemetry device

and has no visual or audible patient alarm indicators. The

device will only display INOP messages.

Alarms are switched off.

Alarm volume is set to 0.

2 IntelliVue CL SpO2 Pod

Silencing an Alarm

To silence an alarm, select the alarm message and press the  key.

This will silence the alarm tone and clear the alarm message. If the condition which caused the alarm is

still present, the alarm indicator will be displayed in the icon tray of the screen.

When using a Cableless Measurement Pod with an IntelliVue Information Center iX Release A, make

sure to remove the pod at the telemetry device and only when in SRR range of the telemetry device.

Otherwise you will get a technical alarm (cl SpO₂ Disconnect) that can not be silenced at the telemetry

device. You will then have to reboot the telemetry device to remove the message.

Displaying a List of Current Alarms

To display a list of the currently active alarms,

1Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms.

2Select Alarm Messages.

Setting the Volume of the Alarm Tone

To 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:

NOTE

No Alarm tone will sound at the device as long as it is within the SRR range.

Minimum Volume for No Host Monitoring INOP

If your device is connected to a host monitor, and the connection is interrupted, the INOP message

No Host Monitoring will appear within 30 seconds, accompanied by an INOP tone. To help ensure

that this INOP, and any other active alarm, is not overlooked, the INOP and alarm tones may be

configured to have a minimum volume. In this case, INOP and alarm tones will sound even if the

device alarm volume is set to zero.

1Full length alarm message

2Alarm indicator

2 IntelliVue CL SpO2 Pod

Alarm Reminder

If Reminder is configured on your device, you will get an audible reminder of alarm conditions that

remain active after you have silenced the alarm. This reminder may take the form of a repetition of the

alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new

alarm). Alarm Reminder is not available for standard, light blue INOPs but for yellow and red INOPs.

In Configuration Mode, you can set the interval between silencing the alarm and sounding the

reminder tone to one, two, or three minutes.

Pausing or Switching Off Alarms

If you want to temporarily prevent alarms from sounding, for example while you are moving a patient,

you can pause alarms. Depending on your device configuration, alarms are paused for one, two, or

three minutes, or infinitely. Infinite alarm pause is equivalent to switching the alarms off.

To view the alarm pause setting chosen for your unit,

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 Alarms

Select the key in the SmartKeys Menu followed by Alarms On/Off. If your device is

configured to infinite pause time, selecting this key switches alarms off.

Press the  hardkey to complete the change.

Restarting Paused Alarms

To manually switch on alarm indication again after a pause, select the key again.

Alarm indication starts again automatically after the pause period expires. If the device is configured to

stay paused infinitely, you must select again to restart alarm indication.

Alarm Limits

The alarm limits you set determine the conditions that trigger yellow and red limit alarms. For SpO2,

where the value ranges from 100 to 0, setting the high alarm limit to 100 switches the high alarm off. In

these cases, the alarms off symbol is not displayed.

WARNING

Be aware that the devices in your care area may each have different alarm settings, to suit different

patients. Always check that the alarm settings are appropriate for your patient before you start

monitoring.

2 IntelliVue CL SpO2 Pod

Adjusting the Alarm Limits

1Select 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.

WARNING

High oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a

consideration do NOT set the high alarm limit to 100%, which is equivalent to switching the high

alarm off.

Adjusting the Desat Limit Alarm

The Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in

oxygen saturation.

1In the SpO₂ menu, select DesatLim.

2Adjust the limit.

Setting Up Tone Modulation

Only when the CL device is not connected to a host:

If tone modulation is on, the pulse tone pitch lowers when the SpO2 level drops.

Select Main Setup followed by User Interface. In this menu, select Tone Modulation to switch

between Yes (for on) and No (for off).

NOTE

If the SpO2 level drops below 52%, two short tones will be issued rather than one long tone.

Tone modulation is licensed under USpatent US 4.653.498 from Nellcor Puritan Bennett

Incorporated.

Latching Alarms

The alarm latching setting for your device defines how the alarm indicators behave when you do not

acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition

ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed

or announced by the device after the alarm condition ends. The indication lasts until you acknowledge

the alarm.

Viewing the Alarm Latching Settings

To see the alarm latching setting for your device

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:

2 IntelliVue CL SpO2 Pod

Alarm Latching Behavior

All INOPs are non-latching.

Testing Alarms

When you switch the CL SpO2 Pod on, a selftest is started. You must check that the backlight switches

on, and that you hear a single tone. This indicates that the alarm indicators are functioning correctly.

For further testing of individual measurement alarms, perform the measurement on yourself or use a

simulator. Adjust alarm limits and check that appropriate alarm behavior is observed.

Alarm Behavior at Power On

If the device is switched off (Device Off), 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 13 and “Using Profiles” on page 15 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 Latching

Red&Yellow Red&Yellow

Red&Yellow Red Only

Red&Yellow Off

Red Only Red Only

Red Only Off

Off Off

Red & Yellow Measurement

Alarms

Non-latching alarms Visual and audible latching Visual latching, audible

non-latching

Alarm has not

been

acknowledged.

Alarm condition

still present.

Alarm tone on. Alarm message. Alarm tone on. Alarm

message.

Alarm tone on. Alarm

message.

Alarm condition

no longer present.

All audible and visual alarm

indicators automatically stop.

Alarm tone on.

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 Pod

Reference List of Patient Alarms

Reference List of all INOPs

Alarm 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 limit

INOP Message, Indication Source What to do

Batt Incompatible

INOP tone

Battery Battery cannot be used with this Cableless Measurement

Device. Replace battery with one that has been approved

for use with this Cableless Measurement Device. Contact

your service personnel.

Batt Malfunction

INOP tone

Battery Malfunction of the battery system detected (charger

circuit or battery). Contact your service personnel.

Battery Empty

INOP tone

Battery The remaining monitoring time is below 30 minutes.

Charge battery.

Battery Low

INOP tone

Battery The remaining monitoring time is below 2 hours.

Check Batt Temp

INOP tone

Battery The temperature of the battery is critically high. Check

that Cableless Measurement Device is not covered and

not exposed to a heat source. If INOP persists, remove

Cableless Measurement Device from patient and contact

your service personnel.

Check Battery

INOP tone

Battery The maximum number of charge/discharge cycles of the

battery will be reached in less than 50 cycles. Contact

your service personnel to replace the battery.

Check Charger I/F

INOP tone

Battery Overvoltage or undervoltage detected at the charger

interface. Clean contacts of charger interface at Cableless

Measurement Device and charging station. If the INOP

persists, contact your service personnel.

2 IntelliVue CL SpO2 Pod

cl SpO₂ Chk Sett

INOP tone

Cableless

Measurement Device

If 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 Disconnect

only at the host

Cableless

Measurement Device

The SpO2 Pod has lost the SRR connection to the

telemetry device or the patient monitor.

No Host Monitoring

INOP tone

Cableless

Measurement Device

There 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 Device

There 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 Pat

INOP tone

Cableless

Measurement Device

Displayed 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 Battery

INOP tone

Battery 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 Malf

Numeric is replaced by -?-

INOP tone

SpO2The SpO2 Pod is faulty. Contact your service personnel.

<SpO₂ Label> Erratic

Numeric is replaced by -?-

INOP tone

SpO2Check the sensor placement. Try another adapter cable

and sensor. If the INOP persists, contact your service

personnel.

<SpO₂ Label> Extd.Update

Numeric 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>Interference

Numeric is replaced by -?-

INOP tone

SpO2There 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 Perf

Numeric is replaced by -?-

SpO2Accuracy may be compromised due to very low

perfusion. Stimulate circulation at sensor site. If INOP

persists, change the measurement site.

INOP Message, Indication Source What to do

2 IntelliVue CL SpO2 Pod

<SpO₂ Label> NeoPatient?

Numeric is replaced by -?-

INOP tone

SpO2The 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.

<SpO₂ Label> No Pulse

Numeric is replaced by -?-

INOP tone

SpO2Check 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 Sensor

Numeric is replaced by -?-

INOP tone

SpO2Make 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> NoisySignal

Numeric is replaced by -?-

INOP tone

SpO2Excessive 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 tone

SpO2The detectable pulsations of the SpO2 signal are outside

the specified pulse rate range.

<SpO₂ Label> Searching

Numeric is unavailable

SpO2The patient signal is analyzed, but no valid numerics are

available yet.

<SpO₂ Label> Sensor Malf

Numeric is replaced by -?-

INOP tone

SpO2The SpO2 sensor is faulty. Try another sensor. If the

INOP persists, contact your service personnel.

<SpO₂ Label> Sensor Off

Numeric is replaced by -?-

INOP tone

SpO2The 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.Sensor

Numeric is replaced by -?-

INOP tone

SpO2The connected SpO2 sensor is not supported by this

measurement hardware.

<SpO₂ Label> Upgrade

Numeric is replaced by -?-

SpO2SpO2 in upgrade mode, no patient monitoring possible.

INOP Message, Indication Source What to do

2 IntelliVue CL SpO2 Pod

SpO2 Default Settings

These 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 Defaults

Adult Pedi Neo

Mode Continuous Continuous Continuous

Repeat Time 15 min 15 min 15 min

Alarms On On On

QRS Volume 111

ToneMod. Yes Yes Yes

Perfusion OnOnOn

Average 10 sec 10 sec 10 sec

NBP Alarm Suppr. On On On

Aging Time 10 min 10 min 10 min

Color Cyan (light blue) Cyan (light blue) Cyan (light blue)

Average in Mon. No No No

Signal Quality OnOnOn

Label SpO₂SpO₂SpO₂

SpO2 Alarm Default Settings

Setting Adult Pedi Neo

DesatLim 80 80 80

Low Lim 90 90 85

High Lim 100 100 95

Desat Delay 20 sec 20 sec 20 sec

High Alarm Delay 10 sec 10 sec 10 sec

Low Alarm Delay 10 sec 10 sec 10 sec

Pulse Settings Factory Defaults

Adult Pedi Neo

Pulse OnOnOn

Alarms On On On

High Lim 120 160 200

Low Lim 50 75 100

Δ Brady 202020

2 IntelliVue CL SpO2 Pod

Integrated Battery Handling

Battery Care

Battery 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 Precautions

Lithium 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).

Brady Clamp 404050

Δ Tachy 202020

Tachy Clamp 200 220 240

Pulse Settings Factory Defaults

Adult Pedi Neo

Activity When to perform

Perform a visual inspection Before using the IntelliVue Cableless Measurement Device

Charge 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 Pod

Storage

If 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 months

Storing 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.

NOTE

Storing the devices at temperatures above 40°C (104°F) for extended periods of time could

significantly reduce the battery's life expectancy.

Battery Lifetime Management

The 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 Pod

Accessories

You can order parts and accessories from Philips supplies at www.medical.philips.com or consult your

local Philips representative for details.

WARNING

Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or

single patient use only. Reuse may compromise device functionality and system performance and cause

a potential hazard, in particular with regard to cross-contamination.

Philips’ approval: Use only Philips-approved accessories. Using non-Philips-approved accessories

may compromise device functionality and system performance and cause a potential hazard.

IntelliVue CL SpO2 Pod Accessories

All 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 geographies

Order Number Description Contents

989803165941 Mobile CL 20 single patient SpO2 Sensors

and Cradles for use on pediatric and adult

patients >10 kg

20 Single-Patient Mobile CL DSpO2-1A

Sensors

20 Single-Patient Wristbands

20 Single-Patient Cradles

pre-assembled

989803165921 Mobile CL 20 single patient SpO2 Sensors

for use on pediatric and adult patients >10 kg

20 Single-Patient Mobile CL DSpO2-1A

Sensors

9898031659311Mobile CL reusable SpO2 sensor and Cradles

for use on pediatric and adult patients > 15 kg

1 Reusable Mobile CL RSpO2-1A Sensor

20 Single-Patient Cradles with pre-attached

Wristbands

989803165951 Mobile CL 20 SpO2 Cradles (single patient) 20 Single-Patient Cradles with pre-attached

Wristbands

989803165961 Mobile CL 50 SpO2 Wristbands (single

patient)

50 Single-Patient Wristbands

989803168861 Mobile CL SpO2 Battery Kit 1 Battery

1 disassembly tool

1 front housing

2 IntelliVue CL SpO2 Pod

Maintenance and Troubleshooting

WARNING

Schedule: Failure on the part of the responsible individual hospital or institution employing the use of

this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure

and possible health hazards.

Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips,

or your authorized supplier.

Inspecting the Equipment and Accessories

You should perform a visual inspection before every use, and in accordance with your hospital's policy.

With the device switched off:

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.

WARNING

If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working

properly, do not use it for any monitoring procedure on a patient, contact your service personnel.

Maintenance Task and Test Schedule

All maintenance tasks and performance tests are documented in detail in the service documentation

supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for 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.

Troubleshooting

If a device will not switch on when you press a key, place it onto a charger slot on the charging

station.

If you suspect a problem with an individual measurement device, read the Instructions for Use

and double check that you have set up the measurement correctly. Check also that the measurement

has not been switched off at the patient monitor that the device is assigned to.

If you suspect an intermittent, system-wide problem call your service personnel.

3IntelliVue CL NBP Pod

To measure NBP, you need Philips standard cuffs, a Mobile CL NBP Cradle and a pouch and

extension air hose, or a Mobile CL NBP Cradle and Mobile CL Cuffs. When using Mobile CL Cuffs,

the cradle is used to attach the Pod to the cuffs and to allow easy removal of the Pod.

Standard Philips cuffs and specialized single-patient and reusable NBP cuffs are available for use with

the IntelliVue CL NBP Pod. For details regarding the cuffs and single-patient cradle, refer to

“IntelliVue CL NBP Pod Accessories” on page 74.

General Operation of the NBP Pod

The following sections describe operation on the NBP Pod itself. For operation from a patient

monitor, see “Controls Available with a Patient Monitor” on page 54. For operation from an

Information Center via a telemetry system, see “Controls Available with a Telemetry Device” on

page 55. For operation with IntelliVue GuardianSoftware, see “Controls Available with

GuardianSoftware” on page 55.

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.

3 IntelliVue CL NBP Pod

Switching the Devices On

The first time an NBP Pod is used, or after the device has been powered off for storage, place it on the

IntelliVue CL Charging Station. This will automatically switch the device on.

If the NBP Pod has only been switched off temporarily (see “Switching the Device Off” on page 13),

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.

Screen Layout

There are three variations of the Main Screen layout depending on the Alarm status and the general

activity level.

Standard Layout

When assigned to a monitor, telemetry device or a patient in GuardianSoftware:

1Connection status indicator

2Indicator 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 indicator

4Measurement values

5Measurement-related symbols (see the measurement

chapters for details)

6Patient identification

When not assigned to a monitor or telemetry device:

1Connection status indicator

2Battery indicator

3Measurement values

4Measurement-related symbols (see the Monitoring

chapter 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 label

3 IntelliVue CL NBP Pod

Alarm Layout

If an alarm occurs the full alarm message appears at the top of the screen. After the alarm message has

been silenced the alarm indicator is shown as a symbol on the right side of the screen.

Low-Activity Screen

If the Cableless Measurement Device has not been operated for a while, the screen lighting will switch

itself off and a little later the screen will switch to a pre-configured "low-activity" screen.

When a Cableless Measurement Device Cannot be Activated

If you cannot activate a device by pressing a key, place it on the IntelliVue CL Charging Station. The

device becomes active. Check the battery status. If necessary, leave the device on the charger until the

battery is fully charged.

Using the Hardkeys

The IntelliVue Cableless Measurement Devices have three hardkeys: ◄, , ►.

Use ◄ and ► to navigate through SmartKeys and menus and to select items or to silence alarms.

The three hardkeys also have an additional function when the key is held down for a couple of

seconds:

Using the SmartKeys

A SmartKey is a graphical key which appears on the screen and gives you fast access to functions.

SmartKeys Menu

Press the  hardkey (without any screen element highlighted) to get to the SmartKeys menu.

1Full length alarm message

2Alarm indicator

◄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 Pod

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.

List of Available SmartKeys

SmartKey Text Labels

Main Setup

- start/stop manual NBP measurement

- start auto series

- start measurement sequence

- stop current automatic measurement within series

stop any NBP measurement and measurement series

start NBP STAT measurement

start venipuncture (inflate cuff to subdiastolic pressure)

set the NBP repetition time

Add/Remove device

enter Battery menu

change Screen

enter Profiles menu

switch device off (or power off when pressed for more than two seconds)

3 IntelliVue CL NBP Pod

Using the Main Setup Menu

In addition to the hardkeys and SmartKeys for the most needed functions, the Main Setup menu gets

you to all settings that can be adjusted for the respective device. Select the Main Setup SmartKey to get

to the Main Setup menu.

Switching the Device Off

To switch off a device manually, select the Device Off SmartKey, then Confirm.

If you keep Device Off pressed for more than two seconds, you can choose between Device Off or

Power Off.

•Device Off 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.

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.

enter Patient menu

enters the Alarms menu to access: Alarm Messages, Alarm Limits, Alarms

On/Off/Pause, Alarm Volume.

change alarm volume

change pulse tone volume

access NBP mode selection and setup, with direct start/stop function

SmartKey Text Labels

Main Setup

NBP

Alarms

Patient

Equipment

User Interface

Device Off

Profiles

Operating Modes

Date, Time

Battery

Revisions