Philips TRNSBV1, CLNBPBV2, SRRBV7 User Manual

Instructions for Use

IntelliVue Cableless Measurements

CL SpO2 Pod – CL NBP Pod – CL Respiration Pod

Release D.00

Patient Monitoring

1Table of Contents

1 Introduction and Basic Operation 5

Safety Information 6 Security Information 8 Introducing the IntelliVue Cableless Measurements 10

2 IntelliVue CL SpO2 Pod 13

General Operation of the SpO2 Pod 13 Connection with Host Systems 20 Monitoring SpO2 28 Alarms 34 Local Attended Monitoring 43 SpO2 Default Settings 49 Integrated Battery Handling 50 Accessories 52 Maintenance and Troubleshooting 53

3 IntelliVue CL NBP Pod 55

General Operation of the NBP Pod 55 Connection with Host Systems 62 Monitoring NBP 69 Alarms 77 Local Attended Monitoring 86 NBP Default Settings 91 Integrated Battery Handling 92 Accessories 93 Maintenance and Troubleshooting 97

4 IntelliVue CL Respiration Pod 99

General Operation of the Respiration Pod 99 Connection with Host Systems 100 Monitoring Respiration 104 Technical Alarms (INOPs) 108 Respiration Default Settings 109 Integrated Battery Handling 110 Accessories 111 Maintenance and Troubleshooting 112

5 Cableless Measurement Auxiliary Devices 113

IntelliVue CL Transmitter and IntelliVue CL Hotspot 113 IntelliVue CL Transmitter Base Station 117

3

IntelliVue CL Charging Station 118 Maintenance and Troubleshooting 119

6 Care and Cleaning 121

General Points 121 Cleaning and Disinfecting the IntelliVue Cableless Measurement Devices 122 Disposing of the IntelliVue Cableless Measurement Devices 123

7 Specifications 125

Indications for Use 125 Compatible Medical Devices 127 Symbols 127 Manufacturer's Information 129 Regulatory and Safety Specifications 129 EMC and Radio Regulatory Compliance 130 Safety and Performance Tests 132 Electromagnetic Compatibility (EMC) 132 Accessories Compliant with EMC Standards 133 Electrosurgery Interference/Defibrillation 133 IntelliVue CL SpO2 Pod Specifications 133 IntelliVue CL NBP Pod Specifications 135 IntelliVue CL Respiration Pod Specifications 138 Alarm Specifications for CL NBP, CL SpO2 and CL Resp Pod 140 Telemetry Device Battery Runtime Specifications 141 IntelliVue CL Transmitter Specifications 141 IntelliVue CL Transmitter Base Station Specifications 143 IntelliVue CL Hotspot Specifications 144

Index 147

4

1Introduction and Basic Operation

These Instructions for Use are for clinical professionals using the IntelliVue Cableless Measurements and their specified compatible accessories.

IntelliVue Cableless Measurements refers to the IntelliVue Cableless Measurements product family consisting of the IntelliVue CL SpO

Respiration Pod (865218) with their accessories. Also included are the auxiliary devices: the IntelliVue CL Charging Station (865220), IntelliVue CL Transmitter (865221), IntelliVue CL Transmitter Base Station (865237) and IntelliVue CL Hotspot (865222).

The IntelliVue Cableless Measurements are used for monitoring and recording arterial oxygen saturation, pulse rate, noninvasive blood pressure and respiration rate of adult and pediatric patients.

Familiarize yourself with all instructions including warnings and cautions, and attend one of the training courses, before starting to make measurements with patients. Read and keep the Instructions for Use that come with any accessories, as these contain important information about care and cleaning that is not repeated here.

When using the IntelliVue Cableless Measurements with an IntelliVue Patient Monitor, an Avalon Fetal Monitor, a telemetry system or IntelliVue GuardianSoftware, refer to and adhere to all warnings in the Instructions for Use of the respective device or software.

This guide may contain descriptions of functionality and features that are not implemented in the equipment currently shipped to Japan and/or of products that are not currently sold in Japan due to limitations and restrictions under the applicable local laws and regulations in Japan. Please contact your local sales representative and/or Philips Customer Support for details.

In these Instructions for Use:

•A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.

•A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.

Pod (865215), IntelliVue CL NBP Pod (865216) and IntelliVue CL

2

1

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.

5

1 Introduction and Basic Operation

Safety Information

Use Environment

WARNING

• If a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are not transmitted to the patient monitor or the Information Center. Keep the patient monitor with the patient during transport.

• Always make sure that the applied pod is assigned to the correct patient.

Electrical Hazards

WARNING

• Electrical shock hazard: Do not open the device housing. Refer all servicing to qualified service personnel.

• Always use the supplied power cord with the grounded mains plug to connect the charging station to a grounded AC mains socket. Never adapt the mains plug from the charging station to fit an ungrounded AC mains socket.

• Do not use AC mains extension cords or multiple portable socket outlets. If a multiple portable socket outlet without an approved isolation transformer is used, the interruption of its protective grounding may result in enclosure leakage currents equal to the sum of the individual ground leakage currents, so exceeding allowable limits.

• Do not connect any devices that are not supported as part of a system.

Radiofrequency Interference

WARNING

• Short Range Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a

SpO₂ Disconnect

important, refer to the Configuration Guide for details.

or cl Resp Disconnect INOP at the host monitor. Correct channel configuration is

Battery Handling

WARNING

• Do not crush or puncture - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally.

• Do not incinerate the devices or expose them to temperatures above 60°C (140°F).

No Host Monitoring INOP on the NBP or SpO

Pods, or a cl NBP Disconnect, cl

2

6

Accessories

Maintenance

1 Introduction and Basic Operation

WARNING

• Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard, in particular with regard to cross-contamination.

• Philips’ approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance and cause a potential hazard.

• Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the IntelliVue Cableless Measurement Devices.

WARNING

• Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.

• Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier.

• If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient, contact your service personnel.

Care, Cleaning and Disposal

WARNING

• If you spill liquid on the equipment, or if the equipment is accidentally immersed in liquid, contact your service personnel or Philips service engineer. Do not operate the equipment before it has been tested and approved for further use.

• Do not use flammable agents for disinfecting the equipment in an oxygen-enriched environment, as this might lead to sudden ignition of vapors, resulting in injury to the patient or staff.

• To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the IntelliVue Cableless Measurement Devices appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories, where not otherwise specified, follow local regulations regarding disposal of hospital waste.

7

1 Introduction and Basic Operation

Security Information

Protecting Personal Information

Protecting personal health information is a primary component of a security strategy. Each facility using the devices must provide the protective means necessary to safeguard personal information consistent with country laws and regulations, and consistent with the facility’s policies for managing this information. Protection can only be realized if you implement a comprehensive, multi-layered strategy (including policies, processes, and technologies) to protect information and systems from external and internal threats.

As per their intended use, the devices operate in the patient vicinity and contain personal and sensitive patient data. They also include controls to allow you to adapt the devices to the patient's care model.

To ensure the patient's safety and protect their personal health information you need a security concept that includes:

• Physical security access measures - access to the devices must be limited to authorized users. It is essential that you consider physical security measures to ensure that unauthorized users cannot gain access.

• Operational security measures - for example, ensuring that devices are powered off after monitoring in order to remove patient data from the device.

• Procedural security measures - for example, assigning only staff with a specific role the right to use the devices.

In addition, any security concept must consider the requirements of local country laws and regulations.

Always consider data security aspects of the network topology and configuration when connecting devices to shared networks. Your medical facility is responsible for the security of the network, where sensitive patient data from the monitor may be transferred.

When a device is returned for repair, disposed of, or removed from your medical facility for other reasons, always ensure that all patient data is removed from the device by powering it off.

NOTE

Log files generated by the devices are used for system troubleshooting and do not contain protected health data.

About HIPAA Rules

If applicable, your facility’s security strategy should include the standards set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), introduced by the United States Department of Health and Human Services. You should consider both the security and the privacy rules and the HITECH Act when designing policies and procedures. For more information, please visit: http://www.hhs.gov/ocr/privacy/

About the EU Directives

If applicable, your facility’s security strategy should include the practices set forth in the Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data (Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995). In addition, your facility should also take into account any additional applicable regulation or statutory requirement.

Philips Product Security Policy Statement

Additional security and privacy information can be found on the Philips product security web site at: http://www.usa.philips.com/healthcare/about/customer-support/product-security

8

1 Introduction and Basic Operation

Manufacturer Disclosure Statement for Medical Device Security – MDS2

You can view the Manufacturer Disclosure Statements for Medical Device Security (MDS2) for specific devices at: http://www.usa.philips.com/healthcare/about/customer-support/product-security

9

1 Introduction and Basic Operation

Introducing the IntelliVue Cableless Measurements

The IntelliVue Cableless Measurement Devices provide measurement values and communicate them to other system components using a wireless short range radio (SRR) interface.

Introduction

IntelliVue CL SpO2 Pod

The IntelliVue CL SpO cableless Pulse Oximetry measuring device.

Pod is a battery powered,

2

IntelliVue CL NBP Pod

The IntelliVue CL NBP Pod is a battery powered, cableless, noninvasive blood pressure (NBP) measuring device.

10

IntelliVue CL Respiration Pod

The IntelliVue CL Respiration Pod is a battery powered, cableless device for measuring respiration rate and, optionally, pulse. It also provides basic information about patient posture and activity.

Basic Operation

IntelliVue CL SpO2 Pod and IntelliVue CL NBP Pod

1 Introduction and Basic Operation

The IntelliVue CL SpO Monitors MP5/MP5SC/MP5T, MP2/X2, IntelliVue Telemetry System Transceivers TRx4841A/

TRx4851A, MX40 wearable patient monitors, Avalon Fetal Monitors, and IntelliVue GuardianSoftware. Both devices have an LC display and three keys for basic operation:

IntelliVue CL Respiration Pod

The IntelliVue CL Respiration Pod can be used together with IntelliVue Patient Monitors MP5/MP5SC/ MP5T, MP2/X2, or IntelliVue GuardianSoftware. The device has one multi-color LED for status display and one hardkey for basic operation, e.g. to start a measurement.

Pod and the IntelliVue CL NBP Pod can be used together with IntelliVue Patient

2

1 Integrated monochrome LC display

2 Hardkeys

3 Measurement identifier

1 Multi-color LED

2 Measurement identifier

3 Hardkey

4 Indication for built-in RFID tag

11

1 Introduction and Basic Operation

12

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.

2

Specialized single-patient SpO regarding the complete set of single-patient supplies, cradle, wristband and sensors, refer to “IntelliVue CL

SpO2 Pod Accessories” on page 52.

sensors are available for use with the IntelliVue CL SpO2 Pod. For details

2

General Operation of the SpO2 Pod

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

“Controls Available with a Patient Monitor” on page 25. For operation from an Information Center via a

telemetry system, see “Controls Available with a Telemetry Device” on page 26. For operation with IntelliVue GuardianSoftware, see “Controls Available with GuardianSoftware” on page 27.

The SpO the screen. These are used to activate and navigate through the on-screen menus and to select individual

items. The typical operator's position is such that everything on the device's display can be read clearly and easily.

Switching the Device On

The first time an SpO2 Pod is used, or after the device has been powered off for storage, place it on the IntelliVue CL Charging Station. This will automatically switch the device on.

If the SpO2 Pod has only been switched off temporarily (see “Switching the Device Off” on page 17), press any hardkey to turn the device on again.

When an SpO little later the low-activity screen will be displayed.

Pod has three hardkeys for basic operation and a set of configurable SmartKeys which appear on

2

Pod is not operated, it will automatically switch off the screen lighting after a short time. A

2

13

2 IntelliVue CL SpO2 Pod

Screen Layout

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

Standard Layout

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

1 Connection status indicator

2 Indicator that alarming capability has been transferred to

the host (to the monitor or, for the telemetry device, to the Information Center). No patient alarms will be announced on the Cableless Measurement Device.

3 Battery indicator

4 Measurement values

5 Measurement-related symbols (see the “Monitoring

SpO2” section for details)

6 Patient identification

Alarm Layout

When not assigned to a monitor or telemetry device:

1 Connection status indicator

2 Battery indicator

3 Measurement values

4 Measurement-related symbols (see the “Monitoring

SpO2” section for details). The Alarms Off symbols

indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host.

5 Cableless Measurement Device equipment label

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.

1 Full length alarm message

2 Alarm indicator

14

Low-Activity Screen

If the Cableless Measurement Device has not been operated for a while, the screen lighting will switch itself off and a little later the screen will switch to a pre-configured "low-activity" screen.

When a Cableless Measurement Device Cannot be Activated

If you cannot activate a device by pressing a key, place it on the IntelliVue CL Charging Station. The device becomes active. Check the battery status. If necessary, leave the device on the charger until the battery is fully charged.

Using the Hardkeys

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

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

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

◄ opens the Add To screen to assign a device (or to unassign it when it is already assigned)

2 IntelliVue CL SpO2 Pod

 opens the SmartKeys menu

► returns to the Main Screen. If already on the Main Screen, it locks the keys and a lock symbol

appears on the screen above the battery symbol. If keys are already locked, it unlocks the keys and the lock symbol disappears

Using the SmartKeys

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

SmartKeys Menu

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

Use the ◄ and ► hardkeys to move along the row of SmartKeys. The highlighted SmartKey is displayed in full above the row of SmartKeys. When you use the ◄ or ► hardkey at the end of the row, an appears and then with further presses you move on to the next page of SmartKeys. To leave the SmartKeys menu you can use the 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.

Exit screen

Exit screen or press the ► hardkey for a couple of seconds to return to the Main

15

2 IntelliVue CL SpO2 Pod

List of Available SmartKeys

SmartKey Text Labels

Main Setup

start an SpO

set the SpO

Add/Remove device

Battery menu

enter

Profiles menu

enter

measurement

2

mode

2

change Screen

put device in standby mode (or power off when pressed for more than two seconds)

Patient menu

enter

enters the

Alarms menu to access: Alarm Messages, Alarm Limits, Alarms On/

Off/Pause, Alarm Volume.

16

Change alarm volume

Change pulse tone volume

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

menu.

Setup

Main Setup

SpO₂

Pulse

Alarms

Patient

Equipment

User Interface

Standby

Profiles

Operating Modes

Date, Time

Battery

Revisions

2 IntelliVue CL SpO2 Pod

Main Setup SmartKey to get to the Main

Switching the Device Off

To put the device in standby mode, select the Standby SmartKey, then Confirm.

If you keep

•

Standby pressed for more than two seconds, you can choose between Standby or Power Off.

Standby means that the display is switched off and the measurements are disabled. Use this option if

your device is not used temporarily. Press any hardkey to turn the device on again.

•

Power Off means that the device is switched off completely and can only be switched on again by

putting it on a charger. Use this option when the device is not used for a longer time or prepared for storage or shipping.

Auto Standby and Auto Power Off

The device can be configured to automatically go into standby mode after a configurable time span of inactivity. When in standby mode, the device can be automatically powered off after a configurable time span. See the IntelliVue Cableless Measurements Configuration Guide for details on how to configure these settings.

Operating Modes

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

• Monitoring Mode: This is the normal, every day working mode that you use for making measurements. You can change elements such as measurement modes, patient category and so forth. When you remove the patient from the device, these elements return to their default values. Changes can be stored permanently only in Configuration Mode. You may see items, such as some menu options, that are visible but 'grayed out' so that you can neither select nor change them. These are present for your information only and can be changed only in Configuration Mode.

• Demonstration Mode: Passcode protected, this is for demonstration purposes only. You must not change into Demonstration Mode during monitoring.

• Configuration Mode: Passcode protected, this mode is for personnel trained in configuration tasks. These tasks are described in the Configuration Guide. During installation the Cableless Measurement Device is configured for use in your environment. This configuration defines the default settings you work with when you switch on.

17

2 IntelliVue CL SpO2 Pod

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

When you switch the device on, it starts up in monitoring mode. To change to a different mode:

1 Use the

2 Select

Main Setup SmartKey to get to the Main Setup menu.

Operating Modes and choose the mode you require.

Using the Patient Menu

The Patient menu allows you to see patient demographics information and to remove a patient from a device. Patient Demographic information is only displayed if the Cableless Measurement Device is assigned to a patient monitor or GuardianSoftware. 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

Stop Using a Device for a Patient

To remove a patient from the Cableless Measurement Device,

•in the

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

Patient SmartKey, or

Main Setup SmartKey followed by Patient.

Patient menu select Free Device.

Patient Category is the only item of patient data which can be

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,

1 Select the

2 Select the required profile from the list.

Selecting

Profiles SmartKey or the Main Setup SmartKey followed by Profiles.

New Patient or Free Device will always reset the profile to the default.

18

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,

1 Select the

Main Setup SmartKey and then Date, Time.

2 Enter the data for date and time one after another.

3 Select

Store Date, Time.

If the time has not been set,

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 remaining capacity, voltage, current and temperature.

Battery menu. The Battery menu provides the following information: full-charge and

2 IntelliVue CL SpO2 Pod

--:-- will display on the device.

19

2 IntelliVue CL SpO2 Pod

Connection with Host Systems

The following sections describe how the IntelliVue Cableless Measurement Devices work together with host systems (Patient Monitors, Fetal Monitors, Telemetry Devices / Information Center or GuardianSoftware).

IntelliVue Cableless Measurements Use Models

With these patient-worn measurement devices you can measure and transmit a patient's vitals regularly or on an intermittent data collection basis. There are four typical use models:

With a Patient Monitor

The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T, MP2 or X2 patient monitor (with an SRR interface). They can communicate their measurement values via short range radio to the monitor. The monitor may be assigned to a patient sector at the IntelliVue Information Center (IIC). When assigned to the Information Center, certain actions can be performed at both the patient monitor and the Information Center. See the table “Controls Available with a Patient Monitor” on

page 25.

In situations where patients are becoming more mobile (for example, in step-down/intermediate care units) the lightweight Cableless Measurement Devices allow increased mobility within the short range radio range, without giving up vital signs monitoring.

When assigned to a patient monitor, the Cableless Measurement Device can be selected for use in patient transport at the patient monitor (for details see the Patient Monitor Instructions for Use). In this case, the Cableless Measurement Device will perform local attended monitoring. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See “Alarms” on page 34 for details.

A telemetry device can be assigned to a patient monitor equipped with short range radio at the same time as any Cableless Measurement Devices are also assigned to this monitor.

When assigned to a patient monitor, the admitted patient name is displayed on the SpO

If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be displayed at the monitor:

Pod, and an INOP tone will sound. In this case, visual and audible alarms are still available at the SpO but it is not possible to change the alarm settings.

cl SpO₂ Disconnect. A No Host Monitoring INOP will be displayed on the SpO

Pod.

2

Pod,

2

With a Fetal Monitor

In combination with an Avalon CL Transducer System, the IntelliVue CL SpO2 Pod can be used together with an Avalon FM 20-50 Fetal Monitor. The SpO at the Avalon CL Base Station. For information about Avalon Fetal Monitors, the Avalon CL Transducer

System and the Avalon CL Base Station, please refer to the Avalon Fetal Monitor Instructions for Use.

With a Telemetry Device

The Cableless Measurement Devices can be assigned to a patient with the telemetry device TRx4841A/ TRx4851A or an MX40 wearable patient monitor. They can communicate their measurement values via short range radio to the telemetry device which communicates them to an IntelliVue Information Center to provide a consolidated set of patient values.

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

“Controls Available with a Telemetry Device” on page 26.

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

20

Pods are assigned to the fetal monitor by docking them

2

Pod.

2

When a Cableless Measurement Device is assigned to a telemetry device, it is not possible for the telemetry device to be wirelessly assigned or directly connected to a patient monitor.

If the connection between the telemetry device and the Cableless Measurement Device is lost, an INOP will be displayed at the Information Center: on the SpO

Pod, and an INOP tone will sound.

2

With IntelliVue GuardianSoftware

The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware. GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter, Hotspot or MP5 from the Cableless Measurement Devices. Using the collected data, it provides trending, review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application provides basic assessment guidance, helping you to recognize the early signs of deterioration in your patients. GuardianSoftware is not intended for monitoring in combination with Cableless Measurement Devices.

Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table

“Controls Available with GuardianSoftware” on page 27. GuardianSoftware also manages the patient data.

If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the connection symbol will be displayed gray at GuardianSoftware. A

(no 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 the Pod and resets the Pod to the default profile. The Pod is unassigned.

2 IntelliVue CL SpO2 Pod

cl SpO₂ Disconnect. A No System Monitor. INOP will be displayed

No System INOP will be displayed on the SpO

Free Device. Selecting Free Device removes the current patient from

Pod

2

Device Compatibility

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

• IntelliVue Patient Monitor - Release H.0 or above

• Avalon Fetal Monitor in combination with an Avalon CL Transducer System - Release J.3 or above

• IntelliVue Information Center - Release M or above

• Philips Patient Information Center iX - Release A or above

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

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

• IntelliVue GuardianSoftware - Revision A.0 or above

Availability of Patient Alarms

When the IntelliVue CL SpO2 Pod is used alone, without an assignment to a monitor or telemetry device, no patient alarms will be generated.

When the IntelliVue CL SpO radio connection exists, alarms may be announced at the patient monitor or the Information Center.

• When assigned to a patient monitor / fetal monitor: Alarm messages will be displayed and audible alarm indicators sounded at the monitor in the same way and under the same conditions as for its own measurements. See the Instructions for Use of the patient monitor for details.

If a Cableless Measurement Device that is assigned to a patient monitor is selected for use in patient transport at the patient monitor, the Cableless Measurement Device will perform local attended monitoring. See the Instructions for Use of the patient monitor for details on how to do this. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text

Pod is assigned to a patient monitor or telemetry device and a short range

2

21

2 IntelliVue CL SpO2 Pod

appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See “Alarms” on page 34 for details.

• When assigned to a telemetry device: Measurement values sent via the telemetry device to the IntelliVue Information Center can generate alarms at the Information Center when the values meet the criteria set there for alarms. The alarms will be announced in the same way as measurements from other sources. See the Instructions for Use of the Information Center for details.

• When assigned to GuardianSoftware: Measurement values sent via transmitter, hotspot or MP5 to IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue GuardianSoftware is a data management system, no alarms are announced. The IntelliVue Cableless Measurement Devices will also not generate physiological alarms when connected to IntelliVue GuardianSoftware. See the Instructions for Use of GuardianSoftware.

Assigning an IntelliVue Cableless Measurement Device to a Host

When an IntelliVue CL SpO2 Pod is used with a host system (patient monitor, telemetry device or GuardianSoftware), the Pod must be assigned to that host system.

The assignment can be done at the CL SpO GuardianSoftware).

WARNING

Always make sure that the applied CL SpO

Pod itself or at the host system (patient monitor or

2

Pod is assigned to the correct patient.

2

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 SpO

Correct channel configuration is important, refer to the Configuration Guide for details.

Assignment at the Measurement Device

To make an assignment, select:

•the

• hold the ◄ key pressed.

This opens the range. In order to save power, the list is only visible for a short time; the menu is automatically closed after 40 seconds.

Add/Remove SmartKey , or

Add To menu which lists the available patient monitors and telemetry devices within the SRR

Telemetry device: A telemetry device must be put into assignment mode by pressing the  key on the telemetry device before it can appear in the list. Pressing the  key starts an SRR channel search to find the clearest channel available. During the search all 4 LEDs will blink once per second. The search will

Pod, or a cl SpO₂ Disconnect INOP at the host monitor.

2

22

2 IntelliVue CL SpO2 Pod

take approximately 20-25 seconds. Once a channel is identified, the first LED will light up and blink once per second to indicate that the telemetry device is ready for assignment.

Add To

Mon 1

Mon 2

Tele 33

Tele 44

1 Select a patient monitor or telemetry system using the ◄ and ► keys.

If you select a patient monitor, the measurement selection key on that monitor will change to show the type of measurement device.

2 Activate the assignment by pressing the  key twice on the measurement device.

The Cableless Measurement Device is assigned to the selected patient monitor or telemetry device. A telemetry device plays the assignment tone when the assignment is successful. A patient monitor issues an assignment prompt message.

If the internal measurement in the patient monitor is active (the measurement selection key has a yellow frame), you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign. To do this:

1 Select the measurement selection key on the monitor.

A prompt message appears with the

2 Select

Confirm to deactivate the internal measurement.

Confirm and Cancel keys.

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 SmartKey, then select

Remove From. After confirmation the SRR connection is disconnected.

Assignment at the Patient Monitor

Prepare the Cableless Measurement Device for assignment by activating the

At the patient monitor,

1 Select the Measurement Selection key.

2 Select the

This opens the Devices:

3 Select the device which you want to assign to the patient in the monitor.

4 The monitor displays the assignment prompt message.

If the internal measurement in the patient monitor is active, you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign.

Add cl Msmt pop-up key.

Add cl Measurement window, which shows the available Cableless Measurement

Add/Remove

Add/Remove SmartKey.

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.

23

2 IntelliVue CL SpO2 Pod

An assigned Cableless Measurement Device can be removed in the more details see the Instructions for Use for your patient monitor.

Assignment with an RFID Reader and Tagged Cableless Devices

You can directly assign all cableless devices that have RFID tags with a Philips HS1-R RFID/barcode reader. The SpO

Pod used must have an IntelliVue ProxiTag RFID tag adhesively attached.

2

1 Hold the cableless device close to the reader.

Depending on its configuration, the reader beeps, vibrates or indicates via the LEDs when it has read the tag.

2 Press any hardkey on the cableless device.

The Cableless Measurement Device is now added to the monitor.

If the corresponding internal measurement in the patient monitor is active, you will be asked to confirm that it should be deactivated in favor of the Cableless Measurement Device by selecting

If a Cableless Measurement of the same type is already assigned to the monitor, you will be asked to confirm that it should be removed by selecting

Assignment at the Fetal Monitor

The first time an IntelliVue Cableless Measurement Device is used with an Avalon Fetal Monitor, or after a device has been powered off for storage, place it on the Avalon CL Base Station. This will automatically switch the device on. The device is assigned automatically to the Fetal Monitor working with the CL Base Station.

Measurement Selection window. For

Replace.

24

NOTE

When you place a Cableless Measurement Device onto an Avalon CL Base Station to assign it to an Avalon Fetal Monitor, the Cableless Measurement Device is automatically unassigned from the previous patient.

Special Conditions when Working with Fetal Monitors

The following special conditions apply when CL SpO

Pods are operating with an Avalon Fetal Monitor as

2

a host:

•The SpO

Adult.

•The

Pods are intended to measure the maternal SpO2 and Pulse. The patient category is always

2

Pulse measurement is always On. The Pulse: On/Off setting is not available.

• Physiological alarms are only available at the Avalon Fetal Monitor, not at the Cableless Measurement Devices. Local attended monitoring is not available:

Use for Transp. is not supported. (Local attended

monitoring is used for displaying alarms locally at the Cableless Measurement Devices during patient transport, when the patient is attended by a caregiver).

• Alarm-related operations (e.g. switching alarms on and off, setting the high and low alarm limits) are not available when

Alarm Mode is set to INOP only in the Avalon Fetal Monitor. See the Avalon Fetal

Monitor Instructions for Use and Avalon Fetal Monitor Configuration Guide for further information.

2 IntelliVue CL SpO2 Pod

• You can use the

Remove operation at the host to remove Cableless Measurement Devices, as described

in the Avalon Fetal Monitor Instructions for Use.

• Averaging Time is not configurable.

• Smart Alarm Delay is not supported.

• Pulse tone from the CL SpO

Perfusion is always Off and cannot be changed to On.

•

• Perfusion Change Indicator is not supported.

• It is not possible to change the label, it is always

• Continuous mode only. The functions for starting a measurement, selecting the measurement mode and setting the repetition time are not supported.

• Configuration of

Aging Time (for Aging Numerics) is not possible.

• Pleth wave is not available.

Assignment with GuardianSoftware

To assign a Cableless Measurement Device to a patient in GuardianSoftware:

1 Select the patient on the

2 Take the Cableless Measurement Device from the charger.

3 On the

4 Click

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).

Use for Patient to assign the device to the patient.

Pod is not supported at the Avalon Fetal Monitor.

2

SpO₂.

Chalkboard.

Controls Available with a Patient Monitor

The controls available when working with the Cableless Measurement Device and a patient monitor are described in the table below.

Action At the Cableless

Start SpO

Change SpO

Select SpO

Assign SpO

Remove SpO

Change Alarm Limits Yes* Yes No

Place Device in Standby Yes Yes Yes

Alarm Silence Yes Yes Yes

Alarm Off/Pause Yes Yes Yes

* except when SRR connection to host is lost

2

Mode Yes Yes No

2

Repetition Time Yes Yes No

2

Pod Yes Yes No

2

Pod Yes Yes No

2

Measurement

At the Patient Monitor

At the IIC

Device

Yes Yes No

25

2 IntelliVue CL SpO2 Pod

WARNING

If a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are not transmitted to the patient monitor or the Information Center. The measurements are available on the Cableless Measurement Device only. If this occurs, the displayed on the measurement device. The measurement device will also sound the INOP tone.

Controls Available with a Telemetry Device

The controls available when working with the Cableless Measurement Device and a TRx4841/TRx4851A Transceiver or MX40 wearable patient monitor with a short range radio adapter (SRRA) are described in the table below.

No Host Monitoring message is

Action At the Cableless

At the IIC

Measurement Device

Start SpO

2

Change SpO

Select SpO

2

Assign SpO

Remove SpO

Mode Yes Yes

2

Repetition Time Yes No

Pod Yes No

2

Pod Yes Yes

2

Yes Ye s

Change Alarm Limits No Yes

Place Device in Standby No No

Alarm Silence No Yes

Alarm Off/Pause No Yes

NOTE

When you unplug the ECG cable from the telemetry device and plug it into the monitor associated with the same patient, the ECG source will automatically be from the monitor. The SpO

measurement devices

2

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 SpO IntelliVue CL SpO is available and the IntelliVue CL SpO

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

2

measurement. The SpO2T measurement is sent to the Information Center as long as it

2

measurement is available on the measurement device only.

2

26

Controls Available with GuardianSoftware

The controls available when working with the Cableless Measurement Device and GuardianSoftware are described in the table below.

2 IntelliVue CL SpO2 Pod

Monitoring SpO2

Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier artifact suppression technology (FAST). A sensor is used that transmits light of two different wavelengths through the tissue of the patient. The measurement principle of pulse oximetry is based on the specific absorption characteristics of oxyhemoglobin and deoxyhemoglobin and the pulsating arteriolar vascular bed at the measurement site. It provides four measurements:

• Oxygen saturation of arterial blood (SpO 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 SpO patient monitor or telemetry device.

The SpO cardiac defibrillator according to IEC 80601-2-30.

measurement is suitable for use in the presence of electrosurgery and during the discharge of a

2

) - percentage of oxygenated hemoglobin in relation to the

2

and Pulse when measuring SpO2 with the SpO2 Pod not assigned to a

2

SpO2 Sensors

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

SpO2 Pod Accessories” section for details.

Familiarize yourself with the Instructions for Use supplied with your sensor before using it. In particular, check that the sensor being used is appropriate for your patient category and application site.

Additional Information

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

• Mobile CL Single-Patient SpO

• Mobile CL Reusable SpO

• Mobile CL SpO

1

may not be available in all geographies

Sensor Instructions for Use

2

Sensor1 Instructions for Use

2

Wristband Instructions for Use

2

28

Connecting SpO2 Sensors

1 Connect the sensor to the single patient Mobile CL SpO2 Cradle (if not already connected).

2 IntelliVue CL SpO2 Pod

2 Insert the SpO

Pod into the Mobile CL SpO2 Cradle. The correct orientation is indicated by a

2

matching blue dot inside the cradle.

CAUTION

Make sure that the contacts of the SpO

Pod and the sensor are dry and free of residues.

2

3 Secure the cradle on the patient's arm using the wristband.

a. Feed the free end of the wristband through the slot in the cradle, starting from the underside of the

cradle.

b. Slide the wristband onto the patient's arm and pull the free end until the wristband fits snugly.

c. Close the wristband using the Velcro patch on the free end of the band.

29

2 IntelliVue CL SpO2 Pod

Removing the Pod from the Cradle

To remove the SpO2 Pod from the cradle, pull on the Pod at the opening in the cradle, while holding the cradle in place on the patient's arm.

Applying the Sensor

1 Choose a finger of the patient that matches the sensor dimension in a way that the sensor optical

components are properly aligned and the sensor is neither too loose nor applies too much pressure to the finger. For small pediatric patients consider the thumb.

2 Remove colored nail polish from the application site.

3 Apply the sensor to the patient. The application site should match the sensor size so that the sensor can

neither fall off, nor apply excessive pressure. See the sections below for details on applying the different sensors.

4 Check that the light emitter and the photodetector are directly opposite each other. All light from the

emitter must pass through the patient's tissue.

30

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.

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

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

WARNING

2 IntelliVue CL SpO2 Pod

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

• If not specified otherwise in the SpO

sensor's instructions for use, the following applies:

2

– 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 SpO

sensor in close proximity (e.g. when more than one SpO2 measurement is

2

performed on the same patient). Always cover both sensors with opaque material to reduce crossinterference.

– Electromagnetic interference, especially at perfusion indicator values below 1.0 or signal quality

indicator below medium.

– Excessive patient movement and vibration.

Selecting Measurement Modes

There are three different modes available for making SpO2 measurements:

• Continuous mode - SpO

• Manual mode - a single SpO 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 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.

Repeat Time SmartKey or the Repeat menu item. The measurement starts

is measured continuously until the measurement is switched off.

2

measurement is made when the Start SpO₂ SmartKey or the Start SpO₂

2

31

2 IntelliVue CL SpO2 Pod

Starting and Stopping Measurements

Use the setup menu or SmartKeys to start measurements manually:

Action to be Performed SpO

Start manual measurement

When manual measurements are made, there will be no continuous SpO manual measurement value reflects a momentary status. The numerics from SpO manual mode will remain for a time on the main screen. They are annotated with the time that the

measurement was made to distinguish them from continuously measured values.

Understanding SpO2 Numerics and Symbols

1 SpO2 numeric

2 Pulse rate numeric

3 Symbol indicating pulse rate

4 Measurement mode - indicates here that Auto mode is

active and shows the time to the next measurement.

5 Alarms Off symbol for Pulse

6 Timestamp

7 Alarms Off symbol for SpO

menu SmartKeys

2

Start SpO₂

monitoring or alarming. The

2

Start

measurements made in

2

Note: The Alarms Off symbols indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host.

SpO2 Signal Quality Indicator

The SpO2 numeric is displayed together with a signal quality indicator (if configured and enough space is available) which gives an indication of the reliability of the displayed values.

The level to which the triangle is filled shows the quality of the signal; the indicator below shows a medium signal quality, the signal quality is at a maximum when the triangle is completely filled.

1 SpO2 Quality Indicator

32

Assessing a Suspicious SpO2 Reading

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

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

2

correct calculation of SpO

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

2

When pulse rate is very low, or strong arrhythmia is present, the SpO rate calculated from ECG but this does not indicate an inaccurate SpO

If you doubt the measured SpO

, use the signal quality indicator (if available) or, when used with a patient

2

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

WARNING

With pulse oximetry, sensor movement, ambient light (especially strobe lights or flashing lights) or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might occur when the sensor is dangling.

Changing the Averaging Time

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

The averaging time represents the approximate time period used for the calculation. The exact averaging time also depends on the signal conditions. The longer the averaging time, the longer the time needed until the SpO

pulse rate and perfusion (only available at the patient monitor). Fast averaging is useful for situations where an extremely fast measurement is required or few artifacts are expected. Use slow averaging where you expect the number of artifacts to be relatively high.

1 In the

2 Select the required averaging time from the list.

values reflect the physiological event. The same averaging is applied to all numerical values: SpO2,

2

SpO₂ menu, select Average.

2 IntelliVue CL SpO2 Pod

pulse rate may differ from the heart

2

value.

2

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 SpO optimal, between 0.3-1 is acceptable. Below 0.3 is marginal; reposition the sensor or find a better site.

measurement. Above 1 is

2

33

2 IntelliVue CL SpO2 Pod

Alarms

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

Patient Alarms

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

Technical Alarms (INOPs)

Technical alarms, also known as INOPs, indicate that the measuring device cannot measure reliably. If an INOP interrupts monitoring, there will be a question mark in place of the measurement numeric. An INOP tone sounds at the Cableless Measurement Device only when there is no SRR connection to a host. Exception: the Battery empty INOP tone sounds also with SRR connection.

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

Alarm Delays

There is a delay between a physiological event at the measurement site and the corresponding alarm indication at the Cableless Measurement Device. This delay has two components:

• The general measurement delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing.

• The time between the displayed numerical values crossing an alarm limit and the alarm indication on the device is the system alarm delay. The system alarm delay is the processing time the system needs for any alarm on the Cableless Measurement Device to be indicated after the measurement has triggered the alarm. This delay depends on the Cableless Measurement Device and the connected host system. See the performance specifications in the chapter “IntelliVue CL SpO2 Pod Specifications” on

page 133 for the system alarm delay specification of the Cableless Measurement Device.

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

Multiple Alarms

If more than one alarm is active, the alarm messages are shown in the alarm status area in succession. An arrow symbol next to the alarm message informs you that more than one message is active.

The Cableless Measurement Device sounds an audible indicator for the highest priority alarm. If more than one alarm condition is active in the same measurement, the Cableless Measurement Device announces the most severe.

NOTE

If you want to use local attended monitoring, make sure to have all Cableless Measurement Devices upgraded to at least Rev. B.02.

Visual Alarm Indicators

WARNING

• No patient alarms are available on the Cableless Measurement Devices when assigned to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware.

• Visual patient alarm indicators are disabled on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware.

34

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 ( yellow alarms. Standard INOPs do not have a symbol, red and yellow INOPs have exclamation marks beside the alarm message:

An alarm message that appears is automatically highlighted. Use the  key to silence the message. A message is displayed at the bottom of the screen and highlighted. Press  again to confirm the acknowledgment of the alarm. After the confirmation, any ongoing alarm message is displayed in the icon tray of the screen.

Alarm States

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

Icon Description

2 IntelliVue CL SpO2 Pod

*) beside the alarm message match the alarm priority: *** for red alarms, ** for

!!! for red INOPs and !! for yellow INOPs.

Silence

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.

Audible Alarm Indicators

Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching).

Cableless Measurements Devices alone (without host, e.g. a patient monitor) are not suitable for unattended monitoring due to their limited alarm volume.

WARNING

• Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.

• No patient alarms are available on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or to GuardianSoftware.

• When connected to a host monitor or GuardianSoftware, no alarm tones are available on the Cableless Measurement Devices (unless they are selected for use in patient transport at the monitor they are assigned to).

Alarms are switched off.

Alarm volume is set to 0.

35

2 IntelliVue CL SpO2 Pod

Silencing an Alarm

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

This will silence the alarm tone and clear the alarm message. If the condition which caused the alarm is still present, the alarm indicator will be displayed in the icon tray of the screen.

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,

1 Select the

2 Select

Alarms SmartKey or Main Setup SmartKey, followed by Alarms.

Alarm Messages.

1 Full length alarm message

2 Alarm indicator

Setting the Volume of the Alarm Tone

To set the volume for the Alarm tone,

1 Select the

2 Select

Alarms SmartKey or Main Setup SmartKey, followed by Alarms.

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

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.

will appear within 30 seconds, accompanied by an INOP tone. To help ensure that this

36

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,

1 In the SmartKeys Menu select

2 Check the setting.

This setting can only be changed in Configuration Mode.

To Pause or Switch Off Alarms

2 IntelliVue CL SpO2 Pod

Main Setup, Alarms, then OffDurat.

Select the key in the SmartKeys Menu followed by Alarms. Press the  hardkey to switch to

Paused. If your device is configured to infinite pause time, selecting this option switches alarms off.

Restarting Paused Alarms

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

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

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

37

2 IntelliVue CL SpO2 Pod

Alarm Limits

The alarm limits you set determine the conditions that trigger yellow and red limit alarms. For SpO2, where the value ranges from 100 to 0, setting the high alarm limit to 100 switches the high alarm off. In these

cases, the alarms off symbol is not displayed.

WARNING

Be aware that the devices in your care area may each have different alarm settings, to suit different patients. Always check that the alarm settings are appropriate for your patient before you start monitoring.

Adjusting the Alarm Limits

1 Select the Alarms SmartKey followed by Alarm Limits (or select Main Setup followed by SpO₂):

2 Select

3 Select

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.

High Lim then choose the high alarm limit.

Low Lim then choose the low alarm limit.

Adjusting the Desat Limit Alarm

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

1 In the

SpO₂ menu, select DesatLim.

2 Adjust the limit.

Setting Up Tone Modulation

Only when the Cableless Measurement Device is not connected to a host:

If tone modulation is on, the pulse tone pitch lowers when the SpO

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

Select (for on) and

No (for off).

NOTE

If the SpO

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

2

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.

level drops.

2

38

Viewing the Alarm Latching Settings

To see the alarm latching setting for your device,

1 In the

2 Here you can see the

Main Setup menu, select Alarms.

Visual Latching and Audible Latching settings.

This setting can only be changed in Configuration Mode. You should be aware of the settings chosen for your unit. There are three possible choices each for visual and audible latching, red only, red and yellow, and off. These choices can be combined to give the following settings:

Visual Latching Audible Latching

Red&Yellow Red&Yellow

Red&Yellow Red Only

Red&Yellow Off

Red Only Red Only

Red Only Off

Off Off

Alarm Latching Behavior

2 IntelliVue CL SpO2 Pod

Red & Yellow Measurement

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

Alarms

Alarm has not been acknowledged.

Alarm has been acknowledged.

Alarm condition still present.

Alarm condition no longer present.

Alarm condition still present.

Alarm condition no longer present.

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

All audible and visual alarm indicators automatically stop.

Audible and visual alarm indicators automatically stop.

All INOPs are non-latching.

Testing Alarms

When you switch the CL SpO2 Pod on, a selftest is started. You must check that the backlight switches on, and that you hear a single tone. This indicates that the alarm indicators are functioning correctly. For further

testing of individual measurement alarms, perform the measurement on yourself or use a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed.

Alarm Behavior at Power On

If the device is switched off (Standby), all alarm settings are maintained. If the device is switched off completely ( settings will be lost unless they were actively saved by storing the active profile before the device was switched off. See “Switching the Device Off” on page 17 and “Using Profiles” on page 18 for details.

When the device is switched back on from either state, it will start in Profile A and you may have to switch to the desired profile which contains your alarm settings.

After any of these situations, you should check that the alarm settings are appropriate for your patient and monitoring situation, and if necessary, select the correct profile and patient category.

Power Off), or the battery is completely empty, resulting in complete power loss, all alarm

message.

Alarm tone on. Alarm message.

All audible and visual alarm indicators automatically stop.

Audible and visual alarm indicators automatically stop.

non-latching

Alarm tone on. Alarm message.

Alarm message. Audible alarm indicators automatically stop.

All audible and visual alarm indicators automatically stop.

Audible and visual alarm indicators automatically stop.

39

2 IntelliVue CL SpO2 Pod

Reference List of Patient Alarms

Alarm Message, Indication Source Condition

*** Brady (Pulse) SpO

2

The heart rate from the Pulse signal has fallen below the bradycardia limit.

*** Desat SpO

2

The SpO2 value has fallen below the desaturation alarm limit.

** Pulse High SpO

** Pulse Low SpO

** <SpO₂ Label> High SpO

2

The pulse rate has exceeded the high alarm limit.

The pulse rate has dropped below the low alarm limit.

The arterial oxygen saturation has exceeded the high alarm limit.

** <SpO₂ Label> Low SpO

2

The arterial oxygen saturation has dropped below the low alarm limit.

*** Tachy (Pulse) SpO

2

The Pulse Rate from the Pleth signal has exceeded the tachycardia limit

Reference List of all INOPs

INOP Message, Indication Source What to do

Batt Incompatible

INOP tone

Batt Malfunction

INOP tone

Battery Empty

INOP tone

Battery Low

INOP tone

Check Batt Temp

INOP tone

Check Battery

INOP tone

Check Charger I/F

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.

Battery Malfunction of the battery system detected (charger circuit

or battery). Contact your service personnel.

Battery The remaining monitoring time is below 30 minutes. Charge

battery.

Battery The remaining monitoring time is below 2 hours.

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.

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.

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.

40

INOP Message, Indication Source What to do

2 IntelliVue CL SpO2 Pod

cl SpO₂ Chk Sett

INOP tone

cl SpO₂ Disconnect

only at the host

No Host Monitoring

INOP tone

No System Cableless Measurement

Cableless Measurement Device

Device

Remove From Pat

INOP tone

Service Battery

Cableless Measurement Device

Battery Maximum number of charge/discharge cycles for battery

INOP tone

<SpO₂ Label> Equip Malf

SpO

2

Numeric is replaced by -?INOP tone

<SpO₂ Label> Erratic

SpO

2

Numeric is replaced by -?INOP tone

<SpO₂ Label> Extd.Update

SpO

2

Numeric is replaced by -?-

<SpO₂ Label>Interference

SpO

2

Numeric is replaced by -?INOP tone

<SpO₂ Label> Low Perf

SpO

2

Numeric is replaced by -?-

<SpO₂ Label> NeoPatient?

SpO

2

Numeric is replaced by -?INOP tone

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.

The SpO

Pod has lost the SRR connection to the telemetry

2

device or the patient monitor.

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.

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.

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.

exceeded. Charging of the battery is inhibited. Contact your service personnel to replace battery.

The SpO2 Pod is faulty. Contact your service personnel.

Check the sensor placement. Try another adapter cable and sensor. If the INOP persists, contact your service personnel.

The update time for displayed values is extended due to an NBP measurement on the same limb or an excessively noisy signal.

There is too much interference, caused by a high level of ambient light and/or electrical interference. Cover the sensor to minimize ambient light. If the INOP persists, make sure that the sensor cable is not damaged or positioned too close to power cables.

Accuracy may be compromised due to very low perfusion. Stimulate circulation at sensor site. If INOP persists, change the measurement site.

The patient monitor the SpO2 Pod is assigned to is in neonatal mode. The INOP will remain active until the monitor is changed to adult or pediatric mode.

41

2 IntelliVue CL SpO2 Pod

INOP Message, Indication Source What to do

<SpO₂ Label> No Pulse

SpO Numeric is replaced by -?INOP tone

<SpO₂ Label> No Sensor

SpO Numeric is replaced by -?INOP tone

<SpO₂ Label> NoisySignal

SpO Numeric is replaced by -?INOP tone

<SpO₂ Label> Poor Signal SpO

<SpO₂ Label> Pulse?

SpO Numeric is replaced by -?INOP tone

<SpO₂ Label> Searching

SpO Numeric is unavailable

<SpO₂ Label> Sensor Malf

SpO Numeric is replaced by -?INOP tone

<SpO₂ Label> Sensor Off

SpO Numeric is replaced by -?INOP tone

<SpO₂ Label> Unkn.Sensor

SpO Numeric is replaced by -?INOP tone

<SpO₂ Label> Upgrade

SpO Numeric is replaced by -?-

2

Check the perfusion at the measurement site. If necessary, stimulate circulation or change the measurement site. If the INOP is due to an NBP measurement on the same limb, wait until the NBP measurement is finished.

2

Make sure the SpO2 sensor is connected. If the INOP persists, try another sensor. If you acknowledge this INOP, the measurement will be switched off.

2

Excessive patient movement or electrical interference is causing irregular pulse patterns. Try to reduce patient movement or to relieve the cable strain on the sensor.

2

The signal quality of the SpO2 measurement is poor. The accuracy may be compromised.

2

The detectable pulsations of the SpO2 signal are outside the specified pulse rate range.

2

The patient signal is analyzed, but no valid numerics are available yet.

2

The SpO2 sensor is faulty. Try another sensor. If the INOP persists, contact your service personnel.

2

The algorithm has determined that a sensor is connected, but not properly applied to the patient. The ability of the algorithm to detect this condition depends on the used sensor type.

2

The connected SpO2 sensor is not supported by this measurement hardware.

2

SpO2 in upgrade mode, no patient monitoring possible.

42

Local Attended Monitoring

When working with an IntelliVue MP5, MP5SC, MP5T Patient Monitor with software revision J.2 or higher as a host, or with an IntelliVue X2 Multi-Measurement Module with software revision K.2 or higher, the IntelliVue CL SpO

you want to have alarm indications at the CL Pods when they are out of reach of the patient monitor (disconnected). The patient monitor setting to switch CL Measurement Alarms on and off (

) is used to enable and disable this functionality. As a default, the CL Measurement Alarms are on.

Off

Local Attended Monitoring Enabled

By default, the patient monitor is set to receive alarms from the CL Pods (can only be changed in configuration mode). This scenario is used for patients who require uninterrupted monitoring. The various alarms from the CL Pods are indicated at the patient monitor if they are enabled at the monitor. When the CL Pod is disconnected from the patient monitor and the caregiver has activated the transport mode at the monitor, physiological alarms are indicated locally at the CL Pod. A the monitor if the SRR connection is lost and the transport mode has not been activated.

CL Pod connected to a patient monitor and CL Measurement Alarms On (Standard Use Model):

and NBP Pods can be used for local attended monitoring. This is for situations where

2

2 IntelliVue CL SpO2 Pod

cl Alarms On/

cl SpO₂ Disconnect INOP is shown at

SRR connection

At the CL Pod: Indication of technical alarms only

At the monitor: Indication of physiological and technical alarms from CL Pods

CL Pod disconnected from patient monitor and CL Measurement Alarms On, Local Attended Monitoring:

No SRR connection

At the CL Pod: Indication of technical and physiological alarms

At the monitor: No indication of physiological alarms from CL Pods. No indication of technical alarms after disconnection.

43

2 IntelliVue CL SpO2 Pod

Local Attended Monitoring Disabled

The patient monitor is set to cl Alarms Off (this can only be done in configuration mode). This scenario is used if the patients do not require permanent monitoring and are mobile, but vital signs are taken from time to time. All alarms from the CL Pods are switched off at the monitor. If the SRR connection is lost, no

SpO₂ Disconnect

CL Pod connected to a patient monitor and CL Measurement Alarms Off:

INOP is shown at the monitor in this scenario.

cl

SRR connection

At the CL Pod: Indication of technical alarms only

At the monitor: No indication of physiological alarms from CL Pods. Indication of technical alarms from CL Pods.

CL Pod disconnected from patient monitor and CL Measurement Alarms Off:

No SRR connection

At the CL Pod: Indication of technical alarms only

At the monitor: No indication of physiological and technical alarms from CL Pods.

44

2 IntelliVue CL SpO2 Pod

Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms On

12

Standard Use Model Local Attended Monitoring

-> Caregiver activates 'Use for transport'

<Caregiver activates 'Use with monitor'

SRR connection

Action / Event Situation Alarm Availability

at CL Pod

no SRR connection

Alarm Availability at Patient Monitor

Standard Use Model:

normal operation, no special action

CL Pod connected to the patient monitor (1)

Technical alarms (own)

No physiological alarms

No Local Alarming icon is displayed:

Technical alarms (own + from Pod)

Physiological alarms (own + from Pod)

45

2 IntelliVue CL SpO2 Pod

Activation of Local Attended Monitoring:

Caregiver activates Local Attended Monitoring and

Patient is in transport without connection to the host system, caregiver attends the patient (2)

Technical alarms (own)

Physiological alarms (own)

disconnects CL Pod temporarily by setting Patient Monitor's

Use for Transp. in the

Equipment

window

Deactivation of Local Attended Monitoring:

Caregiver deactivates Local Attended Monitoring and reconnects CL Pod to a patient monitor by setting

in the patient monitor's

Monitor Equipment window

Use with

Patient returns from transport. Back to the standard use model (1)

Technical alarms (own)

No physiological alarms

No Local Alarming icon is displayed:

Special Case: Connection lost while in Standard Use Model

Action / Event Situation Alarm Availability

at CL Pod

Technical alarms (own)

Physiological alarms (own)

No alarms from CL Pod

Technical alarms (own + from Pod)

Physiological alarms (own + from Pod)

Alarm Availability at Patient Monitor

Alternative Use Model:

CL Pod temporarily disconnected from a monitor due to unintentional loss of connection (e.g. out of range), Local Attended Monitoring has not been activated by the caregiver

No Host Monitoring INOP

at CL Pod

cl SpO₂ Disconnect INOP

at patient monitor

Local Attended Monitoring is automatically activated (2)

Technical alarms (own)

Physiological alarms (own)

Technical alarms (own)

Physiological alarms (own)

No alarms from CL Pod

46

2 IntelliVue CL SpO2 Pod

Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms Off

34

Patient within Range Patient Mobile

->

Patient mobile

<-

Patient back

SRR connection

Action / Event Situation Alarm Availability

at CL Pod

no SRR connection

Alarm Availability at Patient Monitor

Connected, but no CL Alarms (CL Measurement Alarms Off):

normal operation, no special action

CL Pod connected to the patient monitor (3)

Technical alarms (own)

No physiological alarms

No Local Alarming icon is displayed:

Technical alarms (own + from Pod)

Physiological alarms (own)

47

2 IntelliVue CL SpO2 Pod

Patient is leaving the vicinity of the monitor:

no special action

Patient returns to the vicinity of the monitor:

no special action

Patient is mobile without connection to the host system (4)

Patient returns. Back to connected status (3)

Technical alarms (own)

No physiological alarms

Alarms Off icon is displayed in front of each numeric:

Technical alarms (own)

No physiological alarms

No Local Alarming icon is displayed:

Technical alarms (own)

Physiological alarms (own)

No alarms from CL Pod

Technical alarms (own + from Pod)

Physiological alarms (own + from Pod)

48

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

Pulse Volume 111

ToneMod. Yes Yes Yes

Perfusion OnOnOn

Average 10 sec 10 sec 10 sec

NBP Alarm Suppr. OnOnOn

Aging Time 10 min 10 min 10 min

Color Cyan

Average in Mon. No No No

Signal Quality OnOnOn

Label SpO₂ SpO₂ SpO₂

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

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

Brady Clamp 40 40 50

49

2 IntelliVue CL SpO2 Pod

Pulse Settings Factory Defaults

Adult Pedi Neo

Δ Tachy 202020

Tachy Clamp 200 220 240

Integrated Battery Handling

Only qualified and authorized service personnel (biomedical engineers or technicians) should change batteries.

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.

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.

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).

50

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:

1 Select the

2 Press 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.

Battery Smartkey or Main Setup followed by Battery.

2 IntelliVue CL SpO2 Pod

51

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. Also consult the accessories' Instructions for Use, if available.

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.

Accessories Compliant with EMC Standards

All accessories listed in the accessories sections comply, in combination with the IntelliVue Cableless Measurements, with the requirements of IEC 60601-1-2.

IntelliVue CL SpO2 Pod 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.

Part Number Description Contents

989803165941 Mobile CL 20 single patient SpO

Cradles for use on pediatric and adult patients >10 kg

Sensors and

2

20 Single-Patient Mobile CL DSpO2-1A Sensors 20 Single-Patient Wristbands 20 Single-Patient Cradles pre-assembled

989803165921 Mobile CL 20 single patient SpO

Sensors for

2

20 Single-Patient Mobile CL DSpO2-1A Sensors

use on pediatric and adult patients >10 kg

989803165931

1

Mobile CL reusable SpO2 Sensor and Cradles for use on pediatric and adult patients > 15 kg

1 Reusable Mobile CL RSpO2-1A Sensor 20 Single-Patient Cradles with pre-attached Wristbands

989803165951 Mobile CL 20 SpO

Cradles (single patient) 20 Single-Patient Cradles with pre-attached

2

Wristbands

989803165961 Mobile CL 50 SpO

Wristbands (single

2

50 Single-Patient Wristbands

patient)

989803168861 Mobile CL SpO

Battery Kit 1 Battery

2

1 disassembly tool 1 front housing

1

May not be available in all geographies

52

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:

1 Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are

not cracked or broken, that everything is present, that there are no spilled liquids and that there are no signs of abuse.

2 Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use them.

WARNING

2 IntelliVue CL SpO2 Pod

If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient, contact your service personnel.

Maintenance Task and Test Schedule

All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for Philipsqualified service professionals only.

Ensure that these tasks are carried out as indicated by the device's maintenance schedule, or as specified by local laws. Contact a Philips-qualified service provider if your device needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it.

Troubleshooting

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

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

double check that you have set up the measurement correctly. Check also that the measurement has not been switched off at the patient monitor that the device is assigned to.

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

53

2 IntelliVue CL SpO2 Pod

54

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.

3

Standard Philips cuffs and specialized single-patient and reusable NBP cuffs are available for use with the IntelliVue CL NBP Pod. For details regarding the cuffs and single-patient cradle, refer to “IntelliVue CL

NBP Pod Accessories” on page 94.

General Operation of the NBP Pod

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

“Controls Available with a Patient Monitor” on page 67. For operation from an Information Center via a

telemetry system, see “Controls Available with a Telemetry Device” on page 68. For operation with IntelliVue GuardianSoftware, see “Controls Available with GuardianSoftware” on page 68.

The NBP Pods have three hardkeys for basic operation and a set of configurable SmartKeys which appear on the screen. These are used to activate and navigate through the on-screen menus and to select individual items. The typical operator's position is such that everything on the device's display can be read clearly and easily.

Switching the Devices On

The first time an NBP Pod is used, or after the device has been powered off for storage, place it on the IntelliVue CL Charging Station. This will automatically switch the device on.

If the NBP Pod has only been switched off temporarily (see “Switching the Device Off” on page 17), press any hardkey to turn the device on again.

When an NBP Pod is not operated, it will automatically switch off the screen lighting after a short time. A little later the low-activity screen will be displayed.

55

3 IntelliVue CL NBP Pod

Screen Layout

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

Standard Layout

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

1 Connection status indicator

2 Indicator that alarming capability has been transferred to

the host (to the monitor or, for the telemetry device, to the Information Center). No patient alarms will be announced on the Cableless Measurement Device.

3 Battery indicator

4 Measurement values

5 Measurement-related symbols (see the “Monitoring

NBP” section for details)

6 Patient identification

Alarm Layout

When not assigned to a monitor or telemetry device:

1 Connection status indicator

2 Battery indicator

3 Measurement values

4 Measurement-related symbols (see the “Monitoring

NBP” section for details). The Alarms Off symbols

indicate that no physiological alarms are available from the Cableless Measurement Devices when not assigned to a host.

5 Cableless Measurement Device equipment label

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.

1 Full length alarm message

2 Alarm indicator

56

Low-Activity Screen

If the Cableless Measurement Device has not been operated for a while, the screen lighting will switch itself off and a little later the screen will switch to a pre-configured "low-activity" screen.

When a Cableless Measurement Device Cannot be Activated

If you cannot activate a device by pressing a key, place it on the IntelliVue CL Charging Station. The device becomes active. Check the battery status. If necessary, leave the device on the charger until the battery is fully charged.

Using the Hardkeys

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

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

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

◄ opens the Add To screen to assign a device (or to unassign it when it is already assigned)

3 IntelliVue CL NBP Pod

 opens the SmartKeys menu

► returns to the Main Screen. If already on the Main Screen, it locks the keys and a lock symbol

appears on the screen above the battery symbol. If keys are already locked, it unlocks the keys and the lock symbol disappears

Using the SmartKeys

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

SmartKeys Menu

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

Use the ◄ and ► hardkeys to move along the row of SmartKeys. The highlighted SmartKey is displayed in full above the row of SmartKeys. When you use the ◄ or ► hardkey at the end of the row, an appears and then with further presses you move on to the next page of SmartKeys. To leave the SmartKeys menu you can use the 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.

Exit screen

Exit screen or press the ► hardkey for a couple of seconds to return to the Main

57

3 IntelliVue CL NBP Pod

List of Available SmartKeys

SmartKey Text Labels

Main Setup

- start/stop manual NBP measurement

- start auto series

- start measurement sequence

- stop current automatic measurement within series

stop any NBP measurement and measurement series

start NBP STAT measurement

start venipuncture (inflate cuff to subdiastolic pressure)

set the NBP repetition time

Add/Remove device

Battery menu

enter

change Screen

Profiles menu

enter

put the device in standby mode (or power off when pressed for more than two seconds)

Patient menu

enter

enters the

Alarms menu to access: Alarm Messages, Alarm Limits, Alarms On/

Off/Pause, Alarm Volume.

change alarm volume

change pulse tone volume

58

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

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

menu.

Setup

Main Setup

NBP

Alarms

Patient

Equipment

User Interface

Standby

Profiles

Operating Modes

Date, Time

Battery

Revisions

3 IntelliVue CL NBP Pod

Main Setup SmartKey to get to the Main

Switching the Device Off

To put the device in standby mode, select the Standby SmartKey, then Confirm.

If you keep

•

Standby pressed for more than two seconds, you can choose between Standby or Power Off.

Standby means that the display is switched off and the measurements are disabled. Use this option if

your device is not used temporarily. Press any hardkey to turn the device on again.

•

Power Off means that the device is switched off completely and can only be switched on again by

putting it on a charger. Use this option when the device is not used for a longer time or prepared for storage or shipping.

Auto Standby and Auto Power Off

The device can be configured to automatically go into standby mode after a configurable time span of inactivity. When in standby mode, the device can be automatically powered off after a configurable time span. See the IntelliVue Cableless Measurements Configuration Guide for details on how to configure these settings.

Operating Modes

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

• Monitoring Mode: This is the normal, every day working mode that you use for making measurements. You can change elements such as measurement modes, patient category and so forth. When you remove the patient from the device, these elements return to their default values. Changes can be stored permanently only in Configuration Mode. You may see items, such as some menu options, that are visible but 'grayed out' so that you can neither select nor change them. These are present for your information only and can be changed only in Configuration Mode.

• Demonstration Mode: Passcode protected, this is for demonstration purposes only. You must not change into Demonstration Mode during monitoring.

• Configuration Mode: Passcode protected, this mode is for personnel trained in configuration tasks. These tasks are described in the Configuration Guide. During installation the Cableless Measurement Device is configured for use in your environment. This configuration defines the default settings you work with when you switch on.

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

59

3 IntelliVue CL NBP Pod

When you switch the device on, it starts up in monitoring mode. To change to a different mode:

1 Use the

2 Select

Main Setup SmartKey to get to the Main Setup menu.

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. 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

Main Setup SmartKey followed by Patient.

Patient Category is the only item of patient data which can be

Stop Using a Device for a Patient

To remove a patient from the Cableless Measurement Device,

•in the

Patient menu select Free Device.

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

NOTE

Depending on your configuration, when the device is put on the charger, patient data will also be cleared and the device will be free for another patient.

Using the Device for a New Patient

To use a device for a new patient,

•in the

Patient menu, select New Patient.

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

Using Profiles

A profile is a set of measurement and general settings which have been customized for a particular purpose. The Cableless Measurement Devices can have four different profiles configured to your requirements. The default profile is marked with a symbol.

To select a different profile,

1 Select the

2 Select the required profile from the list.

Selecting

Profiles SmartKey or the Main Setup SmartKey followed by Profiles.

New Patient or Free Device will always reset the profile to the default.

60

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,

1 Select the

Main Setup SmartKey and then Date, Time.

2 Enter the data for date and time one after another.

3 Select

Store Date, Time.

If the time has not been set,

Battery Status

The IntelliVue CL NBP Pods show their battery status on their display both in operating and charging condition. The battery status indicator is located in the lower right corner of the screen during operation and in the middle of the screen during charging.

Battery Status Menu

Select the Battery SmartKey or Main Setup followed by Battery using the ◄ and ► keys, then press the  key to open the remaining capacity, voltage, current and temperature.

Battery menu. The Battery menu provides the following information: full-charge and

3 IntelliVue CL NBP Pod

--:-- will display on the device.

61

3 IntelliVue CL NBP Pod

Connection with Host Systems

The following sections describe how the IntelliVue Cableless Measurement Devices work together with host systems (Patient Monitors, Fetal Monitors, Telemetry Devices / Information Center or GuardianSoftware).

IntelliVue Cableless Measurements Use Models

With these patient-worn measurement devices you can measure and transmit a patient's vitals regularly or on an intermittent data collection basis. There are four typical use models:

With a Patient Monitor

The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T, MP2 or X2 patient monitor (with an SRR interface). They can communicate their measurement values via short range radio to the monitor. The monitor may be assigned to a patient sector at the IntelliVue Information Center (IIC). When assigned to the Information Center, certain actions can be performed at both the patient monitor and the Information Center. See the table “Controls Available with a Patient Monitor” on

page 67.

In situations where patients are becoming more mobile (for example, in step-down/intermediate care units) the lightweight Cableless Measurement Devices allow increased mobility within the short range radio range, without giving up vital signs monitoring.

When assigned to a patient monitor, the Cableless Measurement Device can be selected for use in patient transport at the patient monitor (for details see the Patient Monitor Instructions for Use). In this case, the Cableless Measurement Device will perform local attended monitoring. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See “Alarms” on page 34 for details.

A telemetry device can be assigned to a patient monitor equipped with short range radio at the same time as any Cableless Measurement Devices are also assigned to this monitor.

When assigned to a patient monitor, the admitted patient name is displayed on the NBP Pod.

If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be displayed at the monitor: Pod, and an INOP tone will sound. In this case, visual and audible alarms are still available at the NBP Pod, but it is not possible to change the alarm settings.

cl NBP Disconnect. A No Host Monitoring INOP will be displayed on the NBP

With a Fetal Monitor

In combination with an Avalon CL Transducer System, the IntelliVue CL NBP Pod can be used together with an Avalon FM 20-50 Fetal Monitor. The NBP Pods are assigned to the fetal monitor by docking them at the Avalon CL Base Station. For information about Avalon Fetal Monitors, the Avalon CL Transducer System and the Avalon CL Base Station, please refer to the Avalon Fetal Monitor Instructions for Use.

With a Telemetry Device

The Cableless Measurement Devices can be assigned to a patient with the telemetry device TRx4841A/ TRx4851A or an MX40 wearable patient monitor. They can communicate their measurement values via short range radio to the telemetry device which communicates them to an IntelliVue Information Center to provide a consolidated set of patient values.

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

“Controls Available with a Telemetry Device” on page 68.

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

62

When a Cableless Measurement Device is assigned to a telemetry device, it is not possible for the telemetry device to be wirelessly assigned or directly connected to a patient monitor.

If the connection between the telemetry device and the Cableless Measurement Device is lost, an INOP will be displayed at the Information Center: on the NBP Pod, and an INOP tone will sound.

With IntelliVue GuardianSoftware

The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware. GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter, Hotspot or MP5 from the Cableless Measurement Devices. Using the collected data, it provides trending, review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application provides basic assessment guidance, helping you to recognize the early signs of deterioration in your patients. GuardianSoftware is not intended for monitoring in combination with Cableless Measurement Devices.

Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table

“Controls Available with GuardianSoftware” on page 68. GuardianSoftware also manages the patient data.

If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the connection symbol will be displayed gray at GuardianSoftware. A (no 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 the Pod and resets the Pod to the default profile. The Pod is unassigned.

3 IntelliVue CL NBP Pod

cl NBP Disconnect. A No System Monitor. INOP will be displayed

No System INOP will be displayed on the NBP Pod

Free Device. Selecting Free Device removes the current patient from

Device Compatibility

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

• IntelliVue Patient Monitor - Release H.0 or above

• Avalon Fetal Monitor in combination with an Avalon CL Transducer System - Release J.3 or above

• IntelliVue Information Center - Release M or above

• Philips Patient Information Center iX - Release A or above

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

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

• IntelliVue GuardianSoftware - Revision A.0 or above

Availability of Patient Alarms

When the IntelliVue CL NBP Pod is used alone, without an assignment to a monitor or telemetry device no patient alarms will be generated.

When the IntelliVue CL NBP Pod is assigned to a patient monitor or telemetry device and a short range radio connection exists, alarms may be announced at the patient monitor or the Information Center.

• When assigned to a patient monitor / fetal monitor: Alarm messages will be displayed and audible alarm indicators sounded at the monitor in the same way and under the same conditions as for its own measurements. See the Instructions for Use of the patient monitor for details.

If a Cableless Measurement Device that is assigned to a patient monitor is selected for use in patient transport at the patient monitor, the Cableless Measurement Device will perform local attended monitoring. See the Instructions for Use of the patient monitor for details on how to do this. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See “Alarms” on page 34 for details.

63

3 IntelliVue CL NBP Pod

• When assigned to a telemetry device: Measurement values sent via the telemetry device to the IntelliVue Information Center can generate alarms at the Information Center when the values meet the criteria set there for alarms. The alarms will be announced in the same way as measurements from other sources. See the Instructions for Use of the Information Center for details.

• When assigned to GuardianSoftware: Measurement values sent via transmitter, hotspot or MP5 to IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue GuardianSoftware is a data management system, no alarms are announced. The IntelliVue Cableless Measurement Devices will also not generate physiological alarms when connected to IntelliVue GuardianSoftware. See the Instructions for Use of GuardianSoftware.

Assigning an IntelliVue Cableless Measurement Device to a Host

When an IntelliVue CL NBP Pod is used with a host system (patient monitor, telemetry device or GuardianSoftware), the Cableless Measurement Device must be assigned to that host system.

The assignment can be done at the CL NBP Pod itself or at the host system (patient monitor or GuardianSoftware).

WARNING

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

WARNING

Short Range Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a

No Host Monitoring INOP on the NBP Pod, or a cl NBP Disconnect INOP at the host monitor.

Correct channel configuration is important, refer to the Configuration Guide for details.

Assignment at the Measurement Device

To make an assignment, select:

•the

• hold the ◄ key pressed.

This opens the range. In order to save power, the list is only visible for a short time; the menu is automatically closed after 40 seconds.

Add/Remove SmartKey , or

Add To menu which lists the available patient monitors and telemetry devices within the SRR

Telemetry device: A telemetry device must be put into assignment mode by pressing the  key on the telemetry device before it can appear in the list. Pressing the  key starts an SRR channel search to find the clearest channel available. During the search all 4 LEDs will blink once per second. The search will

64

3 IntelliVue CL NBP Pod

take approximately 20-25 seconds. Once a channel is identified, the first LED will light up and blink once per second to indicate that the telemetry device is ready for assignment.

Add To

Mon 1

Mon 2

Tele 33

Tele 44

1 Select a patient monitor or telemetry system using the ◄ and ► keys.

If you select a patient monitor, the measurement selection key on that monitor will change to show the type of measurement device.

2 Activate the assignment by pressing the  key twice on the measurement device.

The Cableless Measurement Device is assigned to the selected patient monitor or telemetry device. A telemetry device plays the assignment tone when the assignment is successful. A patient monitor issues an assignment prompt message.

If the internal measurement in the patient monitor is active (the measurement selection key has a yellow frame), you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign. To do this:

1 Select the measurement selection key on the monitor.

A prompt message appears with the

2 Select

Confirm to deactivate the internal measurement.

Confirm and Cancel keys.

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 SmartKey, then select

Remove From. After confirmation the SRR connection is disconnected.

Assignment at the Patient Monitor

Prepare the Cableless Measurement Device for assignment by activating the

At the patient monitor,

1 Select the Measurement Selection key.

2 Select the

This opens the Devices:

3 Select the device which you want to assign to the patient in the monitor.

4 The monitor displays the assignment prompt message.

If the internal measurement in the patient monitor is active, you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign.

Add cl Msmt pop-up key.

Add cl Measurement window, which shows the available Cableless Measurement

Add/Remove

Add/Remove SmartKey.

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.

65

3 IntelliVue CL NBP Pod

An assigned Cableless Measurement Device can be removed in the more details see the Instructions for Use for your patient monitor.

Assignment with an RFID Reader and Tagged Cableless Devices

You can directly assign all cableless devices that have RFID tags with a Philips HS1-R RFID/barcode reader. The Respiration Pod has a built-in RFID tag. The NBP Pod used must have an IntelliVue ProxiTag RFID tag adhesively attached.

1 Hold the cableless device close to the reader.

Depending on its configuration, the reader beeps, vibrates or indicates via the LEDs when it has read the tag.

2 Press any hardkey on the cableless device.

The Cableless Measurement Device is now added to the monitor.

If the corresponding internal measurement in the patient monitor is active, you will be asked to confirm that it should be deactivated in favor of the Cableless Measurement Device by selecting

If a Cableless Measurement of the same type is already assigned to the monitor, you will be asked to confirm that it should be removed by selecting

Assignment at the Fetal Monitor

The first time an IntelliVue Cableless Measurement Device is used with an Avalon Fetal Monitor, or after a device has been powered off for storage, place it on the Avalon CL Base Station. This will automatically switch the device on. The device is assigned automatically to the Fetal Monitor working with the CL Base Station.

Measurement Selection window. For

Replace.

66

NOTE

When you place a Cableless Measurement Device onto an Avalon CL Base Station to assign it to an Avalon Fetal Monitor, the Cableless Measurement Device is automatically unassigned from the previous patient.

Special Conditions when Working with Fetal Monitors

The following special conditions apply when CL NBP Pods are operating with an Avalon Fetal Monitor as a host:

• The CL NBP Pods are intended to measure the maternal NBP and Pulse. The patient category is always

Adult.

•The

Pulse measurement is always On. The Pulse: On/Off setting is not available.

• Physiological alarms are only available at the Avalon Fetal Monitor, not at the Cableless Measurement Devices. Local attended monitoring is not available:

Use for Transp. is not supported. (Local attended

monitoring is used for displaying alarms locally at the Cableless Measurement Devices during patient transport, when the patient is attended by a caregiver).

• Alarm-related operations (e.g. switching alarms on and off, setting the high and low alarm limits) are not available when

Alarm Mode is set to INOP only in the Avalon Fetal Monitor. See the Avalon Fetal

Monitor Instructions for Use and Avalon Fetal Monitor Configuration Guide for further information.

3 IntelliVue CL NBP Pod

• You can use the

Remove operation at the host to remove Cableless Measurement Devices, as described

in the Avalon Fetal Monitor Instructions for Use.

• STAT mode is not supported.

• Accelerated Measurement mode is not supported.

Assignment with GuardianSoftware

To assign a Cableless Measurement Device to a patient in GuardianSoftware:

1 Select the patient on the

Chalkboard.

2 Take the Cableless Measurement Device from the charger.

3 On the

Equipment List tab, select the Cableless Measurement Device on the Available Equipment list,

highlighted in green on top of the list. The device on top of the list is always the one with the most recent user interaction (taken off the charger, put on the charger, or key pressed).

4 Click

Use for Patient to assign the device to the patient.

Controls Available with a Patient Monitor

The controls available when working with the Cableless Measurement Device and a patient monitor are described in the table below.

Action At the Cableless

Measurement Device

At the Patient Monitor

At the IIC

Start/Stop/Stat NBP Yes Yes Yes

Change NBP Mode Yes Yes No

Change NBP Repetition Time Yes Yes No

Change Alarm Limits Yes* Yes No

Assign NBP Pod Yes Yes No

Remove NBP Pod Yes Yes No

Place Device in Standby Yes Yes Yes

Alarm Silence No Yes Yes

Alarm Off/Pause No Yes Yes

* except when SRR connection to host is lost

WARNING

If a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are not transmitted to the patient monitor or the Information Center. The measurements are available on the Cableless Measurement Device only. If this occurs, the

No Host Monitoring message is

displayed on the measurement device. The measurement device will also sound the INOP tone.

67

3 IntelliVue CL NBP Pod

Controls Available with a Telemetry Device

The controls available when working with the Cableless Measurement Device and a TRx4841/TRx4851A Transceiver or MX40 wearable patient monitor with a short range radio adapter (SRRA) are described in the table below.

Action At the Cableless

Start/Stop/Stat NBP Yes No

Change NBP Mode Yes No

Change NBP Repetition Time Yes No

Change Alarm Limits No Yes

Assign NBP Pod Yes No

Remove NBP Pod Yes Yes

Place Device in Standby No No

Alarm Silence No Yes

Alarm Off/Pause No Yes

NOTE

When you unplug the ECG cable from the telemetry device and plug it into the monitor associated with the same patient, the ECG source will automatically be from the monitor. The NBP measurement devices assigned to the telemetry device will continue to source data to the telemetry device and the Information Center. You may need to change screens on the patient monitor to see the measurements.

Controls Available with GuardianSoftware

The controls available when working with the Cableless Measurement Device and GuardianSoftware are described in the table below.

At the IIC

Measurement Device

Monitoring NBP

The IntelliVue CL NBP Pod uses the oscillometric method for measuring NBP. The blood pressure measurements determined with this device were clinically validated according to ISO 81060-2 in relation to mean error and standard deviation, when compared to auscultatory measurements (depending on the configuration) in a representative patient population. The fifth Korotkoff sound was used to determine the diastolic pressure for adult/adolescent subjects and the 4th for pediatric subjects.

The accuracy of the mean arterial pressure (MAP) was validated using the approximation: MAP

= (SYS

ref

with SYS

ref

The NBP measurement is suitable for use in the presence of electrosurgery and during the discharge of a cardiac defibrillator according to IEC 80601-2-30.

Introducing the Oscillometric NBP Measurement

Oscillometric devices measure the amplitude of pressure changes (oscillations) in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish.

Studies show that, especially in critical cases (arrhythmia, vasoconstriction, hypertension, shock), oscillometric devices are more accurate and consistent than devices using other noninvasive measuring techniques.

+ 2*DIA

ref

and DIA

) / 3

ref

being the blood pressure measured by the auscultatory method.

ref

3 IntelliVue CL NBP Pod

WARNING

Patient Category: Do not use the IntelliVue CL NBP Pod on neonatal patients. The initial inflation pressure and overpressure safety limits are too high for neonatal patients and could cause fractures and bruises.

Intravenous infusion: Do not use the NBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation.

Skin Damage: Do not measure NBP in cases of sickle-cell disease or any condition where skin damage has occurred or is expected.

Existing Wounds: Do not apply the cuff over a wound as this can cause further injury.

Mastectomy: Avoid applying the cuff on the side of the mastectomy, as the pressure increases the risk of

lymphedema. For patients with a bilateral mastectomy, use clinical judgement to decide whether the benefit of the measurement outweighs the risk.

Unattended Measurement: Use clinical judgement to decide whether to perform frequent unattended blood pressure measurements. Too frequent measurements can cause blood flow interference potentially resulting in injury to the patient. In cases of severe blood clotting disorders frequent measurements increase the risk of hematoma in the limb fitted with the cuff.

Temporary Loss of Function: The pressurization of the cuff can temporarily cause loss of function of monitoring equipment used simultaneously on the same limb.

CAUTION

If you spill liquid onto the equipment or accessories, particularly if there is a chance that it can get inside the tubing or the measurement device, contact your service personnel.

69

3 IntelliVue CL NBP Pod

Measurement Limitations

NBP readings can be affected by the position of the patient, their physiological condition, the measurement site, and physical exercise. Thus a physician must determine the clinical significance of the NBP information.

Measurements are impossible with heart rate extremes of less than 40 bpm or greater than 300 bpm, or if the patient is on a heart-lung machine.

The measurement may be inaccurate or impossible:

• with excessive and continuous patient movement such as shivering or convulsions

• if a regular arterial pressure pulse is hard to detect with cardiac arrhythmias

• with rapid blood pressure changes

• with severe shock or hypothermia that reduces blood flow to the peripheries

• with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery

• on an edematous extremity.

Accelerated Measurement

When the accelerated measurement is used the minimum number of oscillations per deflation step is 1, instead of the 2 in the standard measurement. This allows a faster measurement result but requires that the patient keeps the limb in question still. The accelerated measurement is recommended for use when very few or no artifacts are expected, for example with sedated patients.

You can see whether the accelerated measurement is in use by looking in the patient monitor's menu. The measurements or on for changed in Configuration Mode.

When the accelerated measurement is in use, no pulse rate is derived from NBP.

Accelerated Msmt setting shows whether the accelerated measurement is Off, on for Manual

Setup NBP

All measurements. You can see this setting in Monitoring Mode but it can only be

Measurement Modes

There are three modes for measuring NBP:

•

Manual - measurement on demand.

•

Auto - continually repeated measurements (between one minute and 24 hours adjustable interval).

•

Sequence - up to four measurement cycles which will run consecutively, with number of measurements

and interval between them configurable for each cycle.

Auto and Sequence modes must be set up, before a measurement series can be started. See “Enabling

Automatic Mode and Setting Repetition Time” on page 74 and “Enabling Sequence Mode and Setting Up The Sequence” on page 75.

Additionally, you have the possibility to start an immediate, one-time measurement series at any time:

•

STAT - rapid series of measurements over a five minute period. Use only on supervised patients.

After a STAT measurement series, the monitor returns to the previous mode. If an measurement series was running before the STAT measurement, it will continue to run afterwards.

Reference Method

The measurement reference method is always Auscultatory (manual cuff). For further information, see the Application Note supplied on the documentation DVD.

70

Auto or Sequence

Preparing to Measure NBP with Standard Cuffs

1 Apply the carrying pouch to the patient.

2 Apply the cuff to the patient's upper arm at the same level as the heart.

3 IntelliVue CL NBP Pod

If the cuff is not at heart level, you must use the measurement correction formula to correct the measurement.

Make sure that you are using a Philips-approved correct sized cuff and that the bladder inside the cover is not folded or twisted.

A wrong cuff size, and a folded or twisted bladder, can cause inaccurate measurements. The width of the cuff should be in the range from 37% to 47% of the limb circumference. Do not wrap the cuff too tightly around the limb. It may cause discoloration, and ischemia of the extremities.

3 Connect the extension air hose to the cuff.

71

3 IntelliVue CL NBP Pod

4 Connect the extension air hose to the cradle.

Hold the flat part of the connector vertically when plugging it into the inlet, then twist it clockwise to lock into place. Avoid compression or restriction of pressure tubes. Air must pass unrestrictedly through the tubing.

WARNING

Kinked or otherwise restricted tubing can lead to a continuous cuff pressure, causing blood flow interference and potentially resulting in injury to the patient.

5 Place the NBP Pod into the cradle.

6 Put the NBP Pod into the carrying pouch.

Make sure to pinch the velcro enclosures firmly together around the extension hose exiting from the pouch.

CAUTION

Make sure that the air vent, located next to the air tubing connector on the NBP Pod, is not covered during operation. If air cannot enter the air vent, the pump may be damaged.

72

WARNING

Inspect the application site of the cuff regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth and sensitivity. If the skin quality changes, or if the extremity circulation is being affected, move the cuff to another site or stop the blood pressure measurements immediately. Check more frequently when making automatic or stat measurements.

Attaching the Pod Directly to a Mobile CL Cuff

As an alternative to using a carrying pouch, you can attach the NBP Pod directly to the cuff. In this case you do not need the extension hose.

1 Attach the cradle to the NBP cuff.

2 Plug the air tubing into the cradle.

3 Apply the cuff to the patient's upper arm.

Apply the cuff so that the cradle is located at the outside of the arm. The bladder of the cuff is then automatically over the artery.

4 Insert the NBP Pod into the cradle.

Additional Information

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

• Mobile CL Reusable NBP Cuffs Instructions for Use

• Mobile CL Single-Patient NBP Cuffs Instructions for Use

• Mobile CL NBP Cradle Instructions for Use

• Mobile CL Extension Air Hose Instructions for Use

3 IntelliVue CL NBP Pod

Recommendations For Measurements Used in Diagnosis of Hypertension

To make a measurement for use in the diagnosis of hypertension, follow the steps below:

1 Ensure the patient is comfortably seated, with their legs uncrossed, feet flat on the floor and back and

arm supported.

2 Ask the patient to relax and not talk before and during the measurement.

3 If possible, wait 5 minutes before making the first measurement.

73

3 IntelliVue CL NBP Pod

Starting and Stopping Measurements

Use the setup menu or SmartKeys to start and stop measurements.

Action to be Performed NBP Setup menu SmartKeys

Start manual measurement

Start Auto series

Start measurement sequence

Start STAT measurement

Stop Manual measurements

Stop current Auto/sequence measurement

Stop current STAT measurement and end STAT mode

Stop Auto, Manual or STAT measurement, end STAT mode AND Auto/Sequence series

Start/Stop

Start NBP Stat

Start NBP STAT

Start/Stop

Stop All

Depending on the configuration of the NBP Auto/Sequence series, measurements are automatically started within 3 seconds ( has been inserted into the cradle. With

Automatic Start set to Fast) or 3 minutes (Automatic Start set to Slow) after the NBP Pod

Automatic Start set to Off, the Auto/Sequence series have to be

started manually.

No pulse can be derived from the NBP measurement in Accelerated and STAT mode.

If accelerated measurement mode is configured for manual or manual and Auto/Sequence measurements, make sure that the patient is not moving during the measurements.

CAUTION

Use clinical judgment to decide whether to perform repeated series of STAT measurements because of the risk of purpura, ischemia and neuropathy in the limb with the cuff.

Enabling Automatic Mode and Setting Repetition Time

1 In the NBP menu, select Mode and select Auto from the pop-up menu.

2 For an automatic measurement, select

Repeat and set the time interval between two measurements.

74

Enabling Sequence Mode and Setting Up The Sequence

1 In the NBP menu, select Mode and select Sequence from the pop-up menu.

2 Select

3 Select each phase in turn (A, B, C and D) and select the number of measurements and the time interval

4 To have measurements continue after the sequence, set the number of measurements for your last

CAUTION

Setup Sequence to open the Setup Sequence menu.

Up to four measurement phases can be setup which will run consecutively. For each phase you can set the number of measurements and the interval between them. If you want to run less than four phases in a sequence, you can set the number of measurements for one or more phases to

between the measurements.

phase to

Cont and this phase will run indefinitely.

3 IntelliVue CL NBP Pod

Off.

Be aware that, if none of the phases are set to

Cont, NBP monitoring will end after the last measurement of

the last phase.

When the NBP measurement mode is set to Sequence, the repetition time for Auto mode cannot be changed.

Announcement Tone:

Depending on the configuration of the NBP Pod, a tone before each measurement announces the next measurement. Please inform the patient to stop moving, and especially stop moving the arm with the cuff, when the tone sounds and the cuff inflates in order to allow a fast and accurate measurement.

Understanding the NBP Numerics and Symbols

1 Systolic/Diastolic pressure

2 Mean pressure

3 Pulse rate

4 Pulse rate indicator

5 Measurement mode (see below)

6 Alarms Off symbol for Pulse (Pulse from NBP does not

have alarm capability, therefore it cannot be switched on)

7 Timestamp

8 Alarms Off symbol for NBP

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

Measurement Devices when not assigned to a host.

Measurement modes with a series of measurements can be indicated with two different symbols:

indicates that a series is running and shows the relative time to the next measurement.

An S in front of the symbol indicates

Sequence mode and an A, B, C or D indicates which phase of the

indicates that auto or sequence mode is selected but the measurement series has not yet started.

sequence is currently running.

75

3 IntelliVue CL NBP Pod

During Measurements

The cuff pressure is displayed instead of the timestamp.

Correcting the Measurement if Limb is not at Heart Level

To correct the measurement if the limb is not at heart level, to the displayed value

Add 0.75 mmHg (0.10 kPa) for each centimeter higher or

Add 1.9 mmHg (0.25 kPa) for each inch higher. Deduct 1.9 mmHg (0.25 kPa) for each inch lower.

When Unexpected Values are Measured

When values measured are higher or lower than expected, check the following potential causes:

Possible Cause Solution

The patient was talking or moving before or during the measurement.

The incorrect cuff size was used or the cuff was not at heart level

Measurement limitations have not been taken into account.

Switching Pulse from NBP On/Off

In the process of making the NBP measurement, a pulse value can be derived and displayed. The pulse value is displayed together with the time the measurement was made. After one hour the value becomes invalid. There are no alarms associated with pulse from NBP.

When the accelerated measurement is in use, no pulse value can be derived.

To switch the display of the pulse value on or off:

•In the

NBP menu select Pulse.

Deduct 0.75 mmHg (0.10 kPa) for each centimeter lower or

Allow the patient to rest quietly, then try again after three to five minutes.

Check the cuff size, level, and position then repeat the measurement.

Check the list in “Measurement Limitations” on

page 70.

Assisting Venous Puncture

You can use the NBP cuff to cause subdiastolic pressure. The cuff deflates automatically after a set time (adult/pediatric 170 seconds) if you do not deflate it.

1 In the

2 Puncture vein and draw blood sample.

3 Reselect

During measurement, the NBP display shows the inflation pressure of the cuff and the remaining time in venous puncture mode.

NBP menu select Veni Puncture, or select the Veni Puncture SmartKey.

Veni Puncture to deflate the cuff.

Calibrating NBP

NBP is not user-calibrated. NBP pressure transducers must be verified and calibrated, if necessary, at least once every two years by a qualified service professional. See the Service Guide for details.

76

Alarms

3 IntelliVue CL NBP Pod

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

Patient Alarms

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

Technical Alarms (INOPs)

Technical alarms, also known as INOPs, indicate that the measuring device cannot measure reliably. If an INOP interrupts monitoring, there will be a question mark in place of the measurement numeric. An INOP tone sounds at the Cableless Measurement Device only when there is no SRR connection to a host. Exception: the Battery empty INOP tone sounds also with SRR connection.

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

Alarm Delays

There is a delay between a physiological event at the measurement site and the corresponding alarm indication at the Cableless Measurement Device. This delay has two components:

• The general measurement delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing.

• The time between the displayed numerical values crossing an alarm limit and the alarm indication on the device is the system alarm delay. The system alarm delay is the processing time the system needs for any alarm on the Cableless Measurement Device to be indicated after the measurement has triggered the alarm. This delay depends on the Cableless Measurement Device and the connected host system. See the performance specifications in the chapter “IntelliVue CL NBP Pod Specifications” on page 135 for the system alarm delay specification of the Cableless Measurement Device.

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

Multiple Alarms

If more than one alarm is active, the alarm messages are shown in the alarm status area in succession. An arrow symbol next to the alarm message informs you that more than one message is active.

The Cableless Measurement Device sounds an audible indicator for the highest priority alarm. If more than one alarm condition is active in the same measurement, the Cableless Measurement Device announces the most severe.

NOTE

If you want to use local attended monitoring, make sure to have all Cableless Measurement Devices upgraded to at least Rev. B.02.

Visual Alarm Indicators

WARNING

• No patient alarms are available on the Cableless Measurement Devices when assigned to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware.

• Visual patient alarm indicators are disabled on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware.

77

3 IntelliVue CL NBP Pod

Alarm Message

Alarm messages are displayed in black on a light gray background in the alarm status area at the top of the screen indicating the source of the alarm and coded according to their severity. If more than one

measurement is in an alarm condition, the message changes every few seconds, and has an arrow ( ) at the side. The asterisk symbols ( yellow alarms. Standard INOPs do not have a symbol, red and yellow INOPs have exclamation marks beside the alarm message:

An alarm message that appears is automatically highlighted. Use the  key to silence the message. A message is displayed at the bottom of the screen and highlighted. Press  again to confirm the acknowledgment of the alarm. After the confirmation, any ongoing alarm message is displayed in the icon tray of the screen.

Alarm States

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

Icon Description

*) beside the alarm message match the alarm priority: *** for red alarms, ** for

!!! for red INOPs and !! for yellow INOPs.

Silence

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.

Audible Alarm Indicators

Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching).

Cableless Measurements Devices alone (without host, e.g. a patient monitor) are not suitable for unattended monitoring due to their limited alarm volume.

WARNING

• Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.

• No patient alarms are available on the Cableless Measurement Devices when connected to a host monitor (unless they are selected for use in patient transport at the monitor they are assigned to) or to GuardianSoftware.

• When connected to a host monitor or GuardianSoftware, no alarm tones are available on the Cableless Measurement Devices (unless they are selected for use in patient transport at the monitor they are assigned to).

Alarms are switched off.

Alarm volume is set to 0.

78

Silencing an Alarm

To silence an alarm, press the  key.

This will silence the alarm tone and clear the alarm message. If the condition which caused the alarm is still present, the alarm indicator will be displayed on the right hand side of the screen.

When using a Cableless Measurement Pod with an IntelliVue Information Center iX Release A, make sure to remove the pod at the telemetry device and only when in SRR range of the telemetry device. Otherwise you will get a technical alarm (

cl NBP Disconnect) that can not be silenced at the telemetry device. You will

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

Displaying a List of Current Alarms

To display a list of the currently active alarms,

1 Select the

2 Select

Alarms SmartKey or Main Setup SmartKey, followed by Alarms.

Alarm Messages.

3 IntelliVue CL NBP Pod

1 Full length alarm message

2 Alarm indicator

Setting the Volume of the Alarm Tone

To set the volume for the Alarm tone,

1 Select the

2 Select

Alarms SmartKey or Main Setup SmartKey, followed by Alarms.

AlarmVol and select a volume setting. The maximum is 10 and the minimum depends on your

configuration.

If the volume of the Alarm tone is set to zero, the following symbol is displayed on the right icon tray of the

Cableless Measurement Device screen:

Minimum Volume for No Host Monitoring INOP

If your device is connected to a host monitor, and the connection is interrupted, the INOP message No

Host Monitoring

will appear within 30 seconds, accompanied by an INOP tone. To help ensure that this INOP, and any other active alarm, is not overlooked, the INOP and alarm tones may be configured to have a minimum volume. In this case, INOP and alarm tones will sound even if the device alarm volume is set to zero.

Alarm Reminder

If Reminder is configured on your device, you will get an audible reminder of alarm conditions that remain active after you have silenced the alarm. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). Alarm Reminder is not available for standard, light blue INOPs but for yellow and red INOPs.

In Configuration Mode, you can set the interval between silencing the alarm and sounding the reminder tone to one, two, or three minutes.

79

3 IntelliVue CL NBP Pod

Pausing or Switching Off Alarms

If you want to temporarily prevent alarms from sounding, for example while you are moving a patient, you can pause alarms. Depending on your device configuration, alarms are paused for one, two, or three minutes, or infinitely. Infinite alarm pause is equivalent to switching the alarms off.

To view the alarm pause setting chosen for your unit,

1 In the SmartKeys Menu select

2 Check the setting.

This setting can only be changed in Configuration Mode.

To Pause or Switch Off Alarms

Select the key in the SmartKeys Menu followed by Alarms. Press the  hardkey to switch to

Paused. If your device is configured to infinite pause time, selecting this option switches alarms off.

Restarting Paused Alarms

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

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

Main Setup, Alarms, then OffDurat.

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

Choosing the NBP Alarm Source

You can monitor for alarm conditions in systolic, diastolic and mean pressure, either singly or in parallel. Only one alarm is given, with the priority of mean, systolic, diastolic.

In the

NBP menu, select Al. from and choose from:

Menu Option Displayed as Pressure value monitored

Sys. Sys. systolic

Dia. Dia. diastolic

Mean Mean mean

Sys & Dia S & D systolic and diastolic in parallel

Dia & Mean D & M diastolic and mean in parallel

Sys & Mean S & M systolic and mean in parallel

Sys&Dia&Mean S&D&M all three pressures in parallel

Mean is not selected as alarm source (Sys., Dia., or Sys & Dia selected), but the monitor can only derive a

If mean value, mean alarms will nevertheless be announced using the most recent mean alarm limits. Check that the mean alarm limits are appropriate for the patient, even when not using mean as the alarm source. When no value can be derived an

NBP Measure Failed INOP will be displayed.

80

Alarm Limits

The alarm limits you set determine the conditions that trigger limit alarms.

WARNING

Be aware that the devices in your care area may each have different alarm settings, to suit different patients. Always check that the alarm settings are appropriate for your patient before you start monitoring.

Adjusting the Alarm Limits

1 Select the Alarms SmartKey followed by Alarm Limits (or select Main Setup followed by NBP).

2 Depending on your alarm source:

a. Select

b. Select

Sys.High, Dia.High and/or MeanHigh then choose the high alarm limit.

Sys. Low, Dia. Low and/or Mean Low then choose the low alarm limit.

Latching Alarms

The alarm latching setting for your device defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the device after the alarm condition ends. The indication lasts until you acknowledge the alarm.

3 IntelliVue CL NBP Pod

Viewing the Alarm Latching Settings

To see the alarm latching setting for your device,

1 In the

2 Here you can see the

Main Setup menu, select Alarms.

Visual Latching and Audible Latching settings.

This setting can only be changed in Configuration Mode. You should be aware of the settings chosen for your unit. There are three possible choices each for visual and audible latching, red only, red and yellow, and off. These choices can be combined to give the following settings:

Visual Latching Audible Latching

Red&Yellow Red&Yellow

Red&Yellow Red Only

Red&Yellow Off

Red Only Red Only

Red Only Off

Off Off

Alarm Latching Behavior

As NBP is an aperiodic parameter, "Alarm condition no longer present" means either that for a measurement in alarm the alarm limits are changed in such a way that the value is now within the limits, or that a new measurement is done with a value within the limits.

81

3 IntelliVue CL NBP Pod

Red & Yellow Measurement

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

Alarms

Alarm has not been acknowledged.

Alarm has been acknowledged.

Alarm condition still present.

Alarm condition no longer present.

Alarm condition still present.

Alarm condition no longer present.

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

All audible and visual alarm indicators automatically stop.

Audible and visual alarm indicators automatically stop.

All INOPs are non-latching. NBP specific INOPs generated by the CL Pod are latching.

Testing Alarms

When you switch the CL NBP Pod on, a selftest is started. You must check that the backlight switches on, and that you hear a single tone. This indicates that the alarm indicators are functioning correctly. For further testing of individual measurement alarms, perform the measurement on yourself or use a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed.

Alarm Behavior at Power On

If the device is switched off (Standby), all alarm settings are maintained. If the device is switched off completely ( settings will be lost unless they were actively saved by storing the active profile before the device was switched off. See “Switching the Device Off” on page 17 and “Using Profiles” on page 18 for details.

When the device is switched back on from either state, it will start in Profile A and you may have to switch to the desired profile which contains your alarm settings.

After any of these situations, you should check that the alarm settings are appropriate for your patient and monitoring situation, and if necessary, select the correct Profile and patient category.

Power Off), or the battery is completely empty, resulting in complete power loss, all alarm

message.

Alarm tone on. Alarm message.

All audible and visual alarm indicators automatically stop.

Audible and visual alarm indicators automatically stop.

non-latching

Alarm tone on. Alarm message.

Alarm message. Audible alarm indicators automatically stop.

All audible and visual alarm indicators automatically stop.

Audible and visual alarm indicators automatically stop.

Reference List of Patient Alarms

Alarm Message, Indication Source Condition

** NBPs High

** NBPd High

** NBPm High

** NBPs Low

** NBPd Low

** NBPm Low

NBP The measured NBP value is above the high alarm limit.

s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit.

NBP The measured NBP value is below the low alarm limit.

s, d, or m after the label indicates whether the systolic, diastolic or mean pressure has crossed the limit.

Reference List of all INOPs

82

INOP Message, Indication Source What to do

3 IntelliVue CL NBP Pod

Batt Incompatible

INOP tone

Batt Malfunction

INOP tone

Battery Empty

INOP tone

Battery Low

INOP tone

Check Batt Temp

INOP tone

Check Battery

INOP tone

Check Charger I/F

INOP tone

cl NBP ChkSettings

INOP tone

cl NBP Disconnect

only at the host

Cuff Not Deflated

Numeric is replaced by -?INOP tone

During this INOP, alarms cannot be paused or switched off.

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.

Battery Malfunction of the battery system detected (charger circuit

or battery). Contact your service personnel.

Battery The remaining monitoring time is below 30 minutes. Charge

battery.

Battery The remaining monitoring time is below 2 hours.

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.

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.

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.

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.

Cableless Measurement Device

The NBP Pod has lost the SRR connection to the telemetry device or the patient monitor.

NBP The NBP cuff pressure has exceeded 15 mmHg (2 kPa) for

more than 3 minutes.

Remove the cuff from the patient. Make sure that the tubing is not kinked or twisted and that the correct patient category is selected. Try repeating the measurement. You can acknowledge the INOP, but the INOP message remains visible until the next NBP measurement is started or the

Stop All SmartKey is selected.

83

3 IntelliVue CL NBP Pod

INOP Message, Indication Source What to do

NBP Check Cuff

Numeric is replaced by -?INOP tone

NBP Cuff Overpress

Numeric is replaced by -?INOP tone

During this INOP, alarms cannot be paused or switched off.

NBP Equip Malf

Numeric is replaced by -?INOP tone

NBP Interrupted

Numeric is replaced by -?INOP tone

NBP Measure Failed

Numeric is replaced by -?INOP tone

NBP Neo Patient?

Numeric is replaced by -?INOP tone

No Cradle

Numeric is replaced by -?INOP tone

NBP Check if cuff is connected to the NBP Pod and cuff is

applied to the patient; check tubing and cuff for leakage.

Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the

Stop All SmartKey is

selected.

This INOP arises when the maximum time for inflation is exceeded or when there is a significant change in inflation time between two successive measurements in auto and sequence mode.

NBP The NBP cuff pressure exceeds the overpressure safety

limits. Remove the cuff from the patient. Make sure that the tubing is not kinked or twisted and that the correct patient category is selected. Try restarting the measurement. You can acknowledge this INOP, but the INOP message remains visible until the next measurement is started or the

Stop All SmartKey is selected.

NBP Remove the NBP Pod and cuff from the patient. The NBP

hardware is faulty. Contact your service personnel. You can acknowledge this INOP, but the INOP message remains visible until the next measurement is started or the

Stop All

SmartKey is selected.

NBP Check the tubing and cuff for leakages or kinks. Check that

you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the

Stop All SmartKey is selected. This INOP

arises when the measurement needed longer than the maximum time for deflation or the total measurement.

NBP Check that you are using the correct cuff size and

placement, and that the correct patient category is selected. Try restarting the measurement. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the

Stop All SmartKey is selected.

Check the condition and suitability of the patient for NBP monitoring. Use another cuff to continue measuring.

NBP The patient monitor that the NBP pod is assigned to is in

neonatal mode or a neonatal cuff has been detected. The monitor must be in adult or pediatric mode.

NBP The NBP Pod is not in the cradle. You can silence this

INOP, but the INOP message remains visible until the NBP Pod is inserted into the cradle and the next measurement is started or the

Stop All SmartKey is selected.

If INOP appears with the NBP Pod inserted into the cradle, remove and replace the cradle.

84

INOP Message, Indication Source What to do

3 IntelliVue CL NBP Pod

No Host Monitoring

INOP tone

No System Cableless Measurement

Cableless Measurement Device

Device

Remove From Pat

INOP tone

Service Battery

Cableless Measurement Device

Battery Maximum number of charge/discharge cycles for battery

INOP tone

There is a problem with the communication to the assigned patient monitor and monitoring is currently not possible (no patient alarms or information). Check the connection. Contact your service personnel.

There is a problem with the communication to the network and central monitoring is currently not possible. Check the connection.

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.

exceeded. Charging of the battery is inhibited. Contact your service personnel to replace battery.

85

3 IntelliVue CL NBP Pod

Local Attended Monitoring

When working with an IntelliVue MP5, MP5SC, MP5T Patient Monitor with software revision J.2 or higher as a host, or with an IntelliVue X2 Multi-Measurement Module with software revision K.2 or higher, the IntelliVue CL SpO

you want to have alarm indications at the CL Pods when they are out of reach of the patient monitor (disconnected). The patient monitor setting to switch CL Measurement Alarms on and off (

) is used to enable and disable this functionality. As a default, the CL Measurement Alarms are on.

Off

Local Attended Monitoring Enabled

By default, the patient monitor is set to receive alarms from the CL Pods (can only be changed in configuration mode). This scenario is used for patients who require uninterrupted monitoring. The various alarms from the CL Pods are indicated at the patient monitor if they are enabled at the monitor. When the CL Pod is disconnected from the patient monitor and the caregiver has activated the transport mode at the monitor, physiological alarms are indicated locally at the CL Pod. A the monitor if the SRR connection is lost and the transport mode has not been activated.

CL Pod connected to a patient monitor and CL Measurement Alarms On (Standard Use Model):

and NBP Pods can be used for local attended monitoring. This is for situations where

2

cl Alarms On/

cl NBP Disconnect INOP is shown at

SRR connection

At the CL Pod: Indication of technical alarms only

At the monitor: Indication of physiological and technical alarms from CL Pods

CL Pod disconnected from patient monitor and CL Measurement Alarms On, Local Attended Monitoring:

No SRR connection

At the CL Pod: Indication of technical and physiological alarms

At the monitor: No indication of physiological alarms from CL Pods. No indication of technical alarms after disconnection.

86

Local Attended Monitoring Disabled

The patient monitor is set to cl Alarms Off (this can only be done in configuration mode). This scenario is used if the patients do not require permanent monitoring and are mobile, but vital signs are taken from time to time. All alarms from the CL Pods are switched off at the monitor. If the SRR connection is lost, no

NBP Disconnect

CL Pod connected to a patient monitor and CL Measurement Alarms Off:

INOP is shown at the monitor in this scenario.

3 IntelliVue CL NBP Pod

cl

SRR connection

At the CL Pod: Indication of technical alarms only

At the monitor: No indication of physiological alarms from CL Pods. Indication of technical alarms from CL Pods.

CL Pod disconnected from patient monitor and CL Measurement Alarms Off:

No SRR connection

At the CL Pod: Indication of technical alarms only

At the monitor: No indication of physiological and technical alarms from CL Pods.

87

3 IntelliVue CL NBP Pod

Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms On

12

Standard Use Model Local Attended Monitoring

-> Caregiver activates 'Use for transport'

<Caregiver activates 'Use with monitor'

SRR connection

Action / Event Situation Alarm Availability

at CL Pod

no SRR connection

Alarm Availability at Patient Monitor

Standard Use Model:

normal operation, no special action

88

CL Pod connected to the patient monitor (1)

Technical alarms (own)

No physiological alarms

No Local Alarming icon is displayed:

Technical alarms (own + from Pod)

Physiological alarms (own + from Pod)

3 IntelliVue CL NBP Pod

Activation of Local Attended Monitoring:

Caregiver activates Local Attended Monitoring and

Patient is in transport without connection to the host system, caregiver attends the patient (2)

Technical alarms (own)

Physiological alarms (own)

disconnects CL Pod temporarily by setting Patient Monitor's

Use for Transp. in the

Equipment

window

Deactivation of Local Attended Monitoring:

Caregiver deactivates Local Attended Monitoring and reconnects CL Pod to a patient monitor by setting

in the patient monitor's

Monitor Equipment window

Use with

Patient returns from transport. Back to the standard use model (1)

Technical alarms (own)

No physiological alarms

No Local Alarming icon is displayed:

Special Case: Connection lost while in Standard Use Model

Action / Event Situation Alarm Availability

at CL Pod

Technical alarms (own)

Physiological alarms (own)

No alarms from CL Pod

Technical alarms (own + from Pod)

Physiological alarms (own + from Pod)

Alarm Availability at Patient Monitor

Alternative Use Model:

CL Pod temporarily disconnected from a monitor due to unintentional loss of connection (e.g. out of range), Local Attended Monitoring has not been activated by the caregiver

No Host Monitoring INOP

at CL Pod

cl NBP Disconnect INOP

at patient monitor

Local Attended Monitoring is automatically activated (2)

Technical alarms (own)

Physiological alarms (own)

Technical alarms (own)

Physiological alarms (own)

No alarms from CL Pod

89

3 IntelliVue CL NBP Pod

Alarm Availability: Standard Use Model versus Local Attended Monitoring with CL Measurement Alarms Off

34

Patient within Range Patient Mobile

->

Patient mobile

<-

Patient back

SRR connection

Action / Event Situation Alarm Availability

at CL Pod

no SRR connection

Alarm Availability at Patient Monitor

Connected, but no CL Alarms (CL Measurement Alarms Off):

normal operation, no special action

90

CL Pod connected to the patient monitor (3)

Technical alarms (own)

No physiological alarms

No Local Alarming icon is displayed:

Technical alarms (own + from Pod)

Physiological alarms (own)

3 IntelliVue CL NBP Pod

Patient is leaving the vicinity of the monitor:

no special action

Patient returns to the vicinity of the monitor:

Patient is mobile without connection to the host system (4)

Patient returns. Back to connected status (3)

no special action

NBP Default Settings

These are the most important default settings of your IntelliVue CL NBP Pod as they are delivered from the factory. For a comprehensive list and explanation of default settings, see the Configuration Guide supplied with your devices. The default settings can be permanently changed in Configuration Mode. When the Pod is assigned to a patient monitor, the settings defined at the patient monitor will overwrite the settings defined at the Pod.

Technical alarms (own)

No physiological alarms

Alarms Off icon is displayed in front of each numeric:

Technical alarms (own)

No physiological alarms

No Local Alarming icon is displayed:

Technical alarms (own)

Physiological alarms (own)

No alarms from CL Pod

Technical alarms (own + from Pod)

Physiological alarms (own + from Pod)

NBP Settings

Adult Pedi

Mode Auto Auto

Al. from Sys. Sys.

Sys.High 160 120

Dia.High 90 70

MeanHigh 110 90

Sys. Low 90 70

Dia. Low 50 40

Mean Low 60 50

Alarms On On

NBP On On

Repeat Time 10 min 10 min

Pulse On On

Unit mmHg mmHg

Done Tone Off Off

Start Time Synchronized Synchronized

VP Pressure 60 mmHg 40 mmHg

Reference Auscultatory Auscultatory

91

3 IntelliVue CL NBP Pod

NBP Settings

Adult Pedi

Aging Time 10 min 10 min

Color Red Red

AnnouncementTone Off Off

Automatic Start Off Off

Accelerated Msmt Off Off

Integrated Battery Handling

Only qualified and authorized service personnel (biomedical engineers or technicians) should change batteries.

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.

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

Store the device in a state of charge in the range of 40-50% and power off the device completely.

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).

optimize performance, a fully (or almost fully) discharged battery should be charged as soon as possible.

When not in use for an extended period of time, or when the device is shipped.

92

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:

1 Select the

2 Press 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.

Battery Smartkey or Main Setup followed by Battery.

3 IntelliVue CL NBP Pod

Accessories

You can order parts and accessories from Philips supplies at www.medical.philips.com or consult your local Philips representative for details. Also consult the accessories' Instructions for Use, if available.

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.

Accessories Compliant with EMC Standards

All accessories listed in the accessories sections comply, in combination with the IntelliVue Cableless Measurements, with the requirements of IEC 60601-1-2.

93

3 IntelliVue CL NBP Pod

IntelliVue CL NBP Pod Accessories

Mobile CL Cuffs and Accessories

Part Number Description Limb

Circumference Range

989803163171 Mobile CL Reusable Small Adult

Cuff

989803163191 Mobile CL Reusable Adult Cuff 26.0 - 34.5 cm 1 cuff

989803163211 Mobile CL Reusable Large Adult

Cuff

989803163181 Mobile CL Single-Patient Small

Adult Cuff

989803163201 Mobile CL Single-Patient Adult

Cuff

989803163221 Mobile CL Single-Patient Large

Adult Cuff

989803163251 Mobile CL NBP Cradle Kit - 20 cradles

989803163131 Mobile CL Extension Air Hose,

1.0 m

989803187431 Mobile CL Air Hose - Bayonet

Connector

989803163261 Mobile CL NBP Battery Kit - 1 Battery

989803137831 Telemetry Pouch with window - 50 pouches

989803140371 Telemetry Pouch with window - 4 boxes of

989803101971 (9300-0768-050)

989803101981 (9300-0768-200)

White Telemetry Pouch with Snaps; box of 50

White Telemetry Pouch with Snaps; 4 boxes of 50

21 - 27 cm 1 cuff

33.5 - 45.0 cm 1 cuff

21 - 27 cm 20 cuffs

26.0 - 34.5 cm 20 cuffs

33.5 - 45.0 cm 20 cuffs

- 1 extension air hose

- 1 adapter air hose

- 50 pouches

- 4 boxes of

Contents

1 disassembly tool 1 front housing

50 pouches

Comfort Care Reusable Cuffs

Part Number Description Limb Circumference Range

M1571A Infant cuff 10.0 - 15.0 cm

M1572A Pediatric cuff 14.0 - 21.5 cm

M1573A Small adult cuff 20.5 - 28.0 cm

M1573XL Small adult cuff, XL 20.5 - 28.0 cm

M1574A Adult cuff 27.0 - 35.0 cm

M1574XL Adult cuff, XL 27.0 - 35.0 cm

M1575A Large adult cuff 34.0 - 43.0 cm

M1575XL Large adult cuff, XL 34.0 - 43.0 cm

94

3 IntelliVue CL NBP Pod

Part Number Description Limb Circumference Range

M1576A Thigh cuff 42.0 - 54.0 cm

M1577A Kit of small cuffs (M1571A to M1574A)

M1578A Kit of large cuffs (M1573A to M1576A)

M1579A Kit of all cuffs (M1571A to M1576A)

Easy Care Reusable Cuffs

Part Number Description Limb Circumference Range

M4552B Infant cuff 10.0 - 15.0 cm

M4552B5 Pack of 5 M4552B cuffs

M4553B Pediatric cuff 14.0 - 21.5 cm

M4553B5 Pack of 5 M4553B cuffs

M4554B Small adult cuff 20.5 - 28.5 cm

M4554B5 Pack of 5 M4554B cuffs

M4555B Adult cuff 27.5 - 36.0 cm

M4555B5 Pack of 5 M4555B cuffs

M4556B Adult cuff, XL 27.5 - 36.0 cm

M4556B5 Pack of 5 M4556B cuffs

M4557B Large adult cuff 35.0 - 45.0 cm

M4557B5 Pack of 5 M4557B cuffs

M4558B Large adult cuff, XL 35.0 - 45.0 cm

M4558B5 Pack of 5 M4558B cuffs

M4559B Thigh cuff 44.0 - 56.0 cm

M4559B5 Pack of 5 M4559B cuffs

864288 Assortment pack of one small adult, one adult, one large adult

and one thigh cuff

864289 Assortment pack of one infant, one pediatric, one small adult

and one adult cuff

864290 Assortment pack of one infant, one pediatric, one small adult,

one adult, one large adult and one thigh cuff

864291 Assortment pack of one small adult, one adult, one adult XL,

one large adult, one large adult XL and one thigh cuff

Multi Care Cuffs

Part Number Description Limb Circumference Range

989803183311 Infant cuff 10.0 - 15.0 cm

989803183321 Pediatric cuff 14.0 - 21.5 cm

989803183331 Small adult cuff 20.5 - 28.0 cm

989803183341 Adult cuff 27.0 - 35.0 cm

989803183351 Adult cuff, XL 27.0 - 35.0 cm

95

3 IntelliVue CL NBP Pod

Part Number Description Limb Circumference Range

989803183361 Large adult cuff 34.0 - 43.0 cm

989803183371 Thigh cuff 42.0 - 54.0 cm

Single Patient, Gentle Care Cuffs

Part Number Description Limb Circumference Range

M4572B Infant cuff 10.0 - 15.0 cm

M4573B Pediatric cuff 14.0 - 21.5 cm

M4574B Small adult cuff 20.5 - 28.5 cm

M4575B Adult cuff 27.5 - 36.0 cm

M4576B Adult cuff, XL 27.5 - 36.0 cm

M4577B Large adult cuff 35.0 - 45.0 cm

M4578B Large adult cuff, XL 35.0 - 45.0 cm

M4579B Thigh cuff 44.0 - 56.0 cm

Single Care Cuffs

Part Number Description Limb Circumference Range

989803182281 Pediatric cuff 14.0 - 21.5 cm

989803182291 Small adult cuff 20.5 - 28.5 cm

989803182301 Adult cuff 27.5 - 36.0 cm

989803182311 Adult cuff, XL 27.5 - 36.0 cm

989803182321 Large adult cuff 35.0 - 45.0 cm

Value Care Cuffs

Part Number Description Limb Circumference Range

989803160811 Infant cuff 10.0 - 15.0 cm

989803160821 Pediatric cuff 14.0 - 21.5 cm

989803160831 Small adult cuff 20.5 - 28.5 cm

989803160841 Adult cuff 27.0 - 35.0 cm

989803160851 Adult cuff, XL 27.0 - 35.0 cm

989803160861 Large adult cuff 34.0 - 43.0 cm

96

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:

1 Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are

not cracked or broken, that everything is present, that there are no spilled liquids and that there are no signs of abuse.

2 Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use them.

WARNING

3 IntelliVue CL NBP Pod

If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient, contact your service personnel.

Maintenance Task and Test Schedule

All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for Philipsqualified service professionals only.

Ensure that these tasks are carried out as indicated by the device's maintenance schedule, or as specified by local laws. Contact a Philips-qualified service provider if your device needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it.

Troubleshooting

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

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

double check that you have set up the measurement correctly. Check also that the measurement has not been switched off at the patient monitor that the device is assigned to.

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

97

3 IntelliVue CL NBP Pod

98

4IntelliVue CL Respiration Pod

For respiration measurement, attach the Cableless Respiration Pod to the patient's left costal arch using the Mobile CL Respiration Pod Attachment. As an option, the Respiration Pod also provides pulse measurement. The CL Respiration Pod also provides information about patient posture (positions like supine, prone, upright,...) and activity (e.g. very high or very low activity).

For details regarding the adhesive attachment (Mobile CL Respiration Pod Attachment), refer to “IntelliVue

CL Respiration Pod Accessories” on page 111.

General Operation of the Respiration Pod

4

The IntelliVue CL Respiration Pod does not have a display and is generally operated via the host system (e.g. patient monitor). The Pod reports the measured values and status information to the host system via SRR.

The IntelliVue CL Respiration Pod has a multi-color LED and a single operation key to display states and allow some basic operation locally.

Putting the Pod into Operation

The first time a CL Respiration Pod is used, place it on the IntelliVue CL Charging Station. This will automatically switch the device on, and the device will become visible to the host (patient monitor or GuardianSoftware).

Checking the Battery Status

Press the key once to check the battery status:

Status LED

Battery OK green

Battery low yellow

Battery empty red

Battery or system malfunction cyan

If the LED is blinking, this means that the Pod is currently not assigned to a host.

99

4 IntelliVue CL Respiration Pod

Recharging the Pod

To recharge the pod, place it on the charging station. During loading, the pod's LED shows the status:

Status LED

Battery full (≥90%) green

Battery loading yellow

Battery malfunction cyan

Power Off

To power off the IntelliVue CL Respiration Pod, take the device from the charging station, then press and hold the key on the pod for five seconds until the LED blinks red. Release the key and press it again to confirm power off. The LED will switch to solid red and fade out. To switch it back on, you must place the device on a charging station. Use this option when the device is not used for a longer time or prepared for storage or shipping.

Connection with Host Systems

The following sections describe how the IntelliVue Cableless Measurement Devices work together with host systems (Patient Monitors 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 two 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 102.

In situations where patients are becoming more mobile (for example, in step-down/intermediate care units) the lightweight Cableless Measurement Devices allow increased mobility within the short range radio range, without giving up vital signs monitoring.

A telemetry device can be assigned to a patient monitor equipped with short range radio at the same time as any Cableless Measurement Devices are also assigned to this monitor.

If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be displayed at the monitor:

With IntelliVue GuardianSoftware

The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware. GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter, Hotspot or MP5 from the Cableless Measurement Devices. Using the collected data, it provides trending, review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application provides basic assessment guidance, helping you to recognize the early signs of deterioration in your patients. GuardianSoftware is not intended for monitoring in combination with Cableless Measurement Devices.

Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table

“Controls Available with GuardianSoftware” on page 103. GuardianSoftware also manages the patient data.

If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the connection symbol will be displayed gray at GuardianSoftware.

cl Resp Disconnect.

100

Philips TRNSBV1, CLNBPBV2, SRRBV7 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1Introduction and Basic Operation

Safety Information

Use Environment

Electrical Hazards

Radiofrequency Interference

Battery Handling

Accessories

Maintenance

Care, Cleaning and Disposal

Security Information

Protecting Personal Information

About HIPAA Rules

About the EU Directives

Philips Product Security Policy Statement

Manufacturer Disclosure Statement for Medical Device Security – MDS2

Introducing the IntelliVue Cableless Measurements

Introduction

Basic Operation

2IntelliVue CL SpO2 Pod

General Operation of the SpO2 Pod

Switching the Device On

Screen Layout

Standard Layout

Alarm Layout

Low-Activity Screen

When a Cableless Measurement Device Cannot be Activated

Using the Hardkeys

Using the SmartKeys

SmartKeys Menu

List of Available SmartKeys

Using the Main Setup Menu

Operating Modes

Switching the Device Off

Using the Patient Menu

Displaying the Patient Menu

Stop Using a Device for a Patient

Using the Device for a New Patient

Using Profiles

Setting the Date and Time

Battery Status

Battery Status Menu

Connection with Host Systems

IntelliVue Cableless Measurements Use Models

With a Patient Monitor

With a Fetal Monitor

With a Telemetry Device

With IntelliVue GuardianSoftware

Device Compatibility

Availability of Patient Alarms

Assigning an IntelliVue Cableless Measurement Device to a Host

Assignment at the Measurement Device

Assignment at the Patient Monitor

Assignment at the Patient Monitor

Assignment with an RFID Reader and Tagged Cableless Devices

Assignment at the Fetal Monitor

Special Conditions when Working with Fetal Monitors

Assignment with GuardianSoftware

Controls Available with a Patient Monitor

Controls Available with a Telemetry Device

Controls Available with GuardianSoftware

Trending

Monitoring SpO2

SpO2 Sensors

Additional Information

Connecting SpO2 Sensors

Removing the Pod from the Cradle

Applying the Sensor

Measuring SpO2

Selecting Measurement Modes

Starting and Stopping Measurements

Understanding SpO2 Numerics and Symbols

SpO2 Signal Quality Indicator

Assessing a Suspicious SpO2 Reading

Changing the Averaging Time

Perfusion Numeric (only available on the Patient Monitor)

Alarms