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Instructions for Use
IntelliVue Cableless
Measurements
CL SpO2 Pod – CL NBP Pod –
CL Respiration Pod
Release D.00
Patient Monitoring
Table 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 |
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Connection with Host Systems |
62 |
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Monitoring NBP |
69 |
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Alarms |
77 |
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Local Attended Monitoring |
86 |
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NBP Default Settings |
91 |
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Integrated Battery Handling |
92 |
|
Accessories |
93 |
|
Maintenance and Troubleshooting |
97 |
|
|
4 IntelliVue CL Respiration Pod |
99 |
General Operation of the Respiration Pod |
99 |
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Connection with Host Systems |
100 |
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Monitoring Respiration |
104 |
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Technical Alarms (INOPs) |
108 |
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Respiration Default Settings |
109 |
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Integrated Battery Handling |
110 |
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Accessories |
111 |
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Maintenance and Troubleshooting |
112 |
|
|
5 Cableless Measurement Auxiliary Devices |
113 |
IntelliVue CL Transmitter and IntelliVue CL Hotspot |
113 |
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IntelliVue CL Transmitter Base Station |
117 |
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3
IntelliVue CL Charging Station |
118 |
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Maintenance and Troubleshooting |
119 |
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6 Care and Cleaning |
121 |
General Points |
121 |
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Cleaning and Disinfecting the IntelliVue Cableless Measurement Devices |
122 |
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Disposing of the IntelliVue Cableless Measurement Devices |
123 |
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|
7 Specifications |
125 |
Indications for Use |
125 |
|
Compatible Medical Devices |
127 |
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Symbols |
127 |
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Manufacturer's Information |
129 |
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Regulatory and Safety Specifications |
129 |
|
EMC and Radio Regulatory Compliance |
130 |
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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 |
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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 |
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|
|
4
1
Introduction and Basic Operation
These Instructions for Use are for clinical professionals using the IntelliVue Cableless Measurements and their specified compatible accessories.
IntelliVue Cableless Measurements refers to the IntelliVue Cableless Measurements product family consisting of the IntelliVue CL SpO2 Pod (865215), IntelliVue CL NBP Pod (865216) and IntelliVue CL
Respiration Pod (865218) with their accessories. Also included are the auxiliary devices: the IntelliVue CL Charging Station (865220), IntelliVue CL Transmitter (865221), IntelliVue CL Transmitter Base Station (865237) and IntelliVue CL Hotspot (865222).
The IntelliVue Cableless Measurements are used for monitoring and recording arterial oxygen saturation, pulse rate, noninvasive blood pressure and respiration rate of adult and pediatric patients.
Familiarize yourself with all instructions including warnings and cautions, and attend one of the training courses, before starting to make measurements with patients. Read and keep the Instructions for Use that come with any accessories, as these contain important information about care and cleaning that is not repeated here.
When using the IntelliVue Cableless Measurements with an IntelliVue Patient Monitor, an Avalon Fetal Monitor, a telemetry system or IntelliVue GuardianSoftware, refer to and adhere to all warnings in the Instructions for Use of the respective device or software.
This guide may contain descriptions of functionality and features that are not implemented in the equipment currently shipped to Japan and/or of products that are not currently sold in Japan due to limitations and restrictions under the applicable local laws and regulations in Japan. Please contact your local sales representative and/or Philips Customer Support for details.
In these Instructions for Use:
•A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.
•A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.
Display refers to the physical display of the Cableless Measurement Device. Screen refers to everything you see on the IntelliVue Cableless Measurement's display, such as measurement values, patient data and so forth.
IntelliVue CL Transmitter/WLAN functionality may not be available in all countries.
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 No Host Monitoring INOP on the NBP or SpO2 Pods, or a cl NBP Disconnect, cl
SpO Disconnect or cl Resp Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the Configuration Guide for details.
Battery Handling
WARNING
•Do not crush or puncture - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally.
•Do not incinerate the devices or expose them to temperatures above 60°C (140°F).
6
1 Introduction and Basic Operation
Accessories
WARNING
•Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard, in particular with regard to cross-contamination.
•Philips’ approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance and cause a potential hazard.
•Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the IntelliVue Cableless Measurement Devices.
Maintenance
WARNING
•Schedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.
•Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier.
•If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient, contact your service personnel.
Care, Cleaning and Disposal
WARNING
•If you spill liquid on the equipment, or if the equipment is accidentally immersed in liquid, contact your service personnel or Philips service engineer. Do not operate the equipment before it has been tested and approved for further use.
•Do not use flammable agents for disinfecting the equipment in an oxygen-enriched environment, as this might lead to sudden ignition of vapors, resulting in injury to the patient or staff.
•To avoid contaminating or infecting personnel, the environment or other equipment, make sure you disinfect and decontaminate the IntelliVue Cableless Measurement Devices appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories, where not otherwise specified, follow local regulations regarding disposal of hospital waste.
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
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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 SpO2 Pod is a battery powered, cableless Pulse Oximetry measuring device.
IntelliVue CL NBP Pod
The IntelliVue CL NBP Pod is a battery powered, cableless, noninvasive blood pressure (NBP) measuring device.
IntelliVue CL Respiration Pod
The IntelliVue CL Respiration Pod is a battery powered, cableless device for measuring respiration rate and, optionally, pulse. It also provides basic information about patient posture and activity.
10
1 Introduction and Basic Operation
Basic Operation
IntelliVue CL SpO2 Pod and IntelliVue CL NBP Pod
The IntelliVue CL SpO2 Pod and the IntelliVue CL NBP Pod can be used together with IntelliVue Patient
Monitors MP5/MP5SC/MP5T, MP2/X2, IntelliVue Telemetry System Transceivers TRx4841A/ TRx4851A, MX40 wearable patient monitors, Avalon Fetal Monitors, and IntelliVue GuardianSoftware. Both devices have an LC display and three keys for basic operation:
1Integrated monochrome LC display
2Hardkeys
3Measurement identifier
IntelliVue CL Respiration Pod
The IntelliVue CL Respiration Pod can be used together with IntelliVue Patient Monitors MP5/MP5SC/ MP5T, MP2/X2, or IntelliVue GuardianSoftware. The device has one multi-color LED for status display and one hardkey for basic operation, e.g. to start a measurement.
1Multi-color LED
2Measurement identifier
3Hardkey
4Indication for built-in RFID tag
11
1 Introduction and Basic Operation
12
2
IntelliVue CL SpO2 Pod
The IntelliVue CL SpO2 Pod is a wrist-worn device; you need a Mobile CL SpO2 Cradle to hold the sensor connector in place and a wristband to fix the cradle to a patient's arm.
Specialized single-patient SpO2 sensors are available for use with the IntelliVue CL SpO2 Pod. For details
regarding the complete set of single-patient supplies, cradle, wristband and sensors, refer to “IntelliVue CL SpO2 Pod Accessories” on page 52.
General Operation of the SpO2 Pod
The following sections describe operation on the SpO2 Pod itself. For operation from a patient monitor, see
“Controls Available with a Patient Monitor” on page 25. For operation from an Information Center via a telemetry system, see “Controls Available with a Telemetry Device” on page 26. For operation with IntelliVue GuardianSoftware, see “Controls Available with GuardianSoftware” on page 27.
The SpO2 Pod has three hardkeys for basic operation and a set of configurable SmartKeys which appear on
the screen. These are used to activate and navigate through the on-screen menus and to select individual items. The typical operator's position is such that everything on the device's display can be read clearly and easily.
Switching the Device On
The first time an SpO2 Pod is used, or after the device has been powered off for storage, place it on the IntelliVue CL Charging Station. This will automatically switch the device on.
If the SpO2 Pod has only been switched off temporarily (see “Switching the Device Off” on page 17), press any hardkey to turn the device on again.
When an SpO2 Pod is not operated, it will automatically switch off the screen lighting after a short time. A little later the low-activity screen will be displayed.
13
2 IntelliVue CL SpO2 Pod
Screen Layout
There are three variations of the Main Screen layout depending on the Alarm status and the general activity level.
Standard Layout
When assigned to a monitor, telemetry device or a patient in GuardianSoftware:
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
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
Alarm Layout
If an alarm occurs the full alarm message appears at the top of the screen. After the alarm message has been silenced the alarm indicator is shown as a symbol on the right side of the screen.
1 Full length alarm message
2 Alarm indicator
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2 IntelliVue CL SpO2 Pod
Low-Activity Screen
If the Cableless Measurement Device has not been operated for a while, the screen lighting will switch itself off and a little later the screen will switch to a pre-configured "low-activity" screen.
When a Cableless Measurement Device Cannot be Activated
If you cannot activate a device by pressing a key, place it on the IntelliVue CL Charging Station. The device becomes active. Check the battery status. If necessary, leave the device on the charger until the battery is fully charged.
Using the Hardkeys
The IntelliVue Cableless Measurement Devices have three hardkeys: ◄, , ►.
Use ◄ and ► to navigate through SmartKeys and menus and to select items or to silence alarms. The three hardkeys also have an additional function when the key is held down for a couple of seconds:
◄opens the Add To screen to assign a device (or to unassign it when it is already assigned)
opens the SmartKeys menu
►returns to the Main Screen. If already on the Main Screen, it locks the keys and a lock symbol appears on the screen above the battery symbol. If keys are already locked, it unlocks the keys and the lock symbol disappears
Using the SmartKeys
A SmartKey is a graphical key which appears on the screen and gives you fast access to functions.
SmartKeys Menu
Press the hardkey (without any screen element highlighted) to get to the SmartKeys menu.
Use the ◄ and ► hardkeys to move along the row of SmartKeys. The highlighted SmartKey is displayed in full above the row of SmartKeys. When you use the ◄ or ► hardkey at the end of the row, an Exit screen appears and then with further presses you move on to the next page of SmartKeys. To leave the SmartKeys menu you can use the Exit screen or press the ► hardkey for a couple of seconds to return to the Main Screen.
When the required SmartKey is highlighted, press the key to activate the corresponding function.
To get to the next page of the SmartKeys menu, highlight the rightmost SmartKey then press the ► key.
15
2 IntelliVue CL SpO2 Pod
List of Available SmartKeys
SmartKey |
Text Labels |
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Main Setup |
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start an SpO2 measurement |
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set the SpO2 mode |
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Add/Remove device |
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enter Battery menu |
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enter Profiles menu |
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change Screen |
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put device in standby mode (or power off when pressed for more than two |
|
seconds) |
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enter Patient menu |
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enters the Alarms menu to access: Alarm Messages, Alarm Limits, Alarms On/ |
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Off/Pause, Alarm Volume. |
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Change alarm volume |
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Change pulse tone volume |
|
|
16
2 IntelliVue CL SpO2 Pod
Using the Main Setup Menu
In addition to the hardkeys and SmartKeys for the most needed functions, the Main Setup menu gets you to all settings that can be adjusted for the respective device. Select the Main Setup SmartKey to get to the Main Setup menu.
Main Setup
SpO
Pulse
Alarms
Patient
Equipment
User Interface
Standby
Profiles
Operating Modes
Date, Time
Battery
Revisions
Switching the Device Off
To put the device in standby mode, select the Standby SmartKey, then Confirm.
If you keep Standby pressed for more than two seconds, you can choose between Standby or Power Off.
•Standby 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:
1Use the Main Setup SmartKey to get to the Main Setup menu.
2Select Operating Modes and choose the mode you require.
Using the Patient Menu
The Patient menu allows you to see patient demographics information and to remove a patient from a device. Patient Demographic information is only displayed if the Cableless Measurement Device is assigned to a patient monitor or GuardianSoftware. Patient Category is the only item of patient data which can be changed at the Cableless Measurement Device, but only when the device is not assigned to a patient monitor or telemetry device.
Displaying the Patient Menu
To display the Patient menu,
•select the Patient SmartKey, or
•select the Main Setup SmartKey followed by Patient.
Stop Using a Device for a Patient
To remove a patient from the Cableless Measurement Device,
•in the Patient menu select Free Device.
All patient data is cleared, settings are reset to the defaults and the device is removed from the monitor or telemetry device.
NOTE
Depending on your configuration, when the device is put on the charger, patient data will also be cleared and the device will be free for another patient.
Using the Device for a New Patient
To use a device for a new patient,
•in the Patient menu, select New Patient.
If the device was not free, the existing data will be deleted and the profile set to the default.
Using Profiles
A profile is a set of measurement and general settings which have been customized for a particular purpose. The Cableless Measurement Devices can have four different profiles configured to your requirements. The default profile is marked with a symbol.
To select a different profile,
1Select the Profiles SmartKey or the Main Setup SmartKey followed by Profiles.
2Select the required profile from the list.
Selecting New Patient or Free Device will always reset the profile to the default.
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2 IntelliVue CL SpO2 Pod
Setting the Date and Time
If the Cableless Measurement Device is assigned to a patient monitor, telemetry device or GuardianSoftware, the date and time will be taken from the host. If this is not the case, you can set the date and time on the Cableless Measurement Device,
1Select the Main Setup SmartKey and then Date, Time.
2Enter the data for date and time one after another.
3Select Store Date, Time.
If the time has not been set, --:-- will display on the device.
Battery Status
The IntelliVue CL SpO2 Pods show their battery status on their display both in operating and charging
condition. The battery status indicator is located in the lower right corner of the screen during operation and in the middle of the screen during charging.
Battery Status Menu
Select the Battery SmartKey or Main Setup followed by Battery using the ◄ and ► keys, then press the key to open the Battery menu. The Battery menu provides the following information: full-charge and remaining capacity, voltage, current and temperature.
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2 IntelliVue CL SpO2 Pod
Connection with Host Systems
The following sections describe how the IntelliVue Cableless Measurement Devices work together with host systems (Patient Monitors, Fetal Monitors, Telemetry Devices / Information Center or GuardianSoftware).
IntelliVue Cableless Measurements Use Models
With these patient-worn measurement devices you can measure and transmit a patient's vitals regularly or on an intermittent data collection basis. There are four typical use models:
With a Patient Monitor
The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T, MP2 or X2 patient monitor (with an SRR interface). They can communicate their measurement values via short range radio to the monitor. The monitor may be assigned to a patient sector at the IntelliVue Information Center (IIC). When assigned to the Information Center, certain actions can be performed at both the patient monitor and the Information Center. See the table “Controls Available with a Patient Monitor” on page 25.
In situations where patients are becoming more mobile (for example, in step-down/intermediate care units) the lightweight Cableless Measurement Devices allow increased mobility within the short range radio range, without giving up vital signs monitoring.
When assigned to a patient monitor, the Cableless Measurement Device can be selected for use in patient transport at the patient monitor (for details see the Patient Monitor Instructions for Use). In this case, the Cableless Measurement Device will perform local attended monitoring. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See “Alarms” on page 34 for details.
A telemetry device can be assigned to a patient monitor equipped with short range radio at the same time as any Cableless Measurement Devices are also assigned to this monitor.
When assigned to a patient monitor, the admitted patient name is displayed on the SpO2 Pod.
If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be displayed at the monitor: cl SpO Disconnect. A No Host Monitoring INOP will be displayed on the SpO2
Pod, and an INOP tone will sound. In this case, visual and audible alarms are still available at the SpO2 Pod, but it is not possible to change the alarm settings.
With a Fetal Monitor
In combination with an Avalon CL Transducer System, the IntelliVue CL SpO2 Pod can be used together with an Avalon FM 20-50 Fetal Monitor. The SpO2 Pods are assigned to the fetal monitor by docking them
at the Avalon CL Base Station. For information about Avalon Fetal Monitors, the Avalon CL Transducer System and the Avalon CL Base Station, please refer to the Avalon Fetal Monitor Instructions for Use.
With a Telemetry Device
The Cableless Measurement Devices can be assigned to a patient with the telemetry device TRx4841A/ TRx4851A or an MX40 wearable patient monitor. They can communicate their measurement values via short range radio to the telemetry device which communicates them to an IntelliVue Information Center to provide a consolidated set of patient values.
Some of the measurement tasks can be performed remotely from the Information Center. See the table “Controls Available with a Telemetry Device” on page 26.
If the patient name is available at the Information Center, it will be also displayed on the SpO2 Pod.
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2 IntelliVue CL SpO2 Pod
When a Cableless Measurement Device is assigned to a telemetry device, it is not possible for the telemetry device to be wirelessly assigned or directly connected to a patient monitor.
If the connection between the telemetry device and the Cableless Measurement Device is lost, an INOP will be displayed at the Information Center: cl SpO Disconnect. A No System Monitor. INOP will be displayed on the SpO2 Pod, and an INOP tone will sound.
With IntelliVue GuardianSoftware
The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware. GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter, Hotspot or MP5 from the Cableless Measurement Devices. Using the collected data, it provides trending, review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application provides basic assessment guidance, helping you to recognize the early signs of deterioration in your patients. GuardianSoftware is not intended for monitoring in combination with Cableless Measurement Devices.
Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table “Controls Available with GuardianSoftware” on page 27. GuardianSoftware also manages the patient data.
If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the connection symbol will be displayed gray at GuardianSoftware. A No System INOP will be displayed on the SpO2 Pod
(no alarm sound).
If a patient name is available at GuardianSoftware, it will be also displayed on the Pod. Any update of patient data will be synchronized between the Pods and GuardianSoftware. The only patient management action available directly at the Pod is Free Device. Selecting Free Device removes the current patient from the Pod and resets the Pod to the default profile. The Pod is unassigned.
Device Compatibility
The IntelliVue CL SpO2 Pods require the following software levels in the associated equipment:
•IntelliVue Patient Monitor - Release H.0 or above
•Avalon Fetal Monitor in combination with an Avalon CL Transducer System - Release J.3 or above
•IntelliVue Information Center - Release M or above
•Philips Patient Information Center iX - Release A or above
•Telemetry device TRx4841A/TRx4851A - Revision D.00.22 or above
•MX40 wearable patient monitor - Revision A.0 or above
•IntelliVue GuardianSoftware - Revision A.0 or above
Availability of Patient Alarms
When the IntelliVue CL SpO2 Pod is used alone, without an assignment to a monitor or telemetry device, no patient alarms will be generated.
When the IntelliVue CL SpO2 Pod is assigned to a patient monitor or telemetry device and a short range radio connection exists, alarms may be announced at the patient monitor or the Information Center.
•When assigned to a patient monitor / fetal monitor: Alarm messages will be displayed and audible alarm indicators sounded at the monitor in the same way and under the same conditions as for its own measurements. See the Instructions for Use of the patient monitor for details.
If a Cableless Measurement Device that is assigned to a patient monitor is selected for use in patient transport at the patient monitor, the Cableless Measurement Device will perform local attended monitoring. See the Instructions for Use of the patient monitor for details on how to do this. The patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement Device are recognized. In local attended monitoring mode, an alarm message text
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2 IntelliVue CL SpO2 Pod
appears in the alarm status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See “Alarms” on page 34 for details.
•When assigned to a telemetry device: Measurement values sent via the telemetry device to the IntelliVue Information Center can generate alarms at the Information Center when the values meet the criteria set there for alarms. The alarms will be announced in the same way as measurements from other sources. See the Instructions for Use of the Information Center for details.
•When assigned to GuardianSoftware: Measurement values sent via transmitter, hotspot or MP5 to IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue GuardianSoftware is a data management system, no alarms are announced. The IntelliVue Cableless Measurement Devices will also not generate physiological alarms when connected to IntelliVue GuardianSoftware. See the Instructions for Use of GuardianSoftware.
Assigning an IntelliVue Cableless Measurement Device to a Host
When an IntelliVue CL SpO2 Pod is used with a host system (patient monitor, telemetry device or GuardianSoftware), the Pod must be assigned to that host system.
The assignment can be done at the CL SpO2 Pod itself or at the host system (patient monitor or GuardianSoftware).
WARNING
Always make sure that the applied CL SpO2 Pod is assigned to the correct patient.
WARNING
Short Range Radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP on the SpO2 Pod, or a cl SpO Disconnect INOP at the host monitor.
Correct channel configuration is important, refer to the Configuration Guide for details.
Assignment at the Measurement Device
To make an assignment, select:
•the Add/Remove SmartKey 
, or
•hold the ◄ key pressed.
This opens the Add To menu which lists the available patient monitors and telemetry devices within the SRR range. In order to save power, the list is only visible for a short time; the menu is automatically closed after 40 seconds.
Telemetry device: A telemetry device must be put into assignment mode by pressing the key on the telemetry device before it can appear in the list. Pressing the key starts an SRR channel search to find the clearest channel available. During the search all 4 LEDs will blink once per second. The search will
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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
1Select a patient monitor or telemetry system using the ◄ and ► keys.
If you select a patient monitor, the measurement selection key on that monitor will change to show the type of measurement device.
2Activate the assignment by pressing the key twice on the measurement device.
The Cableless Measurement Device is assigned to the selected patient monitor or telemetry device. A telemetry device plays the assignment tone when the assignment is successful. A patient monitor issues an assignment prompt message.
If the internal measurement in the patient monitor is active (the measurement selection key has a yellow frame), you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign. To do this:
1Select the measurement selection key on the monitor.
A prompt message appears with the Confirm and Cancel keys.
2Select Confirm to deactivate the internal measurement.
When the Cableless Measurement Device is assigned, the 
symbol appears on its display indicating that alarming capability has been transferred to the host (to the monitor or, for the telemetry device, to the Information Center). No patient alarms will be announced on the Cableless Measurement Device.
To unassign the measurement device from the monitor or telemetry system, select the Add/Remove SmartKey, then select Remove From. After confirmation the SRR connection is disconnected.
Assignment at the Patient Monitor
Assignment at the Patient Monitor
Prepare the Cableless Measurement Device for assignment by activating the Add/Remove SmartKey. At the patient monitor,
1Select the Measurement Selection key.
2Select the Add cl Msmt pop-up key.
This opens the Add cl Measurement window, which shows the available Cableless Measurement Devices:
3Select the device which you want to assign to the patient in the monitor.
4The monitor displays the assignment prompt message.
If the internal measurement in the patient monitor is active, you will need to confirm that it should be deactivated in favor of the Cableless Measurement Device you want to assign.
When the Cableless Measurement Device is assigned, the 
symbol appears on its display indicating that alarms from the device will be sent to the patient monitor.
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An assigned Cableless Measurement Device can be removed in the Measurement Selection window. For more details see the Instructions for Use for your patient monitor.
Assignment with an RFID Reader and Tagged Cableless Devices
You can directly assign all cableless devices that have RFID tags with a Philips HS1-R RFID/barcode reader. The SpO2 Pod used must have an IntelliVue ProxiTag RFID tag adhesively attached.
1Hold the cableless device close to the reader.
Depending on its configuration, the reader beeps, vibrates or indicates via the LEDs when it has read the tag.
2Press any hardkey on the cableless device.
The Cableless Measurement Device is now added to the monitor.
If the corresponding internal measurement in the patient monitor is active, you will be asked to confirm that it should be deactivated in favor of the Cableless Measurement Device by selecting Replace.
If a Cableless Measurement of the same type is already assigned to the monitor, you will be asked to confirm that it should be removed by selecting Replace.
Assignment at the Fetal Monitor
The first time an IntelliVue Cableless Measurement Device is used with an Avalon Fetal Monitor, or after a device has been powered off for storage, place it on the Avalon CL Base Station. This will automatically switch the device on. The device is assigned automatically to the Fetal Monitor working with the CL Base Station.
NOTE
When you place a Cableless Measurement Device onto an Avalon CL Base Station to assign it to an Avalon Fetal Monitor, the Cableless Measurement Device is automatically unassigned from the previous patient.
Special Conditions when Working with Fetal Monitors
The following special conditions apply when CL SpO2 Pods are operating with an Avalon Fetal Monitor as a host:
•The SpO2 Pods are intended to measure the maternal SpO2 and Pulse. The patient category is always
Adult.
•The Pulse measurement is always On. The Pulse: On/Off setting is not available.
•Physiological alarms are only available at the Avalon Fetal Monitor, not at the Cableless Measurement Devices. Local attended monitoring is not available: Use for Transp. is not supported. (Local attended monitoring is used for displaying alarms locally at the Cableless Measurement Devices during patient transport, when the patient is attended by a caregiver).
•Alarm-related operations (e.g. switching alarms on and off, setting the high and low alarm limits) are not available when Alarm Mode is set to INOP only in the Avalon Fetal Monitor. See the Avalon Fetal Monitor Instructions for Use and Avalon Fetal Monitor Configuration Guide for further information.
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•You can use the Remove operation at the host to remove Cableless Measurement Devices, as described in the Avalon Fetal Monitor Instructions for Use.
•Averaging Time is not configurable.
•Smart Alarm Delay is not supported.
•Pulse tone from the CL SpO2 Pod is not supported at the Avalon Fetal Monitor.
•Perfusion is always Off and cannot be changed to On.
•Perfusion Change Indicator is not supported.
•It is not possible to change the label, it is always SpO .
•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:
1Select the patient on the Chalkboard.
2Take the Cableless Measurement Device from the charger.
3On the Equipment List tab, select the Cableless Measurement Device on the Available Equipment list, highlighted in green on top of the list. The device on top of the list is always the one with the most recent user interaction (taken off the charger, put on the charger, or key pressed).
4Click Use for Patient to assign the device to the patient.
Controls Available with a Patient Monitor
The controls available when working with the Cableless Measurement Device and a patient monitor are described in the table below.
Action |
At the Cableless |
At the Patient |
At the IIC |
|
Measurement |
Monitor |
|
|
Device |
|
|
Start SpO2 |
Yes |
Yes |
No |
Change SpO2 Mode |
Yes |
Yes |
No |
Select SpO2 Repetition Time |
Yes |
Yes |
No |
Assign SpO2 Pod |
Yes |
Yes |
No |
Remove SpO2 Pod |
Yes |
Yes |
No |
Change Alarm Limits |
Yes* |
Yes |
No |
|
|
|
|
Place Device in Standby |
Yes |
Yes |
Yes |
|
|
|
|
Alarm Silence |
Yes |
Yes |
Yes |
|
|
|
|
Alarm Off/Pause |
Yes |
Yes |
Yes |
|
|
|
|
* except when SRR connection to host is lost
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WARNING
If a patient being monitored by Cableless Measurement Devices moves out of range of the patient monitor, the measurements are not transmitted to the patient monitor or the Information Center. The measurements are available on the Cableless Measurement Device only. If this occurs, the No Host Monitoring message is displayed on the measurement device. The measurement device will also sound the INOP tone.
Controls Available with a Telemetry Device
The controls available when working with the Cableless Measurement Device and a TRx4841/TRx4851A Transceiver or MX40 wearable patient monitor with a short range radio adapter (SRRA) are described in the table below.
Action |
At the Cableless |
At the IIC |
|
Measurement Device |
|
|
|
|
Start SpO2 |
Yes |
Yes |
Change SpO2 Mode |
Yes |
Yes |
Select SpO2 Repetition Time |
Yes |
No |
Assign SpO2 Pod |
Yes |
No |
Remove SpO2 Pod |
Yes |
Yes |
Change Alarm Limits |
No |
Yes |
|
|
|
Place Device in Standby |
No |
No |
|
|
|
Alarm Silence |
No |
Yes |
|
|
|
Alarm Off/Pause |
No |
Yes |
|
|
|
NOTE
When you unplug the ECG cable from the telemetry device and plug it into the monitor associated with the same patient, the ECG source will automatically be from the monitor. The SpO2 measurement devices
assigned to the telemetry device will continue to source data to the telemetry device and the Information Center. You may need to change screens on the patient monitor to see the measurements.
NOTE
The SpO2 measurement sourced from the telemetry device (label: SpO2T) has priority over the
IntelliVue CL SpO2 measurement. The SpO2T measurement is sent to the Information Center as long as it is available and the IntelliVue CL SpO2 measurement is available on the measurement device only.
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Controls Available with GuardianSoftware
The controls available when working with the Cableless Measurement Device and GuardianSoftware are described in the table below.
Action |
At the Cableless |
At GuardianSoftware |
|
Measurement Device |
|
|
|
|
Start SpO2 |
Yes |
Yes |
Change Mode |
Yes |
Yes |
|
|
|
Select SpO2 Repetition Time |
Yes |
Yes |
Assign SpO2 Pod |
Yes |
Yes |
Remove SpO2 Pod |
Yes |
Yes |
Place Device in Standby |
No |
No |
|
|
|
Technical Alarm Silence |
No |
Yes |
|
|
|
Alarm Off/Pause |
No |
No |
|
|
|
Trending
The IntelliVue Cableless Measurement Devices provide data for trending of parameters. The trended data are only available via a host system. For details on trends see the Instructions for Use of your host system.
When the connection to the host is lost during measurement, the IntelliVue Cableless Measurement Devices are able to collect data in a local memory. These data can be uploaded to GuardianSoftware, but not to other host systems, when a connection is established at a later stage.
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Monitoring SpO2
Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier artifact suppression technology (FAST). A sensor is used that transmits light of two different wavelengths through the tissue of the patient. The measurement principle of pulse oximetry is based on the specific absorption characteristics of oxyhemoglobin and deoxyhemoglobin and the pulsating arteriolar vascular bed at the measurement site. It provides four measurements:
•Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation).
•Pleth waveform - auto-scaled visual indication of patient's pulse which is not directly proportional to the pulse volume (only on patient monitor, GuardianSoftware or Information Center, if assigned).
•Pulse rate (derived from pleth wave) - detected pulsations per minute.
•Perfusion indicator - numerical value for the pulsatile portion of the measured signal caused by arterial pulsation (only on patient monitor, if assigned).
NOTE
No alarms are generated for SpO2 and Pulse when measuring SpO2 with the SpO2 Pod not assigned to a patient monitor or telemetry device.
The SpO2 measurement is suitable for use in the presence of electrosurgery and during the discharge of a cardiac defibrillator according to IEC 80601-2-30.
SpO2 Sensors
Specialized SpO2 Sensors are available for use with the IntelliVue CL SpO2 Pod. See the “IntelliVue CL SpO2 Pod Accessories” section for details.
Familiarize yourself with the Instructions for Use supplied with your sensor before using it. In particular, check that the sensor being used is appropriate for your patient category and application site.
Additional Information
The following documents contain additional information, depending on which accessories you are using:
•Mobile CL Single-Patient SpO2 Sensor Instructions for Use
•Mobile CL Reusable SpO2 Sensor1 Instructions for Use
•Mobile CL SpO2 Wristband Instructions for Use
1 may not be available in all geographies
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Connecting SpO2 Sensors
1 Connect the sensor to the single patient Mobile CL SpO2 Cradle (if not already connected).
2Insert the SpO2 Pod into the Mobile CL SpO2 Cradle. The correct orientation is indicated by a matching blue dot inside the cradle.
CAUTION
Make sure that the contacts of the SpO2 Pod and the sensor are dry and free of residues.
3Secure the cradle on the patient's arm using the wristband.
a.Feed the free end of the wristband through the slot in the cradle, starting from the underside of the cradle.
b.Slide the wristband onto the patient's arm and pull the free end until the wristband fits snugly.
c.Close the wristband using the Velcro patch on the free end of the band.
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Removing the Pod from the Cradle
To remove the SpO2 Pod from the cradle, pull on the Pod at the opening in the cradle, while holding the cradle in place on the patient's arm.
Applying the Sensor
1Choose a finger of the patient that matches the sensor dimension in a way that the sensor optical components are properly aligned and the sensor is neither too loose nor applies too much pressure to the finger. For small pediatric patients consider the thumb.
2Remove colored nail polish from the application site.
3Apply the sensor to the patient. The application site should match the sensor size so that the sensor can neither fall off, nor apply excessive pressure. See the sections below for details on applying the different sensors.
4Check that the light emitter and the photodetector are directly opposite each other. All light from the emitter must pass through the patient's tissue.
WARNING
Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxemia and tissue malnutrition. Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and lacerations, periodically inspect the sensor application site and change the application site regularly.
Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulation and lead to inaccurate measurements.
Ambient Temperature: At elevated ambient temperatures be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41°C on the skin if the initial skin temperature does not exceed 35°C.
Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff or an intravascular venous infusion line.
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