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

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Document ID	2137735
Application ID	hXg5PVgL2rC0U/DBuPAxpw==
Document Description	User Manual IntelliVue CL
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Document Type	User Manual
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Filesize	183.38kB (2292279 bits)
Date Submitted	2013-12-10 00:00:00
Date Available	2013-12-10 00:00:00
Creation Date	2013-07-15 12:52:32
Producing Software	Acrobat Distiller 10.1.5 (Windows)
Document Lastmod	2013-07-25 10:40:34
Document Title	ait-fm-manual_CL SpO2 Pod – CL NBP Pod – CL Respiration Pod_en_2013-07-15.book
Document Creator	FrameMaker 8.0
Document Author:	300224753

In stru ctio ns fo r Use
IntelliVue Cableless
Measurements
CL SpO2 Pod – CL NBP Pod –
CL Respiration Pod
Rel ease B.02
Patient Monitori ng
1
Table of Contents
1 Introduction and Basic Operation
Introducing the IntelliVue Cableless Measurements
2 IntelliVue CL SpO2 Pod
General Operation of the SpO2 Pod
Connection with Host Systems
Monitoring SpO2
Alarms
SpO2 Default Settings
Integrated Battery Handling
Accessories
Maintenance and Troubleshooting
3 IntelliVue CL NBP Pod
General Operation of the NBP Pod
Connection with Host Systems
Monitoring NBP
Alarms
NBP Default Settings
Integrated Battery Handling
Accessories
Maintenance and Troubleshooting
4 IntelliVue CL Respiration Pod
General Operation of the Respiration Pod
Connection with Host Systems
Monitoring Respiration
Technical Alarms (INOPs)
Respiration Default Settings
Integrated Battery Handling
Accessories
Maintenance and Troubleshooting
5 Cableless Measurement Auxiliary Devices
IntelliVue CL Transmitter and IntelliVue CL Hotspot
IntelliVue CL Transmitter Base Station
IntelliVue CL Charging Station
Maintenance and Troubleshooting
16
22
28
38
39
41
42
43
43
50
56
63
72
73
74
78
79
79
80
84
88
89
89
91
91
93
93
97
97
99
6 Care and Cleaning
General Points
Cleaning and Disinfecting the IntelliVue Cableless Measurement Devices
Disposing of the IntelliVue Cableless Measurement Devices
7 Specifications
Indications for Use
Compatible Medical Devices
Manufacturer's Information
Symbols
Safety Specifications
EMC and Radio Regulatory Compliance
Safety and Performance Tests
Electromagnetic Compatibility (EMC)
Accessories Compliant with EMC Standards
Electrosurgery Interference/Defibrillation
IntelliVue CL SpO2 Pod Specifications
IntelliVue CL NBP Pod Specifications
IntelliVue CL Respiration Pod Specifications
Alarm Specifications
Telemetry Device Battery Runtime Specifications
IntelliVue CL Transmitter Specifications
IntelliVue CL Transmitter Base Station Specifications
IntelliVue CL Hotspot Specifications
Index
101
101
102
103
105
105
107
107
108
109
110
112
112
113
113
113
115
118
119
121
121
123
124
127
1
Introduction and Basic
Operation
These Instructions for Use are for clinical professionals using the IntelliVue Cableless Measurements
and their respective accessories for monitoring and recording arterial oxygen saturation, pulse rate,
non-invasive blood pressure and respiration rate of adult patients.
Familiarize yourself with all instructions including warnings and cautions, and attend one of the
training courses, before starting to make measurements with patients. Read and keep the Instructions
for Use that come with any accessories, as these contain important information about care and
cleaning that is not repeated here.
When using the IntelliVue Cableless Measurements with an IntelliVue Patient Monitor, a telemetry
system or IntelliVue GuardianSoftware, refer to and adhere to all warnings in the Instructions for Use
of the respective device or software.
In these Instructions for Use:
•
A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to
observe a warning may result in death or serious injury to the user or patient.
•
A caution alerts you to where special care is necessary for the safe and effective use of the
product. Failure to observe a caution may result in minor or moderate personal injury or damage
to the product or other property, and possibly in a remote risk of more serious injury.
IntelliVue Cableless Measurements refers to the IntelliVue Cableless Measurements product family
consisting of the IntelliVue CL SpO2 Pod, IntelliVue CL NBP Pod and IntelliVue CL Respiration Pod
with their accessories. Also included are the auxiliary devices: the IntelliVue CL Charging Station,
IntelliVue CL Transmitter, IntelliVue CL Transmitter Base station and IntelliVue CL Hotspot.
Display refers to the physical display of the Cableless Measurement Device. Screen refers to
everything you see on the IntelliVue Cableless Measurement's display, such as measurement values,
patient data and so forth.
IntelliVue CL Transmitter/WLAN functionality may not be available in all countries.
1 Introduction and Basic Operation
Introducing the IntelliVue Cableless Measurements
The IntelliVue Cableless Measurement Devices provide measurement values and communicate them
to other system components using a wireless short range radio (SRR) interface.
IntelliVue CL SpO2 Pod
IntelliVue CL NBP Pod
The IntelliVue CL SpO2 Pod is a battery
powered, cableless Pulse Oximetry measuring
device.
The IntelliVue CL NBP Pod is a battery
powered, cableless, non-invasive blood pressure
(NBP) measuring device.
The IntelliVue CL SpO2 Pod and the IntelliVue CL NBP Pod can be used together with IntelliVue
Patient Monitors MP5/MP5SC/MP5T, MP2/X2, IntelliVue Telemetry System Transceivers
TRx4841A/TRx4851A, MX40 wearable patient monitors, and IntelliVue GuardianSoftware. Both
devices have an LCD display and three keys for basic operation:
Integrated monochrome LCD display
Hardkeys
Measurement identifier
1 Introduction and Basic Operation
IntelliVue CL Respiration Pod
The IntelliVue CL Respiration Pod is a battery powered, cableless respiration rate measuring device
which can be used together with IntelliVue Patient Monitors MP5/MP5SC/MP5T, or IntelliVue
GuardianSoftware. The device has one multi-color LED for status display and one hardkey for basic
operation, e.g. to start a measurement.
Multi-color LED
Hardkey
1 Introduction and Basic Operation
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 41.
General Operation of the SpO2 Pod
The following sections describe operation on the SpO2 Pod itself. For operation from a patient
monitor, see “Controls Available with a Patient Monitor” on page 20. For operation from an
Information Center via a telemetry system, see “Controls Available with a Telemetry Device” on
page 21. For operation with IntelliVue GuardianSoftware, see “Controls Available with
GuardianSoftware” on page 21.
The SpO2 Pod has three hardkeys for basic operation and a set of configurable SmartKeys which
appear on the screen. These are used to activate and navigate through the on-screen menus and to
select individual items. The typical operator's position is such that everything on the device's display
can be read clearly and easily.
Switching the Device On
The first time an SpO2 Pod is used, or after the device has been powered off for storage, place it on
the IntelliVue CL Charging Station. This will automatically switch the device on.
If the SpO2 Pod has only been switched off temporarily (see “Switching the Device Off” on page 13),
press any hardkey to turn the device on again.
2 IntelliVue CL SpO2 Pod
When an SpO2 Pod is not operated, it will automatically switch off the screen lighting after a short
time. A little later the low-activity screen will be displayed.
Screen Layout
There are three variations of the Main Screen layout depending on the Alarm status and the general
activity level.
Standard Layout
When assigned to a monitor, telemetry device or a patient in GuardianSoftware:
Connection status indicator
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.
Battery indicator
Measurement values
Measurement-related symbols (see the measurement
chapters for details)
Patient identification
When not assigned to a monitor or telemetry device:
10
Connection status indicator
Battery indicator
Measurement values
Measurement-related symbols (see the Monitoring
chapter for details). The Alarms Off symbols indicate
that no physiological alarms are available from the
Cableless Measurement Devices when not assigned to
a host.
Cableless Measurement Device equipment label
2 IntelliVue CL SpO2 Pod
Alarm Layout
If an alarm occurs the full alarm message appears at the top of the screen. After the alarm message has
been silenced the alarm indicator is shown as a symbol on the right side of the screen.
Full length alarm message
Alarm indicator
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
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2 IntelliVue CL SpO2 Pod
Using the SmartKeys
A SmartKey is a graphical key which appears on the screen and gives you fast access to functions.
SmartKeys Menu
Press the  hardkey (without any screen element highlighted) to get to the SmartKeys menu.
Use the ◄ and ► hardkeys to move along the row of SmartKeys. The highlighted SmartKey is
displayed in full above the row of SmartKeys. When you use the ◄ or ► hardkey at the end of the
row, an Exit screen appears and then with further presses you move on to the next page of SmartKeys.
To leave the SmartKeys menu you can use the Exit screen or press the ► hardkey for a couple of
seconds to return to the Main Screen.
When the required SmartKey is highlighted, press the  key to activate the corresponding function.
To get to the next page of the SmartKeys menu, highlight the rightmost SmartKey then press the ►
key.
List of Available SmartKeys
SmartKey
Text Labels
Main Setup
start an SpO2 measurement
set the SpO2 repetition time
Add/Remove device
enter Battery menu
change Screen
enter Profiles menu
switch device off (or power off when pressed for more than two seconds)
enter Patient menu
12
2 IntelliVue CL SpO2 Pod
SmartKey
Text Labels
enters the Alarms menu to access: Alarm Messages, Alarm Limits, Alarms
On/Off/Pause, Alarm Volume.
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 Main Setup SmartKey to get
to the Main Setup menu.
Main Setup
SpO₂
Pulse
Alarms
Patient
Equipment
User Interface
Device Off
Profiles
Operating Modes
Date, Time
Battery
Revisions
Switching the Device Off
To switch off a device manually, select the Device Off SmartKey, then Confirm.
If you keep Device Off pressed for more than two seconds, you can choose between Device Off or
Power Off.
•
Device Off means that the display is switched off and the measurements are disabled. Use this
option if your device is not used temporarily. Press any hardkey to turn the device on again.
•
Power Off means that the device is switched off completely and can only be switched on again by
putting it on a charger. Use this option when the device is not used for a longer time or prepared
for storage or shipping.
When an IntelliVue Cableless Measurement Device is not operated, it will automatically switch off the
screen lighting after a short time. A little later the low-activity screen will be displayed.
13
2 IntelliVue CL SpO2 Pod
Operating Modes
Your device has four operating modes. Some are passcode protected.
•
Monitoring Mode: This is the normal, every day working mode that you use for making
measurements. You can change elements such as measurement modes, patient category and so
forth. When you remove the patient from the device, these elements return to their default values.
Changes can be stored permanently only in Configuration Mode. You may see items, such as some
menu options, that are visible but 'grayed out' so that you can neither select nor change them.
These are present for your information only and can be changed only in Configuration Mode.
•
Demonstration Mode: Passcode protected, this is for demonstration purposes only. You must
not change into Demonstration Mode during monitoring.
•
Configuration Mode: Passcode protected, this mode is for personnel trained in configuration
tasks. These tasks are described in the Configuration Guide. During installation the Cableless
Measurement Device is configured for use in your environment. This configuration defines the
default settings you work with when you switch on.
•
Service Mode: Passcode protected, this is for trained service personnel.
When you switch the device on, it starts up in monitoring mode. To change to a different mode:
Use the Main Setup SmartKey to get to the Main Setup menu.
Select Operating Modes and choose the mode you require.
Standby Mode
The IntelliVue Cableless Measurement Devices do not have standby mode. However, when connected
to a monitor that is in standby mode, the IntelliVue Cableless Measurement Device will show a
standby screen.
Using the Patient Menu
The Patient menu allows you to see patient demographics information and to remove a patient from a
device. Patient Demographic information is only displayed if the Cableless Measurement Device is
assigned to a patient monitor or GuardianSoftware. Patient Category is the only item of patient data
which can be changed at the Cableless Measurement Device, but only when the device is not assigned
to a patient monitor or telemetry device.
Displaying the Patient Menu
To display the Patient menu,
•
select the Patient SmartKey, or
•
select the Main Setup SmartKey followed by Patient.
Stop Using a Device for a Patient
To remove a patient from the Cableless Measurement Device,
•
in the Patient menu select Free Device.
All patient data is cleared, settings are reset to the defaults and the device is removed from the monitor
or telemetry device.
14
2 IntelliVue CL SpO2 Pod
NOTE
Depending on your configuration, when the device is put on the charger, patient data will also be
cleared and the device will be free for another patient.
Using the Device for a New Patient
To use a device for a new patient,
•
in the Patient menu, select New Patient.
If the device was not free, the existing data will be deleted and the profile set to the default.
Using Profiles
A profile is a set of measurement and general settings which have been customized for a particular
purpose. The Cableless Measurement Devices can have four different profiles configured to your
requirements. The default profile is marked with a symbol. To select a different profile,
Select the Profiles SmartKey or the Main Setup SmartKey followed by Profiles.
Select the required profile from the list.
Selecting New Patient or Free Device will always reset the profile to the default.
Setting the Date and Time
If the Cableless Measurement Device is assigned to a patient monitor, telemetry device or
GuardianSoftware, the date and time will be taken from the host. If this is not the case, you can set the
date and time on the Cableless Measurement Device,
Select the Main Setup SmartKey and then Date, Time.
Enter the data for date and time one after another.
Select 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: fullcharge and remaining capacity, voltage, current and temperature.
15
2 IntelliVue CL SpO2 Pod
Connection with Host Systems
The following sections describe how the IntelliVue Cableless Measurement Devices work together
with host systems (Patient Monitors, Telemetry Devices / Information Center or GuardianSoftware).
IntelliVue Cableless Measurements Use Models
With these patient-worn measurement devices you can measure and transmit a patient's vitals regularly
or on an intermittent data collection basis. There are three typical use models:
With a Patient Monitor
The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T,
MP2 or X2 patient monitor (with an SRR interface). They can communicate their measurement values
via short range radio to the monitor. The monitor may be assigned to a patient sector at the IntelliVue
Information Center (IIC). When assigned to the Information Center, certain actions can be performed
at both the patient monitor and the Information Center. See the table “Controls Available with a
Patient Monitor” on page 20.
In situations where patients are becoming more mobile (for example, in step-down/intermediate care
units) the lightweight Cableless Measurement Devices allow increased mobility within the short range
radio range, without giving up vital signs monitoring.
When assigned to a patient monitor, the Cableless Measurement Device can be selected for use in
patient transport at the patient monitor (for details see the Patient Monitor Instructions for Use). In
this case, the Cableless Measurement Device will perform local attended monitoring. The patient
must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement
Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm
status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See
“Alarms” on page 28 for details.
A telemetry device can be assigned to a patient monitor equipped with short range radio at the same
time as any Cableless Measurement Devices are also assigned to this monitor.
When assigned to a patient monitor, the admitted patient name is displayed on the SpO2 Pod.
If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be
displayed at the monitor: cl SpO₂ Disconnect. A No Host Monitoring INOP will be displayed on the
SpO2 Pod, and an INOP tone will sound. In this case, visual and audible alarms are still available at the
SpO2 Pod, but it is not possible to change the alarm settings.
With a Telemetry Device
The Cableless Measurement Devices can be assigned to a patient with the telemetry device
TRx4841A/TRx4851A or an MX40 wearable patient monitor. They can communicate their
measurement values via short range radio to the telemetry device which communicates them to an
IntelliVue Information Center to provide a consolidated set of patient values.
Some of the measurement tasks can be performed remotely from the Information Center. See the
table “Controls Available with a Telemetry Device” on page 21.
If the patient name is available at the Information Center, it will be also displayed on the SpO2 Pod.
When a Cableless Measurement Device is assigned to a telemetry device, it is not possible for the
telemetry device to be wirelessly assigned or directly connected to a patient monitor.
16
2 IntelliVue CL SpO2 Pod
If the connection between the telemetry device and the Cableless Measurement Device is lost, an
INOP will be displayed at the Information Center: cl SpO₂ Disconnect. A No System Monitor.
INOP will be displayed on the SpO2 Pod, and an INOP tone will sound.
With IntelliVue GuardianSoftware
The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware.
GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter or
Hotspot from the Cableless Measurement Devices. Using the collected data, it provides trending,
review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application
provides basic assessment guidance, helping you to recognize the early signs of deterioration in your
patients. GuardianSoftware is not intended for monitoring in combination with Cableless
Measurement Devices.
Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table
“Controls Available with GuardianSoftware” on page 21. GuardianSoftware also manages the patient
data.
If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the
connection symbol will be displayed gray at GuardianSoftware. A No System INOP will be displayed
on the SpO2 Pod (no alarm sound).
If a patient name is available at GuardianSoftware, it will be also displayed on the Pod. Any update of
patient data will be synchronized between the Pods and GuardianSoftware. The only patient
management action available directly at the Pod is Free Device. Selecting Free Device removes the
current patient from the Pod and resets the Pod to the default profile. The Pod is unassigned.
Device Compatibility
The IntelliVue CL SpO2 Pods require the following software levels in the associated equipment:
•
Patient Monitor - Release H.0 or above
•
Information Center - Release M or above
•
Telemetry device TRx4841A/TRx4851A - Revision D.00.22 or above
•
MX40 wearable patient monitor - Revision A.0 or above
•
IntelliVue GuardianSoftware - Revision A.0 or above
Availability of Patient Alarms
When the IntelliVue CL SpO2 Pod is used alone, without an assignment to a monitor or telemetry
device, no patient alarms will be generated.
When the IntelliVue CL SpO2 Pod is assigned to a patient monitor or telemetry device and a short
range radio connection exists, alarms may be announced at the patient monitor or the Information
Center.
•
When assigned to a patient monitor: Alarm messages will be displayed and audible alarm
indicators sounded at the patient monitor in the same way and under the same conditions as for its
own measurements. See the Instructions for Use of the patient monitor for details.
If a Cableless Measurement Device that is assigned to a monitor is selected for use in patient
transport at the patient monitor, the Cableless Measurement Device will perform local attended
monitoring. See the Instructions for Use of the patient monitor for details on how to do this. The
patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless
Measurement Device are recognized. In local attended monitoring mode, an alarm message text
17
2 IntelliVue CL SpO2 Pod
appears in the alarm status area at the top of the screen indicating the source of the alarm and an
alarm tone is issued. See “Alarms” on page 28 for details.
•
When assigned to a telemetry device: Measurement values sent via the telemetry device to the
IntelliVue Information Center can generate alarms at the Information Center when the values
meet the criteria set there for alarms. The alarms will be announced in the same way as
measurements from other sources. See the Instructions for Use of the Information Center for
details.
•
When assigned to GuardianSoftware: Measurement values sent via transmitters or hotspots to
IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue
GuardianSoftware is a data management system, no alarms are announced. The IntelliVue
Cableless Measurement Devices will also not generate physiological alarms when connected to
IntelliVue GuardianSoftware. See the Instructions for Use of GuardianSoftware.
Assigning an IntelliVue Cableless Measurement Device to a Host
When an IntelliVue CL SpO2 Pod is used with a host system (patient monitor, telemetry device or
GuardianSoftware), the Pod must be assigned to that host system.
The assignment can be done at the CL SpO2 Pod itself or at the host system (patient monitor or
GuardianSoftware).
WARNING
Always make sure that the applied CL SpO2 Pod is assigned to the correct patient.
WARNING
Short Range Radio connections are subject to interruption due to interference from other radio
sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n) and
cordless phones. Depending on the strength and duration of the interference, the interruption may
occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for
other reasons, is indicated with a No Host Monitoring INOP on the SpO2 Pod, or a cl SpO₂
Disconnect INOP at the host monitor. Correct channel configuration is important, refer to the
Configuration Guide for details.
Assignment at the Measurement Device
To make an assignment, select:
•
the Add/Remove SmartKey
•
hold the ◄ key pressed.
, or
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
18
2 IntelliVue CL SpO2 Pod
search to find the clearest channel available. During the search all 4 LEDs will blink once per
second. The search will take approximately 20-25 seconds. Once a channel is identified, the first
LED will light up and blink once per second to indicate that the telemetry device is ready for
assignment.
Add To
Mon 1
Mon 2
Tele 33
Tele 44
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.
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:
Select the measurement selection key on the monitor.
A prompt message appears with the Confirm and Cancel keys.
Select Confirm to deactivate the internal measurement.
When the Cableless Measurement Device is assigned, the
symbol appears on its display indicating
that alarming capability has been transferred to the host (to the monitor or, for the telemetry device, to
the Information Center). No patient alarms will be announced on the Cableless Measurement Device.
To unassign the measurement device from the monitor or telemetry system, select the Add/Remove
SmartKey, then select Remove From. After confirmation the SRR connection is disconnected.
Assignment at the Patient Monitor
Prepare the Pod for assignment by activating the Add/Remove SmartKey.
At the patient monitor,
Select the Measurement Selection key.
Select the Add cl Msmt pop-up key.
This opens the Add Cableless window, which shows the available Cableless Measurement
Devices:
19
2 IntelliVue CL SpO2 Pod
Select the device which you want to assign to the patient in the monitor.
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.
When the Cableless Measurement Device is assigned, the
symbol appears on its display indicating
that alarms from the device will be sent to the patient monitor.
An assigned Cableless Measurement Device can be removed in the Measurement Selection window.
For more details see the Instructions for Use for your patient monitor.
Assignment with GuardianSoftware
To assign a Cableless Measurement Device to a patient in GuardianSoftware:
Select the patient on the Chalkboard.
Take the Cableless Measurement Device from the charger.
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).
Click Use for Patient to assign the device to the patient.
Controls Available with a Patient Monitor
The controls available when the Cableless Measurement Device is assigned to a patient monitor are
described in the table below.
Action
At the Cableless
Measurement
Device
At the Patient
Monitor
At the IIC
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
No
Yes
Yes
Alarm Silence
Yes
Yes
Yes
Alarm Off/Pause
Yes
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
20
2 IntelliVue CL SpO2 Pod
Monitoring message is displayed on the measurement device. The measurement device will also sound
the INOP tone.
Controls Available with a Telemetry Device
The controls available when the Cableless Measurement Device is assigned to a TRx4841/TRx4851A
Transceiver or MX40 wearable patient monitor with a short range radio adapter (SRRA) are described
in the table below.
Action
At the Cableless
Measurement Device
At the IIC
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.
Controls Available with GuardianSoftware
The controls available when the Cableless Measurement Device is assigned to GuardianSoftware are
described in the table below.
Action
At the Cableless
Measurement Device
At GuardianSoftware
Start SpO2
Yes
Yes
Change Mode
Yes
Yes
Select SpO2 Repetition Time
Yes
Yes
Assign SpO2 Pod
Yes
Yes
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2 IntelliVue CL SpO2 Pod
Action
At the Cableless
Measurement Device
At GuardianSoftware
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.
Monitoring SpO2
Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier artifact
suppression technology (FAST). A sensor is used that transmits light of two different wavelengths
through the tissue of the patient. The measurement principle of pulse oximetry is based on the specific
absorption characteristics of oxyhemoglobin and deoxyhemoglobin and the pulsating arteriolar
vascular bed at the measurement site. It provides four measurements:
•
Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to
the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation).
•
Pleth waveform - auto-scaled visual indication of patient's pulse which is not directly proportional
to the pulse volume (only on patient monitor, GuardianSoftware or Information Center, if
assigned).
•
Pulse rate (derived from pleth wave) - detected pulsations per minute.
•
Perfusion indicator - numerical value for the pulsatile portion of the measured signal caused by
arterial pulsation (only on patient monitor, if assigned).
NOTE
No alarms are generated for SpO2 and Pulse when measuring SpO2 with the SpO2 Pod not assigned to
a patient monitor or telemetry device.
SpO2 Sensors
Specialized SpO2 Sensors are available for use with the IntelliVue CL SpO2 Pod. See the “Accessories”
chapter for details.
Familiarize yourself with the Instructions for Use supplied with your sensor before using it. In
particular, check that the sensor being used is appropriate for your patient category and application
site.
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2 IntelliVue CL SpO2 Pod
Additional Information
The following documents contain additional information, depending on which accessories you are
using:
•
Mobile CL Single-Patient SpO2 Sensor Instructions for Use
•
Mobile CL Reusable SpO2 Sensor1 Instructions for Use
•
Mobile CL SpO2 Wristband Instructions for Use
may not be available in all geographies
Connecting SpO2 Sensors
Connect the sensor to the single patient Mobile CL SpO2 Cradle (if not already connected).
Insert 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.
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.
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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
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.
Remove colored nail polish from the application site.
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.
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.
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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2 IntelliVue CL SpO2 Pod
Measuring SpO2
During measurement, ensure that the application site:
–
–
has a pulsatile flow, ideally with a perfusion indicator value above 1.0 or, if the perfusion
indicator is not available, with signal quality indicator of at least medium.
has not changed in its thickness (for example, due to edema), causing an improper fit of the
sensor.
WARNING
•
For fully conscious pediatric or adult patients, who have a normal function of perfusion and
sensory perception at the measurement site:
To ensure skin quality and correct optical alignment of the sensor, inspect the application site
when the measurement results are suspicious or when the patient complains about pressure at
the application site, but at least every 24 hours. Correct the sensor alignment if necessary.
Move the sensor to another site, if the skin quality changes.
•
For all other patients:
Inspect the application site every two to three hours to ensure skin quality and correct optical
alignment. Correct the sensor alignment if necessary. If the skin quality changes, move the
sensor to another site.
Change the application site at least every four hours.
•
Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin
and carboxyhemoglobin may lead to inaccurate measurements.
•
Inaccurate measurements may result when the application site for the sensor is deeply pigmented
or deeply colored, for example, with nail polish, artificial nails, dye or pigmented cream.
•
Interference can be caused by:
– High levels of ambient light (including IR warmers) or strobe lights or flashing lights (such as
fire alarm lamps). (Hint: cover application site with opaque material.)
– Another SpO2 sensor in close proximity (e.g. when more than one SpO2 measurement is
performed on the same patient). Always cover both sensors with opaque material to reduce
cross-interference.
– Electromagnetic interference, especially at perfusion indicator values below 1.0 or signal
quality indicator below medium.
– Excessive patient movement and vibration.
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2 IntelliVue CL SpO2 Pod
Selecting Measurement Modes
There are three different modes available for making SpO2 measurements:
•
•
Continuous mode - SpO2 is measured continuously until the measurement is switched off.
Manual mode - a single SpO2 measurement is made when the Start SpO₂ SmartKey or the Start
SpO₂ menu item is selected. One set of values is then displayed with the time the measurement was
made.
•
Automatic mode - a series of measurements is made with an interval between them. The interval
is selected using the Repeat Time SmartKey or the Repeat menu item. The measurement starts
automatically when automatic mode is selected.
The values measured in manual mode or automatic mode will be displayed for a configurable time
span. After that the values are regarded as invalid and are no longer displayed. Battery power usage will
be appreciably higher when measuring in continuous mode, in comparison to manual or automatic
mode, resulting in a reduced battery runtime.
Starting and Stopping Measurements
Use the setup menu or SmartKeys to start measurements manually:
Action to be Performed
SpO2 menu
Start manual measurement
Start SpO₂
SmartKeys
Start
When manual measurements are made, there will be no continuous SpO2 monitoring or alarming. The
manual measurement value reflects a momentary status. The numerics from SpO2 measurements
made in manual mode will remain for a time on the main screen. They are annotated with the time that
the measurement was made to distinguish them from continuously measured values.
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2 IntelliVue CL SpO2 Pod
Understanding SpO2 Numerics and Symbols
SpO2 numeric
Pulse rate numeric
Symbol indicating pulse rate
Measurement mode - indicates here that Auto
mode is active and shows the time to the next
measurement.
Alarms Off symbol for Pulse
Timestamp
Alarms Off symbol for SpO2
Note: The Alarms Off symbols indicate that no physiological alarms are available from the
Cableless Measurement Devices when not assigned to a host.
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.
SpO2 Quality Indicator
Assessing a Suspicious SpO2 Reading
Traditionally, pulse rate from SpO2 was compared with heart rate from ECG to confirm the validity of
the SpO2 reading. With newer algorithms, such as FAST-SpO2, this is no longer a valid criteria because
the correct calculation of SpO2 is not directly linked to the correct detection of each pulse.
When pulse rate is very low, or strong arrhythmia is present, the SpO2 pulse rate may differ from the
heart rate calculated from ECG but this does not indicate an inaccurate SpO2 value.
If you doubt the measured SpO2, use the signal quality indicator (if available) or, when used with a
patient monitor, the pleth wave and perfusion indicator on the monitor to assess the signal quality.
WARNING
With pulse oximetry, sensor movement, ambient light (especially strobe lights or flashing lights) or
electromagnetic interference can give unexpected intermittent readings when the sensor is not
27
2 IntelliVue CL SpO2 Pod
attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might
occur when the sensor is dangling.
Changing the Averaging Time
Depending on the monitor configuration, you may be able to change the averaging time for the SpO2
values.
The averaging time represents the approximate time period used for the calculation. The exact
averaging time also depends on the signal conditions. The longer the averaging time, the longer the
time needed until the SpO2 values reflect the physiological event. The same averaging is applied to all
numerical values: SpO2, pulse rate and Perfusion Index (only available at the patient monitor). Fast
averaging is useful for situations where an extremely fast measurement is required or few artifacts are
expected. Use slow averaging where you expect the number of artifacts to be relatively high.
In the SpO₂ menu, select Average.
Select the required averaging time from the list.
Understanding SpO2 Alarms
There is a delay between a physiological event at the measurement site and the corresponding alarm at
the host system. This delay has two components:
•
The general system delay time is the time between the occurrence of the physiological event and
when this event is represented by the displayed numerical values. This delay depends on the
algorithmic processing and the configured averaging time. The longer the averaging time
configured, the longer the time needed until the numerical values reflect the physiological event.
•
The time between the displayed numerical values crossing an alarm limit and the alarm indication
on the device. This delay depends on the Cableless Measurement Device or connected host
system.
Refer to the Alarms chapter for information about the SpO2 and pulse rate alarms.
Perfusion Numeric (only available on the Patient Monitor)
The perfusion numeric (Perf) gives a value for the pulsatile portion of the measured signal caused by
the pulsating arterial blood flow.
You can also use the perfusion numeric as a quality indicator for the SpO2 measurement. Above 1 is
optimal, between 0.3-1 is acceptable. Below 0.3 is marginal; reposition the sensor or find a better site.
Alarms
The IntelliVue Cableless Measurements have two different types of alarm: patient alarms and INOPs.
Patient Alarms
Patient Alarms are high priority alarms (such as a potentially life threatening situation), also called red
alarms, or medium priority alarms, also called yellow alarms.
Technical Alarms (INOPs)
Technical alarms, also known as INOPs, indicate that the measuring device cannot measure reliably. If
an INOP interrupts monitoring, there will be a question mark in place of the measurement numeric.
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2 IntelliVue CL SpO2 Pod
An INOP tone sounds at the Cableless Measurement Device only when there is no SRR connection to
a host.
Most INOPs are low priority, however there are a small number of INOPs which, due to their severity,
are medium or high priority.
Alarm Delays
There is a delay between a physiological event at the measurement site and the corresponding alarm
indication at the Cableless Measurement Device. This delay has two components:
•
The general measurement delay time is the time between the occurrence of the physiological event
and when this event is represented by the displayed numerical values. This delay depends on the
algorithmic processing.
•
The time between the displayed numerical values crossing an alarm limit and the alarm indication
on the device is the system alarm delay. The system alarm delay is the processing time the system
needs for any alarm on the Cableless Measurement Device to be indicated after the measurement
has triggered the alarm. See the performance specifications in the Specifications chapter for the
system alarm delay specification.
The alarm delay configured for a specific measurement is normally a fixed time.
Multiple Alarms
If more than one alarm is active, the alarm messages are shown in the alarm status area in succession.
An arrow symbol next to the alarm message informs you that more than one message is active.
The Cableless Measurement Device sounds an audible indicator for the highest priority alarm. If more
than one alarm condition is active in the same measurement, the Cableless Measurement Device
announces the most severe.
NOTE
If you want to use local attended monitoring, make sure to have all Cableless Measurement Devices
upgraded to Rev. B.02.
Visual Alarm Indicators
WARNING
•
No patient alarms are available on the CL devices when assigned to a host monitor (unless they are
selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware.
•
Visual patient alarm indicators are disabled on the CL device when connected to a host monitor
(unless they are selected for use in patient transport at the monitor they are assigned to) or
GuardianSoftware.
Alarm Message
Alarm messages are displayed in black on a light gray background in the alarm status area at the top of
the screen indicating the source of the alarm and coded according to their severity. If more than one
measurement is in an alarm condition, the message changes every few seconds, and has an arrow ( )
at the side. The asterisk symbols (*) beside the alarm message match the alarm priority: *** for red
alarms, ** for yellow alarms. Standard INOPs do not have a symbol, red and yellow INOPs have
exclamation marks beside the alarm message: !!! for red INOPs and !! for yellow INOPs.
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2 IntelliVue CL SpO2 Pod
An alarm message that appears is automatically highlighted. Use the  key to silence the message. A
Silence message is displayed at the bottom of the screen and highlighted. Press  again to confirm the
acknowledgment of the alarm. After the confirmation, any ongoing alarm message is displayed in the
icon tray of the screen.
Alarm States
Depending on the alarm state of your Cableless Measurement Device, the following icons may be
displayed on the device:
Icon
Description
No local alarming on Cableless Measurement Device. The
device is connected to a host monitor or telemetry device
and has no visual or audible patient alarm indicators. The
device will only display INOP messages.
Alarms are switched off.
Alarm volume is set to 0.
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
30
•
Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm
volume to a low level or off during patient monitoring may result in patient danger. Remember
that the most reliable method of patient monitoring combines close personal surveillance with
correct operation of monitoring equipment.
•
No patient alarms are available on the Cableless Measurement Device when connected to a host
monitor (unless they are selected for use in patient transport at the monitor they are assigned to)
or to GuardianSoftware.
•
When connected to a host monitor or GuardianSoftware, no alarm tones are available on the
Cableless Measurement Device (unless they are selected for use in patient transport at the monitor
they are assigned to).
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.
Full length alarm message
Alarm indicator
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,
Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms.
Select Alarm Messages.
Setting the Volume of the Alarm Tone
To set the volume for the Alarm tone,
Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms.
Select AlarmVol and select a volume setting. The maximum is 10 and the minimum depends on
your configuration.
If the volume of the Alarm tone is set to zero, the following symbol is displayed on the right icon tray
of the Cableless Measurement Device screen:
NOTE
No Alarm tone will sound at the device as long as it is within the SRR range.
Minimum Volume for No Host Monitoring INOP
If your device is connected to a host monitor, and the connection is interrupted, the INOP message
No Host Monitoring will appear within 30 seconds, accompanied by an INOP tone. To help ensure
that this INOP, and any other active alarm, is not overlooked, the INOP and alarm tones may be
configured to have a minimum volume. In this case, INOP and alarm tones will sound even if the
device alarm volume is set to zero.
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2 IntelliVue CL SpO2 Pod
Alarm Reminder
If Reminder is configured on your device, you will get an audible reminder of alarm conditions that
remain active after you have silenced the alarm. This reminder may take the form of a repetition of the
alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new
alarm). Alarm Reminder is not available for standard, light blue INOPs but for yellow and red INOPs.
In Configuration Mode, you can set the interval between silencing the alarm and sounding the
reminder tone to one, two, or three minutes.
Pausing or Switching Off Alarms
If you want to temporarily prevent alarms from sounding, for example while you are moving a patient,
you can pause alarms. Depending on your device configuration, alarms are paused for one, two, or
three minutes, or infinitely. Infinite alarm pause is equivalent to switching the alarms off.
To view the alarm pause setting chosen for your unit,
In the SmartKeys Menu select Main Setup, Alarms, then OffDurat.
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 On/Off. If your device is
configured to infinite pause time, selecting this key switches alarms off.
Press the  hardkey to complete the change.
Restarting Paused Alarms
To manually switch on alarm indication again after a pause, select the key
again.
Alarm indication starts again automatically after the pause period expires. If the device is configured to
stay paused infinitely, you must select
again to restart alarm indication.
Alarm Limits
The alarm limits you set determine the conditions that trigger yellow and red limit alarms. For SpO2,
where the value ranges from 100 to 0, setting the high alarm limit to 100 switches the high alarm off. In
these cases, the alarms off symbol is not displayed.
WARNING
Be aware that the devices in your care area may each have different alarm settings, to suit different
patients. Always check that the alarm settings are appropriate for your patient before you start
monitoring.
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Adjusting the Alarm Limits
Select the Alarms SmartKey followed by Alarm Limits (or select Main Setup followed by SpO₂):
Select High Lim then choose the high alarm limit.
Select Low Lim then choose the low alarm limit.
WARNING
High oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a
consideration do NOT set the high alarm limit to 100%, which is equivalent to switching the high
alarm off.
Adjusting the Desat Limit Alarm
The Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in
oxygen saturation.
In the SpO₂ menu, select DesatLim.
Adjust the limit.
Setting Up Tone Modulation
Only when the CL device is not connected to a host:
If tone modulation is on, the pulse tone pitch lowers when the SpO2 level drops.
Select Main Setup followed by User Interface. In this menu, select Tone Modulation to switch
between Yes (for on) and No (for off).
NOTE
If the SpO2 level drops below 52%, two short tones will be issued rather than one long tone.
Tone modulation is licensed under USpatent US 4.653.498 from Nellcor Puritan Bennett
Incorporated.
Latching Alarms
The alarm latching setting for your device defines how the alarm indicators behave when you do not
acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition
ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed
or announced by the device after the alarm condition ends. The indication lasts until you acknowledge
the alarm.
Viewing the Alarm Latching Settings
To see the alarm latching setting for your device
In the Main Setup menu, select Alarms.
Here you can see the Visual Latching and Audible Latching settings.
This setting can only be changed in Configuration Mode. You should be aware of the settings chosen
for your unit. There are three possible choices each for visual and audible latching, red only, red and
yellow, and off. These choices can be combined to give the following settings:
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2 IntelliVue CL SpO2 Pod
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
Red & Yellow Measurement
Alarms
Non-latching alarms
Visual and audible latching Visual latching, audible
non-latching
Alarm has not
been
acknowledged.
Alarm condition
still present.
Alarm tone on. Alarm message. Alarm tone on. Alarm
message.
Alarm condition All audible and visual alarm
no longer present. indicators automatically stop.
Alarm tone on.
Alarm message.
Alarm message.
Audible alarm indicators
automatically stop.
Alarm has been
acknowledged.
Alarm condition
still present.
All audible and visual alarm
indicators automatically stop.
All audible and visual alarm
indicators automatically stop.
All audible and visual alarm
indicators automatically stop.
Alarm condition Audible and visual alarm
no longer present. indicators automatically stop.
Audible and visual alarm
indicators automatically stop.
Audible and visual alarm
indicators automatically stop.
Alarm tone on. Alarm
message.
All INOPs are non-latching.
Testing Alarms
When you switch the CL SpO2 Pod on, a selftest is started. You must check that the backlight switches
on, and that you hear a single tone. This indicates that the alarm indicators are functioning correctly.
For further testing of individual measurement alarms, perform the measurement on yourself or use a
simulator. Adjust alarm limits and check that appropriate alarm behavior is observed.
Alarm Behavior at Power On
If the device is switched off (Device Off), all alarm settings are maintained. If the device is switched off
completely (Power Off), or the battery is completely empty, resulting in complete power loss, all alarm
settings will be lost unless they were actively saved by storing the active profile before the device was
switched off. See “Switching the Device Off” on page 13 and “Using Profiles” on page 15 for details.
When the device is switched back on from either state, it will start in Profile A and you may have to
switch to the desired profile which contains your alarm settings.
After any of these situations, you should check that the alarm settings are appropriate for your patient
and monitoring situation, and if necessary, select the correct Profile and patient category.
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Reference List of Patient Alarms
Alarm Message, Indication
Source
Condition
*** Brady (Pulse)
SpO2
The heart rate from the Pulse signal has fallen below the
bradycardia limit.
*** Desat
SpO2
The SpO2 value has fallen below the desaturation alarm
limit.
** Pulse High
SpO2
The pulse rate has exceeded the high alarm limit.
** Pulse Low
SpO2
The pulse rate has dropped below the low alarm limit.
**  High
SpO2
The arterial oxygen saturation has exceeded the high
alarm limit.
**  Low
SpO2
The arterial oxygen saturation has dropped below the low
alarm limit.
*** Tachy (Pulse)
SpO2
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
Battery
Battery cannot be used with this Cableless Measurement
Device. Replace battery with one that has been approved
for use with this Cableless Measurement Device. Contact
your service personnel.
Batt Malfunction
Battery
Malfunction of the battery system detected (charger
circuit or battery). Contact your service personnel.
Battery Empty
Battery
The remaining monitoring time is below 30 minutes.
Charge battery.
Battery Low
Battery
The remaining monitoring time is below 2 hours.
Check Batt Temp
Battery
The temperature of the battery is critically high. Check
that Cableless Measurement Device is not covered and
not exposed to a heat source. If INOP persists, remove
Cableless Measurement Device from patient and contact
your service personnel.
Check Battery
Battery
The maximum number of charge/discharge cycles of the
battery will be reached in less than 50 cycles. Contact
your service personnel to replace the battery.
Check Charger I/F
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.
INOP tone
INOP tone
INOP tone
INOP tone
INOP tone
INOP tone
INOP tone
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2 IntelliVue CL SpO2 Pod
INOP Message, Indication
Source
What to do
cl SpO₂ Chk Sett
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.
INOP tone
If this INOP is acknowledged at the Cableless
Measurement Device, it is cleared. If it is silenced
remotely, only the tone is cleared.
cl SpO₂ Disconnect
Cableless
Measurement Device
The SpO2 Pod has lost the SRR connection to the
telemetry device or the patient monitor.
No Host Monitoring
Cableless
Measurement Device
There is a problem with the communication to the
assigned patient monitor or telemetry device and
monitoring is currently not possible (no patient alarms or
information). Check the connection. Contact your service
personnel.
No System
Cableless
Measurement Device
There is a problem with the communication to the
assigned IntelliVue GuardianSoftware and monitoring is
currently not possible (no patient alarms or information).
Check the connection. Contact your service personnel.
Remove From Pat
INOP tone
Cableless
Measurement Device
Displayed on the Cableless Measurement Device. The
temperature of the battery is too high. Remove the
Cableless Measurement Device from the patient and
contact service personnel.
Service Battery
Battery
Maximum number of charge/discharge cycles for battery
exceeded. Charging of the battery is inhibited. Contact
your service personnel to replace battery.
 Equip Malf
SpO2
The SpO2 Pod is faulty. Contact your service personnel.
 Erratic
SpO2
Check the sensor placement. Try another adapter cable
and sensor. If the INOP persists, contact your service
personnel.
 Extd.Update
SpO2
The update time for displayed values is extended due to
an NBP measurement on the same limb or an excessively
noisy signal.
Interference
SpO2
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.
 Low Perf
SpO2
Accuracy may be compromised due to very low
perfusion. Stimulate circulation at sensor site. If INOP
persists, change the measurement site.
only at the host
INOP tone
INOP tone
Numeric is replaced by -?INOP tone
Numeric is replaced by -?INOP tone
Numeric is replaced by -?-
Numeric is replaced by -?INOP tone
Numeric is replaced by -?-
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2 IntelliVue CL SpO2 Pod
INOP Message, Indication
Source
What to do
 NeoPatient?
SpO2
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.
 No Pulse
SpO2
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.
 No Sensor
SpO2
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.
 NoisySignal
SpO2
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.
 Poor Signal
SpO2
The signal quality of the SpO2 measurement is poor. The
accuracy may be compromised.
 Pulse?
SpO2
The detectable pulsations of the SpO2 signal are outside
the specified pulse rate range.
 Searching
SpO2
The patient signal is analyzed, but no valid numerics are
available yet.
 Sensor Malf
SpO2
The SpO2 sensor is faulty. Try another sensor. If the
INOP persists, contact your service personnel.
 Sensor Off
SpO2
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.
 Unkn.Sensor
SpO2
The connected SpO2 sensor is not supported by this
measurement hardware.
 Upgrade
SpO2
SpO2 in upgrade mode, no patient monitoring possible.
Numeric is replaced by -?INOP tone
Numeric is replaced by -?INOP tone
Numeric is replaced by -?INOP tone
Numeric is replaced by -?INOP tone
Numeric is replaced by -?INOP tone
Numeric is unavailable
Numeric is replaced by -?INOP tone
Numeric is replaced by -?INOP tone
Numeric is replaced by -?INOP tone
Numeric is replaced by -?-
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2 IntelliVue CL SpO2 Pod
SpO2 Default Settings
These are the most important default settings of your IntelliVue CL SpO2 Pod as they are delivered
from the factory. For a comprehensive list and explanation of default settings, see the Configuration
Guide supplied with your devices. The default settings can be permanently changed in Configuration
Mode. When the Pod is assigned to a patient monitor, the settings defined at the patient monitor will
overwrite the settings defined at the Pod.
SpO2 Settings
Factory Defaults
Adult
Pedi
Neo
Mode
Continuous
Continuous
Continuous
Repeat Time
15 min
15 min
15 min
Alarms
On
On
On
QRS Volume
ToneMod.
Yes
Yes
Yes
Perfusion
On
On
On
Average
10 sec
10 sec
10 sec
NBP Alarm Suppr.
On
On
On
Aging Time
10 min
10 min
10 min
Color
Cyan (light blue)
Cyan (light blue)
Cyan (light blue)
Average in Mon.
No
No
No
Signal Quality
On
On
On
Label
SpO₂
SpO₂
SpO₂
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
On
On
On
Alarms
On
On
On
High Lim
120
160
200
Low Lim
50
75
100
Δ Brady
20
20
20
SpO2 Alarm Default Settings
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2 IntelliVue CL SpO2 Pod
Pulse Settings
Factory Defaults
Adult
Pedi
Neo
Brady Clamp
40
40
50
Δ Tachy
20
20
20
Tachy Clamp
200
220
240
Integrated Battery Handling
Battery Care
Battery care begins when you receive a new IntelliVue Cableless Measurement Device with built-in
battery and continues throughout the life of the device. The table below lists battery care activities and
when they should be performed.
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).
39
2 IntelliVue CL SpO2 Pod
Storage
If unused IntelliVue Cableless Measurement Devices are stored for an extended period of time:
•
they should be powered off for storage
•
they should be stored in a cool place, ideally between 15°C and 25°C (60°F and 77°F)
•
the state of charge should be between 40 and 50%
•
they should be recharged every six months
Storing in a cool place slows the aging process of the batteries. They should be fully charged prior to
use. Do not store the device at a temperature outside the range of -20°C (-4°F) to 60°C(140°F).
Do not store cableless devices in direct sunlight.
NOTE
Storing the devices at temperatures above 40°C (104°F) for extended periods of time could
significantly reduce the battery's life expectancy.
Battery Lifetime Management
The lifetime of a Lithium Ion battery depends on the frequency and duration of use. When properly
cared for, the useful life is approximately 4 years or 400 complete charge-discharge cycles, whichever
comes first. In addition, experience indicates that the incidence of failure may increase with battery
service life due to the accumulated stresses of daily use. We therefore strongly recommend that lithium
ion batteries be replaced after 4 years or 400 complete charge-discharge cycles.
To see the date of manufacture and the number of charge-discharge cycles:
Select the Battery Smartkey or Main Setup followed by Battery.
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.
40
2 IntelliVue CL SpO2 Pod
Accessories
You can order parts and accessories from Philips supplies at www.medical.philips.com or consult your
local Philips representative for details.
WARNING
Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or
single patient use only. Reuse may compromise device functionality and system performance and cause
a potential hazard, in particular with regard to cross-contamination.
Philips’ approval: Use only Philips-approved accessories. Using non-Philips-approved accessories
may compromise device functionality and system performance and cause a potential hazard.
IntelliVue CL SpO2 Pod Accessories
All listed sensors operate without risk of exceeding 41°C on the skin, if the initial skin temperature
does not exceed 35°C.
Make sure that you use only the accessories that are specified for use with this device, otherwise patient
injury can result.
Order Number
Description
Contents
989803165941
Mobile CL 20 single patient SpO2 Sensors
and Cradles for use on pediatric and adult
patients >10 kg
20 Single-Patient Mobile CL DSpO2-1A
Sensors
20 Single-Patient Wristbands
20 Single-Patient Cradles
pre-assembled
989803165921
Mobile CL 20 single patient SpO2 Sensors 20 Single-Patient Mobile CL DSpO2-1A
for use on pediatric and adult patients >10 kg Sensors
9898031659311
Mobile CL reusable SpO2 sensor and Cradles 1 Reusable Mobile CL RSpO2-1A Sensor
for use on pediatric and adult patients > 15 kg 20 Single-Patient Cradles with pre-attached
Wristbands
989803165951
Mobile CL 20 SpO2 Cradles (single patient) 20 Single-Patient Cradles with pre-attached
Wristbands
989803165961
Mobile CL 50 SpO2 Wristbands (single
patient)
50 Single-Patient Wristbands
989803168861
Mobile CL SpO2 Battery Kit
1 Battery
1 disassembly tool
1 front housing
May not be available in all geographies
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2 IntelliVue CL SpO2 Pod
Maintenance and Troubleshooting
WARNING
Schedule: Failure on the part of the responsible individual hospital or institution employing the use of
this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure
and possible health hazards.
Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips,
or your authorized supplier.
Inspecting the Equipment and Accessories
You should perform a visual inspection before every use, and in accordance with your hospital's policy.
With the device switched off:
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.
Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use
them.
WARNING
If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working
properly, do not use it for any monitoring procedure on a patient, contact your service personnel.
Maintenance Task and Test Schedule
All maintenance tasks and performance tests are documented in detail in the service documentation
supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for 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.
42
3
IntelliVue CL NBP Pod
To measure NBP, you need Philips standard cuffs, a Mobile CL NBP Cradle and a pouch and
extension air hose, or a Mobile CL NBP Cradle and Mobile CL Cuffs. When using Mobile CL Cuffs,
the cradle is used to attach the Pod to the cuffs and to allow easy removal of the Pod.
Standard Philips cuffs and specialized single-patient and reusable NBP cuffs are available for use with
the IntelliVue CL NBP Pod. For details regarding the cuffs and single-patient cradle, refer to
“IntelliVue CL NBP Pod Accessories” on page 74.
General Operation of the NBP Pod
The following sections describe operation on the NBP Pod itself. For operation from a patient
monitor, see “Controls Available with a Patient Monitor” on page 54. For operation from an
Information Center via a telemetry system, see “Controls Available with a Telemetry Device” on
page 55. For operation with IntelliVue GuardianSoftware, see “Controls Available with
GuardianSoftware” on page 55.
The NBP Pods have three hardkeys for basic operation and a set of configurable SmartKeys which
appear on the screen. These are used to activate and navigate through the on-screen menus and to
select individual items. The typical operator's position is such that everything on the device's display
can be read clearly and easily.
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3 IntelliVue CL NBP Pod
Switching the Devices On
The first time an NBP Pod is used, or after the device has been powered off for storage, place it on the
IntelliVue CL Charging Station. This will automatically switch the device on.
If the NBP Pod has only been switched off temporarily (see “Switching the Device Off” on page 13),
press any hardkey to turn the device on again.
When an NBP Pod is not operated, it will automatically switch off the screen lighting after a short
time. A little later the low-activity screen will be displayed.
Screen Layout
There are three variations of the Main Screen layout depending on the Alarm status and the general
activity level.
Standard Layout
When assigned to a monitor, telemetry device or a patient in GuardianSoftware:
Connection status indicator
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.
Battery indicator
Measurement values
Measurement-related symbols (see the measurement
chapters for details)
Patient identification
When not assigned to a monitor or telemetry device:
44
Connection status indicator
Battery indicator
Measurement values
Measurement-related symbols (see the Monitoring
chapter for details). The Alarms Off symbols indicate
that no physiological alarms are available from the
Cableless Measurement Devices when not assigned to
a host.
Cableless Measurement Device equipment label
3 IntelliVue CL NBP Pod
Alarm Layout
If an alarm occurs the full alarm message appears at the top of the screen. After the alarm message has
been silenced the alarm indicator is shown as a symbol on the right side of the screen.
Full length alarm message
Alarm indicator
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.
45
3 IntelliVue CL NBP Pod
Use the ◄ and ► hardkeys to move along the row of SmartKeys. The highlighted SmartKey is
displayed in full above the row of SmartKeys. When you use the ◄ or ► hardkey at the end of the
row, an Exit screen appears and then with further presses you move on to the next page of SmartKeys.
To leave the SmartKeys menu you can use the Exit screen or press the ► hardkey for a couple of
seconds to return to the Main Screen.
When the required SmartKey is highlighted, press the  key to activate the corresponding function.
To get to the next page of the SmartKeys menu, highlight the rightmost SmartKey then press the ►
key.
List of Available SmartKeys
SmartKey
Text Labels
Main Setup
- start/stop manual NBP measurement
- start auto series
- start measurement sequence
- stop current automatic measurement within series
stop any NBP measurement and measurement series
start NBP STAT measurement
start venipuncture (inflate cuff to subdiastolic pressure)
set the NBP repetition time
Add/Remove device
enter Battery menu
change Screen
enter Profiles menu
switch device off (or power off when pressed for more than two seconds)
46
3 IntelliVue CL NBP Pod
SmartKey
Text Labels
enter Patient menu
enters the Alarms menu to access: Alarm Messages, Alarm Limits, Alarms
On/Off/Pause, Alarm Volume.
change alarm volume
change pulse tone volume
access NBP mode selection and setup, with direct start/stop function
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
NBP
Alarms
Patient
Equipment
User Interface
Device Off
Profiles
Operating Modes
Date, Time
Battery
Revisions
Switching the Device Off
To switch off a device manually, select the Device Off SmartKey, then Confirm.
If you keep Device Off pressed for more than two seconds, you can choose between Device Off or
Power Off.
•
Device Off means that the display is switched off and the measurements are disabled. Use this
option if your device is not used temporarily. Press any hardkey to turn the device on again.
•
Power Off means that the device is switched off completely and can only be switched on again by
putting it on a charger. Use this option when the device is not used for a longer time or prepared
for storage or shipping.
When an IntelliVue Cableless Measurement Device is not operated, it will automatically switch off the
screen lighting after a short time. A little later the low-activity screen will be displayed.
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3 IntelliVue CL NBP Pod
Operating Modes
Your device has four operating modes. Some are passcode protected.
•
Monitoring Mode: This is the normal, every day working mode that you use for making
measurements. You can change elements such as measurement modes, patient category and so
forth. When you remove the patient from the device, these elements return to their default values.
Changes can be stored permanently only in Configuration Mode. You may see items, such as some
menu options, that are visible but 'grayed out' so that you can neither select nor change them.
These are present for your information only and can be changed only in Configuration Mode.
•
Demonstration Mode: Passcode protected, this is for demonstration purposes only. You must
not change into Demonstration Mode during monitoring.
•
Configuration Mode: Passcode protected, this mode is for personnel trained in configuration
tasks. These tasks are described in the Configuration Guide. During installation the Cableless
Measurement Device is configured for use in your environment. This configuration defines the
default settings you work with when you switch on.
•
Service Mode: Passcode protected, this is for trained service personnel.
When you switch the device on, it starts up in monitoring mode. To change to a different mode:
Use the Main Setup SmartKey to get to the Main Setup menu.
Select Operating Modes and choose the mode you require.
Standby Mode
The IntelliVue Cableless Measurement Devices do not have standby mode. However, when connected
to a monitor that is in standby mode, the IntelliVue Cableless Measurement Device will show a
standby screen.
Using the Patient Menu
The Patient menu allows you to see patient demographics information and to remove a patient from a
device. Patient Demographic information is only displayed if the Cableless Measurement Device is
assigned to a patient monitor or GuardianSoftware. Patient Category is the only item of patient data
which can be changed at the Cableless Measurement Device, but only when the device is not assigned
to a patient monitor or telemetry device.
Displaying the Patient Menu
To display the Patient menu,
•
select the Patient SmartKey, or
•
select the Main Setup SmartKey followed by Patient.
Stop Using a Device for a Patient
To remove a patient from the Cableless Measurement Device,
•
in the Patient menu select Free Device.
All patient data is cleared, settings are reset to the defaults and the device is removed from the monitor
or telemetry device.
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3 IntelliVue CL NBP Pod
NOTE
Depending on your configuration, when the device is put on the charger, patient data will also be
cleared and the device will be free for another patient.
Using the Device for a New Patient
To use a device for a new patient,
•
in the Patient menu, select New Patient.
If the device was not free, the existing data will be deleted and the profile set to the default.
Using Profiles
A profile is a set of measurement and general settings which have been customized for a particular
purpose. The Cableless Measurement Devices can have four different profiles configured to your
requirements. The default profile is marked with a symbol. To select a different profile,
Select the Profiles SmartKey or the Main Setup SmartKey followed by Profiles.
Select the required profile from the list.
Selecting New Patient or Free Device will always reset the profile to the default.
Setting the Date and Time
If the Cableless Measurement Device is assigned to a patient monitor, telemetry device or
GuardianSoftware, the date and time will be taken from the host. If this is not the case, you can set the
date and time on the Cableless Measurement Device,
Select the Main Setup SmartKey and then Date, Time.
Enter the data for date and time one after another.
Select Store Date, Time.
If the time has not been set, --:-- will display on the device.
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 Battery menu. The Battery menu provides the following information: fullcharge and remaining capacity, voltage, current and temperature.
49
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, Telemetry Devices / Information Center or GuardianSoftware).
IntelliVue Cableless Measurements Use Models
With these patient-worn measurement devices you can measure and transmit a patient's vitals regularly
or on an intermittent data collection basis. There are three typical use models:
With a Patient Monitor
The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T,
MP2 or X2 patient monitor (with an SRR interface). They can communicate their measurement values
via short range radio to the monitor. The monitor may be assigned to a patient sector at the IntelliVue
Information Center (IIC). When assigned to the Information Center, certain actions can be performed
at both the patient monitor and the Information Center. See the table “Controls Available with a
Patient Monitor” on page 54.
In situations where patients are becoming more mobile (for example, in step-down/intermediate care
units) the lightweight Cableless Measurement Devices allow increased mobility within the short range
radio range, without giving up vital signs monitoring.
When assigned to a patient monitor, the Cableless Measurement Device can be selected for use in
patient transport at the patient monitor (for details see the Patient Monitor Instructions for Use). In
this case, the Cableless Measurement Device will perform local attended monitoring. The patient
must be attended by a caregiver during transport, to ensure that alarms on the Cableless Measurement
Device are recognized. In local attended monitoring mode, an alarm message text appears in the alarm
status area at the top of the screen indicating the source of the alarm and an alarm tone is issued. See
“Alarms” on page 28 for details.
A telemetry device can be assigned to a patient monitor equipped with short range radio at the same
time as any Cableless Measurement Devices are also assigned to this monitor.
When assigned to a patient monitor, the admitted patient name is displayed on the NBP Pod.
If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be
displayed at the monitor: cl NBP Disconnect. A No Host Monitoring INOP will be displayed on the
NBP Pod, and an INOP tone will sound. In this case, visual and audible alarms are still available at the
NBP Pod, but it is not possible to change the alarm settings.
With a 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 55.
If the patient name is available at the Information Center, it will be also displayed on the NBP 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.
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3 IntelliVue CL NBP Pod
If the connection between the telemetry device and the Cableless Measurement Device is lost, an
INOP will be displayed at the Information Center: cl NBP Disconnect. A No System Monitor. INOP
will be displayed 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 or
Hotspot from the Cableless Measurement Devices. Using the collected data, it provides trending,
review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application
provides basic assessment guidance, helping you to recognize the early signs of deterioration in your
patients. GuardianSoftware is not intended for monitoring in combination with Cableless
Measurement Devices.
Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table
“Controls Available with GuardianSoftware” on page 55. GuardianSoftware also manages the patient
data.
If the connection between GuardianSoftware and the Cableless Measurement Device is lost, the
connection symbol will be displayed gray at GuardianSoftware. A No System INOP will be displayed
on the NBP Pod (no alarm sound).
If a patient name is available at GuardianSoftware, it will be also displayed on the Pod. Any update of
patient data will be synchronized between the Pods and GuardianSoftware. The only patient
management action available directly at the Pod is Free Device. Selecting Free Device removes the
current patient from the Pod and resets the Pod to the default profile. The Pod is unassigned.
Device Compatibility
The IntelliVue CL NBP Pods require the following software levels in the associated equipment:
•
Patient Monitor - Release H.0 or above
•
Information Center - Release M or above
•
Telemetry device TRx4841A/TRx4851A - Revision D.00.22 or above
•
MX40 wearable patient monitor - Revision A.0 or above
•
IntelliVue GuardianSoftware - Revision A.0 or above
Availability of Patient Alarms
When the IntelliVue CL 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: Alarm messages will be displayed and audible alarm
indicators sounded at the patient monitor in the same way and under the same conditions as for its
own measurements. See the Instructions for Use of the patient monitor for details.
If a Cableless Measurement Device that is assigned to a monitor is selected for use in patient
transport at the patient monitor, the Cableless Measurement Device will perform local attended
monitoring. See the Instructions for Use of the patient monitor for details on how to do this. The
patient must be attended by a caregiver during transport, to ensure that alarms on the Cableless
Measurement Device are recognized. In local attended monitoring mode, an alarm message text
51
3 IntelliVue CL NBP Pod
appears in the alarm status area at the top of the screen indicating the source of the alarm and an
alarm tone is issued. See “Alarms” on page 28 for details.
•
When assigned to a telemetry device: Measurement values sent via the telemetry device to the
IntelliVue Information Center can generate alarms at the Information Center when the values
meet the criteria set there for alarms. The alarms will be announced in the same way as
measurements from other sources. See the Instructions for Use of the Information Center for
details.
•
When assigned to GuardianSoftware: Measurement values sent via transmitters or hotspots to
IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue
GuardianSoftware is a data management system, no alarms are announced. The IntelliVue
Cableless Measurement Devices will also not generate physiological alarms when connected to
IntelliVue GuardianSoftware. See the Instructions for Use of GuardianSoftware.
Assigning an IntelliVue Cableless Measurement Device to a Host
When an IntelliVue CL 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 Add/Remove SmartKey
•
hold the ◄ key pressed.
, or
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
52
3 IntelliVue CL NBP Pod
second. The search will take approximately 20-25 seconds. Once a channel is identified, the first
LED will light up and blink once per second to indicate that the telemetry device is ready for
assignment.
Add To
Mon 1
Mon 2
Tele 33
Tele 44
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.
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:
Select the measurement selection key on the monitor.
A prompt message appears with the Confirm and Cancel keys.
Select Confirm to deactivate the internal measurement.
When the Cableless Measurement Device is assigned, the
symbol appears on its display indicating
that alarming capability has been transferred to the host (to the monitor or, for the telemetry device, to
the Information Center). No patient alarms will be announced on the Cableless Measurement Device.
To unassign the measurement device from the monitor or telemetry system, select the Add/Remove
SmartKey, then select Remove From. After confirmation the SRR connection is disconnected.
Assignment at the Patient Monitor
Prepare the Pod for assignment by activating the Add/Remove SmartKey.
At the patient monitor,
Select the Measurement Selection key.
Select the Add cl Msmt pop-up key.
This opens the Add Cableless window, which shows the available Cableless Measurement
Devices:
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3 IntelliVue CL NBP Pod
Select the device which you want to assign to the patient in the monitor.
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.
When the Cableless Measurement Device is assigned, the
symbol appears on its display indicating
that alarms from the device will be sent to the patient monitor.
An assigned Cableless Measurement Device can be removed in the Measurement Selection window.
For more details see the Instructions for Use for your patient monitor.
Assignment with GuardianSoftware
To assign a Cableless Measurement Device to a patient in GuardianSoftware:
Select the patient on the Chalkboard.
Take the Cableless Measurement Device from the charger.
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).
Click Use for Patient to assign the device to the patient.
Controls Available with a Patient Monitor
The controls available when the Cableless Measurement Device is assigned to a patient monitor are
described in the table below.
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
No
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
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Monitoring message is displayed on the measurement device. The measurement device will also sound
the INOP tone.
Controls Available with a Telemetry Device
The controls available when the Cableless Measurement Device is assigned to a TRx4841/TRx4851A
Transceiver or MX40 wearable patient monitor with a short range radio adapter (SRRA) are described
in the table below.
Action
At the Cableless
Measurement Device
At the IIC
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 the Cableless Measurement Device is assigned to GuardianSoftware are
described in the table below.
Action
At the Cableless
Measurement Device
At GuardianSoftware
Start/Stop/Stat NBP
Yes
Yes
Change NBP Mode
Yes
Yes
Change NBP Repetition Time
Yes
Yes
Assign NBP Pod
Yes
Yes
Remove NBP Pod
Yes
Yes
Place Device in Standby
No
No
Alarm Silence
No
Yes
Alarm Off/Pause
No
No
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Trending
The IntelliVue Cableless Measurement Devices provide data for trending of parameters. The trended
data are only available via a host system. For details on trends see the Instructions for Use of your host
system.
When the connection to the host is lost during measurement, the IntelliVue Cableless Measurement
Devices are able to collect data in a local memory. These data can be uploaded to GuardianSoftware,
but not to other host systems, when a connection is established at a later stage.
Monitoring 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 ANSI/AAMI SP10
and ISO 81060-2 in relation to mean error and standard deviation, when compared to auscultatory
measurements (depending on the configuration) in a representative patient population. The fifth
Korotkoff sound was used to determine the diastolic pressure for adult/adolescent subjects and the
4th for pediatric subjects.
The accuracy of the mean arterial pressure (MAP) was validated using the approximation MAPref =
(SYSref + 2*DIAref) / 3 with SYSref and DIAref being the blood pressure measured by the auscultatory
method.
The NBP measurement is suitable for use in the presence of electrosurgery and during the discharge of
a cardiac defibrillator according to IEC 60601-2-30:1999/EN 60601-2-30:2000.
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.
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.
Unattended measurement: Use clinical judgement to decide whether to perform frequent
unattended blood pressure measurements in cases of severe blood clotting disorders because of the
risk of hematoma in the limb fitted with the cuff.
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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.
Measurement Limitations
NBP readings can be affected by the position of the subject and his or her physiological condition.
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.
The effectiveness of this sphygmomanometer has not been established in pregnant, including
pre-eclamptic patients.
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 Setup NBP menu. The
Accelerated Msmt setting shows whether the accelerated measurement is Off, on for Manual
measurements or on for All measurements. This setting is view-only in Measurement mode and can be
changed in Configuration Mode. When the accelerated measurement is in use, no pulse rate is derived
from NBP.
Measurement Modes
There are four 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.
•
STAT - rapid series of measurements over a five minute period, then the monitor returns to the
previous mode. Use only on supervised patients.
Reference Method
The measurement reference method is always Auscultatory (manual cuff). For further information, see
the Application Note supplied on the documentation DVD.
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Preparing to Measure NBP with Standard Cuffs
Apply the carrying pouch to the patient.
Apply the cuff to the patient's upper arm at the same level as the heart.
If the cuff is not at heart level, you must use the measurement correction formula to correct the
measurement.
Make sure that you are using a Philips-approved correct sized cuff and that the bladder inside the
cover is not folded or twisted.
A wrong cuff size, and a folded or twisted bladder, can cause inaccurate measurements. The width
of the cuff should be in the range from 37% to 47% of the limb circumference.
Do not wrap the cuff too tightly around the limb. It may cause discoloration, and ischemia of the
extremities.
58
Connect the extension air hose to the cuff.
3 IntelliVue CL NBP Pod
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.
Place the NBP Pod into the cradle.
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.
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.
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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.
Attach the cradle to the NBP cuff.
Plug the air tubing into the cradle.
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.
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
Starting and Stopping Measurements
Use the setup menu or SmartKeys to start and stop measurements.
Action to be Performed
NBP Setup menu
Start manual measurement
Start/Stop
SmartKeys
Start Auto series
Start/Stop
Start measurement sequence
Start STAT measurement
Start NBP Stat
Start NBP STAT
Stop Manual measurements
Start/Stop
Start/Stop
Stop current Auto/sequence measurement Start/Stop
Start/Stop
Stop current STAT measurement and end
STAT mode
Start/Stop
Start/Stop
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Action to be Performed
NBP Setup menu
Stop Auto, Manual or STAT measurement, Stop All
end STAT mode AND Auto/Sequence
series
SmartKeys
Stop All
Depending on the configuration of the NBP Auto/Sequence series, measurements are automatically
started within 3 seconds (Autostart set to Fast) or 3 minutes (Autostart set to Slow) after the NBP Pod
has been inserted into the cradle. With Autostart set to Off, the Auto/Sequence series have to be
started manually.
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
In the NBP menu, select Mode and select Auto from the pop-up menu.
For an automatic measurement, select Repeat and set the time interval between two
measurements.
Enabling Sequence Mode and Setting Up The Sequence
In the NBP menu, select Mode and select Sequence from the pop-up menu.
Select Setup Sequence to open the Setup Sequence menu.
Up to four measurement phases can be setup which will run consecutively. For each phase you can
set the number of measurements and the interval between them. If you want to run less than four
phases in a sequence, you can set the number of measurements for one or more phases to Off.
Select each phase in turn (A, B, C and D) and select the number of measurements and the time
interval between the measurements.
To have measurements continue after the sequence, set the number of measurements for your last
phase to Cont and this phase will run indefinitely.
CAUTION
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.
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Understanding the NBP Numerics and Symbols
Systolic/Diastolic pressure
Mean pressure
Pulse rate
Pulse rate indicator
Measurement mode (see below)
Alarms Off symbol for Pulse
Timestamp
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.
indicates that auto or sequence mode is
selected but the measurement series has
not yet started.
An S in front of the symbol indicates Sequence mode and an A, B, C or D indicates which phase of
the sequence is currently running.
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
Deduct 0.75 mmHg (0.10 kPa) for each
centimeter lower or
Add 1.9 mmHg (0.25 kPa) for each inch higher.
Deduct 1.9 mmHg (0.25 kPa) for each inch
lower.
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.
To switch the display of the pulse value on or off:
•
62
In the NBP menu select Pulse.
3 IntelliVue CL NBP Pod
Assisting Venous Puncture
You can use the NBP cuff to cause sub-diastolic pressure. The cuff deflates automatically after a set
time (adult/pediatric 170 seconds) if you do not deflate it.
In the NBP menu select Veni Puncture, or select the Veni Puncture SmartKey.
Puncture vein and draw blood sample.
Reselect Veni Puncture to deflate the cuff.
During measurement, the NBP display shows the inflation pressure of the cuff and the remaining time
in venous puncture mode.
Calibrating 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.
Alarms
The IntelliVue Cableless Measurements have two different types of alarm: patient alarms and INOPs.
Patient Alarms
Patient Alarms are high priority alarms (such as a potentially life threatening situation), also called red
alarms, or medium priority alarms, also called yellow alarms.
Technical Alarms (INOPs)
Technical alarms, also known as INOPs, indicate that the measuring device cannot measure reliably. If
an INOP interrupts monitoring, there will be a question mark in place of the measurement numeric.
An INOP tone sounds at the Cableless Measurement Device only when there is no SRR connection to
a host.
Most INOPs are low priority, however there are a small number of INOPs which, due to their severity,
are medium or high priority.
Alarm Delays
There is a delay between a physiological event at the measurement site and the corresponding alarm
indication at the Cableless Measurement Device. This delay has two components:
•
The general measurement delay time is the time between the occurrence of the physiological event
and when this event is represented by the displayed numerical values. This delay depends on the
algorithmic processing.
•
The time between the displayed numerical values crossing an alarm limit and the alarm indication
on the device is the system alarm delay. The system alarm delay is the processing time the system
needs for any alarm on the Cableless Measurement Device to be indicated after the measurement
has triggered the alarm. See the performance specifications in the Specifications chapter for the
system alarm delay specification.
The alarm delay configured for a specific measurement is normally a fixed time.
Multiple Alarms
If more than one alarm is active, the alarm messages are shown in the alarm status area in succession.
An arrow symbol next to the alarm message informs you that more than one message is active.
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The Cableless Measurement Device sounds an audible indicator for the highest priority alarm. If more
than one alarm condition is active in the same measurement, the Cableless Measurement Device
announces the most severe.
NOTE
If you want to use local attended monitoring, make sure to have all Cableless Measurement Devices
upgraded to Rev. B.02.
Visual Alarm Indicators
WARNING
•
No patient alarms are available on the CL devices when assigned to a host monitor (unless they are
selected for use in patient transport at the monitor they are assigned to) or GuardianSoftware.
•
Visual patient alarm indicators are disabled on the CL device when connected to a host monitor
(unless they are selected for use in patient transport at the monitor they are assigned to) or
GuardianSoftware.
Alarm Message
Alarm messages are displayed in black on a light gray background in the alarm status area at the top of
the screen indicating the source of the alarm and coded according to their severity. If more than one
measurement is in an alarm condition, the message changes every few seconds, and has an arrow ( )
at the side. The asterisk symbols (*) beside the alarm message match the alarm priority: *** for red
alarms, ** for yellow alarms. Standard INOPs do not have a symbol, red and yellow INOPs have
exclamation marks beside the alarm message: !!! for red INOPs and !! for yellow INOPs.
An alarm message that appears is automatically highlighted. Use the  key to silence the message. A
Silence message is displayed at the bottom of the screen and highlighted. Press  again to confirm the
acknowledgment of the alarm. After the confirmation, any ongoing alarm message is displayed in the
icon tray of the screen.
Alarm States
Depending on the alarm state of your Cableless Measurement Device, the following icons may be
displayed on the device:
Icon
Description
No local alarming on Cableless Measurement Device. The
device is connected to a host monitor or telemetry device
and has no visual or audible patient alarm indicators. The
device will only display INOP messages.
Alarms are switched off.
Alarm volume is set to 0.
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Audible Alarm Indicators
Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or
pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching).
Cableless Measurements Devices alone (without host, e.g. a patient monitor) are not suitable for
unattended monitoring due to their limited alarm volume.
WARNING
•
Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm
volume to a low level or off during patient monitoring may result in patient danger. Remember
that the most reliable method of patient monitoring combines close personal surveillance with
correct operation of monitoring equipment.
•
No patient alarms are available on the Cableless Measurement Device when connected to a host
monitor (unless they are selected for use in patient transport at the monitor they are assigned to)
or to GuardianSoftware.
•
When connected to a host monitor or GuardianSoftware, no alarm tones are available on the
Cableless Measurement Device (unless they are selected for use in patient transport at the monitor
they are assigned to).
Acknowledging 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.
Full length alarm message
Alarm indicator
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,
Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms.
Select Alarm Messages.
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Setting the Volume of the Alarm Tone
To set the volume for the Alarm tone,
Select the Alarms SmartKey or Main Setup SmartKey, followed by Alarms.
Select 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.
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,
In the SmartKeys Menu select Main Setup, Alarms, then OffDurat.
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 On/Off. If your device is
configured to infinite pause time, selecting this key switches alarms off.
Press the  hardkey to complete the change.
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3 IntelliVue CL NBP Pod
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.
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
If Mean is not selected as alarm source (Sys., Dia., or Sys & Dia selected), but the monitor can only
derive a mean value, mean alarms will nevertheless be announced using the most recent mean alarm
limits. Check that the mean alarm limits are appropriate for the patient, even when not using mean as
the alarm source. When no value can be derived an NBP Measure Failed INOP will be displayed.
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
Select the Alarms SmartKey followed by Alarm Limits (or select Main Setup followed by NBP).
Depending on your alarm source:
a. Select Sys.High, Dia.High and/or MeanHigh then choose the high alarm limit.
b. Select Sys. Low, Mean Low, Dia. Low and/or Mean Low then choose the low alarm limit.
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Latching Alarms
The alarm latching setting for your device defines how the alarm indicators behave when you do not
acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition
ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed
or announced by the device after the alarm condition ends. The indication lasts until you acknowledge
the alarm.
Viewing the Alarm Latching Settings
To see the alarm latching setting for your device
In the Main Setup menu, select Alarms.
Here you can see the Visual Latching and Audible Latching settings.
This setting can only be changed in Configuration Mode. You should be aware of the settings chosen
for your unit. There are three possible choices each for visual and audible latching, red only, red and
yellow, and off. These choices can be combined to give the following settings:
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.
Red & Yellow Measurement
Alarms
Non-latching alarms
Visual and audible latching Visual latching, audible
non-latching
Alarm has not
been
acknowledged.
Alarm condition
still present.
Alarm tone on. Alarm message. Alarm tone on. Alarm
message.
Alarm condition All audible and visual alarm
no longer present. indicators automatically stop.
Alarm tone on.
Alarm message.
Alarm message.
Audible alarm indicators
automatically stop.
Alarm has been
acknowledged.
Alarm condition
still present.
All audible and visual alarm
indicators automatically stop.
All audible and visual alarm
indicators automatically stop.
All audible and visual alarm
indicators automatically stop.
Alarm condition Audible and visual alarm
no longer present. indicators automatically stop.
Audible and visual alarm
indicators automatically stop.
Audible and visual alarm
indicators automatically stop.
Alarm tone on. Alarm
message.
All INOPs are non-latching. NBP specific INOPs generated by the CL Pod are latching.
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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 (Device Off), all alarm settings are maintained. If the device is switched off
completely (Power Off), or the battery is completely empty, resulting in complete power loss, all alarm
settings will be lost unless they were actively saved by storing the active profile before the device was
switched off. See “Switching the Device Off” on page 13 and “Using Profiles” on page 15 for details.
When the device is switched back on from either state, it will start in Profile A and you may have to
switch to the desired profile which contains your alarm settings.
After any of these situations, you should check that the alarm settings are appropriate for your patient
and monitoring situation, and if necessary, select the correct Profile and patient category.
Reference List of Patient Alarms
Alarm Message, Indication
Source
Condition
** NBPs High
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.
** NBPd High
** NBPm High
** NBPs Low
** NBPd Low
** NBPm Low
Reference List of all INOPs
INOP Message, Indication
Source
What to do
Batt Incompatible
Battery
Battery cannot be used with this Cableless Measurement
Device. Replace battery with one that has been approved
for use with this Cableless Measurement Device. Contact
your service personnel.
Batt Malfunction
Battery
Malfunction of the battery system detected (charger
circuit or battery). Contact your service personnel.
Battery Empty
Battery
The remaining monitoring time is below 30 minutes.
Charge battery.
Battery Low
Battery
The remaining monitoring time is below 2 hours.
Check Batt Temp
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.
INOP tone
INOP tone
INOP tone
INOP tone
INOP tone
69
3 IntelliVue CL NBP Pod
INOP Message, Indication
Source
What to do
Check Battery
Battery
The maximum number of charge/discharge cycles of the
battery will be reached in less than 50 cycles. Contact
your service personnel to replace the battery.
Check Charger I/F
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.
cl NBP ChkSettings
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.
INOP tone
INOP tone
INOP tone
If this INOP is acknowledged at the Cableless
Measurement Device, it is cleared. If it is silenced
remotely, only the tone is cleared.
cl NBP Disconnect
only at the host
Cableless
Measurement Device
The NBP Pod has lost the SRR connection to the
telemetry device or the patient monitor.
Cuff Not Deflated
NBP
The NBP cuff pressure has exceeded 15 mmHg (2 kPa)
for more than 3 minutes.
Numeric is replaced by -?INOP tone
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.
During this INOP, alarms cannot
be paused or switched off.
NBP Cuff Overpress
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.
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
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3 IntelliVue CL NBP Pod
INOP Message, Indication
Source
What to do
NBP Interrupted
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
inflation, deflation or the total measurement.
NBP Measure Failed
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 Neo Patient?
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.
No Cradle
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.
Numeric is replaced by -?INOP tone
Numeric is replaced by -?INOP tone
Numeric is replaced by -?INOP tone
Numeric is replaced by -?INOP tone
If INOP appears with the NBP Pod inserted into the
cradle, remove and replace the cradle.
No Host Monitoring
Cableless
Measurement Device
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.
No System
Cableless
Measurement Device
There is a problem with the communication to the
network and central monitoring is currently not possible.
Check the connection.
Remove From Pat
INOP tone
Cableless
Measurement Device
Displayed on the Cableless Measurement Device. The
temperature of the battery is too high. Remove the
Cableless Measurement Device from the patient and
contact service personnel.
Service Battery
Battery
Maximum number of charge/discharge cycles for battery
exceeded. Charging of the battery is inhibited. Contact
your service personnel to replace battery.
INOP tone
INOP tone
71
3 IntelliVue CL NBP Pod
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.
NBP Settings
72
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
Aging Time
10 min
10 min
Color
Red
Red
AnnouncementTone
Off
Off
Automatic Start
Off
Off
Accelerated Msmt
Off
Off
3 IntelliVue CL NBP Pod
Integrated Battery Handling
Battery Care
Battery care begins when you receive a new IntelliVue Cableless Measurement Device with built-in
battery and continues throughout the life of the device. The table below lists battery care activities and
when they should be performed.
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).
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.
73
3 IntelliVue CL NBP Pod
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:
Select the Battery Smartkey or Main Setup followed by Battery.
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.
Accessories
You can order parts and accessories from Philips supplies at www.medical.philips.com or consult your
local Philips representative for details.
WARNING
Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or
single patient use only. Reuse may compromise device functionality and system performance and cause
a potential hazard, in particular with regard to cross-contamination.
Philips’ approval: Use only Philips-approved accessories. Using non-Philips-approved accessories
may compromise device functionality and system performance and cause a potential hazard.
IntelliVue CL NBP Pod Accessories
Mobile CL Cuffs:
Order Number
Description
Limb
Circumference
Range
Bladder Width
Contents
989803163171
Mobile CL Reusable Small
Adult Cuff
21 - 27 cm
10.5 cm
1 cuff
989803163191
Mobile CL Reusable Adult Cuff 26.0 - 34.5 cm
13.0 cm
1 cuff
989803163211
Mobile CL Reusable Large
Adult Cuff
16.0 cm
1 cuff
989803163181
Mobile CL Single-Patient Small 21 - 27 cm
Adult Cuff
10.5 cm
20 cuffs
74
33.5 - 45.0 cm
3 IntelliVue CL NBP Pod
Order Number
Description
989803163201
Limb
Circumference
Range
Bladder Width
Contents
Mobile CL Single-Patient Adult 26.0 - 34.5 cm
Cuff
13.0 cm
20 cuffs
989803163221
Mobile CL Single-Patient Large 33.5 - 45.0 cm
Adult Cuff
16.0 cm
20 cuffs
989803163251
Mobile CL NBP Cradle Kit
20 cradles
989803163131
Mobile CL Extension Air Hose, 1.0 m
1 extension air hose
989803187431
Mobile CL Air Hose - Bayonet
Connector
1 adapter air hose
989803163261
Mobile CL NBP Battery Kit
1 Battery
1 disassembly tool
1 front housing
989803137831
Telemetry Pouch with window
50 pouches
989803140371
Telemetry Pouch with window
4 boxes of
50 pouches
989803101971
(9300-0768-050)
White Telemetry Pouch with
Snaps; box of 50
50 pouches
989803101981
(9300-0768-200)
White Telemetry Pouch with
Snaps; 4 boxes of 50
4 boxes of
50 pouches
Comfort Reusable Cuffs:
Order 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
M1574A
Adult cuff
27.0 - 35.0 cm
M1575A
Large adult cuff
34.0 - 43.0 cm
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:
Order Number
Description
Limb Circumference Range
M4552B
Infant cuff, limb circumference
10.0 - 15.0 cm
M4552B5
Pack of 5 M4552B cuffs
M4553B
Pediatric cuff, limb circumference
M4553B5
Pack of 5 M4553B cuffs
14.0 - 21.5 cm
75
3 IntelliVue CL NBP Pod
Order Number
Description
Limb Circumference Range
M4554B
Small adult cuff, limb circumference
20.5 - 28.5 cm
M4554B5
Pack of 5 M4554B cuffs
M4555B
Adult cuff, limb circumference
M4555B5
Pack of 5 M4555B cuffs
M4556B
Adult cuff, X-Long, limb circumference
M4556B5
Pack of 5 M4556B cuffs
M4557B
Large adult cuff, limb circumference
M4557B5
Pack of 5 M4557B cuffs
M4558B
Large adult cuff, X-Long, limb circumference
M4558B5
Pack of 5 M4558B cuffs
M4559B
Thigh cuff, limb circumference
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 Xlong, one large adult, one large adult X-long and one thigh
cuff
27.5 - 36.0 cm
27.5 - 36.0 cm
35.0 - 45.0 cm
35.0 - 45.0 cm
44.0 - 56.0 cm
Multi Care Cuffs:
Order 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, X-Long
27.0 - 35.0 cm
989803183361
Large adult cuff
34.0 - 43.0 cm
989803183371
Thigh cuff
42.0 - 54.0 cm
Single Patient, Gentle Care Cuffs:
Order 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
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3 IntelliVue CL NBP Pod
Order Number
Description
Limb Circumference Range
M4576B
Adult cuff, X-Long
27.5 - 36.0 cm
M4577B
Large adult cuff
35.0 - 45.0 cm
M4578B
Large adult cuff, X-Long
35.0 - 45.0 cm
M4579B
Thigh cuff
44.0 - 56.0 cm
Single Care Cuffs:
Order 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, X-Long
27.5 - 36.0 cm
989803182321
Large adult cuff
35.0 - 45.0 cm
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3 IntelliVue CL NBP Pod
Maintenance and Troubleshooting
WARNING
Schedule: Failure on the part of the responsible individual hospital or institution employing the use of
this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure
and possible health hazards.
Contact: If you discover a problem with any of the equipment, contact your service personnel, Philips,
or your authorized supplier.
Inspecting the Equipment and Accessories
You should perform a visual inspection before every use, and in accordance with your hospital's policy.
With the device switched off:
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.
Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use
them.
WARNING
If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working
properly, do not use it for any monitoring procedure on a patient, contact your service personnel.
Maintenance Task and Test Schedule
All maintenance tasks and performance tests are documented in detail in the service documentation
supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for 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.
78
4
IntelliVue CL Respiration Pod
For respiration measurement, attach the 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 Respiration Pod also provides basic information about patient posture (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 91.
General Operation of the Respiration Pod
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 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).
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4 IntelliVue CL Respiration Pod
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
Recharging the Pod
To recharge the pod, place it on the charging station. The device becomes inactive.
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 three typical use models:
With a Patient Monitor
The IntelliVue Cableless Measurement Devices can be used together with an MP5/MP5SC/MP5T
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 82.
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.
80
4 IntelliVue CL Respiration Pod
A telemetry device can be assigned to a patient monitor equipped with short range radio at the same
time as any Cableless Measurement Devices are also assigned to this monitor.
If the connection between the monitor and the Cableless Measurement Device is lost, an INOP will be
displayed at the monitor: cl Resp Disconnect.
With IntelliVue GuardianSoftware
The Cableless Measurement Devices can be used together with IntelliVue GuardianSoftware.
GuardianSoftware collects non-continuous vital signs data that are transmitted via a Transmitter or
Hotspot from the Cableless Measurement Devices. Using the collected data, it provides trending,
review, reporting and notification. The Guardian Early Warning Scoring (Guardian EWS) application
provides basic assessment guidance, helping you to recognize the early signs of deterioration in your
patients. GuardianSoftware is not intended for monitoring in combination with Cableless
Measurement Devices.
Some of the measurement tasks can be performed remotely from GuardianSoftware. See the table
“Controls Available with GuardianSoftware” on page 83. 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.
Device Compatibility
The IntelliVue CL Respiration Pod requires the following software levels in the associated equipment:
•
Patient Monitor - Release J.2 or above
•
IntelliVue GuardianSoftware - Revision B.0 or above
Availability of Patient Alarms
When the IntelliVue CL Respiration Pod is assigned to a host and a short range radio connection
exists, alarms will be announced at the host device.
•
When assigned to a patient monitor: Alarm messages will be displayed and audible alarm
indicators sounded at the patient monitor in the same way and under the same conditions as for its
own measurements. See the Instructions for Use of the patient monitor for details.
•
When assigned to GuardianSoftware: Measurement values sent via transmitters or hotspots to
IntelliVue GuardianSoftware will be visualized in GuardianSoftware. Since IntelliVue
GuardianSoftware is a data management system, no alarms are derived. The IntelliVue Cableless
Measurement Devices will also not generate physiological alarms when connected to IntelliVue
GuardianSoftware. See the Instructions for Use of GuardianSoftware.
Assigning an IntelliVue Cableless Measurement Device to a Host
When an IntelliVue CL Respiration Pod is used with a host system (patient monitor or
GuardianSoftware), the Pod must be assigned to that host system.
The assignment must be done at the host system.
WARNING
Always make sure that the applied CL Respiration Pod is assigned to the correct patient.
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4 IntelliVue CL Respiration Pod
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 cl Resp Disconnect INOP at the host monitor. Correct channel
configuration is important, refer to the Configuration Guide for details.
Assignment at the Patient Monitor
Prepare the Pod for assignment by pressing the hardkey once (LED shows battery and assignment
status).
At the patient monitor,
Open the Add Cableless window, e.g. by using the measurement selection key followed by the
Add cl Msmt pop-up key.
The available Cableless Measurement Devices are shown in the window.
Select the device which you want to assign to the patient on the monitor.
The monitor displays the assignment prompt message.
When the Cableless Measurement Device is assigned, the LED changes from blinking to solid.
An assigned Cableless Measurement Device can be removed in the Measurement Selection window.
For more details see the Instructions for Use for your patient monitor.
Assignment with GuardianSoftware
To assign a Cableless Measurement Device to a patient in GuardianSoftware:
Select the patient on the Chalkboard.
Take the Cableless Measurement Device from the charger.
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).
Click Use for Patient to assign the device to the patient.
Controls Available with a Patient Monitor
The controls available when the Cableless Measurement Device is assigned to a patient monitor are
described in the table below.
82
Action
At the Cableless
Measurement
Device
At the Patient
Monitor
At the IIC
Start Resp/Pulse Measurement
Yes
Yes
No
Change Measurement Mode
No
Yes
No
Change Repetition Time
No
Yes
No
4 IntelliVue CL Respiration Pod
Action
At the Cableless
Measurement
Device
At the Patient
Monitor
At the IIC
Change Alarm Limits
No
Yes
No
Assign Respiration Pod
No
Yes
No
Remove Respiration Pod
Yes
Yes
No
Dynamic Repetition Mode On/Off
No
Yes
No
Posture On/Off
No
Yes
No
Activity On/Off
No
Yes
No
Alarm Silence
No
Yes
Yes
Alarm Off/Pause
No
Yes
Yes
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.
Controls Available with GuardianSoftware
The controls available when the Cableless Measurement Device is assigned to GuardianSoftware are
described in the table below.
Action
At the Cableless
Measurement Device
At GuardianSoftware
Start Resp/Pulse Measurement
Yes
Yes
Change Measurement Mode
No
Yes
Change Repetition Time
No
Yes
Change Alarm Limits
No
Yes
Assign Respiration Pod
No
Yes
Remove Respiration Pod
Yes
Yes
Dynamic Repetition Mode On/Off
No
Yes
Posture On/Off
No
Yes
Activity On/Off
No
Yes
Technical Alarm Silence
No
Yes
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.
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4 IntelliVue CL Respiration Pod
When the connection to the host is lost during measurement, the IntelliVue Cableless Measurement
Devices are able to collect data in a local memory. These data can be uploaded to GuardianSoftware,
but not to other host systems, when a connection is established at a later stage.
Monitoring Respiration
The CL Respiration Pod derives the respiration and pulse signal from the chest and abdomen
movements measured with a built-in acceleration sensor. The CL Respiration Pod gets attached with a
Mobile CL Respiration Pod Attachment to the left costal arch on the patient's chest.
When configured, the CL Respiration Pod provides information on the basic patient posture and
patient activity. Eight different postures such as supine, upright and lying on left/right side are
detected and updated after a posture change has occurred and posture is stable again. The activity is
determined once per second, and an average activity level between 0 and 10 is reported once per
minute to the connected host system. The activity status information provides only an approximate
indication of the actual patient activity.
WARNING
The CL Respiration Pod is not an apnea monitor and does not provide apnea alarming.
Excessive patient movement can interfere with the measured signal. This may result in inaccurate
measurements.
The CL Respiration Pod does not provide continuous measurement. When configured in frequent
mode, the fastest update rate for pulse is 8 sec.
If the patient has a condition where the respiration rate approaches the upper limit of the measurement
range (60 rpm), use other means of respiration rate measurement.
Do not use the CL Respiration Pod in an environment where continuous monitoring is needed, such
as intensive care units or operating rooms, because life-critical events might be missed due to the
intermittent mode of measurement.
Do not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm.
Use under these conditions has not been clinically validated.
Measurement Modes
There are three different modes available for performing respiration/pulse measurements: Manual
Mode, Automatic Mode and Frequent Mode. The mode can only be set on the host system:
84
•
Manual Mode - a single respiration and pulse measurement is performed when a measurement is
started at the host or when the key on the Respiration Pod is pressed (key must be pressed twice if
the LED is off).
•
Automatic Mode - respiration and pulse measurements are performed with an interval between
them. The interval is selected at the host. The first measurement starts immediately after entering
the automatic measurement mode. If configured: When the respiration rate rises above or falls
below the defined alarm limits, the measurement mode changes temporarily to frequent mode.
The automatic mode will resume if the respiration rate readings are valid for at least 1 minute and
no respiration rate reading within the last minute violates the respiration rate alarm.
•
Frequent Mode -Respiration and pulse measurement is active all the time. The respiration Rate is
updated with every new detected breath. The shortest update interval for the pulse rate is 8
seconds.
4 IntelliVue CL Respiration Pod
Assigning the Pod
Take the Pod from the charging station. The multi-color LED blinks if the Pod is not assigned to a
host system.
When working with a patient monitor:
Go to the patient monitor you want to use and select Add cl Msmt. The LED on the Pod changes
from blinking to solid.
When working with GuardianSoftware:
In GuardianSoftware:
Select the patient on the Chalkboard.
On the Equipment List tab, select the Cableless Measurement Device on the Available
Equipment list.
The LED on the Respiration Pod blinks.
Click Use for Patient to assign the Pod to the patient.
Attaching the Pod to the Patient
Put the Pod front side up onto the adhesive attachment according to the positioning markers.
Remove the protective cover from the strap with the adhesive patch.
Fold the straps over the front of the Pod, beginning with the strap that has no adhesive patch.
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4 IntelliVue CL Respiration Pod
Fold the second strap over the Pod and make sure that the pod is securely and tightly enclosed by
the straps.
The arrow symbols on the upper strap must be in line with the end of the lower strap:
Remove the protective cover from the back of the adhesive attachment.
Place the Pod on the patient's skin in the region of the left costal arch, with the operation key
facing upwards. Press down the adhesive attachment all around the Pod.
CAUTION
The patient's skin should be dry, clean and free of excessive hair.
Make sure that the Pod is attached the right way round, with the operation key facing upwards.
Otherwise, the posture detection will not provide correct readings.
WARNING
Do not use an adhesive attachment on a patient with a history of skin irritation, allergies or
hypersensitivity to adhesives. Do not use on patients with lesions, infections or skin inflammations.
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4 IntelliVue CL Respiration Pod
To avoid skin irritations and lacerations, periodically inspect the sensor application site and change the
application site regularly. After use, clean the patient's skin to remove residual adhesive.
Always make sure that the attached pod is assigned to the correct patient. For this purpose, it may be
helpful to put the equipment label on the pod (for example by using a stick-on label) and to write the
patient name on the adhesive attachment.
Do not reuse an adhesive attachment on another patient due to risk of cross-infection.
Measuring Respiration
If the LED is on, press the key once to start a measurement. If the LED is off, press the key twice.
Alternatively, start the measurement from the host system.
If the measurement has been started directly at the Pod, the LED blinks white while the measurement
is in progress.
When the measurement has finished successfully: The LED changes to solid white.
If a measurement fails: The LED blinks white quickly.
Unassigning the Respiration Pod
To unassign the Respiration Pod from a host:
Put the Respiration Pod on the IntelliVue CL Charging Station
or:
Keep the key pressed for 2 seconds, until the LED is blinking yellow. Press the key once more to
confirm. LED changes to solid yellow and fades out (Respiration Pod unassigned).
Basic Posture and Activity Information
The IntelliVue CL Respiration Pod can also provide information on basic posture. The patient's
position is determined and the corresponding information is displayed at the host:
•
Supine
•
Prone
•
Lying on left side
•
Lying on right side
•
Upright
•
Reclined
•
Forward
•
Upside Down
Additionally, the activity level is displayed at the host as a numerical value that ranges in normal
operation between level 1 (very low activity) and level 10 (very high activity). Activity level 0 indicates
that no physiological signal can be detected (for example when the device has fallen off and is lying on
the ground).
NOTE
The information on patient activity is not intended for monitoring or diagnostic purposes. The activity
information is only for reference, showing clinical personnel the approximate activity status of the
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4 IntelliVue CL Respiration Pod
patient. The activity level does not provide information on a specific activity pattern (e.g. if a patient is
walking, or if a patient is rolling over in bed). The activity information is also not intended to recognize
abnormal body movements caused by specific diseases, like Parkinson’s disease, or other neurological
conditions.
Technical Alarms (INOPs)
Technical alarms, also known as INOPs, indicate that the measuring device cannot measure reliably. If
an INOP interrupts monitoring, there will be a question mark in place of the measurement numeric on
the host monitor.
The IntelliVue CL Respiration Pod does not provide any INOP displays or sounds locally at the device
itself. INOPs will be announced visually and audibly at the host monitor.
Some INOPs have a severity indication: !! for a medium severity INOP and !!! for a high severity
INOP.
Reference List of all INOPs
INOP Message, Indication
Source
What to do
Can't Analyze cmRR
Resp
Unable to analyze respiration signal
Can't AnalyzePulse
Resp
Unable to analyze pulse signal
cl Resp Batt Empty
Battery
The remaining monitoring time is below 30 minutes.
Charge battery.
cl Resp Batt Incmp
Battery
Battery cannot be used with this Cableless
Measurement Device. Contact your service personnel.
cl Resp Batt Low
Battery
The remaining monitoring time is below 2 hours.
cl Resp Batt Malf
Battery
Malfunction of the battery system detected (charger
circuit or battery). Contact your service personnel.
cl Resp Batt Temp
Battery
The temperature of the battery is critically high.
Remove Cableless Measurement Device from patient
and contact your service personnel.
cl Resp Check Batt
Battery
The maximum number of charge/discharge cycles of
the battery will be reached in less than 50 cycles.
Contact your service personnel.
cl Resp Chk Sett
Resp
If this INOP appears, check the Cableless
Measurement Device and patient settings before you
resume taking measurements. If the settings are
unexpected, there may be a problem with the Cableless
Measurement Device software. Contact your service
personnel.
cl Resp Disconnect
Resp
The Respiration Pod has lost the SRR connection to
the host.
cl Resp Remove
Resp
The temperature of the battery is too high. Remove the
Cableless Measurement Device from the patient and
contact service personnel.
INOP tone
INOP tone
INOP tone
INOP tone
INOP tone
INOP tone
INOP tone
INOP tone
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4 IntelliVue CL Respiration Pod
INOP Message, Indication
Source
What to do
cl Resp Serv Batt
Battery
Maximum number of charge/discharge cycles for
battery exceeded. Charging of the battery is inhibited.
Contact your service personnel.
clResp License Req
Resp
Unlicensed exchange device. Contact your service
personnel.
cmResp NeoPatient?
Resp
The patient monitor the Respiration Pod is assigned to
is in neonatal mode. The INOP will remain active until
the monitor is changed to adult mode.
cmResp No Signal
Resp
No active signal can be detected.
cmRespCan'tAnalyze
Resp
Unable to analyze respiration and pulse signal
cmRespPediPatient?
Resp
The patient monitor the Respiration Pod is assigned to
is in pediatric mode. The INOP will remain active until
the monitor is changed to adult mode.
INOP tone
Numeric is replaced by -?INOP tone
Numeric is replaced by -?INOP tone
Respiration Default Settings
These are the most important default settings of your IntelliVue CL Respiration Pod as they are
delivered from the factory. For a comprehensive list and explanation of default settings, see the
Configuration Guide supplied with your devices. The default settings can be permanently changed in
the Support Tool Configuration Editor.
Respiration Settings
Factory Defaults
Mode
Auto
Repeat Time
15 min
cmResp
On
Pulse
On
Dyn. Repetition
Enabled
Posture
Off
Activity
Off
Aging Time
10 min
Color
Yellow
Integrated Battery Handling
Battery Care
The IntelliVue CL Respiration Pod has a built-in battery that is not exchangeable. Battery care begins
when you receive a new pod and continues throughout the life of the pod. The table below lists battery
care activities and when they should be performed.
Activity
When to perform
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.
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4 IntelliVue CL Respiration Pod
Activity
When to perform
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.
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).
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 40-50%
•
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. The batteries of the IntelliVue CL Respiration
Pod cannot be exchanged, so the device itself must be replaced after 4 years or 400 complete chargedischarge cycles.
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Accessories
You can order parts and accessories from Philips supplies at www.medical.philips.com or consult your
local Philips representative for details.
WARNING
Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or
single patient use only. Reuse may compromise device functionality and system performance and cause
a potential hazard, in particular with regard to cross-contamination.
Philips’ approval: Use only Philips-approved accessories. Using non-Philips-approved accessories
may compromise device functionality and system performance and cause a potential hazard.
IntelliVue CL Respiration Pod Accessories
Order Number
Description
Contents
989803179541
Mobile CL Respiration Pod Attachment
50 attachments
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:
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.
WARNING
If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working
properly, do not use it for any monitoring procedure on a patient, contact your service personnel.
Maintenance Task and Test Schedule
All maintenance tasks and performance tests are documented in detail in the service documentation
supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for Philipsqualified service professionals only.
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4 IntelliVue CL Respiration Pod
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 the status LED does not light up when you press a key, place the device onto a charger slot on
the charging station.
If you suspect a problem with an individual measurement device, read the Instructions for Use
and double check that you have set up the measurement correctly. Check also that the measurement
has not been switched off at the patient monitor that the device is assigned to.
If you suspect an intermittent, system-wide problem call your service personnel.
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5
Cableless Measurement
Auxiliary Devices
IntelliVue CL Transmitter and IntelliVue CL Hotspot
IntelliVue CL Transmitter
IntelliVue CL Hotspot
The IntelliVue CL Transmitter and the IntelliVue CL Hotspot are auxiliary network devices that
convert the SRR radio technology from the IntelliVue CL SpO2 Pod, the IntelliVue CL NBP Pod and
the IntelliVue CL Respiration Pod into WLAN or LAN technology. This allows data from the
measurement devices to be transmitted to a PC for use with IntelliVue GuardianSoftware.
The IntelliVue CL Transmitter is a mobile device which can be worn by the patient or by an attending
caregiver. It transmits vital signs data to IntelliVue GuardianSoftware while the patient is moving
around. The display on the CL Transmitter shows only technical data that may be useful for
troubleshooting system problems.
The IntelliVue CL Hotspot serves as an access point in a fixed location, to provide communication to
IntelliVue GuardianSoftware for any CL Pods currently in its transmission area. The CL Hotspots will
normally be located in areas where mobile patients regularly pass by or spend time. When the patient
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5 Cableless Measurement Auxiliary Devices
comes into the transmission area, any available measurement results will be automatically
communicated to GuardianSoftware.
The IntelliVue CL Transmitter is battery-powered while the IntelliVue CL Hotspot is powered by an
external power supply or PoE (power over ethernet).
WARNING
The IntelliVue CL Hotspot may not be used in the patient vicinity.
Screen Layout
The CL Transmitter and CL Hotspots have the same hardkeys and display as the CL SpO2 and NBP
Pods.
However, there is no user interaction required during normal operation.
This is the standard screen of a CL Transmitter or CL Hotspot:
Screen of a CL Transmitter / CL Hotspot:
Equipment label
Number of GuardianSoftware Servers connected
Network status symbols (LAN and WLAN)
Connection status
Number of Cableless Measurement Devices connected
Battery gauge
The network status symbols show one of the following states:
State
LAN symbol
WLAN symbol
off
- (no symbol displayed)
- (no symbol displayed)
not connected
no IP address
no Guardian server connected
normally connected
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5 Cableless Measurement Auxiliary Devices
CL Transmitter Integrated Battery Handling
Battery Care
Battery care begins when you receive a new IntelliVue Cableless Measurement Device with built-in
battery and continues throughout the life of the device. The table below lists battery care activities and
when they should be performed.
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).
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.
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5 Cableless Measurement Auxiliary Devices
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:
Select the Battery Smartkey or Main Setup followed by Battery.
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.
Accessories
You can order parts and accessories from Philips supplies at www.medical.philips.com or consult your
local Philips representative for details.
WARNING
Reuse: Never reuse single-patient sensors, accessories and so forth that are intended for single use, or
single patient use only. Reuse may compromise device functionality and system performance and cause
a potential hazard, in particular with regard to cross-contamination.
Philips’ approval: Use only Philips-approved accessories. Using non-Philips-approved accessories
may compromise device functionality and system performance and cause a potential hazard.
IntelliVue CL Transmitter Accessories
Order Number
Description
Contents
989803168881
Mobile CL 20 Transmitter Cradle Kit
20 Single-Patient cradles and straps
989803168871
Mobile CL Transmitter Battery Kit
1 Battery
1 disassembly tool
1 front housing
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5 Cableless Measurement Auxiliary Devices
IntelliVue CL Transmitter Base Station
(shown here with the transmitter inserted)
The IntelliVue CL Transmitter Base Station is used with the IntelliVue CL Transmitter. When the
patient is in their room, the Transmitter can be inserted into the Base Station where it is powered and
recharged and also remains connected to the WLAN to communicate vital signs data.
WARNING
The IntelliVue CL Transmitter Base Station may not be used in the patient vicinity.
Ensure that the CL Transmitter Base Station does not come into close contact with implanted
pacemakers, to avoid magnetic interference affecting the mode of the pacemaker.
CAUTION
The CL Transmitter Base Station generates a magnetic field. Do not store magnetic media (such as
identity cards or credit cards with magnetic strips or magnetic tapes/disks) near to the Base Station, as
the data may be damaged.
IntelliVue CL Charging Station
This chapter contains some general information about charging IntelliVue Cableless Measurement
Devices. For detailed information about the IntelliVue CL Charging Station, please see the separate
IntelliVue CL Charging Station Instructions for Use.
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5 Cableless Measurement Auxiliary Devices
Charging IntelliVue Cableless Measurement Devices
All IntelliVue Cableless Measurement Devices and Auxiliary Devices except the CL Hotspot are
battery powered and need to be recharged using the IntelliVue CL Charging Station. The batteries are
built in and can only be exchanged by trained service personnel, with the exception of the IntelliVue
CL Respiration Pod, where the whole unit needs to be exchanged.
To charge a battery, place the device onto a charger slot on the charging station. The NBP Pod and
Transmitter should always be placed on one of the slots in the upper row. The battery power indicators
will supply information about the charge status.
WARNING
•
Always use the supplied power cord with the grounded mains plug to connect the charging station
to a grounded AC mains socket. Never adapt the mains plug from the charging station to fit an
ungrounded AC mains socket.
•
Do not use AC mains extension cords or multiple portable socket outlets. If a multiple portable
socket outlet without an approved isolation transformer is used, the interruption of its protective
grounding may result in enclosure leakage currents equal to the sum of the individual ground
leakage currents, so exceeding allowable limits.
•
Do not connect any devices that are not supported as part of a system.
Battery Power Indicators
There are various indications which help you keep track of the battery power status:
•
LEDs on the charging station slots
•
battery status information on the charging station's display, the NBP/SpO2 Pod's display and the
Respiration Pod's LED
•
INOP messages
•
battery symbol on the patient monitor's screen (when assigned to a patient monitor)
•
battery symbol in GuardianSoftware (when assigned to a patient in GuardianSoftware)
The indicators always show the remaining capacity in relation to the battery's actual maximum capacity,
which may lessen as the battery ages. You can see the actual capacity in the Battery menu.
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5
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:
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.
Inspect all accessories (cables, sensors and so forth). If any show signs of damage, do not use
them.
WARNING
If the IntelliVue Cableless Measurement Device is mechanically damaged, or if it is not working
properly, do not use it for any monitoring procedure on a patient, contact your service personnel.
Maintenance Task and Test Schedule
All maintenance tasks and performance tests are documented in detail in the service documentation
supplied on the IntelliVue Cableless Measurements documentation DVD. These tasks are for 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.
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5 Cableless Measurement Auxiliary Devices
If you suspect a problem with an individual measurement device, read the Instructions for Use
and double check that you have set up the measurement correctly. Check also that the measurement
has not been switched off at the patient monitor that the device is assigned to.
If you suspect an intermittent, system-wide problem call your service personnel.
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6
Care and Cleaning
Use only the Philips-approved substances and methods listed in this chapter to clean or disinfect your
equipment. Warranty does not cover damage caused by using unapproved substances or methods.
Philips makes no claims regarding the efficacy of the listed chemicals or methods as a means for
controlling infection. Consult your hospital’s Infection Control Officer or Epidemiologist. For
comprehensive details on cleaning agents and their efficacy refer to “Guideline for Disinfection and
Sterilization in Healthcare Facilities” issued by the U.S. Department of Health and Human Services,
Public Health Service, Centers for Disease Control, Atlanta, Georgia, 2008. See also any local policies
that apply within your hospital, and country.
General Points
Keep your IntelliVue Cableless Measurement Devices and accessories free of dust and dirt. After
cleaning and disinfection, check the equipment carefully. Do not use if you see signs of deterioration
or damage. If you need to return any equipment to Philips, decontaminate it first.
Observe the following general precautions:
•
Always dilute according to the manufacturer’s instructions or use lowest possible concentration.
•
Do not allow liquid to enter the case.
•
Do not immerse any part of the equipment or any accessories in liquid if it is not explicitly allowed
and described in the respective accessory Instructions for Use.
•
Do not pour liquid onto the charging station.
•
Never use abrasive material (such as steel wool or silver polish).
WARNING
If you spill liquid on the charging station or accessories, or if any device or accessory is accidentally
immersed in liquid, contact your service personnel or Philips service engineer. Do not operate the
equipment before it has been tested and approved for further use.
Do not use flammable agents for disinfecting cableless measurement devices in an oxygen-enriched
environment, as this might lead to sudden ignition of vapors, resulting in injury to the patient or staff.
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6 Care and Cleaning
Cleaning and Disinfecting the IntelliVue Cableless
Measurement Devices
The following instructions apply to the IntelliVue CL SpO2 Pod, the IntelliVue CL Respiration Pod,
the IntelliVue CL NBP Pod, the corresponding single patient Mobile CL Cradles and the auxiliary
devices: IntelliVue CL Charging Station, IntelliVue CL Transmitter, IntelliVue CL Transmitter Base
Station and IntelliVue CL Hotspot.
Clean with a lint-free cloth, moistened with warm water (40°C/104°F maximum) and soap, a diluted
non-caustic detergent, tenside, ammonia- or alcohol-based cleaning agent. Do not use strong solvents
such as acetone or trichloroethylene.
CAUTION
Solutions: Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may
result.
Hospital policy: Disinfect the product as determined by your hospital’s policy only using the cleaning
agents specified below, to avoid long term damage to the cableless device.
Drying devices: Do not use heat sources, such as ovens or hairdryers, to dry the Pods. Do not put the
Pods in a microwave.
No sterilizing: Do not put the Pods in an autoclave, the devices are not sterilizable.
Rinse the Pods in water, paying special attention to the contact area to remove all residues. Wipe them
dry with a clean cloth and then leave them to dry completely.
Do not allow any liquid to enter the charging station case and avoid pouring it on the charging station
while cleaning.
The wristbands used with the Mobile CL SpO2 Cradles are single-patient items and cannot be cleaned
or disinfected.
Refer to the accessory Instructions for Use for cleaning and disinfection information for SpO2 sensors.
Recommended Disinfection Agents
We recommend that you use one of the following disinfectants:
Product Name
Product Type
Ingredients
Isopropanol
liquid
Isopropanol 80%
Bacillol®
liquid, spray
100 g concentrate contains:
Propan-1-ol 45.0 g;
Propan-2-ol 25.0 g;
Ethanol 4.7 g
Bacillol® 25
liquid
Ethanol 100 mg/g
Propan-2-ol (= 2-Propanol) 90 mg/g;
Propan-1-ol (= 1-Propanol) 60 mg/g
Meliseptol®
spray
50% 1-Propanol
Accel TB RTU
liquid
0.5% accelerated hydrogen peroxide
Oxivir®
spray
0.5% accelerated hydrogen peroxide
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AF
Tb Cleaner Disinfectant
6 Care and Cleaning
Product Name
Product Type
Ingredients
Oxivir® Tb Wipes
wipes
0.5% accelerated hydrogen peroxide
spray
0.5% accelerated hydrogen peroxide
Carpe DiemTM/MC Tb Wipes
wipes
0.5% accelerated hydrogen peroxide
Super Sani-Cloth
wipes
isopropanol 55%
quaternary ammonium chlorides 0.5%
wipes
isopropanol 15%
quaternary ammonium chlorides 0.25%
wipes
isopropanol < 0.15%
quaternary ammonium chlorides 0.14%
Carpe
DiemTM/MC
Tb
Ready-to-Use General Virucide,
Bactericide, Tuberculocide,
Fungicide, Sanitizer
Germicidal Disposable Wipes
SANI-CLOTH® PLUS
Germicidal Disposable Wipes
SANI-CLOTH® HB Germicidal
Germicidal Disposable Wipes
Refer to the accessory Instructions for Use for cleaning and disinfection information for SpO2 sensors
and NBP cuffs.
Disposing of the IntelliVue Cableless Measurement
Devices
WARNING
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 them in accordance with your country's laws for equipment containing electrical and
electronic parts. For disposal of parts and accessories, where not otherwise specified, follow local
regulations regarding disposal of hospital waste.
You will find detailed disposal information on the following webpage:
www.healthcare.philips.com/in_en/about/Sustainability/Recycling/pm.wpd
The Recycling Passports located there contain information on the material content of the equipment,
including potentially dangerous materials which must be removed before recycling (for example,
batteries and parts containing mercury or magnesium).
Do not dispose of waste electrical and electronic equipment as unsorted municipal waste. Collect it
separately, so that it can be safely and properly reused, treated, recycled, or recovered.
For information in disposal of accessories, refer to the accessory Instructions for Use.
103
6 Care and Cleaning
104
7
Specifications
The specifications in this section apply to the:
•
IntelliVue CL SpO2 Pod
•
IntelliVue CL NBP Pod
•
IntelliVue CL Respiration Pod
•
IntelliVue CL Charging Station
•
IntelliVue CL Transmitter
•
IntelliVue CL Transmitter Base Station
•
IntelliVue CL Hotspot
The IntelliVue Cableless Measurement Devices might not meet the performance specification listed in
this chapter, if stored or operated outside the specified environmental conditions.
WARNING
The IntelliVue Cableless Measurement Devices are not intended for use in an MRI environment or in
an oxygen-enriched environment (e.g. hyperbaric chambers). During MR imaging, remove all
IntelliVue Cableless Measurement Devices and sensors from the patient. Induced currents could cause
burns.
Indications for Use
IntelliVue CL SpO2 Pod:
The IntelliVue CL SpO2 Pod is indicated for use by health care professionals whenever there is a need
for acquisition or monitoring of physiological patient parameters SpO2 and pulse rate wirelessly.
The intended use of the IntelliVue CL SpO2 Pod when used together with a patient monitor or with a
telemetry system transceiver is for monitoring and recording of, and to generate alarms for, arterial
oxygen saturation and pulse rate of adult and pediatric patients.
The IntelliVue CL SpO2 Pod is also intended for local attended monitoring of, and to generate alarms
for, arterial oxygen saturation and pulse rate of adult and pediatric patients. Local attended monitoring
refers to situations where clinical staff is close to the patient such that acoustic alarming of the
IntelliVue CL SpO2 Pod will be noticed. Example: In-hospital transport of a patient by hospital staff
to a procedure room.
105
7 Specifications
The IntelliVue CL SpO2 Pod is also intended for acquisition of arterial oxygen saturation and pulse
rate data of adult and pediatric patients for a clinical information management system.
The IntelliVue CL SpO2 Pod is intended for use by health care professionals inside hospitals. It is not
intended for home use. It is not a therapeutic device.
IntelliVue CL NBP Pod:
The IntelliVue CL NBP Pod is indicated for use by health care professionals whenever there is a need
for acquisition or monitoring of physiological patient parameters non-invasive blood pressure and
pulse rate wirelessly.
The intended use of the IntelliVue CL NBP Pod when used together with a patient monitor or with a
telemetry system transceiver is for monitoring and recording of, and to generate alarms for, systolic,
diastolic, and mean pressure and pulse rate of adult and pediatric patients.
The IntelliVue CL NBP Pod is also intended for local attended monitoring of, and to generate alarms
for, systolic, diastolic, and mean pressure, and to measure pulse rate of adult and pediatric patients.
Local attended monitoring refers to situations where clinical staff is close to the patient such that
acoustic alarming of the IntelliVue CL NBP Pod will be noticed. Example: In-hospital transport of a
patient by hospital staff to a procedure room.
The IntelliVue CL NBP Pod is also intended for acquisition of systolic, diastolic, and mean pressure
and pulse rate data of adult and pediatric patients for a clinical information management system.
The IntelliVue CL NBP Pod is intended for use by health care professionals inside hospitals. It is not
intended for home use. It is not a therapeutic device.
IntelliVue CL Respiration Pod:
The IntelliVue CL Respiration Pod is indicated for use by health care professionals whenever there is a
need for intermittent or spot-check acquisition and monitoring of physiological patient parameters
respiration rate and pulse rate wirelessly in specific hospital areas. The IntelliVue CL Respiration Pod is
mainly indicated for use in general medical and surgery wards and in waiting areas of emergency
rooms. It is not indicated for use in hospital areas in which continuous patient monitoring is needed,
such as intensive care units or operating rooms.
The intended use of the IntelliVue CL Respiration Pod when used together with a patient monitor is
for intermittent or spot-check monitoring and recording of, and to generate alarms for, respiration rate
and pulse rate of adult patients.
The IntelliVue CL Respiration Pod is also intended for acquisition of respiration rate and pulse rate
data of adult patients for a clinical information management system.
The IntelliVue CL Respiration Pod is intended for use by health care professionals. It is not intended
for home use. It is not a therapeutic device.
The IntelliVue CL Respiration Pod is not intended for use on patients with extremely high values for
respiration rate (above 60 rpm).
The IntelliVue CL Respiration Pod is not intended for use on acutely ill cardiac patients with the
potential to develop life threatening arrhythmias, e.g. very fast atrial fibrillation or ventricular
tachycardia (rapid irregular pulse rate). For monitoring of these patients, a device for continuous ECG
monitoring is necessary. The IntelliVue CL Respiration Pod is not a substitute for an ECG monitor.
106
7 Specifications
WARNING
Do not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm.
Use under these conditions has not been clinically validated.
Rx only: US Federal Law restricts these devices to sale by or on the order of a physician.
Compatible Medical Devices
•
IntelliVue Patient Monitors MP5/MP5SC/MP5T, MP2 or X21
•
IntelliVue Telemetry System Transceivers TRx4841A/TRx4851A and MX40 wearable patient
monitors2
•
Clinical information management system: IntelliVue GuardianSoftware
1 MP2
and X2 are not compatible with the CL Respiration Pod
not compatible with the CL Respiration Pod
Compatible Medical Devices supporting local attended monitoring together with CL SpO2
and NBP Pods:
•
IntelliVue Patient Monitors MP5/MP5SC/MP5T
Manufacturer's Information
You can write to Philips at this address
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Str. 2
71034 Boeblingen
Germany
Visit our website at: www.healthcare.philips.com/us/.
© Copyright 2013. Koninklijke Philips N.V. All Rights Reserved.
107
7 Specifications
Symbols
These symbols can appear on the IntelliVue Cableless Measurement Devices and associated equipment
and accessories.
Symbols
108
Caution, consult
accompanying
documents
Refer to accompanying
documents
Protective earth
Equipotential grounding
Alternating current
Connector has special
protection against electric
shocks and is defibrillator
proof
Error LED
Built-in wireless
network (WLAN)
USB interface
Non-ionizing radiation
symbol
NBP identifier
SpO2 identifier
Always use separate
collection for waste
electrical and electronic
equipment (WEEE)
Identifies year and
month of manufacture
Indicates location of the
date of manufacture and/
or name and address of
manufacturer
Indicates location of
serial number
Indicates location of
catalog number
Indicates location of
service number
Followed by two
alphanumeric characters,
indicates ingress
protection grade
LAN connection
indicator for
connection to a wired
network
Do not reuse
Not made with natural
rubber latex
Resp identifier
7 Specifications
Safety Specifications
IntelliVue CL SpO2 Pod, CL NBP Pod and CL Respiration Pod:
IntelliVue CL Charging Station and CL Transmitter:
The IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, CL Charging Station, and
CL Transmitter comply with the Medical Device Directive 93/42/EEC.
In addition, the IntelliVue CL SpO2 Pod and CL NBP Pod comply with:
IEC 60601-1:1988 + A1:1991 + A2:1995; EN 60601-1:1990 + A1:1993 + A2:1995; UL 60601-1:2003;
CAN/CSA C22.2#601.1-M90+S1+A2; JIS T 0601-1:1999; IEC 60601-1-1:2000; EN 60601-1-1:2001;
IEC 60601-1-2:2001 + A1 2004; EN 60601-1-2:2001 + A1 2006 and IEC 60601-1-2:2007;
EN 60601-1-2:2007
The possibility of hazards arising from software errors was minimized in compliance with
EN ISO 14971:2000 + A1:2003; ISO 14971:2007; EN ISO 14971:2007, IEC 60601-1-4:1996 +
A1:1999; EN 60601-1-4:1996 + A1:1999.
The CL Respiration Pod complies with:
IEC 60601-1:2005 + Cor1:2006 +Cor2:2007; EN 60601-1:2006 + Cor11:2010; ANSI/AAMI
ES60601-1:2005 + C1:2009 + A2:2010; CAN/CSA-C22.2 No. 60601-1-08 + TC2:2011;
IEC 60601-1-2:2007; EN 60601-1-2:2007 + AC:2010
The possibility of hazards arising from software errors was minimized in compliance with
EN ISO 14971:2000 + A1:2003; ISO 14971:2007; EN ISO 14971:2007
Classification (according to IEC 60601-1):
IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod: Internally powered equipment, Type CF,
Continuous Operation
IntelliVue CL Transmitter: Internally powered equipment, Continuous Operation
IntelliVue CL Charging Station: Class I equipment, Continuous Operation
IntelliVue CL Transmitter Base Station and CL Hotspot:
The IntelliVue CL Transmitter Base Station and CL Hotspot comply with the Low Voltage Directive
2006/95/EC.
In addition, these devices comply with:
IEC 60950-1:2005; EN 60950-1:2006+A11:2009.
109
7 Specifications
EMC and Radio Regulatory Compliance
FCC and Industry Canada Radio Compliance
IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, CL Charging Station, CL
Transmitter:
This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB001 du Canada.
IntelliVue CL Transmitter Base Station:
This Class B digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe B
est conforme à la norme NMB-003 du Canada.
IntelliVue CL Hotspot:
This Class A digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe
A est conforme à la norme NMB-003 du Canada.
These devices comply with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is
subject to the following two conditions: (1) these devices may not cause harmful interference, and (2)
these devices must accept any interference received, including interference that may cause undesired
operation. Any changes or modifications to this equipment not expressly approved by Philips Medical
Systems may cause harmful radiofrequency interference and void your authority to operate this
equipment.
Usage of license-exempt local area network (LE-LAN) in Canada:
IntelliVue CL Transmitter and CL Hotspot
The maximum antenna gain permitted (for devices in the bands 5250-5350 MHz and 5470-5725 MHz)
complies with the e.i.r.p. limits as stated in RSS-210.
The maximum antenna gain permitted (for devices in the 5725-5825 MHz band) complies with the
e.i.r.p. limits specified for point-to-point operation, as stated in RSS-210.
The device for the band 5150-5250 MHz is only for indoor usage to reduce potential for harmful
interference to co-channel mobile satellite systems.
CAUTION
High power radars are allocated as primary users (meaning they have priority) of the bands
5250-5350 MHz and 5650-5850 MHz and these radars could cause interference and/or damage to LELAN devices.
Japanese Radio Law and Japanese Telecommunications Business
Law Compliance
IntelliVue CL Respiration Pod and CL Hotspot
110
7 Specifications
R&TTE Directive Compliance
IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, and CL Charging Station
IntelliVue CL Transmitter, and CL Hotspot
Philips Medizin Systeme Boeblingen GmbH hereby declares that these products are in
compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC
(Radio and Telecommunications Terminal Equipment Directive).
The IntelliVue CL SpO2 Pod, CL NBP Pod, CL Respiration Pod, CL Charging Station, CL
Transmitter, and CL Hotspot incorporate a SRR module, which is Class 1 radio equipment.
The IntelliVue CL Transmitter and CL Hotspot incorporate additionally the IntelliVue 802.11
Adapter, which is Class 2 radio equipment. The products are intended to be connected to the Publicly
Available Interfaces (PAI) and used throughout the EEA. Individual countries may apply restrictions
on putting this device into service or placing on the market.
To obtain a copy of the original Declaration of Conformity, please contact Philips at the address as
stated in the “Manufacturer's Information” section of these Instructions for Use.
WARNING
•
The IntelliVue CL Charging Station is Class A professional equipment. This equipment is not
intended for use in domestic establishments or connection to the public mains network. In
domestic establishments or when connected to the public mains network, this equipment may
cause radio interference or may disrupt the operation of nearby equipment.
•
The IntelliVue CL Hotspot is a Class A product. In a domestic environment this product may
cause radio interference, in which case the user may be required to take adequate measures.
•
This equipment generates, uses and radiates radiofrequency energy, and if it is not installed and
used in accordance with its accompanying documentation, may cause interference to radio
communications.
•
The device, equipped with a wireless network interface, intentionally receives RF electromagnetic
energy for the purpose of its operation. Therefore, other equipment may cause interference, even
if that other equipment complies with CISPR emission requirements.
EMC Directive Compliance
IntelliVue CL Transmitter Base Station and CL Hotspot
The IntelliVue CL Transmitter Base Station and CL Hotspot comply with the EMC Directive
89/336/EEC
In addition these devices comply with:
CISPR 22:2005 + A1:2005; EN 55022:2006 + A1:2007;
CISPR 24:1997 + A1:2001 + A2:2002; EN 55024:1998 + A1:2001 + A2:2003
111
7 Specifications
Radiofrequency Radiation Exposure Information
IntelliVue CL Transmitter
For body worn operation, this device has been tested and meets FCC RF exposure guidelines when
used in the standard configuration with the rear side towards the body, without a gap. Alternatively, it
can be used with any accessory that positions the front side of the device a minimum of 10 mm from
the body. The accessory itself must not contain any metal parts. Use of other accessories may not
ensure compliance with FCC RF exposure guidelines.
Nevertheless it is strongly recommended to operate the CL Transmitter with the rear side towards the
body to achieve best possible radio performance.
Safety and Performance Tests
You must observe any national regulations on the qualification of the testing personnel and suitable
measuring and testing facilities. See the maintenance section for a list of required tests. Safety and
performance tests, and what to do if the IntelliVue Cableless Measurements do not meet these
specifications, are described in the IntelliVue Cableless Measurements Service Guide.
Electromagnetic Compatibility (EMC)
Take special precautions regarding electromagnetic compatibility (EMC) when using the IntelliVue
Cableless Measurements. You must operate your IntelliVue Cableless Measurements according to the
EMC information provided in this book and in the IntelliVue Cableless Measurements Service Guide.
Portable and mobile radiofrequency (RF) communications equipment can affect the IntelliVue
Cableless Measurements.
WARNING
For paced patients: The radiated SRR power of the IntelliVue SpO2, NBP and Respiration Cableless
Measurement Devices, the CL transmitter, and other sources of radiofrequency energy, when used in
very close proximity of a pacemaker, might be sufficient to interfere with pacemaker performance.
Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external
pacemakers. However, caution should be exercised when monitoring paced patients.
In order to minimize the possibility of interference, avoid positioning and wearing the Cableless
Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer
for information on the RF susceptibility of their products.
WARNING
For paced patients: The radiated WLAN power of the IntelliVue CL Transmitter, and other sources
of radiofrequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere
with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat
less vulnerable than external pacemakers. However, caution should be exercised when monitoring any
paced patients.
112
7 Specifications
In order to minimize the possibility of interference, position the IntelliVue CL Transmitter, when
body worn, as far away from the pacemaker as possible. Consult the pacemaker manufacturer for
information on the RF susceptibility of their products.
Accessories Compliant with EMC Standards
All IntelliVue CL SpO2 Pod, CL NBP Pod and CL Respiration Pod accessories comply, in
combination with the IntelliVue Cableless Measurement Devices, with the requirements of
IEC 60601-1-2:2001 + A1 2004; EN 60601-1-2:2001 + A1 2006 and IEC 60601-1-2:2007;
EN 60601-1-2:2007.
WARNING
Using accessories other than those specified may result in increased electromagnetic emission or
decreased electromagnetic immunity of the IntelliVue Cableless Measurement Devices.
Electrosurgery Interference/Defibrillation
Measurement accuracy may be temporarily decreased while performing electrosurgery or defibrillation.
This does not affect patient or equipment safety. Do not expose the equipment to X-ray or strong
magnetic fields (MRI).
IntelliVue CL SpO2 Pod Specifications
Complies with ISO 9919:2005 / EN ISO 9919:2009.
Physical Specifications
Size (W x H x D)
53.5 mm x 27 mm x 65 mm ±5% (2.1 in x 1.1 in x 2.6 in ±5%)
(without cradle and sensor)
Weight
80 g ±10% (2.8 oz ±10%)
Robustness
Provides essential performance during exposure to random vibration
according to IEC TR 60721-4-7 Class 7M1
Survives shock, random vibration and bump according to IEC TR
60721-4-7 Class 7M3 as well as a 1 m drop
Ingress Protection
IP34 according to IEC 60529 (protection against ingress of water when
water drips, falls or splashes from any direction)
Environmental Specifications
Operating Temperature Range
0 to 40°C (32 to 104°F)
Operating Humidity Range
≤95% RH @ 40°C (104°F)
Operating Altitude Range
-500 to 3000 m
Storage/Transportation Temperature
Range
-20 to 60°C (-4 to 140°F)
113
7 Specifications
Environmental Specifications
Storage/Transportation Humidity
Range
≤90% RH @ 60°C (140°F)
no condensation
Storage/Transportation Altitude Range -500 to 4600 m
Measurement Validation: The SpO2 accuracy has been validated in human studies against arterial
blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically
distributed, only about two-thirds of the measurements can be expected to fall within the specified
accuracy compared to CO-oximeter measurements.
Display Update Period: Typical: 2 seconds, Maximum: 30 seconds. Maximum with NBP INOP
suppression on: 60 seconds.
Performance Specifications
SpO2
Measurement Range
0 to 100%
Accuracy
Mobile CL DSpO2-1A single patient sensor:
3%
(70 to 100%)
The specified accuracy is the root-mean-square
(RMS) difference between the measured values Mobile CL RSpO -1A reusable sensor
and the reference values
(may not be available in all geographies):
3% (70 to 100%)
Resolution
1%
Pulse Oximeter Calibration Range
70% to 100%
Pulse
Measurement Range
30 to 300 bpm
Accuracy
±2% or 1 bpm, whichever is greater
Resolution
1 bpm
Sensors
LED Power Dissipation
Temperature rise at sensor skin interface in compliance with ISO 9919
Optical Output Power
≤15 mW
Wavelength Range
500 to 1000 nm
Information about the wavelength range
can be especially useful to clinicians (for
instance, when photodynamic therapy is
performed)
For further information on accessory specifications, refer to the accessory Instructions for Use.
Display Specifications
Type
monochrome (4 gray scales), passive LCD (STN), positive/transflective
Viewing Area
25.6 mm x 19.2 mm
Dot Size
0.2 mm x 0.2 mm
Resolution
128 x 96 pixel
Backlight
white LED
114
7 Specifications
Performance Specifications
Sounds
Hardkey operation tone
Alarm tone
Pulse Tone with and without Tone Modulation
Battery
Integrated rechargeable Li-Ion battery with battery gauge and cycle counter
Runtime (fully charged battery)
Continuous measurement:
Typically 24 hours
Minimum 12 hours in continuous mode
Intermittent measurement:
Typically 60 hours with repetition interval of 2 minutes
Typically 3 days with repetition interval of 5 minutes
Charging Time
max 2.5 hours
Short Range Radio Specifications
Type
built in interface with integrated antenna
Technology
IEEE 802.15.4
Frequency band
2.4 GHz ISM (2.400 - 2.483 GHz)
MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)
Modulation
DSSS (O-QPSK)
Bandwidth
5 MHz
Effective radiated power (ERP)
max. 0 dBm (1 mW)
Electronic Article Surveillance (EAS) EAS tag inside the housing
Real Time Clock Accuracy
better than 5 seconds per day (typically) as long as device is in power state
"Device on" or "Device off". Automatically synchronized with assigned
host system.
IntelliVue CL NBP Pod Specifications
Complies with IEC 60601-2-30:1999/EN 60601-2-30:2000.
NOTE
The effectiveness of this sphygmomanometer has not been established in pregnant, including
pre-eclamptic patients.
Measurement Validation: The blood pressure measurements determined with this device were
clinically validated according to ANSI/AAMI SP10 and ISO 81060-2 in relation to mean error and
standard deviation, when compared to auscultatory measurements in representative patient population.
For the auscultatory reference the 5th Korotkoff sound was used to determine the diastolic pressure
for adult/adolescent subjects and the 4th for pediatric subjects.
Physical Specifications
Size (W x H x D)
65 mm x 138 mm x 30.5 mm ±5% (2.6 in x 5.4 in x 1.2 in ±5%)
(without cradle and cuff)
Weight
220 g ±10% (7.8 oz ±10%)
(without cradle and cuff)
115
7 Specifications
Physical Specifications
Robustness
Provides essential performance during exposure to random vibration
according to IEC TR 60721-4-7 Class 7M1
Survives shock, random vibration and bump according to IEC TR 60721-47 Class 7M3 as well as a 1 m drop
Ingress Protection
IP32 according to IEC 60529 (protected against ingress of water when the
water is dripping vertically and the CL NBP Pod is tilted up to 15° and
protected against contact with or ingress of objects larger than 2.5 mm)
Environmental Specifications
Operating Temperature Range
0 to 40°C (32 to 104°F)
Operating Humidity Range
≤95% RH @ 40°C (104°F) (non-condensing)
Operating Altitude Range
-500 to 3000 m
Storage/Transportation Temperature
Range
-20 to 60°C (-4 to 140°F)
Storage/Transportation Humidity
Range
≤90% RH @ 60°C (140°F) (non-condensing)
Storage/Transportation Altitude Range -500 to 4600 m
IntelliVue CL NBP Pod Performance Specifications
Display Specifications
Type
monochrome (4 gray scales), passive LCD (STN), positive/transflective
Viewing Area
25.6 mm x 19.2 mm
Dot Size
0.2 mm x 0.2 mm
Resolution
128 x 96 pixel
Backlight
white LED
Sounds
Hardkey operation tone
Assignment tone
NBP Announcement tone
NBP done tone
Alarm tone
Battery
Integrated rechargeable Li-Ion battery with battery gauge and cycle counter
Runtime (fully charged battery)
Minimum 12 hours @ 4 measurements per hour
Typical 4 days @ 2 measurements per hour
Typical 5 days @ 1 measurement every 2 hours
Charging Time
Maximum 2.5 hours
Short Range Radio Specifications
Type
built in interface with integrated antenna
Technology
IEEE 802.15.4
Frequency band
2.4 GHz ISM (2.400 - 2.483 GHz)
MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)
116
7 Specifications
IntelliVue CL NBP Pod Performance Specifications
Modulation
DSSS (O-QPSK)
Bandwidth
5 MHz
Effective radiated power (ERP)
max. 0 dBm (1 mW)
Electronic Article Surveillance (EAS) EAS tag inside the housing
Real Time Clock Accuracy
better than 5 seconds per day (typically) as long as device is in power state
"Device on" or "Device off". Automatically synchronized with assigned
host system.
Measurement Ranges
Adult:
Systolic: 30 to 270 mmHg (4.0 to 36.0 kPa)
Mean: 20 to 255 mmHg (2.5 to 34.0 kPa)
Diastolic: 10 to 245 mmHg (1.5 to 32.0 kPa)
Pediatric:
Systolic: 30 to 180 mmHg (4.0 to 24.0 kPa)
Mean: 20 to 160 mmHg (2.5 to 21.0 kPa)
Diastolic: 10 to 150 mmHg (1.5 to 20.0 kPa)
Pressure Transducer Accuracy
(0 to 300 mmHg)
±3 mmHg @ 15 to 25°C
Blood Pressure Measurement
Accuracy
8 mmHg standard deviation
±5 mmHg mean error
Pulse Rate Measurement Range
40 to 300 bpm
Pulse Rate Measurement Accuracy
40 - 100 bpm: ±5 bpm
101 - 200 bpm: ±5% of reading
201 - 300 bpm: ±10% of reading
(average over NBP measurement cycle)
Measurement Time
Auto/manual/sequence mode:
Typical 40 seconds @ >60 bpm and normal adult cuff
Maximum 180 seconds
±(3 mmHg or 2% whichever is greater) @ 10 to 40°C
STAT Mode:
Typical 30 seconds @ >60 bpm and normal adult cuff
Maximum 180 seconds
STAT Mode Cycle Time
5 minutes
Initial Cuff Inflation Pressure
Adult: 165 ±15 mmHg
Pediatric: 130 ±15 mmHg
Venipuncture Pressure Range
Adult: 20 to 120 mmHg in steps of 5 mmHg
Pediatric: 20 to 80 mmHg in steps of 5 mmHg
Venipuncture Pressure Accuracy
±10 mmHg
Cuff size detection
INOP, if neonatal cuff size is detected
117
7 Specifications
IntelliVue CL Respiration Pod Specifications
Physical Specifications
Size (W X H X D)
43.5 mm x 13 mm x 64 mm ±5% (1.7 in x 0.5 in x 2.5 in ±5%)
(without accessories)
Weight
36.4 g ±10% (1.3 oz ±10%)
Robustness
Survives shock, random vibration and bump according to IEC TR 60721-47 Class 7M3 as well as a 1 m drop
Ingress Protection
IP67 according to IEC 60529
Environmental Specifications
Operating Temperature Range
0 to 40°C (32 to 104°F)
Operating Humidity Range
≤95% RH @ 40°C (104°F), no condensation
Operating Altitude Range
-500 to 3000 m
Storage/Transportation Temperature
Range
-20 to 60°C (-4 to 140°F)
Storage/Transportation Humidity
Range
≤90% RH @ 60°C (140°F), no condensation
Storage/Transportation Altitude Range -500 to 4600 m
Storage/Transportation Ambient
Temperature (Altitude Range)
1075 hPa to 570 hPa (-500 m to 4600 m / -1650 ft to 15000 ft)
Performance Specifications
Battery
Integrated rechargeable Li-Ion battery with battery gauge and cycle counter
Runtime (fully charged battery)
Minimum 8 hours in frequent measurement mode
Typically 18 hours in frequent measurement mode
Minimum 1.5 days @ 4 measurements per hour*
Typical 2 days @ 4 measurements per hour*
*If posture or activity is on, the runtime specification of the frequent
measurement mode applies.
Charging Time
max 2.5 hours
Short Range Radio Specifications
Type
built in interface with integrated antenna
Technology
IEEE 802.15.4
Frequency band
2.4 GHz ISM (2.400 - 2.483 GHz)
MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)
Modulation
DSSS (O-QPSK)
Bandwidth
5 MHz
Effective radiated power (ERP)
max. 2 dBm (1.6 mW)
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7 Specifications
Performance Specifications
Real Time Clock Accuracy
better than 5 seconds per day (typically) as long as device is in power state
"Device on". Automatically synchronized with assigned host system.
Respiration
Measurement Range
5 to 60 rpm
Accuracy
±1 rpm
Resolution
1 rpm
Pulse
Measurement Range
30 to 220 bpm
For rapid, irregular heart rates: 30 to 110 bpm
Accuracy
±3% or ±1 bpm (whichever is greater)
Resolution
1 bpm
Posture Information
8 patient postures (supine, prone, upright, reclined, forward, lying on left
side, lying on right side, upside down)
Activity Information
10 levels from 1 (very low activity) to 10 (very high activity);
level 0: no signal
Attachment Specifications
Size (W X H)
196 mm x 64 mm (7.7 in x 2.5 in)
Environmental Specifications
Operating temperature range
0 to 40°C (32 to 104°F)
Storage / Transportation temperature
range
Storage: 12 to 35°C (54 to 95°F)
Transportation: -20 to 60°C (-4 to 140°F)
Storage / Transportation humidity range Storage: 18% RH to 78% RH
Transportation: ≤ 90% RH @ 60°C (140°F); no condensation
Storage / Transportation altitude range
1075 hPa to 570 hPa (-500 m to 4600 m / -1650 ft to 15000 ft)
Alarm Specifications
When the CL Respiration Pod is used alone, without an assignment to a host, no physiological
alarms will be generated.
When the CL SpO2 Pod or CL NBP Pod are used for local attended monitoring, the following
specifications apply:
Alarm Signal
System Alarm Delay
less than 4 seconds
The system alarm delay is the processing time the system needs for any alarm to be
indicated on the device, after the measurement has triggered the alarm.
Delay for alarm availability on the network
less than 5 seconds
This is the time needed after alarm indication on the device until the alarm signal is
available on the network, to the monitor or to other systems.
119
7 Specifications
Alarm Signal
Sound Pressure Range
min. 0 dB(A)
max. 30-65 dB(A)
SpO2 Alarm Specifications
Range
Adjustment
SpO2
Adult: 50 to 100%
Pedi: 30 to 100%
1% steps
Desat
Adult: 50 to Low alarm limit
Pedi: 30 to Low alarm limit
1% steps
Pulse
30 to 300 bpm
Adult:
1 bpm steps (30 to 40 bpm)
5 bpm steps (40 to 300 bpm)
Pedi:
1 bpm steps (30 to 50 bpm)
5 bpm steps (50 to 300 bpm)
Tachycardia
Difference to high limit 0 to 50 bpm
5 bpm steps
Clamping at 150 to 300 bpm
5 bpm steps
Bradycardia
Difference to low limit 0 to 50 bpm
5 bpm steps
Clamping at 30 to 100 bpm
5 bpm steps
SpO2 Alarm Specifications (cont.)
Standard Delay
SpO2 high and low limit alarms
0 to 30 seconds (adjustable in 1 second steps) + system alarm delay
Desat
0 to 30 seconds (adjustable in 1 second steps) + system alarm delay
Pulse
10 seconds + system alarm delay
Tachycardia
10 seconds + system alarm delay
Bradycardia
10 seconds + system alarm delay
NBP Alarm Specifications
Range
Adjustment
Systolic
Adult: 30 to 270 mmHg (4 to 36 kPa)
10 to 30 mmHg: 2 mmHg (0.5 kPa)
>30 mmHg: 5 mmHg (1 kPa)
Pedi: 30 to 180 mmHg (4 to 24 kPa)
Diastolic
Adult: 10 to 245 mmHg (1.5 to 32 kPa)
Pedi: 10 to 150 mmHg (1.5 to 20 kPa)
Mean
Adult: 20 to 255 mmHg (2.5 to 34 kPa)
Pedi: 20 to 160 mmHg (2.5 to 21 kPa)
When the Cableless Measurement Devices are assigned to a monitor or telemetry device, alarms may
be announced at the host monitor (for the telemetry device, at the Information Center). See the
respective Instructions for Use for detailed alarm specifications.
Alarm delay times are as specified in the Instructions for Use of your patient monitor or IntelliVue
Information Center plus 4 seconds.
NOTE
If the SRR connection between the Cableless Measurement Device and the patient monitor or
telemetry device is interrupted, the patient monitor or telemetry device will issue an INOP within
5 seconds.
120
7 Specifications
Telemetry Device Battery Runtime Specifications
Operating Mode
Battery Runtime
ECG Only Telemetry Device with CL SpO2/NBP Pod connected
20 hours
Telemetry Device is host to CL SpO2/NBP Pod
ECG/SpO2 (continuous) Telemetry Device with internal SpO2 running in
continuous mode and CL SpO2/NBP Pod connected
8 hours
Telemetry Device is host to CL SpO2/NBP Pod
IntelliVue CL Transmitter Specifications
Physical Specifications
Size (W x H x D)
55 mm x 26.5 mm x 122 mm ±5% (2.2 in x 1.0 in x 4.8 in ±5%)
(without cradle)
Weight
150 g ±10% (5.8 oz ±10%)
(without cradle)
Robustness
Provides essential performance during exposure to random vibration
according to IEC TR 60721-4-7 Class 7M1
Survives shock, random vibration and bump according to IEC TR 60721-47 Class 7M3 as well as a 1 m drop
Ingress Protection
IP32 according to IEC 60529 (protected against ingress of water when the
water is dripping vertically and the CL Transmitter is tilted up to 15° and
protected against contact with or ingress of objects larger than 2.5 mm)
Environmental Specifications
Operating Temperature Range
0 to 40°C (32 to 104°F)
0 to 35°C (32 to 95°F) when charging the battery with an active WLAN
connection
Operating Humidity Range
≤95% RH @ 40°C (104°F)
no condensation
Operating Altitude Range
-500 to 3000 m
Storage / Transportation Temperature
Range
-20 to 60°C (-4 to 140°F)
Storage / Transportation Humidity
Range
≤90% RH @ 60°C (140°F)
(non-condensing)
Storage / Transportation Altitude Range -500 to 4600 m
Performance Specifications
Display Specifications
Type
monochrome (4 grey scales), passive LCD (STN), positive/transflective
Viewing Area
25.6 mm x 19.2 mm
121
7 Specifications
Performance Specifications
Dot Size
0.2 mm x 0.2 mm
Resolution
128 x 96 pixel
Backlight
white LED
Keys
3 keys with tactile feedback: ◄, , ►
Battery
Integrated rechargeable Li-Ion battery with battery gauge and cycle counter
Runtime (fully charged battery)
Typical 8 hours
Charging Time
(WLAN and SRR not active)
Maximum 2.5 hours
Electronic Article Surveillance (EAS)
EAS tag inside the housing
Short Range Radio Specifications
Type
built in interface with integrated antenna
Technology
IEEE 802.15.4
Frequency Band
2.4 GHz ISM (2.400 - 2.483 GHz)
MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)
Modulation
DSSS (O-QPSK)
Bandwidth
5 MHz
Effective Radiated Power (ERP)
max. 0 dBm (1 mW)
WLAN Specifications
Type
Internal wireless adapter
Technology
IEEE 802.11a/b/g
Frequency Band
USA: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.725 - 5.825 GHz
Europe: 2.400 - 2.483GHz, 5.15 - 5.35 GHz, 5.47 - 5.825 GHz
Japan: 2.400 - 2.483GHz, 4.90 - 5.091 GHz, 5.15 - 5.25 GHz
China: 2.400 - 2.483 GHz, 5.725 - 5.85 GHz
Modulation Technique
802.11b/g
DSSS (DBPSK, DQPSK, CCK)
OFDM (BPSK, QPSK, 16-QAM, 64-QAM)
802.11a
OFDM (BPSK, QPSK, 16-QAM, 64-QAM)
Effective Radiated Power (ERP)
2.4 GHz Band - max. 22 dBm
5 GHz Band - max. 20.5 dBm
Realtime Clock Accuracy
less than 5 seconds per day (typically) as long as device is in power state
"Device on" or "Device off". Automatically synchronized with assigned
patient monitor/telemetry device.
122
7 Specifications
IntelliVue CL Transmitter Base Station
Specifications
Physical Specifications
Size (W x H x D)
75 mm x 45 mm x 173 mm ±5% (3.0 in x 1.8 in x 6.8 in ±5%)
Weight
210 g ±10% (7.4 oz ±10%)
Robustness
Operating within specification during exposure to random vibration
according to IEC TR 60721-4-7 Class 7M1
Survives shock and 0.05 m free fall according to IEC TR 60721-4-7 Class
7M1
Ingress Protection
IP21 according to IEC 60529 (protection against ingress of water when the
water is dripping vertically)
Environmental Specifications
Operating Temperature Range
0 to 40°C (32 to 104°F)
Operating Humidity Range
≤95% RH @ 40°C (104°F)
Operating Altitude Range
-500 to 3000 m
-500 to 2000 m when powered from external power supply 865222 #E90
Storage/Transportation Temperature
Range
-20 to 60°C (-4 to 140°F)
Storage/Transportation Humidity
Range
≤90% RH @ 60°C (140°F)
no condensation
Storage/Transportation Altitude Range -500 to 4600 m
Performance Specifications
Charging Interface (output)
Power output (PoE powered)
5 V ±10%
Power output (USB powered)
USB input voltage - 180 mV (@ 500 mA)
Communication
USB 2.0 full speed
USB Interface
Standard
USB 2.0 full speed Device Port
Power Input
4.5 V - 5.5 V (8 W)
power requirement for service and upgrade of connected Cableless
Measurement Devices 2.5 W
Connector
USB series “Standard-B” receptacle
Network
Standards
IEEE 802.3 10-Base-T, IEEE 802.3af (PoE Class 3)
Connector
RJ45 (8 pin)
External AC/DC 5V requirements (connection to USB)
123
7 Specifications
Performance Specifications
Output voltage
5 V +/-5%
Power output
min. 8 W
Isolation
double according to IEC 60950-1 Class II
Classification
Limited Power Source according to IEC 60950-1
External AC/DC 48V requirements (connection to RJ45)
Output Voltage
48 V +/-10%
Power output
min. 8 W
Compliancy
IEEE 802.3af (PoE Class 3)
Isolation
double according to IEC 60950-1 Class II
Classification
Limited Power Source according to IEC 60950-1
Connector
RJ45 (Data-in), RJ45 (Data&Power Out)
IntelliVue CL Hotspot Specifications
Physical Specifications
Size (W x H x D)
75 mm x 53 mm x 177 mm ±5% (3.0 in x 2.1 in x 7.0 in ±5%)
Weight
330 g ±10% (11.6 oz ±10%)
Robustness
Provides essential performance during exposure to random vibration
according to IEC TR 60721-4-7 Class 7M1
Survives shock and 0.05 m free fall according to IEC TR 60721-4-7 Class
7M1
Environmental Specifications
Operating Temperature Range
0 to 40°C (32 to 104°F)
Operating Humidity Range
≤95%RH @ 40°C (104°F)
no condensation
Operating Altitude Range
-500 to 3000 m
-500 to 2000 m when powered from external power supply 865222 #E90
Storage / Transportation Temperature
Range
-20 to 60°C (-4 to 140°F)
Storage / Transportation Humidity
Range
≤90% RH @ 60°C (140°F)
(non-condensing)
Storage / Transportation Altitude Range -500 to 4600 m
Performance Specifications
Display Specifications
Type
monochrome (4 gray scales), passive LCD (STN), positive/transflective
Viewing Area
25.6 mm x 19.2 mm
Dot Size
0.2 mm x 0.2 mm
124
7 Specifications
Performance Specifications
Resolution
128 x 96 pixel
Backlight
white LED
Short Range Radio Specifications
Type
built in interface with integrated antenna
Technology
IEEE 802.15.4
Frequency Band
2.4 GHz ISM (2.400 - 2.483 GHz)
MBAN (2.360 - 2.400 GHz, for US / FCC regulated countries only)
Modulation
DSSS (O-QPSK)
Bandwidth
5 MHz
Effective Radiated Power (ERP)
max. 0 dBm (1 mW)
WLAN Specifications
Type
Internal wireless adapter
Technology
IEEE 802.11a/b/g
Frequency Band
USA: 2.400 - 2.483 GHz, 5.15 - 5.35 GHz, 5.725 - 5.825 GHz
Europe: 2.400 - 2.483GHz, 5.15 - 5.35 GHz, 5.47 - 5.825 GHz
Japan: 2.400 - 2.483GHz, 4.90 - 5.091 GHz, 5.15 - 5.25 GHz
China: 2.400 - 2.483 GHz, 5.725 - 5.85 GHz
Modulation Technique
802.11b/g
DSSS (DBPSK, DQPSK, CCK)
OFDM (BPSK, QPSK, 16-QAM, 64-QAM)
802.11a
OFDM (BPSK, QPSK, 16-QAM, 64-QAM)
Effective Radiated Power (ERP)
2.4 GHz Band - max. 22 dBm
5 GHz Band - max. 20.5 dBm
Realtime Clock Accuracy
less than 5 seconds per day (typically) as long as device is in power state
"Device on" or "Device off". Automatically synchronized with assigned
patient monitor/telemetry device.
USB Interface
Standard
USB 2.0 full speed Device Port
Power Input
4.5 V - 5.5 V (3 W)
power requirement for service and upgrade of connected Cableless
Measurement devices 2.5 W
Connector
USB series “Standard-B” receptacle
LAN Network
Standards
IEEE 802.3 10-Base-T, IEEE 802.3af (PoE Class 3)
Connector
RJ45 (8 pin)
External AC/DC 5V requirements (connection to USB)
Output voltage
5 V +/-5%
125
7 Specifications
Performance Specifications
Power output
min. 3 W
Isolation
double according to IEC 60950-1 Class II
Classification
Limited Power Source according to IEC 60950-1
External AC/DC 48V requirements (connection to RJ45)
Output Voltage
48 V +/-10%
Power output
min. 3 W
Compliancy
IEEE 802.3af (PoE Class 3)
Isolation
double according to IEC 60950-1 Class II
Classification
Limited Power Source according to IEC 60950-1
Connector
RJ45 (Data-in), RJ45 (Data&Power Out)
126
1
activity 87
alarm delay 28
alarms off symbol 27, 62
ambient light 25
assignment 18
at the measurement device 18
at the patient monitor 19
assignment mode 18
automatic mode 61
automatic mode SpO2 26
averaging time 28
changing 28
battery 39
care 39
lifetime management 40
power indicators 98
status menu 15
status on the cableless device 15
care and cleaning 101
caution, definition 5
charging 98
cleaning and disinfecting 102
compatibility (NBP) 51
compatibility (SpO2) 17
configuration mode 14
connection status symbol 18
continuous mode SpO2 26
date and time 15
default profile 15
demonstration mode 14
device compatibility (NBP) 51
device compatibility (SpO2) 17
disinfecting 102
disinfecting agents 102
disposing of the IntelliVue Cableless
Measurement Device 103
electromagnetic compatibility (EMC) 112
electrosurgery 56
electrosurgery interference/
defibrillation 113
elevated ambient temperatures 24
EMC 110
directive compliance 111
radio regulatory compliance 110
Index
loose sensor 24
low-activity screen 11
hardkeys 11
main setup menu 13, 47
maintenance and troubleshooting 99
maintenance and troubleshooting
(Resp) 99
maintenance task and test schedule 42
manual mode SpO2 26
manufacturer's information 107
monitoring mode 14
MR imaging 105
infection control 101
ingress protection (NBP Pod) 115
ingress protection (SpO2 Pod) 113
injected dyes 25
INOP 11, 45
layout 11
NBP 69
Resp 88
SpO2 35
tone 31
inspecting the equipment and
accessories 42
IntelliVue CL hotspot specifications 124
IntelliVue CL NBP Pod 74
accessories 74
specifications 115
IntelliVue CL Respiration Pod 79
IntelliVue CL SpO2 Pod 41
accessories 41
specifications 113
IntelliVue CL Transmitter 96
accessories 96
specifications 121
IntelliVue CL transmitter and IntelliVue CL
hotspot 93
IntelliVue CL transmitter base station 97
specifications 123
intended use 105
interference 18, 25
intravenous infusion 56
NBP 74
accessories 74
default settings 72
numerics 62
specifications 115
new patient 15
adding 15
no host monitoring 18, 20, 52, 54
FCC and industry canada radio
compliance 110
free device 14, 87
operating modes 14
oscillometric NBP measurement 56
oxygen saturation 22
patient category 14
patient demographics 14
patient menu 14
patient movement 25
perfusion indicator 22, 25
perfusion numeric 28
pleth waveform 22
posture 87
posture detection 87
profiles 15
pulsatile flow 25
pulse oximetry 22
pulse rate 22
pulse rate numeric 27, 62
127
R
R&TTE directive compliance 111
radiofrequency radiation exposure
information 112
removing a patient from the device 14
removing the pod from the cradle 24
repetition time 61
respiration measurement 84
Respiration sensor 84
specifications 121
test schedule 42
timestamp 62
timestamp SpO2 27
transceiver 21
transmitter base station specifications 123
troubleshooting 42
troubleshooting (Resp) 99
use models 16
safety and performance tests 112
safety specifications 109
screen layout 10
sensor (Resp) 85
applying 85
sensor (SpO2) 24
applying 24
sequence mode 61
service mode 14
setup sequence 61
short range radio 18
short range radio (SRR) 6
signal quality indicator 27
skin damage 56, 85
smartkeys 12
SpO2 41
accessories 41
alarms 28
default settings 38
numerics 27
sensors 22
signal quality indicator 27
specifications 113
SpO2 accessories 41
SpO2 Alarms 28
SpO2 numerics 27
SpO2 Sensors 23
Connecting 23
SpO2 specifications 113
standby mode 14
starting and stopping measurements
(NBP) 60
suspicious SpO2 reading 27
symbols 108
technical alarms (INOPs, NBP) 69
technical alarms (INOPs, Resp) 88
technical alarms (INOPs, SpO2)) 35
telemetry device 16
telemetry device battery runtime
128
venipuncture 63
venous pulsation 24
visual inspection 42
warning 5
Part Number 453564378711
Published in Germany 09/2013
*453564378711*

---

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