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Copyright
Copyright © 2012 Koninklijke Philips Electronics N.V. All rights reserved.
Reproduction in whole or in part is prohibited without the prior written
consent of the copyright holder. Philips Medical Systems Nederland B.V.
reserves the right to make changes in specifications and/or to discontinue any
products at any time without notice or obligation and will not be liable for any
consequences resulting from the use of this publication.
This product contains software licensed under an open source license. For
acknowledgments, license texts and source code, please refer to the IntelliVue
Information Center iX M3290B Software\References\README.pdf.
Manufacturer
Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810-1099
(978) 687-1501
Printed in USA
Document Number
4535 643 15721
Warranty
The information contained in this document is subject to change without
notice. Philips Medical Systems makes no warranty of any kind with regard to
this material, including, but not limited to, the implied warranties or
merchantability and fitness for a particular purpose. Philips Medical Systems
shall not be liable for errors contained herein or for incidental or consequential
damages in connection with the furnishing, performance, or use of this
material.
FCC
This device complies with Part 15 and/or Part 95 of the FCC Rules. 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.
Who has access to personal data and under what conditions an individual
has authorization to use that data.
What security controls are in place to protect personal and sensitive data.
How the data is stored and the conditions by which it is stored.
How the data is transmitted and the conditions under which that data is
transmitted.
Protecting personal health information is a primary component of a security
strategy. Personal and sensitive information should be protected according to
the applicable laws, regulations and directives, such as HIPAA, PIPEDA
and/or Council of the European Union security and privacy rules.
Compliance
Uses of the system for purposes other than those intended and expressly
stated by the manufacturer, as well as incorrect use, incorrect operation, or
modifications made to the system without explicit approval from Philips, may
relieve the manufacturer (or his agent) from all or some responsibilities for
resultant noncompliance, damage or injury.
Printing History
New editions of this document will incorporate all material updated since the
previous edition. Update packages may be issued between editions and
contain replacement and additional pages to be merged by a revision date at
the bottom of the page. Note that pages which are rearranged due to changes
on a previous page are not considered revised.
The documentation printing date and part number indicate its current edition.
The printing date changes when a new edition is printed. (Minor corrections
and updates which are incorporated at reprint do not cause the date to
change.) The document part number changes when extensive technical
changes are incorporated.
Document Conventions
In this guide:
Warnings
Warning
Caution
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.
Notes
A Note contains additional information on the product's usage.
Contents
1. Introducing the IntelliVue MX40 1-1
MX40 Features-------------------------------------------------------------------------- 1-2
MX40 Models ---------------------------------------------------------------------------- 1-3
MX40 Release B.0 Compatibility --------------------------------------------------- 1-4
2. What's New? 2-1
New Features and Enhancements------------------------------------------------- 2-2
3. Product Safety 3-1
General Safety -------------------------------------------------------------------------- 3-2
Safety Symbols & Other Marks ----------------------------------------------------- 3-5
4. Basic Operation 4-1
Controls, Indicators and Connectors ---------------------------------------------- 4-2
MX40 Controls and Indicators -------------------------------------------------- 4-2
Multi-Function Button ----------------------------------------------------------- 4-3
Silence Alarm Button ----------------------------------------------------------- 4-3
SmartKeys Button --------------------------------------------------------------- 4-3
Main Screen Button ------------------------------------------------------------- 4-4
SmartKeys ------------------------------------------------------------------------- 4-4
Alarms Area ----------------------------------------------------------------------- 4-5
Patient Information Area ------------------------------------------------------- 4-6
Paced Status --------------------------------------------------------------------- 4-6
Display Lock ---------------------------------------------------------------------- 4-6
Status Area------------------------------------------------------------------------ 4-7
Operating and Navigating ------------------------------------------------------------ 4-8
Power-On Self Test --------------------------------------------------------------- 4-8
Navigating --------------------------------------------------------------------------- 4-8
Selecting Display Elements ----------------------------------------------------- 4-9
Locking the Display---------------------------------------------------------------- 4-9
Measurement Area ---------------------------------------------------------------- 4-9
Measurement Area Display Configurations --------------------------------- 4-9
Connecting/Disconnecting the Patient Cable ----------------------------- 4-10
Understanding Settings -------------------------------------------------------------- 4-12
Changing Measurement Settings --------------------------------------------- 4-12
ECG Settings at the MX40 ----------------------------------------------------- 4-12
Waveform Settings at the MX40 ---------------------------------------------- 4-13
Battery Information -------------------------------------------------------------------- 4-14
Battery Safety Information ------------------------------------------------------ 4-14
Lithium-ion Rechargeable Battery Care ------------------------------------ 4-15
Lithium-ion Rechargeable Battery Handling Precautions ------------ 4-15
Lithium-ion Rechargeable Battery Storage ------------------------------ 4-16
Contents 1
Inserting/Removing Batteries ------------------------------------------------- 4-16
Inserting Batteries---------------------------------------------------------------- 4-17
Removing the Batteries -------------------------------------------------------- 4-19
Battery Charge Status ---------------------------------------------------------- 4-20
Lithium-ion Rechargeable Battery Charge Status -------------------- 4-20
AA Battery Charge Status --------------------------------------------------- 4-21
Pouch Use ------------------------------------------------------------------------------ 4-22
Securing the Pouch-------------------------------------------------------------- 4-22
Showering -------------------------------------------------------------------------- 4-24
Telemetry Mode Use ---------------------------------------------------------------- 4-26
Monitoring Mode Use ---------------------------------------------------------------- 4-27
Briefing the Patient ------------------------------------------------------------------- 4-28
5. Alarms 5-1
Alarms Overview ------------------------------------------------------------------------ 5-2
Visual Alarm Indicators ----------------------------------------------------------- 5-3
Alarm Message------------------------------------------------------------------- 5-3
Alarm Indicator ------------------------------------------------------------------- 5-4
Flashing Numeric ---------------------------------------------------------------- 5-4
Audible Alarm Indicators when in Monitoring Mode ---------------------- 5-5
Traditional Audible Alarms (HP/Agilent/Philips/Carenet) -------------- 5-5
ISO/IEC Standard Audible Alarms ------------------------------------------ 5-5
Acknowledging Alarms ----------------------------------------------------------- 5-6
Pausing or Switching Off Alarms----------------------------------------------- 5-6
To Pause All Alarms ------------------------------------------------------------ 5-6
While Alarms are Paused ----------------------------------------------------- 5-7
Restarting Paused Alarms ---------------------------------------------------- 5-7
Alarm Limits ------------------------------------------------------------------------- 5-7
Viewing Individual Alarm Limits ---------------------------------------------- 5-8
Reviewing Alarms ------------------------------------------------------------------ 5-8
Review Alarms Window -------------------------------------------------------- 5-8
Alarm Reminders ---------------------------------------------------------------- 5-8
Latching Alarms -------------------------------------------------------------------- 5-9
Alarm Latching Behavior --------------------------------------------------------- 5-9
Alarm Behavior at Power On---------------------------------------------------- 5-9
Physiologic Alarms ------------------------------------------------------------------- 5-10
Technical Alarms (INOPs) --------------------------------------------------------- 5-14
6. ECG and Arrhythmia Monitoring 6-1
ECG Safety Information--------------------------------------------------------------- 6-2
For Paced Patients ---------------------------------------------------------------- 6-3
Measuring ECG ------------------------------------------------------------------------- 6-5
Connecting and Positioning ECG Electrodes ----------------------------------- 6-6
2 Contents
Selecting the Primary and Secondary ECG Leads ---------------------------- 6-8
Checking Paced Status --------------------------------------------------------------- 6-9
Understanding the ECG Display -------------------------------------------------- 6-10
Monitoring Paced Patients ---------------------------------------------------------- 6-11
Optimizing Lead Selection for Paced Patients ---------------------------- 6-11
Changing the Size of the ECG Wave -------------------------------------------- 6-12
Choosing EASI or Standard Lead Placement --------------------------------- 6-13
Derived 12-lead ECG----------------------------------------------------------------- 6-14
Hexad -------------------------------------------------------------------------------- 6-14
EASI ---------------------------------------------------------------------------------- 6-14
ECG Configuration -------------------------------------------------------------------- 6-15
ECG Leads Monitored --------------------------------------------------------------- 6-16
Reconstructed Leads ----------------------------------------------------------------- 6-18
Chest Electrode Placement --------------------------------------------------------- 6-19
3-Wire Placement --------------------------------------------------------------------- 6-20
5-Wire Placement (Standard) ------------------------------------------------------ 6-21
5-Wire Placement (EASI) ----------------------------------------------------------- 6-22
6-Wire Placement --------------------------------------------------------------------- 6-23
Selecting Positions of Va and Vb Chest Leads --------------------------- 6-23
6-Wire Placement (Hexad) ---------------------------------------------------------- 6-24
Monitoring during Leads Off -------------------------------------------------------- 6-25
ECG Fallback ---------------------------------------------------------------------- 6-25
Relearning -------------------------------------------------------------------------- 6-25
ST/AR Arrhythmia Monitoring ------------------------------------------------------ 6-27
ST/AR Arrhythmia Algorithm --------------------------------------------------- 6-27
Indications for Use ------------------------------------------------------------- 6-27
How the ST/AR Algorithm Works --------------------------------------------- 6-27
Aberrantly-Conducted Beats ------------------------------------------------ 6-28
Atrial Fibrillation Alarm -------------------------------------------------------- 6-28
Intermittent Bundle Branch Block ------------------------------------------ 6-29
ECG and Arrhythmia Alarm Overview --------------------------------------- 6-29
Using ECG Alarms --------------------------------------------------------------- 6-30
Extreme Alarm Limits for Heart Rate -------------------------------------- 6-30
Arrhythmia Alarm Settings --------------------------------------------------- 6-31
Yellow Arrhythmia Alarms ---------------------------------------------------- 6-31
Viewing Arrhythmia Waves -------------------------------------------------- 6-32
Arrhythmia Beat Labels ------------------------------------------------------- 6-32
Enhanced Arrhythmia Chain------------------------------------------------- 6-33
Basic Arrhythmia Chain ------------------------------------------------------- 6-34
Learning ----------------------------------------------------------------------------- 6-34
Learning Phase ----------------------------------------------------------------- 6-35
Single Lead Analysis ---------------------------------------------------------- 6-35
Multilead Analysis -------------------------------------------------------------- 6-35
Multilead Analysis With Changes in One Lead ------------------------- 6-35
Contents 3
EASI ECG Monitoring -------------------------------------------------------- 6-36
Initiating Arrhythmia Relearning Manually --------------------------------- 6-36
ST/AR ST Analysis Algorithm ----------------------------------------------------- 6-37
Introduction ------------------------------------------------------------------------ 6-37
The Measurements -------------------------------------------------------------- 6-38
Overview --------------------------------------------------------------------------- 6-38
Turning ST or STE On and Off ----------------------------------------------- 6-38
Displayed ST Data --------------------------------------------------------------- 6-39
ST Lead Groups ------------------------------------------------------------------ 6-39
Derived 12 Lead ECG ---------------------------------------------------------- 6-40
EASI ST Analysis -------------------------------------------------------------- 6-40
HEXAD ST Analysis ---------------------------------------------------------- 6-41
ST Alarms -------------------------------------------------------------------------- 6-41
STE Alarms ------------------------------------------------------------------------ 6-41
QT Interval Monitoring--------------------------------------------------------------- 6-42
Intended Use ---------------------------------------------------------------------- 6-43
How the QT Analysis Algorithm Works ------------------------------------- 6-43
Adjusting QT Settings -------------------------------------------------------- 6-44
Limitations for QT Monitoring ----------------------------------------------- 6-45
7. Monitoring Pulse Rate 7-1
Pulse Rate Measurement ------------------------------------------------------------ 7-2
Displaying the Pulse Rate Measurement at the MX40 ----------------------- 7-3
8. Monitoring Respiration Rate (Resp) 8-1
Respiration Rate Measurement----------------------------------------------------- 8-2
Resp Safety Information -------------------------------------------------------------- 8-3
Lead Placement for Monitoring Resp --------------------------------------------- 8-4
Optimizing Lead Placement for Resp ----------------------------------------- 8-4
Cardiac Overlay -------------------------------------------------------------------- 8-4
Abdominal Breathing -------------------------------------------------------------- 8-4
Displaying Resp on the MX40 ------------------------------------------------------- 8-5
9. SpO2 Monitoring 9-1
SpO2 Safety Information -------------------------------------------------------------- 9-2
SpO2 Information for the User -------------------------------------------------- 9-3
Pulse Oximetry Measurement ------------------------------------------------------- 9-5
SpO2 Sensors ----------------------------------------------------------------------- 9-6
Selecting an SpO2 Sensor ------------------------------------------------------- 9-6
Sensor Application Safety Information --------------------------------------- 9-7
Applying the Sensor --------------------------------------------------------------- 9-8
Connecting SpO2 Cables -------------------------------------------------------- 9-8
Tone Modulation Indication------------------------------------------------------ 9-8
Signal Quality Indicator ----------------------------------------------------------- 9-8
Measuring SpO2 -------------------------------------------------------------------- 9-9
4 Contents
Understanding SpO2 Alarms --------------------------------------------------- 9-10
10. Monitoring with other Assigned Devices 10-1
Assigning Devices --------------------------------------------------------------------- 10-3
Device Assignment at the Information Center ---------------------------- 10-3
Device Assignment at the MX40 ---------------------------------------------- 10-3
Device Assignment at the Patient Monitor --------------------------------- 10-4
Controls Available when Assigned to IntelliVue Cableless Measurements10-6
Controls Available when Assigned to IntelliVue Patient Monitors -------- 10-7
Networked Device Synchronized Settings -------------------------------------- 10-8
MX40 Display when Wirelessly Connected to a Patient Monitor --------- 10-9
11. Monitoring with the MX40 at the Information Center 11-1
MX40 Connection to the Information Center ----------------------------------- 11-2
MX40 Controls in the Patient Window (IIC) ------------------------------------ 11-3
MX40 Controls in the Patient Window (IIC iX) --------------------------------- 11-5
Locating the MX40 (Find Device) ------------------------------------------------- 11-7
Viewing Device Location and Location History (optional) ------------------ 11-8
Using the Device Location Client (optional - IIC only) ----------------------- 11-9
Patient Configurable Settings in Telemetry Setup (IIC) ------------------- 11-10
Unit Configurable Settings (IIC) ------------------------------------------------- 11-13
Global Settings (IIC iX)------------------------------------------------------------- 11-21
12. Operating with Information Center Release L or M 12-1
Display ----------------------------------------------------------------------------------- 12-2
Alarms ------------------------------------------------------------------------------------ 12-3
13. Trends 13-1
Viewing Vital Trend Information --------------------------------------------------- 13-2
14. Maintenance 14-1
Cleaning --------------------------------------------------------------------------------- 14-2
Cleaning Materials for the MX40 --------------------------------------------- 14-2
Disposing of the MX40 --------------------------------------------------------------- 14-5
Label Assignment for Replacement MX40 ------------------------------------- 14-6
Re-assigning an Equipment Label at the IntelliVue Information Center14-6
Re-assigning an Equipment Label at the IntelliVue Information Center
iX -------------------------------------------------------------------------------------- 14-7
Charging Lithium-ion Rechargeable Batteries --------------------------------- 14-8
Battery Power Indicators -------------------------------------------------------- 14-8
Charging Station LEDs-------------------------------------------------------- 14-8
Battery Status on the Charging Station Display ------------------------ 14-9
Battery Lifetime Management ------------------------------------------------- 14-9
Battery Disposal ----------------------------------------------------------------- 14-10
15. Safety Standards & Specifications 15-1
Regulatory Information --------------------------------------------------------------- 15-2
Contents 5
Software Hazard Prevention -------------------------------------------------- 15-2
AC Power Source ---------------------------------------------------------------- 15-2
Industrie Canada Compliance (Canada)----------------------------------- 15-2
Safety Standards ----------------------------------------------------------------- 15-2
Intended Use Statement ------------------------------------------------------- 15-3
Indications for Use --------------------------------------------------------------- 15-3
Intended Uses of MX40 -------------------------------------------------------- 15-3
Authorized EU Representative ----------------------------------------------- 15-4
Patient Population --------------------------------------------------------------- 15-4
Rx ------------------------------------------------------------------------------------ 15-4
Essential Performance --------------------------------------------------------- 15-4
Risk Management Considerations ------------------------------------------ 15-5
Electromagnetic Compatibility----------------------------------------------------- 15-8
Reducing Electromagnetic Interference------------------------------------ 15-9
Restrictions for Use-------------------------------------------------------------- 15-9
Electromagnetic Compatibility (EMC) Specifications ------------------- 15-9
Accessories Compliant with EMC Standards -------------------------- 15-9
Electromagnetic Emissions--------------------------------------------------- 15-10
Electromagnetic Immunity ---------------------------------------------------- 15-10
Recommended Separation Distance -------------------------------------- 15-11
Electrosurgery Interference/Defibrillation/Electrostatic Discharge15-13
Restart Time ------------------------------------------------------------------- 15-13
Battery Specifications -------------------------------------------------------------- 15-14
Lithium-ion Battery Charge Time ------------------------------------------------ 15-17
Physical Specifications ------------------------------------------------------------- 15-18
MX40 1.4 GHz Smart-Hopping Radio ------------------------------------------ 15-19
MX40 2.4 GHz Smart-Hopping Radio ------------------------------------------ 15-20
MX40 Short-Range Radio --------------------------------------------------------- 15-22
MX40 2.4GHz WLAN Radio ------------------------------------------------------ 15-23
FCC and Industry Canada Radio Compliance -------------------------- 15-24
Environmental Specifications ----------------------------------------------------- 15-25
Measurement Specifications ----------------------------------------------------- 15-26
ECG -------------------------------------------------------------------------------- 15-26
ECG Performance Disclosure/Specifications ---------------------------- 15-27
Respiration ------------------------------------------------------------------------ 15-29
Respiration Alarm------------------------------------------------------------- 15-29
FAST SpO2 ----------------------------------------------------------------------- 15-30
SpO2 Sensor Accuracy -------------------------------------------------------- 15-31
A. Accessories A-1
MX40 Accessories --------------------------------------------------------------------- A-2
Pouches ------------------------------------------------------------------------------ A-2
Miscellaneous ----------------------------------------------------------------------- A-2
ECG Accessories ----------------------------------------------------------------------- A-3
6 Contents
Electrodes --------------------------------------------------------------------------- A-3
Leadsets and Patient Cables --------------------------------------------------- A-3
SpO2 Accessories ---------------------------------------------------------------------- A-5
Philips/Nellcor Disposable Sensors ------------------------------------------- A-5
Philips Reusable Sensors ------------------------------------------------------- A-5
Adapter Cables --------------------------------------------------------------------- A-6
B. Default Settings B-1
Alarm Default Settings ---------------------------------------------------------------- B-2
ECG, Arrhythmia, ST and QT Default Settings --------------------------------- B-3
Configuration Default Settings at the MX40 ------------------------------------- B-5
C. Sales and Support Offices C-1
Contents 7
8 Contents
1. Introducing the IntelliVue
MX40
This section introduces the IntelliVue MX40 wearable patient monitor.
MX40 Features
Easy for clinicians to use and comfortable for patients to wear.
2.8" color, touch sensitive display.
Smart, multi-measurement cable system available for use with reusable
and single-patient use supplies.
FAST SpO2 (continuous, automatic or manual measurement).
Standard, EASI or Hexad ECG lead system selection.
Impedance-based Respiration measurement.
6-lead with two V-leads for diagnosing multiple cardiac abnormalities,
including wide-QRS complex tachycardias and acute myocardial
ischemia/infarction.
Local measurement trend/alarm history.
Local alarming for measurements (requires IntelliVue Information
Center Release N or later or IntelliVue Information Center iX).
Integrated radio for connection to an Information Center iX.
Integrated short-range radio.
Communication with IntelliVue Patient Monitors and Cableless
Measurements via short-range radio connection (MP5/MP5T/MP5SC,
MP2 and X2 monitors only).
Powered by three AA batteries or rechargeable lithium-ion battery
pack.
Note — The WLAN MX40 (Model Number 865352) is powered only by
the rechargeable lithium ion battery pack.
Audio feedback for out-of-range and lost device.
Battery gauge on device and at Information Center.
Alarm suspend and resume from standby at device and Information
Center.
Pouch with clear front that closes securely.
Note — Unlike a traditional bedside monitor which operates on AC power,
the MX40 is powered by battery and provides time-limited screen display
and local alarming.
MX40 Models
The MX40 is available in three models (ECG only, ECG and FAST SpO2, or
ECG and SpO2 Ready (for future upgrade).
The MX40 is compatible for use with IntelliVue Patient Monitors Release G
or later when wirelessly connected.
The MX40 is compatible for use with Access Point Controller 862147,
Release B.00.19 and Access Point Controller 865346, Release C.00.04.
The MX40 Patient Cable is compatible for use with IntelliVue Patient
Monitor platforms MP2/X2, MP5/MP5T/MP5SC, MP20/30 with MMS or X2,
MP40/50 with MMS or X2, MP60/70 with MMS or X2, MP80/90 with MMS
or X2, and MX800/700/600 with MMS or X2.
You might not have all of these features, depending on the MX40
configuration purchased by your hospital.
Safety symbols and other markings on the MX40 are also described here.
General Safety
Warnings
Caution
Philips recommends that when using a pouch to attach the MX40 to your
patient that you consider your patient's condition and are careful about
placement of the straps as the straps could present a strangulation hazard.
Label Definition
FCC ID: Federal Communications Commission
IC: (FCC) ID
Industry Canada Number
Rechargeable Battery
CE Mark (MX40)
Compliance to Council Directive
93/42/EEC (Medical Device Directive) and
1995/5/EC (Radio Equipment and
Telecommunications Equipment Directive)
Symbol for Class 2 Radio Equipment
Non-Ionizing Radiation
Interference to electronic equipment may
occur in the vicinity of devices marked with
this symbol.
Label Definition
Disposal
Dispose of in accordance with the local
country’s requirements. 2002/96/EC
(Waste Electrical and Electronic
Equipment).
Prescription Device
Defibrillation Proof
Patient connections are protected against
defibrillation (DEFIBRILLATION-PROOF)
and are a TYPE CF APPLIED PART.
Serial Number
Used to identify the equipment during a
call to the Philips Healthcare (Service).
Reference Number
Indicates Philips Product Number
MAC Address
Battery Polarity
Label Definition
IPX Waterproof Rating
Protected against the effects of temporary
immersion in water.
2D Barcode
UL Listed Device
Listed by Underwriters Laboratories
Multi-Function Button
Button Function
Depending on configuration at the Information Center:
generates a Nurse Call;
Initiates a Delayed Recording;
Both, or;
None
Note — the Multi-Function Button does not operate
when paired with an IntelliVue Patient Monitor via the
short-range radio connection.
SmartKeys Button
Button Function
Displays the SmartKey Menu on the touch screen.
SmartKeys
The following table lists the SmartKeys available on the display of the
MX40.
SmartKey Function
Start SpO2 Starts a manual SpO2 measurement.
Note — This
SmartKey is
unavailable when
SpO2 mode is
continuous.
SmartKey Function
Standby Puts the device into Standby locally and
at the Information Center. Displays
purchased/enabled product options. To
resume from Standby, touch the Main
Screen button.
Alarms Area
The Alarm Area of the MX40 displays
physiological alarms and technical alarms.
A multiple alarm indicator (down arrow) is
displayed when multiple alarm conditions are
present and the alarm message rotates every 3
seconds.
A check mark in front of the alarm text signifies
that the alarm has been acknowledged by
touching the Silence Alarms button.
Alarm Indicators display in the Patient Information
Area in place of the time clock when alarm/INOP
conditions are present but have not been
acknowledged.
Touching the Alarms Area displays a list of all
active alarms.
The alarms paused icon communicates whether
the alarm system is on/off.
Local Alarm Audio is off when the alarm volume
symbol is present next to the time..
Paced Status
1. Pacing algorithm is on.
2. Pacing algorithm is off.
3. Pacing algorithm is on.
Patient's paced status
is unknown.
Display Lock
The Lock symbol appears in the lower left of the display when the MX40
is in a locked state after five minutes of non-use. Locking the display
provides additional protection against accidental patient access. The
display is unlocked using the SmartKeys menu.
Status Area
The status area of the MX40 displays short-range radio
connection (optional) and system wireless connection status.
You can also view battery strength for the type of battery
used in the device, AA or rechargeable Li-on.
A successful power-on self test will then transition the MX40 to the start-up
screen. Selectable background colors can be configured and display on the
screen for assistance with device identification. This can be helpful when
devices are in a pooled use setting.
If the MX40 enters a continuous "boot-up" cycle or the main display does
not appear or update, ensure that you are using a freshly charged
lithium-ion battery or new disposable batteries. If the batteries are fresh and
the device reboots or does not update, remove the device from service and
contact your service personnel.
You must visually check that a waveform is present on the display. You can
access further status information is by touching the status area on the
display.
Navigating
Touching the Navigation Bar on the right of the display will scroll through
additional display items. Solid downward arrows indicate there are
additional elements that are not currently displayed. The arrows briefly
illuminate when touched. Your selection from the menu also illuminates
when touched.
Measurement Area
The measurement area of the MX40 display is optimized to show available
parameter numerics, waveforms, and alarm limits. Each element is a touch
object and when you select it, further controls and menus become available.
Portrait - Two Waveforms and two Numerics (IIC Release N and IIC iX
only)
Landscape - Two Waveforms and three Numerics (IIC Release N and
IIC iX only)
Portrait - Viewable Chest Diagram and two Numerics
When connecting to the MX40, there is a slight clicking sound that signifies
that the cable is securely connected.
During initial use of the MX40, the secure connection between the patient
cable and the device may be difficult to disconnect. Should this occur, use
the alternative procedure shown below.
Caution
Never disconnect the patient cable by pulling on the leadwires, as this may
damage wires over time.
Understanding Settings
Each aspect of how the MX40 works and looks is defined by a setting. There
are a number of different categories of settings, including:
Primary I, II, III, aVR, aVL, aVF, V1-V9, MCL, V3R, V4R,
(used for arrhythmia analysis only) V5R. Available waveforms are based on lead set
(Set at IIC Release N or IIC iX. View only.) type. Lead II is the default.
Secondary I, II, III, aVR, aVL, aVF, V1-V9, MCL, V3R, V4R,
(used for arrhythmia analysis only) V5R. Available waveforms are based on lead set
(Set at IIC Release N or IIC iX. View only.) type. Lead V is the default.
Setting Description
ECG Set ECG On/Off
New Lead Setup When IntelliVue Patient Monitor lead sets are in
use, select 3-wire, or 5-wire.
Battery Information
Battery Safety Information
Warnings
Cautions
Charge stored batteries to at least 90% of When not in use for an extended period
their capacity every six months. of time.
Do not short circuit - take care that the terminals do not contact metal
(e.g. coins) or other conductive materials during transport and storage.
Do not crush, drop or puncture - mechanical abuse can lead to internal
damage and internal short circuits that may not be visible externally.
Do not apply reverse polarity.
discontinue use.
dispose of the battery in accordance with the disposal instructions.
If batteries are stored for an extended period of time, they should be stored
in a cool, dry place, ideally at 15oC (60oF), with a state of charge of 20% to
90%. Storing batteries in a cool place slows the aging process.
Inserting/Removing Batteries
Warning
Caution
Remove the batteries before storing the MX40 for an extended period of
time.
To remove the batteries, open the battery compartment door and push from
the opening at the bottom of the compartment to pop the batteries out.
Device settings (patient cable type, SpO2 mode, volume, etc.) are retained
when the batteries are removed.
Do not use AA batteries that have different energy levels remaining. Fresh
AA batteries are recommended for each new application.
Be careful not to short circuit the batteries. Batteries can get hot when
shorted. Short circuits are caused when a piece of metal touches both the
positive and negative terminals simultaneously. More than a momentary
short circuit will generally reduce the battery life. In case of a short circuit,
discard the batteries, or just the shorted one if the batteries are new.
Disposal of Batteries
When disposing of batteries, follow local laws for proper disposal. Dispose
of batteries in approved containers. If local regulations require you to
recycle batteries, recycle batteries in accordance with those regulations.
Low battery level < 30 minutes < 30 minutes SpO2 and 1 Red
to replace/charge short-range radio Red Battery
battery level are disabled. Icon
Display is at half Audio
brightness.
Pouch Use
The MX40 is not intended for direct contact with the patient’s skin. During
normal use, the MX40 should be worn over clothing, in a pocket or,
preferably, in a pouch. The Waterproof Carry Pouch with clear front is an
appropriate means for holding the MX40. See Appendix A, "Accessories"
for ordering information.
4 Secure the pouch on the patient with the ties around the patient’s
shoulder and under the arm.
5 Check that the patient is comfortable wearing the pouch with the MX40.
Cautions
Showering
Warning
When the patient is showering, signal quality and leads off detection may
be compromised due to significant movement. Appropriate clinical
precautions must be taken.
Caution
The MX40 can be used to monitor a patient in the shower, but only when
placed inside a Philips carrying pouch and secured on the patient as
described above. The combination of the MX40 and pouch will withstand
showering for up to 10 minutes.
Caution
The MX40 should not be used for monitoring if the battery compartment is
wet. Remove the batteries and wipe the compartment dry before continued
monitoring use.
Patients should be instructed not to interact with the display of the device
and to not open the battery compartment while the MX40 is in use.
If desired, you can turn off patient use of the Multi-Function button at the
Information Center. For more information see Patient Configurable Settings
in Telemetry Setup p. 11-10.
Alarms 5-1
Alarms Overview
Alarms Overview
The MX40 has two different types of alarms: physiological alarms and
INOPs. For MX40 devices operating with IntelliVue Information Center
Release L and M, physiological alarms are not available locally on the
MX40. INOPs are displayed as described here.
Physiological Alarms
Physiological alarms are red and yellow alarms. A red alarm indicates a
high priority patient alarm such as a potentially life threatening situation
(for example, asystole). A yellow alarm indicates a lower priority patient
alarm (for example, a low SpO2 alarm limit violation). Additionally there
are short yellow alarms, most of which are specific to arrhythmia-related
patient conditions (for example, ventricular bigeminy).
INOPs
INOPs are technical alarms, they indicate that the monitor cannot measure
or detect alarm conditions reliably. If an INOP interrupts monitoring and
alarm detection (for example, LEADS OFF), the monitor places a question
mark in place of the measurement numeric and an audible indicator tone
will be sounded. INOPs without this audible indicator indicate that there
may be a problem with the reliability of the data, but that monitoring is not
interrupted.
Most INOPs are light blue, however there are a small number of INOPs
which are always yellow or red to indicate a severity corresponding to red
and yellow alarms. The following INOPs can also be configured as red or
yellow INOPs to provide a severity indication:
5-2 Alarms
Alarms Overview
Alarms are indicated after the alarm delay time. This is made up of the
system delay time plus the trigger delay time for the individual
measurement. For more information see ECG Performance
Disclosure/Specifications p. 15-27 .
A downward facing arrow symbol next to the alarm message informs you
that more than one message is active and the messages rotate every three
seconds. The monitor sounds an audible indicator for the highest priority
alarm.
Alarm Message
An alarm message text appears in the alarm status area at the top of the
screen indicating the source of the alarm. The background color of the
alarm message matches the alarm priority: red for red alarms, yellow for
yellow alarms, light blue for standard INOPs, red for red INOPs and yellow
for yellow INOPs. The asterisk symbols (*) beside the alarm message match
the alarm priority: *** for red alarms, ** for yellow alarms, * for short 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. If more than one alarm is present, there is a downward
facing arrow symbol at the right side and the active alarm/inop messages
rotate every three seconds.
Alarm limit violation messages are displayed in text form, for example **
SpO2 LOW.
Alarms 5-3
Alarms Overview
Alarm Indicator
An Alarm Indicator on the MX40 main display communicates alarm/INOP
conditions that have not been acknowledged. The alarm indicator is
divided into two sections and appears in the upper right hand corner
normally occupied by the time display. The right section flashes for a
physiological alarm, except for short yellow alarms where the indicator will
light for approximately six seconds. The color is yellow or red
corresponding to the highest priority alarm currently present.
The left section lights continuously for a standard INOP and flashes for
INOPs configured as red or yellow alarms as follows:
Flashing Numeric
The numeric of the measurement in alarm flashes.
5-4 Alarms
Alarms Overview
Warning
Alarms 5-5
Alarms Overview
Acknowledging Alarms
To acknowledge all active physiological alarms and INOPs, touch the
Silence Alarm button. This switches off the audible alarm indicators, if
present, and alarm messages at the MX40 and at the IntelliVue Information
Center iX.
A check mark beside the alarm message indicates that the alarm has been
acknowledged .
If the condition that triggered the alarm is still present after the alarm has
been acknowledged, the alarm message stays on the screen with a check
mark symbol beside it, except for NBP alarms and alarms from other
intermittent measurements. When such an alarm is acknowledged the
alarm message disappears.
If the alarm condition is no longer present, all alarm indicators stop and the
alarm is reset.
Switching off the alarms for the measurement in alarm, or switching off the
measurement itself, also stops alarm indication.
Cautions
5-6 Alarms
Alarms Overview
Warning
Alarm Limits
The alarm limits you set determine the conditions that trigger yellow and
red limit alarms. For some measurements (for example, SpO2), where
setting the high alarm limit to the maximum of 100 switches the high alarm
off, or setting the low alarm limit to the minimum of 0 switches it off. In
these cases, the alarms off symbol is not displayed.
Warning
Be aware that the monitors 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.
Alarms 5-7
Alarms Overview
Reviewing Alarms
You can see which alarms and INOPs are currently active in the respective
alarms and INOPs fields at the top of the screen.
To see the currently active alarms and INOPs listed in one place, touch the
Alarms area.
All alarms and INOPs are erased from the Alarm Messages window when
you discharge a patient, or if you change to Demonstration Mode.
The Review Alarms window also shows when alarms are paused or
silenced.
Note — Alarms that occur during an alarm suspend period will appear in
the Review Alarm window, however, they are not communicated to the
Information Center.
Alarm Reminders
The MX40 provides alarm reminders when operating with IIC Release N or
IIC iX. The reminder time period is selected at the Information Center.
For Information Center Release L/M, reminders are only available for
INOPs.
5-8 Alarms
Alarms Overview
Latching Alarms
The alarm latching setting for your MX40 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 monitor after the alarm
condition ends. The indication lasts until you acknowledge the alarm by
touching the Alarm Silence button.
Alarm condition no All audible and visual Alarm tone on. Alarm
longer present. alarm indicators message . Flashing
automatically stop. numerics.
Alarm has been Alarm condition still Alarm tone off. Alarm Alarm tone off. Alarm
acknowledged. present. message with check message with check
mark. Flashing mark. Flashing
numerics. Audible numerics. Audible
alarm reminder (if alarm reminder (if
configured) configured)
If battery power is lost for less than one minute, the alarm on/off condition
prior to the power loss is restored.
Alarms 5-9
Physiologic Alarms
Physiologic Alarms
Physiologic alarms indicate a life-threatening situation or a less urgent
situation such as heart rate beyond limits.
Warning
In the following table, Red (***) alarms are listed alphabetically, followed by
the Yellow (**) alarms, and the Yellow (*) alarms.
5-10 Alarms
Physiologic Alarms
** dQTc Yellow dQTC value has exceeded the dQTC high ECG/QT
limit for > 5 minutes for 2 consecutive time
periods.
** NBP High Yellow High limit has been exceeded for high NBP
pressure limit.
** NBP Low Yellow Low limit has been exceeded for low NBP
pressure limit.
** QTc High Yellow QTc value has exceeded the QTc high ECG/QT
limit for > 5 minute for2 consecutive time
periods.
Alarms 5-11
Physiologic Alarms
*/** HR High Yellow Heart Rate (yyy) greater than the upper ST/AR Basic
Heart rate limit (xxx). & Enhanced
Arrhythmia
*/** HR Low Yellow Heart Rate (yyy) lower than the lower ST/AR Basic
Heart Rate limit (xxx). & Enhanced
Arrhythmia
* MISSED BEAT Yellow No beat detected for 1.75 x average R-R ST/AR
interval for Heart Rate greater than 120, or Enhanced
no beat for 1 second with Heart Rate Arrhythmia
greater than 120 (non-paced patient only).
* PACER NOT CAPTURE Yellow No QRS for 1.75 x the average R-R ST/AR Basic
interval with Pace Pulse (paced patient & Enhanced
only). Arrhythmia
* PACER NOT PACING Yellow No QRS and Pace Pulse for 1.75 x the ST/AR Basic
average R-R interval (paced patient only). & Enhanced
Arrhythmia
5-12 Alarms
Physiologic Alarms
* R-ON-T PVCs Yellow For Heart Rate less than 100, a PVC with ST/AR
R-R interval less than 1/3 the average Enhanced
interval followed by a compensatory pause Arrhythmia
of 1.25 x average R-R interval, or 2 such
Vs without a compensatory pause
occurring within 5 minutes of each other.
(When Heart Rate is greater than 100, 1/3
R-R interval is too short for detection.)
Alarms 5-13
Technical Alarms (INOPs)
5-14 Alarms
Technical Alarms (INOPs)
Source - Cableless
Measurement Device
cl NBP Batt Empty Severe CL NBP Pod empty battery Replace CL NBP Pod.
condition. Monitoring is not
Recharge depleted CL NBP
possible.
Source - Cableless Pod.
Measurement Device
cl SpO2 Batt Low Hard CL SpO2 Pod weak battery Charge CL SpO2 Pod.
condition.
Source - Cableless
Measurement Device
cl SpO2 Batt Empty Severe CL SpO2 Pod empty Replace CL SpO2 Pod.
battery condition.
Recharge depleted SpO2 Pod.
Monitoring is not possible.
Source - Cableless
Measurement Device
!!!/!! CUFF NOT Severe Cuff pressure has Remove cuff and tubing and
DEFLATED exceeded the specified expel air.
safety limit.
Source - Cableless
Measurement Device
!!!/!! CUFF OVERPRESS Severe Cuff pressure has Remove cuff and tubing and
increased above expel air.
overpressure safety limits.
Source - Cableless
Measurement Device
Alarms 5-15
Technical Alarms (INOPs)
Source - MX40
ECG LEADS OFF Red or Multiple leads are off. Re-attach ECG leads to patient..
Note This INOP may also Yellow or
be configured to display as Hard
a Red or Yellow Technical Technical
Alarm. Alarm
Source - MX40
<electrode> LEAD OFF Hard Single lead is off. Re-attach ECG leads to patient.
If primary lead is MCL,
Source - MX40 lead will be identified as
V/C in INOP text.
LEADSET UNPLUGGED Hard Patient cable has been Re-attach the patient cable.
unplugged from the
Replace the leadset.
MX40.
Source - MX40
Incompatible leadset
attached to patient cable.
LEADSET LIFE Soft The single-patient use Replace with new leadset.
leadset has exceeded its
limit of 25 cycles.
LOCAL AUDIO OFF Soft There is no alarm audio Change to Monitor Mode.
notification when operating
in Telemetry Mode.
Source - MX40
Note — This is normal
operation in Telemetry
Mode.
NBP INTERRUPTED Hard The preset maximum time Reduce patient movement and
for the total measurement avoid interaction with the cuff
has been exceeded. and tubing.
Source - Cableless
Measurement Device
NBP MEASURE FAILED Hard Measurement values Attach cuff to new location on
cannot be derived. patient.
Source - Cableless Replace cuff.
Measurement Device
5-16 Alarms
Technical Alarms (INOPs)
NO ALARM DISPLAY Soft When operating with Condition is not present when
Information Center operating with Information
Release L Or M, there is Center Release N or later
Source - MX40 no local alarming at the (unless specifically configured to
MX40, networked or operate in this way).
non-networked.
NO CENTRAL MONITOR Hard The MX40 is out of Return the MX40 to the
(appears at MX40 only) range of the network. coverage area.
Patient Sector at the Select Resume at the
Source - MX40 Information Center is in Information Center.
Standby.
NO HOST MONITOR Hard The paired MX40/bedside Reduce the distance between
monitor is out of the devices.
short-range radio range or
Source - MX40 Identify and remove
there is excessive radio
interference source.
interference.
NO SIGNAL Hard, The MX40 is outside the Make sure that the MX40 is
(appears at the Information Latched coverage area, or within the coverage area and
Center only) has good batteries.
No batteries in the
Note — When operating MX40, or Replace the MX40 if Power
with IIC iX, the INOP will On Self Test fails.
The MX40 has failed.
display as NO DATA PWM. Put bed in Standby.
Source - Information Contact Service
Center
Alarms 5-17
Technical Alarms (INOPs)
Source - MX40
SpO2T EXTD UPDATE Soft The update period of If NBP is not active, check the
Numeric is replaced by a displayed values is sensor placement. Reposition
extended due to an NBP the sensor on patient, or replace
-?-. measurement on the same sensor.
limb or an excessively
noisy signal.
Source - MX40
SpO2T LOW PERF Soft Accuracy may be reduced Increase perfusion. Change
due to low perfusion. Data sensor site. Avoid site distal to
displayed with ?. BP cuff or intra-arterial line.
Source - Monitor Warm the site.
SpO2T INTERFERENCE Hard Level of ambient light or Reduce ambient light to sensor
level of electrical or electrical noise sources.
interference are so high
Source - MX40 that the SpO2 sensor
cannot measure SpO2 and
pulse rate.
SpO2T NO PULSE Hard Pulse is too weak or not Check connection to patient.
detectable
Change sensor site. Avoid site
Source - MX40 Sensor has fallen off at distal to BP cuff or
patient. intra-arterial line.
Note — When paired
directly with an IntelliVue
MP5 Patient Monitor, the
INOP will display as SpO2T
SENSOR OFF.
5-18 Alarms
Technical Alarms (INOPs)
SpO2T SEARCHING Soft The patient signal is Wait for the measurement to
analyzed, but a valid complete.
numeric is not available
Source - MX40 yet.
SpO2T SENSOR OFF Hard The algorithm has Apply the sensor according to
determined that a sensor is the manufacturer's
Note — The ability of the connected, but not properly instructions.
algorithm to detect this applied to the patient.
condition depends on the If the condition persists,
sensor type in use. relocate the sensor to a
different site on the patient.
SpO2T SENSOR MALF Hard Malfunction of the SpO2 Replace sensor.
sensor/adapter cable
Source - MX40
SpO2 UNKN SENSOR Hard The connected SpO2 Use specified sensor and/or
sensor and/or adapter adapter cable.
cable is not supported by
Source - MX40 the hardware version.
SpO2T UPGRADE Soft SpO2 hardware is in Wait for the upgrade process to
Source - MX40 upgrade process. complete.
Monitoring is not possible.
TELE BATT EMPTY Hard, Lithium-ion battery level is Insert a charged lithium-ion
Latched critically low. A 10-minute battery pack.
Note — This INOP may countdown begins. The
also be configured to MX40 will shut down if the
display as a Red or Yellow condition is not cleared.
Technical Alarm.
Source - MX40
Note — For Information
Center Release L or M, this
INOP will appear as
"REPLACE BATTERY T".
TELE BATTERY TEMP Hard The temperature of the Replace the lithium-ion battery.
Source - MX40 lithium-ion battery is above
o o
55 C or below -5 C.
Note — For Information
Center Release L or M, this
INOP will appear as
"REPLACE BATTERY T"
TELE CHECK BATT Soft Lithium-ion battery has < Be aware that the Lithium-ion
Source - MX40 25 charge cycles battery pack will soon need
remaining before reaching replacement.
the charge cycle maximum
limit.
Alarms 5-19
Technical Alarms (INOPs)
Source - MX40
TELE REMOVE BATT Hard, The temperature of the Replace the lithium-ion
o
Source - MX40 Latched lithium-ion battery is >60 battery.
C and the battery must be Dispose of old battery
Note — For Information removed.
properly.
Center Release L or M, this
INOP will appear as
"REPLACE BATTERY T".
TELE SERVICE BATT Hard The lithium-ion battery has Replace the lithium-ion
Source - MX40 exceeded the maximum battery.
charge cycle limit and
Dispose of old battery
reached the end of its
properly.
useful life.
TELE WEAK SIGNAL Soft Patient is at outer range Return patient to the coverage
of the radio coverage area.
area.
Source - MX40 If patient is in close proximity
The MX40 is receiving a to AP, replace the MX40.
weak signal with high Contact service.
data loss from the AP.
The AP covering the specific
Condition exists for area is suspect. Contact
multiple devices in a Service
specific area
TRANSMITTER OFF Hard RF Auto Shutoff after 10 Reattach ECG leads to
minutes of all leads off and patient.
no SpO2 sensor
Source - MX40 Reattach SpO2 sensor.
connected.
UNSUPPORTED LAN Hard The MX40 (WLAN) is Correct the IP address issue.
connected to the Access
Point, but cannot obtain an
Source - MX40 IP address.
WIFI OUT OF RANGE Hard The MX40 (WLAN) is out Correct the RF coverage issue.
of range of an access
point.
Source - MX40
5-20 Alarms
6. ECG and Arrhythmia
Monitoring
This section covers the specifics of ECG measurement and the ST/AR
Arrhythmia, ST, and QT algorithms used for arrhythmia monitoring.
Caution
The output power of the MX40 and other sources of radio frequency
energy, when used in the proximity of a pacemaker, can be sufficient to
interfere with pacemaker performance. Due to the shielding effects of
the body, internal pacemakers are somewhat less vulnerable than
external pacemakers. However, caution should be exercised when
monitoring any paced patient.
For paced patients who exhibit only intrinsic rhythm, the monitor can
erroneously count pace pulses as QRS complexes when the algorithm
first encounters them, resulting in missed detection of cardiac arrest.
The risk of missing cardiac arrest can be reduced by monitoring these
patients with the low heart rate limit at or slightly above the
basic/demand pacemaker rate. A low heart rate alarm notifies you when
the patient begins pacing. Proper detection and classification of the
paced rhythm can then be determined.
Measuring ECG
The electrocardiogram (ECG) measures the electrical activity of the heart
and displays it on the MX40 and the Information Center as a waveform and
a numeric.
Clinicians will tend to see more motion related artifact on the ECG of
ambulatory patients than on patients that are restricted to a bed. Proper
skin preparation and electrode application are very important in reducing
this problem.
Problems with the ECG signal stem from two main sources:
2 Check electrodes for moist gel, and attach to the clips. If you are not
using pre-gelled electrodes, apply electrode gel to the electrodes before
placement.
Note— Gel must be moist to provide a good signal.
3 Place the electrodes on the patient according to the lead placement you
have chosen (see the electrode placement diagrams following). Place the
edge down, then "roll down" the rest of the pad. Press firmly around the
adhesive edge toward the center.
4 Attach the patient cable to the MX40. An ECG waveform and numeric
appear on the monitor display.
Only the primary lead is used if your device is configured for single lead
arrhythmia analysis.
Note — Paced status is set at the Information Center and can only be
changed at the Information Center.
Pacer Algorithm is switched on. This means that pacemaker pulses are
not counted as extra QRS complexes.
The pacer spikes are shown in white.
The paced symbol is displayed.
When Paced is set to Unconfirmed (IIC iX only):
Pacer Algorithm is switched on. This means that pacemaker pulses are
not counted as extra QRS complexes.
The pacer spikes are shown in white.
The paced symbol with ? is displayed.
When Paced is set to Off and your patient has a pacemaker, pace pulses
may be counted as regular QRS complexes, which could prevent an
asystole event from being detected.
Warning
ECG HR numeric: This is the heart rate derived from the monitored ECG.
1. Normal Beats
2. Pace Pulses/Beats
If you note a visible repolarization tail, choose a lead that decreases the size
of the repolarization tail.
1. Repolarization tail
(note width)
1. Fusion
2. Paced
3. Pseudofusion
Changing the adjustment factor only changes the visual appearance of the
ECG wave on the MX40. It does not affect the ECG signal analyzed by the
algorithm.
Comparing the wave size to the 1 mV calibration bar on the ECG wave
segment can help you get an idea of the true ECG signal strength.
EASI is shown beside the 1 mV calibration bar on the ECG wave on the
display, and EASI is marked on any recorder strips and printouts.
Caution
EASI
The EASI system, a method of deriving 12ECG leads using a five-electrode
configuration (4 monitoring electrodes and a ground electrode), has been
developed to better address the goals and challenges of continuous ECG
monitoring. EASI monitoring makes it possible to obtain 12-lead ECG
information under continuous monitoring conditions across the continuum
of care. The EASI method of obtaining a 12-lead ECG requires only five
electrodes. The electrodes are placed on the upper sternum (S), the lower
sternum (E) at the level of the fifth intercostal space, and on the right and
left midaxillary lines (I and A) at the same level as the lower sternum
electrode. A fifth ground electrode can be placed anywhere.
ECG Configuration
The MX40 supports 3-, 5-, and 6-wire patient cables. The 5-wire patient
cable can be used for either standard or EASI electrode configurations. The
6-wire patient cable can be used for either standard or Hexad electrode
configurations. The MX40 detects the patient cable type attached and
automatically determines the ECG measurement and transmitted leads.
Note—The labels and colors of the ECG electrodes differ according to the
standards that apply for your hospital. The electrode placement references
and illustrations in this chapter use the AAMI labels and colors. See the
table below for additional label and color information.
LA S L Black Yellow
LL A F Red Green
RL N N Green Black
Vb Cb Brown/White White/Blue
5-wire (Standard mode) I, II, III, aVR, aVL, aVF, MCL and V
Sourced (raw) waves are received as:
Channel 1 = II
Channel 2 = III
Channel 3 = MCL
Factory Defaults are II, V, III.
5-wire (EASI mode) I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
In EASI mode, the sourced (raw) waves are
received as:
Channel 1 = Vector 1 (A-I)
Channel 2 = Vector 2 (A-S)
Channel 3 = Vector 3 (E-S)
Factory Defaults are II, V2, III, V5.
Arrhythmia monitoring is performed only on the
primary and secondary leads selected at the
Information Center, although you can view and
perform ST analysis on all 12 EASI derived
leads.
6-wire (Hexad Mode) I, II, III, MCL, aVR, aVL, aVF, V1-V6.
Factory Defaults = Off, V1/V3, V1/V4, V1/V5,
V2/V4, V2/V5, V3/V5, V3/V6
Derived leads are labeled, e.g. dV3.
Reconstructed Leads
Reconstruction of leads from the sourced wave is defined by the
calculations in the following table. EASI reconstructed leads are a linear
combination of all three raw EASI leads
Va Va-(RA+LA+LL)/3, where
Va=V2 (default) position
Vb Vb-(RA+LA+LL)/3, where
Vb =V5 (default) position
3-Wire Placement
1. RA - directly below the clavicle and
near the right shoulder
2. LA -directly below the clavicle and
near the left shoulder
3. LL - on the left lower abdomen
6-Wire Placement
For a 6-lead placement use the positions from the 5-lead diagram above but
with two chest leads. The two chest leads, Va and Vb, can be positioned at
any two of the V1 to V6 positions shown in the chest electrode diagram
below.
The lead placement for the Va and Vb lead labels must be appropriate. If
your unit uses other precordial leads for Va and Vb, they may be assigned
in Unit Settings at the Information Center as defaults for your whole unit,
or you may need to assign the new positions on a per-patient basis in the
Patient Window at the Information Center.
ECG Fallback
ECG Fallback occurs when the primary lead is in "Leads Off" for 10 seconds
and a secondary lead is available.
Multilead Analysis
If there is a "Leads Off" technical alarm in the primary lead for > 10 seconds,
the active secondary lead becomes the primary lead. The arrhythmia
algorithm switches the leads on the display, but relearn does not occur.
When the "Leads Off" condition is corrected, the leads are switched back to
their original state.
Extended Monitoring
If both the primary and secondary leads are in a "Leads Off" condition, the
ECG source on the MX40 will switch to any available lead. Relearning will
occur in this condition.
Relearning
Whenever there is a "Leads Off" condition for more than 60 seconds, the
arrhythmia algorithm performs a Relearn using the available leads.
Warning
The quality of the ECG signal is important for accurate arrhythmia analysis.
The section below provides guidelines for optimizing signals for
arrhythmia analysis.
Aberrantly-Conducted Beats
As P-waves are not analyzed, it is difficult and sometimes impossible for
the monitor to distinguish between an aberrantly-conducted
supraventricular beat and a ventricular beat. If the aberrant beat resembles
a ventricular beat, it is classified as ventricular. You should always select a
lead where the aberrantly-conducted beats have an R-wave that is as
narrow as possible to minimize incorrect calls. Ventricular beats should
look different from these 'normal beats'. Instead of trying to select two leads
with a narrow R-wave, it may be easier to just select one lead and use single
lead arrhythmia monitoring. Extra vigilance is required by the clinician for
this type of patient.
Since most atrial flutters have regular RR intervals, they cannot be detected
by the atrial fibrillation algorithm.
sinus arrhythmia
muscle noise, or
electrode motion artifact
You need to know which value has been configured for your monitor.
Changing the high and low alarm limits automatically changes the extreme
alarm limits within the allowed range.
Non-Sustain VT, Vent Rhythm, Run PVCs, Pair PVCs, R-On-T PVC,
V.Bigeminy, V.Trigeminy, Multif.PVCs, Pause, SVT, HR High, HR Low
Irregular HR (IHR), Missed Beat, PVCs/min, Pacer Not Capture, Pacer
Not Pacing,and Afib.
Alarms that have been turned off at the Information Center will appear as
off in the Arrhythmia menu of the MX40, but they are not accessible, nor
can you change limits locally.
Warning
When arrhythmia analysis is on, all yellow ECG and arrhythmia alarms are
short yellow alarms (one-star). This means that the alarm tones (if volume
is on) are active for six seconds only, after which the blinking numeric and
the alarm message remain for up to three minutes. The only exception to
this are the HR High and Low alarms which can be configured as standard
yellow alarms. Red alarms behave as usual.
N = Normal
V = Ventricular Ectopic
S = Supra-ventricular Premature
P = Paced
V-FIB/TACH
V-TACH
PVC Alarms Chain Rate Alarms Chain Beat Detection Alarms Afib/End Afib
Chain
lHR/End IHR
Run PVCs HR > xxx or HR < xxx Pacer Not Capture/Pacer Not
Pace/Missed Beat.
Pair PVCs
R-On-T PVCs
----------------------------------------------------------------------------------------------------------------------------
Vent Bigeminy
Vent Trigeminy
PVCs >xx/min
Multiform PVCs
Red Alarms
Asystole
V-FIB/TACH
V-TACH
Extreme
Tachy/Extreme
Brady
-----------------------------------------------------------------------------------------------------------------------------
PVCs >xx/min
Learning
The arrhythmia system’s goal is to learn the patient’s normal complexes so
it can differentiate abnormal beats. This "learning" process uses the 15 first
valid beats (for example, free from noise) encountered during the learning
phase.
While the system is learning the complex, the delayed arrhythmia wave
displays the beat label "L".
Learning Phase
A learning phase involves the system learning the patient’s dominant
complexes. During a learning phase:
Multilead Analysis
If multilead analysis is selected, the arrhythmia system begins a learning on
both leads whenever:
A Leads Off INOP condition (that has been active for >60 seconds) ends.
Note — During this learning phase the system will continue monitoring
using the operative lead. Therefore, the delayed arrhythmia wave is not
labeled "L". In addition:
Warning
If beats are still not classified correctly, check that the ECG is optimized for
arrhythmia monitoring. You may need to select a different lead or change
the electrodes or electrode positions if there is excessive noise, unstable
voltage, low amplitude, or large P- or T-waves.
Warning
The ST/AR ST algorithm is approved for use only with adult non-paced
and atrially-paced patients.
Caution
The Measurements
Overview
The ST/STE measurement for each beat complex is the vertical difference
between two measurement points. The isoelectric point provides the
baseline for both measurements.
The ST measurement uses the isoelectric point and the ST point. The ST
point is positioned with reference to the J-point.
The STE measurement uses the isoelectric point and the J point.
Displayed ST Data
ST data displays as values in the Patient Sector and Patient Window at the
Information Center. At the MX40, three ST values can be displayed below
the ECG wave. A positive value indicates ST segment elevation; a negative
value indicates ST segment depression. You can view ST data at the MX40
if ST is assigned to a numeric area. Up to 3 values can display in the
assigned space. If more than three values area available, the last value will
rotate.
STE Data can only be displayed in the Measurements application STE page
at the Information Center iX.
Note — ST/STE data and alarms are only displayed at the MX40 when
operating with IntelliVue Information Center iX.
ST Lead Groups
ECG Leads are clinically grouped as follows:
You can change the group displayed using the ST Views menu.
Caution
EASI ST Analysis
With EASI monitoring, ST analysis is performed on up to 12 leads, and an
additional value of ST index is calculated and displayed. Assessment of
EASI-derived 12-lead ST measurement is recommended for adult patients
that meet the following parameters:
ST values are presented in the patient sector and Patient Window for EASI
derived leads along with STindx (ST Index). STindx is a summation of three
ST segment measurements, using the leads that can indicate ST segment
changes in the different locations of the heart:
anterior lead V2
lateral lead V5
inferior lead aVF
HEXAD ST Analysis
When operating with the IntelliVue Information Center iX, the optional
Hexad algorithm generates a Mason-Likar 12-lead ECG from a 6-wire
leadset (including four limb electrodes and two chest electrodes) placed
according to the Mason-Likar 6-electrode placement.
ST Alarms
ST Alarms are yellow alarms. They are announced after exceeding alarm
limits for one minute. ST Alarm Limits can only be set at the Information
Center. Each ST lead has its own alarm limit. ST alarms are triggered when
an ST value exceeds its limit for more than one minute. Turning ST Alarms
off turns off alarms for all ST leads.
STE Alarms
The STE Alarm is a yellow alarm. It is announced after exceeding alarm
limits for one minute. It can be turned on and off at the Information Center,
however its limits are not adjustable. The STE alarm limits are gender
specific and can be set individually for limb leads, V2/V3 leads, and
V1/V4/V5/V6 leads. The default values, for example on V2 and V3 1.5 mm
for females and 2.0 mm for males, are based on the recommendations from
the American Heart Association and American College of Cardiology.
QT Interval Monitoring
Of special concern for QT monitoring is the administration of QT
prolonging drugs to patients identified with risk factors for Torsade de
Pointe. Females, older patients and patients with bradycardia, impaired left
ventricular function (ischemia, left ventricular hypertrophy), hypokalemia
and hypomagnesemia are in this increased risk category.
The QT interval has an inverse relationship to heart rate. Faster heart rates
shorten the QT interval and slower heart rates prolong the QT interval. To
correct the QT interval for heart rate the Information Center uses the Bazett
correction formula by default. Your system, however, may be set up to use
the Fridericia correction formula as an alternative. The heart rate corrected
QT interval is abbreviated as QTc.
Intended Use
The intended use of the ST/AR QT/QTc analysis is for use by the physician
in the risk assessment process indicated for pediatric and adult patients
with and without symptoms of arrhythmia. QT measurement is intended to
be used by qualified health professionals in hospital or clinical
environments. Composite QT (single or multi-lead derived) measures the
interval only and is not intended to produce any interpretation or diagnosis
of those measurements. Additional information regarding QT monitoring
can be found in the QT Interval Monitoring Application Note, Part Number
452296278601.
Warning
The device provides QT and QTc interval change information; the clinical
significance of the QT and QTc interval change information should be
determined by a clinician.
Adjusting QT Settings
For patients being monitored by the MX40, you can turn QT Monitoring
on/off and adjust QT settings at the IntelliVue Information Center.
Measurement Definition
QT QT interval in milliseconds. The QT interval is the time between the
beginning of the Q-wave and the end of the T-wave.
QTc QTc represents the heart rate corrected QT interval. By default, the
Information Center uses the Bazett correction formula to correct
the QT interval for heart rate. Your system, however, may be set
up to use the Fridericia correction formula.
dQTc The difference between the current QTc value and the QTc
baseline value.
Note—Turning QT analysis off does not clear the baseline value. This
allows you to turn QT analysis off during prolonged arrhythmias, such as
bigeminy, without losing the baseline.
The pulse numeric is displayed at the Information Center only when SpO2
is being measured continuously. Manual measurements are displayed at
the MX40 with a time stamp. There are no alarms associated with the pulse
measurement. Pulse is turned on in the Telemetry Setup window at the
IntelliVue Information Center Release N or earlier and using the
Measurements/SpO2 page at the IntelliVue Information Center iX.
Note — Resp is only available with the IntelliVue Information Center iX.
Settings for Resp On/Off, alarms, alarm limits and apnea time are defined at
the Information Center. When the ECG measurement is turned off, the Resp
measurement is also turned off.
The Resp measurement uses the standard MX40 patient cable. You can use
3-wire, 5-wire, or 6-wire leadsets, using either Standard or EASI placement.
Cardiac Overlay
Cardiac activity that affects the Resp waveform is called cardiac overlay.
Cardiac overlay happens when the Resp electrodes pick up impedance
changes caused by the rhythmic blood flow. Correct electrode placement
can help to reduce cardiac overlay. Avoid the liver area and the ventricles
of the heart in the line between the respiratory electrodes.
Abdominal Breathing
Some patients with restricted chest movement breathe mainly abdominally.
In these cases, you may need to place the left leg electrode on the left
abdomen at the point of maximum abdominal expansion to optimize the
respiratory wave.
Cautions
Physiological SpO2 alarm signals will be generated. For adult patients, the
SpO2 low limit can be set between 50 and 99% inclusive, in 1% increments,
and the SpO2 high alarm limit can be set between 51 and 100% inclusive, in
1% increments. For pediatric patients, the SpO2 low limit can be set between
30 and 99% inclusive, in 1% increments, and the high alarm limit can be set
between 31 and 100% inclusive, in 1% increments. The maximum delay
between the physiological alarm condition and alarm signal generation is
25 seconds.
Pulse rate is also derived from the pulsatile SpO2 measurement, and
displayed results can range from 30 to 300 bpm. There is no alarm function
for pulse rate.
The SpO2 parameter measures the arterial oxygen saturation, that is, the
percentage of oxygenated hemoglobin in relation to the total hemoglobin.
If, for example, a total of 97% of the hemoglobin molecules in the red blood
cells of the arterial blood combine with oxygen, then the blood has an
oxygen saturation of 97%. The SpO2 numeric that appears on the monitor
will read 97%. The SpO2 numeric indicates the percentage of hemoglobin
molecules which have combined with oxygen molecules to form
oxyhemoglobin.
SpO2 Sensors
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. See Appendix A,
Accessories, for a complete listing of supported sensors for the MX40.
Philips reusable sensors in adult, pediatric and infant (an alternative for use
on adult patients only) models can be used, as well as Philips and Nellcor®
disposable sensors.
Caution
The following table will help you in selecting the correct sensor type.
Failure to apply a sensor properly can reduce the accuracy of the SpO2
measurement.
The level to which the triangle is filled shows the quality of the signal. The
signal quality is at a maximum when the triangle is completely filled.
Measuring SpO2
Warning
Removal of the SpO2 sensor from the MX40 patient cable during
Continuous SpO2 monitoring results in a "No Sensor" technical alarm.
Silencing this alarm turns the SpO2 measurement off, however the SpO2
module is still operating in the background and consuming battery
power. If you do not intend to resume continuous SpO2 monitoring,
change to Manual mode. There is no technical alarm for a "No Sensor"
condition in Manual mode.
If you measure SpO2 on a limb that has an inflated NBP cuff, a
non-pulsatile SpO2 technical alarm can occur. If the monitor is
configured to suppress this alarm, there can be a delay of up to 60
seconds in indicating critical patient status, such as hypoxia.
To resume the SpO2 measurement after it has been turned off, touch the
blank measurement area and select SpO2 to turn it back on.
Setting the SpO2 mode can be done at the Information Center or at the
MX40.
The delay between the physiologic alarm condition and alarm annunciation
at the MX40 is <16 seconds. This means that the MX40 will generate an
alarm if the averaged numeric value on the display exists beyond the alarm
limit for more than a maximum of 16 seconds.
Setting the high SpO2 alarm limit to 100% is equivalent to switching off the
high alarm. Therefore the upper alarm limit for oxygen saturation must be
carefully selected in accordance with accepted clinical practices.
The default setting for SpO2 yellow alarms is latched. That is, when an SpO2
limit is exceeded, you will need to acknowledge it at the Information
Center. The sound will be silenced but the message will remain on the
display until the condition is resolved.
Warning
Caution
Note — The MP5T and MP5SC are non-networked devices as they does not
support a connection to the Information Center.
Assigning Devices
Device Assignment at the Information Center
You can assign an MX40 to a patient monitor at the Information Center. The
data from the MX40 automatically displays as a permanent overview
session in the Telemetry Data window on the patient monitor.
At the Information Center the MX40 data and the patient monitor data are
integrated in the patient sector.
Warning
All data presented in the Telemetry Data window are delayed for several
seconds. If you need realtime data, e.g. for defibrillation, always use the
ECG from the patient monitor.
When assigned to the monitor, the display of the MX40 appears as shown
below:
When the devices are networked, all data is sent to the Information Center.
When non-networked, only the additional parameters measured at the
patient monitor (NBP, SpO2, and predictive temperature) are sent to the
Information Center. The Telemetry Data window is not displayed when
devices are non-networked.
NBP
NBP
Warning
To Select Lead
1 Move the cursor over the ECG waveform to display the Lead Selection
control.
2 Select the desired lead from the list.
Important — Do not set the primary and secondary channels to the same
lead.
Warning
To Select Lead
1 Click the appropriate waveform.
2 Select the desired lead label from the list.
Important — Do not set the primary and secondary channels to the same
lead.
You can view the location history for a particular MX40 in the Device
Location History field in the Telemetry Setup window. The field displays
the five most recent Device Location descriptions in ascending order. The
total timespan of the log is 60 minutes.
You can view the location history for a particular MX40 by clicking on the
compass icon in the Patient Window. The location and time-stamped
history is displayed for each equipment label.
Warning
Note — The IntelliVue Device Location feature is not supported for use
with the MX40 WLAN device, Part Number 865352.
Warning
Note — The beds listed are only those equipped with traditional IntelliVue
telemetry devices or the MX40.
To identify and locate the device associated with the bed, simply click on
the desired bed label. The floor plan and the status bar above the floor plan
image now display the location of the device. Additionally, the status bar
lists the Access Point the device is currently associated with.
SpO2 Mode Determine the MX40 Spot Check (Manual)- Provides Spot Check
SpO2 measurement manual measurements so the (Manual)
behavior. clinician can check as needed.
Measurement can be initiated at the
Note — Pulse Rate MX40 from the SmartKeys menu or
and Pleth Wave are not the SpO2 Setup menu and at the
available in Spot Check Information Center by selecting the
(Manual) mode. Spot Check SpO2 icon in the Patient
Window.
Continuous - Sends an SpO2
parameter value to the Information
Center every second. If selected,
Pulse Rate and Pleth Wave may also
be sent.
Warning
If you measure SpO2
on a limb that has an
inflated NBP cuff, a
non-pulsatile SpO2
technical alarm can
occur. If the monitor is
configured to suppress
this alarm, there can be
a delay of up to 60
seconds in indicating
critical patient status,
such as sudden pulse
loss or hypoxia.
Access to unit settings requires a password, and the displays are in English.
Telemetry specific settings are accessed through All Controls -> Unit
Settings -> Telemetry Setup. The setting for telemetry non-arrhythmia
yellow alarms and INOP severity is located in All Controls -> Unit Settings
-> Alarms. For all other information on unit settings, see IntelliVue
Information Center Instructions for Use.
Telemetry/ Determine the Information Nurse Call - generate nurse Nurse Call
Multi-Function Center response when call alarm that can be
Telemetry Button is retrieved from Alarm Review
Button pressed. for later use.
Record - generate a recording
strip
Both - generate nurse call
alarm and recording strip
None
Warning
If you measure SpO2 on a
limb that has an inflated
NBP cuff, a non-pulsatile
SpO2 technical alarm can
occur. If the monitor is
configured to suppress
this alarm, there can be a
delay of up to 60 seconds
in indicating critical
patient status, such as
sudden hypoxia.
5-wire, Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, II
ECG1 V
5-wire, Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V
ECG2 V
5-wire, Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, III
ECG3 V
5-wire EASI, Set the unit default lead. I, II, III, AVR, AVL, AVF, V1, II
ECG1 V2, V3, V4, V5, V6
5-wire EASI, Set the unit default lead. I, II, III, AVR, AVL, AVF, V1, V2
ECG2 V2, V3, V4, V5, V6
5-wire EASI, Set the unit default lead. I, II, III, AVR, AVL, AVF, V1, III
ECG3 V2, V3, V4, V5, V6
5-wire EASI, Set the unit default lead. I, II, III, AVR, AVL, AVF, V1, V5
ECG4 V2, V3, V4, V5, V6
6-wire, Va Set the unit default lead V1, V2, V3, V4, V5, ,V6, V7, V8, V2
V9, V3R, V4R, V5R
6-wire, Vb Set the unit default lead V1, V2, V3, V4, V5, V6, V7, V8, V5
V9, V3R, V4R, V5R
6-wire, Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, II
ECG1 V1, V2, V3, V4, V5, V6, V7, V8,
V9, V3R, V4R, V5R
6-wire, Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V2; V lead
ECG2 V1, V2, V3, V4, V5, V6, V7, V8, choice is
V9, V3R, V4R, V5R determined
by Va and Vb
settings
6-wire, Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, III
ECG3 V1, V2, V3, V4, V5, V6, V7, V8,
V9, V3R, V4R, V5R
6-wire, Set the unit default lead. I, II, III, MCL, AVR, AVL, AVF, V5; V lead
ECG4 V1, V2, V3, V4, V5, V6, V7, V8, choice is
V9, V3R, V4R, V5R determined
by Va and Vb
settings
Diastolic
Mean
Off
Mean High Increment/decrement NBP high Limit Maximum is 260 110 Adult
alarm limit by 5. Limit Minimum is 10 90 Pediatric
Alarm Management
Control Function Setting Choices Factory
Default
Alarms Off Priority Sets the types of alarms that can Red and Yellow Yellow Only
be paused for a configured Yellow Only (red alarms must be
amount of time from the IIC iX.. paused at the device)
Not Allowed
Alarms Off Sets the amount of time all alarms 1, 2, or 3 minutes. 2 min
will be paused if selected.
Audible Latching Sets which alarms must be Red and Yellow Red&Yellow
silenced even if the condition no Red Only
longer exists (applies to
non-arrhythmia alarms only).
No Data Inop Sets the severity of the NO DATA Hard (always for MX40) Hard
FROM MONITOR inop. Soft
ECG Leads Off Sets the severity for the ECG Cyan Cyan
LEADS OFF Inop Yellow
Red
Telemetry Setup
Control Function Setting Choices Factory
Default
Telemetry Button Determines the action when the Nurse Call - generates nurse call Nurse Call
Telemetry Button is pressed. alarm that is marked as an event
in Alarm Review.
Record - generates an automatic
recording.
Call & Record - Creates both the
nurse call alarm and automatically
starts a recording.
Off
SRR Use Model Selects whether the device will Look for Sensor Look for
assing to patient monitor or Look for Monitor Monitor
cableless measurement device.
Default Screen Sets the default display screen. 2 Waves P (portrait) 2 Waves P
1 Wave P (portrait)
2 Waves L (landscape)
Chest Diagram
Wave 1-4 Selects the waveforms that will be ECG Wave 1 and
sent and stored. Wave 1 and Pleth Wave 2 will
Wave 2 will always be Primary always be
and Secondary Lead respectively. Resp Primary and
Secondary
Lead
respectively.
ECG
ECG Management
Control Function Settings Factory
Default
Primary Lead Sets which lead will default to the 1, II, III, aVR, aVF, aVL, V1-6, II
Primary Lead for ECG analysis. V7-9, V3R - V5R
Secondary Lead Sets which lead will default to the 1, II, III, aVR, aVF, aVL, V1-6, V2
Secondary Lead for ECG Multi V7-9, V3R - V5R
Analysis.
Hexad (Va, Vb) Sets the lead pairs for derived Off Off
12-lead ECG. V1, V3
V1, V4
V1, V5
V2, V4
V2, V5
V3, V5
V3, V6
Display
An MX40 operating with either Release L or M of the Information Center
has two screens showing either one measurement waveform and four
numeric parameter values or the ECG lead placement chest diagram along
with two numeric parameter values, depending on configuration.
Alarms
An MX40 operating with Release L or M of the Information Center does not
have physiological alarm capability locally at the device (networked or
non-networked). A No Alarm Display message is present along with the
Alarms Paused icon.
Cautions
Technical alarms (INOPs) are communicated and can be silenced using the
Alarm Silence button.
Note — Not all rechargeable battery technical alarms are communicated via
the Alert Data Integration paging system. The following alarms are not
communicated:
Trends 13-1
Viewing Vital Trend Information
13-2 Trends
14. Maintenance
This section provides procedures for maintaining the MX40 after
installation, including equipment label assignment, cleaning and battery
care.
Maintenance 14-1
Cleaning
Cleaning
The procedure in this section keeps the MX40 and its accompanying patient
cable clean and provides protection against infectious agents and
bloodborne pathogens. Both the outside and the inside of the MX40 battery
compartment and the patient cable must be kept free of dirt, dust, and
debris.
Important — After exposure, the MX40 and the patient cable must be
cleaned as per the instructions contained herein. Sterilization of the MX40
has been qualified using the STERRAD 100NX System. For more
information and instruction on sterilizing the MX40, contact your service
personnel. The alternative Steris V-pro process using hydrogen peroxide
vapor is also acceptable.
14-2 Maintenance
Cleaning
Approved Cleaners
Cleaner Active Ingredient
Isopropyl Alcohol based Isopropyl Alcohol (>70%)
Maintenance 14-3
Cleaning
Note —The cleaners listed above are also suitable for cleaning the patient
cable and the lithium-ion battery.
14-4 Maintenance
Disposing of the MX40
You will find detailed disposal information on the following web page:
http://www.healthcare.philips.com/main/about/Sustainability/Recycling/p
m.wpd
Maintenance 14-5
Label Assignment for Replacement MX40
14-6 Maintenance
Label Assignment for Replacement MX40
Maintenance 14-7
Charging Lithium-ion Rechargeable Batteries
To charge a battery, place it onto a charger slot on the charging station. 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 power supply to fit an ungrounded AC
mains socket.
Do not use AC mains extension cords or multiple socket outlets. If a
multiple portable socket outlet without an approved isolation
transformer is used, the interruption of its protective grounding may
result in 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 the system.
14-8 Maintenance
Charging Lithium-ion Rechargeable Batteries
Status LED
no battery on charger slot off
The age of a li-ion battery begins at the date of manufacture. The date of
manufacture is listed on the side of the battery.
Maintenance 14-9
Charging Lithium-ion Rechargeable Batteries
Battery Disposal
Discharge the battery and insulate the terminals with tape before disposal.
Dispose of used batteries promptly and in accordance with local recycling
regulations.
14-10 Maintenance
15. Safety Standards &
Specifications
This section describes the regulatory standards that the IntelliVue MX40
complies with, along with product and measurement specifications.
Regulatory Information
Software Hazard Prevention
Potential hazards arising from errors in the software program have been
identified. Mitigations applied to reduce the associated risk of such hazards
are included as part of the Risk Management, Clinical Evaluation, and
Verification and Validation phases of the product’s development.
AC Power Source
The system is not intended for connection to the public mains as defined in
CISPR-11.
Safety Standards
The device complies with the following safety requirements for medical
electrical equipment:
Authorized EU Representative
Philips Medizin Systeme Deutschland
Hewlett-Packard-Strasse 2
D 71034, Boeblingen
Germany
Patient Population
This device is not for use with infant or neonatal patients.
The components/accessories which come into contact with the patient’s skin
are in compliance with the relevant requirements of EN ISO 10993-1 for
Biocompatibility. The device is not designed for direct contact with the
patient’s skin. The accompanying pouch is the appropriate means for
holding the device.
Rx
Federal Law restricts this device to sale by or on the order of a physician.
Essential Performance
The IntelliVue MX40 provides Essential Performance (EP) under normal
operating conditions (includes EMC exposure) only as a complete Medical
Electrical System, consisting of the MX40, MPx companion monitor
(Optional), IntelliVue CL SpO2 and NBP Cableless Measurement
devices(Optional), IntelliVue Telemetry Network Infrastructure, and the
Information Center.
Dropouts
Because the MX40 operates exclusively via a wireless network connection,
under certain frequency conditions dropouts can occur. Dropouts result
from a weak signal or RF interference, and appear on the waveform when
the signal "drops" to the bottom of the channel for a minimum of 200 ms. If
dropouts are frequent enough to affect the heart rate count, the "Cannot
Analyze ECG" or "Cannot Analyze ST" technical alarm occurs. If there are
enough dropouts to cause disassociation/reassociation with the Information
Center, events in the Clinical Review application can reflect loss of data for
up to 1 minute in the worst case.
Monitoring Considerations
Patient should be restricted to the designated coverage area. Monitoring
performance will degrade if patients go outside the radius of coverage
of the receiving wireless network.
A patient location strategy is critical to a telemetry system. If a
life-threatening event occurs, the clinician must be able to locate the
patient quickly. The importance of this increases as the coverage area
increases.
Frequency management is the responsibility of the hospital. Philips
Healthcare has no control over the RF environment in the hospital. If
interference exists at the operating frequencies of the telemetry
equipment, telemetry performance will be affected. Careful selection of
frequencies for all wireless devices used within a facility (transceivers,
other wireless medical devices, etc.) is important to prevent interference
between them.
Caution
IEC/ANSI/AAMI 80001-1:2010
Philips recognizes the importance of a safe and effective network that meets
both the business needs of a healthcare facility, IT networking
requirements, and the clinical functionality. Philips supports the IEC
80001-1 standard in regards to working as a partner with a healthcare
organization in the design, implementation, and management of the
Medical IT-Network to properly provision and support not only Philips
devices, but all the devices using the network. Applying the principles of
risk management to hospital frameworks is highly encouraged.
Electromagnetic Compatibility
Medical electrical equipment can either generate or receive electromagnetic
interference. This product has been evaluated for electromagnetic
compatibility (EMC) with the appropriate accessories according to IEC
60601-1-2:2001, the international standard for EMC for medical electrical
equipment. This IEC standard has been adopted in the European Union as
the European Norm, EN 60601-1-2:2001.
Warnings
The use of accessories, transducers and cables other than those specified
in the product service and user documentation can result in increased
electromagnetic emissions or decreased immunity of the product.
Short-range radio connections are subject to interruption due to
interference from other radio sources in the vicinity, including
microwaves, bluetooth devices, and DECT phones. Outside the
frequency band and 5% above and below, i.e. the exclusion band
according to IEC 60601-1-2, the short-range radio connection is immune
up to 3V/m in the frequency range from 80MHz to 2.5 GHz. Depending
on the strength and duration of the interference, the interruption may
occur for an extended period. Any interruption of the signal due to
interference, moving out of range, or for other reasons is indicated with
a Tele Disconnected INOP message.
The product should not be used next to or stacked with other
equipment. If you must stack the product, you must check that normal
operation is possible in the necessary configuration before the product
is used on patients.
Warning
Electromagnetic Emissions
Emissions Test Compliance Avoiding Electromagnetic
Interference
Radio Frequency (RF) Group 1 TheMX40 uses RF energy only for its
emissions internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
Electromagnetic Immunity
The MX40 is suitable for use in the specified electromagnetic environment.
The user must ensure that it is used in the appropriate environment as
described below.
symbol:
Field strengths from fixed transmitters, such as base stations for radio
(cellular, cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the monitor is used
exceeds the applicable RF compliance level above, the MX40 should be
observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the
monitor.
Frequency of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Transmitter
Equation d = 1.2√P d = 1.2√P d = 2.3√P
Electrosurgery Interference/Defibrillation/Electrostatic
Discharge
The equipment returns to the previous operating mode within 10 seconds
without loss of any stored data. Measurement accuracy may be temporarily
decreased while performing defibrillation. This does not affect patient or
equipment safety. Do not expose the equipment to x-ray or strong magnetic
fields (MRI). The MX40 is not for use during electrosurgery.
Restart Time
After power interruption, an ECG wave will be shown on the display after
30 seconds maximum.
Battery Specifications
Battery Life
The battery life specifications listed below are based on the use of three
Duracell MN 1500 batteries. Battery life for other brands may differ.
Battery Life
Telemetry Mode Battery Life
(1.4GHz
Networked (2.4GHz
p/n 865350)
(Display Off) p/n 865351)
The battery life specifications listed below are based on the use of the
Philips Rechargeable Lithium-ion battery.
ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will
range between the ECG Only battery life and the ECG/SpO2
Continuous battery life.
ECG/SpO2 Manual In this mode battery life is dependent on the usage rate and will
range between the ECG Only battery life and the ECG/SpO2
Continuous battery life.
Note — Use of the short-range radio can reduce battery life by 25%.
Nominal Current
Nominal Current Nominal Current Nominal Current
Operating Mode
(p/n 865350) (p/n 865351) (p/n 865352)
ECG Only (Display 67 mA @ 3.6V 67 mA @ 3.6V 70 mA @ 3.6V
inactive)
Physical Specifications
Parameter Specification
Height 126.8 mm (4.99 in)
Weight
Without batteries, includes 1.4 GHz - 240 g (8.5 oz)
SpO2 and short-range radio 2.4 GHz - 215 g (7.6 oz)
WLAN - 206 g (7.3 oz)
Out of Band Spurious <-41 dBm in 1 MHz bandwidth for FCC limit
Emission Levels:
<= 1394 MHz, >= 1401
MHz
<= 1428 MHz, >= 1433
MHz
This device complies with Part 15 of the FCC Rules. Operation is subject to
the condition that this device does not cause harmful interference.
Operation of this equipment requires the prior coordination with a
frequency coordinator designated by the FCC for the Wireless Medical
Telemetry Service.
FCC and Industry Canada Radio Compliance: This device complies with
Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is
subject to the following two conditions: (1) this device may not cause
harmful interference, and (2) this device 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 radio frequency interference
and void your authority to operate this equipment.
The radio device used in this product is in compliance with the essential
requirements and other relevant provisions of Directive 1999/5/EC (Radio
Equipment and Telecommunications Terminal Equipment Directive). Class
2 radio equipment. Member states may apply restrictions on putting this
device into service or placing it on the market. This product is intended to
be connected to the Publicly Available Interfaces (PAI) and used
throughout the EEA.
This ISM device complies with Canadian ICES-001. Cet appareil ISM est
conforme a la norme NMB-001 du Canada.
RF Output Power -1.5 to -4.5 dBm +2/-3dB (0.7 mW to 0.3 mW), into
Antenna load.
Note — For the MX40 WLAN device, Part Number 865352, use of the
MX40's short-range Radio is only supported when operating with 802.11a
(5.6GHz band).
802.11g
Out of Band Emissions (802.11 Meets ETSI, RS210, FCC, ARIB, AU/NZ
b/g) standards
802.11a
Caution
High power radars are allocated as primary users of 5250-5350 MHz and
5650-5850 MHz. These radars could cause interference and/or damage to
LE-LAN devices.
Environmental Specifications
Parameter Specification
Temperature
Humidity
Altitude
Measurement Specifications
ECG
Parameter Specification
5 electrodes Channel #1 = II
Channel #2 = III
Channel #3 = MCL
Resolution 5 V
Time to baseline recovery AAMI: 5 s max (until ECG wave is on display but
from Defibrillator not yet centered, monitoring bandwidth)
Parameter Specification
1
Pacer Rejection Positive pacers
Performance
Amplitude Width
(Pace pulses with no
+2 to +700 mV 0.1, 0.2, 0.5 and 1.0 ms
tails).
+2 to +500 mV 1.5 ms
+2 to +400 mV 2 ms
1
Negative pacers
Amplitude Width
-2 to -700 mV 0.1, 0.2, 0.5 and 1.0 ms
-2 to -500 mV 1.5 ms
-2 to -400 mV 2 ms
1
Philips does not claim, verify, or validate support
for all available pacemakers.
ECG Patient Cable All ECG connections are patient safe within 750
Disconnection Safety msec of patient cable removal, with patient leakage
current <10 Exception: Leadset detection pins
are protected mechanically to prevent patient
contact.
Heart Rate Meter Accuracy and Response Provides correct heart rates (80, 60, 120, 90 b/min) using
to Irregular Rhythm test waveforms as indicated in ANSI/AAMI EC13
Sec. 4. 1. 2. 1 (e).
Response Time of Heart Rate Meter to For a rate increase, the average time to reach the specified
Change in Heart Rate heart rate using test waveforms as indicated in ANSI/AAMI
EC13 Sec. 4. 1. 2. 1 (f) is 10 seconds. For a rate drop, the
average time is 7 seconds.
Pacemaker Pulse Rejection Capability Rejects pace pulses using test waveforms as indicated in
ANSI/AAMI EC13 Sec. 4. 1. 4.1 (with amplitude from +/- 2
to +/- 700 mV, width from 0.1 to 2.0 ms).
Range and Accuracy of Heart Rate Meter Meets the ANSI/AAMI EC13 Section 4.2.7 recommended
minimum range and accuracy.
Heart rate range is 15 - 300 b/min for adults patients and
15-350 b/min for pediatric patients with accuracy of 1% of
the range. (Note: for rates equal to or less than 15, the
displayed heart rate is 0).
Alarm Limit Range Meets the ANSI/AAMI EC13 Section 4.2.8.1 standard.
Lower alarm limit is 15 -295. Upper alarm limit is 20 - 300.
Resolution of Alarm Limit Settings Meets the ANSI/AAMI EC13 Section 4.2.8.2 standard. The
resolution is 5 b/min.
Alarm Limit Accuracy Meets the ANSI/AAMI EC13 Section 4.2.8.3 standard.
Error less than ± 10% or ± 5b/min
Time to Alarm for Cardiac Standstill Meets the ANSI/AAMI EC13 Section 4.2.8.4 standard:
maximum alarm time <10 seconds, using the test
waveforms as indicated.
Time to Alarm for Low Heart Rate Meets the ANSI/AAMI EC13 Section 4.2.8.5 standard:
maximum alarm time <10 seconds, using the test
waveforms as indicated.
Time to Alarm for High Heart Rate Meets the ANSI/AAMI EC13 Section 4.2.8.6 standard:
maximum alarm time <10 seconds, using the test
waveforms as indicated.
ECG Waveform Display Time Base Meets the ANSI/AAMI EC13 Section 4.2.9.6 standard:
Accuracy maximum error = +/-10%.
Aspect Ratio Meets the ANSI/AAMI EC13 Section 4.2.9.7(f) standard: 0.4
+ 0.08 s/mV.
Input Signal Reproduction Accuracy: Meets the ANSI/AAMI EC13 Section 4.2.9.8(a) standard:
Overall Error maximum = +/- 20%.
Frequency Response: Sinusoidal Meets the ANSI/AAMI EC13 Section 4.2.9.8(b) standard:
0.67 to 40 Hz
(3 db down).
Pacemaker Pulse Display Capability Meets the ANSI/AAMI EC13 Section 4.2.9. 12 standard:
minimum = 0.2 mV RTI.
Respiration
Parameter Specification
Leads Used for Measurement RA, LL (standard) or I, A (EASI)
Auxiliary Current, Respiration Excitation < 470 uA rms @48KHz, sinusoidal waveform
Signal
Respiration Alarm
Alarm Range Delay
High Adult/Pediatric: 10 to 100 rpm ≤ 15 seconds
FAST SpO2
Parameter Specification
SpO2 Measurement 0 to 100%
Range (Calibration and
Display)
SpO2 Resolution 1%
Technical Alarms Triggered if the sensor is disconnected, if a pulse is not detected, if the signal
(INOPs) is noisy, if light interference is detected, if the sensor is defective, if the
measurement is erratic, or if the module is malfunctioning
Parameter Specification
Display of SpO2 SpO2 values are displayed as xxx % SpO2 to meet ISO 9919.
numerics
Warning
Accessories A-1
MX40 Accessories
Pouches
Order Number Description
989803174141 Carry Pouch, Waterproof, box of 50
Miscellaneous
Order Number Description
989803176501 Protective caps, adapter cable, MX40
A-2 Accessories
ECG Accessories
Electrodes
Order Number Description
M4612A Solid gel ECG electrode disp. 5/pouch
300/case
Accessories A-3
Order Number Description
989803171861 ECG 6 lead grabber AAMI .85m (35")
All above leadsets require the MX40 to IntelliVue Adapter Cable, p/n 989803172211
and the use of the 3 lead and 5 lead Detachable Shield when showering.
A-4 Accessories
SpO2 Accessories
Philips/Nellcor Disposable Sensors
Order Number Description
989803105481 (A) M1904B Adult Finger, >30 kg
Require M1943A/AL cable to connect to MX40. Sold in packages of 24. (A) Only
available from Philips in Europe and (B) Only available from Philips in Japan.
Accessories A-5
Order Number Description
All sold as one piece each.
A - Sensors plug directly into MX40.
B - Supports use of M1941A extension cable.
C - Not for use with M1941A extension cable.
D - Requires M1943A/AL adapter cable.
Adapter Cables
Order Number Description
989803105691 M1943A Adapter Cable, 1. m
A-6 Accessories
B. Default Settings
This section documents the most important default settings of your MX40
as it is delivered from the factory. For a comprehensive list and explanation
of default settings, see the IntelliVue Information Center Release N
Configuration Guide. The MX40's configuration settings can be changed
permanently in Configuration Mode.
QRS Volume 0
Tone Modulation On
ECG On
Primary Lead II
Arrhythmia On
VTach Run 5
Vent Rhythm 14
SVT Run 5
PVCs/min 10 5
Non-Sustained VT On
Run PVCs On
Pair PVCs On
R-On-T PVCs On
V.Bigeminy On
V.Trigeminy On
PVCs/min On
Multif. PVCs On
Pacer N. Cap On
Pacer N. Pac On
Pause On
Missed Beat On
SVT On
Afib On
Irregular HR On
On the web
www.healthcare.philips.com
Via email
[email protected]
By fax
+31 40 27 64 887
By postal service
Philips Healthcare
Global Information Center
P.O. Box 1168
5602 BD Eindhoven
The Netherlands
Asia
Tel: +842 2821 5888
Latin America
Tel: +55 11 2125 0764
North America
Tel: +1 800 229 6417
Accessories I
ECG • A-3 Initiating Arrhythmia Relearning Manually
MX40 • A-2 • 6-35
SpO2 • A-5 IntelliVue Information Center • 11-1
Alarms • 5-1 L
Pausing • 5-6 Label Assignment • 14-6
Physiologic • 5-10 Lock • 4-6
Reviewing • 5-8
Technical • 5-14 M
Arrhythmia Beat Labels • 6-36 Main Screen Button • 4-4
Multi Function Button • 4-3
B
Battery • 4-14 P
Paced Status • 4-6
Charge Status • 4-19
Patient Configurable Settings in Telemetry
Safety • 4-14
Setup (IIC) • 4-28
C Patient Information Area • 4-5
Cableless Measurements • 10-1 Pouch Use • 4-22
Charging Lithium-ion Rechargeable Pulse • 7-1
Batteries • 4-15
Q
Cleaning • 14-2
QT • 6-42
Materials • 14-2
R
Connecting and Positioning ECG Electrodes
• 8-4 RF Auto Shutoff • 11-13
RF Interference • 15-9
D Risk Management Considerations • 6-6
Default Settings • B-1
S
alarms • B-2 Silence Alarms Button • 4-3
ecg, arrhythmia, ST and QT • B-3 SmartKeys • 4-4
E
SmartKeys Button • 4-3
ECG • 6-5
SpO2 • 9-9
Accessories • A-3
Safety • 9-2
Fallback • 6-25
Sensor Type • 9-6
Relearn • 6-25
Safety • 6-2
Index 1
Status Area • 4-7
Symbols • 3-5
T
Telemetry Setup • 11-10
2 Index
Part Number 4535 643 15721
Printed in USA February 2012
First Edition