Philips IntelliVue MX User manual

IntelliVue MX40

Installation and Service

Notice

Proprietary Information

This document contains proprietary information, which is protected by
copyright.

Copyright

Copyright © 2011 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.

OxiCliq ® and OxiMax ® are registered trademarks of Nellcor Incorporated.

Duracell ® is a registered trademark of Procter & Gamble Incorporated.

STERRAD ® is a registered trademark of Advanced Sterilization Products.

GORE-TEX ® is a registered trademark of W.L. Gore & Assoc. Incorporated

Tone modulation is licensed under US patent 4,653,498 from Nellcor Puritan
Bennett Incorporated.

Manufacturer

Philips Medical Systems
3000 Minuteman Road
Andover, MA 01810-1099

[phone]

Printed in USA

Document number

4535 642 81301

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.

ii

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.

Changes and modifications not expressly approved by Philips Medical
Systems can void your authority to operate this equipment under Federal
Communications Commission's rules

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.

First Edition June 2011

Document Conventions

In this guide:

Warnings

Warning

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

iii

Cautions

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.

iv

Contents

1. Introduction 1-1

2. Installation 2-1

MX40 Compatibility -------------------------------------------------------------------- 2-2
Label Assignment for MX40 --------------------------------------------------------- 2-3
Equipment Label Character Limitations ------------------------------------------ 2-4
Assigning an Equipment Label ----------------------------------------------------- 2-5
Frequency Management and Channel Selection ------------------------------ 2-6

1.4GHz Smart-hopping Channel Definition --------------------------------- 2-8

Short-Range Radio Channel Selection for 1.4GHz Smart-hopping
Systems ---------------------------------------------------------------------------------- 2-10

Channel Comparison - Short-Range Radio and 802.11b,g Channels2-11
SRR Channel Selection for 1.4GHz Installations ------------------------- 2-11
Smart-hopping and SRR Channel Selection for 2.4GHz
Smart-hopping Systems -------------------------------------------------------- 2-12
Channel Comparison - Short-Range Radio and 802.11b -------------- 2-13

802.11 Channel 1,6,11 Deployment ----------------------------------------- 2-14

802.11 Channel 1,4,7,11 Deployment --------------------------------------- 2-15

802.11 Channel 1,4,8,11 Deployment --------------------------------------- 2-15

802.11 Channel 1,7,13 Deployment ----------------------------------------- 2-16

802.11 Channel 1,5,9,13 Deployment --------------------------------------- 2-17

802.11 Channel 2,7,12 Deployment ----------------------------------------- 2-18

802.11 Channel 1,6,11,14 Deployment ------------------------------------- 2-19

802.11 Channel 3,10,14 Deployment --------------------------------------- 2-19
Short-Range Radio Density ---------------------------------------------------- 2-20

3. Test and Inspection 3-1

MX40 Test & Inspection Matrix ----------------------------------------------------- 3-2

4. Operating Modes 4-1

Monitoring Mode ------------------------------------------------------------------------ 4-2

Controls, Indicators and Connectors ----------------------------------------- 4-2
Operating and Navigating ------------------------------------------------------- 4-7
Understanding Settings --------------------------------------------------------- 4-10
Battery Information --------------------------------------------------------------- 4-12
Inserting Batteries ---------------------------------------------------------------- 4-15
Removing the Batteries --------------------------------------------------------- 4-17
Service Information Availabe in Monitoring Mode ------------------------ 4-20

Configuration Mode ------------------------------------------------------------------- 4-22

Clinical Configuration ------------------------------------------------------------ 4-22

Service Mode --------------------------------------------------------------------------- 4-24

Setup Network --------------------------------------------------------------------- 4-24
Revisions ---------------------------------------------------------------------------- 4-24

Contents - 1

Demo Mode ---------------------------------------------------------------------------- 4-25

5. Maintenance 5-1

Cleaning ----------------------------------------------------------------------------------- 5-2

Cleaning Materials for the MX40 ----------------------------------------------- 5-2

Disposing of the MX40 ---------------------------------------------------------------- 5-4
Label Assignment for Replacement MX40 --------------------------------------- 5-5

Re-assigning an Equipment Label -------------------------------------------- 5-5

Charging Lithium-ion Rechargeable Batteries ---------------------------------- 5-7

Battery Power Indicators --------------------------------------------------------- 5-7
Battery Lifetime Management -------------------------------------------------- 5-8
Battery Disposal -------------------------------------------------------------------- 5-9

6. Part and Option Ordering Information 6-1

MX40 Product Structure -------------------------------------------------------------- 6-2
MX40 Support Parts ------------------------------------------------------------------- 6-5

7. MX40 Repair Strategy 7-1

Tools Required -------------------------------------------------------------------------- 7-2
Software License Transfer ----------------------------------------------------------- 7-3

8. Troubleshooting 8-1

Technical Alarms (INOPs) ----------------------------------------------------------- 8-2
Possible User Interface Issues ---------------------------------------------------- 8-10

9. Safety Standards & Specifications 9-1

Regulatory Information ---------------------------------------------------------------- 9-2

Software Hazard Prevention ---------------------------------------------------- 9-2
AC Power Source ------------------------------------------------------------------ 9-2
Industrie Canada Compliance (Canada) ------------------------------------- 9-2
Safety Standards ------------------------------------------------------------------- 9-2
Intended Use Statement --------------------------------------------------------- 9-3
Indications for Use ----------------------------------------------------------------- 9-3
Intended Uses of MX40 ---------------------------------------------------------- 9-4
Authorized EU Representative ------------------------------------------------- 9-4
Patient Population ----------------------------------------------------------------- 9-4
Rx -------------------------------------------------------------------------------------- 9-4
Essential Performance ----------------------------------------------------------- 9-5

Electromagnetic Compatibility ------------------------------------------------------- 9-6

Reducing Electromagnetic Interference -------------------------------------- 9-7
Restrictions for Use---------------------------------------------------------------- 9-7
Electromagnetic Compatibility (EMC) Specifications --------------------- 9-7
Electromagnetic Emissions ------------------------------------------------------ 9-8
Electromagnetic Immunity ------------------------------------------------------- 9-9
Recommended Separation Distance ----------------------------------------- 9-9

Battery Specifications --------------------------------------------------------------- 9-12
Lithium-ion Battery Charge Time ------------------------------------------------- 9-15

Contents - 2

Physical Specifications--------------------------------------------------------------- 9-16
MX40 1.4 GHz Radio ----------------------------------------------------------------- 9-17
MX40 2.4 GHz Radio ----------------------------------------------------------------- 9-18
MX40 Short-Range Radio ----------------------------------------------------------- 9-20
Environmental Specifications ------------------------------------------------------ 9-21
Measurement Specifications ------------------------------------------------------- 9-22

ECG ---------------------------------------------------------------------------------- 9-22
ECG Performance Disclosure/Specifications------------------------------ 9-23
FAST SpO2 ------------------------------------------------------------------------- 9-25
SpO2 Sensor Accuracy ---------------------------------------------------------- 9-27

Contents - 3

Contents - 4

1. Introduction

The MX40 is compatible with the Philips Smart-hopping wireless network
which is designed for use in ambulatory care areas of hospitals,
rehabilitation facilities, and cardiac care centers.

The Smart-hopping wireless network provides ambulatory and bedside
monitoring of ECG, SpO2 and NBP. The network encompasses a number of
individual units which connect to form a complete method of transporting
patient data to a central repository for subsequent distribution to clinical
staff.

The Smart-hopping wireless network is comprised of the following devices
and components:

Introduction 1-1

1-2 Introduction

MX40 Compatibility .................................................................................. 2-2

Label Assignment for MX40 .................................................................... 2-3

Equipment Label Character Limitations ................................................ 2-4

Assigning an Equipment Label ............................................................... 2-5

Frequency Management and Channel Selection ................................... 2-6

Short-Range Radio Channel Selection for 1.4GHz Smart-hopping

Systems ..................................................................................................... 2-10

2. Installation

This section provides compatibility and configuration information for
reference during MX40 installation.

Installation 2-1

MX40 Compatibility

The MX40 is compatible for use with IntelliVue Information Center Release
N. Limited compatibility is offered when used with IntelliVue Information
Center Release L or M. See the "Operating with Release L or M" chapter for
more information.

The MX40 is compatible for use with IntelliVue Patient Monitors Release G
or later when wirelessly connected.

The MX40 is compatible for use with IntelliVue Cableless Measurements
Release A.1.

The MX40 is compatible for use with Access Point Controller 862147,
Release B.00.19 and Access Point Controller 865346, Release C.00.XX.

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.

2-2 Installation

Label Assignment for MX40

When the MX40 is shipped from the factory, it is shipped with an
Equipment Label of "NEW_DEVICE" and an RF Access Code of "0". This
allows connection to any Smart-hopping Access Point.

After the MX40 has connected to the wireless network, the device gets the
RF Access Code and Equipment Label configuration through the "Label
Assignment" function at the Information Center. The Label Assignment
function is password protected. The password is "tele".

Installation 2-3

Equipment Label Character Limitations

Equipment labels are limited to a maximum of 10 bytes. If the equipment
label exceeds the 10 byte maximum, the label assignment process will fail.

UTF-8 encoded characters may use 1-4 bytes depending on the

language. (http://en.wikipedia.org/wiki/UTF-8)

The first 128 Unicode characters (which corresponds directly to the

ASCII character set) take only 1 byte.

Example: Tele1 (English) is 5 bytes long.

If you use special characters, more bytes are required.

Refer to the table below for character limit information:

2-4 Installation

Assigning an Equipment Label

 To assign an equipment label to a device:

1 Select All Controls -> Label Assignment.
2 Enter password (tele)
3 Insert battery power into the MX40 and if attached, disconnect the

patient cable.

4 Select Refresh.
5 Confirm the connection to the wireless network as follows:

6 Select the MAC address of the replacement device from the New

Devices list. If the address does not appear, remove battery power and
re-insert. Select Refresh.

Note — The MAC address appears on the rear label of the MX40.

7 Select the desired equipment label from the Equipment Label list.
8 Select Assign Label to initiate programming of the equipment label

and RF Access Code into the MX40.

9 When prompted, press Confirm on the MX40 to accept the assignment.

The confirmation must occur within 30 seconds of the prompt.

10 On the MX40, wait for the New_Device label to change to the selected

equipment label.

11 Confirm the label assignment by viewing the waveform in the Patient

Sector at the Information Center.

Installation 2-5

Frequency Management and Channel Selection

Management of the RF environment in a facility is important to the overall
performance of any wireless system. Philips Medical Systems cannot
control what wireless devices are used in a healthcare facility, but we will
work with you to select the best frequencies to use in order to avoid
interference with other wireless devices used within the hospital.

Frequency Management

Frequency management is the selection of frequencies for wireless devices
within a facility to prevent interference between devices.

Frequency Management Responsibility

Frequency management is the responsibility of the hospital. Philips
Medical Systems has no control over the RF environment in a hospital. If
interference exists at the operating frequencies, system performance will be
affected. Careful selection of frequencies for all wireless devices used
within a facility is important to prevent interference between them.

Channel Selection

The MX40 has two radios – the Smart-hopping radio and the Short Range
Radio (optional). Channel selection for the two radios is different for a 1.4
GHz Smart-hopping system versus a 2.4 GHz Smart-hopping system.
Therefore they will be discussed separately.

Channel Selection for 1.4 GHz Smart-hopping Systems

The 1.4 GHz MX40 operates in the FCC-allocated, protected Wireless
Medical Telemetry Service (WMTS) in the 1395-1400 and 1427-1432 MHz
bands. Operation of this equipment requires the prior coordination with a
frequency coordinator designated by the FCC for the Wireless Medical
Telemetry Service.

The Smart-hopping channels that can be used will be determined by this
coordination process. A minimum of three Smart-hopping channels is
required for proper operation of the system, but using more channels will
improve performance. Smart-hopping channels are configured in the
Access Point Controller.

Frequency Coordination (WMTS only)

2-6 Installation

Operation of this equipment requires the prior coordination with a
frequency coordinator designated by the FCC for the Wireless Medical
Telemetry Service.

Frequency coordination is a registration and coordination process for
wireless medical telemetry devices used in the U.S.A. which operate in the
FCC-allocated, protected Wireless Medical Telemetry Service (WMTS)
bands (608-614 MHz, 1395-1400 MHz, 1427-1432 MHz). The MX40
operates in the 1395-1400 and 1427-1432 MHz bands.

Under U.S. Federal Communications Commission (FCC) rules, authorized
healthcare providers must register their WMTS devices with an authorized
Frequency Coordinator designated by the FCC. The American Society for
Healthcare Engineering (ASHE) is the current designated Frequency
Coordinator.

Registration/Coordination is a two-step process.

Step 1: Registration: The healthcare facility must register with ASHE. This

is done on-line, from the ASHE website (www.ashe.org - search on
keyword "WMTS"). Click on the link for Wireless Medical Telemetry
Service and you will come to the registration page. Fill out the details, and
pay the associated fee as per the instructions provided. You will receive
confirmation of this registration. Confirmation must be received before
proceeding to the next step.

Step 2: Frequency Coordination: Along with confirmation of

registration, you will receive access information necessary to perform the
second step, frequency coordination. This step involves logging the

equipment and frequencies used into the FCC’s database, so as to identify

any existing potential interference and to help prevent potential future
interference. Like registration, coordination is accomplished via the
ASHE website. Click on the links for Wireless Medical Telemetry Service
and then Frequency Coordination. The way the coordination process is
executed as of today, it will need to be repeated twice for the ITS4840A
system; once for 1395-1400 MHz band, and then again for the 1427-1432
MHz band, both of which are used concurrently by the Philips product.
There is a separate fee for each coordination request. Coordination is
executed by a company named Comsearch, on behalf of ASHE.

To fill in the frequency coordination forms, you’ll need to know the

following:

The county.
Latitude and longitude that represents the center of the area where the

transmitting devices will be deployed. Comsearch can help provide
this information; www.comsearch.com provides contact information.

The name/s of the Clinical Unit/s using the devices (e.g. ICU4,

CCU-West, ER1, Step-Down North, etc)

Installation 2-7

Primary

Low

Center

High

Channel 1:

1395.0977MHz

1395.8977MHz

1396.6977MHz

Channel 2:

1396.6970MHz

1397.4970MHz

1398.2970MHz

Channel 3:

1398.2963MHz

1399.0963MHz

1399.8963MHz

Channel 4:

1427.0979MHz

1427.8979MHz

1428.6979MHz

Secondary

Low

Center

High

*Channel 5:

1428.6972MHz

1429.4972MHz

1430.2972MHz

*Channel 6:

1430.2965MHz

1431.0965MHz

1431.8965MHz

The radius of deployment, expressed in meters. Imagine drawing a

circle around the center of the clinical unit, that encloses/encompasses
the unit. What is its radius?

The number of the highest floor on which a transmitting device will

operate.

How many transmitting devices will be used, i.e. the total number of

MX40 devices, Access Points, Core Access Points, and Remote Antennas
combined.

The Effective Radiating Power: 6.3 mW.
The Equipment Manufacturer: Philips Medical Systems.
The Equipment Models: MX40, etc.
The Frequency Range to be used: Two separate coordinations are

required: For the first one, click on the range of 1395.0 through 1400.0
MHz. For the second one, click on all the frequency ranges listed in the
range of 1427.0 through 1432.0 MHz.

When both Registration and Frequency Coordination have been
successfully completed, the MX40 can be activated. Note that this process

is the responsibility of the customer, as the final “operator” of the

transmitting equipment.

1.4GHz Smart-hopping Channel Definition

1.4GHz Smart-hopping Channel Definition - Standard

2-8 Installation

Primary

Low

Center

High

Channel 1:

1395.0977MHz

1395.8977MHz

1396.6977MHz

Channel 2:

1396.6970MHz

1397.4970MHz

1398.2970MHz

Channel 3:

1398.2963MHz

1399.0963MHz

1399.8963MHz

Channel 4a:

1429.4410MHz

1430.2410MHz

1431.0410MHz

Secondary

Low

Center

High

*Channel 4:

1427.0979MHz

1427.8979MHz

1428.6979MHz

1.4GHz Smart-hopping Channel Definition - Carved-out Areas

Installation 2-9

Short-Range Radio Channel Selection for 1.4GHz
Smart-hopping Systems

When the MX40 is to be connected to an IntelliVue Cableless Measurement
device, the Short-range radio channel assignment is handled at the MX40.
When the MX40 is to be connected to an IntelliVue Patient Monitor, the
Short-range radio channel assignment is handled at the patient monitor.

The Short Range Radio operates in the 2.4 GHz band, and is therefore
subject to interference from other devices that operate in this band like

802.11b, g wireless LANs, microwave ovens, Bluetooth radios, etc.. The
most likely interference will come from 802.11b, g wireless LANs.

In order to avoid interference, the Short Range Radio channels should be
chosen to operate at different frequencies as illustrated in the diagram
below, and as captured in the table below.

For example, if the hospital has an 802.11 deployment using 802.11 channels
1, 6, and 11, Short Range Radio channels that operate at frequencies in
between and above these channels would be SRR channel 15 (between

802.11 channels 1 and 6), SRR channel 20 (between 802.11 channels 6 and

11) and SRR channels 25 and 26 (above 802.11 channel 11).

The table also lists some Short Range Radio channels that may be used if a
frequency survey is performed and a power level check is done to ensure
that the frequency is "clear" (has a power level < -80dBm).

2-10 Installation

Channel Comparison - Short-Range Radio and 802.11b,g
Channels

The diagram below is for use in 1.4GHz Smart-hopping installations when
trying to select the best available Short-range radio channels.

Note — Channel overlap as shown in this diagram is not totally accurate.

There is not sufficient resolution to pick channels solely by using this
diagram. Use it in conjunction with the tables provided.

SRR Channel Selection for 1.4GHz Installations

*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dBm.

Installation 2-11

Smart-hopping and SRR Channel Selection for 2.4GHz
Smart-hopping Systems

For 2.4 GHz Smart-hopping systems, both the Smart-hopping radio and the
Short-Range Radio operate in the 2.4 GHz band, and therefore are subject to
interference from other devices that operate in this band like 802.11b, g
wireless LANs, microwave ovens, Bluetooth radios, etc.. The most likely
interference will come from 802.11b, g wireless LANs. In addition, if the
Short Range Radio will be used, interference between the Smart-hopping
radio and Short-Range Radio must be avoided by separating these channels
by a minimum of 5 MHz.

In order to avoid interference, the Smart-hopping and Short-Range Radio
channels should be chosen to operate at different frequencies as captured in
the tables that follow.

A minimum of three Smart-hopping channels is required for operation of
the system, but we strongly recommend selecting the maximum of six
channels in order to improve performance.

For example, if a 2.4GHz Smart-hopping system is being deployed without
the Short Range Radio in a hospital with an 802.11 deployment of channels
1, 6 and 11, the best channels to use would be the channels listed as
"Primary" in the table, "802.11 Channel 1,611 Deployment", – 13, 14, 28, 42,
43, 44, 45, 46, 47. The best six of these Smart-hopping channels across the
whole coverage area should be selected. A clear Smart-hopping channel is
defined as having a power level of < -90dBm.

If a 2.4GHz Smart-hopping system is being deployed with the Short-Range
Radio in a hospital with an 802.11 deployment of channels 1, 6 and 11, a
number of different deployment options are given in the tables. The clearest
frequencies should be assigned to the Short Range Radio, and then the
Smart-hopping channels can be assigned. So if SRR channels 25 and 26 are
selected, then the best Smart-hopping channels to use would be the
channels listed as "Primary" in the table, "802.11 Channel 1,611
Deployment", – 13, 14, 28, (42, 43, 44, 45, 46, 47 should not be used because
they will interfere with the Short Range Radio). In addition to these three
Smart-hopping channels, best three channels of the "Secondary" (0, 29) and
"Tertiary" (12, 15, 27) channels listed should be selected.

2-12 Installation

Channel Comparison - Short-Range Radio and 802.11b

The diagram below is for use in 2.4GHz Smart-hopping installations when
trying to select the best available Short-range radio channels.

Note — Channel overlap as shown in this diagram is not totally accurate.

There is not sufficient screen resolution to pick channels solely by using this
diagram. Use it in conjunction with the tables provided.

Installation 2-13

802.11 Channel 1,6,11 Deployment

*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dB. Clear Smart-hopping

channels have a power level < -90dBm.

2-14 Installation

802.11 Channel 1,4,7,11 Deployment

*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dB. Clear Smart-hopping

channels have a power level < -90dBm.

802.11 Channel 1,4,8,11 Deployment

*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dB. Clear Smart-hopping

channels have a power level < -90dBm.

Installation 2-15

802.11 Channel 1,7,13 Deployment

*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dB. Clear Smart-hopping

channels have a power level < -90dBm.

2-16 Installation

802.11 Channel 1,5,9,13 Deployment

*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dB. Clear Smart-hopping

channels have a power level < -90dBm.

Installation 2-17

802.11 Channel 2,7,12 Deployment

*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dB. Clear Smart-hopping

channels have a power level < -90dBm.

2-18 Installation

802.11 Channel 1,6,11,14 Deployment

*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dB. Clear Smart-hopping

channels have a power level < -90dBm.

802.11 Channel 3,10,14 Deployment

*Requires RF Frequency Survey and RF Power Level Check for clear channels. Clear SRR channels have a power level < -80dB. Clear Smart-hopping

channels have a power level < -90dBm.

Installation 2-19

Device Density per SRR
Channel

1.4GHz Smart-hopping
Systems

2.4GHz Smart-hopping
Systems

Maximum density of SRR
Device Links in a single
SRR cell

4 Device Links

3 Device Links

Short-Range Radio Density

A Short Range Radio cell is defined as a radius of 20ft (6.1m).
A "Device Link" is defined by use model.

MX40 is coordinating SRR communication with the Cableless
Measurements:

Patient Monitor is coordinating SRR communication with the
MX40 and Cableless Measurements:

2-20 Installation

MX40 Test & Inspection Matrix ............................................................... 3-2

3. Test and Inspection

This section covers Test and Inspection tasks to be performed to ensure the
performance of the MX40 after all Installation procedures are completed.

Test and Inspection 3-1

Test Block
Name

Test or "Inspection" to Perform

What to Record
on Service
Record

Visual Test:

Inspect the system (and packing material if applicable)
for obvious signs of damage. Also check external leads
and accessories.

Expected Test Results: The system does not have any
obvious signs of damage = Pass

V:P or
V:F

where P=Pass
F=Fail

Power On:

Remove leadset. Insert battery into the MX40. The MX40
will go through its self-test and pass. Make sure that an
ECG wave appears on the screen and the battery gauge
displays battery status. Check the INOP Area for any
equipment malfunctions.

The expected test result is pass: the MX40 boots up and
displays an ECG wave and the battery gauge displays
battery status. The wave will be a flat line if no simulator
is attached.

Expected Test Results: Expected answer is "yes". If so,
Power On test is passed.

PO:P or
PO:F

where P=Pass
F=Fail

Performance:

1. Insert battery into the MX40 for the channel being
tested.

2. Attach an ECG leadset to the MX40 and an ECG
simulator.

3. At the Information Center assign the MX40 being
tested to a Sector. Ensure that the Multi-Function
Button is turned "on", and turn on the SpO2
parameter if the MX40 being tested has the SpO2
option. Set the mode to Continuous.

4. An ECG waveform should be visible at the
Information Center.

5. If the MX40 has the SpO2 option, connect an SpO2
sensor and apply the SpO2 sensor to yourself.
Confirm that the MX40 completes a successful
measurement.

P:P or
P:F

where P=Pass
F=Fail

6 .Set the SpO2 mode to the customer's desired setting,

Continuous or Spot Check.

7. Place the device in Standby. At the Information

Center, resume monitoring.

MX40 Test & Inspection Matrix

3-2 Test and Inspection

Test Block
Name

Test or "Inspection" to Perform

What to Record
on Service
Record

8. Press the Multi-Function Button on the MX40. The
button press should generate one of the following,
depending on the configured setting:

Nurse Call & Record - Nurse Call alarm and a

recording generated at the Information Center.

Nurse Call Only - Nurse Call alarm at the Information

Center.

Record Only - A recording generated at the

Information Center.

Disabled - No event at the Information Center.

9. If the MX40 has the Short-Range Radio option,

establish communication between the MX40 and either
the patient monitor or a cableless measurement device,
depending on the chosen use model. . If assigned to a
patient monitor, an ECG waveform should be visible on
the monitor. The display on the MX40 will be:

10. If assigned to a cableless measurement device,
initiate a measurement and view it at the Information
Center.

Expected Test Results: Expected answer to all is "yes". If

so, Performance test is passed.

Revision
Check:

Check the revision of the software/firmware in the Device
Info. screen. Check the INOP Area for an "SpO2 Equip
Malf" message which indicates an SpO2 upgrade
failure.The revision reported should match the revision
loaded. You may also check the Status Log at the
Information Center.

Expected Test Results: Expected answer is "yes". If so,
Revision Check test is passed.

RC:P or
RC:F

where P=Pass
F=Fail

Test and Inspection 3-3

3-4 Test and Inspection

Monitoring Mode ...................................................................................... 4-2

Configuration Mode ................................................................................ 4-22

Service Mode ............................................................................................ 4-24

Demo Mode .............................................................................................. 4-25

4. Operating Modes

This section provides operation information about the MX40 when the
device is in Monitoring Mode, Service Mode, Configuration Mode and
Demo Mode.

Operating Modes 4-1

1. Patient Cable

2. Patient Information Area

3. Active Alarms Area

4. INOP Area

5. Measurement Area 1

6. Measurement Area 2

7. Waveform 1

8. Waveform 2

9. Radio/Network/Battery Status
Area

10. Leads Off Status Area

11. Silence Alarms Button

12. SmartKeys Button

13. Main Screen Button

14. Multi-Function Button

Monitoring Mode

Monitoring Mode is the normal operating mode of th MX40 and a
password is not required.

Controls, Indicators and Connectors

This section describes the clinical controls of the IntelliVue MX40. These
controls include buttons, display icons, visual and auditory indicators,
ports, and safety labeling located on the front and back of the device.

MX40 Controls and Indicators

4-2 Operating Modes

Button

Function

Initiates a local silence/acknowledgment of

all active alarms when enabled.

Silences the "Find Device" sound.

Note — Alarms at the MX40 can be silenced

from the Information Center.

Button

Function

Displays the SmartKey Menu on the touch
screen.

Button

Function

Activates the Touch Display if touched for two

seconds.

Cycles through the display screens if touched

repeatedly.

Resumes from Standby.

Silence Alarm Button

SmartKeys Button

Main Screen Button

SmartKeys

The following table lists the SmartKeys available on the display of the
MX40.

Note—gray text on a SmartKey signifies that the item is unavailable.

Operating Modes 4-3

SmartKey

Function

Start SpO2

Note — This

SmartKey is
unavailable
when SpO2
mode is
continuous.

Starts a manual SpO2 measurement.

Delay Record

Starts a delayed recording at the
Information Center.

Alarms

Review of up to 50 previous alarm
conditions (entries are stored during
power cycle). Pause Alarms for
configured time period (if enabled at
the Information Center).

Mode:
Telemetry /
Mode: Monitor

Toggles between modes. In
Telemetry Mode, display and audio
are off; in Monitor Mode, display and
audio are always on.

Standby

Puts the device into standby locally
and at the Information Center.
Displays purchased/enabled product
options.

Add/Remove

Displays available monitors and
IntelliVue Cableless Measurements
to assign to via the short-range radio.

Print Reports

Prints the pre-configured report as
designated at the Information Center.

Vitals Trends
(Optional)

View up to 24 hours of tabular trend
data.

Screen Setup

Determines time period that the
display remains active after user
interaction.

Lock/Unlock

Locks/Unlocks the display.

Op Mode

Selects either Monitoring, Demo,
Config or Service modes.

4-4 Operating Modes

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.

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.

Alarms Area

Operating Modes 4-5

The Patient Information Area displays the following information:

Bed Label
Patient Name (up to 15 characters will display)
Time

Touching the Patient Information Area displays the Patient Demogr. menu which lists
the following:

Patient Name (Last, First, Middle)
Lifetime ID
Encounter ID
Patient Category
Paced Mode
Height
Weight
Date of Birth
Gender

Note — If you use an alternative ID, it will display at the Information Center and on

printed reports. It will not display at the MX40.

1. Pacing algorithm is on.

2. Pacing algorithm is off.

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.

Patient Information Area

Paced Status

4-6 Operating Modes

Display Lock

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.

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.

Status Area

Multi-Function Button

Operating and Navigating

The principle method of operating your MX40 is via the Touch Display.
Almost every element on the display is interactive. Display elements
include measurement numerics, information fields, alarm fields,
waveforms, SmartKeys and menus.

Power-On Self Test

Once battery power is supplied, the MX40 performs a power-on self test to
check operational status prior to start-up. Should a failure be detected, an
INOP tone will sound and if possible, the appropriate INOP message for
the failure will be communicated to the Information Center and displayed
locally.

Operating Modes 4-7

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.

Function

Display
Locked/Active

Display
Locked/Inactive

Display
Unlocked/Active

Display
Unlocked/Inactive

Display Touch

No

No

Yes

No

Main Screen
Button

No

Yes

Yes

Yes
SmartKeys Button

Yes

No

Yes

No

Silence Button

No

No

Yes

No

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.

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.

Selecting Display Elements

Touch a display element to get to the actions linked to that element. For
example, touch the Patient Information element to call up the Patient Info
window, or touch the HR numeric to call up the Setup ECG menu. Touch
the ECG waveform to call up the wave selection menu.

Locking the Display

To provide additional protection against accidental patient access to the

MX40, the display can be locked using the Lock SmartKey. When Lock is
selected, the SmartKey menu automatically changes to the Main Screen.
When Unlock is selected, you must close the SmartKey menu to return to
the Main Screen.

The display automatically locks when there is no interaction for five
minutes.

4-8 Operating Modes

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.

Measurement Area Display Configurations

The display of your MX40 is configured/can operate in one of four available
orientations:

Portrait - One Waveform and four Numerics
Portrait - Two Waveforms and two Numerics (IIC Release N only)
Landscape - Two Waveforms and three Numerics (IIC Release N only)
Portrait - Viewable Chest Diagram and two Numerics

Connecting/Disconnecting the Patient Cable

The patient cable is connected to the MX40 as shown in the illustration
below.

When connecting to the MX40, there is a slight clicking sound that signifies
that the cable is securely connected.

Operating Modes 4-9

Disconnect the patient cable as 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:

Screen Settings - to define the selection and appearance of elements on

each individual display screen.

Measurement Settings - to define setting unique to each measurement,

e.g. high and low alarm limits.

Monitor Settings -including settings that affect more than one

measurement or display screen, for example alarm volume and alarm
pause time.

You must be aware that, although many settings can be changed during
use, permanent changes to settings can only be done in Configuration
Mode. All settings are restored to their default setting when the patient is
discharged or the MX40 is powered off.

Changing Measurement Settings

Each measurement has a setup menu in which you can adjust its settings.
You enter the setup menu by selecting the measurement numeric.

4-10 Operating Modes

Setting

Description

Alarm Limits

Heart Rate alarm limits can be viewed locally
at the MX40. Limits set at the Information
Center (Release N or later) are reflected at
the MX40 when connected on the network.

Primary
(used for arrhythmia analysis only)

I,II, III, aVR, aVL, aVF, V1-V9, MCL, V3R,
V4R, V5R. Available waveforms are based
on lead set type. Lead II is the default.

Secondary
(used for arrhythmia analysis only)

I,II, III, aVR, aVL, aVF, V1-V9, MCL, V3R,
V4R, V5R. Available waveforms are based
on lead set type. Lead V is the default.

Paced Mode

Yes, No

Adjust Size

Set ECG gain to x1/2, x1, x2, x4

Arrhythmia

Initiate an Arrhythmia Relearn; View
Arrhythmia Alarm Limits; Turn Arrhythmia
Annotation On/Off.

Lead Placement

Set EASI, Standard

ECG

Set ECG On/Off

New Lead Setup

When IntelliVue Patient Monitor lead sets are
in use, select 3-wire, or 5-wire.

Va Lead

Shows position of Va, or C1, electrodes.
Choices are V1-V9, v3R, V4R, V5R.

Vb Lead

Shows position of Vb,or C2, electrodes.
Choices are V1-V9, v3R, V4R, V5R.

Change Numeric

Selects parameter numeric to display in
place of current HR numeric.

ECG Settings at the MX40

Operating Modes 4-11

Setting

Description

Wave 1

Primary, Secondary, I, II, III, aVR, aVL, aVF,
V1-V9, MCL, V3R, V4R, V5R. Available
waveforms are based on patient cable type.
Lead II is the default. If Primary or Secondary
are selected, then the waveform displayed is
the waveform configured as primary or
secondary for arrhythmia analysis.

Wave 2

Primary, Secondary, I,II, III, aVR, aVL, aVF,
V1-V9, MCL, V3R, V4R, V5R, Pleth (if SpO2
is available). Available waveforms are based
on patient cable type. Lead V is the default.If
Primary or Secondary are selected, then the
waveform displayed is the waveform
configured as primary or secondary for
arrhythmia analysis.

Waveform Settings at the MX40

Primary or secondary waveform configuration changes made at the
Information Center change the MX40.

Battery Information

Battery Safety Information

Warnings

The battery compartment door must be closed during defibrillation.
Use the Philips Rechargeable Lithium-ion Battery or 3 Duracell Alkaline

batteries, size AA, MN 1500, 1.5V, to ensure specified performance and
correct battery gauge reporting. Outdated, mismatched, or poor-quality
batteries can give unacceptable performance (e.g., insufficient
Battery-Low warning time). If you are using disposable batteries, the
use of fresh high-quality alkaline batteries is strongly recommended.

Certain failure conditions, such as short circuits, can cause a battery to

overheat during use. High temperatures can cause burns to the patient
and/or user. If the MX40 becomes hot to the touch, remove it from the
patient and place it aside until it cools. Then remove the batteries and
discard them. Have the MX40 checked by your service provider to
identify the cause of overheating.

If you receive a TELE BATTERY LOW, TELE BATTERY EMPTY,

REPLACE BATTERY T, or TELE BATTERY TEMP alarm, the batteries
must be promptly replaced. If these conditions are not corrected, they

4-12 Operating Modes

will result in a device shutdown and cessation of monitoring.

Activity

When to Perform

Perform a visual inspection.

Before inserting a battery in the
MX40.

Charge the battery.

Upon receipt, after use, or if a low
battery state is indicated. To optimize
performance, a fully (or almost fully)
discharged battery should be charged
as soon as possible.

Clean the battery

At each patient discharge, or in cases
when the battery is exposed to
contaminants.

Charge stored batteries to at least
40% of their capacity every six
months.

When not in use for an extended
period of time.

Decommission the battery

When any of the following INOPs are
displayed on the MX40:

TELE SERVICE BATTERY
TELE BATTERY TEMP

Disposable batteries should be removed from the MX40 at the end of

the battery’s useful life to prevent leakage.

If battery leakage should occur, use caution in removing the battery.
The leaked substance may cause eye or skin irritation. Avoid contact
with skin. Clean the battery compartment according to the instructions
in the Maintenance section. Wash hands.

To eliminate the risk of electrical shock or burn, do not carry loose

batteries on your person, e.g. in clothing pockets.

Caution

Use of AA Lithium batteries or batteries with terminal voltage >1.6V may
cause damage to the device.

Lithium-ion Rechargeable Battery Care

Care of the rechargeable battery begins when you receive a new battery for
use and continues throughout the life of the battery. The table below lists
battery care activities and when they should be performed.

Operating Modes 4-13

Rechargeable batteries are charged using the IntelliVue CL Charging
Station. For information on charging station use, see Charging Li-ion
Rechargeable Batteries p. 5-7 .

Note — The battery capacity of re-chargeable batteries degrades over time

and number of recharge cycles. Toward the end of its useful life, the battery
capacity may be reduced by 25-30%. If this reduced battery life is
unacceptable based on your use model, Philips recommends replacing the
rechargeable battery sooner.

Lithium-ion Rechargeable Battery Storage

When storing rechargeable batteries, make sure that the battery terminals
do not come into contact with metallic objects or other conductive
materials.

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
40%. Storing batteries in a cool place slows the aging process.

The batteries should not be stored at a temperature outside the range of

-20oC (-4oF) to 50oC (122oF).

Stored batteries should be should be charged to at least 40% of their
capacity every 6 months.". They should be charged to full capacity prior to
use.

Note — Storing batteries at temperatures above 38

o

C (100oF) for extended

periods of time could significantly reduce the batteries' life expectancy.

Lithium-ion Rechargeable Battery Handling Precautions

Lithium-ion batteries store a large amount of energy in a small package.
Use caution when handling the batteries; misuse or abuse could cause
bodily injury and/or equipment damage.

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.
Do not incinerate batteries or expose them to temperatures above 60

(140oF).

o

C

If a battery has been dropped or banged against a hard surface, whether
damage is visible externally or not:

discontinue use.
dispose of the battery in accordance with the disposal instructions.

4-14 Operating Modes

Inserting/Removing Batteries

Warning

Arrhythmia relearning is initiated whenever the MX40 is powered down

for one minute or longer. Be sure to check your patient’s arrhythmia

annotation for accuracy whenever relearn has occurred.

Caution

Remove the batteries before storing the MX40 for an extended period of
time.

The battery compartment is located on the back of the MX40, accessible by
opening the compartment door from the bottom. It accommodates three
AA 1.5V Alkaline batteries or the Philips Rechargeable Lithium-ion battery.
Only these batteries should be used.

Note— Lithium-ion batteries should be fully charged prior to first use.
Important— Do not use other rechargeable batteries. Use of this type of

battery will adversely affect:

Battery gauge performance
Battery low warnings
Battery life performance

Inserting Batteries

 Insert the rechargeable lithium-ion battery using the

following procedure:

Open the battery compartment by lifting up on both bottom sides of the
compartment door.

1 Remove the AA battery tray if present.

Operating Modes 4-15

2 Insert the battery pack so that the raised tab is aligned with the cutout

in the base of the battery compartment. Close the battery compartment
door.

3 Close the battery compartment door.
4 Watch for the start-up screen on the front of the MX40 to illuminate

briefly.

 Insert AA batteries into the MX40 using the following

procedure:

1 Open the battery compartment by lifting up on both bottom sides of the

compartment door.

2 Insert the AA battery tray if not already present.
3 Insert three AA 1.5V Alkaline batteries, matching the polarity with the

+indications inside the compartment.

Note—all batteries are inserted with the + polarity in the same direction.

4-16 Operating Modes

4 Close the battery compartment door.
5 Watch for the start-up screen on the front of the MX40 to illuminate

briefly.

Removing the Batteries

Batteries should be removed when the MX40 is not in use or is being stored.

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.

If you remove good AA batteries to turn off the MX40, keep them together
as a set for later re-use so that all batteries will have the same level of power
remaining.

Important— Do not "store" disposable AA batteries by leaving them in the

incorrect polarity position in the MX40.

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.

Operating Modes 4-17

Approximate
Battery Life
Remaining

Approximate
Time
Remaining
(ECG only)

Approximate
Time
Remaining
(ECG & Spo2
Continuous)

Functionality
Disabled

Battery
Indicator LCD
Segments

100%

~ 24 hours

~ 9 hours

None

5 Green

75%

< 18 hours

< 7 hours

None

4 Green

50%

< 12 hours

< 5 hours

None

3 Green

25%

< 6 hours

< 2 hours

None

2 Green

10%

< 2 hours

< 1 hours

None

1 Green

Low battery
level to
replace/charge
battery level

< 30 minutes

< 30 minutes

SpO2 and
short-range
radio are
disabled.
Display is at
half
brightness.

1 Red
Red Battery
Icon
Audio
Replace/charge
battery level

< 10 minutes

< 10 minutes

Device
shutdown

1 Red
Red Battery
Icon

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.

Battery Charge Status

The battery charge indicator displays in the Status Area and communicates
the remaining battery charge time when using both AA batteries or the
rechargeable lithium-ion battery.

When the MX40 is initially powered-on, it takes approximately 25 seconds
for the indicator to populate. During this time, the indicator displays a ? in
the battery icon.

In order to guarantee overall device performance, certain functionality is
disabled when the battery charge reaches critical levels. See the tables
below for additional information about battery status.

AA Battery Charge Status

4-18 Operating Modes

Approximate
Battery Life
Remaining

Approximate
Time
Remaining
(ECG only)

Approximate
Time
Remaining
(ECG & Spo2
Continuous)

Functionality
Disabled

Battery
Indicator
LCD
Segments

100%

~ 25 hours

~ 14 hours

None

5 Green

75%

< 19 hours

< 10.5 hours

None

4 Green

50%

< 13 hours

< 7 hours

None

3 Green

25%

< 6 hours

< 3.5 hours

None

2 Green

10%

< 3 hours

< 1.5 hours

None

1 Green

Low battery
level to
replace/charge
battery level

< 30 minutes

< 30 minutes

SpO2 and
short-range
radio are
disabled.
Display is at
half
brightness

1 Red
Red Battery
Icon
Audio
Replace/charge
battery level

< 10 minutes

< 10 minutes

Device
shutdown

1 Red
Red Battery
Icon

Lithium-ion Rechargeable Battery Charge Status

Operating Modes 4-19

Service Information Availabe in Monitoring Mode

While the MX40is operating in Monitoring Mode, important Service
information is available by touching the Status Area. You can view radio
signal strength and device specific information, such as serial number and
software and hardware revisions.

4-20 Operating Modes

Operating Modes 4-21

Setting

Description

MX40 with IIC N

MX40 with IIC L/M

Touch Tone
Volume:

Audio feedback for
button touch events.
Mute (0) or allow
sound feedback

0 -10
4

0-10
4

Default Screen:

Screen displayed after
power on

1 wave - P(ortrait)
2 waves - P(ortrait)
2 waves ­L(andscape)
Chest Diagram

1 wave - P(ortrait)
Chest Diagram

Screen Color:

The color of the
Standby screen can
be changed. This can
be used to distinguish
devices between
different units, e.g.
Blue for CCU, Green
for ED

Blue, Gray, Green,
Pink, Purple, Yellow

Note — Blue, Gray,

and Green apply to
both Startup and
Standby screens.
Pink, Purple and
Yellow apply to
Standby screen
only.

Blue, Gray, Green,
Pink, Purple, Yellow

ECG Cable
Color:

These are the colors
that will be displayed
on the chest diagram
if a patient cable type
cannot be determined.

AAMI, IEC

AAMI, IEC

Alarm Sounds

Sets MX40 alarm
sound type to
Traditional (Carenet)
or ISO.

Traditional, ISO

Traditional, ISO

Configuration Mode

This section describes settings that are configured using the user interface
on the MX40. For information on configuration settings that are entered at
the Information Center, see the IntelliVue Information Center Configuration
Guide contained on the MX40 Documentation CD, p/n 453564255041.

Configuration Mode is password protected. The password to enter is
"71034".

Clinical Configuration

The table below lists the settings that are configured using the

Configuration menu:

4-22 Operating Modes

Setting

Description

MX40 with IIC N

MX40 with IIC L/M

Alarms On:

Enable: All MX40/IIC
Release N features
available.
Disable: MX40
operates as if
connected to IIC
Release L/M.

Disable, Enable

Disable

Unit Defaults:

Setting

Description

MX40 with IIC N

MX40 with IIC L/M

Alarm Volume
for Off
Network:

Sets the default alarm
volume when the
device goes off
network

10 only

10 only
Inop Reminder:

Inop reminders on or
of

Set at IIC

On, Off

Inop Severity:

ECG Leads

Off

Replace

Battery

Sets the severity of
the "ECG Leads Off"
and/or "Replace
Battery" INOP
conditions

Set at IIC

Red, Yellow, Cyan

Setting

Description

MX40 with IIC N

MX40 with IIC L/M

Lead
Placement:

Sets the default lead
placement to either
Standard or EASI
ECG. This impacts the
leads that are
selectable and the
location of the
electrodes displayed
on the Chest Diagram.

Standard, EASI

Standard, EASI

SpO2 Mode:

Sets the default SpO2
mode to either Manual
or Continuous.

Manual, Continuous

Manual, Continuous

The table below lists the settings that are configured using the SmartKeys menu:

Operating Modes 4-23

The table below lists the settings that are configured using the individual parameter Setup menus
for ECG and SpO2:

Default Settings = Bold.

Note — The IntelliVue Support Tool - Mark 2 can be used to copy the configuration of one MX40

to another MX40.

Enabled Product Option #

Product Option

S01

ECG only

S02

ECG and SpO2

S03

ECG and SpO2 Ready (for future upgrade)

C01

Enhanced Arrhythmia

C03

24 hours of Trends

J46

Short-Range Radio

Service Mode

This section describes the menus and settings accessed from the Service
Operating Mode. Service Mode is password protected. The password to
enter is "1345".

Setup Network

The Setup Network menu allows you to set the RF Access Code for the

MX40.

Revisions

The Revisions menu displays the Device Info menu:

Service #: This is the Service Identification Number located on the back

label and used to identify the device.

S/N: This is the Hardware Serial Number for the device located on the

back label and used to identify the device.

SW Service #: This is the Service Identification Number for the software

version on the device. It can be found on the Software License
Certificate that shipped with the Device.

SW SN: This is the Software License Number. It can be found on the

Software License Certificate that shipped with the device.

Note — Customers should save the Software License Certificate for

future reference.

Appl SW: This is the revision of the software installed and running on

the MX40.

HW Rev: This is the Revision Number for the device hardware.
Options: List of enabled product options on the device.

4-24 Operating Modes

Demo Mode

The MX40 has a Demo Operating Mode available for assistance in sales and
training situations. Demo Mode is password protected. The password to
enter is "14432".

In Demo Mode, all menus are accessible, and all buttons and SmartKeys are
operational. There is a simulated ECG wave on the display, and the alarm
system is functional. Data is transmitted to the Information Center and is
labeled "Demo" in the patient sector and on the MX40 in the Leads Off
Status Area.

Operating Modes 4-25

4-26 Operating Modes

Cleaning ...................................................................................................... 5-2

Disposing of the MX40 ............................................................................. 5-4

Label Assignment for Replacement MX40 ............................................. 5-5

Charging Lithium-ion Rechargeable Batteries ...................................... 5-7

5. Maintenance

This section provides procedures for maintaining the MX40 after
installation, including equipment label assignment, cleaning and battery
care.

Maintenance 5-1

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, refer to the instuctions
provided by the manufacturer. The alternative Steris V-pro process using
hydrogen peroxide vapor is also acceptable.

 Perform the following steps to clean the MX40 and the

patient cable of visible surface contamination.

Note — when cleaning, the use of protective gloves is encouraged.

1 Remove the batteries and disconnect the patient cable.
2 If using disposable AA batteries, remove the battery tray and clean

separately.

3 Wipe the MX40 and the patient cable clean by using a cloth dampened

modestly with one of the approved cleaning agents listed in the table
below.

4 Follow the manufacturer's instructions with regard to application

duration.

5 Wipe the M40 and inside the patient cable housing with distilled water

or alcohol to prevent residue build-up.

6 Allow to air-dry, or dry with a non-lint producing cloth.

Cleaning Materials for the MX40

Caution

5-2 Maintenance

Use of abrasive cleaning materials, or disinfectants or cleaning agents

not listed herein, on any part or component of the MX40 may damage
the components.

The Gore-tex patch in the battery compartment of the MX40 can be

damaged by the use of glutaraldehyde and anti-bacterial soap.

Cleaner

Active Ingredient

Isopropyl Alcohol
based

Isopropyl Alcohol (>70%)
Hydrogen Peroxide

Hydrogen Peroxide (3%)

Chlorine Bleach

Sodium Hypochlorite (1:10 concentration,
mixed < 24 hours)

Metrex CaviWipes

Isopropyl alcohol (15-18%)
Sodium hydroxide (0.1%)
2-butoxyethanol (1-5%)

Viraguard

Isopropanol (70%)

Resert XL HLD

Hydrogen peroxide (1.4-2-3%)
2-Fumic Acid (<2.5%)

Sporox II Sterilizing &
Disinfection Solution

Hydrogen peroxide (7.5%)
Phosphoric acid (0.85%)

Sanicloth Plus
Germicidal Cloths

Isopropyl alcohol (55%)
Quaternary ammonium (0.5%)

WipesPlus
Disinfecting Wipes

Phenylphenol (0.28%),
Benzyl-p-chlorophenol (0.03%)

TechSpray General
Purpose Cleaner

Isopropyl alcohol (70%)

Oxivir Tb Cleaner
Disinfectant

Hydrogen peroxide (2.5-3.5%)
Oxivir Tb Wipes

Hydrogen peroxide (3%)

Sanicloth HB

Quaternary ammonium (1%)

Sanicloth Plus

Quaternary ammonium (0.25%)
2-Butoxyethol (1-4%)
Isopropyl alcohol (14.85%)

Super Sanicloth

Quaternary ammonium (<1%)
Isopropyl alcohol (55%)

Sharp or pointed instruments should not be used to remove soil from

recessed areas on the MX40.

Approved Cleaners

Note —The cleaners listed above are also suitable for cleaning the patient

cable and the lithium-ion battery.

Maintenance 5-3

Disposing of the MX40

Warning

To avoid contaminating or infecting personnel, the environment or other
equipment, make sure you disinfect and decontaminate the MX40
appropriately before disposing of it in accordance with your country's laws
for equipment containing electrical and electronic parts. For disposal of
parts and accessories where not otherwise specified, follow local
regulations regarding disposal of hospital waste.

You will find detailed disposal information on the following web page:

http://www.healthcare.philips.com/main/about/Sustainability/Recycling/p
m.wpd

The Recycling Passports located there contain information on the material
content of the equipment, including potentially dangerous materials which
must be removed before recycling (for example, batteries and parts
containing mercury or magnesium).

Do not dispose of waste electrical and electronic equipment as unsorted
municipal waste. Collect it separately, so that it can be safely and properly
reused, treated, recycled, or recovered.

5-4 Maintenance

Label Assignment for Replacement MX40

During installation, an equipment label is assigned to each MX40 in a
clinical unit so that the device can be identified during operation within the
wireless system. If an MX40 is lost, the Assign Label function at the
Information Center enables you to unassign the label from a lost device,
and re-assign its label to a replacement device. Labels are limited to those
available in an individual clinical unit. The Label Assignment function
requires a password for access, and its controls are available in English
only.

Re-assigning an Equipment Label

 To re-assign an equipment label to a replacement

device:

1 At the Information Center, clear the sector that the original equipment

label was assigned to (Patient Window -> Sector Setup -> Clear
Sector -> OK).

Note — Before clearing the sector, ensure that the equipment label of

the lost device is not actively assigned to a patient being monitored.

2 Select All Controls -> Label Assignment.
3 Enter password.

Note — The remaining screens will be in English only.

4 Insert battery power into the MX40 and if attached, disconnect the

patient cable.

5 Select Refresh.
6 Select the MAC address of the replacement device from the New

Devices list. If the address does not appear, remove battery power and
re-insert. Select Refresh.

Note — The MAC address appears on the rear label of the MX40.

7 Select the equipment label that was assigned to the previous device

from the Equipment Label list.

8 Select Assign Label to initiate programming of the equipment label

into the replacement MX40.

9 When prompted, press Confirm on the MX40 to accept the assignment.

The confirmation must occur within 30 seconds of the prompt.

Maintenance 5-5

10 Wait for the new_device label to change to the selected equipment label.
11 In Sector Setup, select the Bed Label and Equipment Label and then

press OK.

5-6 Maintenance

Charging Lithium-ion Rechargeable Batteries

The li-ion rechargeable battery is recharged using the IntelliVue CL
Charging Station.

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.

Battery Power Indicators

There are various indications which help you keep track of the battery
power status.

LEDs on the charging station slots
battery status information on both the MX40 and the charging station's

display

INOP messages

The indicators always show the remaining capacity in relation to the
battery's actual maximum capacity which may lessen as the battery ages.

Charging Station LEDs

The nine charger slot LEDs show the battery status of the device in their
slot and are switched off if no battery is inserted.

If a battery is put on a charging station slot, the corresponding LED will
flash yellow until the battery's current state has been identified. Then a
beep is issued and the LED reflects the battery status as described in the
table below.

Maintenance 5-7

Status

LED

no battery on charger slot

off

battery put on charger slot

flashing yellow

battery not properly recognized,
error

cyan

battery recognized, battery
charging

yellow

battery recognized, battery full
(>90%)

green

The AC Power / Error LED is

green when the charging station is connected to AC power
cyan during startup or to indicate a general charging station error

Note — Wiping of battery contacts with an alcohol solution after cleaning is

recommended.

Battery Status on the Charging Station Display

The IntelliVue CL Charging Station display provides a quick overview of
all the connected devices and their battery status. The screen is arranged in
the same layout as the charger slots.

Battery Lifetime Management

The lifetime of a li-ion battery depends on the frequency and duration of
use. When properly cared for, the useful life is approximately 4 years or 500
complete charge-discharge cycles, whichever comes first. In addition,
experience indicates that the incidence of failure may increase with battery
service life due to the accumulated stresses of daily use. We therefore
strongly recommend that li-ion batteries be replaced after 2 years or 500
complete charge-discharge cycles.

5-8 Maintenance

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.

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.

Maintenance 5-9

MX40 Product Structure ........................................................................... 6-2

MX40 Support Parts .................................................................................. 6-5

6. Part and Option Ordering
Information

This section provides specific part number, option number. support part
number, and descriptive information associated with the MX40.

Part and Option Ordering Information 6-1

Standard

 Optional

MX40
865350

MX40
865351

WMTS 1.4 GHz Smart-hopping network

2.4 GHz Smart-hopping network

Rechargeable battery





AA batteries

Required additional purchases1

S01

ECG only





S02

ECG + Fast SpO2 enabled2





S03

Fast SpO2 ready3





Add-on options

Clinical applications

C01

Enhanced Arrhythmia4





C03

Vitals Trend





Documentation

D01

Paper instructions for use5





Interfaces

J46

Short range radio





865349

Intellivue MX40 accessories

Device accessories

E24

MX40 Lith-ion battery, pkg of 3





E28

AA battery, 8 pieces6





E29

Carry pouch, pkg of 50





Patient accessories

K03

ECG 3-lead grabber, AAMI MX40





MX40 Product Structure

The table below provides MX40 part and option information.

6-2 Part and Option Ordering Information

Standard

 Optional

MX40
865350

MX40
865351

K05

ECG 5-lead grabber, AAMI MX40





K06

ECG 6-lead grabber, AAMI MX40





K07

ECG 3-lead grabber, AAMI + SpO2 MX40





K08

ECG 5-lead grabber, AAMI + SpO2 MX40





K09

ECG 6-lead grabber, AAMI + SpO2 MX40





K13

ECG 3-lead grabber, IEC MX40





K15

ECG 5-lead grabber, IEC MX40





K16

ECG 6-lead grabber, IEC MX40





K17

ECG 3-lead grabber, IEC + SpO2 MX40





K18

ECG 5-lead grabber, IEC + SpO2 MX40





K19

ECG 6-lead grabber, IEC + SpO2 MX40





K23

MX40 extender cable





K24

Adapter cable bedside/MX40 ECG + SpO2





Additional accessories

98980317222
1

ECG trunk cable AAMI/IEC





98980317182
1

ECG 5-lead snap AAMI





98980317184
1

ECG 5-lead snap AAMI+SpO2





865220

Battery charging station7





1 Only one of this category must be chosen.

2 Requires purchase of pulse oximetry accessories. May require adapter cable.

3 Requires purchase of 865348/S02 to enable feature.

4 Not applicable for IntelliVue Information Center release L or M.

5 Applicable for the United States only.

6 Support for disposable batteries is standard. Must purchase AA batteries
separately.

7 Requires purchase of 865349/E24.

Part and Option Ordering Information 6-3

Standard

 Optional

MX40
865350

MX40
865351

865348

IntelliVue MX40 upgrade options

Base Functionality

S02

Enable Fast SpO2 to S03 device



Clinical applications

C01

Add Enhanced Arrhythmia



C03

Add Vitals Trend



Interfaces

J46

Add short range radio



6-4 Part and Option Ordering Information

Description

Part Number

86530

86531

TELE PWM, 1.4 GHz,
ECG Only, Exchange

453564262491

S01

n/a

TELE PWM, 1.4 GHz,
ECG and Sp02, Exchange

453564262511

S02 or S03

n/a

TELE PWM, 2.4 GHz,
ECG only, Exchange

453564262531

n/a

S01

TELE PWM, 2.4 GHz,
ECG &Sp02, Exchange

453564262551

n/a

S02 or S03

ASSY - AA Battery
Adapter, Tele PWM

453564132721

All

All

PLAST - Battery Door
w/Gasket

453564205271

All

All

MX40 Rechargeable
Battery, Pkg 1

989803176201

All

All

MX40 Service Adapter +
Cable (tool for service)

453564270071

All

All

Note — The software license transfer process expects the same hardware number as

original device.For example:

A SW license for S01 can only be transferred to 453564262491 or 453564262531.
A SW license for S02 or S03 can only be transferred to 453564262511 or

453564262551.

MX40 Support Parts

Part and Option Ordering Information 6-5

Service personnel can find the following information on the label on the
back of the MX40:

6-6 Part and Option Ordering Information

Tools Required ........................................................................................... 7-2

Software License Transfer ........................................................................ 7-3

7. MX40 Repair Strategy

The MX40 Repair Strategy is Unit Exchange worldwide through Philips
part centers.

MX40 Repair Strategy 7-1

Tools Required

Repair of the MX40 requires the following tools:

MX40 Service Adapter Cable
PC running the IntelliVue Support Tool - Mark2
Internet Connection to the Philips Software License Server

7-2 MX40 Repair Strategy

Software License Transfer

The MX40 uses Software Licensing functionality to track customer
information, software revisions, and features enabled. Software Licensing
allows service personnel to easily determine what products, features, and
revisions are installed at a particular customer site.

Exchange devices will arrive without a software license.

The software license from the defective device needs to be transferred to the
exchange device using the IntelliVue Support Tool - Mark2. For more
information, see the Support Tool Instructions for Use, p/n 453564296161.

MX40 Repair Strategy 7-3

Note — The MX40 connects to a PC via a USB port and uses a USB cable,

but the MX40 does not operate as a standard USB device. The MX40 does
not support the use of a cable longer than 3 ft. Longer cables may result in
an unacceptable drop in voltage.

7-4 MX40 Repair Strategy

Technical Alarms (INOPs) ....................................................................... 8-2

Possible User Interface Issues ................................................................ 8-10

8. Troubleshooting

This section provides information about the technical alarms generated by
the MX40 and associated troubleshooting suggestions. Also provided are
troubleshooting suggetions for user interface issues and information
regarding the patient cables used with the MX40.

Troubleshooting 8-1

Alarm Text

Priority

Condition

What to do

BATTERY LOW T

Source - MX40

Soft

There is less than 15

minutes of monitoring
time remaining (AA
batteries).

Lithium-ion battery

level is < 10% or has
<30 minutes
remaining time.

Replace batteries

promptly to avoid
shutdown and cessation of
monitoring.

Insert a charged
lithium-ion battery pack.

CANNOT ANALYZE
ECG

Source - MX40 and
Information Center

Hard

Arrhythmia algorithm
cannot reliably analyze
the ECG data on any
monitored leads.

Assess the lead selections,
initiate relearn, and validate
analyzed rhythm. Check
other INOPs for possible
source of problem.

Technical Alarms (INOPs)

Technical Alarms, or INOPs (inoperative conditions), are sourced at the
MX40, the ST/AR algorithm running at the Information Center, or the
IntelliVue Patient Monitor. They identify inoperative conditions (that is
conditions where the system is not operating properly and therefore cannot
measure or detect alarm conditions reliably). There are four levels of
Technical Alarms:

Severe - Monitoring and alarm generation are disabled. Visual alarm

indicator on the MX40. Audible tone at the Information Center. Must be
acknowledged by a clinician.

Hard - Monitoring and alarm generation are disabled. Visual alarm

indicator on the MX40. Audible tone at the Information Center.
If the hard INOP is "latched", the sound will be silenced, but the
message will remain on the display until resolution of the offending
condition.

Soft - Monitoring and alarms remain active. Visual alarm indicator on

the MX40 and at the Information Center. No audible tones are
generated at the Information Center

Red/Yellow - Replace Battery and ECG Leads Off INOPs may be

configured to display as either Red or Yellow Technical Alarms.

Note - The ECG Leads Off INOP will initially display as a cyan

technical alarm until a valid ECG signal is obtained.

In the following table, technical alarms are listed alphabetically.

8-2 Troubleshooting

Alarm Text

Priority

Condition

What to do

CHECK PAIRING

Source - MX40

Yellow
Technic
al Alarm

There is a problem

with device pairing.

When the MX40 is

wirelessly paired with
an X2 patient monitor
(no label) docked with
a larger networked MP
series monitor, and
the network
connection is lost.

Check that the bedside

monitor is correctly paired.

Select the correct device

to be paired.

cl NBP Batt Low

Source - Cableless
Measurement Device

Hard

CL NBP Pod weak
battery condition.

Charge CL NBP Pod.

cl NBP Batt Empty

Source - Cableless
Measurement Device

Severe

CL NBP Pod empty
battery condition.
Monitoring is not
possible.

Replace CL NBP Pod.
Recharge depleted CL

NBP Pod.

cl NBP DISCONNECT

Source - Cableless
Measurement Device

Hard

CL NBP Pod is not
connected with the
MX40.

Resolve interference

condition.

Reduce range between

CL NBP Pod and MX40.

cl SpO2 Batt Low

Source - Cableless
Measurement Device

Hard

CL SpO2 Pod weak
battery condition.

Charge CL SpO2 Pod.

cl SpO2 Batt Empty

Source - Cableless
Measurement Device

Severe

CL SpO2 Pod empty
battery condition.
Monitoring is not
possible.

Replace CL SpO2 Pod.
Recharge depleted SpO2

Pod.

cl SpO2 DISCONNECT

Source - Cableless
Measurement Device

Hard

CL SpO2 Pod is not
connected with the
MX40.

Resolve interference

condition.

Reduce range between

CL SpO2 Pod and MX40.

!!!/!! CUFF NOT
DEFLATED

Source - Cableless
Measurement Device

Severe

Cuff pressure has
exceeded the specified
safety limit.

Remove cuff and tubing and
expel air.

Troubleshooting 8-3

Alarm Text

Priority

Condition

What to do

!!!/!! CUFF OVERPRESS

Source - Cableless
Measurement Device

Severe

Cuff pressure has
increased above
overpressure safety
limits.

Remove cuff and tubing and
expel air.

ECG/ARRH ALARM
OFF

Source - MX40

Soft

ECG is turned off.

Turn on ECG.

ECG LEADS OFF
Note This INOP may

also be configured to
display as a Red or
Yellow Technical Alarm.

Source - MX40

Red or
Yellow
or Hard
Technic
al Alarm

Multiple leads are off.

Re-attach ECG leads to
patient..

<electrode> LEAD OFF

Source - MX40

Hard

Single lead is off.
If primary lead is MCL,

lead will be identified as
V/C in INOP text.

Re-attach ECG leads to
patient.

LEADSET UNPLUGGED

Source - MX40

Hard

Patient cable has

been unplugged from
the MX40.

Incompatible leadset

attached to patient
cable.

Re-attach the patient

cable.

Replace the leadset.

LOCAL AUDIO OFF

Source - MX40

Note — This is normal

operation in Telemetry
Mode.

Soft

There is no alarm audio
notification when
operating in Telemetry
Mode.

Change to Monitor Mode.

NBP INTERRUPTED

Source - Cableless
Measurement Device

Hard

The preset maximum
time for the total
measurement has been
exceeded.

Reduce patient movement
and avoid interaction with the
cuff and tubing.

NBP MEASURE FAILED

Source - Cableless
Measurement Device

Hard

Measurement values
cannot be derived.

Attach cuff to new location

on patient.

Replace cuff.

8-4 Troubleshooting

Alarm Text

Priority

Condition

What to do

NBP EQUIP MALF

Source - Cableless
Measurement Device

Hard

Tubing may be

obstructed or kinked.

Hardware malfunction.

Check tubing.
If condition persists,

contact Service.

NO ALARM DISPLAY

Source - MX40

Soft

When operating with
Information Center
Release L Or M, there is
no local alarming at the
MX40, networked or
non-networked.

Condition is not present when
operating with Information
Center Release N or later
(unless specifically
configured to operate in this
way).

NO CENTRAL
MONITOR
(appears at MX40 only)

Source - MX40

Hard

The MX40 is out of

range of the network.

Patient Sector at the

Information Center is
in Standby.

Return the MX40 to the

coverage area.

Select Resume at the

Information Center.

NO HOST
MONITORING

Source - MX40

Hard

The paired
MX40/bedside monitor is
out of short-range radio
range or there is
excessive radio
interference.

Reduce the distance

between the devices.

Identify and remove

interference source.

NO SIGNAL
(appears at the
Information Center only)

Source - Information
Center

Hard,
Latched

The MX40 is outside

the coverage area, or

No batteries in the

MX40, or

The MX40 has failed.

Make sure that the MX40

is within the coverage
area and has good
batteries.

Replace the MX40 if

Power On Self Test fails.
Put bed in Standby.
Contact Service

REPLACE BATTERY T

Source - MX40

Note — This INOP may

also be configured to
display as a Red or
Yellow Technical
Alarm.

Red or
Yellow
or Hard
Technic
al
Alarm,
Latched

Dead battery. No

monitoring is

occurring.
When operating

wirelessly, the patient

monitor is no longer

providing power to the

MX40, and battery

capacity is now

depleted.

Replace batteries.

Troubleshooting 8-5

Alarm Text

Priority

Condition

What to do

SpO2T EQUIP MALF

Source - MX40

Hard

Malfunction in the SpO2
equipment

Contact Service.

SpO2T ERRATIC

Source - MX40

Hard

Erratic SpO2
measurements, often due
to a faulty sensor or
invalid SpO2
measurements, or
incorrect transducer
position

Repeat measurement,
reposition sensor on patient,
or finally, replace sensor.

SpO2T EXTD UPDATE
Numeric is replaced by a

-?-.

Source - MX40

Soft

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

If NBP is not active, check
the sensor placement.
Reposition the sensor on
patient, or replace sensor.

SpO2T LOW PERF

Source - Monitor

Soft

Accuracy may be
reduced due to low
perfusion. Data displayed
with ?.

Increase perfusion. Change
sensor site. Avoid site distal
to BP cuff or intra-arterial
line. Warm the site.

SpO2T INTERFERENCE

Source - MX40

Hard

Level of ambient light or
level of electrical
interference are so high
that the SpO2 sensor
cannot measure SpO2
and pulse rate.

Reduce ambient light to
sensor or electrical noise
sources.

SpO2T NO SENSOR

Note — Silencing this

technical alarm turns off
the SpO2 measurement
on the MX40 only (not at
the Information Center).

Source - MX40

Hard

No sensor attached to
SpO2 device.

Attach SpO2 sensor.

%SpO2T NOISY SIGN

Source - MX40

Hard

Excessive patient
movements or electrical
interference are causing
irregular pulse patterns

Reduce movement or
electrical noise sources.

8-6 Troubleshooting

Alarm Text

Priority

Condition

What to do

SpO2T NO PULSE

Source - MX40

Note — When paired

directly with an IntelliVue
MP5 Patient Monitor, the
INOP will display as
SpO2T SENSOR OFF.

Hard

Pulse is too weak or

not detectable
Sensor has fallen off

at patient.

Check connection to

patient.
Change sensor site. Avoid

site distal to BP cuff or

intra-arterial line.

SpO2 POOR SIGNAL

Source - MX40

Soft

Although a measurement
may be possible, its
accuracy may be
reduced due to poor
signal quality.

Apply the sensor

according to the

manufacturer's

instructions.
Relocate the sensor to a

different site on the

patient.

SpO2T SEARCHING

Source - MX40

Soft

The patient signal is
analyzed, but a valid
numeric is not available
yet.

Wait for the measurement to
complete.

SpO2T SENSOR OFF

Note — The ability of

the algorithm to detect
this condition depends
on the sensor type in
use.

Hard

The algorithm has
determined that a sensor
is connected, but not
properly applied to the
patient.

Apply the sensor

according to the

manufacturer's

instructions.
If the condition persists,

relocate the sensor to a

different site on the

patient.

SpO2T SENSOR MALF

Source - MX40

Hard

Malfunction of the SpO2
sensor/adapter cable

Replace sensor.

SpO2 UNKN SENSOR

Source - MX40

Hard

The connected SpO2
sensor and/or adapter
cable is not supported by
the hardware version.

Use specified sensor and/or
adapter cable.

SpO2T UPGRADE
Source - MX40

Soft

SpO2 hardware is in
upgrade process.
Monitoring is not
possible.

Wait for the upgrade process
to complete.

TELE BATTERY LOW
Source - MX40

Soft

Lithium-ion battery level
is < 20% or has <30
remaining time.

Insert a charged lithium-ion
battery pack.

Troubleshooting 8-7

Alarm Text

Priority

Condition

What to do

TELE BATT EMPTY

Note — This INOP may

also be configured to
display as a Red or
Yellow Technical Alarm.

Source - MX40

Note — For Information

Center Release L or M,
this INOP will appear as
"REPLACE BATTERY
T".

Hard,
Latched

Lithium-ion battery level
is critically low. A
10-minute countdown
begins. The MX40 will
shut down if the condition
is not cleared.

Insert a charged lithium-ion
battery pack.

TELE BATTERY TEMP
Source - MX40

Note — For Information

Center Release L or M,
this INOP will appear as
"REPLACE BATTERY T"

Hard

The temperature of the
lithium-ion battery is
above 55o C or below -5o
C.

Replace the lithium-ion
battery.

TELE CHECK BATT
Source - MX40

Soft

Lithium-ion battery has <
25 charge cycles
remaining before
reaching the charge
cycle maximum limit.

Be aware that the Lithium-ion
battery pack will soon need
replacement.

TELE MALFUNCTION

Source - MX40

Hard

MX40 malfunction or
self-test failure.

Contact Service to replace
the MX40.

TRANSMITTER OFF

Source - MX40

Hard

RF Auto Shutoff after 10
minutes of all leads off
and no SpO2 sensor
connected.

Reattach ECG leads to

patient.
Reattach SpO2 sensor.

TELE REMOVE BATT
Source - MX40

Note — For Information

Center Release L or M,
this INOP will appear as
"REPLACE BATTERY
T".

Hard,
Latched

The temperature of the
lithium-ion battery is >60o
C and the battery must
be removed.

Replace the lithium-ion

battery.
Dispose of old battery

properly.

TELE SERVICE BATT
Source - MX40

Hard

The lithium-ion battery
has exceeded the
maximum charge cycle
limit and reached the end
of its useful life.

Replace the lithium-ion

battery.
Dispose of old battery

properly.

8-8 Troubleshooting

Alarm Text

Priority

Condition

What to do

TELE WEAK SIGNAL

Source - MX40

Soft

Patient is at outer

range of the radio

coverage area.
The MX40 is receiving

a weak signal with

high data loss from

the AP.
Condition exists for

multiple devices in a

specific area

Return patient to the

coverage area.
If patient is in close

proximity to AP, replace

the MX40. Contact

service.
The AP covering the

specific area is suspect.

Contact Service

Troubleshooting 8-9

Possible User Interface Issues

The MX40 display does not turn on.

The AA Battery Tray may be inserted backwards.

The user may not understand that they need to touch the blue Main
Screen button for two seconds.

The MX40 display does not react to touch.

8-10 Troubleshooting

The screen is locked and needs to be unlocked using the Unlock
SmartKey.

The user is not using their finger to touch the screen. The MX40 does
not react to touches by a fingernail, pen, etc.

The MX40 does not not recognize the patient cable type.

The IntelliVue style leadset adapter cable is being used, therefore,
detection of the cable type is not possible. Configure the MX40 for the
desired settings:

ECG Cable Color, using the Configuration Menu in Configuration

Mode.

Lead Placement, using the HR Menu in Configuration Mode.

If using a 3-wire IntelliVue leadset, it must be selected using the Setup
ECG menu and then selecting the New Lead Setup entry. This will

remove the INOP message.

Troubleshooting 8-11

Regulatory Information ............................................................................ 9-2

Electromagnetic Compatibility ................................................................ 9-6

Battery Specifications .............................................................................. 9-12

Lithium-ion Battery Charge Time ......................................................... 9-15

Physical Specifications ............................................................................ 9-16

MX40 1.4 GHz Radio ............................................................................... 9-17

MX40 2.4 GHz Radio ............................................................................... 9-18

MX40 Short-Range Radio ....................................................................... 9-20

Environmental Specifications ................................................................ 9-21

Measurement Specifications .................................................................. 9-22

9. Safety Standards &
Specifications

This section describes the regulatory standards that the IntelliVue MX40
complies with, along with product and measurement specifications.

Safety Standards & Specifications 9-1

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.

Industrie Canada Compliance (Canada)

This Class B ISM device complies with Canadian ICES-001.

Cet ISM de la classe B est conforme à la norme NMB-001 du Canada.

Safety Standards

The device complies with the following safety requirements for medical
electrical equipment:

EN 60601-1:1990 + A1:1993 + A2:1995 +A11:1993 +A12:1993 + A13:1996

General Requirements for Safety (with worldwide deviations, including
U.S. deviations)

CSA C22.2 #601.1:1992 Medical Electrical Equipment - General Safety
UL 60601-1 Medical Electrical Equipment - General Safety
UL 2054 Standards for Household and Commercial Batteries
EN 60601-1-1:2006 System Requirements
EN 60601-1-4:2000 Safety Requirements for Programmable Electronic

Medical Systems

EN 50371:2005 Low Power Electronic and Electronic Apparatus

Electromagnetic Exposure

EN ISO 9919:2005 Requirements for SpO2 Pulse Oximeters
EN ISO 10993-1:2003 Biocompatibility
EN ISO 10993-1:2003 Biocompatibility (for leadwires and pouch)

9-2 Safety Standards & Specifications

EN ISO 9919:2005 Pulse Oximeters
IEC 60601-1-2:2001 Electromagnetic Compliance
IEC 60601-1-4:1999 +A1 Requirements for Programmable Electrical

Medical Systems

IEC 60601-1-6:2006 General requirements for basic safety and essential

performance - Collateral standard: Usability

IEC 60601-1-8:2006 General Requirements for Safety for Alarm Systems
IEC 60601-2-49:2001 Particular Requirements for Safety for Patient

Monitoring Equipment

IEC 60601-2-27:2005 Particular Requirements for Safety for

Electrocardiograph Monitoring Equipment

IEC 62133:2002 Safety Requirements for Portable Sealed Secondary Cells

(alkaline, lithium-ion)

AAMI EC 13:2007 Performance Standard, Cardiac Monitors
AAMI EC 53:1995 (R) 2001 ECG Cables/Leadwires (excluding 4.2.1)

Intended Use Statement

Intended for monitoring and recording of and to generate alarms for,
multiple physiological parameters of adults and pediatrics in a hospital
environment and during patient transport inside hospitals. Not intended
for home use. Intended for use by health care professionals.

Indications for Use

Indicated for use by health care professionals whenever there is a need for
monitoring the physiological parameters of patients. Intended for
monitoring and recording of, and to generate alarms for, multiple
physiological parameters of adults and pediatrics in hospital environments
and during transport inside hospitals.

Safety Standards & Specifications 9-3

Intended Uses of MX40

The MX40 is to be used primarily as a traditional telemetry medical device.
It connects to the IntelliVue Information Center by way of a wireless
network. When the MX40 is connected the IntelliVue Information Center
the IntelliVue Information Center provides the primary patient monitoring
and alarming function. The MX40 does not automatically provide local
monitoring or alarming when connected to the Information Center.

The MX40 can provide time-limited local monitoring when it is not
connected to the wireless network.

Unlike a traditional bedside monitor which operates on AC power, the
MX40 is powered by battery and cannot provide continuous monitoring.

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.

Use of the device is restricted to one patient at a time.

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.

9-4 Safety Standards & Specifications

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
M3290 Information Center Software.

The System achieves its Essential Performance exclusively through alarm
generation at the M3140-55 IntelliVue Information Center and locally at the
MX40, based on configuration.

The IntelliVue MX40 protects the patient from unacceptable immediate
clinical risk by generating specific Physiological Alarms when appropriate.
If the system cannot generate Physiological Alarms, then relevant Severe or
Hard-Level Technical Alarms (Inops) are created.

Safety Standards & Specifications 9-5

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.

Radio frequency (RF) interference from nearby transmitting devices can
degrade performance of the product. Electromagnetic compatibility with
surrounding devices should be assessed prior to using the product.

Fixed, portable, and mobile radio frequency communications equipment
can also affect the performance of medical equipment. See your service
provider for assistance with the minimum recommended separation
distance between RF communications equipment and the product.

The cables, sensors/transducers, and other accessories for which compliance
is claimed are listed in the Service and User documentation accompanying
the product.

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.

9-6 Safety Standards & Specifications

Reducing Electromagnetic Interference

The MX40 and associated accessories can be susceptible to interference
from other RF energy sources and continuous, repetitive, power line bursts.
Examples of other sources of RF interference are other medical electrical
devices, cellular products, information technology equipment, and
radio/television transmission. If interference is encountered, as
demonstrated by artifact on the ECG or dramatic variations in physiological
parameter measurement values, attempt to locate the source. Assess the
following:

Is the interference due to misplaced or poorly applied electrodes or

sensors? If so, re-apply electrodes and sensors correctly according to
directions in Chapter 6.

Is the interference intermittent or constant?
Does the interference occur only in certain locations?
Does the interference occur only when in close proximity to certain

medical electrical equipment?

Once the source is located, attempt to attenuate the interference by
distancing the MX40 from the source as much as possible. If assistance is
needed, contact your local service representative.

Restrictions for Use

Artifact on ECG and other physiological waveforms caused by
electromagnetic interference should be evaluated by a physician or
physician authorized personnel to determine if it will negatively impact
patient diagnosis or treatment.

Electromagnetic Compatibility (EMC) Specifications

Take special precautions regarding electromagnetic compatibility (EMC)
when using medical electrical equipment. You must operate your
monitoring equipment according to the EMC information provided in this
book. Portable and mobile radiofrequency (RF) communications equipment
can affect medical electrical equipment.

Accessories Compliant with EMC Standards

All accessories listed in the accessories section comply, in combination with
the MX40, with the requirements of IEC 60601-1-2:2001 + A1:2004.

Safety Standards & Specifications 9-7

Emissions Test

Compliance

Avoiding Electromagnetic
Interference

Radio Frequency
(RF) emissions

Group 1

TheMX40 uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.

RF emissions
CISPR 11

Class B

The MX40 is suitable for use in all
establishments.

Harmonized
emissions

Not Applicable

Device is battery powered only

Voltage
fluctuations/Flicker
emissions
IEC 61000-3-3

Not Applicable

Warning

Using accessories other than those specified may result in increased
electromagnetic emission or decreased electromagnetic immunity of the
monitoring equipment.

Electromagnetic Emissions

9-8 Safety Standards & Specifications