Philips IntelliVue MX User manual

IntelliVue MX40

Installation and Service

Notice

Proprietary Information

This document contains proprietary information, which is protected by 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.

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STERRAD ® is a registered trademark of Advanced Sterilization Products.

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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

(978) 687-1501

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.

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.

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