Philips IntelliVue TRx Instructions For Use Manual

IntelliVue TRx/TRx

Transceivers

for the Philips IntelliVue Telemetry System with Smart-Hopping Technology

Notice

Operation of this equipment in the United States requires the prior coordindation with a frequency coordinator designated by the Federal Communications Commission (FCC) for the Wireless Medical Telemetry Service.

Instructions for Use

Part Number: M4841-91001 Printed in the U.S.A. November 2004 First Edition

Printing History

Notice Equipment specifications are subject to alteration without notice. All changes

will be in compliance with regulations governing manufacture of medical equipment.

Printing History

New editions of this document will incorporate all material updated since the previous edition. Update packages can 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 ...............................................................................November 2004

Philips IntelliVue Telemetry System with Smart Hopping Technology is compatible with:

Philips Information Center, software revision F.00 Philips TeleMon Companion Monitor, #A02/A03

About this Book

This book contains operating instructions for use of the IntelliVue TRx and TRx Smart-hopping Technology. It also includes operational information for the Telemetry functions of the IntelliVue Information Center. The intended audience is the clinician who uses and/or teaches others to use the equipment in a healthcare environment. For operating information on other functionality of the Information Center, see IntelliVue Information Center Instructions for Use. For preventive maintenance, repair, and test methods for verification of device performance, refer to the Philips IntelliVue Telemetry System Service Kit.

This book does not address the Philips M2601B Transmitter or the M2600B Philips Telemetry System. For information on those products, refer to the manual Philips Telemetry System Instructions for Use.

Note—Use this product in conjunction with Philips IntelliVue Information

Center Instructions for Use and Online Help, and with Philips TeleMon A02/ A03 Companion Monitor Instructions for Use. See also the Philips IntelliVue Telemetry Training Program.

About this Book

Transceivers as used with the Philips IntelliVue Telemetry System with

Document Conventions

Warnings

WarningWarning

Warnings are information you should know to avoid injuring patients and personnel.

Cautions

Caution

Cautions are information you should know to avoid damaging your equipment and software.

iii

Product Safety Information

Notes

Note—Notes contain additional information on use of the Philips IntelliVue

Telemetry System.

Procedures

Procedures are indicated in text by the heading “Task Summary” followed by the following table:

Step

Action

1 2 3

Bold Typeface

Objects of actions in procedures appear in example:

Select the

Standby button.

Product Safety Information

The following general warnings and cautions apply to use of the Philips IntelliVue Transceivers in a Philips IntelliVue Wireless Network. Additional warnings and cautions specific to a particular feature are provided in the appropriate section.

bold typeface. Note the following

General

WarningWarning

For continued safe use of this equipment, it is necessary that the listed instructions are followed. Instructions in this manual in no way supersede established medical procedures.

Product Safety Information

WarningWarning

Do not touch the patient, or table, or instruments, during defibrillation. The battery door must be closed during defibrillation. These steps protect the clinician from high defibrillator voltage.

WarningWarning

This device is not to be used in the vicinity of electrosurgical units because use may interrupt or interfere with the transmission of signals from the transceiver.

WarningWarning

This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

WarningWarning

Do not use patient cables with detachable lead wires that have exposed male pins. Electrocution could result if these pins are plugged into AC power.

WarningWarning

Use of product accessories (e.g., ECG leadsets, SpO2 sensors) other than those prescribed by Philips could lead to patient injury.

WarningWarning

To avoid strangulation, do not tie a pouch solely around the patient’s neck.

Product Safety Information

ECG/ Arrhythmia All Patients

WarningWarning

ECG SAFETY FOR ALL PATIENTS

Always confirm Information Center observations with clinical observation of the patient before administering interventions.

Every lead must be secured to an electrode on the patient. Conductive parts of electrodes must not contact earth or other conductive parts.

Philips recommends that you change the lead label only to reflect the physical placement of electrodes. This will ensure a match between the monitored lead and the label, and prevent any possible confusion.

When switching between EASI and standard monitoring, there is a loss of data for 30 seconds.

Product Safety Information

WarningWarning

ST/AR ARRHYTHMIA SAFETY FOR ALL PATIENTS

During complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) can be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest.

Learning/Relearning

- If you initiate learning during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib.

- When using EASI ECG monitoring, Relearn happens automatically when there is a LEADS OFF technical alarm. If learning takes place during ventricular rhythm, the ectopics can be incorrectly learned as the normal QRS complex. This can result in missed detection of subsequent events of V-Tach and V-Fib. Be sure to check the beat labels and initiate a relearn to correct. Therefore, when a technical alarm is generated:

1. Respond to the technical alarm [for example, reconnect the electrode(s)].

2. Ensure that the arrhythmia algorithm is labeling beats correctly.

vii

Product Safety Information

ECG/ Arrhythmia Paced Patients

WarningWarning

ECG SAFETY FOR PACED PATIENTS

The output power of the transceiver and other sources of radio frequency energy, when used in the proximity of a pacemaker, can be sufficient to interfere with pacemaker performance. Due to the shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring any paced patient.

In order to minimize the possibility of interference, position electrodes, electrode wires, and the transceiver as far away from the pacemaker as possible.

Consult the pacemaker manufacturer for information on the RF susceptibility of their products and the use of their products with the Philips IntelliVue Telemetry System. See the IntelliVue Information Center Instructions for Use for additional information on monitoring paced patients.

viii

Product Safety Information

WarningWarning

ST/AR ARRHYTHMIA SAFETY FOR PACED PATIENTS

It is possible that pacemaker pulses will not be detected when the ECG analog output of a defibrillator or telemetry unit is plugged into a bedside monitor. This can result in the arrhythmia algorithm’s failure to detect pacemaker non-capture or asystole.

Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias. Keep pacemaker patients under close observation.

-- During complete heart block or pacemaker failure (to pace or capture), tall P-waves (greater than 1/5 of the average R-wave height) can be erroneously counted by the arrhythmia algorithm, resulting in missed detection of cardiac arrest.

-- When arrhythmia monitoring paced patients who exhibit only intrinsic rhythm, the monitor can erroneously count pace pulses as QRS complexes when the algorithm first encounters them, resulting in missed detection of cardiac arrest.

For patients who exhibit intrinsic rhythm only, the risk of missing cardiac arrest can be reduced by monitoring these patients with the low heart rate limit at or slightly above the basic/demand pacemaker rate. A low heart rate alarm alarms you when the patient begins pacing. Proper detection and classification of the paced rhythm can then be determined.

-- When an external pacemaker is being used on a patient, arrhythmia monitoring is severely compromised due to the high energy level in the pacer pulse. This can result in the arrhythmia algorithm’s failure to detect pacemaker non-capture or asystole.

Product Safety Information

SpO

WarningWarning

SpO2 SAFETY

Always confirm Information Center observations with clinical observation of the patient before administering interventions.

Prolonged, continuous monitoring can increase the risk of changes in skin characteristics, such as irritation, reddening, blistering or pressure necrosis, particularly on patients with impaired perfusion and varying or immature skin morphology. Specific attention must be given to sensor site inspection for changes in skin quality, proper optical path alignment and attachment. Check the application site at regular intervals and change the site if any compromise in skin quality should occur. More frequent checking can be required due to an individual patient's condition.

Using a sensor during MR imaging can cause severe burns. To minimize this risk, ensure that the cable is positioned so that no inductive loops are formed. If the sensor does not appear to be operating properly, remove it immediately from the patient.

Do not use disposable sensors on patients who exhibit allergic reactions to the adhesive.

Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin can lead to inaccurate (over-estimated) measurements.

Interference leading to inaccurate measurements can be caused by:

- High levels of ambient light (Hint: cover application site with opaque material)

- Electromagnetic interference

- Excessive patient movement and vibration.

Content s

General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-iv

ECG/ Arrhythmia -All Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-vi

ECG/Arrhythmia - Paced Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-viii

SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-x

1. Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

The Philips IntelliVue Telemetry System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

System Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

The IntelliVue Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Transceiver Controls - Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Transceiver Controls - Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Turning the Transceiver On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

Turning the Transceiver Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

Testing intelliVue Transceiver Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17

Self Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17

Status Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18

Battery Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19

Battery Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19

Inserting/Removing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20

Checking the Battery Power Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22

Briefing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24

Pouch Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

Securing the Pouch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25

Showering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26

Transceiver Use with TeleMon A02/A03. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27

2. Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Alarm Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Testing Alarm Indicators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

Suspending/Pausing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2

Resuming/ Unsuspending Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Alarm Behavior with Own Bed Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Physiologic Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Technical Alarms (INOPs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Contents-1

3. ECG Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

ECG Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-2

Measuring ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

EASI ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

ECG Leadsets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-3

ECG Leads Monitored. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Positioning ECG Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Electrode Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Connecting the ECG Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-19

Verifying Electrode Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-22

Monitoring during Leads Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

ECG Fallback. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-23

Extended Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24

Relearning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24

Using EASI Leads to Troubleshoot. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24

Optimizing ECG Measurement Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-25

The Telemetry Signal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25

Trouble- shooting Signal Disturbances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26

Dropouts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26

Muscle and Movement Artifact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27

4. ST/AR Arrhythmia & ST Segment Monitoring. . . . . . . . . . . . . . . . . . . . . . . . 4-1

ST/AR Arrhythmia Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2

Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2

ST/AR Arrhythmia Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

ST/AR ST Segment Algorithm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

The Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6

Algorithm Processing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

Displayed ST Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

EASI ST Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8

ST Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-9

ST Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

5. SpO2 Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1

SpO2 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2

SpO2 Information for the User . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3

Pulse Oximetry Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4

Pulse Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Selecting a SpO2 Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Applying the Sensor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9

Contents-2

Sensor Application Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9

Site Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9

Sensor Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10

Connecting the SpO2 Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-14

Measuring SpO

2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Spot Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-15

Continuous. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16

SpO

Measurement when Connected to TeleMon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-17

Turning SpO2 Monitoring Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-18

Turning the SpO2 Parameter On/Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19

SpO

Parameter Auto ON. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19

Understanding SpO2 Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20

Optimizing SpO2 Measurement Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21

Optimizing Sensor Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-22

6. Telemetry Functions at the Information Center . . . . . . . . . . . . . . . . . . . . . . . 6-1

Telemetry Controls in the Patient Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2

Locating the Transceiver (Find Device) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3

To locate a transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3

To silence the sound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3

Patient-Configurable Settings in Telemetry Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3

Unit-Configurable Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8

7. Maintenance & Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2

Basic Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2

Label Assignment for Replacement Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2

Transceiver Cleaning, Disinfection, & Cross-Infection Prevention . . . . . . . . . . . . . . . . . . . . . . .7-4

Cleaning the Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-5

Disinfecting the Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6

Cross-Infection Prevention for the Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-7

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15

Basic Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15

Testing Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15

Information Signals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-15

8. Safety Standards & Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-1

Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

Contents-3

Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Rx. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Patient Population . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2

Safety Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-2

Essential Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

System Classification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-3

FCC Compliance (USA only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-4

AC Power Source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Battery Life Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-5

Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-6

Restrictions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8

Radio Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8

M4841A Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-8

WMTS Channel Frequencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10

Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11

ECG-only Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11

ECG/SpO2 Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-12

Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-12

M4841A Transceiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-12

Measurement Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-13

ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-13

SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15

SpO2 Sensor Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-16

A. Accessory List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

Accessory Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

ECG Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

Leadsets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

Trunk Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Pouches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Skin Prep Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

Alignment Guides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Gunk Guards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

SpO2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Reusable Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Disposable Sensors - Single Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5

Wristband. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6

B. Sales and Support Offices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

Contents-4

Basic Operation

This chapter introduces the Philips IntelliVue Telemetry System with Smarthopping Technology and the IntelliVue TRx and TRx the following sections:

• The Philips IntelliVue Telemetry System. . . . . . . . . . . . . . . . . . . . . . . 1-2

• The IntelliVue Transceiver. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

• Turning the Transceiver On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

• Testing intelliVue Transceiver Functionality . . . . . . . . . . . . . . . . . . . 1-17

• Battery Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

• Pouch Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24

• Transceiver Use with TeleMon A02/A03. . . . . . . . . . . . . . . . . . . . . . 1-27

Transceivers. It includes

Introduction

Basic Operation 1-1

The Philips IntelliVue Telemetry System

The Philips IntelliVue Telemetry System with Smart-hopping Technology provides ambulatory and bedside monitoring of ECG and SpO the radio frequency (RF) spectrum newly allocated for medical telemetry applications by the Federal Communications Commission (FCC). The System enables clinically significant data and control information for adult and pediatric patients in healthcare facilities to be received from and sent to the transceiver, a patient-worn device, via a bi-directional RF link over the Wireless Medical Telemetry Service (WMTS) spectrums 1395-1400 MHz and 1427-1432 MHz.

The System uses smart-hopping technology to dynamically manage the RF spectrum utilization per transceiver, thus allowing a virtually unlimited number of simultaneously operating transceivers within the Philips IntelliVue Telemetry System. The frequency-agile system changes frequency without user involvement or awareness whenever interference occurs.

The System encompasses a number of individual units which connect together to form a complete method of transporting ambulatory patient data to a central repository for subsequent distribution to clinical staff. An installation typically consists of the following components:

parameters over

1-2 Basic Operation

• M4841A Transceivers, bi-directional patient-worn devices

• M4842A Access Points (AP), centers for bidirectional communication between the transceivers and the Information Center.

• IntelliVue Wireless Network (IWN) infrastructure (including M4843A Access Point Controllers, M4844A Sync Units, M4845A Power Supply Units)

• M3150A IntelliVue Information Center for centralized monitoring

• M3154A IntelliVue Database Server (optional) for centralized data management

• M2636A TeleMon A02/A03 Companion Monitor (optional) for local display, NBP measurement and local alarms.

The network interconnects Access Points to the Information Center and other central equipment via the same network that connects IntelliVue bedsides to the Information Center. Access points receive signals, and unlike traditional antenna systems, can communicate bidirectionally. Access Points are powered, controlled and managed remotely via the IWN.

The IntelliVue Transceiver

System Features

• Full patient mobility within the areas defined by the wireless coverage

provided by multiple Access Points.

• Expanded geographic coverage area for a a given patient assigned to an

IntelliVue Clinical Network. Physiological data is transported from the transceiver; a reverse data channel enables data to be transported to the transceiver.

• 3-minute Alarm Pause/Suspend initiated at the transceiver.

• Standby mode when a patient is away from the unit and not being

monitored by the Philips IntelliVue Telemetry System.

• Find Device feature for locating a lost transceiver within the coverage

area.

• Access Points operating concurrently with the networked bedside wireless

capability while sharing some of the ICN infrastructure.

• Use of the radio spectrums newly allocated by the FCC specifically for

medical telemetry applications.

• Connectivity to TeleMon for display of patient measurements - including

NBP - at the bedside.

diagram to come

The IntelliVue Transceiver

The Philips IntelliVue transceiver is a patient-worm device for monitoring ECG and SpO

System Information Flow/Smart-hopping

on adult and pediatric patients in the IntelliVue Telemetry System

Basic Operation

1-3

The IntelliVue Transceiver

with Smart-Hopping Technology, a cellular infrastructure network. The transceiver combines traditional transmitter features with two-way communication capability with the IntelliVue Information Center. The transceiver is designed to be easy for clinicians to use and comfortable for patients to wear. Colored labels provide departmental identifiers. The leadsets are optimized for ambulating patients, with a cable length of 79 cm (30 inches). Protective covers prevent dirt from accessing unused ECG and SpO thus simplifying cleaning.

cable ports,

The transceiver is available in two models, the ECG only called the IntelliVue TRx, and the ECG-SPO2 version, called the IntelliVue TRx

. The models are listed below and illustrated on the following pages in this chapter. Subsequent tables describe the buttons, indicators, labels, ports, safety symbols & other markings, and auditory information signals of the transceiver respectively.

Transceiver Model

(M4841A) Measurements

IntelliVue TRx ECG

IntelliVue TRx

ECG, SpO

The transceiver comes with a start-up kit of batteries, electrodes, and pouches.

1-4 Basic Operation

M2601B

IntelliVue TRx

M4841A

EASI, 3

The IntelliVue Transceiver

5,6

Transceiver

Features

IntelliVue TRx Transceiver - ECG only

Note— The IntelliVue Transceiver and M2601B Transmitter are similar in

appearance. If your hospital uses both, you can distinguish between them by:

• Name on the front of the device

• Label background color (pale gray for transceivers, dark gray for transmitters)

• Clinician-selectable 5-lead Standard or EASI leads in same device, at the bedside

• 6-leadset with two V leads for diagnosing multiple cardiac abnormalities, including wide-QRS complex tachycardias and acute myocardial ischemia/infarction

• Powered by two AA Alkaline batteries

• Spot-Check SpO

without using any control buttons

Basic Operation

1-5

The IntelliVue Transceiver

•FAST-SpO2 (Fourier Artifact Suppression Technology) for improved motion artifact rejection and low-perfusion performance

• Audio feedback for Spot Check SpO

completion and other common tasks

• Simultaneous operation in system with M2601A Transmitter

• Two sizes - smaller ECG only version and larger ECG/SpO

version

• Battery gauge on transceiver and, if configured, at Information Center

• Colored labels provide clinical unit identifiers.

• Leadsets are optimized for ambulating patients, with a cable length of 79 cm (30 in).

• Gunk guards prevent debris from accessing unused ECG and SpO

cable

ports and the unused TeleMon/Service port, thus simplifying cleaning.

• Pouch with clear front and flap.

Use with

Information

Center

Use with

TeleMon A02/A03

The bi-directional capability enables remote control from the Information Center of the following transceiver operations:

• From the Telemetry Setup Window:

–SpO

measurement mode (Spot Check, Continuous, or Off)

– Display and storage of real-time pleth wave (enable/disable) – Volume of audible transceiver information signals – Find device – Suppression of SpO

technical alarms during NBP measurement

• From the Patient Window

– Standby mode – Filter bandwidth for ST measurement on/off – Alarm Pause/Suspend (enable/disable)

• From Unit Settings

– Display of battery gauge (enable/disable) – 3-wire Lead Selection

The system supports Own Bed Overview, the pairing of a telemetry bed with an IntelliVue Patient Monitor (Release B or higher) for a single patient. Own Bed Overview provides the telemetry-monitor data (waveforms, numerics and alarms) in an integrated form both on the bedside monitor and at the IntelliVue Information Center.

The transceiver can employ the full functionality of the TeleMon A02/A03 companion monitor, including NBP measurement and local display of alarms. Connection is made through an interface cable, or tether, at the TeleMon service

1-6 Basic Operation

port. Please refer to the TeleMon A02/A03 Instructions for Use for general operating instructions and “Transceiver Use with TeleMon A02/A03” on page 1-27 for an operational summary.

Transceiver Controls - Front

The IntelliVue Transceiver

IntelliVue T R x

M4841A

EASI, 3

5,6

I1 I2

I3 I4

The labeled items in the diagram include: Buttons (B1-B3); Indicators (I1-I4); Labels (L1-L4); Ports (P1-P3). Additional Labels, and Safety Symbols & Other Markings (S1-S12, appear on the back of the transceiver.

IntelliVue TRx+ Transceiver - Front View

L2 L3

Basic Operation

1-7

The IntelliVue Transceiver

Buttons

IntelliVue TRx

M4841A

EASI, 3

5,6

Callout Button Definition

B1 B2

B1 Telemetry Button: Depending on configuration,

B2 Check Button. Initiates a Status Check of the

directs the Information Center to generate a Nurse Call alarm, remote recording, Nurse Call alarm and recording, or none. See “Patient-Configurable Settings in Telemetry Setup” on page 6-3.

Note—Delayed recordings generated by the

Telemetry button are stored in Alarm Review at the Information Center.

When pressed simultaneously with the Check button, turns Alarm Suspend/Pause on/off (not when tethered to TeleMon). See “Suspending/ Pausing Alarms” on page 2-2.

Transceiver. See “Status Check” on page 1-18.

1-8 Basic Operation

When pressed simultaneously with the Telemetry Button, turns Alarm Suspend/Pause on/off (not when tethered to TeleMon). See “Suspending/ Pausing Alarms” on page 2-2.

Silences the Find Device tone.See “Telemetry Controls in the Patient Window” on page 6-2.

B3 Power On/Off Battery Compartment. Insertion of batteries

turns transceiver power on; removal of batteries turns power off. See “Turning the Transceiver On” on page 1-15.

I1 I2 I3

Indicators

IntelliVue TRx

M4841A

EASI, 3

5,6

The IntelliVue Transceiver

Callout Indicator Definition

I1 Lead Indicator.

Illuminates momentarily during leadset insertion to indicate attached leads.

Illluminates when Check button is pressed to indicate attached leads.

During a Leads Off condition, illuminates to indicate the lead(s) that need to be reapplied.

Momentarily illuminates three alternate lights, indicating the transceiver has no Equipment Label assigned.

I2 EASI Indicator. Illuminates momentarily

upon insertion of leadset in EASI position.

EASI

Illuminates when Check button is pressed if EASI is in use.

I3 Alarms Suspend/Pause Indicator.

Illuminates during 3 minute alarm pause initiated at transceiver or Information Center.

I4 Battery Gauge. Illuminates when the EHck

button is pressed to indicate the amount of power remaining in the batteries. Valid only for recommended battery type. See “Checking the Battery Power Level” on page 1-22.

Basic Operation

1-9

The IntelliVue Transceiver

Labels

IntelliVue TRx

M4841A

EASI, 3

5,6

Callout Label Definition

L1 Leadset Insertion Guide. Assist in aligning

IntelliVue TRx M4841A

EASI, 3

the ECG cable for different leadsets. See “Connecting the ECG Cable” on page 3-19.

5,6

Note—If your unit uses only one monitoring

configuration, the transceiver may have special "lock out" plugs that allow only one way to insert the leadset.

L2 Device Identification Label. Identifies the

device within the IntelliVue Wireless Network.

L3 Unit Identification Label. Uses one of

seven color-coded labels to identify a clinical unit.

Ports

IntelliVue TRx

M4841A

EASI, 3

5,6

Callout Definition

Note— Ports can be covered with protective covers (gunk guards) when not in

use. See “Gunk Guards” on page -4.

1-10 Basic Operation

P1 ECG Leadset Port. Connection for 3-wire or 5-wire leadset.

P2 SpO

Sensor Port. Connection for SpO2 sensor. (IntelliVue TRx+

only)

P3 TeleMon/Service Port. Connection for cable to TeleMon

Companion Monitor or to Service Tool.

Transceiver Controls - Back

EASI

FCCID: XXXXXXXX

The IntelliVue Transceiver

S7-S11 not shown

(inside battery compartment)

S2 S3

IntelliVue TRx+ Transceiver - Back View

Basic Operation

1-11

The IntelliVue Transceiver

Labels

EASI

Safety

Symbols &

Other Marks

345

Callout Definition

L4 Electrode Placement Diagrams (See “Positioning ECG

Electrodes” on page 3-8.)

Callout Label Definition

FCCID: XXXXXXXX

Federal Communications Commission (FCC) (PTT) label

S2 Patient connections are protected against

defibrillation (DEFIBRILLATIONPROOF) and are a TYPE CF APPLIED PART.

S3 Prescription device.

1-12 Basic Operation

S4 Non-Ionizing Radiation. Interference to

electronic equipment may occur in the vicinity of devices marked with this symbol.

Complies with all applicable Canadian and American standards.

The IntelliVue Transceiver

Callout Label Definition

S6 Follow operating instructions.

S7 Philips Catalog Number

REF

S8 Serial Number (inside battery

compartment). Needed to identify the

S9 MAC Address of device

equipment during a call to the Response Center.

MAC

Auditory

Information

Signals

S10 Date of manufacture

S11 Battery Polarity

The transceiver produces auditory feedback to inform you of measurement and battery conditions. Adjustable sounds can be set to 5 different volume levels or turned off per patient at the Information Center (see “Patient-Configurable Settings in Telemetry Setup” on page 6-3). Adjustable sounds include Check

Basic Operation

1-13

The IntelliVue Transceiver

button Standby functions, SpO2 measurement complete, outside of coverage area warning, and the pulse detection tone.

Auditory Information Signal

Definition

Single Tone Self Test passed

SpO

Spot Check measurement successfulnoyes

Single Tone, low pitch Pulse detection successful (when locally

initiated)

Double Tone Self Test failed

SpO

Spot Check measurement failed

Double Tone repeated

Out of range yes

every 5 seconds

Continuous Double

Find Device no

Tone, two pitches

Single Tone (when Check button pressed)

Double Tone (when Check button pressed)

Transceiver is associated with sector at Information Center (after Standby).

Transceiver not associated with sector at Information Center (after Standby).

Volume/Mute Adjustable

yes

no yes

yes

Double Tone and all indicators flashing

Fast Double Tone and alternate Leads Off indicators flashing

1-14 Basic Operation

No equipment label is assigned from Information Center. No monitoring.

Equipment label is received from Information Center and is awaiting local acknowledgment by Check button press.

Transceiver

Safety

Information

Turning the Transceiver On

WarningWarning

If another radio medical device is operating at the same frequency as an IntelliVue Transceiver, it is possible that either device will not function properly.

WarningWarning

Although the transceiver is shielded against Electromagnetic Interference (EMI), avoid the use of other electrically radiating devices in close proximity to the transceiver because they might interfere with transceiver operation.

WarningWarning

Place the transceiver in a pouch or over clothing, or both, during patient use. The transceiver should not touch the patient’s skin during use.

Turning the Transceiver On

WarningWarning

Arrhythmia relearning is initiated whenever the transceiver is powered down for one minute or longer. Be sure to check your patient’s arrhythmia annotation for accuracy whenever relearn has occurred.

The transceiver is powered by two AA alkaline batteries. To turn the transceiver on, insert both batteries. Remove the batteries to turn the power off.

The configuration data set by the Service Provider prior to transceiver use is retained after battery removal.

Basic Operation

1-15

Turning the Transceiver On

When the transceiver is turned on, all indicators illuminate briefly and a sequence of sounds indicates the instrument is ready for use. You should hear a single beep indicating that the self test was passed, followed by a series of double beeps while the transceiver attempts to associate with the Information Center. The cessation of sounds indicates a successful association. If you hear a single double beep or any other sound sequence, the automatic self-test of the device has not passed, or there is another problem. Contact your Service Provider.

Sounds at successful start-up

Self-test

insert batteries

Turning the Transceiver Off

Auto Shutoff Automatic Shutoff causes the transceiver to stop broadcasting a radio signal if

Turn off the transceiver by removing the batteries. A NO SIGNAL technical alarm will be in effect at the Information Center until the device is turned on or until Standby is initiated.

Telemetry monitoring can be turned off in the following ways:

• Manually, by activating Monitoring Standby at the Information Center (see “Standby Mode” on page 2-5).

• Automatically, if Transceiver RF Auto Shutoff is enabled and there is no ECG signal for 10 minutes.

Note—Turning off telemetry monitoring does not turn off the transceiver.

there is no ECG signal for 10 minutes. This prevents interference with other transceivers in use. The technical alarm text at the Information Center is Transmitter Off. To conserve battery power, remove batteries.

1 beep (pass)

Transceiver looking for Info Center

beep beep repeated every 3 seconds

Connected

no beep

1-16 Basic Operation

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Philips IntelliVue TRx Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual