Philips Medical Systems North America M4841A, M4842A Instructions for Use

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

Bold Typeface

Objects of actions in procedures appear in example:

Action

1 2 3

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

on adult and pediatric patients in the IntelliVue Telemetry System

System Information Flow/Smart-hopping

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

Testing intelliVue Transceiver Functionality

To restart monitoring, insert batteries if necessary, attach leads to the patient and press the Check button to verify association with the Information Center.

Testing intelliVue Transceiver Functionality

There are two tests of IntelliVue Transceiver functionality:

• Self Test -performed automatically each time the transceiver is turned on

• Status Check - initiated manually by the clinician.

Self Test

WarningWarning

Do not use the transceiver for patient monitoring if it fails the Power On Self Test.

In Case of

Failure

A self test of the transceiver functions is automatically performed each time that the transceiver is turned on (that is, batteries are inserted).

Self Test Status

Passed Single beep All indicators illuminate for 3 seconds

Failed Double beep One or more indicators do not light up.

If any portion of the self test fails, the transceiver will attempt to report the failure to the monitoring system. In case of failure, use another transceiver, and contact your Service Provider.

Auditory Signal (if configured on)

Visual Indicators

Basic Operation

1-17

Testing intelliVue Transceiver Functionality

Status Check

You can check the status of the transceiver indicators at any time. To initiate a Status Check, use the following instructions.

Step Action

1Press the

The following indicators should illuminate for as long as the Check button is depressed.

2 If one or more of the expected indicators do not light up, check the

following:

If there is still a problem, contact your Service Provider for assistance.

Check button.

• Battery gauge

• Type of leadset

• EASI (if in use)

• Lead block insertion. Make sure the leadset is correctly inserted in the transceiver and the orange line at the base of the cable is not visible (see “Connecting the ECG Cable” on page 3-19).

• Power and position of batteries (see “Checking the Battery Power Level” on page 1-22)

• Lead positions and connections (see “Verifying Electrode Connections” on page 3-22)

1-18 Basic Operation

Battery Information

Battery Safety Information

WarningWarning

Use Duracell MN 1500 AA 1.5V Alkaline batteries to ensure specified performance. Outdated, mismatched or poor-quality batteries can give unacceptable performance (e.g., insufficient Battery-Low warning time). The use of fresh high-quality alkaline batteries is strongly recommended.

Batteries should be removed from the transceiver 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 instructions in “Chapter 7. Maintenance & Troubleshooting”. Wash hands.

Certain failure conditions, such as short circuits, can cause a battery to overheat during normal use. High temperatures can cause burns to the patient and/or user. If the transceiver becomes hot to the touch, place it aside until it cools. Then remove the batteries and discard them. Have the transceiver operation checked by your Service Provider to identify the cause of overheating.

Battery Information

The battery door must be closed during defibrillation.

If you receive a BATTERY LOW alarm, the batteries must be promptly replaced. A "Battery Low" condition that is not corrected will result in a transceiver shutdown and cessation of monitoring.

Basic Operation

1-19

Battery Information

Disposal of

Batteries

Caution

The batteries must be removed if a transceiver will be stored for an extended period of time.

Important—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 Life Battery life is dependent upon:

• Condition of the batteries

• Parameters being monitored - ECG only, ECG and Spot Check SpO ECG and Continuous SpO

By observing the following guidelines, you can optimize battery life in the transceiver:

• REMOVE the batteries when the transceiver is not in use.

• Disconnect the SpO disconnected, the SpO an extender cable will continue to drain power from the SpO

extender cable (if used). (When the SpO2 sensor is

functionality is automatically powered down, but

electronics.)

, or

Inserting/ Removing Batteries

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

1-20 Basic Operation

WarningWarning

Caution

Battery Information

The battery compartment is located at the bottom of the transceiver behind a swinging door. It accommodates a pair of AA 1.5V Alkaline batteries. Only this type of disposable battery shall be used.

Important—Do not use rechargeable batteries. Use of this type of battery will

adversely affect:

• Battery gauge performance

• Battery low warnings

• Battery life performance

Insert batteries into the transceiver using the following procedure.

Step Action

1 Open the battery compartment by swinging the compartment door

2 Insert two AA 1.5V Alkaline batteries, matching the polarity with

counterclockwise into an open hinged position.

the +/- indications inside the compartment.

Note— Both batteries are inserted with the + polarity in the same

direction.

Basic Operation

1-21

Battery Information

Step Action

3 Close the battery compartment door. 4 Listen for the start-up sounds.

Watch for the indicators on the front of the transceiver to illuminate briefly.

5 Connect/reconnect the patient cables to the transceiver.

Removing the

Batteries

Checking the Battery Power Level

Batteries should be changed in sets, that is, if you change one battery, change them both. To remove the batteries, simply open the battery compartment door and push from the opening at the back of the compartment to pop the batteries out. Transceiver settings (ECG leadset type, SpO retained indefinitely when the batteries are removed.

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

Batteries should be removed when the transceiver is not in use or is being stored. DO NOT "STORE" BATTERIES BY LEAVING THEM IN THE INCORRECT POLARITY POSITION IN THE TRANSCEIVER.

Be careful not to short circuit the batteries. Short circuits are caused when a piece of metal touches both the positive and negative terminals simultaneously (for example, by carrying batteries in a pocket with loose change). More than a momentary short circuit will generally reduce the battery life. In case of a short circuit, discard both batteries in a pair, or just the shorted one if the batteries are new.

When the Check button is pressed, the battery gauge on the transceiver indicates the battery power level. It is reliable only when specified batteries (i.e., AA 1.5V Alkaline) are used. The battery gauge is also displayed in the Patient Sector at the Information Center to enable you to closely monitor battery status, for example, at change of shift.

mode, volume, etc.) are

1-22 Basic Operation

Battery Information

Important— In the following table, battery life times are based on Duracell MN

1500 batteries. Battery life for other brands may be different.

Approximate

Battery Gauge

Approximate Battery Life Remaining

Operating Time

Functionality

Remaining

4 green indicators > 75% > 34.7 hours Normal operation

3 green indicators > 50% > 23.1 hours Normal operation

2 green indicators > 25% > 11.6 hours Normal operation

1 green indicator 25% to Low Battery level > 15 minutes Normal operation

1 red indicator Battery Low level to

Replace Battery level

no indicator Replace Battery level

(Check batteries for correct polarity)

To check the power level:

Step Action

1Press the

Check button to determine the level.

2 If no indicators flash:

1. Check that the batteries are inserted properly.

2. Replace both batteries.

3. If there are still no indicators on the battery gauge, contact your Service Provider.

If the indicators illuminate but do not behave as described above, the transceiver has malfunctioned. Contact your Service Provider.

< 15 minutes Sp O

disabled

none Transceiver shutdown/

RF shutdown

Basic Operation

1-23

Briefing the Patient

WarningWarning

Patients should be instructed not to open the battery cover while the transceiver is in use.

If the Telemetry button has been configured to generate a Nurse Call, remote recording, or both, instruct the patient to use the button when needed.

Note—If desired, you can turn off patient use of the button at the Information

Center. See “Patient-Configurable Settings in Telemetry Setup” on page 6-3.

Pouch Use The transceiver is not designed for direct contact with the patient’s skin. During

normal use, the transceiver should be worn over clothing, in a pocket or, preferably, in a pouch. The carrying pouch is an appropriate means for holding the transceiver.

1-24 Basic Operation

Securing the Pouch

Briefing the Patient

Step Action

1 Secure the pouch on the patient with upper ties around the patient’s

head and arm, and lower ties around the patient’s lower torso.

WarningWarning

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

2 Insert the transceiver into the pouch with lead wires and SpO2

sensor cable, if used, exiting from the same side.

Important—Do not coil the cables inside the pouch. They are part of

the wireless system, and need to be freely exposed.

Basic Operation

1-25

Briefing the Patient

Step Action

3 Fold the flap down and snap closed. 4 Check that the patient is comfortable wearing the pouch with

transceiver.

Showering

Signal quality and leads off detection may be compromised when showering due to significant patient movement. Appropriate clinical precautions must be taken.

The transceiver can be used to monitor a patient in the shower, but only when placed inside a Philips carrying pouch with the flap closed and the snaps secured. The combination of the transceiver and pouch will withstand showering for up to 10 minutes.

1-26 Basic Operation

WarningWarning

Transceiver Use with TeleMon A02/A03

Drying the

Transceiver

after

Showering

Accidental

Wetting

After showering, perform the following steps to continue monitoring:

1. Pat dry the leadset connections at the electrodes.

2. Wipe the lead wires with care.

3. If wet, dry the outside of the transceiver with a non-lint producing cloth.

4. If wet, wipe the inside of the battery compartment dry. Dry the batteries.

5. If wet, disconnect the ECG lead block and shake out any water. Dry the connector pin area with a cotton swab.

Note—The transceiver should not be used for monitoring if the battery

compartment is wet. Remove the batteries and wipe the compartment dry before continued monitoring use.

If the transceiver is accidentally immersed in liquid for up to 5 minutes, no damage to the device and no electrical safety issues for the patient will result. Remove the device, dry it off, and follow the procedure for cleaning/disinfection or cleaning/cross-infection prevention under “Troubleshooting” on page 7-15 as appropriate.

Transceiver Use with TeleMon A02/A03

When tethered to TeleMon, the following transceiver operational behavior will be in effect.

Alarms

• 3 minute alarm pause/suspend can be initiated only from TeleMon, not from the transceiver or from the Information Center. The Alarm Suspend/ Pause indicator on the transceiver will accurately reflect the current state of alarm pause.

• Standby mode is not available.

ECG Operation

• Vb, the second V-lead in 6-wire lead-set, is not supported.

• After a change in leadset, the TeleMon returns to the default ECG settings, and arrhythmia relearn occurs automatically. Be sure to check the monitoring leads after you switch leads.

SpO2 Operation

Basic Operation

1-27

Transceiver Use with TeleMon A02/A03

•SpO2 is always in continuous mode.

• Changes in SpO disconnected from TeleMon. Mode settings are defined in the following table:

Mode at TeleMon Mode at Disconnected Transceiver

• After a change in SpO2 sensor, TeleMon returns to the default ECG settings, and arrhythmia relearn occurs automatically. Be sure to check the monitoring leads after you change the sensor.

Transceiver Operational Controls & Indicators

• When you press the Telemetry button, a Nurse Call alarm, recording, alarm and recording, or neither will be generated, depending on the configuration at the Information Center.

• When you press the Check button, the transceiver battery gauge indicates full power, regardless of actual battery strength.

• When you press the Telemetry and Check buttons together, there is no action; a 3-minute alarm pause/suspend can be initiated only from TeleMon. The alarm pause indicator on the transceiver will accurately reflect the current state of alarm pause.

• When the transceiver is connected to TeleMon, the battery gauge on the transceiver and displayed at the Information Center always indicates "full" regardless of actual battery power. To update the gauge, disconnect the transceiver and wait several seconds for the updated battery strength to be displayed.

Defibrillation

• In the event of patient defibrillation, it may take several seconds for the ECG trace to reappear on the screen.

mode do not take effect until after the transceiver is

Continuous Continuous

5-min. Continuous 1-min. Continuous

Manual Spot Check

1-28 Basic Operation

Alarms

This chapter describes how to pause/suspend alarms temporarily. It also lists Physiologic (Patient) Alarms and Technical (Inoperative Conditions) Alarms. Both types of alarms are listed alphabetically.

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

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

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

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

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

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

Introduction

Alarms 2-1

Alarm Indicators

A description of visual and auditory information signals for patient and technical alarms on the Information Center is located in the IntelliVue Information Center Instructions for Use and the Information Center Online Help.The Information Center documentation also includes the default alarm settings and physiological alarm limit ranges

Testing Alarm Indicators

The visual alarm information signal on the transceiver is the Alarms Suspend icon. During self test, the Alarm Suspend indicator illuminates, and a single tone indicates association with the Information Center. These positive test results indicate that the Alarm Suspend icon on the transceiver is functioning correctly (see “Status Check” on page 1-18).

Suspending/Pausing Alarms

WarningWarning

If the Alarms Suspend indicator on the transceiver remains illuminated after the button combination to unsuspend alarms is pressed, a the transceiver malfunction may have occurred. Alarms resume automatically after the 3 minute suspension period, or you can resume them manually at the Information Center. The transceiver should be replaced, and the malfunctioning unit should be sent to your Service Provider.

All alarms for a patient can be suspended/paused from the Information Center, from the TeleMon Companion Monitor, or, depending on transceiver configuration, from the transceiver itself. The Alarm Suspend/Pause duration is fixed at 3-minutes. Alarms automatically resume after 3 minutes, and can be reactivated manually earlier.

2-2 Alarms

Suspending/Pausing Alarms

If connected to TeleMon, alarms can be suspended only from TeleMon, and not from the Information Center, and the Alarms Suspend icon on the transceiver is lit (see “Transceiver Controls - Front” on page 1-7), and an ALARMS SUSPENDED message appears at TeleMon and the Information Center.

Important—Patient monitoring (display of patient waveforms and numerics)

continues for the duration of Alarm Suspend/Pause.

Step

Action

1 To activate Alarm Pause/Suspend at the transceiver, press the

Telemetry

and Check buttons simultaneously.

While alarms are suspended:

• The transceiver illuminates the Alarms Suspend icon.

• The message ALARMS SUSPENDED (or ALARMS PAUSED) is displayed in the Patient Sector at the Information Center.

2 For instructions on how to pause/suspend alarms from the

Information Center, see the IntelliVue Information Center Instructions for Use and the Information Center Online Help.

Alarms

2-3

Suspending/Pausing Alarms

Resuming/ Unsuspending Alarms

Alarms will be resumed automatically after 3 minutes. You can cancel alarm suspend manually before the 3-minute period has expired from the transceiver (see following directions) or from the Information Center.

Step Action

1Press the

Telemetry and Check buttons simultaneously.

• Auditory alarm indication at the transceiver is switched on.

• The Alarm Suspend icon is turned off.

• The message ALARMS SUSPENDED (or ALARMS PAUSED) is removed from the display.

2 Alternately, you can unsuspend alarms at the Information Center.

See IntelliVue Information Center Instructions for Use or Online Help for directions.

2-4 Alarms

Standby Mode

Standby mode is useful when the transceiver is temporarily removed from a patient or when a patient is intentionally moved out of range of an Access Point. Standby suspends monitoring so you won’t get any patient alarms or waveforms. It also disables the out of range audio signal. Patient data and current settings are preserved during the Standby period.

Standby also serves to turn telemetry monitoring off when a patient is discharged. Patient data is not erased and unit default settings are not in effect until the discharge operation is performed. A bed should be put into Infinite standby until a new patient is connected to the transceiver. Monitoring can then be restarted by a click of the Resume Monitoring button.

Note—To discharge a patient:

1. Disconnect the patient.

2. Remove batteries from the transceiver.

3. Put bed in Standby.

You place a patient in standby mode at the Information Center. You can select the duration of the standby period (Infinite, 4, 3, 2, or 1 hours, 30, 20, or 10 minutes). The approximate time of resumption of monitoring will be di splayed. To restart monitoring, click on

Resume Monitoring in the Patient Sector.

Initiating

Standby

Note—Unless you are discharging a patient, keep the leads attached until the

patient is in Standby. If you remove the leads before putting a patient into Standby, you’ll get an ECG LEADS OFF technical alarm, as well as reminders, if configured.

Step Action

1 In the Patient Window or All Controls at the Information Center,

select the

Standby button.

2 Select the patient destination from the pre-defined list.

Alarms

2-5

Standby Mode

Step Action

3 Depending on your equipment configuration, select the duration of

the standby period (30, 20 or 10 minutes; 2, 3 or 4 hours; or infinite).

Resuming

Monitoring

4 Select the

Suspend Monitoring button. This suspends all

monitoring and displays the following messages in the Patient Sector: PATIENT LOCATION:xxx (for example, X-ray) and TELEMETRY STANDBY. The approximate time of resumption is also displayed.

Step Action

1 If the standby period has expired when the patient returns to

the unit, monitoring will resume automatically.

To verify the resumption of monitoring, press the Check button. You should hear a single beep.

2 If the standby period has not expired when the patient returns

to the unit, monitoring must be reactivated manually. Either click Resume Monitoring at the Information Center or press the Check button on the transceiver to establish reassociation. The audible tone (single beep) at the transceiver verifies that monitoring has resumed.

Note—When you take an EASI patient out of Standby, the lead settings will be

reset to the Information Center’s default lead settings.

2-6 Alarms

Alarm Behavior with Own Bed Overview

Both the IntelliVue Patient Monitor and the telemetry system source alarms. The following tables summarize alarm behavior when Own Bed Overview is used. For detailed information, see the IntelliVue Patient Monitor Instructions for Use and the IntelliVue Information Center Instructions for Use.

Alarm Pause/Suspend

When alarms are paused/suspended, the messages and types of alarms affected depend on where the pause/suspend was initiated.

If alarms are paused/ suspended

from....

Information Center

IntelliVue Patient Monitor

these alarms are paused/ suspended

both bedside and telemetry measurements

bedside measurements only

and this message appears

Information Center: ALARMS PAUSED or ALARMS SUSPENDED Bedside: ALARMS OFF in Overview window and ALARMS PAUSED or ALARMS OFF on the monitor (depending on configuration)

Information Center: BED ALARMS PAUSED or BED ALARMS SUSPEND (depending on configuration) Bedside: ALARMS PAUSED or ALARMS OFF

Alarms

2-7

Alarm Behavior with Own Bed Overview

Alarm Silence

When an active alarm is silenced, the types of alarms that are silenced depend on the alarm source and where the silence was initiated.

Alarm Source

Where Silenced

Effect at Paired Bedside

Bedside alarm Bedside Alarm is

silenced

Effect at Information Center

Bedside alarm is silenced. There is no effect on telemetry alarms

Telemetry alarm

Bedside No effect on

telemetry

No effect on telemetry alarms

alarms

Bedside and/or telemetry alarm

Overview Silence Control

Bedside or telemetry alarm is silenced

Bedside alarm is silenced (if Silence Overview Alarms is configured)

Bedside and/or telemetry alarm

Note—If tethered to TeleMon, silencing an active alarm at TeleMon silences the

Information Center

Bedside or telemetry alarm is silenced

alarm at TeleMon only. It has no effect on the paired bedside monitor or the Information Center.

2-8 Alarms

Physiologic Alarms

Alarm/INOPs at the Information Center

The alarms and INOPs that are displayed, recorded and stored at the Information Center depend on the type of alarm.

Type of Alarm/INOP Effect at Information Center

Physiologic Alarms

Physiologic alarms indicate a life-threatening situation or a less urgent situation such as heart rate beyond limits. There are no physiologic alarm signals generated by the transceiver. All physiologic alarms are generated at the

IntelliVue Information Center, and all alarm signals must be acknowledged at the Information Center.

All ECG telemetry alarms and INOPs

Note—ECG is generated from

telemetry when paired. Bedside ECG INOPs and RESP

INOPs Bedside non-ECG alarms and

non-ECG INOPs

Displayed, recorded (if configured), and stored

Ignored. Not displayed, recorded, or stored

Displayed, recorded (if configured), and stored

Arrhythmia alarm chaining and other aspects of alarm behavior, such as alarm levels, setting alarm limits, customizing arrhythmia alarm settings on a per patient basis, switching individual measurement alarms on/off, and reviewing alarm messages, are described in IntelliVue Information Center Instructions for

Use.

There are two levels of arrhythmia analysis available at the Information Center: Basic and Enhanced. Enhanced analysis includes Basic alarms.

Alarms

2-9

Physiologic Alarms

In the table, Red (***) alarms are listed alphabetically, followed by the Yellow (**) alarms, the Yellow (*) arrhythmia alarms.

Physiologic (Patient) Alarms

Alarm Text Priority Condition Source

***ASYSTOLE Red Asystole. No QRS for 4 consecutive

seconds

*** BRADY yyy < xxx Red Extreme Bradycardia. HR less than

extreme Brady HR Limit

*** DESAT Red Very Low SpO

Saturation. SpO2 value

below desaturation limit (10% or 10 "points" below low limit).

*** EXTREME BRADY Red Extrem e Bradycardia. HR less than

extreme Brady HR Limit

*** EXTREME TACHY Red Extreme Tachycardia. HR greater than

extreme Tachy HR Limit

*** TACHY yyy > xxx Red Extreme Tachycardia. HR greater than

extreme Tachy HR Limit

ST/AR Basic & Enhanced Arrhythmia

ST/AR Enhanced Arrhythmia

SpO

ST/AR Basic & Enhanced Arrhythmia

ST/AR Enhanced Arrhythmia

*** VFIB/TACH Red Ventricular Fibrillation. Fibrillatory

waveform for 4 consecutive seconds

2-10 Alarms

ST/AR Basic & Enhanced Arrhythmia

Physiologic Alarms

Physiologic (Patient) Alarms

Alarm Text Priority Condition Source

*** VTACH Red Ventricular Tachycardia. Sustained run of

PVCs accompanied by a high heart rate

** NURSE CALL Yellow Patient or nurse button press on the

transceiver (when configured for Nurse Call operation) Also initiated if the installation includes a paging system and if the Information Center is configured for paging upon receipt of Nurse Call signal.

** SpO

HIGH Yellow High SpO2. SpO2 value greater than high

SpO

Limit.

** SpO2 LOW Yellow Low SpO2. SpO2 value less than low

SpO

Limit.

** SpO2 yyy > xxx or Yellow High SpO2. SpO2 value greater than high

SpO

Limit.

** SpO2 yyy < xxx or Yellow Low SpO2. SpO2 value less than low

SpO

Limit.

* HR HIGH Yellow High Heart Rate. HR greater than high

HR Limit

ST/AR Basic & Enhanced Arrhythmia

Clinicianinitiated at transceiver or by paging subsystem

SpO

ST/AR Basic & Enhanced Arrhythmia

* HR LOW Yellow Low Heart Rate. HR less than low HR

Limit

ST/AR Basic & Enhanced Arrhythmia

Alarms

2-11

Physiologic Alarms

Physiologic (Patient) Alarms

Alarm Text Priority Condition Source

* HR yyy > xxx Yellow High Heart Rate. HR greater than high

HR Limit

ST/AR Enhanced Arrhythmia

* HR yyy < xxx Yellow Low Heart Rate. HR less than low HR

Limit

ST/AR Enhanced Arrhythmia

* IRREGULAR HR Yellow Irregular Heart Rate. Constantly irregular

HR.

ST/AR Enhanced Arrhythmia

* MISSED BEAT Yellow Missed Beat. Beat omitted ST/AR

Enhanced Arrhythmia

* MULTI ST Lx, Ly Yellow Multi ST Leads exceeding Limit (EASI

mode or when selected). Two ST leads

ST/AR

Arrhythmia (Lx=Lead X and Ly=Lead Y) exceed alarm limit elevation or depression for > 60 seconds

* MULTIFORM PVCs Yellow Multiform PVCs ST/AR

Enhanced

Arrhythmia

* NON-SUSTAIN VT Yellow Non-Sustained VT. Non-sustained

Ventricular Tachycardia

* PACER NOT CAPT Yellow Pacer Not Capture. Missed beat with pace

pulse (paced patient).

2-12 Alarms

ST/AR

Enhanced

Arrhythmia

ST/AR

Basic &

Enhanced

Arrhythmia

Physiologic Alarms

Physiologic (Patient) Alarms

Alarm Text Priority Condition Source

* PACER NOT PACE Yellow Pacer Not Pacing. Missed beat without

pace pulse (paced patient).

ST/AR Basic & Enhanced Arrhythmia

* PAIR PVCs Yellow Pair of PVCs. ST/AR

Enhanced Arrhythmia

* PAUSE Yellow Pause. No QRS for more than x seconds ST/AR

Enhanced Arrhythmia

* PVC > xx/min Yellow PVCs > xx/min. PVCs greater than Rate

Limit

ST/AR Basic & Enhanced Arrhythmia

* R-ON-T PVCs Yellow R-on-T PVCs ST/AR

Enhanced Arrhythmia

* RUN PVCs Yellow Run PVCs. Run of PVCs length >= 2 ST/AR

Enhanced Arrhythmia

* ST lead > xxx Yellow STx > Elevation limit. ST segment is

elevated

* ST lead < xxx Yellow STx < Depression limit. ST segment is

depressed.

* SVT Yellow Supra Ventricular Tachycardia. SVT for >

15 seconds

ST/AR Arrhythmia

ST/AR Enhanced Arrhythmia

Alarms

2-13

Technical Alarms (INOPs)

Physiologic (Patient) Alarms

Alarm Text Priority Condition Source

* VENT BIGEMINY Yellow Ventricular Bigeminy. Predominant

Bigeminy rhythm present.

* VENT RHYTHM Yellow Ventricular Rhythm. Ventricular rhythm

present.

* VENT TRIGEMINY Yellow Ventricular Trigeminy. Predominant

Trigeminy rhythm present.

Notes: xxx = limit that was exceeded; yyy = current value. * NBP alarms are processed independently at the Information Center. The alarm delay from TeleMon to the Information Center is not more than 10 seconds.

ST/AR

Enhanced

Arrhythmia

ST/AR

Enhanced

Arrhythmia

ST/AR

Enhanced

Arrhythmia

Technical Alarms (INOPs)

Technical Alarms, or INOPs, are sourced at the transceiver, the ST/AR algorithm running at the Information Center, or TeleMon Companion Monitor, and identify inoperative conditions (that is conditions where the system cannot measure or detect alarm conditions reliably). There are three levels of Technical Alarms:

2-14 Alarms

• Severe - Monitoring and alarms disabled. Audible tone at the Information

Center. Must be acknowledged by a clinician.

• Hard - Monitoring and alarms are disabled. Audible tone at the

Information Center.

• Soft - Monitoring and alarms remain active. No audible tones are

generated.

Technical Alarms (INOPs)

Technical Alarms (Inoperative Conditions) (in alphabetic order)

Alarm Text Priority Condition What to do

BATTERY LOW Soft Power is low. Replace batteries promptly to

avoid transceiver shutdown and cessation of monitoring.

CANNOT ANALYZE ECG

Hard Arrhythmia algorithm

cannot reliably analyze the ECG data on any monitored leads.

CANNOT ANALYZE ST Soft ST algorithm cannot

reliably generate any valid ST values on any monitored lead.

CHARGE MON BAT Hard TeleMon battery charge is

less than or equal to 25%.

CUFF NOT DEFLATED Severe Cuff pressure is greater

than a specified safety limit for a period of time.

Assess the lead selections, initiate relearn, and validate analyzed rhythm.

Review the ECG signal quality and correct if necessary. Reposition the Is and J points.

Connect TeleMon to AC power and charge battery, or insert battery with charge greater than 25%.

Remove cuff from patient and disconnect from tubing. Gently expel any air. If water in cuff, replace cuff. Reconnect, and reapply cuff to patient.

Note—If the alarms are

suspended, this INOP will unsuspends them at the Information Center and TeleMon. To clear the INOP message, initiate a new NBP measurement.

Alarms

2-15

Technical Alarms (INOPs)

Technical Alarms (Inoperative Conditions) (in alphabetic order)

Alarm Text Priority Condition What to do

ECG EQUIPMENT MALF Hard Failure of the ECG

equipment or failure to calibrate ECG.

Replace the transceiver or calibrate ECG with Service Tool.

ECG LEADS OFF Hard Multiple leads off Reattach ECG leads to

patient.

<electrode> LEAD OFF Hard Primary lead is off.

Note—If primary lead is

Reattach ECG lead to

patient. MCL, lead will be identified as V in INOP text.

<electrode> LEAD OFF Soft Non-primary lead is off. Reattach ECG lead to

patient.

INVALID LEADSET Hard Bad lead selection switches

in the transceiver

Replace transceiver case.

Use supported leadset.

Contact Service.

NO SIGNAL Hard Patient is out of range,

radio board has failed, ICN connection failure, or no batteries in transmitter.

Make sure that the

transceiver is in own care-

group range and has good

batteries. Replace the

transceiver if Power On Self

Test fails, and notify Service

Provider.

REPLACE BATTERY Hard,

Latched Message remains until acknowle dged by clinician.

2-16 Alarms

Dead battery. No monitoring is occurring.

Replace batteries.

Technical Alarms (INOPs)

Technical Alarms (Inoperative Conditions) (in alphabetic order)

Alarm Text Priority Condition What to do

SOME ECG ALRMS OFF Soft Some yellow arrhythmia

alarms have been turned off for this patient.

T EQUIP MALF Hard Malfunction in the SpO2

SpO

equipment

SpO

T ERRATIC Hard Erratic SpO2

measurements, often due to a faulty sensor or invalid SpO

measurements, or

incorrect transducer position

SpO

T EXTD UPDATE

Numeric is replaced by a

-?-.

Soft The update period of

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

SpO

T INTERFERENCE Hard Level of ambient light or

level of electrical interference are so high that the SpO measure SpO

sensor cannot

and pulse

rate.

For information only.

SpO2 board needs to be replaced. Call Service.

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

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

Reduce ambient light to sensor or electrical noise sources.

SpO

T LOW PERFUSION Soft Accuracy may be reduced

due to low perfusion. Data displayed with ?. Warm the site.

SpO

T NO SENSOR Hard No sensor attached to SpO2

device

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

Attach SpO2 sensor.

Alarms

2-17

Technical Alarms (INOPs)

Technical Alarms (Inoperative Conditions) (in alphabetic order)

Alarm Text Priority Condition What to do

SpO2T NOISY SIGNAL Hard Excessive patient

movements or electrical

Reduce movement or

electrical noise sources. interference are causing irregular pulse patterns

SpO

T NON-PULSATILE Hard Pulse is too weak or not

detectable

Check connection to patient.

Change sensor site. Avoid

site distal to BP cuff or intra-

arterial line.

SpO

T SENSOR MALF Hard Malfunction of the SpO2

Replace sensor. sensor/adapter-cable

TELEMETRY STANDBY Soft Information Center standby

mode timer is active, or

Cancelled when patient is

removed from Standby. patient was not returned to telemetry coverage area. There is no data from bed.

TRANSMITTER MALF Hard Transceiver malfunction Replace and notify Service

Provider.

TRANSMITTER OFF Hard RF shut off after 10

minutes of leads off

WEAK SIGNAL Soft Patient is at outer rang e of

the radio coverage area. Telemetry pack is receiving a weak signal with high data loss from the AP.

Reattach ECG leads to

patient.

Return patient to the radio

coverage area. If patient is in

close proximity to AP,

replace telemetry pack. If

condition exists for multiple

devices in a specific area, the

AP in that area is suspect.

Contact Service.

2-18 Alarms

ECG Monitoring

This chapter covers the specifics of ECG measurement. It includes the following sections:

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

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

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

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

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

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

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

Introduction

ECG Monitoring 3-1

ECG Safety Information

WarningWarning

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.

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

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.

3-2 ECG Monitoring

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

Measuring ECG

The electrocardiogram (ECG) measures the electrical activity of the heart and displays it on the Information Center as a waveform and a numeric.

There is no cardiotach within the transceiver; cardiotach analysis resides in the arrhythmia algorithm at the Information Center. Arrhythmia analysis is always turned on for telemetry patients. Arrhythmia analysis is either basic or enhanced, depending on the product configuration.

Measuring ECG

EASI ECG EASI

conventional 12-lead ECGs. As the 12-lead ECG derived with EASI is not exactly identical to the 12-lead conventional ECG obtained from an electrocardiograph, it should not be used for diagnostic interpretations.

ECG Leadsets

The IntelliVue Transceiver supports 3-, 5-, and 6-wire leadsets. It detects the inserted leadset type and automatically determines the ECG measurement and transmitted leads. The Leadset Insertion Guide on the device will assist you in ensuring the correct measurement during transceiver usage (see “Connecting the ECG Cable” on page 3-19). The 5-wire leadset can be used for either standard or EASI electrode configurations. The leadsets are compatible with the 5- and 3wire leadsets used with the IntelliVue family of monitors and with M2601B transmitters.

The electrode placements for the illustrations in this chapter use the AAMI labels and colors and are summarized in the following table.

Leadset Electrode Color (AAMI) Electrode Location

3-wire Black

derived 12-lead ECGs and their measurements are approximations to

LA White Red

ECG Monitoring

3-3

Measuring ECG

Leadset Electrode Color (AAMI) Electrode Location

ECG Leads Monitored

5-wire (Standard mode)

5-wire (EASI mode)

6-wire Black

Depending on the leadset connected to the transceiver, a different set of viewable leads are available at the Information Center. The transceiver can

Black White Red Green Brown

White Red Brown Green Brown/White

LA RA LL RL V

S I A RL E

LA RA LL Va RL Vb

3-4 ECG Monitoring

Measuring ECG

source up to four raw ECG waves. The transceiver automatically recognizes the leadset connected.

these leads can be selected at the

If you are using ...

Information Center

3-wire I, II, III

If lead selection is enabled, sourced waves are received as:

• Channel 1 - I

• Channel 2 = II

• Channel 3 = III If lead selection is disabled, the sourced wave is II.

Default is II.

5-wire (Standard mode) I, II, III, aVR, aVL, aVF, MCL and V

Sourced waves are received as:

• Channel 1 - I

• Channel 2 = II

• Channel 3 = III Defaults are II, V, III.

5-wire (EASI mode) I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5,

V6 In EASI mode, the sourced waves are received

as:

• Channel 1 = Vector 1 (A-I)

• Channel 2 = Vector 2 (A-S)

• Channel 3 = Vector 3 (E-S)

Note—Arrhythmia monitoring is performed only

on the primary and secondary leads selected at the Information Center, although you can view and perform ST analysis on all 12 EASI derived leads.

ECG Monitoring

3-5

Measuring ECG

If you are using ...

these leads can be selected at the Information Center

6-wire

(not supported in TeleMon)

I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V7, V8, V9, V

, V4R, V5R.

Sourced waves are received as:

• Channel 1 = II

• Channel 2 = III

• Channel 3 = Va

• Channel 4 = Vb

The two chest leads, Va and Vb, can be placed on the patient in any of the V lead positions (V1 through V9, V3R, V4R, V5R). Lead assignment is available at the Information Center. When unassigned, the chest leads use the defaults.

Defaults are II, III, Va=V2, Vb=V5.

Note—When display of the pleth wave is

enabled at the Information Center, the second chest lead (Vb) is not available for monitoring due to bandwidth limit. That is, the lead label assigned to Vb cannot be selected for Va even though Vb does not appear to be used.

Reconstructed

Leads

3-6 ECG Monitoring

Reconstruction of leads from the sourced wave is defined by the calculations in the following table. EASI reconstructed leads are a linear combination of all three raw EASI leads. Default labels/leads are shown in bold text.

ECG Lead

Clinical Calculations

in terms of electrodes

3-Lead

5-Lead

Standard

6-Lead

II ILA-RA

ECG Lead

Measuring ECG

5-Lead

3-Lead

Standard

6-Lead

II II II

III

- MCL - Va-LA, C=Va (see Note)

- aVR aVR RA-(LA+LL)/2

- aVL aVL LA-(RA+LL)/2

- aVF aVF LL-(LA+RA)/2

III III

Va C-(RA+LA+LL)/3, where

Vb Vb-(RA+LA+LL)/3, where Vb

Clinical Calculations

in terms of electrodes

LL-RA

LL-LA

C-(RA+LA+LL)/3, where C=V

V2 position

Va=

ECG Monitoring

3-7

Positioning ECG Electrodes

WarningWarning

Do not mix and match electrodes of different types. In particular, do not use electrodes of dissimilar metals. This helps ensure optimal signal quality.

WarningWarning

When you are connecting the electrodes or the patient cable, make sure that the connectors never come into contact with other conductive parts, or with earth. In particular, make sure that all of the ECG electrodes are attached to the patient, to prevent them from contacting conductive parts or earth.

WarningWarning

Non-manufacturer supplied accessories and supplies can corrupt the performance of the equipment. Use only AAMI EC-12 compliant electrodes with this device. Use of electrodes that are non-compliant may provide erroneous results.

3-8 ECG Monitoring

Caution

To protect the transceiver from damage during defibrillation, to ensure accurate ECG information, and to provide protection against signal noise and other interference, use only ECG electrodes and cables specified by Philips.

To make it possible to compare measured ECG signals, the electrodes (or leadsets) are placed in standardized positions, forming so-called "leads". To obtain ECG signals optimized for use in diagnosis and patient management in different care environments, different leadsets in varying lead placements can be used. You can use either standard lead placements or EASI lead placements with the transceiver.

Positioning ECG Electrodes

When placing electrodes on the patient, choose a flat, non-muscular site where the signal will not be impacted by either movement or bones. Correct lead placement is always important for accurate diagnosis. Especially in the precordial leads, which are close the heart, QRS morphology can be greatly altered if an electrode if moved away from its correct location.

In addition to correct positioning of the electrodes, optimal skin preparation prior to electrode placement will help ensure a clear signal for diagnosis.

Step

Action

1 Prepare the patient’s skin. Good electrode-to-skin contact is

important for a good ECG signal, as the skin is a poor conductor of electricity.

• Select sites with intact skin, without impairment of any kind.

• Clip or shave hair from the site as necessary.

• Wash site with soap and water, leaving no soap residue.

Note--Philips does not recommend using ether or pure alcohol, because they dry the skin and increase the resistance.

• Dry thoroughly.

• Use ECG skin preparation paper (abrasive) to remove dead skin cells and to improve the conductivity of the electrode site.

ECG Monitoring

3-9

Positioning ECG Electrodes

Electrode Placement

Step

Diagrams for 5-lead standard and EASI electrode placement are located on the back of the transceiver. Additional lead placement information is available in the Online Help in the IntelliVue Information Center.

Action

2 Check electrodes for moist gel, and attach to the clips. If you are not

using pre-gelled electrodes, apply electrode gel to the electrodes before placement.

Note—Gel must be moist to provide a good signal.

3 Place the electrodes on the patient according to the lead placement

you have chosen (see Electrode Placement following). Place the edge down, then "roll down" the rest of the pad. Press firmly around the adhesive edge toward the center.

Note—When placing electrodes, choose a flat, non-muscular site

where the signal will not be interfered with by either movement or bones. Correct lead placement is always important for accurate measurement, especially in the precordial leads, which are close to the heart. QRS morphology can be greatly altered if an electrode is moved away from its correct location.

Philips recommends that electrodes be changed every 24 hours.

3-10 ECG Monitoring

Locating the

Fourth

Intercostal

Space

Positioning ECG Electrodes

Angle of Lewis

For accurate chest electrode placement and measurement, it is important to locate the fourth intercostal space. This can be done using the Angle of Lewis.

1. Locate the second intercostal space by first palpating the Angle of Lewis (the bony protuberance where the body of the sternum joins the manubrium). This rise in the sternum is where the second rib is attached, and the space just below this is the second intercostal space.

2. Palpate and count down the chest until you locate the fourth intercostal space.

ECG Monitoring

3-11

Positioning ECG Electrodes

3-Lead

Placement

RA LA

3-12 ECG Monitoring

Lead Placement

RA directly below the clavicle and near the right

shoulder

LA directly below the clavicle and near the left

shoulder

LL on the left lower abdomen

5-Lead

Placement

(Standard

Mode)

RA LA

Lead Placement

Positioning ECG Electrodes

V4V5V6

LLRL

RA directly below the clavicle and near the right

shoulder

LA directly below the clavicle and near the left

shoulder

LL on the left lower abdomen

RL on the right lower abdomen

V on the chest, the position depends on your

required lead selection. The default position is V2.

V1 on the fourth intercostal space at the right sternal

border

ECG Monitoring

3-13

Positioning ECG Electrodes

Lead Placement

V2 on the fourth intercostal space at the left sternal

border

V3 midway between the V2 and V4 electrode

positions

V4 on the fifth intercostal space at the left

midclavicular line

V5 on the left anterior axillary line, horizontal with

the V4 electrode position

V6 on the left anterior axillary line, horizontal with

the V4 electrode position

3-14 ECG Monitoring

5-Lead

Placement

(EASI Mode)

Positioning ECG Electrodes

WarningWarning

EASI derived 12-lead ECGs and their measurements are approximations to conventional 12-lead ECGs. As the 12-lead ECG derived with EASI is not exactly identical to the 12-lead conventional ECG obtained from an electrocardiograph, it should not be used for diagnostic interpretations.

EASI lead placement is supported for adult patients only

Lead

E V on the lower sternum at the level of the

A LL on the left midaxillary line at the same

Corresponds to Standard Lead

Placement

fifth intercostal space

level as the E electrode

ECG Monitoring

3-15

Positioning ECG Electrodes

6-Lead

Placement

Lead

Corresponds to Standard Lead

Placement

S LA on the upper sternum

I RA on the right midaxillary line at the same

level as the E electrode

N Reference can be anywhere, usually below the sixth

rib on the right hip

Make sure that the D and E electrodes line up vertically on the sternum,

Note—

and that the I, E and A electrodes align horizontally.

A 6-lead placement uses the same four limb leads as 5-lead standard placement, and two precordial leads - referred to at the Information Center as Va and Vb.

The default position of Va - the brown lead - is at the V2 position. The default position for Vb - the brown/white lead - is at the V5 position. Your unit may use other precordial leads for Va and Vb. In that situation, you

need to assign those new positions in the Patient Window at the Information Center. The Va and Vb default positions can be changed in the configuration at the Information Center on a per patient basis.

3-16 ECG Monitoring

Lead Placement

Positioning ECG Electrodes

LARA

V4V5V6

LLRL

RA directly below the clavicle and near the right

shoulder

LA directly below the clavicle and near the left

shoulder

RL on the right lower abdomen

LL on the left lower abdomen

Va on the chest, the position depends on your

required lead selection. The Philips default position is V2. For other positions, relabel the lead at the Information Center.

ECG Monitoring

3-17

Positioning ECG Electrodes

Lead Placement

Vb on the chest, the position depends on your

required lead selection. The Philips default position is V5. For other positions, relabel the lead at the Information Center.

V1 on the fourth intercostal space at the right sternal

border

V2 on the fourth intercostal space at the left sternal

border

V3 midway between the V2 and V4 electrode

positions

V4 on the fifth intercostal space at the left

midclavicular line

V5 on the left anterior axillary line, horizontal with

the V4 electrode position

3-18 ECG Monitoring

V6 on the left anterior axillary line, horizontal with

the V4 electrode position

Connecting the ECG Cable

Note—Your transceiver may have alignment guides to assist you in leadset

insertion.

Connecting the ECG Cable

Step

Action

1 Match the arrow on the ECG cable with the arrow on the Lead

Insertion Guide according to the lead type you have chosen, and insert the ECG cable into the transceiver.

Important—Make sure that the cable is pushed completely into

the transceiver. When correctly inserted, the orange line at the base of the cable is not visible.

3-wire

Match the arrow on the cable with the left arrow (labeled EASI, 3) on the Leadset Insertion Guide.

IntelliVue TRx

M4841A

EASI, 3

5.6

Note—Leadset is keyed for

only one insertion position.

ECG Monitoring

3-19

Connecting the ECG Cable

Step

Action

5-wire Standard

IntelliVue TRx

M4841A

EASI, 3

5-wire EASI

Match the arrow on the cable with the right arrow (labeled 5,

6) on the Leadset Insertion Guide.

5.6

Match the arrow on the cable with the left arrow (labeled EASI, 3) on the Leadset Insertion Guide.

3-20 ECG Monitoring

IntelliVue TRx

M4841A

EASI, 3

5.6

Note—If you are using a 5-wire leadset in both Standard and EASI

modes, insert the protective plug into the open lead port with the wide lip facing the leads. Then, press down firmly so that the plug is securely under the leadset and the orange line is not visible.

Connecting the ECG Cable

Step

Action

6-wire

Match the arrow on the cable with the right arrow (labeled 5,6) on the Leadset Insertion Guide.

IntelliVue TRx

M4841A

EASI, 3

5.6

2 Check that the correct Electrode Indicators are lit for the leadset you

are using, and that the EASI indicator light is illuminated appropriately. See “Verifying Electrode Connections” on page 3-22.

• When using 5-lead standard, the EASI indicator does not

illuminate.

• When using EASI, the EASI indicator illuminates momentarily.

Cable

Disconnection

3 For 3-lead, select the lead label(s) at the Patient Window.

When disconnecting the leadset from the transceiver, grasp the leadset firmly and pull free. Do not pull on the lead wires.

ECG Monitoring

3-21

Verifying Electrode Connections

The electrode indicators enable you to verify that the leads are available for the desired monitoring. Each electrode is color-coded. Pressing and holding the Check button enables you to view the leadset status. During routine use of the transceiver for monitoring, all lead indicators are off.

To verify electrode connections, use the following procedure:

Step

Action

1 Press and hold the Check button for 2 seconds

2 Expected Response:

• If 3-wire cable is attached: Red, White and Black indicators illuminate, then all turn off.

• If 5-wire cable in Standard mode is attached: Red, White, Black, Green & Brown indicators illuminate, then all turn off.

• If 5-wire cable in EASI mode is attached: Red, White, Black, Green & Brown indicators illuminate, then all turn off. The EASI indicator also illuminates briefly.

• If 6-wire cable is attached: Red, White, Black, Green, Solid Brown and Brown/White indicators illuminate, then all turn off.

• If no leadset is attached: all indicators are off.

3 Unexpected Response:

Any other response indicates a problem with the transceiver. Check the leadset connection and/or use a new leadset. If the problem is not corrected, contact your Service Provider.

3-22 ECG Monitoring

During routine monitoring, the electrode indicators also notify you if one or more leads are not functioning. When a LEADS OFF condition occurs, the transceiver automatically illuminates the indicator corresponding to the missing lead.

Monitoring during Leads Off

ECG Fallback and Extended monitoring states are supported for the transceiver when the primary and/or secondary leads are in a Leads Off INOP condition. Both these states are entered into after 10 seconds of Leads Off in an attempt to maintain monitoring and arrhythmia analysis.

Monitoring during Leads Off

ECG Fallback

Multilead

Analysis

Single Lead

Analysis

Fallback for

EASI

ECG Fallback occurs when the primary lead is in Leads Off for 10 seconds and a secondary lead is available. ECG Fallback must be configured on by your Service Provider.

If there is a LEADS OFF technical alarm in the primary lead for > 10 seconds, the active secondary lead becomes the primary lead. The arrhythmia algorithm switches the leads on the display, but relearn does not occur. When the Leads Off condition is corrected, the leads are switched back to their original state.

For single lead analysis, if there are two leads available, the secondary lead is made the primary lead until the Leads Off condition is corrected. The arrhythmia algorithm performs a relearn using the available lead.

If one of the derived EASI leads is in a technical alarm condition, a flat line is displayed. After 10 seconds, the directly acquired EASI AI, AS, or ES lead, depending on which is available, is displayed with the label "ECG". Arrhythmia relearn is performed with transition to or from EASI Fallback monitoring using the available lead(s).

ECG Monitoring

3-23

Monitoring during Leads Off

Extended Monitoring

Extended monitoring occurs when both the primary and secondary leads are in Leads Off for 10 seconds and another lead is available. It becomes the primary lead and the arrhythmia algorithm performs a relearn.

Extended Monitoring applies if:

• Telemetry is configured for Extended Monitoring ON.

• The leas set provides more than two leads (e.g., when using a 5-wire leadset ).The leadset must provide more than two leads, and Extended monitoring must be configured on by your Service Provider.

Relearning Whenever there is a Leads Off condition, the arrhythmia algorithm performs a

Relearn, using the available leads.

WarningWarning

Since Relearn happens automatically, 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. For this reason, you should:

1. Respond promptly to any technical alarm.

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

Using EASI Leads to T roubleshoot

If there is artifact in the ECG waves or a CANNOT ANALYZE ECG technical alarm condition is in effect, you can use the three EASI leads to troubleshoot:

1. Click

2. The three directly acquired EASI leads will be displayed so that you can

3-24 ECG Monitoring

12-Lead ECG on the Patient Window, then on 3 EASI Leads.

determine which electrodes are causing the problem and need to be replaced.

Optimizing ECG Measurement Performance

While telemetry monitoring offers many advantages, it can be a challenge. The reliability and quality of the signal transmission through the air and hospital walls is governed by a number of variables which can be difficult to control. A telemetry system cannot be as dependable as a hardwired bedside monitor that transmits its signal through a wire.

The effect of interference on the Philips IntelliVue Telemetry System ranges from a momentary loss of ECG to complete inoperability, depending on the situation. The strength, frequency, and proximity of the source of interference to the transceiver devices or the access point system are factors that determine the degree of severity. In cases where the source of interference is known - for example, cellular phones, magnetic equipment such as MRI, other radio or motorized equipment - removing or moving away from the source of interference will increase the equipment's dependability.

WarningWarning

Philips IntelliVue Telemetry System should not be used for primary monitoring in applications where the momentary loss of the ECG is unacceptable.

The Telemetry Signal

In this section, we'll investigate some of the problems affecting ECG signal clarity and when possible, show you how you can greatly enhance performance.

Important—Philips IntelliVue Telemetry System also emits radio frequencies

that can affect the operation of other devices. Contact the manufacturer of other equipment for possible susceptibility to these frequencies.

The transceiver worn by the patient acquires the patient's physiological data, amplifies and digitizes it, detects pace pulses and broadcasts this information via radio waves to the Philips IntelliVue Telemetry System. Since the signal passes through the air, it is susceptible to interference from many sources.

ECG Monitoring

3-25

Optimizing ECG Measurement Performance

Trouble- shooting Signal Disturbances

Dropouts Because Philips IntelliVue Telemetry System is a wireless system, under certain

conditions RF (Radio Frequency) “dropouts” can occur. Dropouts result from a weak signal or RF interference. There will be signal drops to the bottom of channel for a minimum of 200 ms to indicate to the clinical user that it is a nonphysiological event. If dropouts are frequent enough to affect the heart rate count, the CANNOT ANALYZE ECG or CANNOT ANALYZE ST technical alarm occurs. The following recording strip is an example of dropouts.

If frequent dropouts are occurring, the following section describes some steps you can take to improve performance.

Signal

Strength

3-26 ECG Monitoring

The Philips IntelliVue Telemetry System is custom designed for your unit, so reliable signal reception is only possible where there are receiving access points. When the signal is too low, the following technical alarms occur:

To correct, first check the location of the patient. If the patient is not in the coverage area, do one of the following.

• CANNOT ANALYZE ECG

• CANNOT ANALYZE ST

• WEAK SIGNAL

• NO SIGNAL

• Return the patient to the specified coverage area.

• Put telemetry in Standby Mode. See “Standby Mode” on page 2-5.

• If the patient is in the coverage area and is stationary, try moving the location of the transceiver from its original location by about 15 cm (6 inches).

Optimizing ECG Measurement Performance

Radio

Frequency

Interference

Muscle and Movement Artifact

Problem Cause Remedy

60-Cycle (AC) Interference Poor electrode placement.

Radio frequency (RF) interference is caused by anything that intrudes into the transmitted electrical signal, such as paging transmitters. You are probably familiar with electrical interference in our homes and cars when it causes signal loss or static with cell phones. These same types of interference can occur with the transmitted telemetry signal. Even though the Philips IntelliVue Telemetry System is designed to resist these effects, interference can occasionally be seen in the form of “dropouts”. To improve performance, the source of the interference must be identified and eliminated.

Muscle and movement artifact differ from radio frequency interference since you can prevent much of the occurrence. Noise on the ECG signal can be caused by many sources, such as interference from other electrical equipment, muscle artifact and respiratory variation. It is up to the clinician to use certain techniques to minimize these types of noise.

Use the following table to help you troubleshoot the most common sources of ECG noise.

Troubleshooting Common Causes of ECG Noise

Possible non-grounded instrument near patient

Apply fresh electrodes after recommended skin preparation.

Disconnect electrical appliances near patient (one at a time) by pulling wall plugs, to determine faulty grounding. Have engineering check grounding.

Muscle Artifact Tense, uncomfortable

patient. Poor electrode placement. Tremors. Diaphoresis

Make sure patient is comfortable. Check that electrodes are applied on

flat non-muscular areas of the torso; apply fresh electrodes after recommended skin preparation if necessary (see “Positioning ECG Electrodes” on page 3-8).

ECG Monitoring

3-27

Optimizing ECG Measurement Performance

Troubleshooting Common Causes of ECG Noise

Problem Cause Remedy

Irregular Baseline Poor electrical contact.

Respiratory interference. Faulty electrodes. Dry electrodes.

Baseline Wander Movement of patient.

Improperly applied electrodes.

Respiratory interference.

Poor Electrode Contact Loose electrodes.

Defective cables. Leadset not firmly

connected.

Apply fresh electrodes after recommended skin preparation if necessary (see “Positioning ECG Electrodes” on page 3-8).

Move electrodes away from areas with greatest movement during respiration.

Make sure patient is comfortable. Apply fresh electrodes after

recommended skin preparation if necessary (see “Positioning ECG Electrodes” on page 3-8). Check that patient cable is not pulling electrodes.

Move electrodes away from areas with greatest movement during respiration.

Apply fresh electrodes after recommended skin preparation if necessary (see “Positioning ECG Electrodes” on page 3-8).

Replace cables.

3-28 ECG Monitoring

ST/AR Arrhythmia & ST Segment

Monitoring

This chapter describes the ST/AR algorithms used for telemetry at the Philips Information Center. It includes the following sections:

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

• ST/AR provides Heart Rate and PVC Rate numerics and alarm detection for the conditions listed in the following table. There are two detection

levels: Basic and Enhanced. Enhanced includes the Basic alarms. . . . 4-4

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

• Adjusting ST Measurement Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

• Establishing ST Reference Beats (Baseline) . . . . . . . . . . . . . . . . . . . 4-11

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

Introduction

ST/AR Arrhythmia & ST Segment Monitoring 4-1

ST/AR Arrhythmia Algorithm

Safety Information

WarningWarning

FOR ALL PATIENTS

Learning/Relearning

- Learning: 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.

- Relearning: 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.

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

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

4-2 ST/AR Arrhythmia & ST Segment Monitoring

ST/AR Arrhythmia Algorithm

WarningWarning

FOR PACED PATIENTS

ST/AR Arrhythmia Analysis

For information on arrhythmia detection, refer to the following documentation:

• ST/AR Algorithm - Arrhythmia Monitoring Application Note (4522 981

ST/AR Arrhythmia & ST Segment Monitoring

4-3

ST/AR Arrhythmia Algorithm

• IntelliVue Information Center Instructions for Use and Online Help

The intended use of the ST/AR basic arrhythmia analysis algorithm is to monitor the patient’s ECG for heart rate and ventricular arrhythmias and to produce events/alarms simultaneously for one or more ECG leads. The arrhythmia algorithm is effective when monitoring both paced and non-paced patients in a clinical environment.

IntelliVue Telemetry does not have a dedicated cardiotach. Instead, the arrhythmia cardiotach at the Information Center is used. Therefore, the ST/AR Arrhythmia algorithm is always on for all IntelliVue Telemetry patients, and cannot be turned off.

ST/AR provides Heart Rate and PVC Rate numerics and alarm detection for the conditions listed in the following table. There are two detection levels: Basic and Enhanced. Enhanced includes the Basic alarms.

Asystole Tachy yyy > xxx Vent Bigeminy

93051)

Basic & Enhanced Arrhythmia Detection

Basic Arrhythmia

Detection

Enhanced Arrhythmia Detection

Vent Fib/Tach Brady yyy < xxx Vent Trigeminy V tach Non-Sustain VT Multiform PVCs Extreme Brady Vent Rhythm HR yyy > xxx Extreme Tachy Run PVCs HR yyy < xxx High HR Pair PVCs Irregular HR Low HR Pause PVCs > 30/min Missed Beat Pacer Not Capturing SVT Pacer Not Pacing R-on-T PVCs

4-4 ST/AR Arrhythmia & ST Segment Monitoring

ST/AR Arrhythmia Algorithm

Beat classification determined by the ST/AR algorithm is shown on the primary delayed wave in the Arrhythmia Analysis window at the Information Center. To access this window, select Arrhythmia Analysis from the Patient Window.

The annotation requires clinical validation of the analyzed heart rhythm. If the analysis is inaccurate, perform a relearn of the rhythm.

Annotation Beat Classification Color

A Artifact Blue

I Inoperative Red

L Learning Red

M Missed Beat Red

N Normal Blue

P Paced Blue

S Supraventricular Premature Blue

V Ventricular Premature Red

? Questionable Red

‘ Pacer Mark Blue

When monitoring is initiated, when the Wave 1 lead is changed, or if Relearn is selected, a question mark (?) is displayed next to HR and the annotation “L” appears on the annotated wave until the HR is calculated and the rhythm is learned.

ST/AR Arrhythmia & ST Segment Monitoring

4-5

ST/AR ST Segment Algorithm

WarningWarning

This device provides ST level change information; the clinical significance of the ST level change information should be determined by a physician.

The ST/AR ST algorithm at the Information Center (not available for M3153A) monitors ST segment elevation or depression for each available telemetry ECG lead and produces events/alarms simultaneously. ST values update with every measurement period and enunciate, depending upon the severity of the change, events and alarms as they are detected.

The ST/AR ST algorithm is approved for use only with non-paced and atriallypaced adult telemetry-monitored patients. With EASI monitoring, ST analysis is performed on up to 12 leads, and an additional value of ST index is calculated and displayed (see “EASI ST Analysis” on page 4-8). Assessment of EASIderived 12-lead ST measurement is recommended for adult patients that meet the following parameters:

• Ages: 33-82 years

• Heights: 147 to 185 cm (58 to 73 in)

• Weights: 53 to 118 kg (117 to 261 lbs)

• Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)

All ST analysis and ST alarms for telemetry patients are performed by the Information Center.

For additional information on ST monitoring, refer to the following documentation:

• ST/AR Algorithm - ST Segment Monitoring Application Note (4522 981

92851)

• Information Center Online Instructions for Use and Online Help

The Measurement

4-6 ST/AR Arrhythmia & ST Segment Monitoring

The ST measurement for each beat complex is the vertical difference between two measurement points. The isoelectric point provides the baseline for the

ST/AR ST Segment Algorithm

measurement and the ST point provides the other measurement point. It is positioned with reference to the J-point.

R-WAVE PEAK

AT 0 MSEC

ISO ELECTRIC

POINT

DEFAULT =

-80 MSEC

J POINT

MEASUREMENT

DEFAULT = J+60 MSEC

POINT

DIFFERENCE =

ST VALUE

ST/AR Arrhythmia & ST Segment Monitoring

4-7

ST/AR ST Segment Algorithm

Algorithm Processing

Displayed ST Data

ST analysis analyzes ECG signals to classify the heart beats. Only beats classified as normal or Supraventricular (atrially paced) are used to calculate ST elevations and depressions.

The ST/AR ST algorithm processing includes special ST filtering, beat selection and statistical analysis, calculation of ST segment elevations and depressions, and lead reconstruction and wave generation.

When ST analysis is being performed on two leads, the averaged derived and reconstructed ST waves and associated ST segment values are given for up to six leads, depending on the type of patient cable:

• 3-wire: one lead

• 5-wire: up to two leads if monitoring a chest and a limb lead

• 5-wire: up to six leads if monitoring two limb leads with the Philips Transmitter (without EASI monitoring)

• 5- wire: up to 12 leads if monitoring using EASI

Note—No ST analysis is done on a patient if an electrode falls off.

ST data displays as values in the Patient Sector and Patient Window. A positive value indicates ST segment elevation; a negative value indicates ST segment depression. You can view ST data in ST Review, Trend Review, and Event Review windows.

EASI ST Analysis

4-8 ST/AR Arrhythmia & ST Segment Monitoring

The Information Center generated ST values presented in the patient sector and Patient Window for EASI derived leads is STindx (ST Index). STindx is a summation of three ST segment measurements, using the leads that can indicate ST segment changes in the different locations of the heart:

• anterior lead V2

• lateral lead V5

• inferior lead aVF

Caution

Be sure not to duplicate the lead labels. This can result in incorrect ST values being displayed for those leads.

ST Operation

ST/AR ST Segment Algorithm

Turning ST

Monitoring On/

Off

Adjusting ST

Measurement

Points

The ST Setup Window allows you to turn ST monitoring on or off for all available ECG leads.

To turn ST monitoring on at the Information Center, perform the following steps:

Step

You would turn ST monitoring off if:

• You are unable to get any lead that is not noisy.

• Arrhythmias such as atrial fib/flutter cause irregular baseline.

• The patient is continuously ventricularly paced.

• The patient has left bundle branch block.

The ST Setup Window enables you to adjust the ST measurement points to ensure accurate data.

There are three measurement cursors:

Action

1 From the Patient Window, click the All Controls button. 2 From the All Controls Window, click the 3 From the ST Setup Window, click

ST Setup button.

ST On.

• The ISO measurement cursor positions the isoelectric point in relation to

the R-wave peak.

• The J-point cursor positions the J-point in relation to the R-wave peak.

The purpose of the J-point is to correctly position the ST measurement point.

• The ST measurement cursor positions the ST point a fixed distance from

the J point.

Note—The ST measurement points may need to be re-adjusted if the patient's

heart rate or ECG morphology changes significantly.

ST/AR Arrhythmia & ST Segment Monitoring

4-9

ST/AR ST Segment Algorithm

Perform the following steps at the Information Center to adjust the ST measurement points:

Step

Action

1 Access the ST Setup window by clicking on the All Controls button

in the Patient Window, then clicking on the ST Setup button.

2 If you need to adjust the ISO (isoelectric) point, place the cursor

over the ISO button to access the adjustment arrows. Then use the arrows to position the bar in the middle of the flattest part of the baseline (between the P and Q waves or in front of the P wave).

ISO point

4-10 ST/AR Arrhythmia & ST Segment Monitoring

ST/AR ST Segment Algorithm

Step

Action

3 Adjust the J point, if necessary, by placing the cursor over the J-

point button to access the adjustment arrows. Then use the arrows to position the bar at the end of the QRS complex and the beginning of the ST segment.

SQJ point

4 Adjust the ST point, if necessary, by using the J point as an

“anchor” and placing the bar at the midpoint of the ST segment. Choices are J+0, J+20, J+40, J+60, or J+80.

ST point

Establishing

ST Reference

Beats

(Baseline)

ST Alarm Settings

After adjusting the measurement points, you can establish baseline reference beats for all available leads in the ST Review window at the Philips Information Center. Reference beats enable you to compare waveform changes, for example from admission, or prior to or after treatment. The reference continues to be saved beyond the 24 hour review window, but you can update it to any beat within the last 24 hours. Please refer to the Philips Information Center Instructions for Use18

or on-line Help for directions.

All Philips Information Center alarm settings (limits and on/off status) have unit default settings. The Philips Information Center however, lets you set the high and low ST alarm limits for individual patients based on:

ST/AR Arrhythmia & ST Segment Monitoring

4-11

ST/AR ST Segment Algorithm

• Your assessment of the patient's clinical condition.

• Unit protocols.

• Physician orders or medication specified limits.

You can make the following adjustments to ST alarm limits to accommodate the clinical condition of individual patients:

• Turn all alarms off/on.

• Adjust the alarm limits:

You adjust the ST alarm limits in the ST Alarms Window. Each ST parameter has its own alarm limit. The alarm is triggered when the ST value exceeds its alarm limit for more than 1 minute. The alarm will be a yellow alarm.

When more than one ST parameter is in alarm, only one alarm message displays. For multilead alarms when using an EASI transmitter, an alarm is generated if two or more ST leads exceed the alarm limits. The default setting is +/-1.0. The alarm message indicates the two leads that are in greatest violation of the limits, for example, “**MULTI ST AVR, V6”. If another lead becomes deviant, the message changes but it is considered the same alarm (no new alarm sounds and it is not listed as a new event).

– to specific high and low limits – to Smart Limits (see the Philips IntelliVue Information Center

Instructions for Use for information on Smart Limits)

– back to unit default settings.

See “Physiologic Alarms” on page 2-9 for a list of all ST alarms. See IntelliVue Information Center Instructions for Use for specifics on alarm

management and behavior.

Adjusting ST

Alarms

Make adjustments to ST alarms on the ST Alarms window at the Information Center.

Step

Action

1 From the Patient Window, select the All Controls button.

4-12 ST/AR Arrhythmia & ST Segment Monitoring

Philips Medical Systems North America M4841A, M4842A Instructions for Use

Specifications and Main Features

Frequently Asked Questions

User Manual