Philips ST80IWPIM, ST80IAIM User Manual

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ST80i Stress Test System

Instructions for Use

ST80i Stress Test System

INSTRUCTIONS FOR USE

Edition 1

June 2012

Notices

GMDN 36145

PN 453564XXXXXX June 2012 Edition 1

Printed in the USA

Edition History

Edition 1, June 2012 Applicable to ST80i, version

A01.00 and later. Philips Medical Systems shall not

be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

Warranty

Philips Medical Systems reserves the right to make changes to both this Instructions for Use and to the product that it describes. Product specifications are subject to change without notice.

Nothing contained within this Instructions for Use is intended as any offer, warranty, promise, or contractual condition, and must not be taken as such.

Responsibility of Manufacturer

Philips Medical Systems only considers itself responsible for any effects on safety, reliability, and performance of the StressVue system if:

– assembly operations, exten-

– the electrical installation of the

sions, re-adjustments, modifications or repairs are done by persons authorized by Philips Medical Systems, and

relevant room or vehicle complies with the IEC or national requirements, and

– the instrument is used according

to the instructions for use presented in this manual.

Authorized EU-representative

Philips Medizin Systeme Böblingen GmbH Hewlett Packard Str. 2 71034 Böblingen Germany

European Directives

This product consists of hardware and software. The hardware carries the CE mark based on the declarations provided in the User’s Guide for the IT hardware.

The ST80i software, the wireless patient module, and the Philips thermal printer are class IIa medical devices under the Medical Device Directive 93/42/EEC and carry the 0123 mark accordingly.

CAUTION

THIS PRODUCT IS NOT INTENDED FOR HOME USE. IN THE U.S., FEDERAL LAW RESTRICTS THIS DEVICE TO SALE ON OR BY THE ORDER OF A PHYSICIAN.

Responsibility of Customer

The user of this product is responsible for ensuring the implementation of a satisfactory maintenance schedule. Failure to do so may cause undue failure and possible health hazards.

Global Medical Device Nomenclature (GMDN)

The 5-digit GMDN code adjacent to the symbol is defined in the EN ISO

15225.

WARNINGS

As with all electronic equipment, Radio Frequency (RF) interference between the ST80i system and any existing RF transmitting or receiving equipment at the installation site, including electrosurgical equipment, should be evaluated carefully and any limitations noted before the equipment is placed in service.

Radio frequency generation from electrosurgical equipment and close proximity transmitters may seriously degrade performance. Philips Medical Systems assumes no liability for failure resulting from RF interference between Philips Medical Systems medical electronics and any radio frequency generating equipment at levels exceeding those established by applicable standards.

Use of accessories other than those recommended by Philips Medical Systems may compromise product performance.

Trademarks

Windows is a registered trademark of Microsoft Corporation.

All other brand and product names are trademarks or registered trademarks of their respective companies.

Safety Summary

Conventions Used in the Instructions for Use. . . . . . . . . . . . . . . . . . . i

Symbols Marked on the ST80i System . . . . . . . . . . . . . . . . . . . . . . . i

Symbols Marked on the ST80i System Packaging . . . . . . . . . . . . . . iii

Disposal Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

Important Patient and Safety Information . . . . . . . . . . . . . . . . . . . . iv

Safety Information for the ST80i Stress Test System . . . . . . . . iv

Warning Statements for the ST80i System . . . . . . . . . . . . . . . iv

Caution Statements for the ST80i System . . . . . . . . . . . . . . . vii

Important Notes about the ST80i System . . . . . . . . . . . . . . . viii

Safety Information for the Medical Isolation Transformer. . . . . ix

Warning Statements about the Medical Isolation Transformer ix Caution Statements about the Medical Isolation Transformer ix Important Notes about the Medical Isolation Transformer . . . ix

Safety Information for the Advanced Interface Module . . . . . . .x

Caution Statements for the Advanced Interface Module . . . . .x

Important Notes about the Advanced Interface Module . . . . . .x

Safety Information for the Wireless Patient Interface Module . xi

Warnings about the Wireless Patient Interface Module . . . . . xi

Caution Statements for the Wireless Patient Interface Module xii

Important Notes about the Wireless Patient Interface Module xiii

Security Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .xv

The Philips ST80i Stress Test System . . . . . . . . . . . . . . . . . . . . . . xvii

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii

Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii

The CAlg-STR Exercise ECG Analysis Algorithm . . . . . . . . . . . xviii

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii

Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xviii

Chapter 1Contents

Chapter 1. About the Philips ST80i Stress Test System

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

About ST80i Documentation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Available Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . 1-4

How to Use this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Getting Help Using ST80i. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

Table of Contents

Chapter 2. An Overview of the ST80i Stress Test System

User Accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Starting the Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

User Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4

ST80i Test Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5

Title Bar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Procedure Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8

Toolbar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Waveform Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9

Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

Heart Rate bpm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Target Heart Rate (130). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11

Max (220) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

BP mmhg. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Previous BP mmhg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Double Product (HR*BP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

About METS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

About ST X mm – by Zoom Lead ) . . . . . . . . . . . . . . . . . . 2-13

Treadmill Speed, Grade % . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

Treadmill Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Ergometer Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Using the Toolbar Icons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17

Hide/Show View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17

About the Lead Map. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18

About the Zoom ST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

About the ST Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20

About Trend View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

About HR/METS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-22

About ST J+ mV. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22

About BP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23

About the Average Complex Display. . . . . . . . . . . . . . . . . . 2-23

Freeze . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

Recording an Event. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

Recording RPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26

Note. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27

Compare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27

Page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28

Gear (Quick Settings) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29

Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29

Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-30

Rhythm Print. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31

Sync Out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31

ii ST80i Stress Test System Instructions for Use

Chapter 3. The Patient Session

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Using the Patient Worklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Worklist Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Patient Information Management. . . . . . . . . . . . . . . . . . . . . . 3-5

Patient Information Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6

Add a New Patient to the Worklist. . . . . . . . . . . . . . . . . . . . . 3-6

Find a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Edit Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

Delete a Patient Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8

Download Preregistered Patient Information. . . . . . . . . . . . . 3-9

Review a Previous ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

Select a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Remote Find Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

Before the Patient Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Wireless Patient Interface Module (PIM). . . . . . . . . . . . . . . . 3-12

Checking the Treadmill/Ergometer Connection. . . . . . . . . . 3-14

Starting a Patient Session. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

Select the Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15

Select the Wireless PIM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16

Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

Instructing the Patient about the Test . . . . . . . . . . . . . . . . . . . 3-17

Preparing the Skin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

Attaching the Electrodes/Lead Wires . . . . . . . . . . . . . . . . . . .3-18

Change from Limb Lead to Mason-Likar . . . . . . . . . . . . . . 3-20

Connecting the Patient to the Wireless PIM. . . . . . . . . . . . .3-21

Wireless PIM Button Functions . . . . . . . . . . . . . . . . . . . . . . 3-21

Checking the Lead Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21

Checking Signal Quality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22

Filtering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

Sync Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24

Pre Exercise Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26

Static ECG Resting Interpretation . . . . . . . . . . . . . . . . . . . .3-26

NIBP & SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28

Override NIBP and SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28

Starting the Patient on the Treadmill or Ergometer . . . . . . .3-29

Exercise Phase. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-30

Conducting the Exercise Stress Test. . . . . . . . . . . . . . . . . . . 3-31

Monitoring the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-31

Changing to Another Protocol . . . . . . . . . . . . . . . . . . . . . . . 3-32

Rhythm Print. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33

12-Leads Print. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-33

Controlling the Treadmill or Ergometer. . . . . . . . . . . . . . . . 3-33

Notifications and Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-34

Ending the Exercise Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36

Recovery Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36

Table of Contents

ST80i Stress Test System Instructions for Use iii

Table of Contents

Report Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-38

Global Interpretive Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 3-39

Printing During the Stress Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-41

Printer Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-41

Print Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-43

Ending the Patient Session. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-47

Starting a New Patient Session . . . . . . . . . . . . . . . . . . . . . . . . 3-47

Exiting the Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-47

Post-Recovery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-38

Final Report Manager. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-38

DXL Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-39

CALg Templates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-39

Pace-Pulse Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-39

Real-Time ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-43

12-Lead Resting ECG Report. . . . . . . . . . . . . . . . . . . . . . . . 3-43

Stage Printout and Event Printout . . . . . . . . . . . . . . . . . . . .3-44

Continuous Rhythm Strip. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-45

De-Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-45

Chapter 4. Working with Reports

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

Report Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Post-Recovery Phase. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

Report Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Title Bar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Procedure Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Change (J+) Point. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Save. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Export . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8

Print. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Confirm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9

Replay. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10

Real-Time ECG for One Lead . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Print Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

Current Blood Pressure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12

Final Stress Report Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Report Screen Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Summary Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15

Tabular Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17

Trend Graph Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18

Averages Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

Events Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

Resting ECG Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23

Full Disclose Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

Saving the Final Stress Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

Printing Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

iv ST80i Stress Test System Instructions for Use

Printer Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26

Print Report Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28

ECG Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29

Events Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-30

Rhythm Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-31

Final Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-32

Print (Quick Print Settings) Button. . . . . . . . . . . . . . . . . . . . . 4-33

Printing the Final Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34

Printing Individual Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35

Post-Recovery ECG Printing . . . . . . . . . . . . . . . . . . . . . . . . . 4-37

De-Identify the Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37

Working with Archived Reports . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38

Report (Stress Study) Database. . . . . . . . . . . . . . . . . . . . . . . .4-38

Database Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39

Patient Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40

Search for Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-42

Confirm a Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-42

Transfer Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-42

Delete Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43

V iew a Repo rt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-44

Replay a Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-44

Viewing Reports Saved as PDF Files . . . . . . . . . . . . . . . . . . . 4-45

Exporting Reports (Export Exam) . . . . . . . . . . . . . . . . . . . . . . . . 4-45

External Storage of Stress Study data. . . . . . . . . . . . . . . . . . . 4-46

ECG Export Destination Sites. . . . . . . . . . . . . . . . . . . . . . . . . 4-46

Exporting Reports to an ECG Management System. . . . . . . . 4-47

File Naming Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . .4-47

Exporting Reports for Use with the ECG Connect Option - .4-49

Importing ECGs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49

Working with Batch Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-49

Reviewing and Saving Multiple Reports . . . . . . . . . . . . . . . . 4-50

Deleting Multiple Reports (Delete Exam) . . . . . . . . . . . . . . . 4-50

Printing Multiple Reports (Print Reports). . . . . . . . . . . . . . . . 4-51

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-51

Table of Contents

Chapter 5. Maintaining the ST80i System

Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Cleaning the ST80i System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Cleaning the Printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Cleaning the Equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Appendix A. Troubleshooting and Contacting the Response Center

Troubleshooting ST80i Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2

ST80i Stress Test System Instructions for Use v

Table of Contents

Contacting Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10

Philips Healthcare Customer Care Solution Center . . . . . . . .A-10

North America . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10

South America . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10

Europe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10

Asia Pacific. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-12

Appendix B. Protocol Reference

Bruce Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2

Modified Bruce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3

Balke Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4

Ellestad Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-5

Naughton Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6

Pharmacological Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7

Low Ramp Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-8

Medium Ramp Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-9

High Ramp Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-10

USAF/SAM 2.0 Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11

USAF/SAM 3.3 Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-11

Cycle (Ergometer) Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-12

Astrand Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-13

Appendix C. Configuring and Using the Printer

ST80i Thermal Printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C-1

Thermal Printer Dimensions and Specifications. . . . . . . . . . . .C-2

Loading the Thermal Printer Paper. . . . . . . . . . . . . . . . . . . . . .C-6

Setting Up the Thermal Printer. . . . . . . . . . . . . . . . . . . . . . . . .C-7

Maintaining the Thermal Printer . . . . . . . . . . . . . . . . . . . . . . .C-9

Inspecting the ST80i Thermal Printer . . . . . . . . . . . . . . . . . .C-9

Cleaning the ST80i Thermal Printer . . . . . . . . . . . . . . . . . . .C-9

Testing Printer Operation . . . . . . . . . . . . . . . . . . . . . . . . . . .C-10

About the Supported LaserJet Printers . . . . . . . . . . . . . . . . . . . . .C-11

Appendix D. Ordering Options and Parts

Supplies and Ordering Information. . . . . . . . . . . . . . . . . . . . . . . . .D-1

Optional Parts and Accessories. . . . . . . . . . . . . . . . . . . . . . . . .D-1

Support Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-3

Appendix E. Specifications and Requirements

ST80i System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-1

Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-4

ST80i System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . E-4

vi ST80i Stress Test System Instructions for Use

Medical Isolation Transformer Specifications . . . . . . . . . . . . . E-6

ST80i Thermal Printer Specifications. . . . . . . . . . . . . . . . . . . . E-7

Supported Treadmills and Ergometers . . . . . . . . . . . . . . . . . . . . . . E-8

Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . E-8

Accessories and Cables Warning . . . . . . . . . . . . . . . . . . . . . . . E-9

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions E-10 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity E-11

Recommended Separation Distances . . . . . . . . . . . . . . . . . . . E-15

Table of Contents

ST80i Stress Test System Instructions for Use vii

Table of Contents

viii ST80i Stress Test System Instructions for Use

Safety Summary

This chapter provides important safety information related to the use of the ST80i Stress Test System.

US FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

Conventions Used in the Instructions for Use

The following conventions are used in the ST80i Stress Test System Instructions for Use, this guide.

WARNING Warning statements describe conditions or actions that may result in personal injury or

loss of life.

CAUTION Caution statements describe conditions or actions that may result in damage to equipment or

software.

NOTE Notes contain additional important information about a topic.

Refer to the manual(s) accompanying the ST80i Stress Test System that pertain to the system’s computer hardware for additional definitions of symbols that may be present.

Symbols Marked on the ST80i System

Symbol Description

Attention. See the ST80i Instructions for Use and other product documentation for information.

For information about the Advanced Interface Module, see “Important Notes about the Advanced Interface Module” on page x.

ECG physio isolation is type CF, defibrillator proof. Suitable for all

patient applications including direct cardiac application. System is in continuous operation.

Safety Summary

Symbol Description

Indicates that the system is receiving alternating currents.

Fuse

The connector near this symbol receives an incoming signal.

CE mark.

The number next to this symbol is the serial number of the system.

The number next to this symbol is the product model number of the system.

Dispose of in accordance with the requirements of your country.

An International Protection Rating of “IPX0” indicates that the equipment has no special protection against moisture ingress. The ST80i System carries this rating.

An International Protection Rating of “IPX4” indicates that the equipment is protected against slashing water from any angle. The Wireless Patient Interface Module carries this rating.

Canadian Standards Association (CSA) Certification Mark. Indicates that the product is certified for both the U.S. and Canadian markets, to the applicable U.S. and Canadian standards.

ii ST80i Stress Test System Instructions for Use

Symbols Marked on the ST80i System Packaging

Symbol Description

Keep dry.

Keep out of direct sunlight.

Acceptable temperature range.

Move and store packaging this end up.

Fragile.

Recycle the packaging materials after use.

Manufacturer

Disposal Information

This product consists of devices that may contain mercury, which must be recy cled or disposed of in accordance with local, state, or federal laws. (Within this system the backlight lamps in the monitor display may contain mercury.)

Remove all batteries prior to disposing of any system components. Properly dispose of or recycle depleted batteries according to local regulations. Then dispose of the device in accordance with local, state, or federal regulations for equipment containing electronic parts.

ST80i Stress Test System Instructions for Use iii

Safety Summary

Important Patient and Safety Information

Patient and safety information is divided into several sections:

 ST80i Stress Test System (next section)  Medical isolation transformer (page ix)  Philips advanced interface module (AIM) (page x)  Philips wireless patient interface module (PIM) (page xi)

For information about electromagnetic compatibility (EMC) with surrounding devices, see “Electromagnetic Compatibility (EMC) - To be finalized” on page E-7 of Appendix E, “Specifications and Requirements”

Safety Information for the ST80i Stress Test System

The Philips ST80i Stress Test System, when operated with the ST80i AIM, AIM data cable, ST80i PIM, and lead wires, shall meet all of the EMC requirements specified in the following standards:

 IEC 60601-1:1988 + A1:1991 + A2:1995 Medical Electrical Equip ment – Part 1 - General

requirements for basic safety and performance

 AAMI EC11:8/2007 - Diagnostic Electrocardiographic Devices  IEC 60601-2-25:1993 + A1:1999 - Particular requirements for the safety of

electrocardiographs

 AAMI EC53:12/2008 - ECG cables and leadwires

Warning Statements for the ST80i System

WARNING Failure to follow these warnings could affect both patient and operator safety.

 Do not use the ST80i System in the presence of flammable vapors.  Do not use the ST80i System in the presence of explosive gases. AC power connection/

disconnection or electrostatic discharge (ESD) may result in spark occurring in an environment where explosive gases are used.

 Submersion and/or conditions that subject the ST80i System to liquid ingress create a

shock hazard.

 When operating the ST80i System, ensure that the system and all other electrical

equipment connected to or near the patient are effectively grounded.

 Do not touch accessible connector pins and the patient simultaneously.  The ST80i System has been safety tested with the recommended accessories, peripherals,

and leads, and no hazard was found when the system is operated with cardiac pacemakers or other stimulators.

iv ST80i Stress Test System Instructions for Use

Important Patient and Safety Information

 To maintain designed operator and patient safety when assembling a medical electrical

system for use in the patient environment, the responsible organization shall ensure that peripheral equipment and accessories used that can come in direct patient contact must comply with the following standards:

– IEC 60601-1-1:2000 aka CAN/CSA-C22.2 No.60601-1-1:02 – EN 60601-1-2:2001 (all parts and particularly clause 19), titled, “Medical electrical

equipment - Part 1-1: General requirements for safety - Collateral Standard: Safety requirements for medical electrical systems”

– EN 60601-1:2006 (clause 16 and particularly clause 16.6), titled, “Medical electrical

equipment - Part 1: General requirements for basic safety and essential performance”

 Connecting multiple medical electrical instruments to the same patient may pose a safety

hazard due to the summation of leakage currents. Any combination of medical electrical instruments should be evaluated by local safety personnel before being put into service. For equipment not certified to medical electrical equipment standards that may be used within the patient vicinity, an appropriately rated isolation transformer is required.

 Do not connect to the system any items which are not specified as part of the system.  The PC, LCD, thermal printer, and desk light, purchased as part of a complete system

must be plugged into the medical-grade isolation transformer provided with ST80i.

 Plug all accessories used with ST80i into the medical-grade isolation transformer

provided as part of the “software-only” solution.

 Do not connect additional Multiple Portable Socket-Outlets (MPSOs) or extension cords

to the system.

 The ST80i USB and RS-232 ports should be connected only to treadmills, ergometers, and

NIBP monitors that are certified to meet IEC 60601-1 and are listed as supported devices in the Instructions for Use. See See “Supported Treadmills and Ergometers” on page 7. of Appendix E, “Specifications and Requirements”.

 The performance and safety of the ST80i System cannot be guaranteed if you use

non-compatible accessories.

 Only computers, monitors, and printers approved by a National Certification Body (NCB)

or a Nationally Recognized Testing Laboratory (NRTL) to IEC 60950-1 shall be connected to the ST80i system. All computer, monitor and printer outputs shall comply with IEC 60950-1 limited power source requirements.

 The use of ST80i with equipment (electrosurgical equipment and some respiration

transducers) that applies high frequency voltage to a patient is not supported and may produce undesired outputs.

 To prevent burns to the patient, remove all ECG electrodes and lead wires prior to the use

of high frequency surgical equipment (including electrosurgical equipment and some respiration transducers).

 Only install Philips software on the ST80i System. The installation or use of software,

security patches, or updates not approved by Philips is strictly prohibited and system safety and performance are not guaranteed.

ST80i Stress Test System Instructions for Use v

Safety Summary

 Use only shielded LAN cable when connecting the cable to the ST80i LAN port.  Use Philips-approved lead wires with defibrillator protection resistors.  To avoid the possibility of serious injury or death during patient defibrillation, do not

come into contact with the wireless PIM or lead wires. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.

 Do not contact floating electrodes during defibrillation, and avoid touching the lead wires

or conductive surfaces on the trolley during defibrillation.

 Conductive parts of the patient lead wires, electrodes, and associated Type CF

connections, should not come into contact with other conductive parts, including earth ground.

 Electrodes of dissimilar metals should not be used.  Check lead wires, the cable between the PC and the treadmill, the cable between the PC

and the NIBP module, the AC adapter, and power cords daily for any worn or cracked insulation to ensure that no inner conductive material is exposed. Discard worn accessories and replace them only with Philips accessories.

 The ST80i System should only use grounded power cords (three-wire power cords with

grounded plugs) and connect to grounded electrical outlets that are labeled as “Hospital Only” or “Hospital Grade.” Never adapt a grounded plug to fit an ungrounded outlet by removing the ground prong.

 EMI generated by the ST80i System may cause nearby equipment to fail.  Short-range radio connections are subject to interruption due to interference from other

radio sources in the vicinity, including microwaves, bluetooth devices, and DECT phones. Outside the frequency band and 5% above and below, i.e. the exclusion band according to IEC 60601-1-2, the short-range radio connection is immune up to 3V/m in the frequency range from 80 MHz to 2.5 GHz. Depending on the strength and duration of the interference, the interruption may occur for an extended period. Any interruption of the signal due to interference, moving out of range, or for other reasons is indicated via an RF signal status indicator on both the PIM as well as on the main screen.

 If your system includes the trolley, ensure that components are installed securely and that

no items are placed on the trolley that could cause the trolley to become unstable.

 The maximum weight to be placed on the optional shelf for a laser printer is 45 pounds.  If your system includes the trolley, always lock the wheel brake when the trolley is not in

motion. Press down on the brake tab to set the brake and lift up on the tab to release the brake.

 Safe removal of the all-in-one display from the trolley requires two people.  Placing or spilling liquids on the trolley may cause electrical safety hazards and/or system

malfunction.

 Allow the patient to move freely by:

vi ST80i Stress Test System Instructions for Use

Important Patient and Safety Information

– taking care when dressing the ECG cables so as to minimize the potential tripping

hazard during the stress ECG study process

– securing the patient lead set, power cable, treadmill cable, echo cable, NIBP cable,

and SpO2 cable away from patient’s feet before beginning exercise stage

 The ST80i captures and presents data reflecting a patient’s physiological condition that,

when reviewed by a trained physician or clinician, can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis.

 Both analog ECG output and TTL sync output are not in real time: there is a delay

between the patient’s physiological activity and the appearance of its representative signal at the external port. This signal should not be used for analysis.

 To get the most accurate interpretation during resting ECG, use traditional limb lead

placement.

 For the user’s convenience only, rhythm change notifications are provided when specific

rhythm changes are detected; however, it is the responsibility of the trained healthcare professional to determine the type of rhythm change and take appropriate action. Additionally, the healthcare professional should not assume that all rhythm changes will be detected, and they are responsible for taking action when rhythm changes are observed on the displayed waveforms and the system fails to provide a notification. It is expected that only properly trained healthcare professionals working directly under the supervision of a qualified physician will be operating the ST80i System during testing.

 ST80i cannot import ECGs from another vendor’s stress system.  “Simulated ECG” mode must be turned off when testing patients.  If the “Stop Treadmill” GUI button does not respond for any reason, immediately press the

red “Emergency” button on the treadmill handrail.

 The interpretive algorithm has been validated only with “standard” lead placement.  If the patient data is found to be incorrect, you may edit the ECG file and can print a new

report.

 Entering incorrect NIBP data can cause errors for NIBP-related parameters in reports.

Caution Statements for the ST80i System

CAUTION Caution statements describe conditions or actions that may result in damage to equipment or

software.

 The Multiple Portable Socket-Outlet (MPSO) provided with the system shall only be used

for powering equipment which forms part of the system.

 Do not pull or stretch patient lead wires as this could result in mechanical and/or electrical

failures. Store patient lead wires after forming them into a loose loop.

ST80i Stress Test System Instructions for Use vii

Safety Summary

 Do not attempt to clean the device or patient lead wires by submersion, autoclaving, or

steam cleaning.

 Wipe the exterior surface of the device and patient lead wires with a compatible non-

alcohol sterilizing disinfectant, then dry with a clean cloth. See “Cleaning the ST80i System” on page 5-2 in the “Maintaining the ST80i System” chapter for a list of approved disenfectants.

 Be careful not to damage the display when moving the trolley or when moving other

equipment near trolley.

 To prevent possible damage to the device during transport and storage (while in original

packaging), the following environmental conditions must be adhered to:

Storage Temperature Range:

-20°C to 50°C (-4°F to 122°F)

Storage Humidity Range:

10% to 90% (non-condensing)

Storage Pressure (altitude):

Up to 4,572 m (15,000 ft.) altitude

 Allow the device to stabilize within its intended operating environment for a minimum of

two hours prior to use. The allowable operating environment is as follows:

Operating Temperature Range:

10°C to 40°C (50°F to 104°F)

Operating Humidity Range:

10% to 90% (non-condensing)

Operating Pressure (altitude):

0 to 3,048 m (10,000 ft) altitude (697 mbar)

Important Notes about the ST80i System

 ST80i may become inoperative when the front-end (PIM) signal acquisition is interrupted

due to low PIM battery power, loss of wireless communication between the PIM and the receiver (AIM), and/or loss of USB communication between the AIM and the host PC. ST80i displays a lead-off condition for all leads when signal acquisition is lost and absence of signal strength bars when wireless communication is lost. These inoperative conditions will be saved and indicated on printed reports.

 Power off the system and remove the input AC power cord before installing, repairing, or

servicing any hardware.

 Proper patient preparation is important for proper application of ECG electrodes and

operation of the device. Use medical tape to fix the lead wires to the chest in order to help minimize the strain applied to the electrode connections, thus reducing noise and the possibility of a leads-off condition.

 ST80i automatically prevents connection to a LAN or WLAN while the system is

connected to a patient study.

 As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:

viii ST80i Stress Test System Instructions for Use

Important Patient and Safety Information

– Class I equipment – Type CF applied parts – Ordinary equipment – Not suitable for use in the presence of flammable anesthetics – Continuous operation

 Philips will make available on request circuit diagrams, component part lists, descriptions,

calibration instructions, or other information which will assist the user’s appropriately qualified technical personnel to repair those parts of equipment which are designated by the manufacturer as repairable.

 Because of its sampling characteristics and the asynchronism between sample rate and

signal rate, ST80i may produce a noticeable modulating effect from one cycle to the next, particularly in pediatric recordings.

 ST80i can download ECGs via the TraceMasterVue server for review.

Safety Information for the Medical Isolation Transformer

Warning Statements about the Medical Isolation Transformer

WARNING Failure to follow these warnings could affect both patient and operator safety.

 Use of this transformer with equipment other than originally supplied, or surpassing the

ratings, may cause damage, fire, or injury.

 When using additional peripheral equipment powered from an electrical source other than

the isolation transformer, the combination is considered to be a medical system. It is the responsibility of the operator to comply with IEC 60601-1-1 and test the medical system according to the requirements. For additional information, contact Philips.

 All components (whether supplied by Philips or purchased from another source) attached

to the ST80i PC, including the PC, printer, monitor, and optional blood pressure monitor, must be plugged into a medical isolation transformer to ensure the system is properly grounded. However, do not plug a laser printer into the isolation transformer provided with ST80i. Power for the laser printer must be provided from another source that complies with your facility’s safety requirements or IEC 60601-1.

Caution Statements about the Medical Isolation Transformer

CAUTION Caution statements describe conditions or actions that may result in damage to equipment or

software.

 Before connecting your equipment to the isolation transformer, make sure the voltage

selector (located above the power cord) matches the line voltage.

ST80i Stress Test System Instructions for Use ix

Safety Summary

Important Notes about the Medical Isolation Transformer

 Do not connect the treadmill or the ergometer to the medical isolation transformer

supplied by Philips. It is important that the treadmill and ergometer has its own source of unshared power to avoid an interruption to the power supply to the ST80i System. The treadmill and ergometer should have its own circuit and fuse/breaker in a local power distribution box.

Safety Information for the Advanced Interface Module

Warning Statements about the Advanced Interface Module

WARNING Failure to follow these warnings could affect both patient and operator safety.

 FCC Warning: Changes or modifications not expressly approved by the party responsible

for compliance could void the user’s authority to operate the equipment.

Caution Statements for the Advanced Interface Module

CAUTION Failure to heed these caution statements may result in damage to equipment or software.

 The advanced interface module complies with FCC radiation exposure limits set forth for

an uncontrolled environment.

Important Notes about the Advanced Interface Module

 Use Conditions: This device complies with Part 15 of the FCC rules. Operation is subject

to the following two conditions: – This device may not cause harmful interference – This device must accept any interference received, including interference that may

cause undesired operation

 The manufacturer is not responsible for any radio or TV interference caused by

unauthorized modifications to this equipment. Such modifications could void the user's authority to operate the equipment.

 FCC Note: This device has been tested and found to comply with the limits for a Class B

digital device pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This device generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.

However, there is no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to radio or television rece ption, which can

x ST80i Stress Test System Instructions for Use

Important Patient and Safety Information

be determined by turning the device off and o n, the user is encouraged to try to correct the interference by one or more of the following measures:

– Reorient or relocate the receiving antenna – Increase the separation between the device and receiver – Connect the device into an outlet on a circuit different from that to which the

receiver is connected

– Consult the dealer or an experienced radio/television technician for help

 The radio device used in this product is in compliance with the essential requirements and

other relevant provisions of Directive 1999/5/EC (Radio Equipment and Telecommunications Terminal Equipment Directive). Class 1 radio equipment. Member states may apply restrictions on putting this device into service or placing it on the market.

 Industry Canada Statement:

This device complies with RSS-210 of the Industry Canada rules. Operation is subject to the following two conditions:

– This device may not cause harmful interference, and – This device must accept any interference received, including interference that may

cause undesired operation.

Ce dispositif est conforme à la norme CNR-210 d'Industrie Canada applicable aux appareils radio exempts de licence. Son fonctionnement est sujet aux deux conditions suivantes:

– Le dispositif ne doit pas produire de brouillage préjudiciable, et – Ce dispositif doit accepter tout brouillage reçu, y compris un brouillage susceptible de

provoquer un fonctionnement indésirable.

 This Class B digital apparatus complies with Canadian ICES-003.

Cet appareil numérique de la classe B est conforme à la norme NMB-003 du Canada.

 The AIM’s LED blinks every two seconds when the AIM is functioning properly. If the

AIM LED does not blink, the AIM is not functioning properly.

 The 5-pin connector port on the back of the AIM is non-functional.  Do not connect TC series cardiograph patient interface modules to the 5-pin connector

port on the back of the AIM.

Safety Information for the Wireless Patient Interface Module

ST80i Stress Test System Instructions for Use xi

Safety Summary

Warnings about the Wireless Patient Interface Module

WARNING Failure to follow these warnings could affect both patient and operator safety.

 The wireless patient interface module transmits data reflecting a patient’s physiological

condition to a properly equipped system and when reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis.

 To maintain designed operator and patient safety when assembling a medical electrical

– IEC 60601-1-1:2000 aka CAN/CSA-C22.2 No.6 06 01-1 -1:0 2 – EN 60601-1-2:2001 (all parts and particularly clause 19), titled, “Medical electrical

equipment - Part 1-1: General requirements for safety - Collateral Standard: Safety requirements for medical electrical systems”

– EN 60601-1:2006 (clause 16 and particularly clause 16.6), titled, “Medical electrical

equipment - Part 1: General requirements for basic safety and essential performance”

Any combination of medical electrical instruments should be evaluated by local safety personnel before being put into service. For equipment not certified to medical electrical equipment standards that may be used within the patient vicinity, an appropriately rated isolation transformer is required.

 FCC Warning: Changes or modifications not expressly approved by the party responsible

for compliance could void the user’s authority to operate the equipment.

 To avoid the possibility of serious injury or death during patient defibrillation, do not

come into contact with device or lead sets. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.

 Defibrillation protection is guaranteed only if the original lead set is used.  Ensure that the electrodes or lead wires do not come in contact with any other conductive

materials (including earth-grounded materials), especially when connecting or disconnecting electrodes to or from a patient.

 If your facility is using more than one PIM, each one must be added to the ST80i

application under Settings (System Settings; I/O Devices). When you connect the patient to one of the PIM devices, you also need to verify the address on the device with the address that shows up on the Pre Exercise screen.

 A possible explosion hazard exists. Do not use the device in the presence of flammable

anesthetics, or flammable mixtures with air, oxygen, or nitrous oxide.

 Some stimulators may cause interference with the signal.

xii ST80i Stress Test System Instructions for Use

Important Patient and Safety Information

Caution Statements for the Wireless Patient Interface Module

CAUTION Failure to heed these caution statements may result in damage to equipment or software.

 The wireless patient interface module complies with FCC radiation exposure limits set

forth for an uncontrolled environment.

 The wireless PIM supports 1.5V AA alkaline batteries only. Replace the battery if the

low-battery alert appears before the stress test starts.

 The wireless PIM uses an off-the-shelf disposable AA alkaline battery for power. If you

use an off-the-shelf rechargeable AA battery, the remaining capacity indication may be inaccurate.

 Minimum operating time of the wireless PIM with new, fully charged batteries: 6 tests per

day, 30 minutes average per test, for 5 days. Performance may vary according to brand of batteries used.

 If you use off-the-shelf rechargeable batteries, then you must also provide a compatible

battery recharging unit independent of the ST80i System. To ensure safe use and adequate maintenance of rechargeable batteries, follow the battery manufacturer’s instructions for use.

 Other than the replaceable battery, there are no user-serviceable parts inside. Any

modification of this device may alter defibrillator protection. Any modification to any part of this device is to be performed by qualified service personnel only.

 Follow the correct procedure to select the wireless PIM when multiple modules are

detected. See “Select the PIM” on page 3-13 of the “The Patient Session” chapter.

 To prevent possible damage to the keypad, do not use sharp or hard objects to depress

keys; only use fingertips.

 The wireless PIM and patient lead set should be cleaned between each use.  Do not attempt to clean the wireless PIM or patient lead set by submersion, autoclaving, or

steam cleaning. Wipe the exterior surface of the device and patient cables with a nonalcohol sterilizing disinfectant, then dry with a clean cloth. See “Cleaning the ST80i System” on page 5-2 in the “Maintaining the ST80i System” chapter for a list of approved disenfectants.

 Conductive parts of the patient lead sets, electrodes, and associated Type CF connections,

including the neutral conductor of the patient cable and electrode, should not come into contact with other conductive parts, including earth ground.

 Do not pull or stretch patient lead sets as this could result in mechanical and/or electrical

failures. Store lead sets after forming them into a loose loop.

 The following equipment may cause interference with the RF channel: microwave ovens,

diathermy units with LANs (spread spectrum), amateur radios, and government radar.

ST80i Stress Test System Instructions for Use xiii

Safety Summary

Important Notes about the Wireless Patient Interface Module

 Wireless patient interface module leakage currents are 100% safety tested in production.  Use Conditions: This device complies with Part 15 of the FCC rules. Operation is subject

to the following two conditions: – This device may not cause harmful interference – This device must accept any interference received, including interference that may

cause undesired operation

 The manufacturer is not responsible for any radio or TV interference caused by

unauthorized modifications to this equipment. Such modifications could void the user's authority to operate the equipment.

 FCC Note: This device has been tested and found to comply with the limits for a Class B

However, there is no guarantee that interference will not occur in a particular installation. If this device does cause harmful interference to radio or television rece ption, which can be determined by turning the device off and on, the user is en couraged to try to correct the interference by one or more of the following measures:

– Reorient or relocate the receiving antenna – Increase the separation between the device and receiver – Connect the device into an outlet on a circuit different from that to which the

receiver is connected

– Consult the dealer or an experienced radio/television technician for help

 The radio device used in this product is in compliance with the essential requirements and

 Industry Canada Statement:

This device complies with RSS-210 of the Industry Canada rules. Operation is subject to the following two conditions:

– This device may not cause harmful interference, and – This device must accept any interference received, including interference that may

cause undesired operation.

Ce dispositif est conforme à la norme CNR-210 d'Industrie Canada applicable aux appareils radio exempts de licence. Son fonctionnement est sujet aux deux conditions suivantes:

– Le dispositif ne doit pas produire de brouillage préjudiciable, et

xiv ST80i Stress Test System Instructions for Use

Important Patient and Safety Information

– Ce dispositif doit accepter tout brouillage reçu, y compris un brouillage susceptible de

provoquer un fonctionnement indésirable.

 This ISM device complies with Canadian ICES-001.

Cet appareil ISM est conforme à la norme NMB-001 du Canada.

 Proper patient preparation is important for proper application of ECG electrodes and

operation of the device.

 Use wireless PIM belts and NIBP cuffs appropriate for the patient’s size.  Patient lead sets should be checked for cracks or breakage in its exterior properties prior to

use.

 The wireless PIM includes LEDs that indicate battery power level, wireless signal quality ,

and lead contact status. When the wireless PIM is powered on, the battery power level LED is lit. You can click the power button anytime to check the status of the battery, wireless signal, or lead contacts.

 As defined by IEC 60601-1 and IEC 60601-2-25, the device is classified as follows:

– Internally powered – Type CF applied parts – Ordinary equipment – Not suitable for use in the presence of flammable anesthetics or flammable mixtures

of air, oxygen, or nitrous oxide

– Continuous operation

ST80i Stress Test System Instructions for Use xv

Safety Summary

Security Recommendations

As more patient health information is collected, stored, and transmitted electronically, on a global basis, the concern for patient privacy grows. We consider the security and confidentiality of patient data to be of paramount importance. We adhere to the highest professional standards focused on providing you with resources aimed at your regulatory compliance needs and allowing you to fully manage the safety, effectiveness, and security risks of medical devices, including your ST80i System.

Protecting Personal Information

It is essential that policies and procedures for the proper handling of personal or sensitive data, consider the confidentiality, integrity, and the availability of these types of data. Each organization using this product must provide the protective means necessary to safeguard personal information consistent with each country law, code and regulation, and consistent with the company policies for managing this information. While handling personal information is outside the scope of this document; in g ene ral, each o rganizatio n is responsible for identifying:

 who has access to personal data and under what conditions an individual has authorization

to use that data

 how the data is stored and the conditions by which it is stored  how the data is transmitted and the conditions under which that data is transmitted.

The US Department of Veterans Affairs has developed a widely used Medical Device Isolation Architecture to minimize the risk of a security breach when medical devices are connected to information networks. Such perimeter and network defenses are essential elements in a comprehensive medical device security strategy.

Additional security and privacy information can be found on the Philips product security website at: http://www.healthcare.philips.com/main/productsecurity/.

About HIPAA Rules

If applicable, your facility's security strategy should include the standards set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), introduced by the United States Department of Health and Human Services. You should consider both the security and the privacy rules and the HITECH Act when designing policies and procedures. For more information, please visit:http://www.hhs.gov/ocr/privacy/.

Security Controls and Safety Measures

The following controls and safety measures may further strengthen the security and confidentiality of your patient records and system in general:

 Install ST80i in a secure location and use a privacy filter on the ST80i System monitor that

shields the visibility of the screen contents from angled viewing.

 In case of a power supply disruption, backup options shou ld be h andled by an app ropriate

power failover system.

xvi ST80i Stress Test System Instructions for Use

Security Recommendations

 Implement “best practices” Windows security measures to minimize unauthorized system

access. These measures include making passwords complex, regular changing of passwords, short screen saver intervals, short auto logout intervals when the system is idle, and training your users to lock the desktop when they leave the computer.

 Install McAfee anti-virus software.  Apply Windows-recommended network security and user privilege policies to prevent:

– the installation of any software other than Philips-approved software intended for

installation on ST80i

– the transmission of viruses via removable storage devices (e.g., USB sticks)

 Do not load or download to the computer any software, security patches, or updates not

authorized by Philips. Unathorized software may compromise the operation of the system and is strictly prohibited.

 Remember that the ST80i System contains confidential patient health information (PHI)

that should be safeguarded. Avoid copying pa tient health information to removable media. If you do, maintain physical security of the media at all times. Deleting data from rewritable/erasable media does not make the data inaccessible to a determined individual. Dispose of removable media containing patient health information in accordance with your institution’s policies.

 Upon returning the equipment to Philips, eliminate all patient health information or other

confidential data, unless otherwise directed by Philips for problem investigation. Retain only the information necessary for the investigation with full agreement from both parties.

 Configure the system to not run executables (.exe files) automatically when connecting

external drives. See the ST80i Installation and Configuration Guide for more information.

 Shut down remote desktop services as a best practice.  Rename the built-in Windows Administrator account.  Disable the Guest account. Every user should have his or her own identity.  Set up a BIOS password to prevent unauthorized access to the computer setting.  Although security safeguards to protect the system against the intrusion of malware

(viruses, trojans, worms, and so on) are recommended, a possibility remains that a system can become infected. In all circumstances, the system safety mechanisms are designed to remain intact, even when you might notice unfamiliar system behavior and performance. If this happens repeatedly, such as after the system has been switched off and on again, contact Philips customer support to have the system checked and, if needed, cleansed of malware.

 Malware prevention software should be configured to receive automatic updates. If the

virus scanning software has detected infection by malware, do not use automatic repair utilities because the integrity of the repaired software cannot be guaranteed. Contact Philips service to assess and repair the system. Additionally, please be sure to adhere to local procedures regarding malware infection, which may include disconnecting from the network until the situation is resolved.

ST80i Stress Test System Instructions for Use xvii

Safety Summary

 Perform regular backups of system data and store in a secure location. ST80i allows you to

back up the stored ECG report and the configuration setting. Users with adminstrator accounts can backup and restore ECG reports from the “Archive” screen; administrators can also backup the configuration setting on the “Settings” screen.

 The exported configuration setting can be imported on the “Settings” screen to restore the

ST80i software.

 User must maintain physical security of the media that stores the backup files at all times.  You risk losing ePHI if you transfer it to unsupported and/or obsolete backup media

(e.g., floppy disks).

 Limit W eb browsing to the downloading of Philips-authorized security patches or updates.

Web as browsing dramatically increases the chance of the system being infected by malicious software.

 ST80i is not generally used in situations where emergency access is required. If this is

important to your organization, it is recommended that you establish administrative procedures to permit emergency access to the device when normal logon and authentication credentials are not available.

 Visit the Philips security website at http://www.healthcare.philips.com/main/

productsecurity/ for the latest security updates from Philips.

xviii ST80i Stress Test System Instructions for Use

The Philips ST80i Stress Test System

Intended Use

The Philips ST80i Stress Test System is a PC-based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The cardiac data provided by the Stress system is intended to be reviewed, confirmed, and used for diagnostic purposes by trained medical personnel to assist in the diagnosis of CAD and the patient's physiological condition during stress exercise testing. The arrhythmia detection portion of the ST80i Stress Test System is provided to the user for the convenience of automatic detection of arrhythmias but does not provide alarms.

Indications for Use

The Philips ST80i Stress Test System is indicated for use in exercise ECG testing where the clinician decides to evaluate the electrocardiogram of patients at 10 years or older, as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment, or to rule out causes for symptoms of CAD. The Philips ST80i Stress Test System is not intended to be used as a physiological monitor.

The Philips ST80i Stress Test System

The CAlg-STR Exercise ECG Analysis Algorithm

Intended Use

The intended use of the CAlg-STR Exercise ECG analysis algorithm is to analyze multichannel ECG waveforms acquired from a patient and produce measurements such as heart rate, detect ventricular arrhythmias, form representative beats, and calculate ST segment deviation (elevation or depression) and ST slope for review by a trained physician or clinician in determining a diagnosis. The measurements should not be used as a sole means for determining a patient’s diagnosis.

Indications for Use

The analysis algorithm is indicated for use in those situations where the clinician decides to evaluate the electrocardiogram of patients at 10 years old and old er, as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule out causes for symptoms. The analysis algorithm is not intended to be used as a physiological monitor.

ST80i Stress Test System Instructions for Use xix

Safety Summary

xx ST80i Stress Test System Instructions for Use

1About the Philips ST80i Stress Test

System

The Philips ST80i Stress Test System is a PC-based diagnostic tool for use in the exercise stress testing laboratory. Electrocardiographic data obtained during stress testing is acquired, processed, recorded, analyzed, archived, and exported. The ST80i software creates summary tables, identifies trends, and generates a final statistical report, which trained clinicians review to assist in the diagnosis of the patient’s condition.

The ST80i System interfaces to, and controls, a compatible treadmill or ergometer and noninvasive blood pressure monitor. It can also be used with the pharmacological form of testing. The TTL and analog output options allow a selectable ECG signal to be sent to an Echo system for further tests.

This chapter provides the following information:

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2

About the Testing Process Using ST80i. . . . . . . . . . . . . . . . . . . . . . . . . . .1-3

About ST80i Documentation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Available Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4

Conventions Used in this Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

How to Use this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-5

Getting Help Using ST80i . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-7

1-1

About the Philips ST80i Stress Test System

Overview

The ST80i System is a PC-based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices. The cardiac data provided by the stress system is intended to be reviewed, confirmed and used for diagnostic purposes by trained medical personnel to assist in the diagnosis of coronary artery disease (CAD) and the patient’s physiological condition during stress exercise testing

NOTE The arrhythmia detection portion of ST80i is provided for the convenience of automatic

documentation. ST80i does not offer a diagnostic opinion; rather, it provides a high-fidelity instrument recording ECG waveforms during exercise, for the purpose of providing a tool to expedite the documentation of a test for which a clinician renders his/her own medical opinion.

ST80i provides the standard 12-lead ECG by the use of the 10-lead electrode wireless patient interface module (PIM).

Key features provided by ST80i include the following:

 Continuous ECG acquisition and analysis (ST level, risk scoring & alerts)

 Heart rate, blood pressure & SpO  Intuitive user interface – no user training required  Comprehensive test protocol support  Comprehensive and customizable reports  Comprehensive connectivity (EMR/HIS, TMVue)  Customizable display layout  Wireless patient connection  Support for exercise, pharmacological, and nuclear stress testing  Interface to ADT For patient registration  Remote access to reports

monitoring, display and trending

ST80i is also programmable, allowing you to customize the operational conditions to suit your needs. You can customize:

 Up to 100 different user profiles to meet the needs of individual physicians  Up to 100 different exercise protocols  Automatic 12-lead ECGs  Multiple final report formats

ST80i runs on a PC with the Windows 7 operating system. You control its functions using the keyboard and mouse or touch screen.

1-2 ST80i Stress Test System Instructions for Use

ST80i interfaces with a treadmill, ergometer, or as part of a pharmacological study, and captures four phases of a patient exercise test:

 Pre-exercise  Exercise  Recovery (and Post-Recovery)  Report

About ST80i Documentation

Philips provides detailed instructional and reference materials to help you get the most out of your ST80i System.

Available Documentation

About ST80i Documentation

The following documentation is available with the ST80i system:

Getting Started Sheet Introduces the product, lists the contents, and directs the user to the

installation materials and documentation.

ST80i Installation and

Configuration Guide

Describes how to set up the ST80i System, including hardware and software. Also describes how to set up the trolley and how to perform initial configuration of the software.

ST80i Instructions for

Use (IFU)

Provides detailed information about ST80i functionality. It describes the operation of the product and includes all regulatoryrequired labeling. This guide also includes troubleshooting and maintenance information. The IFU is written for clinical professionals. They are expected to have a working knowledge of medical procedures and medical terminology as required for monitoring potential cardiac patients.

Wireless Patient

Interface Module

Instructions for Use

Provides information about how to set up the Philips wireless patient module and also includes all regulatory-required labeling. Includes a troubleshootingchapter and a service/maintenance chapter.

C-Alg STR

Physician’s Guide

Describes the ECG analysis program available on the ST80i System, and the available report formats. Includes a high-level description of the criteria logic.

ST80i Service Manual Provides guidelines for repair on specific parts as well as

information for how to order replacement parts.

ST80i Stress Test System Instructions for Use 1-3

About the Philips ST80i Stress Test System

Conventions Used in this Guide

The documentation and training materials for ST80i use the following typographic conventions.

Item How Displayed

Menu item

Button name

Field names and list

items

Menu items and button names appear in a bold no-serif font. Example: Click

Settings.

Field names and list items appear in a no-serif font. Example: Select the appropriate format from the

Format dropdown

list.

WARNING Warning statements describe conditions or actions that may result in injury to the

patient.

CAUTION Caution statements describe conditions or actions that may result in damage to equipment or

software.

NOTE Notes provide additional important information about a topic.

How to Use this Guide

This guide is intended to help you use ST80i. It also provides maintenance and troubleshooting information, as well as product specifications.

This guide is organized as follows:

Safety Summary. Lists the warnings, caution statements, and important notes

that apply to using the ST80i system, the patient modules, and the isolation transformer. Read this chapter before operating any of the equipment.

About the Philips ST80i Stress Test System. Provides a high-level

overview of the ST80i System.

Philips ST80i Stress Test System Overview. Provides a general overview of

the ST80i graphical user interface, features, and functionality. It also provides basic information about changing specific default settings during a Patient Session.

The Patient Session. Describes all aspects of the patient session, from getting

started through the four phases of the test.

Working with Reports. Describes how to configure, view, edit, save, and print

the final stress test report.

1-4 ST80i Stress Test System Instructions for Use

About ST80i Documentation

Maintaining the Philips ST80i Stress Test System. Describes how to clean

and maintain the system.

Troubleshooting and Contacting the Response Center. Describes some

issues you might encounter and what to do about them. Also describes how to contact the Philips Response Center.

Protocol Reference. Provides an example of the settings for each of the

protocols provided with ST80i.

Ordering Options and Parts. Provides a list of parts (including support parts)

) and options you can order.

Specifications and Requirements. Lists the product specifications.

Glossary. Defines common terms used with the ST80i System.

Getting Help Using ST80i

For detailed troubleshooting information, as well as details about contacting the Philips Response Center, see Appendix A, “Troubleshooting and Contacting the Response Center.”

ST80i Stress Test System Instructions for Use 1-5

About the Philips ST80i Stress Test System

1-6 ST80i Stress Test System Instructions for Use

1An Overview of the ST80i Stress Test

System

The ST80i Stress Test System is used for the acquisition, analysis, and presentation of stress test data during the patient session. The application also controls the peripheral devices such as the treadmill, ergometer, and blood pressure equipment.

A patient session is the period of time when the exercise stress test is performed and waveforms are acquired and processed for a single patient. Patient information is linked with all waveform data acquired during the patient session. The session starts when you begin to gather exercise data for a new exam and lasts through the generation and review of the final report.

During the patient session, you can change certain default settings as you proceed through each phase using the Toolbar icons - so that you can view or gather more specific ECG data. Other changes can be made directly o n the screen as yo u proceed through the various stages of the exam. This may involve changing the default protocol, manually inserting a blood pressure measurement, or manually taking control of the exercise device. In addition, you can select from various print options during the patient session.

This chapter provides the following information:

User Accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3

Starting the Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3

User Profile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4

ST80i Test Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5

Title Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6

Procedure Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7

Toolbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8

Waveform Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

Side Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

Heart Rate bpm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Target Heart Rate (130) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11

Max (220) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

BP mmhg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Previous BP mmhg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12

Double Product (HR*BP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13

About METS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13

About ST X mm – by Zoom Lead . . . . . . . . . . . . . . . . . . . . . . . . . .2-13

Treadmill Speed, Grade % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13

2-1

An Overview of the ST80i Stress Test System

Treadmill Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Ergometer Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Using the Toolbar Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14

Waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17

Hide/Show View. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17

About the Lead Map. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18

About the Zoom ST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19

About the ST Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20

About Trend View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-21

About HR/METS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-22

About ST J+ mV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-22

About BP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23

About the Average Complex Dis play . . . . . . . . . . . . . . . . . . . . . . . .2-23

Freeze . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-24

Recording an Event. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-24

Recording RPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-26

Note. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-27

Compare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-27

Page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-28

Gear (Quick Settings) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29

Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-29

Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-30

Rhythm Print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-31

Sync Out. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-31

2-2 ST80i Stress Test System Instructions for Use

User Accounts

User accounts are created with specific access privileges based on function. ST80i user accounts are categorized as follows:

 Administrators – these users are allowed to perform all operations on the system.  Clinicians – these users are allowed to perform all operations on the system except most

configuration operations. The only configuration that the Clinician would be able to perform is report configuration for fine tuning on final reporting (“Finalizing”).

 Technicians – these users are allowed to perform all operations on the system except

configuration and “Finalizing.”

Only clinicians and administrators would be able to electronically sign the report. ST80i supports at least 100 user accounts.

Starting the Application

User Accounts

Your user account is used to access the application. When you log into ST80i, you are logging into your preconfigured user profile.

To log in 1

Double-click the ST80i icon on your desktop. The ST80i window opens.

2 Type your User Name and Password. 3 Click OK.

The Main screen opens.

Figure 2-1 Main screen

ST80i Stress Test System Instructions for Use 2-3

An Overview of the ST80i Stress Test System

The Main screen is where you perform all tasks for the application.

 To conduct a stress test, click Patient.  To enter the stress system database to review and retrieve archived reports, click Report.

In this area, you can also replay, delete, or export a selected exercise stress test.

 To review, update, or test software and firmware configurations, click Service.  To hear an audio explanation of the exercise stress test, click Explain Test.

NOTE ST80i ships with a default audio file that explains the exercise stress test; however, you may record

your own audio file and configure ST80i to play this file when the user clicks the Explain Test button. For more information, see the ST80i Installation and Configuration Guide.

 To preconfigure or change system settings, user profiles, exercise protocols and user

accounts, click

Settings.

2-4 ST80i Stress Test System Instructions for Use

User Accounts

User Profile

The system ships with a default user profile that cannot be deleted. The user profile contains preconfigured settings that are used to determine how the test will run and how the test results will be displayed, printed, saved, and exported. Some settings are fixed and cannot be changed; some settings represent a default view, which can be changed during the exercise stress test.

The preconfigured parameters of the user profile include:

 Exercise protocol and equipment  Lead formats  Display settings  Report settings  Freeze display  Filter settings  Algorithm settings  Notifications  Audio prompts

See “Using the Toolbar Icons” on page 2-15 for an explanation of the settings that can be changed during the patient session. See also “Side Panel” on page 2-11 for an explanation of the display features that are continuously updated during the patient session. On this panel you can manually override blood pressure and SpO

, as well as equipment settings that are

preconfigured as part of the user profile and/or protocol. Refer to the ST80i Installation and Configuration Guide for an explanation of how user

profiles are pre-configured. Before beginning with the exercise stress test, it's important to understand the key features of

the ST80i user interface along with the Toolbar icons, since you will be using them during the patient session.

ST80i Stress Test System Instructions for Use 2-5

An Overview of the ST80i Stress Test System

A B

ST80i Test Screen

The ST80i Test screen (user interface) provides:

 All key procedural information including the protocol being used  Pop-ups, drill-down menus, and notes pages that can be viewed then hidden so that the

leads can be viewed in their entirety

 Time of Day for correct time stamp on the start-up screen for every stress test  Real-time ECG as well as NIBP and SpO

, Trends, and other numeric displays that

include ST values, ST slope, Double Product, and ST/HR index

On the Test screen, you have command of several functions during a patient session. You can adjust the speed and elevation of a treadmill and insert manual blood pressure data. You can also abort the exam at any point without losing any patient data. However, note that the exercise data will be lost.

Figure 2-2 ST80i Test screen

Table 2-1 ST80i Test Screen Features

Feature Description

Title Bar - displays patient name date of birth and ID, along with current date and time; during the patient session, you can click the patient name in the Pre Exercise phase or Report phase to update patient information; also where the PIM battery status and RF transmitter LED indicators appear.

2-6 ST80i Stress Test System Instructions for Use

Feature Description

AB C DEF

ST80i Test Screen

Procedure Bar - used to control the exercise stress test process; shows exercise stage; selected patient interface device; protocol;

buttons; and stage time

BP, ECG Print and Rhythm

Toolbar - displays the Toolbar icons that provide quick access to frequently used commands throughout the exercise stress test

Waveform Screen - provides real-time ECG waveforms during the exercise stress test

Side Panel - provides real-time updates during the stress test as well as target heart rate, NIBP and SpO

, and exercise equipment data (speed, grade, stop &

start)

Title Bar

At any time during the Pre Exercise or Report phases of the patient session, you can use the title bar to manually input and edit patient information with data that will be centrally stored in the stress database. The Title Bar includes the features shown and described below.

Figure 2-3 TitleBar

Table 2-2 Title Bar Features

Feature Description

Navigation Keys [Main Test] - Click Main to leave exercise test and return to Main screen

Patient Name - Click the patient name to update patient information and add notes on the

Patient Information tab of the Patient Demographics screen

Patient's Date of Birth

Patient ID

LED indicators for the RF Transmitter and PIM battery status

Current Date and Time

ST80i Stress Test System Instructions for Use 2-7

An Overview of the ST80i Stress Test System

To add or update patient information 1

Click on the Patient Name in the title bar. The system displays the Patient Demographics window.

Figure 2-4 Patient Demographics window

Enter new information for the patient or update the fields as needed during the stress test.

2 3 Click OK when finished to save the data.

If you manually update patient information, including Notes and Symptoms during the test or on the Report screen, this information is not updated in the Patient profile in Worklist.

2-8 ST80i Stress Test System Instructions for Use

ST80i Test Screen

ABCDEF

Procedure Bar

By default, the Procedure Bar is at the top of the screen. You can change the location of the Procedure Bar to the bottom of the screen. See the ST80i Installation and Configuration Guide to change the default setting [Settings  User Profile  Display].

Figure 2-5 Procedure Bar

Table 2-3 Procedure Bar Features

Feature Description

Current exercise phase (Pre Exercise, Exercise, Recovery, Report)

PIM device (only in the Pre Exercise stage)

Protocol (Protocol drop-down list)

button - used to manually command the optional automatic blood pressure

(NIBP) device to take an unscheduled blood pressure measurement

Print ECG

Rhythm print

Advance

button

(to the next stage) or Stop buttons

Exercise stage and time

Phase buttons (Pre Exercise, Exercise, Recovery, Report) - next phase is illuminated in green

ST80i Stress Test System Instructions for Use 2-9

An Overview of the ST80i Stress Test System

Toolbar

The Toolbar contains the Toolbar icons that are used during the patient session. The icons provide quick access to frequently used commands.

During the patient session, the waveform screen is displayed. You can use the Toolbar icons during the patient session to view or hide specific exercise stress test data - which appear as an overlay on the waveform screen.

Some of the icons allow you to change specific default settings as you proceed through each phase of the patient session, while others give you a magnified view of various data in relation to the ECG.

When you mouse over each icon, a Tool Tip is displayed. See “Using the Toolbar Icons” on page 2-15 for a complete description of the icons and their

functionality. The default setting for the Toolbar is at the top of the screen. You can change the location of

the Toolbar to the bottom of the screen. See the ST80i Installation and Configuration Guide to change the default setting [Settings  User Profile  Display].

Waveform Screen

Real-time ECG waveforms appear on the Waveform screen. The default setting is 12-Lead. With the customizable options of ST80i, you can use the Toolbar icons do the following:

 Change the default lead you want to view (12, 6x2, 6, 3)  Display the magnified beat  Display and/or print the average complexes  Show or remove magnified beat, trends, anatomical representations and average

complexes from the ECG print strip

On the bottom of the screen, the current settings appear for the following:

 Limb Lead amplitude  Chest Lead amplitude  Speed of trace display  Filter – low and high pass

Figure 2-6 Limb Lead, Chest Lead, Speed, and Filter Settings

When you change these default settings using the Toolbar icons, they appear in this location.

2-10 ST80i Stress Test System Instructions for Use

Side Panel

B C

The Side Panel shows a continuous display of all relevant physiological parameters as well as visual indicators for current heart rate and a dynamic change in heart rate. From the Side Panel, you can override NIBP and SpO speed and duration during a patient session or stop the treadmill altogether.

The Side Panel provides the following:

Figure 2-7 Side Panel

Side Panel

values. In addition, you can change the treadmill

ST80i Stress Test System Instructions for Use 2-11

An Overview of the ST80i Stress Test System

Table 2-4 Side Panel Features

Feature Description

Heart rate beats per minute

Target heart rate – visual and audible indicators when target heart rage is achieved

Maximum heart rate

BP mmhg – current blood pressure; used also to manually insert current BP measurement

Previous BP mmhg – when BP is taken as pre-configured by stage, previous BP is shown; previous BP is also shown when you manually insert current BP measurement

SpO2 numeric data with appropriate stage; you can manually insert SpO2 data

DP hr*bp (Double-Product – default); drop-down includes:

 METS – establishes metabolic equivalent [Algorithm calculation of HR,

speed of Treadmill, etc.]

 ST mm – ST Index

Treadmill speed (mph), grade %, or ergometer watts

Treadmill or Ergometer button (S tart/S t op). The button displays “Unavailable” when the treadmill or ergometer is unavailable.

Heart Rate bpm

This field shows the current heart rate of the patient.

Target Heart Rate (130)

There are visual and audible indicators when the target heart rate is achieved. This field shows the % of Target Heart Rate achieved.

 Target Heart Rate is X% of maximum heart rate – as established in User Profile  Target Heart Rate % is pre-set (typically 85%)

See the information regarding Target Heart Rate in the ST80i Installation and Configuration Guide.

2-12 ST80i Stress Test System Instructions for Use

Side Panel

Max (220)

Shows the maximum heart rate for patient, male or female.

BP mmhg

When the patient's NIBP is collected during the exercise stress test based on the defined interval in the Exercise Protocol (Off, Begin, End, Every), the BP mmgh field displays the measurement. If you click the measurement also displays in this field.

With this interface, there are visual and audio prompts (if enabled) for NIBP acquisition. To enable audio alerts, see the ST80i Installation and Configuration Guide. This field is also used to manually enter a blood pressure measurement, if an NIBP monitor is

not being used.

To override NIBP or manually insert the blood pressure measurement

BP button during the patient session, the current blood pressure

NOTE Once the NIBP or BP is manually overwritten, ST80i no longer updates the real-time value from the

NIBP monitor.

Click the dashed lines or current BP value in the BP mmhg field.

2 Type in the blood pressure measurement. 3 Click OK.

Previous BP mmhg

When the blood pressure monitor records the current blood pressure measurement, the Previous BP mmgh field displays the previous measurement. It will also display the previous blood pressure measurement when you click the

If you are using a blood pressure cuff, when you manually enter the blood pressure measurement, this field records the previous blood pressure measurement.

SpO

The patient’s SpO2 is collected in real time through a sensor. During the stress test, SpO2 is measured automatically and is continuously displayed on the screen. With this interface, there are also visual and audio prompts (if enabled) for SpO

BP button on the Procedure bar.

acquisition.

To enable audio alerts, see the ST80i Installation and Configuration Guide. You can override the NIBP and SpO

need to manually enter the SpO

values. Depending on the NIBP monitor used, you may

data.

ST80i Stress Test System Instructions for Use 2-13

An Overview of the ST80i Stress Test System

To override or manually enter the Sp0 1 Click the dashed lines or value. 2 Type in the latest SpO

3 Click OK.

Double Product (HR*BP)

Double Product is the current heart rate times the current blood pressure measurement. Use the drop-down arrow to change from Double Product display to the following:

 About METS  About ST X mm (or mV) – X is the selected Zoom Lead

About METS

The METS calculation establishes a metabolic equivalent based on the Algorithm calculation of HR, speed of treadmill, etc.

About ST X mm – by Zoom Lead

You have the option to change the lead in view using the drop-down menu to view the ST Index (ST level).

To change the lead in view 1

Click the Hide/Show View icon.

2 Select Show Zoom ST. 3 Click the Lead drop-down arrow in the Zoom ST lead display. 4 Select the lead to view.

Treadmill Speed, Grade %

These two fields capture the treadmill speed and elevation by stage. You can also use these fields to manually change the treadmill speed and elevation. To do

this, see “Controlling the Treadmill or Ergometer” on page 3-35. During the entire stress test, the host-side application validates the response between the

treadmill (or ergometer) and the PC to ensure that the communication is successful.

2-14 ST80i Stress Test System Instructions for Use

Using the Toolbar Icons

Treadmill Button

The Treadmill button is used to stop and start the treadmill during a patient session.

WARNING The ST80i USB and RS-232 ports should be connected only to treadmills, ergometers, and NIBP

monitors that are certified to meet IEC 60601-1 and are listed as supported devices in the Instructions for Use. See “Supported Treadmills and Ergometers” on page E-7 of Appendix E, “Specifications and Requirements”.

CAUTION If the “Stop Treadmill” GUI button does not respond for any reason, immediately press the red

“Emergency” button on the treadmill handrail.

Ergometer Button

The Ergometer button is used to stop and start the ergometer during a patient session.

Using the Toolbar Icons

Generally, you will not change the settings associated with a selected profile and protocol during an exercise stress test. However, there may be instances when you wish to change specific display settings. You can change display settings by using the Toolbar icons.

Figure 2-8 Toolbar Icons

When you mouse over each icon, a Tool Tip is displayed. Using the

 Select what leads to view in real time  Change the default setting of the waveforms on the waveform screen  Display a zoomed view of an average complex to either a specified lead or for the lead that

 Freeze the ECG or enable a filter to reduce noise  Use the lead map diagram to check the lead wire contact with a predefined, color-coded

Toolbar icons, you can do the following:

shows the most significant change in ST level

indicator to show which lead is off

ST80i Stress Test System Instructions for Use 2-15

An Overview of the ST80i Stress Test System

 Compare the current averages with reference ECG (resting, supine, hyperventilation

averages) and worst case for all 12 leads. ST80i is able to select a new ECG complex or 10s strip as the new reference. This can be done on the screen and is available at any point during the test.

 Hide or show the magnified beat, trends, anatomical representations (ST Map) and

average complexes that appear over the real-time waveform display

 View a two-dimensional, color-coded anatomical representation of ischemic area/

segments (ST Map); 2D real-time updates anatomical representation (ST Map) every 10 seconds

 Create events during the test with associated notes  View trend graphs for Heart Rate, METS, BP, SpO  View magnified ST and morphological changes (including ST morphology changes, T

, and ST values at any time

wave morphology changes, QRS morphology changes) in the various leads.

The following table provides an overview of each icon.

Table 2-5 Toolbar Icons

Icon Description

Waveform The default is 12 leads; you can select from the following:

 12 Leads  6x2 Leads  6 Leads  3 Leads

Hide/Show View Select from the following:

 Show Lead Map  Show Zoom Lead  Show ST Map  Show Trend View [HR/METS; BP; ST Level]  Show Average

Note that these settings are “sticky” – once selected they will remain until deselected.

Freeze Freezes the ECG in a moment in time so that you can print the event

2-16 ST80i Stress Test System Instructions for Use

Using the Toolbar Icons

Table 2-5 Toolbar Icons

Icon Description

Event Select the Event from the drop-down list and do X. The Events include:

 Supine  Stand  Mason-Likar  Hyperventilation  Chest Pain  Shortness of Breath  Add New Event

RPE

Rate of Perceived Exertion; from preconfigured setting

Note

Compare

Page

RELEARN

Insert comments about patient and/or test

Compare the current zoomed ECG with a previous moment in time to compare [the delta]

Form-feed adjustment for thermal paper

ST80i Stress Test System Instructions for Use 2-17

An Overview of the ST80i Stress Test System

Table 2-5 Toolbar Icons

Icon Description

Gear Quick Settings:

 Filter (LP, HP, AC, Artifact, Smart)  Display (Limb Gain, Chest Gain, Speed)  Rhythm Print (Leads, Limb Gain, Chest Gain, Speed)  Sync Out (Analog Out 1 – Amplify Ratio; Analog Out 2 – Amplify

Ratio; TTL Out – Polarity, Duration)

Waveform

Real-time ECG analysis employs the latest C-Alg analysis to calculate an adult patient's ECG for ST segment (elevation or depression) and to produce events and notifications simultaneously for all supported ECG leads.

The real-time waveform default is the 12-Lead. You can choose from four display formats for the real-time ECG:

 12 Leads  6 x 2 Leads  6 Leads  3 Leads

To change the real-time ECG format 1

Click the Waveform icon.

2 Select which lead configuration you want to display from the drop-down menu:

– 12 Leads – 6 x 2 Leads –6 Leads –3 Leads

The Waveform screen display changes to the new setting.

Hide/Show View

To allow maximum viewing of the waveforms, some views are hidden. Use the Hide/Show

View

icon to display the following:

2-18 ST80i Stress Test System Instructions for Use

Using the Toolbar Icons

 Show Lead Map  Show Zoom ST  Show ST Map  Show Trend View (HR/METS; BP; ST Level)  Show Average

About the Lead Map

The Lead Map diagram shows the status of each lead. Yellow indicates lead-off, and green indicates good contact.

To view the Lead Map

Click the Hide/Show View icon.

1 2 Select Show Lead Map.

The Lead Map appears in the top-right corner of the waveform. All connections need to be green.

Figure 2-9 Lead Map Display

If a lead is off, a red “X” is displayed on the lead map and red, dashed flat line is displayed in the real-time ECG view. On the PIM, this condition is verified by a yellow LED light.

3 To close the Lead Map, click the X in the upper-right corner.

NOTE When a leads-off condition is detected, the leads-off indicator string wi ll be printed as a dashed line on

the report and the indicator will be saved when saving the report.

ST80i Stress Test System Instructions for Use 2-19

An Overview of the ST80i Stress Test System

About the Zoom ST

The Zoom ST lead display shows one expanded average ECG complex, which is an averaged ECG enlarged to four times the normal size.

The absolute ST segment values and slope values are displayed for the expanded lead. This function allows you to better visualize the ST segment changes during the test.

The default ST lead is shown in the zoomed QRS window during the exercise stress test. When you begin a test, the default ST lead that is shown in the zoomed display is preconfigured in the user profile. You can select any lead as the zoomed lead from the

Lead drop-down arrow.

You can also select a lead for the default setting. For default settings, see the ST80i Installation and Configuration Guide.

NOTE Whichever lead is selected as the Zoom ST lead, the ST change trend for this lead is also displayed in

the Trend display. See “About Trend View” on page 2-22.

On the Zoom ST display, the following are displayed:

 ST Level (mm or mV)  ST Slope (mV/s or mm/s)  J-Point – default is 60 mm  Default Lead – drop-down  Reference – drop-down

NOTES ST80i can display the lead with the maximum absolute value of the ST level if you select “Max ST

Level” using the drop-down arrow by the default lead. When using the Compare icon, the averaged ECG is superimposed on the blue reference ECG so that

you can compare current and reference data.

The viewing options for zoomed lead are:

Table 2-6 Zoom Lead Options

Zoom Lead Option Description

Any individual lead - Any of the

This selection remains in force until you change it.

twelve leads.

Dynamic The system monitors all twelve leads and displays the

one with the most significant ST change. The lead that appears will change automatically during the stress test; the changes are reflected on printed reports, as well.

2-20 ST80i Stress Test System Instructions for Use

Using the Toolbar Icons

To view the Zoomed ST Lead 1

Click the Hide/Show View icon.

2 Select Show Zoom ST.

The default Zoom lead appears as one expanded average ECG complex on the waveform.

Figure 2-10 Zoom ST Display

To close, click the X in the upper-right corner.

To change the Zoomed ST Lead 1

Click the Hide/Show View icon.

2 Select Show Zoom ST

The default Zoom Lead name appears on the waveform.

3 Use the Lead drop-down menu to change to another Zoom Lead. 4 To close, click the X in the upper-right corner.

About the ST Map

The two-dimensional, color-coded ST map, which can help to identify ischemic areas in the myocardium, is based on both the ST deviation and ST slope. It updates every 10 seconds and can be displayed on the waveform screen.

ST80i Stress Test System Instructions for Use 2-21

An Overview of the ST80i Stress Test System

To view the ST Map 1

Click the Hide/Show View icon.

2 Select Show ST Map.

The ST Map displays on the waveform.

Figure 2-11 ST Map

Click the X in the upper-right corner to close the ST Map.

About Trend View

The Trends graphs show a visual indicator for the current heart rate as well as the dynamic change in heart rate. The Trends data appears in 3 charts that can be viewed at any time.

NOTE Whichever lead is selected as the Zoom ST lead, the ST change trend for this lead is also displayed in

the Trend display.

2-22 ST80i Stress Test System Instructions for Use

To view Trends 1

Click the Hide/Show View icon.

2 Select Show Trend View from the drop-down menu.

Figure 2-1 Show Trend View

Using the Toolbar Icons

The Trends View has three charts: – HR/METS – ST J + mV

– BP (Systolic, Diastolic)

3 Click the X to close the Show Trends view.

About HR/METS

This two-dimensional, color-coded chart is a visual indicator for both the current heart rate and a dynamic change in heart rate. The chart’s X-axis represents time, and the HR value is shown as a curve, representing the dynamic change over time. The Trend graphs of heart rate can be viewed at any time.

METS refers to the estimated metabolic equivalents.

About ST J+ mV

The J-ST time interval is preconfigured in the user profile. This setting specifies the number of milliseconds after the J-point that the ST value is measured. You cannot modify the J-ST time interval during a patient session; it must be done in advance. To modify the J-ST time interval in advance, see the ST80i Installation and Configuration Guide. You can, however, change the J-point on the Report screen. See “Change (J+) Point” on page 4-7 for more information.

The ST-Amplitude calculation is absolute and is shown in mm.

ST80i Stress Test System Instructions for Use 2-23

An Overview of the ST80i Stress Test System

About BP

About the Average Complex Display

The Average Complex display shows one average complex for each of the 12 leads regardless of what lead format is being displayed.

The system displays the S T value in microvolts (or mm) for the on-screen average complexes. To change the ST value from mV to mm, see the ST80i Installation and Configuration Guide.

To view the Average Complex Display

Click the Hide/Show View icon.

1 2 Put a checkmark in the Show Average box.

The Average displays along the right-hand side of the waveform screen.

Figure 2-2 Average mV and mV/s for each Lead

Click X to close the display.

2-24 ST80i Stress Test System Instructions for Use

Using the Toolbar Icons

Freeze

You can print a 12-Lead ECG at any time by clicking the Print button. During the Exercise phase, when you select the that you can view a specific event. A dialog box displays a Freeze image of all leads captured at the moment you clicked the

A scroll bar at the base of the Freeze image allows you to scroll to view any part of the frozen ECG.

To freeze the ECG 1

Select the Freeze icon. The Freeze display appears on the right-hand side of the waveform sc reen.

Figure 2-3 Freeze Display

Freeze icon, it freezes the most recent 10 seconds of ECG data so

Freeze icon.

Use the slide bar or right/left arrows to scroll through the ECG.

2 3 Click X to close the display.

Recording an Event

Events are associated with the user profile. You can add and delete events when you create a user profile. As the test progresses, you can record events, if and when they occur. You can also add events to the drop-down list that appears by clicking the down arrow by the icon in the Toolbar.

ST80i Stress Test System Instructions for Use 2-25

An Overview of the ST80i Stress Test System

When you record an event, ST80i ge ne ra te s a 12-lead ECG and documents the event name on the ECG. The system also stores the event in memory and will print it in the Rhythm Events portion of the final report. User Notes are also associated with the Event, if created. See “Note” on page 2-28 regarding the Note icon.

In addition, ST80i automatically detects an arrhythmia event–if this is enabled. To enable Arrhythmias, see the ST80i Installation and Configuration Guide. See also “Notifications and Alerts” on page 3-36.

The default events include:

 Supine  Mason-Likar  Standing  Hyperventilation  Chest Pain  Short of breath

To record an event

Click the Event button to display the Event drop-down list’

Figure 2-4 Event Drop-Down List

Select the event to record from the drop-down list.

The system prints an ECG and records the event for the final report.

To add an event 1

Click the Event button

2 Click Add New Event from the drop-down list to display the Add New Event pop-up box.

2-26 ST80i Stress Test System Instructions for Use

Using the Toolbar Icons

Figure 2-5 Add New Event Window

Type in a name for the new event.

3 4 Click OK.

The system prints an ECG with the new event label and records the new event for the final report.

Recording RPE

The Rate of Perceived Exertion (RPE) scale provides an indication of the percentage of maximum work being done by a patient. The RPE scale subjectively rates work (physical exertion) as stated by the exercising patient. It provides a means to quantify a patient's level of exertion.

RPE scales can be expressed in two ways, 1 to 10 or 6 to 20. The scale used is associated with the selected user profile. To set the RPE scale, see the ST80i Installation and Configuration Guide.

When you want to record an RPE score, ask the patient to state which number or statement represents their perceived level of work. Then select the corresponding number from the dropdown list. Once the number is selected, the system prints an ECG report, noting the RPE.

Figure 2-6 RPE Drop-down List

To record the patient's RPE

Display the RPE drop-down list by clicking the RPE down arrow.

1 2 Select the RPE statement that matches what the patient reports, and click OK.

The system prints an ECG with the RPE statement.

ST80i Stress Test System Instructions for Use 2-27

An Overview of the ST80i Stress Test System

3 Continue this process throughout the Exercise phase.

The RPE ECG is also held in memory, and is printed in the Rhythm Events section of the final report.

For an explanation of how this appears in the final report, see “Working with Reports” on page 4-1.

Note

During the patient session, you can add notes about the patient's progress as well as important information regarding the exercise stress test. These comments will be stored in the Notes section of Patient Demographics database and they will also appear as part of the Final Stress Report.

For an explanation of how the notes appear in the final report, see “Working with Reports” on page 4-1.

To add a Note 1

Select the Note icon to display a pop-up box in which you can add notes.

Figure 2-7 Note Window

Click OK to save the note.

Compare

ST80i is able to compare the current averages with reference ECG (resting, supine, hyperventilation averages) and worst case for all 12 leads.

As the heart rate increases and/or morphological changes occur, the Compare function is used to view the QRS morphology between a reference zoomed lead and a current event such as Chest Pain or Hyperventilation to compare the delta between the two.

When the zoomed lead is displa yed, the averag ed ECG is superimposed on the reference ECG. The white line represents current data; the reference data is blue.

To use the Compare icon 1

Select the Hide/Show View icon.

2 Select Show Zoom ST to display the zoomed QRS window. Change the default Zoomed

lead, if applicable.

2-28 ST80i Stress Test System Instructions for Use

Using the Toolbar Icons

3 If you do not currently have a particular compare point, click the Event icon to select an

event or create a new event. An ECG will print.

4 Select the Compare icon to compare the current state to when the event occurred or to an

earlier point in time. A drop-down list of current events/compare points allows you to compare the current state

to when the event occurred or to an earlier point in time.

Figure 2-8 Compare Drop-Down List

Select an item from the list.

The current zoomed ECG appears in white; the earlier or baseline zoomed ECG appears in blue so that you can compare the ST elevation/depression of the two images.

Figure 2-9 Compared ECGs

Click the X to close the image.

Page

Use the Page icon to advance the thermal paper, so that the printing starts at the top of the page (at the perforation). This form-feed function for the thermal printer returns the paper to “top of form.” You can also use the

Page icon to advance the paper if there is a paper jam or

after installing a new package of paper.

Relearn

--add information about this button here--

ST80i Stress Test System Instructions for Use 2-29

An Overview of the ST80i Stress Test System

Gear (Quick Settings)

Click the Gear/Quick Settings icon to display the four-tabbed Quick Settings window from which you can change specific default settings that relate to the following:

 Filter  Display  Rhythm Print  Sync Out

Figure 2-10 Quick Settings Window

Filter

The Filters are pre-configured in the Settings section of the application. When you log into ST80i, the active settings of the filters are set to a stored default set that are associated with your user profile.

The ECG data is stored in its unfiltered state (0.02 - 300Hz, all filters off) and user-selected settings are stored with the ECG."

NOTES The ECG data is filtered at 0.05-150Hz before being analyzed by the algorithm. This filter is called the

algorithm filter and cannot be turned off by user. The algorithm filter is independent from other filters and is neither controlled by the user nor affects the saved ECG data.

All filters can be turned on or off as needed to improve signal quality except for the algorithm filter (as described above) and minimum filters (0.02Hz high pass filter and 300Hz low pass filter).

Using the Filter tab in Quick Settings, you can change the default settings. The options include:

 Low Pass (LP) Filter: 40Hz, 100Hz, 150Hz, 300Hz  High Pass (HP) Filter: 0.02Hz, 0.05Hz, 0.15Hz

2-30 ST80i Stress Test System Instructions for Use

Using the Toolbar Icons

 AC Filter: 50Hz, 60Hz, None  Artifact Filter: On, Off  Smart Filter: On, Off

The same filter settings apply to both displayed and printed waveforms. The filter settings are printed with the report.

To change the Filter settings 1

Select the Gear (Quick Settings) icon.

2 Select the Filter tab. 3 Change or modify each filter, as required. 4 Click OK to save changes.

For more information, see “Filtering” on page 3-25.

Display

On the Display tab, you can change the Limb Gain, Chest Gain, and Speed.

To change the Display settings

Click the Gear (Quick Settings) icon.

1 2 Select the Display tab.

3 Use the drop-down arrow to adjust the Limb Gain setting. 4 Change the Chest Gain setting:

–Full –Half

5 Change the speed:

–25 mm/s –50 mm/s

6 Click OK to save your settings.

ST80i Stress Test System Instructions for Use 2-31

An Overview of the ST80i Stress Test System

Rhythm Print

Before you select the Rhythm Print icon from the Procedure bar to print a continuous strip, you can modify your settings based on the following:

 Leads  Limb Gain  Chest Gain  Speed

To change the Rhythm Print settings

Click the Gear (Quick Settings) icon.

1 2 Select the Rhythm Print tab.

3 Place a checkmark for each lead you want to print. (1 - 13 leads are available.) 4 Use the drop-down arrow to adjust the Limb Gain setting. (2.5, 5, 10, 20 mm/mv) 5 Change the Chest Gain setting:

–Full –Half

6 Use the drop-down arrow to adjust the Speed. (5, 10, 25, 50 mm/sec) 7 Click OK to save your settings.

Sync Out

ST80i supports two analog ECG output signals and one TTL ECG Sync Output on the Advanced Interface Module (AIM).

 Analog ECG Output - for synchronization with ECHO device for Stress-Echo procedures.

This signal is not to be considered as diagnostic quality.

 TTL Sync Output - for QRS gating required by the Tango SunTech implementation of

NIBP measurement

CAUTION Sync ECG output signals are not real-time; therefore, they are not diagnostic quality and should not be

used for analysis.

They are pre-configured as part of the user profile. However, they can be changed during the patient session.

See the ST80i Installation and Configuration Guide for how to configure Sync Out settings in the user profile.

2-32 ST80i Stress Test System Instructions for Use

To change Sync Out settings 1

Select the Gear (Quick Settings) icon.

2 Select the Sync Out tab. 3 Use the drop-down menu to modify the following:

– Analog Out 1  Amplify Ratio [drop-down]

– [Example: Analog Out: I; Amplify Ratio: 3 mV/V] – Options: None; Leads I - V6

– Analog Out 2  Amplify Ratio [drop-down]

– [Example: Analog Out 2: None; Amplify Ratio: 1 mV/V – Options: None; Leads I - V6

– TTL Out  Polarity/Duration (ms) [drop-down]

– [Example: TTL Out: None; Polarity: Positive; Duration: 50 ms] – Options: None; Leads I - V6

– Polarity (Positive/Negative)

Using the Toolbar Icons

– Duration: default is 100 ms.

4 Click OK.

ST80i Stress Test System Instructions for Use 2-33

An Overview of the ST80i Stress Test System

2-34 ST80i Stress Test System Instructions for Use

Overview

A patient session is the period of time when the exercise stress test is performed, and waveforms are acquired and processed for a single patient. Patient information is linked with all waveform data acquired during the patient session. The session starts when you begin a new exam and gather pre-exercise data, and lasts through generation of the final report.

In ST80i, the exercise stress test begins with the Pre Exercise phase and ends with the Report phase.

 Pre Exercise  Exercise  Recovery (and Post-Recovery)

1The Patient Session

 Report

CAUTION Do not run any other applications, including screen savers, when performing an exercise stress test.

Once the test has begun, the ST80i application does not allow you to access other system functions.

This chapter provides the following information:

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-1

Using the Patient Worklist. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4

Worklist Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

Patient Information Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5

Patient Information Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6

Add a New Patient to the Worklist. . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6

Find a Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7

Edit Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-7

Delete a Patient Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-8

Download Preregistered Patient Information. . . . . . . . . . . . . . . . . . . .3-9

Review a Previous ECG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9

Select a Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Remote Find Tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-10

Before the Patient Session. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-12

Wireless Patient Interface Module (PIM). . . . . . . . . . . . . . . . . . . . . . . . .3-12

3-1

The Patient Session

Checking the Treadmill/Ergometer Connection . . . . . . . . . . . . . . . .3-14

Starting a Patient Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15

Select the Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15

Select the Wireless PIM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16

Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17

Instructing the Patient about the Test . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17

Preparing the Skin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-17

Attaching the Electrodes/Lead Wires. . . . . . . . . . . . . . . . . . . . . . . . . . . .3-18

Change from Limb Lead to Mason-Likar . . . . . . . . . . . . . . . . . . . . .3-20

Connecting the Patient to the Wireless PIM . . . . . . . . . . . . . . . . . . .3-21

Wireless PIM Button Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-21

Checking the Lead Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-21

Checking Signal Quality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-22

Filtering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24

Sync Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-24

Pre Exercise Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26

Static ECG Resting Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . .3-26

NIBP & SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28

Override NIBP and SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-28

Starting the Patient on the Treadmill or Ergometer. . . . . . . . . . . . . .3-29

Exercise Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-30

Conducting the Exercise Stress Test . . . . . . . . . . . . . . . . . . . . . . . . .3-31

Monitoring the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-31

Changing to Another Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-32

Rhythm Print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33

12-Leads Print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-33

Controlling the Treadmill or Ergometer . . . . . . . . . . . . . . . . . . . . . .3-33

Notifications and Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-34

Ending the Exercise Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-36

Recovery Phase. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-36

Report Phase. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-38

Post-Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-38

Report Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-38

Global Interpretive Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-39

DXL Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-39

CALg T e mplates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-39

Pace-Pulse Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-39

Printing During the Stress Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-41

Printer Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-41

Print Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-43

Real-Time ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-43

12-Lead Resting ECG Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-43

Stage Printout and Event Printout . . . . . . . . . . . . . . . . . . . . . . . . . . .3-44

Continuous Rhythm Strip. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-45

De-Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-45

Ending the Patient Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-47

3-2 ST80i Stress Test System Instructions for Use

Overview

Starting a New Patient Session. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-47

Exiting the Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-47

ST80i Stress Test System Instructions for Use 3-3

The Patient Session

Using the Patient Worklist

When you click Patient on the Main screen, you are taken to the Select Patient screen, where you begin a patient session by selecting the patient for the exam.

The Select Patient screen includes two tabs:

 Worklist  Remote Find

Figure 3-1 Select Patient Screen

Use the Worklist tab to manage patient information. The Worklist enables you to pre-register up to 200 patients. The Worklist database is populated by downloading patient orders or ADT data from a Hospital Information System (HIS), by manually entering information into the Worklist window, or by remote retrieval of information.

Use the

Remote Find tab to do a remote search for a patient using several data points. ST80i

provides an interface with the Philips ECG Gateway or a DICOM server so that you can do the following before conducting an exercise stress test:

 Download a patient's data from DICOM server via ECG Gateway  Download a patient's orders or ADT data from the hospital HIS system (via ECG

Gateway)

Worklist Tab

The Worklist tab of the Select Patient from Worklist screen is used to manage the patient information list, including:

 Adding a new patient  Finding a patient

3-4 ST80i Stress Test System Instructions for Use

 Editing a patient profile  Deleting one or more patient information records  Downloading orders or pre-registered patient information  Selecting a patient to begin the exercise stress test

Using the Patient Worklist

On the

Worklist tab, you can also use the column headings to sort each list.

Figure 3-2 Worklist Tab

Patient Information Management

ST80i displays and reports key patient demographic information such as the patient name, hospital ID number, etc. Some settings are mandatory and configurable. Some settings are set to ON or OFF.

There are two ways to access Patient Demographic information:

 From the Worklist tab before the test:

1 Place a checkmark by the patient's name. 2 Select the Edit button.

The Edit Patient Information screen is displayed.

 From the Test screen during a patient session:

1 Click on the patient's name from the top bar.

The Edit Patient Information screen is displayed.

ST80i Stress Test System Instructions for Use 3-5

The Patient Session

Figure 3-3 Edit Patient Information Screen

You can also access this information from the Report screen. See “Working with Reports” on page 4-1.

Patient Information Fields

ST80i supports predefined and user-defined patient information fields. The predefined patient information fields are shown in the

Patient Information tab of the Edit Patient Information

screen. The patient information fields are configured as mandatory or not. Mandatory fields are displayed in blue text.

CAUTION For better algorithm output, the Patient Information Fields that may affect algorithm output need to be

enabled and complete. At a minimum, the Patient ID, Last Name, First Name, DOB, and Gender must be configured as mandatory fields that will be identified on the Test screen.

To configure or change mandatory patient information fields, see the ST80i Installation and Configuration Guide.

CAUTION Specific patient data is required for each interpretation. If entered patient data are found to be

incorrect, the ECG file may be edited and a new display and/or report can be printed.

Add a New Patient to the Worklist

To manually add a new patient name to the Worklist 1

Click the Add button.

2 In the Add New Patient screen, fill in the patient name and patient information in the

required fields for each of the following tabs:

3-6 ST80i Stress Test System Instructions for Use

– Patient Information –History – Medications/Dosage –Physician/Order –Custom Fields

If you want to:

Using the Patient Worklist

– Save the information and return to the Worklist, click – Save the information and begin the stress test, click

NOTE When mandatory fields are missing, you will be warned with a pop-up message box. If these fields

are changed, a warning message pops up and the resting ECG will be re-interpreted.

Save.

OK.

Find a Patient

You can find a patient already listed in the Worklist by using specific demographic information as search criteria.

To find a patient in the Worklist

Type one of the following into the search field: Patient ID, last name, first name, or order

number.

2 Click Find.

The Worklist displays only the patient(s) matching the search criteria.

3 Click the Back button to restore the full list of names.

Edit Patient Information

In Worklist, you can edit or review patient information by using the Edit button. When you select a patient name, the

To edit patient information in the Worklist

Place a checkmark by the patient's name.

1 2 Click the Edit button to open the Edit Patient Information screen.

Edit button becomes active.

ST80i Stress Test System Instructions for Use 3-7

The Patient Session

Figure 3-4 Edit Patient Information Screen

Update or edit the patient information in each of the following tabs, as required:

– Patient Information –History – Medications/Dosage –Physician/Order –Custom Fields

If you want to: – Save the information and return to the Worklist, click – Save the information and begin the stress test, click

NOTE When mandatory fields are missing, you will be warned.

Delete a Patient Name

You can delete one or many patients from the Worklist.

To delete a patient name from the Worklist

Place a checkmark by the patient's name. You can check more than one patient name to

delete.

2 Click the Delete button. 3 Select Yes from the pop-up box: “Delete record(s) from Worklist.”

Figure 3-5 Delete Record(s) from Worklist Window

Save.

OK.

3-8 ST80i Stress Test System Instructions for Use

Using the Patient Worklist

Download Preregistered Patient Information

With ST80i, you are able to download preregistered patient information by accessing the order or ADT server via the network. The local patient information that you download from remote server or manually add will be stored in a local database. This optional feature permits the creation of a preregistered patient list.

To download orders -- procedure in development... 1

Click Location

2 3

Review a Previous ECG

To review a patient's previous ECG Report 1

Place a checkmark by the patient's name.

2 Click the Previous ECG button.

The Previous ECG Report List is displayed.

Figure 3-6 Previous ECG Report List Screen

Place a checkmark by the patient's name.

4 Click the View Report button.

The report opens in pdf format.

ST80i Stress Test System Instructions for Use 3-9

The Patient Session

Select a Patient

When you are ready begin the patient session for a patient, select his or her name from the Worklist.

Figure 3-1 Report Screen

Click the Back button to return to the Select Patient from Worklist screen.

To select a patient to begin the patient session 1

Place a checkmark by the patient's name.

2 Click OK or press Enter.

This brings you to the first screen of the test: Pre Exercise

Remote Find Tab

The Remote Find tab of the Select Patient from Worklist screen allows you to do a remote search for a patient using several data points. With this feature, you are able to select one or more entries from the search results list and save them to the Worklist.

3-10 ST80i Stress Test System Instructions for Use

Figure 3-2 Remote Find Tab

To do a Remote Find 1

Select the location from the Location drop-down list.

2 Fill in one or all of the following fields:

Using the Patient Worklist

– Patient ID –Last Name –First Name – DOB (MM/DD/YYYY) – Order Number

3 Click the Find button.

Patient's name appears in the Remote Find list.

4 Place a checkmark by the patient's name. 5 Click the OK button to start a patient session.

ST80i Stress Test System Instructions for Use 3-11

The Patient Session

Before the Patient Session

The exercise stress test process requires some advance preparation before running the patient session. Advance preparation includes the following:

 Checking the Wireless Patient Interface Module (PIM)  Checking the equipment connection (treadmill/ergometer), if used  Setting up the Pharma test

Once advance preparation is complete, the patient session follows a series of typical steps from preparing the patient to the final review of the exam.

Wireless Patient Interface Module (PIM)

The wireless PIM is a small data acquisition device that samples patient ECG signals and sends the processed signals to ST80i. The wireless PIM assembly contains the signal acquisition electronics, patient isolation circuits, and system interface circuits. The patient lead set connects to the patient electrodes on one end and plugs into the wireless PIM on the other.

Figure 3-3 Wireless PIM

The wireless PIM digitizes the ECG signal and down-samples the ECG data before transmitting ECG data to ST80i. The wireless PIM uses high and low pass filters to produce filtered ECG data within certain band.

The wireless PIM performs lead signal quality detection to determine if a lead is not connected to patient or electrode/patient contact impedance is excessively high.

3-12 ST80i Stress Test System Instructions for Use

Before the Patient Session

The wireless PIM can also be commanded by the host application to transmit on a user-selected channel to manually override the automatic system driven settings to avoid wireless interference. See the ST80i Installation and Configuration Guide for information on configuring a wireless channel for communication.

The wireless PIM shows the following information:

 Wireless signal quality indicator:

Wireless performance and signal strength are monitored on the curren tly used RF channel. The wireless PIM’s signal quality icon indicates the connection status. If a channel has excessive interference, the wireless PIM will automatically determine a clearer channel with higher signal strength and coordinate with the Advanced Interface Module (AIM) to switch to the new channel.

 Lead-off indication for every lead:

ST80i recognizes when an electrode is not connected and displays that information on the graphic of a human torso on both the wireless PIM and ST80i interface.

 Power indication for battery:

The wireless PIM is battery-powered and the battery voltage is monitored to ensure that the battery is not overly discharged. The remaining battery capacity is displayed in the wireless PIM’s power indicator lights within the battery icon. These lights blink every 5 seconds when the PIM is in use.

In addition, when all patient leads are being connected prior to a test, a low-battery alert warns if there is not enough capacity in the battery to complete test.

ST80i also provides an audible and visual alert on the application screen as a warning that the battery is discharged to the point where PIM is expected to shut down shortly.

The wireless PIM uses off-the-shelf (OTS) disposable AA alkaline batteries for its power source. For the disposable AA battery, the system has been designed to provide approximately one week of battery service life for a “typical” user environment. .

CAUTION ST80i only supports 1.5V AA alkaline batteries for the PIM. Replace the battery if a low-battery alert

appears before the stress test starts.

CAUTION If you use off-the-shelf rechargeable AA-size batteries, the remaining capacity indication may be

inaccurate.

CAUTION If you use OTS rechargeable batteries, you will need to provide a compatible recharger unit for their

batteries that is independent of th e ST80i. To ensure safe use and adequate main tenance of rechargeable batteries, follow the battery manufacturer’s instructions for use.

ST80i Stress Test System Instructions for Use 3-13

The Patient Session

When using the wireless PIM, refer to the ST80i Wireless Patient Interface Module Instructions for Use for details on its preparation, configuration, and use.

If your facility is using more than one PIM, each one must be added to the ST80i application under Settings (System Settings; I/O Devices). When you connect the patient to one of the PIM devices, you also need to verify the address on the device with the address that shows up on the Pre Exercise screen.

To preconfigure multiple PIM addresses, see the ST80i Installation and Configuration Guide.

Checking the Treadmill/Ergometer Connection

During the entire stress test, the host-side application validates the response from treadmill/ ergometer to ensure the communication between PC and treadmill/ergometer is successful.

3-14 ST80i Stress Test System Instructions for Use

Starting a Patient Session

When you select a patient from the Worklist for the stress test, you are immediately brought to the Pre Exercise screen. Based on your user account settings at log-in, a preconfigured profile is loaded for the stress test protocol.

Select the Patient

To select a patient from the Worklist 1

Click Patient on the Main screen.

2 Place a checkmark in the patient name line and click OK, or double-click the patient’s

name. The Pre Exercise screen is displayed. The patient’s name and date of birth appear on the

Title Bar along with the patient ID. The selected protocol is shown on the Procedure Bar.

Figure 3-4 Pre Exercise Screen

Starting a Patient Session

By default, the application displays the real-time ECG waveforms in the format specified in the selected user profile.

To change the real-time ECG display, see “Using the Toolbar Icons” on page 2-15. When Bruce is selected as the protocol, the If you select Cycle as the protocol for the patient, the

Start Treadmill button appears in the Side Panel.

Load Ergometer button appears instead.

ST80i Stress Test System Instructions for Use 3-15

The Patient Session

Select the Wireless PIM

The wireless PIM contains a power on/power off button. Before connecting a patient to the PIM, check the battery status and the wireless signal quality. You will also need to confirm that you are using the right PIM by checking the PIM address.

By default, you will see PIM1 as the first device on the Pre Exercise screen. When you click on the device name, a unique address appears which is used to identify that specific PIM. If there are multiple PIMs registered, they will appear as named during preconfiguration.

To select the wireless PIM 1 2 Click the PIM device to be used (by name).

3 To ensure a correct match, confirm the unique address on the wireless device with the one

4 Press the PIM button on the device to power it on (if it is powered off).

Click the PIM drop-down menu.

you have selected on the Pre Exercise screen.

The PIM wireless status gives feedback that the PIM is selected to communicate with the application.

CAUTION The user should follow the correct procedure to select the PIM when multiple PIMs are detected.

To ensure proper wireless function of the PIM

 Press the PIM’s “light” button to display battery strength.

A battery icon on the ST80i exercise screen also shows the remaining capacity of the wireless PIM battery.

ST80i also provides an audible and visual alert on the application screen as a warning that battery is discharged to the point where PIM is expected to shut down shortly.

NOTE To save the battery power, the PIM can be preconfigured to power off automatically when there is no

action on the PIM for a predefined period.

To preconfigure PIM Power Saving, see the ST80i Installation and Configuration Guide.

3-16 ST80i Stress Test System Instructions for Use

Preparing the Patient

Good ECG technique is very important to achieve the best quality results.

Instructing the Patient about the Test

Before attaching the electrodes, greet the patient and explain the procedure. Explaining the procedure decreases anxiety and informs the patient about what to expect. You may also click the

Explain Test button on the Main screen to play an audio file that explains the test to the

patient.

NOTE ST80i ships with a default audio file that explains the exercise stress test; however, you may record

your own audio file and configure ST80i to play this file when the user clicks the Explain Test button. For more information, see the ST80i Installation and Configuration Guide.

 Privacy is important to relaxation. When possible, prepare the patient in a quiet room or

area where others cannot see the patient.

 Reassure the patient that the procedure is painless.  Make sure the patient is comfortable. The patient’s arms and hands must be relaxed.  Instruct the patient to rest their hands on the handrails and not grasp the handrails tightly.

The more relaxed the patient is, the less the ECG will be affected by noise.

ST80i Stress Test System Instructions for Use 3-17

The Patient Session

Preparing the Skin

Thorough skin preparation is very important. The skin is a poor conductor of electricity and frequently creates artifact that distorts the ECG signal. By performing methodical skin preparation, you greatly reduce the potential for myographic noise and baseline wander, ensuring high-quality printouts and displayed data. There is a natural resistance on the skin surface due to dry, dead epidermal cells, oils, and dirt.

To prepare the skin

Shave hair from electrode sites, if necessary. Excessive hair prevents a good connection.

1 2 Wash the area thoroughly with soap and water.

NOTE Do not use alcohol to clean the skin.

Dry the skin vigorously with a gauze pad to increase capillary blood flow to the tissues

and to remove the dead, dry skin cells and oil.

4 Use an abrading pad to lightly scratch an “X” pattern into the skin, taking care to avoid

excessive abrading.

Attaching the Electrodes/Lead Wires

Placement of the electrodes changes depending on the stage:

 Supine for a resting or baseline ECG  Standing for Exercise Phase

ST80i supports the use of 12-lead wireless PIMs. The 12-lead wireless PIMs connect to the AIM and support 10 electrodes. Using AAMI/IEC labeling, these electrodes are:

 Right Leg [RL/N]  Left Leg [LL/F]  Right Arm [RA/R]  Left Arm [LA/L]  Chest leads [V1/C1, V2/C2, V3/C3, V4/C4, V5/C5, and V6/C6]

3-18 ST80i Stress Test System Instructions for Use

Preparing the Patient

V3/C3

RL/N

RA/R

V1/C1

V2/C2

V4/C4 V5/C5 V6/C6

LA/L

LL/F

All leads are acquired simultaneously. Review the following lead wire labeling and electrode placement information in Figure 3-5 and Table 3-1 to ensure a quality ECG.

Figure 3-5 12-Lead Electrode Placement (AAMI/IEC)

Table 3-1 Leads and positioning

AAMI Lead IEC Lead Electrode Position

Right side of the sternum in the 4th intercostal space

Left side of the sternum in the 4th intercostal space

Midway between V2 and V4

Left midclavicular line in the 5th intercostal space

Between V4 and V6

5th intercostal space, left midaxillary

ST80i Stress Test System Instructions for Use 3-19

The Patient Session

Table 3-1 Leads and positioning

To attach the electrodes to the patient

AAMI Lead IEC Lead Electrode Position

Place the limb electrodes for the arm directly on the clavicle bones (away from major muscles)

Below V6 on the ribcage

On the sternum, midway between the clavicle and the 4th intercostal space

Place the gel area of the electrode over the center of the prepared area, using the

positioning described in Ta ble 3-1 and illustrated in Figure 3-5; then press the adhesive ring into place.

– Avoid pressing the center of the gel area; this might hinder conduction. – Place the electrodes on the soft tissue of the arms, avoiding muscle. See limb lead

placements notes next.

Lead placement is similar to standard 12-Lead ECG placement; however, limb leads are modified, as follows:

– Right Arm and Left Arm leads should be placed close to the shoulders on the clavicle

bone, away from the muscular areas to avoid muscle interference.

– The Right Leg lead is typically placed on the sternum midway between the arm leads

and V1 and V2 leads.

– The Left Leg lead should be placed on a rib, below V6 by about 2 fingers, in the lower

left area of the patient’s chest (avoiding flabby areas and the belt). This may need adjustment depending on body habits.

2 Ensure the electrodes are firmly attached.

A good test for firm electrode contact is to try to move it. If it moves easily, the electrode connection is too loose. Do not allow electrodes to move in any way.

3 Have the patient raise their arms over their head. This will help verify good lead

placement and no strain on the electrodes.

3-20 ST80i Stress Test System Instructions for Use

Change from Limb Lead to Mason-Likar

To attach the electrodes for the Supine (Resting) phase 1

Place the upper body electrodes on the patient.

2 Have the patient lie down. 3 Attach the leg electrodes. 4 Take the BP measurement. 5 Record the ECG. 6 Label the ECG “Supine.”

To attach the electrodes for the Exercise Phase (Standing) 1

Disconnect the limb leads from the patient.

2 Remove the leg electrodes. 3 Hold the PIM as the patient stands.

Preparing the Patient

4 Place the limb electrodes on the torso. 5 Attach the limb leads. 6 Put on the belt and PIM. 7 With the patient standing, record the ECG and label “Standing.” 8 The patient is now ready to move to the exercise device. 9 Explain the test.

Connecting the Patient to the Wireless PIM

All of the ST80i lead sets are designed to share the same connector that will plug into the mating connector on the wireless PIM. Refer to the ST80i Wireless Patient Module Instructions for Use for details on its preparation, configuration, and use.

To connect the patient to the wireless PIM

Plug the lead set connector into the mating connector on the wireless PIM.

Ensure that lead wires do not bump or rub against anything.

2 Place the wireless PIM into the PIM holder. The PIM holder is designed to keep the PIM

steady, thereby minimizing movement of the lead wires and ECG signal artifacts. The PIM holder is adjustable up to a patient waist size of 57".

Wireless PIM Button Functions

The wireless PIM has one button that you can use to:

ST80i Stress Test System Instructions for Use 3-21

The Patient Session

 Power on/off the PIM  Check PIM battery status, wireless link quality, and lead contact quality

When requested to check battery status, the wireless PIM will provide indication of estimated battery power remaining.

When requested to check status of connection to the host system, the wireless PIM will indicate relative signal strength based on the measured signal quality for the link to the host receiver.

When requested to check lead/electrode connections, the wireless PIM will indicate “Poor Lead Signal Quality” condition for any patient electrode connection where the measured impedance is considered excessively high for good quality, low noise ECG measurements. You are able to check the lead signal quality of lead connections while hooking up and preparing patient in an area outside of the range of the system’s radio connection.

3-22 ST80i Stress Test System Instructions for Use

Preparing the Patient

Checking the Lead Map

To check the Lead Map

 Select Show Lead Map from the Hide/Show View icon on the Pre Exercise or Exercise

screen. A color-coded anatomical diagram displays the lead connections.

Figure 3-6 Lead Connections

If a lead is off, a red “X” is displayed on the lead map and red, dashed flat line is displayed in the real-time ECG view. On the PIM, this condition is verified by a yellow LED light.

For more details on checking the lead quality connection, see “About the Lead Map” on page 2-19.

For more details about adjusting the filter, see “Gear (Quick Settings)” on page 2-30.

NOTE Using medical tape to fix the lead wires to the chest may help to minimize strain applied to electrode

connections, thus reducing noise and possibility of leads-off condition occurring.

Checking Signal Quality

ST80i can recognize when an electrode is not connected, and display that information on both the wireless PIM and the Exercise screen. As you adjust the electrodes, the display is updated to reflect changes in the connectivity of the signal. The lead-off condition will be saved with the data and will be indicated on any printed reports which contain that data.

The waveform appears on the real-time display as green. When a lead-off condition is detected, the corresponding lead(s) will be indicated on the real-time display as a red dashed line; when printed, this will also appear as a dashed line.

ST80i Stress Test System Instructions for Use 3-23

The Patient Session

Figure 3-7 Red Dashed Line Showing Leads-Off Condition for V4

ST80i will also provide an indication to the operator when the front-end is inoperative and cannot acquire signal. The indications are lead-off on all leads and the wireless signal quality indicator lights. This condition will be saved with the data and will be indicated on any printed reports which contain that data.

Figure 3-8 Faulty Lead Display Example (V1)

If the screen shows one or more faulty lead connections, re-prep the patient (page 3-17) and replace the electrodes (page 3-18), as necessary, until the display shows satisfactory tracings.

3-24 ST80i Stress Test System Instructions for Use

Preparing the Patient

Filtering

When you open the ST80i application, the active settings of the filters are associated with your user profile. The same filter settings apply to both displayed and printed waveforms. The filter settings are printed with the report.

The smart filter can be enabled or disabled through the Config screen

User Profile tab’s Filters

button. The same filter settings apply to both displayed and printed waveforms. The filter settings are printed with the report.

The filtering techniques developed for ST80i permit the user to identify any clinically significant ST deviation and will not degrade the integrity of the relevant ECG signal content, specifically the ST segment (deviation and slope). This capability is especially important during stages of exercise (stage three and later) where more motion and muscle artifact is present, which could otherwise obscure the ST deviation.

The ECG data is stored in its unfiltered state (0.02 – 300Hz, all filters off) and user-selected settings are stored with the ECG.

NOTES The ECG data is filtered at 0.05-150Hz before being analyzed by the algorithm. This filter is called the

algorithm filter and cannot be turned off by user. The algorithm filter is independent from other filters and is neither controlled by the user nor affects the saved ECG data.

All filters can be turned on or off as needed to improve signal quality except for the algorithm filter (as described above) and minimum filters (0.02Hz high pass filter and 300Hz low pass filter).

If needed, you can change the default filter settings. For details on filter settings, see “Gear (Quick Settings)” on page 2-30.

Sync Output

ST80i supports two analog ECG output signals and one TTL ECG Sync output on the AIM. The AIM accepts real-time ECG data from the wireless PIM and dispatches the data to the PC and output channels. This signal serves as a synchronization signal for coordination of timing between ST80i and another device, such as imaging devices.

ST80i also supports the TTL and Analog output options, which allow selectable ECG signals to be sent to Echo system, NIBP and/or SpO

for further clinical analysis.

The analog-out signals are amplified. TTL/Analog Output Option:

 Specifying the Sync Lead

– User can select the ECG lead used for the TTL/Analog Output.

ST80i Stress Test System Instructions for Use 3-25

The Patient Session

The source signal of the analog ECG and TTL Sync for each output channel can be selected by software from any of the available ECG leads separately. The amplify ratio for the Analog ECG Output can also be configured independently.

To change Analog and/or TTL Output settings during a patient session, see “Gear (Quick Settings)” on page 2-30.

To configure Analog and TTL Output, see the ST80i Installation and Configuration Guide.

WARNING Both analog ECG output and TTL sync output are not in real time: there is a delay between the

patient’s physiological activity and the appearance of its representative signal at the external port. This signal should not be used for analysis.

NOTES ST80i monitors interference and signal strength and automatically selects a clearer frequency band

when excessive interference exists. Software design also ensures that the waveform or lead label can be correctly displayed, stored, and

printed, to avoid data conversion or lead combination errors.

3-26 ST80i Stress Test System Instructions for Use

Preparing the Patient

Pre Exercise Phase

The Pre Exercise phase is used to start the patient on the treadmill or the ergometer. The phase is preset to run for 3 minutes with the speed setting on 01:00 and the elevation is set at 0%.

Figure 3-9 Treadmill Speed and Grade

Note that the Pre Exercise time is separate from the Exercise time. Before the Pre Exercise phase begins with the patient on the treadmill, the following steps are

recommended:

 Baseline ECG (resting or standing)  Baseline Blood Pressure - manual or NIBP  Baseline Sp02

Static ECG Resting Interpretation

Once the waveforms are satisfactory, you are ready to acquire a baseline (resting or standing) ECG. ST80i allows you to acquire and print a 12-lead resting ECG with or without interpretation when the patient is supine or when using the Mason-Likar lead placement. This data will appear as part of the Final ECG Report.

ST80i will provide resting ECG interpretation for all available lead configurations, using the latest Philips DXL algorithm at resting ECG for traditional limb lead placement as well as Mason Likar.

WARNING To get the most accurate interpretation during resting ECG, use traditional limb lead

placement.

When the algorithm finds excessive artifact or AC noise, it will give a related warning/error string. The string will be printed on the report and be saved when saving the report. The algorithm also reports wrong lead placement.

See “Filtering” on page 3-25 regarding artifact or AC noise.

ST80i Stress Test System Instructions for Use 3-27

The Patient Session

To acquire a resting ECG without interpretation 1 2 Click 12 Leads Print button on the Toolbar to obtain a 12-lead resting ECG without

To obtain a 12-lead resting ECG without interpretation: 1 2 From the drop-down menu, select Supine.

To acquire a 12-lead standing ECG without interpretation 1 2 Change the lead position to Mason-Likar.

3 Click the Event button. 4 From the drop-down menu, select Standing.

Have the patient in a supine position.

interpretation.

Click the Event button.

Have the patient in a standing position.

5 Click the 12 Leads Print button on the Toolbar to obtain a 12-lead resting ECG without

interpretation. After a few seconds, the ST80i system prints a full 12-lead resting ECG with

measurements.

To obtain a 12-lead resting ECG with interpretation

 Select an event while in Pre Exercise.

After a few seconds, the ST80i system prints a full 12-lead resting ECG with measurements and interpretation text.

The next step is to connect the patient to the blood pressure monitor and record a baseline blood pressure.

3-28 ST80i Stress Test System Instructions for Use

Philips ST80IWPIM, ST80IAIM User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Safety Summary

Conventions Used in the Instructions for Use

Symbols Marked on the ST80i System

Symbols Marked on the ST80i System Packaging

Disposal Information

Important Patient and Safety Information

Safety Information for the ST80i Stress Test System

Warning Statements for the ST80i System

Caution Statements for the ST80i System

Important Notes about the ST80i System

Safety Information for the Medical Isolation Transformer

Warning Statements about the Medical Isolation Transformer

Caution Statements about the Medical Isolation Transformer

Important Notes about the Medical Isolation Transformer

Safety Information for the Advanced Interface Module

Warning Statements about the Advanced Interface Module

Caution Statements for the Advanced Interface Module

Important Notes about the Advanced Interface Module

Safety Information for the Wireless Patient Interface Module

Warnings about the Wireless Patient Interface Module

Caution Statements for the Wireless Patient Interface Module

Important Notes about the Wireless Patient Interface Module

Security Recommendations

Protecting Personal Information

About HIPAA Rules

Security Controls and Safety Measures

The Philips ST80i Stress Test System

Intended Use

Indications for Use

The CAlg-STR Exercise ECG Analysis Algorithm

Intended Use

Indications for Use

Overview

About ST80i Documentation

Available Documentation

Conventions Used in this Guide

How to Use this Guide

Getting Help Using ST80i

User Accounts

Starting the Application

User Profile

ST80i Test Screen

Title Bar

Procedure Bar

Toolbar

Waveform Screen

Side Panel

Heart Rate bpm

Target Heart Rate (130)

Max (220)

BP mmhg

Previous BP mmhg

Double Product (HR*BP)

About METS

About ST X mm – by Zoom Lead

Treadmill Speed, Grade %

Using the Toolbar Icons

Treadmill Button

Ergometer Button

Waveform

Hide/Show View

About the Lead Map

About the Zoom ST

About the ST Map

About Trend View

Figure 2-1 Show Trend View

About HR/METS

About ST J+ mV

About BP

About the Average Complex Display

Freeze

Recording an Event

Recording RPE

Note

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