Philips ST80IWPIM, ST80IAIM User Manual

ST80i Stress Test System

Instructions for Use

ST80i Stress Test System

INSTRUCTIONS FOR USE

Edition 1

June 2012

Notices

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.

Andover, MA 01810-1099 USA (978) 687-1501

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

–the electrical installation of the 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.

GMDN 36145

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.

Contents

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 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

Table of Contents

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

ST80i Stress Test System Instructions for Use

iii

Table of Contents

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

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

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

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

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

CALg Templates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

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

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

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

Table of Contents

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 View a Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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

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

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

Table of Contents

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

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 recycled 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 Equipment – 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.

ivST80i 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

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:

viST80i 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 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.

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:

viiiST80i 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

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 reception, which can

xST80i Stress Test System Instructions for Use

Important Patient and Safety Information

be determined by turning the device off and on, 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

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.

–IEC 60601-1-1:2000 aka CAN/CSA-C22.2 No.60601-1-1:02

–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

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 reception, which can be determined by turning the device off and on, 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

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

xivST80i 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

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 general, each organization 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 should be handled by an appropriate power failover system.

xviST80i 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 patient 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 Web 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

+ 200 hidden pages