FCC ID: PQC-WPIM Wireless PIM

 

8.5 in. 8.5 in. n i 1 1 ST80i Stress Test System Release A.03 English Instructions for Use

. n i 1 1 ST80i Stress Test System Instructions for Use Release A.03 Revision H April 2024 Notice PN 453564396631 April 2024, Revision H, applies to software version A.03.04 and higher. 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. Koninklijke Philips N.V., 2024. All rights are reserved. Proprietary Notice This document and the information contained in it is proprietary and confidential information of Philips Medical Systems (Philips) and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without the prior written permission of the Philips Legal Department. Use of this document and the information contained in it is strictly reserved for current Philips personnel and customers who have a current and valid license from Philips for use by the customers designated in-house service employee on equipment located at the customers designated site. Use of this document by unauthorized persons is strictly prohibited. Report violation of these requirements to the Philips Legal Department. This document must be returned to Philips when the user is no longer licensed and in any event upon Philips first written request. Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 USA

+1 (978) 687-1501 Authorized EU Representative Philips Medizin Systeme Bblingen GmbH Hewlett Packard Str. 2 71034 Bblingen Germany Australia Sponsor Philips Electronics Australia Ltd. 65 Epping Road North Ryde NSW 2113 Australia Warranty Be advised that the product warranty could be voided by:

service performed by an unauthorized service provider;

use of the device outside of its intended purpose;

any unauthorized device modifications;

use non-Philips accessories or consumables. For specific warranty details, contact your Philips representative or Response Center. ii Responsibility of Manufacturer Philips only considers itself responsible for any effects on safety, reliability and performance of the product if:

assembly operations, extensions, readjustments, modifications or repairs are done by persons authorized by Philips, 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. 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. Instructions for Use This Philips product is intended to be operated only in accordance with the safety procedures and operating instructions provided in this Instructions for Use, and in accordance with the purposes for which it was designed. Installation, use, and operation of this product is subject to the laws in effect in the jurisdiction(s) in which the product is being used. Users must only install, use, and operate this product in such a manner that does not conflict with applicable laws or regulations that have the force of law. Use of this product for purposes other than the express intended purpose provided by the manufacturer, or incorrect use and operation, may relieve the manufacturer (or agent) from all or some responsibility for resultant non-compliance, damage, or injury. Training Users of this product must receive adequate clinical training on its safe and effective use before attempting to operate the product as described in this Instructions for Use. Training requirements vary by country. Users must ensure that they receive adequate clinical training in accordance with local laws or regulations. For further information on available training on the use of this product, please contact a Philips representative. Trademarks Product and company names mentioned herein may be the trademarks or registered trademarks of their respective owners. iii iv Contents Safety Summary Conventions Used in the Instructions for Use. xiii Medical Device Directive . xiii Global Medical Device Nomenclature (GMDN) . xiv REACH. xiv Symbols Marked on the ST80i Device ID Label and System . xiv Symbols Marked on the ST80i System Packaging . xvi Symbols Marked on the ST80i Thermal Printer . xvii Symbols Marked on the ST80i PIM and AIM . xviii Symbols Marked on the ST80i Trolley . xx Disposal Information . xx Important Patient and Safety Information. xxi Compliance . xxi EU Declaration of Conformity . xxi Packaging. xxii Safety Information for the ST80i Stress Test System. xxii Warning Statements for the ST80i System . xxii Caution Statements for the ST80i System. xxvi Important Notes about the ST80i System . xxvii Safety Information for the Medical Isolation Transformer . xxviii Warning Statements about the Medical Isolation Transformer . xxviii Caution Statements about the Medical Isolation Transformer . xxix Important Notes about the Medical Isolation Transformer . xxix Safety Information for the Advanced Interface Module . xxix Warning Statements about the Advanced Interface Module . xxix Caution Statements for the Advanced Interface Module . xxx Important Notes about the Advanced Interface Module . xxx Safety Information for the Wireless Patient Interface Module . xxxii Warnings about the Wireless Patient Interface Module . xxxii Caution Statements for the Wireless Patient Interface Module. xxxiii Important Notes about the Wireless Patient Interface Module . xxxiv Security Recommendations . xxxvi Protecting Personal Information . xxxvi About HIPAA Rules. xxxvi Security Controls and Safety Measures . xxxvii The Philips ST80i Stress Test System . xxxviii Intended Use/Intended Purpose. xxxviii Indications for Use . xxxix Contraindications . xxxix Operating Principle. xxxix Intended Users . xxxix Intended Patient Population . xxxix Medical Conditions. xxxix ST80i Stress Test System Instructions for Use v Contents Environment for Use . xxxix Clinical Benefits. xl The Philips DXL ECG Algorithm . xl Intended Use . xl Indications for Use . xl The CAlg-STR Exercise ECG Analysis Algorithm . xl Intended Use . xl Indications for Use . xl About the Philips ST80i Stress Test System Overview . 1-1 About ST80i Documentation . 1-3 Available Documentation . 1-3 Using the Philips InCenter Site . 1-4 About Adobe Acrobat Versions and InCenter . 1-5 How to Use this Guide . 1-5 Getting Help Using ST80i . 1-6 An Overview of the ST80i Stress Test System User Accounts . 2-1 Starting the Application . 2-2 The Main Screen . 2-2 User Profile . 2-3 ST80i Stress Screen. 2-4 Title Bar . 2-5 Procedure Bar . 2-6 Toolbar . 2-8 Waveform Screen . 2-8 Side Panel . 2-9 Heart Rate bpm. 2-11 Target Heart Rate. 2-11 Max Predicted Heart Rate. 2-11 BP mmHg (Sys/Dia) . 2-12 Previous BP mmHg . 2-13 SpO2 . 2-13 Double Product/METS/ST . 2-13 DP hr*bp. 2-13 METS . 2-14 ST X mm (or mV) . 2-14 Treadmill Speed and Grade Percent or Ergometer RPM and Power. 2-14 Treadmill/Ergometer Buttons . 2-14 Using the Toolbar Icons . 2-15 Waveform . 2-19 Hide/Show View . 2-19 vi ST80i Stress Test System Instructions for Use About the Lead Map View . 2-20 About the Zoom ST View. 2-20 About the ST Map View . 2-22 About Trend View . 2-23 About the Average View . 2-24 Freeze . 2-25 Recording an Event. 2-25 Recording RPE . 2-27 Note . 2-27 Narrative . 2-28 Compare . 2-28 Paper Advance . 2-30 Algorithm Relearn . 2-30 Silent . 2-30 Notification Printing . 2-30 Quick Settings. 2-31 Filter . 2-31 Display . 2-32 Rhythm Print . 2-33 Sync Out . 2-33 Events. 2-34 Pacer Detection . 2-34 The Patient Session Overview . 3-1 Using the Patient Worklist . 3-1 Worklist Tab. 3-2 Patient Information Management . 3-3 Patient Information Fields . 3-4 Add a New Patient to the Worklist. 3-5 Find a Patient . 3-6 Edit Patient Information . 3-6 Delete a Patient Name. 3-7 Download Preregistered Patient Information . 3-7 Review a Previous Study . 3-8 Select a Patient. 3-9 Remote Find Tab . 3-9 Before the Patient Session. 3-10 Wireless Patient Interface Module (PIM) . 3-11 Checking the Treadmill/Ergometer Connection . 3-13 Setting Up a Pharma Test . 3-13 Starting a Patient Session . 3-13 Select the Patient . 3-14 Select the Wireless PIM. 3-15 Prepare Phase . 3-15 Instructing the Patient about the Test. 3-16 ST80i Stress Test System Instructions for Use vii Contents Preparing the Skin . 3-17 Attaching the Electrodes/Lead Wires . 3-17 Connecting the Patient to the Wireless PIM . 3-20 Wireless PIM Button Functions . 3-20 Checking the Lead Map . 3-20 Checking Signal Quality to Verify a Clean ECG . 3-21 Filtering. 3-22 Sync Output . 3-23 Attaching the BP Cuff . 3-24 Attaching the SpO2 Sensor . 3-24 Interpretive Settings . 3-24 DXL Algorithm . 3-25 CAlg Templates . 3-25 Entering the Pre Exercise Phase . 3-26 Pre Exercise Phase. 3-26 Baseline/Reference BP and SpO2 . 3-27 Manually Enter BP and SpO2 . 3-28 Resting ECG with Interpretation . 3-29 Starting the Patient on the Treadmill or Ergometer. 3-30 Exercise Phase. 3-31 Conducting the Exercise Stress Test . 3-32 Monitoring the Patient . 3-33 Changing to Another Protocol . 3-33 Printing During the Stress Test . 3-34 Hot Keys for Printing . 3-34 Printer Settings . 3-34 Print Options . 3-35 Controlling the Treadmill or Ergometer . 3-38 Notifications and Alerts . 3-39 Ending the Exercise Phase . 3-40 Recovery Phase. 3-40 Report Phase . 3-42 Post-Recovery. 3-42 Report Screen . 3-42 Ending the Patient Session. 3-43 Starting a New Patient Session . 3-43 Exiting the Application . 3-44 Working with Reports Overview . 4-1 Report Phase . 4-1 Post-Recovery. 4-2 Report Screen . 4-2 Title Bar . 4-4 Procedure Bar . 4-4 viii ST80i Stress Test System Instructions for Use Change J+ Point . 4-5 Save . 4-5 Export. 4-5 Print. 4-6 Confirm . 4-6 Replay . 4-7 Real-Time ECG for One Lead . 4-9 Print Options . 4-9 Current Heart Rate and Blood Pressure . 4-10 Final Stress Report Overview . 4-10 Report Screen Tabs. 4-11 Summary Tab . 4-12 Tabular Tab . 4-15 Trend Graph Tab . 4-16 Averages Tab. 4-16 Events Tab . 4-17 Resting ECG Tab . 4-21 ST Comparison Tab. 4-22 Max ST Tab . 4-23 Full Disclosure Tab . 4-23 Saving the Final Stress Report . 4-25 Printing Reports . 4-26 Printer Configuration . 4-27 Print Button (Quick Print Settings Dialog Box) . 4-28 Print Options . 4-29 Quick Print . 4-29 Print Final Report. 4-30 Printing the Final Report. 4-30 Printing Individual Reports. 4-31 Post-Recovery ECG Printing . 4-32 Working with Archived Study Data . 4-32 Displaying the List of Archived Studies . 4-34 The Left Pane of the Archive List . 4-35 The Right Pane of the Archive List. 4-36 Changing How the Archive List Is Displayed . 4-36 Searching for Patient Tests . 4-37 Confirming a Test. 4-38 Exporting Test Data . 4-38 Transferring Test Data to a Remote Review Location . 4-38 Deleting Tests . 4-39 Backing Up Tests . 4-39 De-Identifying Tests Using the Back Up Function . 4-40 Restoring Tests. 4-41 Viewing a Test. 4-42 Downloading Test Data at a Remote Review Location . 4-43 Replaying a Test. 4-44 ST80i Stress Test System Instructions for Use ix Contents Exporting Reports . 4-44 PDF Naming Conventions . 4-45 Export Reports to External Media . 4-46 Export Reports to Remote Sites . 4-46 Export Reports to an ECG Management System. 4-47 Export Reports to the Hospital System . 4-47 Export Reports to a Local or Shared Drive . 4-47 Export Reports to an Email Destination . 4-48 Export Exam Data to a Remote Review Shared Drive . 4-48 Export Reports in DICOM Format to a PACS Server. 4-49 Export Reports to the EG Plus DICOM Proxy . 4-49 Viewing and Printing Reports Saved as PDF Files . 4-49 Importing Data or Reports . 4-50 Import Data from IntelliBridge Enterprise (IBE), a DICOM MWL Server, or an EG Plus DICOM Proxy . 4-50 Query a Previous Report . 4-50 Resting ECG Workflow ST80i Resting Screen . 5-2 Resting Title Bar . 5-3 Resting Procedure Bar . 5-4 Waveform Screen . 5-7 Maintaining the ST80i System Daily Maintenance . 6-1 Precautions. 6-1 Cleaning the ST80i System . 6-2 Cleaning the PIM After Each Use . 6-2 Maintaining the ST80i Thermal Printer . 6-3 Inspecting the ST80i Thermal Printer . 6-3 Cleaning the ST80i Thermal Printer. 6-3 Testing ST80i Thermal Printer Operation . 6-4 Replacing the ST80i Thermal Printer Fuse . 6-5 Troubleshooting and Contacting the Philips Response Center Troubleshooting ST80i Issues . A-1 Contacting Your Philips Response Center. A-7 Protocol Reference Bruce Protocol. B-1 Modified Bruce Protocol . B-2 Balke Protocol . B-3 Ellestad Protocol . B-4 Naughton Protocol. B-5 x ST80i Stress Test System Instructions for Use Pharmacological Protocol . B-5 Low Ramp Protocol . B-6 Medium Ramp Protocol . B-7 High Ramp Protocol . B-8 USAF/SAM 2.0 Protocol . B-9 USAF/SAM 3.3 Protocol . B-9 Cycle (Ergometer) Protocol . B-10 Astrand Protocol . B-10 Pharma Ergometer Protocol . B-11 Configuring and Using the Printer ST80i Thermal Printer . C-1 Thermal Printer Dimensions and Specifications. C-2 Loading the Thermal Printer Paper. C-4 Setting Up the Thermal Printer. C-6 About the Supported LaserJet Printers. C-7 Ordering Options and Parts Supplies and Ordering Information. D-1 Optional Parts and Accessories . D-1 Support Parts . D-2 Compatible Products/Parts. D-4 Specifications and Requirements Essential Performance Statement. E-1 ST80i System IT Hardware Requirements . E-2 Specifications . E-3 ST80i System Specifications . E-3 Medical Isolation Transformer Specifications . E-6 ST80i Thermal Printer Specifications . E-7 Supported Treadmills and Ergometers . E-8 Electromagnetic Compatibility (EMC) . E-9 Accessories and Cables Warning . E-10 Reducing Electromagnetic Interference . E-10 ST80i Stress Test System Instructions for Use xi Contents xii 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. Conventions Used in the Instructions for Use The following conventions are used in the ST80i Stress Test System Instructions for Use:. Typeface Usage Bold Italic User interface items and system keys Variables and document titles Example Click Settings. Press CTRL+F.

<product name>-<hardware configuration>-<software version>.cfg ST80i Stress Test System Instructions for Use URL Website URLs www.healthcare.philips.com 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. Medical Device Directive The ST80i Stress Test System complies with the requirements of Medical Device Directive 93/42/EEC and carries the following mark accordingly:

ST80i Stress Test System Instructions for Use xiii Conventions Used in the Instructions for Use Global Medical Device Nomenclature (GMDN) The 5-digit GMDN code adjacent to the symbol is defined in the EN ISO 15225 standard. REACH The EU REACH Regulation 1907/2006 requires Philips to provide chemical content information for Substances of Very High Concern (SVHC), if they are present in the relevant article above a concentration of 0.1% weight by weight. Information on substances contained in the Philips products can be found on the Philips REACH website (www.philips.com/REACH). Symbols Marked on the ST80i Device ID Label and System Symbol Description Follow the Instructions for Use and other product documentation for information. Standard/Reference ISO 7010 M002 Consult electronic instructions for use at www.philips.com/eIFU ISO 15223-1* 5.4.3 Attention. Consult accompanying documents. ISO 15223-1* 5.4.4 ECG physio isolation is type CF, defibrillator proof. Suitable for all patient applications including direct cardiac application. System is in continuous operation. Indicates that the equipment is suitable for AC current only. Fuse IEC 60417 5336 IEC 60417 5032 IEC 60417 5016 The connector near this symbol receives an incoming signal. NA

* ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements IEC 60417 Graphical symbols for use on equipment ISO 7010 Graphical symbols - Safety colours and safety signs - Registered safety signs xiv ST80i Stress Test System Instructions for Use Conventions Used in the Instructions for Use Symbol Description Standard/Reference USB2 or USB3 connector or port. NA Indicates an International Protection Rating of IPX0. The equipment has no special protection against moisture ingress. The ST80i System carries this rating. Interference may occur in the vicinity of equipment marked with this symbol. IEC 60529, Ed. 2.2 Degrees of protection provided by enclosures (IP Code), section 6 IEC 60417 5140 Dispose of in accordance with the requirements of your country. Waste Electrical and Electronic Equipment directive 2012/19/

EU, Article 14.4 Global Medical Device Nomenclature

(GMDN). A five-digit code that is used to create a single general naming system for medical devices. ISO 15225 CE marking accompanied by the Notified Body number 0123. European Medical Device Directive 93/42/EEC The product has been certified by SGS

(Socit Gnrale de Surveillance) Socit Gnrale de Surveillance Identifies the date and country of manufacture. ISO 15223-1* 5.1.3 Packaging unit, To indicate the number of pieces in the package. ISO 7000* 2794 Universal Device Identification information ISO 15223-1* 5.7.10 Indicates that the product is classified as a Medical Device. ISO 15223-1* 5.7.7

* ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements IEC 60417 Graphical symbols for use on equipment ISO 7010 Graphical symbols - Safety colours and safety signs - Registered safety signs ST80i Stress Test System Instructions for Use xv Conventions Used in the Instructions for Use Symbol Description The number next to this symbol is the serial number of the device. Standard/Reference ISO 15223-1* 5.1.7 The number next to this symbol is the catalogue number of the device. ISO 15223-1* 5.1.6 The number next to this symbol is the token number of the device. NA - Philips symbol CAUTION: In the U.S., Federal law restricts this device to sale on or by the order of a physician. 21 CFR 801.109

* ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements IEC 60417 Graphical symbols for use on equipment ISO 7010 Graphical symbols - Safety colours and safety signs - Registered safety signs Symbols Marked on the ST80i System Packaging Symbol Description Keep dry. Standard/Reference ISO 15223-1* 5.3.4 Keep upright. International Air Transport Association, 405B Fragile ISO 15223-1* 5.3.1 Ambient temperature range of 20 oC (4o F) to 50 oC (122o F) (non-condensing) for transport and storage. ISO 15223-1* 5.3.5

* ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements ISO 7000 Graphical symbols for use on equipment - Registered symbols xvi ST80i Stress Test System Instructions for Use Conventions Used in the Instructions for Use Symbol Description Product meets the requirements of European Medical Device Directive (EU) 2017/745 Note: Refers to lead set. Standard/Reference European Medical Device Directive (EU) 2017/745 Battery complies with Taiwan National Communication Commission requirements

(accompanied by certification number) DGT LP00002 Low-power Radio-frequency Devices Technical Specifications Atmospheric pressure range of 0 to 4572 meters (15,000 feet), 572 hPA above sea level for transport and storage. ISO 15223-1* 5.3.9 Relative humidity range of 10% to 90% (non-

condensing) for transport and storage. ISO 15223-1* 5.3.8 Recycle as corrugated fiberboard. GB 18455-2001 National Standard of the Peoples Republic of China -

Packaging recycle mark

* ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements ISO 7000 Graphical symbols for use on equipment - Registered symbols Symbols Marked on the ST80i Thermal Printer Symbol Description Follow the 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 xxx. Consult electronic instructions for use at www.philips.com/eIFU Standard/Reference ISO 7010 M002 ISO 15223-1* 5.4.3 Identifies the name and address of the manufacturer. ISO 15223-1* 5.1.1 IEC 60417 Graphical symbols for use on equipment ISO 7010 Graphical symbols - Safety colours and safety signs - Registered safety signs ST80i Stress Test System Instructions for Use xvii Conventions Used in the Instructions for Use Symbol Description Fuse Standard/Reference IEC 60417 5016 USB2 or USB3 connector or port. NA Dispose of in accordance with the requirements of your country. Waste Electrical and Electronic Equipment directive 2012/19/

EU, Article 14.4 CE marking accompanied by the Notified Body number 0123. European Medical Device Directive 93/42/EEC The product has been certified by SGS

(Socit Gnrale de Surveillance) Socit Gnrale de Surveillance IEC 60417 Graphical symbols for use on equipment ISO 7010 Graphical symbols - Safety colours and safety signs - Registered safety signs Symbols Marked on the ST80i PIM and AIM Symbol Description Follow the 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 xxx. Product meets the requirements of 93/42/

EEC for Medical Devices distributed in the European Economic Area (EEA). Consult electronic instructions for use at www.philips.com/eIFU Standard/Reference ISO 7010 M002 European Medical Device Directive 93/42/EEC ISO 15223-1* 5.4.3 Identifies the name and address of the manufacturer. ISO 15223-1* 5.1.1

* ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements IEC 60417 Graphical symbols for use on equipment ISO 7010 Graphical symbols - Safety colours and safety signs - Registered safety signs xviii ST80i Stress Test System Instructions for Use Conventions Used in the Instructions for Use Symbol Description Indicates that the product is classified as a Medical Device. CAUTION: In the U.S., Federal law restricts this device to sale on or by the order of a physician. Note: PIM only. Standard/Reference ISO 15223-1* 5.7.7 21 CFR 801.109 Indicates conformity with South Korean EMC regulations KRRA Radio Waves Act, Article 58-2 Battery complies with Taiwan National Communication Commission requirements DGT LP00002 Low-power Radio-frequency Devices Technical Specifications Dispose of in accordance with the requirements of your country. Waste Electrical and Electronic Equipment directive 2012/19/

EU, Article 14.4 Indicates compliance with electrical safety, EMC, EME and telecommunications requirements. Australian Communications and Media Authority AS/NZS 4417 The product has been certified by SGS

(Socit Gnrale de Surveillance) Socit Gnrale de Surveillance ECG physio isolation is type CF, defibrillator proof. Suitable for all patient applications including direct cardiac application. System is in continuous operation. Note: PIM only. Indicates an International Protection Rating of IPX4. The equipment is protected against splashing water from any angle. Note: PIM only. IEC 60417 5336 IEC 60529, Ed. 2.2 Degrees of protection provided by enclosures (IP Code), section 6 Indicates that the ST80i PIM requires a single AA battery, inserted in the orientation shown. Note: PIM only. NA

* ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements IEC 60417 Graphical symbols for use on equipment ISO 7010 Graphical symbols - Safety colours and safety signs - Registered safety signs ST80i Stress Test System Instructions for Use xix Disposal Information Symbol Description Power and status indicator button. Press this button to illuminate lights for all leads

(green = connected; amber = not connected) as well as the lights reflecting the wireless signal strength and battery strength. Note: PIM only. Wireless signal strength indicator. One to four lights illuminate, depending on wireless signal strength. Note: PIM only. Battery strength indicator. Every five seconds, one to four lights blink, depending on battery strength. Low battery strength is indicated by continuous illumination of only one light. Note: PIM only. Standard/Reference IEC 60417 5012 IEC 60417 6330B-4 IEC 60417 5001B

* ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements IEC 60417 Graphical symbols for use on equipment ISO 7010 Graphical symbols - Safety colours and safety signs - Registered safety signs Symbols Marked on the ST80i Trolley Symbol Description Do not place more than 3.6 kg (8 lb) of weight on the wire hook. Do not place more than 1 kg (2.2 lb) on the paper tray. Do not place more than 20.4 kg (45 lb) on the laser printer shelf. Standard/

Reference ISO 7010, P012*

ISO 7010, P012*

ISO 7010, P012*

Do not place more than 4.5 kg (10 lb) into the wire basket. IISO 7010, P012*

* ISO 7010:2011 Graphical symbols - Safety colours and safety signs - Registered safety signs 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.) xx ST80i Stress Test System Instructions for Use Important Patient and Safety Information 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. Important Patient and Safety Information Patient and safety information is divided into several sections:

ST80i Stress Test System (next section) Medical isolation transformer (page xxviii) Philips Advanced Interface Module (AIM) (page xxix) Philips wireless Patient Interface Module (PIM) (page xxxii) For information about electromagnetic compatibility (EMC) with surrounding devices, see Electromagnetic Compatibility (EMC) on page E-9 of Appendix E, Specifications and Requirements. Compliance The ST80i Stress Test System complies with all relevant international and national standards and laws. Information on compliance will be supplied on request by a local Philips representative, or by the manufacturer. The Philips ST80i Stress Test System, when operated with the ST80i AIM, AIM data cable, ST80i PIM, and lead wires, meets all of the requirements specified in the following standards:

IEC 60601-1:2005+A1:2012+A2:2020 Medical Electrical Equipment-Part 1:

General Requirements for basic safety and essential performance IEC 60601-2-25: 2011 Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs AAMI EC53: 2020 ECG cables and lead wires When using the Philips-supplied PC, the ST80i Stress Test System also meets the requirements specified in IEC 60601-1-2:2014+A1:2020 and IEC 60601-1-2: 2020. The ST80i Stress Test System also meets the following radio requirements:

EN 300 328 V.2.2.2 EN 301 489-1 V2.2.3 /EN 301 489-17 V3.2.4 EN 62311:2020 EU Declaration of Conformity Philips declares that the ST80i Stress Test System is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: https://www.incenter.medical.philips.com ST80i Stress Test System Instructions for Use xxi Safety Information for the ST80i Stress Test System Packaging Caution In the event that any of the following has occurred, do not attempt to use the ST80i Stress Test System:

The packaging is damaged, or The packaging has been unintentionally opened before use, or The packaging has been exposed to environmental conditions outside the specified parameters (see page xxvi). If any of these conditions has occurred, please contact your Philips Response Center for assistance. Safety Information for the ST80i Stress Test System Warning Statements for the ST80i System WARNING Failure to follow these warnings could affect both patient and operator safety. As with all electronic equipment, Radio Frequency (RF) interference between the ST80i Stress Test System 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 assumes no liability for failure resulting from RF interference between Philips medical electronics and any radio frequency generating equipment at levels exceeding those established by applicable standards. Do not use the ST80i System in the presence of flammable anesthetics or flammable mixtures of air, oxygen, or nitrous oxide. Do not use the ST80i System in Magnetic Resonance Imaging (MRI) applications. Do not use the ST80i System in the presence of explosive gases. AC power connection/disconnection or electrostatic discharge (ESD) may result in a 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. xxii ST80i Stress Test System Instructions for Use Safety Information for the ST80i Stress Test System When operating the ST80i System, ensure that the system and all other electrical equipment connected to or near the patient are effectively grounded. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Do not touch accessible connector pins and the patient simultaneously. 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 IEC 60601-1 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 that are not specified as part of the system. The All-in-One PC, thermal printer, and desk light (powered by AC), purchased as part of a complete system, must be plugged into the medical-

grade isolation transformer provided with the ST80i trolley. Plug all accessories used with ST80i into the medical-grade isolation transformer provided as part of the trolley or as supplied by the customer. Do not connect additional Multiple Port Socket Outlets (MPSOs) or extension cords to the system. Use only the provided isolation transformer outlets. The ST80i 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-8 of Appendix E, Specifications and Requirements. Use of USB cables for these devices is not recommended and may result in abnormal operation of ST80i due to electromagnetic noise interference. 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 62368-1 shall be connected to the ST80i system. All computer, monitor, and printer outputs shall comply with IEC 62368-1 limited power source requirements. The PC used with the ST80i system must comply with IEC/UL 62368-1 Safety Standard for IT Equipment. Customers are responsible for ensuring their final system configuration and integration meets their local safety and EMC compliance regulations as well as meeting AAMI ES 60601-1, IEC 60601-1 and IEC 60601-2-25. ST80i Stress Test System Instructions for Use xxiii Safety Information for the ST80i Stress Test System 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). The installation or use of software, security patches, or updates not approved by Philips for use with the ST80i System is strictly prohibited and is likely to affect system safety and performance. Use only the specified Philips-approved lead wires with defibrillator protection resistors. See Optional Parts and Accessories on page D-1 for a list of approved lead wire sets. 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 following cables should be restricted to less than 3 meters in length:

- USB AIM cable

- BNC Sync AIM cable

- USB printer cable

- USB PC cable (to serial adapter)

- RS-232 Tango NIBP device serial cable 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. See Electromagnetic Compatibility (EMC) on page E-9 for more information. The ST80i System may be interfered with by other equipment even if that other equipment complies with CISPR Emission requirements. For RF transceiver specifications, see Table E-2, ST80i System Specifications, on page E-3. xxiv ST80i Stress Test System Instructions for Use Safety Information for the ST80i Stress Test System 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 belowin other words, the exclusion band according to IEC 60601-1-2the 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 in the trolley drawer is 15 lb (6.8 kg). The maximum weight to be placed on the shelf beneath the trolley drawer is 10 lb (4.5 kg). The maximum weight to be placed on the optional shelf for a laser printer is 45 lb (20.4 kg). 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 an 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:

- 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 patients feet before beginning the exercise stage. If a treadmill is being used, instruct the patient to rest his/her hands on the handrails while on the treadmill. ST80i captures and presents data reflecting a patients 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 patients diagnosis. Both analog ECG output and TTL sync output are considered real-time, with a delay (latency) of no more than 25 ms between the patients 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 users 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 ST80i Stress Test System Instructions for Use xxv Safety Information for the ST80i Stress Test System 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 vendors stress system. Demo mode must be turned off when testing patients. If the Stop Treadmill button on the ST80i interface does not respond for any reason, immediately press the red Emergency button on the treadmill handrail or, if available, pull the safety tether. The interpretive algorithm has been validated only with standard lead placement. Incorrect blood pressure measurement can cause errors for BP-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. This product is not intended for home use. Rx Only: In the U.S., Federal law restricts this device to sale on or by the order of a physician. Philips Medical Systems strongly recommends that your site not use patient identification numbers that are related to any other forms of identity, such as social security number or driver's license number. Using unique patient identification numbers is part of best practices for any information technology system as a way to help health care providers and patients avoid identity theft. The Multiple Portable Socket-Outlet (MPSO) provided with the systemalso referred to as the isolation transformer outletsshall only be used for powering equipment that 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. 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 6-2 in the Maintaining the ST80i System chapter for a list of approved disinfectants. xxvi ST80i Stress Test System Instructions for Use Safety Information for the ST80i Stress Test System 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:

20C to 50C (4F to 122F) 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:

10C to 40C (50F to 104F) Operating Humidity Range:

10% to 90% (non-condensing) Operating Pressure (altitude):

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

The environmental conditions listed above are only applicable to ST80i system parts that acquire and print ECG data, including the AIM, PIM and thermal printer. Off-the-shelf parts such as PC, desk light, and NIBP/SpO2 module have their own operating and storage environment conditions and are not required to meet the condition listed above. Important Notes about the ST80i System The ST80i System is suitable for use in the professional healthcare facility, except in the emergency medical services environment. The system cannot be used in the home healthcare environment. 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. 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 are saved in the logs. ST80i Stress Test System Instructions for Use xxvii Safety Information for the Medical Isolation Transformer 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 treadmill is running. As defined by IEC 60601-1 and IEC 60601-2-25, the ST80i system is classified as follows:

Class I equipment IPX0 Not suitable for use in the presence of flammable anesthetics or flammable mixtures of air, oxygen, or nitrous oxide Continuous operation 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 study data to the TraceMasterVue/IntelliSpace ECG Management System server for review. ECGs captured with the Resting ECG Workflow product option can be downloaded to IntelliSpace ECG. In order to install and configure ST80i in a way that optimizes the users experience, refer to the ST80i Stress Test System Installation and Configuration Guide. If the LCD is smashed accidentally by force, its sharp and broken parts may fly out to persons nearby. 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 isolation transformer with equipment other than originally supplied, or surpassing the ratings, may cause damage, fire, or injury. Plugging into the isolation transformer any electrical equipment that has not been supplied as part of the ST80i System could introduce unwanted leakage currents. xxviii ST80i Stress Test System Instructions for Use Safety Information for the Advanced Interface Module 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 and test the medical system according to the requirements. The PC, thermal printer, monitor, and optional blood pressure monitor, must be plugged into a medical isolation transformer to ensure the user/patient is properly protected from leakage current. Do not plug any of these devices directly into a wall outlet or unwanted leakage currents may be produced. Do not plug a laser printer, treadmill, or ergometer into the isolation transformer provided with ST80i. Power for the laser printer, treadmill, or ergometer must be provided from another source that complies with your facilitys safety requirements or IEC 60601-1. Do not place the isolation transformer on the floor. 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, ensure that:

The voltage selector switch (visible through the rectangular hole on the right rear side of the transformer) matches your line voltage. The correct fuse value (located above the power cord) is selected. Refer to Figure E-1, Medical Isolation Transformer Provided with ST80i, on page E-6. Important Notes about the Medical Isolation Transformer It is important that the treadmill or 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. ST80i Stress Test System Instructions for Use xxix Safety Information for the Advanced Interface Module FCC Warning: Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. This radio transmitter has been approved by Industry Canada to operate with the antenna types listed below with the maximum permissible gain and required antenna impedance for each antenna type indicated. Antenna types not included in this list, having a gain greater than the maximum gain indicated for that type, are strictly prohibited for use with this device. Le prsent metteur radio a t approuv par Industrie Canada pour fonctionner avec les types d'antenne numrs ci-dessous et ayant un gain admissible maximal et l'impdance requise pour chaque type d'antenne. Les types d'antenne non inclus dans cette liste, ou dont le gain est suprieur au gain maximal indiqu, sont strictement interdits pour l'exploitation de l'metteur. Antenna/Antenne Omnidirectional/SMA connector Omnidirectionnel/connection SMA Gain 2 dBi Impedance 50 Ohm 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. Connect the AIM cable only to the ST80i Stress Test System and only to the proper receptacle. The maximum length of the AIM USB cable is 1 meter. The cable should include ferrite beads for EMC purposes. Important Notes about the Advanced Interface Module This equipment complies with FCC& RSS-102 radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20cm between the radiator & your body. Ce matriel est conforme aux limites de dose d'exposition aux rayonnements, FCC / CNR-102 nonce dans un autre environnement.cette eqipment devrait tre install et exploit avec distance minimale de 20 entre le radiateur et votre corps. 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. xxx ST80i Stress Test System Instructions for Use Safety Information for the Advanced Interface Module 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 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 to an outlet on a circuit different from the circuit 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 2014/53/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 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 prjudiciable, et Ce dispositif doit accepter tout brouillage reu, y compris un brouillage susceptible de provoquer un fonctionnement indsirable. This Class B digital apparatus complies with Canadian ICES-003. Cet appareil numrique de la classe B est conforme la norme NMB-003 du Canada. The 5-pin connector port on the back of the AIM is non-functional. ST80i Stress Test System Instructions for Use xxxi Safety Information for the Advanced Interface Module Do not connect PageWriter 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 For information about electromagnetic compatibility (EMC) with surrounding devices, see Electromagnetic Compatibility (EMC) on page E-9 of Appendix E, Specifications and Requirements. 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 patients 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 patients diagnosis. 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 IEC 60601-

1:2005+A1:2012+A2:2020 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. The wireless patient interface module transfers ECG data uniformly at 1000 samples-per-second, with the amplitude resolution of 1?V/least-significant-

bit over the dynamic range of +/ 32 millivolt (16 bits), and with the frequency response of 0.02 to 300 Hertz. Operation of the equipment or system below this amplitude or threshold may cause inaccurate results. FCC Warning: Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with the 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. xxxii ST80i Stress Test System Instructions for Use Safety Information for the Advanced Interface Module 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 Prepare 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. 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. If the low battery message appears after the test has started, there is sufficient power left to finish the test without pausing to replace the battery. 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. The use of rechargeable batteries is not recommended, as the remaining capacity indication may be inaccurate, resulting in the possibility of the PIM powering down during a stress test. 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 depending on the brand of batteries used. Powering off the PIM when not in use and/or configuring the PIM Power Save feature to 3 minutes helps lengthen battery life. Other than the replaceable battery and battery terminals, 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 Wireless PIM on page 3-15. 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 non-alcohol sterilizing disinfectant, then dry with a clean cloth. See Cleaning the ST80i System on page 6-2 in the Maintaining the ST80i System chapter for a list of approved disinfectants. ST80i Stress Test System Instructions for Use xxxiii Safety Information for the Advanced Interface Module 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. Important Notes about the Wireless Patient Interface Module Wireless Patient Interface Module leakage currents are 100% safety tested in production. The wireless Patient Interface Module supports reliable RF transmission within a 3-meter range. With no structures blocking the path to the receiver, the transmission frame error rate is no more than 1% and error frames can be re-transmitted automatically. The wireless transmission stability is 100%

tested during manufacturing. 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 be determined by turning the device off and on, the user is encouraged to try to correct the interference by taking 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 xxxiv ST80i Stress Test System Instructions for Use Safety Information for the Advanced Interface Module The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/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 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 prjudiciable, et Ce dispositif doit accepter tout brouillage reu, y compris un brouillage susceptible de provoquer un fonctionnement indsirable. This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme la norme NMB-001 du Canada. Proper patient preparation is important for proper application of ECG electrodes and operation of the device. Use a wireless PIM belt. Adjust the PIM belt appropriately for the patient and use NIBP cuffs that are appropriate for the patients 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. Note:

Wireless status is displayed only when there is communication between a PIM and the AIM, which begins when a test is started. As defined by IEC 60601-1 and IEC 60601-2-25, the ST80i PIM is classified as follows:

Internally powered Type CF applied part IPX4 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 xxxv Safety Information for the Advanced Interface Module The wireless patient module may be warm to the touch but should not cause a burn. 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. Visit www.healthcare. philips.com, choose your country and language, navigate to the Response Center page, and locate the Product Security link. 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 www.hhs.gov/ocr/privacy/. xxxvi ST80i Stress Test System Instructions for Use Security Controls and Safety Measures Safety Information for the Advanced Interface Module 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. Implement best practices Windows security measures to minimize unauthorized system access. These measures include making passwords complex, regularly changing passwords, short auto logout intervals when the system is idle, and training your users to log off or shut down the computer when they leave the ST80i system. Install anti-virus software such as McAfee VirusScan Enterprise or Symantec Norton 360 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 (for example, USB sticks). Do not load or download to the computer any software, security patches, or updates not authorized by Philips. Unauthorized 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 institutions policies. Communication of unencrypted PHI should only occur across a secured intranet. 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 Stress Test System Installation and Configuration Guide for more information. Rename the built-in Windows Administrator account. Disable the Guest account. Every user should have a unique identity. Set up a BIOS password to prevent unauthorized access to the computer setting. ST80i Stress Test System Instructions for Use xxxvii The Philips ST80i Stress Test System 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. 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 administrator accounts can back up and restore ECG reports from the Archive screen; administrators can also back up the configuration setting on the Settings screen. The exported configuration setting can be imported on the Settings screen to restore the ST80i configuration. 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 (for example, floppy disks). Limit Web browsing to the downloading of Philips-authorized security patches or updates. Web 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 login and authentication credentials are not available. For the latest security updates from Philips, visit www.healthcare.philips.com, choose your country and language, navigate to the Response Center page, and locate the Product Security link. The Philips ST80i Stress Test System Intended Use/Intended Purpose 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 and 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 xxxviii ST80i Stress Test System Instructions for Use The Philips ST80i Stress Test System reviewed, confirmed, and used by trained medical personnel to assist in the evaluation of the patient's cardiovascular condition and the patients 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 cardiovascular disease. The Philips ST80i Stress Test System is not intended to be used as a physiological monitor. Contraindications None known. Operating Principle As a PC-based diagnostic tool, ST80i Stress Test System acquires electrical ECG signal through body surface electrodes attached to patient. The acquired electrical ECG signals are amplified, digitalized, and processed in digital domain. The system records, displays, analyzes, and prints the processed ECG signals for trained medical personnel to evaluate patients cardiovascular and physiological condition. Intended Users The resting ECG function can be performed by a trained clinician, and for performing exercise ECG testing the trained clinician should be under the supervision of an appropriately trained physician. Intended Patient Population The intended patient population are patients 10 years or older. Medical Conditions Clinician use resting ECG testing or exercise ECG testing to evaluate the electrocardiogram of patients at 10 years or older, as part of a decision making process regarding possible diagnosis, potential treatment, or effectiveness of treatment, or to rule out causes for symptoms of cardiovascular disease. Environment for Use The ST80i Stress Test System is intended to be used in hospital and physician office environments. It is not intended for home use. ST80i Stress Test System Instructions for Use xxxix The Philips DXL ECG Algorithm Clinical Benefits The indirect clinical benefits of the ST80i Stress Test System include:

Supports trained healthcare professionals in preliminary diagnosis through its intended use Has a positive impact on clinical outcomes through its intended use The Philips DXL ECG Algorithm Intended Use To analyze multi-channel ECG signals from adult and pediatric patients with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user. The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over read and validate (or change) the computer generated EGG interpretation. Indications for Use Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms. The CAlg-STR Exercise ECG Analysis Algorithm Intended Use The intended use of the CAlg-STR Exercise ECG analysis algorithm is to analyze multi-channel 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 patients diagnosis. Indications for Use The analysis algorithm 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 a decision-making process regarding possible diagnosis, potential treatment, or effectiveness of treatment, or to rule out causes for symptoms. The analysis algorithm is not intended for use as a physiological monitor. xl ST80i Stress Test System Instructions for Use 1 About 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 patients condition. The ST80i System interfaces to, and controls, a compatible treadmill or ergometer and an optional non-invasive 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 a non-invasive BP device or to an echo system for synchronization and timing. 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 and 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 patients 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 or her own medical opinion. ST80i provides the standard 12-Lead ECG using the 10-lead electrode wireless patient interface module (PIM). ST80i Stress Test System Instructions for Use 1-1 Overview Key features provided by ST80i include the following:

Continuous ECG acquisition and analysis (ST level, risk scoring, and alerts) Optional standalone resting ECG acquisition (Resting ECG Workflow product option) Monitoring, display, and trending for heart rate andoptionallyfor blood pressure and SpO2. Optional ability to integrate with device of Cardiopulmonary Exercise Test

(Ultima CPX/BreezeSuite application) for metabolic analysis Intuitive user interface Wireless connection between wireless PIM and ST80i AIM Comprehensive test protocol support Comprehensive and customizable reports Comprehensive connectivity with Electronic Medical Records (EMR), Hospital Information Systems (HIS), IntelliSpace ECG, IntelliSpace Cardiovascular, and third-party departmental systems Customizable display layout Support for exercise, stress echo, nuclear stress, and pharmacological studies Optional interface to patient demographics via DICOM Modality Worklist, HL7 orders, and/or ADT (Admit-Discharge-Transfer) for patient registration Remote access to reports 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 is compatible with Windows 7, Windows 8.1, and Windows 10 operating systems, either 32-bit or 64-bit. You control ST80i functions using the keyboard and mouse or touch screen (if available). ST80i interfaces with a treadmill or ergometer, or supports a pharmacological study. ST80i captures five phases of a patient exercise test:

Prepare Pre Exercise Exercise Recovery Report (Post-Recovery) With the Resting ECG Workflow product option, ST80i can also capture a standalone resting ECG, either prior to a stress test or as a standalone test. 1-2 ST80i Stress Test System Instructions for Use About ST80i Documentation About ST80i Documentation Philips provides detailed instructional and reference materials to help you get the most out of your ST80i System. Available Documentation The following documentation is available with the ST80i system:

ST80i Stress Test System Instructions for Use (IFU) ST80i Stress Test System Installation and Configuration Guide ST80i Stress Test System Service Manual Provides detailed information about ST80i functionality. It describes the operation of the product and includes all regulatory-required 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. 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. Describes preventive and technical maintenance performed by trained service personnel. Includes information about using the service utility for hardware and software management. Also provides troubleshooting procedures and information about the repair and replacement of ST80i components. ST80i Stress Test System Product Options Upgrade Instructions Describes how to upgrade your system with software options purchased after your initial ST80i Stress Test System purchase. CAlg-STR Exercise ECG Analysis Algorithm Physicians 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. Philips DXL ECG Algorithm Physicians Guide Explains how ECG signals are analyzed by the Philips DXL 16-Lead ECG Algorithm. Used with the ST80i Resting ECG Workflow product option. ST80i Stress Test System Instructions for Use 1-3 About ST80i Documentation Using the Philips InCenter Site The Philips InCenter site provides frequent updates to Philips product documentation and product software. The Philips InCenter site requires an active registration and password. To register, go to the InCenter site at incenter.medical.philips.com. Click the Need help? link on the main page (located under the user login and password fields). On the page that opens, click the cardiology product link under Soft-

ware Updates. The Cardiac Systems InCenter Registration Form page opens. Complete all of the information fields on the page to receive a login and password for the InCenter site. Registration for the InCenter site requires the serial number of at least one ST80i system in active use at your facility. The serial number is to the right of the SN symbol on the product identification label. The product identification label is located on the Advanced Interface Module (AIM). Figure 1-1 ST80i Product Identification Label 1-4 ST80i Stress Test System Instructions for Use About Adobe Acrobat Versions and InCenter How to Use this Guide Adobe Acrobat Reader version 9.0 or higher must be installed on the PC that is used to access the Philips InCenter site. Previous versions of Acrobat Reader are not compatible with Philips InCenter, and attempting to access InCenter with a previous version of Acrobat Reader will result in error messages when opening documents. Uninstall all previous versions of Acrobat Reader, and download a free version of Acrobat Reader at:

www.adobe.com. Any version of Adobe Acrobat Professional or Acrobat Elements is also not compatible with the Philips InCenter site, and error messages will appear when opening documents with these applications. Acrobat Reader must be installed To access documents on the Philips InCenter site 1. Exit Acrobat Professional or Acrobat Elements (if open). 2. Start Acrobat Reader. 3. Open Internet Explorer, and go to the Philips InCenter site. Keep Acrobat Reader open the entire time while accessing the InCenter site. How to Use this Guide This guide is intended to help you use the ST80i system. 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. 1 About the Philips ST80i Stress Test System. Provides a high-level overview of the ST80i System. 2 An Overview of the ST80i Stress Test System. 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. 3 The Patient Session. Describes all phases of the patient session, from Prepare through Report. 4 Working with Reports. Describes how to configure, view, edit, save, and print the final stress test report. 5 Resting ECG. Describes the Resting ECG Workflow product option. ST80i Stress Test System Instructions for Use 1-5 Getting Help Using ST80i 6 Maintaining the ST80i System. Describes how to clean and maintain the system. A 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. B Protocol Reference. Provides an example of the settings for each of the protocols provided with ST80i. C Configuring and Using the Printer. Provides information about the ST80i thermal printer. D Ordering Options and Parts. Provides a list of parts (including support parts) and options you can order. E Specifications and Requirements. Lists the product specifications. Getting Help Using ST80i To view an online version of this ST80i Stress Test System Instructions for Use, click the question mark at the upper right of the Main screen. For detailed troubleshooting information, as well as details about contacting the Philips Response Center, see Appendix A, Contacting Your Philips Response Center. 1-6 ST80i Stress Test System Instructions for Use 2 An 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 on the screen as you 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. If you have the Resting ECG Workflow product option, you can also capture a resting ECG either prior to a stress test or as a standalone test. See Chapter 5, Resting ECG Workflow. User Accounts ST80i supports at least 100 user accounts, which are created with specific access privileges based on function. ST80i user accounts are categorized as follows:

Administrators Administrators are allowed to perform all operations on the system. Clinicians Clinicians are allowed to perform all operations on the system, except for system configuration operations and creating and deleting users. Clinicians can create and edit protocols, edit their user profile settings, and edit the final report. Technicians Technicians are allowed to edit their user profile settings and edit the final report. Technicians cannot confirm reports using their own log-in credentials;

however, they can confirm reports on behalf of users with Administrator permissions. ST80i Stress Test System Instructions for Use 2-1 Starting the Application Starting the Application Your user account enables you to access the application. When you log on to ST80i, you are logging on to your preconfigured user profile. To log on 1. Double-click the ST80i icon on your desktop. The ST80i window opens. 2. Type your user ID and password. 3. Click OK. The Main screen opens. The Main Screen The Main screen is where you begin all tasks for the application. Figure 2-1 ST80i Main Screen Table 2-1 ST80i Main Screen Main Screen Button Resting Stress Report Description Click to conduct a resting ECG Note: This button is present only if you have the Resting ECG Workflow product option installed. Click to conduct a stress test, Note: If the Stress button is dimmed, you may be running ST80i on a remote review PC where patient tests are not performed. If you are not running on a remote review PC, see Appendix A, Troubleshooting and Contacting the Philips Response Center for a possible explanation and solution. Click to enter the stress system database to review and retrieve archived reports, or to replay, delete, or export a selected stress test. 2-2 ST80i Stress Test System Instructions for Use Main Screen Button Service Explain Test User Profile Description Click to review, update, or test software and firmware configurations. Note: This button is active only to Administrator users. CAUTION: To avoid the potential of altering system parameters, the Service feature should be accessed only by trained service personnel or under the direction of the Philips Response Center. Click to hear an audio explanation of the exercise stress test. Note: ST80i ships with a default audio file that explains the exercise stress test; however, you can 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 Stress Test System Installation and Configuration Guide. Settings Click to preconfigure or change system settings, user profiles, exercise protocols, and user accounts. User Profile Exercise protocol and equipment 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 runs and how the test results are displayed, printed, saved, and exported. Some settings are fixed and cannot be changed; some settings represent a default view that can be changed during the exercise stress test. The preconfigured parameters of the user profile include:

Display settings Report settings Algorithm settings Notifications Audio alerts 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 2-9 for an explanation of the display features that are continuously updated during the patient session. On this panel you can manually enter blood pressure and SpO2, as well as equipment settings that are preconfigured as part of the user profile and/or protocol. Filter settings ST80i Stress Test System Instructions for Use 2-3 ST80i Stress Screen Refer to the ST80i Stress Test System Installation and Configuration Guide for an explanation of how user profiles are preconfigured and to learn how to modify your user profile (Settings > User Profile). Before beginning an exercise stress test, it is 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 Screen The ST80i Stress screen displays:

All key procedural information including the protocol being used. Menus, windows, 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 SpO2, trends, and other numeric displays that include ST values, ST slope, Double Product, and ST/HR index. On the Stress 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 exit the exam at any point without losing any patient demographics or order information. However, exercise data will be lost. ST80i Stress Screen Figure 2-2 A B C D Start Treadmill E 2-4 ST80i Stress Test System Instructions for Use ST80i Stress Screen Table 2-1 ST80i Stress Screen Features Feature Description A B C D E Title Bar Displays patient name, date of birth, and ID, along with current date and time. During the Prepare or Pre Exercise phase of a patient session, you can click the patient name to update patient information. The title bar also displays the PIM battery status and RF signal strength indicators. Procedure Bar Used to control the exercise stress test process. Displays exercise stage; selected patient interface device; protocol;

BP, ECG Print, and Start Rhythm Printing buttons; and stage time. Toolbar Displays 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, SpO2, and exercise equipment data

(speed, grade, stop, and 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 Title Bar A B C D E F Table 2-2 Title Bar Features Feature Description A B C D Navigation Keys (Main > Stress) Click Main to leave the exercise test and return to the Main screen. Patient name Click the patient name to update patient information and add notes on the Patient Information tab of the Patient Demographics window. Patient's date of birth DOB formatting is determined by operating system. Patient ID ST80i Stress Test System Instructions for Use 2-5 ST80i Stress Screen Feature Description E F Indicators for the RF transmitter and PIM battery status. Current date and time Date formatting is determined by operating system. To add or update patient information 1. Click the patient name in the title bar. The Patient Demographics window appears. 2. Enter new information for the patient, or update the fields as needed during the Prepare or Pre Exercise phase of the stress test. Mandatory fields are displayed in blue text. Note:

You cannot access patient information from the title bar during the Exercise or Recovery phases. 3. Click OK when finished to save the data. The changes are saved and will be visible next time you access this patients information from the worklist. If you manually update patient informationfor example, by entering Notes during the Exercise or Recovery phase, or on the Report screen, the changes appear only as part of the final report. The changes are not saved to the patient data in the worklist. 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 Stress Test System Installation and Configuration Guide to change the default setting (Settings > User Profile > Display). 2-6 ST80i Stress Test System Instructions for Use ST80i Stress Screen Figure 2-4 Procedure Bar A B C D E F G H I J K L Table 2-3 Procedure Bar Features Feature Description A B C D E F G H I Current study phase Prepare, Pre Exercise, Exercise, Recovery, or Report. PIM device Click to display a list of available PIM devices during the Prepare and Pre Exercise phases. Protocol Click to display a list of available protocols. BP button Click to initiate a manual blood pressure measurement with the optional automatic blood pressure (NIBP) device. You can also use the F3 hot key to initiate a Tango BP or to open the BP mm Hg field to enter a manual BP. ECG Print button Click to pr int a 10-second ECG. Start/Stop Rhythm Printing button Click to start or stop continuous printing. Hold Stage button Click to keep the stress test in the current stage, overriding automatic stage changes. Go to Next Stage button Click to manually advance the stress test to the next stage. Unhold Stage button Click to remove the hold on stage changes. Even if the duration of the hold spans what would have been multiple stages, the removal of the hold returns the stress test to the stage following the one during which the hold was placed. ST80i Stress Test System Instructions for Use 2-7 ST80i Stress Screen Feature Description J K L Print count Displays the number of print requests currently in the print queue. Note: If printing is disabledfor example, if the printer is on a network that is disabled during a testthe number of print jobs accumulates until the printer again becomes active. Elapsed time for exercise and stage. Stage time restarts as each new stage begins. Study phase buttons (Prepare, Pre Exercise, Exercise, Recovery, Report) The next phase is always illuminated in green. Toolbar The toolbar contains the 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 hover 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 Stress Test System 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. Note:

When viewing 6 or 3 leads in the default waveform layout, you can change a lead by clicking the lead label on the left side of the display. With the customizable options of ST80i, you can use the toolbar icons do the following:

Change the default waveform layout you want to view (12, 6x2, 6, 3). 2-8 ST80i Stress Test System Instructions for Use Side Panel Display the magnified beat (Zoom ST). Display the average complexes for each lead. Show or remove magnified beat, trends, anatomical representations (ST map), and average complexes from the ECG display. 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) AC Filter setting in Hz (50 or 60) Indicator that the Artifact Filter is on (F) Indicator that the Smart Filter is on (S) Figure 2-5 Limb Lead, Chest Lead, Speed, and Filter Settings When you change these default settings using the toolbar icons, they appear in this location. Side Panel 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 enter NIBP and SpO2 values. In addition, you can start, stop, and manually control the exercise device. ST80i Stress Test System Instructions for Use 2-9 Side Panel Figure 2-6 Side Panel A B C D E F G H I Table 2-4 Side Panel Features Feature Description A B C D E F Heart rate beats per minute Percent of target heart rate Displays visual and audible indicators when target heart rate is achieved. A red vertical bar indicates the highest percentage of target rate achieved during the test. Percent of maximum predicted heart rate. A red vertical bar indicates the highest heart rate achieved during the test. BP mmHg (Sys/Dia) Displays current blood pressure. Also used to manually insert current BP measurement. Previous BP mmHg When BP is taken as preconfigured 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. 2-10 ST80i Stress Test System Instructions for Use Feature Description Side Panel G H I DP hr*bp Double Product (DP) is the current heart rate multiplied by the current systolic measurement. DP is the default displayed in this field. You can also select METS or ST. METS Establishes metabolic equivalent (algorithm calculation of HR, speed of treadmill, and so on). ST X mm (or mV) X can be either of the following:

The default ST lead configured in Settings or selected from the Zoom ST window during a test The lead with the Max ST Level or Max ST Slope configured in Settings. Treadmill speed (mph) and grade percentage or ergometer power in watts. Treadmill (Start Treadmill/Stop Treadmill) or Ergometer (Load Ergometer/Unload...) button 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 There are visual and audible indicators when the target heart rate is achieved. This field shows the percent (%) of the Target Heart Rate achieved. Target Heart Rate is xx% (typically 85%) of maximum heart rate, as established in User Profile. For more information regarding Target Heart Rate, see the ST80i Stress Test System Installation and Configuration Guide. Max Predicted Heart Rate This field shows the percent (%) of the maximum predicted heart rate achieved by the patient. For more information regarding Max Heart Rate, see the ST80i Stress Test System Installation and Configuration Guide. ST80i Stress Test System Instructions for Use 2-11 Side Panel BP mmHg (Sys/Dia) When the patient's NIBP is collected automatically during the exercise stress test based on the defined interval in the Exercise Protocol (Off, Begin, End, Every), the BP mmHg (Sys/Dia) field displays the measurement. This field is also used to manually enter a blood pressure measurement, if an NIBP monitor is not being used. To manually enter a blood pressure, click the BP mmHg field or press F3. With this interface, there are visual and audio prompts (if enabled) for NIBP acquisition. To enable audio alerts, see the ST80i Stress Test System Installation and Configuration Guide. To manually enter the blood pressure measurement Note:

ST80i continues to update the real-time value from the NIBP monitor even when the BP is manually entered. 1. Click the dashed lines or current BP value in the BP mmHg (Sys/Dia) field, or press F3. 2. Type the blood pressure measurement using the following guidelines:

- Use only numbers 1 through 400 for the systolic and diastolic values.

It is not necessary to type the slash (/) between the systolic and diastolic values; ST80i will place the slash after you click OK.

- The following table provides examples of how ST80i accepts manual blood pressure entries. Table 2-5 Methods of Manually Entering Manual Blood Pressure Measurements If you enter Example(s) ST80i assumes that 5 or 6 digits with no slash (/) between the systolic and diastolic values 12080 2 or 3 digits followed by a slash (/) and then another 2 or 3 digits 120/80 4 digits with no slash (/) between the systolic and diastolic values 9880 the first 3 digits are the systolic value and the last 2 or 3 digits are the diastolic value the digits before the slash (/) are the systolic value and the digits after the slash (/) are the diastolic value the first 2 digits are the systolic value and the last 2 digits are the diastolic value 2-12 ST80i Stress Test System Instructions for Use Side Panel If you enter Example(s) ST80i assumes that 2 or 3 digits (with or without the slash (/) after the digits) a slash (/) followed by 2 or 3 digits 120 120/

98 98/

/98

/120 you have entered only a systolic value (ST80i will place dashes representing the missing diastolic value after you click OK) you have entered only a diastolic value (ST80i will place dashes representing the missing systolic value after you click OK) 3. Click OK. The blood pressure measurement is displayed, along with a timestamp for the entry. Previous BP mmHg When the blood pressure monitor records the current blood pressure measurement, the Previous BP mmHg field displays the previous measurement and a timestamp for that entry. When you click the BP button on the procedure bar to trigger a BP measurement or type a BP value, the Previous BP mmHg field is not updated until the new BP value is available. SpO2 The patients SpO2 is collected in real time through a sensor placed on the patients finger or ear. During the stress test, SpO2 is measured automatically and is continuously displayed on the screen if the SpO2 is coming from the Tango NIBP device; otherwise you must manually enter it. You can override the NIBP and SpO2 values. Depending on the NIBP monitor being used, you may need to manually enter the SpO2 data. To override or manually enter the SpO2 1. Click the dashed lines or value. 2. Type the latest SpO2 value, from 0 to 100. 3. Click OK. Double Product/METS/ST You can use the drop-down arrow in this field to select the measurement you want to display. DP hr*bp Double Product (DP) is the current heart rate times the current systolic measurement. This is the measurement shown in this field by default. ST80i Stress Test System Instructions for Use 2-13 Side Panel METS The METS calculation establishes a metabolic equivalent based on the algorithm calculation of the treadmill time, speed, and elevation or the ergometer power. The METS calculation follows a linear progression up to the 2 minute mark. If the stage reaches 2 minutes, the Max Mets for the stage is displayed. ST X mm (or mV) X can be either of the following:

The default ST lead configured in Settings or selected from the Zoom ST window during a test The lead with the Max ST Level or Max ST Slope configured in Settings. You can change the lead displayed in this field by selecting a new lead from the Lead list in the Zoom ST window. To change the lead that is in view 1. Click the Hide/Show View icon in the toolbar. 2. Select Show Zoom ST. 3. 4. Select the lead you want to view. In the Zoom ST window, click the Lead drop-down arrow. Treadmill Speed and Grade Percent or Ergometer RPM and Power These two fields capture the treadmill speed and elevation, or the ergometer RPM and power, by stage. You can also use these fields to manually change the treadmill speed and elevation or ergometer power. To do this, see Controlling the Treadmill or Ergometer on page 3-38. 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. Treadmill/Ergometer Buttons The Start Treadmill/Stop Treadmill buttons are used to start and stop the treadmill during a patient session. The Load Ergometer/Unload... buttons are used to load and unload the ergometer during a patient session. 2-14 ST80i Stress Test System Instructions for Use Using the Toolbar Icons Notes:

Alternatively, you can press F4 to start the treadmill or load the ergometer, or press F6 to stop the treadmill or unload the ergometer. If you have two devices configured, an option is available in the Select Patient from Worklist window to select the device to use for the current patient. WARNING The ST80i 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-8 of Appendix E, Specifications and Requirements. Use of USB cables for these devices is not recommended and may result in abnormal operation of ST80i due to electromagnetic noise interference. Caution If the Stop Treadmill button does not respond for any reason, immediately press the red Emergency button on the treadmill handrail. Using the Toolbar Icons Generally, you do 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 2-7 Toolbar Icons When you hover over each icon, a tool tip is displayed. Using the toolbar icons, you can do the following:

Change the default setting of the waveforms on the waveform screen. Use the lead map diagram to check the lead wire connection integrity with a predefined, color-coded indicator to show any leads that are off. Display a zoomed view of an average complex for either a specified lead or for the lead that shows the most significant change in ST level. ST80i Stress Test System Instructions for Use 2-15 Using the Toolbar Icons Compare the current averages with a referenced event (resting, supine, hyperventilation, chest pain, and so on) and with the worst case of ST elevation or ST slope for all twelve leads (by selecting Max ST Level or Max ST Slope from the Lead drop-down in the Zoom ST window). View magnified ST and morphological changes (including ST morphology changes, T wave morphology changes, QRS morphology changes) in the various leads. View trend graphs for Heart Rate, METS, BP, SpO2, and ST values at any time. 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 1 second. Freeze the ECG. Create events during the test with associated notes. Record Rate of Perceived Exertion scores. Add notes about the patients progress during the stress test. Add narrative information about the patient and the stress test. Advance the thermal paper so that the printing starts at the top of the page. Reset the CAlg-STR algorithm in order to relearn the normal morphology of the patients ECG. Turn audible alerts on or off for the current stage; alerts re-initialize with each stage. Change specific default settings for Filter, Display, Rhythm Print, Sync Out, Events, and Pacer Detection. The following table provides an overview of each icon. Table 2-6 Toolbar Icons Icon Waveform Description 12 Leads The default is 12 leads; you can select from the following:

6x2 Leads 6 Leads 3 Leads 2-16 ST80i Stress Test System Instructions for Use Using the Toolbar Icons Icon Description Hide/Show View Select from the following:

Show Lead Map Show Zoom ST Show ST Map Show Trend View (HR/METS; BP; ST Level, SpO2) Show Average Freeze Captures the most recent 10 seconds of ECG and displays it in a dialog box. You can save and print the freeze ECG. Event RPE Note Narrative Compare Select an event from the drop-down list. The events include:

Supine Stand Mason-Likar Hyperventilation Chest Pain Shortness of Breath Sitting Add New Event Type the name of the event in the Add New Event window and click OK. Rate of Perceived Exertion From preconfigured setting in the user profile. Insert comments about patient and/or test. This information is time-stamped with the current date and time and is printed in the final report. Use to type assessments about the patient and/or test. This information is displayed on the Report screen and printed in the final report. Compares the current zoomed lead with a previous moment in time; shows the delta. Also compares the averages if they are being displayed. Paper Advance Form-feed adjustment for thermal paper. ST80i Stress Test System Instructions for Use 2-17 Using the Toolbar Icons Icon Algorithm Relearn Silent Notification Printing Quick Settings Description Allows the CAlg-STR algorithm to relearn the normal morphology of the patients ECG. Indicates that alerts in the current stage will be audible. Click to silence audible alerts in the current stage. Indicates that alerts in the current stage will not be audible. Click to turn on audible alerts. Events that are preconfigured to print in Settings > User Profile > Notifications are printed automatically when they occur during a patient session. This is called notification printing. At the beginning of each session, notification printing is on by default. Clicking the Notification Printing icon once toggles it off and a red symbol appears on the icon to indicate that notification printing is disabled. Clicking the icon again turns notification printing back on. Only events that are preconfigured to print under Notifications are affected by the status of the Notification Printing icon. The printer itself is not disabled; You can still print stage ECGs, 12-Lead ECGs, rhythm prints, and events. Up to 100 events are saved, even when notification printing is disabled. Subsequent events are not saved, but if preconfigured, display notifications still appear for these events. 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) Events (PVC, V Couplet, VRun) Pacer Detection (Paced Unknown, Paced, Non-paced, Paced (magnet)) 2-18 ST80i Stress Test System Instructions for Use Waveform Using the Toolbar Icons Real-time ECG analysis employs the latest CAlg-STR 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. All ECG data from the start of Pre Exercise through the end of Recovery is saved. 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 Note:

In 6 Leads or 3 Leads display format, you can click on the lead label on the display to change the lead quickly. To change the real-time ECG format 1. Click the Waveform icon in the toolbar. 2. Select the lead configuration you want to display:

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:

Show Lead Map Show Zoom ST Show ST Map Show Trend View (HR/METS; ST Level; BP) Show Average ST80i Stress Test System Instructions for Use 2-19 Using the Toolbar Icons About the Lead Map View The Lead Map diagram shows the status of each lead. Red indicates lead-off, and green indicates good contact. To view the Lead Map 1. Click the Hide/Show View icon. 2. Select Show Lead Map. The Lead Map window appears to the right of the waveform. All connections must be green. Figure 2-8 Lead Map Window If a lead is off, a red X on the lead map and a 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:

A leads-off condition is displayed as a dashed line on the display and on printed ECG reports. About the Zoom ST View The Zoom ST window 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, as well as the delta values for ST level and slope, are displayed for the expanded lead. This function enables you to better visualize the ST segment changes during the test. The default ST lead is shown in the Zoom ST 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. 2-20 ST80i Stress Test System Instructions for Use Using the Toolbar Icons You can also select a lead for the default setting. For default settings, see the ST80i Stress Test System Installation and Configuration Guide. Note:

The Trend view displays the ST change trend for the lead that is elected as the Zoom ST lead. See About Trend View on page 2-23. ST Level (mm or mV) and Delta ST Slope (mV/s or mm/s) and Delta J+ Point (default is 60 mm) Lead (menu) In the Zoom ST window, the following are displayed:

Reference (menu) Delta values for ST Level and ST Slope are calculated in relation to the selected Reference event. You can change the J+ Point in the Zoom ST window by clicking the value. This can be done only during Prepare or Pre Exercise or at the end of the exam on the Report screen. Note:

ST80i can display the lead with the maximum absolute value of the ST level or ST slope if you select Max ST Level or Max ST Slope using the drop-down arrow for the default lead. When you use the Compare feature, the reference QRS (in white) is superimposed on the current QRS to provide a visual comparison of ST change. The viewing options for Zoom ST are:

Table 2-7 Zoom ST Options Zoom ST Option Description Any individual lead Max ST Level Max ST Slope Any of the twelve leads. This selection remains in force until you change it. The system monitors all twelve leads and displays the one with the most significant ST change. The lead shown changes automatically during the stress test; the changes are reflected on printed reports as well. To view the Zoom ST 1. Click the Hide/Show View icon. 2. Select Show Zoom ST. ST80i Stress Test System Instructions for Use 2-21 Using the Toolbar Icons The default Zoom ST appears as one expanded average ECG complex to the right of the waveform. 3. Click the X in the upper-right corner to close the Zoom ST window. To change the Zoom ST lead 1. While viewing the Zoom ST window, use the Lead menu in the Zoom ST window to change to another lead or to Max ST Level or Max ST Slope. 2. Click the X in the upper-right corner to close the Zoom ST window. About the ST Map View 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 1 second and can be displayed on the waveform screen. To view the ST Map 1. Click the Hide/Show View icon. 2. Select Show ST Map. The ST Map window appears to the right of the waveform. Figure 2-9 ST Map Window 3. Click the X in the upper-right corner to close the ST Map. 2-22 ST80i Stress Test System Instructions for Use Using the Toolbar Icons About Trend View The Trend graphs show a visual indicator for the current heart rate as well as the dynamic change in heart rate. The Trend data appears in 4 charts that can be viewed at any time. Note:

The Trend graphs start updating at the beginning of Pre Exercise. The Trend view displays the ST change trend for the lead that is selected as the Zoom ST lead. To view trends 1. Click the Hide/Show View icon. 2. Select Show Trend View. The Trend window appears to the right of the waveform. Figure 2-10 Trend Window The Trend window displays four two-dimensional color-coded charts that show the trend, over time, of the following measurements and clinical information:

- HR/METS

- ST (selected lead) + mV ST80i Stress Test System Instructions for Use 2-23 Using the Toolbar Icons

- BP (Systolic, Diastolic)

- SpO2 3. Click the X to close the Trend window. About the Average View The Average window shows one average complex for each of the 12 leads regardless of which lead format is being displayed. By default, the system displays the ST value in microvolts (mV) for the on-

screen average complexes. The ST unit can be configured in Settings to be mm. For more information, see the ST80i Stress Test System Installation and Configuration Guide. To view averages 1. Click the Hide/Show View icon. 2. Select the Show Average check box. The Average window appears to the right of the waveform. Figure 2-11 Average mV and mV/s for Each Lead A C B 3. To compare the current averages with the averages from an event, click the

<< button (A). Use the down arrow (B) to select a different event for comparison from the drop-down list (C). 4. Click X to close the Average window. 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 ECG Print button. During the Exercise phase, when you select the Freeze icon, it freezes the most recent 10 seconds of ECG data so that you can view a specific event. A dialog box displays a Freeze image of all leads captured at the moment you clicked the Freeze icon. 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. Click the Freeze icon. The Freeze dialog box appears to the right of the waveform. Figure 2-12 Freeze Dialog Box 2. Use the slide bar or the arrow buttons to scroll through the ECG. 3. Click the Save button to save the frozen ECG as an event. 4. Click the Print button to print and save the frozen ECG. 5. To close the Freeze dialog box, click the X in the upper-right corner. Recording an Event Events are associated with the user profile. You can add events to and delete events from the list of event labels when you create a user profile; however, factory-loaded events cannot be deleted. As the test progresses, you can record events, if and when they occur, and you can also add events to the list by clicking the Event icon on the toolbar. New events added from the list ST80i Stress Test System Instructions for Use 2-25 Using the Toolbar Icons during an exam are not saved as new Event labels; they are active only for that particular ECG. When you record an event, ST80i generates a 12-Lead ECG and documents the event name on the ECG. The system also stores the event in memory and prints it in the Events portion of the final report. User Notes are also associated with the Event, if created. See Note on page 2-27 regarding the Note icon. In addition, ST80i automatically detects an arrhythmia event, if this is enabled. To enable arrhythmia detection, see the ST80i Stress Test System Installation and Configuration Guide. See also Notifications and Alerts on page 3-39. The default events include:

Mason-Likar Hyperventilation Chest Pain To record an event 1. Click the Event icon to display the following list:

Shortness of breath Sitting Standing Supine

- Supine

- Mason-Likar

- Standing

- Hyperventilation

- Chest Pain

- Shortness of Breath

- Sitting

- Add New Event 2. Select the event you want to record. The system prints an ECG and records the event for the final report. To add an event 1. Click the Event icon. 2. Click Add New Event to open the Add New Event dialog box. 3. Type a name for the new event. 4. Click OK. The system prints an ECG with the new event label and records the new event for the final report. 2-26 ST80i Stress Test System Instructions for Use Using the Toolbar Icons Note:

New events added from the list during an exam are not saved as new Event labels; they are active only for that particular ECG. Recording RPE The Rate of Perceived Exertion (RPE) scale provides an indication of the patients perceived rate of exertion. It 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, 0 to 10 or 6 to 20. The scale used is associated with the selected user profile. To set the RPE scale, see the ST80i Stress Test System 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 RPE drop-down list. Once the number is selected, the system prints an ECG report, noting the RPE. Figure 2-13 RPE List (Showing 010 Scale and 620 Scale) To record the patient's RPE 1. Click the RPE icon. 2. From the RPE list, select the statement that matches what the patient reports. 3. Click OK. The system prints an ECG with the RPE statement. 4. Continue this process throughout the Exercise phase. The RPE ECG is printed in the Events section of the final report. 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 are stored in the Notes section of the Patient Demographics ST80i Stress Test System Instructions for Use 2-27 Using the Toolbar Icons database and they also appear as part of the final stress report. To add a note 1. Click the Note icon. The Note dialog box appears. There is no limit to the amount of text you can type in this dialog box. Each note is time-stamped with the current date and time. 2. Click OK to save the note. Narrative Compare During the patient session, you can add narrative information about the patient and exercise stress test. Narrative text appears in the Narrative text box in the Comments section of the Summary tab on the Report screen. You can also update Narrative information directly from the Report screen. To add narrative information during the patient session 1. Click the Narrative icon to open a dialog box in which you can type narrative information. 2. Click OK to save the narrative information. ST80i can compare the current averages with a selected event (for example, supine or hyperventilation) and with the worst case of ST elevation or ST slope for all 12 leads. As the heart rate increases and/or morphological changes occur, you can use the Compare function to view the delta between the current QRS morphology and a reference QRS such as a supine event, stage event, or other event. Note:

ST Segment Analysis must be enabled before you can use the Compare function. See the ST80i Stress Test System Installation and Configuration Guide

(Settings > User Profile > Algorithm > CAlg Templates). To use the Compare icon 1. Click the Compare icon. A list of current events/compare points allows you to compare the current state to the state when the event occurred or to an earlier point in time. 2-28 ST80i Stress Test System Instructions for Use Using the Toolbar Icons Note:

The CAlg-STR Exercise ECG analysis algorithm requires one minute of ECG data in order to generate analysis results. This minute begins when you click the Pre Exercise button to start the Pre Exercise phase. If you click the Compare icon before CAlg-STR has acquired one minute of ECG data, or before an ST value is displayed, the current lead view cannot be compared with the selected event. Figure 2-14 Compare List 2. Select the event to use as a reference. The Zoom ST window appears. In the zoomed lead, the reference ECG is superimposed on the averaged ECG. The white line represents reference data; the current averaged ECG data is green. Figure 2-15 Compared ECGs Zoom ST ST Level ST Slope J+ Point Lead Reference Max ST Slope Start Exercise (14... To compare the current averages with the worst case for all 12 leads, select Max ST Level or Max ST Slope from the Lead drop-down arrow. 3. Click the X to close the Zoom ST window. ST80i Stress Test System Instructions for Use 2-29 Using the Toolbar Icons Paper Advance Use the Paper Advance 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 Paper Advance icon to advance the paper if there is a paper jam or after installing a new package of paper. Algorithm Relearn The Algorithm Relearn icon allows the CAlg-STR algorithm to reset in order to relearn the normal morphology of the patients ECG. You can use the Algo-

rithm Relearn icon to recalibrate the algorithm if the ECG becomes noisy, seems to be reporting false-positive rhythm events, or when the ST values or average beats cannot be calculated for several minutes. When you click the Algorithm Relearn icon, current ST values and average beats are cleared and recalculated. The Algorithm Relearn feature may be useful during the Pre Exercise phase if a lead comes off or requires repositioning or during the Recovery phase if many rhythm events are being reported. It is recommended that the Algorithm Relearn feature not be used during the Exercise phase, as important information may be lost. Silent The Silent icon allows you to turn offfor the current stage onlyany audible alerts that may be configured. By default, audible alerts are played. Clicking the Silent icon turns off audible alerts, and the icon toggles to an image showing that audible alerts are not played. If you click on this image, audible alerts are turned back on. Otherwise, the button automatically changes when the next stage begins, resuming audible alerts. Notification Printing Events that are configured to print under Settings > User Profile > Notifica-

tions are printed automatically when they occur during a patient session. You can click the Notification Printing icon to toggle notification printing off or on during the session. When notification printing is turned off, a red symbol appears on the icon. You can also check whether notification printing is turned off or on by hovering over the icon. Turning notification printing off does not disable the printer. You can still print stage ECGs, 12-Lead ECGs, rhythm prints, and events. 2-30 ST80i Stress Test System Instructions for Use Quick Settings Using the Toolbar Icons Filter Click the Quick Settings icon to open the Quick Settings dialog box from which you can change specific default settings (for this study only) that relate to the following:

Display Rhythm Print Pacer Detection Sync Out Events Figure 2-16 Quick Settings Dialog Box Filter The Filters are preconfigured in the Settings section of the application. When you log on to ST80i, the active settings of the filters are set to a stored default set that is associated with your user profile. The ECG data is stored in its recorded state (0.02300Hz, all filters off) and user-selected settings are stored with the ECG. Note:

The ECG data is filtered at 0.05150 Hz and by an AC notch filter before being analyzed by the algorithm. This filter is called the algorithm filter and cannot be turned off by the user. The algorithm filter is independent from other filters, is not controlled by the user, and does not affect the saved ECG data. All filters can be turned on or off as needed to improve displayed and printed waveform 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:

ST80i Stress Test System Instructions for Use 2-31 Using the Toolbar Icons Low Pass (LP) Filter: 40Hz, 100Hz, 150Hz, 300Hz High Pass (HP) Filter: 0.02Hz, 0.05Hz, 0.15Hz AC Filter: 50Hz, 60Hz, Disable Artifact Filter: On, Off The same filter settings apply to both displayed and printed waveforms. The filter settings are printed with the report. Smart Filter: On, Off To change the Filter settings 1. Click the Quick Settings icon. 2. Click the Filter tab. 3. Change or modify each filter, as required. 4. Click OK to save your settings. Note:

Enabling the Artifact Filter and/or Smart Filter causes a brief data loss represented by red dashed lines on the display due to initialization of filtering algorithms. Disabling the Artifact Filter and/or Smart Filter causes a brief data loss represented by a sudden change in waveform morphology. For more information, see Filtering on page 3-22. Display On the Display tab, you can change the Limb Gain, Chest Gain, and Speed. To change the Display settings 1. Click the Quick Settings icon. 2. Click the Display tab. 3. Use the drop-down arrow to adjust the Limb Gain setting. 4. Select a different Chest Gain setting:

- Full

- Half 5. Select a different speed:

25 mm/s

- 50 mm/s 6. Click OK to save your settings. 2-32 ST80i Stress Test System Instructions for Use Using the Toolbar Icons Rhythm Print Before you click the Rhythm Print button from the procedure bar to print a continuous strip, you can modify your settings based on the following:

Leads Limb Gain Chest Gain To change the Rhythm Print settings 1. Click the Quick Settings icon. 2. Click the Rhythm Print tab. 3. Select the check box for each lead you want to print. Speed Note:

You cannot select the aVR lead and the aVR lead at the same time. 4. Use the drop-down arrow to adjust the Limb Gain setting to 2.5, 5, 10, or 20 mm/mV. 5. Select a different Chest Gain setting:

- Full

- Half 6. Use the drop-down arrow to adjust the Speed to 5, 10, 25, or 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). Use Analog ECG Output for synchronization with ECHO device for Stress-Echo procedures. This signal is not to be considered as diagnostic quality. Use TTL Sync Output for QRS gating required by the Tango NIBP device. Caution Analog ECG output signals are not diagnostic quality and should not be used for analysis. The sync outputs are preconfigured as part of the user profile. However, they can be changed during the patient session. See the ST80i Stress Test System Installation and Configuration Guide for how to configure Sync Out settings in the user profile. To change Sync Out settings ST80i Stress Test System Instructions for Use 2-33 Using the Toolbar Icons 1. Click the Quick Settings icon. 2. Click the Sync Out tab. 3. Use the drop-down arrows to modify the following:

Analog Out 1; Scale Example: Analog Out: I; Scale: 3 mV/V Options: None, Leads IV6 Analog Out 2; Scale Example: Analog Out 2: None; Scale: 1 mV/V Options: None, Leads IV6 TTL Out; Polarity; Duration (ms) Example: TTL Out: None; Polarity: Positive; Duration: 50 ms Options: None, Leads IV6; Positive, Negative 4. Click OK. Events You can set the number of events saved per minute for the following events:

PVC VCouplet VRun To change Event settings 1. Click the Quick Settings icon. 2. Click the Events tab. 3. Adjust the number of events per minute for each event you want to reset. 4. Click OK. Pacer Detection To change Pacer Detection settings 1. Click the Quick Settings icon. 2. Click the Pacer Detection tab. 3. Select a new Pacer Detection setting. 4. Click OK. 2-34 ST80i Stress Test System Instructions for Use 3 The Patient Session 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 by entering the Prepare phase, and lasts through the generation of the final report. In ST80i, the exercise stress test begins with the Prepare phase and ends with the Report phase:

Prepare Pre Exercise Exercise Recovery Report (including Post-Recovery) Note:

For information about the patient session when using the Resting ECG Workflow product option, see Chapter 5, Resting ECG Workflow. 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. Using the Patient Worklist When you click Stress on the Main screen, you are taken to the Select Patient from Worklist screen, where you begin a patient session by selecting the patient for the exam. The Select Patient from Worklist screen includes two tabs:

ST80i Stress Test System Instructions for Use 3-1 Using the Patient Worklist Worklist Remote Find Use the Worklist tab to manage patient information. The worklist enables you to pre-register up to 200 patients. Once the 200 patient limit has been reached, you must delete some patients from the worklist before you can add more. The worklist database is populated by downloading patient orders or ADT data from a Hospital Information System (HIS), or by manually entering information using the Worklist tab. Use the Remote Find tab to do a remote search for a patient using several data points. ST80i provides an interface with IntelliBridge (IBE) so that you can do the following before conducting an exercise stress test:

Download a patient's data from DICOM server. Download a patient's orders or ADT data from the hospital HIS system (via IBE). The Select Patient from Worklist screen also includes two menus to enable you to select the appropriate exercise and blood pressure devices:

Exercise Device menu Select the treadmill or ergometer to be used for the test. If you are using an exercise device that is not physically connected to the PC on which ST80i is installed, select Virtual Treadmill or Virtual Ergometer. ST80i uses standard protocol values for these virtual devices. BP Configuration menu Select the blood pressure device to be used for the test. The content of this menu depends on the device selected in the Exercise Device menu. For most exercise devices, only SunTech Blood Pressure is supported. However, for the Ergoline Ergometer, you can select either SunTech Blood Pressure or Ergoline BP. For the Lode Ergometer, you can select either SunTech Blood Pressure or Lode BP. Worklist Tab Finding a patient Editing a patient profile The Worklist tab of the Select Patient from Worklist screen is used to manage the patient information list, including:

Adding a new patient Deleting one or more patient information records Downloading orders or pre-registered patient information On the Worklist tab, you can change the placement of each column by clicking and dragging the column headings. You can also click the column headings to sort each list. Selecting a patient to begin the exercise stress test 3-2 ST80i Stress Test System Instructions for Use Figure 3-1 Worklist Tab Using the Patient Worklist Patient Information Management ST80i displays and reports key patient demographic information such as the patient name, patient ID number, and so on. Some settings are mandatory and configurable. Some settings are set to ON or OFF. There are three ways to access patient demographic information:

From the Worklist

- Click the patients worklist entry to select the patient.

- Click Edit to open the Edit Patient Information window. Patient tab before the test:

demographic information is displayed. From the Stress screen during a patient session (only during the Prepare and Pre Exercise phases):

- Click the patient's name in the title bar. Patient demographic information is displayed. From the Report

- Click the patient's name in the title bar. Patient demographic information screen after a patient session:

is displayed. ST80i Stress Test System Instructions for Use 3-3 Using the Patient Worklist Figure 3-2 Patient Demographic Information Patient Information Fields ST80i supports predefined and user-defined patient information fields. The predefined patient information fields are shown on the Patient Information tab of the Edit Patient Information window. The patient information fields are configured as mandatory or not. Mandatory fields must be populated before you can move to the Prepare phase. Mandatory fields are displayed in blue text. By default, mandatory fields include the following:

Patient ID Last Name First Name DOB (MM/DD/YYYY) Age Gender Height Weight Caution To support optimal algorithm output, ensure that the DOB/Age and Gender fields are enabled and complete. To configure or change mandatory patient information fields, see the ST80i Stress Test System Installation and Configuration Guide. 3-4 ST80i Stress Test System Instructions for Use Using the Patient Worklist Add a New Patient to the Worklist To manually add a new patient name to the worklist 1. Click Add. 2. In the Add New Patient window, complete the required fields for each of the following tabs:

- Patient Information Note:

When you complete the DOB (MM/DD/YYYY) field, the Age field is automatically populated. If you complete the Age field when the DOB (MM/DD/YYYY) field is empty, ST80i populates the DOB (MM/DD/YYYY) field with the calculated year, but uses the current month and day. If you delete either the DOB (MM/DD/YYYY) or Age, ST80i also removes the contents of the other field. If you change the Age while the DOB (MM/DD/YYYY) is populated, ST80i recalculates the DOB year but uses the current month and day. The Indications field is limited to 8 lines with 70 characters per line. The Symptoms field is limited to 5 lines with 70 characters per line.

- History

- Medications/Dosages Note:

When the maximum number of items in a field has been reached, a red The Medications field is limited to eight lines with 30 characters per line. The Dosages field is limited to six lines with 30 characters per line. The Frequency field is limited to six lines with 20 characters per line. exclamation point appears to the right of the field, Hover over the exclamation point for information about the fields limitation. 3.

- Physician/Order

- Custom Fields If you want to:

- Save the information and return to the worklist, click Save.

- Save the information and begin the stress test, click OK. ST80i Stress Test System Instructions for Use 3-5 Using the Patient Worklist Note:

If mandatory fields are missing, the Patient Info message indicates Missing Required Fields. You cannot move beyond this point without supplying the missing information. 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 1. 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 Back to restore the full list of names. Edit Patient Information In the worklist, you can edit or review patient information by clicking the Edit button. The Edit button becomes active when you select a patient name. To edit patient information in the worklist 1. Click the patients worklist entry to select the patient. 2. Click Edit to open the Edit Patient Information window. Figure 3-3 Edit Patient Information Window 3-6 ST80i Stress Test System Instructions for Use Using the Patient Worklist 3. Update or edit the patient information in each of the following tabs, as required:

- Patient Information (See Add a New Patient to the Worklist on page 3-5 for more information on using the DOB (MM/DD/YYYY) and Age fields.)

- History

- Medications/Dosages

- Physician/Order

- Custom Fields Note:

You cannot edit the information in the DICOM Fields tab. It is presented only for informational purposes. 4. If you want to:

- Save the information and return to the worklist, click Save.

- Save the information and begin the stress test, click OK. Note:

If a Race field is configured in Settings, a menu for race selection is included in the Edit Patient Information window. Delete a Patient Name You can delete one or many patients from the worklist. In Settings, you can also configure the Remove from Worklist after the final report is saved option for automatic patient deletion. To delete a patient name from the worklist 1. Click the patients worklist entry to select the patient. You can select more than one patient name to delete. 2. Click Delete. A confirmation dialog box appears. 3. Click Yes. Download Preregistered Patient Information With ST80i, you can download preregistered patient information by accessing the order or ADT server via the network. The local patient information that you download from a remote server or manually add is stored in a local database. This optional feature permits the creation of a preregistered patient list. Before downloading orders, you must connect to the preconfigured remote site. ST80i Stress Test System Instructions for Use 3-7 Using the Patient Worklist Preconfigured IBE or DICOM remote sites are displayed in the Location list. To download orders 1. Click the Location list. 2. Select the server on which the order is stored. 3. Click Download. The requested orders are downloaded and displayed in the worklist. Review a Previous Study Note:

This feature is only available if you have IECG/TraceMasterVue. To review a patient's previous study 1. Click the patients worklist entry to select the patient. 2. Click Previous Study. The Previous Study Report List screen opens. Figure 3-4 Previous Study Report List Screen 3. Click on the study you want to review. 4. Click View. The report opens in PDF format in the Previous Study viewer window. Note that the report contains multiple pages. 3-8 ST80i Stress Test System Instructions for Use Figure 3-5 ECG Report in PDF Format Using the Patient Worklist 5. Click X in the upper-right corner of the Previous Study viewer window to close it. 6. Click Back to return to the Select Patient from Worklist window. Select a Patient When you are ready to begin the patient session for a patient, select his or her name from the worklist. To select a patient to begin the patient session, click the patients worklist entry to select the patient and click OK, or double-click the patients name. This opens the first phase of the testPrepare. Remote Find Tab The Remote Find tab of the Select Patient from Worklist window enables you to do a remote search for a patient using several data points. With this feature, you can select one or more entries from the search results list and save them to the worklist. ST80i Stress Test System Instructions for Use 3-9 Before the Patient Session Figure 3-6 Remote Find Tab Figure 3-6 shows the Remote Find tab for a DICOM remote site. For other remote site types, fewer fields are available for entering search data. To do a remote find 1. Select the location from the Location list. 2. Complete one or more of the following fields:

- Patient ID

Last Name

- First Name

- DOB (MM/DD/YYYY)

- Order Number

- Encounter ID 3. Click Find. The patient's name appears in the Remote Find list. 4. Click the patients entry to select the patient and click OK, or double-click the patients name. This opens the first phase of the testPrepare. 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 or ergometer), if used Setting up a Pharma test, if ordered, according to hospital protocol 3-10 ST80i Stress Test System Instructions for Use 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. Before the Patient Session 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 in to the wireless PIM on the other. Figure 3-7 Wireless PIM and Lead Set The wireless PIM digitizes the ECG signal and downsamples the ECG data before transmitting ECG data to ST80i. The wireless PIM uses high-pass and low-pass filters to produce filtered ECG data within certain bands. The wireless PIM performs lead signal quality detection to determine if a lead is not connected to the patient or if electrode/patient contact impedance is excessively high. Before each patient session, inspect the PIM and lead wires for any visible damage, including worn or cracked insulation on the lead wires. The wireless PIM displays the following information:

Wireless signal strength indicator:

The wireless signal strength indicator appears once the PIM and AIM are synchronized, when the real-time ECG screen is displayed. This occurs when the exam moves to the Prepare phase or when you have clicked Resting from the Main screen. Wireless performance and signal strength are monitored on the currently used RF channel. The wireless PIMs signal quality icon indicates the connection status. If a channel has excessive interference, the wireless PIM automatically determines a clearer channel with higher signal strength and ST80i Stress Test System Instructions for Use 3-11 Before the Patient Session coordinates 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 PIMs power indicator lights within the battery icon. These lights blink every 5 seconds when the PIM is in use. If the battery is discharged to the point where the PIM is expected to shut down shortly:

- The PIM battery indicator blinks once every second.

- The ST80i battery indicator turns red and blinks once every second.

- ST80i displays one of the following Low Battery messages, depending on the current phase of the exam:

- When you enter the Prepare phase: Battery capacity is too low to perform a new test. Please replace battery.

- During an exam: Remaining battery capacity will provide approximately 1 hour of operation. Replace at your discretion. 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 supports only 1.5V AA alkaline batteries for the PIM. Replace the battery before the stress test starts if you receive the Battery capacity is too low to perform a new test message. The message that indicates estimated battery life is at least 1 hour should enable an exam to be completed before you replace the battery. The use of rechargeable batteries is not recommended, as the remaining capacity indication may be inaccurate, resulting in the possibility of the PIM powering down during a stress test or a low-battery alert shortly after replacing the battery. 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 that the address on the device matches the address displayed on the Prepare screen. To preconfigure multiple PIM addresses, see the ST80i Stress Test System In-

stallation and Configuration Guide. 3-12 ST80i Stress Test System Instructions for Use Starting a Patient Session Checking the Treadmill/Ergometer Connection During the entire stress test, the ST80i software validates the response from treadmill/ergometer to ensure the communication between PC and treadmill/ergometer is successful. If there is a connection issue, a communication error message appears across the waveform area. During the Prepare phase, successful connection to the exercise device is indicated the presence of the Start Treadmill or Load Ergometer button at lower right of screen. In later phases, after the exercise device has been started, the buttons are named Stop Treadmill and Unload Ergometer. If the device loses communication with the ST80i system during any exercise phase, these buttons disappear. Setting Up a Pharma Test To set up a Pharma test, follow hospital protocol. Starting a Patient Session When you start a patient session by clicking Stress on the Main screen, you move through the following phases:

Prepare Pre Exercise Exercise Recovery Reports Note:

If you have the Resting ECG Workflow product option installed, you can also start a patient session by clicking Resting on the Main screen. Once you have performed the resting ECG, you can move directly to the Prepare phase of the stress test. For more information, see Chapter 5, Resting ECG Workflow. When you select a patient from the worklist for the stress test, you are immediately brought to the Prepare screen. Based on your user account settings at login, a preconfigured profile is loaded for the stress test. During the Prepare phase, the patient is connected to the electrodes so that the proper placement and ECG quality can be confirmed. ST80i Stress Test System Instructions for Use 3-13 Starting a Patient Session Select the Patient To select a patient from the worklist 1. Click Stress on the Main screen. 2. Click the patients worklist entry to select the patient and click OK, or double-

click the patients name. The Prepare screen appears. The patients name and date of birth appear on the title bar along with the patient ID. The predefined protocol is shown on the procedure bar. Note:

If communication with the BreezeSuite application is enabled, but BreezeSuite is not ready to receive data, a message opens to ask whether you want to proceed without BreezeSuite. Click Yes to continue or No to cancel. Figure 3-8 Prepare Screen Start Treadmill 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 the treadmill is configured in the protocol or selected from the Exercise Device list in the Select Patient from Worklist window, the Start Treadmill button appears in the side panel. If you select Cycle as the protocol for the patient or select an ergometer from the Exercise Device list on the Select Patient from Worklist window, the Load Ergometer button appears instead. 3-14 ST80i Stress Test System Instructions for Use Select the Wireless PIM Prepare Phase Make sure the PIM is powered on and that it shows at least two bars of battery power. In a multiple-PIM environment, make sure that you select the correct PIM once the exam enters the Prepare phase. By default, the last PIM used appears as the current PIM on the Prepare 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 appear as they were named during configuration. To select the wireless PIM 1. Click the PIM menu in the procedure bar. 2. Click the name of the PIM device to be used. 3. Press the PIM button on the device to power it on (if it is powered off). The PIM wireless status provides feedback that the PIM is selected to communicate with the application. Caution Follow the correct procedure to select the PIM when multiple PIMs are detected. To ensure proper wireless function of the PIM, press the PIMs light button to display battery strength. If the battery is discharged to the point where the PIM is expected to shut down shortly:

The PIM battery indicator blinks once every second. The ST80i battery indicator turns red and blinks once every second. ST80i displays this message: Battery capacity is too low to perform a new test. Please replace battery. Note:

To save the battery power, the PIM is preconfigured to power off automatically when there is no action on the PIM for a predefined period. This period of inactivity can be configured from 3 to 15 minutes. To configure PIM Power Saving, see the ST80i Stress Test System Installation and Configuration Guide. Prepare Phase When you select the patient name, the Prepare screen appears. In the Prepare phase, you ensure that everything is ready, including the patient, the PIM, and the exercise device, before the actual test begins. ST80i Stress Test System Instructions for Use 3-15 Prepare Phase Instruct the patient about the stress test. During the Prepare phase, you perform the following tasks:

Prepare the patients skin. Attach the electrodes/lead wires. Note:

You cannot enter the Pre Exercise phase without, at minimum, all limb leads connected. Good ECG technique is very important to achieve the best quality results. Connect the wireless PIM. Check the lead map. Check signal quality (filtering and sync output). Verify a clean ECG. Attach the BP cuff and/or the SpO2 sensor. Click the Pre Exercise button or press F7 to move to the Pre Exercise phase. Note:

If you attempt to start the exercise device during the Prepare phase, you receive the Cannot start equipment in the Prepare Phase message. 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 can also click the Explain Test button on the Main screen to play an audio file that explains the test to the patient. Make sure that the PCs audio is enabled (in other words, that the speakers are not muted). Note:

ST80i ships with a default audio file that explains the exercise stress test;

however, you can 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 Stress Test System 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. 3-16 ST80i Stress Test System Instructions for Use Prepare Phase Make sure the patient is comfortable. The patients arms and hands must be relaxed. If a treadmill is being used, instruct the patient to rest his or her hands on the handrails and not grasp the handrails tightly. The more relaxed the patient is, the less the ECG is affected by noise or muscle artifacts. 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 or dead epidermal cells, oils, and dirt. To prepare the skin 1. Shave hair from electrode sites, if necessary. Excessive hair prevents a good connection. 2. Wash the area thoroughly with mild soap and warm water. Note:

Do not use alcohol to clean the skin. 3. Dry the skin vigorously with a gauze pad to increase capillary blood flow to the tissues and to remove dead or 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 Be sure to place the snap connectors on the electrodes before placing the electrodes on the patient. Ensure that the leadset is long enough to connect limb leads to the patients wrist and ankle if you plan to capture a resting/supine ECG during Pre Exercise. Placement of the electrodes may need to be changed according to the stage of the test:

When performing a supine/resting ECG to capture a baseline during Pre Exercise, place the limb leads on the limb extremities. This provides the most accurate results, ST80i Stress Test System Instructions for Use 3-17 Prepare Phase Note:

You must also place limb leads on the limb extremities if you use the Resting ECG Workflow product option to capture a resting ECG. See Chapter 5, Resting ECG Workflow, for more information. When performing a standing or Mason-Likar ECG, place the limb leads on the torso in the Mason-Likar positions. Left Leg [LL/F]

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]

Right Arm [RA/R]

Chest leads [V1/C1, V2/C2, V3/C3, V4/C4, V5/C5, and V6/C6]

All leads are acquired simultaneously. Review the following lead wire labeling and electrode placement information in Figure 3-9 to ensure a quality ECG. Left Arm [LA/L]

Figure 3-9 Mason-Likar Electrode Placement (AAMI/IEC) 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 3-18 ST80i Stress Test System Instructions for Use AAMI Lead IEC Lead Electrode Position Midway between V2 and V4 Prepare Phase Left midclavicular line in the 5th intercostal space Between V4 and V6 5th intercostal space, left midaxillary Place the limb electrodes for the arm directly on the clavicle bones (away from major muscles) Below V6 on the lower edge of the ribcage On the lower edge of the ribcage To attach the electrodes to the patient 1. Place the gel area of the electrode over the center of the prepared area, using the positioning shown in Figure 3-9; 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 should be placed on the lower edge of the rib cage, in the lower right area of the patients chest (avoiding flabby areas and the belt). This may need adjustment depending on body habits.

- The Left Leg lead should be placed on the lower edge of the rib cage, below V6, in the lower left area of the patients 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 his or her arms over the head. This helps verify good lead placement and no strain on the electrodes. ST80i Stress Test System Instructions for Use 3-19 Prepare Phase Connecting the Patient to the Wireless PIM All of the ST80i lead sets are designed to share the same connector that plugs into the mating connector on the wireless PIM. To connect the patient to the wireless PIM 1. 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 and belt are designed to keep the PIM steady, thereby minimizing movement of the lead wires and ECG signal artifacts. The PIM holder/belt 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:

Power the PIM on or off Check PIM battery status, wireless link quality, and lead contact quality.

- When requested to check battery status, the wireless PIM provides an indication of estimated battery power remaining.

- When requested to check lead/electrode connections, the wireless PIM indicates a poor lead signal quality condition by showing a yellow LED light for any patient electrode connection where the measured impedance is considered excessively high for good quality, low-noise ECG measurements. You can check the lead signal quality of lead connections while hooking up and preparing the patient in an area outside of the range of the systems radio connection. Checking the Lead Map To check the Lead Map 1. Click the Hide/Show View icon in the toolbar on the Prepare or Pre Exercise screen. 2. Select Show Lead Map. A color-coded anatomical diagram displays the lead connections. 3-20 ST80i Stress Test System Instructions for Use Figure 3-10 Lead Connections Prepare Phase If a lead is off, a red X is displayed on the lead map to indicate the affected lead. Red dashed lines are displayed in the real-time ECG view. For the chest leads, the lost lead location is indicated by red dashed lines. If a limb lead is lost, all leads or all but one limb lead display as dashed red lines. For more details on checking the lead quality connection, see About the Lead Map View on page 2-20. For more details about adjusting the filter, see Quick Settings on page 2-31. 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 the possibility of a leads-off condition occurring. Checking Signal Quality to Verify a Clean ECG 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 leads-off condition is saved with the data and is indicated on any printed reports that contain that data. You can set the color of the ECG (waveform) to be green on black or black on red. For green waveforms, a lead-off condition is indicated on the real-time display as a red dashed line; for black waveforms, a lead-off condition is indicated as a black dashed line. When printed, the lead-off condition also appears as a dashed line. ST80i Stress Test System Instructions for Use 3-21 Prepare Phase Figure 3-11 Red Dashed Line Showing Leads-off Condition for V4 Start Treadmill ST80i also provides an indication to the operator when the front-end is inoperative and cannot acquire a signal. If the PIM is off or cannot acquire a signal, then the ST80i display does not show the wireless signal indicator or battery status indicator. If the AIM can find the PIM but no ECG is displayed, then all leads are shown as red dashed lines, but the wireless signal and battery status indicators are displayed. These conditions are saved with the data and are indicated on any printed reports that contain that data. 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. Note:

Enabling the Artifact Filter and/or Smart Filter during a test causes a brief data loss represented by red dashed lines on the display due to initialization of filtering algorithms. Disabling the Artifact Filter and/or Smart Filter causes a brief data loss represented by a sudden change in waveform morphology. The filtering techniques developed for ST80i permit the user to identify any clinically significant ST deviation and do 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. 3-22 ST80i Stress Test System Instructions for Use Prepare Phase The ECG data is stored in its recorded state (0.02300Hz, all filters off) and user-selected settings are stored with the ECG. Note:

The ECG data is filtered at 0.05150 Hz before being analyzed by the algorithm. This filter is called the algorithm filter and cannot be turned off by the user. The algorithm filter is independent from other filters, is not controlled by the user, and does not affect the saved ECG data. All filters can be turned on or off as needed to improve displayed and printed waveform quality except for the algorithm filter (as described above) and minimum filters (0.02Hz high pass filter and 300Hz low pass filter). If the AC Filter is enabled, it is applied at a user-specified 50Hz or 60Hz to ECG data sent to the algorithm. If the Smart Filter is enabled, it automatically detects the frequency of the AC Filter, rather than using the specified 50/60 Hz. If needed, you can change the default filter settings. For details on filter settings, see Quick Settings on page 2-31. 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. The analog-out signals are amplified. TTL/Analog Output Option:

You can specify the ECG lead used for syncing the TTL/Analog Output. 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 Quick Settings on page 2-31. To configure Analog and TTL Output, see the ST80i Stress Test System Instal-

lation and Configuration Guide. WARNING Both analog ECG output and TTL sync output are considered real-time, with a delay (latency) of no more than 25 ms between the patients physiological activity and the appearance of its representative signal at the external port. This signal should not be used for analysis. ST80i Stress Test System Instructions for Use 3-23 Prepare Phase Note:

ST80i monitors drop-out (interference) and signal strength and automatically selects a clearer frequency band when excessive drop-out exists. The drop-out level threshold is configurable from Settings > System Settings > I/O Devices. For more information, see the ST80i Stress Test System Installation and Configuration Guide. 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. Attaching the BP Cuff Note:

If using the SunTech Tango NIBP device, follow the manufacturer's recommendations to attach the cuff. It is important that the microphone be placed in the correct position to ensure accurate BP measurements. There is excellent information on the SunTech Medical website, www.suntechmedical.com, related to Tango and the proper positioning of the cuff. To attach the BP cuff 1. Place the cuff on the patient. 2. Take a pre-stress NIBP connection test to determine whether the cuff is correctly placed on the patient and to ensure NIBP measurements throughout the stress test. Attaching the SpO2 Sensor To attach the SpO2 sensor, attach the SpO2 sensor to the patient's finger and verify that the screen displays an SpO2 value. Interpretive Settings In Settings > User Profile > Algorithm, you can preconfigure interpretive settings for the DXL Algorithm and CAlg templates. This must be done before you begin a patient session. For details on configuring interpretive settings, see the ST80i Stress Test System Installation and Configuration Guide. The settings are listed here for reference only, with the exception of Pacer Detection, which you can access from the Quick Settings menu during a stress test. 3-24 ST80i Stress Test System Instructions for Use DXL Algorithm Prepare Phase Borderline Statement Suppression Pacer Detection The pacer detection algorithm detects both atrial and ventricular pacing. Pacemaker detection is preset in the user profile, but can be changed using the Quick Settings icon. The options include:

- Paced Unknown

- Paced

- Non-paced

- Paced (magnet) Paced Unknown is the default mode, in which the detector uses its default sensitivity setting to determine if pacemaker pulses are present. The pacer detection setting in effect at the time an event is recorded is used for the analysis of that event. If the pace-pulse program is enabled and it detects the presence of pace-pulses, it provides output in textual and graphical formats:

- The interpretive report contains textual statements about the findings for the pace-pulse program.

- Tick marks appear on the printed ECG at locations where pulses are detected. The interpretive report contains textual statements about findings.

- Only one set of tick marks is printed for any given period of acquisition, regardless of the number of channels presented. Lead Check Enable DXL Algorithm for Stress Adult Bradycardia Limit (BPM) Report Confirmation Label Critical Values RR Measurement STEMI-CA LHS Upper Case CAlg Templates Enable ST Segment Analysis Enable Arrhythmia Analysis J-ST (msec) ST80i Stress Test System Instructions for Use 3-25 Pre Exercise Phase Note:

ST Segment analysis must be enabled for ST values to be analyzed and displayed. The same applies to Arrhythmia analysis. There is no printing or saving of arrhythmia ECGs; however, PVCs are counted. Entering the Pre Exercise Phase The Pre Exercise phase does not start automatically. To enter the Pre Exercise phase, click the Pre Exercise button or press F7. Pre Exercise Phase The Pre Exercise phase does not start automatically. Once the leads are in place and the patient has been prepared (during the Prepare phase), you must click the Pre Exercise button or press F7 to move to the Pre Exercise phase. Once you have clicked the Pre Exercise button, the ST template starts and the Max and Target heart rates show real values. During the Pre Exercise phase, you create a baseline for the patient by taking a resting blood pressure and a resting ECG. Note:

To have Pre Exercise averages available in reports, Pre Exercise must run for approximately 40 seconds before entering the Exercise phase. The Pre Exercise phase consists of the following tasks:

1. Wait 40 to 50 seconds for the ST template to be built. The template is complete when an ST value is displayed. This is required if you want to compare the final test results with the resting results. 2. Take a resting/baseline BP to be used as the Reference BP in the final report. Note:

The BP must be taken before the ECG. 3. Take a resting/baseline ECG. 3-26 ST80i Stress Test System Instructions for Use Pre Exercise Phase Note:

The type of baseline ECG (Supine or Standing) to be used as the Reference ECG is preconfigured in Settings. 4. After the Pre Exercise data is gathered, have the patient move to the treadmill or ergometer to begin monitoring.

If you are using a treadmill, have the patient straddle the belt. Then start the treadmill and give the patient time to become accustomed to using it. If you are using an ergometer, seat the patient and instruct the patient to begin pedaling. The patient encounters the initial resistance configured for the protocol.

5. When the patient is accustomed to the device, click the Exercise button or press F7 to begin the Exercise phase. During Pre Exercise, you can adjust the J+ Point value. With the Zoom ST window open, hover the cursor over the current value, then click and type the new value. Finally, click OK. The Pre Exercise phase is preset for treadmill speed and grade or for ergometer power based on the protocol selected. Figure 3-12 Treadmill Speed and Grade Note that the Pre Exercise time is separate from the Exercise time. Note:

If you manually update patient information in the Edit Patient Information window during the Pre Exercise phase, patient information is also updated in the Report screen. Baseline/Reference BP and SpO2 ST80i supports optional SpO2 and motion-tolerant Non-Invasive Blood Pressure (NIBP) devices. ST80i automatically collects the NIBP through a cuff. The patients SpO2 is collected in real-time through a sensor. BP and SpO2 are real-time numeric displays for the NIBP and SpO2 values for an entire study or for a single instance. They can be manually measured and the values can be overridden. ST80i Stress Test System Instructions for Use 3-27 Pre Exercise Phase During the stress test, NIBP is measured according to the intervals defined in the exercise protocol and is continually displayed on the screen. This is recorded in the BP mmHg field in the side panel and also on the ECG. The SpO2 measurement is continuously updated and is recorded in the side panel in the SpO2 field. If enabled, there are also audible prompts for NIBP. To enable audio prompts, see the ST80i Stress Test System Installation and Configuration Guide. To connect the patient to the NIBP device and to the SpO2 sensor, see Attaching the BP Cuff on page 3-24 and Attaching the SpO2 Sensor on page 3-24. Manually Enter BP and SpO2 When you enter or acquire blood pressure values according to the pre-

programmed automatic prompts or at any other times during the test, for each recording, the blood pressure value, phase, and total time of the phase at the time of the acquisition are captured. The automatic timing of blood pressure measurements is established in the exercise protocol. You can, however, take blood pressure measurements with an NIBP device at any time during each stage by using the BP button. Or you can enter the measurement manually, after taking the patient's blood pressure. When you manually enter the values of BP and SpO2, the value of BP and SpO2 are displayed in the stage report and the final stress report. Note:

ST80i continues to update the real-time NIBP or SpO2 values from the NIBP monitor even when or if the values are manually entered. To take a blood pressure measurement (if the patient is connected to an automatic blood pressure monitor) other than a timed BP, click the BP button in the procedure bar. The current blood pressure measurement displays in the BP mmHg (Sys/Dia) field. The previous blood pressure measurement displays in the Previous BP mmHg field. To manually enter the blood pressure measurement when no NIBP device is connected 1. After you take the patient's blood pressure, click the BP mmHg(Sys/Dia) field in the side panel. 2. Type the latest blood pressure measurements in this field using the following guidelines:

- Use only numbers 1 through 400. There is no need to type the slash (/) between the systolic and diastolic values. 3-28 ST80i Stress Test System Instructions for Use Pre Exercise Phase

- Type a minimum of five digits. The systolic value must include three digits, so if the systolic measurement is below 100, type a zero as the first digit

(for example, type 097). 3. Click OK in the BP mmHg (Sys/Dia) field. The display shows the manually entered measurements. The previous blood pressure measurement displays in the Previous BP mmHg field. To override the SpO2 1. Click the SpO2 field in the side panel. 2. Type the latest measurement in this field using numbers between 0 and 100. 3. Click OK in the SpO2 field. The display shows the manually entered measurement. Note:

ST80i software validates the input values of BP and SpO2 before they take effect to ensure that the numbers fall within an expected physiological range. For details about how this information is displayed in the final report, see Chapter 4, Working with Reports. Resting ECG with Interpretation Wait 40 to 50 seconds for the ST template to be built. The template is complete when an ST value is displayed. This is required if you want to compare the final test results with the resting results. Note:

This section describes how to capture resting ECGs during the Pre Exercise phase of a stress test. This information does not apply to using the Resting ECG Workflow product option. See Chapter 5, Resting ECG Workflow, for information about the Resting ECG option. Once the waveforms are satisfactory, you are ready to acquire a resting

(supine) or standing baseline ECG. Note:

If you plan to use the Compare feature with the baseline ECG as a reference, be sure to wait 40 to 50 seconds after the start of Pre Exercise before you capture the ECG. This allows the template to be built. The template is complete when an ST value is displayed. ST80i allows you to acquire and print a 12-Lead resting ECG with or without interpretation when the patient is supine. DXL must be enabled in Settings to ST80i Stress Test System Instructions for Use 3-29 Pre Exercise Phase have interpretation appear on the ECG. This data appears as part of the final ECG report. ST80i provides resting ECG interpretation using the latest Philips DXL algorithm for traditional limb lead placement. To get interpretation, you must first configure Enable DXL Algorithm in Settings > User Profile > Algorithm. For details, see the ST80i Stress Test System Installation and Configuration Guide. WARNING To get the most accurate interpretation during resting ECG, use traditional limb lead placement. Using Mason-Likar electrode placement may result in deviation in interpretation. Interpretations and analysis results provided by the Philips DXL 12-lead Analysis Algorithm for 12-lead ECG captures are intended for use with traditional limb lead placement and are not validated for use with other lead placements When the algorithm finds excessive artifact or AC noise, it gives a related warning/error string. The string is printed on the report and is saved when saving the report. The algorithm also reports wrong lead placement. See Filtering on page 3-22 regarding artifact or AC noise. To obtain a 12-Lead resting ECG with interpretation during the Pre Exercise phase 1. Click the Event icon in the toolbar. 2. Select Supine. After a few seconds, if printing is enabled, the ST80i system prints a full 12-

Lead resting ECG with measurements and interpretation text. If printing is not enabled, ST80i saves the ECG. To obtain a 12-Lead ECG without interpretation (during any phase of the stress test) If you do not want the printed ECG to have a label, click the ECG Print button. If you want the printed ECG to have a label, click the Event icon and select the appropriate label from the menu. After a few seconds, the ST80i system prints a full 12-Lead resting ECG. After taking the baseline measurements, you are ready to instruct the patient in the proper use of the equipment. Starting the Patient on the Treadmill or Ergometer The start and stop control for the treadmill or ergometer appears in the ST80i side panel. There is also an emergency stop button on the treadmill. Depending on the treadmill model, there might also be a safety tether. 3-30 ST80i Stress Test System Instructions for Use Exercise Phase You can manually control the speed and grade of the treadmill or the power

(wattage) of the ergometer during any stage in the Exercise test. See Controlling the Treadmill or Ergometer on page 3-38. To start the patient on the treadmill 1. Have the patient straddle the belt. 2. In the ST80i application, click Start Treadmill. The button changes to Stop Treadmill. The treadmill starts at the preselected speed and grade set for the protocol. Note:

Alternatively, you can press F4 to start the treadmill or load the ergometer, or press F6 to stop the treadmill or unload the ergometer. 3. Allow the patient to become acclimated to the movement of the belt, and then provide the patient with the following instructions:

- Keep your body straight and head up.

- Walk in a normal walking position with arms at your sides, or place your hands lightly on the handrails for stability but do not bear down with too much gripping force.

- Use as little upper-body motion as possible and stay near the front of the treadmill. You are now ready to begin the Exercise phase. To start the patient on the ergometer, instruct the patient to begin pedaling. The patient encounters the preselected resistance set for the protocol. You are now ready to begin the Exercise phase. To begin the Exercise phase, click the Exercise button on the procedure bar or press F7. The Exercise screen appears. Exercise Phase CAlg has a learning phase during which it automatically selects the initial 12-

lead dominant QRS complex. CAlg removes baseline wander and aligns successive non-noisy complexes of similar shape and then averages them together to form a noise-reduced representative beat. As new, similar complexes arrive, they are added to the representative beat, and old complexes are removed from it. When CAlg stops finding good matches for the representative beat and all old complexes have been removed, it automatically detects a new dominant morphology and builds a new representative beat. CAlg makes ST measurements on the noise-reduced representative beat. During the test, you can print 12-Lead ECGs automatically or manually. You can choose any of the following display choices:

ST80i Stress Test System Instructions for Use 3-31 Exercise Phase 12 leads 6x2 leads 6 leads 3 leads You can start the Exercise phase of the test at any time; however, a warning message pops up if the algorithm has not obtained an ST value from all 12 leads. Because baseline ST values, which are used to calculate ST elevation and depression, are recorded at the beginning of the Exercise phase, it is important to make sure there are valid ST values when beginning the Exercise phase. Conducting the Exercise Stress Test When you move into the Exercise phase of the test, the treadmill loads the settings associated with the first stage of the test, and the stage and phase clocks start counting. Figure 3-13 Exercise Screen Stop Treadmill The exercise time builds cumulatively as the patient completes each stage. However, with each new stage, the stage clock restarts at 00:00. The stage time, speed, and elevation for each stage are defined by the protocol. If you want to move to the next stage, without waiting for the system to automatically change, you can click the Go to Next Stage button on the procedure bar. This starts a new stage and a new stage time, but the exercise time continues to build. If you want to keep the stress test in the current stage, overriding automatic stage changes, you can click the Hold Stage button. 3-32 ST80i Stress Test System Instructions for Use Exercise Phase To remove the hold on stage changes, click the Unhold Stage button. Even if the duration of the hold spans what would have been multiple stages, the removal of the hold returns the stress test to the stage following the one during which the hold was placed. If the patient can no longer continue exercising, you can end the Exercise phase of the stress test by clicking the Recovery button, or by clicking the Stop Treadmill button, if necessary, and then clicking Recovery. The Recovery phase is preset to slow down the treadmill and lower the elevation. Monitoring the Patient During the Exercise phase:

The patient walks on the treadmill or peddles the ergometer, unless the patient is unable to exercise or is not using an exercise device. You record blood pressure/SpO2, observe events, and record RPE, while closely monitoring the patient. You can switch from an automated protocol to manual operation, giving you full control over the treadmill. To switch to manual control, see Controlling the Treadmill or Ergometer on page 3-38. You can change the display parameters, as needed during the Exercise phase. For details, see Using the Toolbar Icons on page 2-15. The Exercise phase comprises several stages, which are defined by the selected protocol. For a breakdown, see Appendix B, Protocol Reference. Figure 3-14 Exercise Stage and Protocol In general, you will most likely use the standard settings as specified by the profile and protocol selected. Changing to Another Protocol If you need to switch to a different protocol at any time during the Exercise phase of the test click the drop-down arrow next to the current protocol to select a new protocol from the list that was configured in Settings. The phases and stage settings associated with the newly selected protocol are loaded into ST80i. See the ST80i Stress Test System Installation and Configuration Guide for setting default protocols. To change to another protocol 1. On the procedure bar, click the drop-down arrow next to the current protocol to display the list of preconfigured protocols:

ST80i Stress Test System Instructions for Use 3-33 Exercise Phase

- Bruce

- Modified Bruce

- Balke

- Ellestad

- Naughton

- Pharma Low Ramp

- Med Ramp

- High Ramp

- USAF/SAM 2.0

- USAF/SAM 3.3 2. Select a new protocol from the list. The time on the stage clock resets to 00:00 for the next stage. When you change the protocol, the test advances to the beginning of the next stage. The speed and grade settings (for treadmill) or RPM and power settings

(for ergometer) change to reflect the new protocol. Printing During the Stress Test At any time during the stress test, you can trigger real-time ECG (a real-time ECG is defined as 10 seconds of ECG data) and continuous Rhythm printing using the icons displayed on the Exercise screen or using hot keys. The time latency should be less than 7 seconds. You can also capture and store events and notes for later review and reporting. Arrhythmia events can trigger automatic printing with the context ECG, if configured. In addition, you can also turn off the continuous printing both on the configuration and during the test. Hot Keys for Printing The following hot keys can be used in place of the ST80i icons and buttons:

CTRL+P Prints a selected Event during the Report phase. F10 Starts the printing of a rhythm report. Pressing again stops the printing. F11 Prints a 12-Lead ECG. Printer Settings During the patient session, you can change the Rhythm Print settings using the Quick Settings icon. See Using the Toolbar Icons on page 2-15 for details. See the ST80i Stress Test System Installation and Configuration Guide for information about preconfiguring default printer settings. 3-34 ST80i Stress Test System Instructions for Use Exercise Phase Print Options ST80i supports the following print options during the stress test:

Resting ECG with interpretation Interpretation is printed only during Pre Exercise phase when a Supine event is selected. Real-time ECG Continuous rhythm strip RPE statement printout Event printout Freeze printout Stage printout Resting ECG with Interpretation During the Pre Exercise phase of the stress test, you can print a resting ECG with interpretation by selecting a Supine event. Note:

You can also print a resting ECG with interpretation using the Resting ECG Workflow product option. See Chapter 5, Resting ECG Workflow, for more information. The DXL setting must be enabled in Settings to include interpretation on the ECG. See Interpretive Settings on page 3-24. To print a resting ECG with interpretation 1. Click the Event icon on the toolbar to display the Event list. 2. Select Supine. The system prints a resting ECG. Real-Time ECG Any time during the testing, you can print a real-time ECG using the ECG Print button. The time latency should be less than 7 seconds. To print a real-time ECG, click the ECG Print button on the procedure bar. The system prints a real-time ECG. Continuous Rhythm Strip You can trigger continuous rhythm printing using the Start Rhythm Printing button on the Exercise screen. You can also turn off continuous printing by using the same Start Rhythm Printing button. Before using the rhythm printing option, be aware that:

ST80i software automatically advances the paper to the page header. You can adjust Rhythm Print settings using the Quick Settings icon. ST80i Stress Test System Instructions for Use 3-35 Exercise Phase To print a continuous rhythm strip 1. Click the Quick Settings icon on the toolbar. 2. Click the Rhythm Print tab. 3. Adjust the settings, if applicable, for:

Leads Select the leads you want to print. Limb Gain Options include 2.5 mm/mV, 5 mm/mV, 10 mm/mV, and 20 mm/mV.

- Chest Gain Options include Full and Half.

- Speed Options include 5 mm/s, 10 mm/s, 25 mm/s, and 50 mm/s. 4. Click the Start Rhythm Printing button. 5. To end the printing, click the Start Rhythm Printing button again. RPE Statement Printouts When you want to print an ECG with an RPE statement, ask the patient to state which number or statement represents their perceived level of exertion. Then select the corresponding number from the RPE list. Once the number is selected, the system prints an ECG report, noting the RPE. To print an ECG with an RPE statement 1. Click the RPE icon on the toolbar. 2. From the list, select the RPE statement that matches what the patient reports. 3. Click OK. The system prints an ECG with the RPE statement. Event Printouts An Event printout is triggered when you document patient events and symptoms using the Event icon. The Supine, Mason-Likar, and Standing events are typically selected to provide baseline information. Events such as Hyperventilation, Chest Pain, and so on are used to document patient symptoms as they occur. Note:

If enabled, Arrhythmia events can trigger automatic printing with the context ECG. This can be enabled in the user profile. See the ST80i Stress Test System Installation and Configuration Guide for how to enable Arrhythmia events. To print an event 1. Click the Event icon on the toolbar. 3-36 ST80i Stress Test System Instructions for Use Exercise Phase 2. From the Event list, select the event to record. The system prints an ECG and records the event for the final report. For more information, see Recording an Event on page 2-25. Freeze Printouts When you click the Freeze icon on the procedure bar, the most recent 10 seconds of ECG data is frozen. A dialog box opens to display an image of all leads captured at the moment you click the Freeze icon. To print a freeze 1. Click the Freeze icon on the toolbar. The Freeze dialog box appears to the right of the waveform. 2. Click the Print button to print and save the frozen ECG. For more information, see Freeze on page 2-25. Stage Printouts Stage printouts can be configured in the exercise protocol to print automatically (or to not print at all) during each stage of the Exercise phase of the stress test. A 12-Lead ECG can be printed at the beginning or end, or at some other specified time interval of each stage. However, the stage printout/schedule time is also affected by how the printer type is configured. If the printer type is set to Off in Settings, the stage does not print even if it is configured in the protocol to print. However, the ECGs are saved. The stage printout can also be configured to include the 12-Lead average beats and/or the zoomed lead. These settings are defined for each stage of the exercise protocol when an ECG is automatically generated for the stage. Both Event and Stage printouts include the following:

Report title Protocol name, phase, stage number, and so on Patient demographics (mandatory) Heart rate, blood pressure, and speed and grade (when using a treadmill) or Load (when using an ergometer) ECG Waveform ECG acquisition time and Stage time Average beat (if configured) Maximum ST changes in this stage (for Stage printout only and only if a Event name (for Event printout only) zoomed lead or averages are configured to print) For more information on printing reports, see Chapter 4, Working with Reports. ST80i Stress Test System Instructions for Use 3-37 Exercise Phase Controlling the Treadmill or Ergometer At any point during the Exercise phase of the stress test, you can switch to manual mode and change the speed and/or elevation grade of the treadmill or the power setting of the ergometer. This change overrides the protocol settings for the current stage. Once you enter manual mode, there is no next stage, and you cannot return to the protocol. Caution Be sure to inform the patient of the changes. If the treadmill or ergometer is unavailable, ST80i displays Unavailable where the Start Treadmill or Load Ergometer button would be. To control the treadmill or ergometer manually 1. Click in the field that shows the current speed or current elevation of the treadmill or the current power setting of the ergometer. The Manual Mode confirmation appears. 2. Click OK to enter manual mode so that you can override the protocol settings and operate the treadmill or ergometer manually. Note:

The protocol selection on the procedure bar now shows Manual Mode. 3. Boxes with minus () signs to the left and plus (+) signs to the right of the current settings are displayed. Figure 3-15 Treadmill Speed and Grade Adjustment 4. Make the appropriate adjustment(s), down or up, and click OK to make each change. The maximum change in treadmill grade you can make at one time is 5%. The minimum change in treadmill speed you can make at one time is one-tenth (0.1 mph or 0.1 km/h). To stop the treadmill or unload the ergometer during the Exercise phase, click the Stop Treadmill button to stop the treadmill (or press the red emergency 3-38 ST80i Stress Test System Instructions for Use Exercise Phase stop button). Click the Unload Ergometer button to unload the ergometer. Note:

Alternatively, you can press F4 to start the treadmill or load the ergometer, or press F6 to stop the treadmill or unload the ergometer. Be aware of the following when restarting the treadmill during the existing patient session:

Before restarting, inform the patient that the treadmill will quickly ramp up to the speed and elevation that was in use when the treadmill was stopped. If you used the Stop Treadmill button, you must use the Start Treadmill button to restart the treadmill. If you used the emergency stop button (ESB), you must disengage the ESB before pressing the Start Treadmill button. See Maintaining the ST80i System on page 6-1 for information about inspecting the cables and attachments between the PC and the Treadmill. Notifications and Alerts ST80i provides visual indications or alerts in case of dramatic morphology or rhythm changes. All notifications are preconfigured in Settings > User Profile

> Notifications. The configuration includes the events to be displayed or printed as well as specific audio alerts. Configuration must be completed before you begin a patient session. For details on configuring interpretive settings, see the ST80i Stress Test System Installation and Configuration Guide. In Settings > User Profile > Notifications, you can choose to display and/or print the following Arrhythmia events:

Afib Asystole High Heart Rate (>=220 bpm is the default, but this limit can be configured) Pause >4000 ms PVC (Premature Ventricular Contractions) /+ per minute Sudden drop in BP (>=50 mmHg is the default, but this limit can be configured) 1 missed beat 2 missed beats Ventricular Escape Beat VFIB ST80i Stress Test System Instructions for Use 3-39 Recovery Phase VRun(>=3PVCs) /+ per minute VTACH (>= 9PVCs and >=120BPM) V Bigeminy V Couplet /+ per minute The preconfigured audio alerts consist of the following:

NIBP Notifications Note:

If you enable Notifications, all configured arrhythmia events trigger audible alerts; if you disable Notifications, all arrhythmia event audible alerts are off. Stage Change See the ST80i Stress Test System Installation and Configuration Guide for more information regarding the setting of notifications. See also Interpretive Settings on page 3-24. Ending the Exercise Phase The protocol determines the number of exercise stages as well as their duration. Once the final stage is complete, the application automatically moves into the Recovery phase. During any stage, you can end the exercise stress test and move directly to Recovery by clicking the Recovery button. Generally, you terminate the Exercise phase when the patient reaches a percentage of their target heart rate. The clinician determines the end point according to patient's status, and many patients never reach 100%. The target heart rate is preconfigured in the user profile. If the reading reaches 100% of the target heart rate, the graph indicator color changes from green to red. Recovery Phase When the last stage of the Exercise phase is complete, ST80i automatically moves into the Recovery phase. For the Recovery phase, the factory-loaded protocols are preset for the number of stages and for speed and grade or power. See the ST80i Stress Test System Installation and Configuration Guide for Exercise Protocol settings. When the patient has completed the last exercise stage of the protocol or the 3-40 ST80i Stress Test System Instructions for Use Recovery Phase test has been discontinued (as documented in Reason to End in the Summary), the exercise stress test automatically enters the Recovery phase. If conditions require it, you can manually move to the Recovery phase. To manually enter the Recovery phase, click the Recovery button. The system moves into the Recovery phase of the test. You can now acquire a recovery ECG and blood pressure and proceed with the Recovery phase of the test. During the Recovery phase:

The system automatically prints a 12-Lead ECG. The 12-Lead ECG is printed at this stage of transition regardless of system settings. This is the Peak Exercise ECG. The total exercise time clock freezes and begins displaying the Recovery time instead. If there is more than one Recovery stage, the software displays the stage time and the cumulative Recovery time. ST80i advances the treadmill or ergometer to the recovery workloads specified in the protocol. Click Stop Treadmill or press F6 to stop the treadmill (or press the red emergency stop button). Using the Narrative icon, you can type comments describing why the patient ended the Exercise phase of the test, the patients symptoms, and conclusions. Figure 3-16 Recovery Phase Screen To end the Recovery phase 1. Click the Report button. The End Test confirmation appears. 2. Click OK to confirm. You also have the option to cancel. When the report is finished loading, the Report screen opens. Stop Treadmill ST80i Stress Test System Instructions for Use 3-41 Report Phase Report Phase The Report phase begins when the Recovery phase ends and the Report screen opens. Post-Recovery During the Report phase, a period of post-recovery that lasts from 5 to 60 minutes allows ST80i to continue to monitor the ECG, HR arrhythmia alerts, and BP changes. You can manually enter a BP or initiate a Tango NIBP. To include a record of this BP in the final report, type it in the Narrative or Notes window. If you take a 12-lead ECG in this phase, it is saved as an event and included in the final stress report. Data is not saved unless an event is triggered. If events are triggered, the event data is saved as part of the final report. During post-recovery, you can click the Save button on the Report screen as many times as necessary. All saved data is part of the final report. The patient session ends when you exit the Report screen. When you exit, monitoring stops and no more ECG data is displayed. Note:

ST80i stops streaming test data after the 60-minute post-recovery period. From the Report screen, you can review and modify the content of the final test report. You can print the individual reports that are also included in the final report, save the final report, and print it. After you save the report, you can export it to a PDF file for distribution or storage. Report Screen Summary Report (including Tabular and ST Analysis) Trends Report On the Report screen, you can review and edit the stress test results to prepare the final stress report. The final report includes:

Patient ID Report Average QRS Report 12-Lead ECG Report (including Interpretation and Measurements) Events Report (including manual ECG, manual event, stage report, RPE, arrhythmia, freeze) ST Comparison Report Max ST Report 3-42 ST80i Stress Test System Instructions for Use Ending the Patient Session The report is then confirmed, saved, exported, archived, and/or printed on preconfigured printers. You have the option to print the whole report or specify which page(s) to be printed. From the Report screen, you can also:

Review or replay the stress test Confirm the final report before export Review previous patient studies See Chapter 4, Working with Reports, for information on the Report phase and Report screen. Ending the Patient Session After saving the final stress report, you are ready to close out the patient session. The patient can now be disconnected from the PIM, if not disconnected already:

Detach patient from PIM Remove the electrodes from the patient For details about working with the final report, including viewing, editing, printing, and saving reports, see Chapter 4, Working with Reports. Starting a New Patient Session You do not have to exit the application to start a new session, unless you want to use a different user profile. Otherwise, you exit the application only when you are shutting down the system. Once the data from the previous patient session has been saved, you can begin a new patient session. All user profile settings return to the same as the previous test unless you exit the application and a different user logs in. Note:

When a new patient session begins, all temporary files are deleted and all patient information and stress study data from the previous patient is automatically cleared from memory. To start a new patient session 1. Click Stress on the Main screen. 2. Click the Worklist tab. 3. Select the patients name or add a new patient. ST80i Stress Test System Instructions for Use 3-43 Ending the Patient Session Exiting the Application You exit the application when you need to use a different profile, when a new user is logging on to the system, or when you are shutting down the system. To exit the ST80i application, click the X in the upper-right corner of the Main screen. If Security Mode is not enabled, the application shuts down. If Security Mode is enabled, you are presented with four options:

Restart Operating System Shuts down the application and restarts the operating system. Shut Down Operating System Shuts down the application and the operating system. Restart Application Restarts the application without shutting down the operating system. Cancel Cancels the exit. 3-44 ST80i Stress Test System Instructions for Use 4 Working with Reports Overview When you enter the Report phase, data from the Pre Exercise through Recovery phases of the test are saved as part of the final stress study that is viewed on the Report screen. From the Report screen, you can review and modify the contents of the final stress report, which is displayed in tab format. This includes report summary information, trends, average QRS, events, ST comparison, maximum ST, and resting ECG. You can save the final report, and then print it. In addition, you can print the individual sections that are part of the final report. After you save the report, you can export it for distribution or storage as a PDF file, as XML data, orif you have IntelliSpace ECG version B.01 or lateras raw data

(PDR). If exporting to a DICOM report server, the report can include 12-Lead ECGs and/or PDR, or it can be exported as a DICOM Structured Report (SR). Export settings are preconfigured in Settings > Remote Sites. See the ST80i Stress Test System Installation and Configuration Guide for more information. Note:

If you manually update patient information from the Report screen, this information is not updated in the patient profile in the worklist. However, updating patient information during Prepare or Pre Exercise does update the patient profile on the Select Patient from Worklist screen. Report Phase When stress testing enters the Report phase, you can edit various fields and data and then generate a final stress report. The final report is divided into several pages that include, for example, the report summary, trends, average QRS, events, and resting ECG. During the Report phase:

ST80i freezes the Recovery display while the study information is transferred to system storage. ST80i Stress Test System Instructions for Use 4-1 ST80i loads the Report of the final report. screen, so you can specify the parameters and format A real-time 11.5-second ECG is displayed in the lower-left section of the screen during Post-Recovery. Report Screen Post-Recovery During Post-Recovery, ST80i continues to monitor the patients ECG, configured notifications, and HR. Data is not saved unless an event is triggered, in which case the event data is saved as part of the final stress report. You can manually enter a BP or initiate a BP at a Tango NIBP device. To include a record of this BP in the final report, type it in the Narrative or Notes window. If you take a 12-lead ECG in this phase, it is saved as an event and included in the final stress report. Report Screen During the Report phase of the test, you work from the Report screen to review, update, and save the data for the final stress report, which you can then save, confirm, export, archive and/or print on preconfigured printers. You have the option to print the whole report or specify which individual sections to print and to change default printer settings. From the Report screen, you can also review or replay the exercise stress test and finalize (or confirm) the final report before export. As you prepare the final report on the Report screen, you can do the following:

Review the ECG Note:

If you change the J+ Point, all ST values are recalculated. Add or update patient information Print the individual events and delete extraneous events Review and edit final study data and make any necessary adjustments to the waveforms (for example, adjusting the J+ point) Review events Review the exam Prepare the patients final stress report Archive the patients stress report Save the report and export it, if appropriate 4-2 ST80i Stress Test System Instructions for Use Report Screen The Archive screen provides access to stored stress test results. All reports and study records are stored in the ST80i database and/or exported to servers or stored on the local system based on settings. Note:

When you click the Report button, the Archive screen appears. Each report is labeled according to its status:

Confirmed Unconfirmed For more information regarding archived reports, see Working with Archived Study Data on page 4-32. ST80i Report Screen Figure 4-1 A B C D E F Table 4-1 ST80i Report Screen Features Feature Description A B C Title Bar Where you enter or update patient information in the Patient Demographics window. Procedure Bar Report Status (Unconfirmed or Confirmed) and buttons:

Change J+, Save, Export, Print, Confirm, and Replay Report Tabs Summary, Tabular, Trend Graph, Averages, Events, Resting ECG, ST Comparison, Max ST, Full Disclosure, and Previous Study ST80i Stress Test System Instructions for Use 4-3 Report Screen Feature Description D E F Real-time 11.5-second ECG by selected lead ECG for one lead is displayed in the lower left section of the screen. Click on the lead label to change the selected lead. Two print options for the current ECG lead Print 12-Lead ECG Report and Start Rhythm Printing HR (bpm) and BP (mmHg) Shows the current heart rate of the patient and the patients last blood pressure taken before moving to the Report phase. You can obtain a current blood pressure by manually initiating a blood pressure reading from the NIBP device or manually entering the BP. Title Bar Figure 4-2 Title Bar From the Report screen, you can enter or update information about the patient by clicking the patient name in the title bar. If you did not fill in or update this information during the Pre Exercise phase, you can open the Pa-

tient Demographics window to update this information as necessary. For an explanation of the features of the title bar, see Title Bar on page 2-5. For instructions on editing patient information, see Edit Patient Information on page 3-6. Procedure Bar Figure 4-3 Procedure Bar Save the report Export the report On the procedure bar, you can:

Adjust the J+ Point Print the report Confirm the report Replay the ECG The blinking printer icon shows the number of print jobs currently in the queue for the report. 4-4 ST80i Stress Test System Instructions for Use Report Screen Change J+ Point The ST Measurement J+ Point is preconfigured in the user profile (Settings >

User Profile: Algorithm > J-ST (msec)). You can adjust the J+ Point value on the Report screen to re-analyze the stress test using a different measurement point. Once the J+ms value is modified, ST80i recalculates all related values and updates the corresponding displays on the Report screen. Note:

If you change the J+ Point, all ST values are recalculated. To modify the J+ Point setting and recalculate all ST values based on the new setting 1. On the procedure bar, click the plus (+) or minus () to change the value in milliseconds for J-ST. 2. Click Change J+ on the procedure bar. Save Use the Save button or press CTRL+S to save the report to the stress system database after you have finished updating and reviewing the report data. The system can be configured to automatically export when you save. The Save button saves an unconfirmed report; however, you can also use the Save button if you make changes to a confirmed report. Clicking the Save button after modifying a confirmed report makes the report unconfirmed. The report can then be confirmed again. Once a final stress report is saved, it can be exported. The report can be finalized and signed. The export status and date/time of last export are maintained. The stress study raw data is saved in the local stress study database. You can transfer the raw data:

To a different database, such as IECG version B.01 and later, for editing. To a DICOM Report Server. To a remote PC. where the data can be downloaded for review and editing using Remote Review. See Transferring Test Data to a Remote Review Location on page 4-38 for more information. Export Use the Export button to export your reports to remote sites that have been preconfigured in the Settings section of the application. When you export from the Report screen, the report is exported to all destinations set as defaults in Settings > System Settings > Remote Sites. ST80i Stress Test System Instructions for Use 4-5 Report Screen If no remote sites have been configured, or if Set as Default has not been configured for any remote site, you receive the following error message when you try to export from the Report screen: Error. No destination is selected. Please select a destination in Archive window! If this error appears, the report can still be exported, but you must go to the Archive window (by clicking Report from the Main screen) and then select a destination from the Transfer Destination list. To create remote sites, see the ST80i Stress Test System Installation and Configuration Guide. It is also possible to export a report directly to external media such as a USB flash drive in PDF or XML format. The final stress report in PDF format can be emailed to the referring physician from either the test system or the remote review system. For more information on exporting reports, see Exporting Reports on page 4-44. Print You can use the Print button on the procedure bar to print individual report sections or the final stress report. Before printing individual reports, you must select a printer type that has previously been configured in Settings. When using a laser printer, the grid can be set to print a grid on standard paper. Individual reports can be printed both before and after you save the report. The types of individual reports that can be printed include:

Patient ID Summary Trend Graphs Average QRS 12-Lead Resting ECGs Events (including manual ECG, manual event, stage report, RPE, arrhythmia, freeze) ST Comparison Max ST When printing a final stress report, you can choose which individual sections to include and the number of copies to print for each individual report. You can also print a complete final stress report. Regardless of settings, a patient ID report is always printed on the first page of a final stress report. Confirm Once you review and edit the results, you can then confirm the report before exporting. On the Archive screen, the study status is listed as follows:

Confirmed 4-6 ST80i Stress Test System Instructions for Use Report Screen Unconfirmed Note:

You must save the report before confirming. For more information regarding patient fields, see the section entitled Patient Information Management on page 3-3. When you confirm the report you are also saving the report. To confirm the report 1. Click Confirm in the procedure bar. The Confirm Report dialog box appears, with the current user name displayed in the User ID field. Note:

Technicians cannot confirm reports using their own log-in credentials; however, they can confirm reports on behalf of users with Administrator permissions. 2. If necessary, select a different user in the User ID field. For example, if you do not have Administrator access but you are authorized to confirm reports on behalf of an Administrator user, select the Administrators user name. 3. Type the user password in the Password field. 4. Click OK. Replay When you click the Replay button on the Report screen, you can review the entire exam, as run. The Replay button enables you to review a completed stress report that is either confirmed or unconfirmed. Note:

The Replay function replays from Pre Exercise through Recovery. Prepare is not included. You can also print a 12-Lead ECG or print a rhythm strip during the review of the study. This feature is beneficial if you wish to review a specific segment of the test. When replaying a test, you can:

Pause or stop the ECG stream Change the ECG waveform speed from real-time speed to sixteen times faster or half speed Move quickly to any point in the replay Print or reprint a 12-Lead ECG or rhythm strip for significant episodes ST80i Stress Test System Instructions for Use 4-7 Report Screen To replay the exercise stress test 1. Click Replay on the procedure bar. This brings you to ECG results that were recorded at the start of the Exercise phase. You can then view the exercise stress test by using the floating status bar that appears at the bottom of the ECG. This bar may be hidden. 2. To view the floating status bar, sweep your pointer over the lower part of the waveform area. Figure 4-4 Floating Status Bar 3. Click the Play button on the floating status bar to begin the replay from Pre Exercise. Each stage change or phase change is color-coded with a dark or light blue. The slider control moves across the status bar to show the replays progress. As it moves, the time is displayed to the right showing both elapsed and end time. The changing colors along the status bar represent stage and phase changes. You can hover your cursor over the status bar to identify the exact time, phase, and stage of any point in the replay. To move quickly to any point in the replay, click on the desired location on the status bar or drag the slider control to the desired location. These features work in either Play or Pause mode. From Pause mode, click the Play button to resume the replay from the desired location. Figure 4-5 Floating Status Bar Features To pause the replay, click the Pause button. The replay remains at the elapsed time that was displayed when it was paused. Click the Play button to resume the replay from the moment it was stopped. To decrease the speed of the replay, click the Decrease Speed button. The default replay speed is 1X. You can decrease the replay speed to 0.5X. To increase the speed of the replay, click the Increase Speed button. The default replay speed is 1X. You can increase the replay speed to 2X, 4X, 8X, or 16X. 4. To hide the floating status bar, sweep your pointer away from the lower part of the waveform area. At any time during the Replay of the exercise stress test, you can print an ECG or Rhythm Strip. Click the Print ECG button for a 12-Lead ECG. Click the Rhythm Print button for a rhythm strip. Once you have replayed the ECG, you can return to the Report screen. To return to the Report screen 4-8 ST80i Stress Test System Instructions for Use Report Screen 1. Click the Report button in the upper-right corner of the screen. The End Replay notification appears. 2. Click OK to return to the Report screen. Real-Time ECG for One Lead On the bottom of the Report screen, real-time patient data is still captured for one lead. You can change the lead by using the lead label drop-down menu to the left. Note:

Real-time ECG for one lead is visible on the Report screen immediately after the stress test. If the report is saved and you view it later, this area of the Report screen is empty. Figure 4-6 Lead Label List To change the lead 1. Click the lead label. The lead label list appears. 2. Select the lead you want to see. The system redisplays the real-time ECG, showing the lead you selected. Print Options Start Rhythm Printing At the bottom of the screen, to the right of the real-time ECG, are two print options for the current lead in view:

Print 12-Lead ECG Report When you click the Print 12-Lead ECG Report button, you get a printout of that segment of the ECG. When you click the Start Rhythm Printing button, a rhythm strip begins printing. To turn off rhythm printing, click this button again. ST80i Stress Test System Instructions for Use 4-9 Final Stress Report Overview Current Heart Rate and Blood Pressure The current heart rate of the patient and the patients last blood pressure taken before moving to the Report phase are displayed on the bottom right section of the Report screen. Final Stress Report Overview Exercise The final stress report is based on data gathered during the last four phases of an exercise stress test:

Pre Exercise Recovery Report (including Post-Recovery) The final stress report includes the patient information summary, trends, average QRS, resting ECG results and events. ST80i allows you to choose several individual reports to include in the final stress report. Along with the Patient ID report, which is included in all reports, the composition of a stress report may or may not include the following:

Average QRS Report Summary Report (including Tabular and ST Analysis) Trends Report 12-Lead ECG Report (interpretation and measurements are displayed and printed according to user configuration) Events Report ST Comparison Report Max ST Report After finishing the data acquisition, stress testing enters the report-

generating phase. Once signed by a cardiologist or clinician, the report is finalized. After a stress test procedure, you work from the Report screen to review, update, and save the data for the final stress report. When the report is satisfactory, you can print the individual sections on a laser printer or directly to a thermal printer when printing from ST80i. Data from the Recovery phase is included as part of the final report. In the post-recovery period of the Report phase, the data is not saved unless an event is triggered or a manual ECG is captured. In this case, only the event data or the 12-lead ECG is saved as part of the final report. 4-10 ST80i Stress Test System Instructions for Use Report Screen Tabs WARNING ECG signals printed on a laser printer should not be used to make time-sensitive measurements directly from the printed page. Summary Report Trends Report Each section is configured to print or not to print in a final stress report except the Patient ID section, which is the minimum printed page in a final stress report. It is printed as the first page of the final stress report. You can configure the following to be included in or omitted from the final stress report. The setting for each can be changed from the Report screen. Average QRS Report Max ST Report You can reprint each report manually. You can also specify the number of final report copies to print. In addition, you can specify the printer to send the final report copies and whether or not to have the grid visible. Events Report (If Events is configured, you can select which events to include.) 12-Lead ECG Report (Resting ECG) ST Comparison Report Report Screen Tabs Summary Tabular Trend Graph The sections of the final report are displayed as tabs on the Report screen. The tabs contain the patient's ECG data in a variety of formats:

Averages Resting ECG Max ST Full Disclosure Previous Study The following sections describe each report tab. ST Comparison Events ST80i Stress Test System Instructions for Use 4-11 Report Screen Tabs Summary Tab Study information including test protocol and exercise time. The Summary tab includes:

Clinical information including, for example, the reason for the test and the reason to end the test, the number of PVCs, Risk scores, free-text entry of narrative summary notes, and Max values for BP, ST, and METs HR.You can override the clinical values presented. When you change the values, they appear dark red and italic. On the Summary tab, you can include your comments about the test, along with the Reason for End and Symptoms. All values included are based on data captured during each stage of the exercise stress test. Figure 4-7 Summary Tab The screen is divided into four sections:

Summary The Summary region shows:

- Total exercise time

- Maximum treadmill speed and grade (or ergometer power) achieved during test

- Max grade

- ECG leads that presented more than 100 uV (or 1 mm) of ST elevation or depression during test

- PVCs (count)

- Functional Aerobic Impairment (FAI%)

- Angina menu enabling you to select Unknown, None, Non-Limiting, or Limiting

- Duke Score (treadmill only) Note:

Functional Aerobic Impairment, Angina, and Duke Score do not appear unless Risk Score Calculation is enabled in Settings. 4-12 ST80i Stress Test System Instructions for Use Report Screen Tabs If the Event (Standing or Supine) is not configured as the Reference ECG, the Summary Report does not include the reference HR and BP. Max Values The Max Values region shows:

- Maximum heart rate

- Percentage of maximum predicted heart rate attained

- Maximum metabolic equivalents (METS)

- Maximum Double Product (HR * BP)

- Blood pressures for which both the maximum systolic and maximum diastolic blood pressures were achieved

- Maximum SpO2 percentage Max ST Measurements The Max ST Measurements region shows:

- Absolute ST Elevation and ST Depression times and leads

- Amount of ST Elevation and ST Depression change

- ST/HR Index Note:

Patients may already have ST elevation or depression before exercise begins. It is important for the clinician to see how much change occurs during exercise. Comments In the Comments section, you can:

- Update the comment fields:

Narrative Insert final assessments about the patient and/or test. You can either click the down-arrow to access pre-defined narrative templates, or type directly in the comments field. If you select a pre-

defined template, click Insert to insert the template content into the Narrative field. If you type directly into the Narrative field, there is no limit to the amount of text you can type. If the Narrative text is longer than the printed report area, additional pages are printed for the additional text. For information about creating templates, see the ST80i Stress Test System Installation and Configuration Guide. Reason for End Update the Reason for End using the up and down arrow buttons, as well as the Del and Add buttons. Use the up and down arrows to rearrange the order of the selections in the field. Use the drop-down list below Reason for End to add selections to the Reason for End field. Either type a reason directly in the drop-down box or select a reason from the drop-down list and then click Add to add the selection to the Reason for End field. To remove a selection from the Reason for End field, highlight the selection and click Del. The Reason for End field is limited to five items, with 70 characters per line. ST80i Stress Test System Instructions for Use 4-13 Figure 4-8 Reason for End Field Report Screen Tabs Note:

The system displays vertical and/or horizontal scroll bars in the Reason for End field when necessary. Symptoms Update the Symptoms using the up and down arrows, as well as the Del and Add buttons. Use the up and down arrows to rearrange the order of the selections in the field. Use the list below Symptoms to add selections to the Symptoms field. Either type a symptom directly in the drop-down box or select a symptom from the drop-down list and then click Add to add the selection to the Symptoms field. To remove a selection from the Symptoms field, highlight the selection and click Del. The Symptoms field is limited to five items, with 70 characters per line. Figure 4-9 Symptoms Field Note:

The system displays vertical and/or horizontal scroll bars in the Symptoms field when necessary. To print the Summary Report 1. Click Save on the procedure bar, or press CTRL+S, to save the report. 4-14 ST80i Stress Test System Instructions for Use Report Screen Tabs 2. Click Print on the procedure bar. The Quick Print Settings dialog box appears. See Print Button (Quick Print Settings Dialog Box) on page 4-28 for details. 3. Select a printer from the list. 4. Click Summary. The Summary Report prints from the selected printer. Note:

The Tabular Report automatically prints as the Summary Table section of the Summary Report. This section is included in every report. Tabular Tab Time Speed/Power The Tabular tab displays the following tabular data for the Pre Exercise phase, the Exercise phase, and the Recovery phase by stage or by minute:

Grade Max HR BP (Sys/Dia) METs HR*BP (Double Product) SpO2 ST values per lead Figure 4-10 Tabular Tab Data from the Tabular tab is automatically printed as the Summary Table section of the Summary Report. It cannot be printed as a separate Tabular Report. ST80i Stress Test System Instructions for Use 4-15 Trend Graph Tab Report Screen Tabs The Trend Graph tab displays the following graphs:

Heart Rate Blood Pressure (Systolic, Diastolic, and SpO2) METS/Double Product (HR*BP) Speed/Grade of the Treadmill (or data from the Ergometer) Trends by lead for ST Level and ST Slope (use the right and left arrows to scroll) To review the leads to the right, use the right arrow button. Figure 4-11 Trend Graph Tab To print the Trend Graph Report 1. Click Save on the procedure bar, or press CTRL+S, to save the report. 2. Click Print on the procedure bar. The Quick Print Settings dialog box appears. See Print Button (Quick Print Settings Dialog Box) on page 4-28 for details. 3. Select a printer from the Printer list. 4. Click Trends. The Trend Graph Report prints from the selected printer. Averages Tab The Average Beat Complexes Report is an overview of median morphologies by stage or by minute that are configurable before and after the stress test. For more information, refer to Configuring Print Settings in the ST80i Stress Test System Installation and Configuration Guide. This report includes:

Report title and patient demographic data Averages and ST values for all twelve leads for each phase, including Pre Study information Exercise and Recovery 4-16 ST80i Stress Test System Instructions for Use Report Screen Tabs Figure 4-12 Averages Tab Use the radio buttons on the Averages tab to select whether to print the report by stage or by minute. To print the Averages Report 1. Click Save on the procedure bar, or press CTRL+S, to save the report. 2. Click Print on the procedure bar. The Quick Print Settings dialog box appears. See Print Button (Quick Print Settings Dialog Box) on page 4-28 for details. 3. Select a printer from the Printer list. 4. Click Average QRS. The Averages Report prints from the selected printer. Events Tab On the Events tab, you can review, relabel, and print rhythm events. You can select the events to include in a printed report. You can also delete events that you do not want to include in the final stress report. Events can be deleted one at a time or in multiples. The Events tab displays snapshots of all events, captured arrhythmias, and RPE scale selections acquired during the stress test, including events manually captured during the stress test by selecting an item from the Events menu. Event snapshots are displayed in groups of up to six events at a time. Use the right and left arrow buttons to display the next and previous sets of six. ST80i Stress Test System Instructions for Use 4-17 Figure 4-13 Events Tab Report Screen Tabs 12-Lead ECGs that are printed during the Pre Exercise, Exercise, and Recovery phases are included with the Events Report. The Start Exe event does not print during the stress test but it does appear on the Events tab. The Peak Exe event does print during the stress test. The Events tab includes a List All button that opens the All Events window. In this window, rhythm events are listed according to type, as defined by six tabs. You can use the All Events window to view lists of all events and to select events to include in printed reports. Figure 4-14 All Events Window On the Events tab, you can:

Review rhythm events for all captured events (for example, Chest Pain, Hyperventilation, Shortness of Breath, Ventricular Tachycardia, Bigeminy, Trigeminy, and so on), arrhythmias, and RPE scale selections acquired during the entire stress test. Review 12-Lead ECGs printed during the Pre Exercise, Exercise, and Recovery phases that are included with the Rhythm Events. Print individual events using the Print button on the Events tab. 4-18 ST80i Stress Test System Instructions for Use Report Screen Tabs Relabel events. Select events to include when you print an entire report using the Print button on the procedure bar. These selections do not affect the events configured to be included in the final PDF report. You can select events from the snapshot view or from the All Events window. Delete one event or multiple events. To delete multiple events, press CTRL and select the events to delete. The Delete button displays the number of selected events. To review rhythm events 1. Click the Events tab. Alternatively, click the List All button to open the All Events window, where events are listed by type: Manual ECG, Stage, Arrhythmia, Manual Event, RPE, and Freeze. 2. Double-click anywhere in an event snapshot or on an event in the All Events window to display an expanded view of that event. Figure 4-15 Expanded View of an Event Note:

The expanded view of events shows filtered data by default. To view unfiltered data (only for events created during the Exercise and Recovery phases), click to deselect Filter On. 3. Review the event. 4. Click the X in the upper-right corner to close the window. 5. If you used the All Events window, click the X in the upper-right corner to close it. ST80i Stress Test System Instructions for Use 4-19 Report Screen Tabs Note:

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 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 system fails to provide a notification. It is expected that only properly trained health care professionals working directly under the supervision of a qualified physician will be operating the ST80i Stress Test System during testing. To relabel an event 1. Click anywhere in an event snapshot to highlight the event you want to relabel. 2. Click Relabel. The Event Note dialog box appears. 3. Type a description of the new label for the event. 4. Click OK. 5. The event displays the new label in the lower left corner. To print an individual event 1. Click anywhere in the Event snapshot to highlight the event you want to print. 2. Click the Print button in the Events tab. Note:

The Print button on the procedure bar is used to print the full report or select sections of the final report. To select events to include in a printed report, for each event you want to include in the printed report, do either of the following:

Click the icon in the upper right of the event snapshot: The icon changes to a green check mark.

- Click List All to open the All Events window, click the tab containing the event you want to select, and select the check box to the left of the event. To select all events on a tab, click Print at the top of the check box column. Note:

Selecting an event in snapshot view causes the event to also be selected in the All Events window, and vice versa. 4-20 ST80i Stress Test System Instructions for Use Report Screen Tabs To delete one or more events 1. Click anywhere in an event snapshot to highlight the event you want to delete. To select more than one event, press CTRL while you select. The Events tab displays snapshots of up to six events at a time. Use the right and left arrow buttons to display the next and previous sets of six. When selecting multiple events, you can select only from the six currently displayed events. The Delete button displays the number of events you have selected. 2. Click the Delete button to delete the selected events. A warning appears, asking if you are sure you want to delete the event or events. 3. Click Yes to confirm deletion. All deleted events are removed from the list. Resting ECG Tab Note:

This information applies to resting/supine ECGs taken during the Pre Exercise phase of a stress test. It does not apply to ECGs captured with the optional Resting ECG Workflow feature. See Chapter 5, Resting ECG Workflow. Measurement and interpretation for either Supine or Mason-Likar resting ECGs are included as part of a 12-Lead ECG report only during the Pre Exercise phase when a Supine or Mason-Likar event is selected and the user has selected Enable DXL Algorithm in Settings > User Profile > Algorithm. The 12-Lead ECG is printed according to the user profile settings. A resting ECG can be printed at the beginning of each exercise stress test and is included in the final stress report. Figure 4-16 Resting ECG Tab The Resting ECG tab shows reports of ECGs of Supine and Mason-Likar events. At the top of the report, patient data as well as ECG data appears with interpretation. ST80i Stress Test System Instructions for Use 4-21 Report Screen Tabs The report includes:

Patient Demographic Data Study Information Interpretation of 12-Lead ECG Report 12x1, 6x2, 3x4, 3x4 3R display Caution Specific patient data is required for each interpretation. If patient data such as DOB or gender is edited, the ECG is reinterpreted and updated based on the new data, You can configure mandatory patient information fields in system configuration. When these mandatory fields are missing, you are warned with a pop-up message box. If the values in the age and/or gender fields are changed, a warning message pops up and the resting ECG is re-interpreted. On this screen, you can scroll through the images on the screen using the right and left arrows. You can also print a resting ECG using the Print button on the Resting screen. ST Comparison Tab The ST Comparison tab displays the average ST values captured for all 12 leads at the following points in the test:

Baseline Average beats for one baseline. By default, the baseline is the first event during the test. You can specify a different baseline from the menu of events above the Baseline image. All events printed during the test are included in this menu. Peak Exercise Average beats at peak exercise, which is the point at which the test advances from Exercise phase to Recovery phase. Worst Case Average beats when maximum ST is reached. Maximum ST is the greatest ST elevation or ST depression measured during the test. Test End Average beats at the end of the Recovery phase. 4-22 ST80i Stress Test System Instructions for Use Report Screen Tabs Figure 4-17 ST Comparison Tab Max ST Tab The Max ST tab displays the 5-second 12-lead ECG at the point in the test when the maximum ST elevation or ST depression was measured. Average beats for each lead are displayed to the right of the ECG. Figure 4-18 Max ST Tab Full Disclosure Tab On the Full Disclosure tab, the entire ECG waveform results of the stored stress tests, from Pre Exercise through Recovery, are loaded for full disclosure review. Note:

If you are reviewing an exam performed with a software version prior to A.01, the waveform and progress bar begin with the start of the Exercise phase rather than the Pre Exercise phase. ST80i Stress Test System Instructions for Use 4-23 Figure 4-19 Full Disclosure Tab Report Screen Tabs To view an ECG for the whole exam or a moment in time, use the slide bar and arrow buttons at the bottom of the screen. Each screen holds 18 seconds of data. Figure 4-20 Full Disclosure Tab Slide Bar and Arrows The start time of the portion of the ECG being displayed is noted in the bottom left corner of the waveform screen. The end time of the ECG is noted in the bottom right corner. The changing colors along the status bar represent stage and phase changes. You can hover your cursor over the status bar to identify the exact time, phase, and stage of any point in the exam. To move quickly to any point in the exam, click on the desired location on the status bar or drag the slider control to the desired location. Clicking and dragging the slider control changes the time frame being reviewed. You can also click the left and right arrow buttons to advance backward and forward in the ECG. In addition, you can also create new events while reviewing the Full Disclosure Report. To create a new events, you use your mouse to place an event marker. To capture the intended event and make it visible in the ECG report, the marker must be placed a specific number of seconds following the actual event. The ECG Event format configured in Settings determines the event marker placement delay. The Standard format is 3X4 with one or two rhythm leads. In this format there are four leads groups, each providing 2.5 seconds of ECG. Each leads group requires a different delay, as shown in the following table. 4-24 ST80i Stress Test System Instructions for Use Saving the Final Stress Report Table 4-2 Event Marker Placement Delay for a 3x4 Layout Leads Group Placement Delay I. II. III 10 to 7.5 seconds aVR, aVL, aVF 7.5 to 5 seconds V1, V2, V3 V4, V5, V6 5 to 2.5 seconds 2.5 to 0 seconds As another example, for 6x2 format, there are two groups of six leads each. Each group in this case displays 5 seconds of ECG for a total of 10 seconds. Therefore, the delay after the event would be 10 to 5 seconds for the first groups and 5 to 0 seconds for the second group. To create a new event during the review of the Full Disclosure report 1. Press and hold the left mouse button for a few seconds on the intended maker location inside the waveform area of the Full Disclosure tab. The marker should be placed a specific number of seconds following the event you want to capture. See Table 4-2 on page 4-25 for an example of appropriate event marker placement delays. Release the left mouse button. The Add New Event dialog box appears. Note:

If you press and hold the left mouse button anywhere within the first 15 seconds of the waveform area, a pop-up message states, Cannot add events in the first 15 seconds. 2. Type a description of the event. 3. Click OK. The newly created event is added to the Events tab and saved to the database. You can then print the event. To print the event 1. Click the Events tab. The Events tab displays up to six events at a time. Use the right and left arrow buttons to display the next and previous sets of six. 2. Click to select the event you created. 3. Click the Print button in the Events tab. Saving the Final Stress Report Typically, the final stress report comprises a summary and/or narrative summary page that includes patient name and ID, date of exam, exercise time, maximum HR/ST/BP values, Duke score, FAI%, reasons for ending the ST80i Stress Test System Instructions for Use 4-25 Printing Reports test, symptoms, conclusions, diagnosis, reviewing physician, and real-time ECG. The final stress report is created by the reporting application as unconfirmed or confirmed (finalized) by a cardiologist or clinician. When you finish updating and reviewing the report data, you can save the final stress report to the stress system database. After you save a stress test, the tests status is listed as Unconfirmed on the Archive screen. To save the Final Stress Report, click Save on the procedure bar, or press CTRL+S. The stress test contains the PDF report and can be exported. The Report screen is still displayed. Note:

If the patient is still being monitored when you save the report, and another event occurs after you save, you must save the report again before you can print it. You can now print the final report from the Report screen. Printing Reports On the Report screen, there are three options for printing reports:

Print (Quick Print Settings) button on the procedure bar Print button on the Resting ECG tab and the Events tab Post Recovery ECG (two print buttons to the right of the ECG waveform) The printers, for printing individual reports or the final stress report, are preconfigured in the Settings section of the application. However, the printer default settings and the Print Grid check box (if you are using a laser printer) can be changed on the Report screen. You can also preconfigure the print settings to add your facility logo and site information to the final stress report. The seven main report sections that comprise the final stress report are preconfigured with specific settings as part of the user profile in the Settings section of the application. Summary Report Trends Report 12-Lead ECG Report Average QRS Report Events Report (including manual ECG, manual event, stage report, RPE, arrhythmia, freeze) ST Comparison Max ST 4-26 ST80i Stress Test System Instructions for Use Printing Reports Printer Configuration on page 4-27 provides a general overview of printer configuration options. Printer Configuration on page 4-27 provides basic information about print report settings. See the ST80i Stress Test System In-

stallation and Configuration Guide for more information on how to preconfigure printers, add your facility logo, or preconfigure reports for the final stress report. Printer Configuration ST80i supports the following printer options:

Thermal printer You can print only on the device. The optional thermal printer supports all printing formats, including resting ECG auto/rhythm printing and stress ECG report printing. Laser printer You can print locally on the device to which a laser printer is attached or through the network to a remote laser printer. The laser printer supports all printing formats. If the printer is networked, the network connection is disabled while the treadmill or ergometer is running. Remote printers If ST80i is set up to connect remotely to a default laser printer, this printer path needs to be set up first. The remote printers support all formats except for continuous/real-time printing. The default printer is configurable in the Settings section of the application. However, you can manually change the settings on the Report screen using the Print (Quick Print Settings) button. The grid can also be selected under the Print function on the Report screen. Printed reports provide a calibration pulse on printed waveform reports for an added check on print speed and amplitude accuracy. WARNING ECG signals printed on a laser printer should not be used to make time-sensitive or amplitude-sensitive measurements directly from printed page. You are expected to provide power for the laser printer from a source other than the ST80i isolation transformer in order to be in compliance with your facility's safety requirements or IEC 60601-1. The All-in-One PC, thermal printer, desk light, and NIBP/SpO2 module must be plugged into medical isolation transformer provided with the stress system. During the exercise stress test, ST80i supports several kinds of printing, including:

Resting 12-Lead ECG report (with or without interpretation) Manually generated 12-Lead Stage printout (without interpretation) Event printout (without interpretation) ST80i Stress Test System Instructions for Use 4-27 Real-time rhythm printing Printing Reports ST80i produces an interpretive report if DXL is enabled and a Supine Event is selected during Pre Exercise. The interpretive components are printed at the top of an ECG record. The interpretive report components consist of:

Global ECG measurements: Heart Rate, PR Interval, QT Interval and QTc, Frontal Plane P, QRS and T axis Interpretive statements (left-hand side) Severity label Reasons (right-hand side) All the interpretation components are stored in the ECG file. For information about preconfiguring print report settings, see the ST80i Stress Test System Installation and Configuration Guide. Print Button (Quick Print Settings Dialog Box) From the Report screen you can print individual reports as well as the final stress report. Clicking the Print button opens the Quick Print Settings dialog box, where you can override some preconfigured settings as follows:, On the Report screen, clicking the Print button opens the Quick Print Set-

tings dialog box, which you can use to override certain preconfigured print settings and then print individual reports or the final stress report. 4-28 ST80i Stress Test System Instructions for Use Printing Reports Figure 4-21 Quick Print Settings Dialog Box Print Options In the Print Options section of the Quick Print Settings dialog box. you can override the following preconfigured settings either for individual reports or for the final report:

Printer Print mode (by stage, by minute, or by both) Print Grid (selected or cleared) Quick Print In the Quick Print section of the Quick Print Settings dialog box, you can click to print any of the following individual reports:

Patient ID Summary Trends Average QRS, Resting ECG (for a resting ECG captured during Pre Exercise phase of a stress test, not one captured using the optional Resting ECG Workflow feature) Rhythm Events ST Comparison ST80i Stress Test System Instructions for Use 4-29 Max ST Print Final Report Printing Reports Summary Trends 12-Lead ECGs ST Comparison In the Print Final Report section, you can select the number of copies to print for each of the following sections of the final report:

Average QRS Rhythm Events Max ST To exclude a section from the report, select 0 (zero) for that section. A Patient Data section is always printed at the beginning of each report; you cannot exclude it. If de-identify is preconfigured in Settings, you can de-identify or hide patient names on all final reports before printing. You can also de-identify individual reports from the Archive screen. See De-Identifying Tests Using the Back Up Function on page 4-40 for details about how to protect a patient's confidential information when printing individual and final patient reports. Printing the Final Report Summary Report Trends Report 12-Lead ECG Report (Resting or Supine) By default, the final stress report includes:

Average QRS Report Max ST Report To print the final stress report 1. On the Report screen, click Print. Events Report 12-Lead ECG Report ST Comparison Report The Quick Print Settings dialog box opens. The Print Options.section displays the preconfigured settings for printer, print mode, and grid printing. You can change these settings, as described in steps 2, 3, and 4, or leave the defaults. 2. Select a different printer from the list. 4-30 ST80i Stress Test System Instructions for Use Printing Reports 3. Select a different print mode:

Stage Minute Both 4. Select or clear the Print Grid check box if you want the grid to print or not 5. print on laser paper. In the Print Final Report section, select the number of copies to print for each report, using the minus () and plus (+) indicators. To deselect a report, make the number of copies zero (0). 6. Click Print. Note:

All timestamps on the final reportexcept for 12-Lead ECG timestamps represent the time that has elapsed since the beginning of the Exercise phase. 12-Lead ECG timestamps represent the ECG acquisition time. For more information on the configuration of printers, see Printer Configuration on page 4-27. Printing Individual Reports You can print individual reports from the Report screen. To print an individual report 1. On the Report screen, click Print. The Quick Print Settings dialog box opens. The Print Options.section displays the preconfigured settings for printer, print mode, and grid printing. You can change these settings, as described in steps 2, 3, and 4, or leave the defaults. 2. Select a different printer from the list. 3. Select a different print mode:

- Stage

- Minute

- Both 5. 4. Select or clear the Print Grid check box if you want the grid to print or not print on laser paper. In the Quick Print section, click the button for the report you would like to print

- Patient ID

- Summary

- Trends ST80i Stress Test System Instructions for Use 4-31 Working with Archived Study Data

- Average QRS

- Resting ECG (This is for a resting ECG captured during Pre Exercise phase of a stress test, not one captures using the Resting ECG Workflow product option.)

- Rhythm Events

- ST Comparison

- Max ST Post-Recovery ECG Printing The two print options at the bottom of the Report screen are used to print the current lead (or any lead you select) during Post-Recovery. Print 12-Lead ECG Report Start Rhythm Printing Figure 4-22 Print Options When you click the Print 12-Lead ECG Report button, you get a printout of that segment of the ECG. When you click the Start Rhythm Printing button, a rhythm strip begins printing. To turn off Rhythm Printing, click this button again. Working with Archived Study Data The test database (archive) is a repository for storage of and access to study data. All stored studies can be reviewed. Archived studies can be loaded from the local ST80i archive or restored from a local or network share to the ST80i local archive. For each stress test (and each resting ECG if you have the Resting ECG Workflow product option installed), a database entry is generated to archive patient demographics, reports, and full disclosure data. Together with this study data, also saved into this database are patient information, the events captured during the testing, protocol settings, and the algorithm output. The final report can be exported and stored. The study database stores all archived data from stress tests. If you have the Resting ECG Workflow product option installed, it also stores data from resting ECGs captured using that option. 4-32 ST80i Stress Test System Instructions for Use Working with Archived Study Data To display the patient test database, click Report on the Main screen. The Ar-

chive screen appears. Figure 4-23 Archive Screen The Archive screen provides access to all archived stress studies. If you have the Resting ECG Workflow product option, the Archive screen also provides access to the archived resting ECGs captured with that feature. On the Archive screen, you can:

Display a list of archived tests according to patient names or date/time categories. Search for patient studies. Confirm or unconfirm patient studies. Export patient study data as a PDF report, XML, SR (DICOM Structured Report), or raw study data (PDR). Export destinations and formats are preconfigured in Settings > Remote Sites, as described in the ST80i Stress Test System Installation and Configuration Guide. Transfer patient study data to a remote review location. Delete one or more stored patient studies (Administrator users only). Back up patient studies to another location (Administrator users only). Restore patient studies from another location (Administrator users only). View patient studies. Download patient studies at a remote review location. Replay patient studies. Note:

For archived ECGs captured using the optional Resting ECG Workflow feature, you can do all of the above except:

ST80i Stress Test System Instructions for Use 4-33 Working with Archived Study Data Confirm and unconfirm. Replay. Export as raw data. Export to and download at a remote review location. When you select an archived ECG to view, the ECG opens in a dialog box from which you can update patient data, print, export, or save the report. For details, see Table 5-3, Resting Procedure Bar Features, on page 5-4. Displaying the List of Archived Studies You can display the list of archived studies by patient or by date/time category. The archive list is divided into a left and a right pane. If you have the Resting ECG Workflow product option, the archive list includes all resting ECGs captured and saved with that feature. By default, the left pane lists the names of all patients for whom studies have been archived, and the right pane displays all archived studies for the patient selected in the left pane. Note:

Until you select a patient in the left pane, the right pane lists all studies for the patient with the most recently completed stress test. Figure 4-24 Archive List Displayed for a Selected Patient Left Pane Right Pane You can change the archive list so that the left pane displays date/time categories. When you do, the right pane lists all studies in that category. 4-34 ST80i Stress Test System Instructions for Use Working with Archived Study Data Note:

Until you select a date/time category in the left pane, the right pane lists all studies in the category that contains the most recently archived study. Figure 4-25 Archive List Displayed for a Selected Date/Time Category The following table describes the time periods covered by each Begin Date/

Time category. Table 4-3 Date/Time Categories Begin Date/Time Description Today Yesterday This week Last week Earlier this month Last month Earlier this year Studies saved today Studies saved yesterday Studies saved within the current calendar week

(starting on Sunday), including yesterday and today Studies saved during the previous calendar week Studies saved during the current calendar month, not including this week or last week Studies saved during the previous calendar month Studies saved during the current calendar year, not including this month and last month Last year Studies saved in the previous calendar year A long time ago Studies saved before the previous calendar year The Left Pane of the Archive List In the left pane of the archive list:

ST80i Stress Test System Instructions for Use 4-35 Working with Archived Study Data Items associated with regular Stress tests are grouped under the Stress icon. Items associated with the optional Resting ECG Workflow feature (if you have it) are grouped under the Resting icon The lists in the left pane are expanded by default. You can click the Stress or Resting icon or the double up-arrow to collapse a list. The number to the right of the Stress and Resting icons indicates the number of items (patient names or date/time categories) in that group. The Right Pane of the Archive List In the right pane of the archive list:

Last Transfer Date/Time You can select the check box to the left of any report to select that report You can click Select at the top left of the pane to select or deselect all tests. You can click any of the following column headings to sort the list by that column:

- Patient ID

- Test Status Confirmed or Unconfirmed

- Destination

- Begin Time

- End Time

- Patient Name

- Gender

- Date of Birth

- Commitment Status

- Proxy Commitment Status You can use the scroll bars to scroll right to view all columns, or down to view all listed tests. If the number of listed studies exceeds 50, navigation controls below the archive list become active. You can click the first page, last page, next page, or previous page button, or type a page number you want to display. Changing How the Archive List Is Displayed You can display the archive list in a number of different ways. To change the archive list display from Patient to Begin Date/Time 1. Click Patient at the top of the left pane. 2. In the menu that opens, click Begin Date/Time, 4-36 ST80i Stress Test System Instructions for Use Working with Archived Study Data The list in the left pane shows date/time categories rather than patient names. The right pane lists all studies archived for the selected date/time category. To list all archived stress studies for a patient, with the left pane set to display patient names, click a patient name below the Stress icon. All archived stress studies for the selected patient are listed in the right pane. To list all archived resting ECGs for a patient if you have the Resting ECG Workflow product option, with the left pane set to display patient names, click a patient name below the Resting icon. All archived ECGs for the selected patient are listed in the right pane, To list all archived stress studies within a particular date/time category, with the left pane set to display date/time categories, click a category below the Stress icon. All archived studies within the selected date/time category are listed in the right pane. To list all archived resting ECGs within a particular date/time category if you have the Resting ECG Workflow product option, with the left pane set to display date/time categories, click a category below the Resting icon. All archived ECGs within the selected date/time category are listed in the right pane. Searching for Patient Tests The Archive screen enables you to search for patient tests to confirm/

unconfirm, export, transfer to a remote review location, delete, back up, restore, view, download from a remote review location, or replay. You can search for tests using the Search text box and button. Note:

If you have the Resting ECG Workflow product option, the search results will include all resting ECGs captured and saved with that feature. To search for tests using the Search text box and button 1. Type the search criteria into the text box to the left of the Search button. You can use the Patient ID, Patient Last Name, or Patient First Name as search criteria. 2. Click Search. The Archive screen displays only the results that match the search criteria. To sort the archived reports using column headings, click a column heading

(for example, Test Status) to sort archived patient tests. ST80i Stress Test System Instructions for Use 4-37 Working with Archived Study Data The Archive screen sorts the contents of that column in ascending or descending order. Click the column heading again to reverse the sorting order. To search for tests in a different archive, select an archive from the Select Ar-

chive menu. Test data stored in the selected archive can be searched for by patient ID, first name, or last name. Once you find and download the desired tests, they appear in the archive list. Confirming a Test Any user with confirmation privileges can confirm a report, Note:

Resting ECGs captured with the Resting ECG Workflow product option cannot be confirmed in ST80i. To confirm a patient test 1. Select one or more patient tests to confirm by selecting the check boxes in the Select column to the left of the Patient ID. 2. Click Confirm on the procedure bar. The Confirm Report dialog box appears, with the current user name displayed. If necessary, select a different user. 3. 4. Type the user password. 5. Click OK. The Test Status for the selected test(s) changes to Confirmed. Exporting Test Data For information about exporting test data, see Exporting Reports on page 4-44. Transferring Test Data to a Remote Review Location This optional feature allows you to transfer patient stress tests to a location

(database) from which they may be downloaded to a PC that is not connected to the ST80i Stress Test System. See Downloading Test Data at a Remote Review Location on page 4-43 for details. Note:

ECGs captured with the Resting ECG Workflow product option cannot be transferred to remote review locations. 4-38 ST80i Stress Test System Instructions for Use Working with Archived Study Data Transferring test data to a remote review location removes the test data from your stress test database. This feature requires the purchase of option D57. In addition, the remote review site must be configured under Settings > System Settings > Remote Sites on both the stress test system and the remote PC. For more information, consult the ST80i Stress Test System Installation and Configuration Guide. Deleting Tests If you have administrative privileges, you can select single or multiple stress tests to delete. When doing this, you are warned about the potential data loss. When deleting multiple tests, you can also cancel the operation to stop the delete process. Note:

If you have the Resting ECG Workflow product option, you can delete any ECG captured and saved with that feature. To delete tests 1. Select one or more patient tests or ECGs to delete. To select all tests, click the Select column heading. 2. Click Delete. The Delete Report dialog box appears. 3. Type your password and click OK. The Delete Selected Reports confirmation appears. WARNING This procedure permanently deletes the tests (raw data and metadata) from the local database. 4. Click OK to confirm deletion of the test(s) or click Cancel to exit. Backing Up Tests If you have administrative privileges, you can select single or multiple stress tests to back up to another location, including an external storage location

(such as removable hard disk or USB flash drive). The Back Up function also supports providing data to the factory for troubleshooting. Note:

If you have the Resting ECG Workflow product option, you can back up ECGs captured and saved with that feature. ST80i Stress Test System Instructions for Use 4-39 Working with Archived Study Data Once the stress test data has been backed up, you can delete it from the Ar-

chive screen. If you have the Resting ECG Workflow product option, you can back up resting ECGs in the same manner as stress tests. To back up tests 1. Select one or more patient tests or ECGs to back up. Note:

To select ALL tests, click the Select column heading. 2. Click Back Up. The Back Up Report dialog box appears. 3. Click Browse. The Browse For Folder window appears. 4. Browse to select the location for the backup. 5. Click OK. The Backup Reports confirmation appears. 6. Click OK. The selected test(s) are backed up to the specified location. De-Identifying Tests Using the Back Up Function You can use the Back Up function in the Archive screen to de-identify individual reports on the system. This method is primarily used by Support to get all necessary files for analysis and investigation. 4-40 ST80i Stress Test System Instructions for Use Working with Archived Study Data Note:

If you have the Resting ECG Workflow product option, you can de-identify any ECG captured and saved with that feature. To de-identify individual reports 1. On the Archive screen, select one or more reports to back up. 2. Click Back Up. The Back Up Report dialog box appears. 3. Select the De-Identify Patient Information on Report check box to create a support folder. 4. Click Browse. 5. Browse to select a location for the support folder. 6. Click OK. The support folder contains one folder for each report that is backed up. Each folder contains five files: one raw data (PDR) file and four audit files (DAT) for Algorithm Engineering. Restoring Tests Stress tests that have been backed up to another location and deleted from the Archive screen can be restored. If you have administrative privileges, you can select single or multiple stress tests to restore from another location. Note:

If you have the Resting ECG Workflow product option, archived ECGs captured with that feature can be restored. To restore tests 1. Click Restore. The Open window appears. 2. Browse to locate the test(s) to restore. 3. Click to select the test(s) to restore. ST80i Stress Test System Instructions for Use 4-41 Working with Archived Study Data 4. Click Open. The Restore Reports notification appears, confirming restoration of the test(s). Note:

If any tests selected to be restored are already listed on the Archive screen, the Restore Reports notification states, The following reports already exist in the store: folder location of test(s) that already exist in ST80i. 5. Click OK. All restored reports are displayed on the Archive screen. Viewing a Test When you view an archived stress test, it opens on the Report screen, described earlier in this chapter. When you view an archived ECG captured using the Resting ECG Workflow product option, it opens in the same dialog box as when you click Resting ECG on the Resting screen, as described in Table 5-3, Resting Procedure Bar Features, on page 5-4. To view an archived stress study 1. In the archive list, select the check box to the left of the study you want to view. 2. Click View Report. The Report screen opens. See Report Screen on page 4-2 for details about what you can do on the Report screen. Note:

You can also open the study by double-clicking it in the archive list. To view an archived ECG (if you have the Resting ECG Workflow product option) 1. In the archive list, select the check box to the left of the ECG you want to view. 2. Click View Report. The ECG opens in a dialog box, where you can:

- Print the ECG to the ECG report printer configured in Settings > System Settings > System.

- Export the report to all destinations set as defaults in Settings > System Settings > Remote Sites.

- Double-click the patient name in the dialog box header to modify patient data.

- Save any changes you make. 4-42 ST80i Stress Test System Instructions for Use Working with Archived Study Data Note:

You can also open the ECG by double-clicking it in the archive list. Downloading Test Data at a Remote Review Location The optional Remote Review feature enables you to download patient stress tests at a PC that is not connected to the ST80i Stress Test System. The test data must first be exported to the remote review location using the procedure To export exam data to a remote review shared drive on page 4-48. You can then download and view the tests at the remote PC. The remote PC must have the Remote Review option installed. Note:

ECGs captured with the Resting ECG Workflow product option cannot be downloaded at remote sites. To download test data at a remote review location 1. At the remote PC, select the remote review location from the Select Archive list. The Remote dialog box appears. 2. Click Refresh to get the most updated list of patient tests. 3. Select one or more tests to download. You can select directly from the list or use the Search feature to filter the list as follows:

a Type in the Patient ID and/or Patient Name field, and/or select a status from the Status list. b Click Search. ST80i Stress Test System Instructions for Use 4-43 Exporting Reports The list is refreshed to match your search criteria Select one or more tests. c 4. Click Download. 5. Click Close. The selected tests are downloaded to the Archive screen. You can now view the tests as described in Viewing a Test on page 4-42. Replaying a Test This option enables you to scan the entire exam from the beginning of the Pre Exercise stage to the end of the Recovery stage. For details about how to replay a test, see Replay on page 4-7. Note:

You cannot replay ECGs captured using the Resting ECG Workflow product option. While reviewing the stored stress test, you can change the reference ECG. The stress study data and configuration settings are saved in database. For more information on the Replay function, see Replay on page 4-7. Exporting Reports After a final stress test is saved, it can be exported to the hospital system and/or to IntelliSpace ECG or to a shared drive. The test can be confirmed on both the device side and the server side (IECG). The stress study raw data (PDR) is saved in the local stress study database. The export status and date/time of last export are maintained. You can also export raw data to IntelliSpace ECG version B.01 or later. The final stress study can also be exported in PDF or XML file format to:

Remote sites, including:

External media such as a USB flash drive

- An ECG Management System

- A hospital system

- A local or shared drive

- An email destination

- A remote review shared drive

- A PACS server 4-44 ST80i Stress Test System Instructions for Use Exporting Reports

- An EG Plus DICOM proxy Note:

If exporting to a DICOM report server, your ST80i administrator will have preconfigured the PDF report either to include 12-Lead ECGs and/or PDR, or to be exported as a DICOM Structured Report (SR). Archived ECGs captured with the Resting ECG Workflow product option can be exported. to the following destinations and formats:

Remote sites, including:

External media such as a USB flash drive IntelliSpace ECG (XML)

- An email destination (PDF)

- A shared drive (PDF)

- A DICOM Report Server (DICOM data) Note:

To export a report, you need the appropriate permission level or network. You can still print the report from ST80i at any time. The exported report follows all the settings for the final stress report. See Printing the Final Report on page 4-30. You can also view or print the PDF file through Adobe Acrobat. See Viewing and Printing Reports Saved as PDF Files on page 4-49. See the ST80i Stress Test System Installation and Configuration Guide for how to create folder permissions to protect data. PDF Naming Conventions if the study includes the order number, and ST80i uses two naming formats when exporting PDFs, long and short. The long format is used when the report is being exported to a shared drive. Otherwise, the short report format is used. Report name formats are as follows:

Short format:

SV_Patient ID[Acquisition Date/Time]FirstName_LastName.PDF Long format:

SV_Patient ID[Acquisition Date/Time]FirstName_LastName_Gender_ DOB_Status_MDSignature_OrderNumber_StudyID.PDF ST80i Stress Test System Instructions for Use 4-45 Exporting Reports Export Reports to External Media You can export reports to external media such as a USB flash drive. You can export ECGs captured with the Resting ECG Workflow product option in the same manner. Note:

ST80i does not support exporting directly to a CD or DVD. To save a report to these media, first export the report to a local drive, then transfer the resulting PDF report to the CD or DVD. See To export reports to a local or shared drive on page 4-48. Insert the USB flash drive into a USB port on the PC. To export reports to external media 1. 2. Click Report on the Main screen. The Archive screen appears. 3. From the Transfer Destination list, select Removable Disk (drive letter:). 4. Select the archived report(s) to export. 5. Click Export. The progress bar at the bottom of the screen displays the progress of the export. 6. The Transfer Reports dialog box appears. Click OK. Export Reports to Remote Sites You can export reports from the Report screen or from the Archive screen, as well as by selecting automatic export after saving the report. To export from the Report screen, the destination must already have been configured as a default. See Export on page 4-5 for details. On the Archive screen, you can select the remote site from a list of preconfigured sites. The procedures in this section describe export from the Archive screen. You can export ECGs captured with the Resting ECG Workflow product option in the same manner. For configuration information, see the Configuring Remote Sites section in the ST80i Stress Test System Installation and Configuration Guide. Once the connection is established, all selected ECGs are transferred to the remote site. After each ECG has been successfully transmitted, the information is logged. If the connection fails, the operator is given an alert. No attempt is made to automatically retry the operation. A maximum of 100 remote sites profiles can be created without noticeable performance degradation when switching screens. 4-46 ST80i Stress Test System Instructions for Use Exporting Reports To create remote sites, see the ST80i Stress Test System Installation and Configuration Guide. Export Reports to an ECG Management System You can export PDF files for import into the Philips IntelliSpace ECG Management System (version A.01 and later) or the Philips TraceMasterVue ECG Management System (version C.01 through C.03). You can export the raw data (PDR) file for import into Philips IntelliSpace ECG Management System version B.01 or later, if your ST80i administrator has configured it to do so in Settings > Remote Sites. You can also export ECGs captured with the Resting ECG Workflow product option to an ECG management system. ECGs are exported in XML format. To export reports to an ECG management system 1. From the Transfer Destination list on the Archive screen, select the ECG management system remote site. 2. Select the report(s) to export. 3. Click Export. The progress bar at the bottom of the screen displays the progress of the export. 4. The Transfer Reports dialog box appears. Click OK. The report(s) should now appear in the ECG Management System. Export Reports to the Hospital System You can export reports to the hospital system through an IntelliBridge Enterprise remote site. To export reports to the hospital system 1. From the Transfer Destination list on the Archive screen, select the hospital system transfer destination. 2. Select the archived report(s) to export. 3. Click Export. The progress bar at the bottom of the screen displays the progress of the export. 4. The Transfer Reports dialog box appears. Click OK. The report(s) should now appear in the hospital system. Export Reports to a Local or Shared Drive You can export reports to a local PC hard drive or a shared (network) drive. The file format is PDF or XML, depending on how the drive is configured in Settings > Remote Sites. You can export ECGs captured with the Resting ECG Workflow product option in the same manner. ECGs are exported as PDF files. ST80i Stress Test System Instructions for Use 4-47 Exporting Reports To export reports to a local or shared drive 1. From the Transfer Destination list on the Archive screen, select the name of the local or shared drive for the export. 2. Select the archived report(s) to export. 3. Click Export. The progress bar at the bottom of the screen displays the progress of the export. 4. The Transfer Reports dialog box appears. Click OK. The report(s) should now appear in the local or shared drive folder. Export Reports to an Email Destination You can export reports to an email destination. Reports are exported as PDF files. You can export ECGs captured with the Resting ECG Workflow product option in the same manner. ECGs are exported as PDF files. To export reports to an email destination 1. From the Transfer Destination list on the Archive screen, select the email group for the export. 2. Select the archived report(s) to export. 3. Click Export. The progress bar at the bottom of the screen displays the progress of the export. 4. The Transfer Reports dialog box appears. Click OK. The destination email address(es) receive the report(s). Export Exam Data to a Remote Review Shared Drive For Remote Review systems to download exams for review, you must first export the study data to a remote review shared drive. This is a drive on a system that is not connected to the ST80i Stress Test System. To export exam data to a remote review shared drive 1. From the Transfer Destination list on the Archive screen, select the remote review location. 2. Select the archived exam(s) to export. 3. Click Export. The progress bar at the bottom of the screen displays the progress of the export. 4. The Transfer Reports dialog box appears. Click OK. The remote site receives the exam data. The remote system must have the optional Remote Review application installed in order to download and view the exported exam data. For information, see Downloading Test Data at a Remote Review Location on page 4-43. 4-48 ST80i Stress Test System Instructions for Use Exporting Reports Export Reports in DICOM Format to a PACS Server You can export reports in DICOM format to a PACS server (DICOM Report Server). When exporting to a DICOM Report Server, your ST80i administrator will have preconfigured the PDF report to either include 12-Lead ECGs and/or PDR, or to be exported as a DICOM Structured Report (SR). Note:

You can export ECGs captured with the Resting ECG Workflow product option in the same manner. ECGs are exported in DICOM format. To export reports in DICOM format to a PACS server 1. From the Transfer Destination list on the Archive screen, select the DICOM server destination for the export. 2. Select the archived report(s) to export. 3. Click Export. The progress bar at the bottom of the screen displays the progress of the export. 4. The Transfer Reports dialog box appears. Click OK. The selected remote site receives the report(s). Export Reports to the EG Plus DICOM Proxy You can export reports in DICOM format to an EG Plus DICOM proxy. The proxy then communicates with the remote DICOM server. To export reports in DICOM format to an EG Plus DICOM proxy 1. From the Transfer Destination list on the Archive screen, select the EG Plus destination for the export. 2. Select the archived report(s) to export. 3. Click Export. The progress bar at the bottom of the screen displays the progress of the export. 4. The Transfer Reports dialog box appears. Click OK. The selected remote site receives the report(s). Viewing and Printing Reports Saved as PDF Files To view and print a report saved as a PDF file 1. Exit the ST80i application. 2. From Windows Explorer, locate and select the directory where the file was exported. ST80i Stress Test System Instructions for Use 4-49 Importing Data or Reports 3. Locate the file you want to review and double-click it. Adobe Acrobat Reader automatically opens and displays the file. 4. Press Page Down and Page Up to navigate through the file. If the PC has access to a local or shared printer, you can print the file by selecting File, then Print. Importing Data or Reports If you have the ST80i Inbound Worklist product option installed, you can import data (orders) from IntelliBridge Enterprise (IBE) or a DICOM MWL server into ST80i. Import Data from IntelliBridge Enterprise (IBE), a DICOM MWL Server, or an EG Plus DICOM Proxy You can import data (orders) for a stress test from IntelliBridge Enterprise

(IBE), a DICOM MWL server, or an EG Plus DICOM proxy. In all cases, the remote site must already be configured. For more information, refer to the ST80i Stress Test System Installation and Configuration Guide. To import data from IBE or a DICOM server or proxy 1. Click Stress on the Main screen. 2. On the Worklist tab, select the desired remote site from the Location list. 3. Click Download. The Worklist tab is populated with the imported data. Query a Previous Report You can query previous reports in ST80i. See Review a Previous Study on page 3-8. 4-50 ST80i Stress Test System Instructions for Use 5 Resting ECG Workflow Resting ECG Workflow is an ST80i product option that enables you to capture a resting ECG. It can be used for the following purposes:

To capture a standalone resting ECG not associated with a stress test. To capture a resting ECG before a stress test. You can advance directly from the resting ECG to the Prepare phase of the stress test. Note:

The Resting ECG Workflow option uses the same algorithm as Philips cardiograph products, such as the TC Cardiograph series. This chapter provides the information you need to perform a standalone resting ECG using the Resting ECG Workflow option. Caution Do not run any other applications, including screen savers, when performing a resting ECG. Once the ECG has begun, the ST80i application does not allow you to access other system functions. For information about a patient session for a full stress test, see Chapter 3, The Patient Session. WARNING To get the most accurate interpretation during resting ECG, use traditional limb lead placement. Using Mason-Likar electrode placement may result in deviation in interpretation. Interpretations and analysis results provided by the Philips DXL 12-lead Analysis Algorithm for 12-lead ECG captures are intended for use with traditional limb lead placement and are not validated for use with other lead placements ST80i Stress Test System Instructions for Use 5-1 ST80i Resting Screen ST80i Resting Screen If you have the Resting ECG Workflow product option, the ST80i Main screen includes a Resting icon, which you click to open the Resting screen. On the Resting screen, you have command of several functions during a patient session. You can stop the session at any point without losing any patient demographics or order information. However, in this case, the ECG data will be lost. The Resting screen provides:

All key procedural information. Buttons to manage patient information, capture the resting ECG, move to a stress test, and open the Report screen. Menus to manage the ECG, with windows that can be viewed, then hidden, so that the leads can be viewed in their entirety. Time of Day for correct time stamp for every resting ECG. ST80i Resting Screen Figure 5-1 A B C 5-2 ST80i Stress Test System Instructions for Use ST80i Resting Screen Table 5-1 ST80i Resting Screen Features Feature Description A B C Title Bar Initially displays only current date and time. The patient name, DOB, and ID appear after you click the Patient button in the procedure bar and do one of the following in the window that opens:

Select a patient from the worklist. Use the Find button and search field to find a patient. Add a new patient by clicking Add. During the resting ECG, you can click the patient name in the title bar to update patient information. Procedure bar Displays icons that provide quick access to frequently used commands. Also displays procedure information, such as the selected PIM device and heart rate along with the Start Rhythm Printing/Stop Rhythm Printing button. Waveform screen Displays real-time ECG waveforms. Resting Title Bar You can use the title bar to manually input and edit patient information that will be stored in the patient worklist. The title bar includes the features shown and described below. Figure 5-2 A Resting Title Bar B C D E F G Table 5-2 Title Bar Features Feature Description A B C D Current user name. Navigation Keys (Main > Resting) Click Main to leave the ECG and return to the Main screen. Patient name Click the patient name to update patient information and add notes on the Patient Information tab of the Patient Demographics window. Note: Patient name, DOB, and ID are not displayed until you click the Patient button in the procedure bar to select, find, or add a patient. Patient's date of birth DOB formatting is determined by operating system. ST80i Stress Test System Instructions for Use 5-3 ST80i Resting Screen Feature Description E F G Patient ID Indicators for the RF transmitter and PIM battery status. Current date and time Date formatting is determined by operating system. Resting Procedure Bar The procedure bar contains the icons and buttons you can use during the patient session to access frequently used commands, change default settings, and view or hide specific ECG data. Changes you make to default settings are reset to the preconfigured defaults when you start a new patient session. The procedure bar also displays procedure information, including the selected PIM device and heart rate along with the Start/Stop Rhythm Printing button. When you hover over each icon or button, a tool tip is displayed. By default, the procedure bar is at the top of the screen. You can change its location to the bottom of the screen. See the ST80i Stress Test System Instal-

lation and Configuration Guide to change the default setting (Settings > User Profile > Display). Figure 5-3 B A Resting Procedure Bar C D E F G H I Table 5-3 Resting Procedure Bar Features Feature Description A Waveform icon B Lead Map icon 12 Leads The default is 12 leads; you can select from the following:

6x2 Leads 6 Leads 3 Leads Toggle to display or hide the lead map. The lead map is hidden by default. Display the lead map diagram to check lead wire connection integrity with a predefined, color-

coded indicator to show any leads that are off. 5-4 ST80i Stress Test System Instructions for Use ST80i Resting Screen Feature Description C Paper Advance icon D Quick Settings icon Form-feed adjustment for thermal paper. Opens the Quick Settings dialog box, where you can change the following default settings for this ECG only:

Filter (LP, HP, AC, Artifact, Smart) Display (Limb Gain, Chest Gain, Speed) Rhythm Print (Leads, Limb Gain, Chest Gain, Speed) Pacer Detection (Paced Unknown, Paced, Non-paced, Paced (magnet)) For details about these Quick Settings, see the appropriate sections under Quick Settings on page 2-31:

Filter on page 2-31 Display on page 2-32 Rhythm Print on page 2-33 Pacer Detection on page 2-34 ST80i Stress Test System Instructions for Use 5-5 ST80i Resting Screen Feature Description E Resting ECG button Resting ECG Captures the most recent 10 seconds of ECG and displays it in a dialog box where you can:

Preview the report. If the report is longer than one page, you can navigate through it using the Prev and Next buttons. Click Print to print the report to the ECG report printer configured in Settings > System Settings > System. Click Export to export the report to all destinations set as defaults in Settings > System Settings > Remote Sites. Valid destinations include:

- Email Address List (exports XML)

- Shared Drive (exports PDF)

- DICOM Report Server (exports DICOM data) Click Save to save the report to the patient test IntelliSpace ECG (exports XML) database (archive). Once a report is saved, you can access it by clicking the Report button on the Resting screen or on the Main screen to open the Archive screen, where you select the report from the list of resting ECG reports, then click View Report. The archived report has the same functions described here for 10-second ECG (Print, Export, and so on). See Chapter 4, Working with Reports, for details. F Patient button Patient G Procedure information Click Close to close the report and return to the Resting screen. Opens the worklist so you can select, find, or add a patient. Also enables you to modify patient demographics. See Using the Patient Worklist on page 3-1. Displays the selected PIM device and enables you to choose a different PIM. Also includes the Start/Stop Rhythm Printing button to start or stop real-time rhythm printing. The number to the right of the Printer icon indicates the number of pending print jobs. Heart rate is also displayed. 5-6 ST80i Stress Test System Instructions for Use ST80i Resting Screen Feature Description H Start Stress button Start Stress I Report button Report Advances the patient from resting ECG to the first phase of a stress test. Opens the Stress Study Options dialog box, where you select the exercise device and BP configuration for the test. When you click OK in the Stress Study Options dialog box, the test advances to the Prepare phase of the stress test. Ends the current resting ECG session and opens the Archive screen, where you can search for and select archived reports. See Chapter 4, Working with Reports,for details. Waveform Screen Real-time ECG waveforms appear on the waveform screen. The default setting is 12-Lead. You can use the Waveform icon on the procedure bar to change the waveform layout. Note:

When viewing 6 or 3 leads in the default waveform layout, you can change a lead by clicking the lead label on the left side of the display. At 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) AC Filter setting in Hz (50 or 60) Indicator that the Artifact Filter is on (F) Indicator that the Smart Filter is on (S) Figure 5-4 Limb Lead, Chest Lead, Speed, and Filter Settings You can use the Quick Settings icon to change these settings. The changes are immediately reflected at the bottom of the screen. ST80i Stress Test System Instructions for Use 5-7 ST80i Resting Screen 5-8 ST80i Stress Test System Instructions for Use 6 Maintaining the ST80i System Daily Maintenance Every day, 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 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. Precautions Before cleaning any equipment, unplug the AC power cord connecting the equipment to the power source. Do not attempt to clean the device or patient cables by submersing into a liquid, autoclaving, or steam cleaning. Wipe the exterior surface of the device and patient cables with a non-alcohol sterilizing disinfectant, and then dry with a clean cloth. Conductive parts of the patient cable, 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 cables as this could result in mechanical and/or electrical failures. Patient cables should be stored after use by forming them into a loose loop. Patient cable exteriors should be checked for cracks or breakage prior to use. Caution Dispose of waste material according to local regulations and laws regarding medical and battery waste. ST80i Stress Test System Instructions for Use 6-1 Cleaning the ST80i System Cleaning the ST80i System ST80i system components should withstand cleaning using a cloth dampened with the following solutions. Important:

This applies only to Philips Healthcare custom-designed components. For all commercial off-the-shelf (COTS) components, including NIBP monitors, laser printers, PCs/monitors, LCD displays, keyboards, and mice, customers must follow the manufacturers' cleaning specifications. Isopropyl alcohol, 70% solution Mild soap and water Chlorine bleach (5.25% sodium hypochlorite content), 3% solution in water Steris Coverage Plus NPD, 1/2 fluid ounce per gallon water (one part Coverage Plus NPD to 256 parts water) To clean the ST80i system, advanced interface module (AIM), and transport cart Clean the outside of the computer with a soft cloth lightly moistened with a mild detergent solution. Do not use solvents or abrasive cleaners. Clean the display with a soft cloth lightly moistened with a mild detergent approved for use on the display. Do not use solvents or abrasive cleaners. Follow manufacturers recommendations for all OEM (COTS) components. Clean the AIM with a soft cloth lightly moistened with a mild detergent approved for use on the AIM. Do not use solvents or abrasive cleaners. Clean the trolley with a cloth dampened with mild soap and water, as necessary. Cleaning the PIM After Each Use The wireless patient interface module (PIM), PIM holder, PIM belt, and lead wires must be cleaned after each use with any of the approved solutions described in Cleaning the ST80i System on page 6-2. Caution Do not:

Autoclave the patient module, patient cable/lead wires, or use ultrasonic cleaners Use abrasive materials Immerse 6-2 ST80i Stress Test System Instructions for Use Wet the connectors Maintaining the ST80i Thermal Printer To clean the PIM, PIM holder, and belt 1. Dampen a soft cloth with one of the disinfectants or cleaning agents appropriate for the device, as defined in Cleaning the ST80i System on page 6-2. 2. Wring excess moisture from the cloth before cleaning. 3. Simply wipe off the exterior of the PIM, PIM holder, and belt. To clean the patient cable and lead wires, refer to the instructions in the corresponding accessorys Instructions for Use. Maintaining the ST80i Thermal Printer You should implement a satisfactory cleaning and inspection schedule for this equipment for proper equipment operation and to reduce the possibility of equipment failure. Note:

There are no serviceable parts for this printer. Should you experience problems with the printer, it is replaced as a whole. Inspecting the ST80i Thermal Printer Inspect the equipment for the following conditions on a regular basis:

Examine power cable and the USB cable for obvious damage (for example, torn insulation, broken connectors, and so on). Replace cables as necessary. All cords and connectors are securely seated in their corresponding connections. Examine the equipment for missing screws, cracks or broken areas that might allow unintended access to internal electronics areas. Cleaning the ST80i Thermal Printer Note:

If the system is configured with a laser printer, refer to the User Guide provided with the printer for maintenance and cleaning instructions. ST80i Stress Test System Instructions for Use 6-3 Maintaining the ST80i Thermal Printer To clean the printer 1. Disconnect the power source. 2. Clean the exterior surface of the unit with a damp cloth using a solution of mild dish washing detergent diluted in water. 3. After washing, thoroughly dry the unit with a clean, soft cloth or paper towel. Clean the print head monthly, as described next. Note:

Do not let soap or water come into contact with the writer, plugs, jacks, or vents. To clean the print head 1. Open the printer cover door. 2. Use a cotton swab lightly dampened with isopropyl alcohol to clean the print head. 3. Allow the print head to air dry. 4. Clean the platen by using adhesive tape. Apply the tape and pull it off. Rotate the roller and repeat until the entire roller is clean. 5. Use a cotton swab lightly dampened with isopropyl alcohol to clean the paper sensor. Testing ST80i Thermal Printer Operation After inspecting and cleaning the thermal printer, confirm that the printer is working properly. To test printer operation, using an ECG simulator with the stress testing system, acquire and print ECGs of known amplitude. A successfully printed ECG report has the following characteristics:

Printing should be dark and even across the page. There should be no evidence of print-head dot failure (for example, breaks in printing forming horizontal streaks). Paper motion should be smooth and consistent during printing. Waveforms should appear normal, with proper amplitude, and without distortion or excessive noise. Paper should stop with perforations near the tear-bar (indicating proper cue sensor operation). 6-4 ST80i Stress Test System Instructions for Use Maintaining the ST80i Thermal Printer Replacing the ST80i Thermal Printer Fuse The AC fuse may need to be replaced when the AC power-on indicator light does not illuminate when the printer is plugged into AC power. Figure 6-1 AC Fuse Location and AC Power-on Indicator Light on ST80i Thermal Printer A A AC fuse location B AC power-on indicator light B Only use replacement AC fuses with Philips part number 453564131221, or use a 1.6 amp (250V) time-delay fuse the same size and configuration as the original fuse. To replace the AC fuse 1. Unplug the thermal printer from AC power. Pull out the AC power cord from the AC power connector on the rear of the printer. 2. Locate the AC fuse holder directly above the AC power connector. 3. With a small blade screwdriver or other small blade tool, push on both ends of the fuse and pull out the fuse from the fuse holder slot. Insert the new fuse using the same orientation. 4. 5. Push the fuse all the way into the fuse holder slot. The fuse snaps into place. ST80i Stress Test System Instructions for Use 6-5 Maintaining the ST80i Thermal Printer 6-6 ST80i Stress Test System Instructions for Use A Troubleshooting and Contacting the Philips Response Center When you encounter a problem working with ST80i, address the issue in the following order:

1. Review the Troubleshooting chapter to see if your issue is addressed. 2. Contact your ST80i administrator. 3. Contact the Philips Response Center. The Philips Response Center can assist with product troubleshooting and provide technical expertise to help with any issue with the ST80i system. For details, visit www.healthcare.philips.com, select your country and language, and navigate to the Response Center page. Troubleshooting ST80i Issues When you are using ST80i, you may encounter some problems with the system. The following table describes some of the more common symptoms and provides information regarding possible causes and solutions to help you solve potential problems. Table A-1 Troubleshooting ST80i Issues Problem Waveform Issues Baseline drift Cause Solution Poor skin-to-electrode contact. Re-prep skin and replace faulty electrodes. ST80i Stress Test System Instructions for Use A-1 Troubleshooting ST80i Issues Problem Cause Waveform Issues (continued) Solution A red dashed line is displayed on the real-

time ECG display No waveform signal on the screen Missing or corrupt AIM driver In the Windows Device Manager, check for the presence of Philips ST80i Advanced Input Module under Philips Healthcare Device. In earlier versions of the software, check for the driver Kernel Mode Driver for Advanced Input Module under PMS-PCCI-CDC Device. If not present, try reseating the USB cable and/or reinstalling the AIM driver Missing RL/N lead PIM MAC address incorrect Check leads. Run the Lead test from the Service Utility. Replace leads if necessary. Check PIM configuration in Settings for correct MAC address. Correct if necessary. Wrong PIM selected In multi-PIM setting ensure correct PIM is selected when initiating a test. Correct if necessary. Defective PIM Defective AIM Call the CCSC. Call the CCSC. A-2 ST80i Stress Test System Instructions for Use Troubleshooting ST80i Issues Problem Cause Waveform Issues (continued) Solution ECG artifact caused by muscle interference. Electrode placed over an area of muscle or fatty tissue Non-stress or monitor type electrodes being used. Dried out or expired electrodes Treadmill handles being gripped to tightly Find a stable electrode site, re-prep the skin, and apply a new electrode away from muscular and fatty areas. Replace electrodes Replace electrodes Instruct patient not to grip treadmill handles too tightly. Clothing interfering with lead wires Adjust clothing. System Navigation Issues For wired keyboard/

mouse:

No response to keyboard commands or cursor does not move. USB cable connection to keyboard or mouse Check USB cable connection to the keyboard or mouse. Disconnect and connect the keyboard or mouse to check whether the keyboard or mouse can be identified by the system. Ensure mouse power switch is in the ON position For wireless keyboard/

mouse:

No response to keyboard commands or cursor does not move. Wireless USB connection Remove and reseat the wireless USB receiver. Press and hold the Connect button on the keyboard or mouse for 10 seconds Dead battery in wireless keyboard or wireless mouse Replace the battery in the wireless keyboard or mouse. ST80i Stress Test System Instructions for Use A-3 Troubleshooting ST80i Issues Problem Treadmill Issues Cause Solution Treadmill does not respond to the On command from ST80i Equipment was powered up in the wrong sequence The Treadmill power switch is in the Off position, or the treadmill cable is not properly attached The Emergency Stop button is engaged Safety tether not attached One or more leads are not connected. One or more leads have failed Defective lead set Network is down Remote Site configured incorrectly Export folder does not exist System Error Messages The Lead Map displays a red X on one or more connections An error occurred during export of selected exams A-4 ST80i Stress Test System Instructions for Use Turn the treadmill off by using the treadmill power switch, located at the base of the treadmill hood, on the left side. Wait one minute and turn the power on. Proceed with the test. Ensure the correct equipment is specified in the Configuration settings. Check the treadmill-to-

ST80i cable connection. Turn the Treadmill main power switch to the On position. Ensure the correct COM port is configured. Reset the Emergency Stop button by turning it clockwise one quarter turn. If so equipped, make sure the safety tether is attached. Connect the electrodes. Once connected, the red X disappears. Replace lead set. Check remote location. Try pinging remote location. Test remote site connection from Settings. If it fails, investigate cause and resolve. Check Export directory. Problem Cause Solution Troubleshooting ST80i Issues ST80i has not yet learned the normal morphology of the patients ECG. Click Cancel to allow ST80i more time to learn the normal morphology in the Pre Exercise phase. or Click OK to move to the Exercise Phase. This does not affect analysis in any way. The ST80i had not yet learned the normal morphology when selected Compare event was created Select an Event that was created after the normal morphology has been learned

(ST value present). System Error Messages Information message appears when you attempt to begin the Exercise phase:

At least one ST value is invalid. Do you want to proceed the test?

When Compare is selected, the Compare

(White) Zoomed ECG is flat-lined with the A.01 version of the software. Earlier versions displayed both the Current and Compare as flat-lined. Printer Issues Thermal printer paper out light is on Paper jammed Open writer cover and remove jammed paper. Thermal printer is not printing Uneven printing of ECGs or reports No paper in tray Open printer door Print head needs cleaning Insert new pack of paper in tray. See if writer door is latched. Verify that the correct printer is specified in the configuration settings. See Printer Settings on page 3-34. Clean the print head as specified in Cleaning the ST80i Thermal Printer on page 6-3. Paper door not closed completely See if paper door is closed completely. Paper installed incorrectly Ensure paper is properly aligned. Check for correct paper orientation using sensor hole at bottom left of paper. ST80i Stress Test System Instructions for Use A-5 Troubleshooting ST80i Issues Problem Uneven printing No printing Cause Solution Print head needs cleaning Paper roller Poor or damaged paper

(thermal paper that is old or that was improperly stored can cause light or uneven printing. Exposure to heat or chemical vapors can damage the paper) Power cord or USB cable may be disconnected Printer might not have paper loaded or paper could be loaded incorrectly Printer error Clean the print head as specified in Cleaning the ST80i Thermal Printer on page 6-3. Check the paper roller for uneven wear. Test printer using a fresh pack of properly stored paper. Check AC power cord and USB cable connections and confirm that the Power On indicator is illuminated. Check to see that paper has been loaded and that it has been loaded correctly. Paper sensor mark is at the bottom right Check device manager to ensure driver is loaded by looking for Device Manager/PMS-PCCI-CDC Device/Kernel Mode Driver for Thermal Printer. If it is not present, call the CCSC. A-6 ST80i Stress Test System Instructions for Use Problem Cause Solution Contacting Your Philips Response Center Printer Issues (continued) Blood pressure printout and report discrepancy Use of NIBP field to enter new blood pressure values You must enter blood pressure values using the BP mmHg (Sys/Dia) field in the side panel. For details on entering blood pressure values, see Baseline/

Reference BP and SpO2 on page 3-27. Cuff/mic not positioned correctly. Position cuff and mic correctly. Cuff too large/too small for patient. Tango NIBP device defective. Use properly sized cuff. Call the CCSC. Contacting Your Philips Response Center Your Philips Response Center can assist with product troubleshooting and provide technical expertise to help with any issue with the Cardiac Workstation or any of its accessories. For more information on how to contact your Philips Response Center, go to https://www.healthcare.philips.com, then select the link for your country or region. ST80i Stress Test System Instructions for Use A-7 Contacting Your Philips Response Center A-8 ST80i Stress Test System Instructions for Use B Protocol Reference This appendix provides an example of each of the included protocols. You can define and edit protocols. For details, see the ST80i Stress Test System Installation and Configuration Guide. The following protocols are delivered with every ST80i system. See the indicated page for an example of each of these protocols:

Bruce Protocol . B-1 Modified Bruce Protocol . B-2 Balke Protocol . B-3 Ellestad Protocol . B-4 Naughton Protocol . B-5 Pharmacological Protocol . B-5 Low Ramp Protocol . B-6 Medium Ramp Protocol . B-7 High Ramp Protocol . B-8 USAF/SAM 2.0 Protocol . B-9 USAF/SAM 3.3 Protocol . B-9 Cycle (Ergometer) Protocol . B-10 Astrand Protocol . B-10 Pharma Ergometer Protocol . B-11 Bruce Protocol This sample Bruce protocol produces the following operations and conditions:

A stage change occurs every 3 minutes with an increase in treadmill speed and grade. Blood pressure is automatically measured at the end of each stage (by default, but can be changed by the user). ST80i Stress Test System Instructions for Use B-1 Modified Bruce Protocol A 12-lead ECG report is automatically printed at the end of each stage (by default, but can be changed by the user). ECG acquisition begins 10 seconds prior to the end of a stage. In the Recovery phase, the treadmill slows to 1.5 mph and the following reports are automatically printed:

- The final ECG from the last stage

- Peak exercise ECG

- Recovery ECGs based on your configuration Blood pressure measurement is set to every 2 minutes (2, 4, 6, 8) until the end of the Recovery phase. The following are created and saved as events but are not printed:

- Start Exercise Table B-1 Bruce Protocol Settings Stage #

Time Duration

(mm:ss) Speed

(mph) Pre Exercise 1 Exercise 1 2 3 4 5 6 7 Recovery 1 Unlimited 1.0 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 1.7 2.5 3.4 4.2 5.0 5.5 6.0 1.5 Bruce Grade (%) ECG Print BP Measurement 0.0 10.0 12.0 14.0 16.0 18.0 20.0 22.0 0.0 Off End End End End End End End Off End End End End End End End Every 02:00 Every 02:00 Modified Bruce Protocol Table B-2 Modified Bruce Protocol Settings Modified Bruce Grade (%) ECG Print BP Measurement Stage #

Time Duration

(mm:ss) Speed

(mph) Pre Exercise B-2 ST80i Stress Test System Instructions for Use Balke Protocol 1 Exercise 1 2 3 4 5 6 7 8 9 Recovery 1 Modified Bruce Unlimited 0.5 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 1.7 1.7 1.7 2.5 3.4 4.2 5.0 5.5 6.0 1.0 0.0 0.0 5.0 10.0 12.0 14.0 16.0 18.0 20.0 22.0 0.0 Off End End End End End End End End End Off Begin Begin Begin Begin Begin Begin Begin Begin Begin Every 02:00 Every 02:00 Balke Protocol The Pre-Exercise and Recovery phase settings are the same as for the Bruce protocol. See Bruce Protocol Settings on page B-2. Table B-3 Balke Protocol Settings Stage #

Time Duration

(mm:ss) Speed

(mph) Pre Exercise 1 Exercise 1 2 3 4 5 6 7 8 9 10 11 12 Unlimited 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 Balke Grade (%) ECG Print BP Measurement 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 10.0 11.0 12.0 Off End End End End End End End End End End End End Off Off Off End Off Off End Off Off End Off Off End ST80i Stress Test System Instructions for Use B-3 Ellestad Protocol 13 14 15 16 17 18 19 20 21 22 Recovery 1 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 3:00 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 3.3 1.0 Balke 13.0 14.0 15.0 16.0 18.0 20.0 21.0 22.0 23.0 24.0 End End End End End End End End End End Off Off End Off Off End Off Off End Off 0.0 Every 02:00 Every 02:00 Ellestad Protocol The Pre Exercise and Recovery phase settings are the same as for the Bruce protocol. See Bruce Protocol Settings on page B-2. Table B-4 Ellestad Protocol Settings Stage #

Time Duration

(mm:ss) Speed

(mph) Ellestad Grade (%) ECG Print BP Measurement Pre Exercise 1 Exercise 1 2 3 4 5 6 7 Recovery 1 Unlimited 1.0 3.00 2.00 2.00 3.00 2.00 2.00 2.00 3.00 1.7 3.0 4.0 5.0 6.0 7.0 8.0 1.5 0.0 10.0 10.0 10.0 10.0 15.0 15.0 15.0 0.0 Off End End End End End End End Off End End End End End End End Every 02:00 Every 02:00 B-4 ST80i Stress Test System Instructions for Use Naughton Protocol Naughton Protocol The Pre Exercise and Recovery phase settings are the same as for the Bruce protocol. See Bruce Protocol Settings on page B-2. Table B-5 Naughton Protocol Settings Stage #

Time Duration

(mm:ss) Speed

(mph) Naughton Grade (%) ECG Print BP Measurement Pre Exercise 1 Exercise 1 2 3 4 5 6 7 Recovery 1 Unlimited 0.5 2.00 2.00 2.00 2.00 2.00 2.00 2.00 3.00 1.0 2.0 2.0 2.0 2.0 2.0 2.0 1.0 0.0 0.0 2.0 3.5 7.0 10.5 14.0 17.5 0.0 Off End End End End End End End Off Off End Off End Off End Off Every 02:00 Every 02:00 Pharmacological Protocol Table B-6 Pharmacological Protocol Settings Stage #

Time Duration

(mm:ss) Speed

(mph) Pre Exercise 1 Infusion Unlimited 0.0 1 2 3 4 5 6 7 3.00 3.00 3.00 3.00 3.00 3.00 3.00 0.0 0.0 0.0 0.0 0.0 0.0 0.0 Pharmacological Grade (%) ECG Print BP Measurement Dose 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 Off End End End End End End End Off End End End End End End End Off Off Off Off Off Off Off Off ST80i Stress Test System Instructions for Use B-5 Low Ramp Protocol Post-Infusion 1 3.00 0.0 0.0 Every 01:00 Every 02:00 Off Pharmacological Low Ramp Protocol The Pre Exercise and Recovery phase settings are the same as for the Bruce protocol. See Bruce Protocol Settings on page B-2. Table B-7 Low Ramp Protocol Settings Stage #

Pre Exercise 1 Exercise 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Time Duration

(mm:ss) Unlimited 0:30 0:30 0:30 0:30 1:00 0:30 0:30 0:30 0:30 1:00 0:30 0:30 0:30 0:30 1:00 0:30 0:30 1.00 0:30 0:30 1.00 0:30 0:30 1.00 1:00 Low Ramp Grade (%) ECG Print BP Measurement Speed

(mph) 1.0 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.0 3.1 3.2 3.4 3.6 0.0 0.0 1.0 1.0 2.0 3.0 4.0 4.0 5.0 6.0 7.0 8.0 8.5 9.0 9.5 10.0 10.5 11.0 12.0 13.0 14.0 15.0 16.0 17.0 18.0 19.0 Off End End End End End End End End End End End End End End End End End End End End End End End End End Off End End End End End End End End End End End End End End End End End End End End End End End End End B-6 ST80i Stress Test System Instructions for Use Medium Ramp Protocol Recovery 1 3:00 1.5 0.0 Every 02:00 Every 02:00 Low Ramp Medium Ramp Protocol The Pre Exercise phase settings are the same as for the Bruce protocol. See Bruce Protocol Settings on page B-2. Table B-8 Medium Ramp Protocol Settings Stage #

Pre Exercise 1 Exercise 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Recovery Time Duration

(mm:ss) Unlimited 0:30 0:30 0:30 0:30 1.00 0:30 0:30 0:30 0:30 1.00 0:30 0:30 0:30 0:30 1.00 0:40 0:40 0:40 0:40 0:40 0:40 0:40 0:40 0:40 0:40 Medium Ramp Speed

(mph) Grade (%) ECG Print BP Measurement 1.0 1.5 1.6 1.7 1.7 1.8 1.9 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 3.0 3.2 3.4 3.6 3.8 4.0 4.2 4.5 4.8 5.2 3.0 4.0 5.0 6.0 7.0 8.0 8.5 9.0 9.5 10.0 11.0 11.5 12.0 12.5 13.0 13.5 14.0 14.5 15.0 15.5 16.0 17.0 18.0 19.0 20.0 End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End End ST80i Stress Test System Instructions for Use B-7 High Ramp Protocol 1 3:00 1.0 0.0 Every 02:00 Every 02:00 Medium Ramp High Ramp Protocol The Pre Exercise phase settings are the same as for the Bruce protocol. See Bruce Protocol Settings on page B-2. The Recovery phase settings are the same as for the Medium Ramp protocol. See Medium Ramp Protocol Settings on page B-7. Table B-9 High Ramp Protocol Settings Stage #

Pre Exercise 1 Exercise 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Recovery 1 Time Duration

(mm:ss) Speed

(mph) Unlimited 1.0 0:30 0:30 0:30 0:30 1.00 0:30 0:30 0:30 0:30 1.00 0:30 0:30 0:30 0:30 1.00 0:40 0:40 0:40 0:40 0:40 0:40 0:40 0:40 0:40 0:40 3:00 1.6 1.7 1.7 2.0 2.2 2.4 2.5 2.6 2.8 3.0 3.2 3.4 3.5 3.6 3.7 4.0 4.2 4.4 4.6 4.8 5.0 5.2 5.5 5.8 6.0 1.0 High Ramp Grade (%) ECG Print BP Measurement 0.0 5.0 10.0 10.0 10.0 11.0 11.5 12.0 12.5 13.0 13.5 14.0 14.0 14.5 15.0 15.5 16.0 16.0 16.5 17.0 17.5 18.0 19.0 20.0 21.0 22.0 0.0 Off End End End End End End End End End End End End End End End End End End End End End End End End End Off End End End End End End End End End End End End End End End End End End End End End End End End End Every 02:00 Every 02:00 B-8 ST80i Stress Test System Instructions for Use USAF/SAM 2.0 Protocol USAF/SAM 2.0 Protocol Table B-10 USAF/SAM 2.0 Protocol Settings Stage #

Pre Exercise 1 Exercise 1 2 3 4 5 6 Recovery 1 Time Duration

(mm:ss) Unlimited 3.00 3.00 3.00 3.00 3.00 3:00 3.00 USAF/SAM 2.0 Speed

(mph) Grade (%) ECG Print BP Measurement 0.5 2.0 2.0 2.0 2.0 2.0 2.0 1.0 0.0 0.0 5.0 10.0 15.0 20.0 25.0 0.0 Off End End End End End End Off Off End Off End Off End Every 02:00 Every 02:00 USAF/SAM 3.3 Protocol Table B-11 USAF/SAM 3.3 Protocol Settings Stage #

Pre Exercise 1 Exercise 1 2 3 4 5 6 Recovery 1 Time Duration

(mm:ss) Unlimited 3.00 3.00 3.00 3.00 3.00 3:00 3.00 USAF/SAM 3.3 Speed

(mph) Grade (%) ECG Print BP Measurement 1.2 3.3 3.3 3.3 3.3 3.3 3.3 1.2 0.0 0.0 5.0 10.0 15.0 20.0 25.0 0.0 Off End End End End End End Off Off End Off End Off End Every 02:00 Every 02:00 ST80i Stress Test System Instructions for Use B-9 Cycle (Ergometer) Protocol Cycle (Ergometer) Protocol Table B-12 Cycle (Ergometer) Protocol Settings Cycle (Ergometer) Stage #

Time Duration

(mm:ss) Power

(Watts) ECG Print BP Measurement Pre Exercise Exercise Recovery 1 1 2 3 4 5 6 7 8 9 10 1 Unlimited 10 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3.00 3:00 3.00 25 50 75 100 125 150 175 200 225 250 25 Off Begin Begin Begin Begin Begin Begin Begin Begin Begin Begin Off End End End End End End End End End End Every 01:00 Every 02:00 Astrand Protocol Table B-13 Astrand Protocol Settings Stage #

Pre Exercise Exercise Recovery 1 1 2 3 4 5 6 1 Time Duration

(mm:ss) Unlimited 6.00 6.00 6.00 6.00 6.00 6.00 3.00 Astrand Power

(Watts) ECG Print BP Measurement 50 50 100 150 200 250 300 50 Off End End End End End End Off End End End End End End Every 01:00 Every 02:00 B-10 ST80i Stress Test System Instructions for Use Pharma Ergometer Protocol Pharma Ergometer Protocol Table B-14 Pharma Ergometer Protocol Settings Stage #

Pre Exercise 1 Exercise 1 Recovery 1 Time Duration

(mm:ss) Unlimited 1.00

(configurabl e) 3.00 Pharma Ergometer ECG Print Power

(Watts) BP Measurement SpO2 Measurement 0 0 0 Off End Off End Off End Every 02:00 Every 02:00 Every 02:00 ST80i Stress Test System Instructions for Use B-11 Pharma Ergometer Protocol B-12 ST80i Stress Test System Instructions for Use C Configuring and Using the Printer The ST80i Stress Test System supports the following different printers:

Network printer and local printer with Windows 7, Windows 8.1, or Windows 10 ST80i thermal printer drivers For printer troubleshooting, see Appendix A, Troubleshooting and Contacting the Philips Response Center. ST80i Thermal Printer The ST80i thermal printer uses an eight-dot-per-millimeter (dpm) print head to print ECG tracings and report data. Multiple print formats are supported. The ST80i thermal printer includes:

Hospital-grade power cord for connection to the isolation transformer USB cable for connection to the PC ST80i Stress Test System Instructions for Use C-1 ST80i Thermal Printer Thermal Printer Dimensions and Specifications Figure C-1 ST80i Thermal Printer Dimensions Back Dimensions Top Dimensions Side Dimensions C-2 ST80i Stress Test System Instructions for Use Figure C-2 ST80i Thermal Printer ST80i Thermal Printer Table C-1 ST80i Thermal Printer Specifications Feature Specification Instrument type Thermal printer Paper type Supports the use of the following paper types supplied as Z-fold in packages of 100 and 200 sheets:

A-size Normal, Anti-fade, and Easy Tear A4-size Normal, Anti-fade, thin, and Easy Tear Recording technique Computer-controlled, thermal dot array Print-head width 8.5 inches (216 mm) Print-head resolution Writer speeds External ports and data interfaces Chassis leakage current Power Weight Vertical: 200 dots/inch Horizontal:

5, 10, and 25 mm/sec: 500 dots/inch 50 mm/sec: 250 dots/inch 25 or 50 mm/sec for AUTO report 5, 10, 25, or 50 mm/sec for rhythm print USB 2.0-compliant, type-B socket connector Meet or exceed requirements of IEC 60601-2-25 100-240 VAC at 50/60 Hz 9 lb Dimensions H x W x D 8 cm x 48 cm x 30 cm maximum ST80i Stress Test System Instructions for Use C-3 ST80i Thermal Printer Feature Fuses Special functions Specification T-Type, 1.6 Amp, 250 V, 5 mm x 20 mm Door closed sensor that detects when paper door is open Top-of-form sensor that positions paper at the edge and detects paper out and paper jam conditions Note:

Specifications are subject to change without notice. Table C-2 Input and Output Descriptions Feature AC Power Description The ST80i thermal printer operates on 120/240 VAC at 50/60 Hz. Power is supplied to the thermal printer as soon as the AC power cord is connected to an AC power outlet. Power On Indicator This indicator illuminates in green when AC power is applied. Hard Copy Printout The ST80i thermal printer uses 8 1/2 in x 11 in (21 cm x 27.9 cm) sheets of Z-fold, thermal sensitive paper with cue marks. Printing speeds are 10, 25, and 50 mm per second. Dot density is eight dots per millimeter or 203.2 dpi. Loading the Thermal Printer Paper To load the paper 1. Remove the outer packaging from the paper pack (A). 2. Facing the front of the unit, use the release latch on the left side and slide the paper tray cover to the left (B). Caution To avoid damaging the door open switch activation tab, do not pull the tray cover more than half way. C-4 ST80i Stress Test System Instructions for Use Figure C-3 Loading ST80i Thermal Printer Paper ST80i Thermal Printer A B C D E 3. Place the pack of thermal paper into the paper tray such that the grid side of the paper is up when it is pulled over the paper tray cover (C). The paper cue mark (an oval-shaped hole) should be in the lower left corner. 4. Manually advance one page of paper beyond the closure point of the writer

(D). Make sure the paper lies on the black roller evenly within the channel of the paper door. 5. Slide the paper tray cover to the right until the cover latches in a locked position (E). You hear a sharp click when the door is properly latched. If the door is not completely closed the result may be uneven printing. 6. Click the Paper Advance icon in ST80i to align the cue mark and prepare the paper for printing. ST80i Stress Test System Instructions for Use C-5 ST80i Thermal Printer Setting Up the Thermal Printer To connect the ST80i thermal printer 1 Connect the AC power cord to the AC connector (B) on the printer and to the isolation transformer. 2 Connect one end of the USB cable to the USB cable connector (A) on the ST80i thermal printer and the other end to a USB port on the back of the ST80i PC, as shown in Figure C-5, below. Figure C-4 ST80i Thermal Printer Rear Panel C B A A USB connector C AC fuse B AC connector (for power cord) Figure C-5 ST80i PC Rear Panel USB Ports C-6 ST80i Stress Test System Instructions for Use About the Supported LaserJet Printers About the Supported LaserJet Printers ST80i also supports the use of the HP 4250 LaserJet, HP P2055, and HP P4014 PCL5 printers using drivers for the Windows 7, Windows 8.1, or Windows 10 operating system. It is capable of printing reports, without a grid, at 35 ppm. It prints with a grid at approximately 2 ppm. Note:

The LaserJet printer must be a local printer, connected directly to the ST80i test system, if it is to be used during testing. It cannot be a network printer, as connection to the network is disabled during a test. For details about the printers, refer to the HP website (www.hp.com) or to the printer documentation. ST80i Stress Test System Instructions for Use C-7 About the Supported LaserJet Printers C-8 ST80i Stress Test System Instructions for Use D Ordering Options and Parts This appendix describes the parts and options available for the ST80i Stress Test System. Supplies and Ordering Information The part numbers for all supplies for the ST80i system are listed in this section. All supplies can be ordered on the web at http://shop.medical.philips.com. Use the part numbers listed in the following tables for reference to ensure that the correct supplies are ordered. Optional Parts and Accessories The following items represent the parts available at the time of this manuals printing. Changes to and deletions from this list are likely to occur over time. Not all accessories may be available in all countries. For more information on accessories or to place an order, contact the nearest Philips Response Center. See Contacting Your Philips Response Center on page A-7. For available support parts (which can only be ordered by Philips personnel), see Support Parts on page D-2. Part Number Description 989803180121 989803180131 989803180141 12-Lead Complete Lead Set (AAMI), Standard Length, Grabber 12-Lead Complete Lead Set (IEC), Standard Length, Grabber 12-Lead Complete Lead Set (AAMI), Standard Length, Snaps 989803180151 12-Lead Complete Lead Set (IEC), Standard Length, Snaps 989803180801 STRS, PIM Belt 453564575091 TrackM CBL Treadmill Interface Cable, 7.62M ST80i Stress Test System Instructions for Use D-1 Supplies and Ordering Information Part Number Description 40420A 40493D 40493E M2202A M1708A M1710A M2481A M2483A M3707A M3708A M2485A High-Tack Foam Wet Gel ECG Electrode Foam Wet Gel ECG Electrode Foam Wet Gel ECG Electrode Adult Radio-Translucent Foam Electrode Thermal paper, z-fold, no header, 8.5 in x 11 in Thermal paper, z-fold, no header, A4 size Thermal paper for PageWriter, 8.5 in x 11 in Thermal paper for PageWriter, A4 size Thermal paper, English Thermal paper, A4 Anti-fade paper for PageWriter, 8.5 in x 11 in Support Parts For more information on accessories or to place an order, contact the nearest Philips Response Center. See Contacting Your Philips Response Center on page A-7. The parts listed in the following tables can only be ordered by Philips personnel. New Assembly Part Number Item PIM 453564237251 453564277261 453564277271 453564530561 AIM 453564305221 453564236991 USB STRS MECHASY Battery Door Assy STRS ST80i Wireless PIM, AAMI STRS ST80i Wireless PIM, IEC Battery Terminal Repair Kit STRS, ST80i Advanced Input Module (AIM) STRS, ANT, AIM Antenna 453564336341 USB Cable Printer to PC, 1.8M D-2 ST80i Stress Test System Instructions for Use Supplies and Ordering Information New Assembly Part Number Item Printer Accessories and Thermal Printer Paper 453564048431 453564131221 453564305231 Power Cords 8120-1351 8120-1689 8120-4211 8120-4475 8120-5182 8120-6869 8120-6978 8120-8376 8120-5429 Trolley Parts 453564237601 453564237591 453564398511 453564623661 453564604121 453564604131 453564604101 453564604111 453564334161 453564334701 453564334901 453564334981 453564539721 453564335001 PW, PL, Metric Spacer, A4 paper Fuse (Metric) 1.6A 250V FE IEC STRS ST80i Thermal Printer CBL AC POWER CORD OPTION 900, 2.0M CBL AC POWER CORD OPTION 902, 2.0M CBL AC POWER CORD OPTION 917, 2.0M CBL AC POWER CORD OPTION 901, 2.0M CBL AC POWER CORD OPTION 919, 2.0M CBL AC POWER CORD OPTION 920, 2.0M CBL PWR-CORD-921 18-AWG 3-COND OPTION 921, 2.0M CBL AC POWER CORD OPTION 922, 2.2M CBL AC 3 WIRE POWER CORD, OPTION 903, 2.4M ST80i Isolation Transformer, 240V ST80i Isolation Transformer, 120V STRS Trolley Light Assembly-AAMI STRS Trolley Light Assembly-IEC STRS Lamp, North America (NA) STRS Lamp Driver, North America (NA) STRS Lamp, European Union (EU) STRS Lamp Driver, European Union (EU) STRS CASTER Roll Stand 4" TENTE Locking STRS BRKT VESA 75 x 75mm Adapter STRS PLAST Trolley Base Cover STRS PLAST Trolley Column Rear Cover Mushroom Mount Support Kit STRS PLAST Trolley Wall Channel Cover ST80i Stress Test System Instructions for Use D-3 Supplies and Ordering Information New Assembly Part Number Item Trolley Parts (continued) 453564334881 453665085641 453564335281 453564335271 453564337261 453564334881 453564391881 453564335301 STRS MET Basket Paper Catch USB to RS232 Serial Port Adapter STRS Utility Basket STRS MET Top Shelf Utility Hook STRS 1/2 work surface cover STRS Basket Paper Catch STRS Full cover work surface STRS Tango Arm Kit Software and Documentation 453665003611 ST80i Software and Documentation Disk Compatible Products/Parts The following items represent compatible parts and options available for the ST80i Stress Test System at the time of this manuals printing. For more information on accessories or to place an order, contact your local Philips sales representative or SunTech Medical for ordering and other information pertaining to accessories and options for the SunTech Tango M2. See Contacting Your Philips Response Center on page A-7. Part Number Description 989803197451 Tango M2 automated blood pressure monitor Manufacturer SunTech 91-0011-01 91-0013-01 RT 58 Coax BNC to BNC cable, 3M Tango M2 RS232 serial cable, 3M 98-0062-22 Orbit-K Adult Cuff with Mic 98-0062-25 Orbit-K Adult Plus Cuff with Mic 98-0062-23 989803197221 Orbit-K Large Adult Cuff with Mic STRS CBL SpO2 Adult Finger Kit Tango M2 SunTech SunTech SunTech SunTech SunTech SunTech D-4 ST80i Stress Test System Instructions for Use E Specifications and Requirements For details about setting up the system, see the ST80i Stress Test System In-

stallation and Configuration Guide. Note:

No user serviceable parts are inside. ANY modification of this device may alter defibrillator protection. Any modification to any part of this device is to be performed only by qualified service personnel. See also Chapter 6, Maintaining the ST80i System. Essential Performance Statement Within the intended use and environment, the performance elements critical to the ST80i Stress ECG system remain to be the accurate, safe acquisition of ECG signal, accurate rendering of acquired ECG information, as well as correct processing, analysis, and printing of the ECG report. These functionalities shall not be degraded or negatively impacted by electromagnetic, electrical interference, or environmental conditions that the system is designed to withstand. The ST80i system can receive and store blood pressure (BP) and SpO2 measurements (no waveforms) from a qualified OEM medical device. The BP/

SpO2 product is sold as an option and is not used by all customers. Failure to successfully store the measurements on the ST80i system is not considered to be an essential performance failure. The measurement values are available for review on the OEM device and can be manually entered into the ST80i report if persistent data transmission failures occur during the stress ECG exam. Non-medical equipment in the system has been assessed to determine if failures with that equipment could create an unacceptable level of risk. Specifically, it has been determined that early termination or an interruption of a test protocol does not necessarily preclude the patient from receiving additional therapy in a timely fashion. Inclusion of and failure of the non-

medical equipment in the system does not result in creation of an unacceptable risk and, therefore, does not negatively affect the essential performance of the stress system. ST80i Stress Test System Instructions for Use E-1 ST80i System IT Hardware Requirements Similarly, transmission of the ECG report is not considered an essential performance element under environmental disturbances. The test procedure is observed by a qualified clinician as mandated by hospital protocols. Results from the test are stored in real time. Loss of data due to an interruption in the exam is covered by the previous statement dealing with early termination. A report for the test is generated and stored when the testing has been completed. Failure to transmit the data is a recoverable error and delayed transmission of the data does not result in additional unacceptable risk to the patient. ST80i System IT Hardware Requirements For the ST80i System to function properly, the following minimum specified system requirements must be met. Table E-1 Minimum ST80i System IT Hardware Requirements Component Minimum Hardware/Software Specifications Processor Memory Hard disk Display Network 1.1 GHz, 1 MB L2 cache 8 GB or more No less than 160 GB SATA; 7200 RPM The lowest resolution for each layout:

For 4:3, the lowest resolution is 1280 x 960 For 16:9, the lowest resolution is 1366 x 768 Note: The display used with ST80i must meet UL/IEC 62368-1 Safety Standards for Information Technology Equipment. The PCs LAN interface should support IEEE 802.3 compliant 10M/100M/1000M Base-T(X) Ethernet connections LAN connection for laser printer is required Optional LAN card for networking capabilities Operating system Microsoft Windows 10 Professional, 32-bit and 64-bit E-2 ST80i Stress Test System Instructions for Use Component Minimum Hardware/Software Specifications Specifications External Connectivity The system must have the following external connections:

Two RS232 on the PC (or via the USB to RS232 Serial Port Adapter) 100-240V 50/60Hz AC Power input Display output Minimum of five USB ports ST80i may use an external USB hub to extend the USB LAN ports for easier user access, if required Speaker output Printer port Specifications ST80i System Specifications Caution The system does not contain user-serviceable parts. Any modification of this device may alter defibrillator protection. Only qualified service personnel are authorized to modify any part of this device. Table E-2 ST80i System Specifications Function Specifications Instrument type Exercise stress test system Isolation transformer power Output Voltage: 120/240 VAC @ 50/60 Hz Output power: 600VA Input Channels Standard leads Simultaneous acquisition of all 12 leads I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Exercise equipment interface Automatic blood pressure measurement option Digital serial interface to treadmill or ergometer Supports SpO2 and motion tolerant NIBP modules ST80i Stress Test System Instructions for Use E-3 Specifications Function Specifications Network option Optional Network interface for data transfer and printing across your local network Remote Review Workstation option Optional Remote Review Workstation for review, printing, and editing of patient text data acquired from the ST80i system Display format Display Accuracy Sweep speed: Two supported speeds: 25 mm/s and 50 mm/s Size: Range from 19" to 24"

Resolution: The lowest resolution for each layout:

For 4:3, the lowest resolution is 1280 x 960 For 16:9, the lowest resolution is 1366 x 768 The accuracy of the ECG signals are within +/- 5% (or +/-

40 V whichever is greater), over a range of 0 to +/- 5 mV, in the presence of common mode DC offset voltages of +/-

300 mV. The cardiograph performance is tested to comply with the accuracy requirements over the dynamic ranges and frequency ranges specified in the IEC 60601-2-25:2011 standard. For additional details regarding accuracy and precision, refer to the Physician's Guide and the Manufacturer's Disclosure Statement. ECG input Simultaneous input from all 12 leads Patient physiological signal RF Transceiver Input impedance System transfers ECGs uniformly at 1000 samples-per-second, with the amplitude resolution of 1?V/least-significant-bit over the dynamic range of +/- 32 millivolt (16 bits), and with the frequency response of 0.02 to 300 Hertz. Note: Operation of the equipment or system below this amplitude or threshold may cause inaccurate results. RF Type: IEEE 802.15.4 RF band: 2405MHz~2480MHz. RF channel: 2405MHz+n*5MHz, n=0,1,2,315. Occupied Bandwidth: 2MHz RF Maximum Transmit Power: 6dBm Modulation: Offset-QPSK (O-QPSK). Effective radiated power: 5mW Note: The ST80i System may be interfered with by other equipment even if that other equipment complies with CISPR Emission requirements. Meets the requirements of IEC 60601-2-25 Defibrillator protected when used with specified patient cable E-4 ST80i Stress Test System Instructions for Use Specifications Function Specifications Input dynamic range Meets the requirements of IEC 60601-2-25 Common mode rejection Meets the requirements of IEC 60601-2-25 Patient leakage current Meets the requirements of IEC 60601-1 Overall system error Meets the requirements of IEC 60601-2-25 Frequency response Meets the requirements of IEC 60601-2-25 Digital sampling rate 1,000 sample/sec/channel, used for recording and analysis Recording technique Thermal array printer, 200 dots per inch (dpi) Paper type Thermal, perforated, 8.5 in x 11 in Z-fold Recorder Max Power Rate Consumption Recording speeds: 5mm/sec, 10mm/sec, 25mm/sec, 50mm/

sec Channels: User can select any channels to print to thermal printer Sensitivity: 2.5mm/mV, 5mm/mV, 10mm/mV, 20mm/mV Gain: 2.5mm/mV, 5mm/mV, 10mm/mV, 20mm/mV Data acquisition: Direct connect or wireless connection using ST80i wireless patient interface module Computer: 150 W Monitor: 50 W Thermal printer: 60 W Desk light: 6 W Isolation transformer:600 Volt Amps ST80i system classification:

Class I equipment Not suitable for use in the presence of flammable IPX0 anesthetics, or flammable mixtures of air, oxygen, or nitrous oxide Device Classification Internally powered Continuous operation ST80i PIM classification:

Type CF applied part Not suitable for use in the presence of flammable IPX4 anesthetics, or flammable mixtures of air, oxygen, or nitrous oxide Continuous operation ST80i Stress Test System Instructions for Use E-5 Specifications Function Specifications Data acquisition Direct connect or wireless connection using ST80i digital transmitter External output TTL and analog output Medical Isolation Transformer Specifications The medical isolation transformers used with the ST80i system should meet the following specifications: UL 60601-1, CSA C22.2 601.1, EN60601.1, CE

(LVD), ROHS compliant. Figure E-1 Medical Isolation Transformer Provided with ST80i A B C E D A AC fuse holder/Input voltage selector B On/Off switch C AC input D AC output E Output voltage selector Table E-3 Medical Isolation Transformer Specifications Function Input Output Weight Dimensions Specifications 115 (120)/230 (240) VAC, 50/60 Hz, 5.28/2.64 A 115 (120)/230 (240) VAC 5/2.5 A 600 VA Max 26.5 lb (12 kg) Height: 4.08" (103.5mm) Width: 6.55" (166.4mm) Depth: 10.5" (266.7mm) E-6 ST80i Stress Test System Instructions for Use Specifications Function REF: 1404-102 REF: 1404-003 Fuses Specifications Input 120 VAC 6.3AT Input 230 VAC 3.15AT 120 VAC 6.3AT 230 VAC 3.15AT Use agency-approved fuses only: 250V. The transformer has an internal thermal resettable fuse. ST80i Thermal Printer Specifications Figure E-2 Thermal Printer Provided with ST80i Table E-4 ST80i Thermal Printer Specifications Feature Instrument type Paper type Specification Thermal printer Supports the use of the following paper types supplied as Z-

fold in packages of 100 and 200 sheets:

A-size Normal, Anti-fade, and Easy Tear A4-size Normal, Anti-fade, thin, and Easy Tear Recording technique Computer controlled, thermal dot array Print head width 8.5 inches (216 mm) Print head resolution Vertical: 200 dots/inch, vertical Horizontal:

5, 10, and 25 mm/sec: 500 dots/inch 50 mm/sec: 250 dots/inch ST80i Stress Test System Instructions for Use E-7 Supported Treadmills and Ergometers Feature Printer speeds External ports and data interfaces Specification 25 or 50 mm/sec for AUTO report 5, 10, 25, or 50 mm/sec for rhythm print USB 2.0-compliant, type-B socket connector Chassis leakage current Meet or exceed requirements of IEC 60601-2-25 Power Weight 100-240 VAC at 50/60 Hz 9 lb (4.1 kg) Dimensions H x W x D 8 cm x 48 cm x 30 cm maximum Supported Treadmills and Ergometers The ST80i Stress Test System supports the following treadmills and ergometers. Table E-5 Supported Treadmills and Ergometers Equipment Treadmills Manufacturer Trackmaster Treadmills by Full Vision Models TMX425 TMX425C TMX425CP TMX428 TMX 428C TMX428CP Lode Quinton/Mortara/

Cardiac Science h/p/cosmos (Coscom) All OEM treadmills manufactured by Lode B.V. with the part number 939907, 939908, 939909, or 939910, with serial number 20150001 or later All Katana treadmills with serial number 9349XX to 201X0001 All Valiant 2 treadmills with serial number 9389xx to 20140001 Quinton TM55 All models with manufacturing date after December 31, 2007 GE T2100 E-8 ST80i Stress Test System Instructions for Use Equipment Ergometers Manufacturer Ergoline Electromagnetic Compatibility (EMC) Models ST80i supports all Ergoline ergometers that use the ergoselect protocol Lode Corival (906900) Electromagnetic Compatibility (EMC) Electromagnetic compatibility with surrounding devices should be assessed when using the ST80i Stress Test System. The system should be installed and put into service according to the EMC information provided. An electronic device can either generate or receive electromagnetic interference. Testing for electromagnetic compatibility (EMC) has been performed on the ST80i Stress Test System according to the international standard for EMC for medical devices (IEC 60601-1-2, Editions 4 and 4.1). This IEC standard has been adopted in Europe as the European Norm (EN 60601-

1-2, Editions 4 and 4.1). WARNING Radio frequency (RF) interference from nearby transmitting devices may degrade performance of the electronic equipment. Electromagnetic compatibility with surrounding devices should be assessed prior to using the equipment. WARNING Fixed, portable, and mobile radio frequency communications equipment can also affect the performance of electrical equipment. See your Service Provider for assistance with the minimum recommended separation distance between RF communications equipment and the ST80i Stress Test system. WARNING The use of accessories and cables other than those specified in the Philips ST80i Stress Test system service and user documentation can result in increased emissions or decreased immunity of the system. ST80i Stress Test System Instructions for Use E-9 Electromagnetic Compatibility (EMC) WARNING The ST80i Stress Test system should not be used next to or stacked on top of other equipment. If you must stack the product, you must check that normal operation is possible in the necessary configuration before the product is used. WARNING Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ST80i system including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Note:

The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential area

(for which CISPR 11 class B is normally required), this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or reorienting the equipment. Accessories and Cables Warning The use of accessories and cables other than those specified in Appendix D, Ordering Options and Parts, may result in increased emissions or decreased immunity of the ST80i Stress Test System. Use only a shielded LAN cable when connecting the cable to the ST80i LAN port. Use only an RS-232 cable to connect the ST80i system to treadmills, ergometers, or NIBP devices such as the SunTech Tango M2. Use of USB cables for these devices is not recommended and could result in abnormal operation of ST80i due to electromagnetic noise interference Reducing Electromagnetic Interference The ST80i Stress Test system and accessories may become sensitive to interference from other RF energy sources including power lines. RF energy sources include other medical devices, wireless devices, information technology equipment, and radio/television transmission. Should interference be encountered, as demonstrated by artifact on the ECG trace, unintended change on operating state, or unit lockup, attempt to locate the source by assessing:

E-10 ST80i Stress Test System Instructions for Use Electromagnetic Compatibility (EMC) If the interference is intermittent or constant?

Does the interference occur only in certain locations?

Does the interference occur only when in close proximity to certain medical devices?

Does the ECG signal quality change dramatically when the AC power cord is unplugged?

Once the source of the interference is located, attempt to attenuate the EMC coupling path by distancing the ST80i from the source of the interference as much as possible. If further assistance is needed, contact the Philips Response Center or your certified dealer. The ST80i Stress Test system has been evaluated in the Electromagnetic Environment listed in tables E-6 to E-11 based on Medical Collateral standard IEC 60601-1-2:2020. Table E-6 Electromagnetic Emissions Phenomenon Compliance RF Emissions CISPR 11, Group 1, Class A Harmonic distortion IEC 61000-3-2 Class A Voltage fluctuations and flicker IEC 6100-3-3 Electromagnetic Environment Professional healthcare facility environment Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. Professional healthcare facility environment Professional healthcare facility environment ST80i Stress Test System Instructions for Use E-11 Electromagnetic Compatibility (EMC) Note:

According to clause 7.2.1 and 7.2.2 of IEC 60601-1-2:2014 and IEC 60601-1-

2:2020, Harmonic Emissions and Voltage Fluctuations/Flickers emissions are not applicable to ST80i Stress Test System when working with treadmill or ergometer which is not qualified to connect to PUBLIC MAINS NETWORK. Table E-7 Enclosure Port Phenomenon Compliance Electrostatic discharge IEC 61000-4-2 Radiated RF EM field IEC 61000-4-3 Immunity Test Levels Professional Healthcare Facility Environment 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 3 V/m 80 MHz 2.7 GHz 80% AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000-4-3 Refer to table E-8 Rated power frequency magnetic fields IEC 61000-4-8 30 A/m 50 Hz or 60 Hz Proximity magnetic fields IEC 61000-4-39 Refer to Table E-11

. Table E-8 Proximity fields from RF wireless communications equipment Test Frequency (MHz) Band (MHz) 385 450 380 390 430 470 Immunity Test Levels Professional Healthcare Facility Environment Pulse modulation 18 Hz, 27 V/m FM, 5 kHz deviation, 1 kHz sine, 28 V/m E-12 ST80i Stress Test System Instructions for Use Electromagnetic Compatibility (EMC) Table E-8 Proximity fields from RF wireless communications equipment (continued) Test Frequency (MHz) Band (MHz) Immunity Test Levels Professional Healthcare Facility Environment 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 704787 Pulse modulation 217 Hz, 9 V/m 800960 Pulse modulation 18 Hz, 28 V/m 17001990 Pulse modulation 21 Hz, 28 V/m 24002570 Pulse modulation 217 Hz, 28 V/m 51005800 Pulse modulation 217 Hz, 9 V/m

. Table E-9 Input AC Port Phenomenon Basic EMC Standard Immunity Test Levels Professional Healthcare Facility Environment Electrical fast transients/

burst IEC 61000-4-4 2 kV 100 kHz repetition frequency Surges line-to-line IEC 61000-4-5 0.5 kV, 1 kV Surges line-to-ground IEC 61000-4-5 0.5 kV, 1 kV, 2 kV ST80i Stress Test System Instructions for Use E-13 Electromagnetic Compatibility (EMC) Table E-9 Input AC Port (continued) Phenomenon Basic EMC Standard Immunity Test Levels Professional Healthcare Facility Environment Conducted disturbances induced by RF fields IEC 61000-4-6 Voltage dips IEC 61000-4-11 3 V, 0.1580 MHz 6 V in ISM bands between 0.15 and 80 MHz 80% AM at 1 kHz 0% UT; 0.5 cycle at 0, 45, 90, 135, 180, 225, 270, and 315 0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase at 0 Voltage interruptions IEC 61000-4-11 0% UT; 250/300 cycles

. Table E-10 Signal Input/Output Parts Port Phenomenon Basic EMC Standard Immunity Test Levels Professional Healthcare Facility Environment Electrostatic discharge IEC 61000-4-2 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air Conducted disturbances induced by RF fields IEC 61000-4-6 3 V, 0.1580 MHz 6 V in ISM bands between 0.15 and 80 MHz 80% AM at 1 kHz Electrical fast transients/bursts IEC 61000-4-4 1 kV 100 kHz repetition frequency

. Table E-11 Proximity Magnetic Fields Test Frequency Modulation Immunity Test Levels Professional Healthcare Facility Environment 134.2 kHz 13.56 MHz Pulse modulation 2.1 kHz 65 A/m Pulse modulation 50 kHz 7.5 A/m E-14 ST80i Stress Test System Instructions for Use 0123 www.philips.com/IFU Koninklijke Philips N.V., 2024 All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means, electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner. 453564396631, Revision H

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STRS LBL PIM Wireless Regulatory x 453564237541 Rev P go { MITI0N0000000

@) GMDN:16231 FCC ID:PQC-WPIM Rony CCAO18LPO700T4 1C:3549B-WPIM 0123 kes wl SIP-CRI-PCE-sTeowPIM @S moveL: weiM.oo1 Ie SAMUS 2B S AISA 7540] wg i Made in China from foreign efer to host device []+ 15V AA| gdomestic components,

 

 

 

 

 

 

Philips Medical Systems North America Co. TO:

Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Date: 2024-03-25 Regarding: FCC ID: PQC-WPIM To whom it may concern:

We, the undersigned, hereby authorize Parlam Zhan (Manager of SGS Shanghai Test Lab) to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Where our agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by SGS North America, Inc., still resides with Philips Medical Systems North America Co. This authorization is valid until further written notice from the applicant. Name (Printed): Delroy Smith Title: Principal Architect Signature:

On behalf of Company: Philips Medical Systems North America Co. Telephone: 1-617-798-0865

 

 

Philips Medical Systems North America Co. To:

From: Philips Medical Systems North America Co. SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia United States 222 Jacobs Street, Cambridge, Massachusetts 02141, United States Regarding: Confidentiality Request regarding application for FCC ID: PQC-WPIM LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commissions rules, the applicant hereby request confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. Sincerely, Signature:

Printed Name (on file with the FCC associated with the Grantee Code): Delroy Smith Title: Principal Architect Company Name: Philips Medical Systems North America Co.

 

 

UNITED STATES DESIGNATED AGENT LETTER Date: 2024-03-25 TO:

Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Applicant Company Name: Philips Medical Systems North FRN:

Grantee Code:

Contact Name:

Address:

City/Province/Zip: Cambridge, Massachusetts America Co. 0017950635 PQC Delroy Smith 222 Jacobs Street U.S. designated agent Company Name: Philips Medical Systems North FRN:

Contact Name Address:

City/Province/Zip: Cambridge, Massachusetts America Co. 0017950635 Delroy Smith 222 Jacobs Street 02141, United States 1-617-798-0865 1-617-798-0865 delroy.smith@philips.com 02141, United States 1-617-798-0865 1-617-798-0865 delroy.smith@philips.com Telephone:

Fax:

Email:

Telephone:

Fax:

Email:

ATTN: Director of Certification:

We, Philips Medical Systems North America Co. understand and acknowledge the applicants consent and the designated agents obligation to accept service of process in the United States for matters related to the applicable equipment, and at the physical U.S. address and e-mail of the designated agent listed above. We, Philips Medical Systems North America Co. acknowledge the applicants acceptance of its obligation to maintain an agent for service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. Applicant Name (Printed): Delroy Smith Title: Principal Architect Signature:

U.S. designated agent Name (Printed): Delroy Smith Title: Principal Architect Signature:

 

 

 

 

 

 

SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Declaration Applicant Legal Business Name Philips Medical Systems North America Co. Address FRN Grantee Code FCC ID Authorized Contact Name Contact Email Contact Phone 222 Jacobs Street, Cambridge, Massachusetts 02141, United States 0017950635 PQC PQC-WPIM Delroy Smith delroy.smith@philips.com 1-617-798-0865 I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare;

a) b) c) d) e) f) g) in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for:

labeling the equipment with the exact FCC ID as specified in this application,

(1)

(2) compliance statement labeling pursuant to the applicable rules,

(3) compliance of the equipment with the applicable technical rules, if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCCs technical requirements. in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321. in accordance with ISO 17065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements.

(1)

(2)

(3) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. the Applicant shall, upon request by SGS, at the Applicants expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a party for these purposes. the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fcc.gov/oetcf/kdb/index.cfm Link to RSP-100: https://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01130.html Link to the Covered List: Covered List

[Philips Medical Systems North America Co.] (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules.

[Philips Medical Systems North America Co.] (the applicant) certifies that, as of the date of the filing of the application, the applicant [is not] identified on the Covered list, established pursuant to 1.50002, as an entity producing covered equipment. Applicant Signature:

Print Name:

Title:

Delroy Smith Principal Architect Date: 2024-03-25

*NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database QSF27-14-04 Rev 1.1 Jan 17, 2024 Page 1 of 1 Original Issue: Jan. 4, 2021