ST80i Stress Test System Instructions for Use
ST80i Stress Test System INSTRUCTIONS FOR USE Edition 1 June 2012
Notices PN 453564XXXXXX June 2012 Edition 1 Printed in the USA Edition History Edition 1, June 2012 Applicable to ST80i, version A01.00 and later. Philips Medical Systems shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material. Copyright Copyright © 2012 Koninklijke Philips Electronics N.V. All rights are reserved.
Contents Chapter 1 Safety Summary Conventions Used in the Instructions for Use . . . . . . . . . . . . . . . . . . . i Symbols Marked on the ST80i System . . . . . . . . . . . . . . . . . . . . . . . i Symbols Marked on the ST80i System Packaging . . . . . . . . . . . . . . iii Disposal Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Important Patient and Safety Information . . . . . . . . . . . . . . . . . . . .
Table of Contents Chapter 2. An Overview of the ST80i Stress Test System User Accounts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Starting the Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 User Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 ST80i Test Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Title Bar. . . . . . . . . . . . . . . . . . . . . . .
Table of Contents Chapter 3. The Patient Session Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1 Using the Patient Worklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4 Worklist Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5 Patient Information Management . . . . . . . . . . . . . . . . . . . . . . 3-5 Patient Information Fields . . . . . . . . . . . . . . . . . . . . . . . . . . .
Table of Contents Report Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-38 Post-Recovery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-38 Final Report Manager. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-38 Global Interpretive Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 3-39 DXL Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-39 CALg Templates. . . . . . . . . . . . . . . . . . .
Table of Contents Printer Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26 Print Report Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28 ECG Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29 Events Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30 Rhythm Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31 Final Report . . . . . . . . . . . . . . .
Table of Contents Contacting Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10 Philips Healthcare Customer Care Solution Center . . . . . . . .A-10 North America . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10 South America . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10 Europe. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10 Asia Pacific. . . . . . . . . . . . . . . . . . . . . . . . . . .
Table of Contents Medical Isolation Transformer Specifications . . . . . . . . . . . . . E-6 ST80i Thermal Printer Specifications. . . . . . . . . . . . . . . . . . . . E-7 Supported Treadmills and Ergometers . . . . . . . . . . . . . . . . . . . . . . E-8 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . E-8 Accessories and Cables Warning . . . . . . . . . . . . . . . . . . . . . . .
Table of Contents viii ST80i Stress Test System Instructions for Use
Safety Summary This chapter provides important safety information related to the use of the ST80i Stress Test System. US FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Conventions Used in the Instructions for Use The following conventions are used in the ST80i Stress Test System Instructions for Use, this guide. WARNING Warning statements describe conditions or actions that may result in personal injury or loss of life.
Safety Summary Symbol Description Indicates that the system is receiving alternating currents. Fuse The connector near this symbol receives an incoming signal. CE mark. The number next to this symbol is the serial number of the system. The number next to this symbol is the product model number of the system. Dispose of in accordance with the requirements of your country. An International Protection Rating of “IPX0” indicates that the equipment has no special protection against moisture ingress.
Symbols Marked on the ST80i System Packaging Symbols Marked on the ST80i System Packaging Symbol Description Keep dry. Keep out of direct sunlight. Acceptable temperature range. Move and store packaging this end up. Fragile. Recycle the packaging materials after use. Manufacturer Disposal Information This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or federal laws.
Safety Summary Important Patient and Safety Information Patient and safety information is divided into several sections: ST80i Stress Test System (next section) Medical isolation transformer (page ix) Philips advanced interface module (AIM) (page x) Philips wireless patient interface module (PIM) (page xi) For information about electromagnetic compatibility (EMC) with surrounding devices, see “Electromagnetic Compatibility (EMC) - To be finalized” on page E-7 of Appendix E, “Specifications
Important Patient and Safety Information To maintain designed operator and patient safety when assembling a medical electrical system for use in the patient environment, the responsible organization shall ensure that peripheral equipment and accessories used that can come in direct patient contact must comply with the following standards: – IEC 60601-1-1:2000 aka CAN/CSA-C22.2 No.
Safety Summary vi Use only shielded LAN cable when connecting the cable to the ST80i LAN port. Use Philips-approved lead wires with defibrillator protection resistors. To avoid the possibility of serious injury or death during patient defibrillation, do not come into contact with the wireless PIM or lead wires. Additionally, proper placement of defibrillator paddles in relation to the electrodes is required to minimize harm to the patient.
Important Patient and Safety Information – taking care when dressing the ECG cables so as to minimize the potential tripping hazard during the stress ECG study process – securing the patient lead set, power cable, treadmill cable, echo cable, NIBP cable, and SpO2 cable away from patient’s feet before beginning exercise stage The ST80i captures and presents data reflecting a patient’s physiological condition that, when reviewed by a trained physician or clinician, can be useful in determining a diagn
Safety Summary Do not attempt to clean the device or patient lead wires by submersion, autoclaving, or steam cleaning. Wipe the exterior surface of the device and patient lead wires with a compatible nonalcohol sterilizing disinfectant, then dry with a clean cloth. See “Cleaning the ST80i System” on page 5-2 in the “Maintaining the ST80i System” chapter for a list of approved disenfectants. Be careful not to damage the display when moving the trolley or when moving other equipment near trolley.
Important Patient and Safety Information – – – – – Class I equipment Type CF applied parts Ordinary equipment Not suitable for use in the presence of flammable anesthetics Continuous operation Philips will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information which will assist the user’s appropriately qualified technical personnel to repair those parts of equipment which are designated by the manufacturer as repairable.
Safety Summary Important Notes about the Medical Isolation Transformer Do not connect the treadmill or the ergometer to the medical isolation transformer supplied by Philips. It is important that the treadmill and ergometer has its own source of unshared power to avoid an interruption to the power supply to the ST80i System. The treadmill and ergometer should have its own circuit and fuse/breaker in a local power distribution box.
Important Patient and Safety Information be determined by turning the device off and on, the user is encouraged to try to correct the interference by one or more of the following measures: – Reorient or relocate the receiving antenna – Increase the separation between the device and receiver – Connect the device into an outlet on a circuit different from that to which the receiver is connected – Consult the dealer or an experienced radio/television technician for help The radio device used in thi
Safety Summary Warnings about the Wireless Patient Interface Module WARNING Failure to follow these warnings could affect both patient and operator safety. The wireless patient interface module transmits data reflecting a patient’s physiological condition to a properly equipped system and when reviewed by a trained physician or clinician can be useful in determining a diagnosis. However, the data should not be used as a sole means for determining a patient’s diagnosis.
Important Patient and Safety Information Caution Statements for the Wireless Patient Interface Module CAUTION Failure to heed these caution statements may result in damage to equipment or software. The wireless patient interface module complies with FCC radiation exposure limits set forth for an uncontrolled environment. The wireless PIM supports 1.5V AA alkaline batteries only. Replace the battery if the low-battery alert appears before the stress test starts.
Safety Summary Important Notes about the Wireless Patient Interface Module Wireless patient interface module leakage currents are 100% safety tested in production. Use Conditions: This device complies with Part 15 of the FCC rules.
Important Patient and Safety Information – Ce dispositif doit accepter tout brouillage reçu, y compris un brouillage susceptible de provoquer un fonctionnement indésirable. This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB-001 du Canada. Proper patient preparation is important for proper application of ECG electrodes and operation of the device. Use wireless PIM belts and NIBP cuffs appropriate for the patient’s size.
Safety Summary Security Recommendations As more patient health information is collected, stored, and transmitted electronically, on a global basis, the concern for patient privacy grows. We consider the security and confidentiality of patient data to be of paramount importance.
Security Recommendations Implement “best practices” Windows security measures to minimize unauthorized system access. These measures include making passwords complex, regular changing of passwords, short screen saver intervals, short auto logout intervals when the system is idle, and training your users to lock the desktop when they leave the computer. Install McAfee anti-virus software.
Safety Summary xviii Perform regular backups of system data and store in a secure location. ST80i allows you to back up the stored ECG report and the configuration setting. Users with adminstrator accounts can backup and restore ECG reports from the “Archive” screen; administrators can also backup the configuration setting on the “Settings” screen. The exported configuration setting can be imported on the “Settings” screen to restore the ST80i software.
The Philips ST80i Stress Test System The Philips ST80i Stress Test System Intended Use The Philips ST80i Stress Test System is a PC-based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices.
Safety Summary xx ST80i Stress Test System Instructions for Use
1 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 patient’s condition.
About the Philips ST80i Stress Test System Overview The ST80i System is a PC-based diagnostic tool intended to acquire, process, and store ECG data of patients undergoing stress exercise testing. The software records ECG, heart rate, and ST data, creates summary tables, trends, and produces a final report regarding a variety of cardiac data indices.
About ST80i Documentation ST80i interfaces with a treadmill, ergometer, or as part of a pharmacological study, and captures four phases of a patient exercise test: Pre-exercise Exercise Recovery (and Post-Recovery) Report About ST80i Documentation Philips provides detailed instructional and reference materials to help you get the most out of your ST80i System.
About the Philips ST80i Stress Test System Conventions Used in this Guide The documentation and training materials for ST80i use the following typographic conventions. Item How Displayed Menu item Button name Menu items and button names appear in a bold no-serif font. Field names and list items Field names and list items appear in a no-serif font. Example: Click Settings. Example: Select the appropriate format from the Format dropdown list.
About ST80i Documentation 5 A Maintaining the Philips ST80i Stress Test System. Describes how to clean and maintain the system. Troubleshooting and Contacting the Response Center. Describes some issues you might encounter and what to do about them. Also describes how to contact the Philips Response Center. B Protocol Reference. Provides an example of the settings for each of the D Ordering Options and Parts. Provides a list of parts (including support parts) E Specifications and Requirements.
About the Philips ST80i Stress Test System 1-6 ST80i Stress Test System Instructions for Use
2 1 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.
An Overview of the ST80i Stress Test System Treadmill Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14 Ergometer Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14 Using the Toolbar Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14 Waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17 Hide/Show View . . . . . . . . . . . . . . .
User Accounts User Accounts User accounts are created with specific access privileges based on function. ST80i user accounts are categorized as follows: Administrators – these users are allowed to perform all operations on the system. Clinicians – these users are allowed to perform all operations on the system except most configuration operations. The only configuration that the Clinician would be able to perform is report configuration for fine tuning on final reporting (“Finalizing”).
An Overview of the ST80i Stress Test System The Main screen is where you perform all tasks for the application. NOTE To conduct a stress test, click Patient. To enter the stress system database to review and retrieve archived reports, click Report. In this area, you can also replay, delete, or export a selected exercise stress test. To review, update, or test software and firmware configurations, click Service. To hear an audio explanation of the exercise stress test, click Explain Test.
User Accounts User Profile The system ships with a default user profile that cannot be deleted. The user profile contains preconfigured settings that are used to determine how the test will run and how the test results will be displayed, printed, saved, and exported. Some settings are fixed and cannot be changed; some settings represent a default view, which can be changed during the exercise stress test.
An Overview of the ST80i Stress Test System ST80i Test Screen The ST80i Test screen (user interface) provides: All key procedural information including the protocol being used Pop-ups, drill-down menus, and notes pages that can be viewed then hidden so that the leads can be viewed in their entirety Time of Day for correct time stamp on the start-up screen for every stress test Real-time ECG as well as NIBP and SpO2, Trends, and other numeric displays that include ST values, ST slope, Double
ST80i Test Screen Feature Description B Procedure Bar - used to control the exercise stress test process; shows exercise stage; selected patient interface device; protocol; BP, ECG Print and Rhythm Print buttons; and stage time C Toolbar - displays the Toolbar icons that provide quick access to frequently used commands throughout the exercise stress test D Waveform Screen - provides real-time ECG waveforms during the exercise stress test E Side Panel - provides real-time updates during the stress
An Overview of the ST80i Stress Test System To add or update patient information 1 Click on the Patient Name in the title bar. The system displays the Patient Demographics window. Figure 2-4 Patient Demographics window 2 Enter new information for the patient or update the fields as needed during the stress test. 3 Click OK when finished to save the data.
ST80i Test Screen Procedure Bar By default, the Procedure Bar is at the top of the screen. You can change the location of the Procedure Bar to the bottom of the screen. See the ST80i Installation and Configuration Guide to change the default setting [Settings User Profile Display].
An Overview of the ST80i Stress Test System Toolbar The Toolbar contains the Toolbar icons that are used during the patient session. The icons provide quick access to frequently used commands. During the patient session, the waveform screen is displayed. You can use the Toolbar icons during the patient session to view or hide specific exercise stress test data - which appear as an overlay on the waveform screen.
Side Panel 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 override NIBP and SpO2 values. In addition, you can change the treadmill speed and duration during a patient session or stop the treadmill altogether.
An Overview of the ST80i Stress Test System Table 2-4 Side Panel Features Feature Description A Heart rate beats per minute B Target heart rate – visual and audible indicators when target heart rage is achieved C Maximum heart rate D BP mmhg – current blood pressure; used also to manually insert current BP measurement E Previous BP mmhg – when BP is taken as pre-configured by stage, previous BP is shown; previous BP is also shown when you manually insert current BP measurement F SpO2 numeric
Side Panel Max (220) Shows the maximum heart rate for patient, male or female. BP mmhg When the patient's NIBP is collected during the exercise stress test based on the defined interval in the Exercise Protocol (Off, Begin, End, Every), the BP mmgh field displays the measurement. If you click the BP button during the patient session, the current blood pressure measurement also displays in this field. With this interface, there are visual and audio prompts (if enabled) for NIBP acquisition.
An Overview of the ST80i Stress Test System To override or manually enter the Sp02 1 Click the dashed lines or value. 2 Type in the latest SpO2 3 Click OK. Double Product (HR*BP) Double Product is the current heart rate times the current blood pressure measurement.
Using the Toolbar Icons Treadmill Button The Treadmill button is used to stop and start the treadmill during a patient session. WARNING CAUTION The ST80i USB and RS-232 ports should be connected only to treadmills, ergometers, and NIBP monitors that are certified to meet IEC 60601-1 and are listed as supported devices in the Instructions for Use. See “Supported Treadmills and Ergometers” on page E-7 of Appendix E, “Specifications and Requirements”.
An Overview of the ST80i Stress Test System Compare the current averages with reference ECG (resting, supine, hyperventilation averages) and worst case for all 12 leads. ST80i is able to select a new ECG complex or 10s strip as the new reference. This can be done on the screen and is available at any point during the test.
Using the Toolbar Icons Table 2-5 Toolbar Icons Icon Description Event Select the Event from the drop-down list and do X.
An Overview of the ST80i Stress Test System Table 2-5 Toolbar Icons Icon Description Gear Quick Settings: Filter (LP, HP, AC, Artifact, Smart) Display (Limb Gain, Chest Gain, Speed) Rhythm Print (Leads, Limb Gain, Chest Gain, Speed) Sync Out (Analog Out 1 – Amplify Ratio; Analog Out 2 – Amplify Ratio; TTL Out – Polarity, Duration) Waveform Real-time ECG analysis employs the latest C-Alg analysis to calculate an adult patient's ECG for ST segment (elevation or depression) and to produce
Using the Toolbar Icons Show Lead Map Show Zoom ST Show ST Map Show Trend View (HR/METS; BP; ST Level) Show Average About the Lead Map The Lead Map diagram shows the status of each lead. Yellow indicates lead-off, and green indicates good contact. To view the Lead Map 1 Click the Hide/Show View icon. 2 Select Show Lead Map. The Lead Map appears in the top-right corner of the waveform. All connections need to be green.
An Overview of the ST80i Stress Test System About the Zoom ST The Zoom ST lead display shows one expanded average ECG complex, which is an averaged ECG enlarged to four times the normal size. The absolute ST segment values and slope values are displayed for the expanded lead. This function allows you to better visualize the ST segment changes during the test. The default ST lead is shown in the zoomed QRS window during the exercise stress test.
Using the Toolbar Icons To view the Zoomed ST Lead 1 Click the Hide/Show View icon. 2 Select Show Zoom ST. The default Zoom lead appears as one expanded average ECG complex on the waveform. Figure 2-10 Zoom ST Display 3 To close, click the X in the upper-right corner. To change the Zoomed ST Lead 1 Click the Hide/Show View icon. 2 Select Show Zoom ST The default Zoom Lead name appears on the waveform. 3 Use the Lead drop-down menu to change to another Zoom Lead.
An Overview of the ST80i Stress Test System To view the ST Map 1 Click the Hide/Show View icon. 2 Select Show ST Map. The ST Map displays on the waveform. Figure 2-11 ST Map 3 Click the X in the upper-right corner to close the ST Map. About Trend View The Trends graphs show a visual indicator for the current heart rate as well as the dynamic change in heart rate. The Trends data appears in 3 charts that can be viewed at any time.
Using the Toolbar Icons To view Trends 1 Click the Hide/Show View icon. 2 Select Show Trend View from the drop-down menu. Figure 2-1 Show Trend View The Trends View has three charts: 3 – HR/METS – ST J + mV – BP (Systolic, Diastolic) Click the X to close the Show Trends view. About HR/METS This two-dimensional, color-coded chart is a visual indicator for both the current heart rate and a dynamic change in heart rate.
An Overview of the ST80i Stress Test System About BP About the Average Complex Display The Average Complex display shows one average complex for each of the 12 leads regardless of what lead format is being displayed. The system displays the ST value in microvolts (or mm) for the on-screen average complexes. To change the ST value from mV to mm, see the ST80i Installation and Configuration Guide. To view the Average Complex Display 1 Click the Hide/Show View icon.
Using the Toolbar Icons Freeze You can print a 12-Lead ECG at any time by clicking the Print button. During the Exercise phase, when you select the 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 Select the Freeze icon.
An Overview of the ST80i Stress Test System 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 will print it in the Rhythm Events portion of the final report. User Notes are also associated with the Event, if created. See “Note” on page 2-28 regarding the Note icon. In addition, ST80i automatically detects an arrhythmia event–if this is enabled.
Using the Toolbar Icons Figure 2-5 Add New Event Window 3 Type in 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. Recording RPE The Rate of Perceived Exertion (RPE) scale provides an indication of the percentage of maximum work being done by a patient. The RPE scale subjectively rates work (physical exertion) as stated by the exercising patient. It provides a means to quantify a patient's level of exertion.
An Overview of the ST80i Stress Test System 3 Continue this process throughout the Exercise phase. The RPE ECG is also held in memory, and is printed in the Rhythm Events section of the final report. For an explanation of how this appears in the final report, see “Working with Reports” on page 4-1. Note During the patient session, you can add notes about the patient's progress as well as important information regarding the exercise stress test.
Using the Toolbar Icons 3 If you do not currently have a particular compare point, click the Event icon to select an event or create a new event. An ECG will print. 4 Select the Compare icon to compare the current state to when the event occurred or to an earlier point in time. A drop-down list of current events/compare points allows you to compare the current state to when the event occurred or to an earlier point in time. Figure 2-8 5 Compare Drop-Down List Select an item from the list.
An Overview of the ST80i Stress Test System Gear (Quick Settings) Click the Gear/Quick Settings icon to display the four-tabbed Quick Settings window from which you can change specific default settings that relate to the following: Filter Display Rhythm Print Sync Out Figure 2-10 Quick Settings Window Filter The Filters are pre-configured in the Settings section of the application.
Using the Toolbar Icons AC Filter: 50Hz, 60Hz, None Artifact Filter: On, Off Smart Filter: On, Off The same filter settings apply to both displayed and printed waveforms. The filter settings are printed with the report. To change the Filter settings 1 Select the Gear (Quick Settings) icon. 2 Select the Filter tab. 3 Change or modify each filter, as required. 4 Click OK to save changes. For more information, see “Filtering” on page 3-25.
An Overview of the ST80i Stress Test System Rhythm Print Before you select the Rhythm Print icon from the Procedure bar to print a continuous strip, you can modify your settings based on the following: Leads Limb Gain Chest Gain Speed To change the Rhythm Print settings 1 Click the Gear (Quick Settings) icon. 2 Select the Rhythm Print tab. 3 Place a checkmark for each lead you want to print. (1 - 13 leads are available.) 4 Use the drop-down arrow to adjust the Limb Gain setting. (2.
Using the Toolbar Icons To change Sync Out settings 1 Select the Gear (Quick Settings) icon. 2 Select the Sync Out tab.
An Overview of the ST80i Stress Test System 2-34 ST80i Stress Test System Instructions for Use
3 1 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 and gather pre-exercise data, and lasts through generation of the final report. In ST80i, the exercise stress test begins with the Pre Exercise phase and ends with the Report phase.
The Patient Session Checking the Treadmill/Ergometer Connection . . . . . . . . . . . . . . . .3-14 Starting a Patient Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15 Select the Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-15 Select the Wireless PIM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-16 Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Overview Starting a New Patient Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-47 Exiting the Application. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Patient Session Using the Patient Worklist When you click Patient on the Main screen, you are taken to the Select Patient screen, where you begin a patient session by selecting the patient for the exam. The Select Patient screen includes two tabs: Worklist Remote Find Figure 3-1 Select Patient Screen Use the Worklist tab to manage patient information. The Worklist enables you to pre-register up to 200 patients.
Using the Patient Worklist Editing a patient profile Deleting one or more patient information records Downloading orders or pre-registered patient information Selecting a patient to begin the exercise stress test On the Worklist tab, you can also use the column headings to sort each list. Figure 3-2 Worklist Tab Patient Information Management ST80i displays and reports key patient demographic information such as the patient name, hospital ID number, etc.
The Patient Session Figure 3-3 Edit Patient Information Screen You can also access this information from the Report screen. See “Working with Reports” on page 4-1. Patient Information Fields ST80i supports predefined and user-defined patient information fields. The predefined patient information fields are shown in the Patient Information tab of the Edit Patient Information screen. The patient information fields are configured as mandatory or not. Mandatory fields are displayed in blue text.
Using the Patient Worklist 3 NOTE – Patient Information – History – Medications/Dosage – 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. When mandatory fields are missing, you will be warned with a pop-up message box. If these fields are changed, a warning message pops up and the resting ECG will be re-interpreted.
The Patient Session Figure 3-4 3 4 NOTE Edit Patient Information Screen Update or edit the patient information in each of the following tabs, as required: – Patient Information – History – Medications/Dosage – Physician/Order – Custom Fields If you want to: – Save the information and return to the Worklist, click Save. – Save the information and begin the stress test, click OK. When mandatory fields are missing, you will be warned.
Using the Patient Worklist Download Preregistered Patient Information With ST80i, you are able to download preregistered patient information by accessing the order or ADT server via the network. The local patient information that you download from remote server or manually add will be stored in a local database. This optional feature permits the creation of a preregistered patient list. To download orders -- procedure in development...
The Patient Session Figure 3-1 5 Report Screen Click the Back button to return to the Select Patient from Worklist screen. Select a Patient When you are ready begin the patient session for a patient, select his or her name from the Worklist. To select a patient to begin the patient session 1 Place a checkmark by the patient's name. 2 Click OK or press Enter.
Using the Patient Worklist Figure 3-2 Remote Find Tab To do a Remote Find 1 Select the location from the Location drop-down list. 2 Fill in one or all of the following fields: 3 – Patient ID – Last Name – First Name – DOB (MM/DD/YYYY) – Order Number Click the Find button. Patient's name appears in the Remote Find list. 4 Place a checkmark by the patient's name. 5 Click the OK button to start a patient session.
The Patient Session Before the Patient Session The exercise stress test process requires some advance preparation before running the patient session. Advance preparation includes the following: Checking the Wireless Patient Interface Module (PIM) Checking the equipment connection (treadmill/ergometer), if used Setting up the Pharma test Once advance preparation is complete, the patient session follows a series of typical steps from preparing the patient to the final review of the exam.
Before the Patient Session The wireless PIM can also be commanded by the host application to transmit on a user-selected channel to manually override the automatic system driven settings to avoid wireless interference. See the ST80i Installation and Configuration Guide for information on configuring a wireless channel for communication.
The Patient Session When using the wireless PIM, refer to the ST80i Wireless Patient Interface Module Instructions for Use for details on its preparation, configuration, and use. If your facility is using more than one PIM, each one must be added to the ST80i application under Settings (System Settings; I/O Devices). When you connect the patient to one of the PIM devices, you also need to verify the address on the device with the address that shows up on the Pre Exercise screen.
Starting a Patient Session Starting a Patient Session When you select a patient from the Worklist for the stress test, you are immediately brought to the Pre Exercise screen. Based on your user account settings at log-in, a preconfigured profile is loaded for the stress test protocol. Select the Patient To select a patient from the Worklist 1 Click Patient on the Main screen. 2 Place a checkmark in the patient name line and click OK, or double-click the patient’s name.
The Patient Session Select the Wireless PIM The wireless PIM contains a power on/power off button. Before connecting a patient to the PIM, check the battery status and the wireless signal quality. You will also need to confirm that you are using the right PIM by checking the PIM address. By default, you will see PIM1 as the first device on the Pre Exercise screen. When you click on the device name, a unique address appears which is used to identify that specific PIM.
Preparing the Patient Preparing the Patient Good ECG technique is very important to achieve the best quality results. Instructing the Patient about the Test Before attaching the electrodes, greet the patient and explain the procedure. Explaining the procedure decreases anxiety and informs the patient about what to expect. You may also click the Explain Test button on the Main screen to play an audio file that explains the test to the patient.
The Patient Session Preparing the Skin Thorough skin preparation is very important. The skin is a poor conductor of electricity and frequently creates artifact that distorts the ECG signal. By performing methodical skin preparation, you greatly reduce the potential for myographic noise and baseline wander, ensuring high-quality printouts and displayed data. There is a natural resistance on the skin surface due to dry, dead epidermal cells, oils, and dirt.
Preparing the Patient All leads are acquired simultaneously. Review the following lead wire labeling and electrode placement information in Figure 3-5 and Table 3-1 to ensure a quality ECG.
The Patient Session Table 3-1 Leads and positioning AAMI Lead IEC Lead Electrode Position Place the limb electrodes for the arm directly on the clavicle bones (away from major muscles) Below V6 on the ribcage On the sternum, midway between the clavicle and the 4th intercostal space 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 described in Table 3-1 and illustrated in Figure 3-5; then press the adhesive rin
Preparing the Patient Change from Limb Lead to Mason-Likar To attach the electrodes for the Supine (Resting) phase 1 Place the upper body electrodes on the patient. 2 Have the patient lie down. 3 Attach the leg electrodes. 4 Take the BP measurement. 5 Record the ECG. 6 Label the ECG “Supine.” To attach the electrodes for the Exercise Phase (Standing) 1 Disconnect the limb leads from the patient. 2 Remove the leg electrodes. 3 Hold the PIM as the patient stands.
The Patient Session Power on/off the PIM Check PIM battery status, wireless link quality, and lead contact quality When requested to check battery status, the wireless PIM will provide indication of estimated battery power remaining. When requested to check status of connection to the host system, the wireless PIM will indicate relative signal strength based on the measured signal quality for the link to the host receiver.
Preparing the Patient Checking the Lead Map To check the Lead Map Select Show Lead Map from the Hide/Show View icon on the Pre Exercise or Exercise screen. A color-coded anatomical diagram displays the lead connections. Figure 3-6 Lead Connections If a lead is off, a red “X” is displayed on the lead map and red, dashed flat line is displayed in the real-time ECG view. On the PIM, this condition is verified by a yellow LED light.
The Patient Session Figure 3-7 Red Dashed Line Showing Leads-Off Condition for V4 ST80i will also provide an indication to the operator when the front-end is inoperative and cannot acquire signal. The indications are lead-off on all leads and the wireless signal quality indicator lights. This condition will be saved with the data and will be indicated on any printed reports which contain that data.
Preparing the Patient Filtering When you open the ST80i application, the active settings of the filters are associated with your user profile. The same filter settings apply to both displayed and printed waveforms. The filter settings are printed with the report. The smart filter can be enabled or disabled through the Config screen User Profile tab’s Filters button. The same filter settings apply to both displayed and printed waveforms. The filter settings are printed with the report.
The Patient Session The source signal of the analog ECG and TTL Sync for each output channel can be selected by software from any of the available ECG leads separately. The amplify ratio for the Analog ECG Output can also be configured independently. To change Analog and/or TTL Output settings during a patient session, see “Gear (Quick Settings)” on page 2-30. To configure Analog and TTL Output, see the ST80i Installation and Configuration Guide.
Preparing the Patient Pre Exercise Phase The Pre Exercise phase is used to start the patient on the treadmill or the ergometer. The phase is preset to run for 3 minutes with the speed setting on 01:00 and the elevation is set at 0%. Figure 3-9 Treadmill Speed and Grade Note that the Pre Exercise time is separate from the Exercise time.
The Patient Session To acquire a resting ECG without interpretation 1 Have the patient in a supine position. 2 Click 12 Leads Print button on the Toolbar to obtain a 12-lead resting ECG without interpretation. To obtain a 12-lead resting ECG without interpretation: 1 Click the Event button. 2 From the drop-down menu, select Supine. To acquire a 12-lead standing ECG without interpretation 1 Have the patient in a standing position. 2 Change the lead position to Mason-Likar.
Preparing the Patient NIBP & SpO2 ST80i supports optional SpO2 and motion-tolerant Non-Invasive Blood Pressure (NIBP) devices. ST80i automatically collects the NIBP through a cuff. The patient’s SpO2 is collected in real-time through a sensor. NIBP 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.
The Patient Session To take a blood pressure measurement (if the patient is connected to a blood pressure monitor) other than a timed BP Click the BP button. The current blood pressure measurement displays in the BP mmhg 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 field.
Preparing the Patient 4 Allow the patient to get 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.
The Patient Session Figure 3-10 Exercise Screen Ask Corey what this means... 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 Advance button on the Procedure bar.
Preparing the Patient Figure 3-11 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, use the drop-down arrow by the current protocol to select a new protocol. The phases and stage settings associated with the newly selected protocol are loaded into ST80i.
The Patient Session Rhythm Print You can print a continuous rhythm strip directly from the ST80i screen at any point during the test. The system generates a continuous report (configurable from 1 to 12 leads) of the leads specified in the configuration for the particular profile. For details, see the ST80i Installation and Configuration Guide. The continuous rhythm strip contains the patient's name and the current date and time. You can generate continuous rhythm strips during all phases of a test.
Preparing the Patient Controlling the Treadmill or Ergometer At any point during the stress test, you can switch to “Manual Mode” and change the speed and elevation grade of the treadmill. This overrides the protocol settings for the current stage. Once you enter manual mode, there is no next stage. CAUTION Be sure to inform the patient of the changes. If the treadmill is unavailable, ST80i displays “Unavailable” where the Start Treadmill button would be.
The Patient Session To stop the treadmill during the Exercise phase Click the Stop Treadmill button. The Treadmill stops. Consult “Maintaining the ST80i System” on page 5-1 with regard to the inspection of 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 the user profile.
Preparing the Patient Stage Change See the ST80i Installation and Configuration Guide for more information regarding the setting of notifications. See also “Global Interpretive Settings” on page 3-40. 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.
The Patient Session During the Recovery phase: The system automatically prints a 12-lead ECG. The 12-lead ECG is printed at this stage transition regardless of system settings. The total exercise time clock freezes. ST80i advances the treadmill or ergometer to the recovery workloads specified in the protocol. Select Stop Treadmill to stop the Treadmill.
Preparing the Patient Report Phase When you have determined that the patient has completed the Recovery phase of the stress test, you can manually move to the Report phase where the Report screen is visible. Data from the Recovery Phase is saved as part of the Final Stress Report. When you save the stress test, the patient enters the Post-Recovery phase. This phase appears as part of the Report phase in the Final Stress Report.
The Patient Session Global Interpretive Settings In the Settings section of the ST80i application, you can configure the Global Interpretive Settings for DXL Algorithm and CALg templates, include the following: DXL Algorithm Adult Bradycardia Borderline Statement Sensitivity Pacer Detection Report Confirmation Label CALg Templates Arrhythmia Analysis ST Segment Analysis J-ST Settings Global Interpretive Settings also include: Arrhythmia Event Notification ST Amplitude Ca
Preparing the Patient Tick marks appear on the waveform (both printed and displayed) at locations where pulses are detected. The interpretive report contains textual statements about findings. Only one set of tick marks will be printed for any given period of acquisition, regardless of the number of channels presented. The pace-pulse detection setting, in effect at the time a snapshot is taken, is used for the analysis of that snapshot.
The Patient Session 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. The time latency should be less than 7 seconds. You can also capture and store events for later review and reporting. The events can be saved with notes and can be printed with the context ECG data.
Printing During the Stress Test – Local Thermal Printer Select Rhythm Report Printer: – Off – Local Thermal Printer Select Final Report Printer: – Off – PDF Complete – Microsoft XPS Document Writer – Local Thermal Printer On the Config screen [User Profile ECG Report], ECG Print is preconfigured with the following: ECG Layout Speed (mm/sec) Gain (Limb Leads) Scale (Chest Leads) On the Config screen, the timing of the ECG Print is configured on the Exercise Protocols tab
The Patient Session Print Options ST80i supports several print options during the stress test, including: Real-time ECG Resting 12-Lead ECG report (with interpretation) – interpretion is printed only during Pre Exercise phase when an event is selected Stage printout (without interpretation) Event printout (without interpretation) Real-time rhythm printing Real-Time ECG Any time during the testing, you can print a real-time 12-Lead ECG from the Exercise screen.
Printing During the Stress Test Stage Printout and Event Printout Stage printout and Event printout are 12-Lead ECG reports without any measurement or interpretation during the stress testing. Stage printout is configured in the Protocol. Event printout is printed if the printer type is configured. NOTE The Stage printout is automatically generated if preconfigured.
The Patient Session Maximum ST changes in this stage (for Stage printout only) Current ST change (for Stage printout only) Continuous Rhythm Strip You can trigger continuous rhythm printing using the Rhythm Print button on the Exercise screen. You can also turn off continuous printing by using the same Rhythm Print button.
Ending the Patient Session 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: Detach patient from PIM. Detach electrodes. For details about working with the final report, including viewing, editing, printing, and saving reports, see “Working with Reports” on page 4-1.
The Patient Session 3-48 ST80i Stress Test System Instructions for Use
4 1 Working with Reports Overview When you enter the Report phase, data from all phases of the test are saved as part of the final stress report 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 and resting ECG. You can save the final report, and then print it.
Working with Reports Printing Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26 Printer Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-26 Print Report Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-28 ECG Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-29 Events Report . . . . . . . . . . . . . . . . . . . . . .
Report Phase Report Phase When stress testing enters the Report phase, you can edit the report with the algorithm output to 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 test information is transferred to system storage.
Working with Reports 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 pre-configured printers. You have the option to print the whole report or specify which individual reports to print and to change default printer settings.
Report Screen Figure 4-1 ST80i Report Screen A B C D E Table 4-1 F ST80i Report Screen Features Feature Description A Title Bar - where you enter or update patient information in the Patient Demographics window. B Procedure Bar - [Report, Status: Complete or Incomplete] and buttons: Change J+ , Save, Export, Print, Confirm, Replay C Report Tabs Summary, Tabular, Trend Graph, Averages, Events, Resting ECG, Full Disclose D Real-time 7.
Working with Reports Title Bar From the Report screen, you can enter or update information about the patient before or during the test. If you did not fill in or update this information during the Exercise phase, you can open the Patient Demographics screen to update this information as necessary. For an explanation of the features of the title bar, see “Title Bar” on page 2-7.
Report Screen Procedure Bar Figure 4-2 Procedure Bar On the Procedure bar, you can: Adjust the J+ Point Save the report Export the report Print the report Confirm the report Replay the ECG 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.
Working with Reports It is also possible to export a report [directly to external media such as a USB flash stick in PDF format. The Final Stress Report may also be exported in PDF format which can be reviewed on any PC. The Final Stress Report in PDF format can then be emailed to referring physician. See also “Exporting Reports (Export Exam)” on page 4-44. Export You can export your reports to Remote Sites that have been preconfigured in the Settings section of the application.
Report Screen Print You can use the Procedure bar’s Print button to print individual reports or the Final Stress Report. Before printing individual reports, you need to select a printer type. 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.
Working with Reports For more information regarding patient fields, see the section entitled “Patient Information Management” on page 3-5. When you click the Confirm button, a dialog box is displayed. Figure 4-3 To confirm the report 1 Enter your User ID. 2 Enter your password. 3 Click OK. Replay When you click the Replay button on the Report screen, you can review the real-time ECG waveforms.
Report Screen Figure 4-4 Figure 4-5 3 To hide the bar, sweep your pointer over the image. At any time during the Replay of the exercise stress test, you can print an ECG or Rhythm Strip. Click the 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.
Working with Reports Real-Time ECG for One Lead On the bottom of the Report screen, patient data is still captured for one lead. You can change the lead by using the drop-down menu to the right. Figure 4-6 Print Options On 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 Start Rhythm Printing When you click the Print 12-Lead ECG Report button, you will get a printout of that segment of the ECG.
Final Stress Report Overview Final Stress Report Overview The Final Stress Report is based on data gathering during the 5 phases of an exercise stress test. They include: Pre Exercise Phase Exercise Phase Recovery (and Post-Recovery) Phase Report Phase 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.
Working with Reports A Final Stress Report includes the following: Patient ID Summary Tabular Summary Trends Graph Average Beat Complexes Rhythm Events 12-Lead Interpretative Resting ECG Report Each report is configured to print or not to print in a Final Stress Report except thePatient ID Report, which is the minimum printed page in a Final Stress Report. It is printed as the first page of the Final Stress Report.
Report Screen Tabs Report Screen Tabs The sections of the final report are displayed as tabs on the Report screen.
Working with Reports On this screen, the gender specific parameters, measurements and risk scores that are displayed can be printed. In addition, you can override the algorithm and select Max ST deviation for the risk-score calculation. When you change the parameters, they appear in dark red and italic. NOTE The Summary Report cannot be printed without patient demographics. On the Summary tab of the Report screen, you can include your comments about the test, along with the Reason to End and Symptoms.
Report Screen Tabs – NOTE Max Values data displayed on the Report screen: – Maximum heart rate – Percentage of target heart rate attained – Estimated maximum metabolic equivalents (METS) – Double Product (Sys HR * BP) – Maximum systolic and diastolic blood pressure These values are not necessarily taken from the same blood pressure reading. They are simply the highest measurements recorded of each of these values at any time during the test.
Working with Reports BP METS HR*BP (Double Product) 12 Leads Figure 4-8 Tabular Data Displayed by Stage To print the Tabular Report -- procedure in development-- Trend Graph Report The Trend Graph Report includes the following: Report title and patient demographic data Study information including data and time, test type, and protocol 4-Graph Trends (measurements vs. minutes) ST Level Trends (mms vs.
Report Screen Tabs METS/Double Product (HR*BP) 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 scroll bar. Figure 4-9 Trend Graphs To print the Trends Report -- procedure in development-- Averages Report The Average Beat Complexes Report is an overview of median morphologies by stage or by minute that are configurable at pre- and/or post-test stages.
Working with Reports Events Report You can review Rhythm Events at any time after you enter the Report screen by clicking the Events tab. You can also delete events that you do not want to include in the Final Stress Report, and re-label events more appropriately. The Rhythm Events Report includes prints of snapshots of all events, captured arrhythmias, and RPE scale selections acquired during the Stress test.
Report Screen Tabs with the Rhythm Events. Print and delete Rhythm Events as well as re-label them, as appropriate. Use the Print (Quick Print Settings) button to print the events. You can also review all the events captured during the test. In addition, you can also create new events during the review. The newly captured events are added to the final report and then saved back to the database. To review Rhythm Events 1 Click the Events tab.
Working with Reports 2 IMPORTANT! To select an Event, click anywhere in the Event snapshot to highlight it. 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.
Saving the Final Stress Report Full Disclose Report On this screen, the entire ECG waveform results of the stored stress tests are loaded for full disclosure review. To view an ECG for the whole exam or a moment in time, use the start feature at the bottom of the screen. The start time is noted in the bottom right corner of the waveform screen.
Working with Reports You can now print the final report from the Report screen.
Printing Reports 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 Event tab. Post Recovery ECG (two print buttons below Change Lead at bottom of screen) The printers, for printing individual reports or the Final Stress Report, are preconfigured in the Settings section of the application.
Working with Reports Rhythm Report, Final Report). Printed reports provide a calibration pulse on printed waveform reports for added check on print speed and amplitude accuracy.
Printing Reports Real-time rhythm printing ST80i produces an interpretive report. 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) Reasons (right-hand side) Severity label All the interpretation components are stored in the ECG file.
Working with Reports ECG Report The print report settings for the ECG Report include: ECG Layout (select lead format) Speed Gain Scale R1 Options (Zoom ST Map, 12-Lead Average, Grid On) Figure 4-11 4-28 ECG Report Settings ST80i Stress Test System Instructions for Use
Printing Reports Events Report The print report settings for the Events Report include: ECG Layout (select lead format) Speed Gain Scale R1 Events – Supine – Mason-Likar – Standing – Hyperventilation – Chest Pain – Shortness of Breath Add New Delete Grid On Figure 4-12 Events Report Settings ST80i Stress Test System Instructions for Use 4-29
Working with Reports Rhythm Report The print report settings for the Rhythm Report include: ECG Layout (select leads) Rhythm Settings – Speed – Gain – Scale Figure 4-13 4-30 Rhythm Report Settings ST80i Stress Test System Instructions for Use
Printing Reports Final Report The print settings for the Final Report include: Summary Report (set number of copies) Trends Report (set number of copies) 12-Lead ECG Report (set number of copies) Average QRS Report (set number of copies) Events Report (set number of copies) Print Options – Print Mode (By Stage, By Minute) – Grid On Figure 4-14 Final Report Settings ST80i Stress Test System Instructions for Use 4-31
Working with Reports Print (Quick Print Settings) Button On the Report screen, the Print button on the Procedure bar is used for printing both the Final Stress Report and individual reports.
Printing Reports NOTE – Average QRS – Summary – 12-Lead ECG – Trends – Rhythm Events Print Final Report – Summary [number of copies] – Average QRS [number of copies] – 12-Lead ECG [number of copies] – Trends [number of copies] – Rhythm Events [number of copies] Print button Regardless of which option you choose, a Summary Report will always be printed on the first page of a final report.
Working with Reports To use the Print (Quick Print Settings) button to print the Final Stress Report 1 2 Select the printer from the drop-down list: – PDF Complete – Microsoft XPS Document Writer – Fax – Local Thermal Printer Select the print parameters: – By Stage – By Minute 3 Place a checkmark in the “Print Grid” box, if you want the grid to print on laser paper. 4 Select the reports you want to include in the Final Stress Report.
Printing Reports 3 Place a checkmark in the “Print Grid” box, if you want the grid to print on laser paper. 4 Select which report (or reports) you would like to print from the Quick Print section: – Patient ID – Average QRS – Summary – 12-Lead ECG (Full Disclosure) – Trends – Rhythm Events 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.
Working with Reports Working with Archived Reports The Report database (also referred to as stress study database or stress study archive) is a longterm repository for on-line storage and access of stress study data. It may be located in either of the following: on a stress device for stand-alone stress device configuration, or on a central server, shared by one or more stress devices, in a “central system” configuration All the stored stress tests can be loaded for full disclosure review.
Working with Archived Reports Figure 4-17 Select Archive From List Screen Database Configuration ST80i consists of two major components: Client side – provides the clinical interface to the patient and user interface to the technician. It handles the patient's data acquisition, stress procedure workflow, data analysis, stress report presentation and raw data storage. Server side – provides data storage and retrieval for the stress final reports in PDF format.
Working with Reports STAND-ALONE DEVICE If you are using a stand-alone device with built-in stress study database deployment, all exercise stress test reports will be permanently stored in the device database archive. Using a stand-alone device, you can review, edit, save and sign the stress report from the Report screen. The locally stored stress test is viewable and printable from the Report screen.
Working with Archived Reports Last Transfer Date/Time Destination Begin Time End Time Patient Name Gender Date of Birth The test status is listed as follows: Confirmed Unconfirmed Exported From the Select Archive from List screen, you can: NOTE Search for reports Confirm reports Transfer reports Delete one or more stored reports (administrative users only) Backup reports to another location (administrative users only) Restore reports from ano
Working with Reports Search for Reports The Archive screen allows you to search for reports to confirm, transfer, delete, backup, restore, view, or replay. You may search for reports by using the Search textbox and button or by using the column headings to sort the reports. To search for reports using the Search textbox and button 1 Type the search criteria into the textbox to the left of the Search button. You may use Patient ID, Patient Last Name, or Patient First Name as search criteria.
Working with Archived Reports NOTE To select all of the reports, click the Select column heading; to deselect all of the reports, click the Select column heading again. 2 Select the destination for the transfer from the Transfer Destination drop-down list. Figure 4-20 Transfer Destination Drop-Down List 3 Click the Transfer button. Delete Reports If you have administrative privileges, you can select single or multiple stress studies to delete.
Working with Reports Figure 4-22 Delete Selected Report Window WARNING This procedure will permanently delete the reports (raw data and metadata) from the local database or the PDF reports from the central server. 4 Click OK to delete the report(s); click Cancel to exit. Backup Reports If you have administrative privileges, you can select single or multiple stress studies to backup to another location.
Working with Archived Reports View a Report To view a saved patient report 1 Select the patient report by putting a checkmark in the box by the patient ID. 2 Select the View Report button. The Report screen opens. NOTE Double-clicking on the study record also brings up the report Replay a Report To replay the patient ECG from the Archive screen 1 Select the patient report by putting a checkmark in the box by the patient ID. 2 Click the Replay button.
Working with Reports Exporting Reports (Export Exam) When a final stress report is saved, it may then be exported to the central server. The report can be finalized and signed on both device side and server side. The stress study raw data will be saved in local stress study database. The export status and date/time of last export are also maintained. The final stress report may also be exported into a PDF file format.
Exporting Reports (Export Exam) ST80i provides an indication that the stress data has been copied to an external location. Once the Stress study data has been copied/moved to an external location, it may be deleted if desired. If deleted, a pointer will remain in the stress study database indicating that the data had been moved to external storage. An alert indicates the exporting status, i.e. success or failure. If failure, the error code should be also provided.
Working with Reports Exporting Reports to an ECG Management System You can export PDF files for import into the Philips IntelliSpace Enterprise ECG Manager (version C.04 and later) or the Philips TraceMasterVue ECG Management System (version C.01 through C.03). You can review the ECG, as well as store it in the database. You cannot, however, edit the imported PDF file. For details about working with the imported PDF report, refer to the ECG management system documentation.
Exporting Reports (Export Exam) ST80i file names are of the form: --- procedure in development-SV_PatientID[Date+Time]FirstName_MiddleInitial_LastName.pdf where SV - required AppName format PatientID - required Patient identification number or MRN (if provided) [Date+Time] - required The date and time shown is the date and time that the study was acquired.
Working with Reports Importing Reports You can download pdfs from a TraceMasterVue remote site or import data from a Synapse remote site. Download Pdfs from a TraceMasterVue Remote Site To download pdfs from a TraceMasterVue Remote Site -- procedure in development-1 On the Worklist tab of the Select Patient screen, select “TraceMaster” from the Location drop-down list.
Importing Reports Import Data From a Synapse Remote Site How to import data from a Synapse Remote Site -- procedure in development-1 On the Worklist tab of the Select Patient screen, select “Synapse” from the Location drop-down list. Figure 4-24 Location Drop-Down List 2 Click the Download button. The worklist is downloaded to the table. 3 .....................
Working with Reports 4-50 ST80i Stress Test System Instructions for Use
5 1 Maintaining the ST80i System This chapter describes routine maintenance and cleaning of your ST80i system. It provides the following information: Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1 Cleaning the ST80i System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2 Maintaining the ST80i Thermal Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Maintaining the ST80i System CAUTION – Ordinary equipment – Not suitable for use in the presence of flammable anesthetics – Continuous operation Dispose of waste material according to local regulations and laws regarding medical and battery waste. Cleaning the ST80i System To clean the system, including PC, monitor, and transport cart Clean the mouse every month, as follows: a Remove the ball from the mouse base. b Wipe the ball with a dry cloth. c Reassemble the mouse.
Maintaining the ST80i Thermal Printer 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.
Maintaining the ST80i System Testing 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.
Maintaining the ST80i Thermal Printer 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. Figure 5-2 Replacing the AC Fuse A AC 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, which is directly below the AC power connector.
Maintaining the ST80i System Cleaning the Equipment The wireless patient module (PIM), PIM holder, and lead wires must be cleaned after each use. To clean the PIM, PIM holder, USB interface, and lead wires 1 – Cidex Ortho Phthaladehyde – Cetylcide – Vesphene 2 Aqueous Phenolic Germicidal Agent Do not: CAUTION 5-6 Dampen a soft cloth with one of the disinfectants or cleaning agents listed below.
A Troubleshooting and Contacting the Response Center Appendix A 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 Healthcare Customer Care Solution Center. The Philips Response Center can assist with product troubleshooting and provide technical expertise to help with any issue with the ST80i system.
Troubleshooting and Contacting the Response Center 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 Cause Solution Baseline drift Poor skin-to-electrode contact. Re-prep skin and replace faulty electrodes.
Troubleshooting ST80i Issues Table A-1 Troubleshooting ST80i issues Problem Cause Solution System Navigation Issues No response to keyboard commands. Cursor does not move USB cable connection. USB cable connection. Check USB cable connection. Disconnect and connect the keyboard to check whether keyboard can be identified by the system Check USB cable connection. Disconnect and connect the mouse to check whether mouse can be identified by the system.
Troubleshooting and Contacting the Response Center Table A-1 Troubleshooting ST80i issues Problem Cause Solution System Error Messages (continued) Error message appears: Not all of the selected exams are reported Error message appears: Not reported exam An attempt was made to print or export a final report from the Archive Manager but the report has not been saved as Reported. An attempt to print a final report from the Report screen is made but the report has not been saved as Reported.
Troubleshooting ST80i Issues Table A-1 Troubleshooting ST80i issues Problem Cause Solution Printer Issues Thermal printer paper out light is on Thermal printer is not printing Uneven printing of ECGs or reports Uneven printing Gaps in printing Paper jammed. No paper in tray. Open writer door. Printer head needs cleaning. Paper door not closed completely.
Troubleshooting and Contacting the Response Center Table A-1 Troubleshooting ST80i issues Problem Cause Solution Printer Issues (continued) No printing No motor drive LAN settings may be incorrect. Check to see that the Local Area Network Connection Properties settings on the PC are defined correctly Network cable may be loose. Ensure that a crossover network cable is used and check connections.
Troubleshooting ST80i Issues Table A-1 Troubleshooting ST80i issues Problem Cause Solution It is possible that the Export HL7 check box has been inadvertently selected on the Miscellaneous tab in the Configuration settings. For the affected profile(s), do the following: Data-Entry Issues Cannot manually enter patient data 1 Click Settings, then click the Miscellaneous tab. 2 Ensure the Export: HL7 check box is clear. 3 Click Save Profile and Exit.
Troubleshooting and Contacting the Response Center Contacting Technical Support Philips Healthcare Customer Care Solution Center North America Country Telephone Number Canada (800) 323 2280 United States (800) 722-9377, press option 3 Miami (Spanish speaking) 954 835 2650 South America Country Telephone Number Argentina 54 11 4546 7698 Brazil 0800 701 7789 Chile 0800 22 3003 Mexico 01 800 710 8128 Columbia 01 8000 11 10 10 Peru 51 1620 6440 Puerto Rico 787 754 6811 Europe Country T
Contacting Technical Support Europe Country Telephone Number Germany 0180 5 47 5000 Italy 0800 8256087 Netherlands 31 4 027 87630 Spain 34 90 230 4050 Sweden 08 5064 8830 Switzerland 0800 80 10 23 Asia Pacific Country Telephone Number Australia 1800 251 400 China 800 810 0038 Hong Kong 852 2876 7578 India New Delhi 011 2695 9734 Mumbai 022 5691 2643/2431 Calcutta 2485 3718 Chennai 044 555 01000 Bangalore 080 5091 911 Hyderabad 040 5578 7974 Indonesia 021 794 7542 Japan
Asia Pacific Country Telephone Number Singapore 1 800 Philips Taiwan 0800 005 616 Thailand 02 614 3569
B Appendix B Protocol Reference This appendix provides an example of each of the included protocols. You can define and edit protocols. For details, see ST80i Installation and Configuration Guide. The following protocols are delivered with every ST80i system: Bruce (page B-2) Modified Bruce (page B-3) Balke (page B-4) Ellestad (page B-5) Naughton (page B-6) Pharmacological (page B-7) Low Ramp (page B-8) Medium Ramp (page B-9) High Ramp (page B-10) USAF/SAM 2.
Protocol Reference 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. A 12-lead ECG report is automatically printed at the end of each stage. ECG acquisition begins 10 seconds prior to the end of a stage. In the Recovery phase, the treadmill slows to 1.
Modified Bruce Modified Bruce Table B-3 Modified Bruce Protocol Settings Modified Bruce Stage # Pre-Exercise 1 Exercise 1 2 3 4 5 6 7 8 9 Recovery 1 Time Duration (mm:ss) Speed (mph) Grade (%) ECG Print BP Measurement Unlimited 0.5 0.0 Off Off 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 0.0 5.0 10.0 12.0 14.0 16.0 18.0 20.0 22.0 End End End End End End End End End Begin Begin Begin Begin Begin Begin Begin Begin Begin 3.00 1.0 0.
Protocol Reference Balke Protocol The Pre-Exercise and Recovery phase settings are the same as for the Bruce protocol. See Figure X-1, above. Table B-4 Balke Protocol Settings Balke 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 Recovery 1 B-4 Time Duration (mm:ss) Speed (mph) Grade (%) ECG Print BP Measurement Unlimited 1.0 0.0 Off Off 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 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.
Ellestad Protocol Ellestad Protocol The Pre-Exercise and Recovery phase settings are the same as for the Bruce protocol. See Figure X-1, above. Table B-5 Ellestad Protocol Settings Ellestad Stage # Pre-Exercise 1 Exercise 1 2 3 4 5 6 7 Recovery 1 Time Duration (mm:ss) Speed (mph) Grade (%) ECG Print BP Measurement Unlimited 1.0 0.0 Off Off 3.00 2.00 2.00 3.00 2.00 2.00 2.00 1.7 3.0 4.0 5.0 6.0 7.0 8.0 10.0 10.0 10.0 10.0 15.0 15.0 15.
Protocol Reference Naughton Protocol The Pre-Exercise and Recovery phase settings are the same as for the Bruce protocol. See Figure X-1, above. Table B-6 Naughton Protocol Settings Naughton Stage # Pre-Exercise 1 Exercise 1 2 3 4 5 6 7 Recovery 1 B-6 Time Duration (mm:ss) Speed (mph) Grade (%) ECG Print BP Measurement Unlimited 0.5 0.0 Off Off 2.00 2.00 2.00 2.00 2.00 2.00 2.00 1.0 2.0 2.0 2.0 2.0 2.0 2.0 0.0 2.0 3.5 7.0 10.5 14.0 17.
Pharmacological Protocol Pharmacological Protocol Table B-7 Pharmacological Protocol Settings Pharmacological Stage # Pre-Infusion 1 Infusion 1 2 3 4 5 6 7 Post-Infusion 1 Time Duration (mm:ss) Speed (mph) Grade (%) ECG Print BP Measurement Dose Unlimited 0.0 0.0 Off Off Off 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 0.0 0.0 0.0 0.0 0.0 0.0 0.0 End End End End End End End End End End End End End End Off Off Off Off Off Off Off 3.00 0.0 0.
Protocol Reference Low Ramp Protocol The Pre-Exercise and Recovery phase settings are the same as for the Bruce protocol. See Figure X-1, above. Table B-8 Low Ramp Protocol Settings Low Ramp 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 B-8 Time Duration (mm:ss) Speed (mph) Grade (%) ECG Print BP Measurement Unlimited 1.0 0.0 Off Off 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.
Medium Ramp Protocol Medium Ramp Protocol The Pre-Exercise phase settings are the same as for the Bruce protocol. See Figure X-1, above. Table B-9 Medium Ramp Protocol Settings Medium Ramp 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) Grade (%) ECG Print BP Measurement 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.
Protocol Reference High Ramp Protocol The Pre-Exercise phase settings are the same as for the Bruce protocol. See Figure X-1 on page X. The Recovery phase settings are the same as for the Medium Ramp protocol. See Figure X-8 on page Y. Table B-10 High Ramp Protocol Settings High Ramp 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 B-10 Time Duration (mm:ss) Speed (mph) Grade (%) ECG Print BP Measurement Unlimited 1.0 0.
USAF/SAM 2.0 Protocol USAF/SAM 2.0 Protocol Table B-11 USAF/SAM 2.0 Protocol Settings USAF/SAM 2.0 Stage # Pre-Exercise 1 Exercise 1 2 3 4 5 6 Recovery 1 Time Duration (mm:ss) Speed (mph) Grade (%) ECG Print BP Measurement Unlimited 0.5 0.0 Off Off 3.00 3.00 3.00 3.00 3.00 3:00 2.0 2.0 2.0 2.0 2.0 2.0 0.0 5.0 10.0 15.0 20.0 25.0 End End End End End End Off End Off End Off End 3.00 1.0 0.0 Every 02:00 Every 02:00 USAF/SAM 3.3 Protocol Table B-12 USAF/SAM 3.
Protocol Reference Cycle (Ergometer) Protocol Table B-13 Cycle (Ergometer) Protocol Settings Cycle (Ergometer) Stage # Pre-Exercise 1 Exercise 1 2 3 4 5 6 7 8 9 10 Recovery 1 B-12 Time Duration (mm:ss) Power (Watts) ECG Print BP Measurement Unlimited 10 Off Off 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 Begin Begin Begin Begin Begin Begin Begin Begin Begin Begin End End End End End End End End End End 3.
Astrand Protocol Astrand Protocol Table B-14 Astrand Protocol Settings Astrand Stage # Pre-Exercise 1 Exercise 1 2 3 4 5 6 Recovery 1 Time Duration (mm:ss) Power (Watts) ECG Print BP Measurement Unlimited 50 Off Off 6.00 6.00 6.00 6.00 6.00 6.00 50 100 150 200 250 300 End End End End End End End End End End End End 3.
Protocol Reference B-14 ST80i Stress Test System Instructions for Use
C Appendix A Configuring and Using the Printer The ST80i StressTest System supports the following different printers: ST80i thermal printer Network printer and local printer with Windows 7 drivers. This appendix provides the following information: ST80i Thermal Printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-1 Thermal Printer Dimensions and Specifications . . . . . . . . . . . . . . . . . . . C-2 Loading the Thermal Printer Paper. . . . . . . . . . .
Configuring and Using the Printer Thermal Printer Dimensions and Specifications Figure C-1 C-2 ST80i thermal printer dimensions ST80i Stress Test System Instructions for Use
ST80i Thermal Printer Figure C-2 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.
Configuring and Using the Printer Table C-1 NOTE C-4 ST80i thermal printer specifications Feature Specification Fuses T-Type 1 Amp, 250 V Special functions “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 Specifications subject to change without notice.
ST80i Thermal Printer Table C-2 Input and Output descriptions Feature Description AC Power The ST80i thermal printer operates on 120/240 VAC at 50/60 Hz. Power is supplied to the thermal writer as soon as the AC power cord is connected to an AC power outlet. Power On Indicator This indicator will illuminate 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-folded, thermal sensitive paper with cue marks.
Configuring and Using the Printer 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. The paper cue mark (a small black rectangle) should be in the lower left corner. 4 Manually advance one page of paper beyond the closure point of the writer. Make sure the paper lays on the black roller evenly within the channel of the paper door.
About the Supported LaserJet Printers Figure C-3 Connecting the thermal printer to the ST80i PC 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 operating system. It is capable of printing reports, without a grid, at 35 ppm. It prints with a grid at approximately 2 ppm.
Configuring and Using the Printer C-8 ST80i Stress Test System Instructions for Use
D Ordering Options and Parts Appendix A This appendix describes the parts and options available for the ST80i Stress Test System. This appendix provides the following information: Supplies and Ordering Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1 Optional Parts and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-1 Support Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Ordering Options and Parts Use the part numbers listed in the following tables for reference to ensure that the correct supplies are ordered. Optional Parts and Accessories For more information on accessories or to place an order, contact the nearest Philips Response Center. See “Philips Healthcare Customer Care Solution Center” on page A-8. For available support parts (which can only be ordered by Philips personnel), see “Support Parts” on page D-3.
Supplies and Ordering Information New Assembly Part Number Item PIM 453564237251 STRS MECHASY Battery Door Assy 453564236601 PIM holder 453564236591 STRS, PIM Belt AIM 453564312961 STRS, AIM Box Mounting Bracket 453564236761 STRS, CBL, AIM Analog Out USB 453564096291 USB Cable AIM to PC 1m 453564336341 USB Cable Printer to PC 1.
Ordering Options and Parts New Assembly Part Number Item Trolley Parts D-4 453564237601 ST80i isolation transformer. - 240V 453564237591 ST80i isolation transformer. - 120V 453564334341 FUSE 6.30A 250V IEC 453564334331 FUSE 3.
Supplies and Ordering Information New Assembly Part Number Item 453564312961 STRS, AIM Box Mounting Bracket 453564335301 STRS Tango Arm Kit 453564335271 STRS Utility Hook Software and Documentation 453564xxxxxx ST80i software CD 453564xxxxxx ST80i Documentation and Training CD ST80i Stess Test System Instructions for Use D-5
Ordering Options and Parts D-6 ST80i Stess Test System Instructions for Use
E Appendix A Specifications and Requirements For details about setting up the system, see the ST80i Installation 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 5, “Maintaining the ST80i System” This appendix provides the following information: ST80i System Requirements . . . . . . . . . . . . . . . .
Specifications and Requirements Table E-1 Minimum ST80i system requirements Component Minimum Hardware/Software Specifications Processor Intel® Core™ i5-2400S (2.
Specifications 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.
Specifications and Requirements Table E-2 ST80i system specifications Function Specifications Common mode rejection Meets the requirements of ANSI/AAMI EC-11 Patient leakage current Meets the requirements of ANSI/AAMI ES-1 Overall system error Meets the requirements of ANSI/AAMI EC-11 Frequency response Meets the requirements of ANSI/AAMI EC-11 Methods A and D were used to establish frequency response.
Specifications Medical Isolation Transformer Specifications The medical isolation transformers used with the ST80i system 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 Table E-3 Medical isolation transformer specifications Function Specifications Frequency 50/60 Hz Output ratings 120V 600VA or 240V 600VA Weight 26.5 lb (12 Kg) Dimensions Height. Width. Depth.
Specifications and Requirements ST80i Thermal Printer Specifications Table E-4 ST80i thermal printer specification 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.
Supported Treadmills and Ergometers Supported Treadmills and Ergometers The ST80i Stress Test System supports the following treadmills and ergometers.
Specifications and Requirements ST80i Stress Test System and optional Thermal Printer operates in an acceptable manner in the configuration in which it will be used. Fixed, portable, and mobile radio frequency communications equipment can affect the performance of medical equipment. See Table E-9, “Recommended Separation Distances,” on page E-14 for recommended separation distances between the radio equipment and the ST80i Stress Exercise Testing System and optional Thermal Printer.
Electromagnetic Compatibility (EMC) Guidance and Manufacturer’s Declaration: Electromagnetic Emissions The ST80i Stress Test System and optional Thermal Printer are intended for use in the electromagnetic environment specified in the table below. The customer or the user of the ST80i Stress Test System and optional Thermal Printer should assure that it is used in such an environment.
Specifications and Requirements Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The ST80i Stress Test System and optional Thermal Printer are intended for use in the electromagnetic environment specified in the following tables. The customer or the user of the ST80i Stress Test System and optional Thermal Printer should assure that it is used in such an environment.
Electromagnetic Compatibility (EMC) Table E-7 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity Emissions Test Compliance Compliance Level Electromagnetic Environment Guidance Power frequency (50/60 Hz) magnetic field immunity 3 A/m, 50 & 60 Hz 3 A/m 50 & 60 Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the AC mains voltage prior to application of the test level.
Table E-8 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity Emissions Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted Immunity, Induced RF 3Vrms, 3Vrms, 0.15 MHz to 80 MHz, @ 10 Hz AM 0.
Electromagnetic Compatibility (EMC) Table E-8 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity Emissions Test IEC 60601 Test Level Compliance Level Electrosurgery Interference 100W & 300W Cut/Coag, at 450 kHz ± 100 kHz. 100W & 300W Cut/Coag, at 450 kHz ± 100 kHz. IEC 60601-2-25 Electromagnetic Environment Guidance a.
Specifications and Requirements Recommended Separation Distances The ST80i Stress Test System and optional Thermal Printer are intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.
Philips Medical Systems 3000 Minuteman Road Andover, MA 01810 USA Copyright © 2012 Koninklijke Philips Electronics N.V. All rights are reserved. ST80i Stress Test System Instructions for Use Printed in USA 453564XXXXXX Edition 1 June 2012 *453564214311* Authorized EU-representative: Philips Medizin Systeme Böblingen GmbH Hewlett Packard Str.
