ZOOM LATITUDE Operators Manual April 2014

INFORMATION FOR USE Trademark Statement The following are trademarks of Boston Scientific or its affiliates: LATITUDE, Quick Start, ZIP, ZOOM.

Description and Use The ZOOM LATITUDE Programming System, which includes the Model 3120 Programmer/Recorder/Monitor (PRM), Model 3140 Zoom Wireless Transmitter (ZWT) and accessories, is a portable cardiac rhythm management system designed to be used with Boston Scientific implantable pulse generators. Intended Use The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator. For detailed software application instructions, refer to the associated product literature for the pulse generator being interrogated. Intended Audience This literature is intended for use by professionals trained or experienced in device implant and/or follow-up procedures. Essential Performance In order for the PRM to meet its intended use, it must communicate with Boston Scientific implantable pulse generators. Therefore those functions that pertain to communications with the implanted pulse generator using the telemetry wand are considered essential performance. Contraindications The PRM is contraindicated for use with any pulse generator other than a Boston Scientific pulse generator. For contraindications for use related to the pulse generator, refer to the associated product literature for the pulse generator being interrogated.

WARNINGS •

Use of unspecified cables and accessories. The use of any cables or accessories with the PRM or ZWT other than those specified by Boston Scientific in this manual may result in increased emissions or decreased immunity of the PRM or ZWT. Anyone connecting such cables or accessories to the PRM or ZWT may be configuring a medical system and is responsible to ensure that the system complies with the requirements of IEC/EN 60601-1, Clause 16 for medical electrical systems.

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Connector contacts. Do not simultaneously touch the patient and any accessible connector contacts on the PRM (e.g., USB, parallel port, external VGA monitor, stimulation input, analog output, and expansion port).

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Special committee on radio interference. Other equipment may interfere with the PRM and ZWT, even if that equipment complies with the International Special Committee on Radio Interference (CISPR) emission requirements.

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Electric shock. To avoid the risk of electric shock, only connect the PRM to a grounded/earthed power source.

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PRM location. Do not use the PRM or ZWT adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, check the PRM and ZWT for normal operation in that configuration.

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PRM and ZWT must remain outside sterile field. The PRM and ZWT are non-sterile and cannot be sterilized. They must both remain outside the sterile field.

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Physiological signals. Operation of the PRM with physiological signals that are lower than the minimum detectable amplitude may cause inaccurate results.

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Printer parts. Do not simultaneously touch the patient and the parts inside the printer door.

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PRM is MR Unsafe. The PRM and ZWT are MR Unsafe and must remain outside the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance Document for Safe MR Practices1. Under no circumstances should the PRM be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.

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Modifications. No modification of this equipment is allowed unless approved by Boston Scientific.

PRECAUTIONS General •

Use only appropriate PRM. Use only the appropriate Boston Scientific PRMs equipped with the appropriate software to program Boston Scientific pulse generators.

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Wand use. Use only the Model 6577 Sterilizable Telemetry Wand with the PRM.

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Stylus use. Use the stylus supplied with the PRM; the use of any other object could damage the touchscreen. Using the stylus may also improve accuracy.

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Radio and Telecommunications Terminal Equipment (RTTE). Boston Scientific hereby declares that this device is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. To obtain a full text Declaration of Conformity, contact Boston Scientific using the information on the back cover. NOTE: As with other telecommunications equipment, verify national data privacy laws.

1. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007

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Leakage current. Although optional external equipment connected to the PRM meets leakage-current requirements for commercial products, it may not meet the more stringent leakage requirements for medical products. Consequently, all external equipment must be kept outside the patient environment (at least 1.5 m [4.9 ft] away from the patient).

Preparations for Use •

Telemetry wand shipped nonsterile. The Model 6577 Telemetry Wand is shipped nonsterile. If the telemetry wand is to be used in a sterile field, it must be actively sterilized before use or enclosed in a disposable sterile surgical sheath during use.

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Telemetry wand sterilization. Remove the telemetry wand from all packaging material before sterilizing it.

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Electrical and magnetic interference. Avoid establishing telemetry communication between the PRM and the pulse generator when the PRM or ZWT are in close proximity to monitors, high-frequency electrosurgical equipment, or strong magnetic fields. The telemetry link may be impaired.

Maintenance and Handling •

Cleaning the PRM. Do not use an abrasive cloth or volatile solvents to clean any portion of the PRM or ZWT.

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Disk handling. Keep disks away from magnets and magnetized objects, including telephones, power-supply adapters, and monitors.

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Magnet handling. Do not place a magnet on the PRM or ZWT.

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PRM use. The PRM and ZWT are not waterproof or explosion-proof and cannot be sterilized. Do not use them in the presence of flammable gas mixtures including anesthetics, oxygen, or nitrous oxide.

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Disconnecting the PRM. To completely disconnect the unit from the power source, first use the On/Off button to turn the system off. Then disconnect the power cord from the back of the unit.

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PRM accessibility. Ensure the back of the unit is accessible at all times so that the power cord can be disconnected.

Adverse Effects None known.

System Features The PRM uses the Model 6577 Sterilizable Telemetry Wand to communicate with pulse generators and perform the following functions: •

Interrogate and program the implantable pulse generator

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Display records, store patient data, and allow the physician to evaluate alternative prescription modes

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Store patient session data that can be recalled later in the patient session for analysis (for certain applications only)

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Save patient data to the PRM hard drive or to a floppy disk

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Generate printed reports that detail pulse generator functions, stored patient data, and test results

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Perform tests in an electrophysiology (EP) laboratory, in an operating room, in an emergency room, or at a patient’s bedside

The PRM also: •

Provides a direct interface between an external stimulator and an implanted pulse generator for programmed electrical stimulation (PES) during EP studies

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May be used to support diagnostic activities pertaining to implanting, programming, and monitoring Boston Scientific implantable pulse generators. The PRM is not intended for use as an ECG monitor or general diagnostic device

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Prints simultaneous real-time surface ECG and telemetered signals (intracardiac electrograms and event markers) using the internal printer/recorder

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Exports saved patient data from the fixed internal hard drive to a removable USB pen drive

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Provides the option to encrypt patient data prior to exporting to a USB pen drive

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Creates PDF report(s) from saved patient data and saves the report(s) to the fixed internal hard drive or to an attached USB pen drive

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Prints PDF report(s) to an external printer connected to the PRM

The PRM is equipped with the following features: •

PRM function keys, including PROGRAM, STAT PACE, STAT SHOCK, DIVERT THERAPY, and INTERROGATE

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Printer/recorder function keys, including paper speed, calibrate, zero to baseline, and paper feed

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Touchscreen with tethered stylus

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Color display screen

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Floppy disk drive

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Internal hard drive

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High-speed thermal printer/recorder using 110 mm (4 in) wide paper

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Connections for slaved stimulation via an external signal source (certain applications only)

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Parallel interface supports optional external printer

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High-level analog outputs

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USB ports used for patient data export to a standard USB pen drive, connection to the 3140 Zoom Wireless Transmitter accessory, connection to an external printer or used for software installation by Boston Scientific personnel

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ZIP™ telemetry, a cordless, hands-free radio frequency (RF) communication option that allows the PRM to communicate with the pulse generator NOTE: To communicate wirelessly using ZIP telemetry, certain pulse generators require the Model 3140 Zoom Wireless Transmitter. For more information, refer to the associated product literature for the pulse generator being interrogated. If ZIP telemetry performance is not satisfactory, use the telemetry wand instead.

System Accessories The ZOOM LATITUDE Programming System consists of the Model 3120 PRM and the following accessories: •

Model 3123 Antenna

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Model 3140 Zoom Wireless Transmitter (ZWT)

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Model 3141 USB Cable

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Model 3124 Accessory Bag

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Model 3130 Accessory Kit

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Model 2918 PRM Equipotential Cable

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Model 6577 Sterilizable Telemetry Wand

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Model 6627 Patient Data Disks (10)

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Model 6751 Surface ECG Patient Cable

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Model 6979 Printer Paper (4)

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Model 6629 ECG–BNC Slave Cable

The following AC power cords are also available for use with the PRM: Model

Outlet

2902 AC Power Cord

2903 AC Power Cord

2911 AC Power Cord 2914 AC Power Cord

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2915 AC Power Cord

2916 AC Power Cord

2917 AC Power Cord

To order accessories, contact Boston Scientific using the information on the back cover. WARNING: The use of any cables or accessories with the PRM or ZWT other than those specified by Boston Scientific in this manual may result in increased emissions or decreased immunity of the PRM or ZWT. Anyone connecting such cables or accessories to the PRM or ZWT may be configuring a medical system and is responsible to ensure that the system complies with the requirements of IEC/EN 60601-1, Clause 16 for medical electrical systems.

Optional External Equipment Optional external equipment can be used with the PRM. Contact your sales representative to determine what external equipment can be used. WARNING: Do not simultaneously touch the patient and any accessible connector contacts on the PRM (e.g., USB, parallel port, external VGA monitor, stimulation input, analog output, and expansion port). CAUTION: Although optional external equipment connected to the PRM meets leakage-current requirements for commercial products, it may not meet the more stringent leakage requirements for medical products. Consequently, all external equipment must be kept outside the patient environment (at least 1.5 m [4.9 ft] away from the patient). External Printer You can use an external printer if it is supported by the pulse generator software application. Use only compatible external printers that have been tested and qualified for use. Refer to the instructions to connect the cable ("Preparing the PRM for Use" on page 7). PDF reports generated from saved patient data may be sent to an external printer using the Patient Data Management utility. The utility is accessible from the Patient Data Management button on the PRM startup screen. External VGA Monitor You can use an external VGA monitor that can synchronize to any horizontal scan frequency.

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NOTE: Equipment connected to the external connections must comply with applicable standards (e.g., IEC/EN 60950-1 for data processing equipment and IEC/EN 60601-1 for medical equipment). Anyone connecting such cables or accessories to the PRM may be configuring a medical system and is responsible to ensure that the system complies with the requirements of IEC/EN 60601-1, Clause 16 for medical electrical systems.

Warranty Information A limited warranty is packaged with the PRM. Unless otherwise agreed, the PRM remains the property of Boston Scientific and Boston Scientific must perform all necessary servicing and repair work. For additional copies, contact Boston Scientific using the information on the back cover.

PREPARING THE PRM FOR USE Make necessary external connections as directed below. Prepare the Telemetry Wand Prepare the 6577 Telemetry Wand for the sterile field by following the sterilization procedures below, or by enclosing the wand in a sterile surgical sheath. CAUTION: The Model 6577 Telemetry Wand is shipped nonsterile. If the telemetry wand is to be used in a sterile field, it must be actively sterilized before use or enclosed in a disposable sterile surgical sheath during use. Either ethylene oxide (EO) or steam may be used for active sterilization. Follow the cleaning instructions ("Cleaning the PRM and Accessories" on page 24) before beginning the sterilization process. CAUTION: Remove the telemetry wand from all packaging material before sterilizing it. Ethylene oxide (EO) method: Follow the recommendations of the EO sterilization equipment manufacturer and allow the specified aeration time to fully elapse prior to use. Steam method: Follow customary autoclave procedures for wrapped goods and limit temperature to 132°C (-0°C, +5°C), 270°F (-0°F, +9°F). NOTE: The Model 6577 Telemetry Wand has been tested for 25 sterilization cycles and more than this number of sterilization cycles is not recommended. Discard the wand any time surface cracks appear in the plastic and/or the cable discolors or becomes worn, regardless of the number of completed sterilization cycles. Make Wand and Cable Connections For connector locations, refer to the illustrations of the PRM right side, left side, and rear panels (Figure 1 on page 8, Figure 2 on page 9, and Figure 3 on page 9). 1.

Make the following connections on the right side of the PRM.

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[1] Antenna for ZIP telemetry [2] Stimulator inputs [3] Air intake [4] Analog output channel [5] Telemetry wand connector [6] ECG connector

Figure 1.

Right side panel of the PRM

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Connect the telemetry wand to the telemetry wand connector.

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Connect the Surface ECG Patient Cable to the ECG connector. This connection is electrically isolated. Attach the surface electrodes to the patient in a standard three-wire or five-wire configuration. NOTE: The ECG subsystem may be sensitive to high-frequency ambient noise when the ECG inputs are not terminated. NOTE: The ECG function is intended to be used during patient exams for tests such as pace threshold testing with body-contacting connections. NOTE: The surface ECG traces may exhibit noise interference if the PRM is in close proximity to high-frequency electrosurgical equipment. For corrective action, refer to the troubleshooting section ("Troubleshooting" on page 28).

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2.

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Connect a controller-stimulator cable to the PRM stimulator input and then into the corresponding terminal on the electrical stimulation source.

Make the following connections on the left side of the PRM.

[1] On/Off button [2] External printer connector [3] USB ports [4] External VGA monitor connector

Figure 2.

Left side panel of the PRM

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Connect the Model 3141 USB Cable to either USB port.

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Connect the other end of the Model 3141 USB Cable to the Model 3140 Zoom Wireless Transmitter.

NOTE: To communicate wirelessly using ZIP telemetry, certain pulse generators require the Model 3140 Zoom Wireless Transmitter. For more information, refer to the associated product literature for the pulse generator being interrogated. If ZIP telemetry performance is not satisfactory, use the telemetry wand instead.

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Use a standard parallel printer or USB cable to attach an external printer to the PRM printer connection.

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Use a standard VGA cable to connect an external VGA monitor or equivalent to the PRM VGA monitor connector.

Make the following connections on the rear panel of the PRM.

[1] Equipotential stud [2] AC connector [3] Protective earth terminal

Figure 3.

Rear panel of the PRM

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Connect the equipotential cable to the equipotential stud. Connect the other end of the equipotential cable to a common potential equalization point for the PRM and the other electrical equipment. NOTE: Use this connection to equalize the PRM’s galvanic potential with other electrical equipment. Using this terminal to provide equalization may reduce electrical noise problems and the possibility of indirect leakage currents between the PRM and other electrical equipment.

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Connect the power cord to the alternating current (AC) connector on the rear panel of the PRM.

CAUTION: Ensure the back of the unit is accessible at all times so that the power cord can be disconnected. •

Plug the power cord into the appropriate AC outlet.

WARNING: To avoid the risk of electric shock, only connect the PRM to a grounded/earthed power source. WARNING: Do not use the PRM or ZWT adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, check the PRM and ZWT for normal operation in that configuration. 4.

Start the PRM. •

Raise the screen to a comfortable viewing angle.

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Press the On/Off button.

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Wait for the startup screen to appear.

NOTE: During PRM startup, observe the screen for any messages. If an error message appears, write a detailed description of the error and contact Boston Scientific using the information on the back cover. Prepare for ZIP Telemetry NOTE: The ZIP telemetry feature is not available for all pulse generators. For more information, refer to the associated product literature for the pulse generator being interrogated. 1.

For pulse generators that use the 3140 Zoom Wireless Transmitter to communicate using ZIP telemetry: a.

For optimum ZIP telemetry communication, position the ZWT in an area that is less than 3 m (10 ft) from the pulse generator. Ensure there are no obstructions between the ZWT and pulse generator.

b.

In addition, place the ZWT at least 7.6 cm (3 in) away from the PRM.

NOTE: Repositioning the ZWT further away from the PRM may improve ZIP telemetry performance. If ZIP telemetry performance is not satisfactory, use the telemetry wand instead. 2.

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For pulse generators that do not use the 3140 Zoom Wireless Transmitter to communicate using ZIP telemetry: a.

Raise the antenna on the PRM to its upright position.

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For optimum ZIP telemetry communication, position the PRM antenna within 3 m (10 ft) of the pulse generator.

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Remove obstructions between the PRM and the pulse generator.

NOTE: Reorienting the PRM antenna or repositioning the PRM may improve ZIP telemetry performance. If ZIP telemetry performance is not satisfactory, use the telemetry wand instead.

[1] Antenna

Figure 4.

Antenna in the upright position

USING THE PRM Startup Screen The PRM has a touchscreen and a tethered stylus allowing you to select items such as buttons, checkboxes, and tabs that are displayed on the screen. Only one item can be selected at a time. CAUTION: Use the stylus supplied with the PRM; the use of any other object could damage the touchscreen. Using the stylus may also improve accuracy.

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Figure 5.

Startup screen

When the PRM is powered On, the startup screen is displayed and contains the following information: •

The ECG Display, which shows four ECG traces for patient diagnosis

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The Surface Rate, which displays the ventricular rate of the patient

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The Details button, which expands the ECG Display to a full screen

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The Quick Start™ button, which is an automated method for starting the appropriate application

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The Patient Data Management button, which allows exporting, printing, reading, or deleting patient data and/or reports on an attached USB pen drive or the PRM hard drive

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The Utilities button, which allows access to PRM information and setup functions prior to accessing the application software

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The About button, which allows the user to view, print, and save the PRM configuration information (applications installed on the PRM and their associated version numbers)

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The Select PG button, which allows the desired PG (pulse generator) application software to be selected and started

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The date, time, and PRM information, which are located at the bottom, center area

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Changing Parameter Values The screens for many of the features contain parameter information that can be changed via either a palette window or a keyboard window.

Figure 6.

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Palette window-To change a parameter value, first select the appropriate parameter’s value box. A palette window will appear. Select a value from the palette window by touching the desired value; the window will automatically close when a selection is made. To close a window without making a selection, touch the screen outside the window.

Figure 7.

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Palette window

Keyboard window

Keyboard window-Some screens display value boxes that require unique data to be entered, typically from a keyboard window. To enter data from a keyboard window, first select the appropriate value box. A keyboard window will appear. Touch the first character of the new value; it will appear in the data-entry box in the graphic keyboard. Continue until the entire new value appears in the box. To delete one character at a time, starting with the last character, select the left arrow key on the graphic keyboard. Each time the left arrow key is selected, a character will be deleted in the box. To cancel any deletions or additions just made, select the Cancel Changes button on the graphic keyboard. When all the appropriate characters have been selected, select the Accept Changes button on the graphic keyboard. NOTE: If, when the keyboard window initially appears, it contains data in the data-entry box, select the Clear button on the graphic keyboard to delete all the characters in the data-entry box.

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Copy Button On those screens that contain a Copy button, you can simply copy parameter values from one screen to another. Select the Copy button. A window will appear with a Copy From column and a Copy To column, with buttons below the columns. Select the desired buttons in both columns, and then select the Copy button. To program the pulse generator with the copied values, follow the instructions in the associated product literature for the pulse generator being interrogated. NOTE: If additional parameters require reprogramming, repeat the copy instructions. Multiple parameter changes can be programmed at one time using batch programming.

ECG Display The ECG Display shows surface ECG signals without pulse generator interrogation when the surface ECG patient cable is connected to the PRM and the electrodes are attached to the patient. (However, if a report is being printed, the surface ECG does not display). NOTE: The surface ECG may be printed on the internal printer/recorder; press any speed key on the left-side keypad to record a surface ECG. The PRM can display four surface traces of up to six limb leads or one chest lead. The top displayed lead will be annotated with the pacing spike marker if that feature is selected. To display the pacing spike markers correctly, the Lead II electrodes must be connected to the patient regardless of which lead is displayed. The Surface Rate will display the ventricular rate as the trace runs. NOTE: The ECG functionality of the PRM is intended to support diagnostic activities pertaining to implanting, programming, and monitoring Boston Scientific implantable pulse generators. The PRM is not intended for use as an ECG monitor or general diagnostic device. WARNING: Operation of the PRM with physiological signals that are lower than the minimum detectable amplitude may cause inaccurate results. To expand the ECG Display to a full screen, select the Details button on the startup screen. Use the following screen buttons to change the values and appearance of the traces: •

Trace Speed-Select the desired speed on the ECG display: 0 (stop), 25, or 50 mm/s

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Trace 1, Trace 2, Trace 3, and Trace 4-Select the lead traces to be displayed

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Gain-Select the appropriate value to adjust the surface gain of the traces that are captured on printouts

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Enable Surface Filter-Select the checkbox to minimize noise on the surface ECG

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Display Pacing Spikes-Select the checkbox to show detected pacing spikes, annotated by a marker on the top waveform

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NOTE: The values as set up on the startup screen will be the defaults used for the application traces. The corresponding values can be changed from the Trace Selections screen while in the application. For detailed application programming instructions, refer to the associated product literature for the pulse generator being interrogated. Intracardiac Electrogram You can display intracardiac electrograms on the PRM screen. Also, you can print both intracardiac electrograms and event markers on the internal printer. For detailed instructions, refer to the associated product literature for the pulse generator being interrogated.

Quick Start Button The Quick Start button on the startup screen is used to automatically identify and interrogate the implanted pulse generator. Place the telemetry wand over the pulse generator, and select the Quick Start button. A message window will appear, indicating one of the following conditions, based on the implanted pulse generator: •

Application startup in progress-If the software for the implanted pulse generator is installed on the PRM, the PRM will identify the pulse generator, start the correct application, and automatically interrogate the pulse generator.

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Software not installed-If the software application for the implanted pulse generator is available for the PRM but not installed on it, a message window will appear, identifying the pulse generator and stating that the software is not installed on the PRM.

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Software not available on PRM-If an older model of a pulse generator is identified, a message window will appear, informing the user to use a Model 2035 or Model 2901 programmer to interrogate and/or program the pulse generator. The model number of the software module or application will also be identified.

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PG not identified-If a non-Boston Scientific pulse generator or one of certain older models of Boston Scientific pulse generators is implanted, a message window will appear, notifying the user that the wand is out of range, telemetry noise is present, or the pulse generator is not identified.

To access the demonstration (DEMO) mode (or the Read Disk feature, which is available in some applications), use the Select PG button located on the toolbar below the startup screen to choose the pulse generator family instead of using the Quick Start button.

Patient Data Management Utility Saving patient data to the USB pen drive is a two-step process: (1) The PRM allows you to save pulse generator data to the hard drive or a removable floppy data disk. (2) Data saved to the hard drive can then be transferred to a removable USB pen drive. If a floppy disk is not inserted in the PRM disk drive, any disk operations initiated within any application will be performed on space allocated on the

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PRM hard drive. Data saved to the hard drive can then be exported to the USB pen drive through the Export Data feature of the Patient Data Management utility, accessible from the PRM startup screen. Patient Data Management Features The Patient Data Management utility allows you to export, transfer, print, read, and delete patient data. On the Startup screen, select the Patient Data Management button to access these features. Privacy Notice: By exporting data from the PRM, you are assuming responsibility for the privacy and security of that data. Printing, storing, transferring, reading, and deleting of patient data must be performed in compliance with applicable data privacy and security laws. Using the available secure export methods is recommended. NOTE: For information about PDF functionality available with the pulse generator being interrogated, refer to the associated product literature. Export Data Patient data on the PRM hard drive can be exported to a USB pen drive. 1.

Select the Export tab on the Patient Data Management interface. The system displays a list of patient records currently saved on the PRM hard drive.

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Select the patient records you want to export. You can select all patient records by selecting the Select All button, or select specific patient records by selecting the checkbox next to a patient’s name. You can also undo your selections by selecting the Deselect All button.

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Select the reports you want to export. The selected reports are created as a PDF file from the data for each selected patient. NOTE: Selecting a report is not required to export patient data. If you want to export patient data only, leave the reports selections unchecked and proceed to the next step.

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Select an export method below. a.

To initiate export of the selected patient data, select the Export button. Patient data in plain format is neither encrypted nor compressed on the USB pen drive.

b.

To initiate export of the selected patient data with encryption, select the Export with Password Protection button. Password protection encrypts Protected Heath Information on the USB pen drive. If a pen drive is being used to store patient data for the first time, the system will prompt you to enter and confirm a password: i.

Enter and confirm the password. The password must be alphanumeric and contain at least six characters.

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Select the Initialize button.

If the password does not meet the system requirements, the system displays the Password Creation Failed dialog box and prompts you to try again.

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When using a non-Boston Scientific computer (e.g., a clinic PC), enter your password to access encrypted patient data stored on the USB pen drive. NOTE: The USB pen drive used to store exported patient data cannot contain both encrypted and non-encrypted patient data. 5.

Do not remove the USB pen drive during the export operation. If the export operation fails for any reason, the system displays an error message prompting you to select Try Again or Cancel.

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If the storage capacity of the USB pen drive is reached during the export operation, the system displays a message stating that the export failed. Insert another pen drive and select the Try Again button to continue with the export.

Transfer Data Files can be extracted from the USB pen drive to a PC, and can be viewed, saved, e-mailed, or attached to an Electronic Medical Record. 1.

Insert the pen drive into any USB port on the PC and open Windows Explorer.

2.

Navigate to the pen drive and locate the folder titled “bsc” (in the root directory of the pen drive). Double-click this folder to access the sub-folders.

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Select a transfer method below. a.

To initiate transfer of non-encrypted patient data, copy the patient data to the PC.

b.

To initiate transfer of encrypted patient data, double-click the “ExtractAll.bat” file. i.

When prompted, enter the pen drive password and choose a destination folder.

ii.

Press the Extract All button to extract all of the files from the USB pen drive to the PC.

Each patient record on the USB pen drive is stored in a folder with the following naming conventions: •

For non-encrypted patient data, the patient folder name appears in this format: <last name>-<first name>-<birth date>-<model>-<serial>

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For encrypted patient data, the patient folder name appears in this format: <model>-<serial>

The Export Data operation transfers the most recent patient data from the PRM to the USB pen drive. It also moves the patient data from the previous sessions to the “old” subfolder within the same patient folder on the USB pen drive. Print Data You can print reports for patient data saved on either the PRM hard drive or an attached USB pen drive. 1.

Select the Print tab on the Patient Data Management interface.

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2.

Select the USB Drive or Programmer option to indicate the location from which you want to print patient records.

3.

Select the patient records you want to print. You can select all patient records by selecting the Select All button, or select specific patient records by selecting the checkbox next to a patient’s name. You can also undo your selections by selecting the Deselect All button.

4.

Select the reports you want to print.

5.

Use the Number of Copies button to select the quantity of copies you want to print.

6.

Select the Print button to print selected patient records and any associated, selected reports.

Read Data You can read patient data from the PRM hard drive or the USB pen drive. 1.

When you attempt to read data from the PRM hard drive or the USB pen drive, the appropriate application is initiated. If the operation is unable to read the patient data, the system displays a message indicating that the application could not be started in Disk Mode or that the data could not be read from the USB pen drive. You can then select Try Again or Cancel to continue.

2.

When the read operation initiates successfully, the system displays a message stating that Protected Health Information is being read from the USB pen drive or the PRM hard drive.

NOTE: The Read Data feature is unavailable on the following pulse generator applications which do not support reading patient data from removable storage media: 2865 (CONTAK RENEWAL TR), 2880 (VIGOR), 2881 (DELTA/VISTA), 2890 (PULSAR/DISCOVERY/MERIDIAN/CONTAK TR), 2891 (PULSAR II/DISCOVERY II/VIRTUS II/INTELIS II), 2892 (ALTRUA/INSIGNIA I/NEXUS I). Delete Data You can manage the contents of the patient data archive on the PRM hard drive or the USB pen drive using the Delete Data feature. 1.

Select the Delete tab on the Patient Data Management interface.

2.

Select the USB Drive or Programmer option to indicate the location from which you want to delete patient records.

3.

Select the patient records you want to delete. You can select all patient records by selecting the Select All button, or select specific patient records by selecting the checkbox next to a patient’s name. You can also undo your selections by selecting the Deselect All button.

4.

Select the Delete button to initiate the deletion of selected patient records. The system displays the Delete Confirmation dialog box asking you to confirm that you want to delete the selected patient records. Select the Confirm button to continue with the delete operation, or the Cancel button to cancel the operation.

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5.

When the delete operation initiates successfully, the system displays a message stating that Protected Health Information is being deleted from the system.

6.

Do not remove the USB pen drive during the delete operation. If the delete operation fails for any reason, the system displays an error message prompting you to select Try Again or Cancel.

Saving Episodes from Legacy Pulse Generators When saving patient episodes from a legacy pulse generator, if a record already exists on the PRM hard drive for that patient, new episodes are added to the patient record. The patient record, however, contains an episode index file which lists only the episodes saved during the most recent patient session. Therefore, when saving patient episodes from a legacy pulse generator, if a record already exists on the PRM hard drive for that patient, saving patient data will replace the episode index file in the patient record. When reading the patient record back into the pulse generator application, only the episodes listed in the episode index file are displayed. When exporting the patient record to a USB pen drive, all episodes present in the patient record are exported. Processing Considerations •

When performing multiple patient follow-ups, be sure to start a new session for each patient through the QUICK START or Select PG options (rather than the application’s New Patient option). This will ensure that data saved to the PRM hard drive during the previous session is not lost.

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Be sure to save all pulse generator data to either a floppy disk or USB pen drive before returning a PRM to Boston Scientific, as all patient and pulse generator data will be erased from the PRM when it is returned for service.

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No more than 400 unique patient records may be saved to the PRM. When a pulse generator is interrogated, the PRM evaluates if there is a record on file for this pulse generator, or if a new record needs to be created. If a new record is needed, and the PRM is at the 400 record capacity, the oldest record on file will be deleted to create space for the new patient record.

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Up to 200 episodes can be saved to the PRM hard drive during a session with a patient. Performing the Save All to Disk operation with a patient who has more than 200 episodes will save only the oldest 200 episodes. The system will then notify you that the disk is full and you will need to restart the session and save up to 200 selected episodes.

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If a patient has more than 200 episodes, it is recommended that you perform a selective save operation instead of the Save All to Disk operation.

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With VITALITY applications, ensure a floppy disk is inserted when saving profile data to Disk. Otherwise, the system will not prompt you to insert a floppy disk and the profile data will be lost.

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