Boston Scientific Latitude 3300 Operator's Manual
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Boston Scientific Latitude 3300 Operator's Manual

Programming system
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CAUTION: Federal law (USA) restricts
this device to sale by or on the order of a
physician trained or experienced in
device implant and follow-up
procedures.
OPERATOR'S MANUAL
LATITUDE
PROGRAMMING
SYSTEM
Model 3300
™

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  • Page 1 OPERATOR’S MANUAL ™ LATITUDE PROGRAMMING SYSTEM Model 3300 CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow-up procedures.
  • Page 3 Table of Contents INFORMATION FOR USE ..............1 Trademark Statement ............... 1 Description and Use ................. 1 Intended Use ................1 Intended Audience ................. 1 Required Expertise and Knowledge ........... 1 Essential Performance ..............2 Contraindications ................2 Warnings..................2 Precautions ..................
  • Page 4 Patient Data Management Button ............ 27 STAT Button for Transvenous PGs........... 27 Start a Transvenous PG Session ............29 Quick Start (Button) ..............29 Select PG (Button) ............... 29 Surface ECG................. 29 ECG Display ................30 Intracardiac Electrogram..............31 Pacing System Analyzer (PSA) ............31 Patient Data Management Utility ............
  • Page 5 Environmental Protection and Disposal..........59 Symbols on Devices and Packaging..........59 SAFETY, COMPLIANCE, AND COMPATIBILITY STANDARDS ....62 Safety Standards ................62 Electromagnetic Compatibility Standards ..........62 Radio Spectrum Compliance Standards..........63 Electromagnetic Emissions and Immunity..........63 IEC 60601–1–2:2014 Information ............ 63 Federal Communications Commission (FCC) Information .....

  • Page 7: Information For Use

    INFORMATION FOR USE Trademark Statement The following are trademarks of Boston Scientific Corporation or its affiliates: LATITUDE, Quick Start, and ZIP. Bluetooth ® is a registered trademark of Bluetooth SIG. DisplayPort is a trademark of the Video Electronics Standards Association (VESA).

  • Page 8: Essential Performance

    Contraindications The LATITUDE Programming System is contraindicated for use with any PG other than a Boston Scientific PG. For contraindications for use related to the PG, refer to the associated product literature for the PG being interrogated. The PSA application is contraindicated for use with any programming system other than the Boston Scientific Model 3300 LATITUDE Programming System.
  • Page 9 The use of any cables or accessories with the LATITUDE Programming System other than those provided by or specified by Boston Scientific could result in increased electromagnetic emissions, decreased electromagnetic immunity, or electrical shock of the LATITUDE Programming System. Anyone connecting such cables or accessories to...
  • Page 10 While the device is designed and tested to be electrocautery safe, electrocautery can induce electrical currents in the PSA cables that can be conducted into the patient’s heart. However, Boston Scientific recommends that the Programmer be placed as far from the...
  • Page 11 • Induction. When activating PSA Burst Pacing, which may cause unpredictable arrhythmias, always have cardiac emergency equipment (e.g., external pacemaker, external defibrillator) in an operational status available for immediate life support. • Consider additional preemptive measures in patients where acceleration or a loss of rhythm could cause life-threatening danger. •...
  • Page 12 Always have external cardiac pacing equipment in an operational status available for immediate life support. • Initially, when the Programmer is switched on, the pacing functions are switched off while a self-test is conducted. No pacing is possible during the self-test, which can take up to one minute. •...

  • Page 13: Precautions

    The Model 6753 Battery is a Lithium-ion battery and, as such, is deemed a Dangerous Good in regards to shipping. Do not return the Model 6753 battery to Boston Scientific. Dispose of the battery as required by local regulations. If the battery must be shipped, contact your local shipper for instructions and shipping requirements.
  • Page 14 leakage requirements for medical products. Consequently, all external equipment must be kept outside the patient environment. • Never touch the electrical contacts on the side panels of the Model 3300 Programmer and the patient, a telemetry wand, or any cable at the same time.
  • Page 15 • Inductive telemetry. Using the Programmer on battery power only may reduce the telemetry distance (from wand to implanted device). If needed, use AC power to improve inductive telemetry. • Battery operation during long-term storage . Remove battery to prevent discharging when storing the Programmer for long periods (e.g., months).
  • Page 16 Telemetry Wand from the Programmer to prevent telemetry dropouts. • Equipment modifications. No modification of this equipment is allowed unless approved by Boston Scientific. Changes or modifications not expressly approved by Boston Scientific could void the user’s authority to operate the equipment. Maintenance and Handling •...

  • Page 17: Adverse Effects

    Use high-quality shielded cables with integral conversions (e.g., DisplayPort to HDMI) when possible. – Minimize the use of active adapters other than those identified by Boston Scientific as they can create emissions that can interfere with PG telemetry. Adverse Effects None known.

  • Page 18: Interrogation And Programming

    • May be used to support diagnostic activities pertaining to implanting, programming, and monitoring Boston Scientific implantable PGs • Provides a Pacing System Analyzer (PSA) application to assess electrical...

  • Page 19: Software

    Model 6175 AC Power Cord • Model 6753 Lithium-ion Battery, rechargeable and replaceable To order accessories, contact Boston Scientific using the information on the back cover of this manual. WARNING: The Model 6395 Telemetry Wand does not include a magnet.

  • Page 20: Optional External Equipment

    The use of any cables or accessories with the LATITUDE Programming System other than those provided by or specified by Boston Scientific could result in increased electromagnetic emissions, decreased electromagnetic immunity, or electrical shock of the LATITUDE Programming System. Anyone...

  • Page 21: External Printer

    WARNING: The use of any cables or accessories with the LATITUDE Programming System other than those provided by or specified by Boston Scientific could result in increased electromagnetic emissions, decreased electromagnetic immunity, or electrical shock of the LATITUDE Programming System. Anyone...

  • Page 22: External Display

    WARNING: The use of any cables or accessories with the LATITUDE Programming System other than those provided by or specified by Boston Scientific could result in increased electromagnetic emissions, decreased electromagnetic immunity, or electrical shock of the LATITUDE Programming System. Anyone...

  • Page 23: Patient Side Panel (Right Side)

    Patient Side Panel (Right Side) [1] Model 6763 PSA Cable for LV (green) [2] Model 6763 PSA Cable for A/RV (light gray) [3] Model 3153 ECG Cable (dark gray) [4] connection port for future use (brown) [5] Model 3203 S-ICD Telemetry Wand (black) [6] Model 6395 Telemetry Wand (blue) Figure 2.

  • Page 24: Indicator Lights

    Indicator Lights The Programmer has an indicator light on the left side of the device contained within the power (on/off) button . The Model 6395 Telemetry Wand has an indicator light on the front face. The functions are described below. •...

  • Page 25: Prepare A Telemetry Wand

    NOTE: As long as the Programmer is plugged in (connected to AC power), the battery will charge. The Programmer does not have to be powered on to recharge the battery. Prepare a Telemetry Wand Depending on the PG being used, prepare the appropriate wand. Model 6395 Telemetry Wand CAUTION: The Model 6395 Telemetry Wand is shipped non-sterile.
  • Page 26 [1] Model 6763 PSA Cable for LV (green) [2] Model 6763 PSA Cable for A/RV (light gray) [3] Model 3153 ECG Cable (dark gray) [4] connection port for future use (brown) [5] Model 3203 S-ICD Telemetry Wand (black) [6] Model 6395 Telemetry Wand (blue) Figure 5.

  • Page 27: Make Physician Side Connections

    performance. Refer to "Steps to Improve ZIP (RF) Telemetry Performance" on page 23 for additional information. Make Physician Side Connections As needed, make the following connections on the left side of the LATITUDE Programming System. [1] Power (on/off) button (light gray) [2-4] USB 2.0 ports (dark gray) [5] USB 3.0 port (blue) [6] Ethernet port (orange) [7] DisplayPort out (red-orange) [8] DC power connection for Model 6689 Power Adapter (green) Figure 6.

  • Page 28: Electrosurgical Cables

    Figure 7. Electrosurgical Cables Distance from LATITUDE Programming System Prepare for ZIP (RF) Telemetry NOTE: The ZIP telemetry feature is not available for all Boston Scientific PGs. For more information, refer to the associated product literature for the PG being interrogated.
  • Page 29 [1] Internal antenna locations, approximate Figure 8. Front View of LATITUDE Programming System Indicating Approximate Antenna Locations Within the Enclosure Steps to Improve ZIP (RF) Telemetry Performance Perform the following to increase RF telemetry performance: Disconnect all unused cables and wands and stow them. All remaining connected patient side cables (PSA, ECG) should exit perpendicular to the Programmer and (as much as possible) directly toward the patient.

  • Page 30: Startup

    NOTE: During system startup, observe the screen for any messages. If an error message appears, do not use the device, write a detailed description of the error, and contact Boston Scientific using the information on the back cover of this manual.
  • Page 31 [1] Battery status, Ethernet, and Bluetooth ® indicators [2] ECG and EGM lead trace selections, up to four [3] lead trace display area [4] Snapshot button [5] Real-time Recorder button [6] PSA application button [7] Magnify Traces button [8] Quick Start button [9] Patient Data Management button Figure 9.
  • Page 32 • The Patient Data Management button accesses patient data for export, printing, transfer, and deletion • The Magnify Traces button enlarges the lead trace area to fill the display window and provides additional information as illustrated in Figure 10 Magnify Traces Screen (During PG Session) on page 26 Figure 10.

  • Page 33: Psa Button

    PSA Button The PSA button in the upper right of the startup screen switches the screen view and activates the PSA application. Refer to the Pacing System Analyzer (PSA) Operator’s Manual (Model 3222) for details and instruction on using this application.
  • Page 34 • PSA STAT PACE - when a PSA session has been enabled, it configures the PSA with STAT PACE settings and functionality. NOTE: All emergency function commands prompt the user to exit and start a new session. Figure 11. STAT Button Pop-up in a High-voltage PG Session with the PSA Application Running The top row buttons (PG STAT PACE, DIVERT THERAPY, and STAT SHOCK) display during a PG session.

  • Page 35: Start A Transvenous Pg Session

    PG, start the correct application, and automatically interrogate the PG. • PG not identified – If a non-Boston Scientific PG or a Boston Scientific PG for which there is no application loaded on this Programmer is interrogated, a message window displays indicating that the PG is not identified.

  • Page 36: Ecg Display

    NOTE: The ECG functionality of the LATITUDE Programming System is intended to support diagnostic activities pertaining to implanting, programming, and monitoring Boston Scientific implantable PGs. The LATITUDE Programming System is not intended for use as an ECG monitor or general diagnostic device.

  • Page 37: Intracardiac Electrogram

    • Display Pacing Spikes – Select the check box to show detected pacing spikes, annotated by a marker on the top waveform • Show PG Markers – When in a PSA application session, select the check box to enable the PG markers. NOTE: The values as set up on the startup screen will be the defaults used for the application traces.
  • Page 38 Figure 13. Palette Window - Parameter Selection Example 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.

  • Page 39: Demo Mode

    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. Demo Mode To access the demonstration (DEMO) mode, click on the Select PG button at the bottom of the screen, identify the device/family by clicking the appropriate icon, then click the Demo button on the SELECT PG MODE pop-up.

  • Page 40: Setup - Configure Settings

    • As indicated in Figure 17 Utilities on page 34, ZIP telemetry may not be enabled (the button is grayed out). If needed, contact Boston Scientific using the information on the back cover of this manual to have a representative enable ZIP telemetry.

  • Page 41: Network Setup Tab

    NOTE: The LATITUDE Programming System clock synchronizes automatically when connected to a network. If there is no network connection, then the Boston Scientific representative can set the Programmer internal clock using a special USB key. NOTE: If a pop-up displays asking to synchronize the clocks, follow the prompts to synchronize them.

  • Page 42: About Button

    NOTE: Allow the Programmer to fully restart because an update confirmation will be sent via the network to Boston Scientific indicating a successful software install. About Button Select the About button to display the About screen. Software Install via USB pen drive is available only by your Boston Scientific representative.

  • Page 43: Selecting A Pg

    Figure 20. About Screen Use the About screen to perform the following actions: • Change the name of the institution. Select the value box next to Institution. Refer to detailed instructions for entering new data using the keyboard window (Figure 14 Keyboard Window Example on page 32). •...
  • Page 44 Figure 21. SELECT PG Screen Figure 22. SELECT PG MODE Select the device icon button (Figure 21 SELECT PG Screen on page 38), then select the Interrogate button in the message pop-up as illustrated in Figure 22 SELECT PG MODE on page 38. Once Interrogated, the application loads, checks system status, and then displays the Summary screen (Figure 23 Summary Screen on page 39) for the chosen device therapy.

  • Page 45: Real-Time Log For Transvenous Pgs

    Figure 23. Summary Screen If the PG device is not found, a device not supported message displays and allows you to end the session. Real-time Log for Transvenous PGs The LATITUDE Programming System provides recording of various real-time ECG and EGM events from a transvenous PG and PSA. Two buttons on the header bar of the screen are used for real-time recording of lead traces and PSA activity.

  • Page 46: Real-Time Log Tools

    Figure 24. Real-time Log – List Screen [1] Notes area [2] Real-time Log Tools pop-up [3] Electronic Calipers (slide bar) to adjust time span of event [4] Real-time Log Event display Figure 25. Real-time Log – Event Trace Example The Notes button in the Notes area can be used to add comments. A Real-time Log can be customized using the tools in the Real-time Log Tools pop-up.

  • Page 47: Electronic Calipers

    pop-up displays each time you select another part of the Real-time Log Event display, so that you can use multiple tools anywhere on the display. The five tools are: • Circle tool –places a circle on the display at the target point. •...
  • Page 48 Table 1. PG Events (continued) Event Type Trigger Event Duration of Recording (seconds) INTRINSIC AMPL TEST Intrinsic Ampl Test (A, V, RV, and SSI) Completed TEMP BRADY Temp Start Entered, Temp Start to Temp End Entered Temp End STAT SHOCK STAT SHOCK Commanded Commanded V ATP...

  • Page 49: Maintenance

    Cleaning the Programmer and Accessories In addition to turning off the Model 3300 Programmer and disconnecting the power cord, Boston Scientific recommends removing the battery in the Programmer before cleaning. See "Battery Status, Installation, Replacement, and Recycling" on page 45 for instructions on removing the battery.

  • Page 50: Cleaning Cables And Wands

    Cleaning Cables and Wands At point of use: When necessary, to prevent drying of any possible contaminants immediately after use, clean the cable or wand with a soft cloth dampened with sterile water. Thorough Cleaning: Thoroughly clean the cable or wand with a soft cloth dampened with a mild cleaning solution such as green soap, green soap tincture (U.S.

  • Page 51: Battery Status, Installation, Replacement, And Recycling

    Parameter Value Temperature 50 ºC (122 ºF) minimum and 60 ºC (140 ºF) maximum Humidity 40% minimum and 80% maximum; non- condensing EO dwell time 2 hours EO concentration minimum 450 mg/L Minimum aeration time 12 hours at 60 ºC (140 ºF) Number of sterilization cycles permitted 6395 Telemetry Wand = 25 6763 PSA cable = 50...
  • Page 52 upper left corner on all Programmer screens as illustrated in Figure 27 Battery Status Indicator on Main Screen with AC Power On on page 46. NOTE: The battery should be replaced when it no longer maintains a charge above 25%. NOTE: Depending on the age of the battery, a full charge should last for approximately two hours of normal operation.
  • Page 53 Figure 29. Battery Status - Attention and Warning Pop-ups In addition, there are battery status indicators on the top right of the battery which indicate the remaining charge in 25% increments from 100%, 75%, 50%, and 25%. See Figure 31 Replaceable Programmer Battery (representative image) on page 48.

  • Page 54: Battery Replacement

    (partially hidden) Figure 31. Replaceable Programmer Battery (representative image) Battery Replacement NOTE: To obtain a replacement battery, contact Boston Scientific using the information on the back cover of this manual. To remove the battery: Press and release the power button to turn OFF the Programmer.

  • Page 55: Battery Recycling

    The Model 6753 Battery is a Lithium-ion battery and, as such, is deemed a Dangerous Good in regards to shipping. Do not return the Model 6753 battery to Boston Scientific. Dispose of the battery as required by local regulations. If the battery must be shipped, contact your local shipper for instructions and shipping requirements.

  • Page 56: Operation And Storage

    Operation and Storage The LATITUDE Programming System requires special handling. The internal hard drive of the Model 3300 Programmer must be protected from abusive handling. To protect the device from damage, refer to the following information: • DO NOT turn off the LATITUDE Programming System while the internal hard drive is accessing data.

  • Page 57: Storing The Latitude Programming System

    • Do not submerge the battery in any fluids. • Do not connect the + and – terminals with wire or any conductive objects. • Do not disassemble, modify, or repair the battery. • Only use the Model 3300 Programmer to charge the battery. Use of any other battery charger can permanently damage the battery or even cause a fire or explosion.

  • Page 58: Safety Measurements

    67. Service For questions regarding operation or repair of the LATITUDE Programming System, contact Boston Scientific using the information on the back cover of this manual. The LATITUDE Programming System must be serviced by Boston Scientific personnel only. If the LATITUDE Programming System malfunctions and requires repair, help...

  • Page 59: Troubleshooting

    For the shipping address, contact Boston Scientific using the information on the back cover of this manual. TROUBLESHOOTING If the LATITUDE Programming System does not operate properly, check that electrical cords and cables are securely connected and that cords and cables are in good working order (i.e., free of visible defects).
  • Page 60 PG and repeat interrogation. Use the Model 3203 S- ICD Telemetry wand as an additional antenna. LATITUDE Programming Contact Boston Scientific System software version using the information on not current the back cover of this manual. Noise problems: ECG...
  • Page 61 Connect the equipment to an outlet on a different circuit or use as battery powered. Contact Boston Scientific using the information on the back cover of this manual. Missing shock markers Noise during shock Review surface ECG for...
  • Page 62 The internal clock battery consistently keep time is not field replaceable. after setting Return the LATITUDE Programming System to Boston Scientific for replacement of the internal clock battery. Unable to print to a USB- Not connected properly Check the USB cable...

  • Page 63: Handling

    Table 3. Possible Causes and Corrective Actions for LATITUDE Programming System Problems (continued) Symptom Possible Cause Corrective Action LATITUDE Programming LATITUDE Programming Turn off the LATITUDE System not responding System not functioning Programming System, and then turn it On. If this does not correct the issue, contact Boston Scientific using the information on the back...
  • Page 64 [1] Model 3153 ECG cable, [2] ECG monitor, [3] ECG-BNC slave cable, [4] Programmer ECG connector, [5] Programmer Model 6395 Telemetry Wand connector, [6] Model 6395 Telemetry Wand, [7] LATITUDE Programming System (right side view) Figure 32. External ECG Monitor Configuration To display a tracing on an external ECG monitor and the Programmer, set up equipment as shown in Figure 32 External ECG Monitor Configuration on page In the example in Figure 32 External ECG Monitor Configuration on page 58,...

  • Page 65: Environmental Protection And Disposal

    The Model 6753 Battery is a Lithium-ion battery and, as such, is deemed a Dangerous Good in regards to shipping. Do not return the Model 6753 battery to Boston Scientific. Dispose of the battery as required by local regulations. If the battery must be shipped, contact your local shipper for instructions and shipping requirements.
  • Page 66 Table 4. Symbols on Devices and Packaging (continued) Symbol Description Follow instructions for use Follow instructions for use; see www.bostonscientific-elabeling.com Alternating current The power button on the left side of the Programmer, which is represented by the Standby symbol USB 2.0 USB 3.0 DisplayPort Local Area Network (LAN) Port...
  • Page 67 Table 4. Symbols on Devices and Packaging (continued) Symbol Description Future connection Red STAT button on Programmer provides commands for low voltage and high voltage rescue Warning, electricity – Do not touch the connector terminals in the Programmer battery compartment while removing or replacing the battery as an electrical charge is present ISO 7010-W001 general warning symbol for ECG connector on the Programmer...

  • Page 68: Safety, Compliance, And Compatibility Standards

    Table 4. Symbols on Devices and Packaging (continued) Symbol Description MR Unsafe Battery indicator symbol Bluetooth ® DC power connection SAFETY, COMPLIANCE, AND COMPATIBILITY STANDARDS The following standards apply to the LATITUDE Programming System. Safety Standards The LATITUDE Programming System has been tested and found to comply with applicable safety portions of the following standards: •...

  • Page 69: Radio Spectrum Compliance Standards

    • ETSI EN 301 489-31 V2.1.1:2016 Radio Spectrum Compliance Standards The LATITUDE Programming System complies with the applicable portions of the following radio spectrum compliance standards: • ETSI EN 302 195 V2.1.1:2016 • ETSI EN 300 220-1 V3.1.1:2016 • ETSI EN 300 220-2 V3.1.1:2016 •...
  • Page 70 CAUTION: No modification of this equipment is allowed unless approved by Boston Scientific. Changes or modifications not expressly approved by Boston Scientific could void the user’s authority to operate the equipment. The electromagnetic emissions and immunity information is provided in Table 5 Guidance and Manufacturer’s Declaration—Electromagnetic Compatibility on...
  • Page 71 Table 5. Guidance and Manufacturer’s Declaration—Electromagnetic Compatibility (continued) The LATITUDE Programming System, Model 3300, is suitable for use in professional health care facility environments. The customer or the user of this system should assure that it is used in such an environment. Test Compliance Electromagnetic...

  • Page 72: Latitude Programming System Security

    Programmer has network security safeguards in place to prevent malicious attacks. Software All installed software has been approved by Boston Scientific and general purpose software installation is not permitted. This minimizes the potential for vulnerabilities to be exposed. Internal software that runs the Programmer is locked from change and is re-verified upon each execution.

  • Page 73: Unsupported Hardware

    Programmer, disconnect it from the network, then restart the LATITUDE Programming System. Discontinue use of the Programmer if it fails the start-up self test or does not operate as expected. For further assistance, contact Boston Scientific using the information on the back cover of this manual. SPECIFICATIONS Table 6.
  • Page 74 Table 6. LATITUDE Programming System Nominal Specifications (continued) Characteristic Nominal 31.8 cm (12.5 in) high Weight (approximate) Programmer (without battery or stand): 3.58 kg (7.9 lbs) Battery: 0.45 kg (1.0 lb) Stand: 1.28 kg (2.75 lb) Model 6689 power adapter 100-120 V, 50-60 Hz, 3.8 A power rating 220-240 V, 50 Hz, 1.9 A...
  • Page 75 Up to 5000 V Defibrillator protection a. For questions regarding operation or repair of the LATITUDE Programming System, contact Boston Scientific using the information on the back cover of this manual. The LATITUDE Programming System must be serviced by Boston Scientific personnel only.
  • Page 76 Table 6. LATITUDE Programming System Nominal Specifications (continued) b. After successfully completing safety testing, verify the LATITUDE Programming System continues to meet the essential performance as defined in the beginning of this manual. Table 7. Radio Nominal Specifications Characteristic Nominal ZIP MICS Telemetry (MICS/MedRadio) Frequency band 402 –...

  • Page 77: Warranty Information

    A warranty card is packaged with the LATITUDE Programming System. Unless otherwise agreed, the LATITUDE Programming System remains the property of Boston Scientific and Boston Scientific must perform all necessary servicing and repair work. For additional warranty information, contact Boston Scientific...
  • Page 80 Boston Scientific Corporation 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA www.bostonscientific.com 1.800.CARDIAC (227.3422) +1.651.582.4000 © 2017 Boston Scientific Corporation or its affiliates. All rights reserved. 359487-002 EN US 2017-10 FCC ID: ESCCRM330017 (Contains FCC ID: PD97265NG) *359487-002*...

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