Boston Scientific ZOOM LATITUDE 3120 Operator's Manual
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Boston Scientific ZOOM LATITUDE 3120 Operator's Manual

Boston Scientific ZOOM LATITUDE 3120 Operator's Manual

Programmer/recorder/monitor
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OPERATOR'S MANUAL
™
™
ZOOM
LATITUDE
Programmer/Recorder/Monitor
REF 3120

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Summary of Contents for Boston Scientific ZOOM LATITUDE 3120

  • Page 1 OPERATOR’S MANUAL ™ ™ ZOOM LATITUDE Programmer/Recorder/Monitor REF 3120...

  • Page 3: Table Of Contents

    Table of Contents INFORMATION FOR USE ................Trademark Statement ................. Description and Use..................Warnings ..................... Precautions ....................Adverse Effects ................... System Features ..................System Accessories..................Optional External Equipment ..............Warranty Information................... PREPARING THE PRM FOR USE ............... USING THE PRM ..................Startup Screen ..................

  • Page 5: Information For Use

    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.

  • Page 6: Precautions

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

  • Page 7: Adverse Effects

    • 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 •...
  • Page 8 • Generate printed reports that detail pulse generator functions, stored patient data, and test results • 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...

  • Page 9: System Accessories

    ™ • 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.

  • Page 10: Optional External Equipment

    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.

  • Page 11: Warranty Information

    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.
  • Page 12 [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 • Connect the telemetry wand to the telemetry wand connector. •...
  • Page 13 [1] On/Off button [2] External printer connector [3] USB ports [4] External VGA monitor connector Figure 2. Left side panel of the PRM • Connect the Model 3141 USB Cable to either USB port. • Connect the other end of the Model 3141 USB Cable to the Model 3140 Zoom Wireless Transmitter.
  • Page 14 • 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.

  • Page 15: Using The Prm

    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...
  • Page 16 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 • The Surface Rate, which displays the ventricular rate of the patient •...
  • Page 17 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. Palette window • Palette window—To change a parameter value, first select the appropriate parameter’s value box.

  • Page 18: Ecg Display

    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.

  • Page 19: Quick Start Button

    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.
  • Page 20 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.
  • Page 21 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. Do not remove the USB pen drive during the export operation.
  • Page 22 Select the USB Drive or Programmer option to indicate the location from which you want to print patient records. 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.
  • Page 23 When the delete operation initiates successfully, the system displays a message stating that Protected Health Information is being deleted from the system. 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.

  • Page 24: Utilities Button

    Utilities Button If desired, before accessing the pulse generator software application, you can select the Utilities button to perform the following actions: • Change the language displayed—Select the Setup tab. • Enable ZIP telemetry (if it is approved for use)—Select the Setup tab. •...

  • Page 25: Indicator Lights

    To become familiar with the software without interrogating a pulse generator, select the DEMO button; the main application screen will appear and the DEMO logo will appear at the top of the screen. The software application screens displayed during the DEMO mode reflect the features and programmable values of the pulse generator family.
  • Page 26 [1] STAT PACE [2] DIVERT THERAPY [3] STAT SHOCK [4] PROGRAM [5] INTERROGATE Figure 8. Right-side keypad The following description of the right-side keypad corresponds to the labels in the illustration (Figure 8 on page 22). The PRM must be in telemetry communication with the pulse generator for these functions to be available.

  • Page 27: Maintenance

    • [2] Press the paper-feed key to scroll the printer paper on the internal printer/recorder. • [3] Press the calibration key to cause the internal printer/recorder to print a 1-mV calibration pulse. • [4] Press the baseline key to force the trace back to the baseline after a defibrillation shock.

  • Page 28: Cleaning The Prm And Accessories

    permanence of a patient’s record, store the printed paper away from direct sunlight, heat, or fumes from organic compounds. Storage temperatures above 60°C (140°F), sustained exposure to direct sunlight, or exposure to high humidity, acetone, ammonia, alcohols, or other organic compounds may cause the paper to discolor.
  • Page 29 [1] Write-protect tab closed (black tab covering hole) [2] Sliding shuttle Figure 10. Patient Data Disk The disk must be inserted with the arrow on the top left side and pointing into the disk drive. Insert a patient data disk firmly into the disk drive on the right side of the PRM until the disk ejection button protrudes (Figure 11 on page 25).

  • Page 30: Operation And Storage

    • Do not attach paper clips, staples, or rubber bands to disks. • Do not try to open the sliding shutter that covers the disks (Figure 10 on page 25). • Never touch the exposed disk area beneath the sliding shutter. CAUTION: Keep disks away from magnets and magnetized objects, including telephones, power-supply adapters, and monitors.

  • Page 31: Maintenance Check And Safety Measures

    CAUTION: 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. PRM Storage If using a patient data disk, remove the disk from the disk drive, and store the disk in a safe place.

  • Page 32: Service

    Service For questions regarding operation or repair of the PRM or ZWT, contact Boston Scientific using the information on the back cover. The PRM and ZWT must be serviced by Boston Scientific personnel only. If the PRM or ZWT malfunction and require repair, help to ensure efficient service by following these guidelines: Leave the configuration of the instrument exactly as it was at the time of malfunction.
  • Page 33 Table 2. Possible causes and corrective actions for PRM problems (continued) Symptom Possible Cause Corrective Action Internal Paper loaded upside printer/recorder: no Reload paper. down print visible If the touchscreen is not Internal printer/record: Application did not responsive, turn off the PRM. printing stops handle print request Turn on the PRM and try printing...
  • Page 34 Table 2. Possible causes and corrective actions for PRM problems (continued) Symptom Possible Cause Corrective Action Incorrect telemetry Use only the Model 6577 wand Sterilizable Telemetry Wand. Reorient the PRM antenna (if Excessive radio approved for use) or reposition emissions from the PRM.

  • Page 35: Using An External Ecg Monitor With The Prm

    Table 3. Possible causes and corrective actions for ZWT problems Symptom Possible Cause Corrective Action USB cable not Remove and reconnect both securely connected ends of USB Cable. to ZWT Green indicator light on ZWT does not light Replace with Model 3141 USB USB cable damaged within 60 seconds of Cable only.

  • Page 36: Symbols On Packaging

    Figure 12. External ECG Monitor Configuration To display a tracing on an external ECG monitor and the PRM, set up equipment as shown above (Figure 12 on page 32). In this example, the surface ECG travels via the ECG cable (1) to the external ECG monitor (2), then to the PRM via the ECG-BNC slave cable (3), connected to the PRM’s ECG connector (4).
  • Page 37 Table 4. Symbols on packaging (continued) Symbol Description Lot number Date of manufacture Non-ionizing electromagnetic radiation; ZIP telemetry indicator light Sterilized using ethylene oxide Consult instructions for use Follow instructions for use Temperature limitation CE mark of conformity with the identification of the notified body authorizing use of the mark Authorized Representative in the...
  • Page 38 Table 4. Symbols on packaging (continued) Symbol Description Analog output Telemetry wand input and wanded telemetry indicator light Defibrillation-proof type CF applied part Defibrillation-proof type BF applied part ECG cable connector Paper form feed Calibration pulse Bring trace to baseline Indicates the potential equalization conductor.

  • Page 39: Environmental Protection And Disposal

    Table 4. Symbols on packaging (continued) Symbol Description Waste, Electrical, and Electronic Equipment (WEEE). Indicates separate collection for electrical and electronic equipment (i.e., do not throw this device in the trash). On indicator light Assembly number This side up Fragile, handle with care Keep dry Do not use hooks Humidity limitations...

  • Page 40: Electromagnetic Compatibility Standards

    • ANSI/AAMI ES60601-1:2005 + C1:2009 + A2:2010 • BS EN 60601-1:2006 + C1:2006 + C2:2007 + C3:2010 • CAN/CSA-C22 No. 60601-1-08 Electromagnetic Compatibility Standards The PRM has been tested and found to comply with the applicable portions of the electromagnetic compatibility (EMC) standards: •...
  • Page 41 Table 5. Guidance and manufacturer’s declaration - electromagnetic emissions - for all equipment and systems Emissions test Compliance Electromagnetic environment — guidance The PRM and ZWT use RF energy only for their internal function. RF emissions Therefore, RF emissions Group 1 (CISPR 11) are very low and are not likely to cause any...
  • Page 42 Table 6. Guidance and manufacturer’s declaration - electromagnetic immunity - for all equipment systems (continued) Immunity test IEC 60601 test Compliance level Electromagnetic level environment — guidance Mains power Surge (IEC ±1 kV line(s) to ±1 kV differential 61000-4-5) line(s) mode quality should be that of a...
  • Page 43 Table 7. Guidance and manufacturer’s declaration - electromagnetic immunity - for equipment and systems that are not life supporting Immunity test IEC 60601 test Compliance level Electromagnetic level environment — guidance Conducted RF 3 Vrms 3 Vrms Portable and (IEC 61000-4-6) 150 kHz to 80 MHz mobile RF communications...
  • Page 44 Table 7. Guidance and manufacturer’s declaration - electromagnetic immunity - for equipment and systems that are not life supporting (continued) Immunity test IEC 60601 test Compliance level Electromagnetic level environment — guidance Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey should...

  • Page 45: Specifications

    Table 8. Recommended separation distances between portable and mobile RF communications equipment, and the PRM / ZWT (continued) Rated maximum Separation distance according to frequency of transmitter output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2.5 d = 1.2 √P d = 1.2 √P...
  • Page 46 Table 9. PRM Nominal Specifications (continued) Characteristic Nominal Transport and storage humidity 25% to 95% ≤ 2000 m Operating altitude Transport and storage atmospheric 50 kPa to 106 kPa (7.252 psi to 15.374 pressure psi) External printer support DB 25 parallel port connector External VGA monitor support DB 15 VGA port connector Analog output...
  • Page 47 Table 9. PRM Nominal Specifications (continued) Characteristic Nominal Bandwidth < 1 MHz Modulation ASK/OOK -1.3 dBm Effective radiated power ZIP telemetry (SRD) Short Range Device (SRD) Receiver Category 3 Frequency band SRD-K1 sub-band (869.85 MHz) Bandwidth < 300 kHz Modulation ASK/OOK Effective radiated power 5.0 dBm...
  • Page 48 Table 9. PRM Nominal Specifications (continued) Characteristic Nominal Safety Features to 5000 V 400 J Defibrillator protection a. The ZIP telemetry frequency band is country-specific. To confirm which frequency band your country uses, contact Boston Scientific using the information on the back cover. b.
  • Page 52 Boston Scientific 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA Guidant Europe NV/SA; Boston Scientific Green Square, Lambroekstraat 5D 1831 Diegem, Belgium Boston Scientific (Australia) Pty Ltd PO Box 332 Botany NSW 1455 Australia Free Phone 1 800 676 133 Free Fax 1 800 836 666 www.bostonscientific.com 1.800.CARDIAC (227.3422)

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