OPERATOR’S MANUAL ZOOM® LATITUDE® Programmer/Recorder/Monitor Model 3120 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.
Table of Contents INFORMATION FOR USE ............................................................................ Trademark Statement ................................................................................. Description and Use.................................................................................... Warnings ..................................................................................................... Precautions ....................................................................
Specifications ............................................................................................
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.
• 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. • PRM location. Do not use the PRM or ZWT adjacent to or stacked with other equipment.
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. • Telemetry wand sterilization. Remove the telemetry wand from all packaging material before sterilizing it. • Electrical and magnetic interference.
The PRM also: • Provides a direct interface between an external stimulator and an implanted pulse generator for programmed electrical stimulation (PES) during EP studies • May be used to support diagnostic activities pertaining to implanting, programming, and monitoring Boston Scientific implantable pulse generators.
• 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.
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 6). 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.
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.
[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. NOTE: To communicate wirelessly using ZIP telemetry, certain pulse generators require the Model 3140 Zoom Wireless Transmitter.
• Use the equipotential stud 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. 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.
[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.
Figure 5.
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—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.
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: 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.
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.
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. 6.
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.
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.
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. • Modify the PRM clock—Select the Date and Time tab. Select the appropriate date or time value box to change any of the date or time parameters, and then select the appropriate value in the window that displays.
a. 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. NOTE: STAT PACE, STAT SHOCK, and DIVERT THERAPY commands are functional in DEMO mode only if the telemetry wand is positioned over the pulse generator. b. 4.
[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 21). The PRM must be in telemetry communication with the pulse generator for these functions to be available. • [1] Press STAT PACE to initiate emergency bradycardia pacing at predetermined high-output parameters. • [2] Press DIVERT THERAPY to divert tachycardia therapy delivery.
• [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. MAINTENANCE Loading the Paper The internal printer/recorder uses thermosensitive printing paper that is 110 mm (4 in) wide.
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.
[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 24). To retrieve the disk, press the disk ejection button.
• 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 24). • 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. Operation and Storage The PRM and ZWT require special handling. The hard-disk drive and the floppy-disk drive of the PRM must be protected from abusive handling.
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 1. If using a patient data disk, remove the disk from the disk drive, and store the disk in a safe place. You are responsible for the security of this disk and the associated patient data. 2. Exit the current software application. 3. Press the On/Off button to turn off the power.
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: 1. Leave the configuration of the instrument exactly as it was at the time of malfunction. Contact Boston Scientific using the information on the back cover. 2.
Table 2. Possible causes and corrective actions for PRM problems (continued) Symptom Possible Cause Corrective Action Internal printer/recorder: no print visible Paper loaded upside down Reload paper. Internal printer/record: printing stops Application did not handle print request If the touchscreen is not responsive, turn off the PRM. Turn on the PRM and try printing any incomplete items again.
Table 2. Possible causes and corrective actions for PRM problems (continued) Symptom Possible Cause Corrective Action Incorrect telemetry wand Use only the Model 6577 Sterilizable Telemetry Wand. Excessive radio emissions from equipment Reorient the PRM antenna (if approved for use) or reposition the PRM. Also see Noise problems: ECG. Incomplete telemetry communication Reposition wand over the pulse generator; repeat interrogation. Flip over wand; repeat interrogation.
Table 3. Possible causes and corrective actions for ZWT problems Symptom Green indicator light on ZWT does not light within 60 seconds of powering on PRM Telemetry: intermittent communication Possible Cause Corrective Action USB cable not securely connected to ZWT Remove and reconnect both ends of USB Cable. USB cable damaged Replace with Model 3141 USB Cable only. ZWT fault Contact Boston Scientific using the information on the back cover.
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 31). 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). Connect the telemetry wand (5) to the PRM’s telemetry wand connector (6), ensuring that its cable does not cross any other cable.
Table 4.
Table 4. Symbol Symbols on packaging (continued) Description 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. This connection allows a common ground with other equipment in a clinical setting.
Table 4. Symbols on packaging (continued) Symbol Description On indicator light Assembly number This side up Fragile, handle with care Keep dry Do not use hooks Humidity limitations Atmospheric pressure limitations MR Unsafe Environmental Protection and Disposal Return the PRM and/or accessories to Boston Scientific at the end of their useful lives for appropriate disposal. Compliance Standards The following standards apply to the PRM.
Electromagnetic Compatibility Standards The PRM has been tested and found to comply with the applicable portions of the electromagnetic compatibility (EMC) standards: • FCC Part 15.209:2004 + 15.207:2004 + 15.249:2004 • EN 302 195-2 V1.1.1:2004 • EN 300 220-2 V2.1.2:2007 • EN 301 489-1 V1.8.1:2008 • EN 301 489-3 V1.4.1:2002 The ZWT has been tested and found to comply with the applicable portions of the electromagnetic compatibility (EMC) standards: • EN 301 489–1 V1.9.2:2011 • EN 301 489–27 V1.
Table 5. Guidance and manufacturer’s declaration - electromagnetic emissions for all equipment and systems Emissions test Electromagnetic environment — guidancea Compliance RF emissions (CISPR 11) Group 1 RF emissions (CISPR 11) Class A Harmonic emissions (IEC 61000-3-2) Class A Voltage fluctuations / flicker emissions (IEC 61000-3-2) Complies The PRM and ZWT use RF energy only for their internal function.
Table 6. Guidance and manufacturer’s declaration - electromagnetic immunity for all equipment systems (continued) Immunity test IEC 60601 test level Compliance level Electromagnetic environment — guidancea Surge (IEC 61000-4-5) ±1 kV line(s) to line(s) ±1 kV differential mode ±2 kV line(s) to earth ±2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. <5% UT (>95% dip in UT ) for 0.5 cycleb <5% UT (>95% dip in UT ) for 0.
Table 7. Guidance and manufacturer’s declaration - electromagnetic immunity for equipment and systems that are not life supporting Immunity test IEC 60601 test level Compliance level Electromagnetic environmenta — guidanceb Conducted RF (IEC 61000-4-6) 3 Vrms 150 kHz to 80 MHz 3 Vrms Radiated RF (IEC 61000–4-3) 3 V/m 80 MHz to 2.
Table 7. Guidance and manufacturer’s declaration - electromagnetic immunity for equipment and systems that are not life supporting (continued) Immunity test IEC 60601 test level Compliance level Electromagnetic environmenta — guidanceb Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveyd should be less than the compliance level in each frequency range.e Interference may occur in the vicinity of equipment marked with the following symbol: a.
Table 8. Recommended separation distances between portable and mobile RF communications equipment, and the PRM / ZWT (continued) Rated maximum output power of transmitterb c W Separation distance according to frequency of transmittera m 150 kHz to 80 MHz d = 1.2 √P 80 MHz to 800 MHzd d = 1.2 √P 800 MHz to 2.5 GHz d = 2.3 √P 10 3.8 3.8 7.3 100 12 12 23 a. The PRM and ZWT are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Table 9. PRM Nominal Specifications (continued) Characteristic Nominal Transport and storage humidity 25% to 95% Operating altitude ≤ 2000 m Transport and storage atmospheric pressure 50 kPa to 106 kPa (7.252 psi to 15.374 psi) External printer support DB 25 parallel port connector External VGA monitor support DB 15 VGA port connector Analog output ± 1 V output via seven-pin DIN connector Battery type DL 2450 or equivalent ECG cable 3.9 m to 4.3 m (12.7 ft to 14.
Table 9. PRM Nominal Specifications (continued) Characteristic Nominal Bandwidth < 1 MHz Modulation ASK/OOK Effective radiated power -1.
Table 10. ZWT Nominal Specifications (continued) Characteristic Nominal Weight (approximate) 0.6 kg (1.3 lb) Power rating 5 V DC Power cord Power supplied via USB data cable Duty cycle Continuous Operating temperature 10°C to 35°C (50°F to 95°F) Transport and storage temperature -40°C to 70°C (-40°F to 158°F) Operating humidity 25% to 90% Transport and storage humidity 25% to 95% Operating altitude ≤ 2000 m Transport and storage atmospheric pressure 50 kPa to 106 kPa (7.252 psi to 15.
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Manufacturer Boston Scientific 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA www.bostonscientific.com 1.800.CARDIAC (227.3422) +1.651.582.4000 © 2014 Boston Scientific Corporation or its affiliates. All rights reserved.
