Boston 3300 User Manual

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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.

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........................................................................................	3
Precautions ....................................................................................	7
Adverse Effects .............................................................................	11
SYSTEM CAPABILITIES ..................................................................	11
Hardware .....................................................................................	11
Interrogation and Programming.........................................................	12
Patient Data Management ...............................................................	12
Networking ...................................................................................	13
Software ......................................................................................	13
SYSTEM ACCESSORIES .................................................................	13
Optional External Equipment ............................................................	14
Stand ........................................................................................	14
External Printer............................................................................	15
USB Grounding Plug and Cable ......................................................	15
External Display...........................................................................	16
CONNECTIONS ..............................................................................	16
Patient Side Panel (Right Side) .........................................................	17
Physician Side Panel (Left Side)........................................................	17
Indicator Lights..............................................................................	18
STAT Button..................................................................................	18
USING THE LATITUDE PROGRAMMING SYSTEM ...............................	18
Preparation for Use ........................................................................	18
Battery Charge Level and Charging .................................................	18
Prepare a Telemetry Wand.............................................................	19
Cable Connections.......................................................................	19
Make Patient Side Connections.......................................................	19
Make Physician Side Connections ...................................................	21
Electrosurgical Cables ..................................................................	22
Prepare for ZIP (RF) Telemetry .......................................................	22
Startup ........................................................................................	24
PSA Button.................................................................................	27
Quick Start Button........................................................................	27

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 .......................................................	31
Parameter Changes, Data Entry, Demo Mode, and Utilities .....................	31
Changing Parameter Values...........................................................	31
Demo Mode..................................................................................	33
Utilities Button ...............................................................................	33
Setup - Configure Settings .............................................................	34
Date and Time Tab .......................................................................	34
Network Setup Tab.......................................................................	35
Software Update Tab ....................................................................	35
About Button.................................................................................	36
Selecting a PG ..............................................................................	37
Real-time Log for Transvenous PGs...................................................	39
Real-time Log Tools......................................................................	40
Electronic Calipers .......................................................................	41
Real-time Log Events....................................................................	41
MAINTENANCE ..............................................................................	42
Cleaning the Programmer and Accessories .........................................	42
Cleaning Cables and Wands ..........................................................	43
Disinfecting ECG and PSA Cables...................................................	44
Sterilization.................................................................................	44
Battery Status, Installation, Replacement, and Recycling........................	45
Battery Replacement ....................................................................	48
Battery Recycling.........................................................................	49
Operation and Storage....................................................................	49
Storing the LATITUDE Programming System .....................................	50
Maintenance Check and Safety Measures...........................................	51
LATITUDE Programming System Maintenance Check .........................	51
Safety Measurements ...................................................................	51
Service ........................................................................................	52
TROUBLESHOOTING......................................................................	52
HANDLING ....................................................................................	56
Using an External ECG Monitor with the Model 3300
Programmer .............................................................................	56

Environmental Protection and Disposal.............................................	58
Symbols on Devices and Packaging.................................................	58
SAFETY, COMPLIANCE, AND COMPATIBILITY STANDARDS................	61
Safety Standards ...........................................................................	61
Electromagnetic Compatibility Standards ............................................	61
Radio Spectrum Compliance Standards..............................................	61
Electromagnetic Emissions and Immunity............................................	62
IEC 60601–1–2:2014 Information ....................................................	62
Federal Communications Commission (FCC) Information.....................	62
LATITUDE PROGRAMMING SYSTEM SECURITY ................................	65
Software ......................................................................................	65
Patient Data Management ...............................................................	65
Network .......................................................................................	65
Unsupported Hardware ...................................................................	65
Security Vigilance ..........................................................................	65
Physical Controls ...........................................................................	65
Compromised Programmer ..............................................................	66
SPECIFICATIONS ...........................................................................	66
WARRANTY INFORMATION .............................................................	70

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).

Description and Use

Four separate Operator’s Manuals describe the LATITUDE Programming System:

1.LATITUDE™ Programming System Operator’s Manual (Model 3300)

2.Pacing System Analyzer (PSA) Operator’s Manual (Model 3922)

3.Patient Data Management Operator’s Manual (Model 3931)

4.Network and Connectivity Operator’s Manual (Model 3924)

These manuals are also available online at:

www.bostonscientific-elabeling.com.

The Model 3300 Programmer is the programming device of the LATITUDE Programming System, which is a portable cardiac rhythm management system designed to be used with specific Boston Scientific systems, i.e., implantable pulse generators (PGs) and leads.

Intended Use

The LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the PG. For detailed software application instructions, refer to the associated product literature for the PG being interrogated.

Intended Audience

The LATITUDE Programming System is intended for use by health care professionals trained or experienced in device implant and/or follow-up procedures.

Required Expertise and Knowledge

Users must be thoroughly familiar with electrotherapy of the heart. Only qualified medical specialists having the special knowledge required for the proper use of the device are permitted to use it.

Physician Supervision

The LATITUDE Programming System may only be operated under the constant supervision of a physician. During a procedure, the patient must be

continuously monitored by medical personnel with the aid of a surface ECG monitor.

Essential Performance

In order for the LATITUDE Programming System to meet its intended use, it must communicate with Boston Scientific implantable PGs. Therefore those functions that pertain to communications with the implanted PGs using telemetry wands are considered essential performance.

LATITUDE Programming System performance determined to be essential by Boston Scientific for electromagnetic compatibility testing, as per IEC 60601-1- 2, has the ability to:

•Interrogate and program a supported PG using wanded, inductive, and RF telemetry

•Initiate a STAT PACE, PSA STAT PACE, STAT SHOCK, or DIVERT THERAPY command to a PG where supported

•Display real-time intracardiac electrograms

•Supports touchscreen tap and button press interactions

•Deliver pacing and perform impedance lead measurements with the Pacing System Analyzer (PSA) function

Boston Scientific hereby declares that this device is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC for Radio and Telecommunications Terminal Equipment (RTTE). To obtain a full text Declaration of Conformity, contact Boston Scientific using the information on the back cover of this manual.

NOTE: No recurring calibration of the LATITUDE Programming System or its applications is required or needed.

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.

The following uses of the PSA are contraindicated:

•With AV conduction disorders; atrial single-chamber pacing

•With competing intrinsic rhythms; asynchronous modes

•With chronic atrial tachycardia as well as chronic atrial fibrillation or flutter; modes with atrial control (DDD, VDD)

•With poor tolerance of high ventricular rates (e.g., with angina pectoris); tracking modes (i.e., atrial control modes) and propensity for atrial tachycardia

•Use as an external pacemaker1

WARNINGS

•Use of unspecified cables and accessories.

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 the LATITUDE Programming System, including the use of MSOs (Multiple Socket Outlets), 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.

•Radio frequency (RF) communications equipment.

Keep all RF communications equipment (including peripherals such as antennas, wands, and cables) at least 30 cm (12 in) away from the Model 3300 Programmer, including cables specified by Boston Scientific, to avoid degradation of the performance of this equipment.

•Connector contacts.

Do not simultaneously touch the patient and any accessible LATITUDE Programming System connector or exposed conductor.

•Electric shock.

To avoid the risk of electric shock, only connect the Programmer’s Model 6689 Power Adapter to a grounded/earthed power outlet.

•Battery access.

When accessing the battery, ensure that power to the Programmer is turned off. Do not touch the connector terminals in the battery compartment while removing or replacing the battery because an electrical charge is present.

•Electrostatic charges.

The PSA lead system is in electrical contact with the patient’s heart and blood.

•Do not touch the metal clips on the patient cable or the pacing lead. Electrical currents can be dangerous to the patient and the user.

•Discharge any electrical static charge on your person by touching a grounded metal surface before touching the patient, the patient cables, or the device.

1.During implantation, the PSA application is suitable for temporary external pacing while the patient is being continuously monitored by medical personnel.

•Electrical currents.

Unused PSA cable connections contacting conductive surfaces can induce electrical currents into the patient’s heart.

•Attach unused cable connections to surgical draping near the patient or disconnect the unused cables from the system.

•Electrocautery.

The LATITUDE Programming System is designed and tested to be electrocautery safe.

•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 electrocautery system and associated components as possible to minimize noise being introduced into the LATITUDE Programming System and patient cables.

•Never stack the Programmer on top of an electrocautery system or associated components.

•Do not drape electrocautery components or cables on or near the Programmer or associated cables and components.

•Whenever possible disconnect the PSA cables from the pacing leads when performing an electrocautery procedure.

•If the Programmer is connected to the patient during an electrocautery procedure, check its operation afterwards.

•If the Programmer experiences an issue that causes an error condition, the Programmer will need to be power cycled. During the reset and reboot, which takes up to one minute, there will be no pacing support. For this reason, a backup PSA/pace resource must be available in case electrocautery is applied.

•LATITUDE Programming System location.

Use of the PSA application on the Model 3300 Programmer adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

•LATITUDE Programming System must remain outside sterile field.

The Programmer is non-sterile and cannot be sterilized. Do not allow the device to enter a sterile zone in an implant environment.

•Physiological signals.

Operation of the LATITUDE Programming System with physiological signals that are lower than the minimum detectable amplitude may cause inaccurate results.

•LATITUDE Programming System is MR unsafe.

The LATITUDE Programming System is 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 Practices2. Under no circumstances should the LATITUDE Programming System be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.

•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.

•External defibrillation.

The LATITUDE Programming System is designed and tested to be defibrillation safe.

•While the Programmer is designed and tested to be defibrillation safe, the patient can be endangered and the Programmer can be damaged.

•The PSA cable must be disconnected from the lead(s) before using external defibrillation.

•Whenever possible disconnect all cables from the patient when using external defibrillation equipment.

•If the LATITUDE Programming System is connected to the patient during defibrillation, verify that the Programmer is operating as expected after defibrillation.

•External pacing equipment.

If the patient is pacer dependent and the Programmer encounters a fault condition, pacing operation continues unless the fault was in the PSA component itself. For this reason, always have external pacing equipment available for patient back-up.

•Loss of power.

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

Operating the Programmer with a depleted internal battery or no battery can suspend Programmer function if AC power is temporarily interrupted.

•If an optional battery is used, do not use a depleted or unapproved battery. For additional patient safety, when the battery level indicator shows 25% or less remaining, connect the AC power to the Programmer.

•When operating on battery power, do not attempt to replace the battery.

•A yellow attention message displays on the Programmer screen when the battery reaches 25% depletion. When the battery reaches 10% depletion or less, a red warning message displays. At 5%, there is another red warning message followed by a 60–second automatic shutdown.

•Loss of pacing support.

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.

•Connecting the PSA cable to the wrong lead may result in ineffective sensing and pacing behavior and loss of pacing support.

•If the user manually restarts the Programmer, pacing support is lost until the system completes its self-test, which can take up to one minute and the user must restart PSA manually if desired.

•If there is no battery installed, pacing support will be lost if AC power is lost.

•Impaired AV conduction.

Single chamber atrial modes are contraindicated for patients with impaired AV conduction.

•If the patient has impaired AV conduction, AAI programming and antegrade conduction tests must not be performed.

•Abruptly terminating pacing.

Abruptly terminating pacing may result in extended periods of asystole in some patients.

•Gradually decrease the pacing rate until the patient’s intrinsic rate is detected for a controlled transition from pace to intrinsic rhythm.

•Loss of capture.

Pacing threshold testing implies loss of capture. At loss of capture, asystole and pacing during vulnerable periods can occur.

•Consider the health of the patient prior to performing a pacing threshold test.

•Use of protective sleeves.

Incorrect positioning of the protective silicone rubber sleeves over the PSA cable clip(s) can cause unintended electrical connections that can impair cable function and endanger the patient.

•Before connecting cables, ensure correct position of protective sleeves.

•Do not use wet cables.

Moisture on wet cables can impair cable function and endanger the patient.

•Exposure to fluids.

Before cleaning and disinfecting the Programmer surfaces, power down the device and disconnect the external power supply. Before operating the LATITUDE Programming System, let cleaning and disinfection agents used on the Programmer evaporate.

•Emissions and interference.

The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required), this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or reorienting the equipment. Other equipment may interfere with the LATITUDE Programming System, even if that equipment complies with the CISPR emission requirements.

•Lithium-ion battery.

The Model 6753 Battery is a Lithium-ion battery and, as such, is deemed a Dangerous Good in regards to shipping. For air shipments, the battery charge cannot exceed 30% per applicable aviation regulations. Shipping with a charge greater than 30% is in direct violation of aviation regulations and may result in significant fines to the shipper including the individual responsible for the shipment. When shipping by air, a Lithium-ion battery handling label must be applied to the outer shipping box visible to the carrier. There are no restrictions for ground shipments nor is a Lithium-ion battery handling label required for ground shipments.

PRECAUTIONS

General

•Functional impairment due to external damage. Mechanical impact, for example dropping the Programmer unpackaged, can permanently impair the function of the system. Do not use the Programmer if there is apparent damage. If damage has occurred, contact Boston Scientific to return the Programmer using the information on the back cover of this manual.

•Programming System. Use only the appropriate LATITUDE Programming System equipped with the appropriate software to program specific Boston Scientific PGs.

•Wand use. For transvenous PG telemetry, use only the Model 6395 Telemetry Wand with the LATITUDE Programming System.

•Stylus use. If you want to use a stylus, ensure that it is a projected capacitance stylus. The use of any other object could damage the touchscreen.

•Electrocautery cables. Keep all electrocautery cables at least 30 cm (12 in) away from the LATITUDE Programming System to avoid false signals due to electrocautery energy.

•Leakage current. Although optional external equipment connected to the Model 3300 Programmer must meet the applicable 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.

•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.

•Wand temperature (Model 6395 only). Telemetry procedures exceeding 8 hours may require a thermal insulator between the Model 6395 Telemetry Wand head and the patient’s skin as the wand head temperature can range from 33 - 41 ºC (88 - 106 ºF).

•PSA connections. Ensure leads are connected appropriately for desired use; incorrect setup can result in pacing/sensing events, which display under a different chamber on the screen. The PSA application user interface associates specific lead connections with the RA, RV, and LV chambers on screen to support testing all three chambers with minimal change of physical connections. Saved PSA measurements are also labeled automatically based upon the chamber in use on the screen. These labels can later be adjusted by the user if the decision is made to use one physical connection to test other chambers (for example, using only the RV connection to test RA, RV, and LV leads).

•Ventricular Sensing. During a PSA session, ventricular sensing behavior is driven by the most recently selected ventricular pacing configuration: RV-only, LV-only, or Bi-V.

•At system startup, the PSA mode is set to ODO (non-pacing) and the effective ventricular pacing configuration is Bi-V.

•When a non-pacing mode (ODO or OVO) is selected from the mode palette, sensing is set to Bi-V to ensure sensing is enabled on both leads regardless of any prior configuration.

•ECG cable open/short. Loss of the ECG signal in case of an ECG cable open/short can affect diagnosis and screening by prolonging the procedure or preventing the procedure from completing.

•Check cables first and replace if cracked or worn.

•If cable is not functioning properly, replace it.

•Model 6689 Power Adapter. The power adapter normally gets warm when it is in use or charging. Do not place the power adapter in the storage pocket of the stand while it is in use or charging as the confined space will not allow the heat to dissipate adequately.

•Ethernet. If desired for use, connect the Ethernet cable only to the RJ45 Ethernet port connector on the Model 3300 Programmer. Insertion or removal of the Ethernet cable during operation may affect networking functions. The RJ45 Ethernet connection on the Model 3300 Programmer is for Local Area Networking (LAN) use only. It is not to be used for a telephone connection.

•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).

•Date and time accuracy. Inability to access a remote time server could lead to discrepancies in the Programmer time. As a backup, the Boston Scientific representative can set the time and date manually.

•Patient data. Patient data may be stored on the Programmer up to 14 days and appropriate precautions should be taken to secure the programmer from unauthorized access.

•Delete all patient data from the Programmer (refer to the Patient Data Management Operator’s Manual (Model 3931) for delete instructions) before shipping the Programmer or at any time when the Programmer leaves your direct control.

•Only connect to known Bluetooth® devices to reduce the potential of transmitting patient data to inappropriate printers or devices.

•USB devices. USB devices connected to the Programmer should be controlled to limit the potential introduction of malware.

•External device battery usage. Using external devices (USB, display monitor) will deplete the battery. To extend Programmer performance, refrain from using external devices when on battery power only and the battery level indicator shows 25% or less remaining.

•Software. Ensure that you have the latest software versions installed (see "Software Update Tab" on page 35). As a backup, your local Boston Scientific representative can provide software updates using a USB pen drive.

•Model 6395 Telemetry Wand shipped non-sterile. The Model 6395 Telemetry Wand is shipped non-sterile. Remove the wand from all packaging material before sterilizing it. If the wand is to be used in a sterile field, it must be actively sterilized before use or enclosed in a disposable sterile surgical sheath (Model 3320) during use. Refer to "Cleaning the Programmer and Accessories" on page 42 for sterilization and cleaning information.

•Model 3203 S-ICD Telemetry Wand shipped non-sterile . The Model 3203 S-ICD Telemetry Wand is shipped non-sterile. Remove the wand from all packaging material before use. If the wand is to be used in a sterile field, it must be enclosed in a sterile intraoperative probe cover (Model 3320) during use. Refer to "Cleaning the Programmer and Accessories" on page 42 for cleaning information.

•Electrical and magnetic interference. Avoid establishing telemetry communication between the Programmer and the PG when the Programmer is in close proximity to monitors, high-frequency electrocautery equipment, or strong magnetic fields. The telemetry link may be impaired.

•External antenna usage for RF telemetry. The Model 3203 S-ICD Telemetry Wand may be used as an additional antenna to improve the Programmer’s RF telemetry performance. If the wand is placed in a sterile field, it must be enclosed in a disposable, sterile surgical sheath (Model 3320) during use. When the Model 3203 S-ICD Telemetry wand is not used for RF telemetry, be sure to disconnect the Model 3203 S-ICD 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

•Cleaning the Programmer. Do not use an abrasive cloth or volatile solvents to clean any portion of the device. See "Cleaning the Programmer and Accessories" on page 42 for recommended cleaning.

•Magnet handling. Do not place a magnet on the Programmer.

•Presence of flammables. The LATITUDE Programming System is not waterproof or explosion-proof and cannot be sterilized. Do not use it in the presence of flammable gas mixtures including anesthetics, oxygen, or nitrous oxide.

•Disconnecting the Programmer. To completely disconnect the Programmer from the power source, first press and release the power button to turn the system off. Then disconnect the power cord from the side of the Programmer.

•Programmer accessibility. Ensure that the sides of the Programmer are accessible at all times so that the power adapter cord can be disconnected.

•Lithium-ion battery. The Model 6753 Lithium-ion battery contains highly flammable chemicals and should be handled with caution. Abuse of this battery can result in fire or explosion. Read the following prior to using this battery:

• Do not expose the battery to temperatures above 140°F (60°C).

•Do not puncture the battery as it can lead to a fire or explosion. If the battery housing is punctured, or otherwise visibly damaged, do not attempt to use it.

•Do not strike the battery or otherwise subject it to strong impacts.

•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.

Radio Frequency (RF) Performance

To reduce emissions and improve RF performance, adhere to the following guidelines:

•Avoid establishing telemetry communication between the Programmer and the PG when the device is in close proximity to monitors, high-frequency electrosurgical equipment, or strong magnetic fields. The telemetry link (RF or inductive) may be impaired.

•Do not loop any cables around or over the Programmer.

•Cables on the physician side panel and patient side panel should be kept on their respective sides to minimize coupling.

•Route cables directly away from the Programmer when possible.

•When using the DisplayPort output to external video or a digital monitor:

–Keep the external video or digital monitor and its cable routed away from the Programmer to avoid electrical interference.

–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.

SYSTEM CAPABILITIES

The LATITUDE Programming System communicates with PGs and provides the following capabilities in hardware, interrogation/programming, patient data management, networking, and software:

Hardware

•Color touchscreen display with capacitive touch

•Internal hard drive

•Connections allow for a patient ECG cable and PSA cable to be input and displayed on the Programmer (certain applications only)

•DisplayPort for an optional external display

•USB ports (4) available for patient data export to a standard USB 2.0 or 3.0 pen drive, connection to an external printer, or used for software installation by Boston Scientific personnel

NOTE: The USB ports are forward and backward compatible. USB 2.0 devices work in USB 3.0 ports and USB 3.0 devices work in USB 2.0 ports. The lowest version of USB determines the speed. For example, a USB 3.0 device plugged into a USB 2.0 port runs at 2.0 speed, and a USB 2.0 device plugged into a USB 3.0 port runs at 2.0 speed.

Interrogation and Programming

•Interrogates and programs the implantable PG

•Displays records, stores patient data, and allows the physician to evaluate alternative prescription modes, generate reports, and record episodes

•Performs tests in an electrophysiology laboratory, in an operating room, in an emergency room, in clinical environments, or at a patient’s bedside

•May be used to support diagnostic activities3 pertaining to implanting, programming, and monitoring Boston Scientific implantable PGs

•Provides a Pacing System Analyzer (PSA) application4 to assess electrical performance and placement of cardiac lead systems during implant of cardiac rhythm management devices

•Provides real-time electronic capture of various events from the PG and the PSA application

•Outputs surface ECG and telemetered signals (intracardiac electrograms and event markers) in PDF format

•Provides emergency access to STAT SHOCK, STAT PACE, and DIVERT THERAPY functionality applicable to the PG and PSA application

•Provides ZIP telemetry, a cordless, hands-free RF communication option that allows the Programmer to communicate with the PG

Patient Data Management

The LATITUDE Programming System provides the ability to print, save, or transfer related data (via Bluetooth® or USB pen drive), during or after an implant/follow-up session, to a clinic computer for processing/transferring data to external systems (e.g., EMR systems).

Refer to the Patient Data Management Operator’s Manual (Model 3931) for additional information.

3.The LATITUDE Programming System is not intended for use as an ECG monitor or general diagnostic device.

4.Refer to the Pacing System Analyzer (PSA) Operator’s Manual (Model 3222) for PSA setup and use information.

Networking

The LATITUDE Programming System provides Ethernet and wireless (Wi-Fi) connectivity for data transmission. Bluetooth® connectivity is available for data transfer (e.g., to a laptop) and printing.

Refer to the Network and Connectivity Operator’s Manual (Model 3924) for additional networking and connectivity setup and use information.

Software

Software updates and downloads are provided via Internet or USB pen drive. If a software update or download does not complete successfully, you can reinitiate the update or download.

The Utilities tab on the Programmer screen includes a Software Update selection. The user may choose from downloading and installing all updates or reviewing and selecting updates from those available. See "Software Update Tab" on page 35.

SYSTEM ACCESSORIES

The following accessories have been tested and can be used with the Model 3300 Programmer:

•Model 6395 Telemetry Wand5 (re-sterilizable)

•Model 3203 S-ICD Telemetry Wand6

•Model 3320 Intraoperative Probe Cover, which is to be used with the Model 6395 Telemetry Wand or the Model 3203 S-ICD Telemetry Wand if the S-ICD wand is located within the sterile field

•Model 6697 (Remington Model S-101–97) PSA Disposable Cable, singleuse only, and requires a Model 6133 Safety Adapter

•Model 6763 PSA Cable, re-sterilizable and re-usable; the cable clip protective covers contain Elastosil R401 (silicone rubber)

•Model 6133 (Remington Model ADAP-2R) Safety Adapter

•Model 3153 Fixed Patient Leads ECG Cable7

•Model 6629 ECG-BNC Slave Cable

•Model 6689 Power Adapter (supply)

•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:

5.The Model 6395 Telemetry Wand does not include a magnet.

6.The Model 3203 S-ICD Telemetry Wand can be used as an additional antenna to improve MICS telemetry performance.

7.The 3153 Fixed Patient Leads ECG Cable contains current-limiting features to protect against defibrillation and should be the ECG cable used with the LATITUDE Programming System.

Optional External Equipment

Optional external equipment can be used with the LATITUDE Programming System. Contact your Boston Scientific sales representative to determine what external equipment can be used.

NOTE: If adding external equipment, you are configuring a medical system and are responsible to ensure that the system complies with the requirements of IEC/EN 60601-1, Clause 16 for medical electrical systems.

WARNING:

Do not simultaneously touch the patient and any accessible LATITUDE Programming System connector or exposed conductor.

CAUTION: Although optional external equipment connected to the Model 3300 Programmer must meet the applicable 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.

•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.

Stand

A stand (Model 6755) is available for the LATITUDE Programming System. It easily attaches to the bottom of the Programmer with a clip. It provides two convenient viewing angles and has a storage pocket in the back for storing cables and wands.

When the stand is used in the flat position, do not use downward force on the handle as the unit may tip.

To attach the stand, slip the stand under the Programmer and tilt the stand up to engage the clip as illustrated in Figure 1 Optional Stand for the LATITUDE Programming System on page 15.

[1] Model 3300 Programmer [2] Stand Clip [3] Model 6755 Stand [4] storage pocket

Figure 1. Optional Stand for the LATITUDE Programming System

CAUTION: The power adapter normally gets warm when it is in use or charging. Do not place the power adapter in the storage pocket of the stand while it is in use or charging as the confined space will not allow the heat to dissipate adequately.

External Printer

The LATITUDE Programming System supports a broad range of external USB 2.0 and USB 3.0 printers. Refer to "Connections" on page 16 to connect the printer’s USB cable.

Some Bluetooth® printers are also supported. Refer to the Network and Connectivity Operator’s Manual (Model 3924) for additional setup and use information.

USB Grounding Plug and Cable

A USB grounding plug and cable may be used with the Model 3300 Programmer to provide an earth ground to decrease noise interference to the LATITUDE Programming System. Contact your hospital/clinic biomedical engineering department for this standard piece of equipment.

WARNING:

External Display

You can use an external monitor (or equivalent) that can synchronize to any horizontal scan frequency.

NOTE: External monitors may require an adapter and/or cable to connect to the DisplayPort on the Programmer.

NOTE: Equipment connected to the external connections must comply with applicable standards for data processing equipment and for medical equipment.

WARNING:

CONNECTIONS

Refer to Figure 2 Right Side Panel of the Programmer on page 17 and Figure 3 Left Side Panel of the Programmer on page 17 to identify the port connections to the Programmer.

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. Right Side Panel of the Programmer

Physician Side Panel (Left Side)

NOTE: Equipment connected to the external connections must comply with applicable standards for data processing equipment and for medical equipment.

[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 3. Left Side Panel of the Programmer

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.

• Power (on/off) button is lit when the Programmer is on.

•The light on the Model 6395 Telemetry Wand illuminates to indicate that inductive telemetry is established and is actively communicating to a PG.

STAT Button

The Programmer has a red STAT button on the front top-right of the device. Depending on the situation, the STAT function provides STAT PACE, STAT SHOCK, or DIVERT THERAPY.

[1] Red STAT button

Figure 4. Front View of LATITUDE Programming System Indicating the Red STAT Button Location

USING THE LATITUDE PROGRAMMING SYSTEM

Preparation for Use

Battery Charge Level and Charging

The Lithium-ion battery for the Programmer is not charged when shipped. To charge the battery, perform the following steps.

NOTE: Before using the battery with the LATITUDE Programming System, ensure that the battery is fully charged.

1.Connect the AC power and turn on the Programmer. See Figure 3 Left Side Panel of the Programmer on page 17.

2.Check the battery charge by noting the battery status indicator in the upper left of the screen, which displays the battery charge percent. See Figure 9 Main Screen on page 25.

3.Nominally, battery charging can take 1-2 hours when the battery is less than 30% charged.

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