LATITUDE 3300 Operators Manual

Electrosurgical Cables ... . ... . ... . ... . ... . ... . ... . ... . ... . ..24 Prepare for Telemetry with a Transvenous PG . .. . ... . ... . ... . ... . ... . ..24 Startup ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..26 PSA Button ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..29 Quick Start Button... . ... . ... . ... . ... . ... . ... . ... . ... . ..29 S-ICD Applications Button . . ... . ... . ... . ... . ... . ... . ... . ... . ..29 Patient Data Management Button ... . ... . ... . ... . ... . ... . ... . ..29 STAT Button for Transvenous PGs ... . ... . ... . ... . ... . ... . ... . ..29 STAT Button for S-ICD PGs . ... . ... . ... . ... . ... . ... . ... . ... . .. 31 Start a Transvenous PG Session . .. . ... . ... . ... . ... . ... . ... . ... . .. 32 Quick Start (Button) . . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. 32 Select PG (Button)... . ... . ... . ... . ... . ... . ... . ... . ... . .. 33 Start an S-ICD PG Session . .. . ... . ... . ... . ... . ... . ... . ... . ... . .. 33 Surface ECG. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..34 ECG Display ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. 35 Intracardiac Electrogram . .. . ... . ... . ... . ... . ... . ... . ... . ... . ..36 Pacing System Analyzer (PSA)... . ... . ... . ... . ... . ... . ... . ... . ..36 Patient Data Management Utility .. . ... . ... . ... . ... . ... . ... . ... . ..36 Parameter Changes, Data Entry, Demo Mode, and Utilities... . ... . ... . ... . ..36 Changing Parameter Values... . ... . ... . ... . ... . ... . ... . ... . ..36 Demo Mode . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . .. 37 Utilities Button . . .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..38 Setup - Configure Settings . ... . ... . ... . ... . ... . ... . ... . ... . ..39 Date and Time Tab... . ... . ... . ... . ... . ... . ... . ... . ... . ..39 Network Setup Tab . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..40 Software Update Tab ... . ... . ... . ... . ... . ... . ... . ... . ... . ..40 About Button ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..42 Selecting a Transvenous PG. . ... . ... . ... . ... . ... . ... . ... . ... . ..42 Real-time Log for Transvenous PGs ... . ... . ... . ... . ... . ... . ... . ..44 Real-time Log Tools . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..46 Electronic Calipers... . ... . ... . ... . ... . ... . ... . ... . ... . ..46 Real-time Log Events ... . ... . ... . ... . ... . ... . ... . ... . ... . ..46 MAINTENANCE... 48 Cleaning the Programmer and Accessories... . ... . ... . ... . ... . ... . ..48 Cleaning Cables and Wands... . ... . ... . ... . ... . ... . ... . ... . ..49 Disinfecting the ECG Cable . ... . ... . ... . ... . ... . ... . ... . ... . ..49 Sterilization ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ..49 Battery Status, Installation, Replacement, and Recycling. . ... . ... . ... . ... . ..50 Battery Replacement. ... . ... . ... . ... . ... . ... . ... . ... . ... . .. 53 Battery Recycling. ... . ... . ... . ... . ... . ... . ... . ... . ... . ..55 Operation and Storage ... . ... . ... . ... . ... . ... . ... . ... . ... . ..55 Storing the LATITUDE Programming System... . ... . ... . ... . ... . ... . .. 57

Maintenance Check and Safety Measures . ... . ... . ... . ... . ... . ... . ... 57 LATITUDE Programming System Maintenance Check ... . ... . ... . ... . ... 57 Safety Measurements.. . ... . ... . ... . ... . ... . ... . ... . ... . ... 57 Service .. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ...58 T R O U B L E S H O OT I N G... 5 8 HANDLING...63 Using an External ECG Monitor with the Model 3300 Programmer . . .. . ... . ... . ...63 Environmental Protection and Disposal... . ... . ... . ... . ... . ... . ...65 Symbols on Devices and Packaging .. . ... . ... . ... . ... . ... . ... . ...65 SAFETY, COMPLIANCE, AND COMPATIBILITY STANDARDS... 69 Safety Standards... . ... . ... . ... . ... . ... . ... . ... . ... . ...69 Electromagnetic Compatibility Standards . ... . ... . ... . ... . ... . ... . ...69 Radio Spectrum Compliance Standards... . ... . ... . ... . ... . ... . ...69 Electromagnetic Emissions and Immunity ... . ... . ... . ... . ... . ... . ...70 IEC 60601–1–2:2014 Information . . .. . ... . ... . ... . ... . ... . ... . ...70 Industry Canada (IC) . .. . ... . ... . ... . ... . ... . ... . ... . ... . ...70 LA T I TU D E P R O G R A MM IN G SYS T E M S EC U R IT Y... 7 2 Software . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 72 Patient Data Management... . ... . ... . ... . ... . ... . ... . ... . ... 73 Network. . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 73 Unsupported Hardware.. . ... . ... . ... . ... . ... . ... . ... . ... . ... 73 Security Vigilance . . ... . ... . ... . ... . ... . ... . ... . ... . ... . ... 73 Physical Controls... . ... . ... . ... . ... . ... . ... . ... . ... . ... 73 Compromised Programmer.. . .. . ... . ... . ... . ... . ... . ... . ... . ... 73 SPECIFICATIONS... 74 WARRANTY INFORMATION... 78

INFORMATION FOR USE Tradem ark Statement The following are trademarks of Boston Scientific Corporation or its affiliates: AF Monitor, EMBLEM, ImageReady, LATITUDE, LATITUDE NXT, Quick Start, ZIP, ZOOM, Heart Connect, ALTRUA, INSIGNIA, and NEXUS. Bluetooth® is a registered trademark of Bluetooth SIG. DisplayPort is a trademark of the Video Electronics Standards Association (VESA).

Description and Use Seven 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)

5.

LATITUDE™ Heart Connect™ System Operator’s Manual (Model 3932)

6.

EMBLEM™ S-ICD Automated Screening Tool (AST) Instructions for Use (Model 3889)

7.

EMBLEM™ S-ICD Application Operator’s Manual (Model 3877)

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.

I n t e n de d A u di e n ce This literature is intended for use by health care professionals trained or experienced in device implant and/or follow-up procedures.

Re qu ire d E x p e r t i s e an d K n o w le dg e 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 Super vision 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.

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Me di c al P ro d u c t O p era t o r ’ s O rd i n an ce National regulations may require that the user, manufacturer or manufacturer representative perform and document safety checks of the device during installation. They may also require that the manufacturer or its representative provide training to users on the proper use of the device and its accessories. If you do not know the national regulations in your country, please contact your local Boston Scientific representative.

E s s e n t i a l P e r f o r m a n ce 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 telemetry

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

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Display real-time intracardiac electrograms

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Support touchscreen tap and button press interactions

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Deliver pacing and assess pace sense lead measurements with the Pacing System Analyzer (PSA) function

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

C o n t ra i n d i c a t i o n s 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 LATITUDE Programming System, Model 3300. The following uses of the PSA are contraindicated: •

With AV conduction disorders; atrial single-chamber pacing

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With competing intrinsic rhythms; asynchronous modes

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

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

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Use as an external pacemaker1

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

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WARNINGS •

Us e o f un s p e c i f i e d c ab le s a n d acce s s o r i e s . 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.

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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.

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R a d i o f re q u e n c y ( R F ) co mm u n i c a t i o n s e q u i p m e n t . 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.

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C o nn e c t o r co n t a c t s . Do not simultaneously touch the patient and any accessible LATITUDE Programming System connector or exposed conductor.

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

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B a t t e r y acce s s . 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.

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

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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.

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

Electrical currents.

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

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

E l e c t r o c a u t e r y. The LATITUDE Programming System is designed and tested to be electrocautery safe.

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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.

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Electrocautery may also produce unexpected behavior in the Programmer display or operation. If electrocautery is medically necessary, maintain a distance of at least 30 cm (12 inches) between electrocautery equipment and the Programmer and its associated components. Similarly, maintain this distance between the Programmer and its associated components and the patient during these procedures.

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

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

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

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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.

L A T I T U D E P ro g ra m mi n g Sy s t e m l o c a t i o n . Use of 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.

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L A T I T U D E P ro g ra m mi n g Sy s t e m m u s t re ma i n ou t s i d e s t e r i l e fi e l d . The Programmer is non-sterile and cannot be sterilized. Do not allow the device to enter a sterile zone in an implant environment.

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

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L A T I T U D E P ro g ra m mi n g Sy s t e m i s M R u n s af e .

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.

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Inducti on. 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. •

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Consider additional preemptive measures in patients where acceleration or a loss of rhythm could cause life-threatening danger.

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

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

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The PSA cable m u s t be disconnected from the lead(s) before using external defibrillation.

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

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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.

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L o s s o f p o w e r.

2.

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

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

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If the battery has been depleted to 10% or less, the Programmer may need to be powered Off to allow charging to begin and then may be powered back On to continue charging.

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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.

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

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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.

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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.

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

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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.

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

B a c ku p d e f i b r i l l a t i o n p ro t e c t i o n . Always have external defibrillation equipment and medical personnel skilled in CPR available during implant and follow up testing. If not terminated in a timely fashion, an induced ventricular tachyarrhythmia can result in the patient’s death.

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I m p a i re d AV con d u c t i o n. Single chamber atrial modes are contraindicated for patients with impaired AV conduction. •

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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. •

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

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

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

Us e o f p ro t e c t i v e s le e v e s . 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. •

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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.

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E x p o s u re t o f l u i d s . 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.

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E m i s s i o n s a n d i n t e r f e re nce . 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.

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L i t h i u m - i o n b a t t e r y. 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.

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Power up. Do not touch the screen while the Programmer is powering up, as this may cause the area that you touched to become unresponsive when pressed later on.

EMBLEM S-ICD Warnings For warnings specific to programming the EMBLEM S-ICD pulse generator, refer to the EMBLEM™ S-ICD Application Operator’s Manual (Model 3877).

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PRECAUTIONS G e n e ral •

F u n c t i o n a l i m p a i r m e n t d u e t o e x t e r n a l d a m a g e . 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.

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P r o g ra m m i n g S y s t e m . Use only the appropriate LATITUDE Programming System equipped with the appropriate software to program specific Boston Scientific PGs.

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M o d e l 6 3 9 5 T e l e m e t r y W a n d u s e . For inductive PG telemetry, use only the Model 6395 Telemetry Wand with the LATITUDE Programming System.

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W a n d t e m p e r a t u re ( M o d e l 6 3 9 5 o n l y ) . 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).

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M o d e l 6 3 9 5 T e l e m e t r y W a n d s h i p p e d n o n - s t e r i l e . 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 sterile Model 3320 Intraoperative Probe Cover during use. Refer to "Cleaning the Programmer and Accessories" on page 48 for sterilization and cleaning information.

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M o d e l 3 2 0 3 S - I C D T e l e m e t r y W a n d s h i p p e d n o n - s t e r i l e . 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 Model 3320 Intraoperative Probe Cover during use. Refer to "Cleaning the Programmer and Accessories" on page 48 for cleaning information.

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M o d e l 3 2 0 3 S - I C D T e l e m e t r y W a n d u s e . For S-ICD PG telemetry, use only the Model 3203 S-ICD Telemetry Wand with the LATITUDE Programming System. For transvenous PG programming, the Model 3203 S-ICD Telemetry Wand may be used as an auxiliary antenna to improve RF telemetry performance (see "External antenna usage for RF telemetry with transvenous PGs" on page 11).

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S t y l u s u s e . 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.

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E l e c t r o c a u t e r y c a b l e s . Keep all electrocautery cables at least 30 cm (12 in) away from the LATITUDE Programming System to avoid false signals due to electrocautery energy.

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L e a k a g e c u r re n t . 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. •

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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.

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P S A c o n n e c t i o n s . 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).

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P S A c o n n e c t o r c l i p s . Do not clip any PSA connector directly to the skin, pocket, or other tissue of the patient.

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V e n t r i c u l a r S e n s i n g . During a PSA session, ventricular sensing behavior is driven by the most recently selected ventricular pacing configuration: RV-only, LV-only, or Bi-V.

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

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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.

C ro s s - c h a m b e r o v e r- s e n s i n g . A unipolar configuration may lead to cross-chamber artifact over-sensing that affects pacing behavior. •

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In a unipolar configuration, it is common to see cross-chamber artifacts on electrograms (EGMs). If you move the A+ connector clip back to the atrial lead anode while the Can electrode button and “Use the A+ connection” button are still selected, the PSA remains programmed to a unipolar configuration. In this case, you may see pronounced cross-chamber artifacts on the EGMs which may lead to over-sensing that affects pacing behavior.

E C G c a b l e o p e n / s h o r t . 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.

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If cable is not functioning properly, replace it.

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E l e c t r i c a l a n d m a g n e t i c i n t e r f e r e n ce . Electrical interference or “noise” from devices such as electrocautery and monitoring equipment, monitors, or strong magnetic fields may interfere with establishing or maintaining telemetry for interrogating or programming the device and may produce unexpected behavior in the Programmer display or operation. In the presence of such interference, move the Programmer away from electrical devices, and ensure that the wand cord and cables are not crossing one another. Electrical interference or “noise” from concomitant implanted devices such as a ventricular assist device (VAD), drug pump, or insulin pump may interfere with establishing or maintaining telemetry for interrogating or programming the pulse generator. In the presence of such interference, place the wand over the pulse generator and shield both with a radiation-resistant material.

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E l e c t r o c a u t e r y a n d R F a b l a t i o n . Electrocautery and RF ablation may induce ventricular arrhythmias and/or fibrillation, and may cause inappropriate shocks and inhibition of post-shock pacing and may produce unexpected behavior in the Programmer display or operation. Additionally, exercise caution when performing any

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other type of cardiac ablation procedure in patients with implanted devices. If electrocautery or RF ablation is medically necessary, maintain a distance of at least 30 cm (12 inches) between electrocautery and RF ablation equipment and the Programmer and telemetry wand. Similarly, maintain this same distance between the Programmer and telemetry wand and the patient during these procedures. •

M o d e l 6 6 8 9 P o w e r A d a p t e r. 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.

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E t h e r n e t . 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.

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I n d u c t i v e t e l e m e t r y. 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.

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B a t t e r y o p e r a t i o n d u r i n g l o n g - t e r m s t o ra g e . Remove battery to prevent discharging when storing the Programmer for long periods (e.g., months).

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D a t e a n d t i m e a cc u ra c y. Inability to access a remote time server could lead to discrepancies in the Programmer time. As a backup, contact your Boston Scientific representative to have the time and date set manually.

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P a t i e n t d a t a . Patient data may be stored on the Programmer and appropriate precautions should be taken to secure the Programmer from unauthorized access. •

Patient data from transvenous PGs can be stored on the Programmer internal disk for up to 14 days.

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Patient data from S-ICD PGs can be stored on the Programmer internal disk for up to 50 patient sessions or 90 days.

Before shipping the Programmer or at any time when the Programmer leaves your direct control, refer to the Patient Data Management Operator’s Manual (Model 3931) for instructions to delete all patient data (transvenous and S-ICD) from the Programmer. Only connect to known Bluetooth® devices to reduce the potential of transmitting patient data to inappropriate printers or devices. •

U S B d e v i c e s . USB devices connected to the Programmer should be controlled to limit the potential introduction of malware.

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E x t e r n a l d e v i c e b a t t e r y u s a g e . 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.

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S o f t w a r e . Ensure that you have the latest software versions installed (see "Software Update Tab" on page 40). As a backup, your local Boston Scientific representative can provide software updates using a USB pen drive.

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E l e c t r i c a l a n d m a g n e t i c i n t e r f e r e n ce . 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.

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E x t e r n a l a n t e n n a u s a g e f o r R F t e l e m e t r y w i t h t r a n s v e n o u s P G s . The Model 3203 S-ICD Telemetry Wand may be used as an additional antenna to improve the Programmer’s RF telemetry performance with transvenous pulse generators. If the wand is placed in a sterile field, it must be enclosed in a sterile Model 3320 Intraoperative Probe Cover during use. When the Model 3203 S-ICD Telemetry wand is not used for RF telemetry communication with transvenous PGs, be sure to disconnect the Model 3203 S-ICD Telemetry Wand from the Programmer to prevent transvenous PG telemetry dropouts.

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W i - F i . Wi-Fi connectivity is not permitted in Indonesia due to specific configuration requirements.

E MB L E M S- I CD P re c au t io n s For precautions specific to programming the EMBLEM S-ICD pulse generator, refer to the EMBLEM™ S-ICD Application Operator’s Manual (Model 3877).

Ma in t e n a n ce a n d H a n d l i n g •

C l e a n i n g t h e P ro g r a m m e r. Do not use an abrasive cloth or volatile solvents to clean any portion of the device. See "Cleaning the Programmer and Accessories" on page 48 for recommended cleaning.

•

M a g n e t h a n d l i n g . Do not place a magnet on the Programmer.

•

P r e s e n c e o f f l a m m a b l e s . 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.

•

D i s c o n n e c t i n g t h e P r o g ra m m e r. 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.

•

P r o g ra m m e r a c ce s s i b i l i t y. Ensure that the sides of the Programmer are accessible at all times so that the power adapter cord can be disconnected.

•

L i t h i u m - i o n b a t t e r y. 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.

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•

•

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.

S y s t e m P o w e r u p . Boston Scientific recommends attaching all necessary cables and devices before turning on the Model 3300 Programmer.

Ra di o F req u en c y (R F) Pe r fo r m an ce 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 The following list includes the possible adverse effects associated with programming pulse generators described in this manual. •

Asystole

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Atrial arrhythmia

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Bradycardia

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Tachycardia

•

Ventricular arrhythmia

SY S T E M C A P A B I L I T I E S The LATITUDE Programming System communicates with PGs and provides the following capabilities in hardware, interrogation/programming, patient data management, networking, and software:

H a rd w a re •

Color touchscreen display with capacitive touch

•

Internal solid-state drive

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•

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

N OT E : 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.

I n t e r ro g a t i o n a n d P ro g ra m m i n g •

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, PG STAT PACE, PSA 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 For transvenous PGs, 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. 4.

The LATITUDE Programming System is not intended for use as an ECG monitor or general diagnostic device. Refer to the Pacing System Analyzer (PSA) Operator’s Manual (Model 3922) for PSA setup and use information.

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N OT E : For S-ICD PGs, the S-ICD Application provides functions for patient data management. Refer to the EMBLEM S-ICD Application Operator’s Manual (Model 3877) for additional details.

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. Refer to the EMBLEM™ S-ICD Application Operator’s Manual (Model 3877) for information about using Bluetooth® within the S-ICD application.

Heart Connect™ Heart Connect is a data sharing application that can display and share physiological and/or other medical data from the LATITUDE Programming System. Heart Connect provides health care providers and Boston Scientific personnel with the means to establish an online meeting and share the video display from the Model 3300 Programmer with individuals in a remote location. Refer to the LATITUDE™ Heart Connect™ Operator’s Manual (Model 3932) for additional setup and use information.

A u t o m a t e d S c re e n i n g T o o l The Model 3889 EMBLEM S-ICD Automated Screening Tool (AST) is software used on the Model 3300 LATITUDE Programming System to screen patients to assess them for implant of the EMBLEM Subcutaneous Implantable Cardioverter Defibrillation (S-ICD) system. Refer to the EMBLEM™ S-ICD Automated Screening Tool (AST) Instructions for Use (Model 3889) for additional setup and use information.

Sof tware Software updates and downloads are provided via Internet or USB pen drive. If a software update or download does not complete successfully, you can re-initiate 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 40.

A L TR U A ™ , I N SI G NI A ™ I , an d N E X U S™ I P u l se G e n e rat o r S u p p o r t The Model 3892 ALTRUA/INSIGNIA I/NEXUS I Support Application is available in eight languages: US English, UK English, French, Italian, Spanish, German, Dutch, and Swedish. If a Model 3300 Programmer is configured to an unsupported language when the Model 3892 Support Application is started, the Model 3300 Programmer will default to English. •

Chinese and Japanese default to US English

•

Portuguese and Brazilian Portuguese default to UK English

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SY S T E M A C C E S S O R I E S 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, sterile and disposable, may be required with the re-sterilizable Model 6395 Telemetry Wand and is required with the nonsterilizable Model 3203 S-ICD Telemetry Wand if the wand is located within the sterile field

•

Model 6697 (Remington Model S-101–97) PSA Disposable Cable, single-use only

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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

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Model 3154 Fixed Patient Leads ECG Cable; For Canada and China only, use the Model 3153 Fixed Patient Leads ECG Cable7

•

Model 6629 ECG-BNC Slave Cable

•

Model 6689 Power Adapter (supply)

•

Model 6753 Lithium-ion Battery, rechargeable and replaceable

The following AC power cords are also available for use with the Model 3300 Programmer: AC Power Cord Model

Outlet

Model 6175 and Model 6286 AC Power Cord (Type B; e.g. Canada, Mexico, Japan)

Model 6285 AC Power Cord (Type F; e.g. Europe)

Model 6282 AC Power Cord (Type J; e.g. Switzerland) Model 6343 AC Power Cord (Type G; e.g. United Kingdom)

5. 6. 7.

The Model 6395 Telemetry Wand does not include a magnet. The Model 3203 S-ICD Telemetry Wand must be used to interrogate an S-ICD PG, and it may be used as an additional antenna to improve RF telemetry communication performance with some transvenous PGs. The Model 3154 and 3153 Fixed Patient Leads ECG Cables contain current-limiting features to protect against defibrillation and should be the ECG cables used with the LATITUDE Programming System.

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Model 6289 AC Power Cord (Type N; e.g. Brazil)

Model 6284 and Model 6287 AC Power Cord (Type I; e.g. Australia, China)

Model 6283 AC Power Cord (Type M; e.g. South Africa)

To order accessories, contact Boston Scientific using the information on the back cover of this manual. 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 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.

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.

N OT E : 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.

C A U T I O N : 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. •

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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 17.

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

Fig ure 1.

O p t i o n a l S t a n d f o r t h e L A T I T U D E P ro g ra m m i n g Sy s t e m

C A U T I O N : 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 printer drivers. Refer to "Connections" on page 18 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:

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