Boston Scientific Latitude 3300 User manual

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........................................................................................2
Precautions ....................................................................................7
Adverse Effects ............................................................................. 11
SYSTEM CAPABILITIES .................................................................. 11
Hardware ..................................................................................... 11
Interrogation and Programming......................................................... 12
Patient Data Management ............................................................... 12
Networking ................................................................................... 12
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 .............................................................................. 43
Cleaning the Programmer and Accessories ......................................... 43
Cleaning Cables and Wands .......................................................... 44
Disinfecting the ECG Cable ............................................................ 44
Sterilization................................................................................. 44
Battery Status, Installation, Replacement, and Recycling ........................ 45
Battery Replacement .................................................................... 48
Battery Recycling ......................................................................... 49
Operation and Storage .................................................................... 50
Storing the LATITUDE Programming System ..................................... 51
Maintenance Check and Safety Measures........................................... 51
LATITUDE Programming System Maintenance Check ......................... 51
Safety Measurements ................................................................... 52
Service ........................................................................................ 52
TROUBLESHOOTING...................................................................... 53
HANDLING .................................................................................... 57
Using an External ECG Monitor with the Model 3300
Programmer ............................................................................. 57

Environmental Protection and Disposal............................................. 59
Symbols on Devices and Packaging................................................. 59
SAFETY, COMPLIANCE, AND COMPATIBILITY STANDARDS ................ 62
Safety Standards ........................................................................... 62
Electromagnetic Compatibility Standards ............................................ 62
Radio Spectrum Compliance Standards.............................................. 63
Electromagnetic Emissions and Immunity............................................ 63
IEC 60601–1–2:2014 Information .................................................... 63
Federal Communications Commission (FCC) Information ..................... 63
LATITUDE PROGRAMMING SYSTEM SECURITY ................................ 66
Software ...................................................................................... 66
Patient Data Management ............................................................... 66
Network ....................................................................................... 66
Unsupported Hardware ................................................................... 67
Security Vigilance .......................................................................... 67
Physical Controls ........................................................................... 67
Compromised Programmer .............................................................. 67
SPECIFICATIONS ........................................................................... 67
WARRANTY INFORMATION ............................................................. 71

1
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

2
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 telemetry
• Initiate a PG 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
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.
1. During implantation, the PSA application is suitable for temporary external pacing while the
patient is being continuously monitored by medical personnel.

3
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.
•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.

4
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 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.
2. Kanal E, et al., American Journal of Roentgenology 188:1447-74, 2007.