A Closer Look
SUMMARY
Boston Scientific’s LATITUDE
®
NXT
Patient Management System enables a clinician to periodically monitor patient and device information remotely via a Communicator placed in the patient’s home. The clinician can review this information on the
LATITUDE NXT website to supplement in-clinic visits.
This article describes how to properly configure the Communicator to match the patient’s phone dialing protocol and country location.
How to Set Configuration Switches for
LATITUDE
®
NXT Communicators
A LATITUDE NXT Communicator is an in-home monitor that uses wireless technology to transfer data from a patient’s implanted device to a secure internet website*. Data travels through a standard telephone line (landline) or over a cellular data network using the LATITUDE Cellular/GSM Data Plan ƚ
.
Configuring LATITUDE NXT Communicators
Products Referenced
Wave TM Wireless Communicators, Models 6498, 6280, 6288, and 6290, must be configured to match the patient’s phone dialing protocol and country location. The patient or the attending health care professional may configure the Communicator to meet local conditions by adjusting eight (8) small slide switches located on the bottom of the Communicator (Figure 1).
• LATITUDE NXT Patient Management
System
• LATITUDE NXT Communicator,
Models 6498, 6280, 6288, 6290.
Products referenced herein may not be approved in all geographies. For comprehensive information on device operation, reference the full instructions for use found at: www.bsci.com/ifu .
CAUTION: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
All graphics produced by Boston Scientific
Corporation, unless otherwise noted.
Top View
Turn
Over
Country
Configuration
Switches
Dial-out
Number
All switches shown in
OFF/down position
CRT-D: Cardiac Resynchronization Therapy Defibrillator
CRT-P: Cardiac Resynchronization Therapy Pacemaker
ICD: Implantable Cardioverter Defibrillator
S-ICD: Subcutaneous Implantable Defibrillator
Underside View
Contact Information
Americas
(Caribbean, and Central, North, and South America) www.bostonscientific.com
Technical Services
LATITUDE
®
Customer Support
1.800.CARDIAC (227.3422)
+1.651.582.4000
Patient Services
1.866.484.3268
Figure 1. Configuration switches on underside of NXT Communicator .
Switches 1, 2, and 3 (Figure 1) are used to configure the dial-out number. Switches 4 through 8 (Figure 1) are used to configure the country location. These small switches can be toggled manually by sliding the switch to an ON (up) position or OFF (down) position. Tip! A writing pen can be used to slide the switches up or down.
LATITUDE NXT Communicator switches are factory preset to match the dial-out number and the country most often used for that particular geography.
Europe, Middle East, Africa
Technical Services
+32 2 416 7222 [email protected]
LATITUDE Customer Support [email protected]
Asia Pacific
Technical Services
+61 2 8063 8299 [email protected]
LATITUDE Customer Support [email protected] [email protected] (Japan)
© 2014 by Boston Scientific Corporation or its affiliates. All rights reserved.
• The factory present switch positions may already match the dial-out number and country for the patient’s home location. If this is the case, the Communicator can be used immediately without altering the position of the configuration switches.
• If extra dialing is required to obtain an outside phone line, or if the preset country switch positions do not match the patient’s home country, the Communicator switches may be adjusted using the procedure described below.
*The LATITUDE NXT system is not intended to assist with medical emergencies. Patients who are not ƚ feeling well should call their physician or emergency services number.
LATITUDE data cannot travel through digital phone lines. A standard landline or cellular plan is required to transfer data from the Communicator to the LATITUDE NXT website.
June 27, 2014 100000006022 , Rev. B Page 1 of 4
Setting the Switch Configuration
Switches 1, 2, and 3 are used to configure the dial-out number, which applies to only landline telephone connections.
Switches 4 through 8 are used to configure the country location, which applies to both landline and cellular connections.
STEP 1. Set the dial-out number (switches 1 - 3).
For some landlines, a special “dial-out” number may be needed in order to obtain a dial tone outside of the building in which the Communicator is located. For example, hotels/resorts, businesses, medical or managed care facilities, or large apartment complexes often require a “prefix” to route your call to an outside line. Switches 1 through 3 on the bottom of the Communicator must be set to match the dial-out number. For example, if your building dial-out number is “9”, you must set the first three switches as follows: Switch 1 = ON. Switch 2 = OFF, Switch 3 = ON. Switch settings for various dial-out options are shown in Table 1.
TIPS!
• Most homes require no special dial-out number, so switches 1, 2, and 3 should remain in the OFF (down) position.
• If your communicator uses cellular service, switches 1, 2, and 3 should remain in the OFF (down) position.
Table 1. Position of Switches 1 through 3 to Accommodate Dial-out Numbers
Dial-Out Number Switch 1 Switch 2 Switch 3 Summary
None
Down/OFF Down/OFF Down/OFF
0
Up/ON Down/OFF Down/OFF
1
Down/OFF Up/ON Down/OFF
7
Up/ON Up/ON Down/OFF
8
Down/OFF Down/OFF Up/ON
9
Up/ON Down/OFF Up/ON
*99
Down/OFF Up/ON Up/ON
Pulse Dialing
(Japan Only)
Up/ON Up/ON Up/ON
June 27, 2014 100000006022 , Rev. B Page 2 of 4
STEP 2. Set the country location (switches 4 - 8).
Switches 4 through 8 on the bottom of the Communicator must be set to your home country (Table 2).
Table 2. Position of Switches 4 through 8 to Function in Different Countries
Country Switch 4 Switch 5 Switch 6 Switch 7 Switch 8 Summary
United States of
America
Down/OFF Down/OFF Down/OFF Down/OFF Down/OFF
Australia
Up/ON Down/OFF Down/OFF Down/OFF Down/OFF
Austria
Down/OFF Down/OFF Up/ON Down/OFF Down/OFF
Belgium
Up/ON Up/ON Up/ON Down/OFF Up/ON
Brazil
Down/OFF Down/OFF Up/ON Down/OFF Up/ON
Canada
Up/ON Up/ON Down/OFF Down/OFF Down/OFF
Czech Republic
Up/ON Down/OFF Down/OFF Up/ON Down/OFF
Denmark
Down/OFF Up/ON Up/ON Down/OFF Down/OFF
Finland
Up/ON Up/ON Up/ON Down/OFF Down/OFF
France
Down/OFF Down/OFF Down/OFF Up/ON Down/OFF
Germany
Up/ON Up/ON Up/ON Up/ON Up/ON
Greece
Up/ON Up/ON Down/OFF Up/ON Down/OFF
Hong Kong
Down/OFF Up/ON Down/OFF Down/OFF Up/ON
Ireland
Down/OFF Down/OFF Down/OFF Up/ON Up/ON
Israel
Up/ON Down/OFF Up/ON Up/ON Down/OFF
Italy
Up/ON Up/ON Down/OFF Up/ON Up/ON
Japan
Up/ON Up/ON Down/OFF Down/OFF Up/ON
June 27, 2014 100000006022 , Rev. B Page 3 of 4
Country Switch 4 Switch 5 Switch 6 Switch 7 Switch 8 Summary
Mexico
Up/ON Down/OFF Up/ON Down/OFF Up/ON
Netherlands
Down/OFF Down/OFF Up/ON Up/ON Down/OFF
New Zealand
Down/OFF Up/ON Down/OFF Down/OFF Down/OFF
Norway
Down/OFF Up/ON Up/ON Up/ON Up/ON
Poland
Down/OFF Up/ON Down/OFF Up/ON Down/OFF
Portugal
Down/OFF Up/ON Up/ON Up/ON Down/OFF
Slovakia
Up/ON Down/OFF Up/ON Down/OFF Down/OFF
Spain
Up/ON Up/ON Up/ON Up/ON Down/OFF
Sweden
Down/OFF Down/OFF Down/OFF Down/OFF Up/ON
Switzerland
Up/ON Down/OFF Down/OFF Down/OFF Up/ON
United Kingdom
Down/OFF Down/OFF Up/ON Up/ON Up/ON
Important Notes
• Boston Scientific Wave
TM Communicators are supported by the LATITUDE
®
NXT system. Not all models are approved and/or market-released in all geographies.
• Model 6280, 6288, and 6498 Communicators use either the ISM (US, Australia and Canada) or the SRD
(Europe) frequency band to communicate with the pulse generator. Use of these Communicators outside of the patient’s home country may be restricted by local regulations.The Model 6290 Communicator uses the MICS frequency band to communicate with the pulse generator. This allows traveling patients to use the Model 6290 in any region that permits the MICS band (including US, Europe, Japan, Australia and Canada). o If using a landline connection, the Communicator switches should be set to match the travel country (see
Table 2). o If using a cellular/GSM plan, the Communicator switches should remain set for the home country.
Please contact Boston Scientific LATITUDE Customer Support for additional information.
June 27, 2014 100000006022 , Rev. B Page 4 of 4
LATITUDE
®
NXT Patient Management System from Boston Scientific CRM
Intended Use
The LATITUDE
NXT Patient Management system is intended for use to remotely communicate with a compatible pulse generator from Boston Scientific CRM and transfer data to a central database.
The LATITUDE NXT system provides patient data that can be used as part of the clinical evaluation of the patient.
Contraindications
The LATITUDE NXT Patient Management system is contraindicated for use with any implanted device other than a compatible Boston Scientific implanted device. Not all Boston Scientific implanted devices are compatible with the LATITUDE NXT system. For contraindications for use related to the implanted device, refer to the System Guide for the Boston Scientific implanted device being interrogated.
Precautions
Alerts may appear on the LATITUDE NXT website on a daily basis. Primary notification of alert conditions is through the View Patient List page on the LATITUDE NXT website. The clinician needs to log onto the LATITUDE NXT website in order to receive alerts. Although secondary notification through email and SMS text messages is available, these reminders are dependent on external systems and may be delayed or not occur. The secondary notification feature does not eliminate or reduce the need to check the website. Implanted device data and alerts are typically available for review on the
LATITUDE NXT website within 15 minutes of a successful interrogation. However, data uploads may take significantly longer (up to 14 days). If the Communicator is unable to interrogate the implanted device or if the Communicator is unable to contact the LATITUDE NXT server to upload data, up to two weeks may elapse before the LATITUDE NXT server detects these conditions and informs the clinic user that monitoring is not occurring. If both of these conditions occur at the same time, this notification could take up to 28 days. Implanted device data and alert notification may be delayed or not occur at all under various conditions, which include but are not limited to the following: System limitations; the Communicator is unplugged; the Communicator is not able to connect to the LATITUDE NXT server through the configured phone system; the implanted device and the Communicator cannot establish and complete a telemetry session; the Communicator is damaged or malfunctions; the patient is not compliant with prescribed use or is not using the LATITUDE NXT system as described in the patient manual; if subscribed to the LATITUDE Cellular Data Plan, missing two or more payments discontinues the subscription; the clinic user can identify any patients that are not being monitored as described above by using the Not Monitored filter on the View Patient List.
Adverse Effects: None known.
System Limitations:
The LATITUDE NXT system does not provide continuous real-time monitoring. As a remote monitoring system, the LATITUDE NXT system provides periodic patient monitoring based on clinician configured settings. There are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of implanted device, sensor, and patient information as intended by the clinician.
These factors include: implanted device clock; patient environment; cellular data service; telephone system; communicator memory capacity; clinic environment; schedule/configuration changes; or data processing.
Refer to the product labeling for specific instructions for use. Rx only. (Rev. B)
LATITUDE® (NXT) Communicator
Patient Management System from Boston Scientific
Important Safety Information
LATITUDE® NXT Patient Management is a remote monitoring system that gives your health care provider access to your implanted device data. The LATITUDE Patient Management system is not intended to assist with medical emergencies. If you are not feeling well, call your physician or 911. The Communicator does not provide continuous monitoring. Your Communicator is designed to be used only in the United States, Canada, and Puerto Rico.
The Communicator is designed to operate on standard telephone lines like those found in most homes. The Communicator may work on other telephone systems, such as Digital Subscriber Line (DSL) and Voice Over IP (VoIP) Internet systems, if those systems provide an analog interface for connecting the Communicator.
The Communicator is designed to work only with the implanted device of the patient for whom it was prescribed. It will not work with other patients’ implanted devices and should be used only as authorized by the prescribing physician. The Communicator is not for use with any pulse generator other than a Boston Scientific device. Ask your physician if you have questions about any risks with using the Communicator or your implanted device.
It is very important that the Communicator remain plugged into the power outlet. Your communicator should remain connected to a telephone line, unless you are subscribed to the LATITUDE Cellular
Data Plan. Some household appliances and other sources of electromagnetic energy could interfere with the communication between your Communicator and your implanted device. You should be at least 36 inches (3 ft.) away from televisions, VCRs, DVD players, personal computers, and other electronic equipment, when you are using the Communicator.
It is recommended that the customer install a surge arrestor in the electrical outlet to which the Communicator is connected.
Rx only (Rev.B)
ADDENDUM TO: 100000006022, Rev. B, US
Current Brief Summaries found @ http://www.bostonscientific.com/
June 27, 2014
