The quality of any RF communication, including ZIP™ wandless telemetry, is dependent on the environment in which it operates. Consider the information below to optimize ZIP telemetry.

Optimal Programmer Positioning

• Position the programmer within 3 meters (10 feet) of the patient in case the wand is needed. While successful ZIP telemetry may occur at much greater distances, positioning the programmer within 3 meters (10 feet) of the patient ensures the telemetry wand is within reach.

• Ensure there are no “line-of-sight” obstructions between the programmer and device (e.g., equipment, metal furniture, people, or walls) as these obstructions may diminish signal quality (Figure 1). Note that personnel or objects momentarily moving in and out of the line-of-sight during ZIP telemetry may temporarily interrupt RF communication.

Figure 1. Examples of maintaining a clear line-of-sight between the programmer and device.

• Adjust the programmer’s antenna for optimal reception during RF transmission. Position the programmer screen so that the back (reverse side) of the programmer screen is oriented toward the implantable device. As needed, adjust the black antenna attached on the right side of the programmer screen and/or move the screen forward and backward along its hinge.

• Position the programmer more than 1 meter (3 feet) from walls or metal objects and avoid resting the implantable device on metal furniture. This may reduce signal reflection and/or blocking that can diminish the quality of RF communication.

• Position the programmer and device away from other electrical equipment to avoid sources of environmental noise, including: cordless phones, wireless headsets, patient monitoring systems, electrosurgical equipment, or any piece of electrical equipment operating in the ultra high frequency (UHF) range.1 In addition, consider positioning the programmer away from doorways or hallways where environmental noise outside the room could interfere with the wandless connection.

NOTE: Boston Scientific has identified several models of equipment2 that could potentially diminish the quality of ZIP telemetry and temporarily prevent completion of ongoing interrogation or programming. Contact CR M Technical Services to identify and troubleshoot potential sources of environmental noise specific to a hospital/clinic environment.

1The frequency at which ZIP telemetry operates varies by geography. In the U.S. and Canada, the ZIP telemetry frequency for RENEWAL® 3

RF, CONFIENT™, & LIVIAN™ is 914 MHz; and COGNIS™ & TELIGEN™ devices communicate at 916.5 MHz. In Europe, all devices communicate at 869.85 MHz. 2Under certain circumstances, SpectraLink WTS wireless phone systems, Plantronics CS50 wireless headsets, and InVivo/MDE Escort patient

bedside monitors have demonstrated potential to interfere with ZIP telemetry.

BACKGROUND INFORMATION Following initial interrogation using a traditional programmer wand, Boston Scientific’s devices with radio frequency (RF) telemetry can communicate with a ZOOM® LATITUDE® programmer over a significantly greater distance without using a wand. This wandless/wireless, two-way radio frequency communication technology is referred to as

IP™ wandless telemetry. Z

The quality of any type of RF communication is dependent on the surrounding environment. This article provides suggestions to maintain a strong wandless connection between the ZOOM LATITUDE programmer and implanted RF-enabled cardiac devices, both during the implant procedure and subsequent patient follow-up examinations.

CRM PRODUCTS REFERENCED* CONTAK RENEWAL® 3 RF & 4 RF,

CONFIENT™, LIVIAN™, COGNIS™, TELIGEN™, and

ZOOM LATITUDE programmer *Products referenced herein may not be approved in all geographies. For comprehensive information on device operation, reference the appropriate product labeling.

CRM CONTACT INFORMATION

Technical Services – U.S. 1.800.CARDIAC (227.3422) Tech.Services@bsci.com

Technical Services – Europe

+32 2 416 7222 eurtechservice@bsci.com

LATITUDE Clinician Support

1.800.CARDIAC (227.3422) latitude@bsci.com

Patient Services

1.866.484.3268 – U.S. and Canada 001.651.582.4000 – International

ZIP™ Wandless Telemetry and the ZOOM® LATITUDE® Programmer

Device in packaging

Device in/on patient

Programmer

September 17, 2008 ©2008 Boston Scientific Corporation or its affiliates. All rights reserved. Page 1 of 3

Tips to Identify a Less than Optimal Wandless Connection

The information below may help to determine if environmental factors are diminishing the quality of ZIP wandless telemetry.

Length of Time to Complete Interrogation If attempts to interrogate the device using ZIP telemetry take longer than the times listed below, interference may be present and the wandless connection may not be optimal.

• COGNIS and TELIGEN: 20 seconds (transmits significantly more data upon initial interrogation than previous device generations)

• RENEWAL 3/4 RF, CONFIENT, and LIVIAN: 5 seconds

Wand Telemetry Light

September 17, 2008 ©2008 Boston Scientific Corporation or its affiliates. All rights reserved. Page 2 of 3

ZIP Telemetry Light Power On Light

Telemetry Light Telemetry indicator lights are located in the upper left side of the programmer screen.

• An illuminated green ZIP telemetry light (Figure 2) indicates that ZIP telemetry has been established.

• If wandless communication is not available, the ZIP telemetry light will not illuminate. • A flickering light may indicate ZIP telemetry is being interrupted and the

communication link may be less than optimal. NOTE: RENEWAL 3/4 RF, CONFIENT, or LIVIAN devices: In Storage mode, the ZIP telemetry light remains illuminated only if programming commands are issued; however, loss of a green telemetry light is not always an indicator of a sub-optimal wandless connection in Storage mode.

Figure 2. Illuminated green lights indicate the programmer’s power is On and ZIP telemetry has been established.

Out of Range/Telemetry Noise Message If environmental interference is strong enough or frequent enough to interrupt the ZIP telemetry connection, the programmer may display a message illustrated in Figure 3. Note that this message will automatically disappear from the programmer screen if/when the device is able to re-establish ZIP telemetry, or if the wand is in within range of the device. During ZIP telemetry, continuous appearance and disappearance of this message may indicate the wandless connection is less than optimal.

COGNIS and TELIGEN RENEWAL 3/4 RF, CONFIENT, and LIVIAN

Figure 3. Out of Range / Telemetry Noise message.

Telemetry “Drop-outs” on the Electrogram (EGM) During a programming session, a sub-optimal wandless connection may appear as short intervals of telemetry “drop-outs” on real-time or printed EGMs (Figure 4). Although significant interference to the telemetry link may cause EGM drop-outs in COGNIS and TELIGEN devices, a marginal telemetry link may not always present as a loss in EGM quality. ZIP Telemetry connection

Examples of EGM telemetry drop-out.

The surface ECG remains continuous

during periods of telemetry drop-out.

Figure 4. Sample of a break or telemetry drop-out in a printed electrogram.

September 17, 2008 ©2008 Boston Scientific Corporation or its affiliates. All rights reserved. Page 3 of 3

Additional Information • If the wandless connection is not optimal, consider a new location for the programmer (move it a few inches to a few feet)

and review the programmer position advice provided in this publication. • Despite interruptions in either ZIP or wanded telemetry, no parameter change command will be “partially” completed. The

entire command must be received and confirmed by the device before the programming change will take effect. • If ZIP telemetry cannot be consistently established, use the wand to communicate with the device.

► Even if the wand is positioned over the device, the programmer may continue to communicate using wandless telemetry until ZIP telemetry is disabled. Table 1 lists the programmer key strokes to change the telemetry type.

Device Family Programmer Key Strokes*

COGNIS & TELIGEN Pre-interrogation† or during programming session Utilities > Setup > select the Use wand for all telemetry button or the Enable use of ZIP™ telemetry button > Close

REWEWAL 3/4 RF, CONFIENT, & LIVIAN

Pre-interrogation† Utilities > Setup > select the Use wand for all telemetry button or the Enable use of ZIP™ telemetry button > Close During programming session‡ Utilities > Communication Mode > Programmer Zip Telemetry > select On or Off

*Changing the telemetry type pre-interrogation sets the telemetry communication method for that programmer for all subsequent programming and patient sessions. Changing the telemetry type during a programming session affects the telemetry type for only the programming session in progress. †After programmer power-up, but before initial interrogation of a device. ‡REWEWAL 3/4 RF, CONFIENT, and LIVIAN devices: If ZIP telemetry is disabled during a programming session by using the Setup > PG ZIP Telemetry button instead of the Utilities button, ZIP telemetry must be re-enabled (turned “On”) through the Setup button to interact with the LATITUDE remote monitoring Communicator.