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INFORMATION FOR USE

Trademark Statement

The following are t rademarks of Boston Scientiﬁcoritsafﬁliates: LATITUDE,

Quick Start, ZIP, ZOOM.

Description and Use

The Z OO M LATITUDE Programming System, which inclu des the Model 3120

Programmer/Recorder/Monitor (PRM), Model 3140 Zoom Wireless Transmitter

(ZWT) and accessories, i s a portable

cardiac rhythm management system

designedtobeusedwithBostonScientiﬁc implantable pulse generators.

Intended Use

The PRM is intended to be used as part of the ZOOM LATITUDE Programming

System to communicate with Boston

Scientiﬁc implantable pul se genera t ors.

The software in u se controls all commu nication functions for the pulse

generator. For detailed software application instructions, refer to the associated

product literature for the pulse

generator being interrogated.

Intended Audience

This literature is intended for use by professionals trained or experienced in

device implant an d/or follow-up procedures.

Essential Performance

In order for the PRM to meet its in

tended use, it must communicate with Boston

Scientiﬁc implantable pulse generators. Th erefore those functions that pertain

to communicati ons with th e implanted p ulse generator using the telemetry

wand are considered essential

performance.

Contraindications

The PRM is contrain dicated for use with any pulse generator other than a

Boston Scientiﬁc pulse generator. For contraindications for use related to

the pulse generator, refer to

the associated product litera tu r e for the pulse

generator being interrogated.

WARNINGS

• Use of unspeciﬁed cables and accessories. The use of any cables or

accessories with the PRM or

ZWT other than those speciﬁed by Boston

Scientiﬁc in this manual may result in increased emissions or decrease d

immunity of the PRM or ZWT. Anyone connecting such cables or

accessories to the PRM or Z

WT may be conﬁguring a medical system and

is responsible to e nsure that the system complies with the requirements of

IEC/EN 60601-1, Clause 16 for medical electrical systems.

• Connector contacts. Do not simultaneously touch the patient and any

accessible connector contacts on the PRM (e.g., USB, parallel port,

external VGA m onitor, s

timulation input, analog output, and expansion

port).

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