Boston Scientific Precision User Manual

CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
Precision™ Spinal Cord
Stimulator System
Clinician Manual
Directions for Use
97035873-01
Content: MP97035873-01 REV B

Boston Scientific Precision Specifications

General

Manufacturer	Boston Scientific
Model	Precision
Battery Type	Lithium-ion
Number of Contacts	8 or 16
Indication	Chronic pain
MRI Compatibility	Conditionally MRI compatible
Programs	Multiple programmable settings
Remote Control	Yes
Weight	Varies depending on model
Stimulation Channels	Multiple independent channels

Summary

Indications for Use

Safety Information

Warnings

Details critical warnings for patients, including heat during charging, MRI, pediatric use, and diathermy.

Percutaneous Lead Placement in the Epidural Space

Infinion CX Lead Placement in the Epidural Space with Entrada™ Needle

Describes the specific procedure for placing Infinion CX leads using the Entrada Needle.

Permanent Lead Anchoring and Tunneling

Anchoring the Lead

Explains methods for permanently anchoring leads using suture sleeves or anchors.

Tunneling the Lead or Lead Extension

Details the process of creating subcutaneous tunnels for leads and extensions using tunneling tools.

Rechargeable Stimulator System

Charging Steps

Provides detailed steps for charging the implanted pulse generator using the wireless charging system.

Electromagnetic Compatibility

EN 60601-1-2 Classification Information

Classifies the system according to EN 60601-1-2 standards for electromagnetic compatibility.

Guidance and manufacturer's declaration – electromagnetic immunity

Provides guidance on electromagnetic immunity and environmental considerations for the SCS system.

Recommended separation distances between portable and mobile RF communications equipment and the Precision System