Smith & Nephew EXOGEN 4000+ User Manual

EXOGEN 4000+
™
Low-intensity Ultrasound Fracture Healing
System for the Treatment of Nonunion
and Fresh Fractures
*smith&nephew
Patient’s
Instructions
for Use
& Package
Insert
Caution: This device is intended for use only by
the individual for whom it is prescribed.

Smith & Nephew EXOGEN 4000+ Specifications

General

Brand	Smith & Nephew
Model	EXOGEN 4000+
Category	Medical Equipment
Language	English

Summary

Indications for Use

Contraindications, General Warnings, and Precautions

Device Description

1. The EXOGEN 4000+ Bone Healing System

Describes the EXOGEN 4000+ device as a non-invasive therapy for bone healing, transmitting low-intensity ultrasound.

2. Technical Specifications of the EXOGEN 4000+ Ultrasound Signal

Details the technical specifications of the EXOGEN 4000+ ultrasound signal, including frequency, power, and area.

3. The EXOGEN 4000+ System Components

Lists and describes the main components of the EXOGEN 4000+ system, including the MOU and transducer.

Device Operating Instructions

1. Starting Your Daily Treatment Period

Provides step-by-step instructions for starting a daily treatment period with the EXOGEN 4000+ device.

2. Turning “On” the EXOGEN Model 4000+ for a Daily Treatment

Explains how to turn on the EXOGEN 4000+ device and the processes that occur during system startup.

3. At the End of A Daily Treatment Period:

Details the steps to take at the end of a daily treatment period, including transducer removal and cleaning.

Trouble Signals and Corrective Actions

1. Add Gel

Explains the 'Add Gel' signal, its meaning, and the corrective steps to take when it appears.

2. Error or Problem Messages

Describes error or problem messages, including the Attention Icon, and when to contact customer service.

Care and Handling of the EXOGEN 4000+ System

General Information

Guidance and Manufacturer's Declaration—Electromagnetic Emissions and Immunity Testing