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Precautions

The following precautions should be taken to avoid damage to the Clinical Programmer and to ensure

proper function:

• Do not drop or mishandle the Clinical Programmer. Physical damage to the Clinical Programmer may

impair its function.

• Do not spill fluids on or wash the Clinical Programmer. Excessive moisture may impair its function. If

cleaning is necessary, remove soil with a soft damp cloth.

• Do not use abrasive or caustic cleaning products on the Clinical Programmer.

• Do not attempt to open the case for the Clinical Programmer. Attempts to open the case may expose

the Clinical Programmer to elements that alter its function.

• The Clinical Programmer has an internal magnet. Keep the Clinical Programmer away from any

credit cards, hard drives, or magnetic storage devices as it may demagnetize them.

• Do not operate the Clinical Programmer outside the specified temperature range of 5°C to 40°C.

Rapid temperature changes may affect proper device operation.

• Do not store the Clinical Programmer outside the specified temperature range of -10°C to 50°C.

• Do not leave the Clinical Programmer in a car or other places where temperatures can exceed 50°C.

• Do not burn or otherwise dispose of the Clinical Programmer. Fire may cause the internal battery to

explode.

• Do not allow unauthorized use of the Clinical Programmer to avoid injury to patients.

• The NS device can only be programmed using Spinal Modulation's Clinical or Patient Programmer.

Do not try to use any other manufacturer's device to program it.

• Do not use the Clinical Programmer or NS in the presence of explosive or flammable gases as this

may cause serious injury.

• Do not use the Programmer Charger if the power cord is damaged, excessively worn or frayed. This

may cause injury or damage the Programmer.

• Frequent programming of the implanted device will cause the battery to deplete faster. Avoid

unnecessary programming.

• If there is any concern regarding the proper function of the Spinal Modulation NS System, please

contact your Spinal Modulation representative.

RF OPERATING FREQUENCIES

Nearby equipment emitting strong magnetic fields can interfere with RF communication, even if the other

equipment complies with CISPR emission requirements. The operating characteristics are as follows:

MICS band: 402-405 MHz

The effective radiated power is below the limits as specified in

Europe: EN ETSI 301 839-2

USA FCC 47 CFR Part 95; 95.601-95.673 Subpart E, 95.1201-95.1219

FCC ID: Y8L-MN20700-03

This device may not interfere with stations operating in the 400.150–406.000 MHz band in the

Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept

any interference received, including interference that may cause undesired operation.

Clinical Programmer System Overview

The Axium Clinical Programmer allows you to establish two-way communication with the patient's NS

device for querying and programming.

It is a portable, hand-held device that can be plugged into a power outlet or be powered by an internal

battery. The battery is rechargeable using the power supply provided and a power outlet.

The Clinical Programmer System includes:

• Clinical Programmer with Stylus

• Programmer Charger

• External Auxiliary Magnet

• Programmer Carrying Case

• Clinical Programmer User Manual (this document)

Stylus

Programmer Charger

Clinical Programmer Features

With the Clinical Programmer, you can:

• Turn OFF all stimulation.

• Turn stimulation ON for up to four leads and measure lead impedance.

• Change stimulation settings for each lead.

• Configure Patient Controlled Therapy settings for each lead.

• Enter patient and lead identification information, clinician and clinic name and contact information,

and clinician's notes.

• Create and name groups of stimulation sets with each group containing up to four leads with different

settings on each lead.

• Perform a real time trial (test) to assess the patient stimulation response for each lead.

• Acquire identification, diagnostic, and historic information about the NS device.

Clinical Programmer