Nalu Medical 34001 001 User Manual

Instructions For Use Version A, Dated 8 June 2017

NALU MEDICAL INC

EXTERNAL TRANSMITTER MODULE (ETM)

INSTRUCTIONS FOR USE

1 of 14

Instructions For Use Version A, Dated 8 June 2017

Contents

1 Device Description ........................................................................................................... 3

1.1 Components of the Nalu SCS System: .................................................................. 3

2 Intended Use .................................................................................................................... 5

3 Precautions ...................................................................................................................... 5

4 Potential Adverse Effects and Complications ................................................................... 6

5 ETM User’s Guide ............................................................................................................ 6

5.1 User Interface ........................................................................................................ 6

5.2 Turning ON the ETS and Starting Stimulation ....................................................... 6

5.3 Turning Stimulation OFF ....................................................................................... 7

5.4 Changing Stimulation Level ................................................................................... 7

5.5 Changing Program ................................................................................................ 7

5.6 ETM Battery charging and status .......................................................................... 7

5.6.1 Battery Status Indication ............................................................................. 7

5.6.2 Low Battery ................................................................................................. 7

5.6.3 Charging the ETM ....................................................................................... 7

5.6.4 ETM Charging Status.................................................................................. 8

5.7 Cleaning and Care ................................................................................................. 9

5.8 Troubleshooting ..................................................................................................... 9

6 Technical Specifications ................................................................................................ . 10

6.1 Specifications ...................................................................................................... 10

6.2 Stimulation Parameters: ...................................................................................... 10

7 Contact Information ........................................................................................................ 10

2 of 14

Instructions For Use Version A, Dated 8 June 2017

1 Device Description

The Nalu Spinal Cord Stimulation (SCS) system consists of External Transmitter Module
(ETM), Implantable Neuro Stimulator (INS), ETM clip and ETM charger.

The INS is intended to provide relief from chronic pain by electrically stimulating the spinal
cord. The INS is implanted in the body and derives its power wirelessly from the ETM,
which is worn on the body using a clip. The ETM is a portable, body-worn, battery-powered
device, which delivers power and various stimulation parameters and programs to INS.
The instructions provided herein refer to model Nalu ETM.

1.1 Components of the Nalu SCS System:

3 of 14