Nalu Medical 34001-001 Nalu ETM 34001-001 User Manual 1

Nalu Medical Inc Nalu ETM 34001-001 1

User Manual

Instructions For Use Version A, Dated 8 June 2017
1 of 14
NALU MEDICAL INC
EXTERNAL TRANSMITTER MODULE (ETM)
INSTRUCTIONS FOR USE
Instructions For Use Version A, Dated 8 June 2017
2 of 14
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
Instructions For Use Version A, Dated 8 June 2017
3 of 14
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:
Instructions For Use Version A, Dated 8 June 2017
4 of 14
Figure 1 Nalu SCS System Components
Instructions For Use Version A, Dated 8 June 2017
5 of 14
Figure 2 ETM in Clip
Implantable Neuro Stimulator (INS): INS is implanted in the body and connects to
leads in the epidural space. The INS derives power wirelessly through body tissue
from ETM.
External Transmitter Module (ETM): Is worn outside the body that delivers power to
the INS and controls the stimulation parameters.
ETM Clip: is attached to body by adhesive and is used to securely wear the ETM.
Charger: consists of an AC adapter and cradle that is used to charge the ETM
battery when not in use.
2 Intended Use
The Nalu ETS System is intended as the sole mitigating agent, or as an adjunct to other
modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the
trunk and/or lower limbs, including unilateral or bilateral pain.
3 Precautions
Remove the ETM prior to the following procedures
Diagnostic imaging such as X-Ray, CT, MRI or PET scans
Diathermy
Cardiac Defibrillation
Hyperbaric Chambers
Instructions For Use Version A, Dated 8 June 2017
6 of 14
Electronic Article Surveillance (EAS) Systems
4 Potential Adverse Effects and Complications
A list of side effects that may occur during use of the ETM:
Undesirable changes in stimulation sensation and/or location with or without patient
movement.
Undesirable changes in stimulation sensation and/or location when passing through
metal detectors, library scanners, airport scanners, etc.
Skin irritation or allergy
5 ETM User’s Guide
5.1 User Interface
The ETM User Interface (UI) consists of:
Push button to turn stimulation ON/OFF
Up (+) and down (-) push buttons to increase and decrease stimulation
levels respectively
Tri-color LED for status (Green, Orange, Blue)
Buzzer for status
Figure 3 ETM Button Layout
5.2 Turning ON the ETS and Starting Stimulation
Instructions For Use Version A, Dated 8 June 2017
7 of 14
To start stimulation, press and release the stimulation ON/OFF button. Stimulation
will start with the last used program.
5.3 Turning Stimulation OFF
Press and hold the stimulation ON/OFF button to turn the unit off.
5.4 Changing Stimulation Level
Changing stimulation levels requires that stimulation is turned on. Press and release
the up (+) button to increase stimulation. Press and release the down button (-) to
decrease stimulation. If the maximum or minimum stimulation levels have been
reached a beep will sound and the orange LED will blink rapidly (if they are enabled
during programming).
5.5 Changing Program
With the unit turned on, press and release the program button to change programs.
The ETS can have up to 4 programs. Upon program change the green LED will
blink to indicate the program number.
1 blink indicates program 1
2 blinks indicates program 2
3 blinks indicates program 3
4 blinks indicates program 4
Once the desired program is selected, press the On/Off button to start it. If only one
program is stored on the ETM pressing the program button has no effect. Press the
stimulation ON/OFF button to restart stimulation.
5.6 ETM Battery charging and status
ETM has an internal battery that provides power the unit. This battery is not user
replaceable or user serviceable. To charge the battery use the provided charging cradle.
5.6.1 Battery Status Indication
At start up the battery status is indicated by the orange LED:
1 blink indicates 0%-30% capacity
2 blink indicates 30%-60% capacity
3 blink indicates 60%-100% capacity
5.6.2 Low Battery
When the battery is low the orange LED will blink at a slow rate and a beep will sound if it
is enabled during programming.
5.6.3 Charging the ETM
The ETM system utilizes internal rechargeable batteries to power the device. A charging
station is provided for recharging the unit. The charging station requires the included wall
charger to micro-USB cable for power.
Instructions For Use Version A, Dated 8 June 2017
8 of 14
Plug the wall charger into a standard 120V AC outlet (or internationally compatible
240V AC outlet).
Plug the attached micro-USB connector into the micro-USB port on the charging
station.
Figure 4 AC wall charger
Place the ETM into the charging station, making sure that ETM is aligned with
mating pins on the charger.
Figure 5 Inserting ETM unit into charging station
Once seated, observe the LED indicator for the charging status. It takes
approximately 3 hours to fully charge the unit.
5.6.4 ETM Charging Status
The charging station features an LED indicator that provides battery charging information:
Orange Light ETM is inserted properly and is currently being charged.
Instructions For Use Version A, Dated 8 June 2017
9 of 14
Green Light The ETM is fully is charged and can be removed for use.
Flashing Orange Light remove the device and reinsert. If flashing orange indicator
continues to flash, remove the device and do not attempt to use it. Contact Nalu
Medical for a replacement unit.
5.7 Cleaning and Care
When necessary clean the device with damp cloth. Mild soap or detergent may be
used if needed.
Do not drop, strike or step on the device.
Do not try to open the device. There are no user accessible or serviceable parts in
the device.
Keep the charging contacts clean and void of any deposits.
Keep the device away from children and pets.
The ETM should not be exposed to extreme temperatures (outside of 0 50 °C
range) or pressures.
5.8 Troubleshooting
Stimulation is too strong.
Decrease the amplitude by pressing
the decrease “-” button. Repeat the
button press until desired stimulation
is reached.
Stimulation is too weak.
Increase the amplitude by pressing
the increase “+” button. Repeat the
button press until desired stimulation
level is reached.
Sudden unexpected changes in
stimulation level.
Use the amplitude increase/decrease
buttons to adjust the stimulation
level.
Device does not turn on, when
power button is pressed.
Battery might be depleted. Charge
the device and try again once fully
charged.
No therapy is being provided.
Device might have been
inadvertently turned on. Turn on the
device by pressing the On/Off button.
Amplitude might be too low. Increase
the amplitude by pressing the +
button.
Check if the clip and ETM is placed
within required range of implant.
Refer to clip manual for proper
placement instructions.
Yellow light flashes while charging
and device fails finish charging.
Stop using the device. Remove from
the charger and contact authorized
Instructions For Use Version A, Dated 8 June 2017
10 of 14
service personal.
6 Technical Specifications
6.1 Specifications
75mm Diameter, 8mm thickness
75 gms
0 to C
-10 to 50C
20% to 90%
IP-67
120-240V, 50-60Hz AC
40.68 MHz
40 KHz
AM
2.402 GHz
2AMB3-34001-001
2AAQS-ISP1507
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.
Any changes/modifications to this equipment not approved by Nalu Medical Inc could void the
user’s authority to operate the equipment.
6.2 Stimulation Parameters:
Parameter
Range
Frequency
1Hz - 10kHz
Pulse Width
10µsec 2ms
Amplitude
0µA - 10.2mA
7 Contact Information
Nalu Medical Inc
1525 Faraday Ave
Carlsbad, CA 92008
United States
Phone: 760-448-2360

Navigation menu