Neurolumen PN-1000 User manual

Instruction Manual
Neurolumen PN-1000
Please read all instructions before using the
Neurolumen Product
Caution: Federal Law (US) restricts this device
to sale by or on order of a physician.
Manufactured by Neurolumen, LLC:
9636 N. May Ave. #230. Oklahoma City, OK 73120
Phone: [phone] Fax: [phone]

2 0904900-00 Rev G 6/1/2011

Neurolumen PN-1000 Instruction Manual 3
Table of Contents
Key to Symbols...............................................................3
Device Description..........................................................4
Indications for Use..........................................................4
Contraindications............................................................4
Precautions ....................................................................5
Laser Safety Warning.....................................................7
Classification..................................................................9
Specifications .................................................................9
Electromagnetic Emissions...........................................10
Electromagnetic Immunity ............................................11
Operating Conditions....................................................12
Transportation and Storage Conditions ........................12
Components.................................................................12
Controls........................................................................13
Indicators......................................................................14
Instructions for Use.......................................................15
Maintenance and Care .................................................20
Troubleshooting............................................................21
Waste Disposal Considerations....................................22
Neurolumen Limited Warranty......................................22
Neurolumen Registration Card .....................................24
Key to Symbols
Attention: Consult Accompanying
Documents
(These instructions)
Type BF Patient Applied Part
Warning: Invisible Laser Radiation
Please see Page 7

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Device Description
The Neurolumen is a medical therapy device that delivers
Transcutaneous Electrical Nerve Stimulation (TENS) and
Low Level Laser Therapy (LLLT) to a patient’s body.
The Neurolumen consists of a control unit and wrap(s).
Each wrap contains two laser diodes, 4 light emitting
diodes, and one or two TENS gel pads. After applying
the wraps to the body, the control unit is able to provide
up to 30 minutes of therapy on a single charge of the
internal lithium-ion battery. A charger is provided for
recharging the internal battery.
Indications for Use
The Neurolumen is indicated for the temporary relief of
minor muscle and joint pain, arthritis and muscle spasm,
relieving stiffness, promoting relaxation of muscle tissue,
and to temporarily increase local blood circulation where
heat is indicated.
The Neurolumen is also indicated for the symptomatic
relief and management of chronic, intractable pain and
adjunctive treatment for post-surgical and post-traumatic
acute pain.
Contraindications
The Neurolumen is not indicated for the treatment of
undiagnosed pain syndromes until ethology is
established.

Neurolumen PN-1000 Instruction Manual 5
Warning: The Neurolumen should not be used by
patients who have demand-type cardiac pacemakers.
The safety of TENS devices for use during pregnancy or
birth has not been established.
Precautions
Please read all warnings before operating the
Neurolumen Device.
Environment
Warning:Do not use in or around water.
Warning: Do not use in an oxygen enriched
environment, or in the presence of flammable
anesthetic mixtures.
Warning: Do not use with high frequency surgery
devices at the same time.
Warning: Do not use near shortwave or
microwave devices.
Warning:Electronic monitoring equipment, such
as ECG monitors or alarms, may not operate
properly when TENS stimulation is in use.
Warning:To isolate the unit from mains power,
disconnect the wall adapter.
Application
Warning: Do not use TENS on face, head, or on
any damaged skin.
Warning: Do not use TENS near the thorax, as
this may increase risk of cardiac fibrillation.
Warning: Do not place wraps over necklaces,
rings, jewelry, or any other conductive metals.

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Warning: Do not apply wraps unless skin is free
of all liniments, salves, ointments, lotions, or oils.
Warning: This unit should not be used by children
without adult supervision. It should never be used
on infants.
Use
Warning: Use the controls and adjustments as
specified in this manual. Do not perform any
procedures other than those specified in this
manual.
Warning:Do not tamper with the Neurolumen in
any way. There are no serviceable parts inside.
Warning:Monitor the skin under the wraps
during use. While highly unlikely, burns can occur
regardless of control settings.
Warning:Do not look directly into the laser
diodes or light emitting diodes.
TENS is not effective for pain of central origin,
including headaches.
TENS devices should only be used under the
continued supervision of a physician.
TENS devices have no curative value.
TENS is a symptomatic treatment and as such
suppresses the sensation of pain which would
otherwise serve as a protective mechanism.
Warning: The TENS output contains a small DC
component. In order to avoid burns, use only
electrode pads supplied from Neurolumen. Burns
may result with the use of other pads.
Warning: Use only the approved charger
supplied by Neurolumen. Any other charger may
cause electric shock or battery damage.

Neurolumen PN-1000 Instruction Manual 7
Laser Safety Warning
The Neurolumen wraps contain class 3R Laser Diodes.
Do not look directly into the lasers, located where shown
below.
Laser
Diodes
Laser
Diodes
Single Wrap
Laser Location
Double Wrap
Laser Location
The Laser Diodes have the following beam divergence:
Beam Divergence
(FWHM)
Parallel
12 degrees
Perpendicular
40 degrees
The laser diodes are not adjustable or serviceable. A
failing wrap may only be replaced by Neurolumen LLC.
Please see part number listing in these instructions for
ordering replacement wraps.

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The Neurolumen unit contains the following Laser
Warning Labels:
Label
Location on Unit
INVISIBLE LASER RADIATION
AVOID DIRECT EYE EXPOSURE
CLASS 3R LASER PRODUCT
OUTPUT < 60mw, 808nm, CW
Complies with IEC 60825-1:2007
Bottom Side
Neurolumen
P/N 0904000-00
Max Voltage: 75VDC
Max Current: 100mA
Frequency: 2 Hz
S/N Barcode
Type BF
Applied Part Danger
Laser Radiation
0904180-00
Please See
Accompanying
Documents CONFORMS TO
UL STD 60601-1.
CERTIFIED TO CSA
STD C22.2 NO.
60601-1
XXXXXX
*A01000001*
Neurolumen, LLC
9636 N. May Ave Ste 230
Oklahoma City, OK 73120
405-463-6525
Bottom Side
Wrap cables

Neurolumen PN-1000 Instruction Manual 9
Classification
The Neurolumen is classified as a Class-II medical
device, with Type BF applied parts. The Neurolumen
does not provide any protection against the ingress of
water. The Neurolumen may be disinfected by wiping
with alcohol. The Neurolumen is not intended to be
operated in the presence of a flammable anesthetic
mixture.
Specifications
Unit
Model
Neurolumen PN-1000
Part Number
0904000-00
Battery
Lithium-Ion 3.6V
Charger
220/110 VAC, 50/60Hz input
9VDC 1.5A output
Laser Diodes
Quantity per wrap
2
Wavelength
808nm
Output Power
60mW
LEDs, Red
Quantity per wrap
2
Wavelength
660nm
Output Power
15mw
LEDs, IR
Quantity per wrap
2
Wavelength
940nm
Output Power
22mW
TENS (Load Impedance 500-550 ohms)1
Frequency
2 Hz
Output Current
100mA max
Pulse Voltage
75VDC max
Pulse width
100us biphasic
1. Operation above or beyond the specified impedance range may decrease
voltage / current output.

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Electromagnetic Emissions
Guidance and manufacturer’s declaration – electromagnetic emissions
The Neurolumen is intended for use in the electromagnetic environment
specified below. The customer or the user of the Neurolumen should assure
that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment -
guidance
RF emissions
CISPR 11
Group 1
The Neurolumen uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
The Neurolumen is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Complies
Warning: The Neurolumen was verified to be in
compliance with the above standards using the wraps
and charger supplied by Neurolumen, LLC. The use of
other cables or another charger may result in increased
emissions or decreased immunity of the Neurolumen
medical device.
Warning: The Neurolumen should not be operated while
stacked with other electronic equipment.

Neurolumen PN-1000 Instruction Manual 11
Electromagnetic Immunity
Guidance and manufacturer’s declaration – electromagnetic immunity
The Neurolumen is intended for use in the electromagnetic environment
specified below. The customer or the user of the Neurolumen should assure
that it is used in such an environment.
Immunity Test
IEC 60601
test level
Compliance
level
Electromagnetic
environment -
guidance
ESD
IEC 61000-4-2
± 6kV contact
± 8kV air
± 6kV contact
± 8kV air
Floors should be wood,
concrete, or ceramic tile.
If floors are overed with
synthetic material, the
relative humidity
should be at east 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 1 kV for power
supply lines
± 0.5 kV for
input/output lines
± 1 kV for
power supply
lines
± 0.5 kV for
input/output
lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage dips,
short
interruptions and
voltage variations
on
power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
<5 % UT
(>95 % dip in
UT) for 0,5
cycle
40 % UT
(60 % dip in
UT)
for 5 cycles
70 % UT
(30 % dip in
UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT) for 5 s
Mains power quality
should be that of a typical
commercial or hospital
environment.
If the user of the
Neurolumen requires
continued operation
during power mains
interruptions, it is
recommended that the
Neurolumen be powered
from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
N/A
Power frequency
magnetic fields should be
at levels characteristic of
a typical location
in a typical commercial or

12 0904900-00 Rev G 6/1/2011
hospital environment.
NOTE UTis the a.c. mains voltage prior to application of the test level.
Operating Conditions
0 to +39˚C (32 to 102.2˚F)
65 +/- 20% Relative Humidity
Transportation and Storage
Conditions
0 to +40˚C (32 to 104˚F)
65 +/- 20% Relative Humidity
Components
The following components may be part of your
Neurolumen equipment depending of purchased unit:

Neurolumen PN-1000 Instruction Manual 13
Controls
The Neurolumen contains 5 controls that make the unit
very easy to use and adjust. These are shown in Figure
1.
Figure 1: Neurolumen Controls
On/Off Control
The On/Off button turns the unit on and off. Pressing the
button when the unit is off will turn it on, and pressing the
button when the unit is on will turn it off.
Intensity
Control
Intensity
Control
Intensity
Control
Intensity
Control
On/Off

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Intensity Controls
The four Intensity controls adjust the strength of the
TENS pulse. The intensity of each TENS circuit can be
adjusted independently using these controls. Pressing
the up arrow on each control increases the intensity,
while pressing the down arrow decreases the intensity.
The numeric value of the intensity for each control is
displayed on the LCD screen, from 0 to 99. At 0
intensity, there is no TENS output.
Indicators
The Neurolumen contains several indicators that
communicate the various working conditions of the unit.
The indicators appear within the five buttons of the
device.
On/Off Indicator
OFF: When the On/Off button is not illuminated, the unit
is off.
GREEN: When the On/Off button is illuminated green, the
unit is on and functional.
GREEN BLINKING: When the On/Off button is
illuminated green and blinking, the battery is getting low.
YELLOW BLINKING: When the On/Off button is
illuminated yellow and blinking, the unit is charging the
battery by means of the external power supply.

Neurolumen PN-1000 Instruction Manual 15
YELLOW: When the On/Off button is illuminated yellow
and not blinking, the unit is fully charged and the power
supply can be disconnected.
RED: When the On/Off button is illuminated red, there is
a malfunction with the unit and it should not be used.
Intensity Control Indicators
OFF: When the intensity control for a particular wrap is
off, this indicates that the intensity is at 0, and there is no
TENS output.
YELLOW BLINKING: When the intensity control is
illuminated yellow and blinking, the TENS circuit
associated with that control has not detected current in
that circuit, indicating there is not good contact between
the gel pads and the skin.
YELLOW: When the intensity control is illuminated
yellow and not blinking, the TENS circuit has detected
current through the circuit and there is contact between
the gel pads. This is the normal operating condition.
RED: When the intensity control is illuminated red, there
is a malfunction in that wrap and it should not be used.
Contact Neurolumen for service.
Instructions for Use
Battery Charging
To charge the internal Lithium-Ion battery, connect the
power supply to the Neurolumen by inserting the charger
plug into the jack on the right side of the unit. Plug the

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charger into a wall outlet. While the battery is charging,
the On/Off button will blink yellow. The battery is fully
charged when the On/Off button stops blinking and is a
solid yellow.
It is possible to turn on the unit and use it while the
charger is plugged into the unit. In this case the On/Off
button will be illuminated green, indicating the
Neurolumen is on and functioning.
The amount of battery charge remaining is displayed on
the LCD screen. Each bar in the display represents 20%
of the battery capacity. At 20% capacity (1 bar), the
On/Off button will begin to blink green, indicating the
battery is getting low. Once the battery is discharged to a
point that may cause damage to the battery (3.0V), the
unit will power itself off to prevent further discharging.
The TENS pulse timing and amplitude and light output of
the wraps are not affected by the battery voltage in the
operational range.
Always ensure the battery is fully charged before starting
a therapy session.
Caution: Only use battery charger provided to
charge the Neurolumen.
Preparation
Attach gel pads to each wrap by removing the clear
plastic film from the side of the gel pad with the cross
hatch pattern. Place the gel pad into the cutout in the
wrap, cross hatch pattern side down, as shown in Figure
2. Repeat for all gel pads.

Neurolumen PN-1000 Instruction Manual 17
Place gel pads in
wrap cutouts
Figure 2: Place gel pads onto wraps
Remove the plastic film from the top of the two gel pads
on a single wrap. Press the foam portion of the wrap
and gel pads against the body, with the cord exiting the
top of the wrap. Holding the wrap in place, stretch the
fabric around the body part and back over the foam
portion, holding the wrap in place with the Velcro
fastener. Ensure that the wrap fits snugly in place,
without being uncomfortably tight.
If there are other wraps with your device repeat the
above steps.

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Figure 3: Correct Wrap Location
Connect the wrap cords to the control unit by inserting
the wrap plugs into the connectors on the back of the
control unit. Note: Double wraps have larger plugs and
connect to the two outside connectors. Single wraps
have smaller plugs and attach to the two inside
connectors. See Figure 4.
Note: Always turn unit OFF before connecting or
disconnecting plugs to/from the control unit.
Figure 4: Connecting wrap plugs to control unit

Neurolumen PN-1000 Instruction Manual 19
Operation
Turn the unit on by pressing the On/Off button. A green
illuminated button indicates the unit is on and functioning.
The control unit will turn on all lasers and
LEDs when the unit is on. Avoid direct eye
contact with the lasers or LEDs. It is
preferable to attach wraps to body before
turning unit on.
After several seconds, four digits will appear on the LCD
screen. These digits represent the intensity levels of the
TENS pulses. Pressing an intensity control on the up
arrow will increase the intensity, while pressing the
control on the down arrow will decrease the intensity.
Intensity ranges are from 0 to 99.
Each intensity control will be illuminated yellow for an
intensity above 0. A blinking control indicates a poor
electrical connection between gel pads. A solid control
indicates good electrical contact between gel pads. If a
control is blinking, adjust the wrap so that the gel pads
are in good contact with the skin.
Adjust the intensity of each wrap to a comfortable level.
A few seconds after the intensities have been adjusted,
the LCD screen will display the therapy session timer and
the battery fuel gauge. Once the timer counts down to
00:00, the unit will shut itself off automatically.

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Figure 5: Therapy Session Timer
Removal
Once the therapy session has completed and the unit is
off, remove each wrap one at a time, placing the clear
plastic covers over each gel pad. Plug the charger into
the control unit in preparation for the next therapy
session, or return the unit to its carrying case.
Maintenance and Care
The control unit may be wiped clean with a damp
cloth or alcohol. Do not submerge unit in water.
The gel pads may be cleaned with alcohol. They
may be reused many times. Replace the gel pads
when they become un-sticky.
Replace the clear film covers over the gel pads
when not in use. This will prevent dust and lint
from contaminating the gel pads.
Do not expose the Neurolumen control unit and
wraps to direct sunlight, high temperatures, and
high humidity.