Medical Devices Medlight 630PRO User manual

MedlightTM
Effective Pain Therapy for the
Temporary Relief from Minor Pain
630PRO
Pain Therapy Device
Instructions for Use
Toensurethebestresultsandlongtermsatisfaction
withyourMedlight630PRO,werecommendthatyou
readthefollowingInstructionscarefullybeforeuse.
© 2018Medical Devices, Inc. Medlight 630PRO Operating Instructions and User’s
Guide Rev 5.5 April 1, 2018 P/N 1075-0042
MADEINUSA
Medical Devices, INC
Customer Service Department 4500
140th Ave. North
Suite 101
Clearwater, Florida 33762
Tel. [phone]
Fax. [phone]
e-mail:
[email protected]
web: www.mdevicesinc.com
© 2018 Medical Devices, Inc.

10
GSI
11528 53rd ST N
Clearwater, FL 33760
Office 727-451-7150
Fax [phone]
Medical Devices, INC
Customer Service Department 4500
140th Ave. North
Suite 101
Clearwater, Florida 33762
Tel. [phone]
Fax. [phone]
e-mail:
[email protected]
web: www.mdevicesinc.com
USA Distributor & Authorized Representatives:
© 2018 Medical Devices, Inc.

Warranty Replacement Procedure
Below is the procedure for replacing your Medlight 630PRO unit due to
defect in workmanship or materials within the one (1) year warranty period:
1. The Medlight 630PRO device must be returned with copy of
original purchase receipt and in original product packaging.
2. Call Medical Devices Customer Service at [phone]. The
Customer service representative will provide you with a Return
Merchandise Authorization (RMA) number and a return address.
3. The return shipment must be prepaid and the RMA number must
be displayed on the outside of the shipping container or the
shipment will not be accepted by Medical Devices, Inc..
Returns not in the original packaging will not be honored under the terms
of this warranty.
9
The MedLightTM 630 Pro was manufactured in the USA under license
from Life Without Pain, LLC. All rights to the MedLightTM 630 Pro were
acquired by Medical Devices, Inc. Medical Devices, Inc. will provide all
product support and Warranty management for units sold by Medical
Devices Inc. or any of its authorized distributors or resellers.
Customer Service and Technical Support
For all Customer Service and Technical Support issues including
warranty
returns and replacement parts please contact our Customer Support
Department at:
Medical Devices, INC
Customer Service Department
4500 140th Ave. North
Suite 101
Clearwater, Florida 33762
Tel. [phone]
Fax. [phone]
e-mail:
[email protected]
web: www.mdevicesinc.com
MADEINUSA FDACLEARED
2
Intended Use
Medlight 630PRO Pain Therapy Device is a hand held device used
for the treatment of chronic pain emitting energy in the Near-IR
spectrum for the temporary relief of minor muscle and joint pain,
arthritis and muscle spasm; relieving stiffness; promoting relaxa-
tion of muscle tissue; and to temporarily increase local blood circu-
lation.
Contraindications
There are no known contraindications for the use of the Medlight
630PRO.
Warnings
•Keep the Medlight 630PRO out of reach of young children who are
not able to read and understand the ‘Warnings’ and ‘Cautions’
listed below.
•Do not allow device to come in contact with water; contact with wa-
ter may cause electric shock.
•Do not use other Power Supplies or Car Adaptors with device. Using
other products may cause electrical shock or device failure.
•Do not exceed three (3) treatment cycles per session. Ex-
ceeding treatment cycles may cause excessive skin warming. This
may result in skin irritation or discomfort.
Cautions
•Do not block device fan vents by placing device under clothing, under
or betweens any body part(s) or with Velcro Strap. Blocking vent
may cause device to overheat and turn off.
•Do not look directly at the light source. The Medlight 630PRO emits
high intensity light and prolonged exposure of your eyes directly to
the light may cause discomfort. Use of the supplied goggles is rec-
ommended during facial treatments to reduce the intensity of the light
to your eyes.
•Do not allow the unit to come in contact with broken skin. The device
is not sterile and may cause infection. If necessary, cover the broken
skin with a bandage.
© 2018 Medical Devices, Inc.

Medlight 630PRO
Pain Therapy Device
(front/back view)
Power supply / Car Adapter
Power Supply Cord
Goggles Flexible Velcro Holding Strap
A. Contents of the Medlight 630PRO
B. Medlight 630PRO Detail
Power Supply Connection Fan Vent
Top Label
3
Fan Vent
Light Source
8
The instructions contained in this manual in no way represent a guarantee for
successful treatment. SEEK MEDICAL ATTENTION IF PAIN PERSISTS.
DO NOT discontinue your regular medication without consulting your doctor.
The Medlight 630PRO Pain Therapy Device will not eliminate disease that
causes pain.
Medical Devices, Inc. (MDI) warrants the Medlight 630PRO
device to be free from defects in workmanship and materials
under normal use for a period of one (1) year from the date of
purchase. MDI’s sole obligation under this warranty will be to
repair or replace (new or refurbished), at its option, the
Medlight 630PRO Unit that proves to be defective during the
warranty period. The foregoing shall be the sole remedy under
the warranty.
Except as set forth herein, MDI makes no warranties, either
expressed or implied, including the implied warranties of
merchantability and fitness for a particular purpose. No
warranty is provided if any Medlight 630PRO Unit is modified
without the express written consent of MDI.
This warranty is not assignable and is applicable only to the
original purchaser.
Replacement Parts
Please use the part numbers below when ordering replacement parts. Be
sure to use only Medlight 630PRO parts. Visit our website at
www.mdevicesinc.com for additional Product Information.
1075-0030 Power Supply
1075-0031 Power Supply Cord
1075-0033 Flexible Velcro Holding Strap
1075-0034 Car Adapter
1075-0038 Goggles
Limited Warranty
© 2018 Medical Devices, Inc.

7
Product Life Cycle
MEDLIGHT 630PRO product life cycle: 100,000 treatment cycles.
End of device life cycle will be demonstrated by L.E.Ds no longer
emitting light.
Environmental conditions for transport and storage:
Temperature range: Relative humidity range:
within -40°C to +70°C within 10% to 75%
Technical Specifications
14 cm2
650 nm
12
Treatment area:
Wave length of light emitted: Joules
per minute:
Joules per 4-minute treatment cycle:
50 mw per Square cm :
48
MEDICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK
FIRE AND MECHANICAL HAZARD ONLY
IN ACCORDAANCE WITH UL/IEC/EN 60601-1
And CANSCA C22.2 No. 601.1
0843
Degree of protection
against electric shock:
Type BF Applied Part
CLASSIFICATIONS PER UL/IEC/EN 60601-1
Class II
START STOP
Degree of protection against the ingress of water: IPXO
Attention, Consult
accompanying
documents !
USE
ONLY
WITH
P/N 1075-0030 AC Adapter—Rating 100-240VAC 50/60 Hz, 0.5-0.8 A
or P/N 1075-0034 Car Adapter—Rating: 12 VDC Nominal
4
Treatment Recommendations
Medical Devices, Inc. recommends the use of three, 4-minute treatment
cycles per session. During the first 4-minute treatment cycle your skin
temperature will rise to a therapeutic level. Continue two additional treatment
cycles to achieve optimal therapeutic benefit.
In general, Medical Devices, Inc. recommends two to three sessions
spaced throughout the day. However, treatment may be repeated as
often as needed.
Usage Tips
For minor muscle pain and/or spasm:
•Identify the location of pain and apply the device directly to area.
For joint pain and arthritis:
•Apply the device to the joint line
area where the two bones meet
(Fig. 1).
For hard-to-reach areas:
•A Flexible Velcro Holding Strap is
included with the Medlight
630PRO to provide hands free
operation during treatment. Insert
the device into the loop of the
strap being careful not to cover
fan vents (Fig 2 and 3).
Hold the LED light source over the treatment area and fasten the Velcro
holding strap to comfortably and securely hold the device in place.
Fig.1
Fig. 3
Fig. 2
© 2018 Medical Devices, Inc.

5
Operating Instructions
(Refer to page 3 for illustrations)
3. Hold the Medlight 630PRO over the
area to be treated.
1. Plug the power supply into the Medlight 630PRO power supply
connection, and then into a wall outlet.
4. The Medlight 630PRO has a built in
spacer lip that will help you maintain the optimal distance from the
treatment area. If using the Medlight 630PRO on intact skin, you may
place the device directly on your skin.
If using the Medlight 630PRO over broken skin, hold the device slightly
above the skin so that it does not come in contact with the broken skin.
When using the device correctly, you should feel a gentle warming of
your skin.
2. To operate, press the START button. A
Red light will be emitted from the light
source. If you desire to stop treatment before
the 4-minute cycle is complete press the
STOP button at any time.
5. The Medlight 630PRO treatment cycle is 4-minutes. Completion of the
treatment cycle is indicated by an audible alarm.
6. To achieve the desired pain relief, two additional 4-minute treatments
are recommended.
7. After treatment is complete, unplug the POWER SUPPLY CORD from
the wall outlet.
Wait Light
The Medlight 630PRO has an internal automatic temperature sensor
that will turn the device off and illuminate the Wait Light to prevent the
device from overheating. When the device has cooled to an acceptable
temperature the WAIT Light will turn off allowing the device to resume
treatment. (Please refer to “Cautions“ in Instructions for Use to help
prevent overheating of device.)
Fig. 4
6
International Use
The POWER SUPPLY included with the MEDLIGHT 630PRO is universal
input (100-240 VAC, 50/60 Hz) and can be used anywhere in the world.
User needs to supply appropriate plug-in adaptor.
Note: Data was collected from two subjects by performing three repetitive tests
on three different body parts using a digital thermometer with an insulated cover
attached to the skin of the subjects. The Medlight 630PRO was placed directly
onto the treatment site with the LED lights 1cm (depth of lip on Medlight
630PRO device) from the skin. Prior to the start of the test, subjects skin
temperature ranged from 94° F to 97° F.
FDA requires devices that use thermal energy to provide pain relief must
demonstrate the ability to generate temperatures of 40-42° C (1 04-107.6° F) at
the treatment site for a duration of 5-10 minutes.
Clinical Performance Data
Model MEDLIGHT 630PRO
Time (treatment cycle) 4 min (1) 8 min (2) 12 min (3)
Bicep skin temp. (°F) 103.9 106.0 107.8
Forearm skin temp. (°F) 104.1 106.9 108.0
Calf skin temp. (°F) 103.8 105.2 108.2
Maintenance
Clean the surface of the lens and body with a damp cloth only. Do not use
any type of solvent or other cleanser. To protect the Medlight 630PRO
mechanism, store at room temperature in a dry place, out of the reach of
children and in the original packaging when not in use. The MEDLIGHT
contains no user serviceable parts. Do not disassemble.
Problem Cause Solution
No red light emitted from
the light source. WAIT
light is illuminated.
Device
Overheating
Wait until WAIT light goes off
before resuming treatment
No red light emitted from
light source.
No Power to
device
* Check to make sure the
power supply is securely
plugged into the MedLight 630
Pro.
* Check to make sure the
power supply is securely
plugged into . the wall outlet.
© 2018 Medical Devices, Inc.