Activeforever Medlight 630 Pro Near Infrared Light Therapy Device - Manual (Page 4)

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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

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.
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.
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.
Pg6
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
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Technical Specifications
Treatment area: 14 cm2
Wave length of light emitted: 630 nm
Joules per minute: 12
Joules per 4-minute treatment cycle: 48
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%
0843

MEDICALEQUIPMENT
WITHRESPECTTOELECTRICALSHOCK
FIREANDMECHANICALHAZARDSONLY
INACCORDANCEWITHUL/IEC/EN60601Ͳ1
AndCANCSAC22.2No.601.1
Pg7
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Technical Specifications
Treatment area: 14 cm2
Wave length of light emitted: 630 nm
Joules per minute: 12
Joules per 4-minute treatment cycle: 48
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%
0843

MEDICALEQUIPMENT
WITHRESPECTTOELECTRICALSHOCK
FIREANDMECHANICALHAZARDSONLY
INACCORDANCEWITHUL/IEC/EN60601Ͳ1
AndCANCSAC22.2No.601.1
Pg7