9. LABELING
The labeling supplied with the device contains the following information
•
Date of Manufacture
•
Item Number, Batch Code and Serial Number
•
Operating Environment
•
Manufacturers Information
Please refer to Section 12 (Explanation of Symbols).
10. RECYCLING
This symbol means that this product shall not be disposed of with
normal household waste (2012/19/EU).
We advise you to take your product to an official collection point to have a professional
dispose of the product correctly. Follow your country’s rules for the separate collection
of electrical and electronic products. Correct disposal helps prevent damage to the
environment and human health.
11. TECHNICAL SPECIFICATION
•
Model Number (REF): TN2118
•
Program Time: 10 minutes fixed
•
Wavelengths: 415nm, 633nm and 830nm +/- 10nm
•
Maximum Output Intensity: Blue/Red 44 mw/cm2, Red/NIR 29 mw/cm2
•
Operating Temperature: 5°C to 30°C
•
Operating Humidity: 15% to 90% without condensation
•
Operating Atmospheric Pressure Range of 700 hPa to 1060 hPa
•
Storage and Transport Temperature: -25°C to +5°C and +5°C to +35°C at a relative
humidity up to 90% condensing, > 35°C to 70°C at a water vapor pressure up to 50 hPa
•
Storage and Transport Humidity: 20% to 90% without condensation
•
Electrical Input to Power Adaptor: 100v-240v. 50/60Hz. Rated at 0.7A.
•
Electrical Output from Power Adaptor: 12V, 1A
•
IP22
12. EXPLANATION OF SYMBOLS
There are several safety warning-labels on the Shani Darden LED Light Therapy MaskT
M
,
Controller, user guide and packaging. Use this guide to interpret them.
This symbol on the device label indicates that caution is necessary.
Failure to follow Warning or Cautions may lead to an undesirable outcome.
This symbol on the device label means read the user manual before you start
using the device.
This symbol means that the Shani Darden LED Light Therapy Mask
TM
is specified as
applied part type BF, indicating that it is used on the body and has some conductive
contact.
This symbol means that the device may be used multiple times by a single patient.
This symbol means the Shani Darden LED Light Therapy Mask
TM
conforms to certain
EC Regulations /Directives on health, safety, and environmental protection standards.
CE stands for ‘Conformité Européenne’.
This symbol means “Manufactured by” and provides the name and address of the
legal manufacturer.
This symbol indicates input for the power supply (wall outlet) and that the device
may only be powered with the adapter that is supplied in the package. Usage of
other adapters may not be safe and could lead to electrical shock. The adapter has
the following electrical specification: Electrical Input to Power Adaptor: 100v-240v.
50/60Hz. Rated at 0.7A. Electrical Output from Power Adaptor: 12V, 1A.
This symbol means keep dry.
This symbol indicates the serial number of the device.
This symbol refers to the catalogue number for the Shani Darden LED Light Therapy
Mask
TM
.
This symbol refers to the batch code of the Shani Darden LED Light Therapy Mask
TM
.
This symbol refers to the unique device identifier; an internationally recognized way
of marking and identifying medical devices within the healthcare supply chain.
This symbol indicates the product is a medical device.
This symbol means the product is made in China.
This symbol means keep the device away from direct sunlight.
This symbol means the upper and lower operating temperatures that the Shani
Darden LED Light Therapy Mask
TM
can be safely used at.
This symbol means the upper and lower operating humidity that the Shani Darden
LED Light Therapy Mask
TM
can be safely used at.
This symbol means that the cardboard packaging that the Shani Darden LED Light
Therapy Mask
TM
came in can be recycled.
This symbol means that the device is protected against solid objects over 12.5mm
in diameter (such as fingers) and vertical water droplets when the device is tilted
150C.
This symbol means that this product shall not be disposed of with normal household
waste (2012/19/EU).
Importer (EU only)
Distributed by
15
16
SN
REF
LOT
UDI
MD
CN
IP22
EN
