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SYMBYX PDCare - Separate Power Supply Source; Essential Performance and Basic Safety; Temperature Range for Use; User Restrictions

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8
1.2 Separate power supply source (mains supply transformer)
Not used.
1.3 Essential performance and basic safety
The device does not have an essential performance, the absence of which may result in an unacceptable risk. Basic safety is
maintained when the device is stored, handled and operated in normal condition and in accordance with normal and intended use.
1.4 Temperature range for use
Discharge of batteries: 10 - 90 % atmospheric humidity at temperatures ranging from +5 - 30° C and air pressure of 700 - 1060 hPa.
1.5 User restrictions
Various safety features have been included and built into the design of the device. Failure to follow the instructions for the use,
transport and storage of the device can lead to battery fluid leakage, heat generation, fire or battery explosion. Failure to follow the
safety precautions and instructions for use may lead to a potentially dangerous exposure of the eyes (by intra-beam viewing at close
range). To prevent these situations from occurring, as well as to ensure safe use of the device, the safety precautions mentioned in
this manual should be strictly observed.
1.6 General caution and warning statements
WARNING: The use of controls, adjustments to the device, or performance of procedures other than those specified herein
may result in hazardous situations.” This warning intends to inform the operator that BASIC SAFETY may be compromised by not
using the device in its normal condition and in accordance with its normal use and intended use.
WARNING! No modification of this equipment is allowed.” This statement addresses the HAZARDS that can follow an
unauthorized modification of the ME EQUIPMENT, e.g. BASIC SAFETY may be compromised by a modification or an alteration of the
normal condition of the device.
2 Device description and use
This device is a transportable, hand-held, super-pulsed, near infrared, battery-operated medical laser product, with which the operator
administers non-invasive laser radiation to promote tissue repair. This device is intended to be used as a supplementary treatment

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