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Describes the PDCare 904 nm laser as a transportable, hand-held, non-invasive Class IIa active therapeutic device.
States that the separate power supply source (mains supply transformer) is not used with the device.
Asserts that the device maintains basic safety under normal conditions and intended use.
Specifies operating temperature range for batteries: +5 - 30° C with 10-90% humidity.
Warns against misuse and failure to follow instructions, which can lead to hazards.
Provides general warnings about hazardous situations from improper use or modification.
Explains the point-by-point application procedure, audible/visual signals, and contact with skin.
Discusses risks like misuse, intra-beam viewing, and dazzling effects from Class 1 lasers.
Illustrates the device with views (side, front, top, back, bottom) and labels components.
Directs to Chapter 7.4 for battery replacement instructions.
Provides a table with treatment parameters like wavelength, output power, time, and energy.
Details the intended use for reducing pain, inflammation, and promoting tissue repair.
Describes application on skin and warns against use on eyes/eyelids.
Defines ordinary and patient operators and their roles.
Specifies indoor operating environment conditions: temperature, humidity, air pressure.
Provides a table detailing treatment time per body part for pain/inflammation.
Recommends a treatment interval of approximately every 48 hours.
Lists contraindications, primarily treatment of the eye.
Discusses potential transient pain, tiredness, and the need for caution with first-time treatments.
Outlines responsibilities for device care, document management, and ensuring proper use.
Defines the responsibilities of the organization overseeing the device and operator.
Advises on patient position and cautions for specific conditions like hyperthyroidism.
Warns against using damaged devices or suspecting faults, advising contact with the supplier.
Lists precautions for high temperatures, liquids, humidity, children, and fire.
Covers safe handling, storage, protective eyewear, intra-beam viewing, and maintenance.
Discusses output power maintenance, checks, and contacting the supplier for calibration.
Outlines procedures for cleaning and disinfecting the device before use.
Details a table for visual inspections, potential problems, and actions to take.
Explains how the laser emits and stops radiation based on skin contact and signals.
Describes the ON/OFF switch and the meaning of the Green LED indicator.
Lists detailed technical specifications like laser type, wavelength, output power, and laser class.
Reproduces legible labels and hazard warnings affixed to the device.
Shows symbols and markings found on the product's package label.
Instructs on reporting serious incidents to the manufacturer and authorities.
Provides guidance and declaration regarding the device's electromagnetic emissions.
Details guidance and declaration for electromagnetic immunity of the device.
Specifies separation distances for RF communications equipment to maintain EMC.
General| Brand | SYMBYX |
|---|---|
| Model | PDCare |
| Category | Medical Equipment |
| Language | English |
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