Product information
PATIENT CONTACT MEDICAL DEVICE
The PFG560 instrument is classified as a Patient Contact [Type BF] medical device. The use of a Patient Contact medical device is described as; “used for applied parts that have conductive long-term contact with the patient.”
MANUFACTURING STANDARDS
ThePFG560is manufactured at a facility that is ISO 9002 certified. This provides the client with the assurance that they receive a product that is manufactured using the highest manufacturing standards.
UNPARALLED SAFETY STANDARDS
To meet all safety standards the PFG560 is designed with a power supply that observes the following safety standards: IEC/BS EN/EN60601-1 and ANSI/AAMI ES60601-1 version three with 2XMOPP level.
WHY A MEDICAL APPROVED POWER SUPPLY?
International safety standards require that all devices plugged into the mains power and at the same time have conductive contact with humans, must conform with the highest safety standards.
WHY AN INTERNAL POWER SUPPLY?
An internal power supply prevents the client from accidentally using an external, non-approved, power supply that will compromise safety.
CAN THE PFG560 BE USED INTERNATIONALLY?
The internal power supply enables the PFG560 to be used in all countries.
International mains voltage ranges from 110 to 240 Volts worldwide. The internal power supply of thePFG560 can accommodate a wider range of input voltages, namely 80 ~264VAC.
WHY DOES THE PFG560 USE LI-POLYMER BATTERY TECHNOLOGY?
The internal Li-Polymer battery provides for a minimum of 5 hours of operation while unplugged from the mains power. It charges automatically when the PFG560 is connected to the mains power. High-end cell phones use the same battery technology because of its excellent reliability and long service life.
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