Microflow-S pocket Doppler
User’s Documentation
20 174 C
Page 7/12
5
Standard and regulation
5.1 Quality management
The product is designed produced and serviced in compliance with ISO13485 requirements.
5.2 Regulation
EC: Class IIa
CE 0459
The package must be wasted according the national regulations.
The device must be wasted according the national regulations.
Do not waste the MICROFLOW-S and its accessories. They can be partially recover and re-used.
5.3 Safety and performance
The device is compliant with IEC60601-1 2005/A1:2012 international standard of safety.
Safety class:
Class Internally powered
Applied parts: Doppler probes are BF type.
Mechanical protection index: IP20.
Water leak tightness height of the Doppler probes: 20 mm.
5.4 Ultrasound
Devices are compliant with IEC60601-2-37.
Ultrasound data on probes, TIB and TIS not require to be displayed. (Below the limit)
5.5 Usability
The usability is processed in compliance with IEC60601-1-6
5.6 Risk management
The risk management is processed in compliance with ISO14971
5.7 Electromagnetic compatibility
The
Microflow-S
has been designed to work normally in conditions specified by the international standard
IEC60601-1-2: 2014
Information 1
Refer to the essential performance on this document.
Information relative to the A class limitation
The
MICROFLOW S
emits electro-magnetic perturbations in ultrasound probe working frequencies,
fundamental and third harmonics.
The effects result from the high voltage and high frequency emission pulses.
These perturbations do not allow to be compliant to the B class in every configuration
Table 1
Manufacturer’s Declaration
–
Electromagnetic Emissions (IEC60601-1-2)
The
Microflow-S
is suitable for use in the specified electromagnetic environment. The customer and/or user should
assure that it is used in an electromagnetic environment as described below;
Emission Test
Compliance
Compliance Electromagnetic Environment
RF emission
CISPR 11
Group 1
The
Microflow-S
must emit electromagnetic energy in order to perform its
intended function.
Nearby electronic equipment may be affected.
