Microflow-S pocket Doppler User’s Documentation This document contains all information on the Atys MICROFLOW S devices manufactured by Atys. Information in this document is subject to change without notice and does not represent a commitment on the part of Atys.
Microflow-S pocket Doppler User’s Documentation Symbols Device DEEE Directive Separate collection for 2012/19/UE Electrical Electronic Equipment General medical device CE mark with number of the Directive 93/42/EEC Notified body 04959 ISO7000-434 Consult accompanying documents. IEC60417-5077 HEADPHONES IEC60417-5333 Applied part type BF...
Microflow-S pocket Doppler User’s Documentation Essential performance Main performances are: Doppler sound Detection of flow/backflow for peripheral arteries using LED’s. Loss or alteration of performance for these 2 items cannot result in injury. Then there is no essential performance for this device documentation...
S, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. The Microflow-S emits electromagnetic 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...
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Microflow-S is used exceeds the applicable RF compliance level above, the Microflow-S should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Microflow-S.
Microflow-S pocket Doppler User’s Documentation Operating Theory of operation The 4 MHz and 8 MHz transducers are used to examine the arteries and veins of the upper and lower limbs as well as to examine the vessels supplying the brain, enabling vascular disease to be evaluated quickly and easily.
Microflow-S pocket Doppler User’s Documentation Do not immerse the probe casing. Do not clean the probe with acetone, ethyl alcohol or sodium hypochlorite (bleach) as this will damage the surface Avoid any cleaner that may scratch or dissolve plastic surface High level disinfection using liquid agent.
Microflow-S pocket Doppler User’s Documentation Test Connect a new battery. Switch on the unit: all the leds must switch on and then off. Activate the probe: a clear sound should be eared. Keyboard: does the sound volume control work? ...
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Microflow-S pocket Doppler User’s Documentation DECLARATION OF CONFORMITY / DECLARATION DE CONFORMITE Directive 93/42/EEC / Directive 93/42/CEE Manufacturer’s Name: Atys Nom du fabricant : Manufacturer address: 17 Parc d’Arbora Adresse du fabricant : 69510 SOUCIEU EN JARREST, FRANCE Product name:...
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